bioihbjkbjnl/mcl2 huggingface dataset:
A Dose-escalation Study in Subjects With Pulmonary Arterial Hypertension (PAH)
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK2586881, a purified intravenous (IV) formulation of soluble recombinant human Angiotensin
      Converting Enzyme (rhACE2) is being investigated as a treatment for PAH. This GlaxoSmithKline
      (GSK) study will evaluate the safety, tolerability, pharmacokinetics (PK) and
      pharmacodynamics (PD) of GSK2586881 in subjects with PAH. This open-label, dose-escalation
      study will comprise of 4 separate groups based on the planned dose range, and subjects in
      each group will be administered a single dose of GSK2586881 ranging between 0.1, 0.2, 0.4 and
      0.8 milligram per kilogram (mg/kg) via IV route. Dose escalation will occur after 4 subjects
      have been dosed per cohort and review of safety, tolerability, PK and hemodynamic data up to
      24 hours post dose has taken place. A maximum of 27 subjects will be included in the study
      and the total duration of the study will be up to a maximum of 59 days.
    


Intervention name(s): GSK2586881
Intervention type(s): Drug
Intervention description(s): GSK2586881 is a clear colorless liquid for IV infusion over 3- 5 minutes and will be administered a maximum dose of 0.8 mg/kg.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension; Dose-escalation; Safety; Tolerability; GSK2586881
A Multiple Ascending Dose Study to Investigate Safety of KBP-7072 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, placebo-controlled, multiple oral dose study to evaluate safety,
      tolerability, and pharmacokinetic of KBP-7072 in healthy subjects.
    

Detailed description: 
      This was a double-blind, randomized, placebo-controlled, parallel-group, multiple oral dose
      study. Overall, a total of 24 subjects were studied in 3 groups (Groups 1 to 3); with each
      group consisting of 8 subjects (6 subjects receiving KBP-7072 and 2 subjects receiving
      placebo). Groups 1 and 2 evaluated 100 and 200 mg QD, respectively. The dose level of 150 mg
      QD evaluated in Group 3 was determined based on data obtained from Group 2 of this stud
    

Intervention name(s): KBP-7072; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): QD oral capsules; matching placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: KBP-7072; Multiple ascending dose; Healthy Subjects; Antibiotics; Tetracycline
Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®)
Condition: Anemia; Deficiency Diseases; Anemia, Iron Deficiency; Hematologic Disease; Iron Metabolism Disorders
MeSH terms: Anemia; Anemia, Iron-Deficiency; Hematologic Diseases; Iron Deficiencies; Metabolic Diseases; Deficiency Diseases; Iron Metabolism Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.
    

Detailed description: 
      IDA is highly prevalent in subjects with cancer and gastrointestinal diseases such as
      inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone
      bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on
      the subjects, and treatment of these subjects includes controlling the bleeding and
      replenishing lost iron.
    

Intervention name(s): Iron Isomaltoside
Intervention type(s): Drug
Intervention description(s): The trial is a dose escalating trial.
Other intervention name(s): Monofer
Intervention MeSH terms: Iron isomaltoside 1000
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
Condition: Lateral Epicondylitis; Tennis Elbow
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Lateral epicondylitis (LE), or tennis elbow, is a common and often disabling condition
      affecting young and middle-aged adults-most commonly manual workers and recreational
      athletes. It results in significant pain and disability, limiting work productivity and an
      individual's ability to participate in and enjoy recreational activities. Like many other
      chronic musculoskeletal conditions LE often shows an incomplete response to acute treatments,
      leading to chronic pain and disability. Prolotherapy (PrT) involves the injection of an
      irritant or proliferant solution into tendons, ligaments, and joints to treat chronic
      musculoskeletal pain. We will be conducting a 3-group randomized, blinded trial to determine
      the safety and efficacy of PrT injections in the treatment of chronic LE. Additionally, we
      will seek to determine to what extent any beneficial effect of PrT is derived from deep
      needle placement vs. a specific effect of the injectate. The specific aims for this study
      are: 1) to determine if PrT is a safe, well-tolerated, and effective treatment for
      individuals with chronic LE; and 2) to determine whether the deep needle placement alone is
      responsible for the therapeutic effect, independent of injectate. In order to accomplish
      these aims, we will measure indicators of pain and disability using self-rating scales,
      questionnaires and physical measures. Subjects will be stratified prior to randomization on
      two factors: 1) unilateral vs. bilateral LE; and 2) treatment with steroids within the prior
      6 months. If effective, subjects receiving PrT will show greater reduction of pain and
      functional impairment compared with the other two groups. This research will guide future
      studies on prolotherapy by determining what may be the best control condition. Additionally,
      further studies may explore the mechanism responsible for any beneficial effect.
    

Detailed description: 
      Same
    

Intervention name(s): Prolotherapy; Placebo
Intervention type(s): Drug; Procedure
Intervention description(s): Injection of 15% dextrose with lidocaine at the lateral epicondyle; Saline/lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lateral epicondylitis; Tennis elbow; Prolotherapy
Fluoride Varnish Community Trial
Condition: Dental Caries; Oral Disease; Costs
MeSH terms: Dental Caries; Mouth Diseases
Study type: Interventional

Summary: 
      This cluster-randomized controlled community trial aimed to assess the efficacy and costs of
      fluoride varnish application for caries prevention in a high-risk population in South Africa.
    

Detailed description: 
      Despite advances in oral health, dental caries remains a significant problem - particularly
      in disadvantaged communities in low- and middle-income countries. A study in the Western Cape
      Region, which was conducted between 2001 and 2015, reported for example a caries prevalence
      of 84% for 6-years-old (Smit 2017), highlighting the need for oral health programs and
      cost-effective interventions. Fluoride varnish offers hereby a feasible possibility to
      supplement toothbrushing programs in order to improve fluoride delivery and consequently
      caries prevention. However, many studies failed to confirm the benefits of fluoride varnish
      for caries prevention, which may partially be explained by the fact that many of these
      studies were conducted in high-income countries, in which the caries increment is low due to
      a wide access to fluoride.

      This study, thus aimed to further validate the benefits of fluoride varnish application
      specifically in a primary school setting within a peri-urban, low socio-economic, high-caries
      risk community in South Africa.
    

Intervention name(s): Flairesse varnish
Intervention type(s): Device
Intervention description(s): Flairesse is applied to enamel and dentine as protective varnish to prevent caries formation and to promote remineralization of initial caries. It is also used in the treatment of hypersensitive teeth by sealing dentin tubules and hypersensitive areas at the neck of the tooth and exposed root dentine. Flairesse varnish contains xylitol and fluoride (22,600 ppm). Both components have been well established for oral health by reducing caries prevalence and incidences.
During the application, children sat upright; their teeth were first cleaned and dried with cotton wool rolls. After mixing the fluoride varnish, it was applied as a thin layer to all surfaces of the lower and upper dentition, including proximal surfaces (using floss in case of tight contact points) as well as pits and fissures (using a small brush that was provided together with the varnish by the manufacturer). Children were advised not to drink or eat directly after the application, while this could not be controlled.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Children in the reception grade and grade 1 of two schools in a township in South Africa are class-wise cluster-randomized to the fluoride varnish or control groups.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Caries; Fluoride Varnish; Dental Health; Costs
The Growth and Development of Breast and Formula Fed Term Asian Infants
Condition: Growth
Study type: Observational

Summary: 
      Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta,
      Indonesia
    


Intervention name(s): Breastfeeding; Infant formula
Intervention type(s): Other; Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy infants recruited from Jati Padang, Pasar Minggu District, South Jakarta, Indonesia
      
Biospecimen description: 
      Faecal samples
    
Keywords: Prospective observational study; Breast feeding; Infant formula; Infant; Indonesia
A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the effect of MK0859 when administered alone and when in
      combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in
      Japanese patients with dyslipidemia.
    

Detailed description: 
      This is the dose ranging study to evaluate efficacy and safety of MK-0859 in Japanese
      patients.

      Eligible patients were assigned to 1 of 10 treatment groups (including treatment groups with
      or without administrative atorvastatin) for an 8-week treatment period which was followed by
      a 8-week reversibility period.

      As an additional follow-up, the pregnancy information from women of childbearing potential
      who were treated with MK-0859 in this study will be collected retrospectively for a period of
      4 years after the last dose of MK-0859.
    

Intervention name(s): anacetrapib; Comparator: atorvastatin; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks; atorvastatin tablet, 10mg, once daily for 8 weeks; Placebo tablet, once daily for 8 weeks
Other intervention name(s): MK0859
Intervention MeSH terms: Atorvastatin; Anacetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Rate of Leg Curl to Leg Press During Isokinetic Testing
Condition: Muscle Strain
Study type: Interventional

Summary: 
      The functional condition of the leg muscles is not only relevant to performance in sports,
      but is also of great importance in health, prevention and rehabilitation, where not only the
      general strength level is decisive but also the relationship between individual muscle
      groups. Among other things the H-Q-ratio (strength ratio of "hamstring" muscles to quadriceps
      muscles) is often used to diagnose possible imbalances. Isokinetic force measurements have
      established themselves as the gold standard in competitive football. In this context,
      however, force tests in the open kinetic chain (OKC) have almost exclusively been used so
      far. Especially force measurements in the closed kinetic chain (CKC) could have a higher
      relevance regarding functionality. The H-Q-ratio should better be called the flex-ext-ratio
      in the CKC due to the involvement of the hip muscles. There is little data in the literature
      on leg force or flex-ext-ratio in CKC. In particular, there is hardly any comparative data
      for isokinetic measurement systems in the CKC. Using a cross over design and randomly
      allocating 28 competitive football players into two groups (n=14 each) that either started
      tests with the leg press or legcurl device, the investigators assumed (1) a significantly
      lower flex-ext-ratio in the CKC compared to the OKC, (2) a correlation between the isokinetic
      measurement systems in the OKC and the CKC, and (3) a significant superiority of the leg
      press to predict functional performance of the lower limbs.
    


Intervention name(s): Isokinetic leg extension/-flexion on a legpress device; Isokinetic leg extension/-flexion on a legcurl device
Intervention type(s): Device; Device
Intervention description(s): Maximum strength and rate of leg-flexion /-extension during legpress exercise; Maximum strength and rate of leg-flexion /-extension during legcurl exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the safety & efficacy of brexpiprazole monotherapy in the treatment of
      adolescents with schizophrenia.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo- and active-controlled trial to
      evaluate the safety and efficacy of brexpiprazole monotherapy compared to placebo in
      adolescent subjects (ages 13-17) with a DSM-5 diagnosis of schizophrenia.
    

Intervention name(s): Brexpiprazole (OPC-34712); Aripiprazole; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once-daily, tablets; Once-daily, tablets; Once-daily, tablets
Intervention MeSH terms: Aripiprazole; Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects randomized 1:1:1 to 1 of 3 double-blind treatment arms to evaluate safety & efficacy
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brexpiprazole; Schizophrenia; Adolescent
Evaluation of Skin Irritation Potential With PF-06700841 Cream Formulation Using Negative Control in Adult Japanese Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single center, randomized, vehicle and white petrolatum controlled,
      evaluator blinded study to assess the skin irritation potential with a range of
      concentrations of PF-06700841 cream including vehicle and empty patch with white petrolatum
      under occlusive conditions in adult Japanese healthy participants.
    


Intervention name(s): PF-06700841 cream; White petrolatum
Intervention type(s): Drug; Drug
Intervention description(s): PF-06700841 will be applied topically; White petrolatum will be applied topically
Other intervention name(s): PF-06700841 cream 0% is Vehicle
Intervention MeSH terms: Petrolatum; PF-06700841
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Double-blind, Placebo-controlled Study of Antidepressant Augmentation With Agomelatine
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to investigate the efficacy and safety of antidepressant
      augmentation with agomelatine in the treatment of patients with depression who did not
      demonstrate satisfying response to selective serotonin reuptake inhibitor (SSRI) and
      serotonin-noradrenaline reuptake inhibitor (SNRI) during their early phase of treatment; this
      study also aims to explore the effects of augmenting antidepressant treatment with
      agomelatine on various aspects, including sleep quality, quality of life, social functioning,
      and cognitive function in patients with MDD.
    


Intervention name(s): Agomelatine; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets of agomelatine at a dose of 25-50 mg/d for 8 weeks; Oral tablets of placebos at a dose of 25-50 mg/d for 8 weeks
Intervention MeSH terms: Agomelatine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: agomelatine; antidepressant; augmentation; major depressive disorder; early-nonresponsive
Effects of OMT on ANS: a Thermography Study
Condition: Autonomic Nervous System Imbalance; Healthy
Study type: Interventional

Summary: 
      the study will investigate the effect of a specific type of touch intervention on the
      activity of autonomic nervous system measured using thermography
    


Intervention name(s): osteopathic treatment; sham
Intervention type(s): Other; Other
Intervention description(s): the intervention will be based on 2 phases: 1) assessment to identify areas with somatic dysfunction, 2) treatment to improve the function of the area identified; the sham intervention will consists of 2 overlapping phases as the intervention group but without applying any technique
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomised placebo controlled crossover study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data
Condition: Deep Vein Thrombosis, Pulmonary Embolus
MeSH terms: Pulmonary Embolism; Thrombosis; Venous Thrombosis
Study type: Observational

Summary: 
      Investigators are building an empirical evidence base for real world data through large-scale
      replication of randomized controlled trials. The investigators' goal is to understand for
      what types of clinical questions real world data analyses can be conducted with confidence
      and how to implement such studies.
    

Detailed description: 
      This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE
      initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical
      School. It is intended to replicate, as closely as possible in healthcare insurance claims
      data, the trial listed below/above. Although many features of the trial cannot be directly
      replicated in healthcare claims, key design features, including outcomes, exposures, and
      inclusion/exclusion criteria, were selected to proxy those features from the trial.
      Randomization is also not replicable in healthcare claims data but was proxied through a
      statistical balancing of measured covariates through standard practice. Investigators assume
      that the RCT provides the reference standard treatment effect estimate and that failure to
      replicate RCT findings is indicative of the inadequacy of the healthcare claims data for
      replication for a range of possible reasons and does not provide information on the validity
      of the original RCT finding.
    

Intervention name(s): Rivaroxaban; Enoxaparin
Intervention type(s): Drug; Drug
Intervention description(s): Any rivaroxaban dispensing claim is used as the exposure group; Any enoxaparin dispensing claim is used as the reference group
Other intervention name(s): Xarelto
Intervention MeSH terms: Enoxaparin; Rivaroxaban
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will involve a new user, parallel group, propensity score-matched, retrospective
        cohort study design comparing rivaroxaban to enoxaparin users. The patients will be
        required to have continuous enrollment during a baseline period of 180 days before
        initiation of rivaroxaban or enoxaparin (index date). We will restrict the analyses to
        patients who underwent a total hip arthroplasty.