bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations
Condition: Bioavailability of Coenzyme Q10
Study type: Interventional

Summary: 
      The single-center, randomized, open-label, five-period crossover single-dose bioavailability
      study with five CoQ10 formulations
    

Detailed description: 
      The single-center, randomized, open-label, five-period crossover bioavailability study will
      include 30 subjects who will test five CoQ10 formulations. Study will be conducted with
      single dose CoQ10 to assess bioavailability.
    

Intervention name(s): Single dose intervention with Standard product (SP); Single dose intervention with Investigational product (IP1); Single dose intervention with Investigational product (IP2); Single dose intervention with Investigational product (IP3); Single dose intervention with Investigational product (IP4)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules - 200 mg total CoQ10; 2 softgels - 200 mg total CoQ10; 2 softgels - 200 mg total CoQ10; 2 softgels - 200 mg total CoQ10; 2 capsules - 200 mg total CoQ10
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Five-period crossover bioavailability study will include 30 subjects who will test five CoQ10 formulations. Subjects will test 5 formulations of single dose CoQ10 with 2 week wash-out. to assess bioavailability.
Masking: None (Open Label)
Primary purpose: Other
Keywords: coenzyme q10; single dose bioavailability
The Association Between the Distributions MCH and RBC, and Mortality in Hemodialysis Patients
Condition: Renal Anemia
Study type: Observational

Summary: 
      Patients were classified into two groups based on the values of MCH and RBC, patients with
      MCH ≥30 pg but <35 pg and RBC ≤350×104/μL; and MCH <30 pg and RBC >350×104/μL. Associations
      between all-cause mortality and the distributions of MCH and RBC were assessed by
      Kaplan-Meier curves and Cox proportional hazards regression model.
    

Detailed description: 
      The Hb levels generally provides the value of RBC and iron status because mean corpuscular
      hemoglobin MCH is derived from the Hb divided by RBC. MCH depends on the size and
      concentration of erythrocytes. Thus, the value of RBC and MCH depend on dose of ESA and iron,
      respectively. Guidelines for Renal Anemia in Chronic Kidney Disease of 2015 Japanese Society
      for Dialysis Therapy recommend administration hemoglobin (Hb) levels ≥10 g/dL but <12 g/dL in
      dialysis patients.Patients whose Hb levels is maintained at 10 to 12 g/dL, Hb levels is
      widely distributed when divided into RBC and MCH. Therefore, the investigators examined the
      prognosis of life in the distribution of MCH and RBC.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients has undergone maintenance Hemodialysis for >1 year.
      
Keywords: red blood cell; mean corpuscular hemoglobin; hemoglobin; Hemodialysis patients
Low Level Laser Light Therapy as an Aid to Liposuction
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether low level laser therapy can help the
      recovery process for the procedure of liposuction of the thighs, hips and stomach.
    

Detailed description: 
      The Erchonia EML Laser is designed to administer low level laser therapy (LLLT). It has been
      hypothesized that LLLT may reduce pain and promote nerve regeneration through the speculated
      anti-inflammatory and immune enhancement properties of the therapy. Prior research has
      indicated LLLT to be a potentially safe and effective means of reducing pain. This clinical
      study was designed to evaluate the potential of the Erchonia EML Laser in offering a novel
      means of delivering LLLT to reduce pain and enhance healing following liposuction.
    

Intervention name(s): Erchonia(R) LipoLASER PL; Erchonia(R) EML Laser; Erchonia(R) LipoLASER PL
Intervention type(s): Device; Device
Intervention description(s): The Erchonia(R) EML Laser is a low level laser light therapy medical device that was applied during the liposuction procedure, by emitting 1 mw of red (635nm wavelength) light via a Class II electric laser diode energy source (CDRH classification). The fluence is considered to be at 10.8 joules per area treated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      An open label study to assess the safety and efficacy of tocilizumab in group 1 pulmonary
      arterial hypertension patients
    

Detailed description: 
      In Pulmonary Arterial Hypertension (PAH) raised blood pressure in the lungs leads to heart
      failure and early death. Patients not only have a significantly reduced life expectancy, but
      their quality of life is severely affected. If left untreated life expectancy is 2-3 years.
      Current treatments all aim to relax the vessels in the lung and lower the blood pressures,
      however none target the causes of the disease and currently there is not cure. Despite the
      availability of treatments the impact on mortality has been modest at best with one third of
      patients still dying within two years of diagnosis. There remains an urgent need to test new
      ways of treating PAH.

      PAH is often associated with auto-immune diseases (when the bodies own system attacks itself
      rather than fight infection). Targeting components of the immune system involved in the
      development of disease offer a potential new area of treatment for PAH; an example known to
      be involved in the progression of PAH is the protein Interleukin-6 (IL-6). Tocilizumab is a
      drug which blocks the action of Interleukin-6 and blocking Interleukin-6 has been shown to be
      effective in animal models of PAH. Tocilizumab was demonstrated to be safe and effective in
      trials in other diseases associated with PAH, such as rheumatoid arthritis.

      This study is a 6 month open label phase II trial of IV Tocilizumab in 21 patients with group
      1 PAH. The aim of the trial is to see if Tocilizumab is safe and whether it reduces the blood
      pressure in the lungs. Patients will be given Tocilizumab intravenously once a month for six
      months with close safety monitoring. The trial will be led by Papworth Hospital and a total
      of 7 UK specialist centres will take part. The trial will assess the safety of the drug and
      response to treatment by measuring heart function, blood pressure in the lungs, exercise
      capacity and quality of life measurements.
    

Intervention name(s): Tocilizumab
Intervention type(s): Drug
Other intervention name(s): RoActemra
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Inhaled Cannabis on Driving Performance
Condition: Alcohol Drinking; Cannabis
MeSH terms: Marijuana Abuse; Alcohol Drinking
Study type: Interventional

Summary: 
      The purpose of this study is to expand understanding of the effects of cannabis on driving
      performance with and without the presence of low levels of alcohol.

      This project will involve the development a of a protocol and driving environment that is
      sensitive to the effects of cannabis on driving performance by building on prior driving
      situations used previously for testing the effects of alcohol on driving.
    

Detailed description: 
      Individuals will be recruited who are currently users of cannabis and alcohol to participate
      in this study. They will undergo a physical exam at screening. There will be six study visits
      where the subject will arrive at the Clinical Research Unit(University of Iowa Hospitals &
      Clinics) the night before dosing. At each visit subjects will be receive one of the following
      six dosing regimens: placebo alcohol with placebo cannabis; placebo alcohol with low-dose
      cannabis, placebo alcohol with higher-dose of cannabis, low dose alcohol with placebo
      cannabis; low dose alcohol with low dose cannabis, low dose alcohol with higher-dose of
      cannabis. After dosing, participants will have provide saliva samples and blood drawn
      periodically to check cannabis levels and will complete a driving simulation. After
      completing the drive, additional saliva samples and blood draws will occur and participants
      will be monitored until it is safe to transport home.
    

Intervention name(s): Alcohol(oral) and placebo; Cannabis(THC)(Inhaled) and Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive; Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
Other intervention name(s): Ethanol; Ethyl Alcohol; Marihuana; Marijuana
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cannabis; Marijuana; Marihuana; Alcohol; Driving
Effectiveness Study of CBT for Anxiety in Children
Condition: Separation Anxiety Disorder; Social Anxiety Disorder; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social; Anxiety, Separation
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aims to evaluate the effectiveness of a cognitive behaviour therapy program
      (FRIENDS) for anxiety disorders in children aged 8-15 years who have been referred to child
      and adolescent mental health clinics in Western Norway.
    

Detailed description: 
      Cognitive behaviour therapy (CBT) has been shown to be an efficacious treatment for anxiety
      disorders in youths when delivered in university settings. However, there is a lack of
      studies evaluating the effectiveness of CBT in regular clinical settings.

      The current study will compare a CBT program developed for anxiety in youths (the FRIENDS
      program by Paula Barrett, Australia), with a wait-list control condition. Group and
      individual treatment will also be compared in the study. Groups will be divided by age, with
      younger including 8-12-year-olds, and older 12-15-year-olds. Parents are also involved at the
      end of all therapy sessions, as well as in separate parent sessions. Assessment and treatment
      is delivered by clinicians working in seven outpatient clinics in Western Norway.

      There will be 10 therapy sessions, with booster sessions 4 and 12 weeks later. Effectiveness
      will be evaluated post-treatment, and at 1 and 5 years follow-up. The study will have a
      randomized design. Children randomized to the wait-list condition will be offered treatment
      if they still meet inclusion criteria after the waiting period.
    

Intervention name(s): Cognitive behavioural therapy
Intervention type(s): Behavioral
Intervention description(s): The FRIENDS program developed by Paula Barrett, 10 weekly sessions of 60-90 minutes, with two additional parent meetings, and booster sessions 4 and 12 weeks after treatment.
Other intervention name(s): FRIENDS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Aerosolized Versus Intravenous Colistin-based Antimicrobial Regimens in Hospitalized COVID-19 Patients With Bacterial Coinfection: A Randomized Controlled Trial
Condition: Secondary Bacterial Infection in COVID-19 Patients
MeSH terms: COVID-19; Bacterial Infections; Coinfection
Study type: Interventional
Phase: Phase 3

Summary: 
      Secondary bacterial pathogen infection has been demonstrated to aggravate COVID-19 clinical
      outcomes. Bacterial infections acquired during a hospital stay are likely resistant to
      several antimicrobial medicines, making COVID-19 patient management difficult. As a result,
      it is believed that aerosolized colistin might be a viable choice for treating secondary
      bacterial infections caused by gram-negative resistant strains in individuals who also have
      COVID-19 infection.
    


Intervention name(s): Colistin
Intervention type(s): Drug
Intervention description(s): COVID-19 patients with secondary gram-negative bacterial infections receive colistin IV or aerosolized
Intervention MeSH terms: Colistin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Safety, Tolerability, and Pharmacokinetics of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to assess the safety and tolerability of REGN2477 alone and combined
      with REGN1033.

      The secondary objectives are to:

        -  Assess the effect of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in
           combination on thigh muscle volume

        -  Assess the effects of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in
           combination on total and regional body composition

        -  Evaluate the Pharmacokinetic (PK) profile of REGN2477 and REGN1033

        -  Assess immunogenicity of REGN2477 or REGN1033

        -  Assess REGN2477 or REGN1033 target engagement
    


Intervention name(s): REGN1033; REGN2477; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): REGN1033; REGN2477; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
System Accuracy of the Blood Glucose Monitor for Personal Use BG-709b
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO
      15197
    

Detailed description: 
      This study assesses the system accuracy the blood glucose monitoring systems for personal use
      BG-709b as outlined in DIN EN ISO 15197:2015.
    

Intervention name(s): blood glucose measurement, blood glucose monitor for personal use; blood glucose measurement, laboratory reference device
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): measurement of the blood glucose concentration using the blood glucose monitor for personal use (BG-709b); measurement of the blood glucose concentration using a laboratory reference device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults,
      children and infants in a phase I open-label study, and then assess its immunogenicity and
      safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and
      controlled study.
    

Detailed description: 
      This study is a combination of phases I and II. Phase I study is open-label, and only collect
      safety information of the investigational sIPVs in adults, children and infants. Phase II
      study is double-blind, randomized, controlled study of the immunogenicity and safety of the
      investigational vaccines and two other commercialized inactivated poliovirus vaccines in
      healthy infants.
    

Intervention name(s): Single-dose regimen of high dosage investigational sIPV; Single-dose regimen of medium dosage investigational sIPV; Three-dose regimen of high dosage investigational sIPV; Three-dose regimen of medium dosage investigational sIPV; Three-dose regimen of low dosage investigational sIPV; Three-dose regimen of commercialized sIPV; Three-dose regimen of commercialized IPV
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..; The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..; The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..; The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..; The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..; The control vaccine was manufactured by Chinese Academy of Medical Sciences.; The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Sabin strain; Inactivated poliovirus vaccine; poliomyelitis; safety; immunogenicity; infant
Canakinumab for Pyoderma Gangrenosum
Condition: Pyoderma Gangrenosum
MeSH terms: Pyoderma; Pyoderma Gangrenosum
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a prospective open label evaluation of Canakinumab (Ilaris) for treatment of
      subjects with pyoderma gangrenosum.
    

Detailed description: 
      At the start of the study (week 0), all patients will receive one subcutaneous injection of
      150mg Canakinumab. Patients are then going to be examined at weeks 2, 4, 8, 12 and 16.

      At 2 weeks, all patients are going to be evaluated for response by Physician's global
      assessment (PGA) of the target lesion. Patients with PGA 0-1 are not going to receive another
      injection at this timepoint, while patients with PGA 2-4 are going to receive another 150mg
      Canakinumab.

      At 4 weeks, in case of PGA 4, patients are going to be offered a first or second line drug as
      an alternative therapy (corticosteroids, cyclosporin A or infliximab, dosage see below
      "Alternative therapy in case of missing response") and stay within the trial (due to the long
      half-life of canakinumab) until week 8.

      At week 8, patients with PGA 0 receive another 150mg Canakinumab only, and patients with PGA
      4 are not going to receive additional study drug, but are strongly encouraged to attend
      following medical visits for observation until the end of the study and/or switch to a first
      or second line drug as alternative therapy (see below). All other patients with PGA 1-3
      receive the total accumulative dose of Canakinumab that they had received on week 0 and 2,
      namely 150 or 300mg.

      The study duration for each individual is going to be 16 weeks. At week 8 and 16, safety
      laboratory investigations with blood differential (Neutrophil granulocytes, monocytes,
      eosinophils, basophils, lymphocytes, thrombocytes, erythrocytes, hemoglobin), AST, ALT, y-GT,
      AP, Bilirubin (total), Creatinine, Na, K, CRP are going to be determined.
    

Intervention name(s): Canakinumab
Intervention type(s): Drug
Intervention description(s): Monoclonal antibody inhibiting interleukin 1 beta
Other intervention name(s): Ilaris
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Interleukin 1 beta; Canakinumab; autoinflammatory syndrome
Effects of Ipragliflozin on Excessive Fat in Type 2 Diabetes Patients With Non-alcoholic Fatty Liver Disease Treated With Metformin and Pioglitazone
Condition: Type 2 Diabetes With Non-alcoholic Fatty Liver (NAFLD)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, the investigators investigate beneficial effects of ipragliflozin, newly
      developted SGLT2 inhibitor, on reduction in visceral fat area and degree of fatty liver in
      subjects with T2DM when added to metformin and pioglitazone therapy.
    

Detailed description: 
      Pioglitazone, a peroxisome proliferator-activated receptor-γ (PPARγ) agonist increase insulin
      sensitivity in peripheral tissue and liver by protecting non-adipose tissues against
      excessive lipid overload and by balancing the secretion of adipocytokines.

      However, PPARγ is a key transcription factor that induces the differentiation adipocyte
      maturation and stimulates the induction of enzymes involved in lipogenesis. As a result, the
      effect of pioglitazone is generally accompanied by weight gain and an increase in amount of
      subcutaneous fat.

      Obesity would coexist with fatty liver disease and both conditions aggravate hyperglycemia in
      diabetes. According to recent study, up-regulated PPARγ expression in liver was reported in
      obesity with hepatic steatosis which implies pioglitazone might induce fatty liver disease.

      A novel oral antidiabetic drug, sodium glucose cotransporter 2 (SGLT2) inhibitor reduces
      renal glucose reabsorption and increasing renal glucose excretion thereby promoting energy
      loss. As a result, it prevents weight gain and fluid retention which might counteract the
      unfavorable effects of pioglitazone treatment.

      No study has been conducted on the additional effect on obesity and fatty liver of
      ipragliflozin in T2DM patients treated with pioglitazone and metformin.

      In this study, the investigators investigate beneficial effects of ipragliflozin, newly
      developted SGLT2 inhibitor, on reduction in visceral fat area and degree of fatty liver in
      subjects with T2DM when added to metformin and pioglitazone therapy.
    

Intervention name(s): Ipragliflozin; metformin with pioglitazone
Intervention type(s): Drug; Drug
Intervention description(s): Patients treated with ipragliflozin (50 mg/day) as add on therapy to metformin and pioglitazone dual therapy (triple therapy) for 6 months. During whole periods of study, subjects are educated for nutrition and exercise. (Experimental Group); Patients maintain metformin and pioglitazone dual therapy for 6 months. During whole periods of study, subjects are educated for nutrition and exercise. (Control group)
Other intervention name(s): Suglat®
Intervention MeSH terms: Metformin; Pioglitazone; Ipragliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment