bioihbjkbjnl/mcl2 huggingface dataset:
RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR
Condition: MItochondrial Myopathies
MeSH terms: Muscular Diseases; Mitochondrial Myopathies
Study type: Interventional
Phase: Phase 2

Summary: 
      Mitochondrial myopathies are a multisystemic group of disorders that are characterized by a
      wide range of biochemical and genetic mitochondrial defects and variable modes of
      inheritance. Currently there are no effective treatments for this disease. Despite the
      heterogeneous myopathy phenotypes, a unifying feature of mitochondrial myopathies is that the
      pathogenic mtDNA mutations and/or nuclear mutations of the electron transport chain
      invariably lead to dysfunctional mitochondrial respiration. This reduction in mitochondrial
      respiration leads to a reduced ability to produce cellular adenosine triphosphate (ATP),
      often resulting in muscle weakness, exercise intolerance, and fatigue in patients with
      mitochondrial myopathies.

      RTA 408 is a potent activator of Nrf2 and inhibitor of NF κB (nuclear factor
      kappa-light-chain-enhancer of activated B cells), and thus induces an antioxidant and
      anti-inflammatory phenotype. Several lines of evidence suggest that Nrf2 activation can
      increase mitochondrial respiration and biogenesis. Collectively, available data suggest that
      the ability of RTA 408 to activate Nrf2 and induce its target genes could potentially improve
      muscle function, oxidative phosphorylation, antioxidant capacity, and mitochondrial
      biogenesis in patients with mitochondrial myopathies.

      This study will be a randomized, placebo-controlled, double-blind, dose-escalation study to
      evaluate the safety of omaveloxolone (RTA 408) at various doses in patients with
      mitochondrial myopathies.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): Omaveloxolone capsules, 2.5 mg; omaveloxolone capsules, 5 mg; omaveloxolone capsules, 10 mg; Placebo capsules; omaveloxolone capsules, 20 mg; omaveloxolone capsules, 40 mg; omaveloxolone capsules, 80 mg; omaveloxolone capsules, 160 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Other intervention name(s): RTA 408 Capsules 2.5 mg; RTA 408 capsules, 5 mg; RTA 408, 10 mg; RTA 408 capsules, 20 mg; RTA 408 capsules, 40 mg; RTA 408 capsules, 80 mg; RTA 408 capsules, 160 mg
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: omaveloxolone; RTA 408 capsules; mitochondrial myopathies
Docetaxel and Carboplatin as First-line Chemotherapy in Early Stage as Well as Advanced or Metastatic Ovarian Cancer
Condition: Ovarian Neoplasms
MeSH terms: Ovarian Neoplasms
Study type: Observational

Summary: 
      Primary objective:

      To assess response rate. To record the clinical improvement in relation to stage and
      histopathological grading.

      Secondary objective:

      To determine progression free survival. To find out overall survival. To evaluate the safety
      of the study regimen.
    


Intervention name(s): Docetaxel; Carboplatin
Intervention type(s): Drug; Drug
Intervention description(s): 60-75 mg/m²; AUC 5
Intervention MeSH terms: Carboplatin; Docetaxel
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with advanced or metastatic ovarian cancer
An Invasive Controlled Desaturation Study to Determine the Accuracy of the CART-I Pulse Oximeter
Condition: Healthy
Study type: Interventional

Summary: 
      A pulse oximeter is used for continuous monitoring of peripheral oxygen saturation (SpO2) and
      plays an important role in the early detection of hypoxia, guiding the titration of
      supplemental oxygen, and reducing the need for blood gas analysis. Therefore, the SpO2
      accuracy of a pulse oximeter should be validated for patient safety. The objective of this
      study is to evaluate whether the CART-I pulse oximeter with a ring-type wearable PPG sensor
      (Sky Labs Inc., Seoul, Korea) provides clinically reliable SpO2 readings over the range of
      70-100% SaO2, during steady-state, non-motion conditions.
    


Intervention name(s): CART-I plus
Intervention type(s): Device
Intervention description(s): CART-I noninvasively measures the oxygen saturation of blood in a local area by screening the bloodstream through the user's finger using PPG signals
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Oxygen Saturation
Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention
Condition: Fetal Alcohol Spectrum Disorders
MeSH terms: Fetal Alcohol Spectrum Disorders
Study type: Interventional

Summary: 
      This study on children with fetal alcohol spectrum disorder (FASD) aims to (i) characterize
      their self-regulation deficits, a process important for controlling emotions and behavior,
      (ii) describe brain structure and function underlying self-regulation, and (iii) determine
      whether training to improve self-regulation abilities changes brain and behavior. Individuals
      with FASD have a high risk of cognitive and social deficits, which reflect their difficulties
      in self-regulation and may lead to mental health concerns in adulthood. Importantly, early
      intervention improves long-term outcome. However the full extent of self-regulation problems
      in FASDs is unknown and the underlying neuroanatomy has not been fully described.
      Furthermore, information on how to best treat children with FASDs is lacking. Thus, the
      investigators propose three studies with a sample of 8-12 year old children, 40 with FASDs
      and 20 typically developing controls. In Study 1, the participants will be evaluated on
      cognitive and social self-regulation abilities using clinical and experimental tests. In
      Study 2, the participants will undergo a 1-hour MRI scanning session to obtain measures of
      their brain structure and function. In Study 3, FASDs will be randomly assigned to an
      immediate or delayed treatment group. The immediate group will undergo 12-weeks of therapy
      with the Alert Program for Self Regulation®. On conclusion of training, all will repeat
      Studies 1 and 2 and following this retest, the delayed treatment group will undergo training.
      The investigators will evaluate change in cognitive and social behavior and in brain
      structure and function by comparing performance and neuroimaging findings before and after
      the intervention. The investigators expect Alert training to significantly improve behavior
      and alter brain regions important for self-regulation. The findings will yield important
      information for improving self-regulation in FASDs and mitigating the development of mental
      health challenges.
    


Intervention name(s): Alert Program for Self-Regulation
Intervention type(s): Behavioral
Intervention description(s): Children attend 12 1.5 hour weekly sessions. Alert uses the analogy of a car engine to help children identify their own self-regulatory behavior. Children learn strategies to regulate their own "engine speed" in different situations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Self-Regulation Training; Neuroimaging; Response Inhibition; Behavioral Regulation; Emotional Regulation
Safety, Antiviral Activity, and Pharmacokinetics of GSK2336805 With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK2336805 is a hepatitis C virus (HCV) NS5A inhibitor being developed for the treatment of
      chronic hepatitis C (CHC). This study will assess the safety, antiviral activity, and
      pharmacokinetics of GSK2336805 alone and in combination with peginterferon alfa 2a and
      ribavirin in subjects with chronic hepatitis C (CHC).
    

Detailed description: 
      HCV infection is a major public health problem globally and a leading cause of chronic liver
      disease. New medications are needed that are better tolerated and offer a greater chance of
      achieving sustained viral clearance compared to currently available therapy. GSK2336805 is a
      HCV NS5A inhibitor being developed for the treatment of subjects with CHC. This Phase II,
      double blind, randomized, placebo-controlled study will assess the safety, antiviral
      activity, and pharmacokinetics of GSK2336805 alone and in combination with peginterferon alfa
      2a and ribavirin in subjects with CHC. Subjects will be randomly allocated on a 2:1 basis to
      GSK2336805 or matching placebo and will be stratified by IL28B status and HCV viral genotype
      (genotype 1 or 4). The study consists of 2 parts. In Part 1, GSK2336805 or matching placebo
      will be given as single-dose monotherapy (Day 1). In Part 2, GSK2336805 or matching placebo
      will be co-administered with peginterferon alfa-2a and ribavirin through 4 weeks of treatment
      (Days 2 to 28). After completion of Part 2, GSK2336805/matching placebo will be discontinued
      and subjects will be offered continued standard-of-care anti-HCV therapy.
    

Intervention name(s): GSK2336805; Pegylated interferon alfa-2a; Ribavirin; GSK2336805 Matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Active Investigational Drug; Standard of Care drug; Standard of Care drug; Placebo of Investigational Drug
Other intervention name(s): Pegasys; Placebo
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: chronic hepatitis C; NS5A inhibitor; ribavirin; pegylated interferon; GSK2336805
The Effect of CoQ10 Administration on Hemodialysis Patients
Condition: Chronic Renal Failure; Hemodialysis
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine whether CoQ10 administration is effective as an
      antioxidant in hemodialysis patients.
    

Detailed description: 
      Oxidative stress has been recognized as a potential risk factor for such complications as
      atherosclerosis in hemodialysis patients. This study investigates whether CoQ10
      administration is effective for protecting oxidative stress in hemodialysis patients. The
      subjects were recruited from day-time hemodialysis patients in Iwata City Hospital. 100 mg
      CoQ10 was administered every HD for 6 months. Several oxidative and antioxidative markers
      were measured in plasma at pre, 1, 3, 6 months and after washout.
    

Intervention name(s): Coenzyme Q10 (drug)
Intervention type(s): Drug
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CoQ10; hemodialysis; oxidative marker; antioxidant
A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty
Condition: Total Shoulder Arthroplasty; Glenohumeral Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      The proposed study aims to objectively assess 2-year clinical and radiographic results for
      the rate of glenoid component loosening in total shoulder arthroplasty (TSA). This
      retrospective radiographic review will provide evidence for equivalence or superiority in
      curtailing loosening, a known complication in arthroplasty, when a hemostatic agent is
      utilized in conjunction with cement at the glenoid.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who have previously undergone anatomic total shoulder arthroplasty for the
        treatment of glenohumeral osteoarthritis.
Safety & Suitability of Dabigatran to Inhibit Thrombin in Scleroderma
Condition: Scleroderma; Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates if dabigatran etexilate is safe for use in patients with Scleroderma and
      Interstitial Lung Disease. All patients will receive 75mg of dabigatran etexilate twice a day
      for 6 months.
    

Detailed description: 
      Skin and pulmonary fibrosis result in substantial morbidity in scleroderma (SSc).
      Furthermore, interstitial lung disease (ILD) culminating in pulmonary fibrosis is a major
      cause of death among scleroderma patients. Studies implicate the coagulation system, most
      notably the serine protease thrombin, in the pathogenesis of SSc-ILD. Thrombin can transform
      normal lung fibroblasts to a scleroderma fibroblast phenotype. Dabigatran etexilate is a
      selective thrombin inhibitor which is FDA-approved for the prevention of thromboembolic
      complications in patients with atrial fibrillation. Dabigatran etexilate needs to be studied
      as a potential anti-fibrotic agent for the treatment of SSc-ILD. This study is designed to
      see if dabigatran etexilate is safe for use in patients with scleroderma. If so, the long
      term goal of this study is to determine whether or not the fundamental results will translate
      to a potential clinical intervention for SSc-ILD which can be tested in a future randomized
      control trial.
    

Intervention name(s): dabigatran etexilate
Intervention type(s): Drug
Intervention description(s): dabigatran etexilate 75mg orally twice a day for 6 months
Other intervention name(s): Dabigatran; Pradaxa
Intervention MeSH terms: Dabigatran
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SSc; systemic sclerosis; cutaneous systemic sclerosis
Effect of Frequent Interruptions of Prolonged Sitting on Self-perceived Levels of Energy, Mood, Food Cravings and Cognitive Function
Condition: Mood; Energy; Food Cravings; Cognitive Function
Study type: Interventional

Summary: 
      This study is designed to test the effects of six 5 minute microbursts of physical activity
      spread across the day as compared to either a sedentary control condition or a single 30
      minute bout of moderate intensity physical activity on cognitive function, self-reported
      energy levels, aspects of eating behavior and measures of metabolic health. The primary
      hypotheses are:

        1. Hourly 5 minute bouts of moderate intensity exercise during the day will increase
           afternoon cognitive function as compared to a no exercise condition.

        2. Hourly 5 minute bouts of moderate intensity exercise during the day will increase
           afternoon cognitive function more than a single 30 minute AM bout.

      Secondary exploratory hypotheses include

        1. Hourly 5 minute bouts of moderate intensity exercise during the day will increase
           self-reported energy levels, reduce orexigenic appetitive measures and improve measures
           of metabolic health as compared to a no exercise condition.

        2. Hourly 5 minute bouts of moderate intensity exercise during the day will increase
           self-reported energy levels, reduce orexigenic appetitive measures and improve measures
           of metabolic health more than a single 30 minute AM bout.
    


Intervention name(s): physical activity
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Micro bouts; Physical Activity
Effects of Regular Practice of Yoga on Subjective and Objective Sleep Quality in Primary Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of the study is to assess the effects of regular Viniyoga in patients suffering
      from primary insomnia.
    

Detailed description: 
      Insomnia is very prevalent in Europe (14-27%). Cognitive behavioral therapy is the treatment
      of choice in patients suffering from primary insomnia, allowing to obtain a long term (2
      years) sleep quality improvements in 62% of patients. Yoga is another behavioral therapy that
      have shown benefits in patients suffering from anxiety disorders. Few studies have been
      focused on yoga benefits in sleep disorders. The purpose of the study is to assess the
      effects of regular Viniyoga on sleep quality (subjective and objective) in patients suffering
      from primary insomnia.
    

Intervention name(s): Yoga
Intervention type(s): Behavioral
Intervention description(s): 4 yoga lessons with and instructors on a 3 months period. Patients are asked to exercise yoga daily for 5 to 30 minutes.
Intervention model: Single Group Assignment
Intervention model description: 4 yoga lessons with and instructors on a 3 months period. Patients are asked to exercise yoga daily for 5 to 30 minutes.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: yoga; sleep quality; sleep quantity; sleep efficiency; insomnia
Study of Sitagliptin for the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0431-260)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the insulin-sparing effect of sitagliptin 100 mg
      once-daily compared with placebo over 24 weeks in participants with type 2 diabetes mellitus
      who have inadequate glycemic control on insulin alone or in combination with metformin. The
      primary hypothesis of this study is that after 24 weeks, sitagliptin reduces the dose of
      insulin relative to placebo.
    


Intervention name(s): Sitagliptin; Comparator: Placebo; Insulin Glargine; Metformin
Intervention type(s): Drug; Drug; Biological; Drug
Intervention description(s): Sitagliptin 100 mg tablet once daily for 24 weeks; Placebo to sitagliptin once daily for 24 weeks; Participants on insulin glargine or another insulin regimen for at least 10 weeks prior to screening will continue or switch to open-label insulin glargine once-daily in the evening for the duration of the study.; Participants on metformin oral tablet(s) at a dose of at least 1500 mg/day for at least 10 weeks prior to screening will continue receiving metformin at their current dose for the duration of the study.
Other intervention name(s): Januvia; Glucophage
Intervention MeSH terms: Metformin; Insulin Glargine; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants
Condition: Necrotizing Enterocolitis; Very Low Birth Weight Infants
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing; Body Weight; Birth Weight
Study type: Interventional
Phase: Phase 3

Summary: 
      Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal
      system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in
      newborn infants whose birth weights are < 1500 g. Although bifidobacterium and other
      lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in
      clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing
      enterocolitis in very low birth weight infants yet. The objective of this study is to
      evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence
      and severity of necrotizing enterocolitis in very low birth weight infants.
    


Intervention name(s): Lactobacillus reuteri; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lactobacillus reuteri 100 million CFU/day for 3 months; Placebo for 3 months
Other intervention name(s): BioGaia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)
Condition: Difficult Intubation
Study type: Interventional

Summary: 
      In this second phase of the multicenter study the investigators are going to evaluate the use
      of three different videolaryngoscopes in patients undergoing elective surgery requiring
      general anesthesia with intubation. The investigators are hypothesizing that these three
      videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases
      using a difficult airway simulation with extrication collars. As the gold standard, a
      standard Macintosh blade is being used for comparison.

      The study consists of 4 arms. Each arm includes 120 patients, sums up to a total of 480
      patients.
    


Intervention name(s): Airtraq, blade without channel for tracheal tube intubation; KingVision , blade without channel for tracheal tube intubation; A.P. Advance, blade without channel for tracheal tube intubation; Macintosh
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Intubation
Other intervention name(s): Airtraq; A.P. Advance; KingVision; Macintosh
Intervention MeSH terms: Pyrithione zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Intubation; Difficult
Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)
Condition: Diabetes Mellitus; Glucose Intolerance
MeSH terms: Diabetes Mellitus; Glucose Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effects of pitavastatin for preventing diabetes
      in a population with impaired glucose tolerance.
    

Detailed description: 
      Diabetes mellitus and its complications are major health problems globally. People with
      impaired glucose tolerance (IGT) are at high risk of developing diabetes. It is therefore
      important to focus on preventing diabetes in individuals with IGT. HMG-CoA reductase
      inhibitors (statins) are widely used for hypercholesterolemia, one of the most frequent
      metabolic disorders. However, there is no direct evidence to whether statins are beneficial
      for preventing diabetes. This study is designed to compare the efficacy of life-style
      modification versus life-style modification with pitavastatin (a statin) administration, in
      individuals with IGT.
    

Intervention name(s): life-style intervention; Life style interventions plus concomitant use of pitavastatin.
Intervention type(s): Other; Drug
Intervention description(s): As the life-style interventions aiming to reduce the major risks of developing diabetes mellitus, instruct the following four items:(1)set diet right, (2)maintain normal weight,(3)improve physical activity,(4)normalize smoking and alcohol drinking.; Once-daily dosing of pitavastatin 1 mg(1 tablet of Livalo Tab 1 mg), or 2mg(2 tablets of Livalo Tab 1mg or 1 tablet of Livalo Tab 2mg);Dosing period of pitavastatin should be 60 months.(max.84 months).
Intervention MeSH terms: Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Glucose intolerance; Diabetes mellitus; Statins,HMG-CoA