bioihbjkbjnl/mcl2 huggingface dataset:
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
Condition: Hyperlipidemia and Mixed Dyslipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will contribute to the evaluation of long-term safety, tolerability and efficacy
      of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
    


Intervention name(s): Evolocumab; Standard of Care
Intervention type(s): Biological; Drug
Intervention description(s): Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen; Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Other intervention name(s): AMG 145; Repatha
Intervention MeSH terms: Evolocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High cholesterol; Raised cholesterol; Cholesterol; Elevated Cholesterol
The McKenzie Method Versus Manipulation for Patients With Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Introduction:

      The McKenzie method as well as spinal manipulation is commonly used for the treatment of low
      back pain throughout the western world. Recently, the need for studies testing the effect of
      treatment strategies to specific diagnostic subgroups of patients has been emphasized. The
      present study aims to compare the effectiveness of the McKenzie method and chiropractic
      manipulation, information, and advice for patients with clinical signs of persistent symptoms
      originating from a diskus in the low back.

      Methods:

      After clinical screening 350 patients with or without leg pain who presented with
      centralization of symptoms or signs of disc herniation were randomized to the McKenzie group
      or the manipulation group. The outcome measures, Roland Morris Disability Questionnaire, 11
      point numerical pain scale, 6 point global perceived change scale, and quality of life (Short
      Form-36) were assessed at baseline, at end of treatment, and at 2 and 12 months follow-up.
    

Detailed description: 
      In 1998, Cherkin et al. published a study showing no difference between outcomes following
      the McKenzie method, chiropractic manipulation, or the provision of an educational booklet
      for the treatment of patients with acute non-specific low back pain. Recently, the need for
      studies testing the effect of treatment strategies to specific diagnostic subgroups of
      patients has been emphasized. The present study aims to compare the effectiveness of the
      McKenzie method and chiropractic manipulation, information, and advice for patients with
      clinical signs of disc-related symptoms for duration of more than 6 Weeks.
    

Intervention name(s): spinal manipulation; McKenzie exercises
Intervention type(s): Procedure; Procedure
Intervention description(s): Spinal manipulation to the lumbopelvic spine in combination with information about examination findings and advice about back care; McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; Intervertebral disc; McKenzie; Physical Therapy; Spinal manipulation; Chiropractics; Patient education; Exercise therapy; Random allocation
Study to Evaluate the Effect of Pasteurized Akkermansia Muciniphila (pAkk) on Complaints Related to IBS
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Double-blind, randomised, placebo-controlled study to evaluate the benefit of pasteurized
      Akkermansia muciniphila in reducing complaints related to irritable bowel syndrome.

      Further objectives are to evaluate the beneficial potential of pAkk on any anxiety and
      depression complaints, as well as its safety and tolerability.
    

Detailed description: 
      Irritable bowel syndrome (IBS) is one of the most common disorders of gut-brain interaction,
      globally affecting about 10% of the population. Typical predominant traits are abdominal pain
      and abnormal bowel habits. The use of probiotics in IBS has been continuously assessed; in
      recent systematic reviews and meta-analyses, single or combined probiotic strains were
      indicated to have beneficial effects and good tolerability in the affected population.

      pAkk has recently been assessed as a safe novel food ingredient. Beneficial effects and very
      good tolerability of pAkk have been reported in individuals with metabolic disorders. The
      objective of the present clinical study - a double-blind, randomised, placebo-controlled,
      parallel group design, explorative pilot 12-week nutritional study, is to assess the
      potential of pAkk in IBS management.

      The main study objective is then to evaluate the benefit of pAkk in reducing complaints
      related to irritable bowel syndrome. Further objectives are to evaluate the beneficial
      potential of pAkk on any anxiety and depression complaints, as well as its safety and
      tolerability. In total, 90 participants will be enrolled and will attend 4 study visits: one
      on site and 3 televisits.
    

Intervention name(s): pasteurized A. muciniphila; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): pasteurized A. muciniphila - oral daily dose; Placebo = identical to verum regarding the form, size, taste, color and intake
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment randomized, double-blind, placebo-controlled, parallel group, single center trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IBS
Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the
      leading health burden and cause of mortality worldwide; therefore, the necessity for an
      intervention is paramount. Dietary interventions to improve cardiometabolic health are highly
      sought after as they possess less risk than pharmacological drugs. Anthocyanins, found in
      high quantities in both tart cherries and blueberries are powerful antioxidants, that are
      potentially capable of improving cardiometabolic dysfunction. However, to date, no research
      has explored the cardiometabolic responses to tart cherry and blueberry supplementation.

      Therefore, the primary purpose of the proposed investigation is to test the ability of oral
      tart cherry and blueberry supplementation to improve cardiometabolic parameters in healthy
      individuals.
    


Intervention name(s): Fruit concentrate - either cherry or blueberry
Intervention type(s): Dietary Supplement
Intervention description(s): Fruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
The Effects of Rhus Coriaria L. on Serum Lipid Levels of Patients With Hyperlipidemia
Condition: Hyperlipidemias
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Coronary heart disease and stroke are two main causes of human deaths and is directly related
      to increased levels of plasma lipids.High total cholesterol and low high density lipoprotein
      cholesterol concentrations are often associated with endothelium dysfunction and
      inflammation, which can be followed by atherosclerosis.

      Rhus coriaria L. (Rhus) with the public name of "Somagh" is a plant species in the
      anacardiaceae family that is used as a food supplement, spice in Middle East region (Iran,
      Turkey and Arabic countries).

      In a double blind randomized placebo-controlled clinical trial, the investigators want to
      evaluate the effects of Somagh (Rhus coriaria L.) on serum lipid levels of patients with
      hyperlipidemia.
    

Detailed description: 
      Rhus (Somagh) is found in temperate and tropical regions worldwide, often growing in areas of
      marginal agricultural capacity. Rhus is used as an herbal remedy in traditional medicine
      because of its assumed analgesic, antidiarrhetic, antiseptic, anorexic and antihypergylcemic
      properties. The fruits of Rhus contain flavonols, phenolic acids, hydrolysable tannins,
      anthocyans and organic acids such as malice, citric and tartaric acids. Some studies have
      shown that polyphenols could have beneficial effects on cardiovascular disease and cancer and
      could be regarded as bioactive compounds with a high potential health-promoting capacity.
      Phenolic compounds inhibit lipid peroxidation, scavenge the superoxide anion and hydroxyl
      radical, and enhance the activities of detoxifying enzymes.Moreover, the hypocholesterolemic
      action of dietary polyphenols has been reported. The hypocholesterolemic effect of Rhus fruit
      powder and its components have been reported previously in rabbits and mice.
    

Intervention name(s): Rhus Coriaria L. (Rhus); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg of Rhus Coriaria L. (Rhus) powder in capsule: 1 capsule twice daily for 6 weeks; Placebo capsule: 1 capsule twice daily for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rhus; Cholesterol; Triglycerides; Lipids; Medicine, Traditional; Herbal medicine
Safety and Immunogenicity Study of Inactivated Nasal Influenza Vaccine NB-1008 Administered by Sprayer
Condition: Healthy Adult Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety and immune response of a new intranasal
      vaccine against influenza, called NB-1008. The vaccine is composed of a licensed vaccine that
      is normally given as an injection, called Fluzone, and an adjuvant (additive that helps a
      vaccine work better), called W805EC. In a prior clinical study this vaccine showed promising
      results in terms of being well tolerated and eliciting mucosal and systemic immune responses
      after administration by a dropper. In this study NB-1008 is being administered by dropper as
      well as a nasal sprayer to determine if the sprayer further enhances the immune response.
    


Intervention name(s): NB-1008; Fluzone IN
Intervention type(s): Biological; Biological
Intervention description(s): NB-1008 is composed of Fluzone containing 15 micrograms (mcg) of strain-specific hemagglutinin (HA) and 20% W805EC adjuvant.; The active control is Fluzone containing 15 micrograms (mcg) of strain-specific hemagglutinin (HA).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Patterns of Coronary Artery Anatomy in Children With Congenital Heart Disease by Computed Tomography
Condition: Heart Diseases
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      To test the ability of electron beam CT in evalting the coronary artery pattern in children
      with congenital heart disease.
    

Detailed description: 
      To test the ability of electron beam CT in evalting the coronary artery pattern in children
      with congenital heart disease.
    

Intervention name(s): CT
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: coronary artery
Metabolic Fate Modifications of Saturated Fats After an Overfeeding
Condition: Obesity; Lipid Metabolism; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to determine the partitioning of exogenous lipids in the
      postprandial period while a study of overfeeding. The method is based on the incorporation of
      a stable isotopic tracer (d31_palmitic acid, d31_C16) in lipoprotein triglycerides
      (TG-CHYLOMICRON and TG-VLDL) and in free fatty acids (FFA).
    

Detailed description: 
      Healthy overweight and lean young men are subjected to an overfeeding during 56 days which
      corresponds to a supplement of 761 Kcal/day. During two exploration days (before : D0 et
      after : D56 overfeeding) they have ingested a breakfast with tracer (d31_palmitic acid,
      d31_C16, 20mg/kg) and blood and urine samples were collected every hour of each exploration
      day. The enrichment in deuterium was measured by gas chromatography-organic mass spectrometry
      (GC-OMS) in palmitic acid pool of lipid fractions.
    

Intervention name(s): Hyperlipidic overfeeding
Intervention type(s): Dietary Supplement
Intervention description(s): 100g per day of cheese + 40g per day of almonds + 20g per day of butter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: overfeeding; stable isotopes; lipoprotein metabolism; lipid oxidation; fat distribution; gene expression; endotoxemia; mass spectrometry/gas chromatography
Training Language and Literacy for Children Who Use CIs
Condition: Hearing Loss, Sensorineural
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      This study aims to determine the effectiveness of computer games to improve language and
      literacy outcomes for children who have hearing loss. Children will be assigned to one of
      four conditions: phonological awareness training, working memory training, phonological
      awareness + working memory training, or active control.
    

Detailed description: 
      Both phonological awareness and working memory are known to be important for children's
      language and literacy learning. Though there are computer games that claim to improve
      phonological awareness and working memory, it is unknown if these games will improve language
      and literacy skills for children who have hearing loss.

      The investigators will first determine if the games are effective for improving language and
      phonological awareness in children with hearing loss relative to an active control condition.
      Secondly, the investigators will determine if gains in phonological awareness and working
      memory translate into gains in language and literacy skills relative to active control.
    

Intervention name(s): Phonological Awareness; Working Memory; Phonological Awareness + Working Memory; Active Control
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Earobics training; Cogmed training; Earobics + Cogmed training; Spashmath
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The efficacy of phonological awareness (Earobics) and working memory (Cogmed) training alone and in combination are compared to an active control (Splashmath).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Pravastatin in the Subjects With Prediabetes or Early Diabetes
Condition: Diabetes Mellitus; Prediabetic State
MeSH terms: Diabetes Mellitus; Prediabetic State
Study type: Interventional
Phase: Phase 4

Summary: 
      An increased risk of incident diabetes with statin therapy have been reported in several
      studies. However, it is not recommended to limit the use of statin for this reason since the
      absolute risk increase was small, and the cardiovascular event rate reduction with statins
      overweighed the risk of new diabetes (Scatter N et al. Lancet, 2010). Moreover, each statin
      may have different effect on the development of incident diabetes. In the West of Scotland
      Coronary Prevention Study, pravastatin therapy reduced the hazard of becoming diabetic by
      30%. Also, with pravastatin use, an increase in adiponectin level, which is related to the
      improvement in insulin sensitivity, has been reported. In this clinical trial, the
      investigators are aiming to evaluate the effect of pravastatin on insulin resistance, insulin
      secretion, glycemic control, and adiponectin level in participants with prediabetes or early
      diabetes by assigning them in a 24 weeks of pravastatin therapy group or in a placebo group.
    


Intervention name(s): Pravastatin; Placebo (for Pravastatin); Nutritional education only
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Pravastatin 40mg once daily for 24 weeks and nutritional education by a nutritionist; Pill manufactured to mimic pravastatin 40mg tablet once daily for 24 weeks and nutritional education by a nutritionist; Only nutritional education by a nutritionist
Other intervention name(s): Open-label control
Intervention MeSH terms: Pravastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pravastatin; Insulin Resistance
Safety and Efficacy of the SMART Device for Overweight and Obese Adults
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate that (1) we will observe at least 40% of the
      subjects in the Per Protocol population having a measured ≥5% weight loss at 16 weeks
      compared to week 0; and (2) the observed mean % Total Body Weight Loss at 16 weeks compared
      to Week 0 is ≥4% in the Per Protocol population.
    


Intervention name(s): SMART device
Intervention type(s): Device
Intervention description(s): Sensor Monitored Alimentary Restriction Therapy (SMART) device
Other intervention name(s): Sensor Monitored Alimentary Restriction Therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pharmacokinetic Study of MIN-101 and Its Metabolites in Healthy Subjects to Compare MIN-101 in Poor and Extensive Metabolizers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      -  To evaluate the pharmacokinetic (PK) profile of MIN-101 and its metabolites in extensive
           (EM) and poor (PM) metabolizers

        -  To evaluate the relationship between plasma levels of MIN-101 and changes in QT/QTcF
           intervals

        -  To evaluate safety and tolerability of MIN-101.
    


Intervention name(s): MIN-101
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill
Condition: Obesity
MeSH terms: Obesity; Emergencies
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to determine the effects of obesity on the pharmacokinetics of
      the levonorgestrel (LNG) only emergency contraceptive (EC) regimen and on markers of
      ovulation

      Primary hypothesis:

      1) Obese users of LNG-EC have a pharmacokinetic profile that is consistent with a larger
      volume of distribution of LNG.

      Secondary hypothesis:

        1. Alterations in these pharmacokinetic parameters of the LNG-EC regimen in obese women
           affect the primary mechanism of action, which is inhibition of ovulation.

        2. Obesity may affect other factors that alter levels of LNG, such as sex-hormone binding
           globulin (SHBG) and albumin, which bind LNG and potentially lowers the amount of free
           LNG.
    


Intervention name(s): Levonorgestrel 1.5mg by mouth once
Intervention type(s): Drug
Intervention description(s): Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8
Other intervention name(s): Plan B One Step; Next Choice One Dose
Intervention MeSH terms: Levonorgestrel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Non-smoking women between ages 18-35 years with regular menstrual cycles (24-35 days) will
        be enrolled, to include 10 normal weight (BMI = 18.5-24.9 kg/m2) women, 10 obese (BMI =
        30-39.9 kg/m2) and 10 extremely obese (BMI ≥ 40 kg/m2) women
      
Keywords: Obesity; Emergency contraception; Levonorgestrel emergency contraception
D-serine Monotherapy for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      A first generation of clinical studies, performed during the last decade, demonstrates that
      adjuvant treatment with compounds that enhance NMDAR-mediated neurotransmission due to their
      agonistic activity at the NMDAR-associated glycine (GLY) site (e.g. GLY, D-serine (DSR))
      leads to significant symptom reductions in chronic schizophrenia patients.Furthermore,
      preliminary findings suggest that treatment with NMDAR-GLY site modulators may also be
      beneficial as antipsychotic monotherapy In the proposed project, during a three year period,
      60 schizophrenia patients that fulfill treatment resistance criteria will be randomly entered
      in a 10 week, two phase (fixed/flexible dose), parallel group, double blind controlled study
      assessing the efficacy of olanzapine (OLA) (up to 40 mg/day) vs. DSR (up to 4000 mg/day) as
      antipsychotic monotherapy.Clinical, neurocognitive, electrophysiological, and amino acids
      (i.e. GLY, DSR) levels assessments will be performed during the study. The specific aims of
      the proposed project are: 1) to assess the efficacy and safety of DSR as a new medication for
      treatment refractory schizophrenia, and 2) to assess DSR effects in terms of relevant amino
      acids serum levels, neurocognitive performance, and relevant brain electrophysiological
      parameters. The overall importance of the proposed project consists of its potential to lay
      the foundations for an innovative type of intervention for treatment resistant schizophrenia
      patients.
    


Intervention name(s): D-serine; Olanzapine
Intervention type(s): Drug; Drug
Intervention description(s): 6 week fixed dose phase with D-serine 1500 mg/day to be increased starting from week two to 3000 mg/day followed by a 4 week flexible dose phase allowing for two 500 mg/day dose changes; 6 week fixed dose phase with Olanzapine 15 mg/day to be increased starting from week two to 30 mg/day followed by a 4 week flexible dose phase allowing for two 5 mg/day dose changes.
Other intervention name(s): DSR; Zyprexa
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; treatment resistance; D-serine; Olanzapine; treatment refractory schizophrenia