bioihbjkbjnl/mcl2 huggingface dataset:
A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
Condition: Degenerative Lumbar Spondylolisthesis
MeSH terms: Spondylolisthesis
Study type: Interventional

Summary: 
      This study will explore the use of OP-1 Putty in conjunction with surgical treatment for the
      treatment of spinal decompression and lumbar spinal fusion.
    

Detailed description: 
      It is postulated that the addition of OP-1 Putty to autogenous bone will prove beneficial in
      the treatment of patients requiring decompression and lumbar spinal fusion. The
      Investigational system is intended to stimulate bone growth. It is indicated as an adjunct or
      a replacement for autograft in spinal fusion.
    

Intervention name(s): Use of OP-1 Putty in Uninstrumented posterolateral fusion
Intervention type(s): Device
Intervention description(s): Use of OP-1 Putty in Uninstrumented posterolateral fusion
Other intervention name(s): Uninstrumented posterolateral fusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Degenerative Disc Disease
The Effects of a Ruminococcus Torques Strain Bacterium in Healthy Adults.
Condition: Overweight; Healthy
MeSH terms: Overweight
Study type: Interventional

Summary: 
      A randomized, placebo controlled crossover study investigating the potential metabolic
      effects of the naturally occurring gut microbe Ruminococcus torques in healthy, overweight
      adults.
    

Detailed description: 
      By analyzing blood samples, indirect calorimetric as well as thermographic assessment of
      clavicular temperature we want to investigate whether or not the commensal gut bacterium
      Ruminococcus toqrues strain ATCC 27756 has any metabolic effects in healthy adults. The
      subjects will recieve the intervention with the live bacterium given through a duodenal
      feeding tube. The trial is double blinded and placebo controlled using a crossover design.
      Subjects will be given an intervention with either placebo or Ruminococcus on two different
      study days with up to six weeks of wash-out between each study day.
    

Intervention name(s): Placebo; Ruminococcus torques
Intervention type(s): Biological; Biological
Intervention description(s): The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.; 10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A crossover study where subjects recieve placebo or Ruminococcus torques on two different study days with three to six weeks of wash-out between the study days.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Metabolism; Microbiota; Ruminococcus torques
Pharmacokinetics and Safety of ABT-493 and ABT-530 in Subjects With Normal and Impaired Renal Function
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single dose study designed to assess the pharmacokinetics and safety
      of ABT-493 and ABT-530 in subjects with either normal renal function or impaired renal
      function.
    

Detailed description: 
      Up to 48 subjects will be selected and enrolled according to the subject selection criteria:
      8 subjects with mild renal impairment (Group 1), 8 subjects with moderate renal impairment
      (Group 2), 8 subjects with severe renal impairment (Group 3), 8 subjects with end stage renal
      disease that are not yet on dialysis (Group 4), 8 healthy subjects with normal renal function
      (Group 5), and 8 subjects with end stage renal disease on hemodialysis (Group 6).
    

Intervention name(s): ABT-493; ABT-530
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of ABT-493 will be given orally in combination with ABT-530.; A single dose of ABT-530 will be given orally in combination with ABT-493.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Renal Impairment
Renal Effects of DPP-4 Inhibitor Linagliptin in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to detail the (mechanisms underlying the) actions of the DPP-4
      inhibitor linagliptin on the renal system in patients with type 2 diabetes mellitus.
    

Detailed description: 
      Based on preclinical and small-sized studies in non-diabetic individuals, incretin-based
      therapies, i.e. glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase-4
      inhibitors (DPP-4i), may hold promise in preventing the onset and progression of diabetic
      kidney disease. However, the potential renoprotective effects of these agents, that are
      believed to be effectuated "beyond glucose control", have not been sufficiently detailed in
      human diabetes.

      Therefore, the present study aims to explore the mechanistic and clinical effects of DPP-4i
      on fasting and postprandial renal physiology and biomarkers in patients with type 2 diabetes.

      Forty-eight patients with type 2 diabetes will undergo an eight week intervention with
      linagliptin or glimepiride in order to assess changes in the outcome parameters.
    

Intervention name(s): Linagliptin 5 mg QD (N=24); Glimepiride 1 mg QD (N=24)
Intervention type(s): Drug; Drug
Intervention description(s): Linagliptin 5 mg will be taken orally, once daily for 8 weeks; Glimepiride 1 mg will be taken orally, once daily for 8 weeks
Other intervention name(s): Trajenta; Amaryl
Intervention MeSH terms: Glimepiride; Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; Diabetic kidney disease; Diabetic nephropathy; Renoprotection; DPP-4 inhibitors; Linagliptin; SU derivatives; Glimepiride
Ameliorating Attention Problems in Children With Sickle Cell Disease (SCD)
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess whether methylphenidate is effective in enhancing the
      cognitive performance of children with the HbSS or HbSC genotype of SCD who have sustained
      neurological complications on laboratory-based measures of sustained attention, reaction
      time, and executive functions, and indirectly, verbal short-term and long-term memory.
    

Detailed description: 
      Sickle cell disease (SCD) is a group of autosomal recessive disorders, affecting an estimated
      1 in 400 African American newborns annually. The pathophysiology of this group of disorders
      involves the production of abnormal hemoglobin (HbS), which causes red blood cells to assume
      a rigid, sickled shape upon release of oxygen, thereby reducing their viability in
      circulation. Consequently, chronic anemia and system-wide ischemia result in acute painful
      episodes, organ system failure, and neurological complications. Among the most debilitating
      effects of SCD are neurological complications. Despite the mounting evidence for structural
      and functional involvement of the frontal systems in pediatric SCD, there have been no
      clinical trials designed to manage the cognitive and behavioral sequelae associated with
      pediatric SCD.
    

Intervention name(s): methylphenidate
Intervention type(s): Drug
Intervention description(s): Ritalin 10mg, Ritalin 20mg
Other intervention name(s): Ritalin
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effects of Atorvastatin Versus Probucol on Small Dense LDL
Condition: Chronic Nephropathy
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Small dense low-density lipoprotein (LDL) plays an important role in causing glomerular
      injury through conversion to an oxidatively modified form of LDL. However, few studies
      evaluated the effects of antilipidemic agents on the LDL particle size and renoprotective
      actions in hyperlipidemic patients with non-diabetic nephropathy.
    

Detailed description: 
      The study is a randomized crossover trial comparing the effect of atorvastatin (10 mg/day)
      and probucol (500 mg/day) for 24 weeks in 30 patients (urinary albumin excretion 0.3-2.0
      g/day, and creatinine clearance > 30 ml/min/1.73 m2 or serum creatinine concentration < 2
      mg/L). Lipid parameters, mean LDL particle diameter, creatinine clearance, and urinary
      albumin to creatinine excretion ratio are measured before and during treatment periods. It
      will be evaluated that, first, whether atorvastatin and probucol significantly reduce serum
      total cholesterol and LDL cholesterol concentrations, second, whether atorvastatin and
      probucol significantly increase the LDL particle size, third, whether significant differences
      in urinary albumin/creatinine excretion ratio and creatinine clearance are observed in both
      groups during treatment.
    

Intervention name(s): Effects of atorvastatin versus probucol on small dense LDL
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin; Probucol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: small dense LDL
Nutritional Education and the Prevention of Iron Depletion in Children 9 Months to 2 Years
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      Iron depletion in young children is common and may progress to iron deficiency anemia which
      is associated with irreversible neurodevelopmental effects. Efforts to prevent iron depletion
      are key to preventing these effects. In a recent study of 150 young children (12 to 38
      months), we found that bottle fed children were almost three times as likely to be iron
      depleted compared with cup fed children (37% vs 18%). Thus, we hypothesize that an
      educational intervention designed to encourage timely bottle weaning will lead to a reduction
      in iron depletion.
    

Detailed description: 
      We plan to undertake a randomized controlled trial to evaluate the effectiveness of an
      office-based educational intervention for the prevention of iron depletion in young children.
      Healthy children will be recruited from a community pediatric office which serves a diverse,
      urban population. Children will be randomized to the intervention education group or the
      control education group at 9 months of age. Blood work (~4mL) for complete blood count and
      ferritin along with additional measures such as transferrin, iron, and reticulocyte count
      will be obtained at 24 months of age. Rates of iron depletion and anemia will be compared in
      the two groups. The two groups will also have 25-hydroxy vitamin D, calcium and alkaline
      phosphatase levels analyzed at the 24 month visit to ensure that the intervention for
      prevention of iron depletion does not adversely affect these measures.
    

Intervention name(s): Healthy milk intake; Standard nutrition counselling
Intervention type(s): Other; Other
Intervention description(s): In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.; Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Iron depletion; Children; Educational intervention; Office-based
Efficacy and Safety of Norketotifen in Adults With Allergic Rhinitis
Condition: Allergic Rhinitis; Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a study to evaluate the efficacy and safety of Norketotifen (NKT) in
      subjects with allergic rhinitis.
    

Detailed description: 
      This is a single-center, double-blind, randomized, placebo-controlled, 3-way crossover study
      evaluating the efficacy and safety of NKT in adult subjects with allergen-induced allergic
      rhinitis in an allergen challenge chamber.
    

Intervention name(s): Norketotifen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Norketotifen oral capsule; Placebo oral capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules
      under fed condition.
    

Detailed description: 
      This is a randomized, two-treatment, two-period, two-sequence, single dose, crossover
      bioequivalence study to compare Omeprazole 40 mg Delayed Release Capsules (Dr. Reddy's
      Laboratories Ltd.,) with Prilosec® 40 mg (Omeprazole Delayed Release Capsules) (manufactured
      by Merck & Co., Inc., USA) in 54 healthy, adult, human subjects under fed conditions.
    

Intervention name(s): Omeprazole; Prilosec® 40 mg
Intervention type(s): Drug; Device
Intervention description(s): Omeprazole Delayed Release Capsules 40 mg; Prilosec® 40 mg
Other intervention name(s): Prelosec 40 mg; Omeprazole
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis
Condition: Carotid Stenosis
MeSH terms: Carotid Stenosis; Constriction, Pathologic
Study type: Observational

Summary: 
      This study aims to evaluate ocular changes in patients with carotid artery stenosis by
      optical coherence tomography angiography before and after carotid artery revascularization
      procedure.
    

Detailed description: 
      A growing body of research indicates that abnormal ocular microvascular features may serve as
      a novel biomarker reflecting the severity of underlying cardiovascular, neurodegenerative,
      and microvascular disease. Since blood flow to the retina is predominantly supplied by the
      internal carotid artery (ICA), we hypothesized that ocular microvasculature and structure
      changes may reflect the disease status or therapeutic effects in patients with carotid artery
      stenosis.

      Optical coherence tomography angiography (OCTA) is a novel, non-invasive imaging modality
      that can be a reliable tool for the qualitative and quantitative assessments of ocular
      vessels during various ocular pathological or physiological changes. Recent studies have also
      demonstrated the ability of OCTA to quantify retinal microvascular changes in monitoring
      cardiovascular risk.

      This study aims to evaluate ocular changes in patients with carotid artery stenosis by
      optical coherence tomography angiography before and after carotid artery revascularization
      procedure.In this study, the patients with carotid artery stenosis and control group will
      receive a series of cerebral and ocular examinations including the most important cerebral CT
      perfusion (CTP) and OCTA. After that, the cerebral and ocular data between the two groups
      will be compared. Also, the preoperative and postoperative data acquired will be compared.
    

Intervention name(s): Carotid artery revascularization procedure; Optical coherence tomography angiography
Intervention type(s): Procedure; Device
Intervention description(s): The patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization procedure.; Examination will be performed using optical coherence tomography angiography. This device allows quantitative analysis, since it provides numerical data about flow area and flow density maps.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with carotid artery stenosis undergoing cerebral and eye examination and in
        routine clinical practice will be included
      
Keywords: Carotid Stenosis; OCTA
To Evaluate the Bioavailability of a Single Oral Dose of the Acetylsalicylic Acid Containing Dry Powder 500 mg in Comparison to the Bioavailability of a Single Oral Dose of Aspirin Tablets and Aspirin Effervescent Tablets in Healthy Adults.
Condition: Pharmacology, Clinical
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the bioavailability of a single oral dose of the Acetylsalicylic Acid containing
      dry powder 500 mg in comparison to the bioavailability of a single oral dose of aspirin
      tablets and aspirin effervescent tablets in healthy adults.
    


Intervention name(s): Aspirin (Acetylsalicylic acid, BAYe4465); Aspirin (Acetylsalicylic acid, BAYe4465); Aspirin (Acetylsalicylic acid, BAYe4465)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One stick pack containing 500 mg acetylsalicylic acid dry powder; One tablet containing 500 mg acetylsalicylic acid; One effervescent tablet containing 500 mg acetylsalicylic acid
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Enhancement and Restoring of Low Dose Abdominal CT Images
Condition: Radiation Protection
Study type: Interventional
Phase: Phase 1

Summary: 
      Through the rapid growth of multislice Computer Tomography (CT) imaging, radiation protection
      has become a major issue in the radiological community. Optimizing CT scanning is a key task
      when keeping the radiation doses as low as reasonable achievable (the ALARA principle). Post
      processing filters can improve and restore grainy and noisy low dose CT images by enhancing
      structure and reducing image noise. In our study of 10 patients, the investigators perform a
      preliminary evaluation of a novel post processing filter, which does picture element
      correlations in all three spatial dimensions. By comparing normal dose pictures with
      unprocessed low-dose pictures and pictures processed with two dimentional (2D) and three
      dimentional (3D) filters,the investigators will be able to assess the possible clinical value
      of the 3D filter. This project is collaboration between Buskerud Hospital (BU), Buskerud
      University College, Norwegian Radiation Protection Authority (NRPA) and Center for Medical
      Image Science and Visualization (CMIV). The project is part of the PhD of Lars Borgen.
    


Intervention name(s): Using a 3 dimentional post processing filter
Intervention type(s): Other
Intervention description(s): Using a 3 dimentional post processing filter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
The Effect Of Multiple Occupational Therapies On Functional Remission And Subjective Recovery For Schizophrenia
Condition: Occupational Therapy; Schizophrenia; Remission; Well-Being, Psychological
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Objective: This study aimed to evaluate the effect of multiple occupational therapies on
      functional remission and subjective recovery of individuals with schizophrenic disorder.
      Methods: 26 people with schizophrenic disorder were divided into two groups using a random
      number table. The intervention group participated in routine community mental health center
      services and a total of 24 sessions of occupational therapies three times a week, while the
      control group participated in routine community mental health center services.
    

Detailed description: 
      Background: Occupational therapies are one of the psycho-social intervention methods used in
      the treatment of serious mental disorders characterized by disability, such as schizophrenia.

      Objective: This study aimed to evaluate the effect of multiple occupational therapies on
      functional remission and subjective recovery of individuals with schizophrenic disorder.

      Methods: 26 people with schizophrenic disorder were divided into two groups using a random
      number table. The intervention group participated in routine community mental health center
      services and a total of 24 sessions of occupational therapies three times a week, while the
      control group participated in routine community mental health center services. Data were
      collected using the Subjective Recovery Assessment Scale and the Functional Remission of
      General Schizophrenia Scale.
    

Intervention name(s): occupational therapies
Intervention type(s): Behavioral
Intervention description(s): music, garden-soil and sports practices for individuals diagnosed with schizophrenic disorder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Shizophrenic Disorder; Occupational Therapy; Remission; Well-Being, Psychological
The Effect of Iloprost on Capillary Recruitment and Insulin Sensitivity in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Insulin Sensitivity/Resistance
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      This study examines the effects of iloprost - a stable prostacyclin analogue - on
      insulin-mediated muscle capillary recruitment and whole-body glucose uptake in a cross-over
      design.
    

Detailed description: 
      In type 2 diabetes impaired insulin-mediated muscle perfusion is thought to contribute to
      reduced whole-body glucose uptake. This study aims to identify iloprost - a stable
      prostacyclin analogue - as a possible therapeutic option to increase whole-body glucose
      uptake via enhancement of muscle perfusion.

      All participants will be subjected to two hyperinsulinemic-euglycemic clamps; one with and
      one without simultaneous iloprost infusion in a randomized cross-over design. Microvascular
      blood volume will be measured by means of contrast-enhanced ultrasonography.
    

Intervention name(s): Iloprost infusion
Intervention type(s): Drug
Intervention description(s): Iloprost is a stable prostacyclin analogue
Intervention MeSH terms: Iloprost
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Capillary recruitment