bioihbjkbjnl/mcl2 huggingface dataset:
Low-dose Dual-energy CT for the Pre-surgical Planning of Patients With Progression of Scoliosis
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      The aim of the study is to evaluate the diagnostic accuracy of low-dose dual energy CT in the
      pre-surgical planning of patients with progression of scoliosis
    

Detailed description: 
      CT imaging is the gold standard for assessing bone dysmorphism and vertebral morphometry
      during the pre-surgical planning of vertebral arthrodesis. It is necessary in the definition
      of the fixation points to avoid malposition of transpedicular screws and potential visceral,
      vascular or neurological damage.

      It is known that multislice CT involves an increased radiation exposure for patients, while
      dual-energy CT uses a low-dose acquisition protocol and VEO reconstruction software.

      The aim of the study is to evaluate the diagnostic accuracy of low-dose dual energy CT in the
      pre-surgical planning of patients with progression of scoliosis who are candidated for
      vertebral arthrodesis.
    

Intervention name(s): GE CT 750 HD
Intervention type(s): Diagnostic Test
Intervention description(s): Low-dose dual-energy CT imaging
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with progression of scoliosis selected at the Rizzoli Orthopaedic Institute
      
Keywords: scoliosis; low dose; arthrodesis; dual-energy CT
Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of GSK1278863A in Healthy Subjects
Condition: Anaemia
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK1278863A is a novel small molecule agent, which stimulates erythropoiesis through
      inhibition of hypoxia-inducible factor (HIF)-prolyl hydroxylases (EGLNs). This compound is
      being developed for the treatment of anemia. This study, PHI115385, will be the first
      administration of GSK1278863A to Japanese subjects to investigate the safety, tolerability,
      pharmacokinetics, and pharmacodynamics of single oral doses in healthy Japanese adult
      subjects. Healthy Caucasian adult subjects will be included in order to compare
      pharmacokinetics of GSK1278863A and its metabolite(s), and pharmacodynamics of GSK1278863A.
    


Intervention name(s): GSK1278863A Placebo; GSK1278863A
Intervention type(s): Drug; Drug
Intervention description(s): Matching size, shape and color; A round, biconvex, white film coated tablet
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Fruquintinib Renal Impairment Study
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      A multicenter, open label, single-dose, single-period, sequential study to assess the effect
      of renal impairment on the pharmacokinetics of Fruquintinib
    

Detailed description: 
      This is a multicenter, open label, single-dose, single-period, sequential study in subjects
      without cancer with the primary objective of determining the effect of severe and moderate
      renal impairment on the PK of Fruquintinib. The secondary objective is to evaluate the safety
      in subjects severe and moderate renal impairment and subjects with normal function.

      Initially, subjects with severe renal impairment and subjects with moderate renal impairment
      will be enrolled. Subjects with normal renal function will be enrolled after all other
      subjects have completed the study and will be matched for sex, age and body mass index.
      Subjects with renal impairment will be enrolled based on the renal function classification
      determined by Cockcroft-Gault scoring.

      Subjects with severe renal impairment will receive a single dose of 2 mg fruquintinib to
      account for potential increase in fruquintinib pharmacokinetic (PK) exposure. Subjects with
      moderate renal impairment or normal renal function will receive a single dose of 5 mg
      fruquintinib.
    

Intervention name(s): Fruquintinib
Intervention type(s): Drug
Intervention description(s): Fruquintinib will be administered as a single dose on the morning of Day 1 under fasting conditions
Other intervention name(s): HMPL-013
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Portion Size Over 5 Days in Preschool Children
Condition: Feeding Behavior
Study type: Interventional

Summary: 
      In this study, the investigators varied the portion size of all meals served during two 5-day
      periods. During one period, baseline amounts of all foods and beverages were served, and
      during the other, the portion size of all items was increased by 50%. The primary aim of the
      study is to determine the effect of varying the portion size of foods and beverages served
      over 5 days on energy intake in preschool children.
    


Intervention name(s): Food and Beverage Portion Size
Intervention type(s): Other
Intervention description(s): Variations of Food and Beverage Portion Size (100% Baseline portions and increased 50% for 150% portions)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
The Effect Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has been designed to investigate the effect of lersivirine on the QT/QTc interval
      in order to help establish the safety profile of lersivirine.
    


Intervention name(s): Lersivirine; Placebo; Lersivirine (if necessary); Lersivirine; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Lersivirine 2400 mg single dose; Placebo single dose; Lersivirine 2100 mg single dose (if necessary); Lersivirine 2400 mg single dose (dose may be decreased pending Part A tolerability results); Placebo single dose; Moxifloxacin 400 mg single dose
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: lersivirine QT QTc ECG HIV NNRTI
A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The reason for this study is to see if the study drug LY3471851 (NKTR-358) is safe and
      effective in adults with systemic lupus erythematosus (SLE).
    

Detailed description: 
      LY3471851 is a potential first-in-class therapeutic that may address an underlying immune
      system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2)
      receptor complex in the body in order to stimulate proliferation of inhibitory immune cells
      known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune
      system back into balance.
    

Intervention name(s): LY3471851; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): NKTR-358
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: T regulatory cells (Tregs); Interleukin 2; Interleukin-2
Single-Dose Pharmacokinetics and Safety of Oral Lofexidine in Hepatically-Impaired Subjects
Condition: Liver Failure
MeSH terms: Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, parallel-group, single-dose study of lofexidine in 6 adult
      subjects with mild hepatic impairment (Child Pugh score of 5 6), 6 adult subjects with
      moderate hepatic impairment (Child Pugh score 7 9), 6 adult subjects with severe hepatic
      impairment (Child Pugh score 10 15), and 6 control subjects with normal hepatic function with
      mean age, body mass index (BMI), and gender distribution targeted to be similar to the
      impaired hepatic function cohorts.
    

Detailed description: 
      This is a Phase 1, open-label, parallel-group, single-dose study of lofexidine in 6 adult
      subjects with mild hepatic impairment (Child Pugh score of 5 6), 6 adult subjects with
      moderate hepatic impairment (Child Pugh score 7 9), 6 adult subjects with severe hepatic
      impairment (Child Pugh score 10 15), and 6 control subjects with normal hepatic function with
      mean age, body mass index (BMI), and gender distribution targeted to be similar to the
      impaired hepatic function cohorts. Subjects will be confined to an inpatient facility from
      the evening before dosing to 144 hours after dosing.

      Subjects who successfully complete screening will report to the inpatient facility at an
      appropriate time the evening before study drug administration (Day 1) to ensure a minimum 10
      hour fast. The next morning (Day 1) while still fasting, subjects will receive a single, oral
      dose of 400 µg lofexidine HCl (two 200 µg tablets). Blood samples will be collected for
      pharmacokinetic (PK) analysis at multiple time points over the next 144 hours (Day 7). Pooled
      urine samples will be collected at 0 3 hours, 3 6 hours, 6 12 hours, 12 24 hours, 24 48
      hours, 48 96 hours, 96 120 hours and 120 144 hours post-dose. Safety will be assessed by
      recording adverse events (AEs), measuring vital signs (blood pressure and pulse rate) and
      clinical laboratory tests (chemistry, hematology, and urinalysis), recording 12 lead safety
      and Holter electrocardiograms (ECGs), and performing physical exams.
    

Intervention name(s): Lofexidine Hydrochloride (HCl) tablets
Intervention type(s): Drug
Intervention description(s): Lofexidine HCl tablets (two 200 µg tablets) will be administered orally with 240 mL room temperature tap water as a single 400 µg dose in the morning on Day 1 after a 10 hour overnight fast.
Intervention MeSH terms: Lofexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatic, hepatic impairment, lofexidine
Stress Management for Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The primary goal of this study is to test the efficacy of emotional awareness and expression
      training (EAET), a novel emotional processing intervention that the investigators have
      developed, for people with IBS. In this randomized, controlled trial, the investigators will
      compare EAET to a standard intervention that teaches the conceptually opposite
      approach-relaxation training (RT)-and test how both of these interventions compare to a
      wait-list control condition. The investigators hypothesize that individuals in the EAET group
      will demonstrate greater improvement in their IBS symptom severity, psychological
      functioning, quality of life, and health care utilization at 4 and 12-week follow-up time
      points, compared to individuals in the wait-list control group. It is also expected that both
      of the active interventions (EAET and RT) will be more efficacious than the wait-list control
      condition.
    


Intervention name(s): Emotional Awareness and Expression Training; Relaxation Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An emotional processing intervention, which aims to reduce stress by helping patients become aware of, and express emotions related to stressful life experiences, as well as teaching patients how to relate to others differently.; Teaches patients different relaxation training skills to reduce their distress and discomfort (i.e., progressive muscle relaxation, applied relaxation, or guided imagery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IBS; Relaxation; Emotional exposure; Emotional Processing
Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects
Condition: Dietary Modification
Study type: Interventional

Summary: 
      Dyslipidemia is among the risk factors for cardiovascular diseases (CVD). Is's due to genetic
      and / or environmental factors such as inadequate dietary pattern. The occurrence of adverse
      events with statins, added to recent questions about their benefits on hard outcomes, opens a
      gap for the importance of seeking other forms of treatment of dyslipidemia, particularly in
      patients for secondary prevention. The consumption of oat bran, beta-glucan source of dietary
      fibers with supposed action in reducing the absorption of exogenous cholesterol and the
      endogenous synthesis of it, and source of avenanthramides, phytochemical compounds with
      alleged antioxidant in lipid membranes, can be effective strategy for secondary prevention of
      atherosclerotic disease.
    

Detailed description: 
      Objectives: To evaluate the effect of nutritional counseling associated with the consumption
      of oat bran (40g per day) in lowering cholesterol, glucose profile and anthropometric
      parameters of subjects in secondary prevention, evaluate the quality of the diet and the
      intake of processed foods and ingredients added.

      Methods: A randomized block, double-blind, placebo-controlled trial lasting 90 days.
      Inclusion criteria: individuals aged greater than 20 years, both genders, with LDL-c equal or
      higher than 130mg/dL fasting lipemia. Eligible individuals were considered using oral
      lipid-lowering, since the dose reported in the early nutritional intervention was maintained
      during the study. Exclusion criteria: patients requiring reduction in daily fluid intake,
      supplement use in dietary fiber and gestation / lactation. Data collected: gender; age;
      education; drugs; body mass (BM), height, body mass index (BMI), waist circumference (WC),
      neck circumference (NC); blood pressure; dietary surveys, total cholesterol (TC), LDL-C,
      HDL-cholesterol (HDL-c), triglycerides (TG), fasting glucose (GLU), fasting insulin (INS),
      HOMA-IR and QUICK. The diet quality was evaluated at baseline and end of study through the
      Diet Quality Index Revised (IQD-R). The sample size calculation was performed from a pilot
      study. It came to the need for 63 subjects for each group, oat bran group (GFAV) and placebo
      group (GPL). The level of statistical significance was 5% (p <0.05).
    

Intervention name(s): oat bran - 40g; refined rice flour- 40g
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): oat bran - 40g per day; refined rice flour - 40g per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nutritional counseling; oat bran; dyslipidemia; cardiovascular disease
Does Asthma Phenotype Have Impact on Disease Control
Condition: Asthma
MeSH terms: Asthma
Study type: Observational [Patient Registry]

Summary: 
      The application of biomarkers that are more closely associated with eosinophillic airway
      inflammation, such as measurements of FeNO level, cell count in induced sputum or bronchial
      reactivity could improve asthma control by better directing treatment. A systematic review
      and meta-analysis is to be conducted to assess the efficacy of tailoring asthma intervention
      on clinical symptoms compared with exhaled nitric oxide or induced sputum count.
    

Detailed description: 
      AHR used as outcome
    

Intervention name(s): Pulmicort
Intervention type(s): Drug
Intervention description(s): ACQ and FeNO
Other intervention name(s): RCT study
Intervention MeSH terms: Budesonide
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Newly referred asthma patients
A Multicenter Assessment of ALD403 in Chronic Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess ALD403 in the prevention of migraine headache in
      chronic migraineurs.
    


Intervention name(s): ALD403; Placebo
Intervention type(s): Biological; Biological
Other intervention name(s): Eptinezumab-jjmr; Vyepti
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Migraine Disorders; ALD403
IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically
      infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
    


Intervention name(s): Ribavirin (RBV); BI 201335 (Faldaprevir); Ribavirin (RBV); BI 207127; BI 201335 (Faldaprevir); Ribavirin (RBV); BI 207127; Faldaprevir (BI 201335); BI 207127
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 24 weeks of active RBV; 16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335; 24 weeks of active RBV; 24 weeks of BI 207127; 24 weeks of BI 201335; 16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin; 16 weeks BI 207127 followed by 8 weeks placebo to BI 207127; 24 weeks of 201335; 24 weeks of BI 207127
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Safety and Tolerability Study of an Edible Colon Preparation
Condition: Bowel Preparation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to learn about a new bowel preparation that uses food to clean
      the colon.

      In order to learn about this new food preparation, some people in this study will get the
      food preparation, and others will get the standard liquid bowel preparation.

      Patients will be randomized (like flipping a coin) to one of five groups:

      Group 1 - Menu A Meal Kit - contains bars, shakes, soup, and a rice bowl Group 2 - Menu B
      Meal Kit - contains bars, shakes, soup, and a rice bowl Group 3 - Menu C Meal Kit - contains
      bars and shakes Group 4 - MoviPrep Group 5 - NuLYTELY
    

Detailed description: 
      The purpose of this Phase 2 formulation screening/proof of concept study is to evaluate the
      safety, tolerability, and efficacy of up to 3 ECP-019 formulations/dosing regimens comprising
      a PEG 3350 Colon Prep Kit, containing electrolytes provided by the foods, in 3 formulations/
      dosing regimens as compared to 2 comparators in a Phase 2 study.
    

Intervention name(s): NuLYTELY® (PEG 3350); ECP-019; MoviPrep® (PEG 3350)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Colonoscopy; Preparation
Safety Study Looking at the Effects of Stendra on Vision
Condition: Vision
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if Stendra causes any changes in vision, eye pressure,
      pupil dilation, and color vision in healthy males.
    

Detailed description: 
      The objectives of this study are to assess the effect of Stendra on visual acuity,
      intraocular pressure, pupillometry, and color vision discrimination in healthy male subjects.
    

Intervention name(s): Stendra 200 mg; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): avanafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vision; Stendra; avanafil; PDE5 inhibitor; visual acuity; intraocular pressure; pupillometry; color vision discrimination; healthy males
TOCCATA - Touch+™ for Catheter Ablation
Condition: Atrial Fibrillation; Tachycardia, Supraventricular
MeSH terms: Atrial Fibrillation; Tachycardia; Tachycardia, Supraventricular
Study type: Interventional

Summary: 
      The main objective of this study is to demonstrate the clinical safety of a contact force
      sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and
      atrial fibrillation. In addition, the study will characterize the use and value of contact
      force measurement during ablation, and the long term success (12 months) of the ablation
      procedure using this technology.
    

Detailed description: 
      Safety: The primary safety endpoint assesses the incidence of procedure or device related
      SAEs from procedure to 7 (±1) days post-procedure or hospital discharge, whichever is longer,
      for patients with right-sided SVT or 3 months (±2 weeks) post-procedure for patients with
      atrial fibrillation. Secondary safety objectives were to demonstrate safety (operative and
      post-operative complications) over the 12 months post-procedure.

      Performance: The primary performance endpoint is to demonstrate successful catheter
      deployment, irrigation and ablation at the target area during supra-ventricular cardiac
      ablation. The secondary performance endpoint is to demonstrate successful and effective
      contact force reading between catheter tip and heart wall during mapping and ablation at all
      locations and all angulations.

      Efficacy: Secondary effectiveness objectives will consider acute and chronic elimination of
      the target arrhythmia, the cost-effectiveness of the system and procedure-related parameters
    

Intervention name(s): Contact force assisted irrigated RF ablation
Intervention type(s): Device
Intervention description(s): radiofrequency ablation of atrial fibrillation or SVT
Other intervention name(s): TactiCath®; TactiSys®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial Fibrillation; Supraventricular Tachycardia; Contact Force; RF Ablation; Radiofrequency; Pulmonary Vein Isolation; Paroxysmal Atrial Fibrillation