bioihbjkbjnl/mcl2 huggingface dataset:
Inspiratory Muscle Therapy in Subjects With Fontan Circulations
Condition: Single-ventricle
MeSH terms: Respiratory Aspiration; Univentricular Heart
Study type: Interventional

Summary: 
      Individuals who have undergone the Fontan procedure are uniquely dependent upon respiratory
      mechanics to support pulmonary blood flow (PBF). The investigators hypothesized that enhanced
      respiratory muscle function via inspiratory muscle training (IMT) would improve performance
      on cardiopulmonary exercise stress testing (CPET).
    

Detailed description: 
      Adult Fontan subjects were recruited from 2 academic medical centers. Following
      characterization of pulmonary function and functional class, CPET was performed using
      incremental and constant work rate protocols. Subjects performed 6-8 weeks of IMT using a
      handheld inspiratory loading device (Threshold®, Philips); both exercise tests were then
      repeated. Patient-centered outcome data were collected before and after IMT (RAND-36
      assessment and New York Heart Association (NYHA) functional class).
    

Intervention name(s): Inspiratory muscle therapy
Intervention type(s): Device
Intervention description(s): 6 weeks of inspiratory muscle therapy
Other intervention name(s): No other interventions. Subjects will serve as their own control; single arm study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Iron Interventions and Non-transferrin-bound Iron (NTBI) in Women
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      The overall goal of this research is to develop safe and effective iron interventions that
      can be administered without production of plasma non-transferrin-bound iron (NTBI: iron in
      the systemic circulation not bound to the iron-transport protein transferrin). The appearance
      of plasma non-transferrin-bound iron has been reported in uninfected adult volunteers after
      oral administration of iron supplements in doses similar to those used in the Pemba trial.
      This research project will (i) confirm the appearance of plasma non-transferrin-bound iron
      after administration of an iron supplement like that in the Pemba trial (~1 mg Fe/kg body
      weight, without food), and then determine the effects on production of plasma
      non-transferrin-bound iron and on iron absorption measured with stable isotopes (ii) of
      giving the supplemental iron (~1 mg Fe/kg) with the standard rice meal, and (iii) of giving a
      lower dose of iron (~0.1 mg Fe/kg) - like that used in home fortification - with the standard
      rice meal.
    


Intervention name(s): Ferrous sulfate; Ferrous sulfate; Ferrous sulfate
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 60 mg Ferrous sulfate; 60 mg ferrous sulfate; 6 mg ferrous sulfate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: NTBI; Iron; Absorption
Codeine in Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this study is to determine if a subject's genetic make-up would affect the
      treatment response to codeine in subjects with sickle cell disease.
    

Detailed description: 
      People with sickle cell disease require oral pain medications to manage an acute pain crisis.
      Sometimes these individuals fail to obtain adequate pain relief with the medications
      prescribed for outpatient use resulting in emergency room visits and hospital admissions.
      Subsequently, many patients are admitted to the hospital for pain management for a few days
      until the pain crisis resolves. The most common medications prescribed to sickle cell
      individuals for outpatient use include codeine and hydrocodone containing medications (i.e.
      Tylenol #3™, Vicodin™, Lortab™). These medications must be broken down in the body to make
      the active pain reliever (morphine or hydromorphone, respectively). Some individuals may not
      be able to break down these medications to the active pain reliever; therefore, these
      individuals will likely continue to experience pain unless they take other pain medications.
      We will determine whether genotype estimates the ability of CYP2D6 to break down codeine to
      the active pain reliever in individuals with sickle cell disease.
    

Intervention name(s): Codeine (30 mg)
Intervention type(s): Drug
Intervention MeSH terms: Codeine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: codeine; pain; CYP2D6; genotype; morphine; sickle cell; pharmacokinetic
Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients
Condition: Kidney Transplant; Complications
Study type: Interventional

Summary: 
      The aim of this study is to determine if amiloride, a diuretic drug, is capable of increasing
      renal salt excretion, lowering blood pressure and inhibiting uPA in kidney transplant
      recipients with proteinuria compared to normoalbuminuric transplant patients.
    


Intervention name(s): Standardized sodium diet; Tbl amiloride
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Dietary Supplement: Standardized salt diet 150 mmol NaCl per day given as three meals daily for 5 consecutive days.; Drug: Amiloride Amiloride tablet 10 mg two times daily (morning and afternoon) for one day
Other intervention name(s): Diet; Amiloride
Intervention MeSH terms: Amiloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental: Kidney transplant recipients with ACR > 300mg/g receiving standardized sodium diet (150 mmol NaCl/day) for 5 days and amiloride tablet 10 mg two times daily (morning and afternoon) on the last day.
Interventions:◦Dietary Supplement: Standardized salt diet
◦Drug: Amiloride
•Experimental: Kidney transplant recipient with ACR< 30mg/g (Control) receiving a standardized salt diet (150 mmol NaCl/day) for 5 days, then amiloride tablet 10 mg two times daily (morning and afternoon) for 1 day.
Interventions:◦Dietary Supplement: Standardized salt diet
◦Drug: Amiloride
Masking: None (Open Label)
Primary purpose: Basic Science
Input of the Use of Indometacin in Gitelman Syndrome as Compared to Potassium Sparing Diuretics
Condition: Gitelman Syndrome
MeSH terms: Gitelman Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Gitelman syndrome is a rare renal disease where the kidneys are unable to normally retain
      some salts (sodium, potassium and magnesium). Main consequences of these renal leaks of salts
      are a tendency toward low blood pressure, hypokalemia and hypomagnesemia both contributing to
      cardiac and muscles symptoms.
    

Detailed description: 
      Patients with received in random order 75mg/day indometacin (Chronoindocid®), 10-20 mg/day
      amiloride and 50-150 mg /day eplerenone (Inspra ®). The three 6 weeks-periods of treatment
      will be followed by six weeks washout period. 3-6 weeks before the first period of treatment,
      a supplementation with potassium and magnesium will be orally given, and maintained at the
      same dose throughout the study and stoped 6 weeks after the end of the third period of
      treatment.
    

Intervention name(s): TREATMENT
Intervention type(s): Drug
Intervention description(s): Patients with received in random order 75mg/day indometacin(chronoindocid®), 10-20 mg/day amiloride and 50-150 mg /day eplerenone (Inspra ®). The three 6 weeks-periods of treatment will be followed by six weeks washout period. 3-6 weeks before the first period of treatment, a supplementation with potassium and magnesium will be orally given, and maintained at the same dose throughout the study and stoped 6 weeks after the end of the third period of treatment.
Other intervention name(s): MODAMINE; Inspra and CHRONOINDOCID
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypokalemia; Hypomagnesemia; Salt loosing nephropathy
Mechanisms Underlying Drug-Diet Interactions
Condition: Pharmacokinetics
Study type: Interventional

Summary: 
      Similar to the well publicized "grapefruit juice effect", ongoing studies are evaluating the
      interaction potential of other dietary substances on drug disposition. This study is designed
      to determine whether the mechanism underlying the enhancement of the anticoagulative effect
      of warfarin by cranberry juice is due to inhibition of warfarin metabolism by the juice. A
      secondary objective is to determine whether cranberry juice elicits a grapefruit juice-type
      interaction with midazolam.
    


Intervention name(s): warfarin, vitamin K, midazolam
Intervention type(s): Drug
Intervention description(s): warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)
Other intervention name(s): Coumadin; Mephyton; Versed
Intervention MeSH terms: Vitamin K; Midazolam; Warfarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: warfarin; midazolam; cranberry juice; pharmacokinetics
Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat
      content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR)
      index, and anthropometric measurements (body mass index and waist circumference)in diabetic
      subjects with non-alcoholic fatty liver disease.
    

Detailed description: 
      Helicobacter pylori (HP) antigens have been found in the liver of individuals with benign and
      malignant liver diseases. The role of HP in the pathogenesis of non-alcoholic fatty liver
      disease (NAFLD) is controversial.

      This randomized double blind clinical trial was performed in diabetic dyspeptic patients with
      positive antibody to HP and the evidence of fatty liver in ultrasonography. After excluding
      other causes, participants with persistent elevated serum aminotransferase levels were
      presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and positive
      urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle modification
      alone or lifestyle modification plus HP eradication groups. Quadruple therapy (omeprazole,
      amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was performed in two
      weeks. HP eradication was documented by UBT. Liver fat content, fasting serum glucose,
      alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride,
      cholesterol, high and low-density lipoprotein, HOMA-IR, and anthropometric measurements (body
      mass index and waist circumference) were checked at baseline and six weeks post-treatment.
    

Intervention name(s): H.pylori eradication
Intervention type(s): Drug
Intervention description(s): The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks
Other intervention name(s): Helicobacter pylori treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Steatohepatitis,; Helicobacter pylori,; Insulin resistance,; Alanine aminotransferase,; Aspartate aminotransferase,
Effects of Almond Versus Pistachio on Weight Loss
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of the current study is comparing the effect of almond and pistachio, as the two
      common types of nuts, consumption on healthy obese and overweight female who following a
      hypocaloric diet for 12 weeks. The secondary aim of the current study is to evaluate of these
      two type of nuts on other cardiometabolic risk factors.
    


Intervention name(s): Almond Group; Pistachio Group; Nut free group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Obese or overweight female adults will be randomly allocated to have almond as afternoon snacks, while they have a hypoenergetic diet.; Obese or overweight female adults will be randomly allocated to have Pistachio as afternoon snacks, while they have a hypoenergetic diet.; Obese or overweight female adults will be asked to avoid nuts, seeds and nut products, while they have a hypoenergetic diet.
Other intervention name(s): AG; PG; NFG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: weight loss; Almond; Pistachio; hypoenergetic diet; Nut
Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      Watson's testosterone transdermal system delivers male sex hormone through skin for the
      treatment of men with sex hormone insufficiency.
    

Detailed description: 
      The present study is designed to characterize efficacy and safety of testosterone from the
      Watson's testosterone matrix transdermal system (TMTS).
    

Intervention name(s): testosterone matrix transdermal system
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypogonadism, testosterone, transdermal system
Effects of Coenzyme Q10 Supplementation on Oxidative Stress, Antioxidant Capacity, Inflammatory Responses, Fatigue Elimination, and Exercise Performance in Athletes
Condition: Athlete
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The aims of the study are 1) to compare the differences in plasma coenzyme Q10, oxidative
      stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and
      exercise performances in athletes (i.e., soccer, and taekwondo players) and healthy
      non-athletes; 2) to investigate the relationship between plasma coenzyme Q10, oxidative
      stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and
      exercise performances; 3) to explore the influence on plasma coenzyme Q10, oxidative stress,
      antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and exercise
      performances after 12 weeks of coenzyme Q10 intervention (150 mg/day and 300 mg/day).
    

Detailed description: 
      The long-term high-amount and -intensity exercise training could cause oxidative damage,
      muscle impairment, inflammation and exercise fatigue to athletes easily. Such above
      conditions will affect the exercise performances and health of athletes. The aims of the
      study are 1) to compare the differences in plasma coenzyme Q10, oxidative stress, antioxidant
      capacity, muscle impairment, fatigue recovery, and inflammation and exercise performances in
      athletes (i.e., soccer, and taekwondo players) and healthy non-athletes; 2) to investigate
      the relationship between plasma coenzyme Q10, oxidative stress, antioxidant capacity, muscle
      impairment, fatigue recovery, and inflammation and exercise performances; 3) to explore the
      influence on plasma coenzyme Q10, oxidative stress, antioxidant capacity, muscle impairment,
      fatigue recovery, and inflammation and exercise performances after 12 weeks of coenzyme Q10
      intervention (150 mg/day and 300 mg/day). Eventually, these results of this study can provide
      the information for the known to improve the oxidative stress, anti-oxidation and
      inflammation internal to the bodies of athletes for various competitions. As a consequence,
      the athletic performances can be further enhanced.
    

Intervention name(s): Placebo; Coenzyme Q10
Intervention type(s): Other; Dietary Supplement
Intervention description(s): Placebo (dextrin); 150 mg or 300 mg
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: placebo-control
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
A Study to Evaluate Safety, Tolerability, Plasma Drug Levels, and Cognitive Response Following Multiple Doses of a Drug in Healthy Elderly Participants.
Condition: Healthy; Elderly
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the safety and tolerability of PF-04447943 after administration of multiple doses in
      healthy elderly participants. Evaluate plasma drug levels and effects on cognition.
    


Intervention name(s): PF-04447943; PF-04447943; PF-04447943; PF-04447943; PF-04447943
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days.; Planned oral dose is PF-04447943, 15 mg q12 hours for 7 days.; Planned oral dose is PF-04447943, 35 mg q12 hours for 7 days. Actual dose may be adjusted based on pharmacokinetic and other data from prior dose cohorts.; Planned oral dose is PF-04447943, 35 mg q12 hours for 7 days. Actual dose may be adjusted based on pharmacokinetic and other data from prior dose cohorts.; Planned oral dose is PF-04447943, 35 mg q12 hours for 14 days. Actual dose may be adjusted downward based on pharmacokinetic and other data from prior dose cohorts.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: elderly, multi-dose, safety, efficacy
The Effects of RPL554 on Top of Standard COPD Reliever Medications
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the addition of RPL554 to standard reliever medications for chronic
      obstructive pulmonary disorder (COPD). All patients will receive the same six treatments in a
      randomised sequence:

        1. salbutamol,

        2. ipratropium,

        3. salbutamol + RPL554,

        4. ipratropium + RPL554,

        5. RPL554

        6. Placebo
    

Detailed description: 
      The purpose of this study is to investigate if RPL554 has an additive bronchodilator effect
      when administered in combination with standard of care bronchodilators in patients with
      COPD.This study investigates the pharmacodynamic effect of RPL554 using spirometry and whole
      body plethysmography compared to placebo, when administered in addition to a beta2 agonist
      (salbutamol), a muscarinic antagonist (ipratropium) or placebo.
    

Intervention name(s): Salbutamol; Ipratropium; RPL554; Salbutamol matched placebo; Ipratropium matched placebo; RPL554 matched placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 200 micrograms salbutamol administered using a pressurised metered dose inhaler (pMDI); 40 micrograms ipratropium administered using a pMDI; 6 mg RPL554 administered using a nebuliser; Placebo pMDI; Placebo pMDI; Nebulised placebo
Intervention MeSH terms: Albuterol; Ipratropium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Post Discharge Human Milk Fortifier in Preterm Infants
Condition: Infant, Low Birth Weight
MeSH terms: Birth Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether low birth weight (LBW) infants fed human
      milk (HM)supplemented with a specially designed powdered human milk fortifier until 12 weeks
      after hospital discharge will have better growth and neurodevelopment than infants fed HM
      alone.
    

Detailed description: 
      Consensus exists in the literature that a significant proportion of low birth weight (LBW,
      <1800 g) infants leave hospital with overt signs of under-nutrition (eg. growth retardation).
      Recent evidence from randomized control trials suggest that provision of nutrient-enriched
      feeding to formula-fed premature infants after hospital discharge improves their growth,
      accretion of lean body mass and bone mineral content compared to infants fed a standard term
      formula. While available data suggest an advantage of human milk feeding after hospital
      discharge, experimental evidence on which to base guidelines to enrich, or not to enrich,
      human milk (HM) are notably absent.
    

Intervention name(s): Nutrient-enriched human milk
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low Birth Weight; Fortified Human Milk; breastfeeding; infants; growth
Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine
Condition: Measles; Mumps; Rubella; Hepatitis A
MeSH terms: Hepatitis A; Measles; Rubella; Mumps; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study will explore the immunogenicity of AVAXIM™ 80U-Pediatric in 12-13 months
      Turkish children and check if the administration of the MMR trivalent vaccine on the same day
      but at different site will interfere on immunogenicity for the four valences Hepatitis A,
      Measles, Mumps, and Rubella.
    


Intervention name(s): Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella; Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine; Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, intramuscular (IM) (HAV Day 0 and 168); 0.5 mL, IM (MMR Day 28); 0.5 mL, IM (MMR, Day 0); 0.5 mL, IM (HAV Day 28 and 168); 0.5 mL, IM (HAV Day 0 and 168); 0.5 mL, IM (MMR, Day 0)
Other intervention name(s): AVAXIM™; TRIMOVAX™; TRIMOVAX™; AVAXIM™; AVAXIM™; TRIMOVAX™
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: measles; rubella; mumps; hepatitis A