bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial to Evaluate the Influence of Genotype and DDIs of Aspirin on the PK/PD of Clopidogrel and PK of Digoxin
Condition: DRUG REACTIONS
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 4

Summary: 
      Clinical trial to evaluate the influence of multiple aspirin administration on PK and PD of
      co-administered drugs
    

Detailed description: 
      Clinical trial to evaluate the influence of genotype of drug metabolizing enzyme or
      transporter and drug-drug interactions of aspirin co-administration on the pharmacokinetics /
      pharmacodynamics of clopidogrel and pharmacokinetics of digoxin in healthy volunteers
    

Intervention name(s): Aspirin+Clopidogrel/Digoxin(oral); Aspirin+Clopidogrel/Digoxin(IV)
Intervention type(s): Drug; Drug
Intervention description(s): oral administration of digoxin; intravenous administration of digoxin
Other intervention name(s): Aspirin; Clopidogrel; Digoxin; Aspirin; Clopidogrel; Digoxin
Intervention MeSH terms: Aspirin; Digoxin; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Therapeutic Equivalence of Two Formulations of Fluticasone Propionate and Salmeterol Inhalation Powder in Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, multiple-dose, blinded, placebo-controlled, parallel-group, multiple-center
      bioequivalence study with pharmacodynamic endpoints
    


Intervention name(s): Fluticasone Propionate and Salmeterol Inhalation Powder; Fluticasone Propionate and Salmeterol Inhalation Powder; Placebo Inhalation Powder
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100/50 mcg per actuation; 100/50 mcg per actuation; No active content
Other intervention name(s): ADVAIR DISKUS®
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study in Healthy Volunteers to Assess the Effect of Fedovapagon on the QT/QTC Interval
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the electrocardiogram (ECG) effects of fedovapagon
      dose administration relative to placebo in healthy adult male and female subjects.
    

Detailed description: 
      Regulatory guidance (ICH E14) has emphasized the need to obtain clear robust data on the
      effect of new chemical entities on ECG parameters with focus on cardiac repolarization as
      measured by the QTc duration. Though many Phase 1, 2 and 3 trials may be conducted they
      usually have insufficient sample size, infrequent sampling of ECG data, or the use of
      inadequate controls to overcome the high rate of spontaneous change in QTc duration. This has
      resulted in regulatory guidance recommending a dedicated or thorough trial to define the ECG
      effects of new drugs.

      This study will be conducted in healthy volunteers to eliminate variables known to have an
      effect on ECG parameters (concomitant drugs, diseases, etc.). A supra-therapeutic dose of
      fedovapagon is required to mimic the exposure in healthy volunteers that may occur in the
      target population under the worst of circumstances (e.g., concomitant use of CYP3A4
      inhibitor, concomitant liver disease, presence of heart disease, taking more than the
      clinical dose prescribed, etc.) and to allow for PK to QTc modeling to assess the effect of
      drug concentration on cardiac repolarization.

      A cross-over trial is the preferred design as subjects act as their own controls and since
      there is no accumulation of any clinical relevance and the plasma concentration of parent
      dissipates before 24 hours, a single dose trial will be employed. During the course of the
      study each subject will be administered fedovapagon at both a clinical and supra-therapeutic
      dose, placebo and moxifloxacin (as a positive control).

      The sample size is driven by the need to do a time-matched statistical analysis on the
      primary endpoint as per ICH E14 guidance.
    

Intervention name(s): Fedovapagon; Moxifloxacin; Placebo (for fedovapagon)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: VA106483; fedovapagon; males; females; moxifloxacin; TQT; QT/QTC; ECG; Nocturia
Effect of Speed of Weight Loss on Compensatory Mechanisms Activated During Weight Reduction
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Obesity has become a global epidemic with huge public health implications. Although clinical
      significant weight loss (WL) can be achieved by a combination of diet and behavioral
      modification, strong metabolic adaptations, with increased appetite and suppressed energy
      expenditure, are activated, which compromise WL maintenance and increase the risk of relapse.
      The aim of this project is to investigate the potential role of WL rate in modulating such
      responses. More specifically, the investigators want to determine if a similar WL achieved
      rapidly vs slowly induce the same compensatory responses to weight reduction. A secondary aim
      is to assess if speed of weight loss can influence motivation. A large battery of assessments
      will be performed before and after weight reduction including body composition, resting
      metabolic rate, substrate oxidation, exercise efficiency, fasting and postprandial release of
      several appetite-regulating hormones, subjective feelings of hunger and fullness and
      motivation. This project can bring large practical benefits concerning the design of weight
      loss programs to minimize weight relapse.
    


Intervention name(s): Very-low calorie diet (VLCD); Low calorie diet (LCD)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight loss; Speed of weight loss; Metabolic compensation; Diet therapy
Intraopertive Hypotension and Postoperative Cardiovascular Complications Among Chinese Elderly Patients Undergoing Oncardiac Surgery : a Retrospective Cohort Study
Condition: Hypotension
MeSH terms: Hypotension
Study type: Observational

Summary: 
      To explore the relationship of intraoperative hypotension and perioperative cardiovascular
      complications in elderly noncardiac surgical patients
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        age ≥65 years old patients
Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents
Condition: Fatigue Syndrome, Chronic; Epstein-Barr Virus Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Epstein-Barr Virus Infections; Fatigue Syndrome, Chronic; Fatigue
Study type: Observational

Summary: 
      Chronic fatigue syndrome (CFS) is characterized by unexplained, disabling and long lasting
      fatigue, as well as pain, impaired memory, sleep difficulties and other symptoms.
      Epstein-Barr virus (EBV) infection might precipitate CFS. In this study, 200 adolescents
      undergoing acute EBV infection will be followed prospectively, and also compared with a group
      of healthy controls. The aim is twofold:

        -  To identify factors that predispose to chronic fatigue among adolescents with acute EBV
           infection

        -  To compare pathophysiological features of patients with acute EBV infection with a group
           of healthy controls.

      Possible risk factors for chronic fatigue 6 months after EBV-infection includes:

        -  Severity of the initial infection

        -  Immune responses characteristics

        -  Characteristics of the neuroendocrine stress response

        -  Cognitive functioning

        -  Emotional disturbances

        -  Genetics/ epigenetics of candidate genes

        -  Certain personality traits

        -  Critical life events
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Microbiological laboratories serving the population of Oslo and neighbour conties.
Comparative Study of Clinical Endpoint in DMD: Handheld Myometry (HHM) Versus CINRG Quantitative Measurement System (CQMS)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Observational

Summary: 
      The aim of the proposed research is to compare two commonly used pediatric strength testing
      measures: handheld myometry (HHM) and CINRG Quantitative Measurement System (CQMS), with the
      goal of identifying a sensitive and valid tool for measuring muscle strength in children with
      DMD. The data obtained from this study will be used to make recommendations for strength
      measurement endpoints in prospective muscular dystrophy trials and provide more reliable and
      accurate recommendations in the clinic for strength assessment. This study will be performed
      at six participating sites in the Cooperative International Neuromuscular Research Group
      (CINRG).
    

Detailed description: 
      We propose to compare the reliability of CQMS vs. HHM in the DMD population. The importance
      of this study is to be able to compare the results of clinical trials done by different
      networks using distinct strength endpoints. If results indicate a distinct difference in
      reliability of one tool over the other, a standardized tool could be established for research
      groups throughout the world to interpret strength in the context of clinical trials. If the
      results indicate minor differences then it would be possible to interpret and
      compare/contrast strength measurements used in different studies.

      Understanding the relationship between the HHM vs CQMS will help us examine other surrogate
      measures capable of predicting functionality that are based on strength measurements.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants will be selected from participating CINRG institution's neuromuscular clinics.
      
Keywords: Neuromuscular disease; Duchenne; Muscular Dystrophy; DMD; Strength assessment; CINRG Quantitative Measurement System; CQMS; Hand Held Myometry; HHM
Effects Of Instrument Assisted Soft Tissue Mobilization on Pain, Grip Strength and Functional Activity in Patients With Lateral Epicondylitis
Condition: Lateral Epicondylitis; Tennis Elbow
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      This study aimed to find the effects of Instrument Assisted Soft Tissue Mobilization (IASTM)
      using Ergon Tools on pain, grip strength and functional activity among patients diagnosed
      with Lateral epicondylitis.

      The study concluded that IASTM is effective in improving pain, grip strength and functional
      activity in patients with lateral epicondylitis.
    

Detailed description: 
      Background: Lateral Epicondylitis is a type of "repetitive strain injury" that causes pain on
      the lateral portion of the elbow, especially while gripping and applying resistance to the
      forearm's extensor muscles, both men and women are equally affected by it. Traditional
      Physical Therapy has failed to improve the disorders caused by LE, Instrument Assisted Soft
      Tissue Mobilization is a new approach for its treatment a lot of tools are being used and
      Ergon Tools are among one of them, very less data is available for its efficacy in lateral
      epicondylitis patients.

      Objective: To compare the effects of Instrument Assisted Soft Tissue Mobilization using Ergon
      Technique on pain, grip strength and functional activity in patients with lateral
      epicondylitis.

      Methodology: 72 individuals with lateral epicondylitis pre-diagnosed by an orthopedic
      surgeon, are assessed from Sikander Medical Complex, Gujranwala. After fulfilling the
      inclusion criteria, the participants are randomly divided into two groups, 36 participants
      receiving IASTM using Ergon Tools and 36 participants received conventional physical therapy.
      Both groups receive treatment 2 times a week for 4 weeks. Outcome measures are pain (VAS),
      grip strength (handheld dynamometer), and functional mobility (PRTEE) collected at the
      baseline, 1st week, and 4th week.
    

Intervention name(s): Instrument Assisted Soft Tissue Mobilization (IASTM); Conventional Physical Therapy
Intervention type(s): Device; Other
Intervention description(s): Tools designed for soft tissue mobilization; Moist Hot pack, Ultrasound, Deep Friction Massage, Stretching and Strengthening Exercises.
Other intervention name(s): Ergon Tools; Traditional Physical Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: IASTM; Lateral Epicondylitis; tennis elbow; pain; grip strength; functional activity
LDL-Cholesterol Lowering Effect of KB2115 as Add on to Statin
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      Thyroid hormones are known to reduce cholesterol levels through regulation of a number of key
      enzymes involved in synthesis, degradation, and lipid transport. However, the currently
      marketed thyroid agonists are non-selective, and cannot be used for the treatment of
      hypercholesterolemia due to extrahepatic consequences of hyperthyroidism, especially on
      heart, bone, and muscle.

      To take advantage of thyroid hormone effect on lipid metabolism for the treatment of
      hypercholesterolemia, it is necessary to develop a selective thyroid receptor agonist that
      can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the
      extrahepatic tissue. KB2115 is a thyroid agonist developed to be liver selective.

      The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to
      low and middle doses of statin following 12 weeks of exposure compared to placebo. The aim of
      the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 at
      doses between 25 and 100 µg and to define a clinically relevant dose or dose range for future
      studies.
    


Intervention name(s): KB2115
Intervention type(s): Drug
Intervention description(s): tablet formulation given once daily for 12 weeks
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypercholesterolemia
Factors Influencing the Human Gut Microbiome Profile in Multi-ethnic Groups of the Singapore Community (FAMES)
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      The objectives of this study are to examine the effects of ethnicity, gender, and proton pump
      inhibitor (PPI, omeprazole), on the human gut microbiome. The investigators hypothesize that
      PPI therapy might perturb microbial communities and alter the gut microbiome. Young, healthy
      subjects of Chinese, Malay and Indian ancestry, were enrolled. They were required to provide
      a baseline stool sample (Day 1) and were then given a course of omeprazole at therapeutic
      dose (20 mg daily) for a duration of 7 days. Stool samples were collected again on Day 7 and
      Day 14 (one week after stopping omeprazole). The DNA samples were subjected to 16S ribosomal
      ribonucleic acid (rRNA) sequencing.
    

Detailed description: 
      Background and Aim: The objectives of this study are to examine the effects of ethnicity,
      gender, and proton pump inhibitor (PPI, omeprazole), on the human gut microbiome. PPIs are
      commonly used for the treatment of acid-related disorders. The investigators hypothesize that
      PPI therapy might perturb microbial communities and alter the gut microbiome.

      Methods: Healthy subjects of Chinese (n=12), Malay (n=12) and Indian (n=10) ancestry, aged
      21-37 years old, were enrolled. They were required to provide a baseline stool sample (Day 1)
      and were then given a course of omeprazole at therapeutic dose (20 mg daily) for a duration
      of 7 days. Stool samples were collected again on Day 7 and Day 14 (one week after stopping
      omeprazole). Microbial DNA was extracted from the stool samples. This was followed by PCR,
      library construction, 16S rRNA sequencing using Illumina MiSEQ, and statistical and
      bioinformatics analyses.
    

Intervention name(s): Omeprazole
Intervention type(s): Drug
Intervention description(s): Oral administration of omeprazole at therapeutic dose (20 mg daily) for a duration of 7 days
Other intervention name(s): Omezole20
Intervention MeSH terms: Omeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Changes in Microbiota and Iron Status After Iron Fortification of Complementary Foods
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional

Summary: 
      Infants and children under two years are the group with the highest rates of iron deficiency
      anemia. Provision of sufficient dietary iron to this age group is a challenge, and in-home
      iron fortification of complementary foods using micronutrient powders can be an effective
      approach. However, WHO has recently cautioned against untargeted use of in-home micronutrient
      powders that contain the entire iron RDA for a child in a single dose in areas with high
      rates of infections from malaria and diarrheal disease. Therefore, in this study, we will
      investigate the effect on the infant gut microbiota of a low dose (ca. 25% of the RDA) of
      highly bioavailable iron, provided by a micronutrient powder added to a complementary food.

      The study aim is to determine if in-home fortification using an iron-containing micronutrient
      powder in Kenyan infants will improve iron status and/or modify the composition and metabolic
      activity of the gut microbiota. Active surveillance will be done weekly to monitor the health
      of the infants.

      Our study will be done in a subgroup (n=160) of a larger double-blind controlled feeding
      trial in which 330 infants will be randomized to receive a micronutrient powder containing
      either 2.5 mg iron or no iron for 1 year. In our substudy, the infants will be studied only
      over the first 6 months of the 1 year intervention. Blood samples, taken at baseline and
      after 6 months will be used to define the iron status and the anemia level of the infants.
      Stool samples (2 at baseline before intervention, 6 throughout the study and additional
      samples in case of diarrhea) will be obtained for analysis of the gut microbiota. In the
      entire study (n=330), we will measure changes in iron status over 1 year.
    


Intervention name(s): fortification with iron and micronutrients; Sprinkles
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Iron 0 or 2.5 mg; Copper 0.34 mg; 30 µg Iodine; 7 µg Selenium; 2.5 mg Zinc; 100 µg Vitamin A; Vitamin D 5 µg; 5 mg Tocopherol Equivalent; 30 µg Vitamin K1; 10.5 mg Thiamine; 0.5 mg Riboflavin; 0.5 mg Pyridoxine; 90 µg Folic Acid Anhydrous; 6 mg Niacinamide; 60 mg Vitamin C; 0.9 µg Vitamin B12; Daily 12.5mg Ferrous fumarate iron with microntrient is compared to no iron with micronutrients. Duration of intervention is 4 months, 80 infants will be inclulded.
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study
Condition: Developmental Delay
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine differences in the long-term effects of immediate
      versus delayed cord clamping at birth on developmental outcomes of our study infants at 18-22
      months corrected age.
    

Detailed description: 
      The current obstetrical practice at birth in the United States is that the umbilical cord of
      the very low birth weight (VLBW) infant is clamped immediately. When immediate cord clamping
      occurs, up to 50% of the fetal-placental blood volume may be left in the placenta acutely
      increasing vulnerability to hypovolemia (low blood volume). In the investigators previous
      randomized control trial, it was found that infants who received a simple delay in umbilical
      cord clamping for 30-45 seconds experienced significantly lower incidence of bleeding in the
      brain and fewer systemic infections throughout the Neonatal Intensive Care Unit (NICU) stay
      and had higher scores on muscular control and function at 7 months corrected age. In the
      investigators current Phase 2 randomized controlled trial, examines the motor functioning of
      infants randomized to immediate cord clamping (ICC) or delayed cord clamping (DCC) at 7
      months corrected age (age based on due date and not the pre-term birth rate).

      Our objective for this new grant from the Thrasher Foundation is to examine the differences
      in the long-term effects of ICC vs. DCC on developmental outcomes of our study infants at
      18-22 months corrected age. The investigators hypothesis is that the positive effects of DCC,
      less bleeding in the brain and less infection, may also result in better motor and mental
      functioning at 18-22 months corrected age. Differentiation between cognitive and motor
      function is more obvious in the developing toddler than in younger infants. The diagnosis of
      cerebral palsy becomes more definitive with age and cognitive skills such as expressive and
      receptive language continue to emerge.
    

Intervention name(s): delayed cord clamping
Intervention type(s): Procedure
Intervention description(s): at birth, the obstetrical provider delays the cord clamping for 45 seconds while lowering the infant. At 45 seconds the cord is milked once and then clamped and cut.
Other intervention name(s): DCC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: delayed cord clamping; developmental delay