bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Ready to Use Therapeutic Food (RUTF) Supplement After an Episode of Malaria Falciparum on Weight
Condition: Weight Loss; Weight Gain; Convalescence; Malaria
MeSH terms: Malaria; Body Weight; Weight Loss; Weight Gain; Convalescence
Study type: Interventional

Summary: 
      The primary objective of this study is to determine to what extent provision with RUTF will
      promote catch up growth in children following an acute uncomplicated episode of P. falciparum
      malaria.
    

Detailed description: 
      Anorexia due to infection might lead to weight loss. In many settings total recovery is
      problematic what might result in a permanent lower weight. A short period high quality food
      supplementation could improve weight gain after an infection.

      Children aged 6-59 months presenting with malaria caused by P. falciparum who are provided
      with a RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks will show significantly
      better catch up growth compared to a similar patient group not provided with RUTF (at 2 weeks
      and 4 weeks post-intervention).
    

Intervention name(s): RUTF (Plumpynut®)
Intervention type(s): Dietary Supplement
Intervention description(s): Intervention group receives 500 kcal/day of RUTF for 2 weeks Control group receives no food supplement
Other intervention name(s): RUTF; Ready to use Therapeutic Food; RUF; Lipid based food supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: weight loss; weight gain; malnutrition; convalescence; malaria; RUTF; RUF; supplementation; nutrition
Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The hypothesis of this study is that a Ketamine / Propofol mixture will produce more stable
      hemodynamics as compared to Etomidate during emergent intubations in the intensive care unit.
      Patients that require a breathing tube to be placed in the ICU will be randomized to receIve
      either a Ketamine / Propofol mixture or Etomidate for sedation in order to place the
      breathing tube.
    

Detailed description: 
      Endotracheal intubation is a procedure that may cause significant hemodynamic perturbations
      and can severely impact the outcome of the critically ill. To ensure a safe outcome during
      this particular procedure, there are many factors that the clinician is faced with. One
      decision that confronts the critical care physician involves the correct combination of
      medications with which to facilitate such a safe outcome. Given the reported hemodynamic
      stability, etomidate is a medication that is chosen by many providers in this particular
      situation. However, its association with a possible increase in mortality makes it less than
      ideal for a number of critical care physicians. In recent years, an admixture of propofol and
      ketamine has been studied that demonstrates hemodynamic stability based on the balancing of
      the hemodynamic effects of these two individual agents alone. This novel medication
      combination, sometimes referred to as "ketofol", may offer a valuable alternative to the
      critical care physician. Therefore, a randomized parallel-group clinical trial of adult
      critically ill patients admitted to a medical and/or surgical intensive care unit at Mayo
      Clinic Rochester who meet the criteria designated below for which urgent and/or emergent
      intubation is needed will receive one of two interventions based on stratified randomization.
      The "active" intervention arm will receive ketamine/propofol (ketofol) to facilitate
      endotracheal intubation. The comparison arm will receive etomidate. The primary outcome will
      focus on hemodynamic data recorded during the first 5 minutes post-administration with
      secondary outcomes looking at hemodynamic data at 10 and 15 minutes and addressing intensive
      care unit length of stay, mortality, adrenal function, and vasoactive medication use, among
      others.
    

Intervention name(s): Ketamine / Propofol Admixture; Etomidate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ketamine; Propofol; Etomidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Critical care; Emergent; Etomidate; Hemodynamics; Intensive care unit; Intubation; Ketamine-Propofol admixture
Effect of PRP on the Therapy for Hair Growth
Condition: Hair Loss/Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      The purpose of study is to examine the advantage of PRP on hair loss and male pattern
      baldness. The investigators will inject PRP into the scalp regions where with little or no
      hair, and evaluate the effect and efficiency of PRP on human hair growth.
    

Detailed description: 
      Hair loss is a disorder in which the hair undergoes aberration growth cycles and falls out
      from scalp. A number of factors like hormones, genetic factors, diet, endocrine
      abnormalities, systemic illnesses, drug intake, and hair shaft abnormalities may cause hair
      loss. Androgen alopecia or male pattern baldness is the most common cause of hair loss caused
      by progressive shortening of the anagen and increased number of hair follicles in telogen,
      which has a significant influence on psychological distress.

      Except medical treatment and baldness surgery, a new interest in treating hair loss and
      baldness has been stimulated by using platelet plasma growth factors obtained from the
      patient's own platelet-rich plasma (PRP). PRP is a portion of plasma fraction of autologous
      blood having a high concentration of thrombocytes, and can be activated by Thrombin to
      release multiple growth factors, including platelet-derived growth factor (PDGF), vascular
      endothelial growth factor (VEGF), epidermal growth factor (EGF), insulin-like growth factor
      (IGF), and transforming growth factor beta (TGF-β). PRP is known for the capacity to
      stimulate cell proliferation and differentiation. The action of platelet plasma growth
      factors on the development of hair follicles has already been established. PRP has also been
      shown to increase the yield of implanted follicular units during male baldness surgery.

      Our study will focus on the advantage of PRP for the treatment of hair loss and male pattern
      baldness. PRP from autologous blood can be mixed with thrombin in appropriate ratio and
      inject into the regions on scalp which is interested. We will track and evaluate regularly
      the effect and efficiency of PRP on human hair growth.
    

Intervention name(s): hair loss, baldness (patient's own platelet-rich plasma)
Intervention type(s): Other
Intervention description(s): hair loss, baldness
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Medically-Graded Honey Supplementation Formula To Preterm Infants
Condition: Prebiotics; Honey; Premature Infants; Intestinal Microbiota
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Honey is a natural product that contains multiple nutrients; it is composed of fructose,
      glucose and fructooligosaccharides that can potentially serve prebiotic functions. It also
      contains more than 180 substances including amino acids, vitamins, minerals and enzymes.
      Investigators hypothesized that supplementation of enteral feeds with honey would produce a
      bifidogenic effect and stimulate the immune response in preterm infants. Investigators
      randomly assigned subjects to 4 groups receiving 0, 5, 10 and 15 grams of honey daily for 2
      weeks and measured their effect on stool colonization, systemic immune parameters and
      anthropometric measurements.
    


Intervention name(s): Medically-Graded Honey; Premature Milk Formula
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Honey added to the baby formula once a day for 2 weeks.; Enteral feeds were provided to subjects of all groups using premature milk formula as per routine nutritional management in the neonatal intensive care unit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effect of an Antioxidant-rich Diet During Moderate Altitude Training
Condition: Oxidative Stress; Adaptation Reaction; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Athletes, especially in endurance sports, are at increased risk of oxidative stress and
      inflammation-related diseases and injuries. The production of reactive oxygen and nitrogen
      species (RONS) and inflammatory markers increase during exercise and especially during
      altitude training. Antioxidant supplementation is commonly used among athletes in the belief
      that it prevents oxidative stress and oxidative damage. A transient increase of RONS is
      however necessary to activate signaling cascades initiating training adaptation. Antioxidant
      supplementation has been shown to inhibit the exercise effects in several independent
      studies, possibly by interfering/reducing the signal cascades initiated by RONS. However, it
      is unknown whether a high intake of antioxidant rich foods can affect the amount of RONS,
      inflammation markers and/or training adaptation. The investigators want to examine whether an
      increased intake of natural antioxidants in the form of antioxidant-rich foods fruits,
      vegetables and berries, in line with the official Norwegian dietary advice can affect
      antioxidant status, immune function and training adaptation associated with altitude training
      in Norwegian elite athletes.
    


Intervention name(s): Antioxidant-rich snacks; Control snacks
Intervention type(s): Other; Other
Intervention description(s): Bama Smoothies (Bama, Oslo, Norway), Freia Premium Dark Chocolate (Freia, Oslo, Norway), Walnuts (Eldorado, Norway), Dried fruits and berries (Cranberries, Gojiberries, apricots)(Bama, Oslo, Norway and Rema 1000, Norway); Milkshake (Tine, Oslo, Norway), YT restitusjonsdrikk (Tine, Oslo, Norway), Bixit (Sætre, Oslo, Norway), Ritz (Mondelez, Oslo, Norway), White chololate (Freia, Oslo, Norway)
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: altitude training; antioxidants; oxidative stress; elite athletes; inflammation; diet
Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With OAB
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to assess the efficacy and safety of
      THVD-201(Combination of tolterodine and pilocarpine) in patients with Overactive bladder
      during the period of treatment, 12 weeks.

      This study also includes an open label extension period of an additional 12 weeks following
      the treatment to assess long-term efficacy and safety of THVD-201 in patients with Overactive
      bladder.
    


Intervention name(s): THVD-201; Placebo(For THVD-201); Detrusitol 2mg tablet; Placebo(For Detrusitol 2mg tablet)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Combination of Tolterodine 2mg and Pilocarpine 9mg; Tolterodine 2mg
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Overactive Bladder; Tolterodine (Detrusitol); Pilocarpine
Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      This is a 3-arms randomized-controlled, parallel group, single center, double-blind study
      investigating the bioavailability of olive oil extract (OLE) in two different OLE
      formulations (enzymatically treated and co-administered with a probiotic) compared to
      original OLE formulation in healthy adult subjects.
    

Detailed description: 
      Male or female healthy adults between 25 and 65 years of age will be randomized into one of
      the 3 following groups to receive:

        1. Capsule of OLE + 1 stick of maltodextrin

        2. Capsule of OLE enzymatically treated + 1 stick of maltodextrin

        3. Capsule OLE + 1 stick of probiotic

      52 subjects will be randomized to achieve 15 subjects per group to complete the trial.

      The study will involve 3 phases:

        1. PK1 (all subjects will receive one capsule of OLE in the morning and blood samples will
           be collected at different timepoints for 24h) followed by a washout period of 1 day

        2. 3 weeks intervention (subjects will receive the product thy have benn assigned to)
           followed by a wash-out period of 3 days

        3. PK2 period (subjects will receive one capsule the product thy have benn assigned to
    

Intervention name(s): OLE enzymatically treated; OLE + probiotic; OLE
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): OLE (Olive leaf extract ) enzymatically treated + maltodextrin; OLE (Olive leaf extract) co-administered with probiotic; OLE (Olive leaf extract) + maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3-arms randomized-controlled, parallel group, single center, double-blinded study investigating 3 different formulations of the investigational product
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      A 53-week study to determine the effect of montelukast sodium when given to children (with
      infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.
    


Intervention name(s): MK0476; montelukast sodium; Comparator: placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Early Intervention Following Mild TBI
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      The objective of the study is to implement and measure the efficiency of a standardized acute
      and brief non-pharmacological intervention (Cognitive interventions on Sleep - Anxiety -
      Attention - Memory) following mild TBI and observe their impact pre- and post-treatments. The
      ultimate goal is to have patients be re-integrated to their activities faster with lesser
      symptoms and have patients present lesser post-concussive symptoms. Specific objectives: 1)
      Measure the effect of an acute and brief non-pharmacological intervention on PCS symptoms,
      sleep, headaches, affect, cognition and functional outcome following mild TBI; 2)To redefine
      a model of outcome prediction following mild TBI.
    


Intervention name(s): education and support intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of Preoperative Ketamine on the Emergence Characteristics in Children Undergoing Entropion Surgery
Condition: Entropion
MeSH terms: Entropion
Study type: Interventional

Summary: 
      The investigators evaluate extubation time and recovery profiles in children undergoing
      entropion surgery.
    

Detailed description: 
      This study will compare the extubation time and recovery profiles (degree of postoperative
      agitation and cough) between sevoflurane group and desflurane group. General anesthesia will
      maintained with sevoflurane 2-3vol% or desflurane 6-7vol%. After surgery, the investigators
      will measure the duration of extubation and recovery profiles between two groups.
    

Intervention name(s): Sevoflurane; Desflurane
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.
General anesthesia will maintained with sevoflurane 2-3 vol%.; Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.
General anesthesia will maintained with desflurane 6-7vol%.
Other intervention name(s): sevofrane; suprane
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Anesthesia; Agitation; Extubation
PPI And Food Effect Study For PF-06463922 In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study will be conducted in healthy adult subjects to evaluate the effect of
      proton pump inhibitor and food on pharmacokinetics of PF-06463922, to evaluate the
      bioavailability of the oral solution relative to the tablet formulation of PF-06463922.
    

Detailed description: 
      PF-06463922 is a selective, ATP competitive small molecule tyrosine kinase inhibitor (TKI) of
      the Anaplastic Lymphoma Kinase (ALK) positive (ALK+) or ROS oncogene 1 (ROS1) positive
      (ROS1+) receptor tyrosine kinases (RTK) that also potently inhibits ALK kinase domain
      mutations responsible for resistance to crizotinib. PF-06463922 is being developed as a novel
      anticancer agent for the treatment of patients with advanced ALK+ NSCLC or ROS1+ NSCLC.

      The current study is a Phase 1, randomized, open label, 4 period, 4 treatment, 4 sequence,
      crossover study conducted in healthy adult subjects. Each subject will receive four single
      oral doses of 100 mg PF-06463922 as tablets alone, tablets with food, tablets with
      rabeprazole, and oral solution after overnight fasting with at least a 10 day washout period
      between each PF-06463922 dose.

      Twenty four (24) subjects will be enrolled to obtain at least 20 evaluable subjects who
      complete all treatments. Subjects who withdraw will not be replaced unless the total number
      of completed subjects falls below 20.
    

Intervention name(s): PF-06463922; rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): each subject will receive 4 single oral doses of 100 mg PF-06463922 (treatment A: tablets without food; treatment B: tablets with food; treatment C: tablets without food with rabeprazole; treatment D: oral solution without food). There will be at least 10 days washout period between consecutive PF-06463922 single dose.; 20 mg daily tablets in the evening for 5 days and Pf-06463922 on the morning of day 6 in treatment C.
Other intervention name(s): Pariet
Intervention MeSH terms: Rabeprazole
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-06463922; rabeprazole; proton pump inhibitor (PPI); pharmacokinetics(PK); food effect
Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI
Condition: Central Nervous System Indication; Pediatric Patients; Body Indication
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a pharmacokinetics (PK), open-label, uncontrolled, multicenter phase II trial with
      age-staggered approach.

      The primary objective is to evaluate the PK profile of gadopiclenol in plasma following
      single IV injection of 0.05 mmol/kg body weight (BW) in pediatric population aged from 2 to
      17 years undergoing CNS contrast-enhanced MRI (CNS cohort).
    

Detailed description: 
      A population PK approach and an age-down staggered approach will be used. Patients will be
      recruited into 3 predefined age groups: 12-17, 7-11 and 2-6 years. The inclusions will start
      with the older group (Adolescents, 12-17 years), followed by Preadolescents (7-11 years) and
      finally Young Children (2-6 years of age).
    

Intervention name(s): P03277
Intervention type(s): Drug
Intervention description(s): A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
Other intervention name(s): gadopiclenol
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of Sprinkles With and w/o Fe on Zn Absorption in Kenyan Toddlers
Condition: Micronutrient Deficiencies
Study type: Interventional

Summary: 
      The investigators propose to study the effects of increased iron intake by home fortification
      of complementary foods on the gastrointestinal microbial development, inflammatory responses,
      and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic
      area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups:
      1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test);
      Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™
      with no micronutrients (placebo). The investigators hypothesize that the microbiome will be
      significantly different in the three groups and that Zn absorption and status, in addition to
      immune and oxidant status will be improved in the non-Fe fortified groups when compared to
      the Fe-fortified group.
    

Detailed description: 
      Specific aims include exploration of possible mechanisms of adverse events that have been
      observed in iron supplementation trials in infants in malaria endemic regions by:

        1. Characterizing the impact of enteral iron administration on the evolution of the
           intestinal microbiome in infants from 6 to 9 months of age.

        2. Characterizing iron administration-associated inflammatory responses and correlate these
           with changes in the intestinal microbiome in infants from 6 to 9 months of age.
           Specifically, changes in the microbiome will be correlated with biomarkers reflecting:

             1. Intestinal inflammation;

             2. Systemic inflammation, bacterial translocation, and oxidant stress;

             3. Iron status and homeostasis

        3. Quantify to what degree Fe interferes with Zn absorption (TAZ) and how it affects the
           size of the infant's exchangeable zinc pool (EZP).
    

Intervention name(s): MNP + Zn/Fe; MNP + Zn; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Micronutrient powder with 12 mg Fe and 5 mg Zn provided daily from 6-9 months of age; Micronutrient powder with 5 mg Zn provided daily from 6-9 months of age; Placebo powder without micronutrients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Zinc absorption; Micronutrient supplement; Microbiome; Kenya; Complementary foods; Home fortification