bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, Food Effects, and Drug-drug Interactions of ACP-196 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety, pharmacokinetics/pharmacodynamics (PK/PD), food-effect,
      and drug-drug interaction study of ACP-196 in healthy participants.
    

Detailed description: 
      The study is divided into 3 parts. Part 1 will include 5 cohorts (Cohorts [C] 1 to 5) and
      participants will receive oral ACP-196 2.5 to 50 mg twice daily (BID) and 100 mg once daily
      (QD) on Day 1. In Part 2 (Cohort 6), participants will receive a single oral dose of 75.0 mg
      QD in a fasting and a fed state, with a 7-day washout period between the 2 doses. In Part 3
      (Cohort 7), participants will receive a single oral dose of 50.0 mg QD alone on Day 1 and in
      combination with itraconazole on Day 9. Itraconazole 200 mg will be given twice daily (12
      hours apart) with meals on Days 4 to 8 and once on Day 9 with ACP-196 under a fasting state
      in the morning.
    

Intervention name(s): ACP-196; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive ACP-196 oral capsule(s) in all parts.; Participants will receive itraconazole 200 mg capsules BID from Days 4 to 8 with meals and then 200 mg capsule QD on Day 9 under fasting state.
Other intervention name(s): Acalabrutinib
Intervention MeSH terms: Itraconazole; Acalabrutinib
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acalabrutinib; ACP-196; Drug-drug interaction; Food effects; Healthy participants; Itraconazole; Pharmacodynamics; Pharmacokinetics; PK
Proton Pump Inhibitor (PPI, Rabeprazole) Effect On Tablet Formulation Of Palbociclib
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      to evaluate the effect of the PPI (rabeprazole) on the PK of a potential commercial tablet
      formulation of palbociclib
    


Intervention name(s): Palbociclib; Rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): palbociclib tablet formulation; rabeprazole as PPI
Other intervention name(s): Ibrance; PPI
Intervention MeSH terms: Palbociclib; Rabeprazole
Intervention model: Sequential Assignment
Intervention model description: the subjects will receive palbociclib alone in period 1, and receive palbociclib with rabeprazol in period 2
Masking: None (Open Label)
Primary purpose: Basic Science
Infant-parent Skin-to-skin Contact During Screening for Retinopathy
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity
Study type: Interventional

Summary: 
      Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered
      in time, the disease can be treated, and impaired vision or blindness can be reduced.
      Premature infants are therefore examined regularly after birth. However, the examination is
      painful and stressful for the infant. Painful experiences might lead to a pathological stress
      response later in life and should therefore be prevented.

      In this study skin-to-skin contact with a parent is tested for relief of pain and stress in
      preterm infants being examined for retinopathy of prematurity.
    


Intervention name(s): skin-to-skin contact; incubator; Sucrose
Intervention type(s): Behavioral; Device; Drug
Intervention description(s): skin-to-skin contact with parent during eye examination.; staying in incubator during eye examination.; oral sucrose before eye examination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infant, premature; Pain; Stress, physiological; Stress, psychological; skin-to-skin contact
Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of single and
      multiple intravenous (IV) infusions of Aducanumab in Japanese participants with mild to
      moderate Alzheimer's Disease (AD). The secondary objectives of this study are as follows: To
      evaluate the serum pharmacokinetics (PK) of Aducanumab after single and multiple intravenous
      (IV) infusions of Aducanumab; To evaluate the effect of single and multiple IV infusions of
      Aducanumab on immunogenicity.
    


Intervention name(s): Aducanumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): As described in the treatment arm; IV administration of 0.9% sodium chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Imaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The aim of this study is to examine the mechanisms by which stimulant medications reduce
      symptoms in patients with Attention Deficit Hyperactivity Disorder (ADHD). Using Magnetic
      Resonance Imaging (MRI), the investigators have found that the volumes of certain brain
      regions are reduced in patients with ADHD. The reduced volumes were much less pronounced if
      patients had been treated with stimulant medications, suggesting that stimulants may reduce
      the symptoms of ADHD by reversing these volume reductions. In a second and related study, the
      investigators found that in patients with ADHD, emotional processing was normalized when
      patients were taking stimulant medications. Both studies point to possible mechanisms by
      which stimulants are effective; however, a significant limitation of these findings is that
      they were derived from cross-sectional studies.

      In this current study, the investigators hope to replicate these treatment effects of
      stimulants in a prospective, controlled manner. The investigators plan to measure ADHD
      symptom severity in patients before and after 12-weeks of controlled treatment with either a
      stimulant medication or placebo while utilizing structural and functional MRI. Combining
      imaging with a randomized controlled trial will allow us to better assess the effects of
      stimulants on brain function and structure.
    

Detailed description: 
      A cohort of 100 patients with ADHD will be recruited for a 12 week, double-blind, parallel,
      randomized controlled trial of Lisdexamfetamine (Vyvanse) versus placebo, with 50 patients
      randomized to Lisdexamfetamine and the other 50 patients to placebo. The investigators will
      acquire high-resolution, anatomical and functional MRI images at baseline and after 12 weeks
      of treatment.

      In addition, 75 age- and sex-matched healthy control subjects will be imaged at baseline.
    

Intervention name(s): Lisdexamfetamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): During the first 4 weeks of treatment, the dosage of Lisdexamfetamine will be adjusted based on the patient's response to the medication. The patient will then be maintained at the lowest effective dose for the remaining 8 weeks of treatment.; Placebo dosing will parallel that of Lisdexamfetamine.
Other intervention name(s): Vyvanse; Sugar pill
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two treatment arms plus sample of healthy controls, who were assessed at one time point
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Vyvanse; stimulant medication; ADD
Community Surveillance of Congestive Heart Failure
Condition: Cardiovascular Diseases; Heart Failure, Congestive; Heart Diseases; Heart Failure
MeSH terms: Heart Failure; Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To conduct a surveillance study of congestive heart failure (CHF).
    

Detailed description: 
      DESIGN NARRATIVE:

      Systematic surveillance was conducted of CHF among residents, 35-84 years old, of the
      Minneapolis-St.Paul metropolitan area (population 2.45 million, 1995 estimate) in two
      complementary domains: 1) hospitalization for CHF in two calendar years, five years apart
      (1995 and the year 2000); and 2) newly diagnosed CHF over a 9-year period (1993-2001) among
      members of a large Health Maintenance Organization (HMO). The magnitude and characteristics
      of hospitalized CHF were assessed in all 21 acute care hospitals of the metropolitan area.
      One-third of all discharges with ICD-9 CHF codes were sampled randomly (n about 5,000 per
      surveillance year), abstracted by trained nurses, and classified according to clinical
      criteria and the results of diagnostic tests. Newly diagnosed CHF was distinguished from
      recurrent episodes of decompensated CHF by thorough review of the hospital record. A
      complementary perspective on CHF, including the outpatient setting, was provided by a
      systematic study of members of HealthPartners, one of the largest HMOs in Minneapolis-St.
      Paul. Using the HealthPartners database, all newly diagnosed CHF cases between January 1,
      1993 and December 31, 2001 (n about 1,900) were identified and the diagnosis validated.
      Beginning in January 1, 1999, newly diagnosed CHF cases were identified on an ongoing basis
      (n about 600), surveyed by mail, and followed for one-year from the original diagnosis.
      Surveillance of the HealthPartners population supplemented hospital surveillance and
      contributed data on incidence, prevalence, treatment, use of resources, and patient outcomes.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
Phase 1 Study to Assess the Safety of Inactivated Split Influenza Vaccine and Control Vaccine in Korean Volunteer
Condition: Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study to evaluate the safety of IL-YANG Inactivated Split Influenza
      Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) in comparison with Fluarix Prefilled
      Syringe (inactivated split influenza vaccine) after single-dose intramuscular administration.
    

Detailed description: 
      This was a randomized, open-label, active-controlled clinical study. After providing
      voluntary written informed consent, subjects underwent protocol-specific assessments and
      tests within the 4 weeks prior to administration of the study vaccine, and those who met all
      of the inclusion/exclusion criteria were randomized sequentially to the test group or the
      comparator group according to the pre-generated randomization code. To investigate the safety
      of the study drug with a two-dose regimen in children, the test group received another dose
      28 days after the first dose.

      The investigator evaluated the safety and immunogenicity for each subject throughout the
      study. Safety assessments were performed 28 days after the first dose (Visit 4, End-of-Study
      Visit) for the comparator group receiving a single-dose regimen of Fluarix Prefilled Syringe,
      and for the test group receiving a two-dose regimen of the test drug, 28 days after the first
      dose (Visit 4) and 28 days after the second dose (Visit 6, End-of-Study Visit). Subjects were
      instructed to record any adverse event occurring after vaccination in the Patient Diary Card.
      For the immunogenicity assessment, an antibody titer test was performed prior to dosing at
      Visit 2 (baseline) and 28 days (Visit 4) after the first vaccination for both the test group
      and comparator group.
    

Intervention name(s): IL-YANG FLU Vaccine Prefilled Syringe INJ.; Fluarix Prefilled Syringe
Intervention type(s): Biological; Biological
Intervention description(s): Second vaccination (only for the test group) of IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL; Fluarix Prefilled Syringe 0.5mL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Influenza vaccine; Split influenza vaccine; Seasonal influenza vaccine
Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways)
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This randomized, double-blind, placebo-controlled trial titled "Preventing Weight Regain
      Post-Semaglutide Treatment with Active Fiber Supplement (Soloways)" evaluated the efficacy of
      an active fiber supplement in preventing weight regain post-Semaglutide treatment.
      Participants were adults aged 18-65, with a history of obesity or overweight, and had
      completed a Semaglutide course. The study involved 160 participants, equally divided into two
      groups: one receiving the active fiber supplement (glucomannan, inulin, and psyllium) and the
      other a placebo, both taken 30 minutes before each main meal for 180 days. Co-primary
      endpoints were the percentage of weight regain from baseline to day 180 and metabolic health
      markers (blood glucose levels, HbA1c, lipid profile, blood pressure). Secondary endpoints
      included changes in BMI, body composition, and appetite assessment using VAS ratings and the
      Control of Eating Questionnaire (CoEQ). Participants also adhered to a reduced-calorie diet
      and increased physical activity, with all standard assays performed in a central laboratory.
      The study's objective was to determine the supplement's effectiveness in enhancing satiety,
      improving digestive health, and thus better managing weight compared to a placebo
    


Intervention name(s): Active Fiber Supplement Group; Placebo Group
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Three daily packets of active fiber supplement (each containing 1g of glucomannan, 1g of inulin, and 3g of psyllium), taken 30 minutes before each main meal. The supplement is provided by S.Lab (Soloways), LLC.; Three daily packets of placebo powder, taken 30 minutes before each main meal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Semaglutide; Dietary Fiber; Weight Loss; Appetite Suppression
Single Dose Escalation First Time in Human PK Study
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first time in human (FTIH) study of single escalating doses of investigational
      study drug to investigate safety, tolerability, and pharmacokinetics in healthy subjects
    


Intervention name(s): 100 mg GSK investigational drug; 200 mg GSK investigational drug; 400 mg GSK investigational drug; 800 mg GSK investigational drug; 2000 mg GSK investigational drug; 1500 mg GSK investigational drug; 800mg fed GSK investigational drug; 3000mg GSK investigational drug; 4000mg GSK investigational drug
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Other intervention name(s): selected mg fed study drug; 2000 mg study drug; 800 mg study drug; 400 mg study drug; 200 mg study drug; 100 mg study drug; 1500 mg study drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: healthy subjects; FTIH, single dose, food effect, healthy subjects, double-blind
A Study on the Effect of Renal Impairment on the Pharmacokinetics of RO4917838
Condition: Healthy Volunteer
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and
      safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single
      dose of RO4917838.
    


Intervention name(s): RO4917838; RO4917838
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of RO4917838; Single dose of RO4917838
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Sex Differences in Reflex Responses to Intermittent Hypoxia
Condition: Healthy Participants
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      The purpose of the present study is to determine whether there are sex differences in the
      reflex responses to hypoxia in humans.
    

Detailed description: 
      Over 35% of the US population will develop sleep apnea at some point in their life. Sleep
      apnea is the most common form of sleep disordered breathing and patients with sleep apnea are
      at increased risk of developing high blood pressure. Intermittent, repeated exposures to low
      oxygen during sleep (intermittent hypoxia, IH) has been implicated as the primary stimulus
      for increases in sympathetic nervous system activity and blood pressure with sleep apnea.
      Interestingly there are some reports of a lower incidence of hypertension in women with sleep
      apnea when compared to men. Results from the present study will provide information important
      to the investigator's understanding of potential sex-differences in clinical outcomes for
      conditions related to acute/chronic hypoxia and may have important implications for
      treatments which may improve blood pressure control in patients with sleep apnea.
    

Intervention name(s): Hypoxic exposure
Intervention type(s): Other
Intervention description(s): 30 minutes of intermittent hypoxia
Intervention model: Single Group Assignment
Intervention model description: All participants will undergo same 30 minute intermittent hypoxia protocol.
Masking: None (Open Label)
Primary purpose: Basic Science
Incubator Weaning of Moderately Preterm Infants
Condition: Infant, Newborn; Infant, Moderate Preterm
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The objective of this proposal is to evaluate whether weaning from an incubator to a crib at
      lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay
      among moderately preterm infants.

      The hypothesis of this study is that length of hospital stay (from birth to discharge) will
      be decreased among moderate preterm infants weaned from an incubator to an open crib at a
      lower versus higher weight, 1600g vs. 1800g.
    


Intervention name(s): Weaning from an incubator at a lower weight (1600 grams); Weaning from an incubator at a higher weight (1800 grams)
Intervention type(s): Procedure; Procedure
Intervention description(s): Infants will be weaned from an incubator at a lower weight (1600 grams); Infants will be weaned from an incubator at a higher weight (1800 grams)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Incubator Weaning; Moderately Preterm Infants; Growth Velocity
Different Approaches for the Management of Post-dural Puncture Headache
Condition: Post-Dural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Interventional

Summary: 
      Detecting the efficacy and safety of trans-nasal sphenopalatine ganglion block using either
      lidocaine 2% or bupivacaine 0.5 % as a treatment line for post-dural puncture headache
    


Intervention name(s): sphenopalatine ganglion block; paracetamol
Intervention type(s): Procedure; Drug
Intervention description(s): block of the sphenopalatine ganglion using either lidocaine or bupivacaine to relief postdural puncture headache; intravenous paracetamol every 8 hours
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Tolerability of New Topical Formulations in Subjects With Atopic Dermatitis
Condition: Dermatitis, Atopic; Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 13 week randomized, double blind, parallel group, in home use study among
      approximately 60 male and female subjects, ages 12 to 65 years old inclusive, with atopic
      dermatitis (AD) SCORAD >16. Treatment group assignments will be balanced by disease severity,
      age, and body location of AD lesions. The study will consist of a 1 week washout phase and 12
      week treatment phase. During the washout phase, subjects will be provided with a bar soap for
      bathing and showering and must refrain from using any other products on their body (excluding
      the face) including topical corticosteroids, ointments, lotions, sunscreens, etc. During the
      treatment phase, subjects will be randomized to 1 of 4 test legs. Throughout the treatment
      phase, the subjects will be required to use only the provided bar soap for bathing and
      showering and will apply their test product twice per day, once in the morning and once in
      the evening. No additional creams, moisturizers, lotions or cleansers other than those
      provided will be permitted for the duration of the study. Normal facial or hair care products
      are permitted, however, they must not contain anti-bacterial ingredients (e.g. antidandruff
      shampoo, acne products, etc).

      SCORAD, EASI and PGA will incorporate whole body assessments. However, at the Baseline visit,
      subjects will have an active inflammatory lesion site and adjacent non-lesion,
      non-inflammatory site identified and marked for all instrumental and biopsy evaluations at
      Baseline and subsequent visits. Instrumental evaluations, imaging, expert visual grading and
      self-assessments will be performed throughout the study. Tolerability will be evaluated by
      incidence of AE's (defined per CTCAE), exacerbation of AD lesions, application site
      reactions/infections, and lab evaluations throughout the study. There will be additional
      consumption and compliance checks as well as dermatologic evaluations to ensure the subject's
      condition does not become extensively worse at each visit. A subset of subjects will have 2mm
      punch biopsies collected from the designated lesion and non-lesion sites at 3 time points
      throughout the study. The subset of subjects will be determined by subject willingness to
      participate in the biopsy portion as well as dermatologic evaluation and determination of
      biopsy candidacy.
    


Intervention name(s): Investigational OTC Cream; Cosmetic Eczema Cream; 0.05% Desonide Cream; Placebo Cream
Intervention type(s): Drug; Other; Drug; Other
Other intervention name(s): CeraVe; Actavis
Intervention MeSH terms: Desonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment