bioihbjkbjnl/mcl2 huggingface dataset:
Study of Patients With ITP Estimating the Proportion Administering Romiplostim Correctly After Receiving Home Administration Training
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Observational

Summary: 
      Cross-sectional study, observation made by healthcare professionals of subjects or
      caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after
      training with the home administration training pack. Further observations can also be
      recorded in the study if made within 16 weeks of enrolment. Data will be collected from the
      subjects' dose diary at their first standard of care visit to ensure there were no problems
      with administration while not at the clinic.
    

Detailed description: 
      This cross-sectional study involves direct observation by a healthcare professional of a
      series of subjects and caregivers in the act of administering romiplostim at their first
      standard-of-care visit occurring 4 weeks after training with the HAT pack. Further
      observations, if they occur, will also be recorded in the study if made within 16 weeks of
      enrolment. (Additional observations are voluntary and are not required for study
      participation; they occur only if the healthcare professional requests them.) Additionally,
      data will be collected from the subjects' dose diary at the first standard of care visit to
      ensure there were no problems with administration while not at the clinic.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ITP patients being treated with romiplostim will be approached for possible study
        participation. At each participating site, patients that meet the following criteria will
        be enrolled as a study subject. Adult ITP patients, treated per EU Summary of product
        characteristics (SmPC), or caregiver new (or at least a 3 month gap) to administering
        romiplostim, that has received HAT pack training and is available at a standard-of-care
        medical visit 4 weeks (range 2 to 8 weeks) after HAT pack training, the patient provides
        informed consent.
      
Keywords: romiplostim,; Nplate,; immune thrombocytopenic purpura
BAY14-2222 Continuous Infusion in Surgeries
Condition: Hemophilia
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase III study, to evaluate the efficacy and safety of continuous infusion of rFVIII-FS in
      the treatment of patients with hemophilia A undergoing major elective surgery by achieving
      the required therapeutic concentrations.
    


Intervention name(s): Kogenate (BAY14-2222)
Intervention type(s): Drug
Intervention description(s): 100 IU/mL (250 IU/vial nominal potency) continuous infusion over 6-11 days in 12 patients. 400 IU/mL (1000 IU/vial nominal potency) continuous infusion over 6-11days in 3 patients.
Intervention MeSH terms: Factor VIII
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemophilia,; Continuous Infusion
Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal
Condition: Substance Withdrawal Syndrome
MeSH terms: Substance Withdrawal Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Prescription opioid addiction is a growing public health problem and more pharmacologic
      treatments are needed because current approved medications have had limited patient
      acceptance (naltrexone), limited availability (methadone), and concerns about misuse and
      diversion (methadone and buprenorphine). Tramadol is a currently approved medication used to
      treat moderate-severe pain, and initial studies demonstrate that it may be useful for
      treatment of the uncomfortable syndrome of opioid withdrawal without producing euphoric
      effects. This study will determine whether two different doses of extended release tramadol
      can treat opioid withdrawal and whether tramadol itself produces withdrawal after it is no
      longer taken.
    


Intervention name(s): Tramadol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Medication; Oral Medication
Other intervention name(s): Brand name example: Ultram; Placebo is like a sugar pill
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy
Condition: Dyslipidemias; High Cholesterol; Hypercholesterolemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate
      the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with
      ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy.
    

Detailed description: 
      This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate
      the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with
      ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy. The
      screening period for this study will take up to 2-weeks. Afterwards patients will be
      randomized to placebo, 10 mg obicetrapib monotherapy, or 10 mg obicetrapib + 10 mg ezetimibe
      combination therapy for a 12-week treatment period. After the treatment period, patients will
      continue for a 4-week safety follow-up.
    

Intervention name(s): Obicetrapib; Ezetimibe 10mg; Obicetrapib placebo; Ezetimibe placebo
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): tablets; capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.; tablets; no active ingredient; capsules; no active ingredient
Other intervention name(s): CETP inhibitor
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo-controlled, double-blind, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obicetrapib; statin; LDL-C; cholesterol; atherosclerosis
Minoxidil 1% for Eyebrow Enhancement
Condition: Eyebrow Hypotrichosis; Thin Eyebrow
MeSH terms: Hypotrichosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare efficacy and safety of minoxidil 1% versus placebo in
      enhancement of eyebrows.
    


Intervention name(s): Minoxidil lotion 1%; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Minoxidil lotion 1% is applied twice daily to one eyebrow.
Other intervention name(s): Placebo is applied twice daily on the other eyebrow.
Intervention MeSH terms: Minoxidil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion
Condition: Radial Artery Injury at Wrist and Hand Level; Occlusion of Artery; Vasodilation
Study type: Interventional
Phase: Phase 3

Summary: 
      A total of 600 patients undergoing coronary procedures via transradial access using 6F sheath
      were randomized at the end of the procedure to receive either 250-µg nicardipine or 500-µg
      nitroglycerin administered to the radial artery through the radial sheath before sheath
      removal. A continuous patent hemostasis was applied in each patient with the use of an
      oximetry to maintain an oxygen saturation of >95%, measured in the finger of the accessed arm
      until compression device was totally removed. The primary outcome is early RAO which was
      evaluated by color duplex ultrasonography of the accessed arteries at the day after the
      radial procedure. Secondary outcome was the change of blood pressure at 2-3 minutes after
      drug administration. Radial artery angiogram was performed after radial sheath insertion and
      doppler ultrasound of the accesed radial artery was examined at the day after the procedure.
    

Detailed description: 
      Doppler ultrasound of the accessed artery was performed at the day after the radial procedure
      in all patients. The absence or presence of antegrade flow in the radial artery will be
      examined while compressing the ulnar artery as previously described.

      The internal lumen radial artery diameter was evaluated by doppler ultrasound as the distance
      between the inner walls of the artery by personnel that are blinded to the study protocol.

      Radial artery angiogram was performed soon after radial sheath insertion and the radial
      artery diameter was measured in AP projection in all patients.
    

Intervention name(s): Nitroglycerin
Intervention type(s): Drug
Intervention description(s): 200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal
Other intervention name(s): Nicardipine
Intervention MeSH terms: Nicardipine; Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: nitroglycerin and nicardipine
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 (C-011-404)
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I study will be conducted as a randomized, placebo-controlled, double-blind,
      dose-escalation study in four groups of healthy adult male and female subjects who are
      BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection. The study will
      be conducted at one or two sites located in South Africa. The purpose is to evaluate the
      safety and immunogenicity of two injections of AERAS 404 prepared with four escalating
      amounts of antigen in healthy adult male and female subjects who are BCG-vaccinated,
      HIV-negative, and have no evidence of tuberculosis infection.
    

Detailed description: 
      This Phase I study will be conducted as a randomized, placebo-controlled, double-blind,
      dose-escalation study in four groups of healthy adult male and female subjects who are
      BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection. The study will
      be conducted at one or two sites located in South Africa.

      Forty subjects will be sequentially enrolled into one of four study groups (i.e., Group 1,
      Group 2, Group 3, or Group 4) based on time of completion of screening, with 10 subjects
      enrolled into each group. Within each study group, subjects will be randomized to a treatment
      regimen of either AERAS-404 or placebo control administered by intramuscular injection on
      Study Day 0 and Study Day 56. All subjects will receive the same treatment on Study Day 0 as
      they receive on Study Day 56. The dose of antigen will increase between study groups. All
      subjects will be followed for safety and immunogenicity evaluations for 182 days. A total of
      eleven clinic visits are planned (excluding screening) for all subjects.
    

Intervention name(s): AERAS-404 (mcg H4/nmol IC31); Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaCl
Intervention type(s): Biological; Biological
Intervention description(s): Dose escalation
Other intervention name(s): H4; AERAS-404
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Comparison of Two Commercial Preparations of Botulinum Toxin Type A
Condition: Wrinkles in Frontal Area
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to compare the action halos of the botulinum toxins (Dysport®
      and Botox®) using two equivalence-ratios and to gather supportive information, such as more
      detailed data on the effectiveness in reduction of wrinkles and duration of action on the
      upper part of the face of both products, trough scales and photographs evaluations.
    

Detailed description: 
      This was a monocentric, prospective, randomized and double-blind study. Fifty nine female
      patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had
      never undergone previous BoNT-A injections were enrolled. There were two randomizations, one
      related to the dose-equivalence (2:1U and 2.5:1U), both reconstituted in the same volume of
      0.02 mL per point and another related to the forehead side (left or right) for application of
      the tested drugs. Baseline, twenty-eight and 112 days later, clinical and photographic
      assessments, Minor´s test, and electromyographic (EMG) evaluations were performed.
    

Intervention name(s): BOTULINUM TOXIN TYPE-A
Intervention type(s): Drug
Intervention description(s): On Visit 1 (Day 0):
Botulinum toxin A (Dysport® and Botox®) will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site.
Dysport®: 4 units will be injected in the left or right forehead side.
Botox® : 2 units will be injected in the left or right forehead side.(opposite side of dysport injection)
Other intervention name(s): BoNT A1 = Dysport; BoNT A2 = Botox
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Muscular activity; wrinkles in frontal area; action halos
A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome
Condition: Post-Lyme Disease Syndrome (PLDS)
MeSH terms: Lyme Disease; Post-Lyme Disease Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will determine the effectiveness of a nutraceutical in treating the lingering
      effects of Lyme Disease after antibiotic treatment.
    

Detailed description: 
      A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome will be evaluated during a double
      blind, placebo controlled study. This study is an expansion of RLP042019 NCT04078841 Treating
      Post-Lyme Disease Syndrome With Acetogenins
    

Intervention name(s): RLP; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): RLP nutraceutical; Inert brown powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Lyme
Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section
Condition: Cesarean Section Complications
Study type: Interventional

Summary: 
      Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery
      after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols
      have been widely investigated and have been shown to be associated with improved
      postoperative outcomes, some individual constituents of these protocols, including
      preoperative carbohydrate treatment, have not been subject to such robust analysis.
    

Detailed description: 
      Carbohydrate (sugar-containing) nutritional supplements have become a routine part of the
      package of care for people undergoing planned surgical procedures. the investigator wanted to
      discover whether carbohydrate supplements are a useful part of care packages used by doctors
      to improve recovery after planned cesarean section.
    

Intervention name(s): preoperative carbohydrate loading; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients in the treatment group will receive a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrin; 240 mOsm/L) in a dose of 800 mL. Patients will be free to drink the beverage from the evening before the operation and up to 2 hours before the induction of anesthesia; The control group will receive plain water with the same volume and timing of treatment.
Other intervention name(s): Experimental; Placebo Comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, placebo-controlled, study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Enhanced recovery after surgery; Preoperative carbohydrate drink; cesarean section
Kidney Fibrosis and MRI
Condition: Kidney Diseases
MeSH terms: Kidney Diseases
Study type: Interventional

Summary: 
      The investigators plan a prospective cross-sectional study of pediatric and adult healthy
      volunteers and patients with chronic kidney disease that will correlate a variety of
      quantitative MRI biomarkers with severity of renal insufficiency and available
      histopathology. Over 3 years, the investigators will recruit approximately 20 healthy
      volunteers, 20 patients with chronic kidney disease (CKD) Stage 2-5, and 20 patients with
      renal transplant kidneys. The investigators also plan to assess the effect of inflammation on
      the quantitative MRI biomarkers by recruiting approximately 20 additional patients with
      active lupus nephritis.
    


Intervention name(s): Kidney MRI
Intervention type(s): Diagnostic Test
Intervention description(s): An MRI examination will be completed per research MRI protocol.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Sleep-wake Patterns in Preterm Infants
Condition: Sleep
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The development of sleep-wake behavior is considered to be one of the most important
      maturation processes occurring in the first year of life. Sleep-wake behavior is related to
      neurobehavioral regulation of the infant and cognitive function, and gives important
      information about infant's health. It is suggested that the identification of sleep-wake
      patterns in preterm infants is critical to the detection of future disorders, early diagnosis
      and planning of intervention studies In this study we aimed to recruit a total of 25
      premature babies born between 28 to 37 weeks of gestational age over six month in the
      Neonatal Intensive Care Unit of Marmara University Pendik Training and Research Hospital.
      Sleep wake cycles of these premature infants will be assessed at 32 weeks corrected age by
      actigraphy, sleep diaries, direct observation and Amplitude integrated electroencephalography
      (aEEG). We also aimed to investigate the maturation of sleep patterns of these infants
      included in the study at postconceptional 40th weeks of age, and 12th, and at 24th weeks
      corrected age, by sleep diaries and actigraphic measurements at their home environment.
      Development will be assessed by Bayley and Ages and Stages Questionnaire.
    

Detailed description: 
      Studies show that the patterns of sleep-wakefulness reflect the maturation of the central
      nervous system in preterm infants and are indicative of behavioral development. It is
      emphasized that the identification of sleep-wake patterns in preterm infants is critical to
      the detection of future disorders, early diagnosis and planning of intervention studies.

      The primary objective of this study is to assess factors affecting the maturation of sleep
      wake cycles in preterm infants by actigraphy, sleep diaries, direct observation, and aEEG.
      Our secondary objectives were to assess the neurodevelopment of these infants.

      In this study we aimed to recruit a total of 25 premature babies born between 28 to 37 weeks
      of gestational age over a six month period in the Neonatal Intensive Care Unit of Marmara
      University Pendik Training and Research Hospital. Sleep architecture will be assessed at 32
      corrected age by actigraphy, sleep diaries, and aEEG. Simultaneous video recording and direct
      observation will be performed and sleep stages will be defined. Anderson Behavioral State
      Scale will also be applied. Philips Respironics Actiwatch-2 devices will be used. The follow
      up will be at post conceptional 40 weeks, 12 and 24 weeks corrected age. Development will be
      assessed by Bayley test and Ages and Stages Questionnaire.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Preterm infants born between 28 to 37 weeks of gestational age
      
Keywords: preterm; actigraphy; sleep
Multi-Component Technology Intervention for Minority Emerging Adults With Asthma
Condition: Asthma; Poor Medication Adherence
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This pilot study's main goal is to develop and preliminarily test a technology-based
      intervention to improve asthma medication adherence in urban African American emerging adults
      (ages 18-29). It is hypothesized that youth randomized to MCTI for adherence will show
      improvements in motivation to adhere to asthma medications and self-reported adherence
      compared to the comparison condition at 1- and 3- month follow up.
    

Detailed description: 
      This study collected pilot data with a sample of 48 African American emerging adults with
      asthma with suboptimal medication adherence. Half of the sample were randomized to receive a
      multi-component technology-based intervention (MCTI) targeting adherence to daily controller
      medication. The MCTI consisted of two components: 1) 2 sessions of computer-delivered
      motivational interviewing targeting medication adherence, and 2) individualized text
      messaging focused on medication adherence between the sessions. Text messages were
      individualized based on Ecological Momentary Assessment (EMA). The remaining half of
      participants completed a series of computer-delivered asthma education modules matched for
      length, location, and method of delivery of the intervention session. Control participants
      also received text messages between intervention sessions. Message content was the same for
      all control participants and contain general facts about asthma (not tailored).
    

Intervention name(s): Multi-component, technology based intervention; Asthma education active control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Motivational sessions were adapted from work done with young adults with HIV (MESA).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Technology based intervention; Emerging adults; African Americans; Asthma; Controller medications; Motivational intervention