bioihbjkbjnl/mcl2 huggingface dataset:
No Treatment Versus Oral Ibuprofen Treatment for Patent Ductus Arteriosus in Preterm Infants
Condition: Bronchopulmonary Dysplasia (BPD)
MeSH terms: Bronchopulmonary Dysplasia; Ductus Arteriosus, Patent
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of no treatment compared
      with ibuprofen treatment for patent ductus arteriosus in preterm infants. The study
      hypothesis is that no treatment is not inferior to oral ibuprofen treatment in preterm
      infants. (non-inferiority study)
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled, non-inferiority clinical trial.
    

Intervention name(s): Oral ibuprofen; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Initial dose of 10 mg/kg of oral ibuprofen, followed by two doses of 5 mg/kg 24 and 48 hours later; Initial dose of normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen arm
Other intervention name(s): Brufen® syrup, Samil pharm. Co., Ltd.; Sodium chloride, Huons. Inc.
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Patent ductus arteriosus; Ibuprofen; Bronchopulmonary dysplasia
Have a Good Grasp of the Worldthe World
Condition: Schizophrenic Disorders
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Brief Summary: In schizophrenia, dislocation of psychic functions involving a loss of contact
      with reality is frequently found. A fragmentation of motor and sensory perceptions could be
      held responsible. However, automatic integration between perception and action is the
      necessary condition to be in "relationship with the world." Affordance is the experimental
      link between object perception and potentially associated actions (Gibson, 1977, 1979)
      explored by Stimulus Response Compatibility (SRC) paradigm. With Tucker & Ellis sensory motor
      compatibility task (1998), with a modified response device (responses given with grasp), we
      study the impact of motor activation on these affordance effects. In this study, a group of
      controls will also be included in order to understand, as precisely as possible, the
      mechanisms involved (i.e., interference between the perception of the object and the response
      gesture).
    

Detailed description: 
      Schizophrenic patients will perform: Alert TEA, (Zimmermann and Fimm, 2005), Edinburgh
      laterality questionnaire (Oldfield, 1971), IQ test (IQ: PM38, Raven, 1960), and the PANSS
      (Positive and Negative Syndrome Scale, Kay et al., 1987). Controls will only perform the
      laterality questionnaire. Then all will perform the affordance task, in which photographs of
      20 objects of everyday life, typically graspable with one hand, are presented in 4
      orientations. Participants have to respond in a graspable device, as quickly as possible, if
      the object is presented upright or inverted.
    

Intervention name(s): cognitive tasks + PANSS+ IQ; cognitive tasks
Intervention type(s): Other; Other
Intervention description(s): Patients will perform different tasks: reaction time (Alert TEA, Zimmermann and Fimm, 2005), Edinburgh laterality questionnaire (Oldfield,1971), IQ test (IQ: PM38, Raven, 1960), and the PANSS (Positive and Negative Syndrome Scale (Kay et al., 1987) + the experimental task (affordance task with graspable device); Healthy volunteers will perform only Edinburgh laterality questionnaire (Oldfield, 1971) + the experimental task (affordance task with graspable device).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Schizophrenia, affordance,; perception-action binding,; stimulus-response-compatibility
A Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a Phase 2 randomized, double-blind, double-dummy, parallel-group study designed
      to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple
      doses of ABT 122 in subjects with active rheumatoid arthritis (RA) who are inadequately
      responding to methotrexate (MTX) treatment.
    


Intervention name(s): adalimumab; ABT-122
Intervention type(s): Biological; Biological
Intervention description(s): adalimumab administered as subcutaneous injection every other week (EOW); ABT-122 administered as subcutaneous injection every other week (EOW)
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: efficacy; Methotrexate; safety
A Multiple Meal Stable Iron Isotope Study in Iron Deficient Rwandese Women to Investigate the Performance of Low Phytic Acid Bean Seeds
Condition: Enrichment of Blood With Stable Iron Isotopes
Study type: Interventional

Summary: 
      Recent iron absorption studies with biofortified beans indicated that the currently developed
      beans do not provide an extra amount of iron compared to normal iron beans. This effect was
      ascribed to the inhibitory nature of phytic acid (PA), which is present in high
      concentrations. A possible solution to alleviate problems associated with the high PA
      concentration in beans might be low phytic acid (lpa) bean seeds. These beans, which exhibit
      a good agronomic performance, were tested in a human absorption study in Switzerland and
      provided a higher amount of bioavailable iron compared to their parent beans with normal PA
      concentrations. However, the informative value of the study for the real life situation is
      limited due to the simple study design with a relatively large amount of isotopic label added
      extrinsically (≈30% of total iron). Furthermore, the study was conducted in iron sufficient
      women in a non-bean consuming population. Additional investigations are necessary to verify
      that iron bioavailability from lpa beans is high and that their performance is better
      compared to common biofortified beans in a real life situation. A multiple meal randomized
      crossover study in Rwandese women with low iron status will be done to measure iron
      absorption from three different beans (lpa bean line, biofortified high iron bean, normal
      iron bean as a control). During the study, the subjects will receive multiple meals to reduce
      the amount of extrinsic label, therefore more closely simulating hypothetical dietary iron
      intake from lpa beans. This will also allow to avoid an overestimation of the effect of
      inhibitors and to minimize the influence of intra subject day to day variation. The study
      will be divided into two parts. In part one, two of the three bean varieties will be fed as
      part of composite meals over several days (morning and lunch) and in part two, the remaining
      bean will be administered as part of composite meals over several days (morning and lunch).
      Iron absorption from the three varieties will be measured and compared with erythrocyte
      incorporation of stable isotopic labels 14 days after test meal administration.
    


Intervention name(s): 10 x 55 g/ bean per arm
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: iron biofortification; lpa bean; stable iron isotope study; phytic acid
Auditive and Renal Long Term Outcomes - Risk After Aminoglycoside Therapy in Neonates (AURORA)
Condition: Hearing Loss; Gentamicin Adverse Reaction; Renal Tubular Disorder
MeSH terms: Hearing Loss
Study type: Observational

Summary: 
      Gentamicin, in combination with a beta-lactam antibiotic, is commonly used for treatment of
      neonatal sepsis. Neonates have a high volume of distribution. It is a paradox that most
      neonatal dosing schedules still recommend lower gentamicin doses (4-5 mg/kg) than in older
      children (≥ 7 mg/kg). In the neonatal unit in Tromsø a simplified gentamicin high-dose (6
      mg/kg) regimen has been in use since 2004.

      The investigators have previously shown that this regimen was associated with low number of
      elevated trough levels, low numbers of prescription errors and no evidence for ototoxicity in
      the immediate neonatal period. However, the long-term safety of gentamicin therapy in
      neonates is not well studied when it comes to ototoxicity and possible nephrotoxicity.

      The objective of the current study is therefore to perform a detailed hearing evaluation,
      including an extended high-frequency (EHF; 9-16 kHz) audiometry, in a follow-up study of
      children (participants) aged 6-15 years who were exposed to a high-dose gentamicin regimen in
      the neonatal period. Moreover, we will investigate blood pressure and urine biomarkers to
      assess renal tubular function. The aim is to include 250 children exposed to gentamicin in
      the neonatal period and a control group of 25 healthy children.

      EHF audiometry is a more sensitive method for detecting ototoxic damage and provides evidence
      of ototoxicity before any hearing loss is detected by conventional systems. This is the
      background for choice of method.

      The primary outcome is the difference in average hearing threshold in the EHF range between
      the control group and the exposed group.

      Secondary outcomes are i) difference in average hearing threshold in the EHF range between
      the children with gentamicin trough levels > 1.0 mg/L versus those who had lower trough
      levels, ii) markers of renal tubular function (kidney injury molecule 1) and iii) blood
      pressure.
    


Intervention name(s): Audiometry; Urine biomarkers for renal tubular function; Blood pressure
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Extended high-frequency (EHF; 9-16 kHz) audiometry; Kidney Injury Molecule-1; Blood pressure right arm, measured With standard Methods 3 times
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 6-15 years and Exposed to gentamicin therapy in the neonatal period and
        treated at neonatal unit at the University Hospital of North Norway.
      
Biospecimen description: 
      Urine biomarkers
Study of Physical Health for Women With Posttraumatic Stress or Depression
Condition: Healthy; Stress, Psychological; Depression; Posttraumatic Stress Disorders
MeSH terms: Depression; Depressive Disorder; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Stress, Psychological
Study type: Observational

Summary: 
      The purpose of this study is to obtain a better understanding of how stress is related to
      health risks.
    

Detailed description: 
      Participants complete up to two study visits of approximately 3-4 hours each. The first study
      visit involves an interview about life experiences and emotions. If the participant is
      eligible for the second assessment, the average length of time between visit 1 and visit 2
      will be 1-7 days. The second visit included physical measurements such as cholesterol and
      blood pressure, performing math and speaking tasks, and surveys to help us learn about
      healthy behaviors and emotions. No further follow-up of participants is conducted beyond the
      two study visits.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample, psychology clinics
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)
Condition: Benign Prostatic Hyperplasia (BPH)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      A prospective multicenter randomized blinded study comparing Aquablation of the prostate with
      the AQUABEAM System and TURP for the treatment of Lower Urinary Tract Symptoms (LUTS). The
      primary endpoints for safety and effectiveness were measured at 3 and 6 months, respectively,
      and subjects were followed out to 5 years to collect long-term clinical data.
    


Intervention name(s): AQUABEAM System; Transurethral Resection of the Prostate (TURP)
Intervention type(s): Device; Procedure
Intervention description(s): The AQUABEAM system, a personalized image-guided tissue removal system, utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue.; Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lower Urinary Tract Symptoms (LUTS)
Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate if adjunctive armodafinil treatment can
      improve the cognitive deficits in patients with schizophrenia
    


Intervention name(s): armodafinil; armodafinil; armodafinil; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50 mg/day armodafinil; 100 mg/day armodafinil; 200 mg/day armodafinil; placebo
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Fuel for Fun: Cooking With Kids Plus Parents and Play
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Fuel for Fun: Cooking with Kids Plus Parents and Play (FFF), is an integrated research,
      extension, and education project targeting 4th grade students. Its long-term goal of reducing
      the risk of childhood obesity will be addressed by promoting healthful food and activity
      environments, policies and behaviors through: 1) building and testing the efficacy of a 4th
      grade comprehensive school- and family-based intervention, 2) applying it to an after-school
      setting to broaden its reach, and, 3) disseminating both versions through outreach.
    

Detailed description: 
      Fuel for Fun: Cooking with Kids Plus Parents and Play (FFF) is based on existing,
      evidence-based components: the experiential Cooking with Kids curriculum, the SPARK Active
      Recreation program; principles of behavioral economics in school cafeterias and homes; the
      online About Eating 5-lesson module based on eating competence concepts, and a family-based
      FFF component specifically designed for this intervention.

      Each component addresses policy and environment in addition to behavior change at school and
      home. The main research project - school-based FFF - will be implemented in 8 low-to-moderate
      income schools for two years using an asynchronous design that allows for assessment of the
      school-based program alone and in combination with both parent programs. Changes in fruit and
      vegetable intake (measured by self-report, cafeteria plate waste) and activity levels
      (measured by self-report and accelerometry) are primary outcomes, with measured BMI as a
      secondary outcome. Subsequent studies will involve the development of an after-school version
      and adoption of FFF by other districts.

      University students will gain valuable research experience and school and Extension educators
      will receive important childhood obesity prevention training. The project's long term goal is
      consistent with the United States Department of Agriculture (USDA) goal of improving the
      nation's nutrition and health by promoting the development of healthy eating and activity
      habits in children.
    

Intervention name(s): School; Family; About Eating
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): students receive Cooking With Kids (CWK) - Colorado cooking & tasting lessons, SPARK active recess, and Cafeteria Connections; students receive the FFF family component - family nights, parent blog, and action packs that go home after each CWK-Colorado lesson; parents who completed the parent survey are invited to access the 6 lesson online About Eating program
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: School; Family; Fruit and Vegetables; Cooking; Physical Activity
Effectiveness and Safety of Topical Hyaluronic Acid of Different Molecular Weights in Xerotic Skin Treatment
Condition: Xerosis Cutis
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this clinical trial is to compare 0,1% topical low molecular weight (7 kDa)
      hyaluronic acid with 0,1% high molecular weight (1.800 kDa) hyaluronic acid as therapy of
      xerotic skin in elderly
    

Detailed description: 
      This clinical trial is conducted to compare the effectiveness and safety between moisturizers
      containing 0,1% low molecular weight hyaluronic acid, 0,1% high molecular weight hyaluronic
      acid, and its vehicle on skin hydration of elderly with xerotic skin. It is designed to
      answer following questions:

        1. Is the skin capacitance in the elderly after using moisturizers containing low molecular
           weight hyaluronic acid higher than high molecular weight hyaluronate acid and vehicle?

        2. Is the transepidermal water loss in the elderly after using moisturizers containing high
           molecular weight hyaluronic acid lower than low molecular weight hyaluronate acid and
           vehicle?

        3. Is the dry skin score (SRRC) in the elderly after using moisturizers containing low
           molecular weight hyaluronic acid lower than high molecular weight hyaluronate acid and
           vehicle?

        4. Is there any difference in occurence of side effect in elderly between the use of
           moisturizers containing low molecular weight hyaluronic acid, high molecular weight
           hyaluronic acid, and vehicle?
    

Intervention name(s): Low molecular weight hyaluronic acid; High molecular weight hyaluronic acid; Vehicle
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Topical 0,1% low molecular weight (7 kDa) hyaluronic acid in vehicle; Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid in vehicle; Vehicle ingredients including aqua, paraffinum liquidum, glycerin, petrolatum, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, arachidyl alcohol, squalane, behenyl alcohol, phenoxyethanol, arachidyl glucoside, allantoin, chlorphenesin, and disodium EDTA
Other intervention name(s): LMWHA; HMWHA; Placebo
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a split study, one participant receive three interventions in three area in the leg. The distribution of treatment groups is carried out randomly using the block randomization method.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil
Condition: Cognitive Dysfunction; Memory Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to compare the safety and effects of donepezil (Aricept) for patients reporting
      cognitive or memory issues after receiving chemotherapy for breast cancer. Patients will
      receive either donepezil or placebo for 24 weeks. The primary objective is to see if memory
      improves with the use of donepezil during the study.
    

Detailed description: 
      Randomized, double-blind, placebo-controlled study with 24 weeks of exposure to drug or
      placebo followed by a 12 week wash-out period. Patients who meet the eligibility criteria
      will be stratified by age (<50, 50-59, 60-69, ≥70) and randomized to donepezil or placebo
      with equal probability. A total of 276 patients will be enrolled (138 per arm). We expect an
      accrual rate of 7-10 participants per month based on our prior feasibility study. We expect
      the study to be complete within 40 months.

      Participants will be asked to take one 5mg tablet of donepezil or one tablet of matching
      placebo orally once a day for 6 weeks followed by two 5mg tablets (10mg total) of donepezil
      or two placebo tablets orally once a day for 18 weeks. After 24 weeks, participants will
      begin a 12 week wash-out period.

      Time points for performing study assessments. Participants will be administered the cognitive
      battery of tests and questionnaires at baseline, week 12, week 24 and week 36. In addition, a
      single vial of blood will be drawn at baseline for apolipoprotein E (APOE) genotyping and
      subsequent bioassays (pending supplemental funding).
    

Intervention name(s): Donepezil 5 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be asked to take one 5 mg tablet of donepezil daily for 6 weeks followed by two 5mg tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.; Participants will be asked to take one tablet of matching placebo daily for 6 weeks followed by two tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.
Other intervention name(s): Aricept; Sugar Pill
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Donepezil; Cognition; Breast Cancer
A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects
Condition: Overweight; Obesity
MeSH terms: Overweight; Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, tolerability, and effect on body weight of leptin,
      injected subcutaneously, in combination with pramlintide, injected subcutaneously.
    


Intervention name(s): pramlintide acetate 360 mcg; metreleptin; placebo-pramlintide 600 uL; placebo-metreleptin 1 mL; Pramlintide acetate 180 mcg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): subcutaneous injection, twice a day, 360mcg; subcutaneous injection, twice a day, 5mg; twice a day; twice a day; subcutaneous injection twice a day, 180 mcg
Other intervention name(s): SYMLIN®; recombinant-methionyl human leptin; SYMLIN®
Intervention MeSH terms: Pramlintide; Islet Amyloid Polypeptide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: overweight; obesity; pramlintide; leptin; Amylin