bioihbjkbjnl/mcl2 huggingface dataset:
Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of three concentrations of
      ZK 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic
      dermatitis and to obtain dose-response information for the three concentrations.
    


Intervention name(s): ZK 245186; Placebo (vehicle ointment)
Intervention type(s): Drug; Drug
Intervention description(s): Once daily topical non-occlusive application for up to 4 weeks; Once daily topical non-occlusive application for up to 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Metformin and Cholecystokinin-mediated Gallbladder Emptying on GLP-1 Secretion in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Accumulating evidence suggests that bile acids in our intestines may constitute essential
      components in the complex mechanisms regulating gut hormone secretion and glucose
      homeostasis. Thus, it is likely that modification of the enterohepatic circulation of bile
      acids can lead to changes in gut hormone secretion and consequently affect glucose
      homeostasis.

      The current study is a human interventional randomized controlled cross-over study including
      four study days for each participant. Metformin will be applied as a tool to reduce bile acid
      reuptake in the small intestine; thereby increasing bile acid concentration in the more
      distal parts of the gut where GLP-1-secreting L cell are abundant. Interestingly, metformin
      has been shown to reduce the active reabsorption of bile acids in the ileum and cause
      increased faecal elimination of bile acids. Clinical data has suggested that metformin causes
      an increase in the postprandial secretion of GLP-1 in humans including patients with type 2
      diabetes. Intravenous infusion of cholecystokinin will be used to elicit gallbladder
      contraction and emptying. The aim is to examine how (and if) modification of bile acid
      reabsorption can influence postprandial glucagon-like peptide-1 (GLP-1) secretion and glucose
      homeostasis in patients with type 2 diabetes.

      The investigators hypothesize that higher luminal concentrations of bile acids in the distal
      gut will elicit changes in gut hormone secretion. The current study will help to clarify this
      hypothesis and improve our general understanding of the association between bile acid
      circulation and signalling, gut hormone secretion and glucose metabolism.
    


Intervention name(s): Isotonic saline; Metformin placebo; Cholecystokinin; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Metformin; Cholecystokinin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Early Feasibility Study to Evaluate the Efficacy of the RenewalNail™ Plasma Treatment System in Patients With Onychomycosis (Fungal Nail)
Condition: Onychomycosis of Toenail; Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional

Summary: 
      A study to determine if a three-treatment protocol with the RenewalNail™ plasma treatment
      system over a week will result in mycological cure and/or clear nail growth on the treated
      hallux toe.
    

Detailed description: 
      The purpose of this study is to assess the clinical feasibility of DeviceFarm, Inc.'s
      RenewalNail™ system and the treatment protocol that was developed based on extensive
      laboratory testing on human cadaver nails. The Protocol calls for three 45-minute treatments
      performed over a week to achieve mycological cure. Mycological cure will be assessed with two
      consecutive mycological culture tests done over a week following the third treatment. Two
      consecutive negative mycology culture results confirm the elimination of fungus causing
      onychomycosis infection, as recommended by recent FDA guidance. There will be no placebo arm
      in the study. Clear nail growth will be documented and assessed by photography for 5 months
      after treatment.
    

Intervention name(s): plasma treatment
Intervention type(s): Device
Intervention description(s): application of cold atmospheric plasma to a fungal infected toenail
Other intervention name(s): RenewalNail™ plasma treatment system
Intervention model: Single Group Assignment
Intervention model description: single center open-label study
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD)
Condition: Chorioretinal Vascular Disease
MeSH terms: Vascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to is to assess the ability of retina specialists to
      successfully administer, via an intravitreal (IVT) injection, a 2 mg dose of ABP 938, using
      the ABP 938 aflibercept prefilled syringe (PFS), compared to a 2 mg dose of aflibercept using
      the aflibercept PFS.
    


Intervention name(s): ABP 938; Aflibercept
Intervention type(s): Drug; Drug
Intervention description(s): IVT injection; IVT injection
Other intervention name(s): Eylea®
Intervention MeSH terms: Aflibercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chorioretinal vascular disease; CVD; ABP 938; Eylea®; aflibercept
A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa) in Healthy Subjects
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The purpose of this clinical research study is to determine if different dosage regimens of
      Sinemet® CR (Carbidopa/levodopa) are dose proportional
    


Intervention name(s): Sinemet® controlled release (Carbidopa/levodopa)
Intervention type(s): Drug
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Time perspective: Prospective
Safety and Therapeutic Effects of Sapropterin Dihydrochloride on Neuropsychiatric Symptoms in Phenylketonuria (PKU) Patients
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Interventional
Phase: Phase 3

Summary: 
      This double-blind, placebo-controlled, randomized study is designed to evaluate the safety
      and therapeutic effects of sapropterin dihydrochloride on neuropsychiatric symptoms in
      subjects with PKU.
    

Detailed description: 
      Phenylketonuria (PKU) results from deficient phenylalanine hydroxylase (PAH) activity and
      leads to toxic phenylalanine (Phe) accumulation in patients with PKU causing mental
      retardation, microcephaly, delayed speech, seizures, psychiatric symptoms and behavioral
      abnormalities. Although for most PKU patients early initiation of dietary treatment prevents
      severe complications, discontinuation of dietary restrictions at an early age is associated
      with poor cognitive development and neuropsychiatric disorders are present even in
      early-treated and well controlled PKU patients.

      This study, PKU-016, will be conducted in PKU patients to evaluate the therapeutic effects of
      sapropterin dihydrochloride on the symptoms of attention deficit hyperactivity disorder
      (ADHD), depression, and anxiety.
    

Intervention name(s): Sapropterin dihydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).; Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study.
Other intervention name(s): Kuvan; Phenoptin; BH4; 6R BH4
Intervention MeSH terms: Verapamil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phenylketonuria; PKU; Kuvan; Sapropterin dihydrochloride; Neuropsychiatric disorder; ADHD
Does Oral Propranolol Accelerate Labor Induction/Augmentation With Oxytocin in Nulliparous Women in Abakaliki?
Condition: Duration of Labor
Study type: Interventional

Summary: 
      Labour is usually physiologic, spontaneous and progressive, but occasionally, there may be
      the need for induction or augmentation of labour especially in nulliparous women, who are at
      increased risk of dysfunctional labour. Oxytocin traditionally has been used for induction
      and augmentation of labour however prolonged labour continued to occur with attendant
      sequelae. Newer agents like propranolol, with minimal to no maternal and fetal adverse
      effects in labour have been shown to decreases the duration of labour when used in synergy
      with oxytocin. However, the paucity of information on the use of propranolol in labour.
    

Detailed description: 
      ABSTRACT Background: Labour is usually physiologic, spontaneous and progressive, but
      occasionally, there may be the need for induction or augmentation of labour especially in
      nulliparous women, who are at increased risk of dysfunctional labour. Oxytocin traditionally
      has been used for induction and augmentation of labour however prolonged labour continued to
      occur with attendant sequelae. Newer agents like propranolol, with minimal to no maternal and
      fetal adverse effects in labour have been shown to decreases the duration of labour when used
      in synergy with oxytocin. However, the paucity of information on the use of propranolol in
      labour.

      Methodology: This research was a superiority open labelled randomized controlled trial that
      involved only nulliparous women who met the inclusion criteria and gave consent to the study.
      There was daily recruitment of participants. Randomization was by utilizing
      computer-generated numbers from a pool of 110 participants divided into A and B. Group A
      received 20 mg of oral propranolol before initiation of oxytocin titration. Group B received
      only oxytocin titration. Partograph was used to monitor their labour.

      Analysis: Absolute and relative frequencies of categorical variables, mean, range and
      standard deviation of continuous variables were calculated. Continuous variables were
      analyzed using students t-test while chi-square (χ2) test was used for categorical variables.
      A P-value of <0.05 was considered significant.

      Keywords: Propranolol, Labour, Induction, Augmentation, Nullipara
    

Intervention name(s): 20mg oral propranolol and oxytocin; Oxytocin only
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 20mg of oral propranolol 10minutes prior to initiation of augmentation or induction of labor with oxytocin; Participants will have outright augmentation or induction of labor with oxytocin
Intervention MeSH terms: Propranolol; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: clinical superiority open-labeled randomized controlled trial
Masking: None (Open Label)
Primary purpose: Prevention
Telephone Enhancement Procedure for Continuing Care - 1
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test a feasibility study of a telephone enhancement procedure
      (TELE) to improve participation in continuing care activities.
    


Intervention name(s): Behavior Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Keywords: behavioral intervention
Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The primary objectives of this clinical trial are to determine if replacing sugar sweetened
      beverages with water consumption promote weight loss over 6 months in overweight adults and
      if replacing sugar sweetened beverages with water consumption promote greater weight loss
      over 6 months relative to replacement with other non-caloric sweetened beverages or control.

      The secondary objective is to identify mediators and moderators of the effect of water
      replacement including hydration status, glucose metabolism, anthropometrics, physical
      activity, dietary intake and resting metabolic rate.
    


Intervention name(s): Dietary substitution A; Dietary Substitution B; Healthy Choices
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Substitution of calorie-dense item with lower calorie choice A; Substitution of calorie-dense item with lower calorie option B; Multiple healthy choices presented with self-selection of choices used
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
eSight Eyewear Quality of Life and Efficacy Study
Condition: Vision, Low
MeSH terms: Vision, Low
Study type: Interventional

Summary: 
      The "eSight Quality of Life and Efficacy Study" (eQUEST) is a prospective cohort study
      intended to demonstrate the functional vision and Quality of Life (QoL) improvement provided
      by eSight Eyewear to persons with significant visual impairment resulting from various eye
      conditions. The multi-site study will evaluate the efficacy of the eSight device for various
      Activities of Daily Living (ADLs) across a broad range of subject ages and disease types.
    

Detailed description: 
      Subjects will receive an initial benchmark assessment to determine their visual function.
      This includes standard clinical tests for acuity and contrast performance. Subjects will then
      receive a demonstration of the device. If the demonstration shows favourable results
      (improved functional visual performance for some rudimentary tasks such as reading), and the
      subject consents to the study, the subject will return to the site a week later to receive
      their personalized device (lens prescriptions incorporated into the unit), and more
      comprehensive training on its operation. They will then use the unit in their
      home/work/school environment over a period of three months. At the start of the study, after
      a period of one month, and at the end of the three month period, the subject will visit the
      clinical setting for administration of various specified ADL tasks, and the Veterans Affairs
      (VA) Low Vision (LV) Visual Function Questionnaire (VFQ) 48-question VA LV VFQ-48 survey. The
      intent of this repetition is to understand how ADL proficiency and VFQ-48 QoL assessment
      changes over time, as the subject becomes more accustomed to the device.
    

Intervention name(s): eSight Eyewear
Intervention type(s): Device
Intervention description(s): primary intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol
Condition: Opioid Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the Bioequivalence, assess food administration on
      the Pharmacokinetics with naloxegol.
    

Detailed description: 
      A Phase I, Randomised, Open-label, 3 way Cross-over Study in Healthy Volunteers to
      Demonstrate the Bioequivalence of the Naloxegol 25 mg Commercial and Phase III Formulations
      and to Assess the Effect of Food Administration on the Pharmacokinetics of the Commercial
      Formulation.
    

Intervention name(s): Naloxegol; Naloxegol
Intervention type(s): Drug; Drug
Intervention description(s): Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation; Naloxegol film-coated Phase III formulation 25 mg film-coated IR tablet
Intervention MeSH terms: Naloxegol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Healthy volunteers; Naloxegol; Bioequivalence
Acute Tendon and Nerve Responses to Exercise
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Observational

Summary: 
      The purpose of this study is to use ultrasound to analyze the effects of a bout of circuit
      training on the upper extremity of persons with spinal cord injury and able-bodied controls.
    

Detailed description: 
      Background: Manual wheelchair propulsion is a primary source of mobility for many individuals
      with spinal cord injury (SCI). Propelling a manual wheelchair over an extended period often
      leads to arm pain and, subsequently, to secondary disability. Over 50% of manual wheelchair
      users with SCI experience arm pain that limits their activities of daily living. The
      prevalence of shoulder pain and carpal tunnel syndrome among manual wheelchair users is
      between 31% and 73%, and 49% and 73% respectively. A circuit training protocol has been
      developed to strengthen and protect the muscles of people with SCI, and has been shown to
      improve muscle strength and endurance, and reduce HDLcholesterol levels.

      Purpose: The purpose of this study is to use ultrasound to analyze the effects of a bout of
      circuit training on the upper extremity of persons with SCI and able-bodied controls.

      Hypotheses: All subjects will show an increase in nerve cross-sectional area after
      participation in the circuit training protocol. Nerves and tendons will become less echogenic
      after participation in the circuit training protocol. These changes will be more pronounced
      in persons with SCI.

      Methods: Data collected will include history of pain, a physical exam, and ultrasound images
      of the nondominant upper extremity before and after a bout of circuit training, which
      includes exercises lifting weights and using an arm cycle. Before circuit training,
      ultrasound images will be collected once. After the circuit training, ultrasound images will
      be collected every 10 minutes over an hour. These images and will be used to measure the
      health and properties (such as size) of nerves, muscles, and tendons in the arm. Changes in
      these properties after a bout of circuit training will be related to history and physical
      exam information.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample of persons with spinal cord injury or healthy volunteers.
      
Keywords: Healthy Control
Study to Evaluate the Effect of Food on the Pharmacokinetics of ASC41 in Healthy Volunteers
Condition: Healthy; NAFLD; Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the effect of food on the pharmacokinetics of a single dose of
      ASC41 tablet in healthy volunteers, comparing fasting and postprandial pharmacokinetic
      parameters of Tmax, Cmax, AUC0-t, AUC0-∞.
    


Intervention name(s): ASC41 tablet
Intervention type(s): Drug
Intervention description(s): Oral tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; NAFLD; NASH; Hyperlipidemia; LDL-C
Mycophenolate Mofetil in Membranous Nephropathy
Condition: Glomerulonephritis, Membranous
MeSH terms: Kidney Diseases; Glomerulonephritis; Glomerulonephritis, Membranous
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Patients with idiopathic membranous nephropathy and renal insufficiency are at risk for
      end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a
      treatment modality. Mycophenolate mofetil is a new immunosuppressive agent with fewer side
      effects.

      In this pilot study patients with membranous nephropathy and renal failure will be treated
      with mycophenolate mofetil and prednisone. The outcome will be compared with historical
      controls treated with a similar regimen containing cyclophosphamide.
    


Intervention name(s): mycophenolate mofetil orally 1000 mg twice a day (BID); prednisone 0,5 mg/kg orally on alternate days; intravenous (i.v.) methylprednisolone 1000 mg, total 9
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: membranous nephropathy; mycophenolate mofetil; cyclophosphamide; prednisone
Sarpogrelate Drug Interaction
Condition: Hypertension; Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, single & multiple-dose, three-sequence, three-period
      crossover study to investigate the effect of sarpogrelate hydrochloride on the disposition of
      metoprolol tartrate in healthy male volunteers
    

Detailed description: 
      Eligibility for participation of this study will be determined from demographic information,
      medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests
      within 4 weeks before study drug administration. Subjects suitable for this study will be
      admitted to the Clinical Trial Center of Ajou University Medical Center on the day before
      dosing (Day -1).

      On Day 1, Subjects will be dosed study drug (metoprolol tartrate 100 mg once a day only, or
      metoprolol tartrate 100 mg once a day with sarpogrelate hydrochloride 100 mg three times a
      day, sarpogrelate hydrochloride 100 mg three times a day pretreatment for three days and
      metoprolol tartrate 100 mg once a day with sarpogrelate hydrochloride 100 mg three times a
      day).

      Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 12
      hours after metoprolol tartrate 100 mg dosing.

      After one week of washout period (Day 8), Subjects will be dosed study drug by crossover
      manner, and pharmacokinetic samplings and blood pressure/pulse rate measurement will be done
      upto 12 hours after metoprolol tartrate 100 mg dosing.

      After one week of washout period (Day 15), Subjects will be dosed study drug by crossover
      manner, and pharmacokinetic samplings and blood pressure/pulse rate measurement will be done
      upto 12 hours after metoprolol tartrate 100 mg dosing.
    

Intervention name(s): Sarpogrelate pretreatment; Sarpogrelate; Metoprolol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sarpogrelate hydrochloride 100 mg pretreatment three times a day for three days; Sarpogrelate hydrochloride 100 mg three times a day; Metoprolol Tartrate 100 mg once a day
Intervention MeSH terms: Metoprolol; Sarpogrelate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug-drug interaction; Pharmacokinetics; Pharmacodynamics