bioihbjkbjnl/mcl2 huggingface dataset:
Management of Urinary Tract Infections in Primary Care Facilities.
Condition: Urinary Tract Infection
MeSH terms: Infections; Urinary Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The Emergency Ward Center in Oslo has the last two years used a questionnaire to identify
      patients who qualify for treatment of acute cystitis by the use of a delegation form.

      The aim of the study is to evaluate this practice, the primary objective being to evaluate if
      in a selected patient group the treatment outcome after identifying patients with probable
      acute cystitis by delegation form will be as good or better than the treatment received after
      a regular doctor's consultation.

      The planned study will also investigate which symptoms, signs and laboratory findings that
      coincide with significant bacteruria.

      The reference standard will be a microbiological culture of every patients urine.
    


Intervention name(s): Delegation form
Intervention type(s): Other
Intervention description(s): The study aims to compare the use of a delegation form to identify patient's who qualify for antibiotic treatment for suspected acute cystitis with a regular doctor's consultation. The key outcomes are lack of bacteruria and symptoms of UTI at followup times.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary tract infection; Cystitis; Bacteruria
A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis
Condition: Primary Axillary Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits,
      hands, and feet) affects approximately 4.8% of the US population and is believed to be caused
      by an overactive cholinergic response of the sweat glands. Sofpironium bromide (BBI-4000) is
      a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 2
      study will assess the long-term safety, tolerability, pharmacokinetics and efficacy of
      sofpironium bromide gel applied topically to pediatric subjects with axillary hyperhidrosis.
    

Detailed description: 
      This is an open-label, phase 2 long-term study designed to evaluate the safety, local
      tolerability, pharmacokinetics and efficacy of sofpironium bromide gel when applied topically
      to the axillae.

      Subjects will apply the gel once daily at bedtime, to both axillae.

      A maximum of 24 subjects, will be enrolled to receive sofpironium bromide gel, 15%.

      Adverse events, vital signs, and local tolerability assessments will be collected at each
      visit. Urine pregnancy tests will be taken throughout the course of the study for women of
      child bearing potential. Blood and urine samples will be collected and analyzed for
      pharmacokinetics, routine hematology, chemistry, and urinalysis parameters at specified
      visits. Patient-reported outcome assessments will be recorded during the study at predefined
      time points.

      The study will be comprised of a total of 8 scheduled visits to take place over a 26 week
      period.
    

Intervention name(s): Sofpironium Bromide Gel, 15%
Intervention type(s): Drug
Intervention description(s): Sofpironium Bromide Gel, 15%
Other intervention name(s): BBI-4000
Intervention MeSH terms: Bromides
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
High-Fidelity Simulation Training: A Mixed Method Study
Condition: Simulation of Physical Illness; Satisfaction
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare in describe first-year nursing students'
      skills. The main questions it aims to answer are:

        -  Are nursing students who perform the simulation practice with the scenario-based
           high-fidelity simulation manikin higher than those who perform the practice with the
           standard demonstration method?

        -  Are the satisfaction levels of nursing students who perform the simulation practice with
           the scenario-based high-fidelity simulation manikin higher than those who perform the
           practice with the standard demonstration method? Researchers will compare two groups of
           nursing students training with high-fidelity simulation manikin and training with
           standard demonstration method.
    


Intervention name(s): High-Fidelity Simulation Manikin; Education
Intervention type(s): Device; Other
Intervention description(s): A high-fidelity simulator was developed to teach skills in nursing education, and it is sized to represent an adult male patient. The mannequin can be controlled using a computer program, it can breathe, and its vital signs can be monitored using a bedside monitor.; Training for 26 nursing students who constituted the control group performed personnel protective equipment (PPE) wearing-removal practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: COVID-19; Simulation; Personal protective equipment; Nurse
Wellbutrin XL for Dysthymic Disorder
Condition: Dysthymic Disorder
MeSH terms: Dysthymic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic
      disorder, a form of low-grade chronic depression. We hypothesize that patients taking
      Wellbutrin XL will show greater improvement in depression symptoms and psychosocial
      functioning than patients taking placebo.
    

Detailed description: 
      This is a ten-week, double-blind, placebo-controlled study designed to evaluate the
      tolerability, dosing and efficacy of Wellbutrin XL in outpatients who meet Diagnostic and
      Statistical Manual-IV criteria for early onset, primary type dysthymic disorder (low-grade
      chronic depression). It is hypothesized that patients taking Wellbutrin XL will show greater
      improvement in depression symptoms and psychosocial functioning than patients taking placebo.
    

Intervention name(s): bupropion XL; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Antidepressant medication; Placebo
Other intervention name(s): Wellbutrin XL
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dysthymic Disorder; Dysthymia; Depression; Chronic Depression; Wellbutrin XL
Study to Explore Pharmacokinetics and Pharmacodynamics of a Single Rising Dose of BI 135585 XX
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetics and pharmacodynamics of BI 135585 XX following single
      dose administration.
    


Intervention name(s): BI 135585 XX
Intervention type(s): Drug
Intervention description(s): one single dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Nasal Spray for Relief of Nasal Congestion in Infants and Toddlers With Common Cold
Condition: Nasal Congestion
MeSH terms: Common Cold
Study type: Interventional

Summary: 
      The study will evaluate the safety and efficacy of the study medical device plus standard of
      care versus standard of care in subjects between 3 and 48 months (inclusive) presenting
      symptoms of a common cold.
    

Detailed description: 
      The purpose of the present study is to test the efficacy, safety and tolerability of a
      product in relieving the symptoms of the common cold in children. This nasal spray is
      specifically studied for small children, classified as medical devices and is already on the
      market. Sterimar Blocked Nose Baby (CDEU048-28) nasal spray is a medical device and is a 100
      ml bag-on-valve spray. The spray contains hypertonic solution based on 100% natural sea water
      rich of marine trace elements with added manganese and copper.

      220 subjects will be included in this open label, randomized, parallel group, study product
      and standard of care versus standard of care study.

      Study product will be used as 1 to 2 sprays per nostril (each "dose" is 1 or 2 sprays per
      nostril, the second spray only if needed), for a minimum of 2 times (morning and evening)
      and, as needed, up to a maximum of 6 times per day (i.e., maximum 12 sprays per nostril each
      day). The 10 day study consists of 4 visits- Day 0 onsite, Days 3 and 6 telephone contact,
      and Day 10 onsite.

      There will be 3 strata according to age: (3-12 months), (13-24 months) and (25-48 months).
      Every effort will be made to ensure at least 20% of subjects in each of the study groups are
      3-12 months of age.
    

Intervention name(s): Blocked Nose Baby nasal spray; Standard of care
Intervention type(s): Device; Other
Intervention description(s): One or two nasal sprays will be administered to each nostril for a minimum of 2 times per day up to a maximum of 6 times per day for a maximum of 10 days.; Standard of care consists of hydration, rest at home and antipyretic paracetamol as necessary.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label, randomized, parallel group. Study product and standard of care versus standard of care.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric
Topical Antibiotics in Chronic Rhinosinusitis
Condition: Chronic Rhinosinusitis (Diagnosis)
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Researchers are trying to find out if patients develop antibiotic resistant organisms after
      the use of topical antibiotics in the treatment of chronic rhinosinusitis.
    

Detailed description: 
      There is a certain group of patients that has chronic rhinosinusitis that has continued even
      with treatment including saline and steroid nasal irrigations as well as oral steroids and
      antibiotics and surgery.

      In these patients, the use of topical antibiotic nasal rinses may be of benefit to their
      disease. The use of topical antibiotic nasal rinses is commonly used as standard of care
      already throughout the country for refractory chronic rhinosinusitis including here at the
      Mayo Clinic. Our pharmacy has compounded this medication for this specific purpose. As such,
      this study is not aimed at a 'novel medication', but rather to investigate the efficacy of a
      medication already in common use but without great evidence.

      The investigators are doing this research study to find out if patients develop antibiotic
      resistant organisms after the use of topical antibiotics in the treatment of chronic
      rhinosinusitis.

      In addition, this study will look at the effects of topical antibiotics on patient symptoms
      as measured by a patient survey called the Sino-Nasal Outcomes Test (SNOT-22) and in-office
      an exam of the inside of their nose, including with a scope (a camera on the end of a long
      tube).
    

Intervention name(s): Mupirocin; Tobramycin; Levofloxacin; Vancomycin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.; 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.; 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.; 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
Intervention MeSH terms: Vancomycin; Levofloxacin; Tobramycin; Mupirocin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparisons of Morphological Measurement Between Coronary Computed Tomography and Optical Coherence Tomography
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      The objective of this study is to evaluate the precision of semi-automated lumen boundary
      identification from coronary computed tomography angiography (cCTA) by current version of
      HeartFlow software and the impact on fractional flow reserve (FFRCT) by using optical
      coherence tomography (OCT) as reference standard.
    

Detailed description: 
      Analysis of cCTA and OCT was conducted under blind in independent organizations.

      After unblinding the cCTA and OCT case identification number, the OCT image was co-registered
      to cCTA data.

      After co-registration of cCTA and OCT lesion locations, the minimal lumen area (MLA) was
      detected with both modalities. FFROCT was calculated using OCT-updated models in which
      cCTA-based lumen geometry was replaced by OCT-based lumen geometry.

      Lesions were grouped according to their severity of calcification (using Agatston score) and
      minimum lumen diameter.
    

Intervention name(s): data collection, non-intervention
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        72 vessels in 57 patients
Does Single Dose Imipramine Affect the Opening Pressure of the Urethral and Anal Sphincter?
Condition: Urinary Incontinence, Stress; Fecal Incontinence
MeSH terms: Fecal Incontinence; Urinary Incontinence; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blinded, randomized, crossover study in healthy females with placebo and single dose
      imipramine 50 mg.

      Primary objective: Does imipramine increase the tone of the external urethral sphincter?
      Urethral Opening Pressure (UOP) is measured with Urethral Pressure Reflectometry (UPR). UOP
      increases correlate with effect in treating stress urinary incontinence. Can imipramine treat
      stress urinary incontinence? Secondary objective: Does imipramine increase the tone of the
      anal sphincter? The opening pressure is measured with Anal Acoustic Reflectometry (AAR). The
      investigators also wish to establish the within-subject standard deviation for AAR to enable
      power calculations in future studies.
    


Intervention name(s): Placebo Oral Tablet; Imipramine Hydrochloride 25 MG
Intervention type(s): Drug; Drug
Intervention description(s): Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc; Two Imipramin DAK film coated tablets 25 mg each, single dose
Other intervention name(s): Imipramin DAK
Intervention MeSH terms: Imipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 16 healthy female subjects. Double-blinded, crossover study on two days with 1 week washout. Either placebo or imipramine 50 mg single dose before and after measurement of UOP and AOP.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effect of Adding Renin-Angiotensin System Inhibitors to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Ellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Type 2 diabetes mellitus (T2DM) is a progressive metabolic disorder in which a substantial
      number of patients cannot attain treatment target despite antidiabetic drugs. The
      renin-angiotensin system (RAS) has recently been implicated in the development of insulin
      resistance and impaired glucose metabolism. This study investigates the effect of adding RAS
      inhibitors to standard antidiabetic therapy in patients with T2DM. The primary outcome
      measure is the change in serum glycosylated hemoglobin A1c after 24 weeks of treatment.
      Secondary outcomes measures include changes in plasma lipid profile and blood pressure after
      treatment.
    


Intervention name(s): Valsartan 80 mg and metformin; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Valsartan 80 mg once daily in addition to metformin monotherapy; Metformin monotherapy
Intervention MeSH terms: Metformin; Valsartan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) in Children With ADHD
Condition: Attention-Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady
      state (following up to 5 weeks of treatment) in children using an outpatient, single-center,
      open-label, flexible dose-escalation study design.
    

Detailed description: 
      This dose-escalation study will examine HLD100 in 24 subjects.

      The subjects (n=24) will be tested with HLD100 in ascending doses from 10mg up to 40mg.

      This study will be divided into several phases: Screening, Active Treatment and Follow-Up.
      All visits have a 2 day window to allow for scheduling.
    

Intervention name(s): HLD100
Intervention type(s): Drug
Intervention description(s): Treatment
Other intervention name(s): Dextroamphetamine sulfate, delayed release/extended release
Intervention MeSH terms: Dextroamphetamine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of L-carnitine on Hypothyroidism
Condition: Hypothyroidism
MeSH terms: Hypothyroidism
Study type: Interventional
Phase: Phase 4

Summary: 
      L-carnitine and thyroid hormone tended to antagonize reciprocally in human body. Urinary
      excretion of L-carnitine decreased in hypothyroid patients, and levothyroxine supplementation
      increased excretion of L-carnitine. The investigators hypothesized that supplying L-carnitine
      to hypothyroid patients with fatigue symptom could improve the quality of life, and fatigue
      score in them. Therefore, the investigators planned to compare the efficacy of L-carnitine
      and placebo in hypothyroid patients who had taken levothyroxine.
    


Intervention name(s): L-carnitine; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Insulin Action: Role of Skeletal Muscle and Insulin-Mediated Blood Flow
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The overall objective of this proposal is to examine the contribution of changes in total
      body fat, enhancement in insulin-mediated vasodilatation and enhancement in
      endothelium-derived nitric oxide production to the improvements in metabolic insulin action.
      In addition, the study will track whether these improvements are related to changes in blood
      pressure.
    


Keywords: blood pressure; insulin sensitivity; blood flow
Effectiveness of Naltrexone and/or Ondansetron to Reduce Craving for Alcohol and Drinking
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether naltrexone (an opiate blocking agent
      approved for the treatment of alcohol dependence), ondansetron a serotonin 3 antagonist
      medication approved to treat nausea) or their combination are effective in the reduction of
      alcohol craving and drinking compared to placebo.
    

Detailed description: 
      Non-treatment seeking individuals meeting criteria for alcohol dependence N=160) will be
      recruited through advertisement and paid for their participation. Alcoholics, after baseline
      evaluation, will be assigned through urn randomization (using a double dummy placebo
      controlled design) to one of four experimental groups, naltrexone (50 mg/day) (N=40),
      ondansetron (0.25 mg twice a day) (N=40), naltrexone and ondansetron (N=40) or placebos
      (N=40). Subjects will take the study drugs for 8 days (day 1-5 being the natural observation
      period). After a minimum of 48 hours of abstinence from alcohol day 6-8) they will undergo an
      alcohol administration (priming dose) and motivated free choice drinking procedure (on day
      8). Alcoholic subjects will receive a brief counseling session at the end of the study to
      enhance their awareness of problem drinking and to motivate them to seek treatment. Referral
      for treatment will be offered.A subset of subjects from each medication group (N=15) will
      undergo a functional MRI brain scan with cue stimulation on day 7, on the evening before the
      alcohol administration paradigm.

      A smaller group of social drinker controls (N=16), recruited and paid in a similar fashion,
      will be randomly assigned to the same medication groups (4 per group). They will be used as
      procedure controls for the alcohol administration lab study and as a comparison/contrast
      group for the brain imaging sub-study.
    

Intervention name(s): naltrexone (up to 50 mg/day) for 8 days; ondansetron (0.25 mg twice a day) for 8 days
Intervention type(s): Drug
Intervention MeSH terms: Naltrexone; Ondansetron
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Alcohol dependence; Alcoholism; Craving
Deposition of Terbinafine After Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine how much terbinafine is delivered to the nail bed
      after treatment with a number of modifications to a previously studied method for
      iontophoretic delivery of terbinafine gel. Iontophoretic delivery involves the use of a small
      electric charge to deliver drug across skin and nails.
    


Intervention name(s): Terbinafine HCl
Intervention type(s): Drug
Intervention description(s): 4% w/w terbinafine HCL gel, single dose,
Intervention MeSH terms: Terbinafine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Onychomycosis; Nail fungus; Tinea Unguium
Muscle Mass and Function in Chinese Adults
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Observational

Summary: 
      To describe the normal range of muscle mass and function in Chinese adults.
    

Detailed description: 
      The study objective is to setup a normal range of muscle mass and function in Chinese adults.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cross-sectional, observational study of young Chinese adults