bioihbjkbjnl/mcl2 huggingface dataset:
Inflammatory Parameters as Predictive Factors for Complicated Appendicitis
Condition: Acute Appendicitis
MeSH terms: Appendicitis
Study type: Observational

Summary: 
      Acute appendicitis is a major cause of acute abdomen. Although its diagnosis is clinical, it
      is often supported by complementary diagnostic tests. Sometimes, delay in diagnosis can lead
      to worsening of the clinical picture, resulting in a complicated acute appendicitis. Some
      series have studied some clinical and analytical parameters as possible predictors of
      complicated acute appendicitis.

      A retrospective analysis of patients admitted for acute appendicitis and undergoing
      appendectomy between January 2014 and December 2017 was performed in order to assess the
      possible existence of preoperative analytical predictive factors for complicated acute
      appendicitis (such as leukocytosis, C-reactive protein and ratio between neutrophils and
      lymphocytes).
    


Intervention name(s): dosing of inflammatory parameters
Intervention type(s): Other
Intervention description(s): View and register the dosing of inflammatory parameters
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All patients admitted for acute appendicitis
Swipe Out Stroke (SOS): Feasibility of Using a Consumer Based Electronic Application to Improve Compliance With Weight Loss in Obese Minority Stroke Patients
Condition: Stroke
MeSH terms: Stroke; Weight Loss
Study type: Interventional

Summary: 
      This pilot study evaluates the use of a mobile application to improve weight loss in obese
      stroke patients. The investigators hypothesize that acute stroke patients who use the mobile
      application are more likely to achieve a minimum 5% weight reduction during the critical six
      months post-stroke, yielding considerable improvement in stroke risk factors.
    


Intervention name(s): Mobile Application; Food Journal; Usual Care
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mobile Applications
A Study Evaluating the Absorption Of Varenicline Through The Skin Following Once Daily Application Of A Patch For 14 Days
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the steady-state pharmacokinetics, safety and tolerability of a
      varenicline patch applied once daily to the skin for 14 days.
    


Intervention name(s): varenicline free base patch; varenicline free base patch; placebo patch; varenicline free base patch; placebo patch; varenicline free base patch; placebo patch
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): varenicline transdermal delivery system (12.0 mg payload [drug amount loaded in each patch]) will be applied to the skin once daily for 14 days; varenicline transdermal delivery system (18.0 mg payload [drug amount loaded in each patch]) will be applied to the skin once daily for 14 days; Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days; varenicline transdermal delivery system (24.0 mg payload [drug amount loaded in each patch]) will be applied to the skin once daily for 14 days; Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days; 2 varenicline transdermal delivery systems (combined to achieve a maximum drug payload of 36 mg) will be applied to the skin, side by side once daily, for 14 days; Matched placebo transdermal delivery systems will be applied to the skin, side by side, once daily for 14 days
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: varenicline transdermal percutaneous transcutaneous transdermal delivery system patch
Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine
Condition: Varicocele
MeSH terms: Varicocele
Study type: Observational

Summary: 
      The purpose of this study is to observe the occurrence of adverse events of live attenuated
      varicella vaccine.
    


Intervention name(s): live attenuated varicella vaccine
Intervention type(s): Biological
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participant preventive inoculation of varicella vaccine in 2014-2015
      
Keywords: Vaccine Safety
Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging
Condition: Skin Lesions
MeSH terms: Melanoma
Study type: Observational

Summary: 
      The use of MDS to access the presence of melanoma in the skin.
    

Detailed description: 
      A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to
      provide a score that correlates with the probability for the presence of melanoma in the
      lesion.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individual referred by a dermatologist or plastic surgeon for a skin biopsy or lesion
        excision.
      
Keywords: Melanoma; Skin Cancer
Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders
Condition: Tic Disorder
MeSH terms: Tics; Tic Disorders
Study type: Interventional

Summary: 
      The study aims to clarify the functional anatomy of key brain circuits associated with
      cognitive control in children and adolescents with chronic tic disorders (CTD) and to compare
      and contrast hypothesized mechanisms related to increased tic control associated with Habit
      Reversal Training, a behavioral treatment that been previously shown to be effective in
      treating CTD. We also seek to better understand the relationship between fMRI and
      quantitative EEG in relevant brain circuits with the hope of establishing EEG as a valid and
      cost-effective marker of treatment responsiveness. A total of 25 subjects will be randomized
      to 10 weeks of Habit Reversal Training (HRT), a behavioral treatment, and 25 to 10 weeks of
      minimal-contact waitlist. Treatment responders will be re-assessed at three months. Waitlist
      nonresponders will be provided with 10 weeks of HRT. Study assessments, including a
      neurocognitive battery and quantitative EEG will be administered at baseline, Wk 5, Wk 10,
      and 3-month follow-up. Neuroimaging (fMRI) will be conducted at baseline and Wk 10.
    


Intervention name(s): Comprehensive Behavioral Intervention for Tics (CBIT); Minimal Contact Waitlist
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Habit Reversal Training plus functional assessment/intervention designed to identify and ameliorate tic triggers (antecedents) and maintaining consequences.; Bimonthly phone check-in to assess clinical status and enhance subject retention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Tourette Syndrome; Chronic Tic Disorder; Tics; Behavior Therapy; Habit Reversal Training; Child; Adolescent; Neuroimaging
Is Sheep Ghee Cardioprotective?
Condition: Cholesterol; Metabolic Disorder; Inflammation
MeSH terms: Metabolic Diseases; Inflammation
Study type: Interventional

Summary: 
      Normal volunteers were randomly received Sheep ghee or sunflower oil, and before and after
      the study lipid profile and HS-CRP were measured.
    

Detailed description: 
      During outpatient clinic visits, potentially eligible individuals were screened for
      enrollment according to the inclusion and exclusion criteria.

      Patients were randomly allocated into the treatment and control groups via the blocked
      randomization method.

      The control group received a normal diet for eight weeks with 10 g of sunflower oil. In the
      treatment group, sunflower oil was replaced with 10 g of sheep ghee.

      50 patients in each group were enrollment. Patients' information, including demographic data
      and the serum levels of fasting blood sugar (FBS), LDL, HDL, triglyceride (TG), and hs-CRP,
      were recorded in datasheets twice: once before treatment with sheep ghee and once eight weeks
      later.
    

Intervention name(s): sheep ghee; sunflower oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): natural sheep ghee, given to patient in a commercial box and intervention group 10 gr per day from sheep ghee; natural sunflower oil, given to patients in a commercial box and patient use 10 gr of it
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: clinical trial randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Atherosclerosis; cardiovascular disease; high-sensitivity C-reactive protein; inflammation; sheep ghee
Diet Intake Estimation of Tweens and Teens: The DIETT Study
Condition: Diet Intake Assessment
Study type: Observational

Summary: 
      The purpose of this pilot study is to assess the quality of self-report data obtained using
      the Automated Self Administered 24-Hour Recall (ASA24-Kids-2014) relative to an interviewer
      administered 24-hour recall in a sample of adolescents ages 12-17 years, to determine their
      method preference, and to assess issues related to each method.
    

Detailed description: 
      Self-reported dietary intake currently provides the best approach to quantify foods and
      nutrients for many nutrition research studies. The interviewer administered 24-hour diet
      recall is generally considered the best available method; however, it is limited by a high
      degree of participant burden and cost. A web-based, automated, self-administered 24-hour
      recall (ASA24-Kids-2014) was recently designed by researchers at the National Cancer
      Institute (NCI) to mimic the interviewer administered 24-hour recall approach to collecting
      high quality dietary intake data in children and adolescents while minimizing time and cost.
      Although the ASA24-Kids-2014 is a potentially useful and cost-effective tool for collecting
      dietary data for research studies in children and adolescents, it has not been validated for
      use in pediatric populations. A total of 30 adolescents will be recruited to achieve the
      study aims. For Aim 1, 10 participants will complete one diet recall using ASA24-Kids-2014
      and one interviewer administered 24-hour recall. Their feedback on both methods and
      preference will be assessed. For Aim 2, 20 participants will be randomly assigned to complete
      six (one per week) web-based or interviewer administered 24-hour recalls. Data from Aim 2
      will be analyzed to determine whether the reporting quality decays over time for each method.
      In addition, feedback from participants in both aims will be collected on specific factors
      related to the recall methods such as ease of use, technical challenges, flexibility,
      duration, and database completeness. Results obtained from this pilot study could provide
      critical information to design a larger method comparison study to rigorously assess the
      performance of the ASA24-Kids web-based diet recall.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy male and female adolescents, ages 12-17 years.
      
Keywords: 24-hour diet recall; Adolescents; Web-based diet recall
A Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult Subjects
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the effects of study drug (GSK1605786) on the blood
      levels of multiple commonly used drugs that are given to measure how your liver breaks down
      the study drug. These commonly-used drugs are midazolam, pioglitazone, omeprazole, and
      rosuvastatin which will determine the effect of GSK1605786 on how the body breaks down
      (metabolizes) these commonly-used drugs. Blood samples for pharmacokinetic analysis of
      GSK1605786, and two metabolites, [GSK2635622 (CCX062) and GSK2656694 (CCX304)] and four probe
      substrates will be collected over a 24-hour period after administration. Safety will be
      assessed by the measurement of vital signs, cardiac monitoring, collection of adverse event
      assessments and laboratory tests.
    


Intervention name(s): GSK1605786 500 mg; Midazolam 3 mg; Pioglitazone 15 mg; Omeprazole 40 mg; Rosuvastatin 10 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive 500 milligram (mg) (2 doses of 250 mg) GSK1605786 hard gelatin capsules twice daily orally on Days 5 to 14. GSK1605786 will be administered with 240 milliliter (mL) of water.; Subjects will receive 3 mg oral syrup of Midazolam once daily on Day 1 and Day 11. Midazolam will be administered with 240 mL of water.; Subjects will receive 15 mg tablet of pioglitazone orally once daily on Day 2 and Day 12. Pioglitazone will be administered with 240 mL of water.; Subjects will receive 40 mg hard gelatin capsules of Omeprazole once daily on Days 3 and 13. Omeprazole will be administered with 240 mL of water.; Subjects will receive 10 mg tablet of Rosuvastatin orally once daily on Days 4 and 14. Rosuvastatin will be administered with 240 mL of water.
Intervention MeSH terms: Pioglitazone; Midazolam; Omeprazole; Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Ubiquitous SR-based Memory Advancement and Rehabilitation Training (U-SMART)
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the efficacy of the Ubiquitous Spaced Retrieval-based
      Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild
      cognitive impairment (MCI) by an open-label, controlled, crossover Trial.
    

Detailed description: 
      The Spaced Retrieval-based Memory Advancement and Rehabilitation Training (SMART) which
      consisted of 24 one-hour face-to-face sessions (Lee, Park et al. 2009) was developed based on
      the spaced retrieval training (SRT), which was effective in improving memory retention span
      of very mild to mild Alzheimer's disease patients. The Ubiquitous SMART (U-SMART) by
      transforming the current SMART to a self-administered program using an application working on
      IPAD was developed, and showed its feasibility and efficacy in the elderly individuals with
      mild cognitive impairment in the preliminary study. (ClinicalTrials.gov ID: NCT01628653) To
      validate the efficacy of the U-SMART, an open-label, controlled, crossover design of clinical
      trial were planned in this study.
    

Intervention name(s): Phase I U-SMART (4 wks); Washout (2 wks); Phase II U-SMART (4 wks)
Intervention type(s): Device; Other; Device
Intervention description(s): Intervention_Control Group, 4-weeks U-SMART(2 session/week); Control_Intervention Group, no intervention; 2-weeks wash out period in both arms; Intervention_Control Group, no intervention; Control_Intervention Group, 4-weeks U-SMART(2 session/week, Crossover design)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mild cognitive impairment; Cognitive rehabilitation; Cognitive therapy; Spaced retrieval Training; Alzheimer's disease; Memory enhancement; U-healthcare
Reliability Testing of Silverman-Andersen Retraction Score in Preterm Infants
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Depending on their gestational age, preterm infants need several weeks with different types
      of breathing-support due to immature development of the lungs, respiratory muscles,
      chest-wall and respiratory center in the brain. WHO's recommendation on interventions to
      improve preterm birth outcomes underline the need for more research on respiratory support in
      infants born preterm. This study will test inter-rater and intra-rater reliability of the
      Silverman-Andersen Retraction Score, which is a systematic clinical scoring tool for the
      respiratory work and the severity of respiratory distress in preterm infants. It will examine
      if there is consistency in the assessments done by doctors and nurses, and also if the
      observations correlate with technological monitoring. This easy to use scoring tool will help
      to determine the grade of respiratory distress, to assess respiratory exacerbation, to decide
      when to start weaning from respiratory support, and to give the best respiratory treatment to
      the child. This study will contribute to optimize care for preterm infants with respiratory
      distress.
    


Intervention name(s): Silverman-Andersen Retraction Score
Intervention type(s): Diagnostic Test
Intervention description(s): The Silverman-Andersen Retraction Score (SAs) is used to assess severity of respiratory distress in newborn and preterm infants without respiratory support.The score comprises 4 inspiratory categories of movements (thoraco-abdominal, intercostal, xiphoid, and chin movements) and one expiratory category (grunting).
Other intervention name(s): SAs
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Premature infants born <35 weeks of gestational age. the included infants will be
        stratified in 3 gestational age groups.
      
Keywords: Lung/Growth & Development; Respiration, artificial; Reproducibility of Results; Observer Variation
Relative Oral Bioavailability of BI 44847 as Suspension Compared to Tablet and the Influence of Food Anf of BI 44847 as Solution Compared to Tablet in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the relative oral bioavailability of 400 mg BI 44847 as suspension vs.
      400 mg BI 44847 as tablet, to investigate a food effect on the 400 mg tablet pharmacokinetic
      (PK) and to investigate relative oral bioavailability of 40 mg BI 44847 as solution vs. 40 mg
      BI 44847 as tablet.
    


Intervention name(s): BI 44847 solution, low dose; BI 44847 suspension, high dose; BI 44847 tablet, low dose; BI 44847 tablet, high dose; high fat breakfast
Intervention type(s): Drug; Drug; Drug; Drug; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of L-PRF as an Antibiotic Slow-release Biological Device in the Treatment of Moderate Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aimed to evaluate the efficacy of leukocyte platelet-rich fibrin (L-PRF) as a
      local sustained released device for antibiotics.
    


Intervention name(s): Subgingival application of L-PRF loaded with metronidazole; Subgingival application of L-PRF
Intervention type(s): Drug; Other
Intervention description(s): After phase I therapy, L-PRF loaded medical grade metronidazole was applied sub gingivally into the pockets using blunt gauge needle and Perio-pack was placed (two applications with one week apart were applied subgingivally.; The L-PRF alone was applied subgingivally into the pockets and Perio-pack was placed (two applications with one week apart.
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Exploration of the Regulatory Effect of Zinc on Intestinal Flora in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      In this A Single-center, Prospective, Self-controlled trial, subjects should avoid a
      high-Zinc diet for weeks 1-2 and take Zinc supplements for weeks 3-4
    


Intervention name(s): Zinc Gluconate
Intervention type(s): Dietary Supplement
Intervention description(s): Each participant should receive a regular zinc diet for weeks 1-2 and take zinc supplements for weeks 3-4.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Zinc, gut microbiota, healthy adult
Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
Condition: Tinea Pedis; Tinea Cruris
MeSH terms: Tinea; Tinea Pedis; Tinea cruris
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being done to see how the body is affected when a study drug is applied to both
      feet if the subject has athlete's foot or to both feet and the groin area if the subject has
      both athlete's foot and jock itch. Safety of the drug and how well the drug works will also
      be measured.
    

Detailed description: 
      Study population, diagnosis, and main criteria for inclusion:

      Tinea pedis and Tinea cruris (NAFT-500):

      Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with
      Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide (KOH)
      analysis from both the feet and bikini area. Both cases (feet and bikini area) must be
      characterized by clinical evidence of a Tinea pedis and Tinea cruris infection. Additional,
      approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will
      serve as a control.

      Tinea pedis (NAFT-600):

      Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with
      Tinea pedis infection confirmed by a positive potassium hydroxide (KOH) analysis from both
      feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection.
      Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same
      condition will serve as a control.
    

Intervention name(s): NAFT500 (pediatric); NAFT600 (pediatric); NAFT500 (adult); NAFT600 (adult)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Applied to both feet and groin area; Applied to both feet only; Applied to both feet and groin area; Applied to both feet
Other intervention name(s): NAFT500; naftifine; naftifine hydrochloride; NAFT600; naftifine; naftifine hydrochloride; NAFT500; naftifine; naftifine hydrochloride; NAFT600; naftifine; naftifine hydrochloride
Intervention MeSH terms: Naftifine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tinea Pedis; Tinea Cruris; Athlete foot; Jock itch