bioihbjkbjnl/mcl2 huggingface dataset:
Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris
Condition: Tinea Pedis; Tinea Cruris
MeSH terms: Tinea; Tinea Pedis; Tinea cruris
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate the pharmacokinetics of luliconazole cream 1%, as
      measured by circulating plasma levels of luliconazole, when maximal quantity of luliconazole
      cream 1% is applied to participants of 12 years to less than (<) 18 years of age with
      moderate to severe inter-digital tinea pedis or tinea cruris.
    


Intervention name(s): Luliconazole Cream 1%
Intervention type(s): Drug
Intervention description(s): Luliconazole cream will be applied topically per schedule specified in the arms.
Intervention MeSH terms: Luliconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Piezosurgery and Conventional Rotary Instruments on Third Molar Surgery
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      The aim of this study is to compare piezosurgery and conventional surgery in impacted third
      molar surgery and to determine its effect on postoperative outcomes and quality of life.
    


Intervention name(s): Piezosurgery; Conventional burs
Intervention type(s): Device; Device
Intervention description(s): Piezosurgery used as an osteotomy device; Conventional burs used as an osteotomy device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Impacted Tooth; Piezo-Electric Surgery; Postoperative Complication
Attention Training for Childhood Obsessive Compulsive Disorder: An Open Case Series
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Pediatric Obsessive Compulsive Disorder (OCD) is a chronic, impairing condition that accrues
      significant concurrent and long-term risk to affected youth. Although empirically supported
      psychosocial and pharmacological treatments for OCD exist, many children and their families
      are not able to adequately access these treatments or derive only partial benefit from them.
      Such findings highlight the importance of developing more effective treatment options which
      have the potential to be widely accessible to OCD youth.

      The investigators are proposing to test a computerized attention modification program, AMP,
      in six youth with OCD in an open case series to gather information regarding protocol
      acceptability, feasibility and preliminary efficacy. This phase includes the development and
      refinement of stimuli selection procedures, behavior avoidance task, EEG protocol, and AMP
      parameters for use with children.

      Following ascertainment of study eligibility, participants will undergo a baseline assessment
      consisting of a clinical interview, neurocognitive assessments, EEG, attention bias
      assessment, and self report questionnaires. Study participants will then receive 12 sessions
      of AMP treatment over the course of three weeks. All youngsters and their families will be
      reassessed at treatment endpoint (week 4). Participation will take a total of about 24 hours
      over the course of six weeks. Participants who are treatment responders may be asked to
      return approximately 3 months after completing treatment for a follow-up assessment.

      Preliminary hypotheses: 1) AMP will be acceptable to youth and families and feasible to
      administer; 2) Youth receiving AMP will demonstrate decreases in threat bias and OCD symptom
      severity.
    


Intervention name(s): Attention Modification Program
Intervention type(s): Behavioral
Intervention description(s): Computer-based attention training treatment designed to directly but implicitly modify biased attention patterns in anxious patients in service of symptom relief.
Other intervention name(s): AMP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OCD; obsessive compulsive disorder; children
The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The main objective of this study is to assess the safety and effectiveness of the CYPHER
      SELECT™ Sirolimus-eluting Coronary Stent in reducing angiographic in-stent late loss in de
      novo native coronary lesions as compared to the CYPHER ™ Sirolimus-eluting Coronary Stent.
    

Detailed description: 
      This is a multicenter (up to 10 sites), open, prospective, 2-arm, unbalanced, randomized
      study designed to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting
      Coronary Stent as compared to the CYPHER™ Sirolimus-eluting Coronary Stent. A total of 100
      patients will be entered in the study and will be randomized on a 2:1 basis to the CYPHER
      SELECT™ stent or the CYPHER™ stent. 100 patients with de novo native coronary artery lesions
      <23 mm in length and more than 2.5 to less than 3.5 mm in diameter by visual estimate who
      meet all eligibility criteria will be either randomized.
    

Intervention name(s): Cypher Select; Cypher
Intervention type(s): Device; Device
Intervention description(s): CYPHER SELECT™ Sirolimus-eluting Coronary Stent; CYPHER™ Sirolimus-eluting Coronary Stent
Other intervention name(s): PTCA; PTCA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessing the Impact of "Super-whey" vs. Isonitrogenous Whey on Muscle Protein Synthesis
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      Skeletal muscle accounts for approximately 45-55% of total body mass in healthy adults and
      plays a pivotal role in whole-body metabolic health, locomotion and physical independence.
      Undesirable loss of skeletal muscle mass (atrophy) is, however, a common feature of many
      diseases and scenarios including ageing, bed rest/immobilisation, cancer and physical
      inactivity. Despite the exact mechanisms causing muscle atrophy being not yet fully
      understood, "anabolic resistance" (reduced muscle building in response to protein feeding and
      exercise) is thought to be key, especially for age-related skeletal muscle losses (known as
      sarcopenia). As such, the search for optimal strategies (e.g., exercise and/ or nutritional
      interventions) to combat this anabolic blunting remains a hot-topic in scientific research.

      Leucine, an essential and branched chain amino acid (EAA/BCAA), is thought to be the most
      potent AA for stimulating muscle protein synthesis (MPS; the muscle building process).
      Although, as a stand-alone supplement, leucine is unlikely to provoke a robust and prolonged
      state of MPS, low doses of leucine-enriched mixed-EAAs can elicit similar increases in MPS as
      compared to a large dose of whey protein. As reduced appetite and increased satiety (feeling
      fuller) are common with advancing age, supplementation of a low-dose protein (i.e.,
      leucine-enriched) that can adequately stimulate MPS may contribute to muscle health
      maintenance in older adults and reduce satiation following a meal.

      This study aims to examine whether a novel whey protein with greater leucine content
      ("super-whey") has superior muscle building properties compared to a regular whey protein, at
      rest and after a single bout of exercise, in both young and older adults
    


Intervention name(s): Super-Whey protein; Isonitrogenous whey protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 different protein supplements (as above) will be given in a randomised crossover fashion to participants; 2 different protein supplements (as above) will be given in a randomised crossover fashion to participants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Neural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder
Condition: Binge Eating Disorder; Overweight and Obesity
MeSH terms: Overweight; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional

Summary: 
      The purpose of this research is to conduct a randomized controlled trial (RCT) assessing the
      impact of CBT on neural responses to binge eating stimuli.
    

Detailed description: 
      Females with a BMI>/=25 kg/m2 and BED will be randomized to either a 16-week, one-on-one CBT
      intervention (n=20) or a waitlist control (WL; n=20). Both groups will have blood oxygen
      level-dependent (BOLD) functional magnetic resonance imaging (fMRI) scans at baseline and
      after the 16-week intervention. During the scans, participants will complete the following
      tasks: 1) food-specific stop signal task (SST), and 2) script-driven imagery of binge foods.
    

Intervention name(s): Cognitive behavioral therapy; Waitlist
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The cognitive behavioral therapy intervention will consist of weekly, 50-minute individual meetings for 16 weeks with a clinician trained in cognitive behavioral therapy for binge eating disorder.; The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: binge eating disorder; obesity; cognitive behavioral therapy
Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease
Condition: Perianal Crohns'
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the blood levels of Metronidazole after application
      to the peri anal area after a single dose and 6 or 7 days application.
    


Intervention name(s): Metronidazole
Intervention type(s): Drug
Intervention description(s): Metronidazole 10% ointment three times a day 7 days
Intervention MeSH terms: Metronidazole
Intervention model: Single Group Assignment
Primary purpose: Basic Science
Intervention for Anxiety After Falls
Condition: Posttraumatic Stress Disorder (PTSD); Specific Phobia; Anxiety
MeSH terms: Anxiety Disorders; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether a brief intervention for disabling anxiety
      is practical to conduct and beneficial for older adults injured by falls.
    

Detailed description: 
      Falls are the most commonly occurring cause of traumatic injury among older adults. For many,
      the consequences include reduced mobility, difficulty performing basic self-care, social
      isolation, deteriorating health, or even death. Most interventions for falls do not address
      anxiety in the aftermath of falling.

      After an initial study assessment, participants will complete 8 home-based sessions of a
      Cognitive-Behavioral therapy (CBT). The sessions will be led by a study clinician who will
      cover the 5 intervention components:(a) education (learning about anxiety and the rationale
      for treatment); (b) relaxation training (learning skills to reduce tension); (c) cognitive
      restructuring (learning skills needed to cope better with distressing thoughts); (d)
      behavioral activation (learning to initiate healthy activity); and (e) exposure (coaching in
      how to confront avoided thoughts, situations, and people).

      Participants will also complete assessments following completion of the intervention and 3
      months after completion of the intervention.
    

Intervention name(s): Education; Relaxation Training; Cognitive Restructuring; Behavioral Activation; Exposure
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Learning about anxiety; Learning skills to reduce tension; Learning skills needed to cope better with distressing thoughts; Learning to initiate healthy activity; Coaching in how to confront avoided thoughts, situations, and people)
Other intervention name(s): Psychoeducation; Relaxation; Stress Reduction; Stress Reduction Training; Cognitive Reframing; Positive self-talk; Increasing physical activity; Imaginal exposure; In vivo exposure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTSD; Fear of Falling; Older Adults; Injurious Falls; Exposure Therapy
Reduction Mammaplasty and Improved Quality of Life
Condition: Macromastia; Signs and Symptoms; Quality of Life
Study type: Observational

Summary: 
      The data gathered here will be used to evaluate the efficacy and safety of the mammary
      reduction in patients with macromastia.
    

Detailed description: 
      The data was gathered using retrospective and follow-up prospective study of a group of
      patients, consisting of adult women that underwent a breast reduction surgery at the Clinic
      of Plastic, Reconstructive and Aesthetic Surgery Faculty of Comenius University and at the
      University Hospital in Bratislava, Ružinov, during the time period between 2000 until May
      2014. The data concerning the quality of life of these patients was gathered by using the
      globally standardized questionnaire "Breast Q questionnaire©" with the separate software
      system evaluation tool "QScore©". The statistical analysis was conducted using GraphpadPrism
      program v. 6.01. The total number of respondents consisted of 52 people who were followed-up
      for up to 12 years.
    

Intervention name(s): Reduction mammaplasty
Intervention type(s): Procedure
Intervention description(s): Surgical removal of excess breast tissue
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Females with macromastia undergoing elective reduction surgery.
Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes
Condition: Pregnancy Complications
MeSH terms: Pregnancy Complications; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages,
      birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range
      decreases these pregnancy complications. We hypothesize that metformin will achieve similar
      levels of blood sugar control compared to insulin. In doing so, metformin will prevent the
      increased risk of pregnancy complications associated with T2DM in pregnancy. We propose a
      pilot study of a randomized, controlled trial of metformin versus insulin in the treatment of
      T2DM during pregnancy.
    

Detailed description: 
      Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages,
      birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range
      decreases these pregnancy complications. Currently, insulin is the primary medication used to
      treat pregnant women with T2DM. However, it is administered by injection several times a day
      and compliance is low in health disparity populations with high rates of obesity and
      diabetes. Insulin also has the potential to lead to dangerously low blood sugars. Metformin
      is a medication than can be administered as pills and is not associated with dangerous low
      blood sugars. In addition, this insulin sensitizer is the medication of choice for women who
      are obese and have T2DM outside of pregnancy. We hypothesize that metformin will achieve
      similar levels of blood sugar control compared to insulin. In doing so, metformin will
      prevent the increased risk of pregnancy complications associated with T2DM in pregnancy. The
      aims of this study is to determine if in pregnant women with T2DM, metformin achieves similar
      glycemic control, and similar maternal and neonatal outcomes when compared to insulin. We
      propose a pilot study of a randomized, controlled trial of metformin versus insulin in the
      treatment of T2DM during pregnancy.
    

Intervention name(s): Metformin; Insulin (NPH and Regular)
Intervention type(s): Drug; Drug
Intervention description(s): Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily; Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; Pregnancy; Metformin; Insulin; Pregnant women
Safety and Pharmacokinetic Characteristics of HD203 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203
      with those of etanercept after subcutaneous injection in healthy male volunteers.
    


Intervention name(s): HD203
Intervention type(s): Biological
Intervention description(s): Injectable form
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy volunteer
Rosmalip® for Cancer Infections Prevention
Condition: Infections; Covid19; Cancer
MeSH terms: Infections; Communicable Diseases; COVID-19
Study type: Interventional

Summary: 
      This study is designed to assess the safety and efficacy of Rosmalip® nutritional supplement
      compared to placebo in subjects with solid cancer for the prevention of infections including
      COVID-19.
    

Detailed description: 
      Cancer patients undergoing oncologic treatments frequently have comorbidities and suffer
      immunosuppresion, toxicities and exposure to nosocomial pathogens. As a result, they are at
      increased risk of infections, including COVID-19. It is of utmost importance to find
      therapies that can prevent infections with as less toxicity as possible. Rosmalip® is a
      nutritional supplement developed as a molecular nutrition, composed of a rosemary
      supercritical extract at concentrations approved by EFSA -with in vitro and in vivo antitumor
      effects that are independent of its antioxidant and anti-inflammatory properties- in a
      lipidic vehicle that has shown in preclinical and clinical studies to potentiate innate
      immunity without apparent toxicity. Being a product of easy synthesis its effects on
      immunity, inflammation and cancer, could be of interest to prevent and ameliorate infections,
      including COVID-19.

      In this pilot study it is hypothesized that Rosmalip® could help to prevent or ameliorate
      infections, including COVID-19, in oncologic patients under active treatment. Secondarily, it
      is also hypothesized to have metabolic beneficial effects.
    

Intervention name(s): Rosmalip®; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Nutritional Supplement+Usual Care; Placebo+Usual Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants receive Rosmalip® capsule or Placebo tablet matching Rosmalip® orally once daily for 16 weeks.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Study To Evaluate Safety And Tolerability Of GSK256066 In Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and tolerability of the cfor the first time in mild to
      moderate COPD patients.
    


Intervention name(s): GSK256066; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PDE4 inhibitor; Placebo
Intervention MeSH terms: 6-((3-((dimethylamino)carbonyl)phenyl)sulfonyl)-8-methyl-4-((3-methyloxyphenyl)amino)-3-quinolinecarboxamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease (COPD); COPD; Repeat Dose; GSK256066
The Effects of Plant Bioactives on Platelet Function
Condition: Healthy
Study type: Interventional

Summary: 
      Consumption of a diet rich in fruit and vegetables is associated with a reduced risk of
      cardiovascular disease and the protective effect may be due to polyphenolic compounds
      contained within these foods. The mechanism by which polyphenols exert this effect is not
      clearly understood but research has focused on their potential to affect platelet function.
      The purpose of this study is to quantify the anti-clotting activity of a range of plant food
      extracts and component compounds.
    

Detailed description: 
      A single sample of whole blood will be collected from 15 male or female volunteers aged
      between 18 and 65 years. After collection whole blood will be treated with a range of
      flavonoids to evaluate their effects on platelet function.
    

Intervention name(s): Ex-vivo treatments with flavonoids
Intervention type(s): Other
Intervention description(s): Ex-vivo treatment of platelets with a range of flavonoids
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Flavonoids; Platelets
An Observational Pilot Study to Develop a Behavioral Economics Electronic Health Record Module to Guide the Care of Older Adults With Diabetes
Condition: Diabete Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      This study will develop a new electronic health record module to improve guideline-compliant
      care of older adults with diabetes. The module will incorporate effective behavioral
      economics (BE) principles to improve the degree to which care of older adults is compliant
      with Choosing Wisely guidelines; this generally involves less aggressive targets for HbA1c,
      and reductions of medications other than metformin.

      The implementation of the module will ultimately be triggered by medication prescribing in
      EPIC. The BE principles include suggesting alternatives to medications, requiring
      justification, setting of appropriate default order sets, and incorporation of anchoring and
      checklists to guide behavior. The study will involve provider workflow analysis based on
      observation, module user testing, and live usability testing with direct observation and
      semi-structure interviews.
    

Detailed description: 
      The primary objective of this study is to develop a scalable, EHR customization toolkit that
      applies BE insights to promote appropriate diabetes care in older adults based on the
      American Geriatric Society's Choosing Wisely Guideline, as to assess the acceptability of the
      resulting module.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Providers in NYU outpatient primary care, geriatrics, or endocrine clinics at NYU who care
        for older adults with diabetes