bioihbjkbjnl/mcl2 huggingface dataset:
Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis
Condition: Actively Extending Plaque Psoriasis; Moderate to Severe Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate different dose levels of IMO-3100 compared to
      placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.
    

Detailed description: 
      To evaluate the safety, tolerability and treatment effect of different dose levels of
      IMO-3100 compared to placebo administered for 4 weeks to patients with moderate to severe
      plaque psoriasis.
    

Intervention name(s): IMO-3100 at 0.16 mg/kg; Saline for Injection; IMO-3100 at 0.32 mg/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection; Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL; IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Psoriasis; Plaque Psoriasis
Retinal Changes in Vitamin D Deficiency
Condition: Pediatric Disorder; Vitamin D Deficiency; Retinal Disease; Choroidal Disease; Optic Nerve Diseases
MeSH terms: Nervous System Diseases; Optic Nerve Diseases; Retinal Diseases; Choroid Diseases; Vitamin D Deficiency
Study type: Interventional

Summary: 
      Retinal tissue parameters of pediatric patients with vitamin D deficiency will be evaluated
      in this prospective case-control study. The patients will be divided into 2 groups according
      to the vitamin D level. Retinal vessel diameters, retinal nerve fiber evaluation, choroidal
      thickness will be evaluated. Choroidal thinning decrease in retinal artery diameter and
      increase in retinal vein diameter will be detected in the vitamin D deficiency group.
    

Detailed description: 
      The study of the relationship between vitamin D status and retinal diseases is a new concept,
      and there is a large gap in research focusing on the pediatric population in the literature.
      The importance of vitamin D in retinal maturation and its role in the development of retinal
      diseases at a young age is being investigated. In this sense, as far as known, it is the
      first study investigating retinal structure parameters in pediatric patients with vitamin D
      deficiency.
    

Intervention name(s): Vitamin D deficiency
Intervention type(s): Dietary Supplement
Intervention description(s): Ocular significance of vitamin D deficiency in pediatric cases
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Group 1: 1) age <18 years old; 2) serum vitamin D [(25(OH) D), calcitriol] level <20 ngr/mL in previous two weeks Group 2: 1) age <18 years old; 2) serum vitamin D [(25(OH) D), calcitriol] level >20 ngr/mL in previous two weeks
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine
Condition: Staphylococcal Infections; Yeast Infections; Candidiasis
MeSH terms: Infections; Communicable Diseases; Candidiasis; Staphylococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This partially-blind, placebo controlled study is a Phase 1b study using an investigational
      vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will
      compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose
      level. It will also evaluate a lower dose of NDV-3 without alum delivered intradermally (ID)
      compared to placebo delivered ID.
    

Detailed description: 
      Preclinical studies in mice have established that several members of the Als family of
      proteins induce a protective immune response in mice and allow high survival rates following
      challenge with highly virulent doses of either Candida or S. aureus. Als3 (the antigen in the
      NDV-3 investigational vaccine) is the most effective member of the Als protein family in
      protecting mice from challenge with either Candida or S. aureus. The first Phase 1 study
      enrolled 40 healthy subjects that received placebo (N=10), 1 dose (N=30) or 2 doses (N=19) of
      the NDV-3 vaccine administered intramuscularly (IM). The vaccine was well tolerated and
      highly immunogenic. This study will evaluate the safety, tolerability and immunogenicity of
      one dose of NDV-3 vaccine formulated with and without alum given IM and also a lower dose
      without alum given intradermally (ID). Subjects will have follow-up visits to assess the
      safety tolerability and immune responses at selected time points up to 90 days
      post-vaccination.
    

Intervention name(s): NDV-3 vaccine with alum IM; NDV-3 vaccine without alum IM; Placebo with alum IM; NDV-3 vaccine without alum ID
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): One dose administered IM; One dose administered IM; One dose administered ID; One dose administered ID
Intervention MeSH terms: Vaccines; Aluminum sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Staphylococcal infections; Yeast infections; Candidiasis
Short Term Intermittent Fasting and Mediterranean Diet
Condition: Overweight; Pre-hypertension; Hypertension; Hypercholesterolemia; Glucose Intolerance
MeSH terms: Hypertension; Prehypertension; Overweight; Hypercholesterolemia; Glucose Intolerance
Study type: Interventional

Summary: 
      The purpose of this research study is to evaluate the effects of intermittent fasting in
      subjects that are eating a Mediterranean diet or a Western diet. This study is part of
      ongoing research in the prevention and treatment of age-related diseases at Washington
      University School of Medicine.
    

Detailed description: 
      The primary objective of this study is to determine whether or not IF, independently of
      changes in quality of diet, reduces the level of chronic inflammation as evidenced by a
      decrease in high sensitivity C-reactive protein (hsCRP), as the main outcome measure.
    

Intervention name(s): Mediterranean diet; Control group
Intervention type(s): Other; Other
Intervention description(s): Mediterranean diet for 8 weeks, followed by 8 weeks of Mediterranean diet with intermittent fasting (i.e. 2 non-consecutive days of fasting per week); control group eating their usual Western diet for 8 weeks, followed by 8 weeks of usual diet with intermittent fasting (i.e. 2 non-consecutive days of fasting per week).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intermittent fasting; Mediterranean diet; overweight; Calorie restriction
Stated-Preferences in Knee Arthroplasty
Condition: Arthritis; Knee Osteoarthritis; Arthropathy of Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Joint Diseases
Study type: Observational

Summary: 
      The primary objectives of this study are to apply best-practice stated-preference methods to
      quantify patient preferences for benefit-risk tradeoffs associated with arthroplasty
      treatment options for end-stage osteoarthritis of the knee. Duke will develop and administer
      stated-preference surveys to adult patients (Ages 40-80) with knee pain to collect preference
      data, estimate the relative importance of treatment features and outcomes, and estimate
      maximum acceptable risks for given benefits and minimum acceptable benefits for given harms.
      This study proposal describes plans for the patient stated-preference survey.
    


Intervention name(s): Stated-Preferences Evaluation Instrument
Intervention type(s): Other
Intervention description(s): A discrete choice experiment (Stated-Preferences Evaluation Instrument) will be electronically configured using best practice stated-preference methods to quantify preferences for total knee replacement versus unicompartmental knee replacement surgery.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Orthopaedic Clinics, Adult Reconstructive Surgery Clinics
Video Head Impulse Test and Seasickness Susceptibility
Condition: Sea Sickness
MeSH terms: Disease Susceptibility; Motion Sickness
Study type: Interventional

Summary: 
      This a case control study on seasickness susceptibility. 86 healthy maritime personal were
      divided to seasickness susceptible and non susceptible groups based on a seasickness
      questionnaire (Golding) and motion sickness score.

      All subjects from both groups underwent video head impulse testing (vHIT). VHIT parameters -
      gain, asymmetry ect were compared between both groups.
    


Intervention name(s): Video-head impulse testing
Intervention type(s): Diagnostic Test
Intervention description(s): Video-head impulse testing is a recent diagnostic bed-side test for evaluation of semi-circular canal function.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: motion sickness; video head impulse test; vestibular testing; seasickness susceptibility
Platelet Aggregation During the Shift From Clopidogrel to Ticagrelor
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional

Summary: 
      Antiplatelet therapy with ticagrelor is currently indicated for treatment of patients
      presenting with acute coronary syndrome. Such therapy is started with the administration of a
      loading dose in patients which are not yet under treatment with P2Y12 inhibitors
      (antiplatelet agents). However it is unknown whether a loading dose is needed to maintain a
      satisfactory inhibition of platelet aggregation in patients who are already treated with a
      previous generation P2Y12 inhibitor (clopidogrel) during the passage to the newer compound
      ticagrelor. For this reason aim of the present study is to evaluate the levels of platelet
      aggregation during the pharmacological shift from clopidogrel to ticagrelor performed with or
      without a loading starting dose of the newer drug.
    


Intervention name(s): loading with Ticagrelor; no loading with Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Patients allocated in the two study arms will receive the same anti platelet treatment, except for the administration of the loading dose, which will be only administered to patients allocated in Group 2; Patients allocated in the two study arms will receive the same anti platelet treatment, except for the administration of the loading dose, which will be only administered to patients allocated in Group 2.
In other words, patients randomized to this group (group 1) will not receive a loading dose of ticagrelor during the passage from clopidogrel to ticagrelor.
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: ticagrelor; clopidogrel; platelet aggregation
Reducing Eating Disorder Risk Factors
Condition: Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a web-based program is effective in
      reducing the incidence of eating disorders in college women who are at high risk for
      developing an eating disorder.
    

Detailed description: 
      Female college students who use unhealthy weight control methods and have body image concerns
      may be at risk for developing an eating disorder. Developing and evaluating interventions to
      reduce eating disorders in high-risk populations is of great public health importance.

      Participants are randomly assigned to either join a web-based risk-reduction program or
      receive no intervention. The 9-week risk-reduction program focuses on reducing body image and
      weight/shape concerns, identifying the risks of eating disorders, and increasing healthy
      weight regulation practices. The program includes weekly readings, writing assignments, and
      participation in a moderated electronic discussion group. Changes in body mass index (BMI)
      and the occurrence of major stressors and psychiatric events are assessed to determine their
      impact on the incidence of eating disorders. One-year incidence of eating disorders is
      determined by a diagnostic interview, and follow up may continue for up to 2.5 years.
    

Intervention name(s): Web-based intervention to reduce eating disorder risk factors
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)
Condition: Diabetic Neuropathies; Diabetic Foot; Diabetic Retinopathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Diabetic Retinopathy; Diabetic Foot
Study type: Observational

Summary: 
      The goal of this research is to develop better tools for diagnosing illness of the feet and
      legs of people who have diabetes. Investigators will use thermal videos of the foot to aid in
      the refinement of a system designed to detect signs of diabetic peripheral neuropathy (DPN).
      The team of investigators will also look at diabetic eye disease and how it might relate to
      diabetic foot disease.
    

Detailed description: 
      This study focuses on further development and testing of a microvascular functional imaging
      system, a computer-based system for screening thermal video images, designed to detect
      biomarkers of diabetic peripheral neuropathy (DPN). Additionally, severity levels of diabetic
      retinopathy (DR) will be compared with those of DPN.

      All participants in this study will undergo foot exams, thermal imaging of the foot, and
      standard retinal imaging. These non-invasive assessments will be performed at an initial
      study visit. Some of the participants will be offered additional study visits. One of the
      additional visits involves a standard nerve conduction velocity assessment by a neurologist,
      the other involves a DPN exam by a podiatrist.

      Portions of the study take place at University of New Mexico Health Sciences Center (UNM
      HSC). The research utilizes services of the Clinical Translational Science Center (CTSC).

      The study is approved by University of New Mexico Health Sciences Center's Human Research
      Review Committee (HRRC), which coordinates and supports the activities of the three federally
      mandated Human Research Review Committees (HRRCs) responsible for reviewing and approving all
      human research.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): This study evaluates s system intended to detect bio-markers of DPN. No interventions are involved in this non-invasive study.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population consists of diabetic and non-diabetic individuals who are otherwise
        healthy.
      
Keywords: screen
A Study To Evaluate Methods To Evaluate Back Pain
Condition: Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      The study is designed to assess methods used in clinical research.
    


Intervention name(s): Heat Device; Sham Device; marketed analgesic; Placebo
Intervention type(s): Device; Device; Drug; Drug
Intervention description(s): 8-Hour Heatwrap; Inactive wrap worn for 8 hours; 2 x 200 mg ibuprofen tablets; 2 x placebo tablets
Other intervention name(s): Heatwrap
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Pilot Study to Assess Methodologies
Study of Ranolazine in Myotonia Congenita, Paramyotonia Congenita and Myotonic Dystrophy Type 1
Condition: Myotonia Congenita; Paramyotonia Congenita; Myotonic Dystrophy 1
MeSH terms: Myotonic Dystrophy; Myotonia Congenita; Myotonic Disorders; Myotonia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to gather preliminary data to determine if ranolazine is a safe
      and effective treatment for the symptoms of myotonia congenital, paramyotonia congenita, and
      myotonic dystrophy type 1. The duration of the study is 5 weeks.
    

Detailed description: 
      Recent advances in the understanding of myotonia congenita have identified potential areas
      that could possibly respond to treatment in a drug study. The drug ranolazine (trade name
      Ranexa) is a FDA-approved medication to treat chest pain in patients with heart disease.
      Ranolazine has been studied in mice with myotonia congenita. The data from this animal model
      suggest that ranolazine may improve the symptoms and signs of myotonia. All individuals that
      participate will be placed on active drug. The investigators want to see if this drug is safe
      to take without causing too many side effects for people with myotonia congenita,
      paramyotonia congenital and myotonic dystrophy type 1. Participants will go to The Ohio State
      University for study visits. Participants will take ranolazine for four weeks. Participants
      can expect a total of 4 study visits and 2 phone calls over the 5 week period.
    

Intervention name(s): Ranolazine
Intervention type(s): Drug
Intervention description(s): Ranexa is FDA approved for chronic angina
Other intervention name(s): Ranexa®
Intervention MeSH terms: Ranolazine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myotonia Congenita; ranolazine; Ohio State; Open Label; Paramyotonia Congenita; Myotonic Dystrophy 1
Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center
Condition: Immune System Diseases
MeSH terms: Hypersensitivity; Food Hypersensitivity; Immune System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The long-term goal of the investigators study is to develop a better and safer treatment for,
      and to potentially cure patients with single or multiple food allergies. The investigators
      hypothesize that the application of this protocol will allow patients with severe and single
      or multiple food allergies to be safely and rapidly desensitized.
    


Intervention name(s): Food proteins; Omalizumab
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Food proteins; Drug
Intervention MeSH terms: Omalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple food allergies
Acute Effects of Breakfast Compared With No Breakfast on Cognitive Function and Subjective State in 11-13 Year Old Children
Condition: Healthy
Study type: Interventional

Summary: 
      This study is a school-based, randomised, controlled, parallel groups trial to examine the
      acute effect of breakfast (ready-to-eat-cereal and milk) vs. no breakfast on cognitive
      function and subjective state in 11-13 year old adolescents. It was hypothesised that the
      consumption of breakfast will have a positive acute effect on cognitive performance and
      subjective state compared with breakfast omission in 11-13 year olds.
    

Detailed description: 
      This study is a school-based, randomised, controlled, parallel groups trial to examine the
      acute effect of breakfast (ready-to-eat-cereal and milk) vs. no breakfast on cognitive
      function and subjective state in 11-13 year old adolescents. It was hypothesised that the
      consumption of breakfast will have a positive acute effect on cognitive performance and
      subjective state compared with breakfast omission in 11-13 year olds. The study sample
      consisted of males and females aged 11-13 years who were recruited to take part in the study
      from a UK secondary school. There were two conditions in this parallel groups study:
      Breakfast and No breakfast (fasting). The breakfast intervention consisted of ad libitum
      intake of ready-to-eat-cereal with milk. Cognitive function was assessed at baseline and +70
      and +215 minutes post-intervention. The Cambridge Neuro-psychological Test Automated Battery
      (CANTAB; Cambridge Cognition Ltd) was used to assess cognitive function. The battery
      included: Simple Reaction Time (SRT), 5-Choice Reaction Time (5-CRT), Rapid Visual
      Information Processing (RVIP), and Paired Associates Learning (PAL), which measured reaction
      time, visual-sustained attention, and visual-spatial memory respectively. Concomitant ratings
      of subjective mood, alertness, satiety, and motivation were taken throughout the morning
      using eight unipolar Visual Analogue Scales
    

Intervention name(s): Breakfast: ready-to-eat-cereal and milk
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cognition
Study of Efficacy of a Vasopressin 2 Receptor Antagonist M0002 for Treatment of Ascites in Cirrhotic Subjects With Hypo- or Normonatraemia
Condition: Cirrhotic Ascites
MeSH terms: Ascites
Study type: Interventional
Phase: Phase 2

Summary: 
      M0002, an orally active, selective non-peptidergic antagonist of the vasopressin V2 receptor
      inhibits vasopressin-induced water reabsorption from the kidney. Therefore the aquaretic
      effect of M0002 has a potential clinical benefit in the treatment of ascites and
      hyponatreamia in cirrhotic patients.
    


Intervention name(s): M0002; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Supervised Outdoor-Use Test For Sunscreen Products in Adults
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To assess the safety of a sunscreen product under supervised outdoor-use conditions
    


Intervention name(s): BAY987517; Sunscreen Lotion (Y65-110)
Intervention type(s): Drug; Drug
Intervention description(s): Applied liberally to the skin (Formulation: Y73-161; Applied liberally to the skin
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other