bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Aronia Melanocarpa Extract on Cognitive Function
Condition: Cognitive Function
Study type: Interventional

Summary: 
      There is a great interest in improving cognitive performance, including memory and attention.
      Improved attention is desirable for a large group of people because it is linked to improved
      performance . Students and professionals can benefit from improved attention and thus
      performance in academic and other work environments. In addition, cognitive functioning also
      plays an important role in sports. Various cognitive skills, including attention, reaction
      time and motor function, have shown that they can influence sport performance. A completely
      natural supplement with aronia melanocarpa extract could be a promising way to naturally
      improve cognitive performance.
    

Detailed description: 
      There is a great interest in improving cognitive performance, including memory and attention.
      Improved attention is desirable for a large group of people because it is linked to improved
      performance. Students and professionals can benefit from improved attention and thus
      performance in academic and other work environments. In addition, cognitive functioning also
      plays an important role in sports. Various cognitive skills, including attention, reaction
      time and motor function, have shown that they can influence sport performance. A completely
      natural supplement with aronia melanocarpa extract could be a promising way to naturally
      improve cognitive performance. The product in this study is aronia melanocarpa which contains
      polyphenols. A limited number of clinical studies have already been carried out to see the
      effect of similar products on cognitive functioning. However, these studies have often been
      done in older study populations or over a longer period of time. In this study, in healthy
      adolescents (ages between the 18-35 and with a BMI between 18.5 and 30), the investigators
      want to test the short term (7 days) effect of aronia melanocarpa extract on cognitive
      functioning. The investigators will also test the effect of supplementation on the
      particpant's mood, vascular function, blood biomarkers, retinal vasculature, and subjective
      cognition.
    

Intervention name(s): Aronia; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): daily supplementation; daily supplementation
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Cross-over study with 2 intervention conditions
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: supplementation; cognition; cognitive function; vascular function; microvasculature
Comparison of Inactivated and Live, Attenuated Influenza Vaccine in Children 5-9 Years of Age-Year 3 Amendment
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate how young children's bodies learn to fight against
      flu infection and to see how vaccines may help to fight against the flu. This is a Phase 4,
      single-center, randomized study of the immune responses of 40 children, ages 5-9, given one
      of two licensed influenza vaccines (either inactivated vaccine given in an arm muscle or
      live, attenuated vaccine inhaled through the nose). Study procedures will include up to 3
      blood samples. Participants will complete a diary to document any side effects experienced
      following the vaccination. Participants will return to the clinic for a visit on Day 7-9 and
      again 4-6 weeks following vaccination. Participants that have not been previously vaccinated
      will receive a 2nd dose of vaccine. A follow up telephone call will occur 8-10 weeks
      following vaccination. Total study participation will be up to 75 days.
    

Detailed description: 
      This is a Phase 4, single-center, randomized clinical trial of the immune responses of
      children given one of two licensed influenza vaccines (either inactivated vaccine given IM or
      live, attenuated vaccine given intranasally). This study will enroll 40 healthy children 5-9
      years of age. Subjects will be randomized to receive either FluMist or Fluzone. FluMist is
      approved for children older than 5 years and Fluzone is also approved for a broader age
      indication starting at 6 months of age. Subjects who receive FluMist will have the vaccine
      administered intranasally by large particle aerosol, 0.25 mL per nostril. Subjects receiving
      Fluzone will receive 0.5 mL given intramuscularly into the non-dominant deltoid muscle.
      Children who have not previously been immunized against influenza will receive a second dose
      of vaccine 4 weeks after the first dose. Children who receive two doses of vaccine will
      remain on the study for 8-10 weeks. The primary objective of this study is to compare the
      effector B cell responses at Day7-9 and the CD4 and CD8 T-cell responses, memory B-cell and
      the serology responses at Day 28 post-immunization following administration of one of two
      different influenza vaccines. Researchers will evaluate any increases in the immune response
      (CD4, CD8, B cell and serology responses) Day 0 to Day 7-9 for T-cells and ASCs, and from Day
      0-28 for memory B-cell and serology responses. NK-cell and homing studies will also be
      compared between the groups.
    

Intervention name(s): FluMist; Fluzone
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: inactivated, attenuated, influenza vaccine, FluMist, Fluzone
An Investigational Drug Study in Obese (Considerably Overweight) Patients (0364-006)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and effectiveness of an investigational
      drug in patients with obesity (considerably overweight).
    


Intervention name(s): MK0364
Intervention type(s): Drug
Intervention MeSH terms: N-(3-(4-chlorophenyl)-2-(3-cyanophenyl)-1-methylpropyl)-2-methyl-2-((5-(trifluoromethyl)pyridin-2-yl)oxy)propanamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obesity and obesity-related medical conditions
The Effects of Orally Ingesting Branched Chained Amino Acids on Delayed Onset Muscle Soreness in Diabetic Patients
Condition: Type 2 Diabetes; Healthy Individuals
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of the 3 Branched Chained Amino
      Acids (isoleucine, leucine, and valine) on treating Delayed Onset Muscle Soreness, a type of
      muscle pain which usually develops after exercising.
    

Detailed description: 
      Delayed Onset Muscle Soreness is a common painful sensation experienced by individuals who
      have been recently inactive and begin with an unaccustomed exercise protocol. Branched
      Chained Amino Acids have been found as a useful supplement for promoting muscle recovery
      following exercise; however the effects of this supplement have not been investigated amongst
      individuals with diabetes.
    

Intervention name(s): Branched Chained Amino Acids; Cellulose Placebo mix
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Two doses of the Branched Chained Amino Acid supplement will be taken. The first dose will be taken 35 minutes before the intended exercise, and the other dose will be taken right after completing the exercise. The amount of the Branched Chained Amino Acid supplement administered to the subjects in the experimental group will vary from one person to the other but a total dose of 1 gram of BCAA per kilogram of lean body mass will be used. This dose will be divided in half and administered at the two specified occasions. The ratio of isoleucine, leucine, and valine will be 1:2.5:1 respectively; The control group will also take 2 doses, 1 before the exercise, and the other after completing the exercise. This dose will be divided in half and administered at the two specified occasions.
Other intervention name(s): Isoleucine, Leucine, and Valine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Branched Chained Amino Acids; Delayed Onset Muscle Soreness; Diabetes; Muscle Damage
Sleep Disordered Breathing and Alzheimer's Disease Biomarkers in Normal Aging and Mild Cognitive Impairment
Condition: Sleep Disorder
MeSH terms: Sleep Apnea Syndromes; Alzheimer Disease; Sleep Wake Disorders; Cognitive Dysfunction
Study type: Observational

Summary: 
      The purpose of this study is to determine the sleep patterns of subjects with or without
      sleep disturbances (insomnia, sleep apnea) and compare these findings with their previous
      FDG/PIB PET, structural MRI and brain blood flow scams performed during their participation
      in the Following studies 'Alzheimer's Disease Core Center (ADCC) Clinical Evaluation' (IRB:
      2942), MRI Progression Markers of Cognitive Decline in the Elderly' (IRB:09-0586), or
      'Imaging Neuro inflammation in Alzheimer's Disease with [11C] Arachidonic Acid (AA) and
      PET'(IRB: 10-00442).
    


Intervention name(s): Structural 3T MRI; MRI Based Perfusion Imaging; VR-CO2 MRI Scans
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): measures of global and hippocampal atrophy); brain blood flow; reduced vaso reactivity to carbon dioxide
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        80 cognitively healthy subjects (normal or MCI) previously enrolled in Alzheimer's Disease
        Core Center (ADCC) and CBH studies who have agreed to be contacted about future research
        studies will be asked to additionally participate in this study. The age range of the
        subjects will be of 55-90 years based on the incidence of dementia in middle age and elder
        adults.
Culturally Relevant Exercise for Diabetes (CURE-D)
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The Culturally Relevant Exercise for Diabetes (CURE-D) study will determine whether a
      culturally-sensitive dance intervention is an accepted and effective physical intervention
      for South Asian women with type 2 diabetes mellitus. The CURE-D study will determine if
      Bollywood dance exercise improves diabetes outcomes in South Asian women.
    


Intervention name(s): Bollywood Dance Exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: South Asian
The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer
Condition: Respiratory Viral Infection
MeSH terms: Virus Diseases
Study type: Observational

Summary: 
      The purpose of this study is for the research team to become familiar with and evaluate the
      technical and operational performance of the QuidelOrtho Savanna RVP4 analyzer by testing 120
      archived specimens that were previously tested at the Wisconsin State Laboratory of Hygiene
      (WSLH) by RT-PCR and multiplex respiratory pathogen panel within the last year.
    

Detailed description: 
      To test the technical and operational performance of the QuidelOrtho Savanna RVP4 analyzer,
      the investigator proposes to test samples archived from the ORegon CHild Absenteeism due to
      Respiratory Disease Study (ORCHARDS) study (HSC 2013-1357), a study that had the goal to
      "develop and implement a system for daily school-based monitoring of ILI (influenza-like
      illness) and CLI (COVID-like illness) student absenteeism in kindergarten (K) through grade
      12 schools, and assess the system's usability for early detection of accelerated influenza,
      SARS-CoV-2 and other respiratory pathogen transmission in schools and surrounding
      communities".

      The deidentified paired (WSLH vs. Savanna RVP4) results will be used by QuidelOrtho
      Corporation to evaluate the technical and operational performance of the analyzer.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        School-aged children
      
Biospecimen description: 
      Nasal swabs
Purified Anthocyanin and Nonalcoholic Fatty Liver Disease
Condition: Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Oxidative stress and inflammation are involved in the pathogenesis of non-alcoholic fatty
      liver disease (NAFLD). Anthocyanins from different plant foods have been shown to improve
      features of experimental NASH, such as oxidative stress, dyslipidemia, liver steatosis, and
      inflammation in rodents. The purpose of this study is to investigate whether purified
      anthocyanin supplementation beneficially alters oxidative, inflammatory, and apoptotic
      biomarkers in adults with features of NAFLD.
    


Intervention name(s): Anthocyanin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): MEDOX (natural purified anthocyanin); http://www.medox.no/english
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: oxidative stress; dyslipidemia; inflammation; apoptosis
Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in
      Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of
      dapagliflozin to placebo when given in oral doses.
    


Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): once daily, 12 weeks; once daily, 12 weeks
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; Japanese; phase 2; efficacy; safety; dapagliflozin
MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
Condition: Post Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the efficacy and safety of different treatment regimens of oral
      Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily
      supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+
      years, and the target sample size is 500+ individuals.
    


Intervention name(s): Ibandronate [Bonviva/Boniva]; Ibandronate [Bonviva/Boniva]; Ibandronate [Bonviva/Boniva]; Ibandronate [Bonviva/Boniva]; Calcium; Vitamin D
Intervention type(s): Drug; Drug; Drug; Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): 2.5mg po daily; 100mg po monthly on a single day; 100mg po monthly over 2 consecutive days; 150mg po monthly; 500 mg/day; 400 IU/day
Intervention MeSH terms: Vitamin D; Ibandronic Acid; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Validation of a Food Frequency Questionnaire for the Assessment of Omega-3 Fatty Acid Intake
Condition: Healthy
Study type: Observational

Summary: 
      As essential nutrients omega 3 fatty acids contribute to normal growth and development.
      Inadequate intake is linked to the development of chronic diseases such as coronary heart
      disease, high blood pressure, cancer, arthritis, psychological illnesses and allergies.
      Therefore, it is important to be able to reliably detect the intake of these fatty acids. Due
      to eating habits varying in different countries the questionnaire documenting dietary habits
      needs to be adapted to the situation in question. Based on a US version the investigators
      developed a questionnaire suitable for Switzerland and now wish to validate it by measuring
      the fatty acid composition of red blood cells, which will provide information on the intake
      of the various fatty acids.
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention (observational study)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults
INVESTIGATION AND COMPARISON OF THE EFFECTS OF POSTURE EXERCISES ON DYSFUNCTION, POSTURE AND BALANCE IN INDIVIDUALS WITH POSTERIOR EDENTULOUS AND FULL-TOOTHED TEMPOROMANDIBULAR DISORDER
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to investigate the relationship between neck posture and balance in
      patients with posterior edentulous and full-toothed temporomandibular disorder and to compare
      the effectiveness of the physiotherapy program to be applied.
    

Detailed description: 
      The study was planned as a quasi-experimental controlled study. A total of 26 patients with
      temporomandibular disorder, aged between 18-70 years, 13 of whom were in the Posterior
      Edentulous Group (PDG) and 13 were in the Fully Toothed Group (TDG), were included. Posture
      exercises and manual therapy were applied to both groups twice a week for six weeks.
      Mandibular range of motion, pain, muscle strength, deep neck flexor endurance, flexibility,
      shortness, range of motion (ROM), pressure pain threshold (BAE), psychological state, posture
      and balance were evaluated before and after exercise.

      The results of the study showed that six weeks of postural exercises and manual therapy
      provided significant improvement in all values (p<0.05). A significant difference was found
      in pain, muscle strength, ROM, BAE and balance in PDG compared to TDG (p<0.05).

      The results of the study showed that symptoms can be improved by giving posture exercises in
      patients with tempromandibular disorder. It was concluded that the improvement in PDG was
      higher than in TDG.
    

Intervention name(s): Physiotherapy
Intervention type(s): Other
Intervention description(s): Posture exercises, myofascial release techniques, sternocleidomastoideus and upper trapezius kinesio taping, trigger point ischemic compression, suboccipital release technique, cervical traction, deep neck flexors endurance exercises, massage
Other intervention name(s): Manuel therapy; Kinesio taping
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 26 patients with temporomandibular disorder, aged between 18-70 years, 13 of whom were in the Posterior Edentulous Group (PDG) and 13 were in the Fully Toothed Group (TDG), received same treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: temporomandibular joint; physiotherapy; posture exercises; posterior tooth loss
Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine
Condition: Migraine With or Without Aura
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in
      relieving symptoms of acute migraine and to further explore the dose response relationship of
      eletriptan.
    


Intervention name(s): Placebo; Eletriptan 20 mg; Eletriptan 40 mg; Eletriptan 80 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): matching placebo; 20mg oral; 40mg oral; 80mg oral
Intervention MeSH terms: Eletriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
Condition: Peanut Hypersensitivity
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control
      (placebo) subjects who have completed their final visit (or early termination visit, if
      applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who
      provide consent to participate in this study.
    


Intervention name(s): omalizumab
Intervention type(s): Drug
Intervention description(s): SC repeating dose
Intervention MeSH terms: Omalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TOPS; Peanut allergy; Peanut-induced allergy; Allergy
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week, Dose-Range-Finding Trial of YKP10811 Capsules Administered Once Daily to Subjects With Chronic Idiopathic Constipation
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811
      capsules in patients with chronic idiopathic constipation. Following a 2-week baseline
      period, approximately 320 eligible patients with <3 complete spontaneous bowel movements
      (CSBM) and ≤ 5 SBMs per week will be randomly assigned equally to receive one of the
      following oral treatments; placebo or YKP10811 capsules once daily for 12 weeks followed by a
      2 week follow-up period.

      The objectives of this study are:

        -  To assess the efficacy of YKP10811 once daily at relieving constipation and associated
           symptoms in subjects with chronic idiopathic constipation.

        -  To determine the safety and tolerability of YKP10811 once daily in subjects with chronic
           idiopathic constipation.
    


Intervention name(s): YKP10811; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment