bioihbjkbjnl/mcl2 huggingface dataset:
Inorganic Nitrate and OSA
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The main purpose of this study is to determine if acute beetroot juice supplementation
      reduces peripheral chemoreflex sensitivity in patients with obstructive sleep apnea. All
      subjects will consume low-dose (BRL), higher-dose (BRH), and placebo (BRP) beetroot juice
      randomly on three independent study visits. Beetroot juice also improves blood flow thus, the
      investigators will also measure blood flow to the carotid chemoreceptors.
    

Detailed description: 
      Four-weeks of daily beetroot juice supplementation reduces peripheral chemoreflex sensitivity
      in healthy older adults who have 'normal' responses to acute hypoxia. Patients with
      obstructive sleep apnea have exaggerated peripheral chemoreflex sensitivity. It remains
      unknown if beetroot juice supplementation reduces peripheral chemoreflex sensitivity in
      patients with obstructive sleep apnea. Additionally, increasing blood flow to the peripheral
      chemoreceptors reduces sensitivity. Given that beetroot juice improves blood flow, the
      investigators will also measure common carotid artery blood flow at rest and during hypoxia.
    

Intervention name(s): Pre-beetroot juice supplementation; Post-beetroot juice supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Before administering beetroot juice to subjects.; After administering beetroot juice to subjects.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: inorganic nitrate; blood flow; Peripheral chemoreflex; Common carotid artery
Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis
Condition: Pancreatitis, Chronic
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Study type: Observational

Summary: 
      Numerous treatment modalities have been proposed to treat pain in alcoholic and non-alcoholic
      chronic pancreatitis such as analgesic medication, inhibition of gastric acid production,
      enzyme substitution, somatostatin analogues, nerve blockade,reduction of oxidative stress and
      endoscopic pancreatic duct stenting, but none of these concepts have shown long lasting
      benefits as surgery in clinical studies.Comparison of surgical outcome in non-alcoholic
      chronic pancreatitis and alcoholic chronic pancreatitis has limited data and differences on
      the basis of outcome in between alcoholic and non-alcoholic chronic pancreatitis are not
      available in literature.

      Although it is well known that pain is the main symptom of chronic pancreatitis, it has until
      now been assessed in very common and varying categories. Pain, however, is only one aspect of
      the large variety of sensitive facets of daily life. In addition to an improvement in pain
      symptoms and the preservation of pancreatic exocrine and endocrine function and other
      parameters, occupational rehabilitation of these mostly young patients and quality of life
      also should be considered in the evaluation of surgical outcome in alcoholic and
      non-alcoholic chronic pancreatitis.

      In this prospective study, we intend to find out if there are any differences in the surgical
      outcome on the above mentioned parameters in alcoholic and non-alcoholic chronic
      pancreatitis.We also plan to see if there are differences in the histopathology in these two
      disease settings.
    


Intervention name(s): Frey's procedure/Pylorus preserving pancreatoduodenectomy
Intervention type(s): Procedure
Intervention description(s): Duodenum preserving head resection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients of chronic pancreatitis with unremitting pain requiring surgery at primary
        care clinic
      
Keywords: Alcoholic; Non alcoholic; Idiopathic; Tropical; Exocrine dysfunction; Endocrine dysfunction; Pain control; Frey's procedure; Duodenum preserving pancreatic head resection
Study of Anlotinib in Patients With Esophageal Squamous Cell Carcinoma (ALTER1102)
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the effects and safety of Anlotinib with placebo in patients with esophageal
      squamous cell carcinoma(ESCC).
    


Intervention name(s): Anlotinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Anlotinib p.o. qd; Placebo p.o. qd
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anlotinib
Chronic Pain in Children and Adolescents.
Condition: Pain, Chronic
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      Medically unexplained chronic pain - without identifiable somatic origin - is yet an
      insufficiently known and explored field in children and adolescents by international clinical
      works. This research aims to characterize somatic, psychological, psychopathological and
      environmental (particularly attachment styles and family functioning) processes trough an
      observational study with three pain management centers.

      The study concerns children and adolescents from 7 to 17 years old, suffering of medically
      unexplained chronic pain and their parents who are referred to a pain center. It is composed
      of a somatic, psychological and family functioning assessment on the one hand and
      psychopathological and attachment evaluation on the other hand.
    

Detailed description: 
      Participation in the study involves an additional visit to 1 day pain center to answer
      questionnaires about anxiety, family environment, depression and psychological testing
    

Intervention name(s): questionnaires and psychological testing
Intervention type(s): Other
Intervention description(s): Child/adolescent and parents interview and consultation with both a physician and a psychologist for a somatic and pain indicators assessment within an usual setting.
Then, parents and child or adolescent are interviewed separately using different psychological instruments with only a psychologist:
Psychological (cognitive and projective evaluation) : Intellectual Quotient, mental flexibility, projective evaluation with Rorschach and Thematic Apperception Test, parents and children attachment questionnaires
Psychopathological: anxiety and depression questionnaires, psychiatric disorders evaluation, quality of life, life events questionnaires, family functioning interview.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescent with chronic pain
      
Keywords: Pain, Chronic; children
Human Intestinal Amino Acid Absorption and the Role of a Local (Renin)-Angiotensin System (RAS)
Condition: Healthy Participants; Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Aim of this trial is to investigate the expression and localisation of different amino acid
      transporters and their regulatory proteins derived from the regulatory proteins of the local
      renin angiotensin system (RAS) in the intestine. This is investigated on one hand in patients
      who do not take any drugs interfering with RAS. On the other hand expression analysis is done
      in patients taking daily RAS-active drugs, like ACE inhibitors or sartanes.

      After obtaining informed consent of patients attending the hospital for clarification of
      gastrointestinal symptoms by gastroduodenoscopy or colonoscopy, 2 biopsies (in addition to
      biopsies needed for clinical diagnostics) will be taken from each duodenum, jejunum, ileum
      and descending colon.

      Biopsies are investigated anonymously at the Institute of Physiology of the University of
      Zurich. The mRNA content of amino acid transporters and regulatory proteins, respectively, in
      the biopsies is analyzed by quantitative PCR. Transport proteins are in addition analyzed
      with immunohistochemistry.

      Furthermore amino acid concentration in plasma and urine samples are analyzed by HPLC. From
      plasma and serum samples RAS parameters like renin, aldosterone, ACE and angiotensin(1-7) are
      measured.
    


Intervention name(s): hypertension
Intervention type(s): Biological
Intervention description(s): patients taking daily ACE inhibitors or sartanes
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients attending the hospital for clarification of gastrointestinal symptoms by
        gastroduodenoscopy or colonoscopy
Dementia-friendly Community Training Using Virtual Reality Among College Nursing Students
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional

Summary: 
      This study aims to evaluate the effectiveness of a dementia course using virtual reality,
      world café teaching method and community practice on knowledge of dementia and
      dementia-friendly community, attitude toward dementia, and empathy toward people with
      dementia among nursing college students.
    

Detailed description: 
      This two-group randomised controlled trial aims to evaluate the effectiveness of a dementia
      course using virtual reality on knowledge of dementia and dementia-friendly community,
      attitude toward dementia, and empathy toward people with dementia among nursing college
      students.

      The interventional group will receive the dementia course consists of dementia virtual
      reality activity, intergenerational learning, world café teaching method and community
      practice.

      The control group will only receive the dementia course with intergenerational learning,
      world café teaching method and community practice but no dementia virtual reality activity.

      Both groups will be assessed for their dementia knowledge, attitudes, empathy and knowledge
      of dementia-friendly community at baseline, week 8, and week 18.
    

Intervention name(s): Dementia course with virtual reality; Dementia course with no virtual reality
Intervention type(s): Other; Other
Intervention description(s): dementia virtual reality activity, intergenerational learning, world café teaching method and community practice; dementia course, intergenerational learning, world café teaching method and community practice
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two-group randomised controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Other
the Efficacy and Safety of Ginsenoside Rg3 Capsule in Prevention of Postoperative Recurrence of Hepatocellular Carcinoma
Condition: Stage I Hepatocellular Carcinoma; Stage II Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Recurrence
Study type: Interventional

Summary: 
      Using the subject with hepatocellular carcinoma in the conventional therapy to evaluate the
      efficacy and safety of ginsenoside Rg3 (20mg BID) and placebo in prevention and treatment of
      postoperative recurrence of liver cancer,respectively
    

Detailed description: 
      1. Randomized, double-blind, multi-center, placebo-controlled, parallel-group;

        2. Subject population: patients undergone radical resection of hepatocellular carcinoma;

        3. Active drug group:

      Ginsenoside Rg3 group: general treatment + ginsenoside Rg3 Control group (placebo group):
      general treatment + placebo 4.Method of group assignment: 5research centers,
      central-block-stratified randomization, a ratio of active drug group to control group: 2:1
      5.Dose and mode of administration: Ginsenoside Rg3 group: ginsenoside Rg3 20mg BID, two
      months as one cycle, continue until recurrence occurs Placebo Group: placebo, 2 capsules,
      BID, continue until recurrence occurs 6.Study period: Screening phase: screening for
      enrollment within 8 weeks after the radical resection Follow up: review every 2-3 months
      following the surgery Post-trial investigation: within 28 days after the trial is ended or
      the recurrence occurs
    

Intervention name(s): the ginsenoside Rg3; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Shen Yi capsule
Intervention MeSH terms: Ginsenoside Rg3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Hepatocellular Carcinoma; ginsenoside Rg3
Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the safety and effectiveness of rosiglitazone against a
      sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels
      of the heart.
    


Intervention name(s): Glipizide; rosiglitazone maleate
Intervention type(s): Drug; Drug
Intervention description(s): oral anti-diabetic medication; oral antidiabetic medication
Intervention MeSH terms: Rosiglitazone; Glipizide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: atheroma; IVUS; Intravascular ultrasound; atherosclerosis
BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management
Condition: Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the
      first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight
      loss at the end of the second year of treatment (Week 104)
    


Intervention name(s): Lorcaserin 10 mg BID; Matching Placebo BID
Intervention type(s): Drug; Drug
Intervention description(s): Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks.; Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.
Other intervention name(s): APD356
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Weight loss; lorcaserin; APD356; BLOOM; Hypertension; Dyslipidemia; Sleep apnea; glucose tolerance; cardiovascular disease; Arena
Fecal Calprotectin Level in Patients With Nosocomial Diarrhea
Condition: Diarrhea; Calprotectin
MeSH terms: Diarrhea
Study type: Observational

Summary: 
      Nosocomial diarrhea is a common problem.There are multiple ethiologies of nosocomial diarrhea
      in which can be divided into inflammatory and non inflammatory diarrhea. Fecal calprotectin
      is a good marker to identify inflammatory diarrhea in outpatient setting; for example,
      differentiating inflammatory bowel disease and irritable bowel syndrome. Its performance in
      inpatient setting has not been well established. This study aim to determine the efficacy of
      fecal calprotectin in distinguishing inflammatory nosocomial diarrhea from non-inflammatory
      nosocomial diarrhea.
    

Detailed description: 
      This is a prospective, cross-sectional, and observational study. The patients with nosocomial
      diarrhea whose stool samples are sent for stool examination and Clostridium difficile toxin
      by their treating physicians will be recruited. Their leftover stool samples will be kept at
      - 80 c and will be measured for calprotectin level at the end of study. The patients will be
      treated by their treating physicians. They will be classified into 2 groups - inflammatory
      and non-inflammatory diarrhea.

      The inflammatory diarrhea will be defined if 1) positive for C. difficile toxin or 2) stool
      WBC more than 5/HPF or 3) inflammatory mucosa or ulceration noted on colonoscopy.

      The noninflammatory diarrhea will be defined if 1)negative for C. difficile toxin and 2) no
      WBC on stool examination and 3) dramatic response to diet adjustment or 4) no mucosal
      inflammation or ulceration if colonoscopy is performed

      The patients who do not respond to diet modification, but do not undergo colonoscopy will be
      excluded because the definite diagnosis cannot be made.
    

Intervention name(s): Fecal calprotectin
Intervention type(s): Diagnostic Test
Intervention description(s): Fecal calprotectin is a protein found in human neutrophils, and it is released during active periods of inflammation of intestine. The sensitivity and specificity has been reported at 93% and 96%, respectively in differentiating inflammatory bowel disease from irritable bowel syndrome in outpatient setting.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inpatients in Siriraj hospital, Bangkok, Thailand
      
Biospecimen description: 
      Stool examination Stool C.difficile toxin Fecal calprotectin
    
Keywords: Nosocomial diarrhea; Fecal calprotectin
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'
      quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone®
      Quadrivalent in children 6 to 35 months of age.
    


Intervention name(s): FluLaval™ Quadrivalent; Fluzone® Quadrivalent
Intervention type(s): Biological; Biological
Intervention description(s): 1 or 2 doses administered intramusculary (IM) in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively; 1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively
Other intervention name(s): FLU Q-QIV (GSK2282512A); F-QIV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Fluzone Quadrivalent; Comparator; Children; Seasonal influenza; Safety; Immunogenicity
Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine whether AMG 333 is safe and well tolerated
      in healthy subjects and subjects with migraines. As part of the secondary objectives, this
      study will characterize the pharmacokinetic (PK) profile of AMG 333, as well as characterize
      the effect of AMG 333 on the cold pressor test (CPT)-induced increase in blood pressure after
      single oral doses in healthy subjects and subjects with migraines
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, ascending single-dose study
      evaluating AMG 333 in healthy subjects and subjects with migraines. The study will consist of
      8 cohorts: 7 cohorts of healthy subjects and 1 cohort of subjects with migraines. For cohorts
      1 to 7, 8 subjects each will be enrolled, and subjects will be randomized such that 6
      subjects will receive AMG 333 and 2 subjects will receive placebo (3:1 ratio). In cohort 8,
      up to 24 subjects with migraines will be enrolled, depending on enrollment rate and emerging
      safety and tolerability data. These migraine subjects will be randomized to receive AMG 333
      or placebo in a crossover fashion. Both healthy and migraine subjects will be monitored in
      house for 4 days then allowed to return home for the remainder of the 14 day observation
      period. Both healthy and migraine subjects will keep headache diaries.
    

Intervention name(s): AMG 333; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration available in varying dose strength.; Placebo containing no active drug
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Migraine
Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.
Condition: Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Observational

Summary: 
      Efficacy and safety of MACUGEN in patients suffering from neovascular age-related macular
      degeneration in routine clinical practice at least as good as demonstrated in randomized
      multicenter clinical trials.
    

Detailed description: 
      Eligible patients in routine clinical practice
    

Intervention name(s): pegaptanib sodium
Intervention type(s): Drug
Intervention description(s): pegaptanib sodium intravitreal injection every 6 weeks for 2 years
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Age-related Macula degeneration
      
Keywords: efficacy and safety of Macugen in routine clinical practice
Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the
      treatment of social withdrawal in subjects with autism spectrum disorders
    


Intervention name(s): Arbaclofen
Intervention type(s): Drug
Other intervention name(s): STX209, R-baclofen
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASD; Autism; Asperger Syndrome