bioihbjkbjnl/mcl2 huggingface dataset:
LEAP2 on Postprandial Glucose Metabolism and Food Intake
Condition: Obesity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study aim to delineate the effects of the naturally occurring peptide liver-enriched
      antimicrobial peptide 2 (LEAP-2) on postprandial glucose metabolism and food intake in
      healthy volunteers. The overall objective is to investigate the physiological importance of
      LEAP-2 in healthy subjects.
    

Detailed description: 
      In a recent study, the molecular phenotype of enteroendocrine cells in the small intestine
      before and after Roux-en-Y Gastric Bypass (RYGB) surgery in obese individuals was examined.
      Enteroendocrine cells were identified and isolated from intestinal biopsies and analysed for
      differentially expressed genes by Illumina High Throughput RNA-sequencing. It was discovered
      that the gene encoding liver-enriched antimicrobial peptide 2 (LEAP-2), a naturally occurring
      peptide in humans, was significantly upregulated compared to baseline expression.
      Interestingly, LEAP-2 was recently shown to antagonize ghrelin function in response to
      feeding in mice. Moreover, the mature murine LEAP-2 peptide is identical in mice and humans.
      Thus, LEAP-2 has been identified as an endogenous peptide that may be able to alter feeding
      behaviour and maintenance of glucose levels during calorie restriction.

      The study hypothesis is that LEAP-2 alters postprandial glucose metabolism and decreases
      appetite as well as food intake in relation to a liquid mixed meal and a standardised ad
      libitum meal compared with saline (placebo) in healthy subjects.
    

Intervention name(s): Liver-enriched antimicrobial peptide 2; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): IV infusion of LEAP2, approximately 5 hours; IV infusion of saline, approximately 5 hours
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is designed as a clinical, placebo-controlled, double-blinded cross-over study involving two experimental study days.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Internet-based Program for Prevention and Early Intervention of Adolescent Depression
Condition: Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      Background: Depression is prevalent and can have devastating effects on the life of
      adolescents. Computerized intervention programs for depression have shown positive results.
      There is less evidence in prevention and early treatment for depression in Latin American
      adolescents.

      Purpose: The purpose of this study is to determine whether a stepped internet-based program
      is effective to prevent and early intervene depression in adolescents attending 9th to 11th
      grade in eight schools in Santiago, Chile.

      Study design: A two-arm cluster-randomized clinical trial will be carried out with
      approximately 600 adolescents.
    


Intervention name(s): Take care of your mood (CUIDA TU ANIMO in Spanish); Control
Intervention type(s): Behavioral; Other
Intervention description(s): The adolescents will be registered in the Website www.cuidatuanimo.org; The adolescents will visit the Website www.cuidatuanimo.org, but they can not register
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: depression; adolescence; prevention; early intervention; internet-based
Rivastigmine in Mild Alzheimer's Disease, FMRI Study
Condition: Alzheimer' Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the effect of rivastigmine given as an acute dose
      compared to placebo and after 1 month chronic dosing on fMRI response during a face
      recognition task. Furthermore, the aim is to investigate whether fMRI response is correlated
      with long term treatment effect at 6 months and 12 months.
    


Intervention name(s): rivastigmine
Intervention type(s): Drug
Intervention description(s): Acute dose 3 mg or placebo. Thereafter 1.5 mg x 2 ad 30 days and thereafter increasing the dose upto 4.5 mg x 2 according to instructions.
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Alzheimer's disease; fmri; face recognition; rivastigmine
The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis
Condition: Neuromuscular Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      In the initial evaluation, the degree of spine is measured quantitatively using Cobb's angle
      and Muscular Dystrophy Spine Questionnaire (MDSQ). The patients who had Cobbs angle of 20-45
      'by spinal plain radiography were evaluated for the effects of flexpine brace wearing and
      rehabilitation for 6 months. After 12 months, whole spine X-ray was taken for the followed up
      the patient's status.
    


Intervention name(s): thoracolumbar brace (Flexpine brace)
Intervention type(s): Device
Intervention description(s): Patient's would wear the FLEXpine brace over 18 hours a day for the 6 month
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: brace; neuromuscular disease; scoliosis
Detection of Chlamydia DNA by Polymerase Chain Reaction in Primary Tubal and Ovarian Cancers Tissues : a Pilot Study
Condition: Malignant Neoplasm of Fallopian Tube
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Neoplasms; Fallopian Tube Neoplasms
Study type: Observational

Summary: 
      PCR for chlamydia DNA is done in paraffin blocks of cases of primary tubal cancer and is
      compared to cases of high grade serous ovarian cancer and normal tubes .
    

Detailed description: 
      The investigators shall review the early cancer detection unite pathology records for the
      past 10 years , for cases diagnosed with primary Fallopian tube cancers , cases of high and
      low grade serous ovarian cancer and cases underwent hysterectomy and salpingectomy for non
      oncological reasons. Paraffin blocks for suitable selected patients will be examined
      histologically to confirm the primary diagnosis . Chlamydia DNA in these paraffin blocks of
      the Fallopian tubes and ovarian tissues will be examined using PCR techniques . The possible
      correlation between the presence of Chlamydia DNA and the ovarian serous tumours and primary
      tubal cancer will be analyzed statistically .
    

Intervention name(s): PCR for chlamydia DNA in primary tubal cancer
Intervention type(s): Other
Intervention description(s): PCR for presence of chlamydia DNA in paraffin blocks retrieved for tubal and ovarian tissues in all groups
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Pathology blocks of patients with primary tubal cancer and with high grade serous ovarian
        cancer and normal tubes.
      
Biospecimen description: 
      Archival Paraffin blocks for cases of primary tubal cancers , high grade serous ovarian
      cancers , low grade serous ovarian cancers and normal Fallopian tubes removed during
      Hysterectomy operations for benign Gynecological indications
    
Keywords: Fallopian tubal cancer, high grade serous , ovarian cancer
Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment
Condition: Age-Related Memory Disorders
MeSH terms: Memory Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the safety, tolerability, and effectiveness of 2
      dose levels of LX6171 given over 28 days in patients with Age Associated Memory Impairment
      (AAMI).
    


Intervention name(s): LX6171 High Dose; LX6171 Low Dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.; A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.; Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Managing Childhood Abdominal Pain
Condition: Pediatric Abdominal Pain
MeSH terms: Abdominal Pain
Study type: Interventional

Summary: 
      Functional abdominal pain (FAP) is a common complaint of childhood, associated with
      considerable health care costs, disruption of normal activity, emotional distress, and
      long-term health effects. The study will test a treatment approach which, if successful,
      would substantially change the treatment for FAP and potentially for a wide range of
      childhood medical problems where parental responses to symptoms contribute to these adverse
      effects. The study would also provide a model which would be much more accessible than
      traditional face-to-face therapies to a broader range of families in need than are currently
      served.
    

Detailed description: 
      Functional Abdominal Pain (FAP) affects 10 to 15% of children and has significant social,
      emotional, and financial costs, but no known organic cause and no accepted medical or
      behavioral treatment. The researchers have conducted studies that provide support for a
      theoretical model in which cognitive-behavioral and social learning processes (modeling
      and/or potentially reinforcing responses by parents) may contribute to the maintenance of
      illness behaviors and functional disability in children with FAP. The researchers
      subsequently tested a social learning and cognitive-behavioral intervention for parent-child
      dyads which focused on changing these parent behaviors as well as teaching coping skills to
      children. Results support the effectiveness of the intervention and the explanatory value of
      the theory, demonstrating that parental change is a key element in reducing children's
      symptoms. The proposed study will build on these findings by evaluating a parent-only
      intervention. Furthermore, our experience and that of other investigators indicates that
      alternative intervention models are needed for wider accessibility to the intervention for
      families in need. While a parent-only format is expected to increase accessibility, we will
      also evaluate the use of a remote telephone intervention.
    

Intervention name(s): Cognitive Behavioral Therapy & Social Learning; Education and Support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive Behavioral Therapy & Social Learning; Education about the GI system, nutrition and food safety
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: FAP; RAP; Abdominal Pain; IBS
An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The proposed study is a 12-week, open-label pilot study of sublocade (extended-release
      burprenorphine, BXR) as treatment for opiate use disorder (OUD) testing positive for Highly
      Potent Synthetic Opioids (HPSO). The investigators plan to enroll 10 participants into the
      study.
    

Detailed description: 
      This is an open-label, uncontrolled pilot study. Outpatients seeking treatment for Opiate Use
      Disorder (OUD) will be screened, and those eligible who are positive for fentanyl analogues
      at screening will be consented and inducted onto sublingual buprenorphine (target dose 16mg
      to 24mg). On the fourth day after starting the buprenorphine induction, participants will
      receive sublocade (BXR) 300mg by subcutaneious injection. Participants will be seen twice per
      week for urine collection for toxicology and research assessments and will have Medication
      Management counseling weekly during one of these visits. BXR will be administered monthly and
      dosing will be according to the FDA prescribing instructions of 300mg for the second dose and
      100mg for the third.
    

Intervention name(s): Sublocade
Intervention type(s): Drug
Intervention description(s): The monthly Sublocade buprenorphine extended-release (BXR) injection will be administered in two doses (100 mg and 300 mg). Following a 4 day induction onto oral buprenorphine, the first 300 mg injection of Sublocade will be administered. A second 300 mg Sublocade injection will be administered 1 month later and the third and final monthly injection of 100 mg of Sublocade will be administered 2 months post the successful buprenorphine induction.
Other intervention name(s): buprenorphine extended-release injection
Intervention MeSH terms: Buprenorphine
Intervention model: Single Group Assignment
Intervention model description: open label pilot for sublocade
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opioid use disorder, sublocade, buprenorphine
Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome
Condition: Obesity
MeSH terms: Obesity; Metabolic Syndrome
Study type: Interventional

Summary: 
      The recent dramatic increase in obesity has been linked to a reduction of dietary fibre
      intake. We hypothesized that supplementing the diet of overweight and obesity adults with
      pulse fibre will improve their metabolic status, chiefly defined as greater weight loss.
      Other metabolic health improvements may include improved glucose control and reduced
      inflammatory markers.
    

Detailed description: 
      The main objective of our study is to assess the effects of pulse fibre supplementation on
      weight loss in an overweight and obese adult population.

      Primary objective - To determine the effects of a 12 week intake of 15g/day of pea hull fibre
      on weight loss supported by body composition measures.

      Secondary objective - To measure glucose control and appetite regulation in overweight and
      obese adults consuming 15g/day of pea hull fibre compared to a placebo control with the use
      of plasma HbA1c and an oral glucose tolerance test (OGTT).

      Tertiary objective - To examine mechanisms of action of pulse fibre supplementation by
      determining the impact of pulse fibre supplementation on gut microbiota, serum metabolomics
      and fecal short-chain fatty acid and bile acid concentrations.
    

Intervention name(s): Pulse fibre; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.; Control biscuit with no yellow pea hull fibre.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dietary intervention; Dietary fibre; Obesity; Metabolic syndrome; Weight loss; Glucose regulation; Pulse fibre
Multimodal Neuroimaging of Alcohol Cues, Cortisol Response, and Compulsive Motivation
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study proposes to examine both the peripheral and central nervous system responses when
      light social drinkers and binge/heavy social drinkers are exposed to visual ethanol cues,
      followed by oral ethanol. The findings will provide a greater understanding of the brain
      mechanisms (cerebral blood flow and functional connectivity) underlying the association
      between stress, cortisol release, alcohol craving, and alcohol stimulant and sedative
      effects. This knowledge could be significant in developing new therapies for the treatment of
      alcoholism.
    

Detailed description: 
      Results from the 2014 National Survey on Drug Use and Health show that 26% of adults in the
      US engaged in binge drinking in the past month (SAMHSA 2014). Why some people "mature out" of
      this behavior while others persist may be due to one's physiological response to binge
      drinking. No previous study has assessed whether disrupted cortisol and neural network
      responses to alcohol cues may drive the compulsive alcohol consumption seen in binge drinking
      individuals who do not yet have an AUD.

      The investigator will recruit beer drinking, non-smoking men and women ages 21-45 (N=80,
      equal gender) who are either moderate drinkers or binge/heavy drinkers for two neuroimaging
      and neuroendocrine assessments to determine if their "real world" drinking behavior, in a
      prospective one month follow up, can be predicted based upon the cortisol and neural network
      responses to alcohol cues (with a placebo control, counter-balanced and randomized). Finally,
      the influence of genetic variation in the FK506-binding protein 5 (FKBP5) gene, which
      regulates cortisol activity, on the cortisol and neural network responses to alcohol cues
      will be explored.
    

Intervention name(s): Intravenous blood draw
Intervention type(s): Drug
Intervention description(s): In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session
Other intervention name(s): Indwelling catheter for blood draws
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes
Condition: Hypereosinophilic Syndrome; Systemic Mastocytosis; Chronic Myelomonocytic Leukemia; Dermatofibrosarcoma
MeSH terms: Leukemia; Neoplasms; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Mastocytosis; Mastocytosis, Systemic; Dermatofibrosarcoma; Hypereosinophilic Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is for various types of malignancies which may depend on certain enzymes (tyrosine
      kinases) for growth. The objective of this study is to assess to what extent imatinib
      mesylate blocks these enzymes and to assess the effect on the malignancy.
    

Detailed description: 
      Condition

      Diverse malignancies either associated with or thought to be associated with activated
      tyrosine kinase enzymes including hypereosinophilic syndrome systemic mastocytosis chronic
      myelomonocytic leukaemia, dermatofibrosarcoma protuberans and other diseases.

      Not included:

      Patients with chronic myeloid leukemia, some other types of leukemias (abl-mutated) some
      types of gastrointestinal stromal tumours (c-KIT-positive), some systemic mastocytosis (if
      c-KIT D816V mutation), brain, prostate, breast or lung cancers.
    

Intervention name(s): imatinib mesylate
Intervention type(s): Drug
Other intervention name(s): STI571
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Imatinib mesylate; tyrosine kinases; imatinib sensitivity; Diverse malignancies either associated with; or thought to be associated with; activated tyrosine kinase enzymes; including hypereosinophilic syndrome; systemic mastocytosis; chronic myelomonocytic leukaemia,; dermatofibrosarcoma protuberans and other diseases.; Not included:; patients with chronic myeloid leukemia,; some other types of leukemias (abl-mutated); some types of gastrointestinal stromal tumours (c-KIT-positive),; some systemic mastocytosis (if c-KIT D816V mutation),; brain,; prostate,; breast or lung cancers.
Effectiveness of Training in Reading Rehabilitation for Patients With Diabetic Macular Oedema
Condition: Diabetic Macular Oedema; Parafoveal Scotoma
MeSH terms: Scotoma; Macular Edema; Edema
Study type: Interventional

Summary: 
      Diabetic macular oedema (DMO) is a sight-threatening problem for diabetic patient who has
      swelling in macula. Patients with DMO can receive laser treatment and achieve good acuity
      finally. However, some patients still have difficulties in reading even after proper
      treatment.

      In this project, the investigators aimed to explore the effectiveness of different training
      paradigms in improving reading performance in patients with DMO.
    

Detailed description: 
      Patients with diabetic macular oedema (DMO), after receiving laser photocoagulation, achieved
      good outcomes in distance acuity. However, some patients, particularly those developing
      parafoveal scotoma, still had difficulty in reading. Inability to read or reading very slowly
      leads to the potential loss of job, as well as the enjoyment of reading for leisure.

      In this study, the investigators aimed to investigate the effectiveness of reading
      rehabilitation using perceptual learning paradigms in enhancing reading performance in
      patients with reading difficulties due to DMO. Also, the fundamental mechanisms explaining
      the reading problems in patients with DMO reading Chinese will be examined.

      The investigators hypothesize that the perceptual training would show an improvement in
      reading. The investigators' primary hypothesis is that temporal visual processing speed and
      spatial visual span will be improved after perceptual training. The investigators' secondary
      hypothesis is that the reading speed and fixation stability will be improved after training.
    

Intervention name(s): Temporal Group; Spatial Group; Combined Group; Control Group
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Visual Processing Training; Spatial visual span training; Visual processing speed and spatial visual span training; Leisure reading activities
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Diabetic macular oedema; Perceptual learning; Chinese; Hong Kong
Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)
Condition: Bacteremia; Soft Tissue Infections; Skin Diseases, Infectious
MeSH terms: Infections; Communicable Diseases; Bacteremia; Soft Tissue Infections; Skin Diseases, Infectious; Skin Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, efficacy and pharmacokinetic (PK)
      parameters of daptomycin for injection in Japanese pediatric participants aged 1 to 17 years
      with complicated skin and soft tissue infection (cSSTI) or bacteremia caused by gram-positive
      cocci.
    


Intervention name(s): Daptomycin for Injection
Intervention type(s): Drug
Intervention description(s): Once daily administration of 5, 7, 9, 10, or 12 mg/kg intravenous (IV) daptomycin infused with 25-50 mL saline over 30-60 minutes depending upon infection type and age level.
Other intervention name(s): MK-3009
Intervention MeSH terms: Daptomycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: methicillin-resistant S. aureus (MRSA) infections; complicated skin and soft tissue infections (cSSTI)