bioihbjkbjnl/mcl2 huggingface dataset:
The Role of Vasopressin Antagonism on Renal Sodium Handling
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Vasopressin has primarily been considered to be a water and osmosis regulating hormone that
      mediates its effects on renal aquaporin channels. Recent data suggest that vasopressin,
      through its V2 receptor, may also modulate sodium homeostasis. The purpose of this human
      physiology study was to test whether antagonism of the V2R alters urine sodium excretion in
      normal healthy volunteers.
    

Detailed description: 
      Vasopressin's potential roles in maintaining normal volume homeostasis are expanding. While
      previous data support the concept that vasopressin's primary role is in mediating water
      homeostasis, recent data suggest that vasopressin, through its V2 receptor, may also modulate
      sodium homeostasis. This effect occurs via activation of the epithelial sodium channel
      (ENaC). These studies document that vasopressin via activation of the V2 receptor, not only
      reduces free water excretion but also sodium excretion. These data suggest that blocking this
      receptor under the right circumstances and in the right population may be effective in
      modulating hypertension in humans: specifically a V2 receptor antagonist may be effective in
      treating some individuals that have salt-sensitive hypertension. The current proposal will
      test in normal human subjects the proof of principle of the above stated hypothesis, and to
      assess the best markers to determine such an effect. It is important to perform studies with
      strict environmental control in a clinical research center because of the variability of
      environmental factors that can create confusion in interpreting data (dietary sodium,
      activity, body posture, diurnal variation, ambient temperature, sleep-wake cycle, etc.).

      The overall program objective is to determine if a vasopressin V2 antagonist will be an
      effective treatment for salt-sensitive hypertension and if so, what subtype. The object of
      this specific proposal is to determine the effect of a selective V2 antagonist on sodium
      handling in normal subjects.
    

Intervention name(s): Tolvaptan Oral Tablet
Intervention type(s): Drug
Intervention description(s): Tolvaptan, to block V2R
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, double-blinded, parallel arm clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: vasopressin receptor; renal sodium excretion
Study to Evaluate the Human Infection of the Lower Respiratory Tract in Children at High Risk
Condition: Severe Respiratory Disease
MeSH terms: Respiratory Tract Diseases; Respiration Disorders
Study type: Observational

Summary: 
      - Estimate the incidence rate of hMPV infection detected by RT-PCR from frozen nasal wash
      aspirates in children at high risk for severe LRI disease (hospitalized at <2 years of age).
    

Detailed description: 
      -  A prospective, epdemiological study to estimate the incidence rate of hMPV infection as
           determined by RT-PCR from frozen nasal wash aspirates taken from children hospitalized
           with LRI who are at high risk for severe disease.

        -  No study drug will be administered for this study.
    

Intervention name(s): High Risk Respiratory Disease
Intervention type(s): Behavioral
Observational model: Defined Population
Time perspective: Other
Pomegranate Extract and Memory
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      This project is designed to study whether pomegranate extract benefits cognitive abilities in
      middle-aged and older non-demented volunteers. Subjects will be randomly assigned to one of
      two treatment groups: either a placebo or the pomegranate extract supplement. Both the
      placebo and pomegranate extract will be packaged in 1000 milligram capsules to maintain
      blindness. Subjects will take one 1000 milligram capsule daily for twelve months.

      The investigators expect the people receiving the pomegranate extract supplement to show
      better cognitive performance compared with those receiving a placebo after one, six, and
      twelve months. The investigators believe cognitive decline and treatment response will vary
      according to a genetic risk for Alzheimer's.

      The investigators will study 212 non-demented subjects aged 50-75 years. Initially, subjects
      will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to
      rule out other neurodegenerative disorders linked to memory complaints.

      Subsequently, subjects will undergo the first memory (or neuropsychological) assessments.
      Following the first assessment, subjects will begin taking the supplement (either the
      pomegranate extract or the placebo). Subjects will undergo a brief memory test at one-month
      mark. At six months, subjects will have a second, full neuropsychological assessment. The
      final assessment will take place at the end of the study, the 12-month mark. Additional blood
      will be drawn at baseline and at 12 months and frozen to assess inflammatory markers if
      outcomes are positive. Subjects will also be asked to come to the University of California,
      Los Angeles (UCLA) at 3 and 9 months for supplement refills.

      In total, subjects will be expected to come to UCLA for 7 visits during the course of 12-13
      months.
    


Intervention name(s): POMx; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): "POMx" is a 1,000 milligram capsule of natural pomegranate polyphenol extract.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Double-blind Trial; Placebo-controlled; Pomegranate; Memory; Memory Impairment; Cognition; Ages 50-75
Safety and Immunogenicity Study of HIV-MAG Vaccine +/- IL-12 and Ad35-GRIN/ENV in HIV-uninfected Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and immunogenicity of
      multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human
      IL-12 pDNA (GENEVAX® IL-12) followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine in
      low-risk for HIV-uninfected healthy adults.
    

Detailed description: 
      The study is a randomized, double-blind placebo-controlled trial assessing the safety and
      tolerability of HIV-MAG with or without co-administered GENEVAX® IL-12 given intramuscularly
      by in vivo electroporation (IM/EP) using the Ichor Medical Systems TriGrid Delivery System
      (TDS-IM) followed by Ad35-GRIN/ENV in each of four different regimens. An additional group
      will evaluate the safety and tolerability of Ad35-GRIN/ENV followed by HIV-MAG with
      co-administered GENEVAX® IL-12 given intramuscularly by in vivo electroporation (IM/EP) using
      the Ichor Medical Systems TriGrid Delivery System (TDS-IM).

      Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for
      12 months after the first vaccine administration. It is anticipated that it will take
      approximately 3 months to enrol the study. Approximately 75 volunteers (60 vaccine/15 placebo
      recipients) will be included in the study.
    

Intervention name(s): HIV-MAG (3,000mcg); GENEVAX® IL-12 (100mcg); GENEVAX® IL-12 (1000mcg); Ad35-GRIN/ENV
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Delivered intramuscularly by in vivo electroporation; Co-administered with HIV-MAG, delivered intramuscularly by in vivo electroporation; Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation; (2x10^10vp) Delivered intramuscularly by standard needle injection
Intervention MeSH terms: Interleukin-12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV; AIDS; HIV vaccine; HIV prevention
Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Observational

Summary: 
      The purpose of this study is to evaluate surgical success or failure one year after surgery
      for pelvic organ prolapse.
    

Detailed description: 
      This will be a prospective parallel cohort study comparing a laparoscopic sacral hysteropexy
      (LSHP) to a vaginal Uphold hysteropexy (VUHP). Symptomatic and anatomic improvement of pelvic
      organ prolapse will be evaluated at 3 months and 1 year.
    

Intervention name(s): Laparoscopic sacral hysteropexy; Vaginal mesh hysteropexy
Intervention type(s): Device; Device
Intervention description(s): Laparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance; Uphold device used which includes sacrospinous ligament fixation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult women with symptomatic uterovaginal prolapse planning to undergo laparsocopic sacral
        hysteropexy or vaginal uphold hysteropexy
      
Keywords: Uterovaginal prolapse; hysteropexy; mesh
Role of Acute Exercise Modality on Appetite Regulation and Energy Intake
Condition: Appetite Regulation; Acute Exercise; Energy Intake
Study type: Interventional

Summary: 
      This study plans to learn more about how type of exercise influences measures of appetite
      regulation. In this study, investigators will be evaluating a resistance exercise session
      (using weight machines and free weights) and an aerobic exercise session (using a treadmill).
      Participants will also complete a sedentary control condition.

      A secondary purpose is to compare sex-based differences in appetite-indices in response to
      exercise. Therefore, the responses to aerobic and resistance exercise will also be compared
      between men and women.
    


Intervention name(s): Exercise Modality
Intervention type(s): Behavioral
Intervention description(s): The overall aim of this study is to compare how acute exercise modality (e.g. resistance exercise vs. aerobic exercise) differentially influence hormonal and behavioral indices of appetite regulation and ad libitum energy intake. Both conditions will also be compared to a non-exercise control condition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: acute exercise; resistance exercise; aerobic exercise; appetite; energy intake
Upright Open MRI for Brain Imaging in Children - a Pilot Study
Condition: Brain Tumor
MeSH terms: Brain Neoplasms
Study type: Interventional

Summary: 
      PRIMARY OBJECTIVE To establish feasibility and acceptability of diagnostic brain MRI in young
      children for specified indications using an upright MRI system without sedation or
      anaesthesia.

      SECONDARY OBJECTIVES To establish how young children who undergo brain MRI using upright MRI
      view the experience To establish how parents / carers of young children who undergo brain MRI
      using the upright MRI view the experience for their child and for themselves.

      To establish how image quality compares between brain MRI using the upright MRI scanner and
      the standard MRI scanner used in clinical practice.
    

Detailed description: 
      Study Design Feasibility study collecting data on image quality and experience of upright
      open MRI scanning (performed in addition to standard clinical MRI scan), and comparing
      outcome measures to standard supine MRI scans, in children referred for clinical MRI scanning
      for (i) symptoms or signs suggestive of brain tumour and (ii) symptoms or signs suggestive of
      shunt blockage in children with a ventriculoperitoneal (VP) shunt Study Participants
      Participants that have been referred for brain MRI for symptoms and signs suggestive of brain
      tumour or who have known VP shunts with a clinical suspicion of shunt dysfunction. 20
      participants in total, aiming for an even split between these two groups but will be flexible
      based on the local clinical case load.

      Planned Size of Sample (if applicable) 20 young school-aged children (5 to 10 years) referred
      for brain MRI at NUH. The child participant's parents will be simultaneously recruited
    

Intervention name(s): MRI scan
Intervention type(s): Procedure
Intervention description(s): MRI scan on open scanner and some questionnaires
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Upright open scanner; MRI; Magnetic Resonance Imaging
Evaluation of PKU Start
Condition: Phenylketonuria; Inborn Errors of Metabolism
MeSH terms: Phenylketonurias; Metabolism, Inborn Errors
Study type: Interventional

Summary: 
      To evaluate the acceptability, tolerance and effect on metabolic control of PKU Start, a new
      Phe free protein substitute for the dietary management of PKU in infants from birth.
    

Detailed description: 
      This is an assessment of ten (10) infants who require a protein restricted diet that is low
      in Phe. Infants who routinely use a Phe free infant formula as part of their dietary therapy
      will be recruited for a 28-day assessment of PKU Start, to evaluate tolerance and
      acceptability.

      The outcome of this assessment will be used in a submission to the regulatory authorities,
      Advisory Committee on Borderline Substances (ACBS), for PKU Start to become reimbursable on
      prescription in the UK.

      The participant's dietitian will advise on an appropriate amount of PKU Start based on
      individual requirements. Parents/carers will be asked to substitute their usual Phe-free
      infant formula with PKU Start for one (1) month. The sponsor will supply PKU Start free of
      charge.

      Prior to starting PKU Start, parents/carers will be asked to record information about the
      infant's usual GI tolerance and feeding pattern for a period of three (3) days, to allow for
      comparison between their existing formula and PKU Start.

      They will be asked to record information about the following:

      Stools Vomiting and Spit-up Feed / Fluid Intake and Compliance Phenylalanine Levels Final
      Evaluation about the presentation of the product, ease of preparation and how PKU Start
      flowed through the teat of a bottle.
    

Intervention name(s): PKU Start
Intervention type(s): Dietary Supplement
Intervention description(s): PKU Start is a powdered, phenylalanine-free, infant formula, containing essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals, trace elements and long chain polyunsaturated fatty acids (LCPs); Arachidonic acid (AA) and Docosahexaenoic acid (DHA). It is suitable for use from birth.
The recommended amount of the product for each participant will be determined and prescribed by a dietitian.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phenylketonuria; PKU; Metabolism; Metabolic; Control; Acceptability
Cardiovascular Health Effects of Flavanol Rich Chocolate
Condition: Endothelial Dysfunction
Study type: Interventional

Summary: 
      In the CHOC study the investigators will examine the effect of chocolate flavanols on
      vascular function, inflammation, oxidative stress and markers of endothelial function. The
      effects of both acute consumption and prolonged consumption will be studied. The secondary
      objectives are to investigate if daily intake of chocolate flavanols for 4 weeks will improve
      the response to a high fat/high energy challenge.
    


Intervention name(s): High flavanol chocolate; Low flavanol chocolate; High fat challenge
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): chocolate high in flavanols; chocolate low in flavanols; Milkshake with 95g fat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance
Condition: Osteoarthritis; Obesity
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a substudy to a randomised trial investigating the effect of liraglutide on body
      weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In
      the parent trial, patients will be subjected to an 8-week diet intervention phase including a
      low-calorie diet and dietetic counseling, after which patients will be randomised to receive
      either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on
      re-introducing regular foods and a focus on continued motivation to engage in a healthy
      lifestyle.

      This substudy aims to investigate the impact of, and subsequent change of, joint
      inflammation, articular cartilage composition, overall knee morphology, and clinical
      symptoms, in obese patients with knee osteoarthritis following a randomisation to Liraglutide
      3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.
    


Intervention name(s): Liraglutide 3 mg (Saxenda); Liraglutide 3 mg placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Magnetic resonance imaging; Dynamic contrast enhanced MRI; Liraglutide 3 mg; Liraglutide; Obesity; Osteoarthritis
Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborns Undergoing Venipuncture
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to determine the relative efficacy of sucrose, liposomal
      lidocaine, and sucrose plus liposomal lidocaine, on reducing pain during venipuncture in
      newborn infants.
    

Detailed description: 
      Despite the fact that modern medical practice is greatly advanced, pain is inflicted on all
      Canadian newborn infants in the first days and months of life from blood tests, injections
      and cannulations designed to prevent, diagnose or manage medical conditions. Procedural pain
      in newborn infants is a significant burden to infants, their parents, healthcare workers, and
      society at large.

      This study proposes a large randomized controlled trial to determine the optimal analgesic
      regimen for procedural pain using methods that can be easily implemented in clinical
      practice. We will study liposomal lidocaine cream and sucrose oral liquid, used alone, or
      together, to manage procedural pain. Liposomal lidocaine is a relatively new anaesthetic
      formulation ideally suited for young infants due to the established role of lidocaine in
      neonatal clinical medicine. Sucrose (sugar water) reduces pain responses and is promoted in
      consensus guidelines developed by pain experts. However, it is perceived by many front-line
      clinicians to be simply a comforting agent rather than a true analgesic. Studying liposomal
      lidocaine and sucrose together is important since the combination may prove superior to
      either agent alone, and may even prevent or abolish pain from clinical procedures.
    

Intervention name(s): Lidocaine; 24% Sucrose Solution
Intervention type(s): Drug; Drug
Intervention description(s): 1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.; 2ml of 24% sucrose will be administered 2 minutes prior to venipuncture
Other intervention name(s): Maxilene 4; TootSweet
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatrics; pain; infants; newborn screening; venipuncture; lidocaine; sucrose
Skin Responses and T Cell Immunology After House Dust Mite Exposure in Sensitized Atopic Dermatitis Patients
Condition: Atopic Dermatitis; House Dust Mite Allergy
MeSH terms: Dust Mite Allergy; Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The present study investigates the reaction of the skin upon exposure to house dust mite
      (HDM) in patients with atopic dermatitis who have antibodies against HDM in the blood. A
      further aim is to assess nasal symptoms after exposure to HDM in an allergen challenge
      chamber and compare the results with data from previous studies.
    

Detailed description: 
      Atopic dermatitis (AD) is a chronic skin disease characterized by a relapsing course and
      typical clinical manifestation with itchy, eczematous lesions. The majority of AD patients
      reveals elevated IgE serum levels (> 100kU / L), which classifies the disease as extrinsic
      AD. Mostly, the IgE is directed against aeroallergens like pollen and house dust mite (HDM).
      These allergens may contribute pronouncedly to the relapsing character of the disease.

      Of note, it was already shown in the 1920s that avoiding aeroallergens by sleeping in an
      allergen-free chamber has a positive influence not only on the symptoms of asthma but also on
      the skin condition in AD patients. However, a recent study was the first showing that
      challenge chamber exposure to airborne grass pollen allergens can cause a clinical worsening
      of the skin condition in sensitized AD patients. These standardized settings in the
      Fraunhofer Allergen Challenge Chamber can conduce as a model for the investigation of the
      impact on other allergens on AD patients.

      For the perennial allergen HDM, Sager et al. investigated the epicutaneous application of HDM
      allergens in sensitized AD patients. It led to an aggravation of the eczematous lesions
      through a T-cell-mediated reaction. The binding of the HDM allergen to specific IgE-Fc
      receptors on Langerhans cells leads to the proliferation of specific T cells in the skin and
      a proinflammatory signaling. Until now, however, airborne HDM allergen exposure has not been
      shown to cause aggravation of AD in any controlled setting. This study aims to answer the
      question of the extent to which standardized exposure of AD patients with HDM has an impact
      on objective, subjective and in vitro disease parameters.
    

Intervention name(s): House Dust Mite Allergen; Allergen-free air
Intervention type(s): Drug; Other
Intervention description(s): D. pteronyssinus lyophilisate dissolved in 5% sodium chloride solution, spray dried; No allergen added to room ventilation of allergen challenge chamber
Intervention model: Single Group Assignment
Intervention model description: All subjects are exposed to house dust mite and allergen-free air in the same sequence. Subjects are blinded to the sequence of house dust mite and allergen-free air exposures
Masking: None (Open Label)
Primary purpose: Basic Science