bioihbjkbjnl/mcl2 huggingface dataset:
Reducing Risks and Improving Glucose Control During Extended Exercise in Youth With T1DM: The AP Ski Camp
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The biggest challenges for glycemic control during the day time involve meals and exercise
      variations, which are impacted by age, fitness level, duration, intensity and history of
      exercise. Meal variability has the benefit that meals are typically announced and quantified.
      Glucose control around exercise, on the other hand, is more complicated if the patient
      doesn't announce a change in activity level.
    

Detailed description: 
      The object of this study is to evaluate the Closed-Loop Control (CLC) in an environment where
      muscle glycogen is systematically depleted, glucose uptake systematically increased, and meal
      sizes are naturally larger than normal: a week of camp at high altitude, with the concomitant
      variable of oxygen consumption that this environment involves; during the winter, that will
      expose and challenge the different components of the system during cold temperatures, and
      with twice daily practice of physical activity designed to deplete glycogen reserves such as
      skiing.

      This proposal aims to demonstrate the superiority of the CLC, also known as Artificial
      Pancreas (AP), compared to the state-of-the art system available on the market:
      Sensor-augmented pump (SAP). This system has shown to diminish hypoglycemic events by setting
      the alarms on the continues glucose monitor (CGM) and taken action, such as performing
      self-monitoring blood glucose (SMBG) and treating if it is confirm to be low.
    

Intervention name(s): Closed-Loop Control; Sensor Augmented Pump Therapy
Intervention type(s): Device; Other
Intervention description(s): Subjects will use the CLC during 5 nights/6 days at a ski camp.; Subjects using their personal pumps with study CGM.
Other intervention name(s): CLC; SAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes Mellitus (T1DM); Artificial Pancreas (AP); Sensor-Augmented Pump (SAP) Therapy; Closed Loop Control; Insulin Pump; Continuous Glucose Monitor (CGM)
HPV in Adolescents
Condition: HPV Infection; Cervical/Anal Dysplasia
MeSH terms: Papillomavirus Infections
Study type: Observational

Summary: 
      This study will assess the prevalence of HPV infection in perinatally HIV-infected
      adolescents, intraepithelial neoplasia, and E6E7 biomarker at cervical and anal sites.
    

Detailed description: 
      Human Papillomavirus (HPV) is the most common sexually transmitted disease and it causes
      cervical and anal cancer. Prevalence and incidence of HPV infection among young adults who
      are sexually experienced is high. No data exist for HIV-positive adolescents in regards to
      HPV infection, cervical and anal intraepithelial neoplasia. This study will compare the
      prevalence of HPV infection, intraepithelial neoplasia and E6/E7 biomarker at cervical and
      anal sites among perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents,
      and HIV-negative adolescents.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 60 sexually active adolescents (perinatally and behaviorally HIV-infected
        adolescents, HIV negative adolescents) aged 12-24 will be recruited from the HIV-NAT and
        TRC Anonymous Clinic
      
Biospecimen description: 
      Cervical and anal pap smears specimens will be used for HPV typing. Blood will be collected
      for STI and immune response to HPV/HIV testing
    
Keywords: HPV; HIV; cervical/anal dysplasia; intraepithelial neoplasia; E6/E7 biomarker; perinatally HIV-infected adolescents; behaviorally HIV-infected adolescents; anal and pap smear
Safety and Pharmacokinetics Study of Single Ascending Doses of VV116 in Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The study consists of 5 dose groups, starting at 25 mg, 6 subjects in 25 mg group, and 8
      subjects in each other group (male or female), randomly assigned to study drug or placebo
      group to evaluate the safety, tolerability and PK characteristics. The subject number of
      single dose group may increase or decrease depending on the safety and PK data obtained. The
      dose levels are planned at 25 mg, 200 mg, 400 mg, 800 mg and 1200 mg. Based on observed
      tolerability and safety data or obtained PK data, adjustments are allowed at all dose levels
      in the clinical trial.
    

Detailed description: 
      4 subjects in the 25 mg dose group will receive VV116 tablets and the other 2 subjects will
      receive placebo. In other dose groups, 6 subjects in each group will receive VV116 tablets
      and 2 subjects will receive placebo. 25mg,800mg and 1200 mg dose group will be given by
      sentinel administration (i.e. 1 study drug, 1 placebo). Subjects who receive sentinel
      administration will be observed for 48 hours and investigator will evaluate the safety
      parameters (including symptoms, vital signs, physical examination, etc.).
    

Intervention name(s): VV116 25mg Group; VV116 200mg Group; VV116 400mg Group; VV116 800mg Group; VV116 1200mg Group
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 4 subjects will receive VV116 25mg,orally; 2 subjects will receive placebo,orally.; 6 subjects will receive VV116 200mg,orally; 2 subjects will receive placebo,orally.; 6 subjects will receive VV116 400mg,orally; 2 subjects will receive placebo,orally.; 6 subjects will receive VV116 800mg,orally; 2 subjects will receive placebo,orally.; 6 subjects will receive VV116 1200mg,orally; 2 subjects will receive placebo,orally.
Other intervention name(s): Placebo; Placebo; Placebo; Placebo; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: VV116; Phase I; dose-escalation; Tolerability; Pharmacokinetic
Central Sensitization and Physical Activity in Adolescents With HSD/hEDS
Condition: Joint Hypermobility Syndrome; Hypermobile Ehlers-Danlos Syndrome
MeSH terms: Joint Instability; Ehlers-Danlos Syndrome; Syndrome
Study type: Observational

Summary: 
      Hypermobility Spectrum Disorder and hypermobile Ehlers-Danlos Syndrome (HSD/hEDS) is
      under-recognized and poorly understood and its management is therefore not clear.

      The goal of this study is to better understand pain and its impact on function in the daily
      activities of adolescents with Hypermobility Spectrum Disorder and/or hypermobile
      Ehlers-Danlos Syndrome.

      This study will explore the presence of the pain sensitivity status after physical exercise
      as well as movement behaviour in adolescents with HSD/hEDS compared to a healthy control
      group.
    

Detailed description: 
      All participants will be asked not to undertake physical exercise at least 48 hours before
      the measurements, and to refrain from consuming caffeine, alcohol or nicotine. For ethical
      reasons, the patients are allowed to take non-opioid pain medicine as described in the first
      step of the World Health Organization analgesic ladder (COX-inhibitors and paracetamol),
      however the patients will be asked to abstain from these medications during the 24 hours
      period before the measurements.
    

Intervention name(s): Submax exercise test on a bicycle ergometer
Intervention type(s): Other
Intervention description(s): To achieve exertion and not exhaustion, cycling will be stopped at 75% of the expected maximum heart rate (maximum heart rate of 220 beats per minute minus age) as a target value.
If the participant then indicated that they do not feel strained, the cycling will continue until the participant experienced an effort on Borg Rating of Perceived Exertion Scale scale of 15 (hard).
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolecents diagnosed with HSD/hEDS, at Children's Primary Health Care Clinics in Gothenburg
        and Southern Bohuslän, and at Queen Silvia Children's Hospital and Skaraborgs hospital
        Skövde will be asked to participate. In addition, a control group of healthy pain free
        adolecents, matched for sex, age will be recruited from different schools in the region,
        throw hospital stuff and social media.
      
Keywords: Pain; Hypermobility; Physical activity; Central sensitization; Fatigue; Ehlers Danlos Syndrome
A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective is to assess the safety of different doses of ferroquine with
      artesunate (AS) in adult African patients with uncomplicated malaria.

      The secondary objectives are to assess activity in reducing parasitemia and the
      pharmacokinetics of ferroquine and its metabolites.
    

Detailed description: 
      The study duration is 30 days including a 2 day screening period, a 3 day treatment period
      with a follow-up period of 25 days. Patients remain hospitalized 4 days.
    

Intervention name(s): ferroquine (SSR97193); amodiaquine
Intervention type(s): Drug; Drug
Intervention description(s): associated with artesunate; associated with artesunate
Intervention MeSH terms: Amodiaquine; Ferroquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria
Effects of Trap and Reggaeton Music on Movement Velocity, Power and Muscular Endurance in the Lower Limbs of Physically Active Women
Condition: Female; Sports; Muscle; Exercise
Study type: Interventional

Summary: 
      The influence of music on movement velocity and power during strength training have been
      poorly investigated, and specifically in women there is no evidence of an increase in
      strength performance due to the influence of music.

      Hypothesis: Listening to trap or reggaeton music will improve jumping ability, as well as
      movement velocity and power, muscular endurance, motivation and perception of effort in
      trained women during the performance of back-squats.
    

Detailed description: 
      The investigators pretend to conduct an experimental trial with a randomised crossover design
      in 28 participants physically active young adults with strength training experience aged
      18-30 years. The study will be conducted in the laboratory of Physical Activity and Sport
      Sciences of the University School of Osuna.

      In this way, at the end of the study the investigatos will have contrasted scientific
      information on the effects of music on the following variables of speed of execution in the
      back squat exercise.

      back.
    

Intervention name(s): Effect of music on the manifestation of strength
Intervention type(s): Other
Intervention description(s): After the first 1RM visit, described above, each participant will complete 2 additional randomised, counterbalanced visits, each with one condition: Music (MUS) and No Music (No-MUS). The participants will be instructed to attend the laboratory to perform the screening test in different environmental conditions that do not impact on their health status.
During the MUS session, participants will perform a back squat test and a CJM test while listening to music. The chosen songs will be at least 120 beats per minute (BPM) 15. The tempo of the music for each of the tracks will be calculated using bpm software (Tangerine!v.1.4). The music will be played using an iPhone X (Apple Inc., Cupertino, CA, USA) connected to a portable speaker (Sony MHC-V02, Sony Co., Tokyo, Japan). The sound intensity will be adjusted and standardised for all participants to 75 dB (at ear level) using the Decibel X-dBA sound level meter. Trap and reggaeton music will be played before, during and after the test.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The investigators intend to conduct an experimental trial with a randomised crossover design in 12 participants physically active young women adults with strength training experience aged 18-30 years.
The study will be conducted in the laboratory of Physical Activity and Sport Sciences of the University School of Osuna.
In this way, at the end of the study will have contrasted scientific information on the effects of music on the following variables of speed of execution in the back squat exercise.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Milk Oral Immunotherapy in Children to Treat Food Allergy
Condition: Milk Hypersensitivity
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Background and Rationale

      For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management
      includes identification of the causative food and avoidance. Specifically, among young
      children, cow's milk allergy is the most common food allergy, occurring in as many as 2-3%.
      Given the prevalence of milk and the difficulty to avoid it in the diet, the investigators
      aim to investigate the safety and efficacy of oral immunotherapy for cow's milk allergy.

      Main Objective

      The primary objective is to study the efficacy of milk oral immunotherapy.

      Target Population

      Children aged six to 17 years with a history of cow's milk allergy will be recruited from The
      Children's Hospital of Philadelphia Allergy clinical offices for the investigators study.
    

Detailed description: 
      Primary Study Interventions

      Prior to and after the desensitization, we will conduct double-blind placebo controlled food
      challenges to cow's milk protein. During the desensitization phase, we will give increasing
      doses of cow's milk protein by mouth on a weekly basis, as tolerated. The desensitization
      protocol starts with dilutional doses of milk and build up to a goal of 8 ounces of cow's
      milk.

      Main Study Outcome Measure

      The percentage of children completing the desensitization protocol in each study group will
      be the primary outcome measure.
    

Intervention name(s): Milk Oral Immunotherapy; Milk Protein Powder; Food Challenge
Intervention type(s): Dietary Supplement; Drug; Other
Intervention description(s): Subjects will participate in a desensitization protocol over the course of 13 weeks to reach a goal maintenance dose of 8 ounces of cow's milk. Once reaching maintenance, subjects will continue on this dose for 12 additional weeks.; Milk protein powder will be administered in incremental doses during the desensitization protocol.
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Food hypersensitivity; Milk hypersensitivity; Milk allergy; Food allergy
Food Trial to Evaluate the Safety and Tolerability of SBD111 in Health Adults
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the trial is to determine if the synbiotic (prebiotic and probiotic), provided
      twice daily (capsule) is safe and tolerable in healthy adults.
    


Intervention name(s): Medical Food: SBD111; Placebo
Intervention type(s): Other; Other
Intervention description(s): One capsule administered twice daily with morning and evening meals for 28 days; One capsule administered twice daily with morning and evening meals for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Regional Distribution Differences Between Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Observational

Summary: 
      Neurally adjusted ventilatory assist (NAVA) is an FDA approved mode of mechanical
      ventilation. This mode of ventilation is currently in routine use in adult, pediatric and
      neonatal intensive care units. The electrical activity of the diaphragm, the largest muscle
      used during inspiration, is measured. The ventilator triggers (synchronizes patient effort)
      and applies proportional assistance based on measured electrical activity of the diaphragm
      (Edi). This electrical activity is measured through a feeding tube that also has a
      multiple-array esophageal electrode in it. This mode of ventilation has been proven to be
      equivalent to pressure support ventilation (PSV). Theoretically, the breath-to-breath control
      offered by NAVA may not only trigger faster and synchronize better, but provide the support
      deemed appropriate by the central nervous center on demand. Traditionally in the intensive
      care unit (ICU), pressure support is applied to subject breathing spontaneously. Pressure is
      set to achieve a given tidal volume. The influence of changing lung compliance not only from
      the lung disease itself, but the interactions of the respiratory muscles can drastically
      change minute ventilation and contribute to hyper- or hypoventilation. These changes are
      typically found on assessment of end-tidal carbon dioxide (CO2), blood gas, or oxygen
      saturation (SpO2) monitoring; all of which are potentially preventable if we allowed the
      central nervous system to control the ventilator. NAVA may allow us to couple the central
      nervous system (neuro-coupling) with the ventilator to provide real-time proportional
      assistance, reduce work of breathing and apply physiologic breathing patterns.
    


Intervention name(s): Neurally Adjusted Ventilatory Assist (NAVA)
Intervention type(s): Device
Intervention description(s): Subjects will be placed in the NAVA mode of ventilation.
Observational model: Cohort
Time perspective: Prospective
Keywords: NAVA; neurally adjusted ventilatory support; lung injury; ventilation; lung volume distribution; oxygen cost of breathing
A Study to Assess the Safety of HIV and Hep C Vaccine Candidates When Given Separately or in Combination
Condition: Hepatitis C Infection; HIV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is aimed at assessing the safety of candidate Hepatitis C vaccines
      AdCh3NSmut/MVA-NSmut and HIV vaccines ChAdV63.HIVconsv/MVA.HIVconsv when administered
      separately or in combination to healthy volunteers. The study also aims to assess the
      cellular immune response generated by these vaccines when administered as mentioned above.
    

Detailed description: 
      Hepatitis C and HIV are both widespread pathogens. By the end of 2010, there were 2.3 million
      people in Europe living with HIV, over half of whom were coinfected with the Hepatitis C
      virus (HCV). Although vaccination is the optimal method of preventing infection, it has
      proved extremely difficult to develop an effective vaccine against HIV and HCV due to the
      enormous variation in strains around the world. This is caused by the extraordinary ability
      of the viruses to change their genetic material.

      Researchers at the University of Oxford have developed novel candidate vaccines against HIV
      ('HIV.consv') and HCV ('NSmut'). These vaccines have been inserted into the carrier viruses
      Chimpanzee Adenovirus (ChAd or AdCh) and modified vaccinia virus Ankara (MVA), both of which
      have excellent safety records. The aim of this study is to test for the first time the
      response of the immune system when vaccines to both HIV and HCV are given together.

      During this study, 32 healthy adults aged 18 to 50 years will be recruited into one of three
      groups to receive either two or four intramuscular injections over a period of two months.
      All participants will be followed up for a further six months (12 visits in total).
    

Intervention name(s): AdCh3NSmut1; MVA-NSmut; ChAdV63.HIVconsv; MVA.HIVconsv
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Genetic vaccine against Hepatitis C virus infection; Genetic vaccine against Hepatitis C virus infection; Genetic vaccine against HIV-1 infection; Genetic vaccine against HIV-1 infection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Carbon Dioxide During Screening Unsedated Colonoscopy
Condition: Polyps
Study type: Interventional
Phase: Phase 4

Summary: 
      Colonoscopy is currently most effective procedure used for detecting colon cancer especially
      in the early stages. Screening colonoscopies are performed in the symptom-free patients at
      risk of familial colon cancer. During colonoscopy air commonly used to insufflate the bowel
      may be retained after the procedure causing pain and discomfort to the patients. One of the
      methods used to reduce pain and discomfort is insufflation of carbon dioxide (CO2) instead of
      air during colonoscopy.

      Aim of the study is evaluation of the use of carbon dioxide insufflation during colonoscopy.
    

Detailed description: 
      The study was conducted in 200 consecutive patients undergoing screening colonoscopies for
      the detection of early colon cancer. The examinations were performed with Olympus 165
      colonoscopes by seven experienced endoscopists, each of whom performed alone about over 2000
      colonoscopies. The patients were randomly assigned to Group I and II with either air or
      carbon dioxide insufflation. Both study groups were matched by sex, age, duration of the
      procedure, and BMI. The authors compared for the duration of the procedure, coecal intubation
      time, complication rate, pulse rates immediately after the procedure, 15 minutes after, and
      subjective pain evaluation on a Visual Analogue Scale.
    

Intervention name(s): Colonoscopy
Intervention type(s): Procedure
Intervention description(s): Screening colonoscopy
Other intervention name(s): Endoscopy; Flexible endoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: screening; colonoscopy; carbon dioxide; air; pain score; complications