bioihbjkbjnl/mcl2 huggingface dataset:
Different PEEP Settings of COVID-19 Induced ARDS
Condition: COVID-19; Mechanical Ventilation Pressure High; Acute Respiratory Distress Syndrome
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Interventional

Summary: 
      This was a multi-center prospective study. All consecutive severe cases of COVID-19 whose
      PO2/FiO2<300mmHg with invasive ventilation admitted to 5 fixed-point receive COVID-19
      patients hospitals in Wuhan from 5 March to 15 March 2020 were included. Epidemiological,
      clinical data, lung mechanics, artery blood gas test and hemodynamics at three methods to
      titrate PEEP, optimizing oxygenation, optimizing compliance, ARDSnet. The study was approved
      by the Ethics Committee of Zhongda Hsopital, Southeast University.
    

Detailed description: 
      After PEEP titration, PEEP settings could be set by optimizing oxygenation, optimizing
      compliance, ARDSnet.
    

Intervention name(s): Gas exchanges at different PEEP; lung mechanics at different PEEP; Hemodynamics changes at different PEEP
Intervention type(s): Other; Other; Other
Intervention description(s): Gas exchanges measurement at different PEEP; lung mechanics measurement at different PEEP; Hemodynamics changes measurement at different PEEP
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ARDS; COVID-19; mechanical ventilation; PEEP
A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study is to establish interferon-beta-1a as the treatment of
      choice for chronic Hepatitis C with better efficacy and safety profiles in monotherapy or
      combination therapy.

      This will be a multicenter, randomized, double-blind, placebo-controlled study with a placebo
      to be crossed-over to a combination of interferon-beta-1a and ribavirin or no treatment
      during an open-label extension phase. The duration of the trial will be 48 weeks, with a
      double-blind period of 12 weeks.

      The study will recruit 257 eligible subjects of either sex. It will be conducted by
      approximately 16 Investigators / investigational centers in 3 countries (China, Hong Kong and
      Singapore).
    


Intervention name(s): Interferon-beta-1a; Placebo; Ribavirin plus Interferon-beta-1a
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Interferon-beta-1a will be administered subcutaneously at a dose of 44 microgram (mcg), three times a week up to Week 24; Matching placebo will be administered subcutaneously three times a week for 12 weeks. The placebo responders will continue the study off-treatment after Week 12 up to Week 24; Placebo non-responders at Week 12 will receive ribavirin at a dose of 1000 milligram (mg) or 1200 mg orally once daily in combination with Interferon-beta-1a, administered subcutaneously at a dose of 44 mcg three times a week, from Week 16 up to Week 24
Intervention MeSH terms: Interferons; Ribavirin; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Subjects with chronic hepatitis C who have never previously received interferon therapy.
Study Assessing an Insulin Pump-controlling Algorithm to Minimize Hypo and Hyper in Type 1 During CRC Setting
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Feasibility study assessing the ability of an insulin pump-controlling algorithm to minimize
      hypoglycemia and hyperglycemia in patients with type 1 diabetes in a clinical research
      setting.
    

Detailed description: 
      This study is a non-randomized, uncontrolled feasibility study that looks to enroll people
      with type 1 diabetes who are currently using an insulin pump. During the subject's
      participation, the study staff will closely monitor the study subject in a clinical research
      center environment for approximately 30 hours, while controller algorithm determined insulin
      doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
    

Intervention name(s): Hypo-Hyper Minimizer (HHM) System
Intervention type(s): Device
Intervention description(s): Adjustment of Insulin dosing during meal time
Other intervention name(s): Insulin delivery
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes Mellitus; Artificial Pancreas
The Effects of Compensatory Auditory Stimulation and Transcranial Direct Current Stimulation on Tinnitus Perception
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      This study evaluates the ability of compensatory auditory stimulation (CAS) and transcranial
      direct current stimulation (tDCS) to help alleviate tinnitus. Subjects will receive CAS,
      tDCS, and the combination of the two to assess the effectiveness of the treatment.
    

Detailed description: 
      Tinnitus refers to persistent "ringing in the ears" in absence of external sound. For some
      individuals tinnitus can be disabling. Most tinnitus is of idiopathic origin and currently
      there are no reliable treatment options available. Existing approaches, such as hearing aids,
      counseling, and noise masking typically provide only partial relief and only for a minority
      of patients. Newer exploratory methods include tailored auditory stimulation and various
      brain stimulation techniques. While these techniques show great promise in a subset of
      subjects (maybe about 1/3), it is hard to anticipate which, if any, will benefit a given
      patient.

      Transcranial Direct Current Stimulation (tDCS) has been explored for a number of neurological
      conditions, and it is most effective when paired with some form of training (e.g. motor rehab
      after stroke). For tinnitus however this treatment modality has only been tested in
      isolation. The purpose of this pilot study is to explore the benefits of combining tailored
      compensatory auditory stimulation with tDCS.

      There is widespread consensus in the research community that tinnitus originates with some
      peripheral hearing deficit, and that maladaptive central plastic mechanisms subsequently lead
      to the tinnitus percept. Most individuals with tinnitus have audiometric evidence of hearing
      loss. Our hypothesis is that reduced input to the auditory pathway leads to increased
      sensitivity (auditory gain) and finally aberrant activity in the frequency band with hearing
      loss. In this view, auditory stimulation that compensates for the reduced input can
      potentially revert the maladaptive plasticity.This is consistent with the reported benefits
      of hearing aids and tailored auditory stimulation. Our hypothesis is that tDCS can boost
      adaptation induced by compensatory auditory stimulation to reduce the strength of the phantom
      percept.
    

Intervention name(s): Compensatory auditory stimulation; transcranial direct current stimulation; Combined CAS and tDCS; Sham stimulation
Intervention type(s): Other; Device; Other; Other
Intervention description(s): Compensating for peripheral hearing loss by adjusting sound levels based on individual audiogram.; Low-current electrical brain stimulation; Combined auditory and electrical stimulation; Sham stimulation
Other intervention name(s): CAS; tDCS; CAS + tDCS; Sham
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Implementation of a Cardiometabolic Disease Staging System in Primary Care
Condition: Diabetes; Obesity; Overweight
MeSH terms: Obesity; Overweight
Study type: Observational

Summary: 
      The aim of this study is to develop a clinical decision support system (CDSS) that
      incorporates obesity management guidelines and treatment options for use by physicians and,
      potentially, patients based on a cardiometabolic disease staging system. This CDSS will be
      designed using primary care provider input through a qualitative approach to explore
      physician preferences for the appearance, electronic location, treatment options, referrals,
      accessibility and other user requirements of the CDSS.
    

Detailed description: 
      To provide appropriate medical management of obesity and facilitate the diabetes risk
      assessments of people with excess adiposity, a comprehensive staging system that establishes
      five stages of cardiometabolic disease risk-the cardiometabolic disease staging system (CMDS)
      has been developed. This staging is based on Adult Treatment Panel III metabolic syndrome
      risk factors to guide decision making for selection of treatment modality and intensity in
      the management of obesity. Hence, the study hypothesis is that providing CMDS to PCPs through
      a CDSS for medical management of obesity can aid in reducing the barriers of obesity and
      diabetes treatment at the PCP-level and improve the quality of obesity and diabetes care. In
      this pilot and feasibility study, investigators will implement an early-phase CDSS in a
      pragmatic PCP setting to assess the uptake and acceptability of CDSS delivered to PCPs
      implementing CMDS at the point of care, and collect pilot data to assess change in patient
      engagement and satisfaction.

      Investigators will conduct initial focus groups with PCPs and a series of iterative design
      steps targeting PCP and patient needs. These qualitative interviews would be used to
      determine the initial set of requirements and prototypes of the user interfaces and
      notifications.
    

Intervention name(s): Clinical decision support system
Intervention type(s): Other
Intervention description(s): To develop a clinical decision support system based on a published cardiometabolic disease staging system.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care physicians employed at the University of Alabama at Birmingham within the
        Primary Care or Family Medicine departments
A Study to Assess the Safety and Efficacy of a Microneedle Device for Local Anesthesia
Condition: Local Anesthesia; Intradermal Injections
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the MicronJet microneedle device is
      effective for inducing rapid and painless local anesthesia prior to insertions of intravenous
      catheters.
    

Detailed description: 
      Local anesthesia is routinely administered to reduce patient discomfort and improve the
      outcome of a wide variety of painful medical procedures. However, injection of a local
      anesthetic agent into the skin using a regular needle is in itself painful. Therefore, common
      procedures involving needle pricks (e.g. venipuncture) which may be quite painful are usually
      performed without local anesthesia.

      NanoPass has developed a microneedle injection device (MicronJet) which enables painless
      delivery of drugs directly into the superficial layers of the skin.

      The objective of the study is to assess the safety and efficacy of this device for
      intradermal injection of a local anesthetic agent before insertion of an intravenous catheter
      to healthy adults.

      Each subject will receive an injection of a local anesthetic to one arm, and a control
      placebo injection of physiological water to the other arm. Both injections will be
      administered intradermally using the MicronJet. Following the injections, an intravenous
      catheter will be inserted into the injection site in each arm, and the subject will rate the
      pain caused by the insertion. Safety parameters will be recorded throughout the study.
    

Intervention name(s): MicronJet
Intervention type(s): Device
Intervention description(s): The MicronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the layers of the skin). In this study the MicronJet will be used to inject Lidocaine or Saline.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: microneedles; microneedle; intradermal
Effects of Physical Exercise on Postmenopausal Risk Factors in Women With Osteopenia
Condition: Osteopenia, Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      Menopause usually have a serious impact on a woman's life, associated with negative
      consequences for health and quality of life. Early preventive assessments are very difficult
      to implement due to the complex hormone-deficiency-induced effects on a large variety of
      organs and systems with estrogen receptors. In fact, only a few types of interventions have
      the potential to comprehensively improve the various risk factors and complaints of the
      menopausal transition. In detail, however, not every form of exercise training or every
      training protocol is effective for exerting positive effects on selected risk factors. In
      particular, the training concept for addressing musculoskeletal or cardio-metabolic risk
      factors differ fundamentally.

      In several studies, we confirmed the effect of different complex training programs on risk
      factors of different postmenopausal female cohorts with special consideration of osteoporotic
      aspects. The training programs applied in this context were characterized by the consistent
      implementation of recognized training principles and an in general exercise
      intensity-oriented approach. Recent studies confirmed the effectiveness of this proceeding
      for women with relevant postmenopausal risk factors including low bone strength. However, the
      crucial issue of the most effective, feasible and easily customizable training protocol for
      addressing postmenopausal risk factors remains to be answered, taking into account that the
      majority of exercise programs were realized in an ambulatory group setting.

      The aim of the study will be to evaluate the effects of an optimized physical training on
      risk factors and complaints of (early) postmenopausal women with special consideration of the
      osseous fracture risk.

      Note (05.06.2020): Of importance, the intervention has to be cancelled due to COVID-19
      lockdown in March 2020 after 13 months of intervention.
    


Intervention name(s): High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT); Wellness
Intervention type(s): Other; Other
Intervention description(s): Ambulatory, consistently supervised group exercise training (3 training sessions of 40-45 min/week each). 10-12-week blocks of non-linearly periodized high intensity resistance and high impact aerobic dance exercises (HIT-setting) intermitted by 4-6-week periods of endurance-type exercise with high volume and lower intensity. Indi-vidualized training schedules for the RT-section.; control group: 3x 10 week blocks, 1 training session/week à 45 min; stretching, light functional gymnastics, yoga with less strengthening techniques over 13 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to assess the clinical efficacy of the modified extract
      (depigmented and polymerized with glutaraldehyde) of the subcutaneous injection of Parietaria
      Judaica pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis
      ( with or without episodic asthma) induced by hypersensitivity to grass pollen, evaluating
      the score regarding symptoms and consumption of the medication.
    

Detailed description: 
      Immunotherapy is a specific treatment for allergic diseases. Unlike conventional
      pharmacological treatment, immunotherapy is the only treatment that could modify the natural
      course of allergic disease. This is a prospective double-blind placebo controlled study with
      two arms of treatment: placebo and active.
    

Intervention name(s): Depigoid Parietaria judaica 1000DPP/ml; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Subcutaneous monthly treatment; Subcutaneous monthly treatment
Other intervention name(s): A suspension of depigmented and glutaraldehyde-polymerised allergen extract of Parietaria judaica adsorbed onto aluminium hydroxide.
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: allergic, rhinoconjunctivitis, Immunotherapy
Red Palm Olein on Inflammation and Gut Health
Condition: Diet; Healthy
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      A parallel intervention was conducted to test the effect of consuming diets enriched with red
      palm olein (RPOO), extra virgin coconut oil (EVCO) and extra virgin olive oil (EVOO; positive
      control) in centrally obese individuals over a 12-week period. Following the screening of the
      subjects' health status, including their biochemical and lipid profiles, the subjects
      completed a 12-week dietary intervention. Both fasting blood and urine samples were collected
      at baseline (day 0) and endpoint (week 12); measurements were taken in duplicates. All data
      collected were blinded to the investigators by an independent third party until the
      completion of the analysis.
    

Detailed description: 
      The study was conducted according to the guidelines laid down in the Declaration of Helsinki.
      All subjects gave informed consent prior to the commencement of the study. A parallel
      intervention was conducted to test the effect of consuming diets enriched with red palm olein
      (RPOO), extra virgin coconut oil (EVCO) and extra virgin olive oil (EVOO; positive control)
      in centrally obese individuals over a 12-week period. Following the screening of the
      subjects' health status, including their biochemical and lipid profiles, the subjects
      completed a 12-week dietary intervention. Both fasting blood and urine samples were collected
      at baseline (day 0) and endpoint (week 12); measurements were taken in duplicates. All data
      collected were blinded to the investigators by an independent third party until the
      completion of the analysis. The efficacy of the blinding procedure was assessed by evaluating
      the compliance of participants using the visual analogue scale to the experimental diets.
      Statistical analysis was conducted independently by a statistician not involved in the
      conduct of the study.
    

Intervention name(s): A 12-week parallel dietary intervention
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects consumed 3 isocaloric meals prepared with the 3 oils for a duration of 12 weeks. The test meals were given for 5-day a week and contained 27-30% energy fat, with 2/3 (20% energy fat) replaced by experimental fat.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: We recruited a total of 156 overweight individuals, aged 25-45 years, with waist circumference ≥ 90 cm for men and ≥ 80 cm for women in a single-blind 3-arm randomised controlled trial. The participants consumed isocaloric diets (~ 2400 kcal) enriched with red palm olein (RPOO), extra virgin coconut oil (EVCO) and extra virgin olive oil (EVOO, as a control) for a 12-week duration
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: red palm olein; extra virgin coconut oil; extra virgin olive oil; high sensitivity C-reactive protein; inflammation; obesity
Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of
      MSB11455 and Neulasta in healthy adult subjects.
    


Intervention name(s): MSB11455; Neulasta
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1.; Subjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1.
Other intervention name(s): pegfilgrastim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: MSB11455; Healthy subjects
A Study to Assess the Pharmacokinetics (Uptake of Drugs by the Body), Safety and Tolerability of AZD4831 in Participants With Severe Renal Impairment and Healthy Volunteers
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to compare AZD4831 pharmacokinetic (PK) parameters between participants with
      severe renal impairment and matched healthy volunteers following a single dose
      administration.
    

Detailed description: 
      All participants will receive a single oral dose of AZD4831 under fasted conditions and will
      be involved in the study approximately 2 weeks after dosing and up to approximately 38 days
      from screening.

      Approximately 10 participants will be enrolled into each of the 2 cohorts parallelly and
      receive the study intervention to achieve 8 evaluable participants in each cohort.

        -  Cohort 1: 10 participants with severe renal impairment (Estimated glomerular filtration
           rate [eGFR] of ≥15 to <30 mL/min/1.73m^2)

        -  Cohort 2: 10 matched healthy volunteers with normal renal function (eGFR of ≥90
           mL/min/1.73m^2).

      The study will comprise of the following study periods:

        -  Screening period (21 days): participants will be screened for eligibility.

        -  Treatment period (3 days): participants will be admitted to the study centre in the
           evening of (Day -1) the day before administration of a single oral dose of AZD4831 (Day
           1), and will be discharged after at least 24 h post-dose (Day 2).

        -  Follow-up period (13±2 days): participants will attend 5 visits at the study centre for
           PK sampling and safety assessments on Days 3, 5, 8, 11 and 15.
    

Intervention name(s): AZD4831
Intervention type(s): Drug
Intervention description(s): Participants will receive a single dose of AZD4831 administered with 240 mL of water after an overnight fast of at least 10 hours.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AZD4831; Pharmacokinetics; Estimated glomerular filtration rate