bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of IBI303 in Adult Patients With Active Ankylosing Spondylitis
Condition: AS
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 3

Summary: 
      Study of the efficacy and safety of IBI303 compared with adalimumab in adult patients with
      ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to
      one or more nonsteroidal anti-inflammatory drugs (NSAIDs)
    

Detailed description: 
      Adults patients with active ankylosing spondylitis (AS) were randomized in a 1:1 ratio to
      receive treatment with adalimumab 40 mg every other week (eow) or IBI303, given
      subcutaneously (SC), in the 24-week double-blind (DB) phase. Randomized participants received
      one SC injection of the appropriate DB study medication (adalimumab 40 mg or IBI303) at Week
      0 and then eow until Week 22. A follow-up visit occurred 70 days(Week 32) after the last dose
      of study drug to obtain information on any ongoing or new adverse events (AEs).
    

Intervention name(s): IBI303; Adalimumab
Intervention type(s): Drug; Drug
Intervention description(s): 12 cycles. IBI303: 40 mg, iH; 12 cycles. Adalimumab: 40mg, iH
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ankylosing spondylitis, tumor necrosis factor-α inhibitors
Antibiotics for Children With Severe Diarrhoea
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Although the current World Health Organization (WHO) recommended management package for acute
      diarrhoea (ORS, zinc and feeding advice) has contributed to significant reductions in
      diarrhoea associated mortality, over half a million children continue to die annually as a
      result of acute diarrhoeal episodes. In addition, rates of mortality in young children in the
      90 days following an episode of acute diarrhoea appear at least as high as mortality that
      occurs during the acute episode. The long-term benefits of antibiotic administration may
      result from direct antimicrobial effects on pathogens or from other incompletely understood
      mechanisms including improved nutrition, alterations in immune tolerance or improved enteric
      function. Optimizing antibiotic treatment of acute diarrhoea episodes in very young children
      with severe disease may offer the opportunity to significantly reduce diarrhoea associated
      deaths in the 180 days following presentation for acute diarrhoea and may also improve
      growth.

      The investigators propose to evaluate the efficacy of an antibiotic (azithromycin) delivered
      in a specific, targeted fashion to young children (< 2 years of age) at high risk of
      diarrhoea associated mortality in a multi-site randomized, double-blind, placebo-controlled
      trial. The study will evaluate the ability of the intervention to reduce mortality within 180
      days of the acute diarrhoeal episode, and improve nutritional status over the first 90 days.
    


Intervention name(s): Azithromycin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive rehydration, dietary counseling, one 20 mg tablet of zinc per day and 10 mg (0.35 ml) / kg of azithromycin syrup per day, for three days; Participants will receive rehydration, dietary counseling, one 20 mg tablet of zinc per day and 0.25 ml / kg of placebo drug syrup per day, for three days
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mortality; Infant; Antibiotics; Linear Growth
Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes
Condition: Spinal Cord Injuries; Autonomic Imbalance; Autonomic Dysreflexia; Orthostatic; Hypotension, Neurogenic
MeSH terms: Spinal Cord Injuries; Autonomic Dysreflexia; Hypotension, Orthostatic; Hypotension
Study type: Interventional

Summary: 
      This study looks to characterize autonomic nervous system dysfunction after spinal cord
      injury and identify the potential role that transcutaneous spinal cord stimulation may play
      at altering neuroregulation. The autonomic nervous system plays key parts in regulation of
      blood pressure, skin blood flow, and bladder health- all issues that individuals with spinal
      cord injury typically encounter complications. For both individuals with spinal cord injury
      and uninjured controls, experiments will utilize multiple parallel recordings to identify how
      the autonomic nervous system is able to inhibit and activate sympathetic signals. The
      investigators anticipate that those with autonomic dysfunction after spinal cord injury will
      exhibit abnormalities in these precise metrics. In both study populations, transcutaneous
      spinal cord stimulation will be added, testing previously advocated parameters to alter
      autonomic neuroregulation. In accomplishing this, the investigators hope to give important
      insights to how the autonomic nervous system works after spinal cord injury and if it's
      function can be improved utilizing neuromodulation.
    


Intervention name(s): Tests of sympathetic inhibition; Tests of sympathetic activation; Testing of autonomic dysreflexia; Transcutaneous spinal cord stimulation
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Device
Intervention description(s): Bolus phenylephrine infusion using the Oxford technique will generate the need to inhibit sympathetic activity. Similarly, resting state Mayer waves will be assessed with regard to heart rate and blood pressure responses.; Cold pressor test of the hand will be used to cause sympathetic activation. Valsalva's maneuver will assess the ability to buffer against blood pressure fall (phase II).; Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.; Transcutaneous spinal cord stimulation will be applied at T7-L1 spinal segments to assess alterations in autonomic neuroregulation.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
SLEEP AND OSA ON REPRODUCTIVE FUNCTION IN MEN
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      In view of the hormonal changes induced by both sleep deprivation and obstructive sleep apnea
      syndrome (OSA), and the importance of maintaining these hormones in reproductive processes.
      The present study aims to evaluate the effects of the OSA or sleep deprivation (total or
      selective REM sleep for 48h) on reproductive function in adult men with normal body mass
      index.
    

Detailed description: 
      In this study will be recruited volunteers 25-50 years of age with a body mass index (BMI)
      20-25 kg/m2 (normal) that after performing polysomnography, will be distributed in the
      following groups: healthy or diagnosed with obstructive sleep apnea syndrome (OSA).
      Volunteers without OSA will be submitted to total sleep deprivation (SD) or selective REM
      sleep deprivation for 48 hours. After SD, these volunteers will be allowed to sleep for 48
      hours (period rebound). Blood samples will be taken for hormonal analysis (testosterone,
      luteinizing hormone, follicle-stimulating hormone, progesterone and cortisol)and gene
      expression. The semen collection for evaluation of sperm count (concentration, viability and
      sperm morphology) in three different periods, baseline collection, after SD protocols and the
      end of rebound period. Individuals diagnosed with OSA also have three collections of blood
      and semen samples for analyzes.
    

Intervention name(s): Sleep deprivation
Intervention type(s): Behavioral
Intervention description(s): Volunteers will be submitted to total sleep deprivation (SD) or selective REM sleep deprivation for 48 hours. After SD, these volunteers will be allowed to sleep for 48 hours (period rebound).
Other intervention name(s): Total sleep deprivation; REM sleep deprivation
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Inclusion Criteria:

          -  men

          -  There is no discrimination of economic class

          -  Age between 25 and 50

          -  BMI 30 kg/m2

          -  No prior neurological, psychiatric or use of psychotropic medication

          -  OSA (moderate and severe apnea hypopnea index > 15)

        Exclusion Criteria:

          -  smokers

          -  addiction

          -  Individuals with another sleep disorder
      
Keywords: sleep; obstructive sleep apnea; reproduction; sperm; hormones; men
Towards HIV Functional Cure
Condition: Chronic HIV-1 Infection
MeSH terms: Infections
Study type: Interventional

Summary: 
      During the ERAMUNE-01 and -02 studies, the HIV-DNA quantification in the PBMCs (Peripheral
      Blood Mononuclear Cells) showed showed that some patients had a very low or undetectable
      reservoir.

      Recent studies showed that a low reservoir is associated to a spontaneous virologic control
      in three specific categories of patients:

        -  "Elite Controllers": these rare patients are able to spontaneously maintain an HIV-RNA
           viral load below 50 copies/mL and elevated CD4 counts without any treatment. These
           patients belong to the B27/B57 haplotypes associated to a reduced risk of HIV
           contamination but these haplotypes are very rare in the global population (0,3 %)

        -  "Visconti" patients: early-treated patients, during the primo-infection stage. After 3
           to 5 years of treatment, these patients are able to maintain an undetectable HIV-RNA
           viral load.

        -  "Salto" patients: these patients are treated a bit later compared to the Visconti
           cohort, when their CD4 count was above 350 cells/mm3 and their HIV-RNA viral load below
           50 000 copies/mL. The follow-up of these patients showed the same capacity of control of
           the HIV infection for at least 2 years following treatment interruption.

      Taking into account these 3 categories of patients which common characteristics is a low
      reservoir, our objective is to answer the 2 following questions:

        1. Is it possible to discontinue the treatment in chronically-infected patients with a
           "normal" immune system and with an undetectable HIV-DNA reservoir?

        2. Is a low viral reservoir predictive of a treatment-free remission of the HIV infection
           in chronically-infected patients?

      The main objective of the proof-of-concept ERAMUNE-03 trial is to evaluate the proportion of
      patients in success (i.e. able to maintain a virologic and an immunologic control of the
      infection) after treatment discontinuation, failure is defined as:

        -  An HIV-RNA viral load > 400 copies/mL on 2 consecutive tests starting from Week 4

        -  Or CD4 count < 400 cells/mm3 on 2 consecutive measures starting from Week 4

        -  Or the onset of an AIDS-related event
    


Intervention name(s): Antiretroviral treatment interruption
Intervention type(s): Other
Intervention description(s): pilot study in chronically HIV-infected patients with an ultralow HIV reservoir undergoing treatment-interruption.
Intervention MeSH terms: Anti-Retroviral Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: HIV-1; chronic infection; cure; remission
Daily-life Brain Control Of A Hand Exoskeleton After Cervical Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, 6 volunteer participants with chronic spinal cord injury will be invited to
      use an autonomous hand exoskeleton device controlled by a brain/neural-computer interaction
      (BNCI) system fusing electroencephalography (EEG) and electrooculography (EOG) to detect the
      intention of the user to grasp objects of daily life. The BNCI system consists of a
      lightweight hand exoskeleton connected to portable motors, rechargeable batteries and a
      computerized control system integrated into a wheelchair. Before, during and after use of the
      BNCI system the volunteers will perform standardized assessments and complete questionnaires
      to assess the functional and psychological effects of the exoskeleton. Functional outcomes
      primarily focus on motor function in performing daily life actions while psychological
      outcomes primarily focus on safety, reliability as well as predisposition and perceptions of
      disability.
    


Intervention name(s): BNCI controlled hand exoskeleton
Intervention type(s): Device
Intervention description(s): The BNCI system fuses and translates bio-signals related to user intention into control signals of an assistive device performing grasping motions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to investigate the safety, tolerability, and pharmacokinetics
      of MT-2990 in patients with Japanese cedar pollen-induced seasonal allergic rhinitis
      (JC-SAR). Additional objective of the study is to investigate the efficacy and
      pharmacodynamics profile of MT-2990 in an environmental exposure chamber (EEC) on Day 8, 29,
      57, and 85.
    


Intervention name(s): MT-2990; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MT-2990 solution for injection in vial; Placebo solution for injection in vial
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity in the Offspring
Condition: Food Allergy
MeSH terms: Overweight; Food Hypersensitivity
Study type: Interventional

Summary: 
      The first 1,000 days of life, from the conception to 24 months, are crucial to achieve
      long-term health outcomes and represent a strategic period to intervene under prevention and
      public health perspective. Nutritional exposures during this critical period of life can
      influence the future disease susceptibility. Maternal diet during pregnancy has been linked
      to offspring overweight/obesity risk and it could represent a potential target for
      overweight/obesity prevention. The Mediterranean Diet (MD) is considered one of the
      healthiest dietary models, which impacts beneficially the gut microbiome (GM), providing high
      amounts of fiber, antioxidants polyphenols and vitamins, and a balanced ratio of essential
      fatty acids (ω6:ω3). Notably, the MD beneficial effects are due to the synergistic and
      interactive combinations of nutrients, and the modulation of gene expression through
      epigenetic changes. Unofrtunately, the MD mechanisms during pregnancy in the prevention of
      childhood overweight/obesity are not yet fully known.
    

Detailed description: 
      The PREMEDI study has been designed to evaluate the effects of Mediterranean Diet during
      pregnancy on the occurrence of overweight/obesity at 24 months in the offspring.
    

Intervention name(s): mediterranean diet
Intervention type(s): Behavioral
Intervention description(s): The Mediterranean diet (MD) is highly regarded as a healthy balanced diet. It is distinguished by a beneficial fatty acid profile that is rich in both monounsaturated and polyunsaturated fatty acids, high levels of polyphenols and other antioxidants, high intake of fiber and other low glycemic carbohydrates, and relatively greater vegetable than animal protein intake. Specifically, olive oil, assorted fruits, vegetables, cereals, legumes, and nuts; moderate consumption of fish, poultry, and red wine; and a lower intake of dairy products, red meat, processed meat and sweets characterize the traditional MD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Alpha-GPC and Physical and Cognitive Performances in Volleyball Players.
Condition: Athletic Performance
Study type: Interventional

Summary: 
      In order to attain the elite level on the national scene, volleyball players need several
      attributes. In addition to mastering technical and tactical skills, great jumping ability is
      another important asset. Maximal power output needed to achieve height during a jump
      necessitates coordinated neuromuscular recruitment and muscle mass among others.
      Interestingly, there are claims that alpha-glycerylphosphorylcholine (A-GPC) increases
      acetylcholine synthesis and enhances exercise-induced increases in plasma growth hormone
      concentrations, two factors that could theoretically be associated neuromuscular transmission
      and muscle mass.

      However, until now only a few studies have investigated the role of A-GPC in human exercise
      performance. Published results were mixed. One recent study showed that isometric peak force
      was slightly but significantly increased when subjects had ingested a daily dose of 600 mg of
      A-GPC over a period of 6 days (Bellar et al., JISSN, 2015).

      The objective of our study is to evaluate the longer-term effects (4 weeks) using a higher
      dose (1000 mg/day) of A-GPC on jumping capabilities in elite male and female volleyball
      players.
    

Detailed description: 
      Our study design will be a placebo controlled, randomized, double-blind, crossover study.
      Varsity male and female volleyball players (n=28) will each be asked to participate in both
      arms of the study, i.e. placebo and A-GPC (1000 mg/kg/day). The duration of each arm of the
      study will be 4 weeks separated by a 7-day washout period. The order of treatment (placebo or
      A-GPC) will be determined randomly. Athletes will be asked to maintain their training load
      during the duration of the experiment.
    

Intervention name(s): Placebo; Experimental
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Monitoring of supplementation (e.g., compliance, subject blindness), diet (to control dietary choline ingestion), training volume and adverse effects will be performed on a weekly basis to ensure maximal control of confounding factors as well as the safety of volunteers during the study.; Monitoring of supplementation (e.g., compliance, subject blindness), diet (to control dietary choline ingestion), training volume and adverse effects will be performed on a weekly basis to ensure maximal control of confounding factors as well as the safety of volunteers during the study.
Other intervention name(s): Maltodextrin; Control; Alpha-gpc; Alpha-glycerylphosphorylcholine; Alpha-gpc supplementation; A-GPC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Alpha-GPC; Volleyball; Athletes; Executive functions; Vertical jump; Peak power
Effect of Pumpkin Seeds Phonophoresis on Chronic Non-bacterial Prostatitis
Condition: Chronic Non-bacterial Prostatitis
MeSH terms: Prostatitis
Study type: Interventional

Summary: 
      It has been observed that out of all visits to the clinics by the young and middle age men
      for grievances including the genital and urinary frameworks, about 25% of the visits account
      for Prostatitis. A significant number of men, aged less than 50, visits to urologist due to
      Interminable prostatitis. Nevertheless, just 5 to10% of "prostatitis" cases is really caused
      by a bacterial contamination.

      The purpose was to investigate thoroughly the effect of pumpkin seeds oil phonophoresis among
      males who are diagnosed with chronic non-bacterial prostatitis.
    

Detailed description: 
      sixty male outpatients diagnosed with chronic non-bacterial prostatitis. Through sample
      random sampling procedure the total study population was categorized into three treatment
      groups; Group A, wherein patients received phonophoresis treatment using pumpkin seeds oil;
      Group B, where members of the group received trans-perineal continuous low-intensity
      ultrasound; and Group C, in which the participant received placebo low- intensity ultrasound.
      All of The three groups of the organized trail received their corresponding treatment daily
      up-to 3 weeks.

      For the analysis participants were recruited from a registry of patients with a diagnosis of
      CNBP. To be included in the analysis a patient must be evaluated with a confirmed diagnosis.
      They were examined and diagnosed accordingly by a medical practitioner/urologist.

      Patients with concomitant infection, autoimmune diseases, diabetes mellitus, cancer, heart
      problems/pacemaker, implants (metal, silicone, saline), acute and post-acute injury,
      thrombophlebitis, impaired sensation, psychiatric diseases, and those with well-known
      contraindications of ultrasound treatment were excluded from the study. Similarly, those with
      known hypersensitivity to pumpkin seeds oil and its derivatives, along with those who had
      received other forms of therapies that could influence the therapeutic outcomes of the study
      were excluded from the study sample.
    

Intervention name(s): phonophoresis treatment using pumpkin seeds oil
Intervention type(s): Other
Intervention description(s): phonophoresis treatment using pumpkin seeds oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Patient Satisfaction Study: Clean Intermittent Self-Catheterization Teaching
Condition: Anxiety
Study type: Interventional

Summary: 
      To compare patient satisfaction and anxiety scores between female subjects undergoing urinary
      incontinence and/or pelvic reconstructive surgery who are instructed preoperatively in the
      technique of clean intermittent self-catheterization (CISC) by means of an instructional
      video and those who do not receive specific preoperative instruction in CISC, other than
      basic informed consent regarding risks of postoperative urinary retention.
    


Intervention name(s): Educational video
Intervention type(s): Other
Intervention description(s): Watching an educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Anxiety; Satisfaction; Incomplete bladder emptying; Clean Intermittent Self-catheterization; Prolapse/incontinence surgery