bioihbjkbjnl/mcl2 huggingface dataset:
The Treatment Effect of Bio-Three on Children With Enteritis
Condition: Gastroenteritis; Diarrhea
MeSH terms: Gastroenteritis; Enteritis; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      Diarrhea due to acute enteritis is a common symptom in the children. Lots of patients are
      infected by rotavirus or salmonella.

      Base on the past researches, there is benefit effect of probiotics on patients with diarrhea
      or acute enteritis. In this clinical study, bio-Three, a probiotic which contains three
      independent probiotics, will be used in patients with acute diarrhea.

      This is a single site, controlled clinical research. About 80 patients will be enrolled into
      this study to evaluate the benefit effect of bio-Three among patients with acute enteritis
      due to rotavirus or salmonella or other unknown reason. Patients will be diagnosed and
      screened by inclusion and exclusion criteria and only eligible patients will be enrolled into
      this study.
    

Detailed description: 
      Intervention: Subjects were randomly assigned to receive control treatment (intravenous
      fluid, oral rice and half strength milk formula) or add-on treatment of the probiotics
      (Bio-three®) to the control treatment.

      Main outcome measures: Quantitative Vesikari scales and qualitative severe diarrhea (Vesikari
      scale≥11) Exclusion criteria included immunodeficiency, severe abdominal distension with risk
      of bowel perforation, severe infection or sepsis, history of gastrointestinal tract surgery,
      and probiotics use in the preceding 1 week.
    

Intervention name(s): Bio-three
Intervention type(s): Drug
Intervention description(s): oral Bio-three three times daily for 7 days, Bio-three dosage plan: 1) patients aged 6 years old, 1 tablet t.i.d.; 2) patients aged between 6 and 12 years old, 2 tablets t.i.d.; 3) patients aged 12 years old, 3 tablets t.i.d.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: probiotics; pediatric; salmonella; rotavirus; gastroenteritis
First-in-human Study of Safety, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-089 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety,
      pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of
      the novel monoclonal antibody against the interleukin-6 receptor - BCD-089. The study will
      enroll 19 healthy male volunteers.
    

Detailed description: 
      IL-6 is a new potential therapeutic target which plays important role in pathogenesis of
      several autoimmune disorders including rheumatoid arthritis. BCD-089 is a novel fully human
      monoclonal antibody against the interleukin-6 receptor developed by JCS BIOCAD (Russia) which
      is now on the first step of clinical evaluation. BCD-089-1 study is the first-in-human
      clinical trial which is intended to evaluate tolerability, safety, pharmacokinetics,
      pharmacodynamics and immunogenicity of BCD-089 when used as a single step-by-step escalating
      subcutaneous dose in healthy male volunteers. During this study it is expected to determine
      diapason of safety doses of BCD-089 (incl. MTD) which thereafter can be evaluated in phase 2
      studies.
    

Intervention name(s): BCD-089
Intervention type(s): Biological
Other intervention name(s): human monoclonal antibody to interleukin-6 receptor
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
G-Wound (VZ for Wound Treatment)
Condition: Wounds; Wound Heal
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      This is a prospective, randomized, open-label, controlled, exploratory trial that aims to
      investigate the local skin tolerability of topically administered VZ and to evaluate efficacy
      and safety parameters associated with improved wound condition and healing
    


Intervention name(s): VZ powder (purified clinoptilolite); Standard of care (SoC)
Intervention type(s): Device; Procedure
Intervention description(s): VZ powder will be applied topically to the open surface of the verum treatment-assigned wound to cover the entire wound area. Following each VZ application, wounds will be protected by wound dressing (non-adhesive wound dressing (AdapticTM) and conventional protective Mepore® dressing).; wound cleansing (0.9% saline solution) and wound dressing (non-adhesive wound dressing (AdapticTM) and conventional protective Mepore® dressing) will be applied to the SoC-assigned wound.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wound; Healing
Primary Tube Versus Trabeculectomy Study
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the
      long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with
      mitomycin C in eyes that have not had previous ocular surgery.
    


Intervention name(s): Tube shunt surgery; Trabeculectomy; Mitomycin C
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.; The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.; A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
Other intervention name(s): Baerveldt glaucoma implant
Intervention MeSH terms: Mitomycins; Mitomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tube shunt surgery; Trabeculectomy
Re-challenge of Anti-EGFR for Patients With RAS/BRAF Wild-type Metastatic CRC
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the trial is to study the efficacy and safety of Cetuximab re-challenge for
      Chinese Patients with RAS/BRAF wild-type Metastatic Colorectal Cancer.
    

Detailed description: 
      After first-line treatment of FOLFOX/FOLFIRI/FOLFOXIRI plus Cetuximab failure and defined as
      RAS/BRAF wild-type by molecular detection of cycle tumor DNA, the patients will be treated
      with Cetuximab and Irinotecan as a second-line or third-line treatment.
    

Intervention name(s): C225+CPT-11
Intervention type(s): Drug
Intervention description(s): Patients will receive Systemic C225+CPT-11 every 14 days:
C225 500 mg/m2 IV over 90 minutes on Day 1; Irinotecan 180 mg/m2 IV on Day 1
Intervention MeSH terms: Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Weight Loss on Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis; Weight Loss
Study type: Interventional

Summary: 
      Controlled data show that obesity is a risk factor for psoriasis and that psoriasis severity
      is correlated with the degree of overweight. No controlled interventional studies reporting
      on the effect of weight loss on psoriatic skin manifestations have been published and data
      from case reports are conflicting.

      Patients with psoriasis demonstrate an increased susceptibility to atherosclerotic
      comorbidities such as arterial hypertension, coronary vascular disease, stroke,
      hyperlipidemia and type II diabetes and in severe psoriasis there is an increased risk of
      early death. Lately the role of inflammation in the atherosclerotic process has been
      highlighted and the link between psoriasis and atherosclerosis may be explained by the
      concomitant systemic inflammation in psoriasis. Similarly a state of low level inflammation
      is seen in obesity where macrophages and adipocytes begin to show overlap in function and
      gene expression. This leads to an increased migration of macrophages into the adipose tissue
      and an increased secretion of pro-inflammatory cytokines. In summary, these data and
      theoretical considerations suggest that weight loss in obese patients with psoriasis may
      improve skin manifestations and reduce the risk of atherosclerotic comorbidity.
    


Intervention name(s): Low calorie diet
Intervention type(s): Dietary Supplement
Intervention description(s): Low calorie diet containing 800-1000 kcal/day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of One Day Discharge After Laparoscopic Appendectomy for Uncomplicated Appendicitis in Children.
Condition: Appendicitis Acute
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the value and safety of discharge of a child to home
      care within 24 hours after laparoscopic appendectomy for uncomplicated appendicitis to reduce
      the impact on the child's psyche and need for hospitalisation. Baseline demographic data and
      intraoperative finding will be recorded. Parents are given a two-page questionnaire that is
      completed in three cycles (immediately after discharge, daily until the first control and
      immediately before the first control). All data will be statistically processed using
      descriptive statistics.
    

Detailed description: 
      The research would include children who underwent laparoscopic surgery due to uncomplicated
      acute appendicitis in the period from October 2021 to October 2023 at the Clinic for
      Pediatric Surgery of the University Hospital Center Split. After the suspicion of acute
      inflammation of the appendix is established, the pediatric surgeon decides on surgical
      treatment. Recently, laparoscopic appendectomy has been performed in a standardized manner at
      the Clinic for Pediatric Surgery of the Clinical Hospital Center Split. After the operation,
      and in the current practice, the children would stay in hospital for 2 to 4 days. As the
      generally known psychological aspects of changes in children's behaviour in involuntary
      hospital stays, and now even more pronounced due to the SARS-CoV-2 (Severe acute respiratory
      syndrome coronavirus 2) COVID19 virus pandemic and reduced opportunities for parents to stay
      with children, the main goal of this study is to evaluate and possibly reduce hospital stay
      to a minimum and proof that there are no complications in treatment outcomes due to
      shortening the length of hospital treatment. To conduct this research, parents are given a
      two-page questionnaire that is completed in three cycles (immediately after discharge, daily
      until the first control and immediately before the first control). Baseline demographic data
      and intraoperative findings will be recorded. All data will be statistically processed using
      descriptive statistics.
    

Intervention name(s): Laparoscopic Appendectomy
Intervention type(s): Procedure
Intervention description(s): Laparoscopic Appendectomy for acute uncomplicated appendicitis in children
Intervention model: Single Group Assignment
Intervention model description: prospective nonrandomized cohort study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Surgery; One day discharge; parental satisfaction questionnaire; laparoscopic appendectomy
Genome-Wide Association Study in Patients With Nontuberculous Mycobacterial Lung Disease
Condition: Mycobacterium Infections, Nontuberculous
MeSH terms: Mycobacterium Infections; Mycobacterium Infections, Nontuberculous; Lung Diseases
Study type: Observational

Summary: 
      The aim of this study was to elucidate genetic susceptibility of patients with nontuberculous
      mycobacterial lung disease using genome-wide association study.
    

Detailed description: 
      Nontuberculous mycobacteria (NTM) are ubiquitous environmental organisms. NTM lung disease is
      increasing, however, genetic susceptibility of patients with the disease have not been
      identified. To elucidate the genetic susceptibility of NTM lung disease, the investigators
      perform a genome-wide association study (GWAS) including patients with NTM lung disease and
      healthy controls (case : control = 1 : 3). The age-, sex-matched control group will be
      recruited from the Korean Healthy Twin Study.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with NTM lung diseases and healthy control
      
Biospecimen description: 
      Extraction of DNA will be conducted from serum of patients with NTM lung disease. For
      controls, preexisting dataset of GWAS will be used.
visuALL Field Analyzer (vFA) Compared to Standard Humphrey Automated Perimetry
Condition: Glaucoma, Open-Angle
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      To determine age-adjusted reference values of the visuALL Field Analyzer (vFA) retinal
      sensitivity and to assess the repeatability of the measured values and compare them with
      those measured by a Standard Automatic Perimetry (SAP).
    

Detailed description: 
      Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of central
      and peripheral retinal sensitivity to light for detection and monitoring optic nerve diseases
      such as glaucoma. The current device has its own limitation such as positioning for the
      duration of the test which makes is hard for older patients especially those with back or
      other musculoskeletal diseases, artifact of the corrective lenses used to accommodate the
      patients refractive errors, etc.

      Several devices have been developed since the advent of the Octopus Perimeter 3-5 and the
      Humphrey Field Analyzer (HFA), in an effort to improve the test reliability and patient
      comfort.

      The main goal of this study is to evaluate the repeatability of a novel psychophysical
      platform that takes advantage of a Head Mounted Device (HMD) with eye tracking capabilities.
      Other objectives of this study include the development of an initial reference database and
      comparison of the measured parameters with HFA.
    

Intervention name(s): Standard Automatic Perimetry Humphrey Field Analyzer; visuALL Field Analyzer
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.; visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting.
Other intervention name(s): SAP HFA; vFA
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: open angle glaucoma; visual field; Standard Automatic Perimetry
Counterpulsation Reduces Infarct Size Pre-PCI for AMI
Condition: Acute Myocardial Infarction (AMI)
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased
      MI size.
    

Detailed description: 
      Post clearance device study in which subjects with acute MI will be randomized 1:1 to either
      receive IAB or to receive standard of care without IAB before mechanical reperfusion.
      Subjects will be followed throughout their hospital stay and at 30 days.
    

Intervention name(s): Counterpulsation with IAB
Intervention type(s): Device
Intervention description(s): IABC pre-reperfusion PCI
Other intervention name(s): CS100 & CS300 IAB Linear 7.5F Fidelity 8.0 F Sensation 7.0 F
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IABC; AMI
Developmental Regulation of Proteins Responsible for Transforming Drugs in the Body
Condition: Healthy
Study type: Observational

Summary: 
      This is a drug metabolism study in one-year old children involving caffeine and
      dextromethorphan.
    

Detailed description: 
      For many years, it has been considered dogma that drug biotransformation capability is
      limited at best in the fetus and newborn but increases over the first year of life to levels
      in toddlers and young children that generally exceed adult capacity. There are several
      situations where examination of clinical PK data has revealed discernable patterns of drug
      clearance that can be attributed to developmental differences in drug biotransformation. It
      has become apparent that there are developmental differences in expression among drug
      metabolizing enzyme families (cytochromes P450 or "CYPs", etc.) Furthermore, individual drug
      metabolizing enzymes with in a family may have unique developmental profiles that influence
      the therapeutic response, desired or undesired, to a given agent.

      All subjects will have a single 5 ml venous blood sample taken upon admission to the study.
      All subjects will be given a single oral dose of caffeine and dextromethorphan. Patients will
      be allowed to consume their normal age appropriate diet around the time of study drug
      administration and through the sample collection periods. All spontaneously voided urine will
      be collected for a period of 12 hours following the caffeine and dextromethorphan
      administration

      The specific aim of this proposal is to extend the current longitudinal investigation into
      the preschool age group (1 to 5 years of age). The developmental profile of CYPs, 1A2, 2D6,
      and 3A4 will be determined by caffeine and dextromethorphan phenotyping procedures. The
      purpose of this study is to determine the age/developmental stage at which the CYP2 1A2, 2D6
      and 3A4 activities exceed adult activities.
    

Intervention name(s): Genotyping and Phenotyping using dextromethorphan and caffeine as probes
Intervention type(s): Procedure
Intervention description(s): Single doses of dextromethorphan (0.3 mg/kg)and caffeine (3.0 mg/kg) are administered and urine is collected overnight for measurement of drug and metabolites to determine drug biotransformation activity.
Intervention MeSH terms: Dextromethorphan; Caffeine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy children 12 months of age at study entry. Followed longitudinally until 5 uears of
        age.
      
Biospecimen description: 
      Urine DNA (source: blood or saliva)
    
Keywords: Developmental regulation of CYPs 1A2, 2D6, 3A4; Ontogeny; pharmacokinetics; drug biotransformation; enzymatic biotransformation of drugs
Abdominal Muscle Exercises on Nocturia and Sleep Quality in Women With Type 2 Diabetes
Condition: Nocturia; Sleep Deprivation
MeSH terms: Sleep Deprivation; Diabetes Mellitus, Type 2; Nocturia
Study type: Interventional

Summary: 
      Nocturia is the leading cause of sleep disruption with its subsequent negative impact on
      general health and QoL for a large proportion of the adult population. Nocturia is prevalent
      in men and women of all ages but may be particularly bothersome in younger adults, in whom
      the consequences of sleep disturbance may be more detrimental for daytime functioning and
      possibly for health and mortality.The underlying causes of nocturia obviously influence the
      efficacy of different treatment options. Because a major cause of nocturia is overproduction
      of urine at night, nocturia may not respond to treatments designed to reduce urgency and
      increase bladder capacity or increase urine flow, such as agents for the management of
      bladder outlet obstruction.
    

Detailed description: 
      Nocturia may be more than simply a patient inconvenience, in view of its association with
      increased risk of morbidity and mortality. Clinicians often underestimate the consequences of
      nocturia, however, and thus fail to perform a thorough evaluation of the condition and its
      causes. Patients with nocturia deserve full consultation and implementation of an appropriate
      management strategy to ensure that the specific underlying medical conditions associated with
      nighttime voiding are addressed. Investigators should help women with nocturia as to improve
      their sleep. Participants will strengthen their pelvic floor muscles and abdominal muscles to
      control voiding so their sleep will not disturb to decrease their sufferance.
    

Intervention name(s): pelvic floor exercise; Abdominal muscles exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): pelvic floor exercises(intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week; abdominal exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: nocturia; sleep deprivation; sleep quality; type 2 diabetes mellitus