bioihbjkbjnl/mcl2 huggingface dataset:
Non-invasive Pressure-Volume Analysis (NIPVA)
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      If the heart fails to pump a sufficient amount of blood, it is crucial to know why in order
      to provide the best treatment. Pressure-volume analysis is the gold standard for evaluating
      the heart's pumping function. Unfortunately, current techniques are invasive, so most
      patients will not get this examination. By combining the strengths of echo-Doppler
      ultrasound, blood pressure monitoring and biomedical computing, the investigators aim to
      develop a non-invasive method for pressure-volume analysis, extending its applicability to
      more patients and settings.
    

Detailed description: 
      Background: Current methods to evaluate left ventricular (LV) function either are invasive,
      precluding routine use in the majority of patients, or fail to discriminate myocardial,
      hemodynamic and structural factors, rendering assessment imprecise and incomplete.

      Key question: Can we reliably obtain LV functional characteristics by non-invasive means,
      while being able to differentiate more precisely the factors involved? Proposed research: The
      study team aims to develop a non-invasive method for pressure-volume analysis (NIPVA) of the
      LV by combining echo-Doppler, peripheral blood pressure measurements and biomechanical
      modelling. The validity of this approach will be established by comparison with gold standard
      invasive measurements of pressure-volume relationships in patients undergoing cardiac
      catheterization. Test-retest reproducibility will be also assessed. The study team
      hypothesises that NIPVA will provide reproducible and valid measures of LV function and be
      more widely applicable.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients attending cardiology out-patient clinics
      
Keywords: Heart Failure
High-density in Spinal Cord Stimulation: Virtual Expert Registry
Condition: Failed Back Surgery Syndrome
MeSH terms: Failed Back Surgery Syndrome
Study type: Observational [Patient Registry]

Summary: 
      This is a prospective, multi-center, observational follow-up study observing the
      effectiveness of high density spinal cord stimulation in patients with failed back surgery
      syndrome patients with back and leg pain.
    

Detailed description: 
      DISCOVER will measure the effectiveness of high-density spinal cord stimulation for treatment
      of chronic back and leg pain. Identification of clinical effective parameters concerning
      location of active electrodes, frequency, pulse duration, amplitude and battery consumption
      are, besides safety, the major outcome parameters of this study.
    

Intervention name(s): spinal cord stimulation
Intervention type(s): Device
Other intervention name(s): high density spinal cord stimulation
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic back and leg pain (due to Failed Back Surgery Syndrome) who either
        received SCS or have not sufficient pain reduction with traditional parameters or patients
        with chronic back and leg pain who are candidate for SCS will receive HD SCS.
      
Keywords: High density spinal cord stimulation; Virtual expert registry
Differential Effects of Oral and Intranasal Oxytocin on Attention Control
Condition: Healthy
Study type: Interventional

Summary: 
      The main aim of the present study is to investigate whether oxytocin (24IU) via different
      routes have divergent effects on attention control in a social-emotional saccade/antisaccade
      eye-tracking paradigm.
    

Detailed description: 
      Previous studies have demonstrated oral and intranasal oxytocin's divergent effects on
      arousal rating and neural responses to emotional faces, however, it remains unclear whether
      different routes of oxytocin treatment would have differential effects on attention
      processing to social stimuli. Based on the previous registered studies (ClinicalTrials.gov
      ID: NCT04493515 and NCT03486925) from our group using a validated emotional anti-saccade task
      with social stimuli (emotional faces) and non-social stimuli (oval shape) have separately
      explored oral and intranasal oxytocin's modulatory effects on attention processing, the
      present study aims to conduct a secondary analysis of the previously acquired data to
      directly compare oxytocin's effects on attention control to social emotional stimuli via
      different routes. To this end data from subjects who underwent intranasal oxytocin
      administration (n = 33, NCT03486925) will be compared with data from subjects who underwent
      oral oxytocin or placebo administration (n = 36, or 37 respectively; NCT04493515). To further
      control for non-treatment related factors the intranasal placebo and oral placebo groups from
      the previous studies (ClinicalTrials.gov ID: NCT03486925 and NCT04493515) will be compared
      with respect to primary and secondary outcome measures of the trial, in particular general
      and emotion-specific effects on attentional control.
    

Intervention name(s): Oxytocin; Oxytocin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of oxytocin (24IU) orally; Administration of oxytocin (24IU) intranasally; Administration of placebo orally
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Between-subject randomized placebo-controlled double-blind pharmacological eye-tracking design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Antisaccade task; Attention control; Oxytocin; Eye-tracking
Safety Tolerability and Pharmacokinetic of BI 411034
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study is to investigate the safety, tolerability and
      pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of
      single rising doses.

      The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19
      (Cytochrome P450) genotyped extensive metabolisers (EM).

      Another objective is to compare the safety and pharmacokinetic profiles between two different
      groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)
    


Intervention name(s): BI 411034; Placebo; BI 411034; BI 411034; BI 411034; BI 411034; BI 411034; BI 411034; BI 411034
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Low dose solution for oral administration; Solution for oral administration; Medium dose solution for oral administration; Low dose solution for oral administration; High dose solution for oral administration; High dose solution for oral administration; Medium dose solution for oral administration; High dose solution for oral administration; Medium dose solution for oral administration
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
MHNA-001 for Young Adults With IBS
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The main objective of this prospective, open-label, non-significant risk study is to assess
      the efficacy and safety of Mahana™ IBS together with care as usual in approximately 100 young
      adults with Irritable Bowel Syndrome.
    

Detailed description: 
      Following informed consent, all participants will complete a series of screening
      questionnaires to determine eligibility for study entry. Eligible participants will be
      enrolled, and will receive access to MHNA-001 (Mahana™ for IBS). Participants will use
      MHNA-001 for 12 weeks.
    

Intervention name(s): MHNA-001
Intervention type(s): Device
Intervention description(s): 3-month digital therapy program designed to reduce the severity of IBS symptoms
Other intervention name(s): Mahana™ for IBS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition
Condition: Feeding Patterns; Sleep; Glucose Intolerance; Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Glucose Intolerance
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether advancing the timing of home parenteral
      nutrition from overnight to daytime regimens leads to improved glucose profiles and sleep
      quality, and other changes in plasma metabolic signatures.
    

Detailed description: 
      Emerging evidence suggests that considering the time-of-day in clinical care may optimize
      health, partly through limiting sleep disruption and circadian misalignment. Acute sleep and
      circadian rhythms disturbances are associated with cardiometabolic derangements, including
      persistent hyperglycemia, a significant contributor to life-threatening complications.
      However, it is currently considered standard practice for patients on parenteral nutrition to
      be fed for 12-hour periods overnight. Current guidelines lack explicit guidance regarding the
      time-of-day when nutrition support should be administered. Thus, the overall objective of the
      clinical trial is to comprehensively examine a novel dimension of clinical nutrition by
      determining whether advancing the timing of home parenteral nutrition from overnight to
      daytime regimens leads to improved glucose profiles and sleep quality, and other changes in
      plasma metabolic signatures. The study is a 2-week controlled cross-over feeding trial where
      20 short bowel syndrome patients will follow their usual overnight parenteral nutrition
      regimen for one week, and then advance their feeds to daytime for a second week. Patients
      will be assessed objectively using non-invasive, novel technologies and 'omics techniques.
      The investigators hypothesize that advancing the timing of home parenteral nutrition feeds to
      a daytime regimen is a cost-efficient, effective, and feasible nutrition timing
      countermeasure against metabolic derangements, fragmented sleep, and decreased quality of
      life. Results of this study may provide evidence-based, cost-efficient, and effective
      nutrition support countermeasures against hyperglycemia and sleep disruption, and could
      potentially modify current widespread clinical nutrition support practice.
    

Intervention name(s): Time-of-day of parenteral nutrition provision
Intervention type(s): Dietary Supplement
Intervention description(s): Parenteral nutrition will be provided during the nighttime followed by daytime.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Parenteral Nutrition; Chrononutrition; Chronobiology; Nutrition Support; Sleep; Metabolomics
Metformin in Children With Relapsed or Refractory Solid Tumors
Condition: Solid Tumors; Primary Brain Tumors
MeSH terms: Neoplasms; Brain Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the tolerability and safety of escalating doses of
      metformin on a backbone of vincristine, irinotecan and temozolomide (VIT) in children with
      recurrent and refractory solid tumors.
    

Detailed description: 
      Metformin is an oral anti-diabetes medication that activates AMP-activated protein kinase
      (AMPK). Recent data from in vitro and in vivo experiments, as well as epidemiologic
      retrospective analyses, suggest that metformin has anti-cancer activity. Vincristine,
      irinotecan, and temozolomide (VIT) is a combination of chemotherapeutic agents that have
      different mechanisms of action as well as disparate side effect profiles. Two recent phase 1
      trials have demonstrated that this regimen is safe and well-tolerated in children with
      relapsed and refractory solid tumors.
    

Intervention name(s): Vincristine; Irinotecan; Temozolomide; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Vincristine (VCR) = 1.5 mg/m^2/day (maximum dose 2 mg), days 1 and 8, administered as intravenous (IV) bolus over 1-5 minutes; Irinotecan (IRN) = 50 mg/m^2/day, days 1-5, IV over 60 minutes; Temozolomide (TEM) = 50 mg/m^2/day by mouth (PO) Days 1-5; Metformin (MET) = dose as per dose escalation, divided twice a day (BID), PO continuously for the 21 day cycle.
Other intervention name(s): VCR; Oncovin; NSC #067574; Vincristine sulfate; CPT-11; Camptothecin-11; Camptosar ®; NSC#616348; IRN; Temodar™; NSC #362856; TEM; Glucophage ®; MET
Intervention MeSH terms: Metformin; Irinotecan; Camptothecin; Vincristine; Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: central nervous system (CNS); malignancy; relapsed; refractory; pediatric; recurrent
The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in
      healthy adult males.
    


Intervention name(s): Cohort 1: AR882; Cohort 2: AR882; Cohort 3: AR882; Cohort 4: AR882; Cohort 5: AR882; Cohort 6: AR882 Food Effect; Cohort 7: AR882 Solid Oral Formulation; Cohort 8: AR882 in combination with allopurinol; Cohort 9: AR882 in combination with febuxostat
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose of AR882 or matching placebo; Single dose of AR882 or matching placebo; Single dose of AR882 or matching placebo; Single dose of AR882 or matching placebo; Single dose of AR882 or matching placebo; Single dose of AR882 or matching placebo in a fed state; Single dose of AR882 or matching placebo; Single dose of allopurinol alone and a single dose of AR882 in combination with a single dose of allopurinol; Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat
Intervention MeSH terms: Allopurinol; Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Applying Speed of Processing Training to Individuals With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This pilot study will document the efficacy of a behavioral intervention for Processing Speed
      (PS) in Multiple Sclerosis (MS), Speed of Processing Training (SPT), which has been
      successful used in the aging population in several studies. This study will (1) apply a
      treatment protocol for PS impairments, well-validated in aging, to persons with MS with
      impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess
      the effectiveness of the intervention utilizing global measures of daily life, including an
      objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in
      that it will be the first to evaluate the efficacy of a highly-manualized structured
      behavioral treatment for processing speed deficits in persons with MS utilizing the optimal
      methodology for carrying out such studies, a randomized clinical trial. Given the prevalence
      of PS deficits in the MS population and the significant impact such deficits have on everyday
      functioning, public safety, and overall quality of life, the identification of an effective
      intervention for PS deficits in MS could have a profound impact on the population and society
      as a whole.
    


Intervention name(s): Speed of Processing Training
Intervention type(s): Behavioral
Intervention description(s): SPT involves trainer-guided practice of computer-based exercises, including Target Detection (indicating presence or absence of targets, identifying targets, etc.) and Discrimination and Localization (performing same/ different discriminations of targets presented very quickly and followed by a masking pattern) 10, 19, 84. Display speed, ranging from 17 to 500 ms, is the primary manipulation during training, which increases task demands and thus demands on PS itself.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Processing Speed; Intervention; Multiple Sclerosis; Cognition
Absolute Bioavailability and ADME Study of [14C]AZD9977 in Healthy Male Subjects
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to Assess the Absorption, Metabolism, and Excretion of [14C]AZD9977 after a Single-Dose
      Oral Administration
    


Intervention name(s): AZD9977 capsule 50 mg; [14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL); [14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg dose of AZD9977 capsule 50 mg (as 2 x 50 mg capusles); One 100 µg dose of [14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL); One 100 mg dose of [14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq)
Other intervention name(s): AZD9977; [14C]AZD9977; [14C]AZD9977
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Chronic Heart Failure
Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      To compare the mean length of hospital stay in laparoscopic trans abdominal preperitoneal
      repair versus open mesh repair in patients undergoing inguinal hernia repair with mesh.
    

Detailed description: 
      A total of 334 patients of male gender with Inguinal hernias of any side and ASA score I and
      II were included in the study. History of Immunosuppression, associated with other abdominal
      hernias and recurrent hernia were excluded. 167 patients were in Group A or laparoscopic
      trans abdominal preperitoneal repair group while 167 patients were in Group B or open mesh
      repair. Data regarding length of hospital stay from both groups was recorded by researcher
      himself on especially designed proforma.
    

Intervention name(s): hospital stay
Intervention type(s): Procedure
Intervention description(s): hospital stay in in inguinal hernia repair
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: non-probability consecutive sampling
Masking: None (Open Label)
Primary purpose: Treatment
Positive Pressure at Induction of Anesthesia in Children
Condition: Continuous Positive Airway Pressure; Hypoxia; General Anesthesia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      SCENARIO: Hypoxemia is one of the most common adverse events during the induction of general
      anesthesia and may culminate with more serious complications such as cardiac arrest and
      death. Pediatric patients, due to their anatomical and physiological characteristics, are
      more likely to develop hemoglobin desaturation levels. Some preventive strategies are used
      during this period to reduce the chances of occurrence of adverse event. Continuous Positive
      Airway Pressure (CPAP) may be useful during anesthetic induction in delaying the drop in
      oxygen levels in the blood by increasing this body gas reserves. OBJECTIVES: To assess the
      effectiveness of CPAP during anesthetic induction in increasing apnea time until hemoglobin
      saturation falls to 95% in children undergoing general anesthesia for elective surgery.
      METHODS: Phase III, parallel, randomized clinical trial to be developed at the Teaching
      Hospital of the Federal University of Pernambuco. Patients (72) are divided into two groups
      (36 in each) in which all patients will spontaneously ventilate: group C will receive CPAP
      and group A will use the open system. Children of pre-school age with physical status I or
      II, according to the American Anesthesia Society, candidates for elective surgery under
      general anesthesia will be included. Patients with pre-existing parenchymal lung disease,
      cyanotic children or patients with oxyhemoglobin saturation <95% prior to anesthetic
      induction and recent history (<4 weeks) or active upper respiratory tract infection will be
      excluded. The descriptive statistical analysis will be carried out through measures of
      central tendency and dispersion for quantitative variables and via distribution of
      frequencies for qualitative variables. ETHICAL ASPECTS: This work will respect human rights,
      principles of bioethics, the resolution 466/2012 of the National Health Council and the
      statement from Helsinki. Submission and approval by the research ethics committee is required
      prior to data collection. KEYWORDS: Continuous Positive Airway Pressure, Hypoxia, General
      Anesthesia
    


Intervention name(s): Continuous Positive Airway Pressure; Open system ventilation
Intervention type(s): Device; Device
Intervention description(s): A continuous positive airway pressure will be delivered to the patients during the induction of general anesthesia through the anesthesia work station; Facemask ventilation adapted to the anesthesia work station
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Use of Interlocking Detachable Coils System in Embolization of Peripheral Arterial Embolization
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of interlocking detachable
      coils system in the treatment of Chinese patients with embolization of peripheral arterial in
      comparison with Interlock Fibered IDC Occlusion System
    

Detailed description: 
      This is a prospective, multicenter, open-label, non-inferiority, randomized controlled
      clinical trial. The plan is to recruit patients with peripheral arterial disease requiring
      embolization and then perform peripheral arterial embolization based on randomization using
      devices in the experimental group or control group. This trail will be conducted in a number
      of experimental institutions in China, and a total of 116 subjects are planned to be
      enrolled. All subjects were treated with the interlocking detachable coils system and were
      evaluated during surgery and before discharge from the treatment of experimental or control
      devices, followed up at 1 month, 3 months, and 6 months after surgery.
    

Intervention name(s): Interlocking detachable coils system; Interlock Fibered IDC Occlusion System
Intervention type(s): Device; Device
Intervention description(s): Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.; Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral Arterial Disease