bioihbjkbjnl/mcl2 huggingface dataset:
Postoperative Analgesia After Minithoracotomy
Condition: Postoperative Pain; Mitral Valve Disease
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients scheduled for minimally invasive mitral valve replacement. Each patient will be
      treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Half of the
      patients will be randomly allocated to Erector Spinae Plane (ESP) blockade group.
    

Detailed description: 
      Only patients who are qualified for an elective procedure of mitral valve replacement may
      participate in the study. Each patient will be anesthetized generally. The same drugs will be
      used in each stage of anesthesia. The induction: etomidate, remifentanil, rocuronium, scolina
      as required. The maintenance: sevoflurane, remifentanil, rocuronium. The emergence: oxygen,
      sugammadex or neostigmine a required.

      Patients will be randomly allocated into one of two groups: PCA or ESP. Among the patients
      from ESP group will have ESP blockade before the induction of general anesthesia. ESP
      blockade will be performed under ultrasound control. A single-shot technique will be used
      with 0.375 % solution of ropivacaine: 0.2 mL per patients' KG. The maximum dose is 40 mL.

      Each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA
      with oxycodone (1mg/mL) will be utilized during the postoperative period: 5-minute interval.
      This is standard protocol in our department.

      Only patients who are successfully awakened after the procedure may participate in the study.

      The pain intensity will be assessed with visual-analogue scale (VAS) at 2, 4, 8, 12 and 24
      hour after the end of anesthesia.

      The total consumption of oxycodone will be also monitored.
    

Intervention name(s): Erector Spinae Plane blockade; Oxycodone; general anesthesia; paracetamol
Intervention type(s): Procedure; Drug; Procedure; Drug
Intervention description(s): Before the beginning of the procedure, ESP blockade will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.2 mL per patients' KG. The maximum dose is 40 mL.; Each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA with oxycodone (1mg/mL) will be utilized during the postoperative period: 5-minute interval.; Each patient will generally anesthetized and endotracheal tube will be inserted; Paracetamol will be given i.v. every 6 hours.
Other intervention name(s): ESP; PCA with oxycodone; GA
Intervention MeSH terms: Acetaminophen; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Erector Spinae Plane blockade; patient control anlagesia; mitral valve replacement
Comparison of Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Recent evidence suggests multiple drug therapy is superior to single agents. The study
      compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time,
      and unplanned hospital admission in patients with high risk for PONV treated with oral
      aprepitant with or without transdermal scopolamine preoperatively.
    

Detailed description: 
      Postoperative nausea and vomiting (PONV) is a serious problem complicating surgery. PONV has
      an overall incidence of 30% and a 70% incidence in high-risk patients. PONV yields unplanned
      hospital admission, pulmonary aspiration, esophageal rupture, electrolyte abnormalities,
      dehydration, and delayed discharge from the postanesthesia care unit (PACU). Additional use
      of resources costs the health care industry hundreds of millions of dollars annually. Patient
      satisfaction is greatly improved when PONV is prevented.4 PONV etiology is multifactorial and
      the treatment is multimodal.
    

Intervention name(s): Aprepitant; Scopolamine
Intervention type(s): Drug; Drug
Intervention description(s): 40mg tablet; 1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days
Other intervention name(s): Emend (Aprepitant) + Placebo; Scopolamine + Emend (Aprepitant)
Intervention MeSH terms: Scopolamine; Aprepitant; Fosaprepitant; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Post-operative Nausea and Vomiting (PONV)
Cognitive Rehabilitation Through Personalized Virtual Reality and Paper-and-pencil Interventions in the Alcohol Use Disorder Treatment.
Condition: Alcohol Use Disorder (AUD)
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional

Summary: 
      Cognitive dysfunction is one of the different consequences of excessive alcohol consumption,
      affecting many domains associated with prefrontal and temporal lobes, such as attention,
      verbal fluency, and memory.

      This study will explore the clinical impact of two cognitive rehabilitation tools to promote
      cognitive improvements of AUD individuals.
    

Detailed description: 
      Excessive consumption of alcohol affects many functions associated with the prefrontal and
      temporal lobes, including different executive functions, memory, and complex motor control.
      Among several treatments, the Transtheoretical Model, a multidisciplinary approach, is one of
      the most standardized. However, it lacks effective and innovative cognitive rehabilitation
      tools. In this study, two cognitive rehabilitation tools, already clinically validated for
      stroke patients, will be implemented to promote cognitive recovery of Alcohol Use Disorder
      (AUD) individuals under treatment in the Alcoholic Rehabilitation Center S. Ricardo Pampuri
      from Casa de Saúde S. João de Deus (Madeira, Portugal). Within a randomized controlled trial
      with 60 participants, this study intend to assess and compare the clinical effectiveness of
      both a paper-and-pencil tasks training and content equivalent virtual reality (VR) simulation
      of activities of daily living with time-matched standard treatment.
    

Intervention name(s): Virtual Reality; Paper and Pencil; Control Group
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The Virtual Reality group will be involved in the Standard treatment protocol and will perform personalized activities of daily living in a virtual city environment (Reh@City).; The paper and Pencil group will be involved in the Standard treatment protocol and will perform personalized cognitive paper-and-pencil tasks, using the Task Generator tool.; The standard treatment protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcohol Use Disorder; Cognitive Rehabilitation; Virtual Reality; Paper-and-Pencil Tasks
Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma
Condition: Eosinophilic Asthma; Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging,
      multi-center study to evaluate the clinical effects of oral administration of dexpramipexole
      for 12 weeks on peripheral blood eosinophil count in subjects with eosinophilic asthma.
    

Detailed description: 
      One hundred subjects will receive study drug or matching placebo over 12 weeks of consecutive
      dosing. Following a short Run-in Period, eligible subjects will enter the Primary Assessment
      Period and receive twice-daily dosing of study drug or placebo for 12 weeks. Following 12
      weeks of treatment, subjects will enter a 12-week Eosinophil Recovery Period. The primary
      endpoint for the study is the change in blood absolute eosinophil count from Baseline to Week
      12.
    

Intervention name(s): Dexpramipexole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): dexpramipexole twice daily oral dosing for up to 12 weeks; placebo twice daily oral dosing for up to 12 weeks
Other intervention name(s): KNS-760704; BIIB050; PBO
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Four-arm parallel assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Eosinophilic Asthma; Asthma; dexpramipexole
Fructo-oligosaccharides and Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the
      intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance
      of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable
      Bowel Syndrome (IBS). Thus the objective of the study is to evaluate the effect of
      fructo-oligosaccharides to improve IBS score and to explore which modifications of the
      microbiota are responsible of this improvement.
    


Intervention name(s): Fructo-oligosaccharides; Maltodextrins
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary supplementation for 4 weeks; Dietary supplementation for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Nutritional Practices and Outcomes in Non-Invasive Ventilation
Condition: Non Invasive Ventilation
Study type: Observational

Summary: 
      The Nutritional Practices and Outcomes in Non-Invasive Ventilation (NPO/NIV) study is a
      collaboration with lead sites from pediatric critical care units within US and Canada, and
      participating sites from multiple international regions. The goal of NPO/NIV is to understand
      how non-invasive ventilation (NIV) is used to treat critically ill children and,
      concurrently, how these children are fed while on NIV. Designed as a period prevalence study,
      NPO/NIV will collect observational, cross-sectional data over the course of five study weeks.
      Each study week will require two days of screening for eligible patients. On Mondays, study
      staff will screen for patients eligible in the previous 48 hours. On Tuesdays, study staff
      will screen for patients eligible in the previous 24 hours. Patients meeting study inclusion
      will be eligible to complete V0, V1, and V2. Included patients will be followed for 7 days
      after the initiation of NIV or until the patient is discharged from the pediatric intensive
      care unit. This study was granted exempt status by the University of Arizona Human Subjects
      Protection Program, including a waiver of informed consent. As no personal health information
      is transmitted during the course of the study, the University of Arizona does not require
      Data Use Agreements between sites to participate.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Population admitted to PICU in whom NIV was initiated
Human Photoallergy Test
Condition: Sunscreening Agents
MeSH terms: Dermatitis, Photoallergic
Study type: Interventional

Summary: 
      To evaluate the potential of a test material to produce a photo allergic response.
    


Intervention name(s): Sun screening Sport Lotion, (BAY987516); Untreated skin
Intervention type(s): Drug; Other
Intervention description(s): 50 μl/ cm*2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3 μl/ cm*2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures. (Formulation Number - RB# Y65-110); This site is patched without treatment as control
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Effects of Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation in Subjects With Chronic Hepatitis C Recurrence (P04590AM3)(COMPLETED)
Condition: Liver Transplantation; Hepatitis C, Chronic; Liver Cirrhosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Liver Cirrhosis; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an exploratory study and is a Phase 3, single-arm, multi-center, open-label study of
      pegylated interferon alfa-2b, PEG-IFN alpha-2b (PEG-Intron) and ribavirin (RBV) to determine
      the sustained virologic response (SVR) at 24-week follow-up to 48 week in subjects after
      orthotopic liver transplantation (OLT) with chronic hepatitis C (HCV) recurrence.
    


Intervention name(s): Combination of (a) pegylated interferon alfa-2b and (b) rebetol
Intervention type(s): Drug
Intervention description(s): Powder for injection in vials and Redipen (50, 80, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
200 mg capsules, oral, weight based dose of 400-1200 mg, daily for up to 48 weeks
Other intervention name(s): (a) SCH 54031, PEG-Intron; (b) SCH 18908, Rebetol
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Ribavirin; Peginterferon alfa-2b
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exercise and Virtual Reality Exposure Therapy for Acrophobia
Condition: Fear of Heights
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether aerobic exercise can enhance the effects of
      exposure therapy treatment for fear of heights.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): 30 minutes of aerobic exercise on a treadmill at 80% of participant's heart rate reserve.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Evaluation of DCTclock™ as a Cognitive Assessment Aid
Condition: Cognitive Function
Study type: Interventional

Summary: 
      The overall objective of this study is to demonstrate the safety and effectiveness of
      DCTclock as an adjunctive tool for use by clinicians to evaluate cognitive function in adults
      aged 55-95.
    


Intervention name(s): DCTclock
Intervention type(s): Device
Intervention description(s): DCTclock is a quick and non-invasive test that measures cognitive function based on a computerized algorithmic analysis of the entire drawing process and output of a well-established cognitive assessment called The Clock Drawing Test (CDT).
Intervention model: Single Group Assignment
Intervention model description: This study uses a paired design in which each subject undergoes blinded testing by separate testers administering DCTclock and a battery of reference standard tests to determine cognitive state.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Cognitive assessment; Cognition; Clock Test
Safety of Sticker Pad Containing Essential Oil Containing Lavender and Ylang-ylang Oil
Condition: Healthy
Study type: Interventional

Summary: 
      The aims of the study were to evaluate safety of sticker pads containing lavender and ylang
      ylang oil in healthy volunteers.
    

Detailed description: 
      The lavender and ylang ylang oil pad was attached to the shirts of healthy volunteers for 2
      hours. The outcomes were evaluated before, during and 30 minutes after removal of the pad.
      Adverse reactions, irritation score, and quality of life were assessed. Blood pressure and
      pulse rate were also measured
    

Intervention name(s): Sticker pads containing lavender and ylang ylang oil
Intervention type(s): Device
Intervention description(s): Sticker pads , size 160 mm2, were produced by a certified ISO 9001 manufacturer and contained 0.3% lavender oil and 0.7% ylang ylang oil. The sticker pad was attached to the shirts of healthy volunteers for 2 hours. The outcomes were evaluated before, during and 30 minutes after removal of the pad.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
BI 113608 Administered as Tablets Twice Daily Over 4 Weeks in Patients With Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of the current trial is to investigate safety, tolerability and
      pharmacokinetics of BI 113608 in COPD patients with symptoms of chronic bronchitis.
    


Intervention name(s): Placebo to BI 113608 high dose b.i.d.; Placebo to BI 113608 low dose b.i.d.; BI 113608 high dose b.i.d.; Placebo to BI 113608 medium dose b.i.d.; BI 113608 low dose b.i.d.; BI 113608 medium dose b.i.d.
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Film-coated tablet; Film-coated tablet; Film-coated tablet; Film-coated tablet; Film-coated tablet; Film-coated tablet
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
A Study to Evaluate the Safety and Therapeutic Effects of Transplantation of MNV-BM-BLD in Pediatric Patients With Pearson Syndrome
Condition: Mitochondrial Diseases; Pearson Syndrome
MeSH terms: Muscular Diseases; Lipid Metabolism, Inborn Errors; Mitochondrial Diseases; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Mitochondrial diseases are a genetically heterogeneous group of disorders caused by mutations
      or deletions in mitochondrial DNA (mtDNA) displaying a wide range of severity and phenotypes.
      These diseases may be inherited from the mother (mitochondrial inheritance) or non-inherited.
      The latter are ultra-rare pediatric diseases caused by a mutation or deletion of mtDNA, which
      develop into a systemic multi organ disease and eventually death. MNV-BM-BLD is a therapeutic
      process for enrichment of patient's peripheral hematopoietic stem cells with normal and
      healthy mitochondria derived from donor blood cells. The process, called mitochondria
      augmentation therapy, aims to reduce the symptoms of mitochondrial diseases.
    


Intervention name(s): CD34+ cells enriched with MNV-BLD
Intervention type(s): Biological
Intervention description(s): Transplantation of autologous stem cell enriched with MNV-BLD (blood-derived mitochondria)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autologous stem cell transplantation; Mitochondrial Diseases; Pearson Syndrome; Rare Diseases
The Association of Baseline Characteristics of Male Patients Presented With LUTS and Long Term Clinical Outcomes
Condition: Lower Urinary Tract Symptoms
MeSH terms: Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      Non-neurogenic male lower urinary tract symptom (LUTS) is one of the most common symptom
      presented in urological clinic. Male LUTS could be a result of a combination of many
      different conditions, including benign prostate hypertrophy, overactive bladder, diabetes,
      noctural polyuria, sleep apnoea etc. Also male LUTS has shown to have close relationship with
      metabolic and cardiovascular conditions. Because of the increasing evidences to suggest a
      close relationship of cardiovascular condition and metabolic problems and male LUTS, this is
      a study to retrospective review of the patients assessed in this urology clinic and have a
      more in-depth assessment of the relationship of the baseline characteristics of these medical
      conditions with the presenting symptoms, as well as the long term urological and overall
      clinical outcomes of these patients.
    

Detailed description: 
      This is a retrospective study.Male patients who presented with lower urinary tract symptom to
      our centre and assessed in the urology clinic from 2005 to 2019 would be enrolled to the
      study. This study will be conducted by observation; that is, data will be captured from
      medical records and central medical system (CMS), but patients will not be contacted. All the
      demographic and medical background, as well as investigations performed during the assessment
      including uroflowmetry, post-voiding residual, questionnaires, blood pressure, pulse,
      vascular assessment and blood result will be collected. Follow-up data including usage of
      medication, clinical outcomes (such as development of urinary retention, cardiovascular
      events, need of surgical intervention, mortality etc.) will be captured from the medical
      records.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): There is no intervention in this study
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Male patients who presented with lower urinary tract symptom to our centre and assessed in
        the nurse-led pre-assessment clinic
Assessments of Thrombus Formation in TAVI
Condition: Aortic Valve Stenosis; Heart Valve Diseases
MeSH terms: Aortic Valve Stenosis; Heart Valve Diseases
Study type: Observational

Summary: 
      Transcatheter aortic valve implantation (TAVI) is well established, and can improve clinical
      outcomes of patients with severe aortic valve stenosis (AS) who are inoperable or have high
      surgical risk. Although the rates of periprocedural bleeding events are lower in TAVI
      compared to those in surgical aortic valve replacement, those in TAVI still remains high. In
      addition, current guideline recommended the dual antiplatelet (DAPT), clopidogrel plus
      aspirin, for a 3- to 6-month period after TAVI, however no evidences supports this approach.
      The antithrombotic regimen in patients undergoing TAVI is needed to be established.

      To establish the antithrombotic regimen in patients undergoing TAVI,

        1. the investigators assess the changes in platelet thrombus formation and white thrombus
           formation in patients undergoing TAVI measured by Total Thrombus Formation Analysis
           System (T-TAS).

        2. the investigators analyze plasma microRNAs, and shear stress by using computational
           fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with severe symptomatic aortic valve stenosis, undergoing transcatheter aortic
        valve implantation
      
Keywords: Transcatheter aortic valve implantation