bioihbjkbjnl/mcl2 huggingface dataset:
A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Difficult Airway
Condition: Endotracheal Intubation
Study type: Interventional

Summary: 
      Endotracheal intubation is usually required to allow unrestricted surgical approach. The
      Macintosh laryngoscope is the standard method. However in certain situations as difficult
      airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic
      intubation is the gold standard in this scenario, however sometimes it is not possible due to
      failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA,
      Barcelona, Spain) has been designed specifically for the airway management. However, despite
      its use in clinical practice, there are no comparative studies regarding direct laryngoscopy.
    


Intervention name(s): orotracheal intubation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients
Condition: Bladder Cancer; Smoking; Alcohol Consumption
MeSH terms: Urinary Bladder Neoplasms; Postoperative Complications; Alcohol Drinking
Study type: Interventional

Summary: 
      Radical cystectomy provides the best cancer-specific survival for muscle-invasive urothelial
      cancer. However the postoperative morbidity remains at 11-68 %. Smoking and alcohol
      consumption above two drinks per day is associated with an increased risk of postoperative
      morbidity. Six-eight weeks of smoking and alcohol abstinence prior to elective surgery is
      recommended to reduce this risk, but for cancer patients the preoperative period is often
      very short. This randomised clinical trial (STOP-OP) will reach a conclusion on the effect of
      a new Gold Standard Programme for both smoking and alcohol cessation Intervention using the
      Gold Standard Programme (GSP) on the frequency and severity of postoperative complications
      after bladder cancer surgery.
    

Detailed description: 
      The study is a multicentre randomised clinical trial involving 110 patients with a risky
      alcohol intake (exceeding 21 alcohol units (252 g ethanol) per week or/ and daily smoking
      scheduled for bladder cancer surgery. Patients will be randomised to the 6-weeks GSP or
      treatment as usual (control). The GSP combines patient education and pharmacologic
      strategies. The GSP includes benzodiazepine therapy for withdrawal symptoms, controlled
      disulfiram therapy, and Nicotine replacement.
    

Intervention name(s): Educational programme for smoking and alcohol cessation
Intervention type(s): Behavioral
Intervention description(s): 5 meetings within 6 weeks containing education and pharmacologic support
Other intervention name(s): GSP
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Radical cystectomy; Bladder cancer; Smoking cessation; Alcohol cessation; Postoperative complications
Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled, double-blind (investigator- and
      participant-blinded), sponsor-open, dose-escalating study of PF-07081532 in patients with
      Type 2 diabetes on metformin (Parts A and C). The study may also enroll non-diabetic
      participants with obesity (Part B). Study participants will receive an investigational
      product or placebo every day for up to 28 days (Part A) or up to 42 days (Part B, optional;
      Part C, optional).

      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)
      of multiple oral doses of PF-07081532 in participants with inadequately controlled T2DM on
      metformin and optionally in non-diabetic obese participants.
    


Intervention name(s): PF-07081532; Placebo; Clopidogrel
Intervention type(s): Drug; Other; Drug
Intervention description(s): Investigational Drug once daily for up to 42 days; multiple ascending dose design.; Placebo once daily for up to 42 days.; Part B may include a drug-drug interaction study using open-label clopidogrel. Clopidrogrel may be given as two single doses of 75 mg administered on day -2 and day 41.
Other intervention name(s): Plavix
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology
Condition: Diabetes Mellitus Type 2; Hypertension
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Mobile Sipoo is a randomized controlled trial aiming to improve selfcare and outcomes of
      diabetes and hypertensive patients by introducing a remote patient monitoring system
      supported with automatic patient decision support. The feedback system is coupled with
      back-office health coaching.
    

Detailed description: 
      Self-monitored data from blood pressure meters (SMBP), glucometers (SMBG), scales and
      pedometers are transferred by mobile phone terminals to a tethered personal health record
      (PHR) integrated with the provider EHR. The PHR application includes tools to display of
      self-monitoring data.
    

Intervention name(s): Intervention group
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: patient decision support; telemonitoring; self-management; remote patient monitoring; active assistance technology; selfcare
Evaluation of the Safety and Efficacy of THL-P in Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to obtain evidence from test article with efficacy in Metastatic
      Breast Cancer patients. The average of all changes from baseline to post-treatment
      evaluations in global health/quality of life (QoL) subscale assessed by self-administered
      European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -
      Core 30 (EORTC-QLQ-C30).
    

Detailed description: 
      The test article is extracted from many natural herbals, in which most or their components
      have been shown to have anti-tumor activity. A study in 2004 showed the test article could
      have strong immunomodulatory effect on the antigen-stimulated proliferation response (PR) of
      peripheral blood mononuclear cells (PBMC) and T-cells from recurrent aphthous ulcerations
      (RAU) patients and suggested that it might be a potential immunoceutical agent for treatment
      of RAU. Subsequent study in 2005 also suggested the test article as a potential
      immunoceutical agent for treatment of RAU because the result showed it could modulate the
      antigen-stimulated cytokine production by T-cells isolated from RAU patients. Another study
      in 2005 showed the test article also had a broad-range tumor killing function and provided a
      molecular basis underlying therapeutic activity. It was also suggested in this study will
      could be a potential and promising cancer therapeutic or preventive agent.

      The aim of this current study is to explore the safety and efficacy of the investigational
      product with 20 ml, 3 times per day (daily dose: 60 ml) for a total of 24 weeks in the
      patients with metastatic breast cancer refractory to conventional treatment modalities.
    

Intervention name(s): THL-P
Intervention type(s): Dietary Supplement
Intervention description(s): 20ml/bottle, TID, 24weeks
Other intervention name(s): THL-P solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breast Cancer
Memantine for Executive Dysfunction in Adults With ADHD: A Pilot Study
Condition: Attention Deficit Hyperactivity Disorder (ADHD); Executive Function Deficits (EFD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This is a 12-week clinical trial evaluating the efficacy and safety of memantine
      hydrochloride (Namenda) in the treatment of executive function deficits (EFDs) in adults with
      Attention Deficit Hyperactivity Disorder (ADHD) receiving open-label treatment with
      OROS-Methylphenidate (OROS-MPH, Concerta). The study aims to examine the effects of treatment
      with memantine on ADHD symptoms. Following screening procedures, memantine is prescribed in
      randomized, double-blind fashion (equal chance of medication or placebo) for 12 weeks, along
      with open-label OROS-MPH (everyone receives medication).
    


Intervention name(s): Placebo; Memantine Hydrochloride; OROS-Methylphenidate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.; Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.; OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment.
Other intervention name(s): Namenda; OROS-MPH; Concerta
Intervention MeSH terms: Memantine; Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ADHD; Executive Function; Namenda; Concerta
A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of CKD-501, D759 and D150 (CKD-393)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A Clinical trial to investigate the pharmacokinetic drug interaction and safety of CKD-501,
      D759 and D150
    

Detailed description: 
      A Randomized, Open-label, 2-Part, Multiple-dose, Two-way Crossover Clinical Trial to Evaluate
      Drug-drug Interactions and safety between CKD-501, D759, and D150 in Healthy Adult
    

Intervention name(s): CKD 501; D759, D150; CKD-501, D759, D150
Intervention type(s): Drug; Drug; Drug
Intervention description(s): QD, PO; QD, PO; QD, PO
Other intervention name(s): CKD-501
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Applied Cognition Benchmarking Study
Condition: Healthy
Study type: Interventional

Summary: 
      This is a cross-over randomized study to validate the Sponsor investigational medical device
      against measurements of glymphatic function from MRI-based neuroimaging, EEG, blood
      biomarkers and cognitive tests in healthy older volunteers.
    

Detailed description: 
      The study population will consist of healthy individuals, ages 55 to 65, that are cognitively
      normal and do not have a medical history of neurological or sleep disorder, cardiovascular
      disease, hypertension, or diabetes. The objectives of this study are to define whether sleep-
      and wake-associated device measurements (i) faithfully reflect glymphatic function measured
      by gold-standard contrast enhanced MRI and non-invasive MRI-based measures of glymphatic
      function; (ii) replicate pre-clinical findings between sleep EEG power bands and glymphatic
      flow; (iii) predict plasma levels of Alzheimer's disease (AD)-related biomarkers; and (iv)
      predict morning cognitive performance.
    

Intervention name(s): Device measurements during overnight sleep and morning wake; Device measurements during overnight wake and morning sleep
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Overnight period and morning period device measurements; Overnight period and morning period device measurements
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Cross-over randomized study
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Health-economic Evaulation of Interventional Pain Mangement
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      To establish the cost per QALY (Quality Adjusted life Years) gained all patients that are
      referred to a specialized interventional pain clinic are assessed by Euroqol EQ-5D to measure
      the health-related quality of life at the first visit and then during the following year.
      Quality of life is calculated from EQ-5D by using hte TTO-validated UK-value set. With this
      and calculations of the cost we will be able to calculate the cost per QALY-gained which
      makes it possible to compare interventional pain managment to other treatments for pain
      patients.
    


Intervention name(s): Radio-frequency dennervation of facet joint; Diagnostic nerve-blocks performed under direct x-ray vision
Intervention type(s): Other; Other
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with pain of more then 6 months duration
Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This prospective, randomized, single blinded study is designed to evaluate the postoperative
      analgesic efficacy of the ultrasound-guided subcostal transversus abdominis plane block in
      gastric cancer patients undergoing laparoscopic gastrectomy. We hypothesize that US guided
      subcostal TAP block with ropivacaine can significantly reduce postoperative opioid comparison
      in patients with laparoscopic gastrectomy.
    

Detailed description: 
      Adult patients undergoing elective laparoscopic gastrectomy are randomly allocated to receive
      subcostal TAP block (n=56) or not (n=56), in addition to a standard postoperative analgesic
      regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA) and NSAIDs as
      required. At the end of surgery, the TAP group patients will receive bilateral subcostal TAP
      block under ultrasound guidance with 15ml of 0.375% ropivacaine bilaterally. Each patient was
      assessed by a blinded investigator at 6, 12, 24, and 48 h postoperatively. The primary
      outcome is total fentanyl consumption at 24 h after surgery.
    

Intervention name(s): Ultrasound guided subcostal transversus abdominis plane block (TAPB); Ropivacaine 0.75% Injectable Solution; 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)
Intervention type(s): Procedure; Drug; Device
Intervention description(s): At the end of surgery, an anesthesiologist will perform bilateral subcostal TAP block with 0.375% ropivacaine 15ml at each site under ultrasound guidance.; 0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France); 0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)
Other intervention name(s): TAP block
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective randomized double-blinded study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative pain; Stomach neoplasms; Nerve block
Nucleotides and B Vitamins in the Treatment of Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a double-blind, randomized study in parallel groups of subjects presenting with low
      back pain. Randomized subjects will receive treatment for 60 days with either a combination
      of nucleotides and vitamin B12 or vitamin B1+B6+B12.
    

Detailed description: 
      This is a double-blind, randomized study in parallel groups of subjects presenting with low
      back pain. Randomized subjects will receive treatment for 60 days with either a combination
      of nucleotides and vitamin B12 or vitamin B1+B6+B12. The aim of this study is to evaluate and
      compare the therapeutic effect of the combination of nucleotides + vitamin B12 with that of
      the combination of vitamins B1, B6 and B12 in low back pain. Safety and efficacy will be
      monitored throughout the treatment period. Subjects will be randomized in a double-blind
      fashion to either treatment group.
    

Intervention name(s): Nucleotides + B12; B Vitamins
Intervention type(s): Drug; Drug
Intervention description(s): Oral treatment with either Nucleotides + Vitamin B12; Oral treatment with vitamins B1, B6, and B12
Other intervention name(s): Group A; Group B
Intervention MeSH terms: Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nucleotides (uridine, cytidine); Vitamin B1; Vitamin B6; Vitamin B12
Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.
Condition: Tetanus; Diphtheria; Acellular Pertussis
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and
      Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and
      immunogenicity.
    


Intervention name(s): Infanrix™/Hib; Infanrix; Hiberix
Intervention type(s): Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety, Tolerability and Pharmacokinetic Study of MB12066 in Healthy Volunteers
Condition: Metabolic Syndrome; Obesity
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of MB12066 after a
      single or multiple oral dose and to investigate the pharmacokinetic characteristics of
      MB12066 after a single or multiple oral dose.
    

Detailed description: 
      -  Safety/ Tolerability evaluation Adverse events, Physical examinations, Vital signs, ECG
           (including continuous ECG monitoring), Laboratory tests (including hematology,
           chemistry, coagulation, PBS, NAD(P)+/NAD(P)H ratio, urinalysis), CIC

        -  Pharmacokinetic Evaluation(single)

             -  Serial blood samples and urine collections for pharmacokinetic evaluations will be
                conducted between 0 (pre-dose) and 96 hours after a single oral dose.

             -  Blood sampling time pre-dose, 0.5, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h,
                48h, 72h post-dose

             -  Urine collection time 0h - 6h, 6h - 12h, 12h - 24h, 24h - 48h, 48h - 72h

             -  Evaluation parameters AUClast, AUCinf, Cmax, Tmax, t1/2, Vd/F, CL/F, Ae, fe, CLR

        -  Pharmacokinetic Evaluation(multiple)

             -  Serial blood samples and urine collections for pharmacokinetic evaluations will be
                conducted after a single oral dose and Steady state.

             -  Blood sampling time Day 1 pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h,
                24h, Day3-6 Pre-dose, Day7 Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h,
                24h, 36h, 48h, 72h, 96h post-dose

             -  Urine collection time Day 1 Pre-dose, 0h - 6h, 6h - 12h, 12h - 24h, Day 7 Pre-dose,
                0h - 6h, 6h - 12h, 12h - 24h

             -  Evaluation parameters Cmax,ss, Cmin,ss, Cav,ss, AUCτ, Tmax,ss, t1/2, PTF(peak to
                trough fluctuation ratio), fe, CLss/F, CLR
    

Intervention name(s): MB12066; MB12066; MB12066; MB12066; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): MB12066 300mg; MB12066 400mg; MB12066 100mg; MB12066 200mg; Placebo 300mg (single dose), 400mg (single dose), 100mg (multiple dose), 200mg (multiple dose)
Other intervention name(s): beta-lapachone; beta-lapachone; beta-lapachone; beta-lapachone
Intervention MeSH terms: Beta-lapachone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Safety; Tolerability; Pharmacokinetic
Immunomodulation Therapy for Urinary Tract Infections
Condition: Spinal Cord Injuries; Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Spinal Cord Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Urinary tract infections (UTI) represent one of the most common morbidities in individuals
      with spinal cord injury (SCI) and reason for re-hospitalization. The consequences of
      recurrent UTI are a decrease in quality of life and considerable health costs.
      Immunomodulation therapy with UroVaxom is a very promising method for the prevention of UTI,
      however data in individuals with SCI are very limited. The primary objective of this pilot
      study is to evaluate the feasibility (recruitment rate, patient attrition, compliance,
      assessment procedures etc.) of a main trial. A secondary objective is to collect data for an
      informed sample size calculation. Furthermore, the clinical and biological changes after
      immunomodulation therapy will be investigated.

      This is a randomized, placebo-controlled, mono-centric pilot study investigating the
      feasibility of a main trial regarding the effectiveness of immunomodulation with UroVaxom in
      the prevention of UTI and the effect on the immune system in individuals with acute SCI
      during primary rehabilitation. There will be two parallel groups of 12 participants each.
      Group allocation will be based on a block-randomization stratified according to sex. Study
      participants and outcome assessors will be blinded to the group allocation. The nursing staff
      will be unblinded and will administer the treatment and the placebo. Study participants will
      either receive Uro-Vaxom (one tablet / day) or an off-the-shelf placebo for 90 days. After
      termination of the treatment, the study participants will be followed for 12 months. Blood
      and urine samples will be taken before and 90 days, 6 months and 12 months after treatment
      start.
    


Intervention name(s): Uro-Vaxom; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Uro-Vaxom® (OM Pharma SA, Meyrin, Switzerland) is a lyophilized lysate of 18 E. coli strains.; Placebo oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: spinal cord injury; neurogenic lower urinary tract dysfunction; urinary tract infection; immunotherapy; immunomodulation; immunostimulation; E. coli; Uro-Vaxom