bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Interaction Between Low Dose Sulfamethoxazole-Trimethoprim and Zidovudine
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      To determine if the pharmacokinetics of low doses of zidovudine (AZT) (that is, how fast AZT
      reaches the blood, what concentration of AZT is attained in the blood, and how long AZT
      remains in the blood) changes from day-to-day in the same patient. Also to determine whether
      the pharmacokinetics of AZT is changed by sulfamethoxazole/trimethoprim (SMX/TMP) given at
      the same time or whether the pharmacokinetics of SMX/TMP is altered by AZT therapy. AZT has
      been effective in treating some patients with AIDS, and SMX/TMP is an antibiotic combination
      which is useful in preventing or treating Pneumocystis carinii pneumonia (PCP), which is an
      important cause of disease and death in patients with AIDS. It is important to know how drugs
      interact in patients because addition of a second drug may change the speed at which a drug
      is eliminated from the body, and cause increased toxic effects or decreased therapeutic
      effects.
    

Detailed description: 
      AZT has been effective in treating some patients with AIDS, and SMX/TMP is an antibiotic
      combination which is useful in preventing or treating Pneumocystis carinii pneumonia (PCP),
      which is an important cause of disease and death in patients with AIDS. It is important to
      know how drugs interact in patients because addition of a second drug may change the speed at
      which a drug is eliminated from the body, and cause increased toxic effects or decreased
      therapeutic effects.

      Patients take AZT every 4 hours and/or SMX/TMP every 12 hours by mouth for 4 days as
      outpatients and then come into the clinical research center for 2 days of studies. On day 5
      the final dose of medicine is given orally (SMX/TMP) or by intravenous infusion (AZT). Blood
      samples are drawn 10-20 times over a period of 12 hours and urine is collected for 36 hours.
      Concentrations of the drugs in the blood and urine samples are determined. This sequence is
      repeated twice, so that each patient takes AZT alone, SMX/TMP alone, and the combination of
      AZT and SMX/TMP over a period of about 3 weeks. Patients may be included in the study if they
      are asymptomatic, or have been diagnosed with ARC or AIDS, but not if they have PCP or any
      other severe opportunistic infection.
    

Intervention name(s): Sulfamethoxazole-Trimethoprim; Zidovudine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zidovudine; Trimethoprim; Sulfamethoxazole; Trimethoprim, Sulfamethoxazole Drug Combination
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Trimethoprim-Sulfamethoxazole Combination; Pneumonia, Pneumocystis carinii; Drug Interactions; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine; Sulfamethoxazole-Trimethoprim
Compare Captisol-Enabled (CE) Budesonide + Azelastine Nasal Solution and Rhinocort Aqua + Astelin in an Environmental Exposure Chamber (EEC) Study of Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study was to compare Placebo to Captisol-Enabled Budesonide +
      Azelastine in a single spray and two separate sprays (Budesonide + Azelastine) in patients
      with Seasonal Allergic Rhinitis exposed to controlled ragweed pollen.
    


Intervention name(s): Budesonide + Azelastine; Budesonide + Azelastine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): nasal spray, one spray per nostril at time 0 plus one spray Placebo; nasal spray, one spray of each per nostril at time 0; nasal spray, one spray per nostril from each of 2 bottles at time 0
Other intervention name(s): CDX-313; Captisol; Rhinocort Aqua; Astelin; phosphate buffered saline solution
Intervention MeSH terms: Azelastine; Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy
Condition: Narcolepsy With Cataplexy; Narcolepsy; Narcolepsy Without Cataplexy
MeSH terms: Narcolepsy; Cataplexy
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, open-label extension of the clinical study NLS-1021, evaluating
      long-term safety, tolerability, pharmacokinetics (PK), and therapeutic response to treatment
      with NLS-2 in adult subjects with narcolepsy.
    


Intervention name(s): Mazindol
Intervention type(s): Drug
Intervention description(s): Drug: NLS-2
Other intervention name(s): NLS-2; mazindol extended release
Intervention MeSH terms: Mazindol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
the Pharmacokinetic Profiles of Losartan With DW1029M
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Losartan
      after oral administration in healthy male volunteer
    

Detailed description: 
      A Randomized, open-label, multiple-dose, crossover phase I clinical study to evaluate DW1029M
      influence the pharmacokinetic profiles of Losartan after oral administration in healthy male
      volunteer
    

Intervention name(s): Losartan 50mg; DW1029M 1200mg and Losartan 50mg
Intervention type(s): Drug; Drug
Intervention description(s): Losartan 50mg once daily for 7 days; Losartan 50mg 1 Tablet once daily and DW1029M 300mg 2 Tablets b.i.d. for 7days
Other intervention name(s): Cozaar tablet 50mg; Concomitant of DW1029M 1200mg and Losartan 50mg
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: healthy
Trial on Innovative Technologies in Colonoscopy
Condition: Polyps; Neoplasms; Inflammatory Bowel Disease
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The trial will compare results of screening colonoscopy performed by means of conventional
      colonoscopy and using new visualisation techniques during endoscopic examination.

        -  Electronic colonoscopes Olympus CF-HQ190F with following options: magnetic positioning
           (Scope Guide), responsive insertion technology (RIT), dual focus function, narrow band
           imaging (NBI) will be used for innovative colonoscopies

        -  Electronic colonoscopes Olympus CF-H180DL with Scope Guide and NBI options will be used
           for conventional colonoscopies Endoscopists will archive all images and establish
           presumptive diagnosis based on the results of different visualisation techniques. All
           endoscopes will be attached to Olympus Evis Exera III system. Biopsy of all pathological
           lesions will be performed to establish final diagnosis. The main outcome measure is
           diagnostic accuracy of innovative colonoscopy in comparison with conventional technique.
    

Detailed description: 
      A total of 600 consecutive patients undergoing screening unsedated colonoscopy will be
      randomly assigned to innovative or conventional examination. Randomization will be based on
      computer-generated randomization lists. All patients will be blinded so they will not know
      which techniques will be used to assess lesions found in colon. In innovative colonoscopy
      group narrow band imaging (NBI) and Dual Focus (DF) function will be used to identify and
      classify all lesions acc. to Sano and Kudo classification. Endoscopic biopsy will be taken
      from all lesion and endoscopic diagnosis will be compared with final histological diagnosis.
      Thus sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and
      Youden index will be calculated. As secondary endpoints total examination time, coecal
      intubation rate and pain intensity (VAS scale) will be established. This study will help to
      establish whether new technologies used during colonoscopy may improve diagnostic
      possibilities and whether they prolong examination time or lead to increase of pain intensity
      afterwards.
    

Intervention name(s): Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus); Conventional colonoscopy (Olympus CF-H180DL)
Intervention type(s): Device; Device
Intervention description(s): NBI and Dual Focus options will be used to classify lesions according to Sano and Kudo classifications.; Conventional colonoscopy performed without innovative techniques used in experimental arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: narrow band imaging; dual focus; responsive insertion technique; scope guide; colonoscopy; colorectal cancer screening
Analysis of the Curative Effect of Salvage Surgery on Recurrent Laryngeal Carcinoma
Condition: Recurrent Laryngeal Carcinoma
MeSH terms: Carcinoma; Laryngeal Neoplasms; Recurrence
Study type: Observational

Summary: 
      Early laryngeal cancer can be treatment by laser surgery or radiotherapy, intermediate and
      advanced laryngeal carcinoma mainly surgical treatment. Laryngeal cancer is at risk of
      recurrence after treatment, whether in surgery, laser or radiotherapy. The recurrence rate of
      laryngeal cancer is about 10% reported at home and abroad. Local pain, ulcers, breathing and
      eating difficulties caused by recurrent laryngeal cancer seriously reduce the quality of life
      of patients and seriously endanger their lives. Therefore, head and neck surgeons are
      required to make every effort to give them saving treatment in order to improve their quality
      of life. Prolong the patient's life.
    

Detailed description: 
      medical records and extracted information including age, gender, initial treatment modality
      of glottis cancer, recurrence time, recurrence site, histopathology, tumor grade according to
      World Health Organization (WHO) grade and tumor stage. Stages were defined according to the
      American Joint Committee on Cancer (AJCC) staging system.
    

Intervention name(s): salvage surgery
Intervention type(s): Procedure
Intervention description(s): Salvage surgery hopes to control the recurrence of larynx, pharynx, fistula and neck tumor and improve the quality of life and survival rate
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients with recurrent laryngeal squamous cell carcinoma
      
Keywords: salvage surgery; recurrent laryngeal carcinoma; experience
Medication Use Evaluation (MUE) for Continuous Heparin Infusions in Hospitalized Patients
Condition: Unfractionated Heparin
Study type: Observational

Summary: 
      Unfractionated heparin (UFH) is an anticoagulant to prevent thrombus formation or worsening
      of an existing thrombus. It is indicated for patients with deep vein thrombosis/pulmonary
      embolism (DVT/PE) or acute coronary syndrome (ACS). Unfractionated heparin treatment consists
      of an initial bolus followed by a continuous infusion that is adjusted based on the patient's
      subsequent partial thromboplastin time (PTT) levels
    

Detailed description: 
      Unfractionated heparin is classified as a high-alert medication in the acute care setting.3
      Therapeutic anticoagulation is a high priority for healthcare teams because the impacts of
      inadequate anticoagulation can lead to life threatening events such as a major bleed or
      thrombus formation and/or death.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        • Patient's aged 18 years or older with a confirmed diagnosis of DVT/PE based on imaging or
        a confirmed diagnosis of ACS requiring heparin therapy
Safety, Pharmacokinetics and Pharmacodynamics After Multiple Oral Doses of BIBR 1048 MS Capsule in Healthy Japanese Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral
      administration of multiple doses (150 mg b.i.d., 7 days)
    


Intervention name(s): BIBR 1048 MS
Intervention type(s): Drug
Intervention description(s): 150 mg capsules, b.i.d, 7 days
Other intervention name(s): dabigatran etexilate
Intervention MeSH terms: Dabigatran
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Resistance Training Post Valve Replacement Surgery
Condition: Valve Disease, Heart
MeSH terms: Heart Valve Diseases
Study type: Interventional

Summary: 
      Background: Recent recommendations from the European Society of Cardiology (ESC) are
      multidisciplinary cardiac rehabilitation including therapeutic exercises for patients after
      heart valve surgery unless there is insufficient evidence to decide whether therapeutic
      exercise cardiac training should be provided for such patients. As well, resistance training
      is an extremely safe systemic physical activity, and it has no contraindications if
      well-oriented, in addition to being the fastest-growing physical activity in the world in
      several practitioner settings.

      Purpose: This study was conducted to investigate the effect of early resistance training on
      the fitness level (vo2 max) and (PR interval) of patients post-valve replacement surgery.
    

Detailed description: 
      Method: Forty males post-valve replacement surgery participants' age ranged from 20 to 30
      years old and were selected randomly from National Heart Institute (Imbaba), this study was
      conducted in the period between April and November 2022, and those participants were
      allocated randomly into two equal groups twenty in each group. Group A received aerobic and
      resistance training three sessions per week for one-month, and group B received aerobic
      training three sessions per week for one month. All demographic data was recorded and an ECG
      device was used to record HR and R-P Intervals, Six-Minute Walk Test (6MWT) was used to
      assess of cardiorespiratory fitness for all participants in both groups (A&B)
    

Intervention name(s): Resistance training; Aerobic training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): moderate-intensity resistance training: three sessions per week for one month. Participants had been instructed to perform exercises at a 4:2:4 tempo; that is, four sets of concentric contraction, two sets of isometric hold, and four sets of eccentric contraction. Participants had been instructed to complete a single set until volitional fatigue or been instructed to stop by the physiotherapist when the technique falters; The exercise program consisted of ten minutes warm-up, 45 minutes of moderate aerobic exercises "upper extremity aerobic bulk muscles training and arm ergometer" and cool-down in five minutes, respectively. That was done as 3 sessions/week for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: post valve replacement; resistance exercise; aerobic exercise
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomised, double-blind, parallel group, placebo-controlled study designed to
      evaluate the efficacy and safety of a fixed 30 mg dose of benralizumab administered
      subcutaneously for patients with a history of asthma exacerbations and uncontrolled asthma
      receiving medium to high-dose inhaled corticosteroid plus long-acting β2-agonist (ICS-LABA)
      with or without oral corticosteroids and additional asthma controllers.
    

Detailed description: 
      Approximately 666 patients will be randomised. Patients will be stratified by country/region,
      age group (adult or adolescent), and peripheral blood eosinophil count at time of Visit 1
      (<300 or ≥300 cells/μL).All the patients will be randomised to either placebo or benralizumab
      (1:1 ratio) for a 48-weeks treatment, every 4 weeks for the first 3 doses and then every 8
      weeks thereafter.
    

Intervention name(s): Benralizumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Benralizumab subcutaneously on study week 0 until study week 40 inclusive.; Placebo subcutaneously on study week 0 until study week 40 inclusive.
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma,; Bronchial Diseases,; Respiratory Tract Diseases,; Lung Diseases,; Obstructive Lung Diseases
Paravertebral Block (PVB) Combined Pectoral Musculature Blocks for Modified Radical Mastectomy (MRM)
Condition: Mastectomy, Modified Radical
Study type: Observational

Summary: 
      Previous studies have shown that PVB reduces pain and postoperative nausea and vomiting after
      breast cancer surgery when used in addition to general anesthesia or sedation. However, major
      breast cancer surgery involves areas beyond the breast tissue, such as pectoral musculature.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible patients were that diagnosed to have unilateral breast cancer and undergone
        modified radical mastectomy using regional anesthesia during Jun 1, 2012 and May 31, 2015.
Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Fixed sequence, 2-period crossover study to compare the pharmacokinetic profiles of
      Palbociclib in absence and presence of prior administration of proton pump inhibitor
      Rabeprazole. The increased gastric pH achieved by the treatment with multiple doses of
      Rabeprazole might affect the absorption process of Palbociclib.
    


Intervention name(s): Palbociclib alone; Palbociclib + Rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 125mg Palbociclib capsule will be administered to subjects orally and then PK samples will be collected at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours.; Two Rabeprazole 20mg tablets will be given to subjects orally once daily for 7 days. Then on the same day at least 4 hours after the last dose of Rabeprazole, single dose of 125mg Palbociclib capsule will be given to subjects orally then followed by PK samplings at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours.
Other intervention name(s): Period 1; Period 2
Intervention MeSH terms: Palbociclib; Rabeprazole
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Palbociclib; PD-0332991; Proton Pump Inhibitor; DDI; Healthy Volunteers; Pharmacokinetics; Rabeprazole
Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support:
Condition: Dementia, Vascular; Alzheimer Dementia; Lewy Body Dementia With Behavioral Disturbance
MeSH terms: Dementia; Alzheimer Disease; Lewy Body Disease; Dementia, Vascular; Problem Behavior
Study type: Interventional

Summary: 
      In this Phase II SBIR project we will enhance a wireless WiFi-based insole that was designed
      and successfully tested during a Phase I trial with elderly persons with dementia and their
      caregivers, and then investigate its efficacy in terms of caregiver activity, burden, and
      quality of life in Phase II. Evaluation will use semi-structured interviews and participant
      observation data collected from professional and family caregivers of patients with moderate
      or mild dementia.
    

Detailed description: 
      The efficacy of the Activlink system offering localization information to improve caregiver
      will be evaluated in two studies. Study 2a will use the insole system with dementia patients
      residing in skilled or memory care. Data regarding caregiving activity will be collected from
      their paid professional care providers. Study 2b will use participant localization data
      collected on 80 independently dwelling mild dementia patients. In this case data will be
      collected from their unpaid family caregivers. Both studies will result in evaluating the
      efficacy of the WiFi-based insole to provide caregivers with augmented patient awareness,
      helping to improve their immediate quality of life by reducing their direct burden of
      continuous oversight of their person in care.
    

Intervention name(s): Activlink insole; Activlink Phone Application
Intervention type(s): Device; Other
Intervention description(s): Dementia patients will wear the provided insole inserted into their own shoes. The insole will have a small electronic sensor that measures acceleration, foot force, and/or orientation.; Smartphone tool used for monitoring location
Other intervention name(s): Location Monitoring Technology; Location Monitoring Technology
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Counterbalanced within-subject design. Specifically, each target patient will randomly be assigned to either have the technology or not have the technology applied for a period of three months, followed by three months of the opposite condition. Caregivers will provide caregiver ratings twice monthly during these two epochs.
Masking: None (Open Label)
Primary purpose: Supportive Care
fMRI Study Comparing BOLD Activation Patterns Using GW679769 In Subjects With Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 1

Summary: 
      Evidence suggests the use of neuroimaging to detect therapeutic effects of anxiolytic
      treatment when appropriate cognitive-emotional tasks are use to activate the emotional brain
      neurocircuitry believed to be involved in the core symptoms of the disease.
    


Intervention name(s): GW679769
Intervention type(s): Drug
Intervention MeSH terms: Casopitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: fMRI placebo GW679769 Social Anxiety Disorder SAD