bioihbjkbjnl/mcl2 huggingface dataset:
Avastin in Combination With Chemotherapy for RAS Mutant Unresectable Colorectal Liver-limited Metastases
Condition: Colorectal Neoplasms
MeSH terms: Neoplasm Metastasis; Colorectal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, the investigators assessed the effect of avastin in combination with
      chemotherapy in the treatment of RAS mutant-type, unresectable colorectal liver-limited
      metastases
    

Detailed description: 
      Patients will be eligible for inclusion if the patients have histologically confirmed
      colorectal adenocarcinoma with RAS mutant liver-confined metastases deemed non-resectable.
      Eligible patients will be randomly assigned to chemotherapy plus avastin (arm A) or
      chemotherapy alone (arm B). Treatment will continue until tumor response indicates
      suitability for surgery for liver metastases or until disease progression or unacceptable
      toxic effects. The primary endpoint is the conversion rate to radical resection for liver
      metastases，which will be assessed by local multidisciplinary team (includes more than three
      liver surgeons and one radiologist) with the use of contrast-enhanced CT or MRI after 4
      cycles and then every other 4 cycles up to 12 cycles. To provide an objective assessment of
      changes in resectability, radiological images will be presented by a radiologist to more than
      3 liver surgeons, who are blinded to the clinical data. Patients will be considered
      resectable if 50% or more of surgeons vote for radical resection of LM. For patients whose
      liver-metastases are assessed resectable, resection should be scheduled to be performed
      within 2~3 weeks of the last treatment cycle. Following resection, patients will be advised
      to continue the same therapeutic regimen until the treatments reach a sum of 12 cycles.
    

Intervention name(s): avastin; mFOLFOX6
Intervention type(s): Drug; Drug
Intervention description(s): Drug: avastin On day 1 of a 14 day treatment cycle, patients received a 2-hour infusion of avastin (5mg/kg) followed by chemotherapy of mFOLFOX6 until progressive disease or unacceptable toxicity.; mFOLFOX-6 (oxaliplatin, 85mg/m2 on day 1 infused during 2 hours;LV400mg/m2 on days 1 infused during 2 hours, followed by FU 400 mg/m2 intravenous bolus then 2400 mg/m2 continuous infusion for 46 hours)
Other intervention name(s): Bevacizumab
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal neoplasms; liver metastasis; chemotherapy; avastin
A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Rationale:

      Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product
      Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study
      with AVT05. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed
      biosimilar test product AVT05 and the reference products EU approved Simponi and US-licensed
      Simponi, in addition to evaluating the safety and tolerability of AVT05, when administered as
      a single 50 mg/0.5 mL SC dose.
    


Intervention name(s): AVT05; Simponi
Intervention type(s): Biological; Biological
Intervention description(s): Pre filled syringes filled with AVT05; Pre filled syringes filled with Simponi
Other intervention name(s): Golimumab
Intervention MeSH terms: Golimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
My Mobile Advice Program: A Randomized Pilot Feasibility Study
Condition: Smoking Cessation; Medication Adherence
Study type: Interventional

Summary: 
      The purpose of this pilot study is to evaluate the acceptability and feasibility of the
      proposed smoking cessation intervention (called MyMAP or My Mobile Advice Program).
    

Detailed description: 
      Investigators will develop and pilot test a prototype of the MyMAP intervention.The
      intervention is designed to help smokers better manage issues known to reduce treatment
      adherence (withdrawal symptoms, medication side-effects, low motivation, and inadequate
      behavioral skills for medication adherence) and to facilitate greater communication between
      patients and providers so clinicians can provide appropriate oversight of medication use,
      intervene when medically necessary, and address patient concerns that may otherwise lead to
      non-adherence or early treatment termination.
    

Intervention name(s): Varenicline; Cognitive-behavioral self-help; MyMAP (My Mobile Advice Program)
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): Standard 12 week course of varenicline, provided in both arms; Standard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone.; Same standard self-help intervention as in control arm + automatically-tailored support and advice for managing nicotine withdrawal symptoms + secure messaging with cessation counselor
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking cessation; varenicline; adherence
Muscle Assessment in Women Who Have Undergone Roux-en-Y Gastric Bypass Surgery
Condition: Muscle Function, Handgrip Strength Test
Study type: Observational

Summary: 
      The purpose of this study is to assess muscle function in women at least two years after
      being submitted to Roux-en-Y Gastric Bypass Surgery and compare with a control group
    

Detailed description: 
      Obesity is a public health problem globally. According to the World Health Organization (WHO)
      estimated are 600 million obese worldwide and according to National Health Survey 2010 in
      Chile 67% of the population suffers from some degree of overweight having approximately
      300,000 morbidly obese.

      The first-line treatment for obesity is diet, exercise and cognitive behavioral therapy,
      however, these interventions are not effective enough to control long-term obesity, and so
      bariatric surgery is currently the treatment of choice to control morbid obesity.

      Overall, after bariatric surgery, most patients lose on average 60% of excess weight and
      improve their comorbidities during the first postoperative year, however, the long term
      effects of this weight reduction are not known in detail regarding body composition and
      muscle function.

      The aim of this study is to assess muscle function measured by hand grip strength test in
      women at least 2 years after bariatric surgery (Roux-en-Y Gastric Bypass) and to compare with
      control group.
    

Intervention name(s): Assess muscle function
Intervention type(s): Other
Intervention description(s): Assess muscle function with hand grip test and sit and stand test
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Two groups of study subjects: bariatric surgery group (case group) and nonoperated group
        (control group)

        The case group will be composed of women that were operated two or more years ago of
        Roux-en-Y Gastric Bypass Surgery, with a 50% or less weight regain.

        The control group will be composed of subjects with no history of bariatric surgery and
        match with the surgical group by gender, age, body mass index (BMI) and physical activity

        Control group will be selected form people who work or study in Faculty of Medicine,
        University of Chile and case group will be selected from former patients evaluated at
        Nutrition Department of the University of Chile.
      
Biospecimen description: 
      serum, urine.
    
Keywords: Bariatric surgery, sarcopenia
Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)
Condition: Neoplasms, Glandular and Epithelial; Diphtheria; Tetanus; Whooping Cough; Meningitis
MeSH terms: Tetanus; Diphtheria; Whooping Cough; Neoplasms, Glandular and Epithelial; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Data from this study are expected to demonstrate that V501 (Human Papillomavirus (HPV) [Types
      6, 11, 16, 18] Recombinant Vaccine) , when administered concomitantly with a combined
      diphtheria, tetanus, pertussis (Tdap) vaccine and a meningococcal conjugate vaccine in
      adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity
      of the concomitant vaccines.
    


Intervention name(s): Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine; Comparator: Menactra™ (Concomitant); Comparator: Adacel™ (Concomitant); Comparator: Menactra™ (Non-concomitant); Comparator: Adacel™
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a
0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.; A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Day 1; a single administration of 0.5 mL intramuscular injection administered in a limb opposite that of quadrivalent HPV injection at Day 1; A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1; A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1
Other intervention name(s): Gardasil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Vibration Response Imaging in Chronic Obstructive Pulmonary Disease and Asthma
Condition: Chronic Obstructive Pulmonary Disease; Asthma
MeSH terms: Asthma; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Obstructive lung disease is usually a differential diagnostic consideration when a patient
      presents with breathlessness or cough. Spirometry is the key diagnostic test used to confirm
      airflow obstruction particularly in the primary care setting. Airflow obstruction that
      completely resolves after administration of a bronchodilator, by definition, excludes a
      diagnosis of COPD. Evaluation of obstructive lung disease must include pulmonary function
      testing; bronchoreversibility testing is an adjunct in differentiating between asthma and
      COPD. Bronchoreversibility cannot serve as an absolute diagnostic criterion for separating
      asthma from COPD.

      Vibration response imaging (VRI) technology provides a simple, radiation-free method to image
      the lungs, by visualizing vibration energy (lung sounds) emitted during respiration cycle. In
      this study, regional quantitative and qualitative information on vibration response is
      compared with spirometry in assessing lungs function of COPD and Asthma patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are either suspected of pulmonary obstruction or already diagnosed and are
        scheduled to perform a spirometry test with pre and post administration of bronchodilators
        will be enrolled in this study
      
Keywords: lung sounds,; airway obstruction,; asthma,; auscultation
A Randomized Comparison of Pediatric I-gel, Air-Q With Classic Laryngeal Mask Airway
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this randomized trial will be to evaluate the clinical performance of the I-gel,
      air- Q ILA compared with the LMA classic in pediatric patients undergoing peripheral surgery
      under general anesthesia.
    

Detailed description: 
      The laryngeal mask airway (LMA) Classic has gained popularity for airway management in both
      anesthesia and resuscitation due to its ease of use. However, insertion of the LMA Classic is
      not always easy in children due to differences in airway anatomy compared with adults, and
      more complications are related to its use in younger children compared with adults.

      The i-gel has been commercially available in sizes suitable for children since 2010. It has a
      non-inflatable cuff and an additional lumen for the active or passive drainage of gastric
      contents (except in size 1). It is available in four children's sizes (1, 1.5, 2 and 2.5).

      The air-Q_ ILA, is easily inserted with the index finger of the right hand, while the
      anesthetist performed jaw's lift with left hand, without a rotational technique (Jagannathan
      N et al., 2011, Dar long et al, 2014 and Keil et al, 2015).

      Oropharyngeal leak pressure is defined as the airway pressure at which air leaks into the
      mouth or enters the stomach (Hughes et al., 2012). This feature is the most common primary
      outcome parameter used to evaluate the safety and efficacy of supraglottic airway devices
      because high pressures generally indicate that adequate ventilation can be achieved without
      air leakage during positive pressure ventilation at high inspiratory pressures (Teoh et al.,
      2010).
    

Intervention name(s): LMA Classic; i- gel; Air-Q
Intervention type(s): Device; Device; Device
Intervention description(s): Patients will be anesthetized using Classic laryngeal mask airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air.; Patients will be anesthetized using I-gel LMA with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer.; Patients will be anesthetized using Air-Q_ ILA, with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: anesthesia; airway; laryngeal mask airway; I-gel; Air-Q
The Pharmacokinetics, and Safety of Brexpiprazole Tablets in Chinese Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, open-label study evaluating the pharmacokinetics and safety of
      multiple dose oral administration of Brexpiprazole (1 mg) tablets in Chinese healthy
      subject.10 healthy adult subjects will be enrolled in this study. A single dose
      (Brexpiprazole 1 mg) group is set and the test drug will be administered for 14 consecutive
      days.
    

Detailed description: 
      10 healthy adult subjects will be enrolled in this study. A single dose (Brexpiprazole 1 mg)
      group is set and the test drug will be administered for 14 consecutive days.

      After receiving the informed consent form the subject themselves, the investigators start the
      screening 14 days to 1 days prior to taking the study drug (D-14 to D-1).

      One day before first dosing (D-1), subjects are hospitalized. On the next day (D1), after
      completed the hospitalization inspection, eligible subjects will be selected to start with
      the first dose, and from day 1 to day 14 (D1 to D14), continue once daily dosing and complete
      the corresponding inspection, observation and blood sampling. They continue hospitalization
      and are discharged on day 17 (D17) after completing the relevant examinations. On days 19,
      21, 23，25 (D19, D21，D23 and D25), blood samples are collected and safety evaluation is
      performed.

      Telephone follow-up is performed on day 44 (D44, 30 days after the last dose of the drug).

      Subjects who early terminated the test after taking the study drug should be tested at the
      end of the study (D25/ET) as far as possible.

      Blood samples for pharmacokinetic evaluation are collected before daily dosing; D1 (before
      dosing, and 1, 2, 3, 4, 5, 6, 8, 12 hours after dosing), D2 (before dosing and 24 hours after
      first dosing), D10 (before dosing), D11 (before dosing), D12 (before dosing), D13 (before
      dosing), D14 (before dosing, and 1, 2, 3, 4, 5, 6, 8, 12 hours after dosing), D15 (24 hours
      after last dosing), D16 (48 hours after last dosing), D17 (72 hours after last dosing), D18
      (96 hours after last dosing), D19 (120 hours after last dosing), D21 (168 hours after last
      dosing),D23 (216 hours after last dosing), D25 (264 hours after last dosing). 31 Blood
      samples collecting points in total.
    

Intervention name(s): Brexpiprazole
Intervention type(s): Drug
Intervention description(s): Brexpiprazole , mutiple dose /oral/empty stomach
Other intervention name(s): Brex
Intervention MeSH terms: Brexpiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal
      cleaning modalities with and without chemistry on oral health over 28 days.
    


Intervention name(s): AirFloss + BreathRx; AirFloss + Listerine; Dental Floss; Manual Toothbrush
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.; Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.; Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.; Manual Toothbrush used twice daily, 1 minute.
Intervention MeSH terms: Listerine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingivitis; plaque; interproximal cleaning; dental floss
Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole
      administered as the immediate release formulation plus aspirin, under conditions of reduced
      stomach acidity.
    


Intervention name(s): Aggrenox; Dipyridamole; Aspirin; Lansoprazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Aspirin; Dipyridamole; Lansoprazole; Dexlansoprazole; Aspirin, Dipyridamole Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Butorphanol Combined With Flurbiprofen Axetil on Preventing Hyperalgesia Induced by Remifentanil in Patients
Condition: Pain; Anesthesia
MeSH terms: Hyperalgesia
Study type: Interventional

Summary: 
      Purpose:

      To explore and compare antihyperalgesic effects of butorphanol, flurbiprofen axetil, and a
      combination of both received before anesthesia induction.

      To evaluate and examine the incidence of adverse effects with the purpose of selecting the
      optimum dose.

      .
    

Detailed description: 
      There are a dramatically increasing number of evidences that administration of the potent,
      ultra-short-acting opioid remifentanil seems to cause opioid-induced hyperalgesia (OIH) more
      frequently and predictably compared with the others, likely due to its rapid onset and
      offset. Therefore, prophylaxis of remifentanil induced hyperalgesia is indispensable to
      postoperative comfort and satisfaction.

      There is no denying the fact that OIH is related to central glutaminergic system and
      N-methyl-d-aspartate (NMDA) receptor-activation induced central sensitization. Prostaglandins
      can promote glutamate release from both astrocytes and spinal cord dorsal horns with
      subsequent activation of the NMDA receptors, and flurbiprofen axetil, as non-steroidal
      anti-inflammatory drugs (NSAIDs), not only functionally antagonizes the NMDA receptor
      activation via inhibition of prostaglandins, but also is a targeted drug which gathers at the
      site of inflammation, thus greatly enhances the analgesic effect. While butorphanol has both
      spinal analgesic and sedative functions because of predominantly central κ-receptor agonist
      activation, other advantages of butorphanol include few side effects, very low addiction
      potential, and low toxicity on account of a partial agonist-antagonist activity to
      μ-receptor. Moreover, antihyperalgesic activity of κ opioids at the site of inflammation has
      been reported in various acute pain models. The following study is carried out to evaluate
      whether butorphanol combined with flurbiprofen axetil can be safely and effectively applied
      to preventing postoperative hyperalgesia induced by remifentanil in patients undergoing lower
      abdominal surgery.
    

Intervention name(s): Normal Saline; Butorphanol; Flurbiprofen axetil; Remifentanil; Sufentanil
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Normal Saline is intravenously administrated before anesthesia induction; Butorphanol is intravenously administrated; Flurbiprofen axetil is intravenously administrated; Remifentanil is intravenously administrated; Sufentanil is intravenously administrated
Intervention MeSH terms: Flurbiprofen; Flurbiprofen axetil; Sufentanil; Remifentanil; Butorphanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Remifentanil; Opioid-induced hyperalgesia; Postoperative pain; Pain Intensity
Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans
Condition: Alveolar Bone Atrophy; Bone Resorption
MeSH terms: Bone Resorption; Alveolar Bone Loss
Study type: Interventional

Summary: 
      This study evaluates the effect of citric acid demineralization in autogenous bone blocks
      consolidation. Half of participants will receive citric acid treatment at the bone block and
      recipient site. Other half will receive no demineralization treatment.
    

Detailed description: 
      Autogenous bone grafts are indicated in areas where there is not enough bone height and/or
      width for implant installation. Treatment of bone surfaces with citric acid, promote a slight
      demineralization on surface that mimic natural processes of bone demineralization by
      osteoclasts. Thus, this treatment could accelerate the process of autogenous bone block
      consolidation to its recipient site.
    

Intervention name(s): Control; Acid
Intervention type(s): Procedure; Procedure
Intervention description(s): Control side will receive only perforations on recipient site, which is the conventional technique for bone blocks graft.; Test side will receive treatment with citric acid (10%) for 30s at bone block surface and recipient site
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split mouth design - one side of mouth is test group, other side is control group
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment