bioihbjkbjnl/mcl2 huggingface dataset:
Mandibular Advancement Bite Block Efficacy Observational Study
Condition: Airway Obstruction
MeSH terms: Airway Obstruction
Study type: Observational

Summary: 
      The purpose of this study is to compare the effect of mandibular advancement bite block to
      standard bite block for prevention of hypoxemia, intervention events and adverse effects
      during endoscopic examinations.
    

Detailed description: 
      During endoscopic examinations, especially upper gastrointestinal, bile duct, or
      bronchoscopic examinations, the endoscope need to be placed through the mouth. A bite block
      is used to protect vulnerable endoscope and protect patient's teeth. During sedative
      endoscopic exams, respiratory depression, apnea or upper airway obstruction will occur under
      the influence of the sedative medications. Serious adverse events may occur such as
      hypoxemia. A nasal airway, Larson's maneuver, jaw thrust or chin lift may be needed to open
      airways.

      Mandibular advancement devices has been widely used in treating obstructive sleep apnea. A
      modified bite block that provides mandibular advancement could provide entry inlet of
      endoscope as well as provide mandibular advancement to provide patent airway during sedative
      endoscopy. In this study, we group the patients into test group using mandibular advancement
      bite block and a control group using standard bite block. After anesthetic induction, gastric
      endoscopy was performed. Degree of upper airway obstruction will be evaluated and recorded.
      Differences between the two groups will be evaluated.
    

Intervention name(s): Mandibular advancement bite block
Intervention type(s): Device
Intervention description(s): Mandibular advancement bite block that provides mandibular advancement by 3 mm, 6 mm, or 9 mm from neutral position
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ASA class I or II patients admitted for routine upper gastrointestinal endoscopy
      
Keywords: Gastrointestinal endoscopy; Moderate sedation; Airway management
Correlation of Measured and Calculated Serum Osmolality During Hyperosmolar Drugs Infusion in Patients After Craniotomy
Condition: Brain Edema
MeSH terms: Brain Edema
Study type: Interventional
Phase: Phase 4

Summary: 
      Osmotherapy has been used as the medical treatment for brain edema and intracranial
      hypertension in critically brain injured patients. Measurement of serum osmolality during
      osmotherapy is of clinical importance to determine clinical efficacy, adjust dosage and avoid
      side effect. Serum osmolality is often measured in laboratory by cryoscopic technique as the
      reference method. However, in clinical setting, routine measurement of serum osmolality is
      not feasible at bedside, either in intensive care unit (ICU) or neurosurgical ward.
      Therefore, clinicians usually estimate serum osmolality by using equations derived from serum
      osmoles that can be measured by bedside blood gas analysis or routine laboratory chemical
      analysis, such as sodium, potassium, urea, and glucose. In present study, mannitol or
      hypertonic saline will be used in patients after craniotomy, and serum osmolality will be
      measured before and during drug infusion. Investigators hypothesize that the correlation of
      measured and calculated serum osmolality is better during infusion of hypertonic saline than
      mannitol.
    


Intervention name(s): 20% mannitol solution, 125 ml, IV infusion in 15 min; 3.1% sodium chloride solution, 125 ml, IV infusion in 15 min
Intervention type(s): Drug; Drug
Intervention MeSH terms: Mannitol; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: hyperosmolar drugs; mannitol; hypertonic saline; serum osmolality; correlation
Systemic Effects of Lidocaine Infusion for TAP Block Catheter
Condition: Nephrectomy
Study type: Interventional

Summary: 
      Lidocaine is a local anesthetic that is usually used for nerve blocks to sensory/motor
      blockade. However, lidocaine can also been given intravenously, and it has been shown that
      this method can be used to help alleviate chronic pain. We wish to investigate if lidocaine
      is infused via the transversus abdominis plane (TAP) block catheter will exert systemic
      effect, hence reduce opioid consumption and pain score in patients compared with using local
      anesthetic such as ropivacaine.
    

Detailed description: 
      Following IRB approval and written consents, patients undergoing nephrectomy were randomized
      into 2 groups: standard 0.2% ropivacaine infusion (control) and 0.4% lidocaine infusion for
      TAP catheter. The TAP catheters were placed by the surgeons under direct vision at the end of
      surgery before wound closure. All subjects had a general anesthetic in accordance to the
      discretion of the anesthesiologist in the operating room. At the end of surgery, all patients
      received a patient-controlled analgesia (PCA) in recovery for 48 hours. The primary outcome
      was the total opioid consumption at the first 27 hours post-operatively. The secondary
      outcomes were the total opioid consumption at 4/12/24/36/48/60 hours after the initiation of
      local anesthetic infusion, the numerical rating scale (NRS) at rest and on movement at
      4/12/24/36/48/60 hours after the initiation of the local anesthetic infusion, the incidence
      of nausea and vomiting, and adverse effects.

      The sample size calculation for this non-inferiority trial is based on our previous
      retrospective study on TAP in nephrectomy patients. A sample of 80 patients is needed, using
      a power of 90% with the two-sided significance level of 5%. All parametric data will be
      analyzed using mean and standard deviation. Non-parametric data will be analyzed using median
      and interquartile range. Student's t-test or Mann-Whitney U test will be used to compare
      between groups.
    

Intervention name(s): Lidocaine; Ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Local anesthetic; Local anesthetic
Other intervention name(s): Lignocaine
Intervention MeSH terms: Lidocaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lidocaine; TAP block; nephrectomy; acute pain
Nalbuphine as an Adjuvant to Intravenous Regional Anesthesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The effect of addition of nalbuphine to lidocaine in intravenous regional anesthesia
    


Intervention name(s): Nalbuphine; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): 53 patients received intravenous regional lidocaine plus nalbuphine; 53 patients received intravenous regional lidocaine
Intervention MeSH terms: Lidocaine; Nalbuphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
      growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such
      as docetaxel, also work in different ways to kill tumor cells or stop them from growing.
      Giving bevacizumab together with docetaxel may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel
      works in treating older patients with stage III or stage IV non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the proportion of elderly (≥ 75 years of age) patients with stage III or IV
           non-small cell lung cancer surviving for at least 6 months when treated with a
           combination of bevacizumab and weekly docetaxel.

      Secondary

        -  To assess the progression-free and overall survival of patients treated with this
           regimen.

        -  To determine the response rate in patients treated with this regimen.

        -  To assess the toxicity of this regimen in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV on days
      1, 8, and 15. Treatment may repeat every 4 weeks in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed for 4 weeks.
    

Intervention name(s): bevacizumab; docetaxel
Intervention type(s): Biological; Drug
Intervention description(s): Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
Other intervention name(s): Avastin; TAXOTERE®
Intervention MeSH terms: Bevacizumab; Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
Maintenance Treatment With Liposomal Doxorubicin (Caelyx) in Metastatic Breast Cancer Patients
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, prospective and multicenter phase IV clinical trial, which has been
      designed as a phase III study. One hundred fifty-four women (77 per treatment arm) will be
      recruited in the study.
    

Detailed description: 
      The main variable is time to disease progression. All patients must be treated with first
      line of induction chemotherapy, consisting of doxorubicin 75 mg/m2, day 1 every 3 weeks, and
      docetaxel, 100 mg/m2, day 1 every 3 weeks. Both drugs must be administered sequentially.
      Patients previously treated with anthracyclines must receive 2 courses of doxorubicin and 4
      courses of docetaxel. Otherwise, patients will receive 3 courses of doxorubicin followed by 3
      courses of docetaxel.

      Patients with complete response, partial response or stable disease are eligible for 2001-01
      study.

      The investigators assume that maintenance treatment with Caelyx will increase mean time to
      progression from 10, 46 months (observation) to 17, 43 months. Expected difference in mean
      time to progression is 6, 97 months (Hazard ratio = 0.6). With an alpha error of 0.01
      (unilateral) and power of 80%, 77 patients per arm are needed, 154 patients in total.
    

Intervention name(s): Pegylated liposomal doxorubicin
Intervention type(s): Drug
Other intervention name(s): Caelyx
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; Metastases; Maintenance treatment
Muscle Metabolic Function in Older Adults With Different Vitamin D Status Before and After Exercise
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      This is a small pilot aerobic training trial designed to examine differences between
      normal-high and low vitamin D levels and 7-days of aerobic training on local VO2 measured by
      non-invasive Hybrid Diffuse Optical Spectroscopy.
    


Intervention name(s): 7 continuous days of aerobic training
Intervention type(s): Other
Intervention description(s): For 7 consecutive days, subjects will perform up to 45 minutes of exercise consisting of treadmill walking at a progressive intensity of about 60-65% of their maximum heart rate. This heart rate range is estimated to be below 60% VO2 max.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Muscle Metabolic Function; Vitamin D Status; 25(OH)D; Older Adults
Effectiveness of Cognitive Behavioral Therapy (CBT) for Child Anxiety Disorders in Community Clinics in Norway
Condition: Separation Anxiety Disorder; Social Phobia; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social; Anxiety, Separation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effectiveness of a cognitive-behavioral
      intervention for children aged 7 to 12 years with anxiety disorders who are referred to
      ordinary community clinics. The treatment will be conducted as individual therapy or group
      therapy.
    


Intervention name(s): Cognitive behavioral therapy (individual); Cognitive behavioral therapy (group)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Coping Cat program, 12 weekly sessions, two additional parent meetings; The Coping Cat program, 12 weekly sessions, two additional parent meetings
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles
Condition: Benign Pigmented Lesions; Facial Wrinkles
Study type: Interventional

Summary: 
      Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for
      Treatment of Benign Pigmented Lesions and Wrinkles.
    

Detailed description: 
      Subjects will receive up to 4 study treatments with the PicoWay™ 730 nm laser wavelength,
      PicoWay™1064nm fractional handpiece and/or PicoWay™ 1064nm fractional handpiece for treatment
      of benign pigmented lesions or wrinkles. Subjects will return for three follow-up visit
      evaluations 1-month, 2-months and 3-months post final study treatment. Primary efficacy
      assessed by masked photographic evaluation. Optional biopsy collection for histological
      analysis of laser tissue effects.
    

Intervention name(s): PicoWay™ 532nm fractional handpiece; PicoWay™ 730nm wavelength; PicoWay™ 1064nm fractional handpiece
Intervention type(s): Device; Device; Device
Intervention description(s): PicoWay™ Laser System is picosecond 532/1064/785 laser; PicoWay™ Laser System is picosecond 532/1064/785 laser; PicoWay™ Laser System is picosecond 532/1064/785 laser
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
HER-2 Mutations in Tumor Samples From Patients With Advanced Non-Small Cell Lung Cancer Treated on Clinical Trial ECOG-2598
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Collecting samples of tumor tissue from patients with cancer to study in the
      laboratory may help doctors learn more about changes that may occur in DNA and identify
      biomarkers related to cancer.

      PURPOSE: This laboratory study is looking at HER-2 mutations in tumor samples from patients
      with advanced non-small cell lung cancer being treated with trastuzumab on clinical trial
      ECOG-2598.
    

Detailed description: 
      OBJECTIVES:

        -  Correlate clinical response to trastuzumab (Herceptin®) with the presence of mutation in
           the HER-2 kinase domain in tumor samples from patients with advanced non-small cell lung
           cancer treated on protocol ECOG-2598.

        -  Correlate mutations with time to progression and survival of these patients.

      OUTLINE: This is a multicenter study.

      Tissue specimens are analyzed by polymerase chain reaction to assess mutations in the HER-2
      gene. Laboratory/biomarker analysis data is correlated with clinical data from protocol
      ECOG-2598.

      PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.
    

Intervention name(s): gene expression analysis; mutation analysis; polymerase chain reaction; diagnostic laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Other
Observational model: Other
Time perspective: Retrospective
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
Irinotecan in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with
      recurrent or refractory non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the objective response rate and toxicity of irinotecan when administered to
           patients with recurrent or refractory non-Hodgkin's lymphoma.

      OUTLINE: Patients are stratified by disease category (aggressive vs indolent vs mantle cell
      lymphoma). Patients with aggressive and indolent lymphoma are further stratified as to being
      refractory (no complete response (CR) or partial response (PR) to initial therapy) vs
      recurrent (CR or PR to initial therapy); i.e, the following subcategories are used:

        -  Stratum I:Refractory aggressive non-Hodgkin's lymphoma (NHL)

        -  Stratum II:Recurrent aggressive NHL

        -  Stratum III: Refractory indolent NHL

        -  Stratum IV: Recurrent indolent NHL

        -  Stratum V: Mantle cell NHL All patients receive irinotecan intravenously every 21 days.
           Patients achieving CR or PR receive 6 courses. Patients may receive bone marrow
           transplantation after at least 2 courses.

      Patients are followed every 3 months for survival.

      PROJECTED ACCRUAL: This study will accrue 18 patients per stratum; if at least three patients
      respond, an additional 25 patients will be accrued for a total of 43 evaluable patients per
      stratum. The total number accrued will be 90-215 over a period of approximately 3 years.
    

Intervention name(s): irinotecan hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Waldenström macroglobulinemia; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult Burkitt lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma
Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects
Condition: Healthy; Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75
      mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects. Another
      objective is to assess the safety and tolerability of cabozantinib in these adult subjects.
    


Intervention name(s): cabozantinib
Intervention type(s): Drug
Intervention description(s): 3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation
Other intervention name(s): XL184
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Normal healthy adult subjects; Adult subjects with hepatic impairment
Astragalus Membranaceus for Brain Edema Induced by Hemorrhagic Stroke
Condition: Stroke; Hemorrhagic Transformation Due to Acute Stroke
MeSH terms: Stroke; Hemorrhagic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      Astragalus membranaceus (AM) is used to treat stroke for a long period, and a number of
      studies have known that AM can reduce cerebral infarction area and has anti-oxidation.
      Hemorrhagic stroke will induce secondary peri-blood clot edema and that may increase
      intracranial pressure to exacerbate clinical symptom. Therefore, the purpose of the present
      study was to investigate the effect of AM on hemorrhagic stroke edema. The investigators
      selected 80 hemorrhagic stroke patients , and who the stroke is first attack, they were
      randomly divided into control and experimental groups, and each group was 40 patients as
      follows: 1) control group, accepted AM placebo 2.8 g three times per day (tid) treatment for
      continuously 14 days from second day of admission or operation, except standard ordinary
      treatment; 2) experimental group, accepted AM 2.8 g tid treatment for continuously 14 days
      from second day of admission or operation, except standard ordinary treatment. Computer
      tomography (CT) examination was done at first day, 4th day and 7th day of admission,
      respectively. The ratio of brain edema was calculated by CT image, and inflammatory index
      including the levels of C-reactive protein (CRP), erythrocyte sedimentation rate
      (ESR)，Creatine Kinase BB Isoenzyme (CMBB). D-dimer from venous blood also were measured. In
      addition, the score including Glasgow outcome scale (GOS), Modified rankin scale (MRS),
      Function independence measure (FIM), Barthel index (BI) was recorded one week, four weeks and
      12 weeks after admission or surgical operation, as an index for clinical symptoms. The index
      for the therapeutic effect of AM was according to above-mentioned the ratio of brain edema,
      inflammatory index and clinical symptoms.

      The investigators expected the results of the present study may provide a scientific evidence
      for the hemorrhagic stroke edema treatment of AM, thus, the present study may contribute to
      use the method of integrated Chinese and Western Medicine for the treatment of stroke, and to
      the research of Chinese Medicine.
    


Intervention name(s): Chinese Herb Astragalus membranaceus; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Astragalus membranaceus ( AM) at a rate of 3 g three times per day; at a rate of 3 g three times per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Complementary therapies; Acute hemorrhagic stroke