bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Safety and Pharmacokinetics of Isavuconazole in Healthy Chinese Volunteers
Condition: Pharmacokinetics of BAL4815; Pharmacokinetics of BAL8728; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic properties of isavuconazole
      (BAL4815) and the cleavage product (BAL8728) and assess the safety and tolerability after
      single-dose and steady state (multiple-dose) administration of isavuconazole BAL8557 in
      healthy Chinese subjects.
    

Detailed description: 
      This is a two part study:

      Part 1: On Day 1, Period 1, subjects will receive a single dose of isavuconazole orally or
      intravenously according to the treatment sequence allocation. Subjects will remain resident
      in the unit in order to collect blood for pharmacokinetics (PK) and to assess the safety
      tests. They will be released in the morning of Day 15 after collection of blood for safety
      tests. Subjects will have a washout period of 2 weeks returning to the unit for Day -1 of
      Period 2 (Day 29). Subjects will receive a single dose of isavuconazole orally or
      intravenously (opposite mode of administration from Period 1). Subjects will remain resident
      in the unit and will be released in the morning of Day 15, Period 2 (Day 44) after collection
      of blood for tests.

      Part 2: Subjects will be allocated to multiple intravenous (IV) (Group 1) or oral (Group 2)
      dosing. On Day 1, Group 1 will receive multiple intravenous (IV) dosing of isavuconazole as a
      2-hour infusion, three times a day (TID) with 8 hours between doses for 2 days followed by
      isavuconazole as a 2-hour infusion every day (QD) for 10 days. Group 2 will receive multiple
      oral (PO) dosing of isavuconazole TID with 8 hours between doses for 2 days followed by
      isavuconazole PO QD for 10 days. Subjects in Group 1 and 2 will remain resident in the unit
      in order to collect blood and urine for PK evaluations and to assess the safety tests. They
      will be released in the morning of Day 26 after collection of blood for tests.
    

Intervention name(s): Isavuconazole; Isavuconazole (IV)
Intervention type(s): Drug; Drug
Intervention description(s): oral; intravenous (IV)
Other intervention name(s): BAL4815, BAL8557, BAL8728; BAL4815, BAL8557, BAL8728
Intervention MeSH terms: Isavuconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics; Healthy volunteers; Isavuconazole; BAL4815; BAL8728; BAL8557
Shared Care Rehabilitation After Acute Coronary Syndrome
Condition: Acute Coronary Syndrome; Myocardial Ischemia; Acute Myocardial Infarction: Rehabilitation Phase
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Myocardial Ischemia; Coronary Artery Disease; Syndrome; Infarction; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Cardiac rehabilitation is an individual adapted multidisciplinary intervention for people
      suffering from Heart Disease. It involves;

        -  Dietary counseling,

        -  Exercise training,

        -  Psychosocial support,

        -  Physician

        -  smoking cessation

        -  Patient education

      The purpose is quick and complete recovery and to reduce the chance of recurrence.

      In Denmark people admitted with Acute Cardiac Disease is referred to a course of hospital
      based cardiac rehabilitation at discharge.

      The Danish Municipal Reform of 2007 changed the responsibility of rehabilitation from the
      Regions, who runs the hospitals, to the municipalities.

      Shared care is in this setting that elements of treatment are completed different places in
      Health Care.

      The aim of this study is:

        -  to establish a shared care model for Cardiac rehabilitation following admission with
           Acute Coronary Syndrome and

        -  to compare this model to the existing hospital based cardiac rehabilitation after
           admission with Acute Coronary Syndrome.

      Primary outcome is participation in cardiac rehabilitation.
    


Intervention name(s): Shared Care model
Intervention type(s): Behavioral
Intervention description(s): First visit at cardiac ambulatory approximately 14 days after discharge includes physician examination by cardiologist and counseling from nurse specialized in cardiac rehabilitation.
Dietary counseling with dietician
Exercise (1 hour, 2 timer pr week for 12 weeks)
Smoking cessation if smoker with educated smoking cessation instructor
Patient education and psychosocial support in 2 individual consultations and 8 group based consultations with experienced nurse
Examination by the patient´s general practitioner 8-12 weeks after discharge.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Acute Coronary Syndrome; Myocardial Ischemia; Shared Care; Rehabilitation; Community; Cardiac Rehabilitation; Hospital
Quit4Baby Evaluation
Condition: Smoking Cessation; Pregnancy
Study type: Interventional

Summary: 
      The goal of this project is to evaluate the effectiveness (Phase II) of a text-based program
      to be called Quit4Baby to support smoking cessation efforts of pregnant women who smoke.

      In Phase II, Dr. Abroms will conduct a randomized clinical trial among 500 pregnant smokers
      who have been recruited from users of text4baby - the first large scale mobile health
      application in the United States. Developed and operated by Voxiva and Healthy Mothers,
      Healthy Babies (HMHB)-collaborators in this program -text4baby is a free national service
      that has enrolled more than 800,000 pregnant women and mothers of infants 0-1 nationwide and
      delivered more than 150 million health messages to them including messages encouraging them
      not to smoke during pregnancy and referring them to quit lines.

      Hypothesis 1: Pregnant smokers who receive quit4Baby + text4Baby will demonstrate higher
      levels of knowledge about the dangers of second hand smoke and the benefits of smoking
      cessation for mothers and their infants than text4baby only users.

      Hypothesis 2: Pregnant smokers who receive quit4baby + text4baby will report significantly
      higher rates of calling a quit line, discussions with their health provider and/or use of
      cessation counseling than those who receive Text4baby alone.

      Hypothesis 3: Pregnant smokers who receive quit4baby + text4baby will have significantly more
      favorable quitting outcomes compared with text4baby alone.
    


Intervention name(s): Quit4Baby; Text4Baby
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mhealth
Optical Coherence Tomography Measurements in Eyes With Band Atrophy
Condition: Vision Disorders
MeSH terms: Vision Disorders; Atrophy
Study type: Interventional

Summary: 
      The study is designed to evaluate the ability of optical coherence tomography and VCC
      scanning laser polarimetry to measure and identify the pattern of band atrophy of the optic
      nerve in patients with long standing chiasmal lesions. The hypothesis is that these new
      technologies are able to identify such pattern. The idea is that by using eyes with band
      atrophy one is able to investigate the ability of the new technologies in measuring the
      retinal nerve fiber layer particularly in the nasal and temporal portions of the optic nerve.
    


Intervention name(s): Retinal nerve fiber layer and macular thickness measurements
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Band Atrophy; Optical Coherence Tomography; Scanning Laser Polarimetry; Chiasmal Lesions
A Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Elective Surgery Patients
Condition: Induction and Maintenance of General Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, open-label, positive-controlled (propofol) phase II
      clinical trial. The study plans to enroll approximately 46 eligible subjects. Among them, 40
      subjects will be randomly assigned to HSK3486 treatment group (30 cases) and propofol control
      group (10 cases) in a ratio of 3:1. The subjects will be enrolled competitively at all study
      sites. Upon enrollment of the 40 subjects, 6 more subjects will be enrolled by West China
      Hospital of Sichuan University. These 6 subjects will not be randomized, but will directly
      enter into propofol induction + HSK3486 maintenance group for study.
    


Intervention name(s): HSK3486; Propofol; Propofol HSK3486
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The induction dose is 0.4mg/mg. The initial maintenance dose of the first 6 subjects is 1 mg/kg/h. For the subsequent enrolled subjects, the investigator could adjust the subsequent initial maintenance dose according to the dose response of the first 6 subjects, so as to explore the optimal initial maintenance dose. The range of the initial maintenance dose is 1 (± 0.5) mg/kg/h, i.e. the minimum initial maintenance dose should not be less than 0.5 mg/kg/h, and the maximum should not be more than 1.5 mg/kg/h.; The induction dose is 2.0mg/mg. The initial maintenance dose of the first 2 subject is 5 mg/kg/h. For the subsequent enrolled subjects, the investigator could adjust the subsequent initial maintenance dose according to the dose response of the first 2 subjects, so as to explore the optimal initial maintenance dose. The adjustment range of the initial maintenance dose is 5 (± 2.5) mg/kg/h, i.e. the minimum initial maintenance dose should not be less than 2.5 mg/kg/h, and the maximum should not be more than 7.5 mg/kg/h.; The induction dose of Propofol is 2.0mg/mgThe initial maintenance dose of HSK3486 is fixed at 1 mg/kg/h, without adjustment.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gene Therapy in Treating Patients With Recurrent Malignant Gliomas
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Inserting the gene for adenovirus p53 into a person's tumor may improve the body's
      ability to fight cancer.

      PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who
      have recurrent malignant gliomas.
    

Detailed description: 
      OBJECTIVES: I. Determine the biological effects at the molecular level of intratumoral
      administration of adenovirus p53 gene (Ad-p53) in patients with malignant primary glioma. II.
      Determine the maximum tolerated dose of intratumoral Ad-p53 in these patients. III. Evaluate
      the qualitative and quantitative toxicity of intratumoral Ad-p53 in this patient population.

      OUTLINE: This is a dose-escalation, multicenter study. Patients receive an initial
      intratumoral stereotactic injection of adenovirus p53 (Ad-p53) over 10 minutes on day 1. In
      the absence of unacceptable toxicity resulting from this initial injection, patients then
      undergo tumor resection and receive a series of 1-minute injections of Ad-p53 into the
      resected tumor cavity wall on day 4. Cohorts of 3-6 patients receive escalating doses of
      Ad-p53. If 2 of 3 or 3 of 6 patients experience dose limiting toxicity (DLT) at a particular
      dose level, escalation ceases and the maximum tolerated dose is defined as the previous dose
      level. Patients are followed closely for 12 weeks, then every 2 weeks for 8 weeks, then every
      4 weeks for 8 weeks, and then every 8 weeks until death.

      PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
    

Intervention name(s): Ad5CMV-p53 gene; conventional surgery
Intervention type(s): Biological; Procedure
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult glioblastoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult mixed glioma; adult giant cell glioblastoma; adult gliosarcoma
Phase I Study of Chiauranib in Patients With Advanced Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this dose-escalation study is to assess the safety and tolerability of
      treatment with Chiauranib administered orally over a range of doses in patients with advanced
      solid tumors.
    

Detailed description: 
      The purpose of this study is to assess the tolerability and safety include adverse events,
      vital signs, laboratory tests ,etc., of a range of doses of Chiauranib in solid tumor
      patients, and to determine the dose limit toxicity and the maximum tolerable dose.
    

Intervention name(s): Chiauranib
Intervention type(s): Drug
Intervention description(s): Take orally
Other intervention name(s): CS2164
Intervention MeSH terms: Chiauranib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chiauranib, advanced solid tumors, phase 1 study
Incidence Of Hemidiaphragmatic Paralysis After Usg Guided Low Dose Interscalene Brachial Plexus Block
Condition: Respiratory Insufficiency
MeSH terms: Respiratory Insufficiency; Paralysis
Study type: Interventional

Summary: 
      to put a catheter in interscalene brachial plexus USG guided and give a bolus of drug
      followed by 24 hours continous infusion of drug
    

Detailed description: 
      to put a catheter in interscalene brachial plexus USG guided and give a bolus of drug
      followed by 24 hours continous infusion of drug. To see hemidiaphragmatic paralysis by seeing
      diaphragmatic excursion on M mode Usg subcostal approach, to see post operative pain, patient
      satisfaction score, complications if any
    

Intervention name(s): Interscalene Block with Ropivacaine Hcl 0.2% Inj Vil 10Ml; IV diclofenac and IV paracetamol
Intervention type(s): Device; Drug
Intervention description(s): bolus 10ml of 0.5% ropivacaine followed by infusion @ 2ml/hr of 0.2% ropivacaine; iv diclofenac 75 mg TDS iv paracetamol 1gm TDS
Other intervention name(s): ROPIN; vovran and perfalgan
Intervention MeSH terms: Acetaminophen; Diclofenac; Ropivacaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups: 1- block + GA 2- GA with multimodal analgesia
Masking: None (Open Label)
Primary purpose: Diagnostic
Dorsal Penile Nerve Block for Rigid Cystoscopy in Men
Condition: Pain
Study type: Interventional

Summary: 
      This study will determine the effectiveness and safety of dorsal penile nerve block (DPNB) in
      men undergoing rigid cystoscopy.
    

Detailed description: 
      Pain is common in men undergoing rigid cystoscopy. Even with application of a lubricant
      containing 2% lidocaine, about 76% men suffer from mild to severe pain when undergoing rigid
      cystoscopy, and approximately 27% men could still feel mild to moderate pain 7 days after the
      procedure. The most painful part of the procedure for men is when the cystoscope passes
      through the membranous urethra. Song et al did autopsy on males found dorsal nerve of the
      penis (DNP), the terminal branch of the pudendal nerve, innervates the membranous urethra in
      53.3% specimens. In addition, urethral mucosa has branches of DNP innervated. Dorsal penile
      nerve block (DPNB) is usually used for circumcision in children and it has been shown to
      provide effective analgesia for penile surgeries. According to the evidence that some DNP
      branches innervate membranous urethra and urethra mucosa and most pain originates from
      cystoscope passing through membranous urethra, we speculated that DPNB could overall reduce
      pain level in men during rigid cystoscopy.
    

Intervention name(s): Dorsal Penile Nerve Block; Ropivacaine; Tetracaine
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis; 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis; 1% Tetracaine gel instilled into urethra
Intervention MeSH terms: Ropivacaine; Tetracaine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Analgesia; Cystoscopy; Dorsal nerve of penis; Nerve block; Ropivacaine
The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      Proton Pump Inhibitors (PPI) are standard in the therapy of pediatric GERD. In the past it
      has been hypothesized, that either direct inhibition of bacterial ATPase or elevation of the
      pH may lead to changes in the intestinal microbiome. Small series published in adults suggest
      a predominance of streptococci, a possible reason for increased incidences of pneumonia under
      PPI therapy. Studies in children are yet scarce.

      This study will include 20 infants. GERD will be verified by 24h-intraluminal impedance
      monitoring. All patients will have undergone conservative measures prior to initiation of PPI
      therapy (due to persisting symptoms). Children will receive a commercial PPI for 8 weeks
      (esomeprazole 1mg/kg/day). Stool samples will be collected before initiation of PPI, under
      PPI (4 weeks after initiation) and 8 weeks after discontinuing PPI therapy. The intestinal
      microbiome will be determined by 16S rDNA-based microbial community profiling by
      high-throughput pyrosequencing.

      Data will be compared by dependent non parametric test (Wilcoxon). P-values <0.05 will be
      considered statistically significant.
    


Intervention name(s): PPI therapy; Stool sample; Stool sample; Stool sample
Intervention type(s): Drug; Procedure; Procedure; Procedure
Intervention description(s): PPI therapy (medication has FDA approval) for 8 weeks in children with proven GERD.
The medication used (esomeprazole) in this trial is approved by the FDA; Stool sample will be obtained before initiation of PPI (before PPI therapy); Stool sample will be obtained 4 weeks after initiation of PPI (under PPI therapy); Stool sample will be obtained 8 weeks after termination of PPI therapy (after PPI therapy).
Other intervention name(s): esomeprazole
Intervention MeSH terms: Esomeprazole
Intervention model: Single Group Assignment
Intervention model description: Longitudinal study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: infant; ppi; proton pump inhibitor; microbiome; Microbiota
Reducing Delay in Vaccination of Children: Logistic Barriers
Condition: Communicable Disease
MeSH terms: Communicable Diseases; Infections
Study type: Interventional

Summary: 
      This study will assess the impact of automated reminders for the 6 month and 12 month vaccine
      visits to increase vaccination in parents experiencing logistic barriers to vaccination.
    

Detailed description: 
      Parents of children less than 11 months of age will be identified as delayed or missing
      vaccinations due to logistic barriers in the Kaiser Permanente Colorado population. Parents
      identified will be randomized to the intervention arm or the usual care arm. Those in the
      intervention arm will receive automated reminders for the 6 month and 12 month vaccine
      visits. Reminders will include scheduling information as well as access to a website with
      vaccine and scheduling information. They will also have an opportunity to provide preferences
      in how they receive the automated reminders (text, phone or email). There will be 2 reminders
      before the 6 and 12 month visits and 2 after the 6 and 12 month visits. Parents will be
      excluded from receiving reminders if they have received vaccines within the time frame when
      they are eligible to receive another vaccine or have a well child visit scheduled.
    

Intervention name(s): Reminders
Intervention type(s): Behavioral
Intervention description(s): Automated reminders for the 6 month and 12 month vaccine visits for parents experiencing logistic barriers to vaccination.
Other intervention name(s): REDIVAC-Logistic Barriers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Logistic Barriers to Vaccination
Pilot Usability and Feasibility Testing on Kinect-Enhanced Training System for Lymphatic Exercises
Condition: Breast Cancer; Lymphedema
MeSH terms: Lymphedema
Study type: Interventional

Summary: 
      Correct performance of therapeutic lymphatic exercises has the potential to relieve
      lymphedema symptoms and optimize limb volume and lymph fluid level, in turn to improve breast
      cancer survivors' quality of life and reduce the risk of lymphedema. Kinect-TOLF
      (Kinect-Enhanced The-Optimal-Lymph-Flow Training System) is an innovative intelligent
      Kinect-enhanced training system to teach patients to perform the lymphatic exercises
      correctly. The Kinect-TOLF training system is not a medical device but a computer/mobile and
      motion-sensor program that helps patients to perform the lymphatic exercises correctly. The
      Kinect system can automatically detect whether a user is performing the set of lymphatic
      exercises correctly in real time and provide instantaneous feedback to the user, thus
      enhancing patients' self-efficacy to perform the lymphatic exercises correctly. The goal of
      the proposed project is to evaluate the usability and feasibility of Kinect-TOLF.
    


Intervention name(s): Kinect-TOLF Training System
Intervention type(s): Behavioral
Intervention description(s): This system will teach patients to perform the lymphatic exercises correctly. Like playing the video games, patients follow the avatar model in the video to perform the lymphatic exercises. The Kinect system can automatically detect whether a user is performing the set of lymphatic exercises correctly in real time and provide instantaneous feedback to the user, thus enhancing patients' self-efficacy to perform the lymphatic exercises correctly. Patients will be asked to conduct two types of usability testing: heuristic evaluation and end-user testing.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung
Condition: Lung Neoplasms
MeSH terms: Adenocarcinoma; Lung Neoplasms; Adenocarcinoma of Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in
      first-line treatment setting with patients who are having epidermal growth factor receptor
      mutation positive advanced adenocarcinoma of the lung.
    


Intervention name(s): Afatinib; gefitinib
Intervention type(s): Drug; Drug
Intervention description(s): afatinib once daily; Gefitinib once daily
Other intervention name(s): Giotrif® / Gilotrif®
Intervention MeSH terms: Gefitinib; Afatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment