bioihbjkbjnl/mcl2 huggingface dataset:
Eribulin Treatment as 1st-line or 2nd-line Chemotherapy for HER2-negative Hormone-resistant Inoperable or Recurrent Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This is a observational study in a real-world setting, not requiring determining a dosage
      regimen, dose reduction criteria, rest period criteria and withdrawal criteria. The purpose
      of the study is to investigate the efficacy of eribulin as the first or second line
      chemotherapy to prolong overall survival and to explore factors affecting the survival in
      patients with HER2-negative hormone-resistant inoperable or recurrent metastatic breast
      cancer who scheduled to receive the first or second line chemotherapy in clinical practice in
      Japan. The total duration of the study will be a maximum of 5 years, consisting of 2-year
      enrollment period and 3-year observational period; the duration of patient participation will
      be 3 years. All patients will receive adequate treatment for breast cancer which selected by
      the primary physician after enrollment using the Japanese Breast Cancer Society Clinical
      Practice Guideline of Breast Cancer and the National Comprehensive Cancer Network (NCCN)
      Clinical Practice Guidelines in Oncology. Investigators at the investigational sites will
      enter patient data into an electronic data capture (EDC) system up to the third chemotherapy
      in the study. The end of the study is defined as the time the last patient completes
      observational period. Patients will primarily be assessed by overall survival (OS) of the
      first line chemotherapy.
    


Intervention name(s): Eribulin
Intervention type(s): Drug
Intervention description(s): Eribulin 1.4 mg/m2 will be administered intravenously over 2 to 5 minutes on day 1 and 8 of every 21-day cycle, in a real-world setting.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female patients with HER2-negative hormone-resistant inoperable or recurrent metastatic
        breast cancer, who are scheduled to receive the first or second line chemotherapy in
        clinical practice in Japan.
      
Keywords: Breast Cancer; Eribulin; HER2-negative; hormone-resistant; inoperable; recurrent metastatic
Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the
      pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by
      determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary
      pharmacokinetic data as well as first information on food effects after administration of the
      75 mg WIF tablet in healthy male volunteers
    


Intervention name(s): BIIL 284 oral solution; BIIL 284 wetability improved formulation (WIF) tablets; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability
      of two different paracetamol-containing solutions in postoperative total hip replacement.
      They will be compared to placebo (a dummy treatment which contains no active ingredient).
    


Intervention name(s): Paracetamol (acetaminophen); Paracetamol 1% solution; 0.9% sodium chloride solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Four 100 mL, 15 min IV infusions at six hour intervals; Four 100 mL, 15 min IV infusions at six hour intervals; Four 100 mL, 15 min IV infusions at six hour intervals
Other intervention name(s): Perfalgan; Normal saline solution
Intervention MeSH terms: Acetaminophen; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain, postoperative; replacement, total hip; total hip replacement; arthroplasty, replacement, hip
Effects of Epicatechin on Statins for Mitochondrial Dysfunction and Impaired Exercise Capacity
Condition: Statin Intolerance
Study type: Interventional

Summary: 
      The purpose of this study is to gain insight into the side-effects of statin consumption, and
      assess the ability of epicatechin (a compound in dark chocolate) to counteract or reverse
      these changes. The investigators' prior research has shown that epicatechin can improve
      skeletal muscle structure and mitochondrial (which gives us energy) structure.
    

Detailed description: 
      Patient Inclusion Criteria:

        1. Must be between 30-75 years of age.

        2. Must have a VO2max greater than 18 ml/kg/min(non-sedentary individuals).

        3. Subjects with LDL>100mg/dL (or on drug treatment)

        4. Subjects without a prior cerebrovascular event (example: stroke)

        5. Subjects without a prior cardiovascular event (example: heart attack)

      Patient Exclusion Criteria:

        1. Liver, thyroid, or kidney disease.

        2. Currently taking drugs that interfere with statin metabolism (calcium channel blockers,
           colchicine etc.).

        3. Acute or chronic infectious disease; autoimmune/inflammatory disease, cancer, COPD,
           anemia, diabetes, psychiatric illness.

        4. Non-smokers, prior smokers, or illicit drug users with abstinence >1 year.

        5. Subjects taking blood thinners (Coumadin, xarelto, pradaxa, Plavix, effient, apixiban,
           etc) will be excluded. If subjects are taking aspirin for routine prevention they will
           be asked to hold aspirin for 7 days prior to biopsy. Routine prevention means that the
           patients are taking aspirin to reduce their risks, but do not have established
           cardiovascular disease.

        6. History of previous knee surgery and active history of knee pain or neuromuscular
           disease are exclusions as they are known to affect muscle structure and function.

      The study will be a double blind placebo controlled study where subjects will be randomized
      to either of two groups:

        1. Simvastatin 40 mg + placebo once daily (statin only group) for 3 months

        2. Simvastatin 40 mg + Epi 50 mg once daily (statin + Epi group) for 3 months
    

Intervention name(s): Pure epicatechin capsules (50mg); Simvastatin (40mg); Placebo
Intervention type(s): Dietary Supplement; Drug; Other
Intervention description(s): Epicatechin is a compound found naturally in dark chocolate.; A cholesterol-lowering medication that blocks the production of cholesterol.; A substance that has no therapeutic effect and will act as a control.
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: myopathy; muscular weakness; cramping; fatigue
Impact of Pollution on Allergic Rhinitis and Sleep Quality: the POLLAR Study
Condition: Sleep Apnea; Allergic Rhinitis; Allergic Asthma; Pollution Exposure; Pollution Related Respiratory Disorder
MeSH terms: Rhinitis; Rhinitis, Allergic; Respiration Disorders; Respiratory Tract Diseases
Study type: Interventional

Summary: 
      It has been demonstrated that allergic rhinitis (AR) reduces sleep quality by some components
      such as nasal obstruction. Pollution and allergen exposure worsening AR, sleep quality is
      deteriorated.

      Sleep is associated to physical and mental health, alterations in sleep could explain the
      link between AR and work productivity diminution, impairment in daily activities or emotional
      problems.

      However, interactions between air pollution, sleep and allergic diseases are insufficiently
      understood.

      The main objective of this study is to determine the impact of pollution and pollens on sleep
      parameters.
    

Detailed description: 
      Over 150 million people have allergic rhinitis (AR) in Europe and around 30% have
      uncontrolled AR during allergen exposure. It has been demonstrated that AR reduces sleep
      quality by some components such as nasal obstruction. Pollution and allergen exposure
      worsening AR, sleep quality is deteriorated.

      Sleep is associated to physical and mental health, alterations in sleep could explain the
      link between AR and work productivity diminution, impairment in daily activities or emotional
      problems.

      However, interactions between air pollution, sleep and allergic diseases are insufficiently
      understood.

      Moreover, the prevalence of OSA in patients with AR is higher than in subjects without AR.
      Nasal obstruction could explain the increased risk of OSA.

      This prospective, open study will compare sleep quality in 2 different groups: AR patients
      and patients without AR during the pollen season and outside the pollen season.The main
      objective is to determine the impact of pollution and pollens on sleep parameters for
      subjects with AR
    

Intervention name(s): Pollution exposure
Intervention type(s): Other
Intervention description(s): Pollution exposure and sleep data will be recorded by pollution sensor and polysomnography respectively. In order to compare the variations according to the pollinisation season and the allergic rhinitis status of the patients.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Prospective, open study comparing sleep quality in 2 different groups: AR patients and patients without AR during the pollen season and outside the pollen season.
Masking: None (Open Label)
Primary purpose: Other
Concussion in Motor Vehicle Accidents: The Concussion Identification Index
Condition: Motor Vehicle Accidents; TBI (Traumatic Brain Injury); Brain Contusion; Brain Injuries; Cortical Contusion; Concussion Mild; Cerebral Concussion; Brain Concussion; Accidents, Traffic; Traffic Accidents; Traumatic Brain Injury With Brief Loss of Consciousness; Traumatic Brain Injury With no Loss of Consciousness; Traumatic Brain Injury With Loss of Consciousness
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Unconsciousness; Brain Contusion; Wounds and Injuries; Contusions
Study type: Observational

Summary: 
      The primary goal of this study is to provide clinicians with a brief, patient self-administer
      instrument yielding a single composite score that reliably correlates with objective findings
      on standardized neurocognitive assessment for concussion.
    

Detailed description: 
      This Phase 2 study, Concussion in Motor Vehicle Accidents - The Concussion Identification
      Index (CIDI), focuses on the psychometric properties of the relationship between acute injury
      events, i.e. head impact, loss of consciousness (LOC), and post-traumatic amnesia (PTA),
      commonly reported post-crash signs and symptoms, and neurocognitive outcomes.

      Cohort 1 is the validation group and will be used to confirm the optimal cut-off score of the
      Concussion Identification Index (CIDI) with the score on the ImPACT.

      Cohort 2 is the cross-validation group.
    

Intervention name(s): The Concussion Identification Index; ImPACT
Intervention type(s): Other; Other
Intervention description(s): Patient completion of the Concussion Identification Index, a report of crash characteristics, injuries sustained, and post-accident neurological signs and symptoms; Patient- completed computerized neurocognitive test battery
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Cohort 1 - Validation Group: Consecutive patients who presented for care between November
        1, 2013 and December 31, 2014 at the MVA Center for Rehabilitation, a public health clinic
        in Springfield, MA which provides specialized outpatient auto accident treatment and
        rehabilitation

        Cohort 2 - Cross Validation Group: Consecutive patients who presented for care between
        January 1, 2015 and June 30, 2016 at the MVA Center for Rehabilitation, a public health
        clinic in Springfield, MA
      
Keywords: Mild traumatic brain injury
Quality of Life in Children With Psychiatric Disorders and Parental Well-being: Effects of Group CBT
Condition: Quality of Life
MeSH terms: Mental Disorders; Problem Behavior
Study type: Interventional

Summary: 
      This study examines the immediate and long-term effectiveness of a group cognitive behavioral
      therapy intervention (GCBT) in improving health-related quality of life (HRQOL) in children
      treated for mixed psychiatric disorders in naturalistic child psychiatric outpatient
      settings. The effects of a treatment-as-usual condition (TAU) is also examined. Further, the
      study aims to explore the associations among children´s HRQOL dimensions and parental
      well-being, and how GCBT may influence these associations.
    

Detailed description: 
      The effectiveness of GCBT and TAU at the different time points are measured using
      nonparametric tests, such as Friedman tests and Wilcoxon tests. The associations among
      children´s HRQOL dimensions and parental well-being variables at different time points are
      explored using a network analysis approach.
    

Intervention name(s): Friends program; TAU
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A GCBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions; Individually tailored and delivered specialized child psychiatric care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quality of life; Health-related quality of life; Children; cognitive behavioral therapy; group cognitive behavioral therapy; parental wellbeing
Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the
      2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in
      the EU and many other worldwide countries, according to the US FDA Draft Guidance for
      Industry "Clinical data needed to support the licensure of trivalent inactivated influenza
      vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and
      immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional
      influenza vaccine already licensed in US. The purpose of the control arm is primarily to
      provide a comparative assessment for safety, not immunogenicity or effectiveness.
    


Intervention name(s): Influenza virus vaccine; Comparator influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.; Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza, Egg-Derived, Healthy Children, Healthy Adolescents, Healthy Adults, Safety, Immunogenicity, Trivalent, Inactivated, Vaccination
SmokefreeMOM: Reaching Pregnant Smokers With Health Information Via Text Messaging
Condition: Pregnancy; Smoking Cessation
Study type: Interventional

Summary: 
      Despite the great health benefits associated with smoking cessation in pregnancy to both
      mother and baby, few studies to date have examined the applications of text messaging or
      other communication technologies for smoking cessation in this population. This project is
      the first step in developing a new dissemination strategy for reaching pregnant smokers. This
      research will explore how a state-of -the-art, interactive and intensive, text messaging
      program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers. This program
      may have the potential to reach pregnant smokers who are not currently being reached with
      traditional smoking cessation services. The study Aims are: 1) to elicit qualitative feedback
      from pregnant smokers and recent quitters (in the past month) about the concept of
      SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed messages in
      SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of SmokefreeMoms which is
      consistent with Clinical Practice Guidelines (Phase 2), and 3) To conduct a formative
      evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent quitters (Phase 3). 4) To
      measure the likelihood that pregnant women who smoke cigarettes will join an SMS program by
      responding to different types of recruitment messages.
    


Intervention name(s): SmokefreeMOM Text
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mHealth
A Comparison of Volatile Anesthesia and Total Intravenous Anesthesia (TIVA)
Condition: Rhinoplasty; Ecchymosis; Edema; Hemorrhage
MeSH terms: Ecchymosis; Hemorrhage
Study type: Observational [Patient Registry]

Summary: 
      In this study, investigators wanted to investigate the effect of volatile anesthesia and
      total intravenous anesthesia (TIVA) on ecchymosis, edema, and intraoperative bleeding in
      rhinoplasty.
    

Detailed description: 
      Routine monitorization (blood pressure, pulse, oxygen saturation with pulse oximetry and
      electrocardiogram) will be applied to all patients taken into the operation room.

      In Group P (TIVA), induction of anesthesia will be achieved with 2 mg/kg propofol, 0.6 mg/kg
      rocuronium, and 1 μ / kg fentanyl. Propofol and remifentanil will be used in the continuation
      of anesthesia.

      In Group S (Volatile), anesthesia will be induced with 2 mg / kg propofol, 0.6 mg / kg
      rocuronium and 1 μ / kg fentanyl. 50% nitrous oxide + 50% oxygen and 2% sevoflurane will be
      used in the continuation of anesthesia.

      All patients will receive 2 ml/kg/hour Ringer's lactate solution during the operation.
    

Intervention name(s): Different anesthesia methods
Intervention type(s): Other
Intervention description(s): Total intravenous anesthesia (TIVA)and volatile anesthesia
Intervention MeSH terms: Anesthetics
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Rhinoplasty patients
A Multiple Dose Study of LY2541546 in Healthy Postmenopausal Women
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and side effects of multiple doses of
      LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin)
      and intravenously (directly into a vein). The study will also test how long it takes the
      study drug to get into the body, how long it takes the body to get rid of it, the overall
      effect of the study drug on the body, and whether antibodies to the study drug are formed.
    


Intervention name(s): LY2541546 - SC; LY2541546 - IV; Placebo - SC; Placebo - IV
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered SC; Administered IV; Administered SC; Administered IV
Other intervention name(s): Blosozumab; Blosozumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Postmenopausal females; Volunteers
Clinical Sciences Research Proposal- The Effect of Physical Exercise on PCOS Overweight Female Adolescents
Condition: Polycystic Ovary Syndrome; Overweight
MeSH terms: Polycystic Ovary Syndrome; Overweight; Syndrome
Study type: Interventional

Summary: 
      The Poly Cystic Ovary Syndrome (PCOS), is one of the most common reasons for subfertility,
      oligomenorrhea and amenorrhea. With the occurrence of 6-20% of the general adult women
      population. One of the main criteria of this syndrome is a hyper androgenic state.

      More than 50% of women who have PCOS are overweight. In the teenage population, PCOS is
      common in 5-10% of teenage girls. A recent research has shown that elite athlete teenage
      girls have higher serum androgen levels, especially in anaerobic types of sport.

      The purpose of this experiment is to examine the reaction of teenage PCOS overweight girls
      towards anaerobic exercise. To determine if their hyperandrogenic state is more adapted to
      excel in anaerobic exercise compared to teenage overweight girls without PCOS.
    

Detailed description: 
      30 teenage and young adult females, aged 10-25 years old. The minimum hormonal age for
      inclusion is menarche. Overweight- with a Body Mass Index (BMI) percentage above 85%, divided
      into 2 groups: 15 girls with diagnosed PCOS, and 15 girls without diagnosed PCOS, without any
      other medical comorbidities. Followed at the pediatric endocrinology unit.

      The 2 groups would participate in 2 anaerobic tests to evaluate their performances. The data
      received will be used to evaluate their anaerobic attributes, and for comparison between the
      2 groups to determine any differences.

      The participants will be asked to refrain from any form of physical exercise during the
      previous day.

      After explanation to the patient and his parent and obtaining an informed consent, the
      participants will start the tests.

      The first test is the Repeated Sprint Test: The participant will run a distance of 40 meters,
      for 6 repetitions. The optimal running time will be calculated, total running time and the
      Performance Decrement of the run will be calculated.

      After that, there will be a 1-1.5 hours resting phase. The second test is the "Wingate Test"-
      the participants will be instructed to pedal at a maximal pace for 30 seconds on an
      ergometric bicycle against a resistance adjusted according to their BMI. The Peak Anaerobic
      Power, the Mean Anaerobic Power and the Fatigue Index will be calculated.
    

Intervention name(s): anaerobic exercise
Intervention type(s): Other
Intervention description(s): assessing anaerobic exercise status
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic