bioihbjkbjnl/mcl2 huggingface dataset:
Phase III Study of Liquid Formulation of ROTAVIN
Condition: Diarrhea; Diarrhea Rotavirus
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is conducted to demonstrate non-inferiority in the immunogenicity of the liquid
      formulation of ROTAVIN in comparison to currently licensed frozen formulation of the vaccine
      (ROTAVIN-M1), 28 days after the second vaccination when administered as two dose series
      starting at 2-3 months of age.

      The study will also assess the reactogenicity of the vaccine 7 days after each vaccination
      and safety from first vaccination up to 4 weeks after the last vaccination.
    

Detailed description: 
      The study is designed as a phase III, randomized, partially double-blinded, active controlled
      study with two groups of infants receiving vaccines at the ratio of 2:1 (liquid formulation
      of ROTAVIN to frozen formulation ROTAVIN-M1), to compare their immunogenicity and safety. Two
      doses of vaccine will be administered 8 weeks apart with the first vaccine administration
      between 60-91 days of age. All childhood vaccines as per the Expanded Program for
      Immunization of the Government of Vietnam (including Diphtheria, Tetanus, Pertussis,
      Haemophilus influenzae type b and Hepatitis B vaccine (DTwPHib-HepB), and Oral Polio Vaccine
      at at 2, 3 and 4 months of age) will be allowed as per the immunization schedule.

      Active surveillance for vaccine reactogenicity (solicited reactions) over the 7-day period
      after each vaccination, unsolicited adverse events (AEs) for 4 weeks after each vaccination
      and serious adverse events (SAEs) including intussusception over the period between first
      vaccination and four weeks after the last vaccination will be conducted for all infants.

      This trial will generate immunogenicity and safety data which would be submitted to Ministry
      of Health in Vietnam for license of new formulation of ROTAVIN vaccine.
    

Intervention name(s): ROTAVIN (liquid formulation); ROTAVIN-M1 (frozen formulation)
Intervention type(s): Biological; Biological
Intervention description(s): Live attenuated human rotavirus vaccine containing ≥ 2x10^6 plaque forming units (PFU) of strain G1P[8] per dose of 2 mL.; Live attenuated human rotavirus vaccine containing ≥ 2x10^6 PFU of strain G1P[8] per dose of 2 mL.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible infants will be randomized to receive either ROTAVIN or ROTAVIN-M1 vaccines in the ratio of 2:1.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ROTAVIN; Rotavirus vaccine; Rotavirus; Diarrhea
Family and Personal History of Malignancy in Intraductal Papillary Mucinous Neoplasm (IPMN)
Condition: Pancreatic Cancer; Neoplasm
MeSH terms: Neoplasms; Pancreatic Neoplasms; Neoplasms, Cystic, Mucinous, and Serous
Study type: Observational

Summary: 
      This is a retrospective observational study to determine the proportion of patients with a
      family history of pancreatic cancer and other malignancies among patients who have
      intraductal papillary mucinous neoplasm (IPMN).

      The investigators will be reviewing the demographic, clinical, radiologic, pathologic, and
      follow-up information from the Pancres Center database. The investigators will also conduct a
      chart review to collect information recorded by clinicians on each subject's family history
      of malignancy and personal history of malignancy. Results of this database and chart review
      will be incorporated into a datasheet in which all patient identifiers have been removed.

      The primary outcome will be the percentage of IPMN patients with at least one first-degree
      relative with pancreatic cancer or IPMN, or at least two first or second degree relatives
      with pancreatic cancer, IPMN, or malignancies related to pancreatic cancer syndromes,
      including colorectal, gastric, breast, ovarian, and melanoma neoplasms. Secondary outcomes
      will be the relative risk of IPMN subtypes of higher malignant potential (main duct or mixed
      type location), more advanced histology (carcinoma in situ or invasive carcinoma), and
      recurrence following surgical resection amongst subjects with a family history.
    

Detailed description: 
      Intraductal papillary mucinous neoplasm (IPMN) is a cyst-like cancer of the pancreas that is
      increasingly being identified in medical practice, including during the screening of
      individuals at high risk of pancreatic cancer. It has been established that 10 to 20% of
      pancreatic cancers are familial. In comparison, there has been little research into the
      importance of genetic risk in IPMN incidence. The investigators will perform a retrospective
      chart review of patients with IPMN who were evaluated for surgical intervention at our
      tertiary referral center. The investigators are interested in determining the proportion of
      IPMN patients with a family history of pancreatic and other cancers. In addition, the
      investigators will assess if familial cancer risk is associated with increased risk for
      malignant IPMN and recurrence, relative to those patients without an inherited
      predisposition.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients seen at Columbia University Medical Center's Pancreas Center who have been
        diagnosed with intraductal papillary mucinous neoplasm, a cystic neoplasm of the pancreatic
        duct that has malignant potential.
      
Keywords: Pancreatic Cancer; Family History; Pre-cancerous lesion; Intraductal Papillary Mucinous Neoplasm (IPMN); Intraductal Papillary Mucinous Neoplasm
Evaluating a Web-Based Cardiovascular Disease Risk Factor Reduction Program Among American Indians
Condition: Cardiovascular Diseases; Diabetes Mellitus, Type 2; Hypertension; Obesity; Tobacco Use Cessation
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Cardiovascular disease (CVD) is a serious health concern for American Indians, but there have
      been few behaviorally based programs to lessen CVD risk among this population. The purpose of
      this study is to evaluate whether a Web-based program, in addition to usual medical care, can
      lower CVD risk factors among American Indians who have type 2 diabetes and a high risk of
      developing CVD.
    

Detailed description: 
      Cardiovascular disease (CVD) is a leading cause of death among American Indians. Significant
      risk factors for CVD within the American Indian population include type 2 diabetes, tobacco
      use, poor dietary and physical activity habits, and poor medication and treatment adherence.
      Despite the fact that these risk factors can be reduced through behavior change, there have
      been few behaviorally based interventions aimed at American Indians to lessen their CVD risk.
      Research has shown that medical care is moving away from sporadic, standard doctors' office
      visits to a more continuous and interactive relationship with health care providers. A
      Web-based program that allows people to interact with remotely located doctors who can answer
      questions and provide advice may be beneficial at increasing treatment adherence and lowering
      CVD risk. This study will evaluate the use of a Web-based program at lowering CVD risk among
      American Indians with type 2 diabetes. Researchers will also analyze the cost-effectiveness
      of the Web-based program and the possible healthcare cost savings.

      This 3-year study will enroll American Indian adults at high risk for CVD. Participants will
      be randomly assigned either to usual care at their local health facility or usual care plus
      the Web-based program. Participants using the Web-based program will have access to a Web
      site that will allow them to interact with two remotely based doctors. Participants will be
      able to send e-mail and instant messages to ask questions and receive information, advice, or
      motivational messages from the doctors. Participants will periodically enter their blood
      glucose test results and complete questionnaires online. Study visits, occurring twice a year
      for 3 years, will include blood pressure and body mass index (BMI) measurements, blood
      collection, and smoking status assessments.
    

Intervention name(s): Chronic disease management Web-based software
Intervention type(s): Behavioral
Intervention description(s): Participants will have access to remotely based medical providers through the use of the Web-based software.
Other intervention name(s): CliniPro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
RCT Comparing Ion Levels and Clinical Outcomes of A-Class BFH to Metal on Polyethylene Total Hip Replacement
Condition: Hip Joint; Osteoarthritis; Arthroplasty
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The main purpose of this prospective randomized controlled trial is to compare the
      concentrations of metal ions in the blood and urine of patients receiving implants that are
      identical except for the acetabular component: one is a monoblock and all cobalt chrome, and
      the other is modular with a titanium acetabular shell with a polyethylene insert.
    

Detailed description: 
      The primary aim of this study is to demonstrate that blood ion levels (cobalt and chromium)
      are lower at one year in patients who receive a metal on polyethylene total hip as compared
      to CONSERVE® A-Class Total Hip with BFH® technology. Secondary aims include the gathering of
      clinical data regarding survival and dislocation rates at two years post surgery, as well as
      the assessment of pain, physical function, radiographic and clinical outcome at the two year
      interval.
    

Intervention name(s): Blood metal ion levels
Intervention type(s): Diagnostic Test
Intervention description(s): Blood and urine will be collected and the levels of cobalt and chromium ions will be tested.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Individuals undergoing unilateral total hip replacement.
Asthma in the Delta Region of Arkansas (ADRA): Prevalence and Morbidity
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of the study is to conduct a cross-sectional study to examine asthma prevalence
      and morbidity in a predominately minority, low-income population in rural Arkansas.
    

Detailed description: 
      Asthma is the leading chronic disease of childhood in the United States and an important
      public health concern in Arkansas. Arkansas, a predominately rural state, has one of the
      leading mortality rates in the nation for African Americans. The specific aims of the study
      will examine asthma prevalence in children age 4-17 years old in public schools in Eudora and
      Marvell Arkansas. The study will also examine asthma morbidity among identified asthmatics by
      characterizing activity limitation, days missed from school, daytime and nocturnal symptoms,
      healthcare utilization and medication use. The specific aims of the current study will
      provide novel data on an understudied population of asthmatics and will test our working
      hypotheses that pediatric asthma prevalence in the Delta region of Arkansas is higher than
      national estimates; and asthma diagnosis is related to significant morbidity among rural
      asthmatics.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        During the 2005-2006 school year, primary caregivers of all students aged 4-17 years
        attending public school in Eudora and Marvell Arkansas were asked to complete an asthma
        screening survey regarding their child. The schools are located in two non-contiguous
        counties in the Delta region of Arkansas and are in rural low-income areas of the state
        where more than one-third of families with children 5-17 years old meet the 2000 poverty
        line (Census bureau).
      
Keywords: Asthma; minority; low-income; African American; Arkansas
Serum Concentration of lgG in Patient With Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Observational

Summary: 
      The aim of this study is to investigate the changes in glycopeptides of serum immunoglobulin
      G in patients with acute myocardial infarction and the relationships between its change and
      prognosis.
    

Detailed description: 
      Immunoglobin G (IgG), a highly abundant glycoprotein in serum, is known to participate in
      blood immune responses.It has been an increasing interest in the analysis of the abnormal
      glycosylation of human lgG in healthy and disease states, such as autoimmune diseases and
      cancer.However, there is few relevant studies about the changes in glycopeptides of serum
      immunoglobulin G in patients with acute myocardial infarction. This study was performed for
      the frst timeto assess the quantitative changes of serum IgG glycosylation in patients with
      acute myocardial infarction and the relationships between its change and prognosis.
    

Intervention name(s): Quantitative measurements the changes of IgG glycosylation
Intervention type(s): Diagnostic Test
Intervention description(s): Serum (50 each group) is obtained into ethylenediaminetetraacetic acid（EDTA） tubes from all subjects via antecubital venepuncture.Blood is obtained into ethylenediaminetetraacetic acid（EDTA） tubes from all subjects via antecubital venepuncture to assess the quantitative changes of IgG glycosylation by HPLC-MRM at 0 , 3 and 7 days after admission.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        50 with ST-elevation myocardial infarction (STEMI) patients and 50 age and body mass index
        matched healthy subjects with neither coronary artery disease nor any of the components of
        the metabolic syndrome are studied as Control group. They will all undergo coronary
        angiography.The diagnosis is made according to American Heart Association(AHA, 2014 and
        2015) guidelines. Patients who had autoimmune diseases, malignancies, chronic or acute
        infections, asthma, severe heart failure (NYHA class 3 and 4) and advanced liver or renal
        diseases are excluded.
      
Keywords: immunoglobulin G
Premature Fatigue in Veterans With Heart Failure: Neuronal Influences
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A hallmark of patients with heart failure (HF) is premature fatigue which impairs their
      quality of life and depicts a major source of morbidity. Premature fatigue may be attributed
      to a) contraction-induced transient changes within muscles (i.e. peripheral fatigue) and/or
      b) failure of the central nervous system to 'drive' / activate locomotor muscles (i.e.
      central fatigue). Both determinants of fatigue can lead to a reduction in a muscle's force
      and power generating capacity and to a compromised ability to perform whole body activities
      (e.g. walking). Recent findings in health have documented that group III/IV afferent fibers
      from the working muscle play a critical role in the development of both components of
      fatigue. Specifically, group III/IV muscle afferents limit central motor drive (CMD) during
      exercise and thereby exaggerate the development of central fatigue. In contrast, muscle
      afferents optimize muscle O2 delivery through the precise regulation of circulation and
      ventilation during exercise and thereby attenuate the development of peripheral fatigue.
    

Detailed description: 
      Recent findings in HF suggest an altered effect of group III/IV muscle afferents in this
      population. Although normal afferent feedback is crucial for adequate O2 delivery during
      exercise, excessive neural feedback has substantial negative consequences. HF patients are
      characterized by augmented neural feedback arising from overactive muscle afferents. It has
      been hypothesized that this abnormality compromises locomotor muscle O2 delivery in these
      patients. Therefore, the abnormally elevated muscle afferent feedback in HF might exacerbate,
      compared to healthy age- and activity matched individuals (CTRLs), the development of both
      peripheral (via limiting O2 delivery) and central (via restricting CMD) fatigue during
      exercise. Recent advances in non-invasive stimulation techniques offer a genuine opportunity
      to identify the sites and synaptic mechanisms that mediate central and peripheral fatigue
      including alterations in the responsiveness of the corticospinal tract (i.e. a determinant of
      central fatigue). Taken together, the proposed studies aim to determine the impact of HF on
      the precise development of central and peripheral fatigue during both whole body and single
      muscle exercise and evaluate the extent to which group III/IV muscle afferents contribute to
      this development.
    

Intervention name(s): Electrical and Magnetic Nerve Stimulators; Intrathecal Fentanyl
Intervention type(s): Device; Drug
Intervention description(s): Stimulation of motor nerve and central nervous system; Mu-opioid receptor agonist
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Heart Failure
MIDCAB (Mid-Calf Block) for Foot Surgery
Condition: Ankle Surgery; Foot Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      MIDCAB is defined as a group of ultrasound guided distal nerve blocks at the level of the
      individual branches. It is similar to an Ultrasound Guided (USG) Ankle block but the probe is
      placed higher on the calf covering all and any surgery of the foot and ankle, providing
      prolonged analgesia since we are blocking the individual nerves and preserving the proximal
      motor function.

      This study is determining the potential therapeutic effect of MIDCAB during the hospital stay
      and recovery period in patients undergoing foot/ankle surgeries that require spinal
      anesthetic and peripheral nerve blocks. A total of 20 patients at HSS will participate to see
      if MIDCAB is not only effective at providing analgesia (pain relief) but to see if it allows
      allows patients to maintain motor function (movement) of the foot and ankle unlike the
      current popliteal block which is done above the knee and prevents patients from moving their
      foot.

      During the course of the study we will also be looking at patients numeric pain scores with
      movement and at rest along with post-operative nausea and vomiting, the presence of numbness
      and it patients can move their foot. Along with all of these, the study will also look at the
      amount of opioid pain medications taken by patients along with medication-related side
      effects. As a result, the study will be used to determine if MIDCAB provides analgesia for
      patients undergoing foot/ankle surgery while allowing them to maintain movement of the foot.
      This pilot study will also be used to gather preliminary data that will allow us to perform a
      power analysis for a subsequent randomized clinical control trial that would compare the
      MIDCAB block to the popliteal block.
    


Intervention name(s): MIDCAB
Intervention type(s): Drug
Intervention description(s): Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients.
Other intervention name(s): Bupivacaine and dexamethasone
Intervention MeSH terms: Dexamethasone; Bupivacaine
Intervention model: Single Group Assignment
Intervention model description: All participants will receive the active MIDCAB block.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: foot and ankle surgery
Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP
Condition: Purpura, Thrombocytopenic, Idiopathic
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine if the safety and tolerability of Immune Globulin
      Intravenous (Human), 10% Caprylate/Chromatograph Purified (IGIV-C) is similar when infused at
      two different infusion rates.
    

Detailed description: 
      This is a prospective, randomized, single-center, open, cross-over trial in patients with a
      confirmed diagnosis of Idiopathic Thrombocytopenia Purpura (ITP). ITP is defined as isolated
      thrombocytopenia in a patient with no other clinically apparent associated conditions or
      factors that are known to cause thrombocytopenia as defined by the ITP Practice Guidelines
      Committee of the American Society of Hematology.

      Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) at a dose
      of 1.0 g/kg will be given on 2 occasions as a single daily infusion for platelet counts <
      30,000 microliters (uL) or if clinically indicated, at maximum intervals of six weeks.
      Eligible patients will be randomized into one of two cross-over groups. Patients randomized
      to Group 1 will receive their first IGIV-C infusion at a rate of 0.08 mL/kg/min and their
      second infusion at a rate of 0.14 mL/kg/min. Conversely patients randomized to Group 2 will
      receive their first IGIV-C infusion at a rate of 0.14 mL/kg/min and their second infusion at
      a rate of 0.08 mL/kg/min according to the following schema:

      Group 1:

        -  Infusion #1 (Week 0) IGIV-C (0.08 mL/kg/min)

        -  Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)

      Group 2:

        -  Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min)

        -  Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
    

Intervention name(s): Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified
Intervention type(s): Drug
Intervention description(s): IGIV-C 10% at a dose of 1.0g/kg was to be given on 2 occasions as a single daily infusion: Group 1 were to receive their first IGIV-C, 10-% infusion at a rate of 0.08 mL/kg/min and a second infusion at 0.14 mL/kg/min. and Group 2 were to receive their first IGIV-C, 10-% infusion at a rate of 0.14 mL/kg/min and a second infusion at a rate of 0.08 mL/kg/min.
Other intervention name(s): Gamunex®; IGIVnex®; Gaminex; IGIV-C; IGIV-C, 10%; IVIG; BAY 41-1000; TAL-05-00004; Immune Globulin (Human), 10% (IGIV); Immune Globulin Intravenous, 10% by Chromatography Process; NDC 13533-645-12; NDC 13533-645-15; NDC 13533-645-20; NDC 13533-645-24; NDC 13533-645-71
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Idiopathic (Immune) Thrombocytopenic Purpura; Immunoglobulin G