bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part V
Condition: Hypothermia; Newborn
MeSH terms: Hypothermia
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall hypothesis is that plastic bags used in combination with WHO thermoregulation
      care will reduce the incidence of hypothermia in preterm/low birth weight and full term
      infants when compared to routine WHO thermoregulation care alone. Part V is comparing
      standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso
      wrap in full term infants from resuscitation to one hour after birth.
    

Detailed description: 
      Due to delivery rooms without adequate climate controls, even full term infants have high
      rates of hypothermia in the developing world. This study will compare the rates of
      hypothermia one hour after birth in full term infants randomized to receive standard WHO
      thermoregulation care (control group) or standard WHO thermoregulation care without immediate
      drying plus a plastic bag covering their torsos and lower extremities (intervention group).
      The axillary temperature of each infant will be taken within 15 minutes of birth at at one
      hour after birth with removal of the plastic bag. Hyperthermia, room temperature, and death
      will be recorded throughout the hospitalization for all infants. With an estimated baseline
      hypothermia rate of 15% and a hypothesized 10% absolute risk reduction (66% relative risk
      reduction), a sample size of 276 will be used to have a power of 80% and a confidence
      interval of 95%.
    

Intervention name(s): Resuscitation with torso plastic bag; Resuscitation-no plastic bag
Intervention type(s): Procedure; Procedure
Intervention description(s): Infant will be placed within 10 minutes of his birth into a plastic bag to his/her axillae and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. After his/her head is dried, the infant will receive a cloth cap. Resuscitation will occur in the delivery room and the infant will be wrapped in a blanket and taken to the nursery where he/she will remain in the plastic bag until 1 hour after birth.; Infant will be immediately dried and resuscitated in the delivery room per standard of care. The infant will be wrapped in a blanket and will receive a cloth hat before being taken to the nursery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypothermia; Newborn; Plastic bag; Resuscitation
A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain
Condition: Adult Intracranial Tumor; Adult Solid Tumor
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This will be a randomized blinded clinical trial. Patients will be randomized to receive
      either a remifentanil or dexmedetomidine infusion for general anesthesia. The anesthesia team
      will know the result of randomization at induction. Data will be gathered by research
      personnel who will be blinded to the anesthetic method used. Patients will be blinded to the
      anesthetic they receive till they are discharged from the PACU when they will have the option
      to be unblinded. The Data Safety and -Toxicity Committee will review all serious adverse
      events and toxicity reports as well as annual reviews.
    

Detailed description: 
      Anesthesia for craniotomy presents a unique challenge to the anesthesiologist. Anesthesia for
      neurosurgical procedures should provide optimal surgical conditions while maintaining
      appropriate cerebral oxygen supply and stable systemic hemodynamics. (1) It is important to
      prevent patient response to noxious stimuli during the procedure like pinning, drilling of
      the bone, opening and manipulation of the dura etc., avoid coughing and bucking during
      surgery and during extubation thus necessitating a deeper level of anesthesia and analgesia.
      At the same time it is desirable to have the patient fully awake toward the end of the
      surgery in order to facilitate neurologic evaluation. Management of the above presents a
      challenge during induction, maintenance and extubation and also during multiple critical
      stages of surgery Fear of the side effects of analgesic drugs frequently leads to the
      under-treatment of post-craniotomy pain. (2) Nevertheless, this pain continues to be commonly
      observed, is frequently severe, and, if unrelieved, may cause distress for the neurosurgical
      patient and serious complications for the operative brain. (2) There is a need for larger
      trials to delineate safety and efficacy of analgesic therapies with a focus on short- and
      long-term outcomes.
    

Intervention name(s): Remifentanil; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS; a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Other intervention name(s): Ultiva, G187084B; Precedex, Dexmedetomidine Hydrochloride
Intervention MeSH terms: Dexmedetomidine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Craniotomy, pain relief; Adult solid neoplasm
Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage
Condition: Post Partum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Maternal Death; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      Null hypothesis: 10 IU Oxytocin is better than sublingual misoprostol 600µg in management of
      third stage of labor Alternative hypothesis: Sublingual misoprostol 600µg is non- inferior to
      10 IU oxytocin and will not be more than 6% worse [than 10 IU oxytocin] in management of
      third stage of labor
    

Detailed description: 
      Background: In Sub- Saharan Africa, one in 35 women die in child birth, 1000 times higher
      than the western world and Post-Partum Hemorrhage (PPH) accounts for the biggest percentage
      of maternal morbidity and mortality (WHO, 2005; WHO, 2010). Maternal Mortality in Uganda is
      one of the highest in the world at 435 for every 100,000 and 25% of these are due to PPH
      happening within 24 hours after delivery. Oxytocin, the standard of care in PPH management
      has registered challenges like requirement of sterile injections, requirement of trained
      personnel, special supply chain/storage conditions like refrigeration and protection from
      light affecting maximum treatment outcomes especially in poorly resourced developing
      countries where these are not realized. It has been argued that any effort or developments
      based on physiological processes towards the reduction of this horrific PPH rate would
      greatly have a significant impact on the lives of families and women worldwide. Several
      scholars have thus stressed a vital need to develop simple, practical and inexpensive
      techniques relevant to prevent and treat PPH in developing countries.
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): Is a prostaglandin
Other intervention name(s): Prostaglandin, Cytotec
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or
      24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation
      of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue
      PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or
      relapsers patients coinfected with HIV
    


Intervention name(s): PegIFN/RBV; PegIFN/RBV; BI201335; BI201335 24W; PegIFN/RBV; Bi 201335
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): PegIFN/RBV for 24 or 48w; PegIFN/RBV for 24 or 48w; BI201335 for 12w; BI201335 for 24w; PegIFN/RBV for 24 or 48w; BI 201335 for 24 w
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Iontophoretic Application of Acyclovir Cream to Treat Recurrent Herpes Labialis
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional
Phase: Phase 2

Summary: 
      Currently approved drugs for the treatment of herpes labialis (cold sores) exhibit low levels
      of efficacy due to the limited ability of the drugs to penetrate the skin to the site where
      the herpes virus is replicating. Iontophoresis uses electric current to enhance the delivery
      of drugs through the skin. This trial is testing a new iontophoretic device for the delivery
      of acyclovir cream to treat cold sores.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the
      safety and efficacy of iontophoretically-applied acyclovir 5% cream for the treatment of
      herpes simplex labialis lesions including an open label arm using Zovirax (acyclovir) Cream
      5% as per standard of care in the same patient population. Subjects who meet the eligibility
      requirements at the screening/randomization visit will be randomized in a 1:1:1 ratio to one
      of the three treatment groups. After being enrolled and randomized into the study, subjects
      will be sent home with a locked kit containing the iontophoretic device with either active or
      placebo cream or a locked kit containing Zovirax Cream 5%. At first signs and/or symptoms of
      a recurrent herpetic episode (Stage 0 or 1, prodromal or erythema), the lesion will be
      confirmed by telephone interview with the subject, and upon confirmation of the lesion, the
      subject will be given the combination to the locked kit and instructed to begin treatment
      immediately, thereby initiating the Treatment Phase of the study. Subjects will be followed
      for at least 5 consecutive days post-treatment up until a maximum of 10 consecutive days
      post-treatment, until the herpes lesion is healed.
    

Intervention name(s): iontophoretic acyclovir
Intervention type(s): Device
Intervention MeSH terms: Acyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: herpes labialis; cold sore; acyclovir; iontophoresis; topical
Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study is to investigate the relative bioavailability of a single
      dose of nintedanib low or high dose with and without coadministration of ketoconazole at
      steady state
    


Intervention name(s): Nintedanib; Nintedanib; Ketoconazole; Nintedanib; Nintedanib; Ketoconazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): low or medium dose depending on pilot part; low dose oral administration; oral administration; low dose oral administration; low or medium dose depending on pilot part; oral administration
Intervention MeSH terms: Ketoconazole; Nintedanib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-term Follow Up of Patients in the Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) Study
Condition: Fatty Liver; Liver Diseases
MeSH terms: Liver Diseases; Fatty Liver
Study type: Observational

Summary: 
      This study will follow-up a cohort of patients from the Birmingham and Lambeth Liver
      Evaluation Strategies (BALLETS) study using a database search based on their individual
      National Health Service (NHS) numbers. The investigators will interrogate the Hospital
      Episode Statistics database and the Office of National Statistics database, and examine three
      categories of end points: death, inpatient attendance primarily due to liver disease, and
      outpatient attendance primarily due to liver disease.

      A logistic regression analysis will then be conducted to determine associations between these
      end points and the presence, and degree, of fatty liver in the original BALLETS study,
      adjusted for age, sex, alcohol intake, BMI, and baseline ALT measurement.
    

Detailed description: 
      The Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) study was a prospective
      study of people in General Practice who had an abnormal liver function test result.
      Recruitment took place between 2005 and 2008, and patients were able to be grouped into four
      primary categories: hepato-cellular disease, hepato-biliary disease, tumour, non-specific
      with or without fatty liver. This study will focus on the fourth, non-specific, group of
      which there were 1,237 patients.

      This study will follow-up this cohort of patients using a database search based on their
      individual National Health Service (NHS) numbers. The investigators will interrogate the
      Hospital Episode Statistics database (health outcomes) and the Office of National Statistics
      database (death), and examine three categories of end points: death, inpatient attendance
      primarily due to liver disease, and outpatient attendance primarily due to liver disease.
      Deaths would be sub-categorised as including liver disease, or not.

      A logistic regression analysis will then be conducted to determine associations between these
      end points and the presence, and degree, of fatty liver in the original BALLETS study, with
      adjustment for age and sex. Similar age- and sex-adjusted analyses will be conducted to
      investigate the association with other patient risk factors - alcohol intake and BMI. The
      analyses will be repeated incorporating an additional adjustment for baseline Alanine
      Aminotransferase (ALT) measurement.
    

Intervention name(s): BALLETS
Intervention type(s): Other
Intervention description(s): Cohort were not exposed to any intervention. There information will be analysed from database searches.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients in primary care with no known liver disease, who had a liver function test (LFT)
Everolimus Stent in Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized trial to test the efficacy and safety of newer Drug Eluting Stent generation in
      patient with acute myocardial infarction treated with primary percutaneous coronary
      intervention (PCI)
    

Detailed description: 
      The efficacy and safety of drug-eluting stents (DES) in the treatment of coronary artery
      disease is well established. It is well known that Drug Eluting Stent (DES) have dramatically
      decreased Restenosis rates for both on-label and off-label indications. However, the concern
      for increased (late) stent thrombosis is still present DES implantation in patient with acute
      myocardial infarction is still controversial because acute coronary lesion presents the
      highest possible thrombotic burden Newer DES with new antiproliferative drugs and more
      biocompatible polymers have shown a significant reduction of (late) stent thrombosis in
      patients in stable condition.

      Aim of the study was to asses the long term efficacy and safety on second generation
      everolimus eluting stent compared with first generation sirolimus eluting stent
    

Intervention name(s): everolimus eluting stent; sirolimus eluting stent
Intervention type(s): Device; Device
Intervention description(s): experimental arm of a comparison between drug eluting stents; control arm of a comparison between drug eluting stents
Other intervention name(s): XIENCE V Abbott Vascular; CYPHER Johnson & Johnson
Intervention MeSH terms: Sirolimus; Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary PCI; Drug Eluting Stent
Compare the Properties and Characteristics of an Investigational Formulation of Lamotrigine With Placebo
Condition: Mental Disorders
MeSH terms: Mental Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this sensory analysis study is to determine whether volunteers observe a
      significant difference in organoleptic properties between lamotrigine (430C78) cherry
      flavoured orally disintegrating tablets (ODT) and a placebo cherry flavoured orally
      disintegrating tablet. The aim is to assess the value of the placebo as a marketing aid,
      whereby physicians and patients may assess the personal acceptability of the organoleptic
      properties and potential convenience prior to prescription of the ODT formulation.
    


Intervention name(s): Cherry lamotrigine ODT; Cherry Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25mg, taken orally on one study visit; Taken orally on one study visit
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lamotrigine; placebo; properties; characteristics
The Human Mucosal Immune Responses to Influenza Virus (SLVP026)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will examine the immune responses to the seasonal influenza vaccine in single
      cells of the nasal passages when compared with cells in circulating blood.
    

Detailed description: 
      Using state-of-the-art technology, the investigators hope the information learned from this
      study will help identify and describe important factors in the early-stage development of
      influenza immunity and possibly lead to the development of more effective vaccines. This
      study will be conducted in healthy male and female volunteers 18-30 years of age who received
      one of two seasonal influenza vaccine types, intramuscular standard trivalent inactivated
      influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV) given by intranasal
      spray.

      Participants are divided into two groups. The control group will receive the 2012-2013
      formulation of the standard intramuscular trivalent inactivated influenza vaccine (TIV). A
      blood sample and nasopharyngeal swab samples (one from each nostril) will be collected at a
      single visit, Day 0. For those in the live, attenuated influenza vaccine (LAIV) group, at the
      first visit, they will receive a single administration of the 2012-2013 formulation of LAIV.
      At the second study visit two days later, they will provide a blood sample and two
      nasopharyngeal swab samples (one from each nostril).
    

Intervention name(s): Fluzone®; FluMist®
Intervention type(s): Biological; Biological
Intervention description(s): Influenza Virus Vaccine Suspension for Intramuscular Injection; Influenza Virus Vaccine Live, Intranasal Spray
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Trivalent, inactivated influenza vaccine; Live, attenuated influenza vaccine; Nasopharyngeal swabs; Young adults
Backwards Examination of the Right Colon: A Back-to-back Study
Condition: Colon Neoplasms
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the examination of the proximal colon with the
      retroflexion colonoscopic technique in terms of feasibility and its possible additive
      contribution in the detection of important lesions, namely polyps and cancers.
    

Detailed description: 
      The investigators prospectively examined the additional diagnostic yield of right colon
      examination with colonoscope retroflexion in consecutive, symptomatic and screening -
      surveillance patients. Right colon was examined in forward-view first and thereafter,
      retroflexion was performed to re-inspect it.
    

Intervention name(s): retroflexion; forward view
Intervention type(s): Procedure; Procedure
Intervention description(s): examination of the right colon with scope retroflexion; examination of the right colon in forward view
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: colonoscopy; right colon retroflexion; adenoma detection rate; feasibility; surveillance interval
Early Exposure to OMT Prevents Long LOS
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The application of osteopathic manipulative treatment (OMT) in preterm infants has been
      demonstrated to be effective in reducing length of stay (LOS). The scope of the present study
      is to investigate the association between earlier exposure to OMT and reduction of LOS in
      premature infants
    


Intervention name(s): osteopathic manipulative treatment; Usual care
Intervention type(s): Other; Other
Intervention description(s): Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.; Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteopathic manipulative treatment; neonatology; neonatal care; prematurity; complementary and alternative medicine; length of stay