bioihbjkbjnl/mcl2 huggingface dataset:
Sensitivity of Hyomental Distance Ratio as a Single Predictor of Difficult Intubation in Obstetrics
Condition: Caesarean Section
Study type: Observational

Summary: 
      This is a study to detect the sensitivity of thyromental distance ratio as a single predictor
      for difficult intubation in patients undergoing cesarean section under general anesthesia.
    

Detailed description: 
      The authors intend to use the HMDR for detection of difficult intubation in parturient
      undergoing cesarean section that is either elective or emergency.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting for cesarean section under general anesthesia.
      
Keywords: Difficult intubation; Hyomental distance; Obstetric; Mallampati classification; Thyromental distance; Sternomental distance
Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine
Condition: Respiratory Disorders
MeSH terms: Influenza, Human; Respiration Disorders; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK
      Biologicals' NTHi candidate vaccine in adults, administered for the first time in humans.
    


Intervention name(s): GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A); GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A); Saline placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Administered intramuscularly (IM) in the deltoid region of non-dominant arm; 2 doses administered IM in the deltoid region of non-dominant arm; 2 doses administered IM in the deltoid region of non-dominant arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Healthy adults; Safety; Reactogenicity; Immunogenicity; Non-typeable H. Influenzae (NTHi)
Shotblocker and Breastfeeding on Pain/Comfort During Heel Lance
Condition: Pain, Acute; Comfort
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      Shotblocker and breastfeeding are an attempt to reduce pain during invasive procedures in
      newborns. This study was planned to evaluate the effect of non-pharmacological interventions
      on the pain and comfort level of newborns, whose heel blood will be taken in the 1st Level
      Neonatal Intensive Care Unit.
    

Detailed description: 
      Hypotheses H1: Newborns who undergo breastfeeding attempt during heel lance procedure feel
      less pain and have a higher comfort level.

      H2: Newborns who undergo breastfeeding attempt and are applied shotblocker during heel lance
      procedure feel less pain and have a higher comfort level.

      H3: Newborns who undergo shotblocker intervention during heel lance procedure feel less pain
      and have a higher comfort level.

      H4: There are a difference between the comfort levels, HR and PO2 of newborns in terms of
      group, group-time and time according to the intervention applied.

      Data collection process Mothers of newborns whose heel blood will be taken will be informed
      about the research. Consent will be obtained from the mother regarding the video recording
      during the heel lance precedure. After informed consent is obtained, it will be determined
      which group the newborn belongs to by stratified randomization.

      A standard approach will be applied to all newborns. Standard approach involves performing
      the heel lance procedure on the caregiver's lap. Heel lance procedure will be scheduled
      between 09:00 and 10:00 in the morning, one hour after babies are breastfed. Babies to be
      included in the study in each group; they will be in their beds, in the undisturbed rest
      period, until 30 minutes before the start of the test. All babies; 2 minutes before, during
      and up to 2 minutes after blood collection; they will be video-recorded including their heart
      rate, faces, and upper and lower extremities (especially the heel to be operated). No
      additional care will be given to ensure physiological stability during each intervention
      (breastfeeding, shotblocker, etc.)
    

Intervention name(s): breastfeeding; Breastfeeding and Shotblocker; shotblocker
Intervention type(s): Behavioral; Combination Product; Device
Intervention description(s): nonphamacological methods; combined Breastfeeding and Shotblocker device; it is a small plastic tool
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: breastfeeding; shotblocker
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/20 mg
      combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin
      20 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.
    


Intervention name(s): Atorvastatin; Ezetimibe; Ezetimibe/atorvastatin; Placebo to atorvastatin; Placebo to ezetimibe; Placebo to ezetimibe/atorvastatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 20 mg tablet administered orally once daily; 10 mg tablet administered orally once daily; Ezetimibe/atorvastatin 10 mg/20 mg combination tablet administered orally once daily; Administered orally once daily; Administered orally once daily; Administered orally once daily
Other intervention name(s): Lipitor®; Zetia®; Liptruzet®; MK-0653C
Intervention MeSH terms: Atorvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      A drug interaction study to evaluate the effect of ASP015K (twice daily) on the
      pharmacokinetics (PK) of once weekly oral methotrexate (MTX).
    

Detailed description: 
      Patients check in on day -1 and remain confined until all the exit procedures are performed
      on the morning of day 10. Patients to return for 1 post-treatment follow-up visit on day 13.

      Patients receive a single dose of methotrexate on day 1 and day 8 and ASP015K (twice daily)
      on days 3 through 8 plus the morning of day 9.
    

Intervention name(s): peficitinib; methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): ASP015K
Intervention MeSH terms: Methotrexate; Peficitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ASP015K; Rheumatoid Arthritis
Study to Assess the Effect of Metformin Supplementation on IVF Outcome in Patients With Polycystic Ovarian Syndrome.
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was performed to investigate the effects of metformin on controlled ovarian
      stimulation (COS), in vitro fertilization (IVF) outcomes, pregnancy outcomes, and comparison
      of serum and follicular fluid cytokines and hormones in patients with polycystic ovary
      syndrome (PCOS) undergoing IVF using gonadotropin-releasing hormone(GnRH) antagonist
      protocol.
    

Detailed description: 
      Polycystic ovary syndrome is the common cause of the female infertility that features insulin
      resistance and hyperinsulinemia participate in the reproductive as well as metabolic
      disturbances.

      In many studies, metformin treatment reduces androgen levels and attenuates hyperinsulinemia
      in women with PCOS. This favorable effect on insulin and androgens levels, justifies the use
      of metformin in reproductive disturbances in PCOS women. Metformin treatment was shown to
      diminish ovarian androgen secretion, while lowering insulin levels in women with PCOS.

      In women with PCOS, metformin treatment may increase ovulation, improve menstrual cyclicity,
      and reduce seum androgen levels. Metformin has direct effects on the ovary and also reduces
      the level of insulin that act upon the ovary. It has been indicated that metformin has
      direct, insulin-independent actions on theca cell steroidogenesis, because in human ovarian
      theca-like tumor cells, metformin suppressed androstenedione production. Metformin also exert
      a direct effect on granulosa cells and subsequent reduction of steroid production.

      Metformin was shown to improve endothelium dependent vasodilation in insulin resistant
      patients and potentially protect against atherogenesis and cardiovascular disease.

      Considering gonadotropin ovulation induction or IVF in women with PCOS, metformin
      coadministration improves the pregnancy outcome and reduces the risk of ovarian
      hyperstimulation syndrome. Metformin therapy throughout pregnancy can reduce the risk of
      early miscarriage or the incidence of gestational diabetes.

      All patients were pretreated for 3 weeks with monophasic oral contraceptive (OC)(Yasmin;
      Bayer Schering Pharma, Berlin, Germany) before COS. Five days after OC discontinuation, COS
      for IVF/ICSI was commenced. GnRH antagonist protocol was used for COS in all subjects.
      Patients were randomly allocated into the metformin or control groups, using sealed
      envelopes.
    

Intervention name(s): Metformin
Intervention type(s): Drug
Other intervention name(s): Glucophage Tab 500mg, National Drug Code(NDC) 0087-6060-05
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Metformin
Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetic parameters of intravenous
      diclofenac sodium (DIC075V) 18.75 mg and 37.5 mg following single- and multiple-dose
      administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved
      reference product.
    

Detailed description: 
      This study is an open-label, three-treatment, six sequence, three-period, single center
      crossover study to evaluate the pharmacokinetics of intravenous diclofenac sodium DIC075V
      (18.75 mg and 37.5 mg) versus oral diclofenac potassium (Cataflam® 50 mg) in healthy adult
      volunteers following single- and multiple-dose administration. Each treatment sequence
      received 1 dose every 6 hours (for a total of 4 doses per treatment sequence) with a 48-hour
      washout period between treatment sequences.
    

Intervention name(s): Intravenous diclofenac sodium (DIC075V) 18.75 mg; Intravenous diclofenac sodium (DIC075V) 37.5 mg; Oral diclofenac potassium 50 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DIC075V 18.75 mg; DIC075V 37.5 mg; Oral diclofenac potassium 50 mg
Other intervention name(s): Cataflam
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy; Diabetes
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of
      Clonidine Gel in the treatment of pain associated with PDN. Subjects who have completed their
      12-week participation in Study CLO-290 or Study CLO-310 are eligible to rollover into this
      study and receive active study drug in an open-label manner.
    

Detailed description: 
      Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of
      Clonidine Gel in the treatment of pain associated with PDN. Subjects who have completed their
      12-week participation in Study CLO-290 or Study CLO-310 are eligible to rollover into this
      study and receive active study drug in an open-label manner. All eligible subjects will
      receive Clonidine Gel regardless of the blinded treatment they have received in the previous
      double-blind study (Clonidine Gel or Placebo Gel). Study drug will be applied topically TID
      to both feet for 12 months during an Open-Label Treatment Phase. Approximately 400 adult
      subjects with PDN are estimated to enroll in this study.
    

Intervention name(s): clonidine hydrochloride topical gel, 0.1%
Intervention type(s): Drug
Intervention MeSH terms: Clonidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain; diabetic neuropathy; pain in feet
The Effect of Music Therapy on Comfort, Pain and Anxiety
Condition: Bone Marrow Disease; Hematological Malignancy
MeSH terms: Hematologic Neoplasms; Bone Marrow Diseases
Study type: Interventional

Summary: 
      Objectives: This study was conducted to determine the effect of music therapy on the pain,
      anxiety, and comfort levels of patients who underwent bone marrow aspiration and biopsy.

      Methods: This research was conducted as a randomized controlled study in the hematology
      polyclinic of a university hospital. Music therapy will used with the intervention group
      throughout the procedure. During data evaluation, paired t-test, independent t-test and
      effect size will used. The sample group was calculated based on the sample groups of other
      studies in the literature (Çelebi et al., 2020; Özdemir et al., 2019). According to the
      preliminary power analysis results using the G.Power 3.1.9 program, the sample size was
      calculated at 80% power, at medium effect size at 5% alpha value. According to the analysis
      results, the sample size per group was calculated as 30. However, since there was 10%
      probability that some patients may drop, the sample size for the study was recalculated as 66
      (Experimental Group: 33, Control Group: 33).The patients will informed about using music. In
      addition, it will explained that they could adjust the sound levels and that they should
      report when they are disturbed by the tone. Music continued throughout the process.
      Communication with the patient will maintained, and symptoms such as discomfort, anxiety were
      observed throughout the procedure. The music player will switched off after the procedure was
      completed. The patients will asked whether they had any discomfort while the music played.
      TThe music therapy will last an average of 30 minutes. After completing the procedures, the
      patient's pain, comfort, and anxiety levels were re-evaluated using VAS and STAI.
    


Intervention name(s): Musictherapy
Intervention type(s): Other
Intervention description(s): The patients were asked about the type of music they wanted to listen to. Especially in the last meta-analyses, it was determined that listening to the music that patients chose was more effective (Witten 2020). For this reason, after the intervention group is asked about the music they want to listen to, the music they want will be played from the music application.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: bone marrow; aspiration; biopsy; musictherapy; anxiety; pain; comfort
Facilitation of NGT Insertion
Condition: Nasogasrtic Tube Insertion
Study type: Interventional

Summary: 
      Insertion of a nasogastric tube (NGT) in anesthetized patients can be a disappointing
      experience. Many techniques have been explained to improve success rate along with increasing
      safety, such as forward displacement of the larynx, tube rigidity improvement methods,
      pushing it down directly through pharynx or using a guide tube. Failure of insertion under
      general anesthesia reached 50% in some publications
    


Intervention name(s): Digital facilitation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Asthma Management Project University Leiden
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The long-term course of asthma shows variable outcome with regard to the incidence of
      exacerbations and the decline of lung function over time. The present study aimed:

        1. to investigate whether asthma management additionally guided by the degree of bronchial
           hyperresponsiveness leads to a better outcome

        2. to examine the predictors among clinical and inflammatory disease markers of the
           long-term decline in lung function
    

Detailed description: 
      Asthma is associated with a specific inflamma¬tory state of the airways. Assuming that the
      degree of airway inflammation is a determinant for the long-term disease outcome, it follows
      that, asthma therapy should be aimed at maximal reduction of airway inflammation, in addition
      to reducing symptoms. However, according to current guidelines, therapy should only be
      directed to the clinical severity of the disease. There is increasing evidence that bronchial
      hyper¬respon¬siveness can be used as a non-invasive reflection of airway inflamma¬tion [29].
      However, it is still unknown whether bronchial responsiveness provides relevant additional
      information for adjusting therapy during follow-up of patients with asthma. Therefore, in
      this study we will:

        1. compare the disease outcome in two parallel groups of patients with asthma, receiving
           therapy aimed at either clinical severity only, or therapy aimed at both clinical
           severity, and bronchial hyper¬responsiveness to methacho¬li¬ne. The outcome will be
           assessed at three levels. First, the severity, second, lung function and bronchial
           responsive¬ness, and third, humoral, cellular, and histological indices of airway
           inflamma¬tion. To that end we will assess symptoms, lung function, bronchial
           respon¬siveness, and immunological parameters in blood, every three months. Furthermore,
           a bronchos¬copy with a bronchoalveolar lavage and bronchial biopsy will be carried out
           to provide for material for immunologic and pathologic anatomical examination, at the
           beginning and at the end of the study.

        2. analyse the predictors among clinical- and inflammatory parameters of exacerbations and
           long-term decline in lung function during long-term follow-up
    

Intervention name(s): Guiding therapy by bronchial hyperrsponsiveness
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Bronchial hyperresponsiveness; Atopy; Inhaled steroids; Exacerbations; Lung function decline; Prognosis
Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma
Condition: Adult Ependymoblastoma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Medulloblastoma; Adult Mixed Glioma; Adult Oligodendroglial Tumors; Adult Pineoblastoma; Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)
MeSH terms: Glioblastoma; Glioma; Gliosarcoma; Medulloblastoma; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Pinealoma; Sarcoma, Ewing; Neuroectodermal Tumors, Primitive, Peripheral
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This pilot phase I/II trial studies the side effects and best dose of plerixafor after
      radiation therapy and temozolomide and to see how well it works in treating patients with
      newly diagnosed high grade glioma. Plerixafor may stop the growth of tumor cells by blocking
      blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving plerixafor
      after radiation therapy and temozolomide may be an effective treatment for high grade glioma.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To assess the safety of using continuous infusion Plerixafor subsequent to irradiation in
      patients with newly diagnosed glioblastoma multiforme (GBM).

      II. To assess the efficacy of Plerixafor as measured by progression free survival at 6 months
      (PFS6) from the start of irradiation.

      OUTLINE: This is a phase I, dose-escalation study of plerixafor followed by a phase II study.

      Within 4 weeks of surgery, patients undergo radiation therapy and receive temozolomide orally
      (PO) over 42 days. Beginning 8 days prior to completion of chemoradiotherapy, patients
      receive plerixafor intravenously (IV) continuously for 2-4 weeks. Patients also receive
      temozolomide PO 5 days a month beginning 35 days after completion of radiation therapy.

      After completion of study treatment, patients are followed up every 12 weeks for 5 years.
    

Intervention name(s): radiation therapy; temozolomide; plerixafor; laboratory biomarker analysis; pharmacological study
Intervention type(s): Radiation; Drug; Drug; Other; Other
Intervention description(s): Undergo radiation therapy; Given PO; Given IV; Correlative studies; Correlative studies
Other intervention name(s): irradiation; radiotherapy; therapy, radiation; SCH 52365; Temodal; Temodar; TMZ; AMD 3100; Mozobil; pharmacological studies
Intervention MeSH terms: Plerixafor; Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment