bioihbjkbjnl/mcl2 huggingface dataset:
Combined Spinal-Epidural Versus Traditional Labor Epidural
Condition: Labour Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study to compare the use of spinal-epidural versus traditional labor
      epidural on maternal and fetal effects. The hope is to determine the safest and most
      effective epidural method of relieving pain during labor.
    

Detailed description: 
      Combined spinal-epidural anesthesia (CSE) was developed to allow excellent pain control for
      the pregnant woman who arrives in advanced labor and does not have much time for the
      anesthetic to have its effect. This has been extended recently to women in all stages of
      labor because of its rapid and excellent control of pain. Recent case series comparing CSE
      with traditional epidural have shown a slight difference in the rate of hypotension and fetal
      bradycardia, with the CSE technique having a higher rate of both of these side effects. This
      study will compare the two techniques in a prospective, randomized method.

      The aim is to compare the maternal and fetal effects of two neuraxial block techniques for
      pain control during labor, to document blood pressure changes in upper and lower extremities
      pre- and post- block placement, and to document side effects (e.g. pruritus) and patient
      satisfaction with both techniques.
    

Intervention name(s): Bupivacaine and Fentanyl (for CSE); Bupivacaine and Fentanyl (for traditional epidural)
Intervention type(s): Drug; Drug
Intervention description(s): Bupivacaine 0.25% x 1 cc + Fentanyl 20 mcg, followed by infusion of Bupivacaine 0.0625% with Fentanyl 2 mcg/mL at 12 cc/hr; Bupivacaine 0.0625% with Fentanyl 2 mcg/mL x 15 cc, followed by infusion of Bupivacaine 0.0625% with Fentanyl 2 mcg/mL at 12 cc/hr
Other intervention name(s): combined spinal-epidural; labor analgesia; traditional epidural; labor analgesia
Intervention MeSH terms: Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Epidural; Labour pain; Pregnant women; Epidural anesthesia; Labour, Obstetric; labor pain; labor, obstetric; labor analgesia
A Qualitative Study About Smoking Practices
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This study involves in-depth interviews with parents of urban children with asthma and focus
      groups with additional parents in order to understand their attitudes and beliefs about
      smoking.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Parents of children with asthma in Rochester, NY
Functional Monitoring for Motor Pathway in Brain Tumor Surgery Within Eloquent Area
Condition: Glioma, Motor Pathway
MeSH terms: Glioma
Study type: Interventional

Summary: 
      Resection of brain tumors in eloquent areas involves the risk of postoperative motor
      deficits. For brain tumors within or adjacent to the eloquent area, maximizing tumor
      resection while preserving motor function is crucially important.we used DTI-based
      tractography to visualize the spatial relationship between brain lesions and the nearby
      pyramidal tract(PT) in patients with malignant brain tumors and confirmed functional
      connections of the illustrated PT by direct electrical stimulation. We evaluated the
      reliability of DTI-based tractography for PT mapping using intraoperative subcortical
      stimulation ) and the usefulness of the combination of two techniques.
    

Detailed description: 
      Adverse effects caused by electrical stimulation during the operation were recorded. All
      subjects adopted early postoperative MRI examinations (within 3 days) to evaluate both the
      extent of tumor resection and the integrity of the PTs. Muscle strength was assessed
      preoperatively and postoperatively.The Karnofsky Performance Scale (KPS) was adopted for
      grading functional status at the 6-month evaluation. Further tumor progression interval and
      survival analysis was conducted for each subject with high-grade glioma (HGG)
    

Intervention name(s): diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation
Intervention type(s): Procedure
Intervention description(s): All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diffusion tensor imaging, Glioma, Intraoperative monitoring, Pyramidal tract, Subcortical; stimulation, Tractography
A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants
      taking metformin for type 2 diabetes.
    


Intervention name(s): MK-0941; Glimepiride; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MK-0941 will be taken three times a day (TID), within 15 minutes before each meal. MK-0941 will be titrated to a maximally effective dose. The treatment period will be 6 weeks.; Glimepiride will be taken once a day (QD) in the morning, within 15 minutes before the breakfast meal. Glimepiride will be titrated to a maximally effective dose. The treatment period is 6 weeks.; The study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], the participant should remain on the same metformin dose throughout the study.
Other intervention name(s): Amaryl®
Intervention MeSH terms: Metformin; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose/aim of this study is to assess the safety and antibody response to vaccination
      with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess
      the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects
    

Detailed description: 
      This is a phase 3b, controlled, open-label, multi-center study to evaluate safety and
      immunogenicity of Menveo after a single vaccination in healthy individuals who were
      vaccinated with Menveo or Menactra 4 to 6 years before and in vaccine-naive individuals.
      Vaccine-naive subjects: subjects who have not received any meningococcal vaccine prior to
      participation to this clinical trial.

      Subjects will be randomised into one of the two different blood draw schedules according to a
      1:1 ratio.

        -  Blood draws at Day 1, Day 4 and Day 29

        -  Blood draws at Day 1, Day 6 and Day 29
    

Intervention name(s): Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
Intervention type(s): Biological
Intervention description(s): One intramuscular injection of MenACWY at Day 1.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal disease; Booster vaccination; Meningitis; Antibody persistence
Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the change in the expression of FcεRI receptors of blood basophils and
      dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in
      adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal
      therapy.
    


Intervention name(s): omalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Omalizumab was supplied in 5mL vials with solution for subcutaneous injection.; Placebo was supplied in vials with solution for subcutaneous injection.
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Severe asthma,; non-atopic,; omalizumab
Clowns as Treatment for Preoperative Anxiety in Children: A Randomized Controlled Trial
Condition: Pre Operative Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study wants to test the hypothesis that trained clowns can reduce anxiety in children
      undergoing general anesthesia. We will compare the effect of the clowns to the commonly used
      anti-anxiety medication we commonly use
    

Detailed description: 
      The perioperative environment, often anxiety-provoking for adults, may be quite frightening
      for children. The detrimental effects of preoperative anxiety are not confined to the
      preoperative period. Anxiety during induction of anesthesia is correlated with increased
      distress early in the postoperative period, (Holms Knud, Kain) and maladaptive behavior will
      follow for the first 2 weeks following surgery in up to 54% of children.

      Many preoperative systems allow parental, pharmacologic, and anticipatory interventions to
      facilitate a relaxed perioperative environment for children. Unfortunately, scheduling
      conflicts, side effects, and limited resources conspire to limit their usefulness. For
      example, only 10% of respondents in a recent survey used parental presence during induction
      of anesthesia (PPIA) for a majority of their patients. This may be due to the belief by some
      that parental anxiety may in fact increase children's anxiety. (Bevans) According to the same
      survey, only 50% of children undergoing surgery receive sedating premedication. (Kain).
      Distraction techniques, such as the use of toys or video games, may also decrease
      perioperative anxiety, however their effectiveness during induction of anesthesia is not well
      characterized. The efficacy of toys and video games is somewhat dependent upon the child
      reaching certain developmental milestones. Anesthesiologists continue to search for an easy
      and comprehensive method for anxiety reduction in the pediatric surgical population. We
      propose that specially trained professional clowns may allay preoperative anxiety and result
      in a smooth anesthetic induction.
    

Intervention name(s): clowns present; midazolam
Intervention type(s): Behavioral; Drug
Intervention description(s): clowns present during the proccess of induction of anesthesia; midazolam
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: children anesthesia anxiety clowns
A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical trial results demonstrate that anti-PD-1 antibodies prolonged OS to approximately 9
      months compared with 6 months in docetaxel group. Anti-PD-1 therapy in Chinese squamous NSCLC
      patients will be investigated in this clinical trial.

      Additionally, the correlation between PD-L1 expression and the response to IBI308 treatment
      in Chinese squamous cell NSCLC patients as well as the role of irRECIST in immune checkpoint
      inhibitor treatment evaluation will also be assessed
    


Intervention name(s): IBI308; Docetaxel
Intervention type(s): Drug; Drug
Intervention description(s): Anti-PD-1 therapy in Chinese squamous NSCLC patients will be investigated in this clinical trial.; As 2nd line treatment to subjects with squamous NSCLC
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of Vitamin D on renal phosphate and bone
      loss, which are common in HIV infected adolescents and young adults being treated with
      tenofovir.
    

Detailed description: 
      ATN 063 tests the hypothesis that in a population of adolescents and young adults with HIV
      infection who are being treated with tenofovir as part of an antiretroviral (ARV) combination
      regimen, vitamin D supplementation will decrease renal phosphate loss, increase plasma
      phosphate, decrease plasma PTH, and improve markers of bone turnover, including a decrease in
      plasma N-telopeptide and BAP.
    

Intervention name(s): Vitamin D supplement; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Groups A and C once every four weeks during study visits.; A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vitamin D; Treatment Experienced
3 Simple Questions to Predict Labor Pain and Epidural Analgesia Use in Parturients
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Observational

Summary: 
      Labor pain is complex to understand and challenging to define because of the interaction of
      multiple maternal and fetal factors. Poorly controlled acute post-procedural pain may result
      in harmful physiological and psychological consequences for both mother and baby. It is
      therefore important to understand the prelabor factors that may affect the labour pain to
      facilitate the intrapartum pain management. The goal of this prospective observational study
      is to verify if expectations regarding pain experience translate to actual pain outcomes for
      women who are undergoing induction of labor.
    

Detailed description: 
      A prospective observational cohort study. 100 parturients having induction of labor that
      match inclusion criteria will be asked to participate. After written informed consent, vital
      signs and patient demographics will be obtained and recorded. A 3 question survey will be
      given. Patients will be asked to rate, using a 0-10 cm visual analog scale (VAS), their
      anxiety level ("On a scale of 0-10 cm, with 0 being not anxious at all through 10 being
      extremely anxious, how anxious are you about your upcoming labor and delivery?"), their
      anticipated pain ("On a scale of 0-10, with 0 being no pain at all and 10 being pain as bad
      as you can imagine, how much pain do you anticipate experiencing during your upcoming labor
      and delivery?"), and using a categorical scale, to rate their anticipated epidural analgesic
      need ("On a scale of 0-5, with 0 being none at all, 1 being much less than average, 2 being
      less than average, 3 being average, 4 being more than average, and 5 being much more than
      average, how much epidural pain medication do you anticipate needing during your upcoming
      labor and delivery?"). Then 24 hours after delivery, patient VAS scores will be recorded,
      number of boluses, total number of hours of labor, patient comfort level and satisfaction
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Patients coming for induction of labor will be handed a survey regarding their expectation of their coming labor pain. And then will be followed up after 24 hours of their delivery.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy full term pregnant patients with singleton pregnancy
Serum Lipid Levels and Other Biomarkers of Cardiovascular Disease in Patients With Psoriasis
Condition: Psoriasis; Cardiovascular Diseases; Dyslipidemia
MeSH terms: Cardiovascular Diseases; Psoriasis; Dyslipidemias
Study type: Observational

Summary: 
      Psoriasis patients are known to be at increased risk for heart disease. This may be due to
      the increased prevalence of cardiovascular disease risk factors in this population, including
      high blood pressure, diabetes, obesity, and high cholesterol. Although cholesterol levels are
      known to be altered in psoriasis, most studies have used standard lipid profiles to measure
      cholesterol. These tests indirectly measure LDL (bad cholesterol) and become less accurate
      when triglyceride levels are high, as often see in individuals with psoriasis. We have
      designed a case-control study that uses a more specific and detailed cholesterol test to
      measure serum lipid levels in psoriasis patients, allowing for more accurate determination of
      LDL and better assessment of the lipid-contribution to cardiovascular risk. We will also
      measure other markers of inflammation that may contribute to cardiovascular disease.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants will be selected from the Dermatology Clinic at George Washington University
        Medical Faculty Associates.
      
Keywords: psoriasis; heart disease; cardiovascular disease; hyperlipidemia
Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis
Condition: Rheumatoid Arthritis; Periodontal Disease
MeSH terms: Arthritis; Arthritis, Rheumatoid; Periodontal Diseases; Inflammation
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the association of Rheumatoid Arthritis (RA)-related
      antibodies and periodontal inflammation in subjects at-risk for Rheumatoid Arthritis.
      Subjects will undergo periodontal and joint examinations, as well as collection of body
      fluids to measure Rheumatoid Arthritis-related antibodies.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population will include: subjects at-risk for RA, subjects with early RA, and
        healthy controls >40 years old.
Phase II Study to Investigate the Kinetics of the Immune Response Generated by Influenza Virus Vaccine.
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study was to perform a variety of assays on blood, serum, nasal
      wash and cell samples obtained from healthy adult subjects for the purposes of developing
      assays for application in the further investigation of immune responses generated by
      influenza virus vaccine, trivalent, types A & B, live, cold-adapted (liquid formulation
      CAIV-T; Wyeth, Marietta, PA).
    

Detailed description: 
      This was a randomized, open-label, placebo-controlled, outpatient study carried out in
      healthy adults 18 to < 65 years of age. The study was designed to evaluate the kinetics of
      the immune responses generated by each of the study products in order to determine the best
      sampling time for future studies. Subjects were randomized in a 1:1:1 ratio to receive a
      single dose of either CAIV-T, inactivated influenza virus vaccine (TIV), or placebo.
    

Intervention name(s): CAIV-T; TIV; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Liquid CAIV-T vaccine for this study consisted of three cold-adapted, attenuated, reassortant strains representing the hemagglutinin (HA) and neuraminidase (NA) antigens of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2) and B/Yamanashi/166/98 influenza virus strains. The reassortant vaccine strains were grown in specific pathogen-free (SPF) eggs and the allantoic fluid, which contained virus, was harvested, concentrated and purified. Each dose of CAIV-T used in this study was formulated to contain approximately 107 FFU of each of the 6:2 influenza reassortant vaccine strains.; TIV in this study consisted of Flushield™, manufactured by Wyeth Vaccines, Marietta, PA, USA. Each 0.5 mL dose contained no less than 15 ug of the hemagglutinin antigens from each of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Yamanashi/166/98 strains, making TIV in this study antigenically matched to the influenza strains contained in CAIV-T.; Placebo in this study consisted of physiological saline. The total volume of 0.2 mL was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
Other intervention name(s): FluMist; Flushield
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Pilot Trial to Test the Feasibility of Prolonged Fasting and Ketogenic Diet in Relapsing-remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional

Summary: 
      It is well accepted that nutrition as an environmental factor is involved in the pathogenesis
      of multiple sclerosis. But is there a role for prolonged fasting and ketogenic low glycemic
      load treatment to alter the course of multiple sclerosis (MS)? The investigators think yes
      there is. Primarily the investigators want to detect if these diets are feasible for MS
      patients. Therefore the investigators examine the impact of this dietary intervention on the
      health related quality of life for individuals after 7 days, 3 months and 6 months in compare
      to baseline. Secondarily the investigators focus on endocrinological and immunological
      changes after 7 days, 3 months and 6 months in compare to baseline.
    

Detailed description: 
      In this controlled randomised pilot study the patients are allocated to 1. a ketogenic low
      glycemic load treatment from the outset of the study for 24 weeks or 2. enhance their regular
      diet with an initial 7-day fasting followed by a Mediterranean diet pattern until the study
      end or 3. stay on their regular diet (control group) from the outset of the study for 24
      weeks. The investigators will then assess the differences between the groups.
    

Intervention name(s): Prolonged Fasting; Ketogenic low glycemic load treatment; Control diet
Intervention type(s): Other; Other; Other
Intervention description(s): Patients enhance their regular diet with an initial 7-day fasting episode.; 6 months of ketogenic low glycemic load treatment from the study outset.; Patients stay on their regular diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis; diet; prolonged fasting; caloric restriction; ketogenic low glycemic load treatment; health related quality of life; ketogenic diet; neurodegeneration; neuroinflammation