bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Study on the Effect of Quadratus Lumborum Block Versus Intrathecal Morphine on the Incidence of Chronic Pain Post Caesarean Section in a University Hospital of Middle-income Country
Condition: Chronic Post Cesarean Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The aim of this study is to compare the incidence of CPSCP in patients receiving QLB
      quadratus lumborum block and ITM versus control as a primary outcome and associated risk
      factors that might predispose patients to develop CPSCP.
    

Detailed description: 
      The aim of this study is to compare the incidence of chronic post cesarean pain in patients
      receiving quadratus laborum block and and intrathecal morphine versus control as a primary

      Study design:

      Patients will be randomly allocated to the procedure through closed envelopes and so syringes
      and medication will be prepared and labelled by anesthetist other than the anesthetist giving
      the block Patients will be randomly allocated to the procedure through closed envelopes and
      so syringes and medication will be prepared and labelled by anesthetist other than the
      anesthetist giving the block Data will be collected regarding the demographic data,
      gestational stage, parity and number of previous cesarean section, previous abdominal
      surgeries, and narcotic consumption.

      Postoperative pain day 1 and day2 will be followed by anesthetist who is blinded to the
      applied technique used. Follow up for the subsequent period of observation (2,4and 6 months)
      will be done by the department secretary who will contact the patients by phone to ask them
      if there is any "concern" after the operation. If the patient refers to a pain at the
      surgical site that has been lasting for the past three months a call will be conducted by the
      anesthetist and a referral schedule will be appointed to the pain clinic consultant for
      further evaluation
    

Intervention name(s): Quadratus laborum block; Intrathecal morphine; intrathecal bupivacaine
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): quadratus lumborum block will be performed using ultrasound machine (Sonosite Portable Ultrasound System, SonoSite, Bothell, Washington, USA). A 5-8 MHZ curved probe will be used with the patient positioned on the lateral side; Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg; intrathecal bupivacaine 0.5% 15mg and fentanyl
Intervention MeSH terms: Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized control study
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Bacterial Composition and Immune Responses in the Nose and Oropharynx During Influenza Infection
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will serve to determine how influenza infection alters the bacterial colonization
      patterns in the nasal and oropharyngeal compartments, and whether the immune response
      correlate with these alterations. The investigators will be determining bacterial composition
      and immune responses in the nose and oropharynx during influenza infection.

      Specific Aims

      Therefore, the overall aims of this study are as follows:

        1. To identify baseline composition and kinetic changes in the nasal and oropharyngeal
           microflora and immune responses after administering intranasal live attenuated influenza
           virus (i.e., FluMist® vaccine) or saline mist to healthy subjects;

        2. To identify nasal and oropharyngeal microbial composition and local immune responses
           during influenza infections and after resolution of infection, and correlate these
           changes with clinical outcomes.
    

Detailed description: 
      Randomization and Post-Randomization Visits After undergoing the nasal swabs and
      nasopharyngeal washes, and nasal epithelial brushing, healthy volunteers will be randomly
      assigned to receive either saline nasal spray (placebo) or FluMist® nasal influenza vaccine
      (live attenuated influenza vaccine, or LAIV). They will return 1-2 weeks and 4-6 weeks later
      to repeat the nasal swabs and nasopharyngeal washes, and nasal epithelial brushings done at
      the Enrollment Visit.

      Samples will be processed to isolate 16s bacterial RNA and host RNA. 16s rRNA will be
      analyzed by 16S sequencing for to determine the composition of the bacterial microbiome pre
      and post LAIV or saline (placebo) administration. Host immune responses will be assessed
      based upon microarray analysis of host RNA pre and post LAIV or saline administration.
    

Intervention name(s): LAIV; Saline
Intervention type(s): Biological; Other
Intervention description(s): Subjects underwent nasal swabs, nasopharyngeal saline wash, and nasal brushings pre, and 1-2 weeks and 4-6 weeks following intranasal administration of LAIV.; Subjects underwent nasal swabs, nasopharyngeal saline wash, and nasal brushings pre, and 1-2 weeks and 4-6 weeks following intranasal administration of saline nasal spray.
Other intervention name(s): Ocean spray
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: immunology; Microbiota
Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This is the trial to see how our product is similar to remicade by comparing the results of
      blood samples when co-administered with methotrexate between 12.5 to 25 mg/week, oral or
      parenteral dose and folic acid in rheumatoid arthritis patients who are not receiving
      adequate response to methotrexate alone up to week 30.
    


Intervention name(s): Infliximab
Intervention type(s): Drug
Intervention description(s): Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.
Other intervention name(s): remicade
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection
Condition: Laparoscopic Colecctomy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the transversus abdominis plane (TAP)
      blocks are effective in postoperative pain control of adult patients undergoing laparoscopic
      colectomy.
    


Intervention name(s): Ultrasound Guided Transversus Abdominis Plane (TAP) Block; bupivacaine; Placebo
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Ultrasound Guided Transversus Abdominis Plane (TAP) Block; 0.25 bupivacaine 30ml (15ml on each side); placebo
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Zidovudine Levels in HIV Infected Patients Being Treated for HCV
Condition: HIV Infections; Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will test the amount of anti-HIV drugs in the blood cells of HIV-infected patients
      who are also being treated for hepatitis C virus (HCV) infection.
    

Detailed description: 
      An estimated 50,000 people in Puerto Rico are infected with HCV. HIV and HCV have similar
      routes of transmission, and HCV co-infection occurs in 8% to 23% of HIV infected patients.
      Researchers have shown that treatment for HCV with Rebetron (ribavirin plus interferon
      alfa-2b) significantly decreases HCV viral load without affecting HIV viral load. However,
      measurements of intracellular levels of the active forms of zidovudine (ZDV-MP and ZDV-TP)
      were not performed. Such measurements are needed to provide a more rational basis for dosing
      in HIV/HCV co-infected patients. This study will investigate the intracellular exposure to
      active ZDV metabolites prior to and after treatment with Rebetron or treatment with
      PEG-Intron (pegylated interferon) and ribavirin.

      Participants in this study will remain on their usual antiretroviral regimen; no changes may
      be made to that regimen for the first 4 weeks of the study. Upon study entry, participants
      will have intracellular pharmacokinetic studies. During Week 2, participants will start
      either Rebetron or PEG-Intron plus ribavirin therapy, will have intracellular pharmacokinetic
      studies, and will undergo liver biopsy. Additional intracellular pharmacokinetic studies will
      be performed at Weeks 12 and 24. Rebetron or PEG-Intron plus ribavirin will be given for 48
      weeks. A second liver biopsy will be performed 24 weeks after discontinuing Rebetron or
      PEG-Intron plus ribavirin therapy. Participants will be followed for 72 weeks.
    

Intervention name(s): Ribavirin plus interferon alfa-2b; Ribavirin; Peginterferon alfa-2b
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablets taken daily; Oral tablet taken daily; Subcutaneous injection
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; HCV; Ribavirin; Interferon; Co-infection; Treatment experienced
Bacterially-synthesized Folate Absorption Across the Large Intestine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether folate produced by bacteria that live in
      our colon can be absorbed in human colon using a stable isotope method. This study would lead
      a better understanding of the bioavailability of colonic bacterially-synthesized folate and
      its quantitative contribution to whole body folate homeostasis.
    


Intervention name(s): 13C6-p-aminobenzoic acid
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension
Condition: Essential Hypertension and Healthy Controls
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional

Summary: 
      The aim of the study is to test the following hypotheses:

        -  that the function and/or regulation of AQP2 and/or ENaC in the principal cells is
           abnormal in essential hypertension.

        -  if an abnormal function of the principal cells is present in essential hypertension,
           this will become more pronounced at high and low sodium intake.
    


Intervention name(s): high sodium diet; Low Sodium Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 250-350 mmol; 25-35 mmol
Other intervention name(s): For four days; For four days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: urinary aquaporin-2; ENaC; fractional sodium excretion; High/low sodium diet
A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled Phase 2A study to evaluate safety,
      efficacy, PK, and dose response of oral CIN-102 in adults with idiopathic and diabetic
      gastroparesis. The study will assess three oral doses of CIN-102 versus placebo in three
      separate cohorts.
    


Intervention name(s): CIN-102 Dose 1; CIN-102 Dose 2; CIN-102 Dose 3; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): CIN-102 Dose 1; CIN-102 Dose 2; CIN-102 Dose 3; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months
      infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine
      (PANFLU.1).
    


Intervention name(s): Pandemic influenza A/H1N1 vaccine; Pandemic influenza A/H1N1 vaccine; Seasonal trivalent vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose; Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose; Trivalent Inactivated Influenza Vaccine (ANFLU), 7.5 micrograms of each strain per dose per 0.25 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
Condition: Shoulder Pain; Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Shoulder Pain
Study type: Observational

Summary: 
      This study will utilize Rasch analysis to study the construct validity and reliability of
      five shoulder-related patient-reported outcome measures in patients reporting shoulder
      impairment following surgery for head and neck cancer.
    

Detailed description: 
      This study is a cross-sectional, questionnaire-based psychometric study. The purpose of the
      study is to: (1) use Rasch methodology to assess the reliability, construct validity, and
      overall appropriateness of test score interpretation of 5 shoulder-related patient reported
      outcome measures in patients experiencing shoulder dysfunction following neck dissection
      surgery for head and neck cancer; and (2) based on these findings, provide recommendations of
      which patient reported outcome measure or combination of measures most accurately reflects
      shoulder disability in patients who experience shoulder dysfunction following neck dissection
      surgery. Two-hundred and fifty subjects will be recruited during regularly scheduled clinical
      visits at Mayo Clinic. Subjects will complete five shoulder-related patient reported outcome
      measures on only one occasion, therefore subjects will be responsible for study participation
      only at the time of enrollment and same day completion of study-related documents. Upon the
      conclusion of data collection, Rasch analysis will be utilized to analyze data related to the
      research objectives, and descriptive statistics will be utilized to describe the sample.
    

Intervention name(s): Questionnaires
Intervention type(s): Other
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients reporting shoulder discomfort, stiffness or weakness following a neck dissection
        procedure for management of head and neck cancer.
Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
Condition: Heptic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the impact of mild to moderate hepatic impairment on
      the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054
    


Intervention name(s): Lu AE58054 encapsulated film-coated tablets
Intervention type(s): Drug
Intervention MeSH terms: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AE58054; Hepatic impairment
Optimizing PEEP in Laparoscopic Bariatric Surgery Using Bedside Lung Ultrasound
Condition: Atelectasis, Postoperative Pulmonary
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      Lung ultrasound imaging is a promising non-invasive, non-radiant, portable and easy to use
      tool that as yet to be studied in the intraoperative setting.

      in our current study, we are trying to reach the optimum PEEP in laparoscopic bariatric
      patients to prevent postoperative collapse and atlectasis with simple non-invasive procedure.
    


Intervention name(s): stepwise PEEP
Intervention type(s): Device
Intervention description(s): a PEEP of 4 cmH2O will be used after intubation till 5 minutes after pneumoperitonium, and adjusted in a step wise approach after lung ultrasound by adding 2 cmH2O, repeating ultrasound 5 minutes after every change in peep till no lung collapse is detected by lung ultrasound with a maximal peep of 10 cmH2O, or if hemodynamic instability occurs.
Lung ultrasound examination will be performed at a minimum three times in each patient; the first will be performed 1 min after starting mechanical ventilation of the lungs, 5 minutes after pneumoperitonium, 5 min after every peep increase in stepwise peep group and the last time at the end of the surgery.
We define anaesthesia-induced atelectasis to be significant if any region has a consolidation score of ≥ 2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
Condition: Allergic Asthma
MeSH terms: Asthma; Airway Obstruction
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled study designed to
      demonstrate the safety and efficacy of MILR1444A compared with placebo in reducing the airway
      reaction to an inhaled aeroallergen solution in adult patients with mild allergic asthma. The
      study will randomize approximately 24 patients at five study centers. In the event of patient
      discontinuation from the study, additional patients may be enrolled at the discretion of the
      Sponsor.
    


Intervention name(s): lebrikizumab (MILR1444A); placebo
Intervention type(s): Drug; Drug
Intervention description(s): Repeating subcutaneous injection; Repeating subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Asthma
To Study Safety, Tolerability and Pharmacokinetics of AZD1305 in Healthy Male Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the
      medication is metabolised by the body ( how it is taken up into the body, distributed around
      the body and disappears from the body) in healthy Japanese males.
    


Intervention name(s): AZD1305; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for iv infusion, single dose; NaCl solution for iv infusion, single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: AZD1305; safety; pharmacokinetics; single ascending doses; Japanese; male
Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin With or Without Metformin, in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid
      add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus
      inadequately controlled on insulin with or without metformin treatment.
    


Intervention name(s): Vildagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patient will receive vildagliptin 50mg twice daily (bid) in addition to their stable dose of insulin with or without metformin for 24 weeks; Patient will receive matching placebo to vildagliptin in addition to their stable dose of insulin with or without metformin for 24 weeks
Other intervention name(s): Galvus, LAF237
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; Vildagliptin
Efficacy of Cilostazol in Prevention of Peripheral Neuropathy
Condition: Peripheral Neuropathy; Breast Cancer
MeSH terms: Breast Neoplasms; Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      There are several mechanisms concerning pathophysiology of paclitaxel induced peripheral
      neuropathy. One of the main mechanisms is induction of Schwann cell dedifferentiation by
      paclitaxel. At the preclinical level, cilostazol potently inhibited paclitaxel-induced
      dedifferentiation of cultured Schwann cells, yet this positive effect have not been
      clinically investigated.
    


Intervention name(s): Cilostazol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cilostazol 100 mg twice daily; Placebo twice daily
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Effect of Sufentanil on the Rate of Anesthesia
Condition: Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was to compare the effects of Lidocaine/epinephrine with and without
      Sufentanil on the rate of anesthesia after supplemental intraligamentary injection (PDL) in
      teeth with irreversible pulpitis.
    


Intervention name(s): Lidocaine with Epinephrine+ Normal saline; Lidocaine with Epinephrine + sufentanil
Intervention type(s): Drug; Drug
Intervention description(s): PDL injection of 0/4 ml of lidocaine %2 with epinephrine,and Normal saline; PDL injection of 0/4 ml lidocaine with epinephrine and0/4 ml sufentanil ( 0/04 μg)
Other intervention name(s): Brand name:Sufenta
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Sufentanil; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: sufentanil; irreversible pulpitis; intra ligament injection