bioihbjkbjnl/mcl2 huggingface dataset:
Airway Complications After LMA in Children
Condition: Anesthesia Recovery
Study type: Interventional

Summary: 
      Background: The removal of Laryngeal Mask Airway (LMA) in children may be associated with
      respiratory adverse events. The incidence of these adverse events may be influenced by the
      type of anesthesia maintenance. It is not clear whether Total Intravenous Anesthesia (TIVA)
      with propofol is associated with a lower incidence of respiratory events upon removal of LMA
      as compared to maintenance with sevoflurane.

      Specific Aim: The primary aim of this study is to compare the prevalence of respiratory
      adverse events following LMA removal in patient receiving TIVA versus sevoflurane
      inhalational anesthesia in a pediatric population aged between 6 month and 6 years old.
      Secondary outcomes include quality of induction, maintenance and emergence from anesthesia
      between the 2 groups as evidenced by ease of LMA insertion, absence of bucking or movement
      during the procedure, time to LMA removal, and absence of emergence agitation.

      Methods: In this prospective randomized clinical trial, children will be enrolled in one of
      two groups: Group 1 will receive propofol for induction and maintenance of anesthesia, Group
      2 will receive sevoflurane for induction and maintenance of anesthesia. In both groups
      patients will be mechanically ventilated. At the end of the procedure, LMAs will be removed
      when patients are fully awake as defined by the return of reflexes, eye opening, and
      purposeful movements.

      Significance: Data comparing the influence of TIVA and sevoflurane on the occurrence of
      respiratory adverse events after LMA removal are limited. Both techniques are standard of
      care at our institution. However, as per our clinical observations, we hypothesize that TIVA
      is superior to sevoflurane. This study will identify the technique that provides optimal
      anesthetic conditions and improved patient's safety.
    


Intervention name(s): Sevoflurane; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance; Propofol 5-6 mg/kg and fentanyl 2 µg/kg for induction of anesthesia and propofol 250-300 µg/kg/min for maintenance
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes (0893-019 AM4)(COMPLETED)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the effect of combined treatment with MK0893 plus propranolol versus
      placebo plus propranolol on hypoglycemia.
    


Intervention name(s): MK0893; MK0893-matched Placebo; Propranolol Hydrochloride (HCL)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of MK0893 1000 mg (ten 100 mg tablets); Single dose of placebo to MK0893 (ten tablets); Propranolol tablets titrated up to 80 mg three times daily over a four week period. Total treatment was approximately 7 weeks.
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study for Patients With Lung Metastatic Advanced Gastric Cancer and NSCLC Treated With Apatinib
Condition: Gastric Cancer Metastatic to Lung; Lung Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      The primary end point was progression-free survival (PFS), secondary end points included
      duration of locoregional control (LRC), overall survival (OS), quality of life and safety.
      For metastatic lung cancer, LRC is the local control of metastatic lung tumor here.
    

Detailed description: 
      Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric adenocarcinoma,
      lung adenocarcinoma and lung squamous cell carcinoma, multiline chemotherapy failure and lack
      of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of
      Qingdao University. Histologically proven were identified retrospectively using the Clinical
      Research Information Systems (CRIS) database. All patients were with Karnofsky performance
      status ≥70% or an Eastern Cooperative Oncology Group performance status of 0 to 1, with
      stable hepatic, hematologic, and renal functions. Cardiac disease and hemorrhagic disease
      were excluded. All patients had pre-therapy chest computed tomography (CT) prior to apatinib
      treatment, and follow-up chest CT at least every 4 weeks. The primary end point was
      progression-free survival (PFS), secondary end points included duration of locoregional
      control (LRC), overall survival (OS), quality of life and safety. For metastatic lung cancer,
      LRC is the local control of metastatic lung tumor here. Other patient demographic and
      clinical data, including age, gender; stage of disease, apatinib administered inclusion and
      withdrawal date, adverse events, oncologic clinical response, comorbid conditions, and
      smoking history, were retrieved from the CRIS database.
    

Intervention name(s): lung cavitation
Intervention type(s): Other
Intervention description(s): apatinib treated patients developed lung cavitation
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        1. Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric
             adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma

          2. Multiline chemotherapy failure and lack of standard treatment, received oral apatinib
             250 mg daily at the Affiliated Hospital of Qingdao University.

          3. Histologically proven were identified retrospectively using the Clinical Research
             Information Systems (CRIS) database.

          4. All patients were with Karnofsky performance status over 70% or an Eastern Cooperative
             Oncology Group performance status of 0 to 1, with stable hepatic, hematologic, and
             renal functions.
      
Keywords: Cavitation; PFS
Effective High Aerobic Intensity Endurance Training Regimes in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Pulmonary Disease, Chronic Obstructive; Hyperoxia
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Hyperoxia
Study type: Interventional

Summary: 
      4 times 4 minutes interval training with and without hyperoxia is more effective than low
      intensity endurance training.
    


Intervention name(s): 4 times 4 minutes high aerobic intensity one leg cycling
Intervention type(s): Behavioral
Intervention description(s): 3 times per week for 10 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; training; VO2peak; performance; ventilation; high aerobic intensity treadmill walking; one leg training by cycling
The Effect of a Low FODMAP Oral Nutrition Supplement On Breath Hydrogen Response In Healthy Human Subjects
Condition: Food Selection
Study type: Interventional

Summary: 
      The goal of this study is to determine subjective gastrointestinal tolerance response and
      differences in breath hydrogen response following the consumption of different types of low
      FODMAP oral nutrition supplements. This randomized, crossover study requires participants to
      arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete
      gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen
      analysis at various time points over a 4 hour time period.
    

Detailed description: 
      This randomized, crossover study requires participants to arrive to the lab 12 hours fasted,
      consume an oral liquid supplement and complete gastrointestinal tolerance questionnaires as
      well as produce samples for breath hydrogen and methane analysis at various time points over
      a 4 hour time period. Subjects will also be asked to rate gastrointestinal symptoms via a
      questionnaire at various time points throughout the study.
    

Intervention name(s): Low FODMAP Oral Nutrition Supplement
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy of First Time Anterior Shoulder Decision Tool
Condition: Shoulder Dislocation
MeSH terms: Shoulder Dislocation
Study type: Interventional

Summary: 
      This study is a randomized controlled trial using Duke patients to test, compared to the
      standard of care, a questionnaire and statistical model used to determine how patient
      preference regarding shoulder pain, physical limitations, physical therapy, recovery period,
      prognosis, and cost impact choice of surgical versus non-surgical intervention.

      Phase 1 of this study is the initial testing of the instrument and involves a small group of
      up to 10 individuals who will partake in one-on-one interviews while completing the Shoulder
      Injury Survey to provide feedback. In Phase 2 of this study, 200 subjects will be randomized
      to receive either the Decision Tool or the standard Information on Shoulder Dislocation
    

Detailed description: 
      An anterior shoulder dislocation is a common problem for people between the ages of 15 to 35.
      Recurrent instability is common and dependent on age and gender. Treatment options include
      surgical intervention and repair or non-surgical options that include intensive
      rehabilitation. Level I evidence suggests early surgical repair can significantly reduce the
      risk of recurrent instability. The risk of arthritis is increased with multiple dislocation
      episodes.

      Traditionally, the combination of 1) history and physical exam performed by the provider, 2)
      clinical and diagnostic tools to assess the extent of injury and impact on physical activity,
      and 3) patient-voiced preference has guided the selection of an optimal solution for an
      individual patient. When providing a recommendation to individual patients and their unique
      circumstances, the health care provider may gather patient preferences on factors such as
      desire to avoid pain, chance of recurrent shoulder dislocation, time needed for
      rehabilitation and physical therapy, and operative versus non-operative costs. Surgical and
      non-surgical options have distinct differences in these outcomes. When combined, the
      interaction between these variables creates important tradeoffs of risks and benefits for
      each option.

      No studies have been conducted to determine the objective weight of these different
      dimensions of patient preferences and how they might guide the provider-patient conversation.
      Conjoint analysis is a statistical method that seeks to quantify the relative importance of
      various aspects of the decision-making process, such as cost or probability of repeat injury
      as described above. Combined with a validated survey tool, conjoint analysis of patient
      preferences in shoulder repair can assist the physician in recommending a patient-centered
      option.
    

Intervention name(s): Decision Tool; Information on Shoulder Dislocation
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Multifactorial Approach to Emergent Cerclage
Condition: Cervical Insufficiency
MeSH terms: Uterine Cervical Incompetence
Study type: Interventional

Summary: 
      Though cervical insufficiency is a common cause of second trimester pregnancy loss, the
      placement of an emergent cerclage in these patients is thought to improve perinatal outcomes.
      It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated
      by need for emergent cerclage.

      The objective is to determine whether administration of peri-operative antibiotics and
      indomethacin to patients receiving emergent cerclages for cervical insufficiency increases
      latency period to delivery compared with patients receiving emergent cerclage alone.
    


Intervention name(s): Indomethacin and antibiotics (cefazolin or clindamycin)
Intervention type(s): Drug
Intervention description(s): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin
Other intervention name(s): indocin, cleocin, ancef
Intervention MeSH terms: Anti-Bacterial Agents; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cefazolin; Indomethacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cervical insufficiency
Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to characterize the safety and immunogenicity of 1 dose of
      GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9
      and 12 months of age.
    

Detailed description: 
      The protocol posting has been amended to reflect changes as a consequence of an amendment to
      the protocol and also to comply with the FDA amendment Act, Sep 2007. Sections impacted are
      Brief Title, Official Title of the study, Brief Summary, Key Inclusion & Exclusion criteria.
    

Intervention name(s): Meningococcal vaccine GSK134612
Intervention type(s): Biological
Intervention description(s): One or 2 intramuscular injections.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Neisseria meningitidis;; Humans;; Meningococcal vaccines;; Safety; Vaccines, conjugate;; Toddlers;; Immunogenicity;
Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma, Kaposi; Sarcoma
Study type: Interventional

Summary: 
      RATIONALE: Herpesvirus is found in the lesions of most patients with Kaposi's sarcoma, and
      may have a role in causing Kaposi's sarcoma. Valganciclovir is an antiviral drug that acts
      against many types of herpesviruses and may be an effective treatment for Kaposi's sarcoma.

      PURPOSE: This clinical trial is studying how well valganciclovir works in treating patients
      with classic non-HIV-associated Kaposi's sarcoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the antitumor activity of valganciclovir in patients with classic
           non-HIV-associated Kaposi's sarcoma (KS).

      Secondary

        -  Determine the effect of this drug on lytic and latent human herpesvirus-8 gene
           expression in KS lesions of these patients.

        -  Determine the effect of this drug on the markers of angiogenesis in KS lesions of these
           patients.

        -  Determine the safety and tolerability of this drug in these patients.

      OUTLINE: This is a pilot study.

      Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks
      in the absence of disease progression or unacceptable toxicity.

      All patients are followed for 1 month after completion of therapy. Patients with responding
      disease are followed monthly for up to 1 year.

      PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 1 year.
    

Intervention name(s): valganciclovir
Intervention type(s): Drug
Intervention MeSH terms: Valganciclovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: classic Kaposi sarcoma; recurrent Kaposi sarcoma
GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label
      pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 mg) in
      patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone
      during the run-in period. The study comprises a 2-week enrollment period, 4 week placebo
      single blind run in period followed by a 12-week double blind treatment period and a 3-week
      follow-up period
    


Intervention name(s): Tesaglitazar; Pioglitazone; Dietary and Lifestyle Modification Counseling
Intervention type(s): Drug; Drug; Behavioral
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Tesaglitazar; type 2 diabetes
A Study to Evaluate Different Intervals Between Dosing and Feeding on the Pharmacokinetics
Condition: Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study use a single-center, randomized, open, three-cycle, self-control trial design. It
      is planning to enroll 15 healthy adult male subjects. Fifteen subjects will randomize into 3
      test groups which corresponding to 3 different dosing sequences. Subjects will be giving a
      single oral dose in per cycle, and there will have three types of breakfast administration
      after each treatment. Washing period is 10 days during the cycle.
    


Intervention name(s): Hetrombopag Olamine
Intervention type(s): Drug
Intervention description(s): 7.5mg in each cycle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Randomized Controlled Trial of Acyclovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand
Condition: HIV; Herpes
Study type: Interventional
Phase: Phase 4

Summary: 
      Herpes infection is an important co-factor in HIV transmission. A recent meta-analysis
      demonstrated that HSV infection contributed to a 2-fold increased risk of HIV transmission.
      Suppressive therapy with acyclovir has been a method proposed to reduce HIV transmission. We
      are conducting a randomized controlled cross-over trial to evaluate the effect of acyclovir
      suppressive therapy on HIV genital shedding in women co-infected with HIV-1 and Herpes
      Simplex Virus Type-2 (HSV-2) in Thailand.
    

Detailed description: 
      65 women ages 18-49 years old with HIV-1 and HSV-2 co-infection are being recruited from
      general medicine clinics, family planning clinics, postnatal clinics, community based
      organizations and community outreach in Chiang Rai, Thailand.

      Our study objectives are:

        -  To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.

        -  To determine the association between HIV and HSV genital shedding, and the effect of
           acyclovir suppressive therapy on this association.

        -  To determine the acceptability of acyclovir suppressive therapy for women with HIV
           infection.

        -  To evaluate the association of genital symptoms and HIV or HSV genital shedding.

        -  To evaluate the association between cervicovaginal (CVL) specimens and self-collected
           genital swabs for detection of HIV and HSV-2.
    

Intervention name(s): acyclovir
Intervention type(s): Drug
Intervention MeSH terms: Acyclovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Acyclovir; HIV; HSV
Quadratus Lumborum Block for Pediatric Hip Surgery
Condition: Hip Dislocation, Congenital; Postoperative Pain; Anesthesia
MeSH terms: Joint Dislocations; Hip Dislocation; Hip Dislocation, Congenital; Developmental Dysplasia of the Hip
Study type: Interventional

Summary: 
      Caudal blockade (CB) is one of the most frequently performed regional anaesthetic techniques
      in children. It's an efficient way to offer perioperative analgesia for painful sub-umbilical
      interventions but with high incidence of motor block and urinary retention. In one study,
      psoas compartment block was associated with less morphine comsumption and prolonged duration
      of analgesia compared to single-shot caudal Block in small children undergoing open hip
      reduction/osteotomies. Ultasound guided anterior Quadratus lumborum block (AQLB) provides
      unilateral analgesia to the nerves between the psoas muscle (PM) and the quadratus lumborum
      muscle (QLM). The first pediatric study evaluating Quadratus lumborum block is encouraging .

      The first pediatric study evaluating Quadratus lumborum block is encouraging. To the best of
      the investigator's knowledge, there are no previously published data comparing the AQLB with
      other regional techniques in infants undergoing hip surgery.
    

Detailed description: 
      The aim of this prospective randomized study was to compare the analgesic effects between
      AQLB and CB in children undergoing unilateral open hip reduction/osteotomies for hip
      dislocation.

      Patients were randomly assigned, into 1 of 2 groups, namely, group CB (n = 20) and group AQLB
      (n = 20).

      Preoperatively all children were premedicated by using oral midazolam (0 .5mg/kg).

      anesthesia was induced with 3 to 4% sevoflurane and 50% with 60% nitrous oxide in oxygen.Then
      fentanyl 3 μg/kg and Propofol 1 - 2mg/Kg were administered for anesthesia induction. Airway
      was secured with endotracheal tube placed in the mouth facilited by 0.15 mg/kg cistracurium.
      Anesthesia maintenance was performed with sevoflurane 2% in 50% nitrous oxide.

      AQLB and CB were done with 1 ml/kg, 0.25% Ropivacaine (maximum dose limited to 20 ml)

      Postoperative follow-up:

      All patients received 15 mg/kg paracetamol before extubation. Tramadol 2 mg/kg intravenous
      was planned as rescue analgesia when CHEOPS score was more than 3. Supplemental IV tramado, 1
      mg/kg could be added if necessary every 6 hours.
    

Intervention name(s): anterior Quadratus lumborum block; caudal block
Intervention type(s): Procedure; Procedure
Intervention description(s): ultrasound anterior quadratum lumborum block with 1 ml/kg 0.2% ropivacaine; ultrasound guided caudal block with 1 ml/kg 0.2% ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hip dislocation; regional anesthesia; surgery