bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Postoperative QoR-15 Scores Between Sevoflurane and Remimazolam
Condition: Anterior Cervical Discectomy and Fusion (ACDF) Surgery
Study type: Interventional

Summary: 
      The purpose of the study is to compare the quality of recovery (QoR)-15 scores according to
      the use of maintenance anesthetics in the cervical spine surgery. Total intravenous
      anesthesia (TIVA) have been known to help reducing risks of postoperative nausea/vomiting and
      malignant hyperthermia. However, it is still not enough to explain which is better between
      TIVA or inhalation anesthesia. In particular, there is no study to investigate overall
      postoperative functional recovery via QoR-15 in patients receiving TIVA with remimazolam. The
      hypothesis of the investigators study is that, in patients with cervical spine surgery, total
      intravenous anesthesia based on remimazolam can improve the the quality of recovery compared
      to inhalation anesthesia based on sevoflurane.
    


Intervention name(s): Sevoflurane based inhalation anesthesia; Remimazolam based total intravenous anesthesia
Intervention type(s): Drug; Drug
Intervention description(s): Sevoflurane group will be inducted with bolus of propofol 1% and maintained with sevofulrane as inhalation and TCI Minto model of remifentanil for general anesthesia.; Remimazolam group will be inducted with remiamazolam at 6 mg/kg/h and maintained with remimazolam at 0.5-1.5 mg/kg/h and TCI Minto model of remifentanil for general anesthesia.
Intervention MeSH terms: Anesthetics; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Cervical surgery; Quality of Recovery; Remimazolam; sevoflurane
Treatment of Acute Lymphoblastic Leukemia HIGH RISK BCR / ABL NEGATIVE IN ADULTS
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      Trial protocol intended the optimization of induction treatment with:

        1. Inclusion of PEG-ASP in induction and in the three blocks of consolidation.

        2. Reduction of the dose of daunorubicin, and recent studies have shown that the use of
           high doses of anthracyclines has not brought higher response rates or longer duration

        3. Replacing the poor cytological response at day 14 by the level of ER at the end of
           induction as a criterion to decide the further treatment (consolidation or second
           induction), so as to have only one criterion (the ER) throughout the study to decision
           making.

      For another hand, reducing non-essential drugs consolidation blocks to try to reduce toxicity
      during it, and replace the ASP E. coli in induction and consolidation of PEG-ASP to ensure a
      more sustained asparagine depletion. Also, increasing the dose of methotrexate (3 to 5 g/m2)
      in patients with ALL-T, since there is recent evidence of a higher response rate with this
      strategy.

      Performing an allo-HSCT early (after one cycle of consolidation) for patients with inadequate
      level of ER after two cycles of induction or in those patients who required two courses of
      induction and have obtained proper ER after the second.

      Conducting studies of RD centrally by cytofluorometry following Euroflow consensus standards,
      to avoid bias in making treatment decisions
    


Intervention name(s): Vincristine in induction; Daunorubicin in induction; Prednisone in induction; Metotrexato in induction; Cytarabine in induction; Hydrocortisone in induction; Idarubicin in induction-2; Fludarabine in induction-2; Ara-C in induction-2; G-CSF in induction-2; Dexamethasone in consolidation-1; Vincristrine in consolidation-1; Metotrexato in consolidation-1; PEG-ASP in consolidation-1; Dexamethasone in consolidation-2; ARA-C in consolidation-2; PEG-ASP in consolidation-2; Dexamethasone in consolidation-3; Vincristine in consolidation-3; Metotrexato in consolidation-3; PEG-ASP in consolidation-3; allogeneic HSCT; Allo HSCT with reduced-intensity conditioning
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Cytarabine; Dexamethasone; Dexamethasone acetate; Prednisone; Hydrocortisone; Fludarabine; Vincristine; Daunorubicin; Idarubicin; Methotrexate; Pegaspargase; Asparaginase; BB 1101
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ALL patients
      
Keywords: Acute Lymphoblastic Leukemia
Diagnosis et Treatment of Asthma in Athlete : Boundary Between Disease and Doping
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine the pharmacokinetic profile of the salbutamol concentration in the
      urine while athletes are resting or during exercise.
    


Intervention name(s): blood sample; urine sample
Intervention type(s): Other; Other
Intervention description(s): blood sample; urine sample
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; athlete
A Mass Balance and Biotransformation Study of [14C]SKLB1028 in Chinese Healthy Male Subjects
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, open-label, mass balance and biotransformation study in healthy male
      subjects utilising a single oral dose of [14C] SKLB1028.
    


Intervention name(s): [14C] SKLB1028
Intervention type(s): Drug
Intervention description(s): A single 150 mg oral dose of [14C] SKLB1028 containing approximately 120 microcurie of [14C] SKLB1028
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Chemotherapy in Treating Women With Previously Treated Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Randomized phase II trial to compare the effectiveness of ISIS 5132 with ISIS 3521
      in treating women who have metastatic breast cancer that has not responded to previous
      therapy.
    

Detailed description: 
      OBJECTIVES: I. Estimate the proportion of women with previously treated metastatic breast
      cancer who are progression free at 4 months after receiving ISIS 5132 or ISIS 3521. II.
      Determine duration of response to these treatment regimens in this patient population. III.
      Evaluate toxicities and tolerability of these treatment regimens in this patient population.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number
      of prior therapies for metastatic breast cancer (1 vs 2). Patients are randomized to one of
      two treatment arms. (Arm I closed 12/22/99) Arm I: Patients receive ISIS 5132 IV continuously
      over 21 days. (closed 12/22/99) Arm II: Patients receive ISIS 3521 IV continuously over 21
      days. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable
      toxicity. After every 2 courses, patients are evaluated for response. Patients are followed
      every 3 months for the first 2 years, every 6 months the next 3 years, then annually
      thereafter.

      PROJECTED ACCRUAL: A maximum of 68 patients (34 per arm) will be accrued in this study (Arm I
      closed 12/22/99).
    

Intervention name(s): ISIS 3521; ISIS 5132
Intervention type(s): Biological; Drug
Intervention MeSH terms: ISIS 5132
Allocation: Randomized
Primary purpose: Treatment
Keywords: recurrent breast cancer
The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty
Condition: Total Knee Replacement
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that Arixtra patients will be less likely to experience wound
      infection than patients who have received low-molecular weight heparin, coumadin or aspirin
      with mechanical compression.
    


Intervention name(s): Fondaparinux Sodium (Arixtra)
Intervention type(s): Drug
Intervention description(s): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.
Other intervention name(s): Arixtra
Intervention MeSH terms: PENTA; Fondaparinux
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neurocognitive Enhancement in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of neurocognitive enhancement on
      cognitive abilities and related social and adaptive behaviours in individuals diagnosed with
      major depressive disorder. Subjects in this study will be randomized to receive
      Neurocognitive Enhancement Therapy (NET) or to a wait list and then NET . Secondary aims
      include examining whether the cognitive benefits are potentiated by repeated exposure during
      in-home practice with complementary exercises. Additionally, the investigators will examine
      the durability of the effects and their generalization to functional capacity and everyday
      functional performance after completion of the groups.
    


Intervention name(s): Neurocognitive Enhancement; Wait List
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Neurocognitive Enhancement Therapy (NET) uses behavioural treatment strategies that are designed to improve a range of cognitive skills. NET uses strategies such as coaching, repetition, practice, teaching, group discussion, and compensation for deficits by using cognitive strengths.; Participants will be wait listed for 10 weeks, following which time they will receive the intervention previously described.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
to Evaluate Effect of Multi Doses Flibans 100 mg Film-c Tablets on Single Dose PK of Digoxin 0.5 mg, Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this trial is to investigate the effect of multiple doses of flibanserin on the
      single dose pharmacokinetics of digoxin in healthy female and male volunteers. Digoxin is a
      narrow therapeutic index drug for which a large number of relevant drug-drug interactions are
      known. Flibanserin is now under evaluation in postmenopausal women which increases the
      likelihood that flibanserin and digoxin will be administered together in the clinical
      setting.
    


Intervention name(s): Flibanserin plus Digoxin; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): Flibanserin 100 mg once daily for 7 days plus Digoxin 0.5 mg as single dose; Digoxin 0.5 mg as single dose
Intervention MeSH terms: Digoxin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Innovative Physiotherapy in Stroke Rehabilitation
Condition: Stroke, Ischemic; Stroke Hemorrhagic
MeSH terms: Stroke; Ischemic Stroke; Hemorrhagic Stroke
Study type: Interventional

Summary: 
      The current study has the potential to improve rehabilitation during the subacute phase of a
      stroke, aiming to reduce the individual's disabilities and risk of falling, enhance health
      promoting physical activity and independence in ADL.
    

Detailed description: 
      The purpose of the RCT is to investigate the effects of an innovative physiotherapy
      intervention, called I-CoreDIST when applied in comprehensive rehabilitation after discharge
      from a stroke unit and throughout the rehabilitation chain.The project investigate: 1)
      effects on postural control and balance in various positions and functional activities.
      Effects on and level of physical activity, and 2) user's identifications of positive and
      negative features in content and coordination of physiotherapy integrated in post stroke
      rehabilitation. Function parameters of balance, gait and levels of physical activity at
      baseline and at 12 weeks will be compared to those obtained from the standard care group.
      Semistructured interviews will be conducted to identify patients' perceptions of key positive
      and negative features of content and coordination of I-CoreDIST and standard care
      rehabilitation after a stroke.
    

Intervention name(s): ICoreDIST; Standard Care
Intervention type(s): Procedure; Procedure
Intervention description(s): The intervention consists of exercises that demand enhancement of dynamic trunk stability and functional movements, combined with the following:
Optimised alignment and adaptation to the base of support and often using an unstable reference point for the trunk (therapeutic ball) or the distal body parts.
Enhanced somatosensory integration of hands, feet and face, including reduced influence of vision to enhance somatosensory integration.
Proximal stability prior to selective task-oriented movement of limbs, head, eyes.
Inclusion of dual tasks (motor/motor and motor/cognitive) in exercises and activities such as walking indoors, out-doors and climbing stairs.
Specific hands-on interactions or other adaptations to optimise alignment and neuromuscular recruitment.
Exercises combining core activation and moderate increase in heart rate: in lying, sitting, standing and walking.; According to national guidelines for stroke care, every patient in Norway will receive in-patient rehabilitation, home-based and out-patient based physiotherapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a parallel trial. After baseline assessment, the participants will be randomly assigned to one of two trial arms, A and B, in a 1:1 ratio.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physiotherapy; Rehabilitation; Trunk Stability; Stroke; Sub-acute; Innovative; Randomized controlled trial; Qualitative study; Gait; Balance
Cortical GABA Concentrations in Insomnia
Condition: Insomnia; Major Depression
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder
Study type: Observational

Summary: 
      Disturbances in the amino acid neurotransmitter (AANt), gamma-amino butyric acid (GABA)
      function are hypothesized to contribute to the neurobiology of Major Depressive Disorder
      (MDD) and insomnia. The principal objective of this project is to use magnetic resonance
      spectroscopy (MRS) to provide the first in vivo characterization of cortical GABA levels in
      individuals with primary insomnia, and to determine whether subjects with MDD, achieving a
      partial response with selective serotonin reuptake inhibitor treatment but still experiencing
      significant residual symptoms including insomnia, have altered levels of this
      neurotransmitter. The investigators are also exploring the correlation between cortical AANt
      levels and abnormalities in sleep parameters in primary insomnia and as a residual symptom of
      major depression.
    

Detailed description: 
      Three groups of subjects (MDD with partial remission and residual insomnia, primary insomnia,
      and healthy) will participate in the study. All subjects will complete a telephone screening,
      and if appropriate a complete face-to-face evaluation, to determine their eligibility for the
      study. All subjects meeting eligibility criteria for the study will complete a baseline MRS
      session to evaluate differences in GABA concentrations between the three groups.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Keywords: Insomnia; depression; GABA; magnetic resonance spectroscopy; MRS; Sleep; antidepressant medication use
Energy Value of Macronutrients From Almonds and Mechanisms of Nutrient Action
Condition: Healthy
Study type: Interventional

Summary: 
      The U.S. Department of Agriculture (USDA) wants to learn more about the number of calories in
      almonds and the mechanisms of the health effects of almonds. Epidemiologic studies have
      demonstrated an inverse or no relationship between nut consumption and body weight, despite
      the fact that nuts are an energy dense food. Intervention studies have shown that consumption
      of nuts has no effect on body weight or an effect that is significantly less than predicted.
      Fecal analyses in studies with peanuts, almonds, and pecans have found increased fecal fat
      and energy loss with nut consumption; however studies with almonds are lacking.
    

Detailed description: 
      The objective of this study is to measure the energy value of almonds in the human diet and
      study molecular mechanisms that may help explain the beneficial health effects of almonds.

      Epidemiologic studies have demonstrated an inverse or no relationship between nut consumption
      and body weight, despite the fact that nuts are an energy dense food. Intervention studies
      have shown that consumption of nuts has no effect on body weight or an effect that is
      significantly less than predicted. Fecal analyses in studies with peanuts, almonds, and
      pecans have found increased fecal fat and energy loss with nut consumption; however studies
      with almonds are lacking.

      Previous studies have suggested that nut consumption imparts a variety of health benefits,
      including reduction of cardiovascular disease and improved satiety. However, studies of
      almonds are extremely limited. The aim of this study is to determine the energy value of
      almonds in the human diet and to probe mechanisms by which almonds impart health benefits.
      The metabolizable energy value of almond nuts will be calculated based on the chemical
      composition and energy content of the consumed diet and excreta. This will provide a better
      estimate of the energy value of almonds than simply calculating energy value based on Atwater
      factors. In addition to determining the energy value of almonds, we will evaluate the effects
      of almond-rich diets on plasma phytonutrient levels and on gene expression changes to
      determine what protective mechanisms are activated by almond consumption.
    

Intervention name(s): 1.5PD almonds; 3.0PD almonds; Base (without almonds)
Intervention type(s): Other; Other; Other
Intervention description(s): average American diet plus 1.5 oz per day almonds; average American diet plus 3.0 oz per day almonds; average American diet without almonds
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: almond; nuts; energy value; cardiovascular disease; phytonutrient; gene expression; energy value of almonds; energy
Dimensional Approach to Evaluate Reward Processing in Major Depressive Disorder Pre- and Post-Desvenlafaxine Treatment
Condition: Depression; Anhedonia
MeSH terms: Anhedonia; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      Anhedonia (the lack of pleasure in normally pleasurable things) is a common symptom of major
      depressive disorder (MDD), and it may impact how patients with depression experience reward.
      Understanding how anhedonia is related to the experience of reward may help improve how
      depression is treated. Computer tasks can be used to measure how reward is experienced, and
      these measures might be able to predict things like who is likely to become depressed, or who
      will respond to antidepressant medication. Studying the relationship between anhedonia and
      reward in patients with depression might also tell us something about how to improve
      diagnosis and treatment of other psychiatric disorders.This is an open label controlled
      treatment study lasting 8 weeks. The brain scans will be used to find changes in brain areas
      that may be related to how people perform on the tasks. The investigators goal is to use this
      information to help us find a reliable predictor that can be used to guide MDD treatment.
    


Intervention name(s): Desvenlafaxine
Intervention type(s): Drug
Intervention description(s): Patients will be provided 50mg dose of desvenlafaxine for 1 week titrated up to 100mg dose of desvenlafaxine for 7 weeks.
Other intervention name(s): Pristiq
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Remifentanil Propofol Infusion in Pediatric Spinal Surgery
Condition: Spinal Fusion
Study type: Observational

Summary: 
      Total intravenous anesthesia(TIVA) is a commonly used anesthetic technique. Although TIVA can
      be accomplished with a variety of drug combinations, infusions of Propofol and Remifentanil
      are often used with dosage adjusted manually by the anesthesia provider.The pharmacokinetics
      of these drugs are well understood, and that knowledge has led to the development of computer
      controlled infusion pumps that can administer the drugs based upon pharmacokinetic models.
      Computer controlled infusion schemes automatically adjust the drug administration based upon
      pharmacokinetic models which typically dictate a tapering infusion scheme. When one considers
      the dosage of a computer controlled infusion it is obvious that manually imitating a similar
      scheme may be difficult.This study will evaluate manually controlled infusion schemes using
      the models built into the Applied Medical Visualizations (Medvis) display and compare the
      manual dosage schemes to the predicted effect site concentrations and pharmacodynamic effect.
    

Detailed description: 
      During Total intravenous anesthesia (TIVA), the anesthetic propofol and the opioid
      remifentanil are often used together. Previous studies have demonstrated the synergy between
      these combinations of medications. From these data, drug interaction models have been
      developed to pair drug effect-site concentrations with event markers of interest to the
      clinical anesthesiologist. For example, the amount of remifentanil and propofol typically
      required during the induction of anesthesia to cause loss of responsiveness to verbal or
      moderate stimuli has been studied. Likewise, the blood concentration levels present during
      emergence from anesthesia have been explored describing levels typically present for patients
      to return to consciousness.

      The purpose of this study is to retrospectively analyze the infusion doses of both
      remifentanil and propofol for pediatric patients undergoing spinal fusion surgery at CHOP.
      These data will be applied to the pharmacokinetic models to determine the predicted effect
      site concentration, and the relationship of that concentration to the 50% and 95% doses as
      predicted by the model.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients having spinal surgery procedures completed at CHOP from April 2007
        through March 2008
      
Keywords: Propofol; Remifentanil; Total Intravenous Anesthesia