bioihbjkbjnl/mcl2 huggingface dataset:
The Long Term Effects of COVID on Pulmonary Function
Condition: Covid19; COVID-19 Pneumonia; Critical Illness; Quality of Life
MeSH terms: COVID-19; Critical Illness
Study type: Observational

Summary: 
      An observational cohort study of patients discharged from the ICU following admission with
      COVID19 infection, looking at their medical wellbeing 6 months after discharge from the ICU.
    

Detailed description: 
      The COVID-19 epidemic has placed an unprecedented strain on medical services worldwide.
      Throughout 2020 and early 2021, hospitals and their critical care services have been
      inundated with patients suffering from critical illness due to COVID-19, some of whom
      developed multi-organ failure and required a prolonged ICU stay. While the medical literature
      is now replete with publications and research on the acute phase of illness due to COVID-19,
      including critical illness, there is a paucity of studies detailing the long-term outcomes
      following COVID-19 critical illness.

      While the negative long-term physical health, mental health and quality-of-life related
      effects of ARDS have been well documented, there has been very little long-term COVID-19 ARDS
      specific outcome studies published.

      This is an observational cohort study that aims to assess the long-term health outcomes of
      adult patients admitted to Mater Dei Hospital Intensive Care Unit with COVID-19 infection.
      Patients will initially be assessed at 6 months after discharge from ITU. They will be
      interviewed by trained researchers using validated questionnaires. These questionnaires will
      assess their physical health, mental health and functional status. Participants will be
      examined and asked to do a 6minute walk test also using validated non-invasive physical
      assessment tools. They will be offered pulmonary function tests to be carried out at the
      Pulmonary function laboratory.
    

Intervention name(s): Spirometry; 6-minute walk
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Spirometry to assess lung function; Exercise tolerance
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients will be included
      
Keywords: Covid19; Critical Illness
A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions
Condition: Cheek Line Depressions
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic
      radial cheek line skin depressions.
    


Intervention name(s): Juvéderm® VOLIFT®™ with Lidocaine
Intervention type(s): Device
Intervention description(s): Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine is injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine will be injected on Day 14; volume will not exceed 1 mL per side.
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Interaction Study of Multiple Doses of Isavuconazole and a Single Dose of Bupropion
Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Bupropion; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics of a single dose of bupropion.
    


Intervention name(s): Isavuconazole; bupropion hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): BAL8557
Intervention MeSH terms: Isavuconazole; Bupropion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Isavuconazole; Bupropion; Bupropion hydrochloride; Healthy Volunteers; BAL8557; BAL4815; BAL8728
Lenalidomide & Adriamycin & Dexamethasone (RAD) in Newly Diagnosed, Multiple Myeloma Patients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to assess the efficacy and safety of lenalidomide in combination with
      adriamycin and low dose dexamethasone in newly diagnosed patients with symptomatic multiple
      myeloma as well as to collect information regarding the effect of this regimen on
      angiogenesis and bone remodeling of the study population.
    

Detailed description: 
      This is a Phase II, non randomized, non- comparative, open label trial which assess the
      efficacy and safety of lenalidomide, adriamycin and low dose dexamethasone combination (RAD)
      in 45 newly diagnosed patients with symptomatic multiple myeloma as well as to collect
      information regarding the effect of this regimen on angiogenesis and bone remodeling of the
      study population. The recruitment period is estimated for 5 months while the treatment period
      and the follow up period 4 months and 1 month respectively. During the treatment initiation
      visit the response to the combination RAD according the International Myeloma Working Group
      (IMWG) criteria will be evaluated, biochemical markers of bone metabolism and angiogenic
      cytokines will be measured as well. IMWG Response evaluation will be repeated the day 1 of
      each treatment cycle as well as at the response evaluation visit. Finally biochemical markers
      of bone metabolism and angiogenic cytokines will be measured once more at the end of
      treatment visit.
    

Intervention name(s): Lenalidomide; Adriamycin; Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lenalidomide 25 mg by mouth for the first 21 days of a 28-day-cycle for 4 cycles; Adriamycin as intravenous bolus infusion at a dose of 9 mg/m2, on days 1-4 of a 28-day cycle for 4 cycles; Dexamethasone by mouth at a dose of 40 mg, on days 1, 8, 15, and 22 of a 28-day cycle for 4 cycles
Other intervention name(s): Combination of Lenalidomide, adriamycin & dexamethasone; Combination of Lenalidomide, adriamycin & dexamethasone; Combination of Lenalidomide, adriamycin & dexamethasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lenalidomide; Doxorubicin; Liposomal doxorubicin; BB 1101
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma
Cognitive Behavioral Therapy and Chronic Pain Self-Management Within the Context of Opioid Reduction: The EMPOWER Study
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The proposed study will fill several critical gaps in evidence that are preventing patients
      and physicians from making informed decisions about their pain care. This project will
      provide patients taking opioids and physicians with the specific evidence they need to choose
      the most effective route to pain control, reduced pain interference, opioid reduction, and
      improved role function, thereby improving patient care.

      The aims of this study are to (1) reduce or contain prescription opioid use while maintaining
      pain control and (2) compare the effectiveness of the Chronic Pain Self-Management Program
      (CPSMP), Cognitive Behavioral Therapy for chronic pain (pain-CBT), and no behavioral
      treatment within the context of patient-centered collaborative opioid tapering (Taper Only).

      The acronym EMPOWER stands for Effective Management of Pain and Opioid-Free Ways to Enhance
      Relief.

      To learn more about the EMPOWER study, please visit: empower.stanford.edu.
    


Intervention name(s): Cognitive Behavioral Therapy; Chronic Pain Self Management Program; Usual Care
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): A trained psychologist delivers pain-CBT to individual patients or groups of patients with chronic pain. Group treatment is delivered across 8 weekly sessions that last for 2 hours each. Pain-CBT incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session. Pain-CBT is effective for reducing pain intensity, pain catastrophizing, depression and social impacts.; The CPSMP is similar to pain-CBT in format and content but is peer-led, and is effective across pain conditions (e.g., back pain, arthritis) for improving pain and pain self-efficacy. The CPSMP consists of six weekly 2-hour group sessions in which two peer co-leaders provide patient education about pain, effective self-management, pain impacts, and other symptoms from a highly structured manual. Similar to pain-CBT, CPSMP incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session; Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Analgesic Effect of Auditory Inputs and Its Relation to Psychological and Neurobiological Mechanisms
Condition: Analgesia
Study type: Observational

Summary: 
      The study investigates the analgesic effect of different auditory inputs. Employing a
      within-subject design, the study includes healthy participants that are exposed to thermal
      stimuli while listening to three different auditory inputs. By repeating this on separate
      test days, the involvement of bodily processes is investigated.
    


Intervention name(s): Auditory inputs
Intervention type(s): Behavioral
Intervention description(s): Three different auditory inputs
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy participants
      
Keywords: Pain; Auditory inputs
Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
Condition: Major Depressive Disorder; Alcohol Use Disorder
MeSH terms: Alcoholism; Depressive Disorder; Depression; Depressive Disorder, Major; Alcohol Drinking
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators will compare 3 treatment groups (ketamine plus naltrexone vs. ketamine
      alone vs. placebo) for treating major depressive disorder (MDD) and alcohol use disorder
      (AUD) in an 8-week randomized, double-blind, placebo-controlled, between-subjects trial.
      First, prior to the double-blind trial, the investigators will conduct an open-label trial
      that will include 5 patients with comorbid MDD and AUD to test safety and efficacy of
      repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a total of 4 ketamine
      infusions) with a follow-up of 4 weeks. Second, after reviewing the safety and efficacy of
      repeated ketamine treatment from the open-label trial, the investigators will conduct an
      8-week, randomized, double-blind, placebo-controlled trial that will include 60 patients with
      comorbid MDD and AUD to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg;
      once a week for 4 weeks; a total of 4 ketamine infusions) plus naltrexone with a follow-up of
      4 weeks. The 4-month follow-up session will also occur.
    


Intervention name(s): Ketamine + Naltrexone; Ketamine + Placebo; Placebo (psychoactive placebo midazolam) + Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 2 injections).; Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).; Subjects in this arm will receive (1) intravenous psychoactive placebo midazolam (0.045 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).
Intervention MeSH terms: Midazolam; Naltrexone; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas
Condition: Length of Labor; Second Stage of Labor; Intravenous Hydration of Labor
Study type: Interventional

Summary: 
      This randomized controlled trial aims to compare three groups of intravenous fluids and their
      impact on labor: 1) 125 mL/hr of 5% dextrose in normal saline 2) 250 mL/hr of normal saline
      3) 250 mL/hr of 5% dextrose in normal saline
    

Detailed description: 
      Currently, patients who arrive to labor and delivery automatically receive IV fluid hydration
      as part of a standard order set. The current default IV fluid order is 125mL/hr of 5%
      dextrose, either in normal saline or lactated ringers.

      Any patient delivering for the first time presenting to labor and delivery in active labor
      will be screened. If they meet inclusion requirements they will be offered enrollment.

      Subjects will be blindly randomized to receive one of three different types of IV fluids:

        1. 5% dextrose Normal saline (Normal saline plus 5g/dl of glucose) at 125 mL/hr (the
           current LBMMC default inpatient IV order set)

        2. Normal saline (a solution containing sodium and chloride) at 250 mL/hr

        3. 2.5% dextrose Normal saline at 125 mL/hr

             -  Management of labor will be at the discretion of the attending physician(s).

             -  Maternal outcomes to be measured include: 1) total amount of IV fluids
                administered, 2) length of labor, 3) epidural use, 4) oxytocin use, 5) mode of
                delivery, 6) development of maternal infections or other morbidity such as
                postpartum hemorrhage.

             -  Neonatal outcomes to be measured include: 1) birth weight, 2) Apgar scores, 3)
                hospital course (nursery placement and length of stay), 4) need for treatment of
                jaundice.
    

Intervention name(s): Dextrose; Normal Saline
Intervention type(s): Other; Other
Other intervention name(s): Intravenous fluids, normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Length of labor; second stage of labor; intravenous hydration of labor; intravenous glucose
MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A single rising dose study to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM).
      The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe
      and well tolerated, based on the assessment of clinical and laboratory evaluations and
      adverse experiences, in Japanese participants with T2DM.
    


Intervention name(s): MK-1006; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C.; Matching placebo to MK-1006 in a single oral dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Differences in Pharmadynamics, Pharmacokinetics, and Safety Between Ciprofol and Propofol
Condition: Anesthesia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, randomized, two-stage, two-way crossover Phase I study
      in healthy male subjects.The main objective is to evaluate the differences in pharmadynamics
      (PD), pharmacokinetics (PK), and safety between ciprofol injectable emulsion and propofol
      injectable emulsion at different doses in healthy subjects.
    


Intervention name(s): Ciprofol; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): First-stage: 0.4mg/kg, 0.6 mg/kg, 0.8 mg/kg Second-stage: 0.4mg/kg, 0.6 mg/kg, 0.8 mg/kg; First-stage: 2.0mg/kg, 3.0 mg/kg, 4.0 mg/kg Second-stage: 2.0mg/kg, 3.0 mg/kg, 4.0 mg/kg
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics of PCI-32765 in Participants With Varying Degrees of Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations
      change over time) of PCI 32765 in participants with mild, moderate, or severe hepatic
      impairment.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-dose,
      multi-center (study conducted at multiple sites), non-randomized study to access the
      pharmacokinetics of PCI-32765 in participants who either have mild, moderate, or severe
      hepatic impairment or qualify for the control group (normal liver function). The study mainly
      consists of 3 phases: screening phase (within 21 days prior to the first dose of study
      medication), treatment phase, and a follow up phase (10 to 12 days after the last dose of
      study medication). In the treatment phase, participants will receive single oral dose of
      PCI-32765 on Day 1. Liver impairment will be classified according to the Child-Pugh
      Classification of Severity of Liver Disease, as: normal, mild, moderate, and severe. Total 30
      participants (24 with hepatic impairment [6 mild, 9 moderate and 9 severe] at baseline and 6
      in the control group according to Child-Pugh criteria) will be enrolled. Participants in the
      control group will be enrolled after the participants with mild or moderate hepatic
      impairment have completed the study. Safety evaluations for adverse events, clinical
      laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored
      throughout the study. The total duration of study for each participant will be approximately
      for 29 to 33 days.
    

Intervention name(s): PCI-32765
Intervention type(s): Drug
Intervention description(s): PCI-32765 140 mg will be administered as a single dose, orally, on Day 1.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment; PCI 32765; Metabolite PCI-45227; Pharmacokinetics
Effect of Paracetamol and Ibuprofen Reducing Morphine Requirements After Total Knee Arthroplasty
Condition: Analgesia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Adequate pain management has an important role in supporting early ambulation after the Total
      Knee Arthroplasty (TKA). Multimodal analgesia is one of the modalities of overcoming
      postoperative pain. The use of combination Paracetamol and Ibuprofen injection is expected to
      reduce total morphine consumption after TKA.
    

Detailed description: 
      The research will compare the effect of paracetamol injection and ibuprofen injection when
      given alone or in combination to reduce morphine requirement in a patient after total knee
      arthroplasty
    

Intervention name(s): Paracetamol injection and Ibuprofen injection; Paracetamol injection and normal saline; Ibuprofen Injection and normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Use of combination acetaminophen and ibuprofen to reduce morphine requirement inpatient after Total knee arthroplasty; Use of paracetamol and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty; Use of ibuprofen and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty
Other intervention name(s): Paracetamol and Ibuprofen; Paracetamol injection; Ibuprofen injection
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Patients in Group 1 received a combination of 1000 mg IV paracetamol and 800 mg IV ibuprofen at the end of operation followed by 1000 mg IV paracetamol and 800 mg IV ibuprofen every 6 hours up to 72 hours.
Patients in Group 2 received 1000 mg IV paracetamol and 100 ml IV normal salines at the end of operation followed by 1000 mg IV paracetamol and 100 ml IV normal salines every 6 hours up to 72 hours.
Patients in Group 3 received 800 mg IV ibuprofen and 100 ml IV normal salines at the end of operation followed by 800 mg IV ibuprofen and 100 ml IV normal salines every 6 hours up to 72 hours.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: multi modal analgesia
Safety and Effectivity Immunotherapy to Treat Ovarian Cancer With Cancer Stem Cells Vaccine
Condition: Neoplasms,Ovarian
MeSH terms: Ovarian Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors
      into immunosuppressed mice, preventing an assessment on the immunologic interactions and
      effects of CSCs. In this study, the investigators examined the vaccination effects produced
      by CSC-enriched populations from histologically distinct murine tumors after their
      inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic
      and more effective as an antigen source than unselected tumor cells in inducing protective
      antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which
      bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from
      peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were
      capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed
      antibodies and T cells were capable of selective targeting CSCs and conferring antitumor
      immunity.
    

Detailed description: 
      To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the
      investigators will harvest peripheral blood and tumor specimen from patients with ovarian
      Cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the
      ovarian cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow
      tumor cells from the tumor specimen of the ovarian cancer patient using a similar protocol as
      investigators reported .

      Aim 1: To demonstrate, in vitro, the relative cellular anti-ovarian cancer CSC immunity
      induced by ovarian cancer CSC-DC primed cytotoxic T cells.

      Aim 2: To determine, in vitro, specific binding and lysis of ovarian cancer CSCs by
      antibodies produced by purified B cells from PBMCs stimulated with ovarian cancer CSC-DC.
    

Intervention name(s): CSC-DC
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment