bioihbjkbjnl/mcl2 huggingface dataset:
Etodolac-lidocaine Patch in Subjects Experiencing Acute Delayed Onset Muscle Soreness
Condition: Acute Delayed Onset Muscle Soreness (DOMS)
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluate the efficacy and safety of Etodolac-lidocaine topical patch applied one
      time daily when compared with placebo in the treatment of acute Delayed Onset Muscle Soreness
      (DOMS) of the upper limbs.
    


Intervention name(s): Etodolac-lidocaine topical patch; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once daily; Once daily
Other intervention name(s): Etoreat
Intervention MeSH terms: Etodolac; Lidocaine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Overall Survival of Large Cell Neuroendocrine Lung Cancer Patients - a Retrospective Study
Condition: Survival Outcomes of Patients With Pulmonary LCNEC
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      This is a retrospective study. 132 patients with LCNEC and combined LCNEC were included to
      the analysis. Patients were treated with radical, palliative or symptomatic intension between
      2002-2018 in central and north-eastern centres in Poland. The group of patients consists of
      47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period
      ranged from 0 to 192 months.
    

Detailed description: 
      This is a retrospective study. 132 patients with LCNEC and combined LCNEC were included to
      the analysis. Patients were treated with radical, palliative or symptomatic intension between
      2002-2018 in central and north-eastern centres in Poland. The group of patients consists of
      47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period
      ranged from 0 to 192 months.

      For all patients included to the analysis, the clinical stage was estimated according to TNM
      Classification of Malignant Tumours - UICC from 2017. The degree of pathomorphic stage (pTNM)
      was assessed in 60 patients treated with intention to treat (ITT), which is 45% of the total
      population.

      The degree of clinical stage (cTNM) was assessed in 72 patients based on the imaging
      examinations (including PET, CT, MRI, bone scintigraphy, etc.) and fine needle aspiration
      biopsy (FNA) (including EBUS, with pathological confirmation of LCNEC, which is 55% of the
      total population.

      The clinical stage (cTNM) was used in case of patients disqualified from radical surgery due
      to: advanced disease, contraindications to surgery, no patient's consent for treatment.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        132 patients with LCNEC and combined LCNEC were included to the analysis. Patients were
        treated with radical, palliative or symptomatic intension between 2002-2018 in central and
        north-eastern centres in Poland. The group of patients consists of 47 women (36%) and 85
        men (64%). Ratio of women to men is 1:1,81. The observation period ranged from 0 to 192
        months.
      
Keywords: LCNEC-Large cell neuroendocrine carcinoma; Lung cancer
Supplementation of 500mg Trans-resveratrol Within Hypoxic and Normoxic Conditions, in Healthy Humans.
Condition: Hypoxia, Brain
MeSH terms: Hypoxia, Brain; Hypoxia
Study type: Interventional

Summary: 
      Objectives: Resveratrol, a non-flavonoid polyphenol, has been found to consistently modulate
      cerebral blood flow (CBF) following oral supplementation. Although, this has not resulted in
      subsequent predicted benefits to cognitive performance in young healthy populations. However,
      it is argued that those who suffer a reduction in CBF and cognition, such as aging
      populations, may benefit more from resveratrol administration.

      Hypothesis: The current investigation aimed to employ a mild hypoxia as an experimental model
      of aging in a young healthy population, to assess if resveratrol can attenuate the deficits
      elicited by the reduction in oxygen supply. It was hypothesized resveratrol would module CBF,
      to provide a more efficient supply of oxygen to overcome any associated decreases to
      performance caused by the hypoxic model.

      Design: This repeated measures, double blind, placebo controlled, balanced design assessed
      the cognitive and CBF effects of resveratrol in hypoxia (equivalent to ~2000m above sea
      level) and normoxia (sea level).

      Methods: 24 participants arrived fully fasted (except water) for 12 hrs before completing a
      baseline measure of a cognitive task battery, and taking the treatment for the day. Following
      a 45 min absorption period, participants completed 3 full repetitions of the cognitive test
      battery and, if appropriate, the oxygen level was altered. Changes in CBF were measured by
      near-infrared spectroscopy throughout the full testing session.
    


Intervention name(s): Resveratrol; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Resveratrol; Cerebral blood flow; Cognition
Use of Care Services by Patients With Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Observational

Summary: 
      Borderline personality disorder (BPD) is characterized by a pervasive pattern of instability
      and impulsivity. Several North American prospective studies support the high level of mental
      health care utilization in this population. There is little data in other systems of health
      organization, such as France. Furthermore, little is known on the variables associated with
      the mental health service utilization among BPD patients.

      The main objective was to compare the utilization of mental health care among BPD patients,
      to the general population and patients with another personality disorder (PD) and to describe
      the demographic and clinical factors associated with the group of patients who use the most
      health care.
    


Intervention name(s): Psychologic test; No intervention
Intervention type(s): Behavioral; Other
Intervention description(s): Assessment by a psychologist including the Structured Interview for Diagnostic and Statistical Manual (DSM)-IV Personality Disorders (SIDP-IV) was given straight to those who had a score above 28. This questionnaire allowed us to distinguish one group of subjects with BPD and a group with other PD (without BPD). Clinical evaluation included Axis I (MINI), Axis II (SIDP-IV), psychopathological features (YSQ-I, Defense Style Questionnaire (DSQ-40), demographic variables and therapeutic alliance (Haq-II).; No intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        First, four groups were composed: BPD, other PD, control groups for PD and other PD. The
        first two groups were recruited from a screening of inpatients including a
        self-administered questionnaire (Personality Disorder Questionnaire 4+). Matched controls
        (age, sex) composed the 3rd and 4th group (BPD control and other PD control). They were
        randomly chosen in the health database insurance previously used.
Educational Intervention to Promote Control Behaviors and Prevention of Dengue
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional

Summary: 
      This study will assess the effect of an educational nursing intervention in adults to promote
      dengue control and prevention behaviors, in comparison with the usual strategy of a health
      service provider institution. The intervention uses the Nola Pender Health Promotion Model as
      a theoretical framework. Findings will be assessed using the nursing outcomes "risk control"
      and "participation in health care decisions" from the Nursing Outcomes Classification (NOC).
    

Detailed description: 
      Annually, there are 390 million cases of dengue, mostly due to the inadequate application of
      sanitary behaviors in the management and control of the vector, having as background the lack
      of knowledge of the population in the appropriation and incorporation of sanitary measures in
      the different environments. In addition to the cognitive and behavioral component, dengue has
      cultural, political, social and economic causes.

      The evidence indicates that, from health education, educational interventions have been
      developed to reduce the disease, but most of them have not been carried out in rural areas
      following a theoretical framework that guides the intervention that leads to an impact on
      health promoting behaviors.

      The use of the NOC results makes it possible to visualize the impact of nursing care and
      constitute scientific support for the advancement of the nursing discipline.
    

Intervention name(s): Educational nursing intervention
Intervention type(s): Behavioral
Intervention description(s): Four weekly individualized intervention sessions, with a duration of 40 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Standardized Nursing Terminology; Prevention & control; Dengue
Antagonism Research Between Antiemetics Agents and Acetaminophen in Thyroidectomy's Post-operative Analgesia.
Condition: Interaction Between Antiemetic Drugs and Paracetamol
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of our study is to determine if there is an antagonism between drugs used in the
      prevention of postoperative nausea and vomiting (PONV) on the analgesia led by acetaminophen
      after thyroidectomy.
    

Detailed description: 
      It was shown that there was an antagonism of the ondansetron on the analgesia led by
      acetaminophen in a model of nociception by electrical stimulation using the PainMatcher in
      healthy volunteers. Our study try to determinate if a such antagonism exist in clinical
      conditions : 66 patients with an Apfel-score II undergoing thyroidectomy were randomized in 3
      equal groups. Each group received an antiemetic (ondansetron, droperidol or dexamethasone) at
      the begining of the intervention and paracetamol at the end of the intervention for the
      postoperative analgesia. During 2 hours in the postoperative unit, we raised : the electrical
      pain's threshold with the PainMatcher, the numeric pain intensity scale and the presence of
      nausea or vomiting. For each patients we determined the cytochrome P450 2D6 activity that
      should have been able to explain a diminution of ondansetron's efficiency. Paracetamol blood
      levels were also raised in the postoperative unit.
    

Intervention name(s): ondansetron; Droperidol; Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ondansetron: 4 mg intravenous administration afer the induction of anesthesia.; droperidol: 1.25 mg intravenous administration after the induction of anesthesia.; dexametasone: 4 mg intravenous administration after the induction of anesthesia.
Intervention MeSH terms: Dexamethasone; Droperidol; Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: postoperative analgesia; paracetamol; 5-HT3 antagonist; ondansetron; PainMatcher
Comparison of Two Videolaryngoscopes (C-MAC vs Airtraq) for Awake Intubation
Condition: Intubation
Study type: Interventional

Summary: 
      Patients with anticipated difficult airway are recommended to be managed with an awake
      tracheal intubation. Initially fibreoptic bronchoscopy was considered the gold standard, but
      in the last decade videolaryngoscopes have been demonstrated to be an efficacy alternative
      technique. Recently, a systematic review and meta-analysis was published investigating the
      efficacy and safety of videolaryngoscopy compared with fibreoptic bronchoscopy for awake
      tracheal intubation. Eight prospective, randomized studies were included, with different
      videolaryngoscopes (C-MAC, GlideScope, Pentax AWS, McGraft, and Bullard). However, a direct
      comparison of two different videolaryngoscopes for awake tracheal intubation in patients with
      anticipated difficult airway has not been performed.
    

Detailed description: 
      This is a clinical prospective randomized-controlled trial. The aim of this study is to
      compare two different devices (C-MAC videolaryngoscope and Airtraq videolaryngoscope) for
      awake tracheal intubation in patients with difficult airways scheduled for surgery. The
      primary endpoint will be to compare first-attempt intubation success rate between the two
      videolaryngoscopes. Secondary outcomes will be to compare: difference in the overall success
      rate, number of intubation attempts, Cormack-Lehane grade of glottic view, incidence of
      complications related to intubation, difficulty experienced by the operator, patient's
      tolerability of the procedure.
    

Intervention name(s): C-MAC videolaryngoscope; Airtraq videolaryngoscope.
Intervention type(s): Device; Device
Intervention description(s): Patients with anticipated difficult airway will be awake intubated with a C-MAC videolaryngoscopy; Patients with anticipated difficult airway will be awake intubated with a Airtraq videolaryngoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: intubation; difficult airway; videolaryngoscope
The Performance of Two Oxygen Delivery Devices Used After General Anesthesia.
Condition: Hypoxemia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      After general anesthesia, there are the risks for airway obstruction, hypoventilation,
      atelectasis, ventilation-perfusion mismatch, hypercarbia and hypoxemia,so oxygen supplement
      in PACU seems necessary.

      This study aim is to compare the two methods of oxygen supplement which are 1.nasal cannula
      at O2 flow 4 L/min. 2.oxygen mask with O2 flow 5 L/min. The hypothesis in this study is the 2
      methods can equally provide effective oxygen supplement to prevent anesthesia-related
      hypoxemia. Choosing nasal cannula would be reasonable because it is cheaper and more
      comfortable to patient.
    

Detailed description: 
      The incidence and causes of hypoxemia in PACU will be identified, if necessary, a higher flow
      or changing oxygen delivery system can be used to prevent and treat hypoxemia. If any
      patients fail from oxygen weaning protocol in PACU and need longer oxygen therapy at ward,
      the duration of oxygen therapy will be recorded and also the compliance with oxygen delivery
      devices.
    

Intervention name(s): oxygen mask; oxygen cannula
Intervention type(s): Device; Device
Other intervention name(s): Oxygen mask or simple mask
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Oxygen; PACU; Hypoxemia
Use Of SB-705498 In The Acute Treatment Of Migraine
Condition: Migraine, Acute
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Despite the success of the triptan class of drugs, approximately 60% of patients who take
      medication at the moderate to severe pain stage of acute migraine, still have pain of mild or
      greater degree at 2 hrs post dose. SB-705498 is a novel, first in class TRPV1 receptor
      antagonist under development for the treatment of migraine pain. Preclinical experiments have
      demonstrated that the TRPV1 receptor is expressed both centrally and peripherally in the
      trigeminal system and inhibition of TRPV1 with SB-705498 can both prevent and reverse
      established central sensitisation.
    


Intervention name(s): SB-705498
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: SB-705498 acute migraine single dose TRPV1 combination inpatient outpatient study
Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients
Condition: Stem Cell Transplant Complications; Delirium
MeSH terms: Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      This research study proposes to conduct an open label, feasibility study administering
      prophylactic oral haldol to patients undergoing a hematopoietic stem cell transplant (HSCT).

      The study will address the following research aims: 1) To demonstrate the feasibility of
      enrolling HSCT patients in a prophylactic medication trial, 2) To determine the tolerability
      of oral haldol in HSCT patients and 2) To compare rates of delirium in HSCT patients who
      receive prophylactic haldol with an untreated historical control group.
    

Detailed description: 
      This is an open label, safety & feasibility, clinical drug trial. We will use historical
      controls from previous research with bone marrow transplant patients and delirium incidence
      at University of Iowa Hospitals and Clinics (UIHC) to evaluate the efficacy of prophylactic
      Haldol in the prevention of delirium. This study will recruit adult cancer patients
      undergoing hematopoietic stem cell transplant (HSCT) at UIHC.
    

Intervention name(s): Haldol
Intervention type(s): Drug
Other intervention name(s): haloperidol
Intervention MeSH terms: Haloperidol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Adaptation Among Adolescents and Adults With Klinefelter Syndrome
Condition: Klinefelter Syndrome
MeSH terms: Klinefelter Syndrome; Syndrome
Study type: Observational

Summary: 
      This study aims to understand the impact of living with Klinefelter syndrome (KS) and the
      factors that contribute to adaptation in adolescents and adults. Individuals with KS may have
      variable symptoms, including hypogonadism, gynecomastia, learning disabilities, and delay and
      underdevelopment of secondary sexual characteristics. Perhaps the most challenging symptom of
      KS is infertility, which seems to be a universal symptom. It is not fully understood how
      males with KS conceptualize their condition, cope with their diagnosis, and adapt to living
      with this condition. In this study, Lazarus and Folkman s Transactional Model of Stress and
      Coping provides a framework for examining coping and adaptation in males with KS. A
      cross-sectional research design using a quantitative survey will be utilized to examine the
      relationships among appraisals (illness perceptions and perceived stigma), time elapsed since
      learning of diagnosis, coping, and adaptation. Adolescents and adults with KS will be
      recruited from national KS support networks via website postings, email listservs, and
      printed newsletter postings. Adolescents will also be recruited from a private practice.
      Participants will have the option to complete an online or paper version of the survey. The
      main outcome variable is adaptation to living with a KS diagnosis.
    

Detailed description: 
      This study aims to understand the impact of living with Klinefelter syndrome (KS) and the
      factors that contribute to adaptation in adolescents and adults. Individuals with KS may have
      variable symptoms, including hypogonadism, gynecomastia, learning disabilities, and delay and
      underdevelopment of secondary sexual characteristics. Perhaps the most challenging symptom of
      KS is infertility, which seems to be a universal symptom. It is not fully understood how
      males with KS conceptualize their condition, cope with their diagnosis, and adapt to living
      with this condition. In this study, Lazarus and Folkman s Transactional Model of Stress and
      Coping provides a framework for examining coping and adaptation in males with KS. A
      cross-sectional research design using a quantitative survey will be utilized to examine the
      relationships among appraisals (illness perceptions and perceived stigma), time elapsed since
      learning of diagnosis, coping, and adaptation. Adolescents and adults with KS will be
      recruited from national KS support networks via website postings, email listservs, and
      printed newsletter postings. Adolescents will also be recruited from a private practice.
      Participants will have the option to complete an online or paper version of the survey. The
      main outcome variable is adaptation to living with a KS diagnosis.
    

Time perspective: Retrospective
Keywords: Klinefelter Syndrome; 47,XXY; XXY
A Brief Family-centered Care Program for Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Family interventions have been emphasized in the treatment of BPD and have benefits for
      patients' symptoms and health; however, the effects of family interventions on family
      function and caregivers' health-related outcomes have not been well investigated. This
      randomized controlled trial with 47 hospitalized patient-with-BPD/family-caregiver dyads at a
      medical center in northern Taiwan compared the effects of a brief family-centered care (BFCC)
      program with treatment-as-usual (TAU). The findings support both the feasibility of using the
      BFCC program for inpatients and its specific benefits for family function. An intensive
      family intervention during hospitalization has been suggested in psychiatric practice to
      support patients with BPD and family caregivers.
    

Detailed description: 
      All of the family caregivers in two groups were invited to attend a routine 60-minute family
      discussion group about violence and suicide prevention. The TAU group without specific family
      interview for patient and family caregiver dyad. In the BFCC group, four 90-minute BFCC
      program sessions were additionally provided twice a week for each hospitalized family dyad.
      It was hypothesized that family caregivers in the BFCC group could primary increase their
      family function, and secondary improve perceived health status and reduce caregiver's burdens
      compared to the TAU. The results showed family caregivers in the BFCC group significant time
      group interaction effects in overall family function (p=0.03) and subscale-conflict (p=0.04),
      communication (p=0.01), and problem solving (p=0.04), but there were no significant
      interaction effects on the caregivers' perceived health status and caregiver's burdens.
    

Intervention name(s): Brief family-centered care (BFCC) program
Intervention type(s): Other
Intervention description(s): The therapist provided the 4-session BFCC program twice a week for each dyad. The core principles treated family as a single unit and provided individually tailored interventions to improve family function through psychoeducation, social and emotional support, and actively raising questions to facilitate constructive awareness and changes. It was initially held to assess family function, then to provide information about BPD, to support and empower the dyads to change communication styles and resolve conflicts, and to sustain or improve family function in the cognitive, affective, and behavioral domains.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment