bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability of Intranasal Dexmedetomidine
Condition: Pharmacokinetics; Arthritis Knee; Arthritis of Hip; Anesthesia
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim of this study is to characterize the pharmacokinetics of dexmedetomidine in supine,
      anesthetized adult patients after intranasal dosing.
    

Detailed description: 
      To date, intranasal dexmedetomidine pharmacokinetics have not been studied before on
      anesthetized adult patients in supine position. As use of intranasal dexmedetomidine is
      growing, it is crucial to enhance knowledge of its pharmacokinetics.

      Open, exploratory study design will be used. Study population will consist of patients coming
      to elective unilateral hip or knee arthroplasty under general anesthesia in Turku University
      Hospital, Salo unit. Thirty patients compatible with the inclusion and exclusion criteria
      will be entered into the study after receiving informed consent. Plasma concentrations of
      dexmedetomidine and other significant data will be collected prospectively.

      Intranasal dexmedetomidine 100 ug will be administered shortly after induction of general
      anesthesia using a mucosal atomization (LMA MAD Nasal™) device, according to normal local
      protocol. Second cannula will be placed after patient is anesthetized, in order to obtain
      blood samples. Venous blood samples will be obtained immediately prior to administration of
      dexmedetomidine (baseline) and thereafter at 5, 15, 45 min and 1, 4 h into EDTA tubes for
      determination of dexmedetomidine, and possibly adrenaline and noradrenaline plasma
      concentrations.

      Vital signs (heart rate, blood pressure and peripheral oxygen saturation) will be followed
      during the operation, as well as in the post anesthesia care unit according to the local
      protocol. Before patients will be admitted to the ward, they are expected to be appropriately
      arousable and have vital signs in normal limits.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Device
Intervention description(s): Single intranasal dexmedetomidine dose of 100 µg. Intranasal dexmedetomidine will be administered shortly after induction of anesthesia using a mucosal atomization devise (LMA MAD Nasal™)
Other intervention name(s): Dexdor
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Intranasal; Dexmedetomidine
Sequential Compression Device on Body Temperature
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      We hypothesized that sequential compression device (SCD) compression system might induce more
      decreases on core temperature by increasing lower extremity blood flow. And, this study
      investigated the effects of SCD compression system on body temperature in patients during
      total intravenous anesthesia (TIVA) with propofol and remifentanil.
    

Detailed description: 
      Anaesthesia was induced and maintained with propofol and remifentanil. During the surgery,
      temperature was measured and recorded using oesophageal temperature and the calf-minus-toe
      skin-surface temperature gradient, respectively.
    

Intervention name(s): sequential compression device; elastic stockings
Intervention type(s): Device; Device
Intervention description(s): applying sequential compression device during the surgery; applying elastic stockings during the surgery
Other intervention name(s): SCD; ES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: core temperature; sequential compression device; total intravenous anesthesia
Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae
Condition: Breast Neoplasms; Pain, Chronic; Kinesiophobia; Breast Cancer
MeSH terms: Breast Neoplasms; Chronic Pain; Kinesiophobia
Study type: Interventional

Summary: 
      Introduction: Breast cancer represents the most common type of malignant neoplasm worldwide.
      Advances in diagnosis and treatment have increased the life expectancy of patients. However,
      the sequelae associated with treatment and disease in survivors such as chronic pain,
      kinesiophobia and loss of physical function represent a long-term health problem. Physical
      therapy is a frequently used strategy for the treatment of sequelae in the acute stage of the
      disease, but there is a need to evaluate its effectiveness in cancer survivors with chronic
      sequelae. Therapeutic exercise and pain neuroscience education have been shown to be
      effective in the management of populations with chronic pain and loss of function; however,
      more evidence is needed in specific populations of cancer survivors. Objective:To evaluate
      the effectiveness of a physical therapy program based on pain neuroscience education and
      therapeutic exercise for the treatment of chronic pain, kinesiophobia and loss of physical
      function in breast cancer survivors. Methodology. Quasi-experimental study. The sample will
      consist of 40 female breast cancer survivors. The intervention will last 9 weeks, with 3
      sessions of pain neuroscience education and 24 sessions of therapeutic exercise, 3 times per
      week (16 face-to-face sessions and 8 sessions at home). The intervention will be carried out
      in small groups of 8 to 12 people. The frequency and intensity of pain, the level of
      kinesiophobia and physical functionality and the range of of motion of the shoulder will be
      evaluated in 4 assessments, before the intervention (T0), 3rd (T1), 6th (T2) and 9th (T3)
      week of the intervention. Different validated measurement instruments will be used in this
      population such as self-report scales, questionnaires and the use of a goniometer.
    


Intervention name(s): Pain neuroscience education and therapeutic exercise
Intervention type(s): Other
Intervention description(s): Participants will receive a 9-week physiotherapy program. Consisting of 3 sessions of pain neuroscience education and 24 sessions of therapeutic exercise (16 face-to-face sessions and 8 at home).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast neoplasms; Breast cancer survivors; Chronic pain; Pain; Kinesiophobia; Pain neuroscience education; Exercise
Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Observational

Summary: 
      The celiac disease (CD) is a disease with an immune and genetic component that is activated
      by the presence of gluten, and damages the intestine mucosa and causes malabsorption of food.

      In the oral environment the investigators see enamel defects and recurrent ulcers.

      Celiac patients have to keep a restrict gluten-free diet, in order to prevent the clinical
      symptoms of the disease (such as diarrhea, stomach ache and weight loss).

      It has been assumed that the patients have less cariogenic diet, and that caries prevalence
      is not as high as in normal population.

      In celiac patients the investigators find enamel defects that are characterized with pits and
      deep fissures and sometimes the complete loss of enamel. These defects are classified by the
      grading of the CD related DED's (dental enamel defects) according to Aine. These defects are
      symmetrical defects in the permanent dentition, in teeth that develops at the same time. The
      cause is thought to be hypocalcaemia or genetic.

      These defects were found in 42.2% of celiac patients in appose to only 5.4% in healthy
      population.

      Recurrent ulcers were found in 41% in the oral cavity of celiac patients, compare to 27% in
      healthy population.

      After changing the diet to a gluten-free diet, an improvement is seen in the presence of
      these ulcers.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        chilren with celiac disease
      
Keywords: oral health in children with celiac disease
Peer-Led Dissonance Eating Disorder Prevention: Virtual Delivery
Condition: Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      This proposed pilot study will evaluate whether this body acceptance class produces greater
      reductions in eating disorder risk factor symptoms (pursuit of the thin ideal, body
      dissatisfaction, dieting, dietary restraint and negative affect), eating disorder symptoms,
      and future onset of eating disorders over 6-month follow-up in this population.
    

Detailed description: 
      Dozens of eating disorder prevention programs have been evaluated, but only the 4-hr Body
      Project has reduced eating disorder symptoms and future eating disorder onset over 3-4 year
      follow-up, produced larger reductions in outcomes than credible alternative interventions,
      been shown to engage the intervention target (valuation of the thin beauty ideal), and
      produced effects in trials from several independent teams. Although undergraduate
      peer-educator-led Body Project groups have produced larger reductions in outcomes than an
      eating disorder education video, an unmoderated Internet-based prevention program, and even
      clinician-led Body Project groups, it can be logistically difficult to schedule in-person
      Body Project groups with high school and college students. One solution to this key
      implementation barrier is to have peer educators deliver Body Project groups virtually over
      the Internet. A pilot trial in Sweden provided initial evidence that virtually-delivered
      peer-led Body Project groups produced greater reductions in eating disorder symptoms and
      future onset of eating disorders than an active expressive-writing intervention. The proposed
      pilot study will evaluate whether Body Project produces greater reductions in risk factor
      symptoms, eating disorder symptoms, and future onset of eating disorders in this population.

      Participation in the intervention will last four weeks. Participants will be randomly
      assigned to the intervention condition or waitlist-control condition. Assessments will take
      place at pre-intervention, post-intervention, and 6 month follow up. Waitlist control
      participants will receive the intervention after they complete their post-test assessment.
    

Intervention name(s): Peer Led Group Intervention
Intervention type(s): Behavioral
Intervention description(s): Four week dissonance-based program wherein women with body image concerns complete verbal, written, and behavioral activities. The program consist of four 60-minute sessions.
Other intervention name(s): Body Project
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention; Peer Leader; Feeding and Eating Disorders
Effects of Pre-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals
Condition: Heroin Dependence; Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders; Heroin Dependence; Drug-Seeking Behavior
Study type: Observational

Summary: 
      The purpose of this study is to determine whether the opportunity to take free supplemental
      hydromorphone (HYD) influences drug seeking behavior in heroin dependent individuals.
    

Detailed description: 
      Drug dependence is a condition in which drug seeking holds a higher priority than behaviors
      controlled by other reinforcers. Learning to understand, predict, and control this
      maladaptive choice behavior may lead to improved prevention and treatment strategies. HYD is
      a drug currently used as a cough suppressant and to relieve pain. The purpose of this study
      is to determine the extent to which opioid drug seeking behavior in heroin dependent
      individuals can be reduced by environmental factors, including supplemental opioid drug
      availability, drug price, and non-drug alternative reinforcers. Specifically, this study will
      determine whether pre-session opportunity to take "free" supplemental HYD influences HYD
      seeking by using a choice progressive ratio schedule as well as by varying the dose of HYD.

      Participants in this observational study will undergo multiple test sessions in which they
      will select between acquiring drug or money. Because participants may choose money on all 12
      trials of test sessions as a way to avoid receiving an injection, a placebo injection will be
      given when money is chosen. Prior to each test session, participants will receive a sample of
      the drug dose. During each test session, participants will have 12 opportunities to select
      either drug (administered as HYD) or money. Prior to each individual choice trial,
      participants will receive supplemental HYD. Participants will use a computer to earn choices.
      Respiration rate, oxygen saturation, heart rate, and blood pressure will be monitored
      throughout choice trials. Pupil diameter will be measured with a digital camera. Participants
      will complete self-report questionnaires at different times during the study. Participants
      will be maintained on buprenorphine throughout the study, with a fixed 3-week detoxification
      after study completion.
    

Intervention name(s): Hydromorphone
Intervention type(s): Drug
Intervention MeSH terms: Hydromorphone
Time perspective: Prospective
Keywords: opiate dependence
Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this trial is to assess the ability of Transcranial Magnetic
      Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training,
      to improve cognitive performance in patients with Alzheimer's disease which received drug
      treatment. This study is a single-center, double-blind 4 months duration trial.
    

Detailed description: 
      Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome
      measure: CGI-C,FAB, ADL, Neuropsychological computerized test(time frame baseline, 2 months,
      4 months.

      Estimated enrollment: 40 patients Estimated Study start Date: November 2008 Estimated Study
      Completion date: November 2009 Number of arms: 2

      Ages: 50-85 Genders: both
    

Intervention name(s): TMS, H coil
Intervention type(s): Device
Intervention description(s): TMS, H Coil, High/ Low Frequency
Other intervention name(s): TransCranial Magnetic Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
ABSORICA in Patients With Severe Recalcitrant Nodular Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an uncontrolled, open-label study being conducted in approximately 200 healthy males,
      non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.

      ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by
      1.0 mg/kg/day for 16 weeks. Female subjects consenting to use two forms of birth control or
      abstinence are included.
    

Detailed description: 
      This study is designed to collect efficacy, safety, and quality of life (QOL) data from
      subjects who receive Absorica® without food. The study will investigate the treatment
      efficacy, frequency of relapse once the treatment has been discontinued, quality of life
      during the active treatment and during a 2-year post treatment period and the overall safety
      of treatment with Absorica®.

      This is a single-arm, open-label study consisting of 2 phases: a 20-week (5-month) open-label
      Active Treatment Period (ATP) and a 104-week (2-year) post treatment period (PTP). The total
      study duration is to be 124 weeks, excluding a screening period. During the ATP, after week 2
      visit, visits will be scheduled at 4-week intervals for a total of 8 visits (1 screening
      visit, 1 baseline visit, and 6 on-study visits). During the PTP, the first visit will be 4
      weeks after End of Treatment (EOT), the second visit will be 12 weeks after EOT, and
      subsequent visits will be scheduled at 26-week (± 2 weeks) intervals for a total of 6 visits.
    

Intervention name(s): Isotretinoin
Intervention type(s): Drug
Intervention description(s): ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
Other intervention name(s): ABSORICA
Intervention MeSH terms: Isotretinoin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acupuncture for Sleep Disturbances in OEF/OIF Veterans With Post Traumatic Stress Disorder
Condition: Post Traumatic Stress Disorder; Sleep Disturbance
MeSH terms: Dyssomnias; Parasomnias; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Post traumatic stress disorder (PTSD) has emerged as a significant problem among troops
      returning from combat zones. A majority of these veterans will report difficulty maintaining
      or initiating sleep. The purpose of this research will be to conduct a prospective,
      randomized, wait list controlled, small scale feasibility study to examine if the use of an
      auricular acupuncture regimen improves quality of sleep for Operation Iraqi Freedom/Operation
      Enduring Freedom (OIF/OEF)veterans with PTSD receiving standard PTSD treatment. Hypothesis:
      Objective and subjective sleep disturbances and sleep quality will be improved in OIF/OEF
      veterans who receive auricular acupuncture in conjunction with standard PTSD therapy or
      standard therapy alone.
    


Intervention name(s): Auricular Acupuncture
Intervention type(s): Device
Intervention description(s): Subjects receiving the auricular acupuncture intervention will be treated in a quiet private room sitting in a comfortable chair. The external ear cartilage of both ears will be cleaned with isopropyl alcohol swabs. A clean insertion technique will be used with stainless steel SEIRIN D type acupuncture needles (0.20mm diameter, 15mm length) on each of the identified acupuncture points (Shen men, Point zero, brain, thalamus, Pineal, Master cerebral, Insomnia 1, Kidney, Heart, Insomnia 2, Occiput, Forehead) to bilateral ears for a total of 30 minutes. Acupuncture will be administered by a board certified Psychiatrist with supplemental privileges to perform acupuncture.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Post Traumatic Stress Disorder; Sleep Disturbance; Acupuncture
Acceptance and Efficacy of Live Supervision
Condition: Mental Disorders
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      In order to meet an existing lack of empirical studies in the field of cognitive behavioral
      therapy supervision, the present randomized controlled trial is aimed at comparing two
      different types of supervision. This study compares computer-assisted live supervision and
      delayed video-based supervision regarding efficacy and acceptance among therapists, patients
      and supervisors. The efficacy of supervision is defined on different levels such as change of
      psychotherapeutic competence, nondisclosure, self-efficacy, self-awareness of the supervisee
      as well as therapeutic alliance, supervisory alliance and therapy outcome.
    


Intervention name(s): Computer-assisted live supervision; Delayed video-based supervision
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 BITE sessions, 4 video-based sessions (each 50 minutes) during treatment of 2 patients; 12 video-based sessions (each 50 minutes) during treatment of 2 patients
Other intervention name(s): "bug-in-the-eye" (BITE) supervision; video-based live supervision; monitor-based live supervision; videotape supervision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Computer-assisted live supervision; "Bug-in-the-eye" supervision; Delayed video-based supervision; Cognitive behavioral therapy supervision
LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this prospective randomized study was to investigate if the LigaSure vessel
      sealing system can reduce the operation duration and the postoperative drainage amount in
      patients undergoing neck dissection.
    

Detailed description: 
      We compared the differences in perioperative and postoperative variables between LigaSure
      Small Jaw®-assisted and conventional neck dissection in head and neck cancer patients.

      Patients who were scheduled to undergo neck dissection due to head and neck cancer were
      eligible for this study. After receiving a detailed explanation, all patients signed an
      informed consent form before randomization. The study group were treated using the LigaSure
      vessel sealing system (Small Jaw®; Covidien, Colorado, USA) for dissection and hemostasis
      throughout the whole procedures during neck dissection. Relevant data included tumor-related
      variables, perioperative parameters, postoperative drainage status, postoperative subjective
      pain, and analgesic consumption amount were recorded and analyzed.
    

Intervention name(s): Neck dissection
Intervention type(s): Procedure
Intervention description(s): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device.
Other intervention name(s): Ligasure vessel sealing system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: LigaSure; Neck dissection; Operative duration; Postoperative drainage; Postoperative pain