bioihbjkbjnl/mcl2 huggingface dataset:
Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia
Condition: Anesthesia Recovery; Anesthesia Emergence; Shivering; Postoperative Recovery
Study type: Interventional
Phase: Phase 4

Summary: 
      In a prospective randomized clinical trial involving adult patients undergoing elective
      surgery under general anesthesia, the investigators will enroll 216 patients, and evaluate 3
      doses of prophylactic dexmedetomidine as a means to reduce postoperative shivering and
      quality of emergence from anesthesia versus placebo.
    

Detailed description: 
      Patients undergoing surgery under general anesthesia may experience several complications
      during the postoperative period. Shivering has been reported to occur in up to 65% of
      patients recovering from general anesthesia, and has been shown to cause detrimental effects
      to the patient. Previous studies have shown that dexmedetomidine 1µg/kg at the end of surgery
      significantly reduces the incidence of postoperative shivering and improves quality of
      emergence from anesthesia. However, this beneficial effect of dexmedetomidine is at the
      expense of prolonged time to extubation and awakening. The aim of this study is to find the
      optimal dose of dexmedetomidine that would be beneficial without delaying recovery from
      general anesthesia.
    

Intervention name(s): dexmedetomidine 0.25 µg/kg IV; dexmedetomidine 0.5 µg/kg IV; dexmedetomidine 1 µg/kg IV; Placebo Comparator
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients in Group IV will receive same volume of normal saline at closure of sevoflurane
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: optimal dose of dexmedetomidine; prevent shivering; improve quality of emergence; anesthesia; without delay; recovery
TBI Project Amsterdam
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      Traumatic Brain Injury (TBI) is the world leading cause of acquired brain injury. Literature
      suggests a pivotal role for attentional functioning in neurocognitive and behavioural
      consequences of paediatric TBI. Limitations of traditional neuropsychological measures of
      attentional functioning have interfered with identification of the effect of paediatric TBI
      on attentional networks so far. Moreover, the associations between attentional networks,
      learning abilities, academic performance and behavioural and emotional problems following
      paediatric TBI are yet to be explored.
    

Detailed description: 
      Background:

      Traumatic brain injury (TBI) is the world leading cause of disability in children (Winslade,
      1998), causing deficits in motor function, neurocognition and adaptive behaviour (Anderson,
      2001). Literature shows that age at injury is inversely related to the magnitude of deficits
      following TBI, highlighting the vulnerability of children for the effects of TBI.

      The neurocognitive consequences of paediatric TBI have primarily been characterized by
      impairments in speed of information processing, attentional functioning and learning
      (Babikian & Asarnow, 2009; Catroppa & Anderson, 2009), interfering with typical
      neurocognitive development. We aim at elucidating the effects of TBI on neurocognitive
      function and investigate the relations between neurocognitive deficits, academic achievement
      and emotional and behavioural function, in order to improve our understanding of the
      post-injury functioning of children that have suffered TBI.

      Methods:

      Patients with TBI will be compared to a control group consisting of orthopedically injured
      patients. Orthopaedic control (OC) groups offer a better comparison to TBI patients than
      typically developing children by controlling for TBI risk factors related to neurocognition
      (e.g. Attention Deficit Hyperactivity Disorder, socioeconomic status), hospitalisation and
      the type of injuries other than brain injuries.

      Measures:

      Child's Orientation and Amnesia Test, Attention Network Test, Probabilistic Learning Test,
      Child Behaviour Checklist, Strengths & Difficulties Questionnaire, Experimental
      Neurocognitive Test developed at the VU University and Pupil Monitoring System.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children that have been admitted to the hospital after sustaining trauma.
      
Keywords: TBI; Traumatic Brain Injury; Children; Prognosis; Neurocognition
Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy
Condition: Pregnancy
Study type: Observational

Summary: 
      This protocol is a prospective, open-label, multicenter, population pharmacokinetic and
      pharmacodynamic study of selected anti-infective agents in pregnant women being treated for
      suspected or documented infections.
    


Intervention name(s): ciprofloxacin; azithromycin; gentamicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ciprofloxacin 500 mg twice a day for five doses.; azithromycin 500 mg on day 1 followed by 250 mg on days 2-5; a single intravenous dose of gentamicin 1.5mg/kg infused over 60 minutes
Intervention MeSH terms: Azithromycin; Ciprofloxacin; Gentamicins
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women who are prescribed antibiotics as part of their clinical care
Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Open-label multi-center, 48 week safety study, consistent with standard practice for
      long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly)
      and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.
    

Detailed description: 
      Open-label multi-center, 48 week safety study, consistent with standard practice for
      long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly)
      and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.

      Patients who are currently taking sublingual (SL) BPN (weekly or monthly prescription visits)
      or individuals who are actively seeking BPN treatment but who have not yet begun a treatment
      regimen, may be eligible for the study.

      Following Screening, qualified subjects meeting inclusion criteria and not meeting exclusion
      criteria will be initiated on either CAM2038 q1w or q4w, based on their current treatment
      status (qualified subjects currently on SL BPN or seeking BPN treatment). Qualified subjects
      will be initiated or transitioned to CAM2038 q1w or q4w as follows:

      Initiation of BPN treatment - initiate with CAM2038 q1w

      Currently receiving SL BPN treatments - transfer to corresponding CAM2038 q1w or q4w dose
    

Intervention name(s): CAM2038 q1w or q4w exposure to SL BPN/NX; CAM2038 q1w or q4w new to BPN treatment
Intervention type(s): Drug; Drug
Other intervention name(s): Buprenorphine injection; Buprenorphine injection
Intervention MeSH terms: Buprenorphine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Heart Rate Variability Biofeedback for Smoking Cessation
Condition: Tobacco Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      Open trial of heart rate variability biofeedback as an adjunct to individualized smoking
      cessation counseling (SCT) plus transdermal nicotine replacement patch (NRT) in smokers with
      elevated emotional distress.
    

Detailed description: 
      The investigators propose to develop and pilot test heart rate variability biofeedback (HRVB)
      for smokers with elevated emotional distress as an adjunct to individual smoking cessation
      counseling (SCT) and transdermal nicotine patch (NRT). In this open trial, all participants
      received the active intervention. Findings will be used to refine the protocol in advance of
      a subsequent Phase III randomized clinical trial.
    

Intervention name(s): Cognitive-Behavioral Smoking Cessation; Heart Rate Variability Biofeedback (HRVB); Transdermal Nicotine patch
Intervention type(s): Behavioral; Behavioral; Drug
Intervention description(s): Participants were provided with six individualized smoking cessation counseling sessions designed to help them prepare to quit, set a quit date, behaviorally manage early abstinence, and to resume cessation upon lapse.; All participants were provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.; All participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
Other intervention name(s): Cognitive-behavioral therapy; Smoking cessation counseling (SCT); Biofeedback; Respiratory biofeedback; Nicotine patch; Nicotine replacement therapy (NRT)
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Intervention model description: All participants received individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking Cessation; Heart rate variability biofeedback
Relative Bioavailability of Single Doses of Dabigatran Etexilate in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate whether and to what extent the suggested P-glycoprotein (P-gp) inducer
      rifampicin affects plasma exposure of dabigatran.
    


Intervention name(s): Dabigatran etexilate; Rifampicin
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg Dabigatran etexilate; 600 mg Rifampicin
Other intervention name(s): Pradaxa®; BIBR 1048 MS; Rifa® 600
Intervention MeSH terms: Rifampin; Dabigatran
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Observational Study on the Prevalence of Urinary Incontinence in Federates Athletes.
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Observational [Patient Registry]

Summary: 
      To study the prevalence of urinary incontinence (UI) in female athletes from Castilla y León,
      as well as the category of athletics with the highest number of losses, the most incident
      risk factors and the bio-psycho-social consequences that it leads to.
    

Detailed description: 
      Elaboration of a survey, based on two validated questionnaires to which 63 participants have
      answered, to carry out an analytical, transversal and observational study. All the
      participants are women, of age, federated in athletics and belonging to Castilla y León.

      UI has a high prevalence (44.4%) in female athletes, being more common in those who practice
      long-distance races. As age and years of sport increase, the incidence of this pathology
      increases. Absorbent pads are used by more than half of the incontinent women, while the rest
      wet their underwear. Menopause, childbirth and surgery in the region are risk factors for
      UTIs, while the presence of urinary tract infections or candidiasis are not. The results
      affirm that urine leaks do not cause anxiety or depression, but they do affect your sporting
      life.
    

Intervention name(s): female athletes
Intervention type(s): Behavioral
Intervention description(s): The type of incontinence is assessed, whether there are risk factors and quality of life and psychological performance
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        female athletes over 18 and under 65
      
Keywords: Women health; Sports; Incontinence, urinary stress
Topical-RAPA Use in Inflammation Reversal and Re-setting the Epigenetic Clock
Condition: Aging; Epigenetics; Inflammatory Mediators
MeSH terms: Inflammation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Topical Rapamycin ointment will be applied to participant forearms to test whether epigenetic
      changes in the skin are elicited.
    

Detailed description: 
      Rapamycin 8% ointment will be applied topically to one of the participant's forearms and
      matching placebo to the opposite forearm daily for a total of 6 months. After consenting,
      screening and randomization of arms, the participants will be monitored at monthly visits
      until study completion.
    

Intervention name(s): Rapamycin Topical Ointment; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 8% topical rapamycin ointment; Petrolatum ointment containing no active ingredient
Other intervention name(s): Sirolimus Topical Ointment; RAPA Topical Ointment; Placebo Topical Ointment; Petrolatum
Intervention MeSH terms: Sirolimus; Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be their own control, either right or left arm will be randomized to treatment or placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Epigenetic clock
Effect of Virtual Reality on Balance in Autism
Condition: Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Children with ASD have poorer postural balance when compared to normal individuals. So, The
      aim of this study is to assess the effect of Virtual Reality on postural control in Autistic
      children
    

Detailed description: 
      Autism spectrum disorders are a collection of persistent neurodevelopmental disorders
      characterized by difficulties in social interactions, communication, and repetitive,
      stereotyped, and restricting behaviors. Movement problems can occur throughout infancy and
      are one of the early indications of autism. Furthermore, movement impairments are the most
      often observed nonverbal deficits in autistic children.

      Postural stability is described as the capacity to maintain an upright posture by keeping the
      body's center of gravity over its base of support with little swaying or maximal steadiness,
      and it is considered a fundamental skill required for normal motor development.

      Virtual Reality has been used in the field of balance rehabilitation and training because of
      its relatively low cost and enjoyment. Therefore, the purpose of this study was to study the
      effect of VR on balance in children with ASD.
    

Intervention name(s): Virtual reality rehabilitation; Traditional physical therapy
Intervention type(s): Device; Other
Intervention description(s): Children in this group received Virtual Reality Rehabilitation plus traditional physical therapy; Flexibility exercises, strengthening exercises, endurance exercises, and postural stability exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study and control groups
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: autism spectrum disorder; Biodex; Postural Control; Virtual Reality
Nutritional Status of Cerebral Palsy Patients in Turkey
Condition: Nutritional Status
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      This is a single visit, non-interventional, cross sectional study about risk factors,
      etiology, nutritional status and feeding methods in CP patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of patients at pediatric neurology outpatient clinic
        diagnosed with CP, 12 months to less than 19 years old.
Study of Human Regular U-500 Insulin in Adult Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to compare the effectiveness of Human Regular U-500 Insulin
      three times a day versus twice a day.
    


Intervention name(s): Human Regular U-500 Insulin
Intervention type(s): Drug
Other intervention name(s): LY041001; Humulin R; U-500R
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Experimental Ebola Vaccine Trial
Condition: Hemorrhagic Fever, Ebola; Healthy
MeSH terms: Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety of an experimental vaccine developed to protect against Ebola
      virus infection and to determine if the vaccine induces an immune response to the virus. The
      Ebola virus causes a disease called Ebola hemorrhagic fever. Symptoms begin with fever and
      muscle aches and progress to breathing problems, severe bleeding, kidney problems, and shock.
      The infection may be mild, but it can also lead to death. The vaccine used in this study is
      made from small parts of Ebola genetic material. It cannot cause Ebola hemorrhagic fever to
      develop in those who receive it.

      Healthy volunteers 18 to 44 years of age may be eligible for this study. Candidates will be
      screened with a medical history, physical examination, and laboratory tests, and complete an
      "assessment of understanding" questionnaire to show that they understand the study.

      Depending on their order of entry into the study, participants are assigned to receive one of
      three vaccine doses or placebo. The first group receives the lowest dose (2 milligram) of
      vaccine or placebo. If this dose is safe, then the second group receives 4 mg, and if this
      dose is safe, the third group receives 8 mg. Injections are given in a muscle in the upper
      arm. Participants receive three injections, each 4 weeks apart (on study days 0, 28, and 56).

      Participants record their temperature and symptoms in a diary card for 7 days following each
      injection. They return to the clinic 2 to 3 days after each injection and then 2 weeks after
      each injection until study week 10. Additional follow-up visits are then scheduled at weeks
      12, 24, 38, and 52. At each visit, participants provide a blood and urine sample for testing
      and have their vital signs, and lymph nodes checked, their weight measured, and their
      symptoms reviewed. Additional laboratory tests may be requested between visits.
    

Detailed description: 
      This is a Phase I, randomized, placebo-controlled, dose-escalation study of an Ebola DNA
      plasmid vaccine. The hypothesis is that the vaccine will be safe for human administration and
      elicit immune responses to Ebola. Primary objectives are to evaluate the safety and
      tolerability of the investigational vaccine and the secondary objective is to evaluate immune
      responses. Randomization assignment will be blinded to subjects, clinical investigators and
      laboratory investigators.
    

Intervention name(s): VRC-EBODNA012-00-VP
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: Healthy; T Cells; Immunity; Hemorrhagic Fever; Healthy Volunteer; HV
Project JAY HAP Registration Study
Condition: Femoral Neck Fractures
MeSH terms: Femoral Neck Fractures
Study type: Interventional

Summary: 
      This is a prospective, randomized, multicenter clinical study in elderly Chinese subjects to
      compare the safety and efficacy of the SS Bipolar Head and SL-TWIN Stem with Bipolar Head and
      SL-PLUS Stem in hemiarthroplasty of the hip
    

Detailed description: 
      Elderly patients, especially post-menopausal women, often suffer a femoral neck fracture due
      to osteoporosis, even with very little trauma. Femoral neck fracture is a common disease in
      elderly patients, it accounts for 3.6% of total body fractures. In China, as the population
      continues to age and life expectancy increases, the incidence of femoral neck fracture has
      significantly increased.

      Hip replacement surgery includes total hip arthroplasty (THA) and hemiarthroplasty (HAP).
      Hemiarthroplasty of the hip involves replacement of the diseased, affected, or broken femoral
      head and/or neck with a prosthetic component. Hemiarthroplasty does not involve resurfacing
      of the acetabulum, and therefore a bipolar or unipolar prosthetic head articulates against
      the host acetabular articular cartilage. Avoiding the need, when appropriate, to resurface
      the acetabulum helps to minimize surgical trauma, operative time and dislocation risk, while
      preserving acetabular bone stock. These also result in shorter bed stay and faster recovery
      comparing with the THA.

      There has been an increase in imported hip prostheses during the past decade, so that
      surgeons now have more choices of implants. However, the high cost of imported prostheses has
      become a barrier to the development of hip replacement in China and caused many patients
      requiring immediate hip replacement to have to delay or miss their surgery. The development
      and promotion of high-quality domestic joint implants and surgical instruments is the key to
      the development of joint replacement technique in China.

      The primary objective of this study is to demonstrate non-inferiority of subjects implanted
      with the SS Bipolar Head + SL-TWIN Stem compared to a randomized concurrent control group of
      subjects implanted with the Bipolar Head + SL-PLUS Stem in terms of mean Harris Hip Score
      (HHS) at 1 year.
    

Intervention name(s): SS Bipolar Head + SL-TWIN Stem; Bipolar Head + SL-PLUS Stem
Intervention type(s): Device; Device
Intervention description(s): Subject will undergo hemiarthroplasty surgery with SS Bipolar Head & SL-TWIN Stem; Subject will undergo hemiarthroplasty surgery with Bipolar Head & SL-PLUS Stem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment