bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia
Condition: Perioperative/Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study to compare the efficacy of intravenous or intrathecal
      dexmedetomidine on the incidence of shivering on patients who scheduled spinal anesthesia for
      elective surgery.
    

Detailed description: 
      The design of the study includes three study groups done in random order. The groups are as
      follows: 1) Control group received 15 mg levobupivacaine intrathecally and intravenous 0.9%
      sodium chloride; 2) Intravenous group received 15 mg levobupivacaine intrathecally and
      intravenous dexmedetomidine (1mcg/kg/10min, 0.5mcg/kg/h infusion) ; 3) Intrathecal group
      received 15 mg levobupivacaine + 3 mcg dexmedetomidine intrathecally and intravenous 0.9%
      sodium chloride.

      Throughout the study period,shivering scores, tympanic temperature were recorded, heart rate
      were measured continuously using an electrocardiogram; blood pressure was determined
      oscillometrically at 5 min intervals at the ankle. In case heart rate decreased by more than
      30% of the baseline atropin received and blood pressure decreased 30% of the baseline
      effedrin received.

      Side effects (bradycardia, hypotension, hypothermia, nausea and vomiting etc ) were recorded
      peroperatively in the operating room and postanesthetic care unit.
    

Intervention name(s): Levobupivacaine; Dexmedetomidine; Dexmedetomidine; sodium chloride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intrathecal 3ml (15 mg); Intrathecal 3 microgram (diluted 1/10, 0.3 ml); Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion (dexmedetomidine diluted 1 microgram/ml); Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion in the control and intrathecal groups, intrathecal 0.3 ml in the control and intravenous groups.
Other intervention name(s): Chirocaine, 0.5%, 10 ml, Abbott; Precedex, 100 mcg/ml, Abbott; Precedex, 100 mcg/ml, Abbott; 0.9 Sodium chloride
Intervention MeSH terms: Dexmedetomidine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Shivering; Dexmedetomidine; Spinal anesthesia
A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two part study to compare the relative bioavailability (BA) of 2 fixed dose
      combinations (FDCs) of GSK3640254/DTG with GSK3640254 and DTG administered together as single
      agents (Part 1) and to assess the effect of food on the pharmacokinetic (PK) of the selected
      FDC of GSK3640254/DTG (Part 2).
    


Intervention name(s): GSK3640254; DTG; GSK3640254/DTG
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK3640254 will be administered via oral route.; DTG will be administered via oral route.; GSK3640254/DTG will be administered via oral route.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a 2-part crossover study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dolutegravir; GSK3640254; Fixed Dose Combinations; Bioavailability
Study of the Blood Concentrations of Two Formulations of REGN2222 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective: Determine blood concentrations of two formulations of REGN2222

      Secondary Objective: Assess safety and tolerability of REGN2222
    


Intervention name(s): REGN2222
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Ultrasound Guided Peribulbar Anaesthesia - A Novel Dual Quadrant Injection Technique
Condition: Eye Diseases
MeSH terms: Eye Diseases
Study type: Interventional

Summary: 
      Peribulbar anaesthesia for ocular surgery depends on the spread of local anaesthetic throught
      the orbit to be successful and has a relatively high failure rate. This study will examine a
      novel ultrasound guided approach to peribulbar anaesthesia which should extend the depostion
      of local anaesthetic by using a dual quadrant injection technique. The study will assess the
      feasibility of this technique, how successful it is and whether any obvious safety issues
      arise with its use.
    

Detailed description: 
      Peribulbar anesthesia is widely used for anterior and posterior chamber ophthalmic
      procedures. It is a blind technique which is traditionally carried out by inserting a needle
      in the infero-lateral aspect of the orbit below the globe and injecting a volume of 8 - 12 mL
      of local anesthetic in the periorbital space. The goal of this inejction is to achieve
      akinesia and anesthesia of the eye sufficient for surgery. The technique has a relatively
      high failure rate of up to 30%. A failure or insufficient block requires a second or rarely a
      third peribulbar injection to achieve success. Ultrasound can be used to guide needles in the
      human body and has been successfully used in many anatomic locations for anaesthesia. This
      study will assess whether ultrasound can guide the block needle in ophthalmic anesthesia to
      deliver local anesthetic via a single entry into two discrete locations within the
      periorbital space - the first in the infero-lateral quadrant and the second in the
      infero-medial quadrant. If this can be done the investigators may achieve a higher success
      rate for this block with a lower volume potentially improving the quality of the block and
      its safety.
    

Intervention name(s): Ultrasound guided Dual Quadrant Peribulbar Anaesthesia
Intervention type(s): Procedure
Intervention description(s): Landmark Guided single injection vs Ultrasound guided dual quadrant injection
Intervention MeSH terms: Anesthetics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Ultrasound guided peribulbar anesthesia
Effects of a Peer-led Walking In ScHools Intervention
Condition: Physical Activity
Study type: Interventional

Summary: 
      Children and young people are recommended to undertake at least 60 minutes of moderate to
      vigorous intensity physical activity each day. However recent findings have indicated that
      only 51% of children aged 7 years were meeting these guidelines. Previous research has also
      highlighted girls are significantly less active than. Furthermore, children living in
      Northern Ireland are least likely to meet the guidelines, with only 43.4% of children here
      reaching the recommended ≥ 60 minutes a day. The development of interventions which can
      successfully increase levels of physical activity in adolescent girls in Northern Ireland is
      of key importance. The aim of this intervention is to investigate whether or not girls (aged
      11-13 years) can increase their daily levels of physical activity over a 12 week period by
      taking part in a school-based brisk walking intervention. The impact of participating in a
      school-based brisk walking intervention on a range of other outcome measures will also be
      investigated. A total sample of 200 adolescent females will be recruited onto the study, with
      recruitment of participants taking place at the school level. Following written consent from
      parents/guardians and assent from participants, participants will be randomised at the school
      level to either participate in the walking intervention or to act as controls. Objective
      physical activity will be assessed at 3 time points using an Actigraph accelerometer. At
      baseline, post-intervention (12 weeks) and follow up (4 months post-intervention)
      participants will also undergo measurements of height, weight, waist and hip circumference,
      bloody pressure, and cardiorespiratory fitness. Participants will also complete
      questionnaires assessing levels of physical activity and a number of psychosocial variables
      at each time point. Following completion of follow up measurements, a sub-sample of
      participants (n=45) will be invited to take part in focus groups to evaluate their
      experiences of the intervention.
    


Intervention name(s): Physical Activity
Intervention type(s): Behavioral
Intervention description(s): 15 mins physical activity per day within the school setting.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Physical activity; Walking; Intervention; Adolescent girls; Randomised trial
Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to investigate the immunogenicity and safety of the inactivated
      split-virion vaccine in infants.
    


Intervention name(s): split-virion, non-adjuvanted vaccine of 7.5 μg; split-virion, non-adjuvanted H1N1 vaccine of 15 μg; split-virion, non-adjuvanted vaccine of seasonal influenza
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 120 infants were assigned to receive 2 dose of 7.5μg split-virion, non-adjuvanted H1N1 vaccine.; 120 infants were assigned to receive 2 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.; 120 infants were assigned to receive 2 dose of split-virion, non-adjuvanted seasonal influenza vaccine.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: H1N1; Vaccine; Immunogenicity; Safety; infants
Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement
Condition: Osteoarthritis; Postoperative Pain
MeSH terms: Osteoarthritis; Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Pregabalin added to the standard of care with dosing starting preoperatively and continuing
      for up to 6 weeks post surgery will decrease the intensity of post-operative pain following
      total knee replacement.
    


Intervention name(s): pregabalin; pregabalin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150 milligram (mg)/ day (double blind); 300 mg/day (double blind); Placebo
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: opioid
The Effect on Blood Cells, Known as Platelets, Using Prasugrel vs Clopidogrel in Patients With the Heart Problem Acute Coronary Syndrome (ACS)
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, cross-over study to compare the
      pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg
      maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel,
      following a 900-mg loading dose (LD) of clopidogrel.
    


Intervention name(s): Prasugrel; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Prasugrel 10-mg tablet taken orally as a daily maintenance dose for a 14-day treatment period.; Clopidogrel two 75-mg tablets taken orally as a daily maintenance dose for a 14-day treatment period.
Other intervention name(s): LY640315; Effient; Efient
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this this study is to confirm absence of immune interference between HRV vaccine
      and routine infant vaccinations currently in use in the USA.
    

Detailed description: 
      A phase III randomized multi-center study to assess the immunogenicity of three doses of
      Pediarix®, Prevnar® and ActHIB® given to healthy infants at 2, 4 and 6 months of age when
      administered with GlaxoSmithKline (GSK) Biologicals' two-dose oral live attenuated human
      rotavirus (HRV) vaccine given during the same vaccination visit (at 2 and 4 months of age) or
      given separately (at 3 and 5 months of age).
    

Intervention name(s): 2-dose oral live attenuated G1P[8] human rotavirus vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HRV vaccine; diarrhoea; rotavirus
Lung Deposition of Beclometasone Dipropionate/Formoterol Fumarate/Glycopyrronium Bromide Administered Via pMDI in Healthy, Asthmatic and COPD Patients
Condition: Chronic Obstructive Pulmonary Disease; Asthma
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the lung deposition and distribution pattern of
      Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide using a
      Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled CHF
      5993 Administered via pMDI in healthy volunteers, asthmatic and COPD patients.
    


Intervention name(s): Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium
Intervention type(s): Drug
Intervention description(s): single inhalation of 99mTc radiolabelled CHF 5993 pMDI (4 puffs for a total dose of: Beclometasone diproprionate (BDP) 400 μg, Formoterol fumarate (FF) 24 μg, Glycopirronium bromide (GB) 50 μg)
Other intervention name(s): CHF5993 pMDI
Intervention MeSH terms: Beclomethasone; Glycopyrrolate; Formoterol Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Metabolic and Psychological Changes Associated With Menopause Among Women With HIV
Condition: HIV Infections; Menopause
Study type: Observational

Summary: 
      This study will investigate the prevalence and extent of both metabolic and psychosocial
      changes associated with the menopause transition over 1 year among women with HIV compared to
      women without HIV of similar age, weight, menstrual status, and ethnic background. It is
      hypothesized that HIV positive women will demonstrate increased abdominal fat, abnormal
      cholesterol and blood sugar levels, reduced bone density, and greater psychosocial challenges
      than HIV negative women during the menopause transition.
    

Detailed description: 
      Treatment with combination antiretroviral therapy (ART) has resulted in substantial
      improvement in survival among women living with HIV in the United States, many of whom have
      entered or will soon enter the menopause transition. Significant changes are seen across the
      menopause transition among women without HIV including increased abdominal fat and waist
      circumference, reduced muscle mass, and changes in lipids, glucose metabolism and bone
      density. HIV and potentially ART use have been associated with similar manifestations such as
      reduced bone density, changes in lipid and glucose metabolism, and body composition, though
      little is known regarding how the virus may influence or exacerbate such changes across the
      menopause transition. In addition to metabolic factors, menopause has been associated with
      changes in mood state, decreased quality of life, and presence of vasomotor symptoms among
      women without HIV. Psychosocial indices, such as depression and decreased quality of life are
      common among women with HIV, and may manifest or worsen during the menopause transition.
      However, research investigating the presence and acuity of these symptoms among women with
      HIV during menopause is limited.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female subjects in the perimenopausal transition will be recruited via referral by
        infectious disease providers, newspaper advertisement, posted flyers, community based
        programs at local AIDS Service Organizations and Partners subject recruitment broadcast at
        Massachusetts General Hospital (MGH). The HIV negative control subjects will be recruited
        through advertisements, flyers, and email announcements. Both HIV positive and negative
        subjects will be recruited from the same neighborhoods to ensure similar demographic
        characteristics.
      
Biospecimen description: 
      Whole blood, serum
    
Keywords: HIV; Women; Menopause; Dyslipidemia; Bone Mineral Density
A Safety and Efficacy of DRM02 in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether DRM02 is safe and effective in the
      treatment of atopic dermatitis when applied twice daily for 6 weeks.
    

Detailed description: 
      This is a double-blind, randomized, within-subject control, study enrolling 20 subjects with
      atopic dermatitis and designed to assess the safety, tolerability, and preliminary efficacy
      of DRM02.

      Safety will be assessed during the study, through adverse events, local skin responses,
      urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital
      signs.

      Preliminary efficacy will be assessed through the Physician's Lesion Assessment (PLA) and the
      Eczema Area and Severity Index (EASI) from only the two lesions identified at the baseline
      visit.
    

Intervention name(s): DRM02; Vehicle
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Atlas of Experimental Gingivitis in Humans
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      Pilot case series with a split-mouth design to track subjects with known exposure (dental
      biofilm accumulation) over 21 days. Descriptive design, using single cell RNA sequencing as a
      "digital biopsy" to catalog and contrast inflamed versus non-inflamed tissues from within the
      same mouth and across patients. Specimens (human) will biobanked from the 'digital biopsy'
      site for future analysis, including: Gingival crevicular fluid, oral epithelial
      stem/progenitor cells, and plaque samples, for 'omics analyses including metabolomics,
      microbiomic, and genomic data.
    

Detailed description: 
      Purpose is to conduct the first study of human gingiva in health and after biofilm-induced
      inflammation in the gingiva using scRNAseq. The pilot will involve induction of experimental
      gingivitis in all participants.

      Participants include recruitment of 6 participants. Following consenting, screening, and
      enrollment, a customized acrylic stent will be used only on the selected sextant/teeth
      specified in the protocol, and only during tooth brushing to prevent oral hygiene in selected
      sextant/teeth. After the completion of the 3-week gingivitis induction phase, participants
      will enter a 2 week resolution phase. In the resolution phase, participants will reinstate
      full mouth oral hygiene, with the exception of flossing. Oral prophylaxis will be performed
      to regain health. During the 3 week gingivitis induction phase, participants will be required
      to return to the clinic every 7 days for safety checks.

      Study Procedures (methods): Medical history, demographics (height/weight), urine based
      pregnancy test, vital signs (to include blood pressures, and pulse), standard dental clinical
      measures (to include plaque index, gingival index, bleeding on probing, and clinical
      attachment level), alginate impressions taken for fabrication of an acrylic stent (mouth
      guard), 2 gingival biopsies, 4 subgingival (below the gum line) plaque samples, 4 Gingival
      Crevicular Fluid (naturally occurring fluid between the gum and teeth) samples, and adult
      prophylaxis
    

Intervention name(s): Stent-Induced Biofilm Overgrowth
Intervention type(s): Procedure
Intervention description(s): Customized acrylic dental (sextant) stent will be used during brushing for 21 days to influence reversible gingival tissue inflammation.
Other intervention name(s): Dental Stent
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy
Condition: Non-small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was a single-arm, multi-center, prospective, phase 3 trial aimed to evaluate the
      efficacy and safety of icotinib in patients with locally advanced or metastatic NSCLC after
      failure of at least one platinum-based chemotherapy regimen.
    


Intervention name(s): icotinib
Intervention type(s): Drug
Intervention description(s): Patients were administered with oral icotinib (tablet form, 125 mg) three times daily within two days after enrollment until disease progression or unacceptable toxicity.
Other intervention name(s): Conmana
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Ketamine On Precipitated Opioid Withdrawal Under General Anaesthesia
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether low-dose ketamine infusion is effective in
      suppressing the symptoms of opiate withdrawal during rapid opiate antagonist induction (RAI).
    


Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study of SHP620 (Maribavir) in Healthy Adults
Condition: Cytomegalovirus (CMV)
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how an investigational treatment (maribavir) is
      handled by the body when administered with two already approved drugs (digoxin and
      dextromethorphan). The study will also look at the safety and tolerability when maribavir is
      coadministered with digoxin and dextromethorphan versus digoxin and dextromethorphan alone.
    


Intervention name(s): Digoxin; Maribavir; Dextromethorphan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.5 mg (2 x 0.25 mg) Digoxin oral dose; 200mg twice a day for 8 days; 30 mg oral dose
Intervention MeSH terms: Maribavir; Digoxin; Dextromethorphan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Maribavir