bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Fatty Acid Supplementation on Substance Dependent Individuals
Condition: Substance-related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Many substance dependent individuals continue to abuse a variety of substances during
      treatment for their disorder. Often, substance dependent individuals are co-diagnosed with
      depression and violence problems. Supplements of n-3 polyunsaturated fatty acids (PUFAs) may
      play a role in treating individuals with such substance abuse problems. The purpose of this
      study is to evaluate the effectiveness of the n-3 PUFAs eicosapentaenoic acid (EPA) and
      docosapentaenoic acid (DPA) in treating relapse, aggression, and depression in substance
      dependent individuals.
    

Detailed description: 
      Past research suggests that low levels of some PUFAs play a role in the pathophysiology of
      depressive and aggressive disorders. In addition, there is also evidence that PUFAs play a
      role in treating substance dependent individuals. The purpose of this study is to determine
      the efficacy of EFA and DPA in treating substance dependent individuals.

      Participants will be randomly assigned to receive either 3 grams of n-3 PUFAs or placebo.
      Treatment will last 3 months, followed by an observation period of 3 months. Study visits
      will occur monthly and will last approximately one hour. Study visits will include blood
      tests and a physical exam. Throughout the study, participants will continue to receive
      standard substance abuse treatment and will complete urine tests at regular intervals.
    

Intervention name(s): Pro-eicosapentaenoic acid (EPA); Pro-docosapentaenoic acid (DPA); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 450 mg 5x/day; 100mg 5x/day; 5 capsules/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Substance abuse; Depression; Aggression
Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing
      parenteral support volume in patients with short bowel syndrome.

      Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
    

Detailed description: 
      A Phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial to
      evaluate the efficacy and safety of glepaglutide subcutaneous (SC) injections in patients
      with short bowel syndrome (SBS).
    

Intervention name(s): glepaglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Glucagon-Like Peptide-2 (GLP-2) analog; Placebo for glepaglutide
Other intervention name(s): ZP1848
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Cohort Study to Assess Sustained Immunogenicity to qHPV Vaccine Among HIV-infected Girls and Boys Age 9-14 Years
Condition: Human Papillomavirus; HIV-1 Infection
Study type: Observational

Summary: 
      The purpose of this study is to determine sustained immunogenicity of the quadrivalent
      vaccine 'Gardasil', 48 months after initial vaccination, among HIV-1 infected boys and girls
      age 9-14 years. This age range is within the World Health Organization (WHO) stipulated
      guidelines for national programs for the vaccine.
    

Detailed description: 
      HIV-infected individuals bear a disproportionate disease burden of HPV-related diseases
      suggesting more rapid progression from HPV acquisition to malignancy. HIV infected women have
      a 2-22 fold increased risk for cervical cancer compared to uninfected women. The quadrivalent
      HPV vaccine marketed as "Gardasil" has demonstrated efficacy against type specific HPV
      infections known to cause 70% cervical cancer (HPV 16 & 18) and HPV 6 & 11 known to cause 90%
      of anogenital warts in populations of HIV negative young women.

      Since the risk of HPV exposure persists throughout a person's sexual life, the duration of
      protection, especially when the vaccine is given in the pre-adolescent period, is critical to
      overall vaccine effectiveness. Extended follow up of HIV-uninfected individuals has shown
      sustained response to HPV vaccine for 8.4 and 6 years respectively to the bivalent and
      quadrivalent vaccines. However, other vaccines such as the hepatitis B vaccine have been
      shown to require additional dosages to be effective among HIV-infected persons.

      Data on immunogenicity of the HPV vaccine among HIV infected adolescents is limited to a 12
      month follow up period.

      Current HPV vaccine guidelines target pre-sexual adolescents. Since the risk of HPV exposure
      persists throughout an individual's sexual life, the duration of protection provided by
      vaccination is critical to the overall vaccine effectiveness. Duration of sustained HPV
      6/11/16/18 antibody response is directly related to vaccine effectiveness and determines the
      need for booster dosing.

      The investigators therefore propose to extend follow up of 179 girls and boys in Kenya, age
      9-14 years who have received 3 doses of the quadrivalent 'Gardasil' vaccine and assess for
      immunogenicity annually.

      Study Location: Partners in Prevention, Thika site
    

Intervention name(s): Gardasil vaccine
Intervention type(s): Biological
Intervention description(s): 0.5ml of intramuscular vaccine in three doses
Other intervention name(s): Gardasil
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study participants will be enrolled from the paediatric HIV-care clinic
      
Biospecimen description: 
      Plasma for HPV antibody testing there will be no long term sample storage
    
Keywords: quadrivalent vaccine; Human Papillomavirus
Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      During this study, the pharmacodynamic interactions between sevoflurane and remifentanil will
      be studied.
    


Intervention name(s): Fixed sevoflurane dose 1; Fixed sevoflurane dose 2; Fixed sevoflurane dose 3; Fixed sevoflurane dose 4; Fixed sevoflurane dose 5; Fixed sevoflurane dose 6; Fixed remifentanil dose 1; Fixed remifentanil dose 2; Fixed remifentanil dose 3; Fixed remifentanil dose 4; Fixed remifentanil dose 5; Fixed remifentanil dose 6
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dose 1 of sevoflurane; Dose 2 of sevoflurane; Dose 3 of sevoflurane; Dose 4 of sevoflurane; Dose 5 of sevoflurane; Dose 6 of sevoflurane; Dose 1 of remifentanil; Dose 2 of remifentanil; Dose 3 of remifentanil; Dose 4 of remifentanil; Dose 5 of remifentanil; Dose 6 of remifentanil
Intervention MeSH terms: Remifentanil; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women
Condition: Healthy; Nursing Caries
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Introduction: This study was conducted to determine the effect of reflexology on sleep
      quality and fatigue in postmenopausal women.
    

Detailed description: 
      This study was conducted in Batıkent Family Health Center of the Ministry of Health between
      May-December 2018. The sample of the study consisted of 72 postmenopausal women. The data
      were collected by using the Introductory Information Form, Pittsburgh Sleep Quality Index and
      Fatigue Severity Scale. A total of 12 reflexology sessions were applied to the postmenopausal
      women by the researcher twice a week. No intervention was applied to the postmenopausal women
      in the control group.
    

Intervention name(s): reflexology
Intervention type(s): Other
Intervention description(s): Reflexology is the stimulation of the reflex points in the hands and feet by massage, designed to provide relaxation and relief in the body.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study was conducted as a pretest-posttest trial model with a control group in order to determine the effect of reflexology applications on sleep quality and fatigue in postmenopausal women
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: Nurse; postmenopausal women; sleep; reflexology; fatigue
Laryngoscope Types and The Cervical Motion
Condition: Cervical Motion During Endotracheal Intubation
Study type: Interventional

Summary: 
      To ensure minimal cervical motion during the intubation of trauma patients is important for
      the prevention of cervical spine injury (CSI) or further deterioration of existing CSI.

      Intubation is required to secure the airway in patient during an anesthesia management or a
      mechanical ventilation at intensive care units. Laryngoscopes are the assisting tools for
      intubations. The most widely used laryngoscope type is one with a Macintosh blade. However,
      various types of laryngoscopes have been developed to be used for in case of difficult
      intubations, the intubation of the patients with head and neck trauma, or the intubation
      attempts carried out by inexperienced individuals. Truview EVO2® and Airtraq® are newly
      developed laryngoscopes, integrated with an optical view system.

      The Truphatek TruView EVO2® (Truphatek International Ltd, Netanya, Israel) is a recently
      introduced, easy viewing type of laryngoscope, modified from the blades of Macintosh type
      laryngoscopes, having an angle of 46° at the end of blade and including a camera system that
      magnifies the image.

      The Airtraq® laryngoscope (ATQ; King Medical Systems, Newark, DE) is also a newly developed
      type of laryngoscope, including optical imaging system. There is a channel on the device for
      the placement of the endotracheal tube. Endotracheal tube is inserted into the channel before
      the laryngoscopy. It has been reported that Airtraq is a novel single use laryngoscope which
      provides glottis display without any deviation in the normal position of the oral, pharyngeal
      or the tracheal axes.

      In the literature, there are many studies comparing the effects of these newly developed
      laryngoscopes on cervical motions in different scenarios with cadavers and normal patients.
      However, in these studies, individual vertebral motion was reported during the placement of
      the tube, while the angulation of the head and neck and the difficulty of the intubations
      were not clear.

      In this study our first hypothesis was cervical motion during endotracheal intubation in
      Truview EVO2® and Airtraq® types of laryngoscopes is lesser than Macintosh. The second one
      was the endotracheal intubation time is similar to the Macintosh that is used more often.
    


Intervention name(s): Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Clinical Performance and Wear Mechanism of Hot-Pressed Ceramic Crowns
Condition: Ceramic and Dental Enamel Wear
Study type: Interventional

Summary: 
      The objectives of this study are to characterize the clinical performance and wear mechanisms
      of all-ceramic posterior crowns. The wear rate of all-ceramic crowns and opposing enamel in
      selected patients will be quantified. The relationship of each subject's maximum clenching
      force and wear rate will also be analyzed.
    

Detailed description: 
      High strength ceramics have been used in dentistry for constructing fixed partial denture.
      Their advantages are their acceptable fracture resistance, excellent biocompatibility,
      moderate opacity, etc. Because the increase in demand for more esthetic restoration, various
      ceramic materials have been used as a core material for several all-ceramic systems. Their
      properties have been investigated extensively in many in vitro studies. Currently, there are
      not much results regarding clinical performance and wear mechanism of ceramic-based
      prosthesis and more information are required for future research.
    

Intervention name(s): lithia-disilicate-based crown
Intervention type(s): Other
Intervention description(s): all-ceramic crown
Other intervention name(s): ceramic crown
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ceramic; wear rate; opposing enamel
Comparison of Efficacy of Single Oral Dose Fluconazole and Itraconazole in Patients With Pityriasis Versicolor
Condition: Tinea Versicolor
MeSH terms: Tinea Versicolor; Pityriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Pityriasis versicolor (PV) also called tinea versicolor is a common superficial chronic
      fungal infection of the skin caused by species of lipophilic yeast known as Malassezia
      species. Itraconazole is an oral synthetic triazole while fluconazole is an oral synthetic
      bis-triazole compound. Only a few studies are available to find a direct comparison of the
      efficacy of single dose of oral fluconazole (400 mg) and oral itraconazole (1000 mg) in the
      treatment of PV. The objective of the study was to compare the efficacy of single dose
      fluconazole (400 mg stat) to single dose itraconazole (1000 mg stat) in the treatment of
      pityriasis versicolor in the local population of Pakistan.
    

Detailed description: 
      Pityriasis versicolor (PV) also called tinea versicolor is a common superficial chronic
      fungal infection of the skin caused by species of lipophilic yeast known as Malassezia
      species. Itraconazole is an oral synthetic triazole while fluconazole is an oral synthetic
      bis-triazole compound. These both acts by inhibiting the cytochrome-P450 dependent
      14-alpha-demethylation step in the formation of ergosterol thereby impairing the functions of
      certain membrane bound enzyme systems, and ultimately inhibiting the growth of fungi. Both
      the drugs have been studied in different dose regimen, however, there are variable results in
      studies on this subject. There is still no standard drug and its dosage that can ensure
      complete cure. Fluconazole (300mg) in 2 doses with an interval of one week has been used
      effectively, however, fluconazole (400 mg) as a single dose has also been used, and found to
      cure the PV. Itraconazole 200 mg/day can be given in a dose of for 7 days however, higher
      concentrations of itraconazole in the stratum corneum are achieved that persist for 3-4 weeks
      so the drug is presumed to be effective even in a single dose. Therefore, only a few studies
      are available to find a direct comparison of the efficacy of single dose of oral fluconazole
      (400 mg) and oral itraconazole (1000 mg) in the treatment of PV. The objective of the study
      was to compare the efficacy of single dose fluconazole (400 mg stat) to single dose
      itraconazole (1000 mg stat) in the treatment of pityriasis versicolor in the local population
      of Pakistan.
    

Intervention name(s): Fluconazole; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg stat. Follow up at 4 weeks; 1000 mg stat. Follow up at 4 weeks
Other intervention name(s): Fluderm; Icon
Intervention MeSH terms: Itraconazole; Fluconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Flavonoids on Cognitive Performance in Healthy Young Adults
Condition: Neurodegeneration
MeSH terms: Nerve Degeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate changes in cerebral blood flow, blood flavonoid
      levels, brain-derived neurotrophic factor, vascular reactivity and cognitive performance in
      young adults as a result of acute administration of a fruit-derived flavonoid-rich or
      flavonoid-poor drink.
    

Detailed description: 
      There has recently been an increasing interest in the potential of flavonoids, plant derived
      compounds found in foods such as fruit and vegetables, to ameliorate age-related cognitive
      decline. Research suggests that flavonoids improve memory and learning, possibly as a result
      of their anti-oxidant, anti-inflammatory and neuroprotective effects for example by
      increasing cerebral blood flow, protecting vulnerable neurons, enhancing existing neuronal
      function or by stimulating neuronal function. The research will initially involve a
      randomised cross-over human dietary intervention trial using two flavonoid-rich drinks
      (flavanone-rich and flavanone-poor) to investigate changes in cerebral blood flow in young
      adults (n=6; age range 18-30 years). Changes in cognitive performance and measures of serum
      BDNF levels will then be investigated in a second randomised cross-over trial using the
      intervention drink showing the greatest effect on cerebral blood flow in young adults (n=24;
      age range 18-30 years) and using a range of sensitive tests of executive function. The study
      is designed to measure acute effects of types of flavonoid supplementation and, as well as
      the primary cognitive outcome, will assess flavonoid/metabolite and BDNF (brain-derived
      neurotrophic factor) levels in blood and changes in vascular reactivity.
    

Intervention name(s): Fruit juice beverage
Intervention type(s): Other
Intervention description(s): 500ml fruit juice beverage, single dose per visit
Other intervention name(s): Tropicana Ruby Breakfast; Copella English Apple; Robinson's Lemon Barley Water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Flavonoid; Cognitive performance; Cognitive function; Executive function; fMRI; Cerebral blood flow; Acute
A Study to Compare 2 Formulations of LY900014 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study involves a comparison of a LY900014 U-200 formulation with a LY900014 U-100
      formulation. LY900014 is a type of fast acting insulin. Study participants will be
      administered LY900014 U-100 two times and LY900014 U-200 two times, over 4 study periods, by
      injection under the skin. Blood samples will be taken to compare how the body handles the
      study drugs and how they affect the blood sugar levels. Side effects and tolerability will be
      documented. The study will last about 4 weeks, not including screening and follow up.
      Screening is required within 28 days prior to the start of the study and follow up is
      required at least 2 weeks after the last dose of study drug.
    


Intervention name(s): LY900014-U200; LY900014-U100
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): Ultra-Rapid Lispro; Ultra-Rapid Lispro
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Greenwich Lumbar Stenosis SLIP Study
Condition: Spinal Stenosis; Spondylolisthesis
MeSH terms: Spinal Stenosis; Spondylolisthesis; Constriction, Pathologic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine the proper use of lower back screws and rods
      (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing
      (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another
      (spondylolisthesis). There are two types of operations that surgeons perform for this
      problem. Some spinal surgeons remove some bone in the back (laminectomy) to decompress the
      nerves. Other surgeons perform a laminectomy (decompression) as above, but feel that it is
      also important to strengthen the back by placing screws and rods into the spine and adding
      more bone to obtain a new bridge of bone away from the nerves (decompression with
      instrumented fusion). This study aims to test the hypothesis that adding instrumented fusion
      to a decompression for this spinal problem will improve long term patient outcomes.
    

Detailed description: 
      There is considerable debate among spinal surgeons regarding the optimal surgical procedure
      for lumbar spinal stenosis with a grade I spondylolisthesis. The major question is whether or
      not instrumented pedicle screw fusion should be undertaken when a decompressive laminectomy
      is performed to relieve neural compression. This multi-center, randomized, prospective
      clinical study aims to address this question by testing the hypothesis that adding
      instrumented fusion to a decompression for this spinal problem will improve long-term patient
      outcomes.
    

Intervention name(s): Lumbar Laminectomy with Instrumented Pedicle Screw Fusion; Lumbar Laminectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Removal of bone to decompress spinal nerves with placement of spinal screws and extra bone to strengthen the spine; Removal of bone to decompress spinal nerves
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Stenosis; Lumbar Spine; Decompression; Fusion; Spondylolisthesis; Prospective, randomized clinical trial