bioihbjkbjnl/mcl2 huggingface dataset:
Omarigliptin & Trelagliptin in Twelve Healthy Egyptian Volunteers
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The proposed study will consider the LC-MS/MS quantitative determination of Omarigliptin &
      Trelagliptin after administration to twelve Egyptian volunteers. The main aim of the study is
      to confirm that the developed LC-MS/MS method is applicable for the bio-assay of the drugs in
      the actual biological samples at the time of Cmax (nearly about 1.5 hours). The design of the
      study is open labeled, randomized, one treatment, one period, single dose study. The
      concentration of the drugs after 1.5 h will be determined in healthy human subjects according
      to the ethical regulations of World Medical Association Declaration of Helsinki (October
      1996) and the International Conference of Harmonisation Tripartite Guideline for Good
      Clinical Practice. Written informed consent was provided (attached and signed by the twelve
      volunteers) in order to be approved by the ethics committee of the Faculty of Pharmacy, The
      British University in Egypt. The good health of the human subjects was confirmed by a
      complete medical history and physical examination. Samples from twelve, healthy, adult, male,
      smoking, Egyptian volunteers (age: 23-37 years, Average weight: 81.6 kg, Average BMI: 30.4)
      will be collected at 1.5 h, to be transferred to heparinized centrifuge tubes in order to be
      analyzed by LC-MS/MS study (developed & validated) after single oral dose administration of
      one Marizev® tablet nominally containing 25 mg of Omarigliptin (first arm as 6 volunteers) or
      one Zafatek® tablet nominally containing 100 mg of Trelagliptin (second arm as 6 volunteers).
      The blood samples (0.5 mL of each sample) will be centrifuged at 3000 rpm for 5 minutes, 100
      µL of the plasma will be separated and spiked with the internal standard working solution and
      then the sample preparation and LC-MS/MS determination will be applied. Blood glucose level
      will be determined for all volunteers at different time intervals to monitor any hypoglycemic
      effect to ensure their safety all over the study. The study will be conducted as per FDA
      guidelines & the evaluation of safety of the study will be based on monitoring of blood
      glucose level, vital signs, pulse rate, monitoring of adverse events, and physical
      examination.
    


Intervention name(s): Omarigliptin 25 mg; Trelagliptin 100 mg
Intervention type(s): Drug; Drug
Intervention description(s): Once weekly new anti-diabetic drug approved only in Japan; Once weekly new anti-diabetic drug approved only in Japan
Other intervention name(s): Zafatek tablets; Marizev tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Identification of Integrin ab Expression in Lung Cancer Patients
Condition: Expression of Integrin ανβ3 in Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      It has been reported that the expression rates of integrin αvβ3 and integrin αvβ5 in NSCLC
      are 89% and 100%, respectively. Among RGD (Arg-Gly-Asp) peptides, cRGDyK peptide (cRGD) known
      as integrin ανβ3 and ανβ5 antagonist has been widely used for targeting various cancers
      including NSCLC, glioblastoma, and colon carcinoma as well as prostate cancer. In this study,
      the investigators aim to analysis the expression of integrin ανβ3 in lung cancer patients.
    

Detailed description: 
      Patient samples: From the Human Resource Bank of the Institute of Pathology, Korea
      University, the investigators collected paraffin-embedded tissue sections from 61 patients
      with NSCLC (adenocarcinoma =50, squamous cell carcinoma = 11) who had undergone surgical
      treatment for NSCLC at Korea University Guro Hospital between 2015 and 2018 under the IRB of
      Guro Hospital 2019GR0460. Samples were excluded when patients had undergone perioperative
      chemo- or radiotherapy. Among the tissues excised from lung cancer patients, lung cancer and
      normal tissue were classified as pathologically, defined as normal tissue and cancer tissue,
      and stained with an integrin ανβ3 primary antibody.
    

Intervention name(s): Lung cancer types
Intervention type(s): Biological
Intervention description(s): Cancer tissue matched to normal tissue, all from the same patient
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        NSCLC (adenocarcinoma or squamous cell carcinoma) who had undergone surgical treatment for
        NSCLC at Korea University Guro Hospital between 2015 and 2018
      
Biospecimen description: 
      tissue slide of lung cancer patients.
Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy
Condition: Cat Allergy; Cat Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This trial will test whether a novel therapeutic approach, cat immunotherapy combined with an
      investigational new drug called MEDI9929/AMG 157 (an anti-TSLP [thymic stromal lymphopoietin]
      antibody being co-developed by Amgen and MedImmune) can lead to lasting tolerance to cat
      allergen.The objective of the study is to determine whether one year of immunotherapy
      combined with MEDI9929/AMG 157 can induce tolerance to cat allergen.
    

Detailed description: 
      This study will implement the concept referred to as "allergen-plus," which aims to enhance
      the disease-modifying mechanisms of allergen-specific immunotherapy by combining it with
      other anti-inflammatory or immune-modulating agents. Thymic stromal lymphopoietin (TSLP) is a
      cytokine which appears to be instrumental in both initiating and maintaining allergic
      sensitivity to antigens, and Immune Tolerance Network (ITN) investigators hypothesize that
      blocking TSLP during the administration of cat immunotherapy will induce durable immune
      changes that lead to tolerance.

      CATNIP will be conducted at multiple sites in the US and enroll cat-allergic adults who will
      be randomized to four possible treatment groups: immunotherapy plus MEDI9929/AMG 157,
      immunotherapy plus placebo, placebo plus MEDI9929/AMG 157, or two corresponding placebos.
      This study is specifically enrolling cat allergic individuals who do not live with cats in
      order to limit exposure to the allergen outside of the study. Treatment will be given for
      about one year, followed by one year off therapy.
    

Intervention name(s): AMG 157; Cat Immunotherapy; Cat Immunotherapy Placebo; AMG 157 Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.; A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection; Placebo for allergen-specific immunotherapy administered subcutaneously; Placebo for AMG 157 administered intravenously
Other intervention name(s): MEDI9929/AMG 157; Cat Allergen Extract; Placebo for Cat Immunotherapy; Placebo for AMG157
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cat-allergic; cat immunotherapy; anti-thymic stromal lymphopoietin (anti-TSLP)
Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children
Condition: Dental Pain; Muscle Sensitivity to Pressure; Skin Sensitivity to Electric Stimulation
MeSH terms: Respiratory Aspiration; Hypersensitivity
Study type: Interventional

Summary: 
      To assess the analgetic effect of nitrousoxide-oxygen inhalation on pain perception in 12-15
      years old children from 1) the dental pulp; 2) the masseter muscle; 3) the skin on the upper
      lip
    

Detailed description: 
      The present study is a randomized, cross-over blinded study on the analgetic effect of
      nitrousoxide-oxygen on sensitivity of the dental pulp, the skin and muscles.

      It is conducted in healthy 12-15 year old Danish children attending public schools in the
      municipality of Aarhus, Denmark
    

Intervention name(s): Nitrousoxide-oxygen and atmospheric air; Atmospheric air; nitrousoxide-oxygen
Intervention type(s): Drug; Drug
Intervention description(s): Nitrousoxide-oxygen and atmospheric air; Atmospheric air; nitrousoxide-oxygen
Other intervention name(s): Nitrousoxide-oxygen first; Atmospheric air first
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: children; analgesia; dental treatment; inhalation
Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The study hypothesis is that XOMA 052 is likely to improve glycemic control in subjects with
      Type 2 Diabetes Mellitus.

      The purpose of this study is to determine whether XOMA 052 improves glycemic control in
      subjects on Metformin monotherapy whose diabetes is still not adequately controlled.
    


Intervention name(s): XOMA 052; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sterile solution, dose level varies by dose group and study drug administration day, SC injections administered by study personnel at time points specified in the protocol (the subject will receive a total of 8 injections); Sterile solution, SC injections administered by study personnel (the subject will receive a total of 8 injections)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Type 2; Mellitus
A Study to Evaluate if ID-085 is Safe, Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the tolerability, safety, and pharmacokinetic of
      single- and multiple-ascending doses of ID-085 in healthy subjects.
    

Detailed description: 
      The study is designed in two parts, A and B.

      Part A: single-center, double-blind, randomized, placebo-controlled, single ascending dose.

      Part B: single-center, double-blind, randomized, placebo-controlled, multiple ascending dose.
    

Intervention name(s): ID-085; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg; Placebo capsules matching ID-085 capsules
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Behaviors of Children Ages 15 Months to Five Years Around Microwave Ovens
Condition: Scald Burn Injuries
MeSH terms: Burns
Study type: Observational

Summary: 
      The purpose of this study is to assess the typical behavior of children ages 15 months to
      five years around a microwave oven. The UCH Burn and Complex Wound Center has observed scald
      burn injuries in young children operating and/or removing hot liquids from microwave ovens.
      The knowledge we hope to gain is the developmental age that a child is able to open and/or
      operate a microwave oven safely. This work may influence future microwave oven design to
      protect young children from microwave-related scald burn injuries. These injuries have
      resulted in visits to the emergency room, stays in the hospital and debridement and skin
      grafting procedures in the operating room.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Typically developing children ages 15 months to 5 years born full term
      
Keywords: Typical; Development; Microwave; Children; Behavior
Central Venous Catheterization Techniques in Neonates
Condition: Catheterization, Central Venous
Study type: Interventional

Summary: 
      The purpose of this study is to compare the differences in central venous catheter insertion
      time, success rate, and complication between the Seldinger and modified Seldinger technique
      for ultrasound-guided central venous catheterization in neonates.
    


Intervention name(s): Ultrasound; General anesthesia
Intervention type(s): Device; Other
Intervention description(s): Ultrasound-guided central venous catheterization in internal jugular vein; Scheduled operation under general anesthesia
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Infant, Newborn; Ultrasonography
Effect of Quadratus Lumborum Block on Perioperative Analgesia and Inflammatory Responses in Laparoscopic Nephrectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Quadratus lumborum (QL) block can reduce intraoperative opioid consumption, decrease
      inflammation responses of IL-6, and reduce acute pain intensity in comparison with
      non-receiving QL block as the control group.
    

Detailed description: 
      Quadratus lumborum block had been studied as an effective postoperative analgesia in lower
      abdominal surgery, due to its spread to the thoracic paravertebral space and thoracolumbar
      fascia nerve. The effect of preincisional ultrasound (US)-guided QL block as "preemptive
      analgesia" on patient underwent laparoscopic living donor nephrectomy has never been
      evaluated. As preemptive analgesia, quadratus lumborum block could provide analgesics before
      and after surgery. Both groups immediately received basic postoperative analgesia regimen
      paracetamol 1 gr IV 8th hourly.
    

Intervention name(s): Bilateral QL block; Non-QL block
Intervention type(s): Drug; Drug
Intervention description(s): Bilateral lateral Quadratus Lumborum block using 20 ml of 0.25% bupivacaine each injection as preemptive analgesia.; Only received fentanyl IV during surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: quadratus lumborum block; pre-emptive analgesia; laparoscopic nephrectomy
Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants (MK-0518-851)
Condition: Human Immunodeficiency Virus (HIV) Infection
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to evaluate safety, tolerability, and pharmacokinetics of a single
      1200-mg dose of raltegravir (MK-0518, ISENTRESS®) in healthy Japanese male participants.
    


Intervention name(s): Raltegravir
Intervention type(s): Drug
Intervention description(s): Raltegravir 600 mg tablet
Other intervention name(s): MK-0518; ISENTRESS®
Intervention MeSH terms: Raltegravir Potassium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of the Use of Ophthalmic Viscosurgical Devices (OVD) FIDIAL PLUS vs IAL®-F During Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      This is a Prospective, single-center, randomized, controlled, paired-eye, single-masked
      clinical investigation to compare the efficacy and safety of FIDIAL PLUS (bacterial derived
      1.8% sodium hyaluronate OVD) and IAL®-F (comparable animal derived 1.8% sodium hyaluronate
      OVD) while used during phacoemulsification cataract surgery.
    

Detailed description: 
      Viscoelastics, also referred to as OVDs (ophthalmic viscosurgical devices), are viscous
      substances that are routinely used in cataract surgery. The most basic benefit of OVD use in
      ophthalmic surgery is maintaining the anterior chamber during surgical maneuvers. One of the
      main aspects in OVD use remains the protection of intraocular structures and in particular of
      corneal endothelium cells (CECs) during cataract surgery.
    

Intervention name(s): FIDIAL PLUS; IAL®-F
Intervention type(s): Device; Device
Intervention description(s): 1.8% solution of sodium hyaluronate that is derived from a bacterial fermentation (not of animal origin).; Animal derived 1.8% sodium hyaluronate equivalent to FIDIAL PLUS
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each eye will be randomly assigned to Test or Reference such as the subject has one eye treated with FIDIAL PLUS solution and the other with IAL-F solution. For all subjects the worst eye will be operated on first.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ophthalmic Viscosurgical Devices; Corneal endothelium cells; Cataract Surgery; Hyaluronic acid
Safety and Clinical and Microbiological Efficacy of the Combination of Fluconazole and Secnidazole for the Treatment of Symptomatic Vaginal Discharge
Condition: Vaginal Discharge
MeSH terms: Vaginal Discharge
Study type: Interventional
Phase: Phase 3

Summary: 
      Genital tract infections (GTIs) have increased in the past decade and there is an association
      between sexually transmitted infections (STIs) and other infections like bacterial vaginosis
      (BV), with the HIV transmission. BV and Candida are the most common causes of vaginal
      infections in symptomatic women, the prevalence of BV being 22-50% and the prevalence of
      Candida 17-39%. In an effort to reduce the transmission of GTIs, the World Health
      Organization (WHO) proposed a syndromic diagnostic approach as a low cost alternative in
      places with no access to laboratory diagnostic tests.

      Justification. In patients with syndrome of vaginal discharge, an effective treatment against
      Candida albicans, Trichomonas vaginalis, and bacterial vaginosis is adviced, therefore, for
      syndromic management of symptomatic vaginal discharge the combination of fluconazole and
      secnidazole could be used. No studies evaluating this combination were found in the
      literature reviewed.

      Objectives: To describe the safety and the clinical and microbiological efficacy of a single
      oral dose of a combined treatment with secnidazole + fluconazole for the syndromic management
      of symptomatic vaginal discharge.

      Methods: Design: open label, uncontrolled clinical trial to estimate clinical efficacy and
      safety of the combination of fluconazole and secnidazole for the treatment of symptomatic
      vaginal discharge. The participants will be sexually active women with lower genital tract
      symptoms (leukorrhea, itching, burning, pain, foul-smelling vaginal discharge, or urethral
      symptoms) compatible with symptomatic vaginal discharge syndrome. The study will be conducted
      in an outpatient service of a hospital in Bogota, Colombia. Given the descriptive character
      of the study, no a priori hypothesis is considered. A consecutive convenience sample size of
      100 symptomatic patients is calculated. The statistical analysis will be performed with STATA
      11.0 software (College Station, Texas, USA). Simple and relative frequencies and measures of
      central tendency and dispersion appropriate for the distribution of the variables will be
      calculated. The study has been submitted and approved by the Ethics Committee of the Faculty
      of Medicine of the National University of Colombia and the Institutional Review Board of the
      participating institution. All women must sign a written informed consent form agreeing to
      voluntarily participate in the study.
    


Intervention name(s): Fluconazole and Secnidazole
Intervention type(s): Drug
Intervention MeSH terms: Fluconazole; Secnidazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vaginosis, bacterial; Candidiasis, vulvovaginal
Suan Tsao Jen Tang for Treating Menopause With Sleep Problem: a Clinical Observation
Condition: Menopausal and Female Climacteric States
Study type: Observational

Summary: 
      A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City
      Hospital.Climacteric women with sleep difficulty received SZRT at a rate of 4.0 g, thrice
      daily for four weeks.
    

Detailed description: 
      A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City
      Hospital between April 2008 and April 2010. Sixty-seven climacteric women with sleep
      difficulty received SZRT at a rate of 4.0 g, thrice daily for four weeks. Baseline scores
      were measured on the Pittsburg Sleep Quality Index (PSQI), followed by further measures at
      the end of weeks one and four. The World Health Organization Quality of Life (WHOQOL)
      assessment and the Menopause Rating Scale (MRS) were undertaken as secondary outcomes.
      Regression models were constructed to explore the score differences between the baseline and
      at weeks one and four by various determinants including age, body mass index (BMI), and
      severity of baseline menopausal symptoms. Among 99 surveyed patients, 67 and 61 were screened
      for intention to treat (ITT) and per-protocol population set analysis, respectively.
      Statistically significant reductions in the PSQI index scores evidenced on the fourth week.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects enrolled in the study were climacteric women, ranging from 40-65 years of age,
        with a Pittsburg Sleep Quality Index (PSQI) of greater than six. These women spent 45
        minutes or more falling asleep, slept less than six hours, and had struggled with this
        issue continuously for at least one month.
      
Keywords: Suan Zao Ren Tang, climacteric, PSQI, WHOQOL-BREF
Pharmacokinetic Interaction of Darapladib and CYP 3A4 in Healthy Subjects
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the effect of single and repeat administration of darapladib, a
      novel, selective, orally active inhibitor of lipoprotein associated phospholipase A2
      (Lp-PLA2) currently under clinical development on the pharmacokinetics of a single oral dose
      of midazolam, a cytochrome P450 3A4 (CYP3A4) probe substrate. This study will investigate the
      inductive and inhibitory effect of darapladib on CYP3A4 metabolic pathway.
    


Intervention name(s): Darapladib; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): The subjects will receive darapladib 160 mg once daily on Days 3-14. It is provided as Enteric coated, free base (micronized) 160 mg tablet.; The subjects will receive a single oral dose of midazolam 5 mg on Day 1, 3 and14. It is provided as syrup. Each mL of syrup contains midazolam hydrochloride equivalent to 2 mg midazolam
Intervention MeSH terms: Midazolam; Darapladib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug interaction, healthy volunteer, SB-480848, Lp-PLA2, darapladib, atherosclerosis, midazolam