bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Solifenacin Succinate & Mirabegron From Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma, Egypt) Versus Vesicare 5 mg FCT & Betmiga 50 mg Prolonged-Release Tablets (Astellas Pharma Europe B.V, the Netherlands / Astellas Pharma Europe B.V, the Netherlands)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label randomized, single dose, three-way, partial replicate bioequivalence study to
      determine the bioequivalence of Solifenacin Succinate & Mirabegron From Mirfenacin MR 5/50 mg
      Extended Release Tablets (Hikma Pharma, Egypt) Versus Vesicare 5 mg Film Coated Tablets &
      Betmiga 50 mg Prolonged-Release Tablets (Astellas Pharma Europe B.V, the Netherlands /
      Astellas Pharma Europe B.V, the Netherlands)
    

Detailed description: 
      Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the
      selection criteria. 30 Healthy volunteers (28 volunteers + 2 extra volunteers to compensate
      for drop-outs) will participate in the study. All dosed subject samples will be analyzed and
      their data will be included in the final study report.

      For Solifenacin:

      Primary Pharmacokinetic Parameters: Cmax and truncated AUC0→72 Secondary Pharmacokinetic
      Parameters: Tmax

      For Mirabegron:

      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for log transformed (with
      the 90% confidence intervals), untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e, for Mirabegron and untransformed data of Cmax and
      truncated AUC0→t and for untransformed data of tmax for Solifenacin.
    

Intervention name(s): Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference first dose); Mirfenacin MR (Solifenacin Succinate 5 mg & Mirabegron 50 mg) (Test); Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference second dose)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet Vesicare contains Solifenacine succinate 5 mg & 1 tablet Betmiga contains Mirabegron 50 mg orally administrated followed by 240 ml of water; 1 tablet Mirfenacin MR contains Solifenacine succinate 5 mg & Mirabegron 50 mg orally administrated followed by 240 ml of water; 1 tablet Vesicare contains Solifenacine succinate 5 mg & 1 tablet Betmiga contains Mirabegron 50 mg orally administrated followed by 240 ml of water
Other intervention name(s): Vesicare & Betmiga; Mirfenacin MR; Vesicare & Betmiga
Intervention MeSH terms: Mirabegron; Solifenacin Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: An open label randomized, single dose, three-way, partial replicate crossover design
Masking: None (Open Label)
Primary purpose: Other
A Time-motion Study Comparing Self- to Nurse-vaccination With Influenza Vaccine
Condition: Influenza; Vaccination Site Reactions (HT)
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that people working in an acute care hospital setting will be
      able to successfully self-administer the intradermal vaccine (Intanza) in less time than
      nurse-administration of the regular intramuscular influenza vaccine (Vaxigrip). The
      investigators also hypothesize that people administering the intradermal vaccine for the
      second time will take less time to successfully administer than people administering it for
      the first time.
    

Detailed description: 
      Vaccination of healthcare workers has been shown to reduce mortality and morbidity in the
      patients they care for, as well as reducing illness and absenteeism in the healthcare workers
      themselves, and healthcare worker vaccination programs have been shown to be cost-effective
      for hospitals because of the reduced absenteeism. Although influenza vaccination programs
      based on nurse-administered intramuscular vaccination are effective, easy access to
      vaccination for hospital staff remains a challenge, in part because of large numbers of staff
      working evening, night and weekend shifts. In addition, in the Canadian setting, increasing
      the efficiency of all hospital programs is a priority. If regular recipients of seasonal
      vaccine became accustomed to the practice, self-administration may significantly improve the
      efficiency of pandemic mass vaccination campaigns.
    

Intervention name(s): Intanza; Vaxigrip
Intervention type(s): Biological; Biological
Intervention description(s): Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere; Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: influenza; vaccine; administration
Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD
Condition: Fetal Alcohol Syndrome; Attention Deficit Disorder With Hyperactivity (ADHD); Attention Deficit Disorder (ADD)
MeSH terms: Hyperkinesis; Fetal Alcohol Spectrum Disorders; Syndrome; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if atomoxetine hydrochloride improves inattention,
      hyperactivity, and impulsivity problems in children exposed to alcohol during birth.
    

Detailed description: 
      Abnormalities of attention, function, and activity level in children exposed to alcohol in
      utero share similarities and differences to children who do not have alcohol exposure.
      Previous psychological studies have examined either core attention deficit hyperactivity
      disorder (ADHD)symptoms of hyperactivity, inattention, and impulsivity or hypothesized
      neuropsychological differences in children with fetal alcohol syndrome (FAS) and ADHD.
      Atomoxetine Hydrochloride is a non-stimulant medication used to treat ADHD. This study will
      determine if atomoxetine HCL significantly reduces symptoms of ADD/ADHD in children with
      fetal alcohol exposure.
    

Intervention name(s): Strattera; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): escalating dosage: 0.5 mg/kg, 1.0 mg/kg, and 1.4 mg/kg titrated up or down according to adverse effects to therapy; 0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with breakfast.
Other intervention name(s): atomoxetine HCL
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: attention deficit hyperactivity disorder; ADHD; fetal alcohol syndrome; FAS; FASD; atomoxetine hcl
The Effect of Dexmedetomidine on Hemodynamic Response During Double Lumen Endotracheal Intubation
Condition: Intubation Complication; Tracheal Intubation Morbidity; Anesthesia Intubation Complication; Hypertension; High Blood Pressure; Tachycardia
MeSH terms: Hypertension; Tachycardia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of dexmedetomidine on hemodynamic
      responses during laryngoscopy and double lumen endotracheal intubation and assess the adverse
      effect related to complications of dexmedetomidine.
    

Detailed description: 
      The cardiovascular responses to laryngoscopy and tracheal intubation are mediated by both
      sympathetic and parasympathetic nervous system. The hemodynamic responses resulting from
      sympathetic nervous system stimulation are tachycardia, cardiac arrhythmias, hypertension,
      increased intraocular pressure, increased intracranial pressure, bronchospasm and myocardial
      ischemia. Tachycardia is one of the major predictor of intraoperative myocardial ischemia and
      causes an imbalance of myocardial oxygen supply and demand. Although hemodynamic responses to
      laryngoscopy and intubation is transient, these effect may be harmful to patients suffering
      from myocardial and cerebrovascular diseases. The placement of double lumen endotracheal tube
      may produce similar or greater pressor response than endotracheal tube because of larger
      sizes and greater carinal stimulation.
    

Intervention name(s): Dexmedetomidine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): dexmedetomidine 0.7 microgram per kilogram in saline 20 ml given within 10 minutes before intubation; normal saline 20 ml( the same volume as dexmedetomidine) giving within 10 minutes.
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan
Condition: Migraine With or Without Aura
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the tolerability and efficacy of eletriptan in patients who had discontinued
      oral sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous
      clinical treatment (not a controlled trial).
    


Intervention name(s): Placebo; Eletriptan 40 mg; Eletriptan 80 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.; Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.; Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.
Intervention MeSH terms: Eletriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Estrogen Pretreatment Prior to GnRH Antagonist Protocol
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of
      2 additional oocytes in GnRH antagonist protocol.
    


Intervention name(s): 17beta-estradiol
Intervention type(s): Drug
Intervention description(s): Pretreatment with 17beta-estradiol (Provames®, Aventis, Paris, France) was administered daily (2 mg twice a day) during the cycle preceding the IVF/ICSI cycle, starting 7 days before the predicted onset of menses and administered up until to the following Thursday after the occurrence of menses.
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Assisted reproductive treatment; GnRH antagonist; Estrogen pre-treatment; Ovarian stimulation
Study to Determine Results of Vibratory Stimulus on Subject's Neck
Condition: Sleep Apnea; Snoring
MeSH terms: Sleep Apnea Syndromes; Snoring
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will validate whether an external vibratory stimulus applied to a subject's neck
      causes head, neck or jaw movement.
    

Detailed description: 
      This study will validate whether an external vibratory stimulus applied to a subject's neck
      causes head, neck or jaw movement, and provide information regarding the optimum location and
      variable vibration parameters of vibratory stimulus on a subject's neck to cause head, neck,
      or jaw movement. The study will also provide information whether the subject experienced or
      did not experience a change in sleep stage or arousal by vibratory stimulus on a subject's
      neck. The data gathered from this study will be used for future studies in analyzing whether
      such vibratory stimulus can serve as a potential treatment for sleep disorders, such as
      snoring and obstructive sleep apnea.
    

Intervention name(s): Kai Strap
Intervention type(s): Device
Intervention description(s): Medical device component that vibrates on a subject's neck.
Other intervention name(s): Kai Patch
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Apnea; Sleep apnea; Snoring; Hypoglossal nerve stimulation; Laynx stimulation
Post-operative Analgesic Effects of Dexamethasone Added to Bupivacaine in Transversusabdominis Plane (TAP) Block
Condition: Postoperative Analgesia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To compare the postoperative analgesic effect of two doses of dexamethasone added to
      bupivacaine in ultrasound-guided TAP block for inguinal hernia repair.
    

Detailed description: 
      The transverses abdominis plane block (TAP block) is a regional anesthesia technique that
      provides analgesia following abdominal surgery . The TAP block significantly reduces pain
      after open inguinal hernia repair, regardless of whether it is used as a primary anesthesia
      technique or as a complement to general anesthesia, spinal or local anesthesia .

      The investigators designed this study to compare the postoperative analgesic effect of two
      doses of dexamethasone( 4 mg and 8 mg ) added to bupivacaine in ultrasound-guided TAP block
      for inguinal hernia repair.
    

Intervention name(s): Dexamethasone; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): After the surgery, dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.; After the surgery,1mg/kg of 0.5% bupivacaine in the TAP block.
Other intervention name(s): dexamethasone acetate; plain marcaine
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Bupivacaine; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 60 patients will be divided into two groups according to the dose of dexamethasone added to bupivacaine in the TAP block, I - group ( Group D4 ) 4mg of dexamethasone will be added II - group ( Group D8 ) 8mg of dexamethasone will be added. III-group(control) bupivacaine alone
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: TAP block; inguinal hernia
Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration
Condition: Narcolepsy; Obstructive Sleep Apnea; Excessive Daytime Somnolence; Excessive Sleepiness; Postpartum
MeSH terms: Sleep Apnea, Obstructive; Narcolepsy; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of study JZP110-401 is to evaluate solriamfetol pharmacokinetics (PK) in the
      breast milk and plasma of healthy postpartum women following the administration of the drug.
      The study also aims to estimate the potential daily solriamfetol dose received by the infant
      from the breast milk of the nursing mother. The safety and tolerability of single oral doses
      of solriamfetol will also be assessed.
    


Intervention name(s): Solriamfetol 150 mg Oral Tablet
Intervention type(s): Drug
Intervention description(s): Single-dose 150 mg tablet orally administered.
Other intervention name(s): Sunosi®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sunosi; Solriamfetol; Healthy Postpartum Women; Breast Milk; Plasma
Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab Treated With Ocrelizumab or Natalizumab
Condition: Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes
MeSH terms: Multiple Sclerosis; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases; Immune System Diseases; Sclerosis; Pathologic Processes
Study type: Observational

Summary: 
      The primary goal of this study is to provide additional data regarding B and T-cell mediated
      responses to COVID-19 vaccines in MS patients treated with OCR and to determine which
      clinical and paraclinical variables correlating with vaccine immunogenicity. B-cell mediated
      humoral responses and adaptive T-cell mediated cellular responses were measured in patients
      treated with OCR who received any of the available SARS-CoV-2 vaccines, 3-4 weeks after
      completion of vaccination.
    

Detailed description: 
      The purpose of this study is to see if patients on ocrelizumab (Ocrevus) produce a humoral
      and T-cell response to the coronavirus vaccine. Ocrelizumab depletes B-lymphocytes and has
      the potential to reduce the effectiveness of vaccines. The impact of ocrelizumab treatment on
      coronavirus vaccines is unknown.

      Natalizumab (Tysabri) likely has a minimal impact the efficacy of vaccines. In this study the
      investigators will take blood samples in patients being treated with either ocrelizumab or
      natalizumab before and after vaccination with an FDA-authorized coronavirus (COVID-19)
      vaccine and compare the antibody response in both groups.
    

Intervention name(s): Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test; T-Detect COVID T-cell blood test
Intervention type(s): Device; Device
Intervention description(s): Subjects will receive an Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test within 4 weeks of receiving their first COVID-19 injection. Within 3-4 weeks of receipt of their final COVID-19 vaccine dose, subjects will receive another Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test.; A select number of subjects will also receive a qualitative SARS-CoV-2 t-cell immunity test, the T-Detect COVID test, within 3-4 weeks of receipt of their final COVID-19 vaccine dose.
Intervention MeSH terms: Antibodies
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult Multiple Sclerosis patients receiving treatment with natalizumab or ocrelizumab at
        the Elliot Lewis MS Center.
      
Keywords: COVID-19; Natalizumab; Ocrelizumab; Ocrevus; Tysabri; Antibody; Coronavirus; Vaccine
Study of the Enterprise Self-Expanding Stent System With Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms
Condition: Intracranial, Wide-Neck, Saccular Aneurysms
MeSH terms: Aneurysm
Study type: Interventional
Phase: Phase 1

Summary: 
      Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck,
      intracranial, saccular aneurysms arising from a parent vessel
    


Intervention name(s): Cordis Neurovascular Self-Expanding Stent
Intervention type(s): Device
Allocation: Non-Randomized
Primary purpose: Treatment
Keywords: Intracranial; Wide-neck; Saccular; Aneurysms
A Phase IIa Multi-Center Study of 18F-FDG PET, Safety, and Tolerability of AZD0530 in Mild Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      AZD0530 is an inhibitor of Src and Abl family kinases1. It has been developed as treatment
      for malignancies because these kinases play a role in tumor invasion and proliferation.
      However, the Src family kinases (SFKs) are highly expressed in brain and have major effects
      on synaptic plasticity2. Moreover, the investigators have recently shown that a specific SFK,
      namely Fyn, is aberrantly activated by specific conformations of the Amyloid Beta (Aß)
      peptide from Alzheimer's disease (AD). Genetic deletion of Fyn rescues AD deficits in
      preclinical models. This clinical trial will test the potential benefit of AZD0530 for
      Alzheimer's disease modification.
    


Intervention name(s): AZD0530 100mg daily; AZD0530 125mg daily; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All patients in experimental group (50%) will be started on 100mg AZD0530 daily; Patients with plasma drug level <100ng/ml after 2 weeks of 100mg AZD0530 daily will receive 125mg daily of AZD0530.; 50% of patients will receive placebo treatment for the duration of the study.
Other intervention name(s): saracatinib; saracatinib; saracatinib
Intervention MeSH terms: Saracatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment