bioihbjkbjnl/mcl2 huggingface dataset:
CT18 Infant Influenza Priming Study in Vaccine Naive Infants
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates whether priming influenza naive infants, age six to 23 months, with a
      MF59-adjuvanted (oil in water emulsion) influenza vaccine is preferred to priming with an
      inactivated unadjuvanted influenza vaccine. All participants will receive a priming vaccine,
      either MF59-adjuvanted trivalent influenza vaccine (aTIV) or unadjuvanted quadrivalent
      influenza vaccine (QIV). For the booster shot the following year, two thirds of participants
      will receive QIV and one third will receive MF59-adjuvanted vaccine.
    

Detailed description: 
      Children under 24 months of age suffer from an influenza burden (high morbidity and
      mortality) similar to that of the elderly, and have been identified as a high priority target
      for vaccination programs by Canada's National Advisory Committee on Immunization. There is
      evidence that a person's first exposure to influenza antigens may have long-term implications
      for protection.

      This is a randomized, controlled, observer-blind study that will assign participants to one
      of three groups. Group 1 will receive MF59-adjuvanted influenza vaccine (two doses one month
      apart) in the fall of year 1, followed by QIV (one dose) in the fall of year 2. Group 2 will
      receive QIV (two doses one month apart) in the fall of year 1, followed by QIV (one dose) in
      the fall of year 2. Group 3 will receive MF59-adjuvanted IV (two doses one month apart) in
      the fall of year 1, followed by MF59-adjuvanted IV (one dose) in the fall of year 2.
    

Intervention name(s): aTIV Primer; QIV Primer; aTIV Booster; QIV Booster
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): MF59-adjuvanted trivalent influenza virus primer: 2 doses (0.25mL) one month apart; Unadjuvanted quadrivalent influenza vaccine primer: 2 doses (0.5mL) one month apart; MF59-adjuvanted influenza virus vaccine booster: 1 dose (0.25mL), year 2; Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2
Other intervention name(s): FLUAD Pediatric®; Fluzone® Quadrivalent; FLUAD Pediatric®; Fluzone® Quadrivalent
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to one of three groups: Group 1 will receive aTIV as a primer and QIV as a booster, Group 2 will receive QIV as both primer and booster, and Group 3 will receive aTIV as both primer and booster.
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: infants; priming; Fluad; Fluzone
Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective Carotid Endarterectomy
Condition: Atherosclerosis
MeSH terms: Atherosclerosis; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to compare the effect of VIA-2291 vs. Placebo on various inflammatory
      biomarkers in patients with carotid stenosis scheduled for elective carotid endarterectomy
    


Intervention name(s): VIA-2291; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg, oral dosing, 1 time daily for 12 weeks; oral dosing, 1 time daily for 12 weeks
Other intervention name(s): atreleuton
Intervention MeSH terms: Atreleuton
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain
Condition: Migraine; Pain; Nausea; Vomiting; Aura
MeSH terms: Migraine Disorders; Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine
      Pain.
    

Detailed description: 
      A Multicenter, Randomized, Double-Blind, Comparator-Controlled, Placebo-Controlled Study to
      Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain, With
      or Without Aura, and the Prevention of Migraine-Associated Nausea and Vomiting (MANV)
    

Intervention name(s): Arm 1: CL-H1T; Arm 2: CL-H1T; Arm 3: Sumatriptan Succinate 100 mg capsule; Arm 4: Promethazine HCl 18.75 mg; Arm 5: Promethazine HCl 37.5 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 18.75 mg); One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 37.5 mg); One capsule of sumatriptan succinate 100 mg; One capsule of promethazine HCl 18.75 mg; One capsule of promethazine HCl 37.5 mg; One capsule of placebo
Other intervention name(s): sumatriptan succinate 90mg/promethazine HCl 18.75mg; sumatriptan succinate 90mg/promethazine HCl 37.5mg; Sumatriptan succinate 100 mg; Promethazine HCl 18.75; Promethazine HCl 37.5
Intervention MeSH terms: Promethazine; Diphenhydramine; Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acute Migraine Pain; Acute Migraine Pain, With or Without Aura; Prevention of Migraine Associated Nausea and Vomiting (MANV)
Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
Condition: Unstable Angina; Coronary Artery Bypass Graft; Dexmedetomidine; Lidocaine; Myocardial Injury; Arrhythmia; Blood Electrolyte Balance
MeSH terms: Arrhythmias, Cardiac; Angina, Unstable
Study type: Interventional

Summary: 
      The aim of the present study is to compare the antiarrhythmic and myocardial protective
      effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing
      coronary artery bypass graft.
    

Detailed description: 
      Lidocaine has been reported to have an antiarrhythmic and myocardial protective effect. A
      previous study has reported that low-dose lidocaine infusion can decrease the incidence of
      ventricular fibrillation and tachycardia during the first 24 hours after coronary artery
      bypass graft (CABG). A recent study also reported that the lidocaine infusion during CABG
      could decrease the myocardial injury by measuring the CK-MB and Troponin-I blood level.

      Dexmedetomidine is an alpha-2 agonist and reduces the sympathetic tone and neuroendocrine
      stress response. Dexmedetomidine was reported to have a cardioprotective effect by a previous
      animal study. However, there was no clinical study evaluating the cardioprotective effect of
      dexmedetomidine.

      Therefore, we are trying to evaluate and compare the antiarrhythmic and myocardial protective
      effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing
      coronary artery bypass graft.
    

Intervention name(s): Lidocaine infusion; Dexmedetomidine infusion
Intervention type(s): Drug; Drug
Intervention description(s): a bolus dose of Lidocaine 1.5 mg/kg after anesthetic induction with following infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.; Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
Other intervention name(s): 2% lidocaine hydrochloride; Precedex injection; Dexmedetomidine hydrochloride 118 mcg/ml
Intervention MeSH terms: Lidocaine; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Coronary artery bypass graft; dexmedetomidine; lidocaine; myocardial injury; arrhythmia; blood electrolyte balance
Prevalence of H.Pylori in Patients With Acne Vulgaris Acne Vulgaris
Condition: Helicobacter Pylori Infection; Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Observational

Summary: 
      The objective of the study is to investigate prevalence of H.Pylori infection among acne
      vulgaris patients.
    

Detailed description: 
      The study included patients with acne vulgaris and healthy control participants. The study
      recruited both sexes, all grades of acne, adolescents and young adults.

      All patients were subjected to complete history, general and skin examination Acne vlugaris
      Patients were classified into mild, moderate and severe according to the classification of
      American Academy of dermatology for acne vulgaris.

      Detection of H. pylori infection:

      Blood and stool samples were taken from each participant and was directly transferred to
      laboratory for detection of H. Pylori antigen and antibody.

      An enzyme-linked immune sorbent assay (ELISA) was used for quantitative assessment of IgG
      antibodies against H.Pylori in human serum.

      A monoclonal antibodies based enzyme-linked immunosorbent assay was used to detect H.Pylori
      specific antigen in stool samples.
    

Intervention name(s): Blood and stool samples collection
Intervention type(s): Other
Intervention description(s): Collection of blood and stool samples from each participants for H.pylori antigen/ antibody detection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with acne vulgaris and presented to Dermatology outpatient clinic, Sohag
        University hospital.

        Healthy volunteers.
      
Biospecimen description: 
      Blood and stool samples were retained for a short period (few hours) till completion of
      laboratory analyses
    
Keywords: acne vlugaris; prevalence; Helicobacter Pylori
Effect of L-Arginine and Pycnogenol on Light to Moderate Hypertension and Endothelial Function
Condition: Endothelial Dysfunction; Hyperhomocysteinemia; Hypertension Grade I, Subgroup "Borderline" (WHO)
MeSH terms: Hypertension; Hyperhomocysteinemia
Study type: Interventional

Summary: 
      The effect of a combination product (Verum ) with L-arginine, Pycnogenol, vitamin K2,
      R-(+)-alpha-lipoic acid and vitamins B6, B12 and folic acid is investigated in a double blind
      placebo-controlled cross-over study. Volunteers with hypertension and hyperhomocysteinemia
      are randomly assigned to the dietary supplement or placebo.
    

Detailed description: 
      25 patients were included in the trial. Intervention period was 4 weeks with 2 months wash
      out phase. The screening visit of all volunteers before study start included volunteer
      information, signature of informed consent, anamnesis, medical history, ECG and blood routine
      analysis.

      Efficacy parameters were measured at visit 1, 2, 3, and 4. Endothelial function and
      postprandial endothelial Reaction was tested using EndoPAT (validated diagnosis tool). Blood
      pressure was measured by volunteers over a period of 7 days before each visit. As additional
      parameters homocysteine and ADMA (assymmetric dimethyl arginine) were determed. For safety
      evaluation AEs (Adverse Events), CC (compliance control), tolerability, blood routine
      parameters and vital signs were assessed.
    

Intervention name(s): Verum; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.; corn starch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: L-Arginine; Pycnogenol; vitamin K2; vitamin B; endothelial function; hypertension; Homocystein >10
Sexual Quality of Patients After Bladder Cancer Cystectomy
Condition: Sexual Dysfunction
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      Bladder cancer is the second most prevalent urological cancer in France. About 1 in 5 new
      cases of bladder cancer infiltrate the muscles. The standard treatment is neoadjuvant
      chemotherapy followed by radical cystectomy associated with reconstruction of the urinary
      tract. The short-term effects on well-being and quality of life are well known. The long-term
      effects are, on the other hand, poorly understood, particularly sexual function. This study
      aim to asses the quality of sexual life in patients with cystectomy for bladder cancer. This
      will be done via various questionnaires given before and after surgery.
    

Detailed description: 
      The study is a prospective observational cohort study of the quality of sexual life in
      patients with cystectomy for bladder cancer. Data is collected via Qlq-C30, EORTC-Shq22, MSHQ
      if male, Female Sexual Function Index (FSFI) questionnaires that the patients complete by
      themselves. They are given before surgery and then 8 months after surgery.

      The study consists of the compilation of relevant clinical data and questionnaire results.
    

Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): Patients will fill in multiple questionnaires for this study :
EORTC quality of life questionnaire (QLQ) QLQ-C30, EORTC Shq22, Male Sexual Health Questionnaire (MSHQ) only for Men, FSFI (only for women)
Intervention model: Single Group Assignment
Intervention model description: Prospective observational study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: bladder cancer; cystectomy; sex life; sex quality
A Study to Help People Quit Smoking.
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      You are invited to participate in a research study at the VA Connecticut Healthcare System
      (West Haven campus) that examines whether a medication called galantamine can improve your
      learning and memory, and also help you to quit smoking. You have been invited to participate
      because you currently smoke cigarettes, and want to quit smoking. If you are eligible and
      agree to be in the study, your participation will last for approximately 8 weeks. To
      determine if galantamine (8 or 16 mg) is superior to placebo a) in reducing smoking
      self-administration in a human laboratory model and b) improving abstinence rates at the end
      of 4 weeks of treatment.
    

Detailed description: 
      We propose a double-blind, placebo-controlled, outpatient study with a between-groups design.
      Seventy-two male and female smokers will be randomly assigned to one of the 3 treatment
      conditions: GAL (8 or 16 mg/day) or placebo. The dose of GAL will be gradually increased to
      the target doses over a 2-week period (Table 2). During Week 3, following overnight
      abstinence from smoking, participants will present for a laboratory Test Session in which
      they will have the option of cigarette self-administration. After this Test Session is
      completed, smokers will be maintained on their randomized medication condition for an
      additional 4-week period. Smokers will establish a quit date at the beginning of this
      Treatment Phase, and will receive brief weekly behavioral treatment for the 4 weeks of this
      phase. Additionally, at the beginning of Week 3, participants will be given a PDA that will
      administer EMA assessments. The study medication will be tapered after the end of Week 4 of
      the Treatment Phase. Participants will be contacted by phone at one week, and one month,
      after treatment termination to inquire about any adverse events and about their recent
      smoking status.
    

Intervention name(s): placebo; Galantamine 8mg; Galantamine 16mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): placebo compared to 8mg of Galantamine; 8mg of galantamine compared to placebo; 16mg of galantamine compared to placebo
Other intervention name(s): sugar pill; Acetylcholinesterase inhibitors, Galantamine ER,; Razadyne, Razadyne ER, Reminyl; Acetylcholinesterase inhibitors, Galantamine ER,; Razadyne, Razadyne ER, Reminyl
Intervention MeSH terms: Galantamine; Cholinesterase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: addiction; smoking; tobacco; cigarettes
Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents
Condition: Cough
MeSH terms: Cough
Study type: Interventional

Summary: 
      Cough is a frequent symptom in children and infants and is one of the most common reasons
      parents visit a healthcare provider for their child. The US Food and Drug Administration has
      issued a warning that over-the-counter cough and cold medicines including antihistamines,
      decongestants, anti-tussives, and expectorants should not be administered to children younger
      than 2 years of age due not only to lack of proven efficacy, but also because of important
      safety concerns. Honey, another method of soothing cough cannot be used in children <1 year
      due to concerns for infantile botulism. A preparation from agave syrup has been created to
      address the need for an infant cough syrup. Although no studies have formally evaluated the
      use of agave nectar for nocturnal cough associated with Upper Respiratory Infections, the
      demulcent effect and sweet taste of agave nectar may provide some relief from cough in
      children.
    


Intervention name(s): Agave Syrup
Intervention type(s): Dietary Supplement
Other intervention name(s): Zarbee's Naturals Agave Baby Cough Syrup
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cough; Nocturnal Cough; Agave; Sleep Quality; Childhood cough
Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to evaluate the efficacy of Lacosamide (LCM) administered in addition to 1 to ≤3 other
      Anti-Epileptic Drugs in subjects with epilepsy ≥4 years to <17 years of age who currently
      have uncontrolled partial onset seizures.
    

Detailed description: 
      The primary objective of this study is to evaluate the efficacy of LCM administered
      concomitantly with 1 to ≤3 Anti-Epileptic Drugs (AEDs) in subjects with epilepsy ≥4 years to
      <17 years of age who currently have uncontrolled partial onset seizures.

      The secondary objective is to evaluate the safety and tolerability of LCM in subjects ≥4
      years to <17 years of age.

      An additional objective is to evaluate the pharmacokinetics (PK) of LCM in subjects ≥4 years
      to <17 years of age.
    

Intervention name(s): Lacosamide; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Subjects <30 kg (LCM oral solution): 4 mg/kg - 6 mg/kg BID ( 8mg/kg/day - 12 mg/kg/day)
Subjects ≥30 kg to <50 kg (LCM oral solution): 3 mg/kg - 4 mg/kg BID (6 mg/kg/day - 8 mg/kg/day)
Subjects ≥50 kg (LCM tablets): 150 mg - 200 mg BID (300 mg/day - 400 mg/day); Subjects <30 kg (placebo oral solution): 4 mg/kg - 6 mg/kg BID (8 mg/kg/day - 12 mg/kg/day)
Subjects ≥30 kg to <50 kg (placebo oral solution): 3 mg/kg - 4 mg/kg BID (6 mg/kg/day - 8 mg/kg/day)
Subjects ≥50 kg (placebo tablets): 150 mg - 200 mg BID (300 mg/day - 400 mg/day)
Other intervention name(s): Vimpat(R)
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lacosamide; Vimpat; UCB; Epilepsy; Partial Onset Seizures; Pediatric
Combining Lesinurad With Allopurinol in Inadequate Responders
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      This study that compare the serum uric acid lowering effects, clinical benefits, and safety
      of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who
      have had an inadequate response to allopurinol.
    

Detailed description: 
      Allopurinol is the standard of care for the treatment of gout. Nevertheless, most patients
      treated with allopurinol do not achieve the recommended serum urate (sUA) target of < 6.0
      mg/dL and need additional therapy to achieve the target. Probenecid and benzbromarone are
      uric acid transporter 1 (URAT1) inhibitors, generally recommended as second-line agents for
      patients who are either resistant to or intolerant of allopurinol. However, benzbromarone is
      not available in the US and probenecid is rarely used. Consequently, there is a clear unmet
      medical need for a new safe and effective therapy for gout, such as lesinurad, a potent URAT1
      inhibitor, that can be used in combination with allopurinol in patients not responding
      adequately to allopurinol monotherapy so that very high rates of response can be achieved by
      nearly all gout patients, rather than a minority.The subjects selected for this study will
      have moderate to severe gout with an inadequate response to allopurinol
    

Intervention name(s): Lesinurad; Lesinurad; Placebo; Allopurinol; Allopurinol; Allopurinol
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, 200 mg once daily (qd); Tablets, 400 mg qd; Tablets, Placebo qd; Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment); Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment); Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
Intervention MeSH terms: Allopurinol; Lesinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Automated 3D (SonoAVC) Versus 2D Ovarian Follicles Assessment in IVF Cycles: a Randomized Controlled Trial
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Accurate assessment of the size of follicles is important in IVF treatment.Timing of oocyte
      maturation and subsequent egg collection is largely based on follicle size. An accurate
      assessment of follicle size and appropriate timing of HCG result in retrieval of more mature
      oocytes, improved fertilization and higher pregnancy rates. in 3D technology- fter the
      capturing of a 3D image of an ovary, SonoAVC automatically analyzes the volume dataset,
      identifies the boundaries of hypoechoic follicles, and provides estimates of their absolute
      dimensions. These measurements include the largest diameters in three orthogonal planes, the
      mean follicular diameter (MFD), the volume of the follicle, and the volume-based diameter
      (d(V)) of the follicle. In the current study the investigators aim to evaluate the use of
      this automated technique of follicle measurement vs. standard 2D technology on the timing of
      oocyte maturation and subsequent oocyte retrieval. The investigators speculate that 3D
      assessment will increase the rate of mature oocyte collection, and eventually will improve
      other treatment outcomes such as fertilization rate.
    

Detailed description: 
      Not desired
    

Intervention name(s): 3D follicles assessment; 2D follicles assessment
Intervention type(s): Other; Other
Intervention description(s): 3D ultrasound evaluation in IVF treatment (vs 2D ultrasound); 2D ultrasound in IVF treatment (vs 3D ultrasound)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: IVF; 3D ultrasound; SonoAVC; patients in IVF treatment