bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared
      to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial
      V118_05
    


Intervention name(s): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV); non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
Intervention type(s): Biological; Biological
Intervention description(s): 1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months; 1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
The Influence of Peripheral Nerve Blocks in Patients Undergoing Limb Orthopedic Surgery
Condition: Pain, Postoperative; Change; Circulatory; Surgical Injury
MeSH terms: Pain, Postoperative; Intraoperative Complications
Study type: Interventional

Summary: 
      To investigate pre-op peripheral nerve block in reducing peri-op IL-6 level and post-op pain
    

Detailed description: 
      In orthopedic surgery, peripheral nerve block can be used as an anesthesia adjuvant prior to
      surgery. In this study, we hypothesized that peripheral nerve blocks may alleviate
      inflammatory response and reduce the analgesics requirement. Sixty patients undergoing limb
      orthopedic surgery will be enrolled. Peripheral nerve block was injected with 0.25%
      bupivacaine under ultrasound guidance. 30 patients (Study group) underwent surgery with nerve
      blocks and another 30 patients (Control group) underwent surgery with morphine. The
      anesthetic protocol was standardized for both groups by experienced anesthesiologists.
      Surgical stress was assessed by blood pressure fluctuation and proinflammatory cytokine. Pain
      intensity was measured by numeric rating scale (NRS) score for 24 hours
    

Intervention name(s): 0.25% bupivacaine
Intervention type(s): Procedure
Intervention description(s): nerve block procedure will be decided by patients' will for post-op pain
Other intervention name(s): nerve block with 0.25% bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: peripheral nerve block; IL-6; post-operative pain; limb surgery
A Study to Evaluate the Safety of DA-3030 and to Explore the Efficacy for Diabetic Neuropathic Pain
Condition: Diabetic Neuropathy
MeSH terms: Neuralgia; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 1

Summary: 
      A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is
      designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for
      Neuropathic pain.
    


Intervention name(s): 600㎍ of DA-3030 Injection; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Bolus of GnRHa at the Time of Implantation - a RCT
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      Purpose:The aim of this project is to prospectively determine whether a single dose of
      GnRH-agonist administered at the time of implantation increases or not the reproductive
      outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm
      injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic
      gonadotropin (hCG 1500 IU) the day of oocyte retrieval.

      Acronyms:

      GnRH: gonadotropin-releasing hormone FSH: follicle stimulating hormone LH: luteinizing
      hormone HCG:human chorionic gonadotropin IVF:In vitro fertilization ICSI:intracytoplasmatic
      sperm injection OHSS:ovarian hyperstimulation syndrome OMEGA: oocyte maturation employing
      GnRH-agonist OPU: ovum pick up NaCl: sodium chloride
    

Detailed description: 
      It has been reported in previous publications that the ovarian hyperstimulation syndrome
      (OHSS) was eliminated when GnRH agonist was used to trigger ovulation and the delivery rate
      has improved after modified luteal support especially when a small bolus of hCG is used on
      the day of oocyte retrieval. (OMEGA/HCG 1500 IU).

      However, a risk difference of 7% in delivery rates is still in favor of HCG trigger. Thus,
      further modifications in the luteal phase supplementation are required in order to optimise
      the reproductive outcome after GnRH-agonist triggering.

      Recently, many papers showed, that independently of the GnRH analogue used to prevent the
      premature LH surge, the addition of GnRH-agonist during the luteal phase seems to be
      beneficial in terms of pregnancy. Nevertheless, their use in practice is not yet admitted
      because of controversial results in terms of efficacy and safety particularly on the
      conceptus.
    

Intervention name(s): Triptorelin 0.1mg
Intervention type(s): Drug
Intervention description(s): Triptorelin 0.1 mg administered subcutaneously 6 days after ovum pick-up (OPU) in IVF/ICSI cycles triggered by triptorelin 0.2 mg followed by hCG 1500 iu the day of OPU.
Other intervention name(s): Decapeptyl 0.1 mg
Intervention MeSH terms: Triptorelin Pamoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GnRH agonist; GnRH antagonist; Luteal phase
PANDA-Regional Feasibility Study of a Smartphone Pain Management Application
Condition: Postoperative Pain; Anesthesia, Conduction
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Despite the numerous benefits of peripheral nerve blocks (PNBs) over general anesthesia (GA)
      in a variety of surgical procedures, PNBs can be associated with increased post-operative
      pain if pain medications are not taken correctly (titrated). Unfortunately, this is a common
      occurrence as patients often have difficulty titrating medications in the absence of direct
      medical care. PANDA, a smartphone-based postoperative pain management tool, is designed to
      address this issue by helping patients manage their pain medications. The purpose of this
      study is to demonstrate the feasibility of this application in patients who are discharged
      after receiving PNBs. The goal is to identify areas of improvement for the application
      itself. It is hypothesize that PANDA will be successful in supporting patients' postoperative
      pain management.
    

Detailed description: 
      As above
    

Intervention name(s): Panda application
Intervention type(s): Other
Intervention description(s): A smartphone-based postoperative pain management tool
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study Evaluating the Pharmacokinetics of Doravirine (MK-1439) in Participants With Severe Renal Impairment (MK-1439-051)
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of severe renal impairment on the pharmacokinetics of
      doravirine.
    


Intervention name(s): Doravirine
Intervention type(s): Drug
Intervention description(s): Following an overnight fast, a single coated tablet of 100 mg doravirine will be administered orally
Other intervention name(s): MK-1439, PIFELTRO
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transdermal Testosterone Gel/Effect on Erection Quality as Measured by DIR
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Observational

Summary: 
      Low testosterone may be responsible for "soft" erections in men. The purpose of our study is
      to see whether the daily application of a testosterone gel to raise testosterone levels will
      also increase the "hardness" of a man's erection.
    


Intervention name(s): AndroGel (Transdermal Testosterone Gel)
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Time perspective: Prospective
Keywords: hypogonadism; low testosterone level; gonadal deficiency
Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)
Condition: Leukemia, Myeloid, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, maximum tolerated dose of volasertib in Japanese
      patients with AML
    


Intervention name(s): Volasertib
Intervention type(s): Drug
Intervention description(s): Patient to receive volasertib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan (BR-A-657•K) During 24 Hours in Patients With Mild to Moderate Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the antihypertensive efficacy and safety of
      Fimasartan (BR-A-657•K) during 24 hours by dose in patients with mild to moderate essential
      hypertension.
    

Detailed description: 
      Fimasartan(BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and
      potent antihypertensive effect in many hypertensive models. Phase I study,
      Fimasartan(BR-A-657-K) 20mg ~ 480mg single dosing with healthy subjects, demonstrated that
      the Fimasartan(BR-A-657-K) was very safe and well tolerated. Another phase I study,
      Fimasartan(BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that
      Fimasartan(BR-A-657-K) was safe and tolerable though one temporal adverse event was observed
      in high dose.

      A Randomized, Double-blind, Valsartan-referenced, Parallel Grouped, Therapeutic Exploratory
      Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan(BR-A-657•K) during
      24hoursby dose in Patients with Mild to Moderate Essential Hypertension.

      Approximately 90 patients will be enrolled over 12 months in 5 centers nationwide.

      After 2 weeks of placebo run-in period, all subjects will be randomized into one of the
      following 3 groups. Subjects will take test/control drug for 8 weeks of treatment period.

      If subjects take any antihypertensive medications before screening, the subjects will have 1
      week of wash-out period.

      Group I : Fimasartan 60mg group. Group II : Fimasartan 120mg group Group III : Valsartan 80mg
      group
    

Intervention name(s): Fimasartan 60 mg group; Fimasartan 120 mg group; Reference (Valsartan 80 mg) group
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fimasartan 60 mg; Fimasartan 120 mg; Reference (Valsartan 80 mg)
Other intervention name(s): BR-A-657.K; BR-A-657.K; Diovan
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fimasartan; Essential Hypertension; 24hour ABPM; Population PK
Bilateral Prefrontal Modulation in Alcoholism
Condition: Drug Addiction; Executive Dysfunction
MeSH terms: Alcoholism; Substance-Related Disorders
Study type: Interventional

Summary: 
      In this study, eligible alcoholic inpatients recruited from a specialized clinic for
      addiction treatment, filling inclusion criteria and not showing any exclusion criteria, were
      randomized to receive the repetitive (10 sessions, every other day) bilateral dorsolateral
      Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2 milliamperes, 5 x 7 cm2, for
      20 min) or placebo (sham-tDCS). Craving to the use of alcohol was examined before (baseline),
      during and after the end of the tDCS treatment.

      Based in our previous data, our hypothesis was that repetitive bilateral tDCS over dlPFC
      would favorably change craving in alcoholism and this would be a long-lasting effect.
    

Detailed description: 
      Before (baseline) and after tDCS or sham-tDCS treatment, subjects were clinically examined
      regarding craving (obsessive compulsive drinking scale) and they were followed-up for
      relapses at least 3 months after treatment.
    

Intervention name(s): transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): Direct currents were transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current will be delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode was placed over F3 according to the 10-20 international system while the anode was placed over the contralateral F4 region. The currents flowed continuously for 20 minutes with an intensity of 2 milliamperes.
Other intervention name(s): tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sham-controlled double-blind randomized trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcoholism; tDCS; dlPFC; craving; cognition
Bioequivalence of Telmisartan Film-coated Tablet Compared With Two Tablets of the Conventional Telmisartan Tablet in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to demonstrate the bioequivalence of the telmisartan 80 mg film-coated tablet vs. two
      tablets of the telmisartan 40 mg conventional tablet
    


Intervention name(s): Telmisartan film-coated tablet; Telmisartan uncoated tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterizing Upper Airway Collapse to Guide Patient Selection for Oral Appliance Therapy for Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Obstructive Sleep Apnea (OSA) is characterized by collapse of one or more pharyngeal
      structures during sleep (velum, tongue base, lateral walls, epiglottis). Structure-specific
      therapies for OSA have emerged as alternatives to positive airway pressure (PAP). Oral
      appliance (OA) therapy is increasingly being indicated for OSA treatment, although a complete
      response occurs in approximately 50% of patients. In general, OA devices are designed to
      maintain the mandible and/or tongue in a protruded posture during sleep, preventing upper
      airway obstruction. Limited studies in awake or sedated patients have demonstrated the
      effects of mandibular advancement on aspects of pharyngeal structure and function. The
      objective of the proposed research is to fully characterize upper airway collapse in OSA
      patients during natural sleep and use this information to understand why some patients appear
      to exhibit a large improvement in pharyngeal collapsibility whereas others do not.
    

Detailed description: 
      OSA patients will undergo a baseline sleep endoscopy study to identify the site of pharyngeal
      collapse. Subsequently, they will undergo two clinical polysomnographies (PSGs) to measure
      the effect of an oral appliance (a site specific therapy) on upper airway collapsibility and
      sleep apnea severity. During the first hour of each clinical PSG, the passive pharyngeal
      collapsibility will be determined using the standard 5-breath continuous positive airway
      pressure (CPAP) drop method. During the remainder of the night, patients will be monitored to
      determine sleep apnea severity (apnea-hypopnea index). These measurements will allow the
      investigators to determine which pharyngeal collapsing site responds best (both in terms of
      collapsibility and AHI) to mandibular advancement with an oral appliance. Patients who have
      their own oral appliance will be recruited. In addition, patients without an oral appliance
      will be provided with a temporary oral appliance for the study.
    

Intervention name(s): Oral appliance; BluePro oral appliance
Intervention type(s): Device; Device
Intervention description(s): Patients will bring their prescribed oral appliance.; Patients without a prescribed oral appliance will have a device provided for the duration of the study (BluePro, BlueSom; used for investigational purposes only). The device provided is a prefabricated thermoplastic customizable mandibular advancement splint.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Ibuprofen Sodium Tension Headache Study
Condition: Pain
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the ability of a single-dose of a novel ibuprofen formulation to
      relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type
      headache
    


Intervention name(s): Ibuprofen Sodium; Standard Ibuprofen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single-dose of ibuprofen sodium tablets (equal to 400 mg ibuprofen); Single-dose of standard ibuprofen tablets (400mg); Single-dose of placebo
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Headache
Reference Values of Cerebrospinal Fluid Outflow Resistance and Intracranial Pressure in Healthy Elderly
Condition: Healthy Elderly
Study type: Observational

Summary: 
      Objective. The intracranial pressure and cerebrospinal outflow resistance are essential
      parameters to describe the cerebrospinal fluid dynamic system. Outflow resistance effects
      intracranial pressure, pulse amplitudes, cerebrospinal fluid absorption as well as the
      compliance of the system. The objective of this study was to determine the reference values
      in the elderly.

      Methods. Elderly people (60-82 years), considering themselves healthy, were recruited through
      an ad in the local paper. All were evaluated with a 3 Tesla magnetic resonance imaging
      apparatus. Subjects were eligible if they did not have any psychiatric or neurological
      disorder or signs of advanced atherosclerotic disease. Intracranial pressure and outflow
      resistance were determined by a constant pressure infusion method with the patient in the
      supine position. The study population consisted of 40 subjects (mean age 70 years; 23 women).
    


Intervention name(s): CSF dynamic investigation
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy elderly
      
Keywords: Intracranial pressure; resistance; CSF outflow; elderly; reference value
Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two
      recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®,
      in haemophilia A subjects, investigating the action and safety of the drugs.
    


Intervention name(s): Advate®; turoctocog alfa
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session; After a washout period of 4 days, subjects will subsequently receive turoctocog alfa (recombinant factor VIII (N8)) at a dose of 50 IU/kg body weight in the second session
Other intervention name(s): recombinant FVIII; N8
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010)
Condition: Neisseria Meningitidis; Bacterial Infections; Virus Diseases
MeSH terms: Bacterial Infections; Virus Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the immune response and the safety of a primary series schedule that includes
      V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age

      Primary objectives

        -  To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (HB)
           one month after completion of the mixed schedule

        -  To demonstrate that the mixed schedule induces acceptable responses for Haemophilus
           influenzae type b (Hib) one month after completion of the mixed schedule

      Secondary objectives

        -  To describe the antibody response to all PR5I antigens one month after completion of the
           mixed schedule

        -  To describe the antibody response to meningococcal serogroup C (MCC) conjugate vaccine
           one month after the second dose of MenC vaccine

        -  To describe the safety profile after each dose of study vaccines administered
    


Intervention name(s): PR5I; Pediacel®; NeisVac-C®; RotaTeq®; Prevenar 13®
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Hexavalent PR5I vaccine (DTaP-HB-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed [DTaP], Hepatitis B [HB; Recombinant DNA], Inactivated Poliovirus [IPV], and Haemophilus influenzae type b [Hib] conjugate vaccine [adsorbed]) at 0.5 mL for IM injection (left upper thigh) at 2 and 6 months of age.; Pentavalent Pediacel® vaccine (DTaP-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed [DTaP], Inactivated Poliovirus [IPV], and Haemophilus influenzae type b [Hib] conjugate vaccine [adsorbed]) at 0.5 mL for IM injection (left upper thigh) at 4 months of age.; Meningococcal group C (MCC) polysaccharide conjugate vaccine (adsorbed) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.; Human-bovine rotavirus reassortants (live) vaccine 2 mL oral administration at 2, 4 and 6 months of age. RotaTeq® administered prior to any other vaccine administration to avoid having the infant participants spit up the RotaTeq® when crying.; Pneumococcal polysaccharide conjugate vaccine [PCV; 13-valent, adsorbed]) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.
Other intervention name(s): V419; Vaxelis®; DTaP-HB-IPV-Hib; DTaP-IPV-Hib; PCV-13
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention