bioihbjkbjnl/mcl2 huggingface dataset:
Open Label Clinical Trial of Vascanox® HP on Nitric Oxide and Blood Pressure
Condition: Hypertension; Elevated Blood Pressure
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Conversion of dietary nitrates to nitric oxide (NO) is a non-canonical pathway that plays an
      important role in NO biology, particulalry under pathological conditions. Nitrate
      supplementation has been shown to help control mild hypertension. Recent studies have
      suggested that another gaseous transmitter, hydrogen sulfide, also influences NO biosynthesis
      and metabolism. This open-label clinical trial will evalute the effect of Vascanox® HP, a
      proprietary formulation that combines dietary sources of nitric oxide and hydrogen sulfide,
      on nitric oxide bioavailability and on blood pressure in subjects experiencing elevated blood
      pressure. Participants will supplement with Vascanox® HP for four weeks. Blood pressure will
      be measured at baseline, two weeks, and fours weeks. Salivary nitric oxide will be assessed
      prior to and two, six, and 24 hours after dosing on the first day of the study and prior to
      and two hours after dosing at subsequent study visits. Participants will also self-monitor
      their saliva nitric oxide levels and blood pressure daily for 4 weeks. Changes in study
      outcomes over time will be evaluated via analysis of variance (ANOVA) and paired t-tests.
    


Intervention name(s): Vascanox® HP
Intervention type(s): Dietary Supplement
Intervention description(s): Vascanox® HP is a proprietary formulation that combines dietary sources of nitric oxide and hydrogen sulfide aimed at increasing the levels and duration of nitric oxide biosynthesis. Vascanox® HP contains an advanced blend of berry extracts in addition to beet root powder, black garlic, vitamin C, and minerals known to influence nitric oxide biosynthesis and metabolism. Because of the particular combination of ingredients, Vascanox® HP is expected to affect both canonical and non-canonical pathways of nitric oxide production and to augment nitric oxide reservoir in the body leading to an increased and prolonged nitric oxide bioavailability.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: hypertension; elevated blood pressure; nitric oxide; S-allylcysteine; dietary nitrate; Vascanox HP
Antepartum Chronic Epidural Therapy (ACET) to Improve Blood Flow to the Uterus, Placenta and Baby in Pre-Eclampsia and Intrauterine Growth Restriction
Condition: Pre-Eclampsia; Fetal Growth Retardation
MeSH terms: Eclampsia; Pre-Eclampsia; Fetal Growth Retardation
Study type: Interventional
Phase: Phase 3

Summary: 
      Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are common and important
      disorders of pregnancy. Both disorders are associated with an impairment of uteroplacental
      blood flow (UPBF). No effective therapy has been identified to reliably improve UPBF in these
      patients and typically, obstetric management involves interventional delivery, particularly
      problematic when remote from term. This study assess the hypothesis that epidural local
      anesthetics may improve UPBF in these patients.
    

Detailed description: 
      Women with sonographic uterine artery flow abnormalities and either PE or IUGR (or both) were
      randomized to either ACET or non ACET control. Both groups were able to receive standard
      therapies (in-hospital monitoring, magnesium and anti-hypertensives as appropriate). The
      first five days of the therapeutic arm (ACET) consisted of a dose-finding trial, where
      epidural ropivacaine infusions (10ml/hr for 24 hours) of 0•04%, 0•06%, 0•08% and 0•1% and a
      saline placebo were each administered via tunneled epidural catheters in a randomized,
      double-blinded, cross-over design over five consecutive days; all three women received all
      doses. Doppler measurement of flow in the uterine artery was performed at baseline and at the
      end of each dose period. The ideal dose for an individual was determined to be lowest dose of
      drug giving maximal effect without side effects; in the second stage of the study, this dose
      was administered until delivery with the addition of a second placebo day to during this
      period.
    

Intervention name(s): Epidural ropivacaine
Intervention type(s): Drug
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pre-Eclampsia; Fetal Growth Retardation; Anesthesia, Epidural; Placental Circulation; Dose-Response Relationship, Drug
A Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate symptomatic remission rate in patients with
      schizophrenia using long acting risperidone microspheres
    

Detailed description: 
      Although most of Korean schizophrenic patients currently take oral antipsychotic medications,
      it is estimated that up to 75% of them have difficulty adhering to daily oral regimen.
      Long-acting injectable formulation may eliminate this need for daily medication. This is a
      prospective, open-label, multicenter study to determine the long-term efficacy, especially
      symptomatic remission rate of long-acting risperidone microspheres administrered in the
      muscle at 2 week intervals in patients with schizophrenia.

      The patients will receive intramuscular injections either 25, 37.5, 50 mg equivalent of
      risperidone at every 2 weeks for 1 year
    

Intervention name(s): risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; risperidone; Intramuscular injection, long-acting risperidone
Nasonex Compared With Placebo in Participants With Seasonal Allergic Rhinitis (SAR) and Concomitant Asthma (P03280)
Condition: Rhinitis, Allergic, Seasonal; Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare mometasone nasal spray to placebo in treating the nasal and asthma
      symptoms experienced by participants with seasonal allergic rhinitis (SAR) and concomitant
      asthma.
    


Intervention name(s): Mometasone; Placebo; Albuterol/Salbutamol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril.; Matching placebo nasal spray, administered QD as 2 sprays in each nostril.; Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication.
Other intervention name(s): Nasonex; Proventil HFA
Intervention MeSH terms: Mometasone Furoate; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Seasonal Allergic Rhinitis; Asthma
Virtual Reality Analgesia in Labor: The VRAIL Pilot Study
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The purpose of the proposed study is to evaluate the feasibility of using immersive Virtual
      Reality (VR) during labor. We will also explore whether VR distraction is helpful for
      reducing subjective pain during labor, even if this pain is severe or excruciating. We
      predict that VR is feasible in this setting and that VR distraction will reduce acute pain
      and anxiety during labor.
    

Detailed description: 
      This study used an over the counter consumer product to create a virtual reality experience
      so that we could assess whether there was a decrease in perception of pain.
    

Intervention name(s): Virtual Reality
Intervention type(s): Device
Intervention description(s): Using Virtual Reality during labor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual Reality; Analgesia; Immersive Virtual Reality; VR; Labor; Pain
A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up
      to 90 μg/kg/h for 60 hours reduces depressive symptoms in participants with moderate
      postpartum depression (PPD) compared to placebo injection as assessed by the change from
      baseline in Hamilton Rating Scale for Depression (HAM-D) total score.
    


Intervention name(s): Placebo; SAGE-547 90 μg/kg/h
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion of matching placebo for SAGE-547.; Intravenous infusion of SAGE-547
Intervention MeSH terms: Brexanolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Moderate Postpartum Depression; SAGE-547
Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL
Condition: Cataracts
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate postoperative visual function in patients
      implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).
    


Intervention name(s): AcrySof ReSTOR Aspheric IOL
Intervention type(s): Device
Intervention description(s): Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cataract; visual acuity; AcrySof ReSTOR Aspheric Intraoculare Lens; Bilateral cataract
Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat
Condition: Moderate to Severe Convexity of Submental Fat; Safety; Efficacy
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to explore the safety and efficacy of subcutaneous
      injections of Deoxycholic Acid relative to placebo, in the submental area in patients with
      mild or extreme fullness of the submental fat and ratings of 1 or 4.
    


Intervention name(s): Deoxycholic Acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.; Phosphate buffered saline placebo for injection.
Other intervention name(s): ATX-101 deoxycholic acid injection
Intervention MeSH terms: Deoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan
Condition: Vaccines; Pneumococcal Conjugate Vaccine
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal
      conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Taiwan.
    


Intervention name(s): 13-valent pneumococcal conjugate vaccine (13vPnC); 7-valent pneumococcal conjugate vaccine (7vPnC)
Intervention type(s): Biological; Biological
Intervention description(s): 13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.; 7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Prevention against pneumococcal disease
Bioequivalence Study of Escitalopram Tablets 10 mg
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to confirm if two formulations of escitalopram tablets are
      bioequivalent.

      Test product was escitalopram (10 mg; GlaxoSmithKline) and reference product Lexapro® (10 mg
      escitalopram; Lundbeck). The single dosage was one tablet.

      The study was prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods, under fasting conditions.

      The population was composed of 26 healthy volunteers, male adults between 18-50 years.

      The comparative bioavailability of the two formulations was evaluated based in statistical
      comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
      in blood.
    


Intervention name(s): escitalopram 10 mg; escitalopram 10 mg
Intervention type(s): Drug; Drug
Intervention description(s): Reference product; Test product
Other intervention name(s): Lexapro® LUNDBECK MEXICO SA de CV; escitalopram GLAXOSMITHKLINE MEXICO SA de CV
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric
      emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups
      to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4
      weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12
      weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a
      paracetamol test at intervals during the study. The anticipated time on study treatment is 3
      months, and the target sample size is <100 individuals.
    


Intervention name(s): Placebo; taspoglutide; taspoglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sc once weekly for 12 weeks; 10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks; 10mg sc once weekly for 12 weeks
Intervention MeSH terms: Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Iontophoresis vs. Ultrasound and Iontophoresis in Plantar Fasciitis". Plantar Fasciitis"
Condition: Iontophoresis; Ultrasound Therapy; Complications; Fasciitis, Plantar; Pain, Acute
MeSH terms: Fasciitis; Fasciitis, Plantar; Acute Pain
Study type: Interventional

Summary: 
      Plantar fasciitis is inflammation of plantar fascia.The main symptom of plantar fasciitis
      manifests itself as localized pain in the inner area of the foot and increases in intensity
      after long periods of standing or resting. Its etiology is multifactorial and risk factors
      include overweight, female gender, physical exercise (impact sports), biomechanical
      imbalances of the foot and possible dysfunction of the functional twin-ankle-plantar
      system.Generally speaking, conservative measures are recommended as initial treatment for
      plantar fasciitis, and in situations where these are ineffective, corticosteroids are
      sometimes administered. At the local level, the route of administration can be by
      infiltration or iontophoresis.Iontophoresis consists of administering a drug through the skin
      by applying an electric current locally. This technique can be considered as a safe and
      effective method within the SLTF (Transcutaneous Drug Delivery Systems). It consists of
      introducing ions through the skin by means of electricity using a direct current, with an
      electrode carrying a positive charge (anode) and a negative charge (cathode). Its
      administration is produced thanks to the repulsive force to carry the compound through the
      skin by means of galvanic current.

      This study aims to assess whether treatment with iontophoresis in subjects with plantar
      fasciitis can show a more positive evolution in pain after a 6-week treatment period
      (treatment frequency: 1 time per week) versus ultrasound (3 times per week) for 6 weeks.
    


Intervention name(s): Application of lidocaine together with dexamethasone; Application of ultrasound as physical therapy
Intervention type(s): Drug; Device
Intervention description(s): Lidocaine 2% is applied on the positive pole while dexamethasone 4 mg/ml is applied on the negative pole. Through the use of current the drugs penetrate the fascia.; The application dose will be 0.65 Watt for 7 minutes in the area of most painful affectation by means of a circular movement and a 1MZ head.
Intervention MeSH terms: Dexamethasone; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Isometric Exercises With and Without Pressure Biofeedback in Computer Users With Cervical Spine Overload
Condition: Pain, Neck
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Neck pain is defined as the pain experienced from the base of the skull or occiput to the
      upper part of the back and extending laterally to the outer and superior bounds of the
      shoulder blade. Office work is a kind of job that demands sitting for prolonged time
      requiring the use of computer. These two factors are mainly responsible for overloading of
      the spine. Neck pain and computer users are clearly connected due to extended periods of
      sitting in a certain position with no breaks to stretch the neck muscles. Prolonged computer
      use with neck bent forward will cause the anterior neck muscles to gradually get shorter and
      tighter, while the muscles in the back of neck will grow longer and weaker. These changes
      will lead to development of neck pain. Neck problem also accounts for a large proportion of
      occupational illness and disability. Neck pain is common among computer workers in our
      country and contributes importantly to the demand for medical services and the economic
      burden of absence from work due to sickness.

      The main purpose of this randomized clinical trial will be to find out the effects of
      Isometric exercises with and without Pressure Biofeedback Unit on Cervical pain and Muscle
      strength in Computer users with cervical spine overload. Patients will be recruited in the
      study by convenient sampling technique after that will be allocated to groups by simple
      random assignment with an inclusion criteria having chronic neck pain for more than 3 months,
      current pain level ranging greater than 3 on NPRS, patient with minimum and moderate
      disability and male and female computer users with age 25 to 40 years with cervical pain.
      Patients with history of cervical trauma, postural deformity, spinal cord deformity, current
      pregnancy and significant neurological deficits were excluded.

      Numeric Pain Rating Scale (NPRS) and Neck Disability Index (NDI) will be used to measure
      before and after treatment session. Treatment will be given to both groups for 4 weeks and
      each group will receive 3 sessions per week. After collecting the data it will entered and
      analysed using Statistical Package for the Social Sciences (SPSS) version 25. Data will be
      assessed by using parametric/ non parametric test after completion of the study.
    


Intervention name(s): pressure biofeedback; isometric exercises
Intervention type(s): Other; Other
Intervention description(s): 10 patients will be treated with isometric exercises and pressure biofeedback.; 10 patients will be treated with isometric exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      This is a prospective randomised study.

      Primary objective: Evaluation of success rates of Actifuse ABX and INFUSE in achieving bone
      fusion.

      Secondary objectives: Assess clinical outcome measurements.
    


Intervention name(s): Actifuse ABX; INFUSE, plus Mastergraft granules
Intervention type(s): Procedure; Procedure
Intervention description(s): bone graft to be used in posterolateral instrumented lumbar fusion; bone graft to be used in posterolateral instrumented lumbar fusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: actifuse; INFUSE; InductOs; DDD; Degenerative disc disease; PLF; posterolateral lumbar fusion; bone substitute; bone graft; synthetic bone substitute; spinal surgery
Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is
      efficacious in subjects with idiopathic restless leg syndrome (RLS). Additional objectives
      are to investigate the safety and tolerability of rotigotine.

      The primary variables are the absolute change from Baseline in the International Restless
      Legs Severity Scale (IRLS) sum score and Clinical Global Impression-Global Improvement (CGI)
      Item 1 (severity of illness) score at the end of the Maintenance Period.

      Subjects will be randomized to receive either placebo, 2.25, 4.5 or 6.75 mg/day rotigotine in
      a 1:1:1:1 (active:placebo) fashion. Approximately 450 subjects will be enrolled in this
      trial, participating at approximately 50 sites. The maximum duration of the trial is
      approximately 8 months (3-week Titration Period, 6-month Maintenance Period, 7-day Taper
      Period, and 30-day Safety Follow-Up Period). Subjects who complete the 6-month Maintenance
      Period will be eligible to participate in an open-label extension trial. Subjects who do not
      complete the 6-month Maintenance Period or who choose not to participate in the open-label
      extension trial will complete a 3-day Safety Follow-Up Period. Two different patch sizes will
      be used (5 and 10 cm2). Active patches will contain either 2.25mg (5cm2) or 4.5mg (10cm2) of
      rotigotine.
    


Intervention name(s): Rotigotine
Intervention type(s): Drug
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Idiopathic RLS