bioihbjkbjnl/mcl2 huggingface dataset:
Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery
Condition: Placental Transfusion; Hematocrit Anemia
Study type: Interventional

Summary: 
      The investigators conducted a RCT (parallel group study with 1:1 randomisation) comparing ECC
      (at 60 seconds) and DCC (at 180 seconds) in 90 cases of normal birth by' two-step' delivery.
      In term infants born by' two-step' delivery, DCC results is a higher blood volume in the
      newborn and facilitates the maternal-placental-fetal exchange of circulating compounds,
      without potentially detrimental neonatal outcomes.
    

Detailed description: 
      Introduction: Placental transfusion supports an important blood transfer to the neonate,
      promoting a more stable and smooth transition from fetal to extra-uterine life with the
      potential to prevent iron deficiency in young children. Several studies have demonstrated
      that cord clamping timing is greatly relevant for facilitate placental transfusion, the
      transfer of extra blood from the placenta to the infant in the third stage of labor.
      Therefore, during natural 'two-step' delivery umbilical cord management may play a relevant
      role on blood passage to the neonate and it may affect neonatal hematological values and
      placental transfusion. The most effective way to manage umbilical cord in in 'two-step'
      delivery remains to be established.

      Objective: The aim of the present study is to evaluate the effect of two different methods of
      umbilical cord management (Early Cord Clamping - ECC vs. Delayed Cord Clamping - DCC) on the
      placental transfusion, defined by in two-step delivery, by ∆ haematocrit (Hct) from arterial
      cord blood at birth and capillary blood at 48 h of age. Accounting for physiological body
      weight decrease. Secondary outcomes included contemporary estimate of blood gases, lactate,
      and glucose concentrations in arterial cord blood gas analysis.

      Material and methods: This is a randomized clinical trial on the effect of different cord
      management newborns born by 'two-step' delivery. After obtaining parental consent, all
      mothers > 38 weeks' gestation will be assigned to either ECC or DCC group in a 1:1 ratio
      according to a randomized sequence generated by an opened, sealed, numbered, opaque envelope
      containing the cord clamping interventions allocation, ECC (at 1 minute) or DCC (at 3 minutes
      after delivery).
    

Intervention name(s): Cord clamping
Intervention type(s): Procedure
Intervention description(s): Umbilical cord clamping after delivery.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators conducted a randomized controlled trial (RCT) ,(parallel group study wit(h 1:1 randomisation) comparing early cord clamping( ECC) (at 60 seconds) and delayed cord clamping DCC) (at 180 seconds) in 90 cases of normal birth by' two-step' delivery.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Placental transfusion; Two-step delivery; Early cord clamping; Delayed cord clamping
Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      When post-operative parenteral analgesia is discontinued, oral dosing with study medication
      may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS
      (pain intensity score greater than or equal to 40).

      This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer
      promotes opioids and no longer markets Opana® ER.
    


Intervention name(s): Oxymorphone IR
Intervention type(s): Drug
Intervention description(s): Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs
Other intervention name(s): Opana IR
Intervention MeSH terms: Oxymorphone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid tolerant; Pediatric; Pain; Non malignant; Malignant
A Bioequivalence Study of Advil PM Liqui-Gels Minis (Ibuprofen/Diphenhydramine Hydrochloride 200 mg/25 mg) Compared to the Current Marketed Advil PM Liqui-Gels (Ibuprofen/Diphenhydramine Hydrochloride 200 mg/25 mg) in Healthy Adult Subjects Under Fasted Conditions
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to support the submission of Advil PM Liqui-Gels Minis
      (ibuprofen/diphenhydramine hydrochloride 200 milligrams [mg]/25 mg) which is a size reduction
      of the currently marketed Advil PM Liqui-Gels, by determining if this product is
      bioequivalent to the reference product Advil PM Liqui-Gels (ibuprofen/diphenhydramine
      hydrochloride 200 mg/25 mg) under fasting conditions.
    

Detailed description: 
      This is a single center, single dose, open-label, randomized, two-treatment, two-sequence,
      two-period crossover, bioequivalence study in healthy adult participants with at least a
      7-day washout period. A sufficient number of participants will be screened to randomize
      approximately 44 to ensure at least 37 evaluable participants complete the entire study.
      Participants will be randomly assigned to one of 2 treatment sequences and receive a single
      dose of one of the treatments in each period following a crossover design.
    

Intervention name(s): Advil PM Liqui-Gels Minis; Advil PM Liqui-Gels
Intervention type(s): Drug; Drug
Intervention description(s): Ibuprofen/diphenhydramine hydrochloride 200 mg/25 mg, Oral capsule which is a size reduction of the currently marketed reference product.; Ibuprofen/diphenhydramine hydrochloride 200 mg/25 mg, Oral capsule.
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Blood Brain Flow and Exercise
Condition: Cerebrovascular Circulation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Cerebral vasodilator responses to CO2 will be measured in young healthy adults, healthy
      sedentary older adults, and healthy exercise trained older adults. This variable will be
      examined before and after administering the cyclooxygenase inhibitor indomethacin, which has
      been shown to blunt cerebral vasodilator responses. In addition, the investigators will
      examine these counter-regulatory hemodynamic mechanisms to hypoperfusion caused by
      indomethacin.
    

Detailed description: 
      Normal aging reduces cerebral blood flow and cognitive function. Aging also appears to alter
      functional connectivity within the brain, which is associated with cognitive functioning.
      Observational studies suggest that regular physical activity is associated with higher
      cerebral blood flow and improved cognitive function. However, the mechanistic links among
      regular physical activity and cerebral blood flow with advancing age are unknown. In this
      context, it is unclear if aging or exercise training status alters the neurovascular coupling
      of blood flow in the brain. Thus, the overall goal of this study is to examine the
      age-related changes in cerebral vasodilatory capacity, an important homeostatic mechanism and
      marker for effective regulation of cerebral perfusion, in order to determine how it is
      mechanistically linked to cognition. Additionally, the investigators will explore the
      potential beneficial effect of physical activity on the relationships between cerebral
      vasodilation and cognition in humans.

      The research aims are:

        1. To determine if cerebral vasodilator responses are affected by age and exercise training
           status in healthy adults.

        2. To compare the effect of cyclooxygenase inhibition on cerebral vasodilator responses in
           healthy adults.

        3. To determine the neurovascular counter-regulatory response to cyclooxygenase inhibition
           in healthy adults.
    

Intervention name(s): Control; Indomethacin
Intervention type(s): Other; Drug
Intervention description(s): Transcranial Doppler
Blood Pressure
Heart Rate
Oxygen Saturation; Transcranial Doppler
Blood Pressure
Heart Rate
Oxygen Saturation
Intervention MeSH terms: Indomethacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cerebral Vasodilator Function; White Matter Hyperintensity Volume; Default Mode Network Connectivity; Cognitive Function; Cardiorespiratory Fitness; Aging
Peripheral Insulin Uptake in Type 2 Diabetes Mellitus and in Non-Diabetic Individuals
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Impaired uptake of glucose by skeletal muscle is a key feature of type 2 diabetes mellitus.
      It is unclear to what extent impaired insulin uptake from capillaries into skeletal muscle
      interstitium plays a role in this process.

      We hypothesize that impaired uptake of insulin from capillaries into skeletal muscle
      interstitium is involved in impaired glucose uptake by skeletal muscle in type 2 diabetes
      mellitus.
    


Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        50 subjects with T2DM and 50 nondiabetic individuals
      
Biospecimen description: 
      Blood will be collected
Vascular Endothelial Growth Factor (VEGF) & LOC387715/HTRA1 Polymorphism in Polypoidal Choroidal Vasculopathy
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Polypoidal Choroidal Vasculopathy
Study type: Observational

Summary: 
      This study is to investigate whether there is an association of the LOC387715/HTRA1 and
      vascular endothelial growth factor polymorphism with response to treatment with intravitreal
      ranibizumab injections for patients with polypoidal choroidal vasculopathy.
    

Detailed description: 
      This is a retrospective comparative case series comprised of 70 patients being treated for
      polypoidal choroidal vasculopathy with intravitreal ranibizumab injections and 112 control
      subjects. Patients were genotyped for the LOC387715 (rs10490924), HTRA1 gene (rs11200638),
      and VEGF (rs3025039 and rs833069)polymorphism using Real-Time polymerase chain reaction.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The authors did a retrospective chart review of 70 patients with PCV who visited the
        Department of Ophthalmology, Kyungpook National University Hospital in Daegu, Korea.
      
Biospecimen description: 
      Genomic DNA was extracted from peripheral blood with the Qiagen QIAamp Blood Kit (Qiagen,
      Valencia, CA).
Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the safety and effectiveness (immune response) to one
      or two doses of adjuvanted H1N12009 influenza vaccine in young children. An adjuvant is an
      additive that can boost the immune response. The study will enroll 300 children (ages 6-35
      months). Participants will receive 2 doses of adjuvanted H1N12009 vaccine 3 weeks apart.
      Study procedures include: medical history, blood samples and completing a memory aid.
      Participants will be involved in study related procedures for approximately 6 weeks.
    

Detailed description: 
      The goal of this study is to determine if one or two doses of the H1N12009 influenza vaccine
      are needed in young children, a population group at high risk of influenza infection and
      subsequent hospitalization.

      The objectives of this study are two-fold:

        1. To compare the safety and immunogenicity of 1 and 2 doses of adjuvanted H1N12009
           influenza vaccine in children 6-35 months of age.

        2. To conduct the trial soon after the vaccines become available and share the observations
           with health officials and the public as soon as possible.
    

Intervention name(s): adjuvanted Arepanrix
Intervention type(s): Biological
Intervention description(s): Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart
Other intervention name(s): Influenza vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; influenza; H1N1 influenza vaccine; influenza vaccine; Arepanrix
The Effect of Glycaemic Index Variation on Blood Glucose and Mood in Healthy Participants Across the Day
Condition: Mood; Diet Modification; Glucose, Low Blood; Glucose, High Blood
Study type: Interventional

Summary: 
      This study provided 24 healthy subjects with two diets that varied in their glycaemic index
      values. One condition was a low GI diet, whilst the other was a high GI diet. Glucose
      concentrations and mood were measured throughout each test day.
    

Detailed description: 
      Therefore, the aim of this study is to feed to participants meals which differing in their
      glycaemic index across the course of a day, and thus produce different glycaemic responses.
      The outcome variables will be blood glucose levels and subjective mood. The purpose of this
      study is to identify the appropriate times (according to glycaemic response) at which
      cognitive functioning should be tested. Importantly, this study is also the first step to
      characterizing glycaemic and cognitive profiles associated with food consumption over a whole
      day (breakfast, lunch, snack) rather than just one meal (e.g. breakfast), ranging from the
      most favourable (stable glucose regulation) to the least favourable (variability; many peaks
      and troughs).
    

Intervention name(s): Low Glycaemic Diet; High Glycaemic Diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This intervention consisted of three low GI meals.; This intervention consisted of three meals, all with a high GI value.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants took part in both diet conditions
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: glycaemic index; mood; glucose; diet
Behavioral Treatment for Substance Abuse
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This pilot project will evaluate a new mind-body intervention called Mind-Body Bridging (MBB)
      for reducing substance abuse problems in women who are undergoing a substance abuse treatment
      program. The main hypothesis is that MBB will be more effective than the control (standard)
      intervention program in helping people reduce their craving for illicit substances and/or
      alcohol.
    

Detailed description: 
      This is a randomized clinical pilot study in which MBB will be compared with a standard
      treatment program for substance abuse. Both groups will run concurrently over the course of a
      10-week period, twice per week.
    

Intervention name(s): Substance Abuse Education; Mind-body Bridging
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 10 weeks of usual care for substance abuse.; Two sessions per week for 10 weeks, besides usual care treatment for substance abuse.
Other intervention name(s): Substance abuse usual care; Substance abuse treatment as usual; Mind and Body Bridging Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Substance Abuse; Substance Addiction; Substance Dependence; Treatment program
Effect of Quadratus Lumborum Muscle Energy Technique in Sacroilliac Joint Dysfunction.
Condition: Sacroiliac Disorder
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      Sacroiliac joint as a potential source of low back pain is an overlooked problem. Yet, in the
      existing years there has been an increasing interest in sacroiliac joint as a pain originator
      and more attention is being paid into its assessment and treatment in the current literature.
      Muscle imbalance due to postural dysfunction involves mainly gluteus medius and hamstring;
      however the role of quadratus lumborum working on compensatory mechanism and its treatment
      effect in the management of sacroiliac joint dysfunction is yet not discovered.
    

Detailed description: 
      Going through current literature, it is evident that sacroiliac joint dysfunction as a
      postural dysfunction is highly prevalent among adult population. This dysfunction due to
      major muscle imbalances if not treated timely can result in serious consequences later in
      life where it becomes the permanent dysfunction involving the major changes in the joint
      itself. Muscle imbalance due to postural dysfunction involves mainly gluteus medius and
      hamstring; however the role of quadratus lumborum working on compensatory mechanism and its
      treatment effect in the management of sacroiliac joint dysfunction is yet not discovered. All
      patients will be assessed and screened by consultants as indicated and will refer to
      physiotherapy with diagnosed non- specific chronic back pain.Patients will further be
      screened for SIJ dysfunction by physiotherapist.Only those patients who fulfill the criteria
      of Quadratus lumborum tightness & Gulteus medius weakness will randomly be selected and the
      sample of 70 will finally be selected for intervention.Written consent form will be taken
      from all study participants.Simple randomization technique will be used through
      "Randomization Main" software and randomization sheet will be generated. Patients will be
      further be assigned equally into two groups as per randomization sheet.Treatment will be
      performed three sessions per week for 4 weeks with postural advice and home exercise program
      with daily record of home diary. The selected outcome measures will be taken on initial visit
      (pre intervention), session 6 and final session 12 (post intervention).
    

Intervention name(s): physiotherapy
Intervention type(s): Other
Intervention description(s): Treatment will be performed three sessions per week for 4 weeks with postural advice and home exercise program with daily record of home diary.
The selected outcome measures will be taken on initial visit (pre intervention), session 6 and final session 12 (post intervention).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MET, Quadratus lumborum, Sacroilliac joint
Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy
Condition: Seizures
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed
      at 1200 mg/day, in three equally divided doses, compared with placebo in patients with
      epilepsy who are receiving up to three established antiepileptic drugs (AEDs).
    

Detailed description: 
      This Phase 3 study is being conducted in North America, Argentina, and Brazil to evaluate the
      efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses,
      compared with placebo in patients with epilepsy who are receiving up to three established
      antiepileptic drugs (AEDs). The primary objective is to demonstrate a superior change in
      total partial seizure frequency for four weeks from baseline to the double-blind period. The
      proportion of responders (greater than or equal to 50% reduction in total partial seizure
      frequency for four weeks from baseline to the double-blind period) will also be evaluated.
    

Intervention name(s): Retigabine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 7, patients will enter a 12 week maintenance phase; Oral tablet.
Other intervention name(s): D-23129; GKE-841
Intervention MeSH terms: Ezogabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Partial Seizures; Anticonvulsant; Complex Partial Seizures; Potassium Channels; Epilepsy
Randomized Study to Compare the Bioavailability of Two Fluticasone Propionate 0.005% Topical Ointments
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study was to compare the relative vasoconstrictive effects of test and
      reference topical Fluticasone Propionate 0.005% Ointments in healthy, female subjects.
    


Intervention name(s): Fluticasone Propionate 0.005% Ointment-Reference Product; Fluticasone Propionate 0.005% Ointment-Test product
Intervention type(s): Drug; Drug
Intervention description(s): Small amount applied and evaluated over the course of one day; Small amount applied and evaluated over the course of one day
Intervention MeSH terms: Fluticasone; Xhance
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Community Volunteers
      
Keywords: Bioequivalence; Fluticasone Propionate
Patient Generated Goals in Mental Health: Better Outcomes?
Condition: Mental Health
Study type: Interventional

Summary: 
      Researchers believe that clinical care can be improved by engaging patients and families
      directly in planning the care process. Engagement efforts have included asking
      patients/families to provide information about whether they are getting better. But what does
      "getting better" mean? The merits of surveys, questionnaires, or rating scales have been
      widely discussed. Should they be disorder-specific or global? What should the investigators
      do if patients have difficulty reading or understanding these instruments? Investigators in
      the United Kingdom have proposed a simple solution: ask the patients and families what their
      primary goal treatment goal is and track progress together on that goal (Goal-Based Outcomes
      or GBO). Although there has been some work to suggest that this is helpful, it has never been
      tested in a controlled way. This study will do a randomized controlled trial to test whether
      GBO improves clinical care in child and youth mental health. Although the study will use this
      in child and youth mental health care, if it is successful, it can be tested and applied in
      any care setting with any type of medical problem. This could change practice at the
      Children's Hospital of Eastern Ontario (CHEO) and throughout Canada.
    


Intervention name(s): Goal Based Outcomes; Treatment as Usual
Intervention type(s): Other; Other
Intervention description(s): Up to three goals can be tracked during treatment, although patients often decide to just focus on one. Progress on the goal is then quantitatively rated by the patient, with the provider, at every appointment. Adjustments in the care are then made in an iterative process to ensure that the goal will be met.; Patients will receive their standard care at the Outpatient Mental Health Service
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Psychosis; Personality Disorder; Substance Abuse