bioihbjkbjnl/mcl2 huggingface dataset:
Effectivness and Safety of Acupuncture Combined With Moxibustion for Allergic Rhinitis
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 2

Summary: 
      A multi-centre clinical trial done by us（ISRCEN90807007）showed that active acupuncture had
      significantly greater effect on symptoms of allergic rhinitis than either sham acupuncture or
      no active treatment. The object of that study was to evaluate the effectiveness and safety of
      acupuncture for allergic rhinitis. As an explanatory research, acupuncture was defined as the
      only intervention for treatment group and sham acupuncture, no active treatment as its
      control groups. Besides, acupuncture combined moxibustion showed better and longer effect
      than acupuncture on allergic rhinitis patients in our previous pilot study. According to this
      result, we are taking a pragmatic randomized controlled trial to further evaluate whether
      acupuncture combined moxibustion is more effective than conventional treatment.
    


Intervention name(s): acupuncture combined moxibustion; Loratadine
Intervention type(s): Other; Drug
Intervention description(s): Points: Hegu(LI4),Yingxiang(LI20),Chize(LU5),Sibai(ST2), Yintang(EX-HN3),Shangyingxiang(EX-HN8),Shangxing(GV23),Dazhui(Du14).
Pierced the skin, needles are inserted 0.5 to 2cm into the acupoints. Each needle are roated until the participants and the practitioner felt de-qi sensation. After that, moxibustion is applied to Dazhui(Du14). A 1cm long moxa cone is putted on the top of the needle at the acupoint, then ignite moxa cone until the cone is burn. The needles are left in place for 30 minutes. once every two days, 3 times in a week for consecutive 4 weeks, 12 times altogether.; Loratadine will be taken orally at the dose of 10mg/day in the morning. Each treatment cycle will be given for continuous 4 weeks.
Other intervention name(s): warming needle
Intervention MeSH terms: Loratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: allergic rhinitis; acupuncture; moxibustion; efficacy; safety
Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Interferon alfa may interfere with the growth of tumor cells. Giving azacitidine together
      with interferon alfa may be an effective treatment for melanoma.

      PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine when
      given together with interferon alfa in treating patients with metastatic melanoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose (MTD) of azacitidine in combination with interferon
           alfa-2b in patients with metastatic melanoma.

        -  Determine if the MTD of this regimen is biologically active in these patients.

        -  Define and describe the toxicities associated with this regimen.

      Secondary

        -  Determine, preliminarily, the response in patients treated with this regimen.

        -  Describe, preliminarily, the time to progression and overall survival of patients
           treated with this regimen.

      OUTLINE: This is a dose-escalation study of azacitidine.

      Patients receive azacitidine subcutaneously (SC) once daily on days 1-5 (week 1) followed by
      interferon alfa-2b SC 3 days a week in weeks 2-4. Treatment repeats every 28 days for up to 6
      courses in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of azacitidine until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity.

      PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
    

Intervention name(s): recombinant interferon alfa-2b; azacitidine
Intervention type(s): Biological; Drug
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Azacitidine
Primary purpose: Treatment
Keywords: recurrent melanoma; stage IV melanoma
Outcomes of Stem Cells for Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to assess the safety and effectiveness of autologous bone marrow
      mononuclear stem cells in patients with cerebral palsy.
    

Detailed description: 
      The aim of this study is to assess the safety and effectiveness of autologous bone marrow
      mononuclear stem cells in 30 patients with cerebral palsy at Vinmec International Hospital,
      Hanoi, Vietnam.
    

Intervention name(s): Autologous Bone Marrow Mononuclear Cells
Intervention type(s): Biological
Intervention description(s): Transplantation of Autologous Bone Marrow Mononuclear Cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Stem Cells
Detrusor Contraction During the Ice-water-test
Condition: Urinary Bladder, Neurogenic; Neuropathic Bladder
MeSH terms: Urinary Bladder, Neurogenic
Study type: Interventional

Summary: 
      In this randomized, double-blind clinical trial including patients with a neurogenic lower
      urinary tract dysfunction undergoing urodynamic investigation at the Spinal Cord Injury
      Center, Balgrist University Hospital, Zürich, we aim to investigate whether the detrusor
      contraction during the ice-water-test is provoked by the ice water or the rapid filling.
    

Detailed description: 
      The ice-water-test (IWT) was first described 1957 by Bors and Blinn and it was thought to
      differentiate between lesions of the upper and lower motoneuron. In cat studies, it was shown
      that the IWT is a C-fiber mediated lower motoneuron segmental reflex and that these
      unmyelinated C fibers are associated with cold receptors. This explains the positive IWT in
      patients with upper motoneuron lesions. In healthy humans, the IWT is positive up to the age
      of 4 years and becomes negative thereafter since the reflex is centrally inhibited. However,
      this reflex might be unmasked by a neurological disease and/or injury.

      Considering that C-fibers are involved in the pathogenesis of detrusor overactivity, the IWT
      seems to be a useful diagnostic tool in daily practice. However, although there are many
      studies published on the IWT, it is unclear whether the detrusor contraction during the IWT
      is provoked by the ice water or whether it might be caused by the rapid filling. Therefore,
      we designed this randomized, double-blind trial.
    

Intervention name(s): Ice-water-test
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Lower urinary tract; Bladder; Neuropathic bladder; Overactive bladder
Vitamin D to Reduce Colds and Asthma Attacks in Young Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Viral infections are the main cause of asthma attacks in preschoolers, an age group with the
      highest rate of emergency visits due to asthma. While high doses of inhaled or oral
      corticosteroids provide benefits, these have been associated with adverse outcomes. Most
      asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children.
      Low vitamin D level has been linked to more frequent and more severe asthma attacks as well
      as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin D
      supplements can reduce the number of asthma attacks triggered by viral infections in
      children. Unfortunately, most people forget to take vitamin D every day during the fall and
      winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth.
      This has been shown to safely and effectively increase vitamin D levels in children. The
      investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase
      the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared
      with placebo in preschool-aged children with asthma. This six-month pilot randomized
      controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising
      vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled
      participants; and (3) identify problems that may call for protocol changes.
    


Intervention name(s): Vitamin D; daily vitamin D supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 100,000IU cholecalciferol given in a 2ml dose by mouth at baseline.; Each group receives a daily vitamin D supplement for 6 months, providing 400IU per day.; placebo given in a 2ml dose by mouth at baseline.
Other intervention name(s): cholecalciferol; cholecalciferol (Pediavit)
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: asthma; virus diseases; pediatric; RCT; steroid
Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus
Condition: End Stage Renal Disease; Pruritus
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      Pruritus is a major disorder among the skin derangements in advanced renal failure. Recent
      information suggests that interactions between dermal mast cells and distal ends of
      nonmyelinated C fibers may be important in the precipitation and regulation of the sensory
      stimuli.Patients having uremic pruritus have been noted to have increased levels of plasma
      histamine and tryptase as well as increased numbers of dermal mast cells.Cromolyn sodium is a
      mast cell stabilizing agent that inhibits degranulation of mast cells and the release of
      histamine, tryptase, and leukotrienes. It is hypothesized that oral cromolyn sodium may
      attenuate uremic pruritus by decreasing serum tryptase level.
    


Intervention name(s): cromolyn sodium; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral cromolyn sodium, capsule 135mg, 1 capsule 3 times daily for 8 weeks; capsule contains 135 mg lactose, 1 capsule 3 times daily for 8 weeks
Intervention MeSH terms: Cromolyn Sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: End Stage Renal Disease; Cromolyn Sodium; Pruritus; Tryptase
Handling Comparison Between Two Contact Lens Types
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      Subjects will evaluate each study lens in a random order. The lenses will be worn in both
      eyes for a short period.
    


Intervention name(s): etafilcon A (multi-focal); etafilcon A (sphere)
Intervention type(s): Device; Device
Intervention description(s): Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.; Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
Other intervention name(s): Investigational Multifocal Contact; 1-DAY ACUVUE® MOIST®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
Condition: Partial Seizures With or Without Secondary Generalization; Epilepsy
MeSH terms: Neoplasm Metastasis; Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to
      placebo (PBO) as adjunctive treatment in subjects (>=16 to 80 years of age) with partial
      seizures with or without secondary generalization despite current treatment with 1 or 2
      concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in
      subjects >= 16 years to 80 years of age.
    


Intervention name(s): Placebo; Brivaracetam
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: Film-coated tablets
Route of administration: Oral use; Pharmaceutical form: Film-coated tablets
Concentration: 25 mg tablets and 50 mg tablets
Route of administration: Oral use
Other intervention name(s): Briviact
Intervention MeSH terms: Brivaracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsy; Partial seizures with or without secondary generalization; Brivaracetam; Briviact
Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the bioavailability of a single 1mg dose of
      treprostinil diethanolamine sustained release (SR) tablets manufactured by two independent
      facilities.
    


Intervention name(s): Treprostinil diethanolamine
Intervention type(s): Drug
Intervention description(s): sustained release tablets. One 1mg tablet per period. Two total doses.
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treprostinil; bioavailability; bioequivalence
A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will
      evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease
      remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at
      least one second controller medication. Participants will be randomized in 1:1:1 ratio to
      receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo,
      administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their
      standard-of-care therapy. This will be followed by a 52-week double-blind active treatment
      extension. During double-blind active treatment extension period, all participants will
      receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study
      treatment is 104 weeks. After study treatment, all participants will complete a 20-week
      safety follow-up.
    


Intervention name(s): Lebrikizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.; Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.
Other intervention name(s): RO5490255
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Orofacial Difficulties in Rooming-in
Condition: Orofacial Difficulties in Newborns; Maternal Breastfeeding in Newborns; Newborns in Rooming-in
Study type: Observational

Summary: 
      The purpose of this study is to identify the orofacial difficulties during the maternal
      breastfeeding in rooming-in.
    

Detailed description: 
      Cross-sectional and quantitative study with sample consisted of 28 dyad present in rooming-in
      of the Assis Chateaubriand School Motherhood during August and December of 2009.
    

Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Cross-sectional study of 29 dyads in rooming-in. The data collection consisted in the
        detection of the main orofacial difficulties during the maternal breastfeeding in
        rooming-in.
      
Keywords: Maternal Breastfeeding; Orofacial Difficulties; Rooming-in; Speech and Language Therapy
Autologous Stem Cell Therapy for Fracture Non-union Healing
Condition: Non-union of Fractures
MeSH terms: Fractures, Bone; Fractures, Ununited
Study type: Interventional

Summary: 
      Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.
    

Detailed description: 
      Do mesenchymal stem cells accelerate new bone formation in persistent non-unions treated with
      carrier plus in vitro expanded autologous BMSCs or carrier alone (control). Secondary aims
      were to analyze predictors of union in these patients and describe adverse events at final
      follow-up.
    

Intervention name(s): carrier plus in vitro expanded autologous BMSCs
Intervention type(s): Biological
Intervention description(s): The non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Non-union; fracture; bone marrow stem cells
A Study to Describe Mothers' and Babies' Outcomes After Exposure to HyQvia During Pregnancy
Condition: Exposure During Pregnancy
Study type: Observational

Summary: 
      The main aim of this study is to provide further information on the safety profile of HyQvia
      during pregnancy. This will be done by checking the characteristics of the mother and their
      babies. They will also be checked for any safety outcomes that will occur when exposed to
      HyQvia during pregnancy.
    

Detailed description: 
      This is a non-interventional, retrospective, case series of commercially insured pregnant
      women exposed to HyQvia during their pregnancy identified according to the MarketScan
      Research Database. This study will assess maternal characteristics, patterns of HyQvia
      utilization and pregnancy outcomes in all pregnancies exposed to HyQvia during pregnancy.

      This study will enroll approximately at least 7 patients based on feasibility assessment.
      Participants will be enrolled in the following cohort:

      • HyQvia

      This study will have a retrospective data collection from 1 January 2014 to 31 December 2020.
      This study would be conducted in the US.

      The overall time for data collection in this study will be approximately 7 years.
    

Intervention name(s): No intervention
Intervention type(s): Drug
Intervention description(s): No intervention was given as this is an observational study.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Commercially insured US pregnant women exposed to HyQvia from 90 days before LMP to the end
        of pregnancy and their infants included in the MarketScan Research Database during the
        period 2014-2020.
      
Keywords: Drug Therapy
Pharmacokinetics of Oxytocin at Cesarean Delivery
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      The primary objective is to obtain data to inform the design of a population pharmacokinetic
      study of oxytocin after administration at CD as per standard institutional practice.
    

Detailed description: 
      In this pilot study the investigators will compare plasma oxytocin concentrations measured in
      arterial and venous blood, after oxytocin administration at cesarean delivery, in order to
      assess the validity of venous samples. They will also measure oxytocinase to explore how
      levels vary around the time of delivery of the placenta and to assess the effect that this
      may have on the metabolism of oxytocin.
    

Intervention name(s): oxytocin; Shore durometer
Intervention type(s): Drug; Device
Intervention description(s): PK measurements of oxytocin; The investigators will take serial readings from a digital durometer at the uterine fundus at 3, 6, 9 and 12 minutes following OXT administration to provide data that will inform an estimate of the timing of peak effect. Shore durometers measure the hardness of materials on a scale of 0-100 Shore Units (SU). Preliminary (unpublished) data provided a range of 10-56 SU after oxytocin administration at cesarean delivery. Durometer readings were also shown to correlate positively with the obstetrician's manual assessment of uterine contractility, which is traditionally used to determine the success or failure of uterotonic therapy.
Intervention MeSH terms: Oxytocin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women scheduled for cesarean delivery of their babies at term
Hippotherapy to Improve the Balance of Children With Movement Disorders
Condition: Neuromuscular Diseases; Cerebral Palsy; Down Syndrome; Autism; Developmental Coordination Disorder
MeSH terms: Cerebral Palsy; Down Syndrome; Movement Disorders; Neuromuscular Diseases; Motor Skills Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine if adding hippotherapy treatment will improve
      balance for children ages 5-17 who have disabilities such as cerebral palsy and down
      syndrome. We also want to find out if by improving their balance the children increase their
      participation in age appropriate activities.
    

Detailed description: 
      The primary purpose of this study is to determine the effects of hippotherapy on the balance
      of children with developmental disorders that cause mild to moderate balance problems. The
      secondary purpose is to determine if the use of hippotherapy also improves perceived
      functional abilities and thus quality of life as measured by the pediatric balance scale and
      Activities Scale for Kids (respectively)
    

Intervention name(s): Hippotherapy
Intervention type(s): Other
Intervention description(s): Children will receive treatment by a licensed physical therapist using hippotherapy as the treatment strategy. This includes sitting on a horse who's movement is controlled by a horse leader, with the PT directing the movements required of the horse, as well as supplying supplemental cues to the participant. Alternative positions (such as sitting backward and sideways) may also be used during the treatment session.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hippotherapy; neuromuscular disorders; balance deficits; participation