bioihbjkbjnl/mcl2 huggingface dataset:
A Bioequivalence Study Between Fluticasone and Salmeterol vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence study between two inhaler products (discus) of fixed dose combination of
      fluticasone propionate and salmeterol xinafoate inhalation powder
    

Detailed description: 
      A bioequivalence study of a single dose of the fixed-dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder administered from Fluticasone
      propionate 100 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent
      Pharmaceuticals (test-Τ) as 2 inhalations and SERETIDE DISKUS® 100/50 mcg inhalation
      powder/GSK (reference-R) in healthy volunteers under fasting conditions with charcoal
      blockade. The study will be one-center crossover, randomized, 2-period, 2-sequence (RT and
      TR), single dose, laboratory-blinded.
    

Intervention name(s): Test Product (Fluticasone propionate and salmeterol xinafoate inhalation powder/Respirent Pharmaceuticals); Reference Product (SERETIDE DISKUS® 100/50 inhalation powder/GSK); Activated Charcoal suspension
Intervention type(s): Drug; Drug; Other
Intervention description(s): Fluticasone propionate 100 mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals; 2 inhalations in one study period; oral suspension before and after inhalation of study Investigational Products
Other intervention name(s): Fluticasone propionate 100 mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals; SERETIDE DISKUS® 100/50 inhalation powder/GSK
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: One-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded study
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: bioequivalence; fluticasone propionate; salmeterol xinafoate; SERETIDE; charcoal blockade
Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders
Condition: Multiple Sclerosis; Chronic Pain; Neurological Disorder
MeSH terms: Multiple Sclerosis; Nervous System Diseases; Chronic Pain
Study type: Interventional

Summary: 
      Participants with neurological disorders will be recruited to complete sessions of virtual
      reality (VR) immersion. VR has been shown to have therapeutic benefit in certain patient
      populations and requires further clinical study to determine the extent to which VR can be
      used to rehabilitate and reduce symptom burden. This study seeks to pilot newly developed VR
      methods and collect preliminary data in order to support research grants and inform larger
      clinical trials. Additionally, this proposed study will explore the tolerability and
      preliminary efficacy of Virtual Reality (VR), specifically to determine whether VR can
      acutely reduce the severity of symptom burden caused by neurological disorders.
    


Intervention name(s): HTC Vive Virtual Reality (VR) system
Intervention type(s): Device
Intervention description(s): VR treatment will entail use of computer software designed to immerse participants and engage them in exercises. Software includes virtual painting, walking through vivid and calming settings, solving puzzles, among others.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antidepressants and Bone Mineral Density
Condition: Bone Mineral Density Quantitative Trait Locus 7
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this five arm randomized trial was thus to compare selective serotonin reuptake
      inhibitor (SSRI)sertraline and citalopram to a dual reuptake inhibitor venlafaxine, a
      nor-adrenaline reuptake inhibitor reboxetine and a control group receiving placebo, with the
      primary endpoint being bone mineral density, and secondary endpoints being bone turnover
      markers.
    

Detailed description: 
      These results have overt clinical implications. They suggest a noxious effect, particularly
      of selective serotonin reuptake inhibitor (SSRI) antidepressants, on bone. Osteoporosis and
      fracture is overtly the problem of the elderly. However, the process of skeletal
      consolidation begins in childhood and the corresponding phase of demineralisation proceeds at
      a glacial pace and lasts throughout adulthood, as a consequence antidepressant therapy is
      likely to have a substantive impact on a phenomenon likely to manifest decades hence. It is
      known that numerically small changes in bone mineral density are associated with a
      substantial increase in fracture risk. Because the SSRIs have only been in widespread use for
      two decades, it is plausible that the consequences of this adverse effect are yet to emerge.
      These data consequently suggest a recalibration of the risk/benefit ratio of this class of
      agents and additionally beg the question of the potential role of screening for bone mineral
      density in this at-risk population group.
    

Intervention name(s): sertraline; citalopram; venlafaxine; reboxetine; control
Intervention type(s): Drug; Drug; Drug; Drug; Behavioral
Intervention description(s): 50mg, 50-150mg/d,qd for one year; 20mg, 20-40mg/d,qd,for one year; venlafaxine,25mg, 75-100mg/d, bid, for one year; reboxetine,4mg, 4-8mg/d,qd for one year; 50min, every week for three months, every month, for nine months
Other intervention name(s): Zoloff; Cipramil; Effexor; Edronax; cognitive behavioral therapy
Intervention MeSH terms: Sertraline; Venlafaxine Hydrochloride; Citalopram; Reboxetine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Antidepressants; bone mineral density; bone turnover markers
Effect of Warfarin in the Treatment of Metachromatic Leukodystrophy
Condition: Metachromatic Leukodystrophy
MeSH terms: Leukodystrophy, Metachromatic
Study type: Interventional

Summary: 
      Objectives/Purpose:

      To determine the safety and efficacy of a Vitamin K (Vit K) antagonist (warfarin) in treating
      Metachromatic Leukodystrophy (MLD).
    

Detailed description: 
      Hypothesis:

      Vit K has an essential role in biosynthesis of sulfatides and other sphingolopids in the
      brain. Administering warfarin, a Vit K antagonist, may ameliorate the phenotype in MLD by
      decreasing t he amount of sphingolipid storage in the neuronal cells.

      Study Design Prospective: we will enroll eligible consenting subjects into the study. The
      study will not include a control group and the families and treating physicians are informed
      administration of the drug.

        1. Duration of Treatment: 4 weeks

        2. Pharmacological Intervention: The patients will receive warfarin 1.5 mg at the beginning
           of the study period. The dosage then will be adjusted to the INR values on weekly basis.

        3. Clinical evaluation: The patients will undergo clinical assessment prior to starting the
           treatment and at the end of the treatment period. The clinical assessment will also
           include administration of Gross Motor Function Measure (GMFM), a clinical toll for
           evaluation of motor development in children.

        4. Urine Sulfatide Quantification: Urine samples for quantification of the sulfatide level
           will be collected at the time of enrollment, after 2 weeks and at the end of treatment
           period.

        5. Blood Monitoring: The patients will undergo blood test for PT/INR at baseline and
           afterwards, at weekly bases for 4 weeks. The INR will be kept in a safe range of 2-2.5.
           If the INR is greater than 4.0 the dosage of warfarin will be lowered and another blood
           draw will be performed in 3 days.
    

Intervention name(s): Warfarin
Intervention type(s): Drug
Intervention description(s): Oral administration (QD), variable dosage: patients will undergo blood test for PT/INR at baseline and afterwards, at weekly bases for 4 weeks. The INR will be kept in a safe range of 2-2.5
Intervention MeSH terms: Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MLD
A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effect of an aqueous nasal spray investigational
      compound GW685698X compared to placebo on the hypothalamic pituitary adrenocortical (HPA)
      axis system in children 2 to 11 years of age with perennial allergic rhinitis.
    


Intervention name(s): GW685698X aqueous nasal spray
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GW685698X; perennial allergic rhinitis; pediatric; intranasal corticosteroid; HPA axis function
Scapulo-Thoracic Mobilization Compared to IASTM in Patients With Mechanical Neck Pain
Condition: Mechanical Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      SCAPULO-THORACIC MOBILIZATION COMPARED TO IASTM IN PATIENTS WITH MECHANICAL NECK PAIN
    

Detailed description: 
      Mechanical neck pain is common musculoskeletal condition that causes work disabilities and is
      not self-limiting. One of the main causes for mechanical neck pain is forward head posture,
      which is common and but not ideal posture adopted by many workers and students who presents
      with head being anterior to the shoulder. Imbalances in the normal muscle function reported
      in such patients with inhibited deep neck flexors, serratus anterior and rhomboids and
      tightened pectoralis, upper trapezius and levator scapula.

      Neck and scapula have some common muscle attachments and abnormal loads on cervical or
      thoracic spine change the biomechanics of muscles present in these regions, which eventually
      cause trigger points Management of scapulo-thoracic joint focuses on correcting posture,
      restoring flexibility of the scapula including the pectoralis minor, levator scapulae,
      rhomboids, mobilization and soft tissue techniques.

      IASTM is ergonomically designed stainless steel tool, and has recently gained much popularity
      for elevating pain, reducing trigger points and improving ROMs because it has deeply
      penetrating power as compared to mobilization through hand. This technique works by both
      along the mobilizing muscle fibers or parallel to the muscle fibers.
    

Intervention name(s): scapulothoracic mobilization; IASTM
Intervention type(s): Other; Other
Intervention description(s): Patient in prone lying position. The left hand of the physical therapist lifts the scapula to distract from the thoracic wall while the right hand mobilizes and stretches the inferior muscle groups attached to the scapula.; Restrictions and myofascial adhesions should be assessed prior to treatment along both sides using IASTM tool and a lubricant.
Once restrictions are assessed, fanning strokes at 45 degree angles to skin should be applied using the tool. This technique should be performed for 20 seconds parallel to the muscle fibers and 20 seconds perpendicular to the muscle fibers for each muscle group in scapulothoracic region. Total time for IASTM application is 10 mints. Upon completing all this patient should be given a home plan consisting of 2 different self-stretches targeting levator scapulae and upper trapezius
Other intervention name(s): Instrument assisted Soft tissue mobilization.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 32 Participants were recruited in the study and divided into two groups. Group A was given intervention Scapulothoracic mobilization and Group B with IASTM.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IASTM; scapulo-thoracic mobilization; mechanical neck pain
Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      PROSPER-FM is a multi-center, randomized, non-significant risk device study to evaluate the
      safety and efficacy of two digital therapy smartphone applications in participants with
      fibromyalgia. Eligible participants are randomized (1:1) to either the Digital Acceptance and
      Commitment Therapy (Digital ACT) group or the Digital Symptom Tracker group and receive
      assigned therapy for 12 weeks.
    


Intervention name(s): Digital ACT; Digital Symptom Tracker
Intervention type(s): Device; Other
Intervention description(s): Participants in this arm receive Digital ACT as well as standard of care.; Participants in this arm complete a digital symptom and function tracker and monitor, are provided access to digital fibromyalgia and health education, and receive standard of care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Sitagliptin Versus Insulin Dose Increase in Type 2 Diabetes on Insulin Treatment
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose
      levels and preserves pancreatic beta cell function in patients with type 2 diabetes. DPP-IV
      inhibitors stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon
      secretion from pancreas by increasing incretin (GLP-1) levels. Recent studies reported that
      combination therapy with DPP-IV inhibitors and other oral antidiabetic medication have
      additive or synergistic effects in lowering glycose level, preserving beta-cell mass and
      function as well as enhancing insulin sensitivity. However, there have been few studies about
      the glucose lowering effect of DPP-IV inhibitors in patients with type 2 diabetes on insulin
      treatment.

      The researchers hypothesized that DPP-IV inhibitor add-on therapy to insulin treatment may
      have favorable effects on glucose control and endogenous insulin secretory function in type 2
      diabetic patients. The researchers plan to compare between sitagliptin (DPP-IV inhibitor)
      add-on therapy and insulin dose increase therapy in uncontrolled type 2 diabetes on insulin
      treatment.
    


Intervention name(s): sitagliptin; insulin dose increase
Intervention type(s): Drug; Drug
Intervention description(s): sitagliptin 100mg once daily, orally, for 24 weeks.; insulin dose increase
Other intervention name(s): Januvia; Long acting insulin (Lantus)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Sitagliptin Phosphate; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Sitagliptin; insulin; C-peptide
Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo
Condition: Infantile Hemangioma
MeSH terms: Hemangioma; Hemangioma, Capillary; Port-Wine Stain
Study type: Interventional
Phase: Phase 2

Summary: 
      There is an unsatisfied medical need for a first-line treatment of localized uncomplicated
      proliferating Infantile Hemangioma with a good benefit/risk profile.

      Pierre Fabre Dermatologie has developed a new formulation of propranolol (V0400 GL 01A) which
      is a topical gel adapted to paediatric use.

      The objective of this study is to evaluate topical propranolol efficacy and safety in the
      management of localized hemangioma.
    


Intervention name(s): propranolol gel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Topical administration twice daily; Topical administration twice daily
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Propranolol gel; Hemangioma; capillary neoplasm; vascular tissue; neoplasm by histologic type; neoplasm; therapeutic uses; pharmacologic actions; adrenergic beta-antagonists; adrenergic antagonist; adrenergics agent; neurotransmitter agent; molecular mechanism of pharmacological action; physiological effects of drugs
Safety and Immunogenicity Study of Live Attenuated Mumps Vaccines in Healthy Infants
Condition: Mumps
MeSH terms: Mumps
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated
      mumps vaccine in healthy infants between 8 - 18 months old with a commercialized live
      attenuated mumps vaccine as the control vaccine.
    

Detailed description: 
      This study is a randomized, blind, single-center, controlled phase III clinical trial. The
      purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps
      vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control vaccine is
      a commercialized live attenuated mumps vaccine manufactured by ZheJiang VACN
      bio-pharmaceutical Co. Ltd. All participants are healthy infants between 8 - 18 months old,
      and will be randomly assigned into experimental group or control group in the ratio 1:1.
    

Intervention name(s): Investigational live attenuated mumps vaccine; control live attenuated mumps vaccine
Intervention type(s): Biological; Biological
Intervention description(s): The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.; The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: live attenuated mumps vaccine; safety; immunogenicity; infant
Effect of Itraconazole on the Pharmacokinetics of BIIB074
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the effect of cytochrome P450 (CYP) 3A4
      inhibition on the pharmacokinetics (PK) of BIIB074. The secondary objectives of this study
      are to assess the safety and tolerability of BIIB074 when co-administered with a strong
      CYP3A4 inhibitor and to assess the effect of CYP3A4 inhibition on the PK of 3 metabolites of
      BIIB074 (CNV3000497 [M13], CNV2283325 [M14], and CNV2288584 [M16]).
    


Intervention name(s): BIIB074; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm; 200 mg twice daily [BID] on Day 8 and once daily (QD) from Day 9 to Day 15 inclusive
Other intervention name(s): CNV1014802; Sporanox, Onmel
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Of Pharmacokinetic (PK) Profile of Bazedoxifene (BZA) in 2 BZA/Conjugated Estrogen Forms
Condition: Postmenopause
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to understand how bazedoxifene is absorbed in the body when it is
      given in combination with 2 different formulations of conjugated estrogens. It is an open
      label study with no placebo control or comparator drugs. Subjects will take one dose of the
      investigation formulation daily for 14 days.
    


Intervention name(s): Bazedoxifene/conjugated estrogens
Intervention type(s): Drug
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postmenopause
Dietary Strategies to Promote Muscle Protein Anabolism in the Elderly
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      Aging is associated with the loss of lean muscle mass, termed sarcopenia. Food intake and in
      particular the ingestion of protein or amino acids has been shown to be a powerful stimulus
      to promote net muscle protein anabolism. However this anabolic response following a meal-like
      protein bolus seems to be blunted in the elderly as compared to young adults.

      The first aim of this proposal is to investigate the post-prandial muscle protein synthesis
      rates in young and elderly men in response to a meal-like protein bolus after a period of
      rest or physical activity (study A). The rest trial (REST) will act as a proof-of-principle
      study to examine the blunted protein synthetic response in the elderly, and as a control
      trial in comparison with the exercise trial (EXC) to establish the surplus value of physical
      activity prior to protein intake on muscle protein synthesis.

      The second aim of this proposal is to determine the surplus value of an increased quantity of
      the ingested protein bolus (study B). Large amounts of protein (40 and 60 g) will be compared
      to a meal-like amount of protein (20 g) as a means to maximize plasma amino acid availability
      and/or to stimulate muscle protein anabolism.

      The third aim of this proposal is to study the differences in quality of the ingested protein
      bolus (study C). Instead of significantly increasing the quantity of the protein bolus, we
      will also apply a more practical approach to augment skeletal muscle protein synthesis rates;
      modifying the digestibility or amino acid composition of a meal-like protein bolus.
    


Intervention name(s): Protein/Amino Acids; Physical exercise
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Casein Whey Leucine; The physical exercise protocol will consist of low intensity cycling and light resistance-type exercise; after 5 minutes of self-paced cycling, subjects will perform 6 sets of 10 repetitions on the horizontal leg press machine (Technogym BV, Rotterdam, The Netherlands) and 6 sets of 10 repetitions on the leg extension machine (Technogym BV, Rotterdam, The Netherlands). The first 2 sets of both resistance exercises will be performed at 40% of the subjects' 1RM. Sets 3-4, and 5-6 will be performed at 55% and 75% of 1RM, respectively, with 2 minutes rest intervals between sets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: muscle loss; aging; protein; amino acids; exercise; protein synthesis