bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Effects of Single Dose Corticosteroids on Response to Allergens
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate whether changes in inflammatory mediators produced by the nose
      after exposure to an allergen can be used to evaluate the anti-inflammatory effects of novel
      drugs for the treatment of allergic asthma.
    


Intervention name(s): Placebo; prednisone; prednisone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of 5 tablets matching placebo (5 x 0 mg) to prednisone. The washout between treatment periods will be approximately 4 weeks; Single dose of 5 tablets prednisone totaling 10 mg (3 x 0 mg + 2 x 5 mg). The washout between treatment periods will be approximately 4 weeks.; Single dose of 5 tablets prednisone totaling 25 mg (5 x 5 mg). The washout between treatment periods will be approximately 4 weeks.
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Development of an Informed Consent Statement Which Communicates the Risk of Adverse Events Associated With Dry Needling
Condition: Dry Needling
Study type: Observational

Summary: 
      As Dry Needling (DN) continues to see increased use in the clinic, there is a need to
      establish adverse events that could occur as a result of DN intervention. The adverse events
      are important to consider when an individual needs to make an informed decision regarding
      their care. It is important to consider how such information should be presented during the
      informed consent process to improve an individual's ability to make a sound decision
      regarding their own personal care.
    

Detailed description: 
      Dry Needling (DN) has been defined by a Task Force organized by the Federation of State
      Boards of Physical Therapy (FSBPT) as "a skilled intervention performed by a physical
      therapist using filiform needles to penetrate the skin and/or underlying tissues to affect
      change in body structures and functions for the evaluation and management of
      neuromusculoskeletal conditions, pain, movement impairments, and disability". As DN interest
      continues to expand and studies continue to show the feasibility of applying DN to a wider
      range of pathological conditions, there is a need to understand the risks related to the use
      of DN. Understanding the risks associated with DN will allow for improvements in clinical
      decision making regarding it's application in the clinic.

      Enhancing patient choice is a central theme of medical ethics and law. Informed consent (IC)
      is the legal process used to promote patient autonomy while concepts of shared decision
      making (SDM) is a widely promoted ethical approach. IC is a means of respecting the
      autonomous preferences of persons seeking health care or participation in research.
      Empowerment of the patient is important in healthcare and can lead to improvements in overall
      quality of patient care and outcomes.

      To date, there has been little research conducted that explored the topic of how risks should
      be presented during the IC process. The purpose of this study will be to utilize expert
      consensus to establish a risk statement for adverse events associated with DN that an be used
      during IC.
    

Intervention name(s): Nominal Group Technique - 2 to 3 hour virtual meeting
Intervention type(s): Other
Intervention description(s): Participants will be invited to a 2-3 online virtual online meeting with the goal of constructing and defining elements for producing a risk statement for dry needling that can be used for informed consent.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Dry Needling Experts, Legal Experts, Policy Experts, and Patients (Defined with inclusion
        criteria above).
      
Keywords: informed consent; adverse event; nominal group technique
A Phase 1 Drug-drug Interaction Study in Healthy Volunteers
Condition: Drug-drug Interaction Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-sequence, drug-drug interaction study in healthy male and
      female subjects. There is no formal research hypothesis to be statistically tested. It is
      expected that coadministration of BMS-986020 with montelukast, flurbiprofen, and digoxin may
      increase the exposure of montelukast, flurbiprofen, and digoxin.
    


Intervention name(s): BMS-986020; Montelukast; Flurbiprofen; Digoxin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Flurbiprofen; Digoxin; Montelukast
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Dorsomedial Prefrontal Cortex and the Antidepressant Efficacy of Theta Burst Stimulation in Depressed Patients
Condition: Treatment Resistant Depression
MeSH terms: Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      This study evaluates an association between different dosage and the antidepressant efficacy
      of theta burst stimulation in patients with treatment-resistant depression. In a double-blind
      design, All patients are randomized to three groups, i.e. standardized dosage intermittent
      theta-burst stimulation treatment, high dosage intermittent theta-burst stimulation treatment
      or sham treatment.
    


Intervention name(s): Active standardized iTBS-DMPFC; Active high-dosage iTBS-DMPFC; Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC
Intervention type(s): Device; Device; Device
Intervention description(s): Participants in the standardized dosage(600 pulse) of intermittent TBS(iTBS) active stimulation group will receive 3-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to bilateral DMPF, twice a day. Bilateral side DMPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the DMPFC using a Magstim stimulator.; Participants in the standardized dosage(1800pulse) of intermittent TBS(iTBS) active stimulation group will receive 3-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to bilateral DMPF, twice a day. Bilateral side DMPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the DMPFC using a Magstim stimulator.; Half of the patients in the sham group received 3-week the same standardized iTBS parameter stimulation (standardized sham-iTBS), and the other half received the same high dosage iTBS parameter stimulation using a sham coil (high dosage sham-rTMS), which also improved the blinding process
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar
Condition: Visceral Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is:

        1. To evaluate the Safety and Efficacy of four different short-course regimens of
           Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who
           are either treatment naive or treatment resistant to other antileishmanial drugs except
           amphotericin B containing preparations.

        2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in
           treatment of Kala-azar.
    

Detailed description: 
      1. To evaluate the Safety and Efficacy of four different short-course regimens of
           Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who
           are either treatment naive or treatment resistant to other antileishmanial drugs except
           amphotericin B containing preparations.

        2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in
           treatment of Kala-azar.

      Subjects will be administered the study drug in either of the following four dose levels in
      an ascending manner, starting with the first dosage regimen:

        -  7.5 mg/kg on day 1 and day3 (Regimen 1)

        -  10 mg/kg on day 1, followed by 5 mg/kg on day 3 (Regimen 2)

        -  12.5 mg/kg on day 1, followed by 2.5 mg/kg on day 3 (Regimen 3)

        -  Single-bolus infusion of 15 mg/kg over 2-4 hours on day 1 (Regimen 4)
    

Intervention name(s): Amphotericin B fat emulsion in visceral leishmaniasis; Amphotericin B fat emulsion; Amphotericin B in fat emulsion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 & 3 in group A Amphotericin B in fat emulsion (Amphomul) 10 & 5 mg/kg on day 1 & 3 in group B Amphotericin B in fat emulsion (Amphomul) 12.5 & 2.5 mg/kg on day 1 & 3 in group C Amphotericin B in fat emulsion (Amphomul) 15 mg/kg on day 1 in group D; Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1; Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Other intervention name(s): Amphomul; Amphomul; Amphomul
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B; Soybean oil, phospholipid emulsion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Visceral Leishmaniasis; Amphotericin B; Fat emulsion
Analysis of Three-dimensional Movements of the Head in Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Observational

Summary: 
      This study addresses postures and range of motion in cervical dystonia (Spasmodic
      Torticollis). It uses 3D miniature and wireless motion captures sensors, and aims to increase
      the understanding of the biomechanics of the movement disorders of the cervical column in
      this pathology. In addition, the clinical state of cervical dystonia of the patients will be
      assessed, using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). The
      investigators will compare the results between control and study groups.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Study-group: 30 patients meeting the criteria for cervical dystonia (Spasmodic Torticollis)
        and without botulinum toxin injections during the last 6 previous months before baseline.
        Patients will be selected consecutively among the outpatients with movement disorder of 3
        study sites: Fondation OPH Rothschild, Salpetriere Hospital and Sainte-Anne Hospital
        (Paris)

        Control-group: 30 healthy volunteers matched in age (+/- 5 years) and gender with the 30 CD
        subjects. They will be selected in Sainte-Anne Hospital (Paris)
Substrate Metabolism, Growth Hormone Signaling (GH), and Insulin Sensitivity During GH and Ketone Bodies Infusion
Condition: Healthy
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Background: Humans naturally produce ketone bodies under daily living conditions. The main
      ketone bodies are two functioning acids, beta-hydroxybutyric acid (3-OHB) and acetoacetate,
      and the pH-neutral, but odorous, acetone. In the fed state, level of 3-OHB is suppressed to
      an almost unmeasurable level while, in the fasted state, it rises to 0.1-0.5 millimoles (mM).
      Main regulation of ketone synthesis is the abundance of sugars and resulting adaptations in
      insulin secretion. Thus, ketone bodies are formed when sugar is not readily available and
      insulin is suppressed. This picture is, to a certain degree, seen in acute inflammatory
      states and, indeed, during starvation, where level of 3-OHB increases to 5-8 mM.

      Hypothesis:

        1. Ketone bodies changes the insulin sensitivity and substrate metabolism in human subjects

        2. Ketone bodies changes the GH signaling in muscle and adipose tissue

      Aim: The investigators wish to provide knowledge on changes in metabolites and shift in
      signaling pathways and insulin sensitivity during GH infusion and concomitant ketone bodies
      infusion among healthy subjects.
    


Intervention name(s): Somatropin; Ketone bodies
Intervention type(s): Drug; Other
Intervention description(s): Somatropin infusion (Genotropin®); ketone bodies infusion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a one-day single dose trial conducted to compare patient's preference for Nasonex®
      (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2
      sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take
      one dose of the opposite medication. Questionnaires were given to each patient after each
      drug dose to evaluate patient product preference.
    


Intervention name(s): Mometasone Furoate Nasal Spray; fluticasone nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): One dose (2 sprays in each nostril) of Mometasone Furoate Nasal Spray; One dose (2 sprays in each nostril) of fluticasone nasal spray
Other intervention name(s): Nasonex, SCH 032088; Flonase®
Intervention MeSH terms: Fluticasone; Mometasone Furoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
25-Hydroxyvitamin D Levels in Patients With Periodontitis (Stage III)
Condition: Vitamin D Deficiency; Periodontitis
MeSH terms: Periodontitis; Vitamin D Deficiency
Study type: Observational

Summary: 
      Periodontitis; is an inflammatory disease of tissues characterized by bone destruction around
      the teeth. Vitamin D plays an important role in several inflammatory diseases by promoting
      the expression of inflammatory cytokines such as interleukin IL-1, IL-6, and IL-1β, which are
      directly related to periodontal attachment loss and bone demineralization. These facts
      suggest that vitamin D may be associated with periodontal disease. Many studies have been
      conducted on the relationships between serum 25-hydroxyvitamin D (25(OH)D) levels,
      periodontal disease, and tooth loss. However, as far as we know, there is no study on the
      relationship between periodontitis and free and bioavailable 25 (OH) vitamin D. In our study,
      over the age of 35; two groups will be formed, consisting of 40 healthy and 40 periodontitis
      individuals. Serum total 25 (OH) D level and vitamin D binding protein level will be analyzed
      by ELISA method, and bioavailable 25 (OH) D level will be calculated using total 25 (OH) D
      and vitamin D binding protein levels. The aim of this study; To evaluate the total, free and
      bioavailable 25 (OH) vitamin D levels of patients with periodontitis by comparing them with
      healthy controls, and to investigate whether bioavailable 25 (OH) D plays a role in the
      pathogenesis of periodontitis or can be a simple marker of disease activity in the light of
      these findings.
    


Intervention name(s): taking a blood sample
Intervention type(s): Diagnostic Test
Intervention description(s): blood collection for routine biochemical analysis
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Forty patients with stage 3 periodontitis and 40 healthy volunteers were included in this
        case-control study at Atatürk University, Department of Dentistry, Department of
        Periodontology.
      
Keywords: Total 25(OH)D; Bioavailable 25(OH)D; Free 25(OH)D; Periodontitis
Transcranial Magnetic Stimulation in Bipolar Depression
Condition: Bipolar Affective Disorder
MeSH terms: Bipolar Disorder; Mood Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare antidepressant efficacy of left or right to sham Repetitive Transcranial Magnetic
      Stimulation (rTMS)

      to determine if non-responders can become responders if treated on the other side of the
      hemisphere

      (rTMS)
    

Detailed description: 
      Patients will be assigned to one of 3 treatment arms for 10 days of treatment with either
      left high frequency or right high frequency, or sham rTMS. After 10 days of treatment, and no
      improvement, another 10 days of treatment follows, this time with the coil placed on the
      other hemisphere. Subjects will be followed for 2 months respectively with unrestricted
      treatment provided by their regular physician. Mood stabilizers will be continued throughout
      this trial.
    

Intervention name(s): Transcranial Magnetic Stimulation (TMS)
Intervention type(s): Device
Intervention description(s): Phase l clients receive either True or Sham TMS treatments on left or right side of head for 10 days.
Phase ll clients will receive either Sham or True TMS treatments on the other side of the head - the same type as in phase l -
Other intervention name(s): HamD; BDI II; VAS
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Magnetic Stimulation; TMS
How Does Dietary Carbohydrate Influence the Formation of an Atherogenic Lipoprotein Phenotype (ALP)?
Condition: Non-alcoholic Fatty Liver Disease (NAFLD)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The hypothesis of this study is that a diet high in sugars will increase abnormalities in
      blood lipids which are associated with increased cardiovascular disease risk, relative to a
      diet which is low in sugar. We predict that this potentially adverse effect of dietary sugars
      on blood lipids will be more pronounced in people with a raised level of stored fat inside
      their liver, as compared to people with a low level of stored fat.
    

Detailed description: 
      This study aims to determine the metabolic mechanism(s) by which dietary extrinsic sugars
      (sucrose and fructose), promote the formation of a high risk dyslipidaemia, known as an
      atherogenic lipoprotein phenotype (raised plasma triglyceride, low HDL and predominance of
      small, dense LDL), in men with raised cardio-metabolic risk and percentage of liver fat, as
      determined by magnetic resonance spectroscopy (MRS). The study examined the impact of diets
      high and low in extrinsic sugars, on the metabolism of lipids and lipoproteins in vivo, of
      two groups of men with a high (>10%)and low (<2%)percentage of liver fat, by the
      trace-labelling of these lipid moieties with stable isotopes, and detection by gas
      chromatography mass spectrometry. The study had a two-way cross-over design, with two, 12
      week dietary interventions separated by a six week wash-out period. The dietary intervention
      with high and low sugars was achieved by a dietary exchange with supermarket foods, which
      were consumed within the homes of the participants.
    

Intervention name(s): High sugar low starch diet; Low sugar high starch diet
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Sugars, Fatty liver, Lipoprotein kinetics, Triglycerides
Pulse Oximeter and Respiratory Rate Test
Condition: Hypoxia; Hypercapnia; Hypocapnia
MeSH terms: Hypoxia; Hypercapnia; Hypocapnia
Study type: Interventional

Summary: 
      Assessment of Spry Health's Loop oximetry accuracy in profound hypoxia Assessment of Spry
      Health's Respiratory rate accuracy in normal conditions and profound hypoxia
    


Intervention name(s): Spry Loop Band
Intervention type(s): Device
Intervention description(s): Loop band measures pulse oximetry and respiration rate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of an Herbal-Based De-Pigmenting System
Condition: Melasma; Hyperpigmentation
MeSH terms: Melanosis; Hyperpigmentation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effectiveness and tolerability of an herbal
      de-pigmenting regimen applied to one side of the face compared with hydroquinone applied to
      the other side of the face in treating mottled hyperpigmentation and melasma.
    

Detailed description: 
      This clinical study is being conducted in order to evaluate the effectiveness and
      tolerability of a de-pigmenting regimen when used by subjects with mild to severe mottled
      hyperpigmentation and melasma. Efficacy will be assessed using visual grading, device
      measurements and digital photography. Tolerance and safety will be evaluated by grading for
      objective and subjective signs of irritation, and the incidence and severity of adverse
      events. Efficacy and tolerance of this product are compared to that of Hydroquinone, which is
      applied to one side of the subject's face while the herbal de-pigmenting regimen is applied
      to the other side of the face.

      The two product pigmentation reducing herbal regimen is based on the novel concept of
      inhibiting all 14 major and the 3 branch steps in the melanin cascade.
    

Intervention name(s): Herbal depigmenting agent (Epionce); Hydroquinone
Intervention type(s): Other; Drug
Intervention description(s): A two product herbal pigmentation reducing regimen is applied twice a day to either the left or right side of the face for a duration of 4 months.; Hydroquinone 4% is applied twice a day to either the left or right side of the face for a duration of 4 months.
Other intervention name(s): Epionce
Intervention MeSH terms: Hydroquinone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hyperpigmentation; melasma; sun spots; dark spots