bioihbjkbjnl/mcl2 huggingface dataset:
High Energy Phosphate Metabolites in Brain
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this research project is to determine the impact on brain HEP metabolites
      and fluxes of an oral consumption of a commercially available nutrition product (Peptamen®
      1.5 vanilla) in healthy volunteers.

      Therefore, we intend to perform 31P-MRS before and after oral intake of the nutrition
      product.
    


Intervention name(s): Peptamen® 1.5 vanilla
Intervention type(s): Other
Intervention description(s): Administration orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Physiological Responses in Tobacco Chippers
Condition: Smoking; Stress
Study type: Observational

Summary: 
      This study will analyze a series of biological and behavioral markers in different
      populations of smokers. The study groups will differ in their cigarette consumption and level
      of nicotine dependence. This analysis will help to identify factors that might be important
      for smoking behavior and nicotine addiction. The results from this study will contribute to
      improve campaigns for smoking prevention and treatments for smoking cessation.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        General population
Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1
      to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum
      bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup
      B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean
      concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary
      vaccination course of two doses administered one month apart.
    

Detailed description: 
      Novartis will consider this study a success if, at one month following the second
      vaccination, the two-sided 95% CI of the ratio of the hSBA GMTs for each of 3 serogroup B
      reference strains (H44/76, 5/99, and NZ98/254) and the two-sided 95% CI of the ratio of the
      ELISA GMCs against vaccine antigen 287-953 are contained within the interval (0.5, 2.0).
    

Intervention name(s): Serogroup B meningococcal vaccine
Intervention type(s): Biological
Intervention description(s): All subjects will receive two rMenB+OMV NZ vaccinations one month apart and will be followed for a total of 2 months. Subjects will be randomized to 1 of 2 treatment arms to receive either two doses of rMenB+OMV NZ vaccine Lot 1 or two doses of rMenB+OMV NZ Lot 2.
A total of 2 blood samples will be collected (at the first vaccination and 1 month after the 2nd vaccination). An additional blood draw will be collected in a subset of approximately 160 subjects (approximately 80 subjects in Group 1 and approximately 80 subjects in Group 2) at 2 weeks after the second vaccination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningococcal Meningitis; prevention, vaccination; adolescents
Effects of Myofascial Release and TENS Over Pain, Hand Prehensile Strength and Functionality of Superior Extremity in Women With Lateral Epicondylalgia
Condition: Musculoskeletal Manipulations
Study type: Interventional

Summary: 
      This study evaluated the additive effect of myofascial release therapy on the brachial biceps
      on conventional management (TENS) in pain intensity, hand prehensile strength and upper limb
      functionality of individuals with lateral epicondylalgia.
    

Detailed description: 
      This study determined the additive effect of the myofascial release therapy of brachial
      biceps on TENS in the variables pain intensity, hand prehensile strength and upper limb
      functionality of individuals with lateral epicondylalgia, compared to a group that received
      only TENS. This was done in a sample of 32 individuals, assigned in two groups: group A that
      received an application of TENS and group B that received an application of TENS plus
      myofascial release therapy.

      Contrary to the hypothesis, the application of myofascial release therapy added to the
      application of TENS proved to generate a significant change only in the prehensile hand force
      with respect to the group that received only TENS.
    

Intervention name(s): TENS; Myofascial therapy
Intervention type(s): Other; Other
Intervention description(s): 100 Hz and 100 usec for 20 minutes; Seven to fifteen transverse sliding repetitions and three repetitions of longitudinal sliding of myofascial release therapy
Other intervention name(s): Transcutaneous electrical nerve stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Quantitative, experimental prospective, explanatory type, randomized controlled parallel with simple blind.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Manual therapy; Myofascial release; Lateral epicondylitis; Transcutaneous electrical nerve stimulation; Pain; Strength; Functionality
Comparative Tolerability of Protease Inhibitors
Condition: HIV
Study type: Observational

Summary: 
      This study will be a retrospective observational study assessing identifiable tolerability
      problems in terms of their comparative incidence among Human Immunodeficiency Virus (HIV)
      patients treated with cART regimens including one of four different protease inhibitors
      [Atazanavir sulfate (ATV), Darunavir (DRV), Fosamprenavir (FPV), or Lopinavir (LPV)] and the
      impact of these identifiable tolerability problems on PI persistence, healthcare utilization,
      and healthcare costs.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Employees and dependents with employer-based health insurance coverage
RCT to Evaluate the Cosmetic Efficacy of Demo-cosmetic Active Ingredient CLS02021
Condition: Overall Skin Appearance; Dry Skin; Eczema
MeSH terms: Eczema
Study type: Interventional

Summary: 
      This study will explore the potential of probiotic based, novel cosmetic active ingredient to
      rebuild the collagen based skin barrier with the overall aim to rejuvenate ageing or damaged
      skin, improve skin integrity, appearance, beauty, and support personal well-being and
      vitality.
    


Intervention name(s): Cosmetic Active Ingredient CLS02021; Placebo PLC01021
Intervention type(s): Other; Other
Intervention description(s): Topical, face application of the cream base with the CLS02021, two times a day in a period of 30 days; Topical, face application of the cream base, two times a day in a period of 30 days
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Infra-subject comparisons study. As the study is intraindividual, every subject will apply study product on the one side of the face and placebo on the other side of the face at the same time. Subject will not be aware what product is the study product and application is indicated only by the side of the face products are applied.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Skin Hydration; Cosmetic Appearance; Skin Health; Skin Sensitiviry
A Phase II Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is intended to evaluate the efficacy and safety of MBA-P01 compared to placebo in
      treatment of glabellar lines.
    


Intervention name(s): MBA-P01 (Botulinum toxin A); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MBA-P01 will be injected into the Glabellar line; Placebo will be injected into the Glabellar line
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Acupuncture for Functional Dyspepsia: a Functional Magnetic Resonance Imaging (fMRI) Study
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      He-Mu-point combination（ST36 and CV12） is one of the most commonly used acupoints combination
      with synergistic effect for functional dyspepsia(FD). The investigators design the trial to
      identify the efficacy and explore the central integrated mechanism of puncturing at
      He-Mu-point combination on FD with functional magnetic resonance imaging (fMRI).
    

Detailed description: 
      105 participants with functional dyspepsia will be allocated into three groups: Low-He point
      group, Mu point group and He-Mu-point combination group.Every participant will receive 20
      sessions of manual acupuncture treatment during 4 weeks. Clinical evaluations will be
      assessed three times, as measured after randomization, 10 and 20 sessions of treatment.The
      fMRI scans will be conducted twice, after randomization and treatment completion.
    

Intervention name(s): acupuncture
Intervention type(s): Other
Intervention description(s): Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.
Other intervention name(s): Manual acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acupuncture; functional dyspepsia; functional magnetic resonance imaging (fMRI)
Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair
Condition: Hernia, Inguinal
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Investigators are testing whether tacking mesh or self-fixating mesh used for inguinal hernia
      repair makes any difference in short-term pain or return to normal activities following the
      operation. Other studies have shown no significant difference in hernia recurrence rate when
      metal tacks are not used to hold the mesh in place.
    

Detailed description: 
      Participants will be placed into two groups. One group of participants will have mesh tacked
      into place for their hernia repairs. The other group will have self-fixating mesh into place.
      Both groups will have a piece of mesh that will widely cover the hernia defect. Before
      surgery, the participant will be asked to rate discomfort on a 0-10 scale. Zero stands for no
      pain and 10 is the worst pain they can imagine. Investigators will record information about
      general medical condition, medications and activity level. During the operation information
      will be recorded about the pain medicines the participant may receive. In the recovery room
      the participant will be asked to rate their pain on the 0-10 scale and more information will
      be recorded about any additional pain medicines that they may receive and assess activity
      level. Following surgery, Investigators will contact the participants by survey to obtain
      more information about pain level, medication use, and activity level.
    

Intervention name(s): PROLENE Polypropylene Tacking Mesh; ProGrip Self-fixating Mesh
Intervention type(s): Device; Device
Intervention description(s): Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks; ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of "Velcro" to the soft tissue surfaces resulting in self-fixation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mesh; Repair; Peritoneal
Zomig - Treatment of Acute Migraine Headache in Adolescents
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age
      12-17 years) with migraine headaches feel better. This will be done by comparing 3 different
      doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).
    


Intervention name(s): Placebo; Zolmitriptan; Zolmitriptan; Zolmitriptan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo nasal spray; 0.5 mg nasal spray; 2.5 mg nasal spray; 5.0 mg nasal spray
Other intervention name(s): Zomig® Nasal Spray; Zomig® Nasal Spray; Zomig® Nasal Spray
Intervention MeSH terms: Oxazolidinones; Zolmitriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Headache; Pain; Efficacy; Adolescents
The Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders
Condition: vonWillebrand Disease; Hemophilia; Platelet Coagulation Disorders
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Von Willebrand Diseases
Study type: Interventional

Summary: 
      The high percentage of failure using available non-surgical options to treat menorrhagia in
      women with bleeding disorders shows a continuing need for innovative treatments. This has led
      to development of this protocol in order to make available tranexamic acid as a potentially
      effective menorrhagia therapy option in women with an underlying bleeding disorder. We
      anticipate that Tranexamic Acid may be a beneficial choice for controlling menorrhagia in
      bleeding disorder patients.
    

Detailed description: 
      Women with heavy periods and with a diagnosed bleeding disorders are prescribed cyclokapron
      pills to be taken during their periods. Their periods are assessed at 3 and 6 months by
      filling out a pictorial blood assessment chart. If the drug appears to be working with no
      adverse effects the patients can continue to take the medication as long as it is available
      with follow up with the investigator every 6 months.
    

Intervention name(s): Cyclokapron
Intervention type(s): Drug
Intervention description(s): (2) 500mg tablets taken by mouth every 6-8 hours
Other intervention name(s): tranexamic Acid
Intervention MeSH terms: Tranexamic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reversal of Neuromuscular Blockade in Diabetic Patients
Condition: Observation of Neuromuscular Block
Study type: Observational [Patient Registry]

Summary: 
      In this study the investigators aimed to compare the time of antagonism and intensity of
      effect of sugammadex which is used for antagonism of rocuronium on diabetic and non-diabetic
      patients.
    

Detailed description: 
      Aim: In this study the investigators aimed to compare the time of antagonism and intensity of
      effect of sugammadex which is used for antagonism of rocuronium on diabetic and non-diabetic
      patients.

      Methods: Included patients were divided into 2 groups: diabetic (n=21) and non-diabetic
      (n=20). All patients were premedicated. After arrival in the operating room, all patients
      were monitorised with Datex Ohmeda S/5 Anesthesia Machine and electrocardiography (DII
      derivation), hemodynamic variables, respiratory rate, and inspiratory sevoflurane
      concentrations were recorded. Neuromuscular monitoring system was used. Anesthesia was
      induced with propofol 2 mg/kg and fentanyl 1 mcg/kg. After the loss of eyelid reflex the
      neuromuscular monitoring system automatically identified supramaximal stimulating currents
      and after that rocuronium 0,6 mg/kg was given. Train of four (TOF) stimulation with the
      supramaximal current were applied and by recording of second TOF value (TOF2) the patient was
      intubated. Anesthesia was maintained with 50% O2 + 50% air and sevoflurane of 1-2 %
      concentration. TOF stimulation was applied and recorded every 20 seconds. Intraoperatively by
      return T2 rocuronium 0,15 mg/kg was given. T2i time was recorded as intubation time and T2d
      time was recorded as clinical effect time. At the end of the operation sugammadex 2 mg/kg was
      given. When TOF rate reached 0,9 patients were extubated and the time was recorded.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients (diabetic and non-diabetic) between 18-65 years
      
Keywords: diabetes mellitus; neuromuscular blockade; sugammadex
The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to observed prospectively the efficacy and safety of 6 months
      treatment of iguratimod alone, or with methotrexate (MTX), hydroxychloroquine (HCQ) and
      prednisone step by step on Chinese rheumatoid arthritis (RA) and early rheumatoid arthritis
      (ERA) patients who were naïve or shown insufficiency response or intolerance to DMARDs. If
      volunteered, patients who completed the 6-month study can continue to follow our plans for 24
      months.
    

Detailed description: 
      This study will enroll 200 cases of rheumatoid arthritis (RA) and early rheumatoid arthritis
      (ERA) patients in China, who are naïve or shown insufficiency response or intolerance to
      DMARDs. The participants plan to be treated with iguratimod alone, or along with methotrexate
      (MTX)/ hydroxychloroquine (HCQ) / prednisone (Pred) step by step for 6 months if participants
      are in medium or high disease activity (DAS28≥3.2). Participants can choose to continue the
      study up to 24 months.The efficacy and safety of 6 months and 24 months Iguratimod treatment
      in RA and ERA patients will be evaluated with DAS28-ESR and other disease activity indices.
    

Intervention name(s): Iguratimod; MTX; HCQ; Pred
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Iguratimod tablet，25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.; MTX，7.5mg to 15mg, po, once per week (Qw) prescribed if needed and adjusted due to patient response or unacceptable toxicity develops.; HCQ，200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.; Pred, 5-15mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response
Other intervention name(s): T-614; methotrexate; Hydroxychloroquine; Prednisone
Intervention MeSH terms: Hydroxychloroquine; Prednisone; Methotrexate
Intervention model: Single Group Assignment
Intervention model description: Drug: Iguratimod（T-614），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.
Drug: Methotrexate （MTX），7.5mg to 15mg, po, once per week (Qw) prescribed if needed and adjusted due to patient response or unacceptable toxicity develops.
Drug: Hydroxychloroquine （HCQ），200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
Drug: Prednisone （Pred）： 5-15mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Iguratimod
Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the long-term safety of LDX administered
      as a daily morning dose (30, 50, and 70 mg/day) in the treatment of adolescents (13-17 years
      of age inclusive at the time of consent).
    

Detailed description: 
      Not Required
    

Intervention name(s): Lisdexamfetamine Dimesylate (LDX)
Intervention type(s): Drug
Intervention description(s): optimal dose of 30, 50 or 70 mg once daily
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of the Hemodynamic Interactions of TPN171H Tablets & Alcohol in Healthy Male Subjects
Condition: Alcohol; Phosphodiesterase Inhibitor; Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is primarily to evaluate the effects of taking TPN171H tablets with
      alcohol on blood pressure, pulse,and pharmacokinetic in Chinese healthy male subjects.
    

Detailed description: 
      This study will be divided into two parts: pre-test and formal test. The pre-trial is an open
      design to evaluate the safety and tolerability of TPN171H tablets in combination with alcohol
      in healthy male subjects. Two subjects at 5 mg and 10 mg doses will be taken with alcohol,
      blood pressure (SBP and DBP), pulse, alcohol breath monitoring and PK blood sample collection
      were required, and the time point was the same as the formal test.

      The dosage of TPN171H tablets in the formal trial will be determined according to the
      preliminary test results.

      The formal trial is a single-centre, blind, randomized, placebo-controlled, three-period,
      three-way crossover study, in which each subject will be randomized to receive each of the
      following three treatments with a washout period of at least 3 days between treatments:

      Treatment A: a single oral dose of one10 mg or 5 mg TPN171H tablet plus an oral dose of
      alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).

      Treatment B: a single oral dose of one placebo tablet plus an oral dose of alcohol drink
      mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).

      Treatment C: a single oral dose of one10 mg or 5 mg TPN171H tablet plus an oral dose of
      placebo drink mixed with fruit juice.

      For each treatment period, supine blood pressure and pulse rate will be measured pre-dose and
      every 15 minutes for 4 hours post-dose,and at 6h,8h,24h and 48h post-dose. Alcohol levels
      using a breathalyzer will be measured at pre-dose and up to 8 hours post dose during all 3
      treatments by designated unblinded personnel.
    

Intervention name(s): TPN171H tablet plus alcohol; alcohol; TPN171H tablet
Intervention type(s): Drug; Other; Drug
Intervention description(s): 10 mg TPN171H tablet QD plus 0.5 g/kg alcohol; 0.5 g/kg alcohol; 10 mg TPN171H tablet QD
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase I; Crossover Study; Alcohol; TPN171H