bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Clinical Onset of Type 1 Diabetes in High Risk First Degree Relatives
Condition: Diabetes, Type I
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      Prophylactic administration of metabolically active insulin can prevent or delay clinical
      onset of diabetes in a high risk group of nondiabetic siblings as defined by positivity for
      autoantibodies against IA-2 (IA-2-A).
    

Detailed description: 
      Hypotheses:

      Primary: Prophylactic administration of metabolically active insulin can prevent or delay
      clinical onset of diabetes in a high risk group of nondiabetic siblings as defined by
      positivity for autoantibodies against IA-2 (IA-2-A).

      Secondary: 1) Untreated siblings with positivity for IA-2-A develop clinical diabetes
      significantly faster than untreated offspring with the same marker positivity. 2) Plasma
      proinsulin levels increase disproportionately before clinical onset of Type 1 diabetes both
      in siblings and offspring. 3) Prophylactic administration of metabolically active insulin
      reduces the plasma proinsulin/C-peptide ratio in non-diabetic antibody positive siblings and
      offspring. 4) Prophylactic administration of metabolically active insulin reduces the
      presence and/or levels of diabetes-associated autoantibodies directed against islet cell
      components.

      Endpoints: Fasting glycemia; fasting and stimulated plasma C-peptide and proinsulin values;
      islet cell autoantibodies; incidence of hypoglycemia; body weight gain.
    

Intervention name(s): Actrapid HM
Intervention type(s): Drug
Intervention description(s): 56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prevention
Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study was to To investigate whether the administration of BIA 6-512 (25
      mg, 50 mg, 75 mg and 100 mg) at steady-state affects the pharmacokinetics of levodopa when
      administered in combination with a single-dose of immediate release levodopa/benserazide
      200/50 mg or with a single-dose of immediate release levodopa/benserazide 200/50 mg plus a
      single-dose of entacapone 200 mg.
    

Detailed description: 
      Single centre, double-blind, randomised, placebo-controlled, rising multiple-dose study in
      four sequential groups of healthy male and female subjects. Eligible subjects were admitted
      to the Human Pharmacology Unit (UFHBIAL - Portela & Cª, SA) on the day prior to receiving the
      first study medication. Starting in the morning of Day 1 (first dose), subjects received BIA
      6-512/Placebo thrice-daily until the morning of Day 5 (last dose). Concomitantly with the
      morning dose of BIA 6-512/Placebo, on Day 4 a levodopa/benserazide 200/50 mg (Madopar® 250)
      single-dose was administered. On Day 5, a Madopar® 250 single-dose and a entacapone 200 mg
      (Comtan®) single-dose were administered concomitantly with the morning dose of BIA
      6-512/Placebo. In the morning of Day 4 and Day 5, products were administered in fasting of at
      least 8 hours and subjects remained fasted until 2 h post-dose. Subjects were resident in the
      UFH from admission (Day 0) until at least 24 h post last dose (Day 6); then, they were
      discharged and returned for the follow-up visit.
    

Intervention name(s): Placebo; BIA 6-512; Madopar® 250; Comtan®
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 capsule of placebo [to be taken orally, with 240 mL of potable water]; 1 capsule of BIA 6-512 25mg or 1 capsule of BIA 6-512 50 mg or 1 capsule of BIA 6-512 75 mg or 1 capsule of BIA 6-512 100 mg [to be taken orally, with 240 mL of potable water]; Levodopa/benserazide immediate release tablets 200mg/50mg [to be taken orally, with 240 mL of potable water]; Entacapone 200 mg tablets [to be taken orally, with 240 mL of potable water]
Other intervention name(s): Trans-resveratrol
Intervention MeSH terms: Resveratrol; Benserazide, levodopa drug combination
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis
Condition: Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With; Glucocorticoid-induced Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score as
      assessed by dual-energy X-ray absorptiometry (DXA) at 12 months in children 5 to 17 year of
      age with Glucocorticoid (GC)-induced osteoporosis (GiOP).
    


Intervention name(s): Denosumab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 1mg/kg BW (up to a maximum of 60 mg) SC Q6M; SC Q6M placebo
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Denosumab; Pediatric GIOP; Glucocorticoid-induced; Osteoporosis
Effect of Adjunctive Intracoronary Streptokinase on Late Term Left Ventricular Infarct Size and Volumes in Patients With Acute Myocardial Infarction
Condition: Acute Coronary Syndromes; Acute Myocardial Infarction; Reperfusion Injury
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Reperfusion Injury; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesized that complementary intracoronary streptokinase administration
      to primary percutaneous intervention in patients with acute myocardial infarction may provide
      limitation infarct size and improvement in left ventricular volumes and function in acute and
      late phases (6 months).
    


Intervention name(s): Streptokinase; primary percutaneous coronary intervention
Intervention type(s): Drug; Procedure
Intervention description(s): intracoronary infusion, 250.000 Units; balloon catheter, stent
Other intervention name(s): Streptase (Streptokinase)
Intervention MeSH terms: Streptokinase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: coronary microcirculation; acut myocardial infarction; infarct size; streptokinase; reperfusion
Rasagiline and Apathy in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether rasagiline is effective in the treatment of
      apathy in patients with Parkinson's disease.
    

Detailed description: 
      The primary objective of this study is to evaluate the efficacy of rasagiline in patients
      with Parkinson's disease (PD) and apathy. Secondary objectives are 1) to evaluate the
      affective and cognitive response to rasagiline and their correlates to apathy and 2) to
      investigate the metabolic and neurophysiologic correlates of the behavioural, cognitive and
      emotional, aspects of apathy in PD. This will be an exploratory, randomized, double-blind,
      placebo controlled, parallel-group study. 40 PD patients with apathy and without dementia
      will be recruited. Rasagiline 1 mg or matching placebo will be administered once daily in
      conjunction with the subjects' usual oral antiparkinsonian medications for up to 12 weeks.
      Patients will be evaluated at screening (-7 days) and baseline (0), as well as at weeks 4, 8,
      and 12. A perfusion SPECT will be performed at baseline and at week 12. The study will be
      conducted at the Movement Disorders Unit of the Neurology Department at Sant Pau Hospital
      (Barcelona, Spain).
    

Intervention name(s): Rasagiline
Intervention type(s): Drug
Intervention description(s): rasagiline 1 mg daily, oral use, during 12 weeks
Other intervention name(s): Azilect
Intervention MeSH terms: Rasagiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; Apathy; Rasagiline
Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 on Microcirculation in Severe Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional

Summary: 
      This study aimed to investigate the effect of Glucocorticoid combined with vitamin C and
      vitamin B1 versus hydrocortisone alone on microcirculation in septic shock patients.
    

Detailed description: 
      This prospective, double-blind, randomized, controlled trial enrolled septic shock patients
      admitted to the intensive care unite of a tertiary teaching hospital. We randomly assigned
      the enrolled patients to the treatment group (hydrocortisone combined with vitamin C and
      vitamin B1 added to standard care) and the control group (hydrocortisone alone added to
      standard care) in a 1:1 ratio. The primary outcome was perfusion vascular density (PVD) at 24
      hours after treatment. We used the sublingual microcirculation imaging system to monitor PVD.
      We further validated the primary outcome by observing differences in renal perfusion
      monitored by renal contrast-enhanced ultrasound (CEUS) between the treatment group and the
      control group.
    

Intervention name(s): Glucocorticoid combination therapy; Glucocorticoid
Intervention type(s): Drug; Drug
Intervention description(s): Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1.; The glucocorticoid group was defined as the use of hydrocortisone alone.
Other intervention name(s): Hydrocortisone, vitamin C and vitamin B1; Hydrocortisone
Intervention MeSH terms: Vitamins; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Glucocorticoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: septic shock; glucocorticoid; vitamin C; microcirculation; Vitamin B1
Accuracy of Pulse Oximeters With Profound Hypoxia
Condition: Healthy Volunteers
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and
      severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief,
      steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin saturation
      (arterial blood sample processed in a laboratory hemoximeter). The data obtained is submitted
      by pulse oximeter manufacturers to the FDA for device approval.
    

Detailed description: 
      The study will include at least 10 subjects (up to 14 if needed to reach the 200 necessary
      data points to meet the ISO 80601-2-61:2017).

      Per FDA guidance, at least 2, or 15% of the subjects will have dark skin.
    

Intervention name(s): Respiree
Intervention type(s): Device
Intervention description(s): The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin saturation (arterial blood sample processed in a laboratory hemoximeter). The data obtained is submitted by pulse oximeter manufacturers to the FDA for device approval
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study will include at least 10 subjects (up to 14 if needed to reach the 200 necessary
        data points to meet the ISO 80601-2-61:2017).

        Per FDA guidance, at least 2, or 15% of the subjects will have dark skin
Effects of Ciclesonide MDI 50mg/Day and 200mg/Day (Ex-Valve) Once-Daily on Growth in Children With Mild Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to determine if CIC 50 mg/day or 200 mg/day (ex-valve) administered
      once daily in the morning is non-inferior to placebo with respect to growth velocity in
      children with mild persistent asthma following a 12-month treatment period

      The secondary objective is to investigate changes in growth in terms of bone age (wrist
      X-ray), and maintenance of asthma control and safety with ciclesonide
    


Intervention name(s): ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Safety; Pediatrics
A Study To Assess Absorption Of Study Drug Dacomitinib (PF-00299804), Given As An Oral Tablet Compared To An Intravenous Infusion In Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to determine the proportion of study drug dacomitinib or PF-00299804, that is
      taken up from the digestive tract into the body when given as an oral tablet compared with
      that taken up by an intravenous dose.
    


Intervention name(s): dacomitinib oral; dacomitinib intravenous
Intervention type(s): Drug; Drug
Intervention description(s): Dacomitinib 45 mg oral tablet; Dacomitinib 20 mg solution will be given as 1 hour intravenous infusion
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: dacomitinib; PF-00299804; pharmacokinetics; bioavailability
Vardenafil in Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 2

Summary: 
      There is incidental evidence (casuistic findings) that the treatment with vardenafil of male
      patients suffering from erectile dysfunction and comorbid tinnitus experienced an improvement
      of their tinnitus.

      Randomized, parallel-group, double-blind, placebo-controlled trial over 16 weeks (12 weeks of
      treatment + 4 weeks follow-up) with 10 mg vardenafil BID p.o. in men and women with chronic
      tinnitus.
    


Intervention name(s): Levitra (Vardenafil, BAY38-9456); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up; Placebo BID p.o. for 12 weeks + 4 weeks follow-up
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vardenafil,; Tinnitus
Tamoxifen-MRI Study
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The project is a double blind, randomized, placebo-controlled phase II chemoprevention trial.
      Study participants will be randomly assigned to receive either tamoxifen or placebo for one
      year. Participants will subsequently be followed for one year off of medication. The primary
      objective is to evaluate the effectiveness of tamoxifen in reducing breast density by
      mammogram.
    

Detailed description: 
      The project is a double blind, randomized, placebo-controlled phase II chemoprevention trial.

      The study outcomes will be biological markers, rather than cancer incidence or mortality.
      Eligible study subjects will be women, between the ages 25-45, whose calculated lifetime
      breast cancer risk is > 20% (25% by the Couch model).

      Study participants will be randomly assigned to receive either tamoxifen or placebo for one
      year. Participants will subsequently be followed for one year off of medication.

      The primary objective is to evaluate the effectiveness of tamoxifen in reducing breast
      density by mammogram. Mammographic density has been correlated with breast cancer risk and
      reduced breast density may have the added benefit of improving the sensitivity of breast
      cancer screening in young women. Breast density will be employed as a marker of
      progression-related - proliferative - mechanisms of carcinogenesis.

      Secondary study outcomes will include estrogen ratios (catechol estrogen/estradiol), and
      markers of oxidative DNA damage in peripheral blood and urine (markers of progression-related
      - mutational - events in carcinogenesis). The responsiveness of these outcomes will suggest
      the mechanisms through which tamoxifen exerts its preventive effect. Persistence of the
      markers after one year of treatment may also provide early information about the anticipated
      duration of the tamoxifen effect.
    

Intervention name(s): Tamoxifen
Intervention type(s): Drug
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Tamoxifen; Prevention; Breast Cancer; MRI
Integrin α6-targeted SPECT Imaging of Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A novel radiotracer 99mTc-RWY targeting Integrin α6 was developed, and the pilot
      first-in-human study for SPECT imaging of breast cancer was performed in seven healthy
      volunteers and two breast cancer patients to assess the safety and potential clinical
      applications of 99mTc-RWY.
    

Detailed description: 
      Integrin α6 associates with the survival and migration of breast cancer cells, which emerges
      as a predictor of reduced overall survival and worse prognosis. In this study, we developed
      an integrin α6-targeted radiotracer 99mTc-RWY for SPECT imaging of breast cancer. The safety,
      biodistribution and radiation dosimetry were studied in seven healthy volunteers, and the
      clinical potential of 99mTc-RWY was examined in two breast cancer patients. A single dose of
      11.1 MBq/kg 99mTc-RWY was injected intravenously. Visual and semiquantitative methods were
      used to assess the SPECT/CT images. The routine Hematoxylin-Eosin (HE) staining and
      immunohistochemistry (IHC) staining were subsequently carried out to confirm the Integrin α6
      expression of tumors.
    

Intervention name(s): 99mTc-RWY
Intervention type(s): Drug
Intervention description(s): 99mTc-RWY were injected into volunteers and patients before the SPECT/CT scans .
Other intervention name(s): 99mTc-labeled peptide targeting integrin α6
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Breast cancer; integrin α6; SPECT
Evaluation the Safety and Tolerance of GP681 Tablets in Healthy Subjects
Condition: Influenza
Study type: Interventional
Phase: Phase 1

Summary: 
      Influenza (influenza for short) is an acute respiratory infectious disease caused by
      influenza virus. The symptoms of the disease range from mild, moderate to severe, and severe
      cases require hospitalization and may die. According to estimates by the US Centers for
      Disease Control and Prevention in 2018, influenza causes approximately 290,000 to 640,000
      deaths worldwide each year. Therefore, the prevention and treatment of influenza has become a
      serious public health problem.
    

Detailed description: 
      The GP681 in this test is a prodrug of a polymerase acidic protein (PA, Polymerase Acidic
      protein) inhibitor. Its metabolite GP1707D07 can selectively inhibit the cap-dependent
      endonuclease of influenza virus and prevent influenza virus replication. Mechanism of action
      against influenza virus. The results of previous non-clinical studies show that GP681 can
      effectively inhibit influenza virus replication, has good safety, and has antiviral activity
      1,000 times that of oseltamivir phosphate. It also has good antiviral activity against
      oseltamivir resistant strains. And it is expected to have a longer half-life than oseltamivir
      phosphate. Therefore, it is expected that a new type of PA inhibitor can be developed to
      provide patients with influenza with a new mechanism of action, better efficacy, and higher
      compliance.
    

Intervention name(s): GP681 Tablet
Intervention type(s): Drug
Intervention description(s): Designed as 5 dose groups (20mg, 40mg, 60mg, 80mg, 120mg), the starting dose group (20mg) 8 subjects (including 2 placebo), each other 10 subjects (including Placebo (2 cases), male and female.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: According to the initial dose and maximum dose interval, it is designed as 5 dose groups (20mg, 40mg, 60mg, 80mg, 120mg), the initial dose group (20mg) has 8 subjects (including 2 placebo), and each of the others 10 subjects in the dose group (including 2 placebo), male and female.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Neural Tensioner Exercise on Conditioned Pain Modulation
Condition: Neck Pain; Diffuse Noxious Inhibitory Control
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Background: There is evidence linking conditioned pain modulation (CPM) deficiency with
      musculoskeletal pain syndromes such as fibromyalgia, migraine, tension-type headaches and
      irritable bowel syndrome, as well as with temporomandibular disorders, idiopathic facial pain
      and chronic fatigue syndrome. Evidence shows that in pre-surgical situations of chronic pain
      there is no activation of CPM.

      Objectives: The purpose of this study is to measure the CPM response and determine whether
      neural tensioner exercise in patients with chronic neck pain is effective in the improvement
      of neck pain intensity, neck disability and cervical range of motion.

      Design: Double-blind, randomized placebo clinical trial. Methods: Patients with neck pain
      will be randomly allocated into two groups: the neural tensionner exercise group (NTE) or the
      sham technique (ST) group.

      Individuals will be included in the study if they meet the following inclusion criteria: aged
      18-65 years, neck pain perceived in the posterior region of the cervical spine, from the
      superior nuchal line to the first thoracic spinous process with more than 12 weeks of
      evolution and without radicular symptoms radiated to the head. Neck pain intensity with a
      visual analogue scale (VAS), neck disability index (NDI), CPM, and cervical rang of motion
      will be measured pre and port intervention.
    


Intervention name(s): manual therapy
Intervention type(s): Procedure
Intervention description(s): manual therapy with neural exercise will be applied on patients with neck pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain measurement