bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess Safety and Efficacy of Oral Senicapoc Administration on Exercise-induced Asthma
Condition: Exercise Induced Asthma
MeSH terms: Asthma; Asthma, Exercise-Induced
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether 4 weeks of dosing with senicapoc alleviates
      exercise induced asthma symptoms.
    

Detailed description: 
      Based on the unmet medical need for new agents in the treatment of asthma and the role of
      KCa3.1 in the function of several different cell types involved in the inflammatory response,
      and the effects seen in an animal model of allergic asthma, it is reasonable to explore the
      utility of senicapoc, a KCa3.1 blocker, as a novel treatment of asthma. This study will test
      the ability of senicapoc to alleviate bronchospasm induced by an exercise challenge in
      subjects with asthma. Exercise challenge studies have been conducted for many currently
      approved asthma medications. Exercise challenge studies provide a controlled environment and
      test conditions to investigate the potential usefulness of novel study drugs for the
      treatment of asthma. This study will be the first to test the ability of senicapoc to reduce
      airway bronchospasm after exercise challenge, which is one clinically important manifestation
      of asthma seen in patients. In summary, with a demonstrated safety profile across a wide
      range of doses in humans and efficacy in an animal model of allergic bronchospasm and
      hyper-responsiveness, the initiation of exploratory studies of senicapoc for treatment of
      asthma is justified.
    

Intervention name(s): senicapoc; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Loading Dose: 80 mg twice daily x 3 days Maintenance Dose: 40 mg daily for remainder of the treatment period (total 4 weeks); Placebo looks identical to active study medication and will be dosed according to the same dosing regimen
Other intervention name(s): ICA-17043
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bronchospasm; exercise asthma; inflammation; KCa3.1
Comparison of Fluid Resuscitation in Pediatric Burn Patients Using Crystalloids and With Albumin on Day Two.
Condition: Burns
MeSH terms: Burns
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goal of this comparative, interventional randomized controlled trial is to use albumin
      during resuscitation in pediatric burn patients on day 2, as it can reduce extravasation of
      fluids and decrease the overall fluid requirements, along with mortality and maintain
      circulation.

      Participants will be divided into 2 groups. Albumin will be administered additionally in
      group A, while only crystalloids will be used for resuscitation in group B.
    

Detailed description: 
      The randomized controlled trial will be done at Department of Pediatric Surgery, Mayo
      Hospital Lahore from January 2022 to December 2022. Ninety patients (forty-five patients in
      each group) will be enrolled using a non probability convenient sampling technique. Patients
      will be randomly divided into 2 groups. Albumin solution will be administered in group A and
      in group B only routine crystalloids will be given. Basic demographic information will be
      noted. Effect modifiers (hemoglobin, Albumin level, weight and height) will be noted.

      Group A: After first 24 hours, maintenance fluid, N/2+5%Dextrose solution will be started
      according to weight(100ml/kg/day for first 10kg, 50ml/kg/day for next 10kg and 20ml/kg/day
      for the remainder) and will be increased or decreased by 1/3 to maintain the urinary output
      to 1-1.5ml/kg/hour. 12, 75 5% Albumin solution will be administered @0.5ml/kg/%burn over
      initial 8 hours of day 2 and It's amount will be subtracted from the 24 hours fluid
      calculated earlier.

      Group B: After first 24 hours, maintenance fluid, N/2+5%Dextrose solution will be started
      according to weight (100ml/kg/day for first 10kg, 50ml/kg/day for next 10kg and 20ml/kg/day
      for the remainder) and will be increased or decreased by 1/3 to maintain the urinary output
      to 1-1.5ml/kg/hour.
    

Intervention name(s): 5% Albumin (human) Solution; Paeds solution
Intervention type(s): Biological; Drug
Intervention description(s): Albumin is a biological product derived from human blood donors.; Paeds solution contains dextrose 4.3%, and Sodium Chloride 0.18%
Other intervention name(s): ALBURX® 5; Revasol-Paeds IV Infusion
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Albumin; Resuscitation; Pediatric Burns; Fluid creep; Shock; Crystalloids
Laser-assisted Hyaluronic Acid Delivery by Fractional CO2 Laser in Facial Skin Remodeling
Condition: Facial Skin Remodeling
MeSH terms: Facies
Study type: Interventional

Summary: 
      The main endpoint will be to evaluate the efficacy of laser-assisted hyaluronic acid delivery
      by fractional CO2 laser in facial skin remodeling. The secondary endpoint will be to confirm
      the safety of this protocol compared to a standard treatment by fractional CO2 laser.
    

Detailed description: 
      Fractional CO2 lasers are already used in skin remodeling. They can also create vertical
      channels to enhance topical drug delivery deep into the dermis. Combining the efficacy of
      fractional CO2 laser to laser-assisted hyaluronic acid delivery has not yet being studied,
      the combination of these two techniques could improve facial skin remodeling.

      The main endpoint will be to evaluate the efficacy of laser-assisted hyaluronic acid delivery
      by fractional CO2 laser in facial skin remodeling. The secondary endpoint will be to confirm
      the safety of this protocol compared to a standard treatment by fractional CO2 laser.
    

Intervention name(s): Laser-assisted hyaluronic acid delivery
Intervention type(s): Other
Intervention description(s): The facial skin remodeling corresponds to a request for repair treatment on the stigmas of heliodermia, irregularity of cutaneous texture, dyschromias, loss of radiance of the complexion, fine lines, as well as on the fine scars of the face for example, the finely depressed cicatrices sequellaires acne.
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Intranasal Esketamine and Its Effects on the Pharmacokinetics of Orally-Administered Midazolam and Bupropion in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the induction potential of repeated
      administration of intranasal esketamine on cytochrome P450 (CYP) 3A4 and CYP2B6 activity in
      healthy participants using orally administered midazolam and bupropion as probes,
      respectively and to evaluate the pharmacokinetics of esketamine after a single dose and
      repeated administration.
    

Detailed description: 
      This is a parallel group, single-center, repeat-dose, fixed-sequence, open-label (all people
      know the identity of the intervention), study. The effects of repeated administration of
      intranasal esketamine on the pharmacokinetics of midazolam and bupropion will be evaluated in
      Cohort 1 and Cohort 2, respectively. Participants in Cohort 1 will receive a single oral dose
      of midazolam in the morning of Day 1 and Day 17. Participants in Cohort 2 will receive a
      single oral dose of bupropion in the morning of Day 1 and Day 19. In Cohort 1 and 2
      participants will self-administer 5 doses of intranasal esketamine over a 15-day period. The
      duration of study, from the Screening Phase through Follow-up, is up to 51 days and 54 days
      for Cohort 1 and Cohort 2, respectively. Blood samples for participants in Cohort 1 will be
      collected for up to 24 hours after dosing on Days 1 and 17 (midazolam) and for up to 24 hours
      on Days 2 and 16 (esketamine); For participants in Cohort 2, blood and urine samples for
      assessment of bupropion pharmacokinetics will be collected for up to 72 hours after dosing on
      Day 1 and Day 19. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Midazolam; Esketamine; Bupropion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose of midazolam 6 mg Day 1 and Day 17.; Intranasal esketamine will be self-administered 5 times during 15 days.; Single oral dose of bupropion 150 mg on Day 1 and 19.
Other intervention name(s): JNJ-54135419
Intervention MeSH terms: Midazolam; Bupropion; Esketamine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Pharmacokinetics; Esketamine; JNJ-54135419; Midazolam; Bupropion
Assessment of Safety & Efficacy of Light Weight Breast Implant
Condition: Breast Implants
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate safety and effectiveness of Light Weight Breast
      Implant (LWBI) in breast augmentation.
    

Detailed description: 
      This is a Single-center. The purpose of the study is to evaluate safety and effectiveness of
      LWBI in breast augmentation.
    

Intervention name(s): Light Weight Breast Implants
Intervention type(s): Device
Intervention description(s): Light Weight Breast Implants
Intervention model: Single Group Assignment
Masking: None (Open Label)
Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Drug drug interaction study between PF-05221304 and PF-06865571
    

Detailed description: 
      A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The
      Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult
      Subjects
    

Intervention name(s): PF-06865571 administered Day 7-14; PF-06865571 administered Day 1-14; PF-05221304 administered Day 1-14; PF-05221304 administered Day 7-14
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PF-06865571 administered Q12hr on Days 7-14; PF-06865571 administered Q12hr on Day 7-14; PF-05221304 administered Q12hr on Days 1-14; PF-05221304 administered Q12hr Days 7-14
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of tDCS on Anaerobic Power of Lower Limb Muscles
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Anaerobic power and capacity are essential in many human activities, especially during sports
      practice that demand a high strength and power of the limbs. Transcranial direct current
      stimulation is a noninvasive technique that can modulate motor brain areas involved in motor
      functions and has the potential to optimize muscle capacity. However, their effects on
      mechanical power are lacking.

      This study aims to investigate the effects of transcranial direct current stimulation (tDCS)
      on mechanical power in healthy subjects.
    

Detailed description: 
      In this study, a randomized, crossover, double-blind, placebo-controlled experimental design
      will be used. The 50 participants will be randomized into two groups: (1) Anodal tDCS(real)
      and (2) Sham tDCS. A single session of anodal and sham tDCS will be performed on each task
      (pre and post-jump test).

      All evaluations will be performed by a single researcher who, like the participants, will not
      know which stimulation group will be participating. Subjects who agree to the conditions and
      sign the consent form may participate in the study. Participants who meet the eligibility
      criteria will be included in the study.
    

Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various health conditions. However, its ergogenic effect still has controversial results.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine in detail the acute and chronic effects of
      pitavastatin on plasma lipid transport and atheroma biomarkers in patients at elevated risk
      for the premature development of atherosclerosis (CAPITAIN).
    


Intervention name(s): Pitavastatin
Intervention type(s): Drug
Intervention MeSH terms: Pitavastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment
Condition: Brain Neoplasms
MeSH terms: Neoplasm Metastasis; Brain Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE

        -  Fractionated radiotherapy uses high-energy photons to kill, or damage tumor cells. High
           daily dose temozolomide combined with fractionated radiotherapy may make tumor cells
           more sensible to treatment.

      PURPOSE

        -  This randomized phase II trial, assess in patients with brain metastases from solid
           tumors, whether the whole brain radiotherapy (WBRT) plus temozolomide is able to improve
           the results obtained with WBRT.
    

Detailed description: 
      Primary Outcome Measures

        -  Objective Response Rates

      Secondary Outcome Measures

        -  Survival Free of Brain Metastases progression

        -  Overall Survival

        -  Systemic Side effects

      Objectives

      Primary

        -  Compare objective response rates in both arms of treatment

      Secondary

        -  Compare survival free of progression in both arms of treatment

        -  Compare Overall Survival in both arms of treatment

        -  Compare side effects
    

Intervention name(s): Temozolomide; Whole brain irradiation
Intervention type(s): Drug; Radiation
Other intervention name(s): Temodar; or; Temodal; Whole brain radiotherapy
Intervention MeSH terms: Temozolomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain metastases; Temozolomide; Whole-brain radiotherapy; Phase II trial
Blood Markers in Adult Patients With Sudden Sensorineural Hearing Loss (SSNHL)
Condition: Idiopathic SSNHL; Age Over 18
MeSH terms: Hearing Loss
Study type: Observational [Patient Registry]

Summary: 
      The roles of thrombophilia and cardiovascular risk factors in sudden sensorineural hearing
      loss (SSNHL) remain controversial. Cochlear micro-thrombosis has been hypothesized as a
      possible pathogenic mechanism of SSNHL. The objective was thus to measure the levels of
      markers of macrovascular thrombosis and microvascular risk factors
    

Detailed description: 
      To recruit adult consecutive outpatients referred for SSNHL to the otolaryngologist clinic of
      our university hospital starting June 2016 and prospectively until december 31th 2018.

      Plasma sampling and biomarkers quantification : After a 48-hours diet excluding serotonin-
      and tryptophan-rich food, fasting blood samples were collected into vacuum tubes containing
      109 mM sodium citrate (Becton-Dickinson, Le Pont de Claix, France) with a 9:1
      blood-to-anticoagulant ratio. After removing 0.5 mL of whole blood for serotonin
      measurements, the remainder was centrifuged at 1,000 x g for 10 minutes, and the supernatant
      was then centrifuged at 3,000 x g for 15 minutes to isolate platelets and obtain
      platelet-poor plasma. Importantly, the time between blood sampling and platelet/plasma
      isolation was less than one hour. Aliquots of whole blood, platelets, and plasma were kept
      frozen (-20°C) until serotonin and homocysteine measurements performed within one week after
      congelation. Whole blood, platelet and plasma 5-HT as well as plasma homocysteine (Hcy)
      levels were measured by high pressure liquid chromatography coupled to fluorimetric
      detections .

      Thrombophilia screening included measurements of antithrombin , protein C, protein S, factor
      V Leiden, prothrombin G20210A, methylene tetrahydrofolate reductase (MTHFR) C677T,
      antiphospholipid antibodies anticardiolipin IgG and IgM and anti-beta2 glycoprotein 1 IgG),
      dilute Russell viper venom time , Rosner index, factor VIII, von Willebrand factor (vWF)
      activity and antigen. Tests were performed on citrated plasma, serum or DNA as appropriate
      and as previously described
    

Intervention name(s): microvascular markers
Intervention type(s): Diagnostic Test
Intervention description(s): follow up of microvascular biomarkers during patient follow up
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        unrelated adult consecutive outpatients referred for SSNHL to the otolaryngologist clinic
        of our university hospital
      
Biospecimen description: 
      venous peripheral blood
    
Keywords: sudden hearing loss,; SSNHL; serotonin; homocystein; antiphospholipid syndrom; thrombophilia
Characterization of Myocardial Blood Flow During Heat Exposure
Condition: Hot Weather; Adverse Effect; Healthy; Coronary Artery Disease; Aging
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine the increase in myocardial blood flow during heat
      exposure and how this response is affected by age and coronary artery disease.
    

Detailed description: 
      As a result of climate change, heat waves are more frequent and of longer duration. These
      heat waves are associated with a higher risk of hospitalization and mortality in vulnerable
      populations such as people with cardiovascular disease or cardiovascular risk factors. It has
      been hypothesized that this observation may be explained by the cardiovascular demands
      imposed by heat exposure.

      Heat exposure requires increased cardiac work that may place individuals with cardiovascular
      disease at risk of ischemic events if the metabolic demand is not compensated by adequate
      blood supply. However, the extent to which cardiac work increases during heat exposure
      remains unknown. The aim of this study is to test the hypothesis that heat exposure increases
      myocardial blood flow and that this increase is affected by age and coronary artery disease.
    

Intervention name(s): Heat exposure
Intervention type(s): Other
Intervention description(s): Participants will be exposed to heat exposure via a water-perfused suit to increase internal body temperature by 1.5 degrees Celsius.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Heat; PET imaging; Myocardial blood flow
4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare change in fractional calcium absorption following administration of MK0217A
      relative to matching placebo, in postmenopausal women with osteoporosis
    

Detailed description: 
      Placebo will be administered over a 4 week, single-blind run-in phase. Calcium, as
      citrate-malate, will be administered throughout the study at an individualized dose
      supplementing the patient's daily dietary calcium intake to a total of approximately 1200 mg.
      At the end of the stabilization period, baseline calcium absorption will be determined and
      patients will be randomized to receive either MK0217A, or matching placebo once weekly for 4
      weeks.
    

Intervention name(s): alendronate sodium (+) cholecalciferol; Comparator: Placebo (unspecified)
Intervention type(s): Drug; Drug
Intervention description(s): MK0217A, a tablet containing alendronate 70-mg and vitamin D3 2800 IU, once weekly for 4 weeks. All patients will be instructed to take the tablet fasting upon arising for the day with 6 to 8 oz. of plain water (i.e., tap), wait at least one-half hour while continuing to fast and before the first food, beverage (except water), or other medication. All patients must eat before lying down.; MK0217A, Pbo tablet, once weekly for 4 weeks. All patients will be instructed to take the tablet fasting upon arising for the day with 6 to 8 oz. of plain water (i.e., tap), wait at least one-half hour while continuing to fast and before the first food, beverage (except water), or other medication. All patients must eat before lying down.
Other intervention name(s): MK0217A
Intervention MeSH terms: Cholecalciferol; Vitamin D; Alendronate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Serum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab
Condition: Infant, Premature, Diseases
MeSH terms: Retinopathy of Prematurity; Infant, Premature, Diseases
Study type: Interventional

Summary: 
      To determine the serum concentrations of ranibizumab and vascular endothelial growth factor
      (VEGF) in infants with retinopathy of prematurity (ROP) who received intravitreal ranibizumab
    

Detailed description: 
      Infants with ROP are studied. They received 0.25 mg or 0.5 mg of intravitreal ranibizumab to
      either 1 eye (unilateral cases) or both eyes (bilateral cases) with vascularly active ROP.
      Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal
      ranibizumab. The serum concentrations of ranibizumab and VEGF are measured by enzyme-linked
      immunosorbent assay, and the changes of the serum VEGF levels are determined.
    

Intervention name(s): intravitreal ranibizumab
Intervention type(s): Drug
Intervention description(s): 0.25 mg intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases)
Other intervention name(s): lucentis
Intervention MeSH terms: Ranibizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: retinopathy of prematurity; ranibizumab; vascular endothelial growth factor
Bioequivalence Study of Telmisartan/Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to demonstrate the bioequivalence of 40 mg telmisartan / 5 mg amlodipine fixed dose
      combination vs. its monocomponents
    


Intervention name(s): Telmisartan/Amlodipine; Telmisartan; Amlodipine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fixed dose combination tablet
Other intervention name(s): Micardis®; Norvasc®
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment