bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics of Vildagliptin in Mild, Moderate and Severe Renal Impaired Patients
Condition: Renal Impairment; Diabetes
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal
      impaired patients
    


Intervention name(s): Vildagliptin; Vildagliptin; Vildagliptin; Vildagliptin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Mild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily; Mild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily; Matching healthy volunteers receiving 25 mg vildagliptin once daily.; Matching healthy volunteers receiving 50 mg vildagliptin once daily
Intervention MeSH terms: Vildagliptin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal impairment; Diabetes; vildagliptin; Galvus; Eucreas
A Study to Understand the Effect and Safety of the Study Medicine PF-07817883 in Adults Who Have Symptoms of COVID-19 But Are Not Hospitalized
Condition: SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to understand the effects and safety of PF-07817883 treatment.
      The study wants to know how PF-07817883 treatment lowers the level of the virus that causes
      COVID 19. To understand that samples are collected from adult participants who have the
      symptoms of COVID 19 but are not hospitalized.

      The study is seeking for participants who:

        -  are 18 years of age or older at the time of entering the study.

        -  have a positive rapid antigen test within 48 hours before entering the study. Rapid
           antigen test is a test done to confirm the presence of a specific virus in the body.

        -  have onset of signs or symptoms of COVID-19 within 5 days before entering the study.

        -  have at least 1 of the specified signs or symptoms of COVID-19 present on the day of
           entering the study.

      Around 228 participants with a confirmed case of COVID 19 are planned to be taken into the
      study. Participants will be randomly grouped to receive PF-07817883. Three groups will
      receive 100, 300, 600mg of PF-07817883 and one of the groups will receive placebo (a pill
      that doesn't have any medicines) orally every 12 hours for 5 days.

      The study is going to last up to 5 weeks. This includes the initial period of selecting
      participants, participants receiving the medicine or the placebo and then a 4-week follow-up
      period after giving the participants the last medicine.

      The study team will monitor how each participant is doing with the study treatment during the
      study.
    


Intervention name(s): PF-07817883; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Arm 1: low dose Arm 2: medium dose Arm 3: high dose; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COVID-19; SARS COVID-19
Effect of Gamma Tocopherol Supplementation on Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to learn whether high dose vitamin E (gamma tocopherol)
      will affect the way your body responds to an acute inflammation in your lungs. Vitamin E is
      found in soybean and vegetable oils as well as many plant seeds. Gamma tocopherol (gT), a
      component of vitamin E, composes 70-80% of Vitamin E in the U.S. diet. Alpha tocopherol (aT),
      another large component of vitamin E, makes up less than 10% of vitamin E in the U.S. diet,
      but is the major form in blood and tissue. It is also the major form of Vitamin E in
      over-the-counter supplements. However, gT has anti-inflammatory properties which are not
      present in aT. Preliminary data suggests that gT protects from ozone-induced exacerbation in
      animal studies, and previous studies have shown levels of gT are inversely associated with
      heart disease.

      We will ask you to undergo a challenge with endotoxin, which is a bacterial component of air
      pollution. From other studies we have done, we know that if you inhale 20,000 EUs (endotoxin
      units) we will see an increase in the number of neutrophils (a type of white blood cell that
      your body produces to fight infection) in your lung cells without causing you to have
      flu-like symptoms. We will investigate if there is a change in your lung inflammatory cells
      after the endotoxin challenge when you take the gT versus when you take a placebo.
    


Intervention name(s): gamma tocopherol
Intervention type(s): Drug
Intervention description(s): Maxi Gamma softgels 1200mg QD
Intervention MeSH terms: Tocopherols; Vitamin E; Tocotrienols; alpha-Tocopherol; gamma-Tocopherol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: healthy nonsmoking nonasthmatic volunteers
Investigation of Vascular Relaxing Effects of Candesartan and Pioglitazone.
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The study is designed to test the hypothesis in healthy subjects that candesartan and
      pioglitazone provide additional vascular relaxing or modulating effects in addition to their
      blood-pressure and blood glucose level reducing ability, respectively.
    

Detailed description: 
      The aim of the study is to investigate the effect of oral candesartan and/ or rosiglitazone
      therapy on the vascular responsiveness of different vasoactive compounds (angiotensin II,
      insulin, histamine and glyceroltrinitrate) in healthy subjects. Pioglitazone will be given
      orally (4 weeks 30mg/d, titrated to 45 mg/d for another 4 weeks). Candesartan will be given
      orally (4 weeks 8mg/d, titrated to 16 mg/d for another 4 weeks) as treatment. Every subject
      will receive intravenous stimulation with phenylephrine, angiotensin II, histamine, insulin
      and glyceroltrinitrate before and after an 8 weeks treatment interval with study medication
      or placebo. In addition, pulse wave velocity will me measured non-invasively before and after
      treatment.
    

Intervention name(s): Pioglitazone (drug) and/or candesartan (drug)
Intervention type(s): Drug
Intervention MeSH terms: Pioglitazone; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: vascular reactivity; venodilation; pulse wave velocity
Comparison of Ultrafast Echo With Echotracking
Condition: Essential Untreated Hypertension; Healthy Volunteers
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The aim is to compare a new technique for assessing mechanical properties of large arteries:
      the Ultrafast echo with the reference technique, the echotracking. This will be done by
      studying in parallel hypertensive patients and controls with both techniques and this will
      revisit old concepts of increased stiffness in hypertensive arteries.
    

Detailed description: 
      Ultrafast ECHO is a new non invasive method for assessing stiffness of living tissues. It
      takes advantage of very fast imaging technologies (up to 20 000 images/sec) to measure the
      diffusion of pressure waves in the tissues. This pressure wave can be either natural (blood
      pressure), or generated by an very short ultrasonic impulsion at a given place. By using both
      modes, it is possible to have a precise cartography of tissue mechanical properties. This
      technique is applied to solid tissues such as breast or liver, but not yet currently to
      hollow tissues such as arteries. The aim of the present study is to compare the values of
      stiffness obtained with Ultrafast ECHO with the reference non invasive technique, the
      Echotracking, which measures stiffness by assessing the deformation of arteries in response
      to changes in blood pressure. On the physiological part, we will revisit old concepts of
      increased stiffness of hypertensive's arteries. Indeed, hypertension is associated with
      increased stiffness due to recruitement of collagen fibers, but also to chronic remodelling.
      We have shown before that this remodelling conducts to accumulation of arterial tissue of
      lesser intrinsic stiffness. The latter finding was done through models based on echotracking
      measurements. It will be interesting to see whether it holds true when stiffness is directly
      measured.

      Sixty subjects (30 normotensive and30 hypertensives) will be included and studied once.
      Measurement will be performed in random order 3 time on the common carotid artery on both
      sides. Aortic stiffness will be measured by pulse wave velocity
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting Essential untreated hypertension Healthy Volunteers
      
Keywords: Large arteries; stiffness; intima media thickness; ultrasound imaging
Clinical Study to Evaluate the Sun Protection Factor (SPF) of Three Sunscreen Products
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      The purpose of this study is to determine the static SPF of three sunscreen products
      (ChapStick Active Performance [CAP] UnScented, CAP Herbal Mint Flavour and CAP Mountain Berry
      Flavour) using the methodology described in the Food and Drug Administration (FDA) Final Rule
      (2011).
    

Detailed description: 
      A single-center, randomized, controlled, intra-individual comparison, evaluator-blind,
      clinical study to determine the SPF of three sunscreen lip balms. Each participant will
      evaluate the three test products, an SPF standard and no treatment. Study treatments will be
      randomly assigned to 5 test sites delineated on the skin of the participant's back. Test
      sites will be exposed to doses of ultraviolet (UV) radiation and erythemal response evaluated
      16-24 hours later. Minimal erythema dose (MED) will be determined for protected and
      unprotected sites and used to determine the SPF value of each test product.
    

Intervention name(s): CAP UnScented; CAP Herbal Mint Flavour; CAP Mountain Berry Flavour; SPF Standard Sunscreen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sunscreen lip balm.; Sunscreen lip balm.; Sunscreen lip balm.; SPF Standard (7 percent [%] Padimate-O and 3% Oxybenzone)
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study: Manometry With & Without Lidocaine
Condition: Normal
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether subjects report a difference in comfort
      with High Resolution Pharyngeal Manometry (HRPM) conducted following application of lidocaine
      as an anesthetic as compared to HRPM conducted without anesthetic.
    

Detailed description: 
      High resolution pharyngeal manometry (HRPM) is used for assessing swallowing pressure along
      the length of the pharynx and upper esophageal sphincter. Pressure measurements in the region
      of the velopharynx, tongue base, and upper esophageal sphincter are obtained by passing a
      catheter with pressure sensors through the patient's nose and past the upper esophageal
      sphincter. Patients are presented various volumes of liquid to swallow and potentially asked
      to perform postural strategies such as a head turn or chin tuck during swallowing while the
      catheter is in place. Clinically, approximately 90% of patients report various discomfort
      associated with the procedure. Discomfort can result in patient refusal to participate or an
      inaccurate picture of a patient's swallowing pressures. Conversely, use of anesthesia can
      potentially alter swallowing physiology.

      Recent studies have studied the effects of lidocaine on penetration/aspiration and subject
      discomfort during flexible endoscopic evaluations, yet findings are inconclusive or
      contradictive. Investigators aim to determine whether subjects report a difference in comfort
      with HRPM conducted following application of lidocaine as an anesthetic as compared to HRPM
      conducted without anesthetic.
    

Intervention name(s): 4% Lidocaine Spray; 2% Viscous Lidocaine
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 2% Viscous Lidocaine is applied to the nares as standard of care. In this intervention, 4% lidocaine spray is applied additionally.; 2% Viscous Lidocaine is applied to the nares as standard of care. This intervention is considered as the control group.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: During both the anesthetized and non-anesthetized conditions as per standard of care, the study team member will apply 1 mL of 2% viscous lidocaine to each nares prior to the passage of the catheter. During only the anesthetized condition, subjects will receive up to .8 ml of a 4% Lidocaine spray to both nares.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Manometry; Lidocaine; Pharyngeal; High Resolution Pharyngeal Manometry (HRPM); Pressure
A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT
Condition: Leukemia
MeSH terms: Leukemia
Study type: Interventional
Phase: Phase 1

Summary: 
      20010133 is an open-label, dose escalation study in pediatric patients with acute leukemias
      receiving myelotoxic therapy (high dose etoposide, cyclophosphamide and total body
      irradiation [TBI]) followed by hematopoietic stem cell transplant (HSCT). The study will
      evaluate the safety and pharmacokinetics of palifermin in pediatric patients. Three doses (40
      μg/kg/day, 60 μg/kg/day, and 80 μg/kg/day) are to be evaluated in each age group (1 to 2, 3
      to 11, and 12 to 16 years, respectively) using a conventional dose escalation design.
      Palifermin is administered for 3 consecutive days (Day -10 to Day -8, respectively) before
      the start of the conditioning regimen and for 3 consecutive days (Day 0 to Day +2) following
      HSCT. Patients will be enrolled simultaneously to each age group to identify a safe, well
      tolerated, efficacious dose in each age group. Patients will also be followed for secondary
      malignancies, progression-free survival (PFS) and overall survival (OS)
    


Intervention name(s): Palifermin; Total Body irradiation; Chemotherapy
Intervention type(s): Drug; Radiation; Drug
Intervention description(s): Palifermin will be administered as an IV bolus injection (40, 60 or 80 µg/kg/day)once daily for 3 consecutive days before the start of conditioning regimen and after HCST (Day -10, -9, -8 and Day 0, +1, +2 respectively).; High dose etoposide, Cyclophosphamide
Other intervention name(s): Kepivance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Oral Mucositis; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Palifermin; Kepivance
Evaluation of Esthetic Performance of Resin Infiltration Technique on Enamel Lesions
Condition: Tooth Demineralization
MeSH terms: Tooth Demineralization
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the esthetic performance of resin infiltration
      technique on superficial hypo-mineralized and demineralized enamel lesions of anterior teeth
    

Detailed description: 
      The teeth that meet the inclusion criteria will be cleaned from debris and clinical
      intra-oral photos of the lesions will be taken before and after the treatment. Resin
      infiltration technique will be performed according to manufacturer's instructions under
      rubber-dam isolation. Intra-oral photos will be taken directly after infiltration (1 day),
      and 1 week and 6 months later.

      The system of the Commission Internationale de l'Eclairage (CIE) involving 3 color
      parameters: lightness (L), red/ green chromaticity (a), and yellow/blue chromaticity (b),
      will be used to assess the extent and durability of color and lightness changes between
      lesion and sound enamel areas before and after resin infiltration. The extent of assimilation
      and durability of effect will be assessed by comparing CIE L*a*b data collected before
      infiltration (baseline), directly after infiltration (1 day), and 1 week and 6 months later.

      The color assessments were standardized using a spectrophotometer (SpectroShade, Italy).
      Lesion areas will be measured for each time point by using an image analysis toolkit (ImageJ,
      National Institutes of Health, Bethesda, Md.).

      Multifactorial analysis of variance with repeated measures will be used for statistical
      analyses.
    

Intervention name(s): Resin infiltrate
Intervention type(s): Device
Intervention description(s): A resin that used for micro-invasive treatment of enamel-restricted, non-cavitated caries or hypo/demineralized smooth enamel surfaces.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: image analysis
Determine the Effects of Gene Differences and Voriconazole on Enzyme CYP2B6 Activity in the Liver in Healthy Volunteers
Condition: Efavirenz, Metabolism and Pharmacokinetics Changes
Study type: Interventional

Summary: 
      The purpose of this study is to see if administration of medicines and genetic differences
      affects the activity of a liver enzyme called CYP2B6 in healthy volunteers.
    

Detailed description: 
      The investigators will test the hypothesis that CYP2B6 genetic variants that show effects in
      vitro also influence the in vivo activity of CYP2B6 and its responsiveness to metabolic
      inhibition, using the metabolism of efavirenz (100 mg dose) as a marker of activity. The
      metabolism and pharmacokinetics of efavirenz will be determined in a total of 60 healthy
      volunteers with CYP2B6*1/*1, CYP2B6*1*6 and CYP2B6*6*6 at baseline (control) and after
      pretreatment with voriconazole.
    

Intervention name(s): Efavirenz; voriconazole
Intervention type(s): Drug; Drug
Intervention description(s): In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered.
In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily.; In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered.
In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily.
Other intervention name(s): Sustiva; Vfend
Intervention MeSH terms: Efavirenz; Voriconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Cytochrome P450; CYP2B6; Voriconazole; Efavirenz; Pharmacokinetics; Drug-Interactions; Pharmacogenetics; Healthy volunteers
Efficacy and Tolerability of LAS41004 Formulations in a Non-occlusive Psoriasis Plaque Test
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the exploratory study is to compare dose related effects of LAS41004 formulations
      in a non-occlusive PPT.
    

Detailed description: 
      Going for a non-occlusive application design will allow to draw practical conclusions as
      being similar to a real treatment situation (compared with a occluded design to maximise
      effects)
    

Intervention name(s): LAS41004
Intervention type(s): Drug
Intervention description(s): once daily, topical ointment, 100 microgram per day
Other intervention name(s): fixed combinations of retinoid and steroid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis Plaque Test; topical; ointment
An Efficacy and Safety Study of Miconazole and Hydrocortisone Cream in the Treatment of Vulvar Candidiasis
Condition: Vulva; Candidiasis
MeSH terms: Candidiasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of miconazole plus
      hydrocortisone cream in the treatment of participants with vulvar candidiasis (yeast
      infection of the vulva).
    

Detailed description: 
      This is an open label (all people know the identity of the intervention), single-arm,
      prospective (study following participants forward in time) study to evaluate the efficacy and
      safety of miconazole plus hydrocortisone cream in participants with vulvar candidiasis.
      Participants will be evaluated and assessed on the degree of pruritus (itchiness) and
      screened for candidiasis on the baseline. Participants will apply the cream once enrolled and
      will be assessed for 1-hour to get the time to relief. Each participant will apply the study
      medication topically (applied to skin) to the lesion twice daily up to Day 14 by rubbing
      gently until it has been completely penetrated into the vulvar area affected and the
      treatment should be continued without interruption. Participants will be followed-up after 14
      days and will be assessed clinically for signs and symptoms of vulvar candidiasis; if not
      cured, participants will continue the medication up to Day 28. Primary efficacy endpoint will
      be the time needed to achieve pruritus relief. Participants' safety will be monitored
      throughout the study.
    

Intervention name(s): Miconazole plus Hydrocortisone
Intervention type(s): Drug
Intervention description(s): Participants will apply miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14 by rubbing gently until it has been completely penetrated into the affected vulvar (the tissues around the opening to the vagina) area and the treatment should be continued without interruption. Participants will be assessed for signs and symptoms of vulvar candidiasis at Day 14. Medication will be continued till Day 28, if signs and symptoms of vulvar candidiasis are not cured clinically on Day 14.
Intervention MeSH terms: Miconazole; Hydrocortisone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vulvar Candidiasis; Miconazole; Hydrocortisone; Daktacort Feminine Care Cream