bioihbjkbjnl/mcl2 huggingface dataset:
On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.
Condition: Barrett Esophagus; Proton Pump Inhibitor; Symptom; Reflux
MeSH terms: Barrett Esophagus
Study type: Interventional

Summary: 
      On-demand PPI therapy is feasible for the long-term treatment of patients with Barrett's
      esophagus.
    

Detailed description: 
      Consecutive patients with symptomatic Barrett's esophagus are recruited and receive biopsy
      for esophageal metaplastic mucosa and gastric mucosa over the antrum and body during
      endoscopy on enrollment. The biopsy protocol for esophageal metaplastic mucosa is following
      Seattle protocol. GERD Q score will be conducted on enrollment. Additionally, blood sampling
      for CYP2C19 genotyping is also conducted on enrollment. The eligible subjects will be treated
      by 8-week esomeprazole, and are then randomly assigned to receive either maintenance or
      on-demand esomeprazole therapy (40 mg q.d.) for 40 weeks. The patients were asked to come
      back every four weeks for the recording of symptom days and PPI tablet consumption numbers.
      Follow-up endoscopy with biopsy for esophageal and gastric mucosa is performed at the end of
      the 48th weeks. We will compare the effects of maintenance and on-demand PPI therapy on (1)
      histological changes of esophageal metaplastic mucosa (2) symptom control (3) tablet
      consumption number
    

Intervention name(s): Esomeprazole 40mg; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): On-demand Esomeprazole 40 mg QD; Continuous Esomeprazole 40 mg QD
Other intervention name(s): nexium 40 mg; nexium 40 mg
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized-controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Barrett's Esophagus; Erosive esophagitis; Proton pump inhibitor; On-demand therapy; Continuous therapy
Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia
Condition: Androgenic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetics/
      Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects with Androgenic Alopecia.
    


Intervention name(s): DA-4001 H; DA-4001 L
Intervention type(s): Drug; Drug
Intervention description(s): 5% minoxidil / high dose of finasteride; 5% minoxidil / low dose of finasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Compare the pharmacokinetic profiles when the contents are emptied into a soft food and
      orange juice compared to the SPD489 when swallowed as an intact capsule.
    


Intervention name(s): Lisdexamfetamine Dimesylate
Intervention type(s): Drug
Intervention description(s): Single dose of a 70 mg capsule on Day 1
Other intervention name(s): SPD489
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Effectiveness of the Calhoun Vision Light Adjustable Intraocular Lens (LAL)
Condition: Cataracts
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate, for the visual correction of aphakia, the
      safety and effectiveness of the Calhoun Vision Light Adjustable intraocular lens (LAL) and
      Light Delivery Device (LDD) in treating postoperative residual refractive error by providing
      a stable, targeted refractive adjustment of the LAL power and lock-in treatments with the
      LDD.
    


Intervention name(s): Lens implantation +1.00 D postop target; Lens implantation -1.00 D postop target; Lens implantation 0.00 D postop target
Intervention type(s): Device; Device; Device
Intervention description(s): Lens implantation +1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.; Lens implantation -1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.; Lens implantation 0.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
Other intervention name(s): Light Delivery Device; Light Delivery Device; Light Delivery Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 2 medical device study
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Effects of Itraconazole and Rifampin on Lazertinib in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of multiple doses of strong cytochrome
      P450 (CYP) 3A4 inhibitor itraconazole and strong CYP3A4 inducer rifampin on the single dose
      pharmacokinetics (PK) of lazertinib in healthy adult participants.
    


Intervention name(s): Lazertinib; Itraconazole; Rifampin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lazertinib tablets will be administered orally.; Itraconazole capsules will be administered orally.; Rifampin capsules will be administered orally.
Other intervention name(s): JNJ-73841937; YH25448
Intervention MeSH terms: Itraconazole; Rifampin; Lazertinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effects AZD8529 on Ketamine-induced Impairment of Working Memory in Healthy Volunteers
Condition: Healthy; Memory Impairment
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to assess if ketamine will induce, in healthy volunteers,
      impairment of working memory and if the drug AZD8529 will block the effects of ketamine on
      working memory as assessed by functional magnetic resonance imaging (fMRI).
    


Intervention name(s): AZD8529; Placebo to match AZD8529
Intervention type(s): Drug; Drug
Intervention description(s): 6 capsules by mouth 1 time 12 to 24 prior to assessments; 6 capsules by mouth 1 time 12 to 24 hours prior to assessments
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy normal volunteers
Cyanoacrylate and Laser and Dentin Sensitivity
Condition: Dentin Hypersensitivity; Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      This study aimed to evaluate the effectiveness of two treatments for dental hypersensitivity:
      cyanoacrylate (Super Bonder®) compared with use of low intensity laser treatment (LILT). As
      the cyanoacrylate is a lower cost treatment, the hypothesis in investigation is if this
      product is equally effective as the laser treatment.
    

Detailed description: 
      The present study included 62 patients (15 male and 47 females, aged 12 to 60 years). The
      initial cervical dentin hypersensitivity was checked throughout a thermal test (air blast).
      The 434 teeth included were that with a score ≥5 in a numerical scale rating of pain. Teeth
      were randomly assigned according quadrants (split mouth design) - 216 were allocated to LILT
      group and 218 for the Super Bonder® group. Thermal tests with a tetrafluoroethane spray
      (Endo-Ice®) and air blast were performed and considered as baseline. Pain parameters were
      recorded using a numerical scale rating with 24 hours, 30, 90 and 180 days after the
      interventions. Quality of life of the patients was also assessed with the use of OHIP-14 at
      baseline and after 180 days.
    

Intervention name(s): Cyanoacrylate; Laser
Intervention type(s): Other; Radiation
Intervention description(s): 3 applications of cyanoacrylate (48 hours interval) at the cervical region of the sensitive tooth; This process was conducted three times with an interval of 48 hours between applications, according to laser's manufacturer advice Clean Line Easy Laser - LILT®, Clean Line Easy Laser Doctor Dental Products Industry LTDA, BRA). For dentin hypersensitivity, the application of 1Joule/cm^2 is recommended for eight seconds at three points along the dental neck, using the infrared wavelength (795nm).
Other intervention name(s): Superbonder; LILT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dentin hypersensitivity; cyanoacrylate; laser
Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation
Condition: Primary Renal Transplant
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Campath-1H induction therapy and the
      associated lymphocyte depletion will permit long-term, rejection free renal allograft
      function in the absence of maintenance calcineurin inhibitor (CI) therapy.
    


Intervention name(s): Calcineurin inhibitor withdrawal
Intervention type(s): Drug
Intervention description(s): stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
Intervention MeSH terms: Calcineurin Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Timing of Intrauterine Insemination (IUI) 24 or 48 Hours After Spontaneous Luteinizing Hormone (LH) Peak
Condition: Pregnancy
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present study is to prospectively evaluate whether performing an intra-uterine
      insemination 24 hours after the spontaneous LH peak may result in significantly higher
      ongoing pregnancy rates compared to 48 hours.
    


Intervention name(s): intra-uterine insemination
Intervention type(s): Procedure
Intervention description(s): Artificial insemination is the process by which sperm is placed into the reproductive tract of a female for the purpose of impregnating the female by using means other than sexual intercourse or natural insemination.
Other intervention name(s): no other interventions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: insemination; donor sperm; natural cycle
Interscalene Block Versus Supraclavicular Block for Shoulder Surgery
Condition: Pain, Postoperative; Shoulder Pain; Surgical Procedure, Unspecified; Diaphragmatic Paralysis
MeSH terms: Shoulder Pain; Respiratory Paralysis; Paralysis; Pain, Postoperative
Study type: Interventional

Summary: 
      Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder
      surgery. However it is associated with a high incidence of hemidiaphragmatic paralysis (HDP)
      that may not be tolerated by patients with chronic pulmonary disease.

      This randomized controlled trial will compare ultrasound-guided interscalene block (ISB) and
      supraclavicular block in patients undergoing arthroscopic shoulder surgery.

      The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit
      (PACU) as measured by a numerical rate scale (NRS) from 0 to 10.

      Our research hypothesis is that interscalene and supraclavicular blocks will result in
      equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set
      at 2 points
    


Intervention name(s): Interscalene block; Supraclavicular block
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound guided brachial plexus block injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in the interscalene groove, under the prevertebral fascia.; Ultrasound guided brachial plexus injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL (3 mL in the "corner pocket" followed by 17 mL posterolateral to the brachial plexus).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, crossover study in healthy adult subjects with 5 treatment
      groups over 5 dosing periods. This study will evaluate pharmacokinetic parameters and
      relative bioavailability of a dispersible, fixed-dose combination (FDC) tablet of TRIUMEQ™
      ([abacavir, ABC]/[dolutegravir, DTG]/[lamivudine, 3TC]) when dispersed and consumed under
      four different dosing conditions in comparison to an oral dose of TIVICAY™ (DTG) + EPZICOM™
      (ABC/3TC) non-dispersible tablets administered in the fasted state. Approximately 20 subjects
      will be randomized, each to one of 5 treatment groups. The total duration of participation of
      a subject in this study will be approximately 10-11 weeks. It will include a screening visit
      within 30 days prior to the first dose of study drug, five treatment periods each with a
      single dose of study drug per treatment period and a follow up visit within 7 10 days after
      the last dose. There will also be a washout of at least 7 days between doses in each
      treatment period. TRIUMEQ, EPZICOM, and TIVICAY are trademarks of the GlaxoSmithKline group
      of companies.
    


Intervention name(s): DTG/ABC/3TC FDC DISPERSIBLE TABLET; EPZICOM (ABC/3TC); TIVICAY (DTG)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DTG/ABC/3TC FDC dispersible tablet; EPZICOM will be available as orange, film coated, modified capsule shaped tablets, debossed with "GS FC2" on one side.; TIVICAY will be available as white, round, biconvex tablets
Intervention MeSH terms: Lamivudine; Dolutegravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dolutegravir; abacavir; relative bioavailability; palatability; GSK2619619; palatability questionnaire; lamivudine; pediatric; calcium; dispersible tablet
Randomized Study to Compare the Bioavailability of Three Halobetasol Propionate 0.05% Topical Creams
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study was to compare the relative vasoconstrictive effects of two test
      and one reference Halobetasol Propionate 0.05% Cream in healthy, female subjects.
    


Intervention name(s): Halobetasol Propionate 0.05% Cream-Reference Product; Halobetasol Propionate 0.05% Cream-Test product 1; Halobetasol Propionate 0.05% Cream-Test Product 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Small amount applied and evaluated over the course of three days; Small amount applied and evaluated over the course of three days; Small amount applied and evaluated over the course of three days
Intervention MeSH terms: Clobetasol; Halobetasol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Community Volunteers
      
Keywords: Bioequivalence; Halobetasol Propionate
Oral β-Alanine Supplementation in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Preliminary evidence suggest that patients with chronic obstructive pulmonary disease (COPD)
      suffer from lower-limb muscle dysfunction. This may, at least in part, be due to a
      combination of physical inactivity and muscle oxidative stress. Pilot data (not published)
      clearly show that patients with COPD have significantly lower carnosine, which is a pH
      (acidity-basicity level) buffer and antioxidant, levels in the m. vastus lateralis compared
      to healthy subjects. Beta-alanine supplementation has shown to increase muscle carnosine in
      trained and untrained healthy subjects. This study will assess if muscle carnosine can be
      augmented by beta-alanine supplementation in 40 COPD patients (20 patients receive
      beta-alanine, 20 patients receive placebo). 10 healthy elderly controls will also be assessed
      to compare baseline muscle carnosine levels.

      The aims of this study are to:

        1. Investigate baseline muscle carnosine levels to confirm the pilot data in a larger
           sample of patients with COPD compared with healthy elderly subjects

        2. Investigate if beta-alanine supplementation augments muscle carnosine in COPD patients
           and whether it has an influence on exercise capacity, lower-limb muscle function and
           quality of life

        3. To investigate baseline and post supplementation structural and metabolic muscle
           characteristics and markers of oxidative stress and inflammation in COPD patients and
           it's association with muscle carnosine levels
    


Intervention name(s): beta-alanine; placebo; control
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Patients receive beta-alanine; Patients receive placebo; Healthy controls will be assessed to compare baseline muscle carnosine levels
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Natural Antioxidant Ice-cream, Oxidative Stress and Vascular Function
Condition: Vascular System Injuries
MeSH terms: Vascular System Injuries
Study type: Interventional

Summary: 
      Formation of reactive oxygen species (ROS) contributes to pathogenesis and progression of
      several diseases. Polyphenols, have been shown to be beneficial against ROS.

      This study evaluate the effects of a natural antioxidant ice-cream,rich in polyphenols, on
      oxidative stress, vascular function and physical performance. In this controlled,
      single-blind cross-over study, 14 healthy subjects were randomized to assume 100 mg of
      antioxidant ice-cream consisting of dark cocoa powder, extract of hazelnut and green tea, or
      milk chocolate ice-cream (control ice-cream). Subjects were studied at baseline and two hours
      after the ingestion of the ice-creams. Serum polyphenols, antioxidant status (ferric reducing
      ability of plasma, FRAP), NO bioavailability (NOx), markers of oxidative stress (D-Roms and
      H2O2), endothelium function (FMD and RHI) and exercise tolerance (Stress Test) with
      measurement of the double product were assessed.
    

Detailed description: 
      14 healthy, non-smoking, volunteers (7 males ), aged between 20 and 40 years were enrolled.
      The study was randomized, placebo-controlled. After enrollment, 3 days before entering the
      study, all subjects performed an exercise stress test. They were then randomly allocated to
      the treatment sequence with 100 mg of natural anti-oxidant ice cream or milk chocolate
      ice-cream (control icecream) in a cross-over single-blind design. There was 1 week wash-out
      between 2 phases of the study.

      Markers of oxidative stress (D-ROMs and H2O2); serum antioxidant status (FRAP), NO
      bioavailability (NOx), the endothelium flow-mediated vasodilation (FMD and the RHI by Endopat
      2000) were evaluated in fasting condition at baseline (time 0) and 2 hours after the
      ingestion of the anti-oxidant or control ice-creams. The exercise stress test was performed
      before randomization and 2 hours after each ice-cream meal test. In both experiments, the
      ice-cream was consumed within 10 min.

      Each subject was asked to refrain from any kind of medication, diet integrators, intensive
      physical activity and to avoid consumption of polyphenols rich foods, such cocoa-containing
      products, red wine, tea within the previously 2 weeks. All participants gave written informed
      consent, and the study was approved by the Medical Ethics Committee of La Sapienza University
      of Rome (Rif: 3727, Prot: 2325/15).
    

Intervention name(s): Antioxidant ice-cream; Control Ice-cream
Intervention type(s): Other; Other
Intervention description(s): Narutal Antioxidant ice-cream; Natural Control Ice-cream
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Measurement of Endothelial Function and Cardiac Output: New Methods
Condition: Heart Failure; Hypertension, Pulmonary; Hypertension; Diabetic Nephropathies
MeSH terms: Hypertension, Pulmonary; Kidney Diseases; Diabetic Nephropathies; Hypertension; Heart Failure
Study type: Observational

Summary: 
      The main purpose of this study is to analyse test-retest-reliability of functional
      quantification of endothelial dysfunction through puls-amplitude-tonometry in patients with
      heart failure with preserved/reduced ejection fraction, pulmonary hypertension, arterial
      hypertension and diabetic nephropathy. In the same group, test-retest-reliability of
      circulating endothelial cells as well as test-retest reliability of non invasive cardiac
      output Monitoring will be observed and analysed.
    


Intervention name(s): Endo-PAT; NICOM
Intervention type(s): Device; Device
Intervention description(s): Analysis of endothelial function through pulse-amplitude-tonometry; Non-invasive measurement of cardiac output
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering from the conditions stated above
      
Biospecimen description: 
      Blood samples, 51,4ml per Patient
    
Keywords: EndoPAT; NICOM; circulating endothelial cells