bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations
Condition: Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Interventional

Summary: 
      This was a study that compared the efficacy and safety of a generic butoconazole nitrate
      vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of
      vulvovaginal candidiasis caused by Candida species.
    


Intervention name(s): Butoconazole Nitrate Vaginal Cream; Placebo; Gynazole 1 vaginal cream
Intervention type(s): Drug; Drug; Drug
Intervention description(s): vaginal cream; vaginal cream; vaginal cream
Other intervention name(s): vehicle of the test product; Gynazole 1
Intervention MeSH terms: Butoconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: bioequivalence; butoconazole; vulvovaginal; candidiasis
Interventions To Help Asthma Clinical Adherence
Condition: Asthma in Children; Humans; Hispanic Americans; Child
MeSH terms: Asthma
Study type: Interventional

Summary: 
      To conduct a pilot test to estimate the effect of a novel reminder system in improving daily
      asthma controller medication adherence rates in children with monolingual Spanish-speaking
      guardians who have limited English Proficiency (LEP).
    

Detailed description: 
      The primary hypothesis is to conduct a pilot test to estimate the effect of the SmartInhaler
      device in improving daily asthma controller medication adherence rates in children with
      monolingual Spanish- speaking guardians who have LEP during a six-week intervention period
      when compared to baseline medication adherence rates in a preceding six-week run-in period.
      The secondary hypothesis is to determine whether the patient reminder system can improve
      asthma symptom control during the same six-week intervention period. The third hypothesis is
      to assess if there are specific, patient behavior characteristics which are associated with
      the success of a novel asthma medication reminder system.
    

Intervention name(s): SmartInhaler with reminder function turned on; SmartInhaler
Intervention type(s): Device; Device
Intervention description(s): The SmartInhaler is a medication monitoring system that functions as a patient reminder device. It monitors asthma medication adherence and also functions by providing an audiovisual reminder.; The SmartInhaler is a medication monitoring system manufactured by Adherium that also functions as a patient reminder device. It monitors asthma medication adherence and also functions by providing an audiovisual reminder.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Asthma/drug therapy; Medication Adherence/statistics & numerical data; Reminder Systems; Communication Barriers
Treatment of Surgical Scars Using the Pulsed Dye Laser
Condition: Scar; Laser Therapy
MeSH terms: Cicatrix
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether treatment of fresh surgical scars with a
      pulsed dye laser using purpura-inducing settings will improve clinical appearance better than
      one using non-purpura-inducing settings or no treatment.
    


Intervention name(s): Laser treatment with Purpuric settings; Laser treatment with Nonpurpuric settings; No treatment
Intervention type(s): Other; Other; Other
Intervention description(s): Pulsed dye laser treatment at purpuric settings with pulse duration of 1.5msec.; Pulsed dye laser treatment with nonpurpuric settings with pulse duration 10msec.; No laser treatment
Other intervention name(s): Pulsed dye laser, 595nm VBeam, Candela; Pulsed dye laser, 595nm VBeam, Candela
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: scar; laser therapy; lasers, pulsed dye
Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.
Condition: Obesity
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      Obesity is a chronic disease of multifactorial etiology that develops from the interaction of
      the influence of nutritive , metabolic , cellular and molecular psychological factors.

      Tadalafil is Is a drug inhibiting the enzyme phosphodiesterase-5 (PDE-5), responsible for
      inactivating the vasodilator nitric oxide. USING paragraph was mainly treat erectile
      dysfunction, and recently approved for the treatment of pulmonary hypertension , it is
      innovative because of its longer life means, provides efficacy after 36 hours and the highest
      selectivity.

      The aim of this study is to evaluate the effect of tadalafil on insulin sensitivity and
      insulin secretion in obese men.

      The investigators hypothesis is that the administration of tadalafil improve the insulin
      sensitivity and insulin secretion in obese men.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled clinical trial in 18 men aged between 30 and
      50 years with obesity (BMI 30-39.9) according to the World Health Organization (WHO) criteria
      without treatment.

      They will be assigned randomly in two groups of 9 patients, each to receive 5 mg of tadalafil
      or placebo every day at night during 28 days.

      There will be evaluated Insulin secretion, both first phase of insulin secretion by Stumvoll
      Inex as well as Total Insulin Secretion by Area Under the Curve of glucose and insulin and
      Insulinogenic Index, and Insulin sensitivity by Matsuda index.

      Waist circumference, glucose and insulin levels, lipid profile and blood pressure are going
      to be load will be evaluated before and after intervention in both groups.

      Statistical analysis will be presented through measures of central tendency and dispersion,
      average and deviation standard for quantitative variables; frequencies and percentages for
      variable qualitative. Qualitative variables will be analyzed by X2, will be used for
      differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups
      differences. Will be considered statistical significance p ≤0.05.

      This protocol was approved by a local Ethics Committee and written informed consent will be
      obtained from all volunteers.
    

Intervention name(s): Tadalafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tadalafil capsules: 5 mg, one per day, at night, during 28 days.; Calcined magnesia capsules: one per day, at night, during 28 days.
Other intervention name(s): Tadalafilo; Calcined magnesia
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Tadalfil; Insulin secretion; Insulin sensitivity
Acid Pocket: Position and Aspiration
Condition: GERD - PPI Responders; GERD - PPI Non-responders; Barrett Esophagus; Healthy Volunteers
MeSH terms: Barrett Esophagus
Study type: Interventional

Summary: 
      Gastroesophageal reflux disease (GERD) is a very common condition affecting up to 30% of
      adults. To date, therapy consists of powerful acid suppression with proton pump inhibitors
      (PPI). Nevertheless, only 60-70% of GERD patients report complete symptom relief with this
      therapy. As the mechanisms underlying symptom perception in PPI resistant patients are not
      fully understood, there is currently no adequate therapy available.

      It is becoming increasingly clear that reflux, especially in the postprandial period, occurs
      from a reservoir of acid floating on top of the meal: the so-called "acid pocket". In this
      study, we aim to investigate further the acid pocket by determining its exact position and
      chemical contents between healthy volunteers, GERD patient who respond well and bad to PPI
      therapy and GERD patients with barrett's esophagus.
    

Detailed description: 
      A costume made multi-pH-impedance manometry catheter will be placed in the esophagus and
      clipped to the Z-line. Patients then will be given a standardized meal and the position of
      the acid pocket will be measured. After two hours the pocket will be aspirated through a
      gastric catheter. Then, patients will be allowed to return home and the study will be
      continued for another 22 hours.

      The special catheter will be removed at the end of the study. Collected acid pockets will be
      used to analyze content and perform permeability experiments.

      Data of the 24-hour experiment will be used to evaluate the position of the acid pocket and
      number of reflux episodes.
    

Intervention name(s): multi-pH-impedance manometry catheter
Intervention type(s): Device
Intervention description(s): a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: acid pocket; GERD; Barrett
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
Condition: Hepatic Impairment; Healthy Volunteers
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is proposed to evaluate whether there is any clinically meaningful effect
      of hepatic impairment on the plasma PK of PF-06865571.
    


Intervention name(s): PF-06865571 100 mg
Intervention type(s): Drug
Intervention description(s): PF-06865571 in 100 mg oral tablet will be administered on Day 1
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Non-alcoholic Fatty Liver Disease; Non-alcoholic steatohepatitis
Efficacy of a Mindful-eating Program to Reduce Emotional Eating
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      Mindfulness-Based Interventions have been applied in different fields to improve physical and
      psychological health. However, little is known about its applicability and effectiveness in
      Spanish adults with overweight and obesity. The aim of the present study protocol is to
      evaluate the feasibility and efficacy of an adapted MBI programme to reduce emotional eating
      in adults with overweight and obesity in primary care (PC) settings.
    

Detailed description: 
      This study is a multi-centre, two-armed randomized controlled trial (RCT), with
      pre-treatment, post-treatment and 1-year follow-up measures, and a 1:1 allocation rate
      between groups. Patients from four mental health units in Zaragoza (Spain) will be randomly
      assigned to two different parallel conditions, with one psychological intervention group ('ME
      + TAU') and usual treatment ('TAU alone') managed by their general practitioner (GP), to test
      the superiority of 'ME + TAU' provision compared with 'TAU alone' provision. For ethical
      reasons, those patients allocated to 'TAU alone' will be offered the ME programme after
      finishing the trial at 1-year follow-up.
    

Intervention name(s): Mindful Eating
Intervention type(s): Behavioral
Intervention description(s): The ME group will be composed by 7 weekly group sessions with a minimum duration of two hours, mixing theoretical contents with practices. Sessions will always be the same day of the week, except for bank holidays or eventualities, and will be conducted by a psychologist specially trained and certified in ME with experience in leading mindfulness groups. Group sizes will range between 10 and 12 participants. At the end of each session, participants will receive theoretical contents and homework activities to be practiced along the week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Overweight; Mindful Eating; Primary Care; Randomized controlled trial (RCT)
A Study to Assess the Effect of Timing of Food Intake on the Pharmacokinetics of Abiraterone Following Single-Dose Administration of Abiraterone Acetate Tablets in Healthy Caucasian and Japanese Men
Condition: Pharmacology
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of timing of food intake on systemic
      abiraterone exposure observed in healthy adult Japanese and Caucasian men.
    

Detailed description: 
      This is a randomized (individuals will be assigned by chance to study treatments), open-label
      (individuals will know the identity of study treatments), single dose, 4-way crossover study
      of abiraterone acetate in approximately 48 healthy adult Japanese and Caucasian men. For the
      crossover design, the treatment sequences are defined as follows: 1 - ADBC, 2 - BACD, 3 -
      CBDA, and 4 - DCAB; where Treatment A = abiraterone acetate administered in the fasted state,
      Treatment B = standardized meal administered 1 hour after abiraterone acetate dose, Treatment
      C = standardized meal administered 2 hours after abiraterone acetate dose, and Treatment D =
      standardized meal administered 2 hours before and 2 hours after abiraterone acetate dose.
      This study will consist of a screening period followed by four open-label treatment periods
      separated by a washout period of at least 14 days between dosing. Eligible participants will
      be randomly assigned on Day 1 to 1 of 4 treatment sequences that differ with regard to timing
      of food intake before and/or after dosing with a single dose of 1000 mg of abiraterone
      acetate. Serial pharmacokinetic (study of what the body does to a drug) samples will be
      collected during the open-label treatment phase as detailed in the protocol. Safety will be
      monitored throughout the study. End-of-study assessments will be performed on Day 4 of Period
      4 or upon early withdrawal.
    

Intervention name(s): Abiraterone: Treatment A; Abiraterone: Treatment B; Abiraterone: Treatment C; Abiraterone: Treatment D
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1000 mg abiraterone acetate administered in the fasting state; Standardized meal administered 1 hour after the 1000 mg abiraterone acetate dose; Standardized meal administered 2 hours before the 1000 mg abiraterone acetate dose; Standardized meal administered 2 hours before and 2 hours after the 1000 mg abiraterone acetate dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacology; Pharmacokinetics; Pharmacodynamics; Abiraterone acetate; Food intake; Caucasion; Japanese; Healthy
Cervical Spine Motion During Tracheal Intubation: Video Laryngoscope vs Rigid Video Stylet
Condition: Intubation
Study type: Interventional

Summary: 
      In this study, investigators are going to compare cervical spine motion during tracheal
      intubation using video laryngoscope or rigid video stylet in patients with simulated cervical
      immobilization.
    

Detailed description: 
      In patients with an unstable cervical spine, neck extension during tracheal intubation may
      result in harmful events such as spinal cord injury. Thus, it is important to minimize
      cervical spine motion in these patients. In this randomized crossover study, investigators
      are going to compare cervical spine motion during tracheal intubation using video
      laryngoscope or rigid video stylet in patients with simulated cervical immobilization.
    

Intervention name(s): rigid video stylet intubation; video laryngoscope intubation
Intervention type(s): Device; Device
Intervention description(s): intubation using rigid video stylet; intubation using video laryngoscope
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: cervical spine motion; video laryngoscope; rigid video stylet
Temperature Change of the Pulpal Floor and Restoration With Preheated Resin Composite (A Randomized Clinical Trial)
Condition: Preheating of Resin Composite
Study type: Interventional

Summary: 
      clinical evaluation of the effect of preheating BIS-GMA free resin composite at different
      temperatures on temperature change of the pulpal floor and restorations and compare it with
      BIS-GMA containing resin composite.

      Hypothesis: Could the preheated composite affect the temperature of the pulpal floor
    


Intervention name(s): preheating of resin composite
Intervention type(s): Other
Intervention description(s): evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Other intervention name(s): warming of resin composite
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Forty posterior teeth were randomly divided into two groups of 20 teeth. According to types of restorative materials used (A), the first group was restored by Bis-GMA free resin composite (A1) and the second group was restored by Bis-GMA containing resin composite (A2).
Each group was subdivided into 2 subgroups of 10 teeth each according to preheating temperatures used (T), the first subgroup (T1) was preheated at 50◦ C and the second subgroup (T2) was preheated at 70◦ C.
Masking: None (Open Label)
Primary purpose: Other
Keywords: preheating of resin composite; pulpal floor temperature; resin composite; BIS-GMA free resin composite; BIS-GMA containing resin composite; restoration temperature
Safety of Remifentanil Infusion
Condition: Urinary Tract Problem
Study type: Interventional
Phase: Phase 4

Summary: 
      The effect of maintenance remifentanil infusion with target controlled infusion during
      laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be
      investigated.
    

Detailed description: 
      In all patients (control group and remifentanil group induction of anesthesia will be
      achieved with desflurane and remifentanil.Anesthesia will be maintained with remifentanil
      (1-4 ng/mL) by TCI target controlled infusion, and desflurane . Throughout the surgery
      hemodynamic parameters are going to be recorded. As soon as the surgery has been finished, in
      control group remifentanil infusion and desflurane inhalation is going to be stopped.In
      remifentanil group,desflurane inhalation is going to be stopped and remifentanil infusion
      will be maintained until the removal of LMA. During the emergence period the time of eye
      opening, hemodynamic parameters and emergence quality (score 1-2)are going to be recorded.
    

Intervention name(s): remifentanil
Intervention type(s): Drug
Intervention description(s): 1-4 ng/mL i.v. infusion during the surgery, maintenance dosage till LMA removal is 1.5 ng/mL.
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Remifentanil; Laryngeal mask airway removal; Hemodynamic changing; Infusion; Ureterorenoscopy
Empagliflozin and Renal Oxygenation in Healthy Volunteers
Condition: Nephropathy
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      SGLT-2 inhibitors belong to a new class of hypoglycemic drugs with the unique property of
      decreasing blood glucose through an increase in glucosuria. These drugs inhibit the sodium
      glucose transporter 2 (SGLT2) expressed at the luminal membrane of the proximal tubule.

      SGLT-2 inhibition in type 2 diabetic subjects and in healthy volunteers shifts the threshold
      for renal glucose excretion to lower levels. This effect is independent from insulin. The
      inhibition of SGLT2 decreases HbA1C, systolic blood pressure and weight in diabetic subjects.
      Recently, the EMPA-REG trial demonstrated a decrease in cardiovascular mortality and renal
      endpoints in empagliflozin treated type 2 diabetic patients with established cardio-vascular
      disease.

      Because this novel hypoglycemic drug has unique and direct effects on renal tissue
      metabolism, it is important to better examine its effects on the kidney. With this study, we
      propose to explore the effects of empagliflozin on renal tissue oxygenation. Our hypothesis
      is that SGLT-2 inhibition decreases renal cortical energy requirements with consequently an
      increase in renal tissue oxygenation.
    

Detailed description: 
      This study is a double-blind, randomized, placebo-controlled study that will examine the
      acute and chronic renal effects of empagliflozin in healthy volunteers.

      A total of 45 healthy volunteers will be included in the study: 15 normal weight, 15
      overweight (BMI: 25-30kg/m2) and 15 obese (BMI>30kg/m2) non diabetic subjects (as determined
      after an oral glucose tolerance test).

      Empagliflozin 10mg vs placebo will be administered in a blinded fashion qd. The acute and
      chronic renal response to empagliflozin will be assessed.
    

Intervention name(s): Empagliflozin 10 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Prescription of empagliflozin 10 mg once a day Follow-up of renal parameters including BOLD MRI; Prescription of a placebo once a day Follow-up of renal parameters including BOLD MRI
Other intervention name(s): Jardiance
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised placebo-controlled double blind trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: empagliflozin; kidney; BOLD-MRI
A Study to Evaluate the Pharmacokinetics of Single Oral Doses of Ozanimod in Healthy Adult Chinese Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, single-dose study. Approximately 24 Chinese healthy adult
      subjects will be enrolled to receive a single oral dose of ozanimod 0.46 mg or 0.92 mg (12
      subjects per dose cohort).

      Subjects will be screened for participation within 28 days prior to dosing. Eligible subjects
      will be admitted to the clinical research unit (CRU) or hospital one day before dosing (Day
      -1) and will be domiciled until Day 15 (approximately 336 hours after ozanimod dosing).
      Serial PK blood samples for the measurement of plasma concentrations of ozanimod and active
      metabolites will be collected predose and up to 336 hours after ozanimod dosing.

      Physical examinations,12-lead electrocardiograms (ECGs) and ambulatory ECGs, vital sign
      measurements,pulmonary function tests (PFTs), and clinical laboratory tests will be performed
      and adverse events and concomitant medications will be monitored throughout the study to
      assess safety.

      Subjects will be contacted by telephone approximately 30 ± 5 days after dosing for a
      follow-up safety assessment.
    


Intervention name(s): Ozanimod
Intervention type(s): Drug
Intervention description(s): Ozanimod
Intervention MeSH terms: Ozanimod
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteer; Pharmacokinetics (PK); Ozanimod; Adult Chinese Subjects