bioihbjkbjnl/mcl2 huggingface dataset:
The Acute Effect of Mango Intake (Mangifera Indica L.) on Blood Pressure and Blood Glucose
Condition: Blood Pressure
Study type: Interventional

Summary: 
      In the current proposal the investigators seek to evaluate the acute effects of mango intake
      on blood pressure, blood glucose and insulin in postmenopausal women between 50 and 70 years
      old.
    

Detailed description: 
      Cardiovascular disease (CVD) is the leading cause of mortality in the U.S, and aging is the
      largest risk factor for vascular diseases. Both male and female adults have increased risk
      for CVD as they age. For postmenopausal women, this risk is particularly elevated due to the
      loss of the protective effect of estrogen. It is evident that nutrition plays a crucial role
      in prevention of chronic diseases such as heart disease, stroke and cancer. Scientific
      evidence shows that high intake of plant-based food lowers the risk of CVD and many other
      chronic diseases.

      Polyphenolic compounds in fruits and nuts have been the focus of extensive research regarding
      their potential to reduce risk for a number of chronic diseases. However, fruits and nuts
      vary largely in the type and amounts of phytonutrients they provide. Mango (Mangifera Idica
      L.), a commonly cultivated fruit worldwide, is rich in polyphenolic compounds such as gallic
      acid, mangiferin, quercetin glycosides, ferulic acid, and hydroxybenzoic acid. Many of those
      bioactive compounds have been found to have anti-diabetic and anti-inflammatory effects in
      cell models. For instance, mangiferin has been proved to effectively reducing glucose-induced
      endoplasmic reticulum stress by inhibiting IREα phosphorylation and ROS production in
      endothelial cells. However, it is unknown if the phytonutrients in mango will demonstrate a
      similar impact in humans. Therefore, the overall objective of this study is to investigate
      the effects of acute mango intake on blood pressure and blood glucose.
    

Intervention name(s): further fasting; white bread consumption; mango consumption
Intervention type(s): Other; Other; Other
Intervention description(s): 2 hours of fasting; 113 grams of white bread consumption; 330 grams of mango consumption
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Blood glucose; Insulin
Spirulina Platensis for PPI Withdrawal
Condition: Gastro Esophageal Reflux Disease; Dyspepsia; Rebound Acid Hypersecretion
MeSH terms: Gastroesophageal Reflux; Dyspepsia
Study type: Interventional
Phase: Phase 2

Summary: 
      Background: Rebound acid hypersecretion after proton pump inhibitors (PPIs) discontinuation
      may be accompanied by dyspepsia.

      Aim: To assess whether Spirulina platensis, by its anti-inflammatory properties, could
      minimize rebound symptoms after PPIs withdrawal.
    

Detailed description: 
      Forty-five regular users of PPIs entered in a 28-day run-in phase of pantoprazole 40 mg/day,
      followed by clinical and endoscopic evaluation. In the absence of large hiatal hernia, peptic
      ulcer, or moderate to severe reflux esophagitis, patients stopped PPIs and were randomly
      assigned to receive Spirulina (1.6 g/day) or placebo for 2 months, when evaluation was
      repeated. Primary outcomes were dyspepsia and typical reflux symptoms (either appearance or
      maintenance of symptoms > 50% from baseline). Intention-to-treat analysis was applied.
    

Intervention name(s): Spirulina platensis; Placebo comparator
Intervention type(s): Combination Product; Other
Intervention description(s): Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days; Placebo in capsules, 1 capsule orally each 8 hours, for 60 days
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Forty-five regular users of PPIs entered in a 28-day run-in phase of pantoprazole 40 mg/day, followed by clinical and endoscopic evaluation. In the absence of large hiatal hernia, peptic ulcer, or moderate to severe reflux esophagitis, patients stopped PPIs and were randomly assigned to receive Spirulina (1.6 g/day) or placebo for 2 months, when evaluation was repeated. Primary outcomes were dyspepsia and typical reflux symptoms (either appearance or maintenance of symptoms > 50% from baseline). Intention-to-treat analysis was applied.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gastroesophageal reflux disease; Dyspepsia; Proton Pump Inhibitors; Spirulina platensis
Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective is to assess whether dupilumab as adjunct to AR101 compared to placebo
      improves desensitization at the completion of up-dosing, defined as an increase in the
      proportion of participants who pass a post up-dosing double-blind placebo-controlled food
      challenge (DBPCFC) at visit 16.

      Secondary objectives are:

        -  To assess whether dupilumab as adjunct to AR101 compared to placebo improves
           desensitization at the completion of up-dosing, defined as an increase in the cumulative
           tolerated dose (log transformed) of peanut protein during a post up-dosing DBPCFC at
           visit 16

        -  To assess whether dupilumab as (indefinite [continuously]) adjunct to AR101 compared to
           placebo maintains desensitization, defined as an increase in the proportion of
           participants who pass a post maintenance DBPCFC at visit 22

        -  To assess whether dupilumab as (limited [previously]) adjunct to AR101 compared to
           placebo maintains desensitization, defined as an increase in the proportion of
           participants who pass a post maintenance DBPCFC at visit 22

        -  To evaluate the safety and tolerability of dupilumab as adjunct to AR101 compared to
           placebo

        -  To assess the effect of dupilumab (compared to placebo) as adjunct to AR101 on the
           change in peanut-specific Immunoglobulin E (sIgE), Immunoglobulin G (IgG),
           Immunoglobulin G4 (IgG4), and peanut-specific IgG4/IgE ratio

        -  To assess if dupilumab increases the tolerability of AR101 as measured by the daily
           symptoms (electronic diary [e-diary]) during the up-dosing phase
    


Intervention name(s): Dupilumab; Placebo matching dupilumab; AR101
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dupilumab will be administered subcutaneously (SC) in a single-use, pre-filled glass syringe every two weeks (Q2W); Placebo matching dupilumab is prepared in the same formulation without the addition of protein; AR101 will be provided in dose-escalating capsules and then sachets during maintenance phase
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dexmetomedine as an Adjuvant to Bupivacaine in Ultrasound Guided PECS Block
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Regional anesthesia is an essential component of anesthesia and analgesia. It has many
      advantages, it decreases pain post operatively, improves patient outcome and allow early
      recovery and ambulation Post-operative pain following breast surgery results from injured
      muscles and nerves, management of acute post operative pain is a consistent factor for better
      outcome and patient satisfaction
    

Detailed description: 
      All patients will be monitored by standard intraoperative monitoring that includes continuous
      electrocardiography (ECG), capnography, pulse oximetry, and non invasive blood pressure.

      Induction of general anesthesia will be done by propofol 1.5-2 mg/kg and fentanyl 3µg/kg.

      Tracheal intubation will be facilitated by administration of rocuronium 0.8 mg/kg. Anesthesia
      will be maintained with isoflurane 1MAC (Pecs block):the block will be performed with the
      patients in the supine position.The infraclavicular and axillary regions will be cleaned with
      antiseptic solution. the in plane technique will be used from proximal and medial to distal
      and lateral in an oblique manner at dermatome level T2 and T3.The puncture site was
      infiltrated with 2%lidocaine and once the structures is identified with Ultrasound
    

Intervention name(s): Pecs block
Intervention type(s): Procedure
Intervention description(s): (Pecs block):the block will be performed with the patients in the supine position.The infraclavicular and axillary regions will be cleaned with antiseptic solution. the inplane technique will be used from proximal and medial to distal and lateral in an oblique manner at dermatome level T2and T3.The puncture site was infiltrated with 2%lidocaine and once the structures is identified with ultrasound.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized study
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Expressive Writing in Male Infertility
Condition: Infertility, Male
MeSH terms: Infertility; Infertility, Male
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether expressive writing can be effective in
      improving the well-being and sperm quality in patients with male infertility.
    

Detailed description: 
      Expressive writing is a therapeutic intervention designed by the psychologist James W.
      Pennebaker. Individuals write on three days for about 20 minutes about particularly stressful
      experiences in their life. Several studies showed that expressive writing can have beneficial
      effects on the frequency of health care utilization and well-being. Particularly in patients
      with rheumatism, kidney cancer and posttraumatic stress disorder expressive writing showed an
      positive effect on subjective well-being. Furthermore, in several studies expressive writing
      showed a positive effect on immune parameters.

      As many studies suggest an important negative effect of stress on well-being and sperm
      parameters in male infertility, we want to investigate the effect of expressive writing in
      male infertility.The expressive writing condition is compared to a non emotional writing
      condition, in which individuals write about mainly non emotional topics such as time
      management. In this randomized-controlled trial subjects were allocated sequentially by block
      wise randomization (block size of 4). For randomization a computer generated random list was
      used. The allocation was concealed in a series of numbered sealed envelopes. The envelope was
      opened immediately before the first writing session.
    

Intervention name(s): Expressive writing
Intervention type(s): Behavioral
Intervention description(s): Patients in the intervention group write on three day for 20 minutes about highly emotional topics In the control group patients write on three days for 20 minutes about topics with relatively low emotional involvement such as diet, time management and sport.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Expressive writing; Male infertility
Bioequivalence Study of Cyproterone Acetate and Ethinyl Estradiol in Healthy Female Volunteers
Condition: Drug Use
Study type: Interventional

Summary: 
      The study was conducted to investigate whether 2 mg cyproterone acetate (CPA) and 0.035 mg
      ethinyl estradiol (EE) film-coated tablet (Elzsa®) manufactured by PT. Sydna Farma was
      bioequivalent to its reference product, Diane®-35 sugar-coated tablet manufactured by Bayer
      Weimar GmbH, Germany, imported by PT. Bayer Indonesia, Depok, Indonesia.
    

Detailed description: 
      Twenty four healty female subjects were given a single dose of Elzsa® FCT or or Diane®-35
      with 240 mL of water. Then the blood samples for CPA and EE were drawn and analyzed using
      LCMS/MS. All subjects sample plasma were analyzed for pharmacokinetic evaluation
    

Intervention name(s): Elzsa film-coated tablet; Diane-35 Sugar-coated tablet
Intervention type(s): Drug; Drug
Intervention description(s): Administered with 240 mL of water; Administered with 240 mL of water
Other intervention name(s): 2 mg cyproterone acetate + 0.035 mg ethinylestradiol; 2 mg cyproterone acetate + 0.035 mg ethinylestradiol
Intervention MeSH terms: Cyproterone Acetate; Ethinyl Estradiol; Cyproterone; Cyproterone acetate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, single blind, two-period, single dose, crossover study with three weeks washout period in 24 healthy female subjects under fasting condition.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: cyproterone acetate; ethinyl estradiol; bioequivalence; cross-over design study; pharmacokinetics; Indonesian healthy female
Study to Evaluate the Efficacy, Safety and Tolerability of 3% LTX-109 for Nasal Decolonisation of Staphylococcus Aureus
Condition: Nasal Decolonization of Staphylococcus Aureus
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase IIa, double-blind, placebo-controlled, randomised study designed to evaluate the
      efficacy, safety and tolerability of two dosing regimens with LTX-109 administered topically
      to the anterior nares in subjects with persistent carriage of Staphylococcus aureus (S.
      aureus).
    

Detailed description: 
      Approximately 90 subjects planned screened to achieve 27 randomised and dosed subjects with
      persistent S. aureus carriage.

      On Day 1, subject randomisation in a 2:1 ratio to receive either LTX-109 (n=18) or placebo
      (n=9). Cohort (1 [8 doses] or 2 [6 doses]) used as a stratification variable to preserve the
      2:1 treatment randomisation ratio in each cohort (LTX-109 n=9 or placebo n=5/4).

      For all subjects, the IMP was to be applied 4 times during an intensive dosing regimen for 4
      ½-hours (on Day 1 at 0, 1 ½, 3 and 4 ½ - hours). For subjects in Cohort 1, this was followed
      by 4 additional applications: on Day 1 at 12 hours, on Day 2 at 24 and 36 hours, and on Day 3
      at 48 hours. For subjects in Cohort 2 the IMP was likewise applied 4 times during the 4
      ½-hour period (on Day 1 at 0, 1 ½, 3 and 4½ hours), but was followed by 2 applications: on
      Day 1 at 12 hours and on Day 2 at 36 hours. On each dosing occasion, a large drop
      (approximately 250 μL) of IMP was applied into each nostril and distributed to cover the
      whole area of the nostril. The subjects were carefully monitored by clinical staff during and
      after dosing. Safety assessments (AEs, vital signs, safety laboratory assessments and local
      tolerability) and efficacy assessments (nasal swab) were performed.

      All subjects were instructed to wash the body and hair with chlorhexidine body wash and
      shampoo at the CRU on Day 1 (prior to the first dose) and on Day 2. Subjects were provided
      with chlorhexidine body wash and shampoo for body and hair wash at home on Day 3, Day 4, Day
      5, Day 6 and Day 7. On Day 3 and Day 7, subjects used the chlorhexidine shower before the
      visits to the CRU.

      A final end-of-study visit (Visit 5) took place on Day 7 (+2 days) or after early withdrawal.
    

Intervention name(s): Vehicle gel, 4 + 4 applications or 4 + 2 applications; LTX-109 3% gel, 4 + 4 applications; LTX-109 3% gel, 4 + 2 applications
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Control arm/placebo; Cohort 1 active treatment; Cohort 2 active treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, Double-blind, Placebo-controlled Randomization 2:1, active to placebo
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Processing Speed as an Objective Measure of Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Observational

Summary: 
      The overall purpose of this research is to assess whether both the "60 second Brain Game" and
      the "Brain Speed Test" computer-based programs can be used as assessment tools for
      objectively defining the severity of the functional impact of tinnitus.
    

Detailed description: 
      This cross-sectional study aims to assess for deficits in brain processing speed and
      attention (two cognitive domains whose deficits have been implicated in tinnitus) with the
      use of the "Brain Speed Test".
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Tinnitus subjects recruited from speciality clinic and community at large.
      
Keywords: tinnitus; cognition; brain processing speed; Brain Fitness Program; Posit Science
Subarachnoid Hemorrhage Recovery And Galantamine
Condition: Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to examine the effects of the study drug--Galantamine-on
      patients with subarachnoid hemorrhage (SAH). The study will examine how patients with SAH
      will tolerate the study drug and how it may improve brain functioning in patients after SAH.
    


Intervention name(s): Placebo; 8mg galantamine twice daily; 12mg galantamine twice daily
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo will match drug capsules.; Drug will be administered within 36 hours of hospitalization and continued for 90 days.; Drug will be administered within 36 hours of hospitalization and continued for 90 days.
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
BI 655066 (Risankizumab) Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS)
Condition: Ankylosing Spondylitis (AS)
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall purpose of the trial is to assess the clinical efficacy of three different
      subcutaneous doses of BI 655066 (risankizumab) in adult patients with AS, in order to provide
      clinical proof of concept and to select dose (s) for confirmatory clinical trials.
    


Intervention name(s): placebo for risankizumab; risankizumab
Intervention type(s): Drug; Drug
Intervention description(s): Placebo for risankizumab administered by subcutaneous (SC) injection; Risankizumab administered by subcutaneous (SC) injection
Other intervention name(s): ABBV-066; BI 655066; SKYRIZI
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Blood Gas and Bleeding Disorders in Healthy Volunteers Exposed to Nitroglycerin and Nitrogen Compounds
Condition: Disorder of Blood Gas; Bleeding Disorder
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhagic Disorders; Hemorrhage
Study type: Observational [Patient Registry]

Summary: 
      The aim of the study was to investigate the possible relationship about blood gas and
      bleeding disorders in healthy volunteers of blasters and no blasters groups of the Italian
      National Mountain and Cave Rescue who handled nitrogen compounds and nitroglycerine and then
      they were exposed to combustion products from an accidental uncontrolled detonation of
      micro-charges during a cave unblocking procedure.
    

Detailed description: 
      This was a field report of clinical data collected during an accidental uncontrolled
      detonation of micro-charges, while the cave unblocking procedure was performed by volunteers
      of blaster group and non blasters group of the Italian National Mountain and Cave Rescue, in
      a cave in Trieste (Italy; altitude entrance: 348 meters above sea level; total length: 413,5
      meters; total depth of 307 meters).

      Before going into the cave (Time 0), the following clinical data were collected: age, sex,
      body mass index; smoke (yes/no), heart rate, arterial blood pressure (mean arterial
      pressure), oxygen saturation measured with pulse oxymetry, epitympanic temperature, blood
      gases analyses and the haemostasis measures.

      After the accidental uncontrolled detonation of micro-charges, (Time 1) heart rate, arterial
      blood pressure, oxygen saturation measured with pulse oxymetry, epitympanic temperature,
      blood gases analyses and the haemostasis measures were recorded in each volunteers.
    

Intervention name(s): Arterial blood gas analyses and haemostasis measures
Intervention type(s): Diagnostic Test
Intervention description(s): Under aseptic conditions, a puncture of radial artery was performed: three mL of the arterial blood sample were used for the haemostasis measure, while one mL was tested for the blood gases analysis.
Intervention MeSH terms: Hemostatics
Observational model: Case-Control
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Healthy volunteers of Blasters and No Blasters Group of the Italian National Mountain and
        Cave Rescue
      
Keywords: Arterial blood gas; Coagulation; Nitrogen compounds
A Comparison of SmartPill Capsule With Scintigraphy for Determining Gastric Residence Time
Condition: Gastrointestinal Diseases; Stomach Diseases; Gastroparesis
MeSH terms: Gastroparesis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases
Study type: Observational

Summary: 
      The purpose of this study is to determine the correlation between gastric residence time of
      the SmartPill Capsule and the time required for partial emptying of a standard radiolabeled
      meal as measured by gastric emptying scintigraphy.
    

Detailed description: 
      Gastric emptying scintigraphy is considered the gold standard for evaluating gastric emptying
      and is widely available. Accurate characterization of gastric emptying may guide medical and
      surgical treatment choices. In addition, these techniques may allow for monitoring of
      therapeutic results for follow-up patient management.

      The SmartPill GI Monitoring System offers an alternative non-invasive method for
      characterizing disorders of the stomach. The system consists of an ingestible capsule that
      houses sensors for pH, temperature, and pressure, a receiver for receiving and storing
      signals from the capsule, and software for displaying data on a personal computer. The
      capsule samples at regular intervals and transmits the sensed pH, pressure, and temperature
      data to a portable receiver worn by the subject. After test completion, the recorded data is
      downloaded to a personal computer for subsequent evaluation.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with gastroparesis referred to a tertiary motility center
      
Keywords: gastroparesis; Digestive; Gastrointestinal; Stomach; Motility; Non-Invasive; Capsule; GI; Device; Digestive System Diseases