bioihbjkbjnl/mcl2 huggingface dataset:
Double-Blind, Randomized, Cross-Over Trial of Aged Garlic Extract for Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The primary objective of this trial is to assess the effect of consumption of aged garlic
      extract powder on 24 h systolic and diastolic ambulatory blood pressure in hypertensive
      individuals following 8 weeks of supplementation.

      Additional secondary objectives are to assess the effects of aged garlic extract powder
      intake for 8 weeks on lipid profile (TC, HDL-C, LDL-C, and TG concentrations), blood glucose,
      office blood pressure, pulse-wave velocity and augmentation index, body mass index, and waist
      and hip circumference.
    

Detailed description: 
      Forty hypertensive volunteers between 18 and 75 years will be recruited from the Winnipeg
      (Manitoba, Canada) area to participate in a two arm crossover, double-blind, randomized,
      placebo-controlled intervention study for 8 weeks per study period following obtainment of
      informed consent.

      The 2 periods of treatment will include:

        1. Treatment period: One capsule twice a day, providing 600 mg each of aged garlic extract
           powder, for a total of 1200 mg/day of aged garlic extract powder.

        2. Control period: The control product will be an identical-looking placebo capsules
           containing cellulose, which is being used as a filler in the treatment capsules.
    

Intervention name(s): Aged garlic extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Each capsule contains 600mg of aged garlic extract powder; Each capsule contains cellulose as a filler.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Mucins and Toll-like Receptors in Asthma
Condition: Asthma; Inflammation
MeSH terms: Asthma; Inflammation
Study type: Observational

Summary: 
      This study raises two main hypotheses: 1) Asthmatics patients who present with bronchial
      hypersecretion differ phenotypically from asthmatic patients without hypersecretion and 2)
      mucins in asthmatic patients with hypersecretion of bronchial mucus and the expression of
      TLRs differ from non-mucus hypersecretory asthmatics patients.
    

Detailed description: 
      Asthma with bronchial hypersecretion is a type of asthma poorly studied. Its pathogenesis is
      not well understood but probably is related to the innate impaired immunity, particularly
      with "toll-like receptors" (TLR) and secretory mucin (MUC).

      Objectives 1) Define the clinical and inflammatory phenotype of asthma with bronchial
      hypersecretion of mucus. 2) Compare the type of mucin present in induced sputum (IS) of
      patients with and without bronchial hypersecretion. 3) Determine the expression of TLRs in
      the IS and in the peripheral blood of asthmatics with and without bronchial hypersecretion.

      Method: Cross-sectional study which included 43 asthmatic patients, 19 with and 24 without
      bronchial hypersecretion. All patients underwent the following: IS, spirometry, fractional
      exhaled nitric oxide (FeNO), prick test, total IgE and blood albumin. Analysis of mucins
      (MUC2, MUC5AC, MUC5B and MUC1) was determined by ELISA and expression of TLR2 and TLR4 by
      flow cytometry. The level of asthma control was determined by the asthma control test
      questionnaire (ACT) and quality of life was assessed by the MiniAQLQ questionnaire.
    

Intervention name(s): clinical study
Intervention type(s): Other
Intervention description(s): It is a comprehensive study in a large sample using multiple techniques to assess various aspects of the disease. All patients underwent the following : Induced Sputum, spirometry, fractional exhaled nitric oxide (FeNO), prick test, total IgE and blood albumin. Analysis of mucins and TLRs
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Male and female subjects aged > 18 years, non-smokers, who fulfilled the diagnostic
        criteria of asthma were consecutively enrolled from the Asthma Unit outpatient clinic of
        our institution. We defined asthma as a history of variable respiratory symptoms and
        evidence of variable expiratory airflow limitation. All patients had a positive
        bronchodilator test or daily peak expiratory flow variability greater than 20%, or a
        positive methacholine challenge test documented in case history. Asthma severity was
        defined according to the Global Initiative for Asthma Management (GINA)
Validation of BIVA for Nutritional Assessment in Cirrhotic Patients
Condition: Liver Cirrhosis; Malnutrition
MeSH terms: Liver Cirrhosis; Malnutrition; Fibrosis
Study type: Observational

Summary: 
      Despite the importance of nutritional status in patient's outcome, there is no gold standard
      for nutritional assessment. Traditional techniques used in healthy subjects to assess
      nutritional status cannot be used in cirrhotic patients due especially to ascites and
      peripheral edema, and altered rates of biochemical markers due to liver failure.

      Bioelectrical impedance vector analysis has emerged as a useful method to assess body
      composition and nutritional status especially in patients at the extremes of body weight
      (fluid overload, excess of adipose tissue, etc.).

      With previous results from our research group, BIVA showed to be useful for evaluating
      cirrhotic patients.

      The aim of this study is to validate our previous results and validate BIVA for nutritional
      assessment in patients with liver cirrhosis
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participants will be recruited from the Gastroenterology Department of a tertiary care
        setting.
      
Keywords: bioelectrical impedance vector analysis; nutritional assessment; nutritional status; mortality; complications
Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia
Condition: Achalasia
MeSH terms: Esophageal Achalasia
Study type: Interventional

Summary: 
      This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be
      recruited for this trial, with the intent to treat 20 patients.
    

Detailed description: 
      This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be
      recruited for this trial, with the intent to treat or attempt to treat 20 patients. Patients
      for whom a POEM has been attempted but not completed (conversion to open or laparoscopic
      surgery, POEM surgery aborted and not re-attempted). Patients who proceed to study treatment
      will undergo ten years of follow-up as part of this study.
    

Intervention name(s): Peroral Endoscopic Myotomy (POEM)
Intervention type(s): Procedure
Intervention description(s): Endoscopy myotomy for treatment of achalasia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: achalasia; POEM; peroral endoscopic myotomy; myotomy; Heller myotomy
Evaluation of the Effect of Chicory Inulin-type Fructans in Constipated Adults
Condition: Constipation - Functional
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Constipation is common in the general population, especially in women and in the elderly,
      which can significantly affect quality of life of the individual. There is a general consumer
      trend to seek natural food options, also when addressing health issues such as constipation.
      Consumers seek tasty options and there is a paucity of tasty functional foods to address
      constipation. Adding natural fiber to food, like inulin-type fructans from chicory root
      fiber, can increase fiber intake and potentially prevent or resolve constipation issues. This
      study aimed to increase the body of scientific data on inulin-type fructans by way of a
      randomized, placebo-controlled, cross-over study. Maltodextrin was used as the placebo in
      this study.
    


Intervention name(s): chicory inulin-type fructan
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary supplement: chicory inulin-type fructan
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This was a randomized, double-blind, placebo-controlled, cross-over study to evaluate the effects of chicory inulin-type fructans in adults with functional constipation.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adults; functional constipation; inulin-type fructans
A Comparison of the Laryngeal Mask Airway (LMA) Proseal and LMA Supreme in Children
Condition: Children
Study type: Observational

Summary: 
      The aim of this randomized prospective study is to compare two laryngeal mask airways with a
      provision for evacuation of gastric contents, the LMA Proseal and The investigators
      hypothesize that airway leak pressures with the LMA Proseal will be significantly different
      (higher) when compared with the LMA Supreme.
    

Detailed description: 
      The goal of this study is to compare the LMA Proseal and LMA Supreme in children having
      surgery. The investigators hypothesize that the airway leak pressures with the LMA Proseal
      will be superior to the LMA Supreme. Airway leak pressures will be measured by recording the
      circuit pressure at which equilibrium is reached. The ease of placement of the device and
      gastric tube, fiberoptic grade of laryngeal view, feasibility of use during positive pressure
      ventilation, and complications (airway related, gastric insufflation, trauma) will also be
      assessed.
    

Intervention name(s): LMA Proseal: control device; LMA Supreme: comparison device
Intervention type(s): Device; Device
Intervention description(s): LMA Proseal will be placed in children weighing 10-20kg based on a computer generated randomization; LMA Supreme will be placed in children weighing 10-20kg based on a computer generated randomization
Other intervention name(s): laryngeal mask airway; laryngeal mask airway
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children weighing 10 to 20 kg undergoing surgical or medical procedures under anesthesia
        requiring a supraglottic airway device
Performance Assessment of a Remote Patient Monitoring Device
Condition: Physiologic Monitoring
Study type: Observational

Summary: 
      This study will evaluate the performance of the Zephyr BioPatch in measuring heart rate,
      respiration rate, posture, and activity level compared to reference devices in healthy adult
      subjects during a variety of situations including hospital room movements, talking, and a
      short bout of exercise.
    


Intervention name(s): Zephyr BioPatch
Intervention type(s): Device
Intervention description(s): Remote patient monitoring devices: BioPatch™ (ZephyrLIFE Hospital System™)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers, Adults 18 to 50 years old
Prospective Biceps Study
Condition: Biceps Tendon Rupture
MeSH terms: Rupture
Study type: Observational

Summary: 
      The primary goal of this study is to determine if surgical repair of the distal biceps fully
      restores the supination strength of the forearm. Secondarily, the investigators want to
      examine the insertion site location of the tendon and determine if it correlates with the
      patients' functional outcome as determined by Disabilities of the Arm, Shoulder, and Hand
      (DASH), Visual Analog Pain Scale (VAPS), and isometric supination torque testing.
    


Intervention name(s): Distal Biceps Re-Insertion Surgery
Intervention type(s): Procedure
Intervention description(s): Surgical Repair of the Distal Biceps Tendon
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have received primary distal biceps repair by Dr. Schmidt
      
Keywords: Rupture of Distal Bicep Tendon
Effects of Palatinose™ on Weight Management and Body Composition
Condition: Overweight and Obesity; Diet Modification; Body Weight
MeSH terms: Overweight; Body Weight
Study type: Interventional

Summary: 
      The study aims to assess body weight and body composition changes in overweight and obese
      persons consuming an energy-reduced diet containing foods with either sucrose or isomaltulose
      (Palatinose(TM)) over a period of 3 months.
    


Intervention name(s): isomaltulose (Palatinose(TM); Sucrose
Intervention type(s): Other; Other
Intervention description(s): isomaltulose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet; sucrose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Neoadjuvant Cetuximab, Fluorouracil, and Pelvic Irradiation in Treating Patients With Locally Advanced or Locally Recurrent Rectal Cancer
Condition: Colorectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill
      them or deliver tumor-killing substances to them without harming normal cells. Drugs used in
      chemotherapy such as fluorouracil work in different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Giving cetuximab with fluorouracil and radiation therapy may kill more tumor cells.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the safety profile of neoadjuvant cetuximab, fluorouracil, and pelvic
           irradiation in patients with locally advanced or locally recurrent rectal cancer.

      Secondary

        -  Determine the activity of this regimen, in terms of pathological complete response rate,
           in these patients.

      OUTLINE: This is a non-randomized, open-label, pilot study.

      Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64
      and fluorouracil IV continuously on days 1-42. Patients undergo whole-pelvic radiotherapy
      once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Treatment continues in the
      absence of disease progression or unacceptable toxicity.

      Approximately 1-3 weeks after completion of study treatment, patients undergo surgical
      resection followed by adjuvant chemotherapy off-study.

      Patients are followed for up to 5 years.
    

Intervention name(s): cetuximab; fluorouracil; neoadjuvant therapy; radiation therapy
Intervention type(s): Biological; Drug; Procedure; Radiation
Intervention MeSH terms: Fluorouracil; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent rectal cancer; stage II rectal cancer; stage III rectal cancer; adenocarcinoma of the rectum
Dose Esmolol Infusion Have an Adjuvant Effect to TAP Block for Pain Control in Laparoscopic Cholecystectomy.
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Pain after laparoscopy differs considerably from that seen after laparotomy. Laparotomy
      results mainly in parietal pain (abdominal wall), where as Pain in laparoscopy results from
      stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic
      irritation caused by residual carbon-dioxide in the peritoneal cavity. The transverse
      abdominis plane (TAP) block is a peripheral nerve block designed to anesthetize the nerves
      supplying the anterior abdominal wall (T6 to L1). While esmolol is an ultra-short acting
      intravenous β-blocker having a rapid onset and offset effect. It provides an unprecedented
      level of tolerability and safety in the perioperative setting. When used as an adjunct, it
      has been shown to improve the postoperative recovery by reducing postoperative pain intensity
      and intraoperative anesthetic and opioid requirements and preventing opioid-induced
      hyperalgesia . The mechanism of this synergistic effect is uncertain, but both
      pharmacokinetic and pharmacodynamics interactions with anesthetic drugs have been proposed.
    


Intervention name(s): Esmolol
Intervention type(s): Drug
Intervention description(s): administration of a loading dose esmolol infusion 0.5 mg/kg in 30 ml isotonic saline in the IV line, followed by an IV infusion of esmolol 0.05 mg/kg/min till the completion of surgery
Intervention MeSH terms: Esmolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Esmolol infusion; TAP block; cholecystectomy
Novel Rapid POC Diagnostics for COVID-19
Condition: COVID-19 Respiratory Infection
MeSH terms: COVID-19; Respiratory Tract Infections
Study type: Observational

Summary: 
      This is a prospective, multicentre study in which the diagnostic accuracy of multiple
      Covid-19 Antigen rapid diagnostic tests will be assessed for COVID-19 case detection using
      prospectively collected nasal swabs and saliva samples from participants suspected to have
      Covid-19 infection (with or without symptoms). The study will last approximately 9 months.
    

Detailed description: 
      Adult individuals with presumptive Covid-19, either symptomatic or asymptomatic, will be
      screened for inclusion at 4 different study sites located in Georgia and South Africa.

      Enrolled participants will be asked to provide 2 samples: one nasopharyngeal swab that will
      be utilized for Covid-19 diagnosis by standard PCR and one sample (either nasal swab or
      saliva) to be used for the new antigen rapid diagnostic test under evaluation. At least 2
      different antigen tests will be evaluated to determine sensitivity and specificity: Novel
      Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Jiangsu Bioperfectus Technologies) and
      GeneFinder COVID-19 Ag Rapid test (Osang Healthcare).

      The data gathered from this study, could be used as part of the dossier to be submitted to
      WHO (world health organization) for review.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals (≥ 18 years old) suspected to have COVID-19 (as per national or WHO guidelines)
        presenting at the testing site(s) will be invited to participate. Each participant will
        have two respiratory swabs collected: one for RT-PCR testing and diagnosis, paired with a
        second swab to be used on the index Ag RDT. In order to meet the study objectives, two
        different population groups will be considered:

          1. SYMPTOMATIC: Individuals (≥ 18 years old) suspected to have COVID-19 (as per national
             or WHO guidelines) and presenting at the testing site(s) with symptoms of COVID-19.

          2. ASYMPTOMATIC: Individuals (≥ 18 years old) at risk of COVID-19 (as per national or WHO
             guidelines) and presenting at the testing site(s) with no symptoms of COVID-19
Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic
Condition: Colic
MeSH terms: Colic
Study type: Interventional
Phase: Phase 2

Summary: 
      Infantile colic is a common medical condition which remains a frustrating problem for parents
      and health care providers with no clear treatment guidelines. To fill the void in existing
      literature, we present a protocol to examine whether probiotics are effective in decreasing
      infantile colic symptoms when compared to placebo treatment.

      We hypothesize that oral administration of the probiotic L. reuteri DSM 17938 will reduce
      symptoms of infantile colic in breastfed infants in comparison to placebo.

      An interim analysis will be conducted after 50 infants randomized to monitor both safety and
      efficacy.
    

Detailed description: 
      Infantile colic is one of the most commonly reported medical problems within the first three
      months of life causing appreciable distress for both parents and pediatricians. The reported
      incidence of infantile colic ranges from 3% to 28% in prospective studies and up to 40% in
      retrospective surveys.

      The pathogenesis of infantile colic remains elusive despite decades of research. It appears
      that multiple independent origins might be involved: amongst them infant's difficult
      temperament, inadequate mother-infant communication or maternal anxiety, transient lactase
      deficiency, exposure to cow's milk, abnormal gastrointestinal function, maternal smoking
      during pregnancy or after delivery. Consequently, various treatment approaches have been
      tried to alleviate this condition.

      Recent studies have suggested that changes of intestinal microflora of a newborn may play an
      important role in pathogenesis of infantile colic. Therefore, dietary supplementation with
      probiotics has been proposed for the improvement of this condition.
    

Intervention name(s): Biogaia L. reuteri DSM 17938; Probiotic Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Freeze-dried Lactobacillus reuteri DSM 17938 suspended in oil. Brand Name Active Agent: BioGaia™; Description of Placebo: contains same excipients as Active Agent, without the active ingredient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: pediatric; infantile colic; probiotic treatment