bioihbjkbjnl/mcl2 huggingface dataset:
Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the study is to investigate whether lactulose, given orally as powder or
      liquid, increases blood glucose levels in patients with diabetes mellitus type 2. The dose of
      lactulose given in the study is normally used for treatment of constipation.
    


Intervention name(s): Lactulose crystals 20 g; Lactulose crystals 30 g; Lactulose liquid 20 g; Lactulose liquid 30 g; Glucose; Still water
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): White or almost white crystalline powder. The product will be provided in sachets to be dissolved in 250 mL water.; White or almost white crystalline powder. The products will be provided in sachets to be dissolved in 250 mL water.; Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.; Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.; White crystalline powder. To standardise for 30 g glucose, 33 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water.; 250 mL still water will be used. Water from the same source will be also used to dissolve investigational and control products
Other intervention name(s): Laevolac crystals 20 g; Laevolac crystals 30 g; Laevolac liquid 20 g; Laevolac liquid 30 g; Glucose Monohydrate; Water
Intervention MeSH terms: Methamphetamine; Lactulose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Blood glucose; Diabetes Mellitus, Type 2; Lactulose; Constipation; Oral intake
Vericiguat Drug-drug Interaction Study With Isosorbite Mononitrate in Stable Coronary Artery Disease Patients
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to investigate the pharmacodynamic drug-drug interaction as well as
      the safety and tolerability of isosorbite mononitrate and vericiguat in patients with stable
      coronary artery disease.
    


Intervention name(s): Vericiguat (BAY1021189); Placebo; Isosorbide mononitrate (ISMN)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2.5 mg/tablet; 5 mg/tablet or 10 mg/tablet; Matching placebo; 30 mg/tablet or 60 mg/tablet
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Preoperative Gabapentin for Post-tonsillectomy Pain in Children
Condition: Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The typical post-operative course for children following surgical removal of their tonsils
      and adenoids can be challenging, especially for pain control. First line medications for pain
      include intravenous and enteral narcotics, acetaminophen and nonsteroidal anti-inflammatory
      drugs (NSAIDs) or N-methyl-D-aspartate (NMDA) antagonists but their effects appear to be
      short-lived. Gabapentin has been shown in adult studies to tone down the body's response to
      pain and decreases opioid use post-operatively. The purpose of this study is to see if a
      single preoperative dose will reduce post-operative pain scores and the amount of analgesic
      used.
    

Detailed description: 
      This is a randomized, double blind, placebo-controlled trial to study the effect of a
      preoperative oral dose of gabapentin on postoperative analgesic requirements and subjective
      pain levels in children undergoing tonsillectomy with adenoidectomy. Investigators will also
      look for a limited set of genotypic variations to explain any difference between individuals
      or groups in their response to the medication. Additionally, investigators will document
      potential adverse effects including excessive sedation, respiratory issues, surgical bleeding
      and emergence agitation/delirium.

      Investigators hypothesize that gabapentin will reduce opioid analgesic requirements and pain
      scores up to 36 hours post adenotonsillectomy without increased adverse effects such as
      emergence delirium, respiratory complications or bleeding. The clinical effect may depend on
      the individual's pharmacogenetic profile to look for a specific set of genetic polymorphisms
      that relate to the metabolism and effect of the study drug, gabapentin, and opioid analgesic
      pain medications.
    

Intervention name(s): Gabapentin; liquid placebo
Intervention type(s): Drug; Drug
Intervention description(s): The active comparator, Gabapentin, is a structural analog of g-aminobutyric acid which has anticonvulsant properties. This study is a prospective randomized double-blinded trial examining the effectiveness of a single dose of liquid Gabapentin given 60 minutes prior to surgery for pain management in pediatric tonsillectomy/adenoidectomy pediatric patients.; Subjects randomized to the liquid placebo will receive an identical appearing liquid placebo of 0.4mL/kg.
Other intervention name(s): Neurontin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatric pain; post operative pain; opioids; emergence agitation; preoperative anxiety; pharmacogenomics
Varenicline for Adolescent Smoking Cessation
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21.
      After assessment and inclusion into the study, participants will be randomized to receive a
      12-week double blind course of varenicline or placebo.
    

Detailed description: 
      The objective of this protocol is to examine the efficacy and safety of varenicline for
      smoking cessation in adolescents. The guiding design philosophy was to model the adult
      smoking cessation literature (allowing for indirect comparisons of efficacy in different
      populations) while fine-tuning some elements specifically geared for adolescents. After
      assessment and inclusion into the study, participants will be randomized to receive a 12-week
      double blind course of varenicline or placebo. Participants will provide smoking self-report
      (cigarettes per day) throughout the study. Biological confirmation with carbon monoxide
      breathalyzer will occur at all visits, and urine cotinine measurement will occur at key time
      points (baseline, end of treatment and final post-treatment follow-up). Psychiatric/medical
      visits will occur weekly throughout active treatment to systematically monitor safety and
      tolerability. After the 12-week treatment course, participants will return for 3
      post-treatment follow-up visits (Week 13, Week 18, and Week 26).
    

Intervention name(s): Varenicline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.; participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Liquid Biopsy Using Methylation Sequencing for Lung Cancer
Condition: Lung Cancer; Diagnoses Disease
MeSH terms: Lung Neoplasms; Disease
Study type: Observational

Summary: 
      This study aims to investigate the utility of circulating tumor DNA (ctDNA) methylation
      sequencing in the diagnosis of primary lung cancer.
    

Detailed description: 
      Plasma sample of patients with and without lung cancer will be collected and analyzed using
      methylation-sensitive enzyme sequencing method. Diagnostic performance of ctDNA methylation
      sequencing will be compared with that of tumor markers (CEA, Cyfra 21-1, and NSE) combined.
    

Intervention name(s): Circulating Tumor DNA Methylation Sequencing
Intervention type(s): Diagnostic Test
Intervention description(s): Whole blood (21mL) collection through venipuncture. Analysis of tumor markers and ctDNA methylation sequencing.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Lung cancer

               1. Pathologically proven lung cancer

               2. Clinically suspected lung cancer on chest CT scan

                    1. nodule, mass, pulmonary infiltrate, or consolidation

                    2. size : diameter at least 1 cm

                    3. CT attenuation of solid or part-solid

                    4. planned to follow-up, biopsy, or surgical resection

          -  Benign pulmonary disease

               1. COPD : post bronchodilator FEV1/FVC < 0.7 and FEV1 pred < 80%

               2. ILD : either histologic or clinical diagnosis

               3. Pneumonia : community or hospital acquired

               4. Bronchiectasis : chest CT diagnosis

               5. NTM : at least 2 isolation of pathogen from sputum

               6. Pulmonary vascular disease : embolism, pulmonary hypertension, arteriovenous
                  malformation
      
Keywords: Lung Cancer; Methylation Sequencing; Liquid Biopsy
To Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and safety of oral
      administration of BR9001 compared with BR900A in healthy subjects
    

Detailed description: 
      This is an open-label, randomized, crossover study to evaluate the pharmacokinetics and
      safety. Within each period, randomized subjects will be take 2 dosing regimens that BR9001 or
      BR900A.
    

Intervention name(s): BR9001; BR900A
Intervention type(s): Drug; Drug
Intervention description(s): BR9001 is a test drug as generic; BR900A is a reference drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Generic
Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of Cetaphil® Restoraderm® skin restoring
      moisturizer in reducing the signs and symptoms of very dry atopic skin in young children.
      Subjects with atopic dermatitis (AD) in remission phase will be randomized to receive either
      Cetaphil® Restoraderm® skin restoring body wash only, or the same body wash in association
      with Cetaphil® Restoraderm® skin restoring moisturizer.
    


Intervention name(s): Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash; Cetaphil® Restoraderm® body wash
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Efficacy of Autologous Fibrin Glue in Pterygium
Condition: Pterygium
MeSH terms: Pterygium
Study type: Interventional

Summary: 
      Pterygium is wing-shaped, vascular, fleshy growth that originates on the conjuntiva and that
      can spread to the corneal limbus and beyond The surgical exeresis with autologous
      conjunctival autograft technique is the treatment of choice. Commercially available fibrin
      glue has been used preferentially for graft fixation due to its benefits compared to sutures;
      However, its cost and the risk of inflammatory immune reaction limit the its use. There are
      few studies about autologous fibrin glue.

      OBJECTIVE: To determine the efficacy of autologous fibrin glue preparation in patients
      undergoing pterygium resection surgery. To compare with autologous conjunctival graft
      fixation with suture.

      This is a randomized clinical trial. Two patient groups will undergo pterygium excision
      surgery. Group 1 will have autologous conjunctival graft fixation with autologous fibrin glue
      and group 2 will have suture graft fixation using 10.0 mononylon. Early and late
      postoperative surgical results as well as complication rates will be analyzed.
    


Intervention name(s): Autologous fibrin glue; Suture
Intervention type(s): Other; Other
Intervention description(s): Conjunctival graft fixation with autologous fibrin glue; Graft fixation using 10.0 mononylon
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Anti-IgE in Chronic Urticaria
Condition: Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being done to find out if a drug called Xolair (omalizumab), an anti-IgE
      antibody, is safe and effective for people with chronic urticaria (hives) with persistent
      symptoms in spite of taking antihistamines.
    

Detailed description: 
      Omalizumab (Xolair®) is a recombinant humanized monoclonal antibody that binds specifically
      to the FcEpsilonR1 binding site on human IgE. The binding of omalizumab inhibits the ability
      of IgE to bind to basophils or mast cells. Free IgE levels fall by 89% and 98% over 16 and 24
      weeks of therapy respectively (Busse, 2001). Total IgE levels rise in patients treated with
      omalizumab though almost all IgE is bound and thus inactive. Omalizumab has also been shown
      to decrease expression of the FcEpsilonR1 receptor on both basophils and mast cells (Beck et
      al, 2004). Omalizumab recently received FDA approval for the treatment of moderate to severe
      persistent allergic asthma in pediatric (12 years of age and above) and adult patients.
      Studies have also shown efficacy in the treatment of allergic rhinitis and similar anti-IgE
      compounds have been efficacious as food allergy therapeutics (Casale, 2001, and Leung 2003).

      Given the efficacy of omalizumab in the treatment of moderate to severe allergic asthma, the
      researchers will conduct a double-blind study to evaluate the safety and efficacy of
      omalizumab in a small number of patients with chronic urticaria with persistent symptoms in
      spite of background antihistamine therapy. Omalizumab is currently not indicated for patients
      with chronic urticaria. The primary hypothesis is that omalizumab will lead to a reduction in
      serum IgE levels and blood basophil high affinity IgE receptor expression in subjects with
      chronic idiopathic urticaria. Additionally, clinical outcomes such as quality of life,
      symptoms scores, and medication use will be explored. This study should allow for further
      understanding of the role IgE plays in chronic urticaria.
    

Intervention name(s): Xolair® (Omalizumab)
Intervention type(s): Drug
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: urticaria; hives; Xolair
Pharmacokinetics and Pharmacodynamics of Anthocyanins
Condition: Gout
MeSH terms: Gout
Study type: Interventional

Summary: 
      The purpose of the study is to establish the pharmacokinetic parameters of cherry juice
      concentrate and identify its potential to alter inflammatory markers in gout patients.
    


Intervention name(s): Tart cherry extract 60 mL; Tart cherry extract 120 mL
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will receive a single 60 mL oral dose of tart cherry extract.; Subjects will receive a single 120 mL oral dose of tart cherry extract.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Gout; Tart Cherry; Pharmacokinetics
Technology That Permits Focal Dose of Antibiotics to be Delivered to Lower Limb(s) of Diabetic Patients
Condition: Diabetes; Infection
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The use of the Percutaneous Isolated Limb Procedure (PILP) which enables the use of existing
      antibiotic therapies in a more targeted and concentrated fashion in patients with diabetes
      who have a significant lower limb infection and it is deemed that IV antibiotics are needed
      in order to salvage the limb or life.
    

Detailed description: 
      During the PILP procedure, the circulation of the limb is isolated separately from the
      general circulatory system thereby enabling the delivery of antibiotics only to the limb.
      Limb isolation is achieved by creating an "artificial" circuit where catheters are inserted
      into the major artery and vein of the lower limb.
    

Intervention name(s): Percutaneous Isolated Limb Perfusion (PILP) delivery; Timentin
Intervention type(s): Procedure; Drug
Intervention description(s): The Percutaneous Isolated Limb Perfusion (PILP) delivery intervention procedure enables the use of existing antibiotic therapies in a more targeted and aggressive fashion; it addresses limitations associated with the use of conventional antibiotic drug delivery. As part of the procedure, the circulation of the limb is isolated separately from the general circulatory system enabling the delivery of antibiotic at high therapeutic doses that are not achievable when standard doses are administered intravenously.; The Control Group will receive standard dosings of intravenous Timentin plus other standard care.
Other intervention name(s): Ticarcillin and Clavulanate
Intervention MeSH terms: Clavulanic Acid; Ticarcillin-clavulanic acid; Ticarcillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Lower limb infection; Significant wound infections; Intravenous antibiotics; Timentin
Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      It was conducted a prospective study with a series of 153 patients treated with PRP
      injections in patient affected by knee osteoarthritis. One independent observer performed
      clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection),
      T2 (three months after the last injection) and T3 (six months after the last injection).

      The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Score
      Society (KSS) score and the Visual Analogue Scale (VAS) were evaluated and recorded for each
      patient at each follow up.
    


Intervention name(s): PRP injections
Intervention type(s): Procedure
Intervention description(s): The 5 mL PRP concentrate was injected every week for three times, starting from recruitment. The patient was placed supine whit a knee flexion of 90°.All the procedures were carried out in an aseptic condition, injected in the knee soft spot through an anterior approach, using a 21-gauge needle.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        One hundred and fiftythree patients referring to the Orthopaedic and Trauma Unit of the
        local University Hospital between January 2018 and January 2020 with knee osteoarthritis
      
Keywords: knee osteoarthritis (KOA); Platelet-rich plasma (PRP);
Efficacy and Safety of CONAN® Proctological Cream for Treatment of Haemorrhoidal Disease
Condition: Hemorrhoid Pain; Haemorrhoid Inflammation
MeSH terms: Hemorrhoids; Inflammation
Study type: Interventional

Summary: 
      Aim of the study is to assess the efficacy, safety and tolerability of CONAN® (Proctological
      Cream, Medical Device, Omikron Italia Srl) on most frequent symptoms in grade 1-2 of
      haemorrhoidal disease and anal fissures.
    

Detailed description: 
      Background: To evaluate the role of CONAN® Proctological Cream containing escin, hesperidin
      and hyaluronic acid in topical treatment of haemorrhoidal disease and anal fissures and its
      potential efficacy in reducing related symptoms.

      Methods: Forty patients with haemorrhoidal disease and anal fissures were enrolled. Of them,
      20 were randomized to receive the medical device CONAN® Cream (Group A) and 20 to the
      untreated control group (Group B). At each scheduled visit, total symptoms were assessed and
      recorded by assigning a Numerical Rating Scale score from 0 to 10. The adverse events
      reported by study subjects were also assessed and recorded.
    

Intervention name(s): CONAN® Proctological Cream
Intervention type(s): Device
Intervention description(s): The active treatment samples used for the duration of the study were allocated at the site involved and consisted in 30 g tubes with an endorectal applicator, identified by the batch number, expiry date and information on the study on dedicated labels. The treatment of patients randomized to Group A consisted in applying the local treatment (1 application 3 times/day) for 30 days. Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study population was randomized into two treatment arms: Group A, active treatment (CONAN® Proctological Cream, Medical Device, Omikron Italia Srl) and Group B, the control group (bowel-function regulation).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Haemorrhoids; anal fissures; controlled clinical trial.