bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole
Condition: Graves' Disease
MeSH terms: Graves Disease; Hyperthyroidism
Study type: Interventional

Summary: 
      Evaluation of the efficacy of the combined treatment (methimazole plus selenium) in the
      control of hyperthyroidism as compared to methimazole alone in 30 Graves' disease (GD)
      untreated patients.
    

Detailed description: 
      30 untreated GD hyperthyroid patients will be randomized into two groups (A and B). Group A
      patients will be treated with an anti-thyroid drug (methimazole) at the dose aimed to control
      hyperthyroidism. Group B patients will be treated with methimazole plus selenium (160 mg
      daily). Patients will be evaluated at time 0, 45 and 90 days for symptoms of hyperthyroidism
      (by a specific questionnaire), clinical status (weight, heart rate), laboratory (thyroid
      function tests, TSHR autoantibodies, serum selenium, index of oxidative stress-MDA,
      cholesterol, SHBG) and EKG. The aim of the study is to evaluate if the combined treatment
      (methimazole plus selenium) is more effective than methimazole alone in controlling GD
      hyperthyroidism.
    

Intervention name(s): Selenium; Methimazole
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Selenium 80 mg bid for 90 days; Methimazole starting dose depending on FT3 values (15 mg/day or 20 mg/day or 30 mg/day, for FT3 values <10 pg/ml, 10-15 pg/ml, >15 pg/ml, respectively) to be tapered by 5 mg/day every 15 days down to values sufficient for FT3 to be normal
Other intervention name(s): Syrel; Tapazole
Intervention MeSH terms: Selenium; Methimazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperthyroidism; Methimazole; Selenium
Measuring Comfort and Clarity With Low Gain Feature in Pediatric Hearing Aid Users
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Comfort and clarity of speech will be measured in hearing impaired children age 8-17 using
      standard speech processing algorithm with a soft speech enhancer feature, referred to as the
      Adaptive Situational Gain (ASG) feature in study documents.
    


Intervention name(s): Phonak Audeo hearing aid
Intervention type(s): Device
Intervention description(s): receiver in the canal devices with custom earmolds
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      ECOS is a cross-sectional, observational, longitudinal, multicenter study enrolling 100-200
      patients during a COPD exacerbation.
    

Detailed description: 
      Patients will be followed for 12 months. Information to be collected includes clinical,
      analytical, immunological, microbiological, hemodynamic, imaging, environmental, social and
      other blood markers of inflammation (IL-8, IL-6, TNF, TNF-alpha, endothelin-1, SLPI, IL10,
      TGF-beta and markers oxidative stress (TEAC)), and sputum (cell count, IL-6, IL-8, SLPI, ET
      1, IL10).

      Each center will collect clinical data, blood gas, microbiological and functional data for
      their patients, which will be centralized through the website of the Red Respira
      (www.redrespira.net).

      A frozen serum sample and another of frozen sputum supernatant will be sent to the
      coordinating center (Palma de Mallorca).

      Statistical analysis will include descriptive statistics: mean, standard deviation and range.
      Comparison of quantitative variables to be assessed using Student's t-test and ANOVA.
      Correlations between variables will be performed using bivariate analyzes (Pearson's linear
      correlation coefficient) and multivariate (multiple regression) analyses, among others.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COPD patients admitted in any of the participating ECOS hospitals with a diagnosis of COPD
        exacerbation
      
Biospecimen description: 
      Blood
    
Keywords: Biomarkers; Exacerbations; COPD
Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578)
Condition: Atherosclerosis; Hypercholesterolemia; Hyperlipoproteinemia Type II
MeSH terms: Atherosclerosis; Hypercholesterolemia; Hyperlipoproteinemias; Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine whether ezetimibe plus simvastatin will be more
      effective than simvastatin alone in preventing progression of atherosclerosis of the inner
      layer of the carotid artery.
    


Intervention name(s): ezetimibe (plus simvastatin); placebo (plus simvastatin)
Intervention type(s): Drug; Drug
Intervention description(s): oral tablets; ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months; tablets; placebo to match ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months
Other intervention name(s): ZETIA; VYTORIN; SCH 58235; SCH 465981
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bioequivalence Study of Adapalene Gel 0.3% in Subjects With Facial Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% (Aleor
      Dermaceuticals Limited, India) and Differin® (Adapalene) Gel 0.3% (Galderma Laboratories, LP
      USA) in the treatment of acne vulgaris.
    


Intervention name(s): Adapalene Gel 0.3%; Differin 0.3% Topical Gel; Adapalene Gel 0.3% Vehicle Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days; Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days; Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days
Intervention MeSH terms: Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double (Participant, Investigator)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacist-Driven Stress Ulcer Prophylaxis Minimization in the Intensive Care Unit
Condition: Stress Ulcer
MeSH terms: Ulcer
Study type: Interventional

Summary: 
      Pharmacologic stress ulcer prophylaxis is routinely used in the intensive care unit (ICU) to
      prevent upper gastrointestinal (GI) bleeding in critically ill patients.
    

Detailed description: 
      1 Historically, the two independent risk factors for stress-related GI bleeds were
      coagulopathy and mechanical ventilation for more than 48 hours; however, several additional
      risk factors have been identified, such as shock, multiple organ failure, traumatic brain
      injury, and major burns.

      Acid suppressive medications such as proton pump inhibitors or histamine-2 receptor
      antagonists are prescribed to reduce the rate of bleeding from stress ulceration despite a
      lack of benefit from placebo-controlled trials.6-8 In addition to lack of proven benefit, the
      incidence of clinically significant stress-related GI bleeding has decreased over time,
      likely due to improvements in critical care and earlier enteral feeding.1
    

Intervention name(s): To evaluate the effectiveness and safety of a pharmacist-driven protocol to discontinue stress ulcer prophylaxis in ICU patients when it is no longer indicated according to pre-defined criteria.
Intervention type(s): Behavioral
Intervention description(s): To evaluate the effectiveness and safety of a pharmacist-driven protocol to discontinue stress ulcer prophylaxis in ICU patients when it is no longer indicated according to pre-defined criteria.
To compare the incidence of overt GI bleeds (defined as hematemesis, bloody nasogastric tube aspirate, or melena) between patients who were on stress ulcer prophylaxis versus patients whose acid suppression therapy was discontinued through the stress ulcer prophylaxis minimization protocol.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Body Responses to Bean Physical Form and "Beano"
Condition: Appetite and Glucose Responses
Study type: Interventional

Summary: 
      The aim of this study is to determine the effects of bean physical form (whole versus
      blended) and Beano on postprandial responses. The postprandial responses the investigators
      will examine include blood glucose, appetite, metabolic rate, physical symptoms, and mood. To
      accomplish this aim the investigators will conduct a randomized, placebo-controlled trial in
      overweight and obese but otherwise healthy (non-diabetic) men and women
    


Intervention name(s): blended lentils; whole lentils; no lentils
Intervention type(s): Other; Other; Other
Intervention description(s): blended lentils burritto breakfast; whole lentils breakfast burritto; No lentils control breakfast burritto
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Study to Gather Information on the Acceptability of a New Flavor System With Increasing Levels of 2, 4, 6 g or Higher of Mannitol for PEG 3350 in Subjects Having Infrequent Bowel Movements.
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      Study to gather information on the acceptability of a new flavor system with increasing
      levels of 2, 4, 6 g or higher of the sugar alcohol Mannitol for Polyethylene glycol (PEG)
      3350 a drug stimulating bowel movement to pass stool in subjects having infrequent bowel
      movements. The taste of the various preparations will be measured by use of a rating scale.
    


Intervention name(s): Polyethylene glycol (MiraLAX, BAY81-8430); Mannitol
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution, 17g polyethylene glycol, one time; Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Intervention MeSH terms: Mannitol; Polyethylene glycol 3350
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Two Different Applications in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The study aims to determine the effect of connective tissue massage and taping applications
      on the pain and depression complaints of fibromyalgia patients and to compare their impact on
      quality of life.
    


Intervention name(s): Connective tissue massage; Kinesio Tape Application
Intervention type(s): Other; Other
Intervention description(s): Connective Tissue Massage will be applied by starting from the lumbosacral region, continuing from the lower thoracic region, and finishing by applying it to the scapular region, interscapular region, and cervico-occipital region.; Taping will be applied to the levator scapula and upper trapezius muscles in a "Y" shape, with 25% tension and while the participants were in an upright position. Again in the same position, this time the "C" shaped taping technique will be adhered with 50% tension from the middle fibers of the trapezium to the last rib.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
TIVA Versus Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery
Condition: Total Intravenous Anesthesia; Desflurane; Obesity; Pain, Postoperative; Nausea, Postoperative
MeSH terms: Nausea; Pain, Postoperative; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      Many factors during laparascopic surgery leads to PONV (postoperative nausea and vomiting),
      such as C02 insufflations causing peritoneal stretch and irritation and type of anaesthesia
      given during surgery.

      The two anesthetic techniques used in bariatric surgery are gas anesthesia (Remifentanil TCI
      and Desfluran) and Total Intra Venous Anesthesia (TIVA) with propofol. There are studies
      which have shown a reduction in postoperative nausea and vomiting following TIVA, and there
      are publications showing no statistically significant difference.

      The aim of this study was to investigate the best anaesthetic approach for obese subjects,
      evaluating awakening time, postoperative nausea and pain.

      Our hypothesis was based on the fact that Propofol is a lipid-soluble anesthetic and
      therefore might have a prolonged effect in obese patients, leading to a longer awakening time
      along with postoperative nausea and vomiting. This hypothesis is also described earlier by
      obese patients have more depots (bulk fat) and also more fat surface making anaesthetics
      storage more easier, and also that the anesthetic will return into the circulation when the
      administration is stopped [18].
    


Intervention name(s): Desflurane
Intervention type(s): Drug
Intervention description(s): Desflurane vs TIVA, bariatric surgery. Postoperative nausea and pain
Other intervention name(s): PROPOFOL
Intervention MeSH terms: Propofol; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized control trial.
Masking: Single (Participant)
Primary purpose: Treatment
Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation
Condition: Postoperative Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      Atrial Fibrillation (AF) is one of the most common postoperative complications after coronary
      artery bypass grafting (CABG). Postoperative AF produces a substantial impact on hospital
      resources with an estimated annual expenditure of over $1 billion. This includes the cost of
      pharmacological treatment and the cost of the increased length of stay. The incidence of AF
      is about 30-40% in CABG patients and increases with age of the patient. As the average age of
      the patient that undergoes CABG surgery is increasing, it is critical to find a way to
      prevent or reduce the incidence of this complication.

      We propose a prospective, randomized, controlled study to determine the role of pulmonary
      vein isolation by bipolar ablation in the prevention or reduction of postoperative AF. The
      block- randomization plan will be used to maintain balance of the study and control arms
      throughout the study.
    


Intervention name(s): Isolation of pulmonary veins with Bipolar radiofrequency ablation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers
Condition: Duodenal Ulcer Due to Helicobacter Pylori
MeSH terms: Duodenal Ulcer; Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      Helicobacter pylori (Hp) infection is one of the important causes of gastrointestinal
      diseases, including gastritis, peptic ulcer, and malignancies, nd the eradication of Hp can
      effectively cure or prevent these diseases. Now, owing to the increasingly serious antibiotic
      resistance, Hp eradication rate is, however, becoming decreased. In order to improve the
      eradication rate of Hp, clinicians pay great attention to choose more effective treatment.

      Ilaprazole Enteric-Coated Tablets is a new generation of proton pump inhibitor (PPI).
      Previous research found that Ilaprazole had a more prolonged half-life and higher suppression
      of gastric acid secretion. In addition, its metabolism is not significantly influenced by
      CYP2C19, compared to the available PPIs. Doxycycline is in the tetracycline antibiotic class,
      has a stronger antibacterial force than tetracycline and its antibacterial spectrum is
      basically the same as tetracycline and doxycycline, so far, it is not widely used.
      Preliminary observations showed that Ilaprazole/Doxycycline-based quadruple therapy was
      effective in treating Hp infection, with less adverse reactions and good compliance with
      patients.

      In this study, a multi-center, randomized, parallel controlled trial will be conducted in 7
      hospitals in Hunan Province, China, to observe the clinical efficacy and safety of the
      Bismuth-containing quadruple therapy with Ilaprazole, Doxycycline, Furazolidone and Bismuth
      Potassium Citrate in the treatment of Hp infected duodenal ulcer. It is expected to complete
      200 effective cases, including 100 cases in the experimental group and 100 cases in the
      control group.
    


Intervention name(s): Doxycycline Hyclate Enteric-Coated Capsules; Amoxicillin Capsules; Ilaprazole Enteric-Coated Tablets; Furazolidone Tablets; Potassium Citrate Tablets
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): group 1,0.1g*10 capsules/box, produced by Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd.; group 2,0.5g*24 capsules/box, produced by United Laboratories（Zhuhai）; group 1 and group 2,5mg*6 capsules/box, produced by Livzon Pharmaceutical Group Inc; group 1 and group 2,0.1g*100 tablets/bottle,produced by Shanxi Yunpeng Pharmaceutical co.,Ltd.; group 1 and group 2,110mg*40 tablets/bottle,produced by Livzon Pharmaceutical Group Inc
Intervention MeSH terms: Amoxicillin; Doxycycline; Furazolidone; Potassium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori eradication; Duodenal Ulcer; Ilaprazole/Doxycycline-based Bismuth-containing quadruple therapy
Efficacy of Vortioxetine on Cognitive Dysfunction in Patients With Partial or Full Remission of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the efficacy of vortioxetine (10 to 20 mg/day) as adjunctive treatment to stable
      selective serotonin reuptake inhibitor (SSRI) dose versus stable SSRI monotherapy on
      cognitive performance (focusing on the aspect concerning speed of processing, executive
      functioning and attention) in patients who are in partial or full remission from their Major
      Depressive Episode (MDE).
    


Intervention name(s): Vortioxetine 10-20 mg; Placebo; SSRI
Intervention type(s): Drug; Drug; Drug
Intervention description(s): escitalopram, citalopram or sertraline
Other intervention name(s): Brintellix®; Lu AA21004
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pramipexole (BI-Sifrol®) Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this trial is to investigate the efficacy and safety of pramipexole
      (0.125-0.75 mg) orally once daily as compared with placebo for 6 weeks in patients with
      primary restless legs syndrome (RLS) and to investigate the reliability of the Japanese
      version of the RLS rating scale by the International Restless Legs Syndrome Study Group
      (IRLSSG) as a sub-study.
    


Intervention name(s): Pramipexole 0.125 mg tablets; Pramipexole 0.125 mg tablets Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Botulinum Toxin in the Treatment of Raynaud's
Condition: Raynaud's Syndrome
MeSH terms: Raynaud Disease
Study type: Interventional

Summary: 
      The investigators are studying a medical condition known as Raynaud's Phenomenon (RP). RP is
      a painful condition in which cold surroundings or stressful events trigger pain, a cold
      sensation, and in severe cases, sores and ulcers on one's fingers. The investigators think
      that RP results from problems with some of the components of the blood vessels, surrounding
      nerves, and some of the circulating messengers in the bloodstream. Although there are many
      different medicines that are currently used to treat RP, the investigators have not yet found
      a cure for severe cases of this condition. Furthermore, the investigators have found few
      medicines that show consistent healing of the ulcers that may be associated with RP. Some of
      the treatments include medicines that are used to treat high blood pressure known as calcium
      channel blockers. Medications that thin the blood (anticoagulants) such as aspirin have also
      been used to treat RP.

      In this study, the investigators will investigate a new treatment for RP known as Botulinum
      toxin A. Botulinum toxin is a chemical that is temporarily toxic to nerves, but has been
      approved by the government for the treatment of several other conditions including but not
      limited to: excessive sweating, neck pain associated with a condition known as cervical
      dystonia, uncontrollable forcible closure of the eyelids known as blepharospasm, and a
      condition known as strabismus in which the eyes are not in alignment with one another.

      This study will aim to greatly improve the quality of life and pain associated with RP.
      Previous studies also support the chance that Botulinum toxin will help to heal some of the
      ulcers associated with RP. Although there is no current standard of care, many of the
      patients in the study will have already failed or are unable to tolerate commonly used
      treatments such as lifestyle modifications, calcium channel blockers, nitroglycerin, and
      anticoagulants. If the patient chooses to participate in the study, he/she will be randomly
      assigned to receive an injection with Botulinum toxin in either the left or right hand. The
      other hand will be injected with saline solution. Neither the patient nor the physician or
      research personnel seen in follow-up will know which hand is injected with Botulinum toxin.
    


Intervention name(s): botulinum toxin A
Intervention type(s): Drug
Intervention description(s): Botulinum toxin A will be injected into participants hand total 40units
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Scleroderma; Raynaud's Syndrome