bioihbjkbjnl/mcl2 huggingface dataset:
Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy
Condition: Helicobacter Pylori Infection
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      Increasing drug resistance presents a significant challenge to the efficacies of common
      empiric eradication regimens for Helicobacter pylori treatment in the mainland of China.
      Tailored therapy may be the best choice to achieve good efficacy, especially in patients with
      penicillin allergy. Few studies had evaluated the patients with penicillin allergy.This study
      is designed to evaluate the efficacy and safety of antibiotic sensitivity-based tailored
      therapy for Helicobacter pylori treatment in the patients with penicillin allergy.
    


Intervention name(s): Esomeprazole; Bismuth Potassium Citrate; Clarithromycin; Metronidazole; Levofloxacin; Tetracycline
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Proton pump inhibitor; Gastric mucosal protective drug with anti-H. pylori effect; antibiotic for H. pylori eradication; antibiotic for H. pylori eradication; antibiotic for H. pylori eradication; antibiotic for H. pylori eradication
Intervention MeSH terms: Metronidazole; Clarithromycin; Levofloxacin; Tetracycline; Potassium Citrate; Esomeprazole; Bismuth
Intervention model: Single Group Assignment
Intervention model description: After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid and two sensitive ones of clarithromycin, metronidazole,levofloxacin and tetracycline.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Tailored therapy; Penicillin allergy; Antimicrobial susceptibility testing
Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess the activity of 4 escalating doses of
      AVE0657 in comparison to placebo in patients with Obstructive Sleep Apnea Hypopnea Syndrome.
    


Intervention name(s): AVE0657; placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsules once a day at bedtime; capsules once a day at bedtime
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea
Metabonomics Fingerprinting of Multiple Trauma
Condition: Trauma
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      The aim of this study is to establish plasma metabonomics fingerprinting atlas for severe
      multiple trauma patient using 1H nuclear magnetic resonance (NMR) based metabonomics
      methodology and advanced mathematics tools.
    

Detailed description: 
      Metabonomics is a set of measurements of the dynamic metabolic responses of living systems to
      stimuli or modifications. This field of study developed from the application of nuclear
      magnetic resonance (NMR) spectroscopy and mass spectrometry as tools for the study of complex
      biofluids. Metabonomics is one of the emerging fields of systemic biology researches
      concerned with the high-throughput identification, quantification and characterization of
      small molecule metabolites. A metabonomics fingerprinting can be defined as the complete
      complement of all small molecule (<1500 Da) metabolites found in a specific cell, body fluid,
      organ or organism.

      Severe poly trauma involves complex injuries that consist of multiple pathological mechanisms
      involving cytotoxic, oxidation stress and immune-endocrine. The complexity of the
      pathological physiology and biochemistry process are determined not only by the initial
      mechanical assault, but also by secondary processes including abnormality of inflammation
      regulation, ischemia, anoxia, free-radical formation, and immune dysfunction that occur over
      hours and days following the injury. For the clinical perspective, one of the key
      difficulties is to identify the most at-risk patients who could develop multiple organ
      failures and consequently death.

      This study aims to establish the dynamics of NMR-based metabonomics fingerprinting of severe
      multi-trauma patients in order to provide a possible multiple organs failure (MOF) or death
      event prediction.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are suffering from poly trauma.
      
Biospecimen description: 
      Plasma from peripheral blood.
    
Keywords: Poly Trauma; Metabonomics; NMR; MOF
To Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets
Condition: Immunosuppression; Rheumatism
MeSH terms: Rheumatic Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.
    


Intervention name(s): Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.); Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Hydroxychloroquine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunosuppressant and Antirheumatic
Study of Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy
Condition: Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a randomized, double-blind, placebo-controlled, multi-center, Phase II study of s.c.
      secukinumab 300 mg in 98 randomized patients with overuse rotator-cuff tendinopathy without
      systemic inflammatory disease.
    

Detailed description: 
      This was a randomized, double-blind, placebo-controlled, multi-center, Phase II study of s.c.
      secukinumab 300 mg in 98 randomized patients with overuse rotator-cuff tendinopathy without
      systemic inflammatory disease and refractory to NSAIDs/acetaminophen, physiotherapy or
      corticosteroids.

      The study consisted of a 4-week screening period, a 2-week run-in period, a 12-week treatment
      period and a 12-week follow-up period after last treatment. The population consisted of
      patients with unilateral overuse (non-systemic inflammatory) shoulder tendinopathy, 18 - 65
      years of age.

      Safety assessments included physical examinations, ECGs, vital signs, standard clinical
      laboratory evaluations (hematology, blood chemistry, and urinalysis), adverse event and
      serious adverse event monitoring.
    

Intervention name(s): secukinumab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): AIN457 300 mg subcutaneously for 12 weeks; Placebo to match AIN457 subcutaneously for 12 weeks
Other intervention name(s): AIN457
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Overuse tendinopathy; shoulder; rotator cuff; IL-17A-Ab; AIN457X
Use of Ozonized Water With Toothpaste and Mousse in Non Surgical Periodontal Therapy for Patients With Diabetes Mellitus Type 1: a Randomized Clinical Trial.
Condition: Diabetes Mellitus With Periodontal Disease
MeSH terms: Periodontal Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy of Peribioma Toothpaste and Mousse for home
      oral care in patients with Diabetes Mellitus Type 1.

      Patients will undergo a professional oral hygiene procedure, followed by irrigation with
      ozonized water.

      Patients will be randomly divided into two groups:

        -  Trial Group: patients will use Biorepair Peribioma Toothpaste and Mousse for home oral
           care

        -  Control Group: patients will use Biorepair Plus Parodontgel toothpaste for home oral
           care.

      The variations of the following indices will be evaluated at the baseline, after 3 and 6
      months: glycosylated hemoglobin (HbA1c) , Clinical Attachment Level (CAL), Plaque Index (PI),
      Probing Pocket Depth (PPD) and Bleeding on Probing (BoP).
    

Detailed description: 
      The aim of this study is to evaluate the efficacy of Peribioma Toothpaste and Mousse for home
      oral care in patients with Diabetes Mellitus Type 1.

      Patients who respond to eligibility criteria and that will sign the informed consent will
      undergo a professional oral hygiene procedure; then, ozonized water (aquolab) will be used to
      irrigate periodontal pockets for 1 minute.

      Then, patients will be randomly divided into two groups:

        -  Trial Group: patients will use Biorepair Peribioma Toothpaste and Mousse for home oral
           care until the end of the study;

        -  Control Group: patients will use Biorepair Plus Parodontgel toothpaste for home oral
           care until the end of the study.

      Changes in the following indices will be evaluated at the baseline, after 3 and 6 months:
      glycosylated hemoglobin (HbA1c) , Clinical Attachment Level (CAL), Plaque Index (PI), Probing
      Pocket Depth (PPD) and Bleeding on Probing (BoP).
    

Intervention name(s): Peribioma Toothpaste and Mousse; Standard toothpaste
Intervention type(s): Other; Other
Intervention description(s): Use of Peribioma Toothpaste and Mousse for home oral care.; Use of Biorepair Plus Parodontgel for home oral care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ozonized water; glycosylated hemoglobin
Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate whether rosuvastatin improves measures of
      endothelial function, decreases measures of inflammation, and improves pulmonary function in
      patients with stable chronic obstructive pulmonary disease.
    


Intervention name(s): Rosuvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10mg tablets, once daily in three months; 1 tablet, once daily in three months
Other intervention name(s): Hydroxymethylglutaryl-CoA Reductase Inhibitor
Intervention MeSH terms: Rosuvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inflammation; Atherosclerosis; Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors
Effect of IV Infusion of Lidocaine Compared to IV Infusion of Dexmedetomidine on Proinflammatory Cytokines
Condition: Inflammatory Response
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to compare between intravenous infusion of dexmedetomidine and
      intravenous infusion of lidocaine in reduction of proinflammatory cytokines as IL-6 and
      TNF-α, some stress reactions (serum insulin and serum lactate),and postoperative analgesic
      requirements in patients undergoing surgery for pelviabdominal cancers.
    

Detailed description: 
      Cancer patients who undergo surgery face many sources of stress. Surgery causes major
      cytokine and neuroendocrinal changes like increased levels of catecholamine and steroid
      hormones and other metabolic consequences .This stress response is considered a defense
      mechanism important for developing resistance to noxious insults.

      The cytokine cascade caused by surgical stimulation is complex with various effects on the
      injured host. Increased production of proinflammatory cytokines from the site of injury
      causes many systemic changes such as metabolic derangements and hemodynamic instability. Some
      released cytokines like tumor necrosis factor alpha (TNF-α) and Interleukin 6(IL-6) can cause
      long lasting hyperalgesia. These proinflammatory cytokines change pain signal transmission
      through cytokine induced release of some neuroactive substances like nitric oxide, oxygen
      free radicals and excitatory amino acids. On the other hand anti-inflammatory cytokines are
      also released during inflammation to counteract these effects and keep balance.

      Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist that has sedative,
      analgesic, anesthetic-sparing properties with no respiratory depression. Its
      anti-inflammatory effects are being studied.

      Intravenous lidocaine can be used in management of chronic pain. Lidocaine has
      anti-inflammatory properties and is capable of reducing postoperative analgesic requirements
      and the length of hospitalization.

      The effect of both drugs on proinflammatory cytokines and stress response will be assessed
    

Intervention name(s): dexmedetomidine infusion; lidocaine infusion; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): a loading dose of 1µg/kg of dexmedetomidine (precedex) made to 50 ml using normal saline will be given over 10 minutes followed by infusion of dexmedetomidine with a dose of 0.5µg/kg/hour till the end of surgery.; a loading dose of 1.5 mg/kg of lidocaine made to 50 ml using normal saline and given over 10 minutes followed by infusion of lidocaine with a dose of 1.5 mg/kg/hour till the end of surgery.; 50 ml of normal saline given over 10 minutes followed by saline infusion intraoperatively at a rate of 10 ml/hour till the end of surgery.
Intervention MeSH terms: Lidocaine; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Gycabiane and Glycemic Control of Prediabetic Subjects
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of supplementation Glycabiane, a dietary
      supplement, on glycemic control of overweight prediabetic subjects.
    

Detailed description: 
      Cinnamon's effects on blood glucose have been the subject of many clinical and animal
      studies; however, the issue of cinnamon intake's effect on fasting blood glucose (FBG) in
      people with prediabetes still remains unclear.

      The main purpose of this study is to examine the effects of supplementation with Glycabiane,
      a dietary supplement rich in cinnamon extract, on fast blood glucose of overweight
      prediabetic subjects in a randomized, placebo-controlled, clinical trial.
    

Intervention name(s): Glycabiane; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 gelule per day for 4 months; 2 gelules per day for 4 months
Other intervention name(s): Dietary supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cinnamon; chromium; prediabete; overweight
A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants
Condition: Ebola Virus Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and reactogenicity of a heterologous 2-dose
      regimen utilizing Ad26.ZEBOV (first vaccination; Dose 1) and MVA-BN-Filo (second vaccination;
      Dose 2) administered intramuscularly (IM) on Days 1 and 57, respectively (Main Study) and
      also to provide the heterologous 2-dose vaccination regimen (Ad26.ZEBOV on Day 1 and
      MVABN-Filo on Day 57) to participants in the control arm of the main study (Extension Phase).
    


Intervention name(s): Ad26.ZEBOV; MVA-BN-Filo; MenACWY
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Participants will receive 0.5 mL IM injection of Ad26.ZEBOV as first vaccination.; Participants will receive 0.5 mL IM injection of MVA-BN-Filo as second vaccination.; Participants will receive 0.5 mL IM injection of MenACWY.
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Investigation of Food Effect and Gastric ph Increase on the Bioavailability of Faldapravir
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the effect of food and of gastric pH
      increase on the relative bioavailability of faldaprevir.
    


Intervention name(s): faldaprevir; faldaprevir; omeprazole; faldaprevir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): medium dose of faldaprevir; medium dose of faldaprevir; medium dose of omeprazole; medium dose of faldaprevir
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Adiponectin Genetic Polymorphism on Rosiglitazone Response
Condition: Diabetes Mellitus
Study type: Observational

Summary: 
      The aims of the present study were to investigate the association between adiponectin gene
      polymorphisms and the response to rosiglitazone monotherapy in T2D patients.

      A total of 255 T2D patients and 120 health volunteers were enrolled in this study. 42 T2D
      patients with -11377(C/G) or +45(T/G) genotypes were selected to administrate orally 4mg
      rosiglitazone daily for 12 consecutive weeks.
    

Detailed description: 
      The aims of the present study were to investigate the association between adiponectin allele
      +45(T/G) and -11377(C/G) polymorphisms and the response to rosiglitazone monotherapy in T2D
      patients.

      A total of 255 T2D patients (138 males, 117 females) aged from 25 to 70 years (mean 48.6 ±
      10.7 years) and 120 healthy controls (53 females, 67 males) aged from 25 to 70 years(mean
      47.1 ± 11.0 years) were enrolled to participate in this study. Physical examination, medical
      history and serum biochemical tests were performed to identify healthy or T2D subjects. The
      diagnosis criteria of T2D patients were made according to the World Health Organization in
      1997 by fasting plasma glucose (FPG  7.0 mmol/L) and/or postprandial plasma glucose test
      (PPG  11.1 mmol/L). The inclusion criteria of all subjects were that subjects had the range
      of body mass index (BMI) from 18.5 to 30 kg/m2 and did not administrate any PPAR agonists in
      the last 3 months. Patients who were receiving insulin treatment, pregnant or lactating
      women, or with serious diseases such as acute myocardial infarction, cerebral vascular
      accident, trauma, and kidney disease or liver disease were excluded from this study. Table 1
      showed the characteristic profiles of T2D patients and healthy controls. There were no
      statistical differences in the age, height, weight, and BMI value between T2D patients and
      healthy controls. All subjects were recruited from local residents in Changsha city, Hunan
      Province, P. R. China. The study protocol was approved by the Ethics Committee of Xiangya
      School of Medicine, Central South University and written informed consents were obtained
      before the start of this study. A total of 42 T2D patients (23 male, 19 female) were randomly
      selected to be only treated with 4mg rosiglitazone daily for 12 consecutive weeks without
      change in previous medications.
    

Intervention name(s): rosiglitazone
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Observational model: Defined Population
Time perspective: Prospective
Keywords: pharmacodynamics; insulin resistance; therapy; volunteer
Improving Asthma Care Together (IMPACT): A Shared Management Pilot Study
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This study aims to iteratively develop, refine and test the Improving Asthma Care Together
      (IMPACT) Intervention for school-age children (7-11 years) with persistent asthma and their
      parents.
    

Detailed description: 
      Asthma is one of the most common chronic conditions of childhood, affecting over six million
      US children. Asthma treatment relies on self-management including symptom monitoring and
      response, trigger avoidance, and timely and appropriate medication use. Unfortunately, fewer
      than 50% of children with asthma are adherent to asthma treatment regimens, leading to
      increased disease morbidity and mortality and potentially irreversible airway damage.

      Children with asthma are missing a voice in their own care. The school-age years (7-11)
      represent a natural transition in asthma management, as children must assume some
      responsibility for asthma-related care while they spend increasing time away from parents at
      school and other extracurricular activities. Yet, existing interventions focus on parents
      alone and use prescriptive approaches, telling the parent what to "do" to the child to manage
      their asthma. As a result, current strategies are failing to provide children with asthma and
      their families the tools they need to manage asthma successfully within the realities of
      their daily lives.

      Using a Human-Centered Design (HCD) framework, the investigators co-designed a tailored
      asthma shared management mobile health application that pairs the parent and child together
      as a team and facilitates the intentional transition of some asthma management to the child.
      The hypothesis is that by involving children in their own care, participants will improve
      asthma management in the present, but also establish lifelong successful self-management
      skills. The objective of the proposed study is to pilot test the Improving Asthma Care
      Together (IMPACT) mobile health application with parent-child dyads. Based on the preliminary
      data, the central hypothesis is that IMPACT will be effective for delivering a shared asthma
      management intervention for children and their parents.
    

Intervention name(s): Improving Asthma Care Together (IMPACT)
Intervention type(s): Behavioral
Intervention description(s): IMPACT is a novel health application and wearable device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Self-management; Shared management; mHealth