bioihbjkbjnl/mcl2 huggingface dataset:
Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal
      carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that
      intensity-modulated radiation therapy(IMRT) with concomitant boost schedule by increasing
      daily dose starting at the fifth week after initiation of IMRT might improve tumor control
      and decrease treatment toxicities for locoregionally advanced nasopharyngeal carcinoma. The
      study is designed to test if late-course accelerated hyperfractionated IMRT can improve the
      outcomes as compared with conventionally fractionated IMRT in newly diagnosed patients with
      locoregionally advanced nasopharyngeal carcinoma.
    


Intervention name(s): Late-course accelerated hyperfractionated IMRT; Concomitant cisplatin chemotherapy; Conventionally fractionated IMRT
Intervention type(s): Radiation; Drug; Radiation
Intervention description(s): IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease
IMRT delivery scheduling: (1) Six-week treatment: PTV1=60Gy/30fractions, PTV2=57Gy/30fractions,PTV3=54Gy/30fractions.(2) Concomitant boost to PTV1 as a second daily treatment for the last 10 treatments of the Six-week treatment: PTV1=12Gy/10fractions.(3) PTV3 will be treated with conventional radiotherapy technique separately.; cisplatin:40mg/m2 weekly infusion for 6 weeks; IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease IMRT delivery scheduling: (1) Seven-week treatment: PTV1=70Gy/35fractions, PTV2=63Gy/35fractions,PTV3=55.8Gy/31fractions.(2) PTV3 will be treated with conventional radiotherapy technique separately.
Intervention MeSH terms: Cisplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasopharyngeal carcinoma; Locally advanced disease; Intensity-modulated radiation therapy; Accelerated hyperfractionation; Concomitant boost radiation therapy; Concurrent chemotherapy
Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects
Condition: Healthy
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Probiotic administration is associated with health benefits on gut barrier integrity and
      immunological functions of the gastrointestinal tract. Recently, probiotic consumption was
      proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al.
      2009). Changes in energy metabolism might be involved in the effects of probiotics on weight
      control.

      The objective of this study was to assess the efficacy of the consumption of a probiotic
      formulation on energy balance in overweight subjects.
    


Intervention name(s): Probiotic formulation; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Twice a day for 24 days; Twice a day for 24 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Probiotics; Energy balance
Endoscopic Tri-Modal Imaging in Patients With Barrett's Esophagus
Condition: Barretts Esophagus; High Grade Dysplasia; Early Esophageal Adenocarcinoma
MeSH terms: Adenocarcinoma; Barrett Esophagus
Study type: Observational

Summary: 
      This study is being done to determine if a new endoscope will help doctors identify
      pre-cancer or early cancer lesions in patients who have Barrett's esophagus. This new
      endoscope allows the doctor to look at the lining of the esophagus in 3 different ways by
      modifying light.
    

Detailed description: 
      Patients with Barrett's esophagus are advised to undergo periodic endoscopic surveillance
      with random biopsies in an attempt to identify high-grade dysplasia (HGD) or early
      adenocarcinoma (ACA) at a time when intervention can be curative. This approach, however, can
      be time-consuming and is hindered by low sampling yield and random sampling error. Endoscopic
      Tri-Modal Imaging (ETMI) is a novel diagnostic modality that encompasses three advanced
      imaging features in one system: high-resolution endoscopy (HRE), autofluorescence imaging
      (AFI) and narrow-band imaging (NBI). HRE and AFI provide a bird's-eye view of 'red flag'
      areas which are then assessed by NBI for focused and more specific tissue characterization.
      The aim of this prospective, multi-center study is to compare the diagnostic performance of
      ETMI with that of standard white-light endoscopy (WLE) for identifying high-grade dysplasia
      (HGD) and early adenocarcinoma (ACA) in BE. A total of 84 BE patients will be recruited for
      the study and they will undergo both ETMI and WLE examinations in a randomized, crossover
      fashion. Standard surveillance biopsies and ETMI-targeted biopsies will be performed. The
      primary outcome will compare the number of patients and lesions with HGD or early ACA
      detected with WLE and ETMI. It is anticipated that ETMI will enhance the detection of
      high-grade Barrett's lesions relative to WLE.
    

Intervention name(s): Upper endoscopy with biopsy
Intervention type(s): Procedure
Intervention description(s): Endoscopy with biopsy 6 weeks after the initial endoscopy
Other intervention name(s): ETMI system (Olympus, Tokyo, Japan)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with barrett's esophagus or esophageal cancer referred for endoscopy
      
Biospecimen description: 
      esophageal biopsies
    
Keywords: Barrett's Esophagus; Esophageal Cancer; High Grade Dysplasia
Osteoarthritis Structural Changes Assessed by Magnetic Resonance Imaging and Neuropathic Pain in Knee Osteoarthritis
Condition: Neuropathic Pain; Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Neuralgia
Study type: Observational

Summary: 
      The primary objective of this study is to identify osteoarthritis (OA) structural changes, as
      assessed by MRI, that best correlate with the presence of neuropathic pain (NP) using the
      PainDETECT questionnaire (PainDETECT ≥ 13) on a population of patients with OA of the knee
      experiencing moderate to severe pain (VAS ≥ 40 mm).
    

Detailed description: 
      This study is a multicentre, cross-sectional observational pilot study. The presence of NP
      was determined based on use of the PainDETECT questionnaire (score 1 to 38), the score of
      which was defined for the purpose of the study as ≥ 13. A total of 50 OA patients with
      moderate to severe pain (VAS ≥ 40), 25 without the presence of NP (OA/NP-) (PainDETECT score
      < 13), and 25 with the presence of NP (OA/NP+) (PainDETECT score ≥ 13) were enrolled. Since
      this is a pilot study, we arbitrarily determined the number of patients at 50, which
      represents 25 patients per arm, a number deemed sufficient to identify the knee OA structural
      changes that could be preferentially associated with NP.
    

Intervention name(s): Magnetic Resonance Imaging (MRI)
Intervention type(s): Other
Intervention description(s): All participants from both arms will be subjected to MRI
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Presence or absence of neuropathic pain on a population of patients with OA of the knee
        experiencing moderate to severe pain (VAS ≥ 40 mm)
      
Keywords: Neuropathic pain; Knee osteoarthritis; MRI
Lifestyle in Turkish-Background Diabetics
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      Background: Life-style interventions are indicated in patients with metabolic syndrome and/or
      type 2 diabetes. However, cultural differences are substantial confounders to not only
      compliance, but also whether or not the interventions are offered in the first place. In
      Germany, the large Turkish-background minority has a particularly high incidence of type 2
      diabetes, but there is no recorded evidence of a life-style intervention in this patient
      group.

      Objective: The investigators tested the body weight-reducing effect of a 30% calorie-reduced
      diet, adjusted to individual eating habits and preferences regarding quality and resources of
      food in a Turkish-background cohort.
    

Detailed description: 
      The investigators conducted a prospective, randomized, two-arm parallel study. In both arms,
      patients were instructed in a 12-week diet that was reduced by in caloric content by at least
      30% based on calorimetric measurements of 24 h resting energy expenditure and estimated
      additional expenditures by diet- and activity-induced thermogenesis. Before and after the
      diet, anthropometric measures and various MetS-associated blood parameters were determined.

      The subjects were not instructed in an exercise program. However, the subjects were advised
      on the value of increased physical activity. For additional motivation, effects were tested
      by an activity monitor. Therefore, in one of the arms, 24 hour locomotor activity and energy
      expenditure were determined by means of the SenseWear® MF armband (Body Media Inc., AliphCom
      dba Jawbone®, Pittsburgh, PA, U.S.A.). This device detects activity contest using
      accelerometers and assesses daily energy expenditure. For allocation of the subjects, a
      computer-generated list of random numbers was used. The randomization sequence was created
      using SPSS 18 (SPSS, Inc., Chicago, IL, USA) statistical software and subjects were assigned
      to be tested or not for locomotor activity with a 1:1 allocation using random block sizes of
      2, 4, and 6.
    

Intervention name(s): Diet
Intervention type(s): Behavioral
Intervention description(s): Individually tailored diets; 30% caloric reduction according to daily energy requirements measured by indirect calorimetry
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Intravenous Lidocaine and Dexamethasone Combination on Postoperative Sore Throat, Cough and Hoarseness.
Condition: Postoperative Sore Throat, Cough, Hoarseness
MeSH terms: Pharyngitis; Cough; Hoarseness; Dysphonia
Study type: Interventional
Phase: Phase 4

Summary: 
      Post operative sore throat (POST) following tracheal intubation is a common problem causing
      dissatisfaction and discomfort to the patients. Prophylactic use of both lidocaine and
      dexamethasone has been used independently for this purpose. However, there is no study
      assessing the synergistic analgesic effects of lidocaine and dexamethasone for POST. The
      purpose of this study is to compare the effect of lidocaine, dexamethasone and lidocaine
      dexamethasone combination on the incidence and severity of POST.
    

Detailed description: 
      Sore throat and hoarseness following tracheal intubation are common postoperative problems
      causing dissatisfaction and discomfort to the patients. Their incidence varies from 30%-70%.

      Both non pharmacological and pharmacological measures have been tried to minimize the
      incidence and severity of POST with variable success rate. Prophylactic use lidocaine and
      steroids have been used independently for this purpose. Dexamethasone as an adjuvant to
      lidocaine has shown to improve the quality of analgesia. However, there is no study assessing
      the combine effects of lidocaine and dexamethasone for POST.
    

Intervention name(s): LD: Lidocaine and dexamethasone; L:Lidocaine; D: Dexamethasone; N: Normal saline (placebo)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): LD: intravenous lidocaine 1.5 mg/kg and dexamethasone 8 mg before induction of anesthesia; Intravenous lidocaine 1.5 mg/kg before induction of anesthesia; D:intravenous dexamethasone 8 mg before induction of anesthesia; Normal saline: 2ml
Other intervention name(s): Xylocard, dexona; Xylocard; Dexona
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lidocaine; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Lidocaine, Dexamethasone, Postoperative sore throat
Licorice and Home Blood Pressure
Condition: Hypertension,Essential
MeSH terms: Essential Hypertension
Study type: Interventional

Summary: 
      Out-of-office blood pressure is more strongly associated with cardiovascular risk than office
      blood pressure. Licorice is known to raise blood pressure, but no previous studies have
      measured the effects on home blood pressure. The aim of this study is to analyze the
      association between licorice intake and home blood pressure.
    

Detailed description: 
      Healthy volunteers will be invited to participate in a randomized, non-blinded, cross-over
      study. Participants will be randomized to either of two groups with a 1:1 allocation ratio,
      stratified by sex. Intervention will be sweet licorice and control will be salty licorice. A
      run-in period of 1 week will be followed by a 2-week intervention/control, a 2-week washout
      period, another 2-week control/intervention period and again a 2-week washout period. Home
      blood pressure will be measured continuously, and blood samples (including potassium and
      aldosterone) will be collected every two weeks. Analyses will be made comparing baseline
      characteristics of the two groups, intervention/control and washout period results of the two
      groups to look for potential carry-over effects, and finally comparing intervention and
      washout period results respectively to the baseline data to look for the effects of licorice.
    

Intervention name(s): Sweet licorice; Salty licorice
Intervention type(s): Other; Other
Intervention description(s): Ecologic, vegan and gluten free, low-sodium sweet licorice pastilles made from Glycyrrhiza glabra, with a manufacturer specified content of 4% sugars, 2% glycyrrhizin and 0.03% salt, will be used as intervention. The exact glycyrrhizin content will be determined before the study begins, and participants will be instructed to consume a daily licorice dose that is equivalent to 100 mg of glycyrrhizin.; A vegan and gluten free salty licorice without glycyrrhizin, flavored with ammonium chloride, with a manufacturer specified content of 0% sugars and 0.05% salt, will be used as control. The amount of salty licorice will be the same as for sweet licorice, and thus determined after the glycyrrhizin content analysis of the sweet licorice.
Other intervention name(s): Glycyrrhiza glabra
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Effect of Exercise and Manuel Therapy Methods on Pain, Posture, Daily Living in People With Cervical Pathologies
Condition: Musculoskeletal Disorder of the Neck
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      The aim of the study is to determine the effect of exercise and two different manual therapy
      methods on pain, quality of life and posture in people with neck pain.
    

Detailed description: 
      Deep friction massage will use on cervical regions in first group, muscle energy technic will
      use second group and cervical stabilization exercise will use as an third group. For all
      groups, pain intensity, Quality of life and posture will assess.
    

Intervention name(s): Muscle Energy Technic; Deep Friction Massage; Exercise
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): post isometric relaxation technics were applied to levator scapulae, trapezius, pectoralis muscles three sessions per week, totally six weeks.; deep friction massage was applied to cervical region included tendons, muscles and soft tissue.; spinal stabilization exercise were applied three sessions in a week totally six weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neck pain; physiotherapy; rehabilitation
Comparison of LASIK and SBK
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of the study is to compare clinical outcomes from LASIK and SBK using
      FDA-approved laser technology on the same patient
    

Detailed description: 
      Patients undergoing bilateral refractive surgery on the same day will have one eye randomized
      to LASIK and the fellow eye assigned to SBK treatment.
    

Intervention name(s): LASIK; SBK
Intervention type(s): Procedure; Procedure
Intervention description(s): Refractive surgery; Refractive surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reducing Unsafe Alcohol Use in HIV-Positive Individuals
Condition: Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      The main aim of this study is to test an intervention to reduce unsafe drinking among
      HIV-positive primary care patients. The intervention consists of a brief motivational
      interview, which is combined with daily alcohol monitoring through the use of an interactive
      voice response system IVR (automated telephone system). Subjects who receive the enhanced
      motivational interview are expected to show greater improvements in drinking than individuals
      who receive the standard motivational interview or view a DVD on HIV self-care.
    

Detailed description: 
      HIV infection is a widespread health problem in the U.S. Antiretroviral treatment has
      increased longevity and changed the nature of risk factors for morbidity and mortality.
      Alcohol consumption has become an increasingly serious health issue among HIV primary care
      patients. Drinking is a key factor in progression to severe liver damage (especially those
      co-infected with hepatitis), and liver disease is now one of the most common causes of death
      among those with HIV. Excess drinking is also associated with medication noncompliance,
      reduces the effect of antiretroviral treatment, and is linked to other health problems.
      Therefore, helping HIV patients reduce unsafe drinking is crucial to their long-term health.
      The intervention combines the brief MI, an established, evidence-based counseling approach,
      with an innovative procedure designed to strengthen the effects of the MI. An effective,
      easily implemented alcohol-reduction intervention could be incorporated into standard care in
      HIV clinics helping prevent or slow the progress of some medical problems in HIV-infected
      individuals, improve medication compliance, prolong lifespan and decrease risk behavior
      associated with alcohol use.

      Comparison(s): Enhanced brief motivational interview (including an IVR component for alcohol
      self-monitoring purposes), brief motivational interview, viewing a DVD on HIV self-care.
    

Intervention name(s): Enhanced Motivational Interview; Standard Motivational Interview or viewing DVD
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone system).; Brief motivational interview, viewing a DVD on HIV self-care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Unsafe drinking; Human Immunodeficiency Virus; Motivational Interviewing
Bivalent Norovirus Vaccine Study
Condition: Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four dosage
      levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with MPL and Al(OH)3
      compared to controls. Participants will receive two doses, by IM injection, 28 days apart.

      The hypotheses for this study are:

        -  The incidence of adverse events after vaccination with IM Norovirus Bivalent VLP Vaccine
           will be similar to the incidence of adverse events after other IM vaccines including
           CERVARIX® which contains MPL and Al(OH)3.

        -  Two doses of IM Norovirus Bivalent VLP Vaccine will be more immunogenic than one dose.

        -  The post-vaccination serum antibody responses, the number of antibody secreting cells
           (ASC), including homing markers, and memory B-cell responses directed against norovirus
           antigens will be increased after IM Norovirus Bivalent VLP Vaccine compared to controls.
    


Intervention name(s): NoV GI.1/GII.4 Bivalent VLP Vaccine; Saline
Intervention type(s): Biological; Biological
Intervention description(s): 2 Doses 28 days apart Cohort A: 18-49 Years
Cohort A1: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (5/5 mcg)
Cohort A2: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (15/15 mcg)
Cohort A3: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)
Cohort A4: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (150/150 mcg)
Cohort B: 50-64 Years IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)
Cohort C: 65-85 Years IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)
Cohort D: 18-49 Years IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg); Two doses 28 days apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Vaccine, norovirus, acute gastroenteritis
Study in Healthy Subjects to Measure Amount of Drug in Blood After Dosing With Different Saxagliptin / Metformin Produc
Condition: Bioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and Metformin
Study type: Interventional
Phase: Phase 1

Summary: 
      Study in healthy subjects to measure amount of drug in blood after dosing with different
      saxagliptin / metformin products.
    

Detailed description: 
      Bioequivalence Study of the Fixed-dose Combination of Saxagliptin/Metformin XR Tablets
      Relative to Saxagliptin (Onglyza� ) Tablets and Australia-sourced Diabex XR Tablets
      Coadministered to Healthy Subjects in the Fed State During Steady-state Administration
    

Intervention name(s): Onglyza (saxagliptin); Diabex; 5-mg saxagliptin/1000 mg metformin; Diabex; 5-mg saxagliptin/500 mg metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral tablets, 5 mg , single dose; Extended release oral tablets, 1000 mg, single dose; Extended release fixed dose combination tablet, single dose; Extended release oral tablets, 500 mg, single dose; Extended release fixed dose combination tablet, single dose
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1, Healthy male volunteers, pharmacokinetics, saxagliptin/ metformin , Diabex