bioihbjkbjnl/mcl2 huggingface dataset:
Medical Staff: Higher Risk for Gastrointestinal Polypoid Lesions
Condition: the Incidence of Gastrointestinal Diseases Diagnosed by Endoscopy in Physicians and General Population
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Observational

Summary: 
      This is a single center, retrospective, propensity score-matched analyzed study. Patients who
      underwent gastroscopy and colonoscopy for physical examination in Qilu Hospital of Shandong
      University, China, from January 2017 to September 2018, were retrospectively reviewed to
      compare the incidence of gastrointestinal diseases diagnosed by endoscopy between physicians
      and general population.
    

Detailed description: 
      This is a single center, retrospective, propensity score-matched analyzed study. Patients who
      underwent gastroscopy and colonoscopy for physical examination in Qilu Hospital of Shandong
      University, China, from January 2017 to September 2018, were retrospectively reviewed.To
      compare the incidence of gastrointestinal diseases diagnosed by endoscopy between physicians
      and general population.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent gastroscopy and colonoscopy for physical examination in Qilu
        Hospital of Shandong University, China, from January 2017 to September 2018, were
        retrospectively reviewed. Subjects who had a history of gastrointestinal surgery or
        subjects who did not finish the endoscopic examination were excluded. All selected subjects
        were age- and sex- matched to form two groups: Group 1, medical staff from Qilu Hospital,
        and Group 2, general population.
Anti-diabetic Effects of Persimmon Leaf Extract
Condition: Prediabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The investigators performed a 8-week, randomized, double-blind, placebo-controlled crossover
      human trial to evaluate the efficacy and safety of persimmon leaf extract on blood glucose.
      The investigators measures changes in diabetes associated parameters, including fasting blood
      glucose, postprandial blood glucose, insulin, C-peptide and HbA1c.
    


Intervention name(s): Persimmon leaf extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Persimmon leaf extract (PLE), crossover design; Placebo, crossover design
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: prediabetes; blood glucose; clinical trial
Motivational Program for Smokers Enrolled in a Methadone Maintenance Program
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional

Summary: 
      RATIONALE: Stop-smoking programs may help patients stop smoking and prevent cancer from
      forming.

      PURPOSE: This clinical trial is studying how well a motivational program works in helping
      smokers enrolled in a methadone maintenance program quit smoking.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of a brief motivational intervention on smoking cessation in
           smokers enrolled in a methadone maintenance program.

      OUTLINE: Patients are assigned to 1 of 2 groups.

        -  Group 1: Patients undergo assessment at baseline and at 1, 3, and 6 months.

        -  Group 2: Patients receive a brief motivational intervention at the time of their
           baseline assessment and undergo assessment as in group 1.

      All patients will be offered a 2- to 3-month supply of nicotine patches.

      PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
    

Intervention name(s): smoking cessation intervention; educational intervention
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: unspecified adult solid tumor, protocol specific
Compare the Renal Protective Effects of Febuxostat and Benzbromarone
Condition: Chronic Kidney Disease; Hyperuricemia; Abnormal Renal Function
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperuricemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether febuxostat and benzbromarone could protect
      renal function, and which one could be better.
    

Detailed description: 
      Chronic kidney disease patients with hyperuricemia and glomerular filtration rate (GFR) 20-50
      ml/min were treated by febuxostat or benzbromarone. Follow up the changes of serum uric acid,
      serum creatinine and GFR levels. Compare the effects on renal function of these two drugs.
    

Intervention name(s): Febuxostat; Benzbromarone
Intervention type(s): Drug; Drug
Intervention description(s): It acts as an inhibitor of xanthine oxidase, thus lowering urate concentrations in the body; It is structurally related to the antiarrhythmic amiodarone, and it is a uricosuric agent and non-competitive inhibitor of xanthine oxidase
Other intervention name(s): Uloric; Adenuric; Desuric
Intervention MeSH terms: Febuxostat; Benzbromarone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyperuricemia; Renal Function; Chronic kidney disease; Febuxostat; Benzbromarone
Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex
      for production of human IL-12. IL-12 is a protein that can improve the body's natural
      response to disease by enhancing the ability of the immune system to kill tumor cells and may
      interfere with blood flow to the tumor.

      The main purpose of this study is to evaluate the safety and tolerability of a single
      intratumoral injection of Ad-RTS-hIL-12 given with oral veledimex.
    

Detailed description: 
      Patients who are scheduled for craniotomy and tumor resection will receive one dose of
      veledimex before the resection procedure. Ad-RTS-hIL-12 will be administered by free-hand
      injection. Patients will continue on oral veledimex for 14 days.

      The study is divided into three periods: the screening period, the treatment period and the
      follow-up period.
    

Intervention name(s): Ad-RTS-hIL-12; veledimex
Intervention type(s): Biological; Drug
Intervention description(s): 2.0 x 10^11 viral particles (vp) per injection
intratumoral injection of Ad-RTS-hIL-12; 20mg/day
15 oral daily doses of veledimex
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Cardio Mato (Grade A Lyc-O-Mato, a Tomato Extracted Lycopene) on Blood Pressure
Condition: Prehypertension
MeSH terms: Prehypertension
Study type: Interventional

Summary: 
      The hypothesis of the study is that supplementation with Cardio Mato (a Tomato Extracted
      Lycopene)for 12 weeks will decrease the blood pressure of subjects with prehypertension
      compared to Placebo.
    

Detailed description: 
      Blood-pressure reading of 140/90 mmHg (systolic/diastolic pressure) are typically regarded as
      having high blood pressure as defined in the most recent guidelines. From a physiological
      perspective, the regulation of blood pressure is a complicated process involving different
      biological systems and a number of feedback systems, including the nervous system, hormones,
      control of body fluid and regulators within the vessels themselves. In 90-95% of patients
      with high blood pressure the cause is unknown, whereas the remaining 5-10% may have secondary
      hypertension related to congenital heart defects, certain cancers or kidney abnormalities.
      Prehypertension [systolic blood pressure (SBP) 120-139 mm Hg, diastolic blood pressure (DBP)
      80-89 mm Hg] is considered a precursor of hypertension and has been associated with an
      increased risk of up to 3.5 times in cardiovascular morbidity and mortality later in life.

      According the report of the Joint National Committee on High Blood Pressure (JNC 7) and other
      international guidelines, weight control, reduced intake of salt and reduced alcohol
      consumption, as well as increase of potassium are recommend nutritional approaches to prevent
      and treat hypertension. In observational studies significant inverse association between high
      blood pressure and vegetarian diet rich in fibers, magnesium, potassium, calcium and protein
      have been reported. In addition various studies demonstrated the ability of antioxidant
      vitamins of natural origin to improve vascular function.
    

Intervention name(s): Cardio Mato; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Soft gel capsule for oral use; Soft gel capsule without test material
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Prehypertension; anti oxidation; lycopene
Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.
Condition: Infections, Streptococcal; Streptococcus Pneumoniae Vaccines
MeSH terms: Pneumonia, Pneumococcal; Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a
      booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine
      co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) in preterm born
      children at the age of 16-18 months. This protocol posting deals with objectives & outcome
      measures of the booster phase. The objectives & outcome measures of the primary phase are
      presented in a separate protocol posting (NCT number =NCT00390910 ). Subjects participating
      in this study should have received three doses of pneumococcal vaccine in the primary study.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    


Intervention name(s): GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A); Infanrix™-IPV/Hib
Intervention type(s): Biological; Biological
Intervention description(s): Single dose, intramuscular injection; Single dose, intramuscular injection
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Time-Restricted Intake of Meals Study
Condition: PreDiabetes; Obesity
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      TRIM is a randomized, controlled feeding study to evaluate if eating earlier in the day vs.
      later in the day impacts weight and glucose homeostasis.
    


Intervention name(s): Time-restricted feeding; Usual feeding pattern
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants consume food earlier in the day; Participants consume food later in the day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Comparison of the Different Exercises on Chronic Neck Pain
Condition: Neck Pain; Pain, Neck
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Neck pain is a widespread problem in the general population and is second only to low back
      pain in musculoskeletal issues.
    

Detailed description: 
      The aim of this study is to compare the conventional therapy, cervical stabilization exercise
      approach, and core stabilization exercise in addiction to cervical stabilization in patients
      with chronic neck pain.
    

Intervention name(s): Group 1; Group 2; Group 3
Intervention type(s): Other; Other; Other
Intervention description(s): Physical therapy agents and isometric exercise training will be applied to the patients. These will be administered a combination of transcutaneous electrical nerve stimulation, ultrasound, a hot pack, and isometric training 3 times a week for 4 weeks by the physical therapist.; Physical therapy agents and deep cervical flexor muscle training will be applied to the patients. These will be administered a combination of transcutaneous electrical nerve stimulation, ultrasound, a hot pack, and muscle training 3 times a week for 4 weeks by the physical therapist. Training of the craniocervical flexor muscles is going to be focused on the deep flexor muscles such as longus capitis and longus colli muscles, making neck flexion, not the head.; Physical therapy agents and core stabilization training will be applied to the patients. These will be administered a combination of transcutaneous electrical nerve stimulation, ultrasound, a hot pack, and stabilization training 3 times a week for 4 weeks by the physical therapist. These exercises will be performed for 10 repetitions with 10 seconds of contraction and 5 seconds of relaxation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
Condition: Menopause
Study type: Interventional

Summary: 
      Insomnia is recognized as the most prevalent and "costly" sleep disorders and is associated
      with considerable morbidity including significantly reduced quality of life, impaired work
      performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom
      of the menopausal transition. Cognitive-behavioral therapy for insomnia (CBT-I) yields
      equivalent short-term efficacy and superior long-term durability to pharmacological treatment
      of insomnia. The efficacy of cognitive behavioral therapy for insomnia comorbid with
      menopause will be tested.
    

Detailed description: 
      Specific Aim 1: Determine the efficacy of multi-component CBT-I compared to a wait-list
      control group on self report and laboratory-based polysomnographic (PSG) sleep parameters. We
      hypothesize that multicomponent CBT-I will increase sleep efficiency, reduce the frequency of
      awakenings, reduce wake after sleep onset, and increase sleep bout duration compared to the
      control group evaluated using polysomnographic (PSG) and self-report measures of sleep.

      Specific Aim 2a: Test the efficacy of a brief two week single component sleep restriction
      therapy (SRT) to a wait-list control group on PSG and self-report sleep measures (sleep
      efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration). We
      hypothesize that brief SRT will be efficacious compared to the control condition in women
      with menopausal-related insomnia.

      Specific Aim 2b: Test the comparability (non-inferiority analysis) of SRT to CBT-I. We
      hypothesize that SRT will produce comparable efficacy in terms of the PSG and self-report
      measures of sleep compared to CBT-I (primary endpoints: sleep efficiency, frequency of
      awakenings, wake after sleep onset, and sleep bout duration).

      Specific Aim 3: Determine if CBT-I and SRT improves specific aspects of daytime functioning
      in patients with menopausal-related insomnia. We hypothesize that patients treated with CBT-I
      or SRT will have greater improvements in depressive symptomatology, quality of life,
      sleepiness and fatigue compared with a wait list control group.
    

Intervention name(s): Cognitive Behavioral Therapy for Insomnia; Sleep Education; Sleep Restriction Therapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: treatment
Safety and Tolerability of HSC835 in Patients With Hematological Malignancies
Condition: Acute Myelocytic Leukemia; Acute Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Myelodysplastic Syndrome; Chronic Lymphocytic Leukemia; Marginal Zone Lymphoma; Follicular Lymphomas; Large-cell Lymphoma; Lymphoblastic Lymphoma; Burkitt's Lymphoma; High Grade Lymphomas; Mantle-cell Lymphoma; Lymphoplasmacytic Lymphoma
MeSH terms: Burkitt Lymphoma; Lymphoma; Leukemia; Neoplasms; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Lymphoma, Mantle-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Hematologic Neoplasms; Waldenstrom Macroglobulinemia; Leukemia, Myeloid, Acute; Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluated the safety and tolerability of using HSC835 in patients with
      hematological malignancies.
    


Intervention name(s): HSC835
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hematologic malignancies; leukemia; lymphoma
The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters
Condition: Dermis Density; Wrinkles; Skin Hydration; Dermis Thickness; Skin Texture; Skin Elasticity
Study type: Interventional

Summary: 
      The aim of the randomized, double-blind, placebo-controlled, one-period effectiveness study
      is to compare the effects of multiple-dose 16 weeks daily dietary supplementation with 5 g
      collagen alone or 5 g of collagen in combination with hyaluronic acid on skin in healthy
      human subjects in comparison to placebo product. The main objective is to show that test
      products have beneficial effects on dermis density, and also on other skin parameters and to
      investigate differences in the effects among test products.
    

Detailed description: 
      Single centre, randomized, double-blind, placebo-controlled, one-period effectiveness study
      will include 84 subjects. Subjects will be divided in three groups, 28 in each. Test group 1
      (TG1) will receive investigational product 1 (CP5HA, daily dose 15 mL: collagen 5 g,
      hyaluronic acid (HA): 30 mg, vitamin C: 80 mg), test group 2 (TG2) will receive
      investigational product 2 (CP5, daily dose 15 mL: collagen 5 g, vitamin C: 80 mg) and the
      placebo group (PG) will receive placebo product without those active ingredients (15 mL: 0 g
      collagen, 0 g HA, 0 g vitamin C). Participants will test continuous administration of placebo
      or investigational products for 16 weeks in order to demonstrate and assess multiple-dose
      effects.
    

Intervention name(s): CP5HA; Placebo syrup; CP5
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Test group 1 will receive investigational product 1 containing collagen (5 g/ 15 mL), hyaluronic acid (30 mg/ 15 mL) and vitamin C (80 mg/ 15 mL); continuous administration of investigational product for 16 weeks.; Placebo group will receive placebo syrup without active ingredients. (daily dose 25 mL: collagen: 0 mg, MSM: 0 mg, vitamin C: 0 mg; continous administration of placebo product for 16 weeks.; Test group 2 will receive investigational product 2 containing collagen (5 g/ 15 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 16 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Intracranial Pressure During Mechanical Ventilation Recruitment Maneuver
Condition: Effect of Recruitment Maneuver on Intracranial Pressure
MeSH terms: Respiratory Distress Syndrome
Study type: Interventional

Summary: 
      Recruitment maneuver is used to reopen atelectasis alveoli. Positive airway pressure applied
      during the recruitment maneuver may increase intrathoracic pressure, resulting in hemodynamic
      instability, venous return disorders, and increased intracranial pressure. Our study will
      examine the effect of recruitment maneuver on intracranial pressure by evaluating Optic Nerve
      Sheath Diameter change.
    

Detailed description: 
      The therapeutic goal of mechanical ventilation shifts from maintaining regular gas exchange
      to preventing ventilator-induced lung injury. Atelectasis aggravates lung injury by reducing
      the lung size available for tidal ventilation. By preventing atelectasis with Positive End
      Expiratory Pressure (PEEP) and recruitment maneuvers, the end-expiratory lung volume can be
      increased, and lung damage can be reduced.

      Although the recruitment maneuver improves oxygenation and reduces mortality, especially in
      patients with Acute Respiratory Distress Syndrome (ARDS), adverse side effects are sometimes
      observed. Most important of these are the risk of barotrauma after positive airway pressure
      applications, increased intrathoracic pressure and hemodynamic instability, and increased
      intracranial pressure risk after venous return disorder.

      Our study aimed to evaluate the effect of recruitment maneuver on intracranial pressure by
      measuring optic nerve diameter with ultrasound before and after its application in patients
      with ARDS with impaired oxygenation and followed up with mechanical ventilator support.
    

Intervention name(s): The recruitment maneuver
Intervention type(s): Diagnostic Test
Intervention description(s): In patients with ARDS, 30 cm H2O positive pressure support and 30 seconds recruitment maneuver will be applied. The effect of the recruitment maneuver on intracranial pressure will be investigated by measuring the optic nerve sheath diameter with the help of ultrasonography before and after the recruitment maneuver. Optic nerve diameter will be evaluated with a linear probe on the eyeball before and after the collection maneuver, taking a value of 3 mm from the eyeball.
Other intervention name(s): Measurement of optic nerve sheath diameter with the help of ultrasonography
Intervention model: Single Group Assignment
Intervention model description: all patients in mechanical ventilation
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Recruitment maneuver; Intracranial pressure; Optic Nerve Sheath Diameter; Acute respiratory distress syndrome