bioihbjkbjnl/mcl2 huggingface dataset:
R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL
Condition: Elderly Patients (>65 Years); Diffuse Large B Cell Lymphoma (DLBCL)
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 3

Summary: 
      The study has the purpose to compare R-CHOP versus R-mini-CEOP in elderly patients (>65
      years) with Diffuse Large B Cell Lymphoma (DLBCL).
    


Intervention name(s): Cyclophosphamide; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Prednisone; Epirubicin; Vinblastine; Rituximab; G-CSF
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 750 mg/mq IV, day 1; 50 mg/mq IV, day 1; 50 mg/mq IV, day1; 1,4 mg/mq (max 2 mg)IV, day 1; 75 mg/mq IV, days 1-5; 60 mg/mq IV/PO, days 1-5; 50 mg/mq IV, day 1; 5 mg/mq IV, day 1; 375 mg/mq IV, day 1; 300 µg tot., SC; days 7-11
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine; Epirubicin; Vinblastine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DLBCL; R-CHOP; R-CEOP; Elderly patients
Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on
      glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients
      will be randomized into one of two AC2993 treatment arms or to placebo treatment and will
      continue with their required existing diabetes medication (metformin) throughout the study.
    


Intervention name(s): AC2993; AC2993; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily; Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5 mcg (0.02 mL) for 4 weeks / AC2993 10 mcg (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily; Placebo Lead In (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily; Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
Other intervention name(s): synthetic exendin-4; synthetic exendin-4
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic
      overactive bladder (IOAB) and urinary incontinence.
    


Intervention name(s): AGN-214868; AGN-214868 placebo
Intervention type(s): Drug; Drug
Intervention description(s): AGN-214868 injected into the bladder.; AGN-214868 placebo injected into the bladder.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Turkish Version of the Vividness of Visual Imagery Questionnaire-2
Condition: Body Image; Assessment, Self
Study type: Observational

Summary: 
      The Vividness of Visual Imagery Questionnaire-2 (VMIQ-2) is originally developed in English
      to determine the vividness of visual imagery. The purpose of this study is to translate and
      cross-culturally adapt the VMIQ instrument into Turkish and investigate its psychometric
      properties.
    

Detailed description: 
      The Vividness of Visual Imagery Questionnaire-2 (VMIQ-2) was originally developed in English
      to determine the vividness of visual imagery. The purpose of this study is to translate and
      cross-culturally adapt the VMIQ-2 instrument into Turkish and investigate its psychometric
      properties. One hundred fifty healthy participants will be included. For cross-cultural
      adaptation, two bi-lingual translators will use the back-translation procedure. Within a
      5-to-7-day period after the first assessment, the participants will complete the Turkish
      version of VMIQ (VMIQ-2-T) to evaluate test-retest reliability. Cronbach's alpha (α) will use
      to assess internal consistency. The correlation with the Turkish version of Kinesthetic and
      Visual Imagery Questionnaire-20 will be determined to check the validity.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The sample will consist of volunteer, healthy participants.
      
Keywords: Imagination; Motor imagery; Body Image; Kinesthesis
A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)
Condition: Neurogenic Detrusor Overactivity; Pediatric
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate long term efficacy and safety of treatment with
      solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity
      after multiple dose administration.
    

Detailed description: 
      In some children with a severe form of spina bifida (which is the consequence of a spinal
      cord defect), the bladder muscle (detrusor) contracts strongly and without warning (also
      known as neurogenic detrusor overactivity) and the urethra (the passage connecting the
      bladder with outside) does not relax. Though these children cannot void, urine leakage can
      happen when the overactive contractions are strong, and/or the pressure in the bladder is so
      high that it overcomes the closed urethra (overflow at high filling bladder pressure). This
      high bladder pressure puts these children at risk for kidney damage and can decrease the
      quality of the bladder. Therapy was aimed to decrease the high filling bladder pressure and
      the overactive detrusor contractions.
    

Intervention name(s): Solifenacin succinate
Intervention type(s): Drug
Intervention description(s): Oral suspension
Other intervention name(s): solifenacin; YM905; solifenacin succinate suspension
Intervention MeSH terms: Solifenacin Succinate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Solifenacin succinate suspension; Efficacy; Safety
Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation
Condition: Type 2 Diabetes Mellitus; Impaired Glucose Tolerance
MeSH terms: Diabetes Mellitus, Type 2; Hyperlipidemias; Hyperlipoproteinemias; Glucose Intolerance; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary goal of this study is to determine the acute effects of exenatide on postprandial
      hypertriglyceridemia. Secondary goals are to determine whether there are additional
      improvements in postprandial lipids and lipoproteins and whether (by the reduction of
      hyperglycemia alone or in combination with declines in hyperlipidemia) exenatide reduces the
      pro-inflammatory potential of the postprandial period.
    


Intervention name(s): Exenatide; Normal Saline
Intervention type(s): Drug; Other
Intervention description(s): Single subcutaneous injection (10 μg); Single subcutaneous injection
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      This research study intends to learn about whether early intervention can help to prevent
      non-alcoholic fatty liver disease (NAFLD) in adolescents. Potentially eligible adolescents
      who are seen at the University of Wisconsin (UW) Pediatric Fitness Clinic will be asked to
      join the study. Patients who agree to participate in the study will be randomized into either
      the intervention group or the control group. The intervention group will follow a
      low-fructose diet. In addition, participants will be asked to return to the clinic for 4
      follow-up visits during a 6-month interval.
    

Detailed description: 
      This will be a prospective, randomized, controlled trial for obese adolescents. Sixty obese
      youth (male and female), age 11-17 years with BMI >95 %tile for age and sex and one
      parent/guardian will be recruited for inclusion into the study at an initial pediatric
      fitness clinic visit. Consented subjects will be stratified by gender and ethnicity and
      randomized into low fructose or standard weight loss dietary intervention groups.
    

Intervention name(s): Experimental: Low-fructose, reduced carbohydrate diet; General Healthy Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Low Carbohydrate (Low Fructose and Sucrose) Diet (Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg;40-45% CHO, 20-25% Protein, 30-40% Fat)
● Aim for less than 25g fructose daily.; Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg; 50-60% CHO, 15-20% Protein, 20-30% Fat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Non-alcoholic Fatty Liver Disease; Adolescent
Hs-CRP and NLR as Markers of Perioperative Stress
Condition: Cesarean Delivery Affecting Newborn; Anesthesia; Inflammatory Response
Study type: Observational

Summary: 
      The stress response to surgery is a result of tissue injury with local and systemic
      inflammation that contributes to the postoperative outcome. Anesthesia is known to effect
      perioperative stress response Regional anesthesia modifies stress response through afferent
      blockage whereas general anesthesia affects the stress response via central modulation. High
      sensitive C-reactive protein and neutrophil to lymphocyte ratio are used for evaluation of
      inflammation. The aim of this study was to document the value hs-CRP and NLR in perioperative
      stress response in two different anesthesia methods applied to term pregnant women undergoing
      elective ceserean section (C/S).
    

Detailed description: 
      The stress response to surgery is a result of tissue injury with local and systemic
      inflammation that contributes to the postoperative outcome. Anesthesia is known to effect
      perioperative stress response. Regional anesthesia modifies stress response through afferent
      blockage whereas general anesthesia affects the stress response via central modulation. High
      sensitive C-reactive protein and neutrophil to lymphocyte ratio are used for evaluation of
      inflammation. The degree of systemic inflammation has been determined by numerous pro- and
      anti-inflammatory cytokines.The cytokines control the release of C -reactive protein (CRP)
      which is an acute phase reactant produced by the liver. CRP is a widely used marker of
      inflammation and tissue damage. High sensitive C -reactive protein (hs-CRP), is a more
      sensitive assay for detection of inflammation measured by particle-enhanced
      immunonephelometry . A rapid increase in hs-CRP may indicate inflammation and tissue damage .
      Another well-known indicator of inflammation is neutrophil-to-lymphocyte ratio (NLR). NLR
      correlates strongly with elevated plasma levels of circulating proinflammatory cytokineS. The
      aim of this study was to document the value hs-CRP and NLR in perioperative stress response
      in two different anesthesia methods applied to term pregnant women undergoing elective
      ceserean section (C/S).
    

Intervention name(s): HSCRP and NLR
Intervention type(s): Diagnostic Test
Intervention description(s): hs-CRP levels and NLR values will be studied from routine blood samples.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is composed of healthy pregnant women without chronic diseases at term
        (36-41 weeks of pregnancy).
      
Keywords: cesarean section, anesthesia, hs-CRP, NLR
A Comparative Study of KES524 in Patients With Obesity Disease
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the efficacy and safety of KES524 in patients with obesity (visceral fat
      obesity with type 2 diabetes and dyslipidemia), a 52-week, double-blind, placebo-controlled
      comparative study is conducted. This study aims to examine superiority of KES524 to placebo
      by employing change and percent change in body weight (primary endpoints) and changes in
      proportion of subjects achieving ≧ 5% weight reduction, BMI, waist circumference, visceral
      fat area, subcutaneous fat area, V/S ratio by abdominal CT scan, HbA1c, TG and HDL-C
      (secondary endpoints).
    


Intervention name(s): Sibutramine Hydrochloride Monohydrate
Intervention type(s): Drug
Intervention MeSH terms: Sibutramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Tart Cherry Supplementation & Gut Microbiome and Inflammation
Condition: Inflammation; Glucose Regulation; Sleep
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      There has been a rapid increase in researching the use of tart cherry supplements in the past
      5 years, particularly for inflammatory conditions. Many formulations of cherry supplements
      exist, however there has been no comparison between these different types. This is
      particularly important in the realm of inflammation research because sugar is known to
      increase the inflammatory response. The pill form of cherry supplementation has no added
      sugar and is naturally low in sugar (< 1g) while the juice form is higher from added sugar.
      Recent work indicates tart cherry consumption can change gut microbiota, which may modify
      inflammation. The purpose of this study is to look at the effects of taking a cherry
      supplement, either in capsule or juice form, on the gut microbiome, inflammation, and
      health-related variables such as blood pressure, glucose regulation and sleep quality.
    

Detailed description: 
      Participants will consume a tart cherry or placebo product for 30 days and attend 5 visits in
      the Exercise Physiology Lab at Ohio University over the 30 day period. They will self-collect
      a stool sample at baseline, 14 days and 30 days after supplementation. Blood samples will be
      taken at baseline, 7 days, 14 days, and 30 days after supplementation. Throughout the study
      participates will rate symptoms (stomach, head, etc.), pain and sleep quality using an online
      survey for which the link will be emailed. Participants will maintain normal diet and
      exercise routine and to track these for the duration of the study.
    

Intervention name(s): Tart cherry juice concentrate; Juice placebo; Freeze dried tart cherry powder; Capsule placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Two 8oz bottles of tart cherry juice concentrate daily for 30 days; Two 8oz bottles of placebo juice daily for 30 days; Two freeze dried tart cherry powder capsules daily for 30 days; Two placebo capsules daily for 30 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects
Condition: Treatment of Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended
      releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.
    


Intervention name(s): Fesoterodine; Fesoterodine
Intervention type(s): Drug; Drug
Intervention description(s): A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg; A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg
Other intervention name(s): Toviaz 8 mg; Toviaz 8 mg
Intervention MeSH terms: Fesoterodine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence, Pharmacokinetics
Flaxseed Lignan (Brevail)
Condition: Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      PCOS is a disorder which is characterized by hyperandrogenism (high serum male hormone
      levels), ovulatory dysfunction, and polycystic ovaries (multiple follicles-over 12- in the
      ovary). There is no universally accepted definition for PCOS. The Rotterdam criteria require
      2 of 3 criteria for diagnosis, including hyperandrogenism (clinical hirsutism or serum
      hormone measurement), oligomenorrhea/amenorrhea, and ultrasound findings of polycystic
      ovaries.

      This study is a prospective randomized pilot study designed to evaluate the effects of
      flaxseed supplementation (with Brevail) on hormonal and lipid metabolism balance in
      polycystic ovarian syndrome (PCOS) patients.
    


Intervention name(s): Birth control; Birth control plus Brevail
Intervention type(s): Drug; Drug
Intervention description(s): In the initial visit, History and Physical Exam,menstrual history, pregnancy history, documentation of hirsutism using Ferriman-Gallwey scoring,body weight, height, and body mass index.The baseline ultrasound blood tests. After the lab tests, the patients in the control group will be started on OC (standard clinical practice) and those in the treatment group will be started on OC with Brevail (2 pills once a day). The patients will return to the clinic for a follow up visit after 3 months. If no side effects, Brevail and OC will be continued for 3 more months. The control group will also have a follow up after 3 months of OC. Six months after the initiation of the study, the patients in the both groups will have another H&P as well as repeat ultrasound and blood tests.; In the initial visit, History and Physical Exam,menstrual history, pregnancy history, documentation of hirsutism using Ferriman-Gallwey scoring,body weight, height, and body mass index.The baseline ultrasound blood tests. After the lab tests, the patients in the control group will be started on OC (standard clinical practice) and those in the treatment group will be started on OC with Brevail (2 pills once a day). The patients will return to the clinic for a follow up visit after 3 months. If no side effects, Brevail and OC will be continued for 3 more months. The control group will also have a follow up after 3 months of OC. Six months after the initiation of the study, the patients in the both groups will have another H&P as well as repeat ultrasound and blood tests.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Near Infrared Spectroscopy and Transcutaneous Oxygen Pressure in Critical Limb Ischemia Before and After Treatment
Condition: Peripheral Vascular Disease; Critical Limb Ischemia
MeSH terms: Vascular Diseases; Chronic Limb-Threatening Ischemia; Peripheral Vascular Diseases; Peripheral Arterial Disease; Ischemia
Study type: Observational

Summary: 
      Comparison of two non-invasive methods for measuring tissue oxygenation. One is
      Transcutaneous Oxygen Pressure (TCPO2) and the other is the new method of Near Infrared
      Spectroscopy (NIRS) - near infrared spectroscopy in patients with critical limb ischemia
      (CLI) undergoing invasive treatment (surgical or endovascular).
    

Detailed description: 
      Comparison of two non-invasive methods for measuring tissue oxygenation. One is TCPO2 and the
      other is the new method of NIRS - near infrared spectroscopy in patients with critical limb
      ischemia (CLI) undergoing invasive treatment (surgical or endovascular).

      The NIRS probe has been used to measure tissue oxygenation in the cerebral circulation up to
      now. While TCPO2 is the established method for measuring tissue oxygenation in patients with
      CLI to evaluate the potential for wound healing.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        10 patients admitted to the vascular surgical department and undergoing invasive treatment
        (surgical or endovacular)
      
Keywords: CLI Critical limb ischemia; PVD peripheral vascular disease; NIRS near infrared spectroscopy; TCPO2 - transcutaneous oxygen pressure
Deep Brain Stimulation (DBS) of the Nucleus Basalis Meynert (NBM) to Treat Cognitive Deficits in Light to Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional

Summary: 
      In the study at hand, six patients with light to moderate Alzheimer's disease will be
      enrolled and implanted with bilateral electrodes in the nucleus basalis Meynert.
    

Detailed description: 
      In the study at hand, six patients with light to moderate Alzheimer's disease will be
      enrolled and implanted with bilateral electrodes in the nucleus basalis Meynert. The
      stereotactic implantation of the electrodes will be guided by computerized tomography (CT)
      and magnetic resonance tomography (MRT).

      Basically, even though deep brain stimulation is an invasive method, there are only few side
      effects. Surgical risks correspond with the risk of DBS in morbus Parkinson or other movement
      disorders (0,4-6%).

      After the baseline examination, the patients will be implanted with the electrodes;
      accordingly all follow-ups are accomplished postoperative. From the second week after the
      operation, the conventional stimulation takes place as a doubleblind, randomized change
      between ON and OFF periods. Modifications of the stimulation parameter to obtain the best
      possible result are possible.

      Throughout the one-year observation-period, the patients will be followed closely to monitor
      the effects of DBS on their cognitive abilities, psychopathological well being, the quality
      of life, praxie and nutritional condition using standardized neurological and psychiatric
      rating scales.
    

Intervention name(s): Deep brain stimulation
Intervention type(s): Other
Intervention description(s): DBS in the Nucleus basalis Meynert
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: (light to moderate)