bioihbjkbjnl/mcl2 huggingface dataset:
A Study In Healthy Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of Three Formulations Of PH-797804
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      There is no difference in the rate and extent of absorption of the material sparing tablet
      (MST), the Phase2b/3 formulation (P2b/3) with sodium lauryl sulphate (SLS) and the p2b/3
      formulation without SLS.
    


Intervention name(s): PH-797804 material sparing tablet; PH-797804 Phase2b/3 with sodium lauryl sulphate; PH-797804 Phase2b/3 with sodium lauryl sulphate; PH-797804 material sparing tablet; PH-797804 material sparing tablet; PH-797804 Phase2b/3 without sodium lauryl sulphate; PH-797804 Phase2b/3 without sodium lauryl sulphate; PH-797804 material sparing tablet; PH-797804 Phase2b/3 without sodium lauryl sulphate; PH-797804 Phase2b/3 with sodium lauryl sulphate; PH-797804 Phase2b/3 with sodium lauryl sulphate; PH-797804 Phase2b/3 without sodium lauryl sulphate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral, 6mg, single dose; oral, 6mg, single dose; oral, 6mg, single dose; oral, 6mg, single dose; oral, 6mg, single dose; oral, 6mg, single dose; oral, 6mg, single dose; oral, 6mg, single dose; oral, 6mg, single dose; oral, 6mg, single dose; oral, 6mg, single dose; oral, 6mg, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetic; single dose bioequivalence study; balanced incomplete block design; PH-797804; P38 kinase inhibitor
Stepping Up For Inflammatory Arthritis
Condition: Arthritis, Psoriatic; Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic
Study type: Interventional

Summary: 
      This study will examine the benefits of a monitored physical activity program for
      participants with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) using a wearable
      activity device (e.g.fitbit). The goals of this pilot study are to examine 1) whether an
      incentive is better than no incentive in maintaining an increased level of physical activity
      and 2) the benefits of physical activity on patient reported disease activity in inflammatory
      arthritis.
    

Detailed description: 
      Rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are chronic, systemic inflammatory
      disorders affecting 1-2% of the US population. Ongoing chronic inflammation and lack of
      exercise due to arthritis are each associated with pain, fatigue, depression, muscle loss,
      obesity, and development of chronic diseases such as cardiovascular disease and diabetes, all
      of which impact physical functioning and quality of life. Increases in physical activity can
      significantly impact each one of these outcomes and are likely to positively impact a
      patients experience of their disease. This study will examine the benefits of a monitored
      physical activity program. This study will use a wearable activity device (e.g. fitbit) to
      monitor step counts and will incentivize one group to achieve higher step counts than the
      control group. The primary goal of this pilot study will be to determine whether one
      incentive (loss aversion) is better than no incentive in increasing step counts and
      maintaining an increased level of physical activity.

      Additional outcomes of interest are patient reported disease activity (using the RAPID3
      patient reported outcome) and physician measured disease activity, quality of life
      assessments and weight loss.
    

Intervention name(s): Incentive
Intervention type(s): Other
Intervention description(s): Both groups will receive fitbits to track their physical activity, however one arm of the study may receive additional incentives to achieve their step count goal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
HD10 for Early Stages
Condition: Hodgkin´s Lymphoma
MeSH terms: Hodgkin Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to find the optimum radiation dose and number of cycles for an ABVD
      chemotherapy combined with an involved field irradiation. It is to be tested whether the
      reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20
      Gy is feasible without a loss of efficacy.
    


Intervention name(s): Adriamycin; Bleomycin; Vinblastine; DTIC; 30 Gy IF-RT; 20 Gy IF-RT
Intervention type(s): Drug; Drug; Drug; Drug; Radiation; Radiation
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Bleomycin; Vinblastine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hodgkin´s lymphoma; early stages
Early Vascular Ageing in the YOUth
Condition: Atherosclerosis; Cardiovascular Risk Factor; Cardiovascular Diseases; Cardiovascular Pathology; Life Style; Vascular Diseases; Vascular Stiffness; Non-Alcoholic Fatty Liver Disease; Hypertension; Obesity; Overweight; Headache; Sleep; Sleep Disorder
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Sleep Wake Disorders; Cardiovascular Diseases; Atherosclerosis; Vascular Diseases; Overweight; Headache
Study type: Observational

Summary: 
      This is a single-center observational study on adolescents to determine predictors of the
      early steps of the formation of atherosclerosis and to quantify their influence on
      Intima-Media-Thickness of the carotid artery and the aorta and on the Pulse-Wave Velocity.

      A long-term follow-up by means of record linkage is furthermore planned to evaluate the
      effect of early atherosclerosis and the cardiovascular risk profile on future morbidity with
      a special focus cardio- and cerebrovascular events.
    

Detailed description: 
      EVA4YOU is a cross-sectional study enrolling 3000 students and apprentices aged between 14
      and 19 years. Examinations are conducted at schools and companies throughout Tyrol, Austria
      and include laboratory measurements; standardized medical interviews; anthropometry; liver
      elastography; ultrasonography of the carotid artery and the aorta, and blood pressure,
      bioelectrical impedance; visceral abdominal fat-tissue-thickness measurement, pulse-wave
      velocity measurements.

      The study hypothesis is that the cardiovascular risk factors measured already influence the
      formation of atherosclerosis (measured as carotid and aortic Intima-Media Thickness and
      Pulse-Wave-Velocity) in adolescents.

      A long-term follow-up by means of record linkage is furthermore planned to evaluate the
      effect of early atherosclerosis and the cardiovascular risk profile on future morbidity with
      a special focus cardio- and cerebrovascular events.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        students and apprentices aged 14-19 years
      
Biospecimen description: 
      -  Blood: (lipidome, proteome)

             -  whole blood (DNA)

             -  Serum

             -  Plasma

        -  Stool (gut microbiome)
    
Keywords: Cardiovascular Diseases; Cardiovascular Risk Factor; Atherosclerosis; Cardiovascular Pathology; Life Style; Vascular Diseases; Early Vascular Ageing; Vascular Stiffness; Intima-Media Thickness; Non-Alcoholic Fatty Liver Disease; Ultrasonography; Liver Elastography; Bioimpedance; Blood Pressure; Body Mass Index; Headache; Sleep; Adolescence
E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia
Condition: Tobacco Smoking
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study is to assess if access to an electronic nicotine delivery device,
      or e-cigarette, in addition to nicotine patch (21 mg) can help reduce cigarette smoking among
      individuals diagnosed with schizophrenia compared to nicotine patch alone.
    


Intervention name(s): Nicotine Patch; E-cigarette
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.; The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA).
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: E-cigarettes; Schizophrenia
Mechanisms of Exercise Resistance in Metabolic Disease
Condition: Impaired Glucose Tolerance
MeSH terms: Metabolic Diseases; Glucose Intolerance
Study type: Observational

Summary: 
      This project will determine exercise capacity and molecular markers of the response to acute
      exercise in human subjects with impaired or normal glucose tolerance.
    

Detailed description: 
      Low exercise capacity is an early clinical marker of metabolic impairment that predicts type
      2 diabetes (T2D) risk, as well as future co-morbidities and complications. Aerobic exercise
      training is the only effective treatment to increase exercise capacity and reduce metabolic
      risk. However, despite maintaining similar levels of physical activity, exercise capacity
      remains lower in people with impaired glucose tolerance and T2D, compared to those with
      normal glucose tolerance, suggesting "exercise resistance". The mechanisms of exercise
      resistance in metabolic disease are unknown. In preclinical studies, exercise-induced
      increases in circulating angiogenic markers and skeletal muscle capillary density predict
      improved exercise capacity with training. Furthermore, it was demonstrated that impaired
      glucose tolerance precedes exercise resistance and impaired exercise-induce angiogenesis in
      muscle. Based on these data, it was hypothesized that exercise resistance in human T2D is
      caused by an impaired angiogenic response to exercise, secondary to impaired glycemic
      control. This study will determine whether the angiogenic response to a single bout of
      exercise in human subjects is blunted in patients with impaired glucose tolerance (IGT),
      compared to those with normal glucose tolerance (NGT). Angiogenic potential will be measured
      using a novel in vitro assay developed to assess endothelial tube-formation induced by
      circulating serum angiogenic regulators following exercise. In addition, a novel
      exercise-activated signaling pathway in skeletal muscle that is predictive of exercise
      resistance in animal models was identified. A second aim of the proposed investigation is to
      determine the effect of impaired glucose tolerance on molecular signaling in response to
      exercise in skeletal muscle. This investigation represents a critical step in determining the
      mechanisms that contribute to low exercise capacity in individuals at risk for diabetes.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Study population will be men and women from the Boston area
      
Biospecimen description: 
      Serum Skeletal Muscle
    
Keywords: Exercise; Cardiorespiratory Fitness; Skeletal Muscle; Angiogenesis
Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine and compare the plasma concentrations of Mucinex® Extended Release (ER) 600 mg
      bi-layer tablet in normal healthy volunteers in fed and fasting conditions
    


Intervention name(s): Mucinex®
Intervention type(s): Drug
Intervention description(s): Mucinex® 600 mg ER bi-layer tablets
Other intervention name(s): guaifenesin
Intervention MeSH terms: Guaifenesin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Biofeedback With Cycling Exercise in OA Knee Patients
Condition: Exercise Therapy; Osteoarthritis Of Knee; Biofeedback
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Osteoarthritis (OA) is one of the most common joint diseases causing pain, muscle weakness
      and disability in older population. Quadriceps muscle weakness is one of the recognized risk
      factors for the development and the progression of the disease. Increasing the muscle
      strength could actually bring many benefits to the knee OA patients. The purposes of this
      study are 1) to investigate the effects of combining the EMG biofeedback technique into a
      stationary cycling exercise on the activities of vastus medialis (VM) in people with medial
      compartment knee OA; 2) To investigate the efficiency of a 6-week cycling exercise program on
      improving of quadriceps muscle strength and endurance, physical functions and pain in these
      patients and compare between the conditions of with or without EMG biofeedback; 3) To
      determine the relationships between the muscle activities and the kinematics of the knee
      joint during this cycling exercise program; and therefore to find the mechanism of the
      improvement on muscle activities in the intervention of cycling combining EMG biofeedback. In
      this study, we will enroll the knee OA patients from our hospital, and they will be randomly
      assigned either to the control group, who will cycle without biofeedback, or the biofeedback
      group, who will cycle with a real-time visual EMG biofeedback, during the six-week training
      program. The exercise program consisted of a 5-minute warm-up with low-resistance cycling,
      30-minute moderate-resistance cycling exercise, and 5-minute cool down session. . The knee
      adduction angle, quadriceps strength and endurance, KOOS Chinese version, VAS scale will also
      be measured at baseline and after six weeks of intervention. Mixed-model repeated measure
      analysis of variance (ANOVA) will be used to determine if there are any differences in the
      kinematic, myoelectric, muscle strength and endurance. It is hoped that the results of this
      study could provide information regarding the proper and efficient training strategy for the
      OA knee patients, and deliver the concepts of proper exercise technique to enhance health in
      the community.
    


Intervention name(s): Exercise therapy
Intervention type(s): Other
Intervention description(s): Six-week training program of stationary cycling with / without a real-time visual EMG biofeedback
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Green Tea Effect on Anthropometric, Oxidation and Inflammation Parameters in Physically Active vs. Sedentary Elders
Condition: Aging
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the beneficial effects of a long term (12 weeks)
      green tea drinking on plasma, erythrocytes and saliva oxidative stress biomarkers and
      antioxidant capacity, as well as on cardiometabolic risk factors: anthropometric,
      inflammation and metabolic parameters in a healthy aging men and women.
    

Detailed description: 
      A prospective, crossover trial in which every individual served its own control. All subjects
      undergo a four weeks washout period, during which they briefed to avoid tea drinking and
      antioxidant supplements until the end of the study. At the end of the washout period, blood
      and saliva samples is collected after 12 hours of night fast. Subsequently, all subjects
      receive the maltodextrin containing placebo "tea bags". The subjects instructed to brew the
      placebo sachets for five minute in 240 mL boiling water without stirring and to drink 4 cups
      per day for 12 weeks period (placebo period). After the placebo period, fasting samples
      collected once more and the subjects receive the green tea bags. Preparation and drinking
      instructions are the same as the placebo drink. At the end of the 12 weeks, green tea
      drinking, fasting blood and saliva samples drawn for the third time. During the study, every
      4 weeks the subjects get additional placebo or green tea bags. Assessment of nutritional
      consumption of macronutrients and antioxidants using a food diary, physical activity
      lifestyle as well as weight, body fat and circumference measurements is made at the
      beginning, middle and end of the study.
    

Intervention name(s): Four green tea bags per day for 12 weeks; 4 daily placebo tea bags for 12 weeks
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Four green tea bags per day for 12 weeks; 4 daily placebo tea bags for 12 weeks
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Green tea, aging, oxidation, anthropometrics.
Comparison Study of Daily Ultrafiltration and Twice-weekly Hemodialysis
Condition: End-stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      In this study, the researchers want to find out how patients who have ultrafiltration
      (removal of excess fluid) 6 times a week and twice-weekly dialysis (removal of excess fluid
      and waste products) do in terms of their blood pressure and weight. The researchers believe
      that maintaining patients at their estimated target weight throughout the week using daily
      ultrafiltration will reduce their blood pressure to levels shown in other similar studies.
      Such a reduction in blood pressure may reduce the incidence of cerebral vascular disease,
      peripheral vascular disease, coronary artery disease, and congestive heart failure. The
      researchers also believe that patients' quality of life will improve while they are
      undergoing daily ultrafiltration.

      Studies show that more frequent dialysis treatments result in fewer symptoms for patients.
      The patients feel better and avoid the weight gains and symptoms that patients have on three
      times a week dialysis. In addition, their blood lab results are better controlled, requiring
      less medication.
    


Intervention name(s): Ultrafiltration
Intervention type(s): Procedure
Intervention description(s): Frequency of ultrafiltration is increased from the conventional 3 times a week to 6 times a week.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: End-stage renal disease; Chronic kidney disease; Hemodialysis
Vincristine and Irinotecan With or Without Temozolomide in Children and Adults With Refractory/Relapsed Rhabdomyosarcoma
Condition: RHABDOMYOSARCOMA
MeSH terms: Rhabdomyosarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an international open-label, randomized, multicenter phase II study of VIT and VI for
      the treatment of patients with recurrent or refractory rhabdomyosarcoma. The study will
      evaluate the safety and efficacy of these combinations in patients with recurrent or
      refractory rhabdomyosarcoma.
    

Detailed description: 
      The dose of vincristine will be 1.5 mg/m² or 0.05 mg/kg for patient ≤ 10 kg (maximum 2 mg)
      and will be administered by direct intravenous infusion on day 1 and 8 of each course, before
      irinotecan.

      The dose of irinotecan will be 50 mg/m²/d. Irinotecan will be given intravenously over 1 hour
      on days 1-5 of each course, one hour following the administration of temozolomide.

      In the absence of any contraindication (ie known allergies), treatment with oral cefixime 8
      mg/kg once daily (maximum daily dose 400 mg) is recommended and will be started 2 days before
      chemotherapy until day 7.

      Temozolomide will be given according to the randomization. The starting dose of temozolomide
      will be 125 mg/m²/d. The dose of temozolomide will be escalated to 150 mg/m²/day at cycle 2
      for patients who do not experience > grade 3 toxicity of any kind. Temozolomide will be given
      orally, on an empty stomach, on days 1 through 5 of each course.

      Dose reductions and/or administration delays will be performed using specific predefined
      rules to accommodate individual patient tolerance of treatment and to maintain optimal dose
      intensity.
    

Intervention name(s): Vincristine, Irinotecan; Vincristine, Irinotecan, Temozolomide
Intervention type(s): Drug; Drug
Intervention description(s): D1 and D8: Vincristine 1.5 mg/m² (max 2mg) direct IV infusion (0.05 mg/kg for patient ≤ 10 kg)
D1 to D5: Irinotecan 50 mg/m²/d, IV
cycle / 21 days; D1 to D5: Temozolomide 125 mg/m²/d, PO (the dose will be escalated to 150 mg/m²/day at cycle 2 for patients who do not experience > grade 3 toxicity of any kind)
D1 and D8: Vincristine 1.5 mg/m² (maximum 2mg) direct IV infusion (0.05 mg/kg for patient ≤ 10 kg)
D1 to D5: Irinotecan 50 mg/m²/d, IV
cycle / 21 days
Other intervention name(s): Vincristine-Irinotecan; Vincristine-Irinotecan-Temozolomide
Intervention MeSH terms: Irinotecan; Vincristine; Temozolomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment