bioihbjkbjnl/mcl2 huggingface dataset:
The Analgesic Efficacy Supra-scapular Nerve RF After Breast Surgery
Condition: Chronic Pain Syndrome
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into
      2 groups; forty patients received fluoroscopically guided supra-scapular nerve pulsed
      radiofrequency (PRF) followed by injection of 0.25% bupivacaine solution containing 40 mg of
      methylprednisolone (group1) and forty patients received fluoroscopically guided
      supra-scapular nerve injection of of 0.25% bupivacaine solution containing 40 mg of
      methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.
    

Detailed description: 
      Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into
      2 groups ; forty patients received fluoroscopically guided supra-scapular nerve pulsed
      radiofrequency (PRF) followed by injection through the radiofrequency needle of 0.25%
      bupivacaine solution containing 40 mg of methylprednisolone (group1) and forty patients
      received fluoroscopically guided supra-scapular nerve injection of 0.25% bupivacaine solution
      containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only
      demo mode was applied.
    

Intervention name(s): suprascapular nerve block
Intervention type(s): Procedure
Intervention description(s): Sixty patients with shoulder dystocia after breast surgery will receive stellate ganglion neurolysis with supra-scapular nerve radiofrequency,
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: post mastectomy pain
Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome
Condition: Interpersonal Psychotherapy; Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The main purpose of this study is to find out whether taking part in a group-based
      interpersonal psychotherapy (IPT) program designed to improve mood and lessen stress in girls
      with PCOS will improve depression, unhealthy eating behaviors, weight, and insulin
      resistance.
    


Intervention name(s): Interpersonal Psychotherapy
Intervention type(s): Behavioral
Intervention description(s): IPT group-virtual
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Food Hedonics on Appetite Hormones Levels
Condition: Eating Behavior
Study type: Interventional

Summary: 
      30-40 healthy male subjects with a BMI between 18.5 and 24.9 kg/m2 will be tested for food
      preferences using a questionnaire with 141 different foods. Accordingly, a high
      acceptability/palatability food will be selected (average score of ≥ 7 on the 9-point hedonic
      scale). Two versions of the selected high palatability food will be devised by modifying it
      to yield the original high and the modified low acceptability versions. The two versions will
      differ only in palatability and will be equicaloric. Subjects who agree on the acceptability
      of the two versions of the food (11 subjects) will consume, at fasting, the two versions of
      the food in a cross over design over two sessions. Each session will include an acceptability
      test, using the 9-point hedonic scale, on three instances: after sampling a spoonful, eating
      the whole portion and after 240 min. The quantity consumed on each session will constitute
      30% of the subject's resting energy expenditure. Moreover, fasting and postprandial hunger
      ratings and blood samples will be collected at time 0 and after 15, 30, 60, 120, 180 and 240
      min of the food/meal's ingestion. The visual analogue scale will be used for huger ratings.
    


Intervention name(s): Low Acceptability Meal; High acceptability meal
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Hedonics, Ghrelin, Hunger
Mechanism of Decreased Iron Absorption in Obesity: Controlling Adiposity-related Inflammation
Condition: Obesity
MeSH terms: Obesity; Inflammation
Study type: Interventional

Summary: 
      The main iron regulatory protein in the human metabolism is hepcidin. In normal weight,
      healthy subjects, hepcidin is regulated through the iron status of the body: low iron status
      results in low hepcidin concentrations, which facilitates dietary iron absorption. In
      obesity, which is an inflammatory state, hepcidin concentrations are increased and iron
      absorption is reduced despite low iron stores, leading to iron deficiency over time. Whether
      lowering the chronic low-grade inflammation during a limited treatment period and thereby
      lowering hepcidin concentration can improve iron absorption is uncertain.
    

Detailed description: 
      In states of high hepcidin concentration, intestinal iron absorption (through enterocytes)
      and recycling of iron (through macrophages) is reduced. The extent to which non-heme iron is
      absorbed from the diet is influenced by the composition of the diet. Ascorbic acid is a
      potent enhancer of non-heme iron absorption. It's mechanism of action is luminal reduction of
      dietary ferric iron (Fe3+) to more soluble ferrous iron (Fe2+). A study in the inestigator's
      laboratory showed that the enhancing effect of ascorbic acid on non-heme iron absorption is
      reduced in overweight and obese individuals. Possible explanations for this fact are the
      different sites of action of ascorbic acid and serum hepcidin on the enterocytes in dietary
      iron absorption. Increased hepcidin reduces iron efflux into the circulation at the
      basolateral membrane of the enterocyte. Therefore the improved iron transport into
      enterocytes through ascorbic acid at the luminal side (via the divalent metal transporter
      (DMT)-1), by reducing Fe3+ to Fe2+ seems to be less successful. To improve iron absorption in
      obese subjects, an intervention at the basolateral membrane of the enterocyte would be
      needed.
    

Intervention name(s): Ibuprofen
Intervention type(s): Drug
Intervention MeSH terms: Ibuprofen
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Iron bioavailability; Inflammation; Hepcidin; Iron absorption
Bortezomib, Doxorubicin Hydrochloride Liposome, and Dexamethasone Followed by Thalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride
      liposome and dexamethasone, work in different ways to stop the growth of cancer cells, either
      by killing the cells or stopping them from dividing. Thalidomide may stop the growth of
      cancer cells by blocking blood flow to the cancer. Giving bortezomib together with
      doxorubicin hydrochloride liposome and dexamethasone followed by thalidomide, dexamethasone,
      and bortezomib may kill more cancer cells.

      PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib
      together with doxorubicin hydrochloride liposome and dexamethasone followed by thalidomide
      and dexamethasone with or without bortezomib works in treating patients with multiple
      myeloma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy and safety of bortezomib, pegylated doxorubicin hydrochloride
           liposome, and dexamethasone followed by thalidomide and dexamethasone with or without
           bortezomib in patients with symptomatic high-risk or primary resistant multiple myeloma.

      OUTLINE: Patients receive BDD comprising bortezomib IV on days 1, 4, 8, and 11; pegylated
      doxorubicin hydrochloride liposome IV over 60-90 minutes on day 4; and oral dexamethasone on
      day 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 3 courses in the
      absence of disease progression or unacceptable toxicity.

      Patients achieving response to BDD receive oral thalidomide on days 1-28 and oral
      dexamethasone on days 1-4, 9-12, and 17-20. Treatment repeats every 28 days for 2 courses in
      the absence of disease progression or unacceptable toxicity.

      Patients experiencing stable or progressive disease on BDD receive oral thalidomide on days
      1-28; oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, 12, and 17-21; and bortezomib IV on
      days 1, 4, 8, and 11. Treatment repeats every 28 days for 2 courses in the absence of disease
      progression or unacceptable toxicity.
    

Intervention name(s): bortezomib; dexamethasone; pegylated liposomal doxorubicin hydrochloride; thalidomide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Thalidomide; Dexamethasone; Doxorubicin; Liposomal doxorubicin; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma
Effects of BPA on Insulin and Glucose Responses
Condition: Environmental Exposure
Study type: Interventional

Summary: 
      The National Institutes of Health has encouraged research examining effects of BPA, yet
      evidence in humans evaluating the effects of BPA on insulin and glucose concentrations
      remains exclusively associative in nature. Thus, the primary purpose of this study is to
      determine whether an acute oral ingestion of BPA impacts insulin and glucose concentrations,
      and other endocrine factors (Pro-insulin, C-Peptide, Estrogen, triglycerides). Findings from
      this pilot study will inform public health recommendations for food packaging and provide
      much needed experimental evidence as to whether BPA poses any public health risk.
    

Detailed description: 
      The prevalence of diabetes is well established affecting >29 million Americans with 90-95% of
      these individuals diagnosed with type 2 diabetes. The etiology of type 2 diabetes is not
      fully understood, but clearly diet, physical activity, and genetics play roles. Emerging data
      suggests a novel hypothesis that synthetic non-persistent endocrine disruptors used in a
      variety of common consumer goods, including the industry-produced chemical bisphenol A (BPA)
      play a pivotal role in type 2 diabetes and obesity rates. In support of this hypothesis,
      National Health and Nutrition Examination Survey (NHANES), Nurses' Health Study II (NHSII),
      and other cross-sectional data have shown associations between urinary BPA concentrations and
      type-2 diabetes, pre-diabetes, insulin resistance, and hemoglobin A1c. The National
      Institutes of Health has encouraged research examining effects of BPA, yet evidence in humans
      evaluating the effects of BPA on insulin and glucose concentrations remains exclusively
      associative in nature. Thus, the primary purpose of this study is to determine whether an
      acute oral ingestion of BPA impacts insulin and glucose concentrations, and other endocrine
      factors (Pro-insulin, C-Peptide, Estrogen, triglycerides) in the pathogenesis of Type 2
      diabetes and cardiovascular disease. Findings from this pilot study will inform public health
      recommendations for food packaging and provide much needed experimental evidence as to
      whether BPA poses any public health risk.
    

Intervention name(s): Placebo; BPA 4 ug/kg BW; BPA 50 ug/kg BW
Intervention type(s): Other; Other; Other
Intervention description(s): Ingestion of Placebo; Oral BPA ingestion of 4 ug/kg BW; Oral BPA ingestion of 50 ug/kg BW
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Plantar Faciitis and Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate
      from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by
      decreased ability of tissue repair and increased reactive ossification. Thus, the
      investigators aimed to determine CS incidence in asymptomatic obese subjects with and without
      type 2 diabetes mellitus (T2DM).
    

Detailed description: 
      OBJECTIVE-Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to
      originate from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS
      by decreased ability of tissue repair and increased reactive ossification. Thus, the
      investigators aimed to determine CS incidence in asymptomatic obese subjects with and without
      type 2 diabetes mellitus (T2DM).

      RESEARCH DESIGN AND METHODS-Ninety-three obese patients with T2DM and forty-two obese
      subjects without any metabolic disturbances as control were evaluated with lateral calcaneal
      x-ray in blinded fashion by a radiologist. All participants were informed and written
      consents have been obtained. Control cases were subjected to 75g glucose challenge test and
      glucose intolerant subjects were excluded.

      RESULTS-T2DM and control groups were statistically similar in mean age (59±10.5 vs. 55±8 yrs,
      P=0.196, respectively) and mean body mass index (BMI)(35.1±4.3 vs. 33.1±3.3 kg/m2, P=0.073,
      respectively). Existence of calcaneal spur was 72% in 93 patients (77%) in T2DM group and 24
      in 42 (57%) in control group. Groups were significantly different according to existence of
      CS (P=0.023). Mean age and mean BMI were significantly higher in diabetic patients with
      calcaneal spur than diabetic patients without calcaneal spur (p=0.001 and p=0.015,
      respectively). There was positive correlation between existence of calcaneal spur and
      peripheral neuropathy (p=0,043) in diabetics but no significant relation between existence of
      CS and glycolysed hemoglobin levels or diabetes duration (all P>0.05).

      CONCLUSIONS-Clinicians should pay attention the increased incidence of CS in patients with
      T2DM to avoid foot complications.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        93 paitents and 42 control group
      
Keywords: Calcaneal Spur, Diabetic Obese Patients
Comparison of Clinical Outcomes Among Patients Treated With Tisagenlecleucel
Condition: Diffuse Large B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Observational

Summary: 
      This is a non-interventional, retrospective cohort study using the Flatiron Health Research
      Database (FHRD) and data from the single-arm phase II JULIET clinical trial (NCT02445248).
    

Detailed description: 
      JULIET is a single-arm, open-label, multi-center phase II study of tisagenlecleucel involving
      adult patients with r/r DLBCL who were ineligible for or had disease progression after
      autologous hematopoietic stem-cell transplantation.

      Patients enrolled in JULIET will be referred to as the trial cohort in this study. Outcomes
      observed in the trial cohort will be compared against a cohort of patients receiving standard
      of care, defined as the real-world cohort in this study. The real-world cohort will be
      derived from the FHRD by applying relevant JULIET trial inclusion and exclusion criteria that
      are feasible to apply in the FHRD.
    

Intervention name(s): Tisagenlecleucel
Intervention type(s): Other
Intervention description(s): The trial cohort is defined as the cohort of patients enrolled in JULIET who were assigned to receive tisagenlecleucel infusion
Intervention MeSH terms: Tisagenlecleucel
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated with tisagenlecleucel in the JULIET trial versus a real-world,
        retrospective cohort of patients treated with standard of care for relapsed or refractory
        diffuse large B-cell lymphoma
The Effect of Walking on Cardiovascular Risk
Condition: Sedentariness
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of an 8 week program of walking for
      45 minutes, twice a week, on fitness, body composition , blood pressure and blood markers of
      cardiovascular risk. We hypothesised that this 90 minutes of walking per week would result in
      measurable increases in fitness and reductions in body fat, resting blood pressure and
      improved blood lipid profiles.
    

Detailed description: 
      Current physical activity guidelines suggest that every adult should accumulate 30 minutes or
      more of moderate intensity physical activity on most days of the week. However, compliance
      with these guidelines requires considerable commitment in terms of time spent exercising per
      week (> 150 minutes) and this may deter individuals from starting an exercise programme.
      Accordingly, randomised controlled trials are needed to evaluate the effects of smaller
      volumes of exercise on health.

      37 civil servants (24 women) aged 41.5 + 9.3 years, were randomly assigned to either two 45
      minute walks per week (walking group) or no training (control group). Aerobic fitness, body
      composition, blood pressure (BP), CRP and lipoprotein variables were measured at baseline and
      following 8 weeks. Steps counts were measured at baseline and during weeks 4 and 8 of the
      intervention
    

Intervention name(s): Walking 45 mins 2x p.w.
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: walking intervention; cardiovascular risk; inflammatory markers; aerobic fitness; fatness
A Study of Two Methodologies for Measuring Blood Flow in the Brain in Response to Non-Drug Stimuli (P08085/MK-0000-180)
Condition: Functional Magnetic Resonance Imaging
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will identify a dose of ferumoxytol that can reliably detect changes in blood
      flow/volume in response to non-drug stimuli. The study will determine whether signal
      detection for functional magnetic resonance imaging (fMRI) using ferumoxytol is better than
      that for blood oxygen level-dependent (BOLD) fMRI in response to sensory stimulation. The
      following procedures will be conducted in each of two study periods: arterial spin labeling
      (ASL) imaging study with increasing exposure to carbon dioxide (CO2); BOLD fMRI study with
      sensory stimulation; MRI studies with sensory stimulation in the presence of increasing doses
      of ferumoxytol; MRI study with increasing exposure to CO2 in the presence of ferumoxytol.
      There will be a 3-week interval between the two study periods. The study will enroll 8
      subjects, but an additional 4 subjects are permitted to enroll to preserve study power.
    

Detailed description: 
      Study Design: Translational Medicine - Imaging Platform Development
    

Intervention name(s): fMRI with sensory stimulation
Intervention type(s): Procedure
Intervention description(s): BOLD fMRI study with sensory stimulation followed by fMRI in the presence of increasing concentrations of ferumoxytol (Feraheme™)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: brain imaging
Bortezomib, Doxorubicin Hydrochloride Liposome, and Thalidomide as First-line Therapy in Treating Patients With Previously Untreated Stage I, II, or III Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride
      liposome, work in different ways to stop the growth of cancer cells, either by killing the
      cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma
      by blocking blood flow to the cancer. Giving bortezomib together with doxorubicin
      hydrochloride liposome and thalidomide may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin
      hydrochloride liposome and thalidomide works as first-line therapy in treating patients with
      previously untreated multiple myeloma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the overall response rate (complete response and partial response) in
           patients previously untreated stage I, II, or III multiple myeloma.

      Secondary

        -  To evaluate the complete response rate in patients treated with this regimen.

        -  To determine the time to disease progression from the start of this therapy in patients
           treated with this regimen.

      OUTLINE: Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on
      days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1
      and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression
      or unacceptable toxicity. Patients with residual disease who continue to show response after
      completion of 6 courses may receive 2 additional courses for a total of 8 courses.

      After completion of study treatment, patients are followed every 3 months.
    

Intervention name(s): bortezomib; pegylated liposomal doxorubicin hydrochloride; thalidomide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV; IV; Oral
Intervention MeSH terms: Thalidomide; Doxorubicin; Liposomal doxorubicin; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma
Tofogliflozin GLP-1 Analogue Combination Trial
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      An open-label, multicenter study to evaluate 52-week long-term safety, tolerability and
      efficacy of Tofogliflozin with GLP-1 analogue treatment in type 2 diabetes mellitus.
    


Intervention name(s): Tofogliflozin; GLP-1 analogue
Intervention type(s): Drug; Drug
Other intervention name(s): DEBERZA; APLEWAY
Intervention MeSH terms: 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment