bioihbjkbjnl/mcl2 huggingface dataset:
Impact of the Rapid Normalization of Chronic Hyperglycemia and the Practice of Moderate Physical Activity on the "Receptor Activator of Nuclear Factor-kappa B Ligand / Osteoprotégérine (RANKL / OPG) System in Patients Living With Type II Diabetes
Condition: Type II Diabetes
MeSH terms: Diabetes Mellitus; Hyperglycemia; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The rapid normalization of hyperglycemia can cause a neuropathy called Diabetes
      Treatment-Induced Neuropathy (NITD). This phenomenon induces the presence of hyper
      vascularization and inflammation in contact with the nerve ends.

      In another register in patients living with diabetes, it has been observed the development of
      a rare and devastating complication for the joints called the so-called neuroarthropathy of
      Charcot (CN).
    

Detailed description: 
      The rapid normalization of hyperglycemia can cause a neuropathy called Diabetes
      Treatment-Induced Neuropathy (NITD). This phenomenon induces the presence of hyper
      vascularization and inflammation in contact with the nerve ends.

      In another register in patients living with diabetes, it has been observed the development of
      a rare and devastating complication for the joints called the so-called neuroarthropathy of
      Charcot (CN). The pathophysiology of CN is not completely known but there is an activation of
      markers of inflammation and bone remodeling, disruption of the osteoblast and osteoclast
      system, activation of the RANKL system (Receptor activator of nuclear factor-kappa B ligand)
      and its antagonist osteoprogesterin (OPG). Inflammation and peripheral hypervascularization
      therefore seem to be a common link between the two pathologies mentioned (NITD and CN). We
      have confirmation that the rapid correction of chronic hyperglycemia can trigger (not
      systematically) NITD, but what about the influence of this rapid correction on the appearance
      of CN. Furthermore, physical activity (PA) and exercise have long been recognized as the
      cornerstones of the prevention and management of chronic diseases, due to their beneficial
      effects on the clinical parameters of various diseases. The practice of PA has a preventive
      and therapeutic effect against osteoporosis (a disease in which the level of RANKL is
      particularly high), so there is in theory a preventive effect of the practice of physical
      activity on the development of CN.
    

Intervention name(s): pratice physical activity
Intervention type(s): Other
Intervention description(s): treadmill walking : walk at a speed of 2.7 km.h-1 in 3 stages of 3 mins with an incline of 0%, 5% and 10%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes's complications; neuroarthropathy Physical activity; RNKL/OPG
Food Effect Study For Apixaban Commercial Image Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of food on the pharmacokinetics of apixaban administered as commercial
      image tablets.
    


Intervention name(s): Apixaban; Apixaban
Intervention type(s): Drug; Drug
Intervention description(s): Period I: 1 x 5 mg Commercial Image Tablet in fasting state(single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: 1 x 5 mg Commercial Image Tablet in fed state (single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period); Period I: 1 x 5 mg Commercial Image Tablet in fed state(single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: 1 x 5 mg Commercial Image Tablet in fasting state (single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period)
Intervention MeSH terms: Apixaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food effect study; Pharmacokinetics; Apixaban
Repository: Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant
Condition: Hematopoietic Stem Cell Transplantation; Graft vs Host Disease
MeSH terms: Graft vs Host Disease
Study type: Observational

Summary: 
      This is a repository to store blood and stem cell samples for future research.
    

Detailed description: 
      Our Hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the
      complications of GVHD by determining the qualitative and quantitative changes in T regulatory
      cells throughout the transplant process. Our understanding of this can lead to new treatment
      strategies and improved clinical therapeutic implications.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant
        for various hematologic conditions
      
Keywords: T-Lymphocyte Subsets
A Study to Evaluate the Pharmacokinetics of VI-0521 Subjects With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      VI-0521, a fixed dose combination of immediate-release (IR) phentermine and
      controlled-release (CR) topiramate, is in Phase III clinical development as a potential
      therapy for obesity. In human, both phentermine and topiramate are primarily cleared by renal
      excretion. The contribution of hepatic metabolism to elimination of phentermine and
      topiramate is not significant. Obese patients, the proposed indicated population for future
      treatment with VI-0521, are likely to have renal impairment. Therefore, this study is
      important in understanding the effect of renal impairment on the pharmacokinetics of
      topiramate and phentermine in subjects with renal impairment compared to subjects with normal
      renal function.
    

Detailed description: 
      This open-label, parallel-group, single dose, non-randomized study will be conducted at
      multiple sites in the United States in which up to 40 male and female subjects, 19-75 years
      of age (inclusive), with varying degrees of renal function may be enrolled and dosed to
      obtain at least 32 evaluable subjects (4 groups, 8 subjects per group). Subjects will report
      to the study site on the evening before treatment and will remain at the site until the
      48-hour PK sample has been drawn (approximately 3 days). All subjects will be fasted
      overnight for a minimum of 8 hours before drug treatment in the morning. A single oral dose
      of the combination product VI-0521 (15 mg phentermine and 92 mg topiramate) will be
      administered with 240 mL of water at hour 0. Standard meals will be provided uniformly to all
      subjects at approximately 4 and 9 hours after dosing, and an evening snack will be provided
      approximately 12 - 13 hours after dosing. Blood samples for the determination of phentermine
      and topiramate concentrations in plasma will be collected at 0 (pre-dose), 1, 3, 4, 5, 6, 7,
      8, 9, 10, 12, 16, 24, 36 and 48 hours post dosing. Subjects will be released from the study
      site following the 48-hour sample but will return to the site for PK sampling at 72, 96, 120,
      144, 168 and 192 hours post dose. The severe renal impairment group will be given the option
      to stay at the site for the duration of the study.
    

Intervention name(s): Topirmate and Phentermine
Intervention type(s): Drug
Intervention description(s): A single oral dose of the combination product VI-0521 (15 mg phentermine and 92 mg topiramate) will be administered with 240 mL of water at hour 0.
Intervention MeSH terms: Phentermine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Ski Sport on Physical Performance
Condition: Physical Performance; Pain; Quality of Life
Study type: Observational

Summary: 
      The aim of the study is to investigate the effect of ski sport on physical performance, pain,
      and quality of life compared to sedentary individuals of similar age groups and to examine
      the existence of gender-specific differences.
    

Detailed description: 
      The aim of the study is to investigate the effects of skiing on physical performance, pain,
      quality of life, and gender-specific differences. In this context, aerobic/anaerobic
      performance, body balance, hand-grip strength, and back-leg-chest strength were evaluated in
      male and female ski athletes and age- and sex-matched sedentary controls.

      In addition, pain experiences, low back pain-related disability level, and quality of life of
      all participants were questioned using SF 36, McGill Pain Questionnaire (MPQ), Oswestry Low
      Back Pain Disability Questionnaire (OLBPDQ), and VAS scales.

      The data thus collected were used to determine whether skiing had any effect on physical
      performance and quality of life, as well as the possible impact of skiing on gender-specific
      differences.
    

Intervention name(s): Physical performance tests and observational assessments
Intervention type(s): Other
Intervention description(s): There will be no interventions. Physical performance tests and observational assessments will be conducted.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The sample of the study consists of a total of 68 participants between the ages of 18-25.
        Licensed ski athletes in Turkey (17 male, 17 female), who have been active in sports for at
        least the last 2 years, were included in the skiers group, and an age-matched non-athletic
        person (17 male, 17 female) with no skiing experience was included in the control group.
        The evaluations of the Skiers group were made at Erciyes Ski Center, and those of the
        control group were made at the Faculty of Health Sciences of Nuh Naci Yazgan University.
      
Keywords: Skiing; Gender difference; Muscle strength; Physical performance; Pain; Quality of life
Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty
Condition: Total Knee Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective, randomized trial asked whether subcutaneous indwelling of vacuum drainage
      has advantages over intraarticular indwelling in terms of blood loss, bleeding related
      complications, and functional outcomes in primary total knee arthroplasty (TKA). The
      investigators hypothesized that the subcutaneous indwelling method would reduce blood loss
      with comparable bleeding-related complications and functional outcomes. The subcutaneous
      indwelling group demonstrated reduced blood loss with comparable prevalence of
      bleeding-related complications and functional outcomes. In conclusion, the investigators'
      study verified the efficacy and absence of risks of subcutaneous indwelling method. So the
      investigators propose that the subcutaneous indwelling drainage can be a good option to
      address the problems related to postoperative bleeding after TKA.
    

Detailed description: 
      There are numerous reports in the literature on drainage options after TKA, but there is no
      consensus. Many studies have shown no apparent advantage of drainage but routine
      intraarticular indwelling drainage after TKA has been extensively used to avoid complications
      associated with hematoma formation. It is of interest to determine if it is possible to
      reduce blood loss while still using drainage. So we came to think about a new and more
      convenient method-subcutaneous indwelling. Theoretically subcutaneous indwelling method which
      still has the advantages over the intraarticular indwelling method but is more convenient
      than drain-clamping method may be a better option. So we hypothesized that subcutaneous
      indwelling method of vacuum drainage has advantages over the intraarticular indwelling
      method.
    

Intervention name(s): subcutaneous indwelling; intraarticular indwelling
Intervention type(s): Procedure; Procedure
Intervention description(s): vacuum drainage is indwelled in subcutaneous layer; vacuum drainage is indwelled in intraarticular space
Other intervention name(s): hemovac; hemovac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: total knee replacement arthroplasty; subcutaneous indwelling; blood loss; complications; functional status
Dietary Interventions for Muscle Mass
Condition: Aging
Study type: Interventional

Summary: 
      Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is
      to test whether meat structure plays an important role in protein digestion, to maximise the
      amino acid availability and to stimulate the muscle protein growth in elderly people.
    


Intervention name(s): Intact or minced beef meat
Intervention type(s): Other
Intervention description(s): 135 gram piece of intact or minced beef meat, beef steak or minced beef resp.
Other intervention name(s): Beef steak; Minced beef; Beef patty; Steak; Hamburger; Ground beef
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: muscle; FSR; protein; meat
Tumor Hypoxia of Head-and-neck Cancer Underwent Radiation Therapy Measured With F-18-FMISO
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms; Hypoxia
Study type: Observational

Summary: 
      The purpose of this study is to describe the regional and global tumor hypoxia in
      head-and-neck cancer during percutaneous radiation therapy
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study includes consecutive patients from the Department of Radiooncology with head and
        neck cancer (HNC) intended for a curative chemoradiotherapy.
      
Keywords: head-and-neck cancer; radiation therapy; F-18-FMISO
A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 1)
Condition: Cellulite
MeSH terms: Cellulite
Study type: Interventional
Phase: Phase 2

Summary: 
      The Stage 1 of this phase 2 study is an open-label single ascending dose (SAD) study to
      assess the efficacy and safety of CBL-514 in participants with Edematous Fibrosclerotic
      Panniculopathy (EFP) cellulite.
    

Detailed description: 
      This Phase 2a study has an integrated design consisting of a single ascending dose (SAD) part
      in Stage 1 followed by a single-arm design in Stage 2. The Stage 1 will include a total of 12
      participants enrolled in 3 sequential escalating CBL-514 dose groups.The groups will be open
      label and each group will enroll 4 participants.

      Eligible participants will be sequentially assigned to receive 1 course of allocated CBL-514
      dose administered by subcutaneous injection on both sides of the posterolateral thighs.
    

Intervention name(s): 40 mg CBL-514; 60 mg CBL-514; 80 mg CBL-514
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CBL-514 will be administered at the raised area of cellulite.; CBL-514 will be administered at the raised area of cellulite.; CBL-514 will be administered at the raised area of cellulite.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oxytocin Effects on Food Motivation Pathways
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Oxytocin is a peptide hormone produced in the brain that regulates food intake. However, the
      mechanisms for this effect in humans is not yet clear.

      In this study, the investigators will therefore examine the effect of a single dose of
      intranasal oxytocin (compared to placebo) on levels of appetite-regulating hormones and
      functional magnetic resonance imaging activation of areas of the brain involved in food
      motivation.
    


Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose, intranasal; Single dose, intranasal
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside
      mixing formulation of adjuvanted influenza vaccines.
    


Intervention name(s): Adjuvanted Influenza Vaccine; Influenza Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 1 dose of Adjuvanted Influenza Vaccine; 1 dose of Influenza Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: influenza; vaccine; adjuvants; flu
AZD3355 Dose-escalation Study in Healthy Males
Condition: Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim is to establish the maximal tolerated dose of AZD3355 for the selection of doses in
      the up-coming studies. This will be done by comparing single and repeated doses of AZD3355 to
      placebo ("inactive substance"). Safety and tolerability variables will be closely monitored
      throughout the study.
    


Intervention name(s): AZD3355; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsules, oral, single or twice daily dose; To match dosing of AZD3355
Other intervention name(s): Lesogaberan
Intervention MeSH terms: Lesogaberan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Safety; tolerability; healthy subjects
The Effects of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis (Study P04271AM2)(COMPLETED)
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3b, randomized, parallel-group, multicenter, active-controlled, open-label
      study of the efficacy and safety of infliximab compared with methotrexate (MTX) in the
      treatment of moderate to severe psoriasis in adults who were diagnosed with moderate to
      severe plaque-type psoriasis for at least 6 months prior to screening (subjects with
      concurrent psoriatic arthritis may also be enrolled).
    


Intervention name(s): infliximab; methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.; Methotrexate will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
Other intervention name(s): SCH 215596; Remicade; Trexall; Rheumatrex
Intervention MeSH terms: Infliximab; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery
Condition: RADICULAR CYSTS
MeSH terms: Cysts; Radicular Cyst
Study type: Interventional

Summary: 
      AIM: The study was intended to evaluate the effectiveness of piezosurgery in enucleation of
      radicular odontogenic cysts in comparison to the conventional technique from both the
      clinical and radiographic perspectives.
    

Detailed description: 
      METHODS: Fourteen (8 females and 6 males) patients with age range of 30-55 years who had
      radicular cysts associated with non-vital teeth, were operated at the Oral and Maxillofacial
      Surgery Department, Faculty of Dentistry, Alexandria University. The patients were randomly
      divided into 2 groups;1) the study group (7 patients) in which cyst enucleation using
      piezosurgery was employed, 2) control group in which the cysts were removed using the
      conventional technique. The following parameters were assessed; postoperative pain, time of
      operation, hemorrhage control and field visibility, ease of operation, neurosensory
      evaluation and radiographic percentage of change in bone defect volume between preoperative
      and 3-months postoperative values.
    

Intervention name(s): PIEZOSURGERY VERSUS CONVENTIONAL SURGERY
Intervention type(s): Other
Intervention description(s): Piezosurgery: SATLEC ACTEON peizotome 2 (A company of ACTEON Group, France) was used. Conventional surgery with rotary instruments
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment