bioihbjkbjnl/mcl2 huggingface dataset:
A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the
      effect of aleglitazar on renal function, the renin-angiotensin system and the
      pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with
      lisinopril. Patients on a stable dose of lisinopril (20 mg daily orally) for 2 weeks will be
      randomized to receive either aleglitazar (150 mcg orally daily) or placebo in addition to
      lisinopril for 4 weeks.
    


Intervention name(s): aleglitazar; lisinopril; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150 mcg orally daily, 4 weeks (Day 15 to Day 43); 20 mg orally daily, 6 weeks (Day 1 to Day 43); aleglitazar matching placebo orally daily, 4 weeks (Day 15 to Day 43)
Intervention MeSH terms: Lisinopril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Acute Effect of Fructose on Lipid Metabolism and Gender Differences
Condition: Lipid Metabolism
Study type: Interventional

Summary: 
      It has been widely documented that fructose overfeeding increases plasma triglycerides and
      hepatic de novo lipogenesis, and impairs insulin sensitivity in healthy male volunteers. The
      effect of gender on the metabolic responses to fructose remains an important open question,
      however.

      The objective of this study is to compare the effect of an acute oral fructose load on
      carbohydrate and lipid metabolism in healthy young males and females.
    

Detailed description: 
      The study is aimed at comparing the effects of oral fructose on several specific metabolic
      pathways in males and females.Participants will receive an isoenergetic diet containing 55%
      carbohydrate, 15% protein and 35% lipids for three days prior to testing. After this period
      of controlled diet, they will be studied for 2 hours in the post-absorptive state (Time 0-120
      min) and over a 6 hours period (Time 120-480 min) during which they will receive 4 loads of
      0,30 g/kg fat free mass U-13C labelled fructose, at times 120, 180, 240, 300. Throughout the
      study, deuterated glucose and glycerol will be infused to monitor whole body glucose
      production and glycerol turnover.

      The following parameters will be monitored in basal conditions and after the ingestion of the
      load of fructose:

        -  Glycerol turnover(glycerol 2H5)

        -  de novo lipogenesis (incorporation of 13C into palmitate of VLDLs)

        -  whole body energy expenditure and net substrate oxydation (indirect calorimetry)

        -  net fructose oxidation (breath 13CO2)

        -  glucose turnover: (6,6 2H2 Glucose)

        -  plasma glucose, free fatty acids, ketone bodies, lactate, insulin, triacylglycerol,
           total cholesterol, VLDL, LDL, and HDL subfractions

      An adipose tissue (periumbilical subcutaneous) biopsy will be obtaine by needle aspiration
      under local anesthesia in fasting conditions (time 0 min) and after fructose (time 480 min)
      to assess the effects of fructose on adipose gene expression profile. Key genes involved in
      the regulation of carbohydrate (GLUT 4, hexokinase, PDH-kinase), lipid (FAT-CD36, FABP,
      acetylCoA carboxylase, malonyl-CoA decarboxylase, PPARg) and energy metabolism (PGC-1a,
      UCP2)will be monitored

      Results obtained in males and females will be compared with two-way analysis of variance
    

Intervention name(s): fructose; Fructose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): acute administration of 4 times 0.3g fructose/kg lean body mass; acute administration of 4 times 0.3 g/kg fat-free mass oral fructose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: dietary fructose; plasma lipids; healthy humans; gender differences; hepatic de novo lipogenesis
Adjusting Challenge-Skill Balance to Improve the Elderly's Quality of Life
Condition: Elderly
Study type: Interventional

Summary: 
      The purpose of this study was to clarify the effects on health-related QOL of occupational
      therapy involving the adjustment of challenge-skill balance in the activity of elderly
      clients.
    

Detailed description: 
      This study was single-blind, randomized controlled trial. Clients were randomly assigned by
      blocked randomization (block size 4) to either the experimental group (occupational therapy
      that included assessment and adjustment of the challenge-skill balance of the activities) or
      to the control group (occupational therapy as normally conducted at the day care center).
      Randomization was stratified by sex and EuroQol visual analogue scale, resulting in four
      layers. The primary outcome was change in health-related quality of life after 10 sessions of
      occupational therapy. Clients were assessed before the intervention (pre-test) and after the
      10th session (post-test). Significant differences were observed in the EuroQol-5 Dimension
      (EQ-5D) score and in the Medical Outcome Study 8-Item Short-Form Health Survey (SF-8) scores
      for general health, physical functioning , and vitality.
    

Intervention name(s): Adjusted the challenge-skill balance; Non-adjusted the challenge-skill balance
Intervention type(s): Other; Other
Intervention description(s): In the first session of occupational therapy, the therapist assessed the client's problems in daily living using the Canadian Occupational Performance Measure. Based on the problems identified, an activity that could be supported in day care was selected. In the second session, the client performed the selected activity, and then the challenge and skill levels of the activity were evaluated. Based on these levels, adjustment of the challenge-skill balance in the activity was attempted. Occupational therapy consisted of 10 sessions of 20 minutes held over about 10 weeks; The first and second sessions were conducted in the same way as for the experimental group, except that the therapists were not informed of the client's subjective perception of the challenge and skill levels for the activity. From the third session, the therapists simply assessed the client's performance and conducted the therapy in the normal manner for the day care center, following the general guidelines for occupational therapy practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Occupational Therapy; Quality of Life
Open Label Pilot Study of the Effects of Memantine on FDG-PET in Frontotemporal Dementia
Condition: Frontotemporal Dementia
MeSH terms: Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Study type: Interventional
Phase: Phase 3

Summary: 
      Memantine has been approved for use in Alzheimer's disease. Its mechanism of action raises
      questions of whether it can also be effective for non-Alzheimer's dementias such as
      frontotemporal dementia (FTD), which currently has no disease-modifying treatment.

      This is an open-label study to probe the effects of memantine in 15 outpatients diagnosed
      with FTD, as shown objectively by comparing PET scans performed before and after use of the
      medication. The specific type of PET scan, FDG-PET, allows the investigators to gauge the
      effects of memantine on cortical activity levels. The investigators hypothesize that subjects
      on memantine will show normalization of cortical metabolic activity.
    


Intervention name(s): memantine hydrochloride
Intervention type(s): Drug
Intervention description(s): memantine hydrochloride oral tablets, 10mg po bid
Other intervention name(s): Ebixa; Namenda
Intervention MeSH terms: Memantine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PET; frontotemporal dementia; memantine; Pick's disease
Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to complete the total safety database size for GlaxoSmithKline
      Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free
      development plan.

      This study used a purposely selected lot for PCV-free liquid HRV vaccine that is in the upper
      range of the usual release potencies. The PCV-free liquid HRV vaccine lots used were stored
      frozen in order to keep the titer stable until administration during the study.

      As the liquid formulation of GSK's HRV vaccine is not licensed in the US, the lyophilized
      formulation of the vaccine was used as a control in all phase III studies as part of the
      PCV-free development plan.
    


Intervention name(s): PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine; Lyophilized formulation of GSK's oral live attenuated HRV vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.; 2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HRV; Lyophilized formulation; Liquid formulation; Human rotavirus vaccine; Rotarix; Healthy infants; PCV-free; Porcine circovirus-free
Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional

Summary: 
      This study evaluates the efficacy and safety of the administration of betalactam antibiotics
      in prolonged infusion compared to intermittent infusion in children with sepsis. Half of
      participants will receive piperacillin/tazobactam, imipenem or meropenem in continuous or
      extended infusion, while the other half will receive piperacillin/tazobactam, imipenem or
      meropenem in intermittent infusion.
    

Detailed description: 
      Sepsis is the leading cause of morbidity and mortality in hospitalised patients globally.
      Betalactams are time-dependent antibiotics, and so, the duration of time for which the free
      drug plasma concentration remains above the minimum inhibitory concentration (fT > MIC) is
      the pharmacokinetic/pharmacodynamic index associated with bacterial killing and clinical
      improvement. Numerous studies have demonstrated that continuous infusion (infusion in 24
      hours) and extended infusion (through prolonging the infusion time to greater than 3 hours)
      allows the maintenance of concentrations above the MIC for a longer period of time within the
      dosing interval (30 minute or 1 hour), and so, capitalises on the pharmacodynamic properties
      of betalactams and maximises bacterial killing, therefore potentially improving clinical
      outcomes. In adult patients, the several studies suggest that prolonged infusion may offer
      clinical benefits and significant reduction in mortality without increasing the risk of
      toxicity, however, there is limited information about these dosing strategies in pediatric
      patients.
    

Intervention name(s): Intermittent Piperacillin/tazobactam; Continuous Piperacillin/tazobactam; Intermittent Imipenem; Extended Imipenem; Intermittent Meropenem; Extended Meropenem
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Piperacillin/tazobactam administered in 30 minutes infusion.; Piperacillin/tazobactam administered in 24 hours infusion.; Imipenem administered in 60 minutes infusion.; Imipenem administered in 6 hours infusion.; Meropenem administered in 60 minutes infusion.; Meropenem administered in 8 hours infusion.
Other intervention name(s): Intermittent Infusion of Piperacillin/tazobactam; PiSA; Continuous Infusion of Piperacillin/tazobactam; PiSA; Intermittent Infusion of Imipenem; PiSA; Extended Infusion of Imipenem; PiSA; Intermittent Infusion of Meropenem; Kener; Merrem, AstraZeneca; Extended Infusion of Meropenem; Kener; Merrem, AstraZeneca
Intervention MeSH terms: Meropenem; Tazobactam; Piperacillin; Imipenem; Piperacillin, Tazobactam Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain
Condition: Typical Facial Pain; Atypical Facial Pain
MeSH terms: Facies; Facial Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Trigeminal neuralgia is a craniofacial pain syndrome that is typically characterized by
      unilateral severe, recurrent, electrical pain in one or more distributions of the trigeminal
      nerve. Current treatment strategies include oral medications as first line therapy with
      surgical interventions reserved for those patients who are refractory to medications or
      unable to tolerate medication side effects. Despite these current treatment options, many
      patients continue to have symptoms. Ultrasound-guided trigeminal nerve block allows for fine
      adjustment of the needle tip and direct observation of the medicine.

      Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic
      nerve pain with great success. Steroids can be short or long acting in duration with varying
      side effects. If there exists a difference in duration of action, using the longer acting
      drug will provide a greater period of symptom relief for the patient and may allow the
      patient to undergo fewer interventional procedures.
    


Intervention name(s): Bupivacaine; Triamcinolone; Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 4 mL of 0.25% bupivacaine; 40 mg of Triamcinolone; 4 mg of Dexamethasone
Intervention MeSH terms: Dexamethasone; Triamcinolone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Eccentric Exercise in Patients With Non-Specific Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Neck pain is one of the most frequently investigated and common musculoskeletal disorders
      that cause disability in the community.If neck pain is due to multifactorial etiology, it is
      defined as non-specific neck pain.Eccentric exercises are used to increase muscle strength
      and muscle mass.

      Non-specific neck pain affects negatively and often leads to severe disability. Various
      rehabilitation techniques are available to reduce pain and disability and increase functional
      level.

      This study aimed to compare the pain and functional status of eccentric exercise training and
      home program exercise groups of people with non-specific neck pain.
    

Detailed description: 
      It is known that exercise treatments are useful in strengthening neck muscles and controlling
      postural disorders in patients with neck pain, which is currently accepted. Eccentric
      exercises are used to increase muscle strength and muscle mass.

      Home exercise and eccentric exercise training groups were included in a total of 24 sessions
      (8 weeks*3 days); home exercise program was applied to the individuals in the control group.
      Visual Analog Scale, Mc Gill Melzack Pain Assessment, Neck Disability Index, hand grip
      strength, and skin resistance assessments.
    

Intervention name(s): Eccentric Exercises
Intervention type(s): Other
Intervention description(s): Eccentric Exercises for neck muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized-controlled study
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Neck pain; Exercise; Eccentric strengthening; Pain; Disability
Seroquel in Bipolar Depression Versus SSRI
Condition: Bipolar Disorder; Bipolar Depression; Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether quetiapine is effective and safe in the
      acute treatment of bipolar depression and whether the effect is maintained when treatment is
      continued.
    


Intervention name(s): quetiapine fumarate (Seroquel); paroxetine; mood stabilizing activity
Intervention type(s): Drug; Drug; Behavioral
Intervention MeSH terms: Quetiapine Fumarate; Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bipolar disorder; bipolar depression; depression
Autologous Adipose-derived Regenerative Cells Injection for Treatment of Radiation-induced Rectovaginal Fistula
Condition: Rectovaginal Fistula
MeSH terms: Rectovaginal Fistula; Fistula
Study type: Interventional
Phase: Phase 1

Summary: 
      A new strategy for treatment of late radiation damage is to develop methods aimed at
      stimulating the regenerative capabilities of irradiated tissues. Since the main pathogenetic
      mechanism of the development of late radiation damage is the death or damage of the
      replicative mechanism of stromal cells (SC), a justified approach can be considered as
      transplantation of intact SC. Currently, there is convincing evidence in the scientific
      literature that the injection of intact autologous SCs into the zone of fibrosis surrounding
      the chronic radiation ulcer leads to the healing of a wound defect.

      An Initiative Clinical Trial. Introduction of autologous regenerative cells of adipose tissue
      for the treatment of post-irradiation vaginal-rectal fistula. It is assumed that patients
      will be included in the project within 12 months; the monitoring of each patient will last
      for 6 months; the total duration of the clinical part of the study will be 18 months; The
      total duration of the clinical trial including the preparatory phase and the writing of the
      report is about 24 months. It is assumed that at least 16 patients aged 20 to 75 years who
      have verified diagnosis of post-irradiation vaginal-rectal fistula will participate in this
      pilot project. The aims of the clinical trial are to preliminarily assess the safety,
      effectiveness and quality of life of patients after introducing autologous regenerative cells
      of adipose tissue for the treatment of post-irradiation vaginal-rectal fistula.
    


Intervention name(s): Injection of autologous regenerative cells of adipose tissue
Intervention type(s): Procedure
Intervention description(s): Autologous regenerative cells of adipose tissue obtained by enzymatic digestion of lipoaspirate are injected diffusively in the submucosal plane of the rectum and vagina with a sharp 27G needle. Adipose tissue that has not been subjected to enzymatic processing is injected through the punctures on the skin into the deep layers of the rectovaginal septum by means of cannula of 1.0-1.2 mm in diameter, 70 mm in length, 0.1-0.2 ml in one retrograde pass of the cannula.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adipose derived stromal cells; stromal vascular fraction; mesenchymal stem cells; rectovaginal fistula
Home Based Exercises With and Without Posture and Ergonomics Training Among Students During COVID-19
Condition: Musculoskeletal Pain
MeSH terms: COVID-19; Musculoskeletal Pain
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of exercises with and without postural and
      ergonomic training among the students returning to university after quarantine due to
      COVID-19.
    

Detailed description: 
      Postural awareness and ergonomic trainings are approaches that can help to relive pain among
      patients with Musculoskeletal complaints. The purpose of this study was to investigate the
      effects of posture and ergonomics training for students receiving distance education during
      the Covid-19 pandemic on musculoskeletal pain and physical activity level
    

Intervention name(s): Home based exercises with postural and ergonomic training; Home based exercises
Intervention type(s): Other; Other
Intervention description(s): Group A will be treated with stretching and strenghtening exercises for 40 minutes along with postural and ergonomic training for 15 minutes session 3 days/week for 4 week.; Group B will be given stretching and strengthening exercises for 40 minutes, every alternate day (3 days per week) for 4 weeks.
Other intervention name(s): Rehabilitation following home based exercises with postural and ergonomic training; Rehabilitation following home based exercises training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Musculoskeletal Pain; posture; ergonomic; exercise; Covid-19