bioihbjkbjnl/mcl2 huggingface dataset:
Continuous Infraclavicular Blocks: Neurostimulation Versus Ultrasound
Condition: Disorder of Upper Extremity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether ultrasound guidance or nerve stimulation is
      the best option for placing continuous peripheral nerve block catheters for upper limb
      surgery.
    

Detailed description: 
      In a multidisciplinary, observer blinded, prospective, single center, randomized study,
      success rate of US guided versus neurostimulation guided catheter placement for continuous
      infraclavicular block in patients scheduled for upper limb surgery will be studied. Block
      effectiveness, time taken, discharge from recovery, postoperative pain and disability and
      patient acceptance will be studied in 210 patients.
    

Intervention name(s): Ultrasound
Intervention type(s): Procedure
Intervention description(s): Block catheter will be introduced using ultraosound
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brachial plexus; Ultrasound
Bioimpedance Analysis for Follow-up of Dieters
Condition: Obesity
Study type: Observational

Summary: 
      Prospective, single arm, dietary intervention study.
    

Detailed description: 
      This prospective study was conducted during the period from December 2011 through June 2013
      in the Department of Endocrinology and Metabolism of Başkent University.

      We enrolled 185 participants who were admitted to hospital for weight loss therapy. After
      initial evaluation, all participants were prescribed an appropriate diet with caloric
      restriction and an exercise program and underwent a follow-up examination 3±1 months later.
      At the end of the follow up, 103 participants attended to the research. Anthropometric,
      bioimpedance and laboratory measurements performed at baseline and second visit. We
      calculated the difference in anthropometric, bioimpedance and laboratory measurements between
      the first and second evaluations. Correlation analysis, multivariate linear regression
      analysis and receiver operating characteristic analysis performed to assess associations of
      laboratory metabolic variables with a decrease in anthropometric and bioimpedance analysis
      (BIA) measures, after diet and/or exercise therapy. The secondary aim was to determine
      whether abdominal BIA was better than simple anthropometric measurements and conventional BIA
      for assessing changes in metabolic variables.
    

Intervention name(s): Diet group
Intervention type(s): Other
Intervention description(s): All participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        One hundred and eighty five participants who were admitted to hospital for weight loss
        therapy enrolled to the study. After initial evaluation, all participants were prescribed
        an appropriate diet with caloric restriction and an exercise program and underwent a
        follow-up examination 3±1 months later. A total of 134 participants reported for the second
        visit; 51 did not. Thirty one participants who, at the second visit, reported that they
        failed to adhere to the diet were excluded from the analysis . Ultimately, data from 103
        participants who reported that they adhered to the diet were included in the analysis.
      
Keywords: Diet; Abdominal bioelectrical impedance analysis; Anthropometry; Insulin resistance
Self-Management of Cancer-Related Fatigue by Adolescents
Condition: Neoplasms; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      This study will investigate self-management of cancer-related fatigue by adolescents through
      pilot study of an evidence based educational resource.
    

Detailed description: 
      Cancer-related fatigue is a prevalent and distressing symptom which has a significant impact
      on quality of life for children and adolescents with cancer and their families. Evidence
      based guidelines issued by the Oncology Nursing Society and National Comprehensive Cancer
      Network recommend educational interventions for preventing and treating cancer-related
      fatigue.The primary study aim is to examine the relationships among: intensity of
      cancer-related fatigue; frequency of use of an evidence based educational resource for
      self-management of cancer-related fatigue; and perceived helpfulness of resource use. The
      secondary aim is to examine the relationship between the Fatigue Scale-Adolescent (FS-A) and
      the Symptom Distress Scale (SDS) 'tired' item as measures of intensity of cancer-related
      fatigue. The tertiary aim is to examine the feasibility of recruiting and retaining
      adolescents with cancer for longitudinal study of cancer-related fatigue.
    

Intervention name(s): 'Fatigue Facts & Fixes'
Intervention type(s): Behavioral
Intervention description(s): 'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: "Why am I so tired?" (description of cancer-related fatigue); "What causes fatigue?" (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and "What can help me to not be so tired?" (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Neoplasms; Fatigue; Self Care
Allergy Immunotherapy for the Reduction of Asthma
Condition: Wheezing; Asthma; Allergy
MeSH terms: Asthma; Hypersensitivity; Respiratory Sounds
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this clinical study we aim to determine the effect of allergy immunotherapy in decreasing
      asthma and allergy related disease in children who had multiple episodes of wheezing and who
      are at high risk for developing persisting asthma. These risks include a history of asthma in
      the parents, allergies to environmental allergens (such as dust mite, cockroach or mouse) and
      other allergic diseases such as eczema or food allergies. Allergy Immunotherapy is not new
      and has been practiced for many years to treat asthma and environmental allergies in older
      children and adults, but has not yet been systematically studied in young children.
    


Intervention name(s): Allergen extracts (subcutaneous injections); Standard of care
Intervention type(s): Biological; Other
Intervention description(s): Allergy immunotherapy consists of regular subcutaneous injections of an individualized mixture of allergen extracts according to the allergy sensitization profile of each child. Increasing doses of allergen extract are given in 1-2 injections until a predetermined maintenance dose is reached. This maintenance dose varies by extract and accords to the general practice guidelines of immunotherapy. To increase safety, the cumulative monthly maintenance doses are divided into biweekly visits during the maintenance phase (year 2-3); standard of care asthma and allergy treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Wheezing; Asthma; Allergy; Immunotherapy
Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters
Condition: Urethral Sphincter Activity
Study type: Interventional

Summary: 
      Lower urinary tract symptoms such as urinary leakage and overactive bladder affect millions
      of American women. Women may develop these problems because the innervation of the muscles of
      the bladder and urethra are injured. Most research on treating these problems has focused on
      the abnormalities of the bladder muscle, but newer studies have shown abnormalities in the
      innervation and muscle function of the urethra.

      Women with these symptoms may benefit from treatment with medications to improve their
      urethral function. However, to truly understand what types of medications will help women
      with these symptoms, the investigators wish to study how these medications affect innervation
      and muscle function in healthy women who do not have lower urinary tract symptoms.
    

Detailed description: 
      Women without urinary incontinence or bladder symptoms (healthy controls)will undergo
      urethral testing prior to randomization to one of 5 medications or placebo. Participants will
      take an oral medication for 2 weeks and then return for repeat testing.
    

Intervention name(s): Pseudoephedrine; Tamsulosin; Imipramine; Cyclobenzaprine; Lactose capsule; Solifenacin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pseudoephedrine ER 120 mg by mouth once daily for 2 weeks; Tamsulosin 0.4mg by mouth daily for 2 weeks; Imipramine 25mg daily by mouth for 2 weeks; Cyclobenzaprine 10mg daily by mouth for 2 weeks; Lactose capsule 1 by mouth daily for 2 weeks; Solifenacin 5mg by mouth daily for 2 weeks
Other intervention name(s): Flomax; Tofranil; Flexeril; VESIcare
Intervention MeSH terms: Pseudoephedrine; Ephedrine; Cyclobenzaprine; Imipramine; Tamsulosin; Solifenacin Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Clinical Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Therapy-based Clinical Setting
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The Mayo Clinic psychiatric pharmacogenomic team has developed a pharmacogenomic algorithm
      that has been designed to improve the effectiveness and safety of antidepressant medications
      by providing guidance in medication selection and appropriate dosing. This algorithm has been
      incorporated into a new genotyping interpretative report. This report is now available from
      AssureRx. The pharmacogenomic algorithm is based on genotyping both copies of four
      informative genes. These four genes are: 1) the Cytochrome P450 2D6 gene; 2) the Cytochrome
      P450 2C19 gene; 3) the Serotonin Transporter gene (SLC6A4); and 4) the Serotonin 2A receptor
      gene (5HTR2A). Though this algorithm is not yet part of the universal standard of care, Mayo
      clinicians have found it helpful in guiding treatment decisions at Mayo Clinic Rochester.
    

Detailed description: 
      The proposed pilot study is designed to evaluate the clinical impact of the interpretive
      report in an outpatient behavioral health clinic in St. Paul, Minnesota. While the ultimate
      goal of this project is to show an improvement in patient outcomes, this pilot study will be
      used to evaluate the feasibility of introducing the pharmacogenomic algorithm to a new
      setting that does not routinely use the algorithm. Secondary outcome data will be collected
      to generate meaningful estimates of the magnitude of potential treatment effects. The study
      will consist of two phases, each enrolling 2530 subjects. In Phase 1, consecutive patients
      will be prospectively monitored to observe standard practice. Patients will be given the
      option to receive genotyping and those that agree will have blood drawn. However, the results
      of the genotyping and algorithm will not be released until all phase 1 patients have
      completed study visits.. Subsequently, in Phase 2, also enrolling 3025 subjects, the results
      of the genotyping and algorithm will be made available immediately for additional consecutive
      prospectively monitored patients. Patients will be prospectively monitored in the same
      fashion as Phase 1. The results of the study will be used to perform preliminary analyses and
      subsequent fully powered multi-site trials will be planned based on the results of this
      study.
    

Intervention name(s): Genotyping results
Intervention type(s): Genetic
Intervention description(s): Genotyping results provided in Phase II
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: AssureRx; Algorithm; Major depressive disorder
Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a randomized, open-label, repeat dose study of once daily relugolix alone or
      relugolix combined with hormonal add-back therapy (combination estradiol/norethindrone
      acetate) (E2/NETA) to assess safety, including markers of bone resorption, pharmacokinetics
      (PK), and pharmacodynamics (PD) endpoints.
    


Intervention name(s): Relugolix; E2/NETA
Intervention type(s): Drug; Drug
Intervention description(s): Administered as an oral tablet once daily.; Administered as an oral tablet once daily.
Intervention MeSH terms: Relugolix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gut Health Response to Dietary Fiber
Condition: Dietary Fiber
Study type: Interventional

Summary: 
      Dietary fiber is known to influence bowel function. The investigators hypothesize that the
      addition of a mixture of fibers to liquid diets will improve bowel function as measured by
      stool weight.
    

Detailed description: 
      Liquid diets are the sole source of nutrition for many patients. Consumption of liquid diets
      is linked to lower stool weight. The objective of this study is to feed liquid diets, with
      and without added fiber, to healthy human subjects to determine if mixed fiber sources can
      normalize stool weight. Secondary objectives of the study include measurement of gut
      microbiota and stool chemistry with fiber addition.
    

Intervention name(s): dietary fiber
Intervention type(s): Dietary Supplement
Intervention description(s): mixture of fiber sources added to liquid nutrition product
Other intervention name(s): mixed fibers include fructans, soluble fiber, and insoluble fiber
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: dietary fiber; enteral nutrition; laxation
The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to explore the safety, feasibility, long-term and
      oncologicaloutcomes of laparoscopic-assisted gastrectomy for advanced Gastric Cancer after
      neoadjuvant chemotherapy.
    

Detailed description: 
      A prospective single-arm study designed to further evaluate laparoscopic-assisted gastrectomy
      for advanced Gastric Cancer after neoadjuvant chemotherapy will be performed, to evaluate the
      safety, feasibility, long-term and oncological outcomes. The evaluation parameters are
      perioperative mobility and mortality, perioperative clinical efficacy, postoperative life
      quality, immune function and 3-year survival and recurrence rates.
    

Intervention name(s): Laparoscopic-assisted gastrectomy with D2 lymphadenectomy
Intervention type(s): Procedure
Intervention description(s): After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed with curative treated intent.The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
Intervention model: Single Group Assignment
Intervention model description: laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stomach Neoplasms; Laparoscopy; Advanced Gastric Cancer; Neoadjuvant Chemotherapy
Additional Effect of Wound Infiltration After Cesarean Section With Optimal Standard Analgesia
Condition: Postoperative Pain; Anesthesia, Local; Breast Feeding
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine wether wound infiltration brings additional
      analgesia effect after cesarean section with optimal standard postoperative analgesia
    

Detailed description: 
      Continuous wound infiltration with local anaesthetic has been shown as a safe and
      opioid-sparing analgesic method after caesarean section with minimal standard analgesia. We
      aim to evaluate if this benefit remains when an optimal analgesia is used.

      Primary outcome is morphine consumption. Secondary outcomes is pain scores, maternal recovery
      including breastfeeding, side effects of morphine, nurse workload and maternal satisfaction.

      Patients scheduled for caesarean delivery will be eligible for the study.

      Patients with emergency caesarean delivery, contraindication to analgesic drugs, hemostasis
      disorder, ongoing infection, diabetes treated with insulin or chronic opioid use will be
      excluded from the study.

      One group will receive standard analgesia including celecoxib and intravenous morphine for 24
      hours with Patient Controlled Analgesia pump. The other group will receive the same standard
      analgesia with additional levobupivacaine initial bolus followed by a continuous subfascial
      infiltration of 1.25 mg/ml at 5 ml/h for 48 hours through a multiperforated catheter
      connected to an elastomeric pump.

      Total morphine consumption, pain and any associated complications will be recorded for 72
      hours. Women wil be asked to fulfill a questionnaire on the second day after cesarean
      section, assessing recovery, satisfaction and breastfeeding comfort.
    

Intervention name(s): Continuous wound infiltration
Intervention type(s): Device
Intervention description(s): Subfascial continuous wound infiltration with Levobupivacaine: bolus 50mg and 6.25mg/h for 48 hours through a multiperforated catheter, in addition to Celecoxib 200mg twice a day, paracetamol 1g four times a day, Nefopam 20mg four times a day, and intravenous morphine for 24 hours with Patient Controlled Analgesia pump (1.2mg by bolus, 7 minutes lockout period).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postcesarean Section; Postoperative Pain; Care, Postoperative; Anesthesia, Local; Breast Feeding; Morphine; Pain Measurement; levobupivacaine
Is T-lymphocyte Calcineurin Phosphatase Up-regulated by Treatment With Tacrolimus?
Condition: Kidney Transplantation
Study type: Observational

Summary: 
      The purpose of this study is to determine whether calcineurin phosphatase in the
      T-lymphocytes is up-regulated after long-term treatment with tacrolimus, a calcineurin
      inhibitor.
    

Detailed description: 
      Background:

      The immunosuppressive effect of both tacrolimus and cyclosporine is believed to be through
      inhibition of the enzyme calcineurin phosphatase (CaN) in T-lymphocytes. We have
      demonstrated, that tacrolimus decreases CaN activity in patients early after renal
      transplantation. In stable renal transplant patients treated this inhibition was hardly seen
      in patients treated with tacrolimus, while it was clearly demonstrated in patients treated
      cyclosporine. One explanation to this finding could be, that calcineurin phosphatase is
      up-regulated by long-term treatment with tacrolimus. The findings seem to imply, that
      tacrolimus has mechanisms of immunosuppression apart from inhibiting CaN. This could have
      implications for side-effects due to CaN inhibition. Among side-effects thought to be due to
      CaN inhibition is nephrotoxicity. The results may therefore be and indication of tacrolimus
      being less nephrotoxic compared to cyclosporine in long-term stable renal transplant
      patients.

      Purpose:

      The aim of the project is find out if long-term treatment with tacrolimus results in
      up-regulation of CaN in lymphocytes.

      Study plan:

      The general plan of the investigation is to compare CaN in lymphocytes in two groups of renal
      transplant patients treated with tacrolimus. One group just prior and just after
      transplantation compared to a group of stable renal transplanted patients a long time after
      transplantation. CaN is determined as enzyme activity, amount of protein, and by
      gen-activation.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Kidney transplant recipients from Department of Nephrology, Aarhus University Hospital,
        Skejby, Denmark
      
Keywords: calcineurin activity; real-time PCR; Gene expression of calcineurin; T-lymphocytes; interferon-gamma; Pharmacodynamics; Pharmacokinetics; tacrolimus; western blot; Hoechst