bioihbjkbjnl/mcl2 huggingface dataset:
Multimodal Perioperative Pain Management
Condition: Degenerative Spondylolisthesis
MeSH terms: Spondylolisthesis
Study type: Interventional

Summary: 
      Convalescence after lumbar fusion is dependent on pain. In orthopaedic and abdominal surgery
      accelerated stay programs with optimized pain management enhance recovery.

      The objective is to evaluate the effect of a revised and optimized perioperative fast track
      program in lumbar fusion surgery.
    

Detailed description: 
      Major spine surgery is usually associated with high postoperative pain scores and opioid
      requirements. Epidural analgesia has been reported to be an effective and safe method to
      control postoperative pain after spinal instrumentation surgery, but the overall effects of
      pain management on postoperative length of stay and recovery remains debatable.

      However, in a multimodal approach, including multimodal non-opioid analgesia to control
      postoperative pathophysiology and rehabilitation, complications and hospital stay have been
      reduced after arthroscopy, hip arthroplasty and knee arthroplasty, hip fractures and
      abdominal surgery and other procedures, when combined with an enhanced recovery program.

      The aim of the study is to assess the effect and safety of a combined analgesic regimen
      consisting of local anesthetic, intra-operative and post-operative continuous epidural
      analgesia and a single dose ketorolac together with a fast track rehabilitation program after
      360 degree lumbar fusion for degenerative disc disease and spondylolisthesis < 2
    

Intervention name(s): Postoperative epidural morphine; Local anaesthesia
Intervention type(s): Drug; Drug
Intervention description(s): The control group received postoperative epidural morphine 0.4 mg/ml four times a day, epidural bupivacaine 2.5 mg/ml, 3-4 ml on request for 75 hours and a 7 day rehabilitation program.; Preemptively and posteruptively, the intervention group received local anaesthesia with bupivacaine 2.5 mg/ml, 10 + 10 ml posteriorly and 10 + 10 anteriorly; preemptive epidural analgesia with 3 ml lidocaine 20 mg/ml, 3 ml, 10 ml morphine 0.4 mg/ml plus 5 ml bupivacaine; postoperative continuous epidural analgesia for 72 hours with 250 ml with bupivacaine 1 mg/ml + morphine 50 ug/ml, and 0.5 ml epinephrine 1 mg/ml, 4 ml/hour, and after wound closure ketorolac 30 mg intravenously.
Other intervention name(s): Convalescence after lumbar fusion; Convalescence after lumbar fusion.
Intervention MeSH terms: Morphine
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: Disc disease; Spondylolisthesis
Temporal Patterns of Diet and the Changes in Body Composition and Blood Pressure
Condition: Body Composition; Blood Pressure; Mealtimes
Study type: Interventional

Summary: 
      The study includes two parts: 1) an observational study examines the association of meal
      frequency, meal timing, and meal regularity with short-term changes in blood pressure and
      body composition; 2) a randomized controlled intervention examines the influence of
      recommendation of increase breakfast frequency and decrease nighttime snacking on 1-year
      changes in blood pressure and body composition.
    


Intervention name(s): Breakfast promotion; Nighttime snack reduction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Recommendation of having breakfast daily; Recommendation of reducing frequency of nighttime snacking
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Clinical Trial to Find Out V81444's Side Effects and Blood Levels in Healthy Men
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind, randomised, placebo-controlled study of the safety, tolerability and
      pharmacokinetics of single and multiple ascending oral doses of V81444 in healthy male
      volunteers
    

Detailed description: 
      Part A - Single Ascending Dose (SAD) Double-blind, randomised, placebo-controlled, single
      ascending dose study.

      Each study subject will participate in a screen visit, three identical treatment periods, in
      each of which they will receive a single oral dose of V81444 or placebo in accord-ance with
      the randomisation schedule, and one post-study visit.

      In each treatment period, subjects will be admitted the day before dosing (Day -1) and,
      subject to satisfactory medical review, discharged in the morning, 4 days later (Day 4).

      Part B - Multiple Ascending Dose (MAD) Double-blind, randomised, placebo-controlled, parallel
      group, multiple ascending dose study

      Each study subject will participate in a screen visit, one treatment period in which they
      will receive repeated oral doses of V81444 or placebo in accordance with the randomisation
      schedule, and one post-study visit.

      In each treatment period, subjects will be admitted the day before dosing (Day -1), dosed
      daily on Days 1 to 14 and, subject to satisfactory medical review, will be discharged in the
      morning, 3 days after the final dose (Day 17).
    

Intervention name(s): V81444
Intervention type(s): Drug
Intervention description(s): Single ascending oral doses of V81444 and placebo
Multiple ascending oral doses of V81444 and placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Influence of Motor Imagery in Fine Motor Skills
Condition: Mental Retardation and Developmental Disabilities With No Organic Condition
MeSH terms: Intellectual Disability; Developmental Disabilities
Study type: Interventional

Summary: 
      The main purpose of this study is to ascertain whether the application of Motor Imagery
      together with normal practice improves fine motor skills in disabled individuals.
    

Detailed description: 
      Imagery is a cognitive process that can play an important role on the planning and execution
      of different movements or actions. The main purpose of this study is to ascertain whether the
      application of Motor Imagery together with normal practice improves fine motor skills in
      disabled individuals. In this study participated 42 subjects of both genders with
      disabilities, with a mean age of 37 (SD=12). Subjects were randomly divided in two groups: a
      control group and an experimental one. The study procedures were applied on five different
      tasks of the Psychomotor Battery of fine motor skills (BPM). This instrument was applied in
      two stages, at the beginning of the study (pretest) and at the end of the 4 weeks (posttest).
      Both groups performed the tasks twice a week for a month. Motor imagery sessions were added
      on in the experimental group. Participants on the experimental group were asked to mentally
      imagine themselves recreating tasks they had performed earlier on the initial assessment. For
      the analysis of the results, descriptive and inferential statistics were used. The T-test for
      independent samples, and the T-test for paired samples were applied.
    

Intervention name(s): Motor Imagery + Psychomotor Battery of fine motor skills; Psychomotor Battery of fine motor skills Practice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects were randomly divided in two groups: a control group and an experimental one. The study procedures were applied on five different tasks of the Psychomotor Battery of fine motor skills (BPM). This instrument was applied in two stages, at the beginning of the study (pretest) and at the end of the 4 weeks (posttest). Both groups performed the tasks twice a week for a month. Motor imagery sessions were added on in the experimental group. Participants on the experimental group were asked to mentally imagine themselves recreating tasks they had performed earlier on the initial assessment.; Subjects were randomly divided in two groups: in the control group were applied on five different tasks of the Psychomotor Battery of fine motor skills (BPM). This instrument was applied in two stages, at the beginning of the study (pretest) and at the end of the 4 weeks (posttest). Both groups performed the tasks twice a week for a month.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Motor Imagery; Fine motor skills; Disabled
Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation
Condition: Oral Mucositis
MeSH terms: Head and Neck Neoplasms; Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the benefits of immunonutrition regarding the prevention of severe
      mucositis. Patients with head and neck cancer (HNC) undergoing definitive concurrent
      chemoradiation including 3-week cycles of cisplatin were enrolled in this double-blind phase
      II study. Patients were randomly assigned to receive an immunonutrition containing
      omega-3-fatty acids, arginine, dietary nucleotides, and soluble fiber or an isocaloric
      isonitrogenous control. All patients received the assigned product 5 days before each
      chemotherapy session. The proportion of patients with severe mucositis was compared between
      the immunonutrition and control groups.
    


Intervention name(s): Oral Impact®
Intervention type(s): Dietary Supplement
Intervention description(s): 3 ready-to-drink bottles/day
Other intervention name(s): Blendera®
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: phase II randomized, double-blind study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: head and neck cancer; nasopharyngeal cancer; immunonutrition; concurrent chemoradiation; survival
Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of neoadjuvant treatment with
      pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by
      docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary
      tumor > 5 cm.
    

Detailed description: 
      Patients with locally advanced or inflammatory breast cancer have a very bad prognosis.
      Several studies have shown that patients who receive a pathological complete response have
      the best prognosis. Neoadjuvant chemotherapy including anthracyclines and taxanes has become
      established as a standard option in the multidisciplinary management of this group of
      patients. In HER2 positive patients, chemotherapy in combination with trastuzumab is
      therapeutically attractive. Recent studies have also demonstrated that evaluation with PET-CT
      scan can be used to stratify treatment and monitor early response to neoadjuvant therapy.
    

Intervention name(s): pegylated liposomal doxorubicin
Intervention type(s): Drug
Intervention description(s): 35 mg/m2, IV, day 1 every 21 days, 4 cycles
Other intervention name(s): cyclophosphamide, 4 cycles; docetaxel, 4 cycles; trastuzumab, 8 cycles
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin; Trastuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; neoadjuvant; liposomal doxorubicin; PET scan
The Economic Impact of Clinical Pharmacist Involvement in the Public Procurement for Medicines and in the Drug and Therapeutics Committee
Condition: Rationalization
Study type: Observational

Summary: 
      The investigators have performed cost-minimisation analysis and compared the expenses based
      on the plan for public procurement (without clinical pharmacist involvement) for drugs with
      the results of public procurement based on the revised plan for public procurement by the
      clinical pharmacist. The plan for public procurements was based on the 1 year quantity for
      each medicine used by the hospital in the previous year, based on the latest deliverable
      prices at the time of extracting the data to workbook for MS Excel program (ver. 2002,
      Microsoft, Redmond, WA, USA).

      The investigators have performed cost-minimisation analysis and compared the expenses for all
      received requests for medicines to the drug and therapeutics committee (DTC) for a decision
      in the 1 year period, before and after involvement of clinical pharmacist in the committee
      work. The expenses were based on approval decisions in the 1 year period for approval time
      period. The denial decisions were also calculated and reported. The denial period calculated
      in rationalisation of expenses were based on 1 year treatment period.
    


Intervention name(s): Public procurement; Drug and Therapeutics Committee
Intervention type(s): Drug; Drug
Intervention description(s): Cost minimisation study through public procurement; Cost minimisation analysis of results of the drug and therapeutics committee before and after clinical pharmacist involvement
Intervention MeSH terms: Coal Tar
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Inhospital patients, all patients receiving any medicine during their stay in the hospital
        within 1 year period.
      
Keywords: Rationalization; Clinical Pharmacist; Public Procurement for Medicines; Drug and Therapeutics Committee
Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg +
      Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in
      healthy adult human subjects, under fed conditions.
    

Detailed description: 
      Open randomized, two treatment, two period, two sequence, single dose, crossover study of 26
      healthy human adult subjects under fed conditions with a washout period of 27 days.
    

Intervention name(s): Naproxen Sodium & Pseudoephedrine HCl
Intervention type(s): Drug
Intervention description(s): Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets
Other intervention name(s): Aleve Cold and Sinus
Intervention MeSH terms: Naproxen; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Naproxen Sodium and Pseudoephedrine Hydrochloride
Fiber Fermentation Kinetics Inside the Gut, and Utilization of Bacterial Metabolites
Condition: Metabolism; Dietary Fiber; Intestine
Study type: Interventional

Summary: 
      In this study, the life course of SCFA and their regulatory role in human metabolism will be
      traced using a nose-intestine catheter. The investigators have methodological questions:
      investigate the envisioned kinetic profiles of stable isotope tracers of SCFAs, and to
      establish the time points of plasma sampling (to determine systemic availability of SCFAs).
      The resulting timepoints established in this pilot study will be applied during a future
      human intervention study.
    

Detailed description: 
      Background: Nowadays there is a strong interest in optimising human health through
      manipulation of non-digestible carbohydrates (NDC). NDC are fermented by the microbiota,
      hereby producing fermentation end products, mainly short chain fatty acids (SCFA) acetate,
      butyrate, and propionate. It is hypothesized that SCFAs mediate parts of the beneficial
      effects of NDC. In mice, the influx of SCFA into the host correlated strongly with
      improvements of markers of the metabolic syndrome, whereas concentrations of SCFA in the
      cecum did not. The production and influx/incorporation of SCFAs in humans will be
      investigated.

      Study design: At day 1 the catheter will be placed. After an overnight fast at day 2, 5
      subjects will consume a NDC bolus. Isotopically 13C-labelled SCFAs will be delivered in the
      cecum. Samples will be taken in the cecum and blood before, and continuously after dispensing
      the 13C-labelled SCFAs.

      Study population: 5 healthy male volunteers (18-60yrs, and BMI between 18.5-30 kg/m2).

      Main study parameters/endpoints: (isotopic) enrichments of SCFAs in cecum, and label
      incorporation in plasma metabolites such as organic acids, glucose, cholesterol, fatty acids.
    

Intervention name(s): fructo- and galacto-oligosaccharides
Intervention type(s): Dietary Supplement
Intervention description(s): A NDC drink rich in fructo- and galacto-oligosaccharides
Intervention model: Single Group Assignment
Intervention model description: All subjects will consume a NDC bolus. When fermentation has started, isotopically 13C-labelled SCFAs will be delivered inside the intestine. Thereafter, production and inter-conversion of SCFAs and breakdown of fiber will be studied in luminal samples. Also blood samples will be taken to study integration of the 13C-label into various metabolic compounds.
Masking: None (Open Label)
Primary purpose: Other
Keywords: short chain fatty acid; dietary fiber
A Single Dose Evaluation of the Effects of Moderate Hepatic Impairment on Deflazacort Pharmacokinetics
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a non-randomized, open-label, single-dose study to compare the PK of 21-desacetyl-DFZ
      and, if data permits, deflazacort in 8 subjects with moderate hepatic impairment (based on
      the Child Pugh classification, Grade B) to that of 8 healthy matched control subjects (age,
      body mass index [BMI], and gender).
    

Detailed description: 
      This is a non-randomized, open-label, single-dose study to compare the PK of 21-desacetyl-DFZ
      and, if data permits, deflazacort in 8 subjects with moderate hepatic impairment (based on
      the Child Pugh classification, Grade B) to that of 8 healthy matched control subjects (age,
      body mass index [BMI], and gender).

      On Day 1, a single oral dose of deflazacort will be administered followed by serial blood
      sampling for 24 hours to assess the PK of 21-desacetyl-DFZ and, if data permits, deflazacort.

      Safety will be monitored throughout the study by repeated clinical and laboratory
      evaluations.

      Subjects will return to the Clinical Research Unit (CRU) 3 days (± 1 day) following study
      drug administration to determine if any adverse events (AEs) have occurred since the last
      study visit. Subjects who terminate the study early will be contacted if the Principal
      Investigator (PI) deems necessary.

      A total of sixteen (16) adult male and female subjects will be enrolled. Hepatic Impaired
      Cohort: Eight (8) subjects with moderate hepatic insufficiency (a score of 7 to 9, on the
      Child-Pugh scale).

      Healthy Match Control Cohort: Eight (8) healthy subjects. Subjects will be matched for age [±
      15 years], BMI [± 15 %], and gender [1:1] to the subjects in the moderate hepatic impaired
      cohort.
    

Intervention name(s): Deflazacort
Intervention type(s): Drug
Intervention description(s): Deflazacort, a glucocorticoid with anti-inflammatory and immunosuppressive effects, is used in treating a variety of diseases. Pharmacologically it is an inactive pro-drug which is metabolized immediately to the active metabolite, 21 desacetyl-DFZ. The elimination of this metabolite is primarily via the urine in humans. Its potency is approximately 70 to 90% of prednisone and 6 mg of deflazacort has approximately the same anti-inflammatory potency as 5 mg of prednisolone or prednisone.
Other intervention name(s): DFZ
Intervention MeSH terms: Deflazacort
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Local Clinical Study for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol] and ANTI-ANGIN® FORMULA, Lozenges, in Treatment of Patients With a Sore Throat
Condition: Sore Throat
MeSH terms: Pharyngitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate no less therapeutic efficacy and safety of the
      Angal, lozenges [Menthol], 1 mg + 5 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA,
      lozenges, 0,2 mg + 2 mg + 50 mg (LLC "Valeant", Russia) in treatment of patients with
      uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a
      sore throat.
    


Intervention name(s): Angal, lozenges [menthol],; ANTI-ANGIN® FORMULA
Intervention type(s): Drug; Drug
Intervention description(s): Angal, administered per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution.; 0,2 mg + 2 mg + 50 mg (LLC "Valeant", Russia). Administered per 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution.
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Angal; ANTI-ANGIN® FORMULA; sore throat; no less therapeutic efficacy