bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Early Enteral Nutrition on Serum Acetylcholine Level and Inflammation in Critically Ill Patients
Condition: Critical Illness; Enteral Nutrition; Inflammation
MeSH terms: Inflammation; Critical Illness
Study type: Observational

Summary: 
      Early enteral nutrition(EEN) is an important treatment for critical ill patients and
      attenuate systemic inflammation, but the mechanisms are not clear. Thus the investigator
      conducted this study to observe if EEN affects systemic inflammation though regulation of
      blood acetylcholine
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study population mainly includes patients who suffered severe complications after surgery
        or severe trauma
Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Vaccines may make the body build an immune response and decrease the recurrence of
      breast cancer.

      PURPOSE: Pilot trial to study the effectiveness of vaccine therapy in treating patients who
      are at high risk for breast cancer recurrence.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether immunization with multiple antigens comprising GM2, Globo-H, Lewis y,
           TF(c), sTn(c), Tn(c), and glycosylated MUC-1 32(aa) conjugated to keyhole limpet
           hemocyanin plus QS21 induces an antibody response against these individual antigens and
           breast cancer cells expressing these antigens in patients at high risk for breast cancer
           recurrence.

        -  Determine the toxic effects of this regimen in these patients.

      OUTLINE: Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate
      vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.

      Patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2-3 months.
    

Intervention name(s): Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine; QS21
Intervention type(s): Biological; Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I breast cancer; stage II breast cancer; stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; male breast cancer
Peak Cough Flow and Cough Clearance in Patients With Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Cough
Study type: Observational

Summary: 
      This study is to determine whether physiologic measures (peak cough flow, measures of
      respiratory muscle strength including MIP, MEP ,SNIP, and spirometry) can predict spontaneous
      cough clearance (as measured by a nuclear medicine study) in children with neuromuscular
      disease. It will also determine whether airway clearance is augmented by high frequency chest
      wall oscillation.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Boys 6-21 years of age with Duchenne Muscular Dystrophy
      
Keywords: Airway Clearance; Duchenne Muscular Dystrophy; Peak Cough Flow
Delayed Release Diclofenac Sodium Formulation vs Voltaren®
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, open-label, randomised, three-arm crossover study with a fourth
      fixed arm in a subset of subjects. Up to 36 healthy male volunteers will participate in the
      study. This study is designed to correlate the gastrointestinal transit behaviour of
      delayed-release diclofenac sodium tablets with their pharmacokinetic (PK) absorption
      profiles.

      The investigators will be looking at:

        1. The behaviour of the tablets (when, where and how quickly they break up)

        2. The gastric emptying time of the tablets (when they leave the stomach)

        3. The gastrointestinal transit of the tablets (how long they take to travel through the
           gut)

        4. Blood levels of the drug (diclofenac)
    


Intervention name(s): Radiolabelled Diclofenac Tablet A; Radiolabelled Diclofenac tablet B; Radiolabelled Diclofenac tablet C; Diclofenac
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Delayed release diclofenac sodium tablet (50 mg); Delayed release diclofenac sodium tablet (50 mg); Delayed release diclofenac sodium tablet (25 mg); Enteric coated delayed release diclofenac sodium tablet (50 mg)
Other intervention name(s): Delayed release diclofenac sodium tablet; Delayed release diclofenac sodium tablet; Delayed release diclofenac sodium tablet; Voltaren
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients
      with schizophrenia.
    


Intervention name(s): OPC-34712; OPC-34712; OPC-34712; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): orally administered once daily; orally administered once daily; orally administered once daily; orally administered once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to assess the efficacy of a levonorgestrel-releasing
      intrauterine system (LNG20) in nulliparous and parous females of child-bearing potential who
      request long-term, reversible contraception for up to 10 years.
    

Detailed description: 
      This is a Phase 3, randomized, open-label, multicenter evaluation of the efficacy of a
      levonorgestrel-releasing intrauterine system (LNG20). The goals of the study include
      provision of information to understand efficacy and safety within the widest range of
      possible users of the LNG20. Typically, intrauterine contraceptive studies only include women
      18-35 years of age for efficacy and safety, and place limits on parity and larger body size.
      Women outside of these characteristics also desire an effective intrauterine contraceptive.
      Accordingly, this study will include women who are both nulliparous and parous as well as
      women less than 18 years of age in the primary efficacy and safety analyses
    

Intervention name(s): LNG20; Mirena
Intervention type(s): Drug; Drug
Intervention description(s): levonorgestrel-releasing intrauterine system for contraception; Mirena intrauterine system
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contraception; intrauterine; long-term; reversible
Compare the Hemostatic Effectiveness of Chitosan Gauze With Traditional Gauze on Open Wound on 10 Participants.
Condition: Hemostasis
Study type: Interventional

Summary: 
      This study recruited 10 subject participants to compare the hemostasis gauze made by chitosan
      with traditional cotton gauze to see which one is better in bleeding time, bleeding volume,
      wound infection and wound healing speed when it is used in open wound treatment.
    

Detailed description: 
      open wound bleeding and infection care policy development is focusing on efficiency to
      strengthen internal bleeding, pain, avoidance of infection and promoting wound healing wound.
      With the changes in the social environment, people caring for hemostasis and wound healing
      have become increasingly demanding. Presently, studies generally aim to stop the bleeding
      using trauma care technology and functional capabilities combined with each other as well as
      inhibit lower infection and can also help assist healing wounds care strategy for the
      protection of human lives. Therefore, the goal of the plan is to establish new care
      strategies on open wounds infection to stop the bleeding and to improve the health and safety
      of the people. The researchers will choose the general biological hemostatic gauze to conduct
      clinical trials comparing the clinical hemostasis focusing on bleeding time, wound infection
      in the wound and the wound bacteria penetrating situations in the hope to build a better
      strategy in rapid hemostasis and wound infection care strategy.
    

Intervention name(s): Chitosan Gauze; placebo
Intervention type(s): Device; Device
Intervention description(s): Gauze made by chitosan material; traditional gauze
Intervention MeSH terms: Chitosan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Each of the participants was been treated with 2 different treatments on different areas of the same wound at the same time.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: bleeding wounds, hemostasis, open wounds, infection, antimicrobial
Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Condition: Bipolar I Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to determine if armodafinil treatment, at a dosage of
      150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are
      experiencing a major depressive episode associated with Bipolar I Disorder and who are
      inadequately responsive to their current treatment for a current major depressive episode.
    


Intervention name(s): Armodafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients were randomly assigned to begin oral treatment with armodafinil, which was titrated to 150 mg/day (3 tablets). Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.; Patients were randomly assigned to begin oral treatment with placebo, which was titrated to 3 tablets. Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors
Condition: Recurrent and Refractory Solid Tumors
MeSH terms: Central Nervous System Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase 1 of this study, utilizing a rolling 6 design, will be conducted to determine a maximum
      tolerated dose (MTD) and recommended Phase 2 dose (RP2D), and to describe the toxicities of
      lenvatinib administered in combination with everolimus once daily to pediatric participants
      with recurrent/refractory solid tumors. Phase 2, utilizing Simon's optimal 2-stage design,
      will be conducted to estimate the antitumor activity of lenvatinib in combination with
      everolimus in pediatric participants with selected recurrent/refractory solid tumors
      including Ewing sarcoma, rhabdomyosarcoma, and high grade glioma (HGG) using objective
      response rate (ORR) at Week 16 as the outcome measure.
    


Intervention name(s): Lenvatinib; Everolimus
Intervention type(s): Drug; Drug
Intervention description(s): oral hard capsules containing 1 mg, 4 mg, or 10 mg lenvatinib, or an extemporaneous suspension; 2 mg, 3 mg, or 5 mg tablets for oral suspension
Intervention MeSH terms: Everolimus; Lenvatinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics; central nervous system tumors; lenvatinib; E7080; everolimus; Ewing sarcoma/peripheral primitive neuroectodermal tumor; rhabdomyosarcoma; high grade glioma; solid tumors
The Effects of Different Degrees of Head-of-bed Elevation
Condition: Surgery; Thyroid; Nursing Caries
Study type: Interventional

Summary: 
      The patient's position is important for ensuring patient comfort and preventing complications
      after thyroidectomy. This study was carried out to determine the effects of different degrees
      of head-of-bed elevation on the respiratory pattern and drainage following thyroidectomy and
      to provide suggestions for evidence-based clinical practice.
    

Detailed description: 
      Thyroidectomy is a safe surgical procedure commonly used for the treatment of benign or
      malignant tumors, multinodular goiter and Graves disease. However, because of the rich
      vascular structure of the thyroid gland, serious complications including hemorrhage, hematoma
      and hematoma-related dyspnea can develop after thyroidectomy. The American Thyroid
      Association also suggested to keep the patient in a head-up at 45°-Fowler's position in the
      post anesthesia care unit following thyroidectomy to prevent hematoma formation on the
      incision site by facilitating venous return from the head and neck. The mentioned guideline
      does not offer any recommendations regarding the position that should be given to the
      patients at surgical clinic after thyroidectomy. Therefore, this study aimed to identify the
      effects of different degrees of head-of-bed elevation on respiratory pattern including
      respiratory rate, peripheral oxygen saturation and dyspnea, and drainage including amount of
      drainage and hematoma formation.
    

Intervention name(s): Head-of-bed elevation
Intervention type(s): Other
Intervention description(s): Respiratory pattern including respiratory rate, peripheral oxygen saturation and dyspnea, and drainage including amount of drainage and hematoma formation of all patients were evaluated at 1st, 2nd, 3rd, and 4th hours after positions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was conducted as a prospective, single-center, parallel, three arm (1:1:1), randomized controlled trial at the Endocrine Surgery Clinic of a university hospital in Turkey.
Masking: Single (Participant)
Primary purpose: Other
Keywords: thyroidectomy; head-of-bed elevation; supine position; respiratory pattern; amount of drainage; peripheral oxygen saturation
Effects of Two Physical Exercise Protocols on Cognition and Physical Performances in Elderly Over 80 Years
Condition: Sedentary
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of different trainings on cognition and
      physical performances in elderly over 80 years.
    

Detailed description: 
      Purpose: To compare the effects of 16-week multicomponent and resistance trainings on
      cognition and physical performances related to falls in oldest old people living in
      community; to analyze the same variables after 6-week detraining. Method: We conducted a
      randomized controlled trial with 69 community elderly over 80 years, sedentary and without
      cognitive disorder. Participants were allocated to control, multicomponent training or
      resistance training group. The multicomponent group performed a protocol involving warm-up,
      aerobic, strength, balance and cool-down exercises. The resistance group underwent to
      strength exercises using six machines: leg press, chest press, calf, back extension,
      abdominal and rowing. The control group did not perform any intervention. The trainings had
      progressive intensity, lasted 16 weeks and included three 1-hour sessions per week. The
      participants were evaluated at baseline, at the end of 16-week training and at 6-week
      detraining. The assessment consisted of anamnesis, depression (Geriatric Depression Scale),
      cognition (Montreal cognitive assessment), dual task walking (associated to cognitive and
      motor tasks), balance (unipedal and tandem tests), strength of lower limbs (sit-to-stand
      test) and history of falls. For statistical analysis by intention to treat, we adopted a
      significance level of α=0.05.
    

Intervention name(s): Multicomponent training; Resistance training
Intervention type(s): Other; Other
Intervention description(s): The multicomponent training consisted of individuals subjected to a multicomponent exercise program: 5 minute warm up, 20 minutes of aerobic exercise, 15-20 minutes of strength exercises, 10 minutes of coordination, agility and balance exercises and 5 minute of cool-down.; The resistance training was subjected to a strength training using weight machines adapted for elderly. The protocol followed three sets of 10 to 12 maximal repetitions, moderate speed (two seconds for the shortening phase and three seconds for the elongation phase) and one minute for rest interval between sets.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aged, 80 and over; Exercise; Cognition; Balance; Randomized controlled trial
EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome
Condition: Failed Back Surgery Syndrome
MeSH terms: Syndrome; Failed Back Surgery Syndrome
Study type: Interventional

Summary: 
      This study is an interventional, observatory single center trial investigating the functional
      connectivity of the electrical brain activity in high frequency/high density spinal cord
      stimulation in failed back surgery syndrome patients with back and leg pain.
    

Detailed description: 
      Based on the reimbursement rules in Belgium, a trial implantation of 4 weeks is necessary
      before implanting the definitive neurostimulator. The definitive neurostimulator will be
      implanted minimum 4 weeks after the trial implantation, when the patient reports more than
      50% pain reduction and/or more than 50% reduction in pain medication.

      Patients who are included in this study will have four extra study visits at the University
      Hospital Brussels. The first assessment will take place during the week prior to surgery, the
      second minimal one month after definitive implantation of the stimulator. The assessments
      consist of filling in the Pittsburgh Sleep Quality Index (PSQI) and the Pain Catastrophizing
      Scale (PCS) and recording brain activity before and during the pain protocol. Additionally,
      patients will wear an Actiwatch for measuring sleep patterns and fill in a VAS diary (back
      and leg pain separately), one month before the baseline assessment and one month before the
      second assessment.
    

Intervention name(s): EEG recording + pain protocol
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: high frequency / high density spinal cord stimulation; EEG; conditioned pain modulation
TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, open-label study of immune checkpoints inhibitors Nivolumab+Ipilimumab
      administered in combination with the anti-TNF-α either Infliximab or Certolizumab, in
      patients with advanced melanoma.
    

Detailed description: 
      The study will be conducted in 2 consecutive parts:

        -  Part 1 with 2 parallel cohorts (Nivolumab+Ipilimumab administered in combination with
           anti-TNF-α Certolizumab (Cohort 1) and Nivolumab+Ipilimumab administered in combination
           with anti-TNF-α Infliximab (Cohort 2)). 6 patients will be included in each cohort.

        -  Part 2 (expansion phase) will then be scheduled after the most promising combination has
           been confirmed; the choice of the combination will be based on safety, efficacy, and PD
           data observed in both cohorts during the Part 1 of the study.
    

Intervention name(s): Nivolumab+Ipilimumab in combination with Anti TNF-α Certolizumab; Nivolumab+Ipilimumab in combination with Anti TNF-α Infliximab
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Induction phase: Nivolumab (1mg/kg) and Ipilimumab (3 mg/kg) injected at Week 0, 3, 6, and 9 with Certolizumab injected at the dose of 400mg at weeks 0, 3, and 6, and at the dose of 200mg at week 9.
Maintenance phase: Nivolumab (3 mg/kg) alone injected from week 12 and then every 2 weeks with Certolizumab (200 mg) injected from week 12 and then every 2 weeks.; Induction phase: Nivolumab (1mg/kg) and Ipilimumab 3 mg/kg injected at Week 0, 3, 6, and 9 with Infliximab (5mg/kg) injected at weeks 0, 3 and 6.
Maintenance phase: Nivolumab (3 mg/kg) alone injected from week 12 and then every 2 weeks with Infliximab (5mg/kg) injected from week 14 and then every 8 weeks.
Intervention MeSH terms: Infliximab; Certolizumab Pegol; Nivolumab; Ipilimumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melanoma; Immune checkpoint; Nivolumab; Ipilimumab; Infliximab; Certolizumab; PD-1; TNFa; CTLA-4