bioihbjkbjnl/mcl2 huggingface dataset:
RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early
      Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.
    

Detailed description: 
      This is a prospective randomised phase 3 study comparing a novel treatment protocol of
      Rituximab with a present first line disease modifying drug regarding both clinical,
      radiological and biochemical parameters. This will be measured via clinical investigations,
      MRI and Cerebrospinal fluid analyses. Each patient will have one treating physician
      responsible for all ongoing medical questions and decisions regarding continuation in the
      study and one examining physician performing the blinded Expanded Disability Status Scale
      examination and assessments of exacerbations. The coordinating nurse will administer the
      study-related tests and administer the rituximab infusions. In order to keep the examining
      physician blinded the patients receiving disease modifying drug will receive infusions with
      sodium chloride solution at the same interval as the rituximab arm is receiving. In both
      instances an opaque cover bag will shield the content of the infusion solution. In this case
      the examining physician will not be able to identify rituximab patients in case of accidental
      meetings on the neurology unit.

      Randomisation will be performed via a randomisation module in the national Swedish MS
      registry. The patients will be randomised in a 1:1 ratio and receive their treatments in
      accordance with clinical practice. Thus, the study will mimic the real-life situation in
      which the treatments will be administered which involves both positive and negative
      consequences. As positive consequence the result of the study will have a high degree of
      validity in relation to expected outcome in clinical practice. As negative consequence there
      may be psychological effects of knowing which medication one is receiving. Since both drugs
      probably are perceived as positive treatment options in MS today it is unlikely that there
      will be a predominant placebo effect of either of the treatment options.
    

Intervention name(s): Rituximab; Dimethyl fumarate; Sodium Chloride solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Infusion of Mabthera/Rituximab every 6 months; Intake of Tecfidera/Dimethyl Fumarate daily acc. to clinical practice.; Placebo/Sham infusion every 6 months so that the examining physician (blinded) should not know which patient gets Mabthera or Tecfidera
Other intervention name(s): Mabthera; Tecfidera; Sodium Chloride
Intervention MeSH terms: Rituximab; Dimethyl Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Nutritional and Dietary Treatment Study for Children/Adults With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      70 children and adults with autism spectrum disorders will be enrolled in a 1-year,
      single-blind treatment study. Assessments will be conducted at the beginning and end of the
      study, including measurements of nutritional, metabolic, and digestive status and assessments
      of autism severity and overall functioning. Half of the participants will be randomized into
      a treatment study, and half will be randomized to no changes in their current treatments.
      Treatments will be added in a sequential manner over 12 months, including vitamin/minerals,
      essential fatty acids, carnitine, digestive enzymes, and healthy, gluten-free, casein-free
      diets. A dedicated team of nutritionists, nurses, and physicians will support and monitor the
      participants throughout the study.

      A group of 50 neurotypical children and adults, of similar age and gender, will be included
      for comparison.
    


Intervention name(s): Nutritional and Dietary Interventions
Intervention type(s): Dietary Supplement
Intervention description(s): Day 0: Vitamin/Mineral supplementation begins. Day 30: Essential Fatty Acid supplementation begins. Day 60: Epsom Salt baths begin (2x/week) Day 90: Carnitine supplementation begins Day 180 Digestive Enzyme supplementation begins; Day 210: Healthy, casein-free, gluten-free diet is begun.
Other intervention name(s): vitamin/mineral supplement; essential fatty acids; Epsom salt bath; carnitine; digestive enzymes; healthy gluten-free casein-free diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitamins; minerals; essential fatty acids; Epsom salts; carnitine; digestive enzymes; gluten-free casein-free diet
Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites
Condition: Postoperative Pain Atskin Graft Site
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Skin grafting; both partial and complete thickness is frequently used in
      reconstruction of traumatic soft tissue defects. It is of great value not only for functional
      and aesthetic purposes in the field of plastic surgery, but also for other surgical
      specialties.

      Of all the problems in the early postoperative period, pain is considered the most important,
      ameliorating it can lead to significant reduction in postoperative morbidity and faster
      recovery of the skin donor site.

      Objective: To evaluate use of dexamethasone as adjuvant for bupivacaine in subcutaneous local
      anesthesia infiltration for skin graft donor sites, on quality of pain relief and total dose
      of analgesic requirements in the early hours postoperatively.

      Methods: 97 patients were randomly allocated to receive local bupivacaine infiltration (group
      LB), or dexamethasone plus bupivacaine (group LB + D) in skin donor site after skin
      harvesting. In addition to basic demographic data; patients were compared for Numerical
      Rating Scale (NRS), total dose of morphine or morphine equivalents, time to 1st breakthrough
      pain, and duration of surgery.

      Keywords: Donor site. skin graft. Breakthrough pain. Rescue analgesia. Bupivacaine
    

Detailed description: 
      The patients included in the study were randomly allocated to 1 of 2 parallel groups: 1)
      bupivacaine plus dexamethasone (LB+D) group (n = 50): received 20 ml bupivacaine 0.5% + 18 ml
      normal saline + 8 mg dexamethasone 2 ml, 2) bupivacaine only (LB) group (n = 50): received 20
      ml bupivacaine 0.5% + 20 ml normal saline. A random allocation sequence was generated
      electronically using online randomization service from https://www.random.org. The project
      medicine was prepared by 2 independent assistants not involved in other parts of the study.
      All persons involved were blinded to the randomized allocation.
    

Intervention name(s): Xylocaine
Intervention type(s): Drug
Intervention description(s): TREATMENT
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: DOUBLE BLINDED RANDOMELY CONTROLLED
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bupivacaine,dexamethasone,Analgesia,Skin Graft ,Donor
Staccato Loxapine Pulmonary Safety in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety of 2 inhaled doses of Staccato Loxapine
      within a day in patients with asthma.
    


Intervention name(s): Inhaled loxapine @ 0 & 10 h; Inhaled placebo @ 2 & 10 hours
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg, 2 doses, 10 hours apart; placebo, 2 doses, 10 hours apart
Other intervention name(s): ADASUVE; ADASUVE PLACEBO
Intervention MeSH terms: Loxapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma, Staccato loxapine
Impact of Celecoxib on Electrophysiological Property in Brain of Healthy Volunteer
Condition: Electrophysiologic Property of Brain
Study type: Interventional
Phase: Phase 1

Summary: 
      the purposes of this study are to evaluate the acute electrophysiological response in brain
      cortex to single oral dose of celecoxib (400mg once) in healthy volunteer and the
      electrophysiological alteration in brain cortex by long-term treatment of celecoxib (200mg
      twice-daily for 7 days) in healthy volunteer
    

Detailed description: 
      Inflammatory response is considered as defense mechanism against physical or infectious
      insults and also prevails within the central nervous system. Following certain kinds of brain
      injuries (i.e trauma, ischemia, hypoxia and seizure), innate immunity and subsequent adaptive
      immunity subserve the robust inflammatory cascades, leading to excitatory synaptic networks.
      Cellular elements, such as neuron, microglia as well as inflammatory molecules
      (cyclooxygenase2, interleukin-1, tumor necrosis factor-alpha, etc) play essential roles in
      enhancing this process.

      In line with these, compelling evidences in animal studies in epilepsy field indicate that
      celecoxib (COX-2 inhibitor) has anticonvulsant actions, although its mechanisms are not fully
      understood. Thus, oral administration of Celecoxib in human has a high potential to suppress
      the neuronal excitability. As a milestone for the big picture, current study is going to
      prove the changes of cortical excitability evoked by transmagnetic stimulation (TMS) and
      electroencephalographic properties revealed by EEG in healthy volunteer, given that power
      spectral analysis of EEG and several parameters of TMS , can detect the small changes of
      neuronal activities by celecoxib.
    

Intervention name(s): Celecoxib; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy Volunteers
Condition: Drug-drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, single-center, open-label, single-sequence, 3-period, PK drug interaction
      study evaluating the effect of napabucasin in healthy volunteers on the single-dose PK of
      several cytochrome P450 (CYP450) probe drugs as well as a BCRP substrate.
    


Intervention name(s): napabucasin; cytochrome P450 (CYP450) probe drugs or BCRP transporter substrate
Intervention type(s): Drug; Drug
Intervention description(s): Napabucasin will be administered at dose of 240 mg twice daily, every 12 hours (BID) on days 1-2 in period 1, and on days 1-11 in period 3.; CYP450 probe drugs or BCRP transporter substrate will be administered once every period during days 1-4 in period 2, and days 6-9 in period 3.
Other intervention name(s): BBI-608; BBI608
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers
Lower Limb Mechanical Characteristics: Effect on Running Mechanics and Energetics
Condition: Healthy
Study type: Interventional

Summary: 
      Inter-individual variability in energetic cost of running may be partly explained by lower
      limbs mechanical characteristics. The transposition of muscle mechanical model with two
      components (contractile and elastic) to the whole lower limb mechanical behavior analysis
      during running. The main aim of present investigation is to study the effects of lower limb
      mechanical characteristic (force, velocity, stiffness) on the energetic cost of running using
      a lower limb mechanical approach including both contractile and elastic components.Twenty
      healthy men will run on a treadmill at 12km.h-1 in 8 different 5 min-conditions. Through
      conditions, stride frequency, sole stiffness and subject's body weight will be changed to
      allow artificial variations in lower limb mechanical characteristics. Energetic and
      non-invasive mechanical measurements analysis will be performed to obtain energetic cost of
      running and to compute force, velocity and stiffness of lower limbs for each condition.
    

Detailed description: 
      Main aim: Identify the effect of mechanical characteristic induced on lower limbs on the
      energetic cost of running.

      Secondary aim : Minimize the energetic cost of running by lower limb mechanical
      characteristics optimization.
    

Intervention name(s): energetic and non invasive limb mechanical measurements
Intervention type(s): Other
Intervention description(s): Force velocity stiffness running
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteers; running; energetic cost; limb mechanical characteristics; contractile components; elastic components; healthy men doing regularly physical activities
Relative Bioavailability BI 10773 and Metformin in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective was to investigate a possible drug-drug interaction between BI 10773 and
      metformin when co-administered as multiple oral doses. Therefore, the relative
      bioavailabilities of BI 10773 and metformin were determined when both drugs were given in
      combination compared with BI 10773 or metformin given alone.
    


Intervention name(s): BI 10773; Metformin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin; Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fostering Shared Decision-making About Prostate Cancer Screening Among Clinicians and African American Men
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This behavioral clinical trial assesses the efficacy of a educational intervention to
      increase shared decision making about prostate-specific antigen (PSA)-based screening for
      prostate cancer among African American males. Half of participants will receive a multimedia
      educational intervention, while the other half will receive usual care.
    

Detailed description: 
      The 2018 U.S. Preventive Services Task Force (USPSTF) final recommendation states that male
      patients and their providers engage in a shared-decision making process about the benefits
      and harms of PSA-based screening. As characterized by the USPSTF, these conversations are
      particularly important for African American men given increased ambiguity due to the lack of
      PSA-based research specific to this population and increased risk of prostate cancer
      mortality attributed to late stage at diagnosis and more aggressive prostate cancer
      phenotypes seen in African American men.

      The goal of this randomized behavioral clinical trial is to advance the translation path of
      implementing the decision-making process in clinical encounters by evaluating the efficacy of
      an educational intervention for African American males to increase shared decision making
      about PSA-screening versus usual care. The intervention will use multimedia educational
      training materials to increase understanding of prostate cancer, PSA-based screening, and
      shared decision making among patients and their primary care providers (PCPs).
    

Intervention name(s): Educational Shared Decision-Making Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention includes a web-based patients' decision aid about PSA-based prostate cancer screening, risks and preferences. The providers receive a summary of the USPSTF 2018 guidelines and main components of the Agency for Healthcare Research and Quality (AHRQ) SHARE curriculum, a link to a video of a prototypical shared decision making conversation, and a laminated shared decision making reminder card.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Prostate cancer; Primary Care; PSA-screening; African American males
Exercise Rehabilitation of Younger and Older People With Claudication
Condition: Intermittent Claudication
MeSH terms: Intermittent Claudication
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effect of age and the effect of exercise
      intensity of rehabilitation programs on claudication pain symptoms and leg circulation of
      younger and older patients with intermittent claudication.
    

Detailed description: 
      Thirty-one patients randomized to low-intensity exercise rehabilitation and 33 patients
      randomized to high-intensity exercise rehabilitation completed the study. The 6-month
      exercise rehabilitation programs consisted of intermittent treadmill walking to near maximal
      claudication pain three days per week at either 40% (low-intensity group) or 80%
      (high-intensity group) of maximal exercise capacity. Total work performed in the two training
      regimens was similar by having the patients in the low-intensity group exercise for a longer
      duration than patients in the high-intensity group. Measurements of physical function,
      peripheral circulation, and health-related quality of life were obtained on each patient
      before and after the rehabilitation programs.
    

Intervention name(s): Walking Exercise
Intervention type(s): Behavioral
Intervention description(s): Intermittent treadmill walking to near maximal claudication pain three days per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: functional ability; gait; musculoskeletal disorder therapy; peripheral blood vessel disorder
Incidence and Risk Factor of Post-ERCP Pancreatitis in Chronic Pancreatitis
Condition: Post-ERCP Acute Pancreatitis
MeSH terms: Pancreatitis
Study type: Observational

Summary: 
      The purpose of this study is to compare the incidence of post-ERCP pancreatitis (PEP) in
      chronic pancreatitis (CP) patients to that in biliary disease patients, to determine whether
      CP patients in early clinical stage have a higher PEP incidence, and to identify the
      predictive and protective factors for PEP in chronic pancreatitis patients.
    

Detailed description: 
      Analysis of patients with chronic pancreatitis (CP group) and biliary disease (BD group) in
      Changhai Hospital from January 2011 to May 2015 were conducted. Difference of PEP incidences
      between BD group and CP group, as well as between M-ANNHEIM subcategories were calculated by
      chi-square test or Fisher's exact test. The predictive and protective factors for PEP were
      investigated by univariate and multivariate analysis.
    

Intervention name(s): chronic pancreatitis
Intervention type(s): Other
Intervention description(s): patients with chronic pancreatitis
Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        Chronic pancreatitis patients underwent ERCP from January 2011 to May 2015 in Changhai
        Hospital.
Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion in Cancer Patients
Condition: Cancer; Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      There is evidence to suggest that red blood cell concentrate (RBC) transfusion may have
      immunomodulatory effects. The aim of this randomized single-center trial is to compare immune
      responses in patients undergoing cancer surgery and given either an unmodified RBC (UN-RBC)
      or a leuko-reduced RBC (LR-RBC) transfusion perioperatively.
    

Detailed description: 
      This single-center study is conducted to compare the effect of peroperative transfusion of
      allogeneic unmodified RBC (UN-RBC) versus leuko-reduced RBC (RED-RBC) on recipient immunity.
      Patients undergoing cancer surgery are randomly assigned peroperatively to receive UN-RBC or
      RED-RBC. Groups are stratified for age, sex, tumor characteristics, prior transfusion and
      prior cancer treatment. Blood sampless are collected before anesthesia (d0) and at days 3, 7,
      14 , 28 after transfusion/surgery and analyzed for complete cell blood count, lymphocyte
      subsets, cytokine production (IL4, IL10, IFNgamma, IL12), T-cells repertoire (TCR) analysis
      and detection of circulating donor cells. Main study endpoint is the influence of the
      treatment arm on IL4/IFNgamma ratio. The effect of transfusion type on any given biological
      parameters is also tested (peripheral blood mononuclear cell phenotyping (PBMC), cytokine
      production by stimulated PBMC, T cell repertoire analysis and microchimerism assessment).
    

Intervention name(s): transfusion of allogeneic red blood cell concentrate; transfusion of leuko-reduced red blood cell concentrate
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cancer; peroperative transfusion; allogeneic red blood cell concentrate; leuko-reduced red blood cell concentrate