bioihbjkbjnl/mcl2 huggingface dataset:
Body Composition Analysis in Patients Undergoing Chemoembolization
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      Hepatocellular carcinoma represents 80-90% of primary hepatic malignant tumors. 80% of
      patients with hepatocellular carcinoma are associated with cirrhosis.

      Chemoembolization is a process in which a chemotherapeutic agent is deposited directly into
      the hepatic tumor where the principal artery is embolized.

      Bioelectrical impedance bases its evaluation in a model where the body is conformed by two
      different compartments: fat mass and fat free mass.

      Bioelectrical impedance is complemented by vectorial analysis, which is independent to the
      state of hydration and is helpful to monitor any changes in corporal composition. It can be
      used as a control for the interpretation of the bioelectrical impedance.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients will be recruited from the Radiology Department of a tertiary care center.
      
Keywords: body composition; hepatocellular carcinoma; chemoembolization
Mesenchymal Stem Cells for Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the study is to evaluate the safety and efficacy of autologous mesenchymal stromal
      cells as treatment for Multiple Sclerosis.
    

Detailed description: 
      MESEMS is a randomised phase 2 trial done at 15 sites in nine countries. Patients (aged 18-50
      years) with active relapsing-remitting or progressive multiple sclerosis were included if
      they had a disease duration of 2-15 years since onset of multiple sclerosis and an Expanded
      Disability Status Scale score of 2·5-6·5. Patients were randomly assigned (1:1), according to
      a crossover design, to receive a single intravenous dose of autologous bone marrow-derived
      MSCs followed by placebo at week 24, or to receive placebo followed by autologous MSCs at
      week 24, with a follow-up visit at week 48. Primary objectives were to test safety and
      activity of MSC treatment. The primary safety endpoint was to assess the number and severity
      of adverse events within each treatment arm. The primary efficacy endpoint was the number of
      gadolinium-enhancing lesions (GELs) counted over week 4, 12, and 24 compared between
      treatment groups. The primary efficacy endpoint was assessed in the full analyis set, after
      all participants completed the week 24 visit. Efficacy endpoints were evaluated using a
      predefined statistical testing procedure. Safety was monitored throughout the study by
      recording vital signs and adverse events at each visit.
    

Intervention name(s): Autologous mesenchymal stem cells
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mesenchymal stem cells; Multiple Sclerosis; Autoimmune diseases
Pharmacokinetics, Efficacy and Tolerability of BIA 2-093
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate
      in children and adolescents with epilepsy.
    

Detailed description: 
      This clinical study was planned to be performed as an open-label, single-centre,
      multiple-dose study, in 30 paediatric epileptic patients distributed by 3 age groups of 10
      patients each: 2-6 years [Group 1], 7-11 years [Group 2], and 12-17 years [Group 3].

      The study was constituted by a 4-week baseline phase, followed by 3 consecutive 4-week
      treatment periods with Eslicarbazepine acetate in which patients received Eslicarbazepine
      acetate once-daily at the following dosage regimens: 5 mg/kg/day (weeks 1-4), 15 mg/kg/day
      (weeks 5-8) and 30 mg/kg/day or 1800 mg/day, whichever less (weeks 9-12). At the end of each
      4-week treatment period, patients were hospitalised and serial blood samples for drug assays
      were obtained over a dosing interval.

      After the last treatment period or in the event of premature discontinuation, the dose had to
      be down-titrated during a 2-week period. After the last treatment period patient could
      continue receiving Eslicarbazepine acetate ("compassionate use") if both
      parent(s)/guardian(s) /patient and his/her physician agreed this was in the best patient's
      interest. A follow-up visit occurred approximately 4 weeks after the last hospitalisation or
      early discontinuation.
    

Intervention name(s): BIA 2-093 (Eslicarbazepine acetate)
Intervention type(s): Drug
Intervention description(s): Eslicarbazepine acetate administered at increasing daily doses of 5 mg/kg, 15 mg/kg, and 30 mg/kg (or 1800 mg, whichever less); once-daily; oral route
Intervention MeSH terms: Eslicarbazepine acetate
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; BIA 2-093
Total30 Sphere Contact Lenses
Condition: Contact Lens Complication; Dry Eye
MeSH terms: Dry Eye Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to map comfort over the full wear day in established,
      asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs.
    

Detailed description: 
      Contact lens (CL) wearers frequently face eye discomfort symptoms, especially towards the end
      of the wear day. This burdensome discomfort can unfortunately cause patients to remove their
      CLs before their desired wear time. While comfortable wear times vary from patient to
      patient, Terry et al. has suggested that patients should be able to comfortably wear their
      CLs for at least 12 hours per day for at least 6 days per week. Nevertheless, the literature
      currently lacks sufficient data to comment fully on the full day wear experience, which for
      many patients may be 16 or more hours per day, especially if they have demanding careers. One
      CL that has the potential to allow for all day comfort is the Total30 Sphere CLs, which is a
      new water gradient, monthly CL aimed at delivering all day comfort and visual performance.
      Thus, the purpose of this study is to map comfort over the full wear day in established,
      asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs. These data are not only
      important for judging the performance of Total30 Sphere CLs, but they will provide some of
      the first insights into the full day CL wearing experience over one month.
    

Intervention name(s): Total30 Sphere Contact Lenses
Intervention type(s): Device
Intervention description(s): Participants will be refit into Total30 Sphere contact lenses and followed for 1 month.
Other intervention name(s): Lehfilcon A
Intervention model: Single Group Assignment
Intervention model description: This prospective, one-month, three-visit study will refit all participants into Total30 Sphere contact lenses.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Total30 Sphere Contact Lenses; Comfort; Dryness; Visual Analog Scale Scores
Spinal Cord Analysis in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Research project in which patients with Multiple Sclerosis (MS) are examined clinically and
      with magnetic resonance imaging (MRI). To evaluate spinal cord (SC) grey and white matter
      changes (incl. lesions) using fast, high-resolution MRI sequences with high contrast between
      SC and cerebrospinal fluid (CSF) as well as high contrast within the SC (grey-white matter
      contrast).
    

Detailed description: 
      The Swiss Multiple Sclerosis Cohort (SMSC-Study) aims to better evaluate specific Multiple
      Sclerosis (MS) phenotypes through the systematic and standardised documentation and
      acquisition of clinical course and paraclinical tests such as magnetic resonance imaging
      (MRI), blood and cerebrospinal fluid (CSF) specimens.

      Determination of the relative contribution of SC metrics (cervical cord volume, cervical grey
      matter (GM) cord volume, cervical white matter (WM) cord volume, SC lesion load) to
      disability in MS.
    

Intervention name(s): spinal cord MRI
Intervention type(s): Diagnostic Test
Intervention description(s): high-resolution spinal cord MRI sequences on a 3Tesla magnet (Siemens Prisma) with high contrast between SC and CSF as well as high contrast within the SC (grey-white matter contrast)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The recruitment of MS patients will take place within the ongoing SMSC study at the MS
        Clinic of the Department of Neurology (Neurologische Klinik und Poliklinik), University
        Hospital Basel (Universitätsspital Basel). Healthy subjects will be recruited by public
        announcements on the University Hospital's and the University's notice board.
      
Keywords: Spinal cord; Spinal cord atrophy; Cerebrospinal Fluid; Swiss Multiple Sclerosis Cohort
MK-8583 Single Dose Study in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8583-002)
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and
      anti-retroviral therapy (ART) activity of the tenofovir prodrug, MK-8583 monotherapy in
      ART-naïve, HIV-1 infected participants. The primary hypothesis is that at a dose that is
      sufficiently safe and generally well tolerated, MK-8583 has superior anti-retroviral activity
      compared to historical placebo, as measured by change from baseline in plasma HIV-1
      ribonucleic acid (RNA) (log10 copies/mL) at 168 hours post-dose.
    


Intervention name(s): MK-8583
Intervention type(s): Drug
Intervention description(s): A single oral dose of MK-8583 in capsule form
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Rhus Coriaria L. on Body Weight
Condition: Body Weight
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as
      "Somagh" on body weight.
    

Detailed description: 
      Rhus coriaria L.(Rhus) is a well-known spice widely consumed in the world which has also been
      utilized extensively for medicinal purposes. The antioxidant components of this plant made it
      a favorable target for laboratory and animal studies in different conditions such as
      oxidative stress cytotoxicity, diabetes and hyperlipidemia. Rhus (Somagh) is found in
      temperate and tropical regions worldwide, often growing in areas of marginal agricultural
      capacity. Rhus is used as an herbal remedy in traditional medicine because of its assumed
      analgesic, antidiarrheic, antiseptic, anorexic and antihyperglycemic properties. The fruits
      of Rhus contain flavonols, phenolic acids, hydrolysable tannins, anthocyans and organic acids
      such as malice, citric and tartaric acids. Some studies have shown that polyphenols could
      have beneficial effects on cardiovascular disease and cancer and could be regarded as
      bioactive compounds with a high potential health-promoting capacity. Phenolic compounds
      inhibit lipid peroxidation, scavenge the superoxide anion and hydroxyl radical, and enhance
      the activities of detoxifying enzymes.

      The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as
      Somagh on body weight.
    

Intervention name(s): Rhus Coriaria L.(Rhus); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg twice daily after meals for 6 weeks; 500 mg twice daily after meals for 6 weeks
Other intervention name(s): Somagh
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Body weight changes; Medicine, Traditional; Herbal medicine; Rhus; Waist Circumference; Waist-Hip Ratio; Body mass index
Evaluation of Walk With Ease in Arthritis
Condition: Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall goal of this study is to determine the whether the Walk with Ease (WWE) program
      in its 2 version (group-assisted and self-directed) can increase physical activity and
      fitness levels among individuals (18 years and older) with arthritis over the long-term.
      Participants will be approximately 657 subjects from 20-24 rural and urban communities across
      North Carolina. It is expected that participants in the WWE program will have reduced pain,
      improved function and increased activity levels after participation in this 6-week program.
    


Intervention name(s): Walk with Ease - Group; Walk with Ease - Self
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participate in 6-week, 1 hour per week group assisted classes (with instructor).; SUbject will receive the WWE workbook and follow it without group/instructor assistance.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthritis; osteoarthritis; rheumatoid arthritis; fibromyalgia; lupus
Effect of HIIT Vs Moderate Intensity Aerobic Exercise on Insulin Resistance in Type 2 DM
Condition: Diabetes Mellitus; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Comparing between the efficacy of high intensity interval training and moderate intensity
      aerobic exercises on insulin resistance in type 2 Diabetes Mellitus.
    

Detailed description: 
      The study aims at differentiating between high intensity interval training and moderate
      intensity continuous aerobic exercise in terms of their effect of Insulin resistance in
      patients diagnosed with type 2 Diabetes Mellitus. All participants will have lab analysis for
      Serum Homa-IR prior to intervention and after 1 month of treatment.
    

Intervention name(s): High intensity interval training; moderate intensity aerobic exercise
Intervention type(s): Other; Other
Intervention description(s): Patients will receive interval training exercise of high intensity. This includes several rounds that alternate between several minutes of high intensity movements to significantly increase the heart rate to at least 80% of one's maximum heart rate, followed by short periods of rest; Patients will receive moderate intensity continuous aerobic exercise (walking) for 40 minutes (preceded by 10 minutes warming up and followed by 5 minutes cooling down)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of a Probiotic On Anxiety and Stress in Healthy Adults Sensible to Daily Stress
Condition: Anxiety; Stress
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of the the study is to determine if PROBIOSTICK® decrease stress and anxiety of
      people sensible to daily stress.
    


Intervention name(s): PROBIOSTICK® during 30 days; Placebo during 30 days
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Every morning subjects will consume a stick of PROBIOSTICK® during 30 days; Every morning subjects will consume a stick of placebo during 30 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: PROBIOSTICK®; Probiotic; Anxiety; Daily stress
Immune Function Following Liver Transplantation
Condition: Liver Transplant; Complications
Study type: Observational

Summary: 
      Post-operative care following liver transplantation is characterized by a high incidence of
      infective and immunological complications. Restauration of liver function following liver
      transplantation is progressive and characterize a period of immuno-infective vulnerability.
      The purpose of this study is to characterize the early post-operative immune function in
      children after liver transplantation.
    

Detailed description: 
      Within a few decades, liver transplantation has become an effective treatment of end-stage
      liver diseases associated with high spontaneous mortality. However, the consequences of
      immediate transplants are frequently complicated by infective (nosocomial infection) and
      immunological complications (acute graft rejection) in up to 40 to 60% of liver transplanted
      patients. In order to ensure graft immunotolerance, immunosuppressive therapy based mainly on
      calcineurin inhibitors, is initiated soon after liver transplantation. Immunosuppressive
      therapy is intended to reduce the response of cytotoxic lymphocytes and NK cells. As a
      result, an important component of the immune response is blocked. In addition, function of
      the transplanted liver, which is a key organ for both immuno-inflammatory signalling and host
      defense against pathogens, is progressively restored post-operatively. Thus in this
      post-transplant period, there is a critical period where liver function is severly impaired
      and progressively get restaured. The aim of this study is to characterize the restauration of
      immune function in the early post-operative period and evaluate its correlation with
      occurence of infective or immunological complications.
    

Intervention name(s): Biological testing on sequential blood sample
Intervention type(s): Genetic
Intervention description(s): Biological characterization of various immune function and blood circulating leukocytes phenotyping before liver transplantation and therafter at day-3, -7, -14 postoperatively and if septic complication occurs.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Child admitted for liver transplantation
      
Biospecimen description: 
      The biological collection will include plasma, RNA and DNA samples, which will be stored at -
      20 ° C for sera, and - 40 ° C for blood RNA and liver biopsy (stabilized in a buffer
      containing RNase inhibitors) and DNA (stabilized in a buffer containing DNase inhibitors)
Botox for Cervical Dystonia Following EMG Mapping
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine how to improve treatment of patients with cervical
      dystonia who have not been helped with standard Botox injections. This study is for patients
      with cervical dystonia who have not benefited from treatment with Botox using conventional
      "single lead electromyographic (EMG) techniques" for injection. The study aim is to see if
      these patients may have significantly more benefit if their Botox is injected into muscles
      that have been chosen with a multi-channel EMG mapping study of the neck prior to Botox
      injection.
    

Detailed description: 
      The most common type of primary late-onset dystonia is cervical dystonia. Botulinum toxin A
      (BTX-A) injections are a safe and effective treatment for cervical dystonia in a majority of
      patients, however, a significant minority of patients (between 15 and 25%) have a suboptimal
      response to Botulinum toxin therapy. It is unclear why some patients do not respond maximally
      to neurotoxin therapy.

      Studies using needle electromyographic "mapping" in the evaluation of cervical dystonia have
      revealed that clinical examination alone is insufficient for determining which muscles
      contribute to the dystonic movement. When compared to needle electromyography (EMG) "mapping
      studies", experienced movement disorders specialists correctly identify only 59% of active
      muscles and believe that 25% of muscles which upon EMG evaluation are found to be quiescent,
      are involved in the dystonia. The selection of incorrect muscles for injection of Botulinum
      toxin may explain why some patients have a sub-optimal response.

      This study seeks to measure outcomes when the muscles involved in dystonia are identified
      using "mapping" via an 8-12 channel EMG. In the proposed study, the most involved/active
      dystonic muscles will be correctly identified through simultaneous 8-12 channel mapping
      resulting in a more informed injection strategy, which may improve response to Botulinum
      toxin A treatment as compared to single lead EMG based injections. This study changes routine
      clinical care only by adding the step of studying the muscles of the neck with simultaneous
      EMG mapping to allow a more objective injection strategy.
    

Intervention name(s): Botulinum toxin A
Intervention type(s): Drug
Intervention description(s): All patients will be treated with Botox using both single-channel and multi-channel EMG mapping.
Other intervention name(s): Botox
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dystonia; cervical dystonia; Botox; idiopathic primary cervical dystonia