bioihbjkbjnl/mcl2 huggingface dataset:
A Trial Using Molecular-Guided Therapy in Patients With Refractory or Recurrent Neuroblastoma
Condition: Refractory Neuroblastoma; Relapsed Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Observational

Summary: 
      The investigators are studying new ways to make treatment decisions for these types of
      cancer. Technologies at the Van Andel Research Institute (VARI) are available to determine a
      tumor's molecular makeup (gene expression profile). This technology (called "Xenobase") is
      being used to discover new ways to understand cancers and potentially predict the best
      treatments for patients with cancer. The researchers at VARI have filed a patent on the
      Xenobase and the specific network analysis method that the investigators will be using as
      part of this study.

      A specimen obtained from the tumor during a recent surgical, biopsy, or bone marrow procedure
      will be sent to the Van Andel Research Institute. Researchers will attempt to identify the
      molecular makeup within the specimen, as well as in blood and urine samples in patients with
      aggressive and/or refractory cancer. This additional testing is different than the routine
      tests currently performed at the hospital for the evaluation of cancer.

      The goals of this part of the study are: To determine if the investigators tumor board
      committee (at minimum a panel of 3 oncologists and 1 pharmacist) can use patient specific
      cancer cells to make real-time treatment decision using patient specific genetic information,
      and predicted therapies generated in the Xenobase report.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Relapsed and refractory Neuroblastoma
      
Keywords: Refractory Neuroblastoma; Relapsed Neuroblastoma
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
Condition: Bladder Cancer Cell Transitional; Non-Muscle Invasive Bladder Cancer; Bladder Cancer; Urinary Bladder; Transitional Cell Carcinoma of the Bladder; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Urinary Bladder Diseases; Urologic Diseases
MeSH terms: Neoplasms; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Carcinoma, Transitional Cell; Urogenital Neoplasms; Urologic Neoplasms; Urologic Diseases; Urinary Bladder Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a single-arm, phase 1/2a study of formulated paclitaxel in subjects with low-grade,
      noninvasive papillary carcinoma (stage Ta) of the bladder.

      Part 1 of the study will enroll 6 subjects (3 per cohort) with low-grade, stage Ta
      transitional cell carcinoma (TCC) of the bladder who will receive escalating doses of
      paclitaxel formulated as TSD-001 every 2 weeks for 6 treatments until Dose Limiting Toxicity
      (or until the Maximum Deliverable Dose) is observed (Maximum Tolerated Dose established).

      Part 2 of the study will enroll an additional 10 subjects with low-grade, stage Ta (uni-or
      multifocal) TCC of the bladder who will receive weekly TSD-001 for 6 weeks at the highest
      nontoxic dose (i.e., MTD) established in part 1 of the study. May meet definition of low
      grade without histological tissue diagnosis if on cystoscopic assessment they have a solitary
      papillary tumor.

      Part 3 of the study will continue to track subjects enrolled in Parts 1 and 2 to determine
      rates of disease-free survival.
    


Intervention name(s): TSD-001
Intervention type(s): Drug
Intervention description(s): Administered via intravesical instillation.
Other intervention name(s): Proliposomal Intravesical Paclitaxel
Intervention MeSH terms: Paclitaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NMIBC; Paclitaxel; Antineoplastic Agents
Effect of C-Peptide on Diabetic Peripheral Neuropathy
Condition: Diabetes Mellitus, Type 1; Diabetic Polyneuropathy
MeSH terms: Peripheral Nervous System Diseases; Polyneuropathies; Diabetic Neuropathies; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to investigate the effect of C-peptide administration on nerve
      function in patients with type 1 diabetes and peripheral sensory neuropathy.
    

Detailed description: 
      It has been observed that C-peptide administration results in an activation of renal tubular
      and sciatic endoneural Na/K-ATPase of the rat and stimulation of endothelial nitric oxide
      synthase. The hypothesis is that C-peptide administration may improve peripheral nerve
      dysfunction in diabetic neuropathy by increasing nerve blood flow and Na/K-ATPase activity.
      The purpose of the trial is to investigate the effect of C-peptide administration on diabetic
      peripheral sensory neuropathy in patients with type 1 diabetes and diabetic neuropathy in the
      lower extremities.
    

Intervention name(s): C-peptide
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia
Condition: Schizophrenia; Cognition; Psychosis
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators propose to test whether curcumin nanoparticles will improve behavioral
      measures and biomarkers of cognition and neuroplasticity in patients with schizophrenia who
      are already receiving a stable dose of antipsychotic.
    

Detailed description: 
      The investigators will use a formulation of curcumin with high bioavailability that possesses
      a pharmacokinetic profile expected to exert biological effects. Specifically, 36 subjects
      will be enrolled in the double-blind randomized controlled trial. They will be randomized to
      curcumin or placebo for 8 weeks. At baseline, and 4 and 8 weeks, subjects will receive
      assessments of neurocognition (e.g., processing speed, attention and vigilance, working
      memory, learning, reasoning and problem solving), social cognition, EEG biomarkers (e.g.,
      visual cortical plasticity and mismatch negativity), a serum marker of neurogenesis (BDNF
      levels), and clinical symptoms (positive and negative symptoms). At weeks 2 and 6 subjects
      will return for additional safety (e.g., vitals, side effects, akathisia) and medication
      adherence assessments. Improvement on the primary outcome measure (MATRICS Consensus
      Cognitive Battery), as well as secondary outcome measures, will be compared between
      participants randomized to placebo versus curcumin. The results of this study will establish
      whether curcumin is a viable adjunctive agent for future larger clinical trials.
    

Intervention name(s): Curcumin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 360 mg/day (divided into twice daily oral doses); Inactive, matched placebo ("Sugar Pill")
Other intervention name(s): Theracurmin; Curcumin nanoparticles
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Curcumin; Turmeric; Schizophrenia; Cognition; Psychosis
Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of REGN727/SAR236553 in
      participants diagnosed with heterozygous familial hypercholesterolemia (heFH)
    


Intervention name(s): Alirocumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Alirocumab two SC injections in the abdomen only.; Placebo two SC injections in the abdomen only.
Other intervention name(s): REGN727/SAR236553
Intervention MeSH terms: Alirocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Influenza Challenge Study of VIS410 in Healthy Volunteers
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2 a study to assess the safety profile and the effect of VIS410 in healthy subjects
      after inoculation with influenza A virus (H1N1).
    

Detailed description: 
      This is a phase 2a randomized, double-blind, placebo-controlled study to be conducted in
      healthy volunteers. The study is designed to compare an infusion of a single dose of VIS410
      against placebo. Eligible volunteers will be admitted to the clinical center and will receive
      a single intranasal administration of influenza A (H1N1). One day (24h) after inoculation,
      subjects will receive a single administration of VIS410 or placebo. Subjects will be confined
      in the clinical center for 10 days after virus administration.

      Assessment of safety will be determined from vital sign measurements, physical examinations,
      hematology, chemistry and urinalysis laboratory testing, 12-lead electrocardiograms (ECGs),
      pulmonary function, use of concomitant medications, and review of adverse events (AEs) should
      they occur. During confinement in the clinical center a symptom score card of influenza
      symptoms will be completed three times a day; nasopharyngeal swabs will be obtained three
      times a day and assayed for the presence of influenza virus and VIS410 concentration; serum
      samples will be assayed for VIS410 and the presence of cytokines. Upon release from the
      clinical center subjects will return for follow-up visits on days 14, 28 and either 56 or 84.
    

Intervention name(s): VIS410; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single fixed IV dose of VIS410; Single IV dose of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Relationship Between Arterial Stiffness and Hemodynamic Responses in Patients With Spinal Anesthesia
Condition: Arterial Stiffness; Hypertension; Spinal Anaesthesia
MeSH terms: Hypertension
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to investigate the importance of pulse wave velocity, an indicator
      of arterial stiffness, in predicting hemodynamic changes in normotensive and hypertensive
      patients undergoing spinal anesthesia.
    

Detailed description: 
      The prospective cross-sectional study will be carried out between September 1, 2021 and
      September 1, 2022 at Aydin Adnan Menderes University Faculty of Medicine. Patients aged
      eighteen and over who will undergo lower extremity surgery under spinal anesthesia will be
      included in the study.

      During the preoperative evaluation, the patient will be asked about age, weight, height,
      smoking and alcohol use history. At the same time, hypertension disease (if any, drugs used),
      diabetes (if any, drugs used), hyperlipidemia (if any, drugs used) and other diseases and
      drugs used will be recorded.

      Before surgery, hemodynamic data (systolic arterial blood pressure, diastolic arterial blood
      pressure, mean arterial blood pressure, heart rate and oxygen saturation), arterial stiffness
      measurement (pulse wave velocity) will be evaluated in the patient preparation room. Arterial
      stiffness measurement will be made with the oscillometric mobil-o-graph device in the
      anesthesia department.

      Hemodynamic data is recorded by the anesthesia device 1.,3.,5.,10.,20. minutes during
      surgery. Intraoperative hypotension is accepted as a 20% reduction in systolic arterial blood
      pressure evaluated before anesthesia. Using this data recorded on the monitor, reductions of
      20% or more in systolic arterial blood pressure will be recorded as hypotension.
    

Intervention name(s): PWV
Intervention type(s): Procedure
Intervention description(s): All cases were evaluated in the service before surgery. Pulse wave velocity measurement was performed with the MOBİL-O-GRAPH device, which is one of the noninvasive methods. Before measuring from patients; It was confirmed that there was no coffee/cigarette consumption within 30 minutes. After resting for 5 minutes in a quiet room, the cuff of the appropriate size was tied to the arm in such a way that it came to the brachial artery. The data recorded by the tonometer was transferred to the computer program. Care was taken that the patient did not move or talk during the measurement.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ASA I-II patients who will undergo elective lower extremity surgery under spinal anesthesia
        in the orthopedic operating room were selected.
Adherence to Hydroxyurea in Children With Sickle Cell Anemia
Condition: Sickle Cell Anemia
MeSH terms: Anemia; Anemia, Sickle Cell
Study type: Interventional

Summary: 
      Medication non-adherence is a true public health problem. Despite advancements in the
      molecular understanding of disease and improvements in therapy, patient health outcomes will
      not improve unless patients take prescribed medications regularly. Decreasing the gap between
      efficacious and effective therapy for patients with SCD is an essential research agenda.
      Hydroxyurea has been shown to be safe and efficacious in children and infants. However, the
      effectiveness of the prophylaxis depends on adherence to the recommended regimen. Medication
      adherence in SCD has previously been found to be sub-optimal in patients taking penicillin,
      desferoxamine, and pain medication. Adherence to HU has been studied to some extent in
      children with SCD. Based on estimates of adherence in other chronic illness we expect
      approximately 50% of patients to be >80% adherent with their HU administration. There is no
      gold standard for improving adherence to treatment. There have been a few attempts in the SCD
      population to improve adherence. These include a day camp to promote education about
      desferoxamine and peer support, a combination of a slide-show about SCD and it complications,
      weekly phone calls by the clinic social worker and a calendar, and a seven-phase educational
      program. Given the striking improvements in the peripheral blood smear findings of patients
      with SCD on HU therapy, with reduction in the numbers of sickled cells, we hypothesize that
      viewing the peripheral blood smear of patients with poor adherence to HU compared to a blood
      smear of someone on HU can be used to improve adherence in non-adherent patients.

      We will conduct a randomized trial between the intervention of regularly showing children and
      their parents the peripheral blood smear and standard care, including reminders of the
      importance of compliance and review of complete blood count parameters, including WBC, MCV,
      and Hgb concentration. The outcome measures will be increase in hemoglobin concentration and
      %HbF and increase in perceived QOL. QOL will be measured with age-appropriate and
      parent/proxy PedsQL™. Medication adherence will also be monitored throughout the study with
      pharmacy prescription refills, physician assessment, and self-report via a visual analogue
      scale. Adherence estimates, hemoglobin concentration, %HbF and QOL will be measured at
      baseline, 3 months and 6 months.
    


Intervention name(s): Blood smear education; standard education
Intervention type(s): Behavioral; Other
Intervention description(s): education at baseline and three month follow-up; standard education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Sickle cell anemia; Children; Hydroxyurea; Treatment Adherence
Brain Dynamics in Response to Jugular Vein Compression
Condition: Concussion, Mild
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      Clinical trials have suggested that this device is effective in mitigating changes in brain
      structure and function in athlete populations. The purpose of the current study is to better
      understand the underlying mechanistic response of the brain hemodynamics to mild jugular vein
      compression
    

Detailed description: 
      Significant morbidity, mortality, and related costs are caused by traumatic brain injury
      (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the
      field, designed to mitigate TBI resulting from blast trauma or concussive events, would save
      lives, and the huge costs currently being experienced for life-treatment of surviving
      victims. An externally-worn medical device (the Device) that applies mild jugular vein
      compression according to the principle of the Queckenstedt Maneuver, is being developed by
      Q30 Sports Science, LLC (Q30). Preliminary research suggests that the Device has the
      potential to reduce the likelihood of TBI. The currently developed collar (Smith 2009, Smith
      and Fisher 2011, Smith and Fisher 2011, Smith 2012) has been approved for studies in humans
      (IRB 2013-2240) and the results indicate safety for use during high demand and maximal
      exertion activities. Regarding safety, the externally worn collar is meticulously designed to
      mimic the body's own omohyoid muscle actions upon the jugular veins that will provide similar
      pressure and volume increases not to surpass that of a yawn or the mere act of just lying
      down. Initial safety testing and early clinical trials indicate that the collar application
      is both safe and efficacious to prevent brain microstructure and neurophysiological changes
      in response to head impacts.
    

Intervention name(s): Q Collar
Intervention type(s): Device
Intervention description(s): measuring changes in brain during MRI while wearing the Q collar
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Improved Effects of MI Plus Alpha-LA in PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      PCOS patients are initially treated with 2 g myo-inositol and 0.2 mg folic acid, two times
      per day by oral route, for three months. Among them, the subjects who have not ovulated
      despite this treatment are administered with 2g myo-inositol and 0.2 mg folic acid plus 50 mg
      α-lactalbumin for three months. Most of them improve and achieve ovulation. Therefore, the
      combination of α-lactalbumin with myo-inositol allows to get a significant result in the
      treatment of PCOS patients.
    

Detailed description: 
      Polycystic ovary syndrome is a complex chronic condition inducing several related disorders,
      such as subfertility and pregnancy complications. So far myo-inositol, successfully used in
      PCOS, has not been always effective in all patients. Aiming at overcoming this drawback, we
      tested a new formulation with myo-inositol and α-lactalbumin, in consideration of the effects
      exerted by α-lactalbumin in favoring molecule passage among body compartments, and also in
      consideration of its anti-inflammatory activity.

      Only PCOS patients, according to Rotterdam ESHRE-ASRM criteria, with anovulation and
      infertility > 1 year, were included in the study. Following a treatment with 2 g myo-inositol
      and 0.2 mg folic acid, a part of them are resistant and do not ovulate.

      These non-responders to myo-inositol alone undergo the second phase of the study, receiving
      2g myo-inositol and 0.2 mg folic acid plus 50 mg α-lactalbumin for three months. After this
      combined treatment, the majority of them ovulate, showing a hormone and lipid profile
      improvement. In addition, myo-inositol plasma levels at the end of the treatment are
      significantly higher than at baseline and comparable to those patients who respond positively
      to myo-inositol alone.
    

Intervention name(s): myo-inositol plus folic acid; myo-inositol plus folic acid plus alpha-lactalbumin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): this treatment is made in the first phase of the study for three months; this treatment is made in the second phase of the study and it has a new molecule added to the previous ones administered in the first phase of the study
Intervention MeSH terms: Folic Acid; Vitamin B Complex; Inositol
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: All the patients were given orally Inofolic® (Lo.Li. Pharma, Rome, Italy), containing 2 g myo-inositol and 0.2 mg folic acid twice a day for three months, in order to induce ovulation. Then, non-responder partecipants were administered orally with 2 g myo-inositol plus 50 mg α-lactalbumin, twice a day for three months
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myo-inositol; alpha-lactalbumin; anovulation; infertility
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will evaluate the safety and immunogenicity of different combinations of A/H1N1
      S-OIV (swine flu) vaccine in healthy young children.
    


Intervention name(s): MF59-eH1N1
Intervention type(s): Biological
Intervention description(s): MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Swine Flu; Flu; Vaccine; Children; Adjuvant
Preoperative Intravenous Omega 3 Fatty Acids Administration in Elderly Patients Undergoing Hip Surgery
Condition: Hip Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      The perioperative administration of n-3 fatty acids has been shown to lead to favorable
      effects on outcome in patients with severe surgical interventions by lowering the magnitude
      of inflammatory response and by modulating the immune response. No study with preoperative
      administration of IV omega 3 fatty acids as a part of total parenteral nutrition (TPN) or
      monotherapy with it to demonstrate its effects on inflammatory and immune response has been
      conducted. So, this study has been planned to judge the inflammatory response of preoperative
      monotherapy with IV omega 3 fatty acids in elderly patients undergoing hip surgery
      considering the hyper-inflammation associated with this type of surgery in elderly patients.
    


Intervention name(s): Omegaven-IV FO
Intervention type(s): Dietary Supplement
Intervention description(s): Will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Omega 3 Fatty Acids; Inflammation; Hip Surgery; Inflammatory status; Infectious complications