bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin E to Prevent Mucositis in Children With Cancer
Condition: Cancer
MeSH terms: Mucositis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective is to determine whether in children undergoing doxorubicin-containing
      chemotherapy, if topical vitamin E, when compared to placebo, decreases an objective
      measurement of oral mucositis.
    

Detailed description: 
      Oral mucositis is a common consequence of chemotherapy and is an important sequela of cancer
      therapy because it is painful and affects quality of life, may lead to hospitalization for
      hydration or pain control, and provides a portal of entry for oral microflora. In addition,
      oral mucositis has become a major dose-limiting toxicity and consequently, may limit delivery
      of anti-cancer therapy.

      Despite the frequency of mucositis, there are no feasible therapies proven to be successful
      in preventing mucositis in children. Vitamin E is a fat-soluble essential vitamin that may
      protect against doxorubicin-induced oral mucositis through its anti-oxidant properties.

      In this study, we will examine the efficacy of topical vitamin E as prophylaxis against
      chemotherapy-induced mucositis with a novel methodology appropriate for the study of rare
      conditions, namely combining N-of-1 trials using Bayesian meta-analysis.

      The primary outcome is an objective mucositis score measured on days 7, 10, 14 and 17.
      Secondary outcomes included daily pain and swallowing visual analogue scale scores, and World
      Health Organization mucositis scores collected on days 5 to 20.

      Comparisons: Objective and subjective mucositis scores will be compared in cycles associated
      with topical vitamin E versus cycles associated with placebo administration. We will use
      repeated measures analysis within a Bayesian framework in order to conduct this comparison.
    

Intervention name(s): Vitamin E
Intervention type(s): Drug
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Vitamin E; Cancer; pediatrics; supportive care; oral mucositis; Bayesian analysis; N-of-1 trial; prophylaxis
Omega-3 Fatty Acids and Health Effects
Condition: Healthy
Study type: Interventional

Summary: 
      The investigators want to study health effects from omega-3 fatty acids, from fishoil with
      different quality.
    


Intervention name(s): Omega-3; sun flower oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsules with omega-3 fatty acids.; Capsules with sun flower oil.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Focus: health effects from omega-3 fatty acids, from fish oil with different quality
Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds
Condition: Nasolabial Folds
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Platelets are a component of blood, which contain factors which can enhance wound healing.
      This study proposes to evaluate the clinical response of laugh lines treated with a
      concentrated preparation of the subject's own platelets injected into or under the skin by
      taking serial photographs of the subject's face over a 12 week period. Also, the same
      preparation will be injected into or under the skin of the arm near the elbows, and serial
      biopsies will be taken over a 12 week period.
    


Intervention name(s): Platelet rich fibrin matrix
Intervention type(s): Biological
Intervention description(s): 0-2 cc of autologous platelet rich fibrin matrix injected intra and subdermally to effect nasolabial fold.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nasolabial folds; platelet rich plasma; fibrin matrix; facial rhytids; dermal filler
Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013)
Condition: Advanced B-cell Lymphoid Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a Phase 0/1 open-label, non-randomized, biomarker and pharmacodynamic study in
      patients with advanced B-cell lymphoid malignancies, including B-cell chronic lymphocytic
      leukemia (CLL), small lymphocytic lymphoma (SLL), acute lymphocytic leukemia (ALL), multiple
      myeloma (MM), Waldenström's macroglobulinemia (WM), mantle cell lymphoma, follicular
      lymphoma, or diffuse large B-cell lymphoma (DLBCL) who have failed at least one prior therapy
      and for whom no standard curative therapy exists. Patients with advanced stage disease are
      those whose disease is resistant or refractory to standard chemotherapy or biological
      therapies.
    

Detailed description: 
      This pilot study will evaluate whether the administration of roflumilast inhibits the
      activity of PDE4 and results in the modulation of AKT/mTOR pathways in patients with B-cell
      hematologic malignancies. Peripheral blood samples will be collected for the purpose of
      determining the pharmacodynamics of roflumilast on PDE4 activity and on biomarkers as related
      to GC resistance. Samples are obtained at baseline prior to starting study treatment, on Day
      8 before the administration of the Day 8 study drugs (prednisone and roflumilast), and on Day
      15. If a bone marrow biopsy is also performed prior to study treatment or at any time during
      treatment, a sample will be sent for analysis. Normal PBMC (and bone marrow when it is
      obtained) will be examined for changes in key targets related to the inhibition of PDE4 and
      potential reversal of glucocorticoid resistance. Biomarker blood samples will be analyzed in
      order to characterize the pharmacodynamics of roflumilast alone and in combination with
      prednisone on PDE4 activity and on biomarkers, such as phospho-AKT, phosphorylation levels of
      mTOR targets.
    

Intervention name(s): Prednisone; Roflumilast
Intervention type(s): Drug; Drug
Intervention description(s): Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.; Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease.
Other intervention name(s): Deltasone; Daliresp
Intervention MeSH terms: Prednisone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BASKA Laryngeal Mask Airway in Either Volume or Pressure Controlled Ventilation in Laparoscopic Cholecystectomy
Condition: Ventilation
Study type: Observational

Summary: 
      this study will be undertaken to compare the efficacy of BASKA mask in volume controlled and
      pressure controlled ventilation in laparoscopic cholecystectomy.
    

Detailed description: 
      Laparoscopic cholecystectomy is one of the most commonly performed surgical procedures and
      the laryngeal mask airway (LMA) is the most common supraglottic airway device used by the
      anesthesiologists to manage airway during general anesthesia. Use of LMA has some advantages
      when compared to endotracheal intubation, such as quick and ease of placement, a lesser
      requirement for neuromuscular blockade and a lower incidence of postoperative morbidity.
      However, the use of the LMA in laparoscopy is controversial, based on a concern about
      increased risk of regurgitation and pulmonary aspiration. The ability of these devices to
      provide optimal ventilation during laparoscopic procedures has been also questioned. The most
      important parameter to secure an adequate ventilation and oxygenation for the LMA under
      pneumoperitoneum condition is its seal pressure of airway The BASKA mask is a novel
      supraglottic airway device. It has many of the features of other supraglottic airways, These
      include; A non-inflatable cuff, that it is continuous with the central channel of the device.
      As the pressure increases with positive pressure ventilation, the cuff itself is 'inflated',
      this may improve the seal, reduce leak, and make ventilation more efficient
    

Intervention name(s): volume controlled ventilation; pressure controlled ventilation
Intervention type(s): Procedure; Procedure
Intervention description(s): the patients will be ventilated by volume controlled ventilation after insertion of the BASKA laryngeal mask airway; the patients will be ventilated by pressure controlled ventilation after insertion of the BASKA laryngeal mask airway
Other intervention name(s): volume controlled; pressure controlled
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ASA I&II in the age range 18-60 years of both sexes and scheduled for elective laparoscopic
        cholecystectomy surgery
      
Keywords: BASKA mask; controlled ventilation
Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      To measure the CRE by a work capacity index obtained in a submaximal testing (W65%/kg) in
      early RA patients treated with tocilizumab compared to Methotrexate alone.

      The secondary endpoints : analyze the clinical efficacy of Tocilizumab in this population and
      correlate the CRE response with other marker (CRP, Hb, DAS, HAQ) and evaluate the safety
      profile of Tocilizumab.
    

Detailed description: 
      Rheumatoid arthritis (RA) is the most prevalent (about 1%) inflammatory rheumatic disorder.

      Interleukin-6 (IL-6) has emerged as a potential therapeutic target in RA. This is based on
      the greater understanding of the role this cytokine can play in various aspects of the
      pathogenesis of RA. It has been shown that IL-6 is responsible for various clinical symptoms,
      including,fatigue, anemia, anorexia, fever, as well as the production of autoantibodies and
      increase in the erythrocyte sedimentation rate, all of which develop in patients with RA.
      Tocilizumab, as monotherapy and in combination with methotrexate, has been shown to be
      effective for RA patients with insufficient response to methotrexate or other
      disease-modifying antirheumatic drugs. These observations about the effects of tocilizumab
      were extended to patients refractory to tumor necrosis factor inhibitors. Tocilizumab also
      slows down the progression of structural joint damage. Furthermore, a 5-year long-term safety
      and efficacy has been shown. The place of Tocilizumab therapy in early RA is still unknown.

      Cardiorespiratory endurance (CRE), the most fundamental component of physical fitness can be
      severely impaired in patients with rheumatoid arthritis (RA). It has been shown that
      intensive and early treatment of RA can induce sustained clinical remission, improve general
      health and physical fitness and might therefore have an impact on the quality of life of RA
      patient. This study was planned to measure the CRE by a work capacity index obtained in a
      submaximal testing (W65%/kg) in early RA patients treated with tocilizumab compared to
      Methotrexate alone.
    

Intervention name(s): Tocilizumab; Methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): Tocilizumab (8 mg/kg monthly from week 0 to 20); MTX at a dose ranging from 10 mg/week at baseline to 20 mg/week at week 8
Other intervention name(s): Roche EU/1/08/492/001; ATC code L04AC07
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; Tocilizumab; Cardiorespiratory endurance
Telerehabilitation in Individuals With Rheumatic Disease
Condition: Rheumatic Diseases
MeSH terms: Rheumatic Diseases; Collagen Diseases
Study type: Interventional

Summary: 
      increasing the prevalence of exercise models designed in accordance with the biopsychosocial
      model is very important in terms of ensuring the sustainability of these models with
      telerehabilitation in periods such as epidemics and pandemics. The aim of this study was to
      investigate the effects of a biopsychosocial exercise model provided via telerehabilitation
      in individuals with rheumatic diseases during the COVID-19 pandemic.
    

Detailed description: 
      Telerehabilitation was applied to the group with rheumatism in 3 sessions a week for 24 weeks
      via a social texting program. The intervention sessions consisted of 10 minutes of dance
      therapy-authentic movement, 40 minutes of exercises, and 10 more minutes of dance therapy.
      This exercise content was based on a biopsychosocial model, named the Cognitive Exercise
      Therapy Approach (BETY) which was used in the study, and it was a method that patients
      already practiced before the pandemic. At the beginning, at the 12th week and 24th week, the
      Health Assessment Questionnaire (HAQ), the Hospital Anxiety and Depression Scale (HADS), the
      BETY Biopsychosocial Questionnaire (BETY-BQ) were applied.
    

Intervention name(s): Telerehabilitation was applied to the group with rheumatism
Intervention type(s): Other
Intervention description(s): Telerehabilitation was applied to the group with rheumatism in 3 sessions a week for 24 weeks via a social texting program. The intervention sessions consisted of 10 minutes of dance therapy-authentic movement, 40 minutes of exercises, and 10 more minutes of dance therap
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Biopsychosocial, rheumatology, remote care, holistic
Effectiveness of Efavirenz-based Regimen in HIV-1-infected Patients With Nevirapine Hypersensitivity
Condition: Treatment Failure, HIV or AIDS; CD4 Cell Counts
Study type: Observational

Summary: 
      The primary objective of this study is to compare the effectiveness of EFV-based regimens in
      HIV-1-infected patients who; (1) were previously allergic to NVP and stopped all ARV
      simultaneously; (2) were previously allergic to NVP and continued the other NRTIs for a
      period of time, i.e. "staggered interruption"; and (3) started EFV-based regimens as an
      initial regimen (as controlled group).
    


Intervention name(s): Efavirenz-based regimens
Intervention type(s): Drug
Intervention description(s): Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.
Other intervention name(s): Stocrin, Sustiva
Intervention MeSH terms: Efavirenz
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-infected patients who started EFV-based regimens between January 2002 and December 2008
        at Bamrasnaradura Infectious Diseases Institute
      
Keywords: HIV; efavirenz; nevirapine; allergy; rash; Cohort Studies, Historical; Retrospective Study; exanthem; Antiretroviral Agents; Highly Active Antiretroviral Therapy; HAART; treatment failure
Post-Approval Clinical Trial of the PCM® Cervical Disc
Condition: Radiculopathy; Myelopathy
MeSH terms: Radiculopathy; Spinal Cord Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM
      Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a
      degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy
      for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck
      pain, or myelopathy due to a single-level abnormality localized to the disc space, and
      manifested by at least one of the following conditions confirmed by radiographic imaging (CT,
      MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of
      osteophytes), and/or visible loss of disc height as compared to adjacent levels.

      The purpose of this post-approval study is to evaluate the long-term (7 year) safety and
      effectiveness of the PCM Cervical Disc.
    

Detailed description: 
      A prospective, multi-center, post approval study with concurrent control group consisting of
      those patients that were enrolled and did not fail in the PCM Cervical Disc IDE clinical
      study and will to give consent to participate.

      All of the PCM IDE investigational sites who have active patients will be chosen to
      participate in this study. All patients who are actively participating in the pivotal IDE
      study will be asked to participate in this study.

      The study consists of follow-up periods only. The follow-up period will last for seven years
      from each patient's surgery date.
    

Intervention name(s): PCM Cervical Disc; Anterior Cervical Discectomy and Fusion (ACDF)
Intervention type(s): Device; Device
Intervention description(s): Patients enrolled in the IDE clinical study and treated with the PCM Cervical Disc to treat degenerated cervical discs and neurological symptoms at one level from C3 to T1; Patients enrolled in the IDE clinical study and treated with an anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Cyclosporine (CsA) Versus Tacrolimus (Tacro) After Campath Induction in Kidney Transplantation
Condition: Acute Graft Rejection; Chronic Allograft Nephropathy; Polyomavirus-related Transplant Nephropathy
MeSH terms: Kidney Diseases
Study type: Observational [Patient Registry]

Summary: 
      After alemtuzumab induction, followed with kidney transplantation, patients will be randomly
      assigned to receive either tacrolimus or cyclosporine microemulsion in combination with
      mycophenolates. Patients will be followed including protocol biopsy at 1, 12, 36, 60 month
      posttransplant, regular nuclein acid testing (NAT) for cytomegalovirus (CMV), Epstein-Barr
      virus (EBV) and BK virus (BKV) in urine and blood.

      The investigation is undertaken to clarify the reason for equal survival rates for patients
      on cyclosporine and tacrolimus despite the lower rejection rate on tacrolimus.
    

Detailed description: 
      Special attention will be paid to the epidemiology of virus infections behind one year post
      transplant. Very limited data are available on this issue and there is suspicion that
      tacrolimus patients suffer more hard with viruses like CMV, EBV, BKV. These viruses can
      induce graft nephropathy and threat to the life of the recipient.
    

Intervention name(s): cyclosporine or tacrolimus
Intervention type(s): Drug
Intervention description(s): after alemtuzumab, cyclosporine or tacrolimus was administered
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Recipients of kidney allograft who underwent previous Campath induction and do receive
        calcineurine inhibitor (CNI)
      
Biospecimen description: 
      blood and urine, taken at the time of protocol or case biopsies will be deeply freeze and
      stocked for future examination for NAT or other molecules - candidates for diagnostic
      markers.
    
Keywords: rejection; survival; alemtuzumab; cyclosporine; tacrolimus
Cohort Study of Risk Factors for Postoperative Cognitive Decline
Condition: Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      Presently, the role of either genetic factors or biological sex in the development of
      postoperative cognitive dysfunction (POCD) is unknown. There is a critical need to determine
      which individuals are at high-risk for developing POCD by virtue of biological sex or genetic
      predisposition. The knowledge gained in the described research has the potential to shed
      light on mechanistic pathways, a necessary next step in order to ultimately identify
      therapeutic strategies.
    

Detailed description: 
      Adults 65 years and older represent the fastest-growing age group in the United States, and
      account for one third of all surgical patients. These older adults are at the highest risk
      for deleterious postoperative neurocognitive outcomes. Postoperative cognitive dysfunction
      (POCD) occurs in up to 40% of older adults after major non-cardiac surgery. POCD is a
      syndrome characterized by a decrease in performance on neuropsychological test battery from
      before to after surgery. Neuropsychological testing for POCD typically spans cognitive
      domains including memory, attention, concentration, and/or executive function. There is an
      increasing body of literature suggesting that exposure to surgery and anesthesia increases
      the risk of Alzheimer's disease (AD). Surgery and anesthesia enhance neuropathologic changes
      known to underlie AD including amyloid beta accumulation and aggregation, neuroinflammation,
      increased levels of tau and tau phosphorylation, and memory decline. However, not everyone
      with a history of surgery and anesthesia develops POCD, suggesting biological risk factors
      are involved.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects who present to spine clinic
      
Biospecimen description: 
      Blood samples will be obtained for DNA extraction and storage. Genotyping will be done in
      batches.
    
Keywords: Anesthesia, Risk Factors, Age