bioihbjkbjnl/mcl2 huggingface dataset:
Immunochemotherapy, Zevalin, and Bone Marrow Transplant for Follicular Lymphoma
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Study type: Interventional
Phase: Phase 2

Summary: 
      Follicular lymphoma has historically been considered an incurable lymphoma. By combining
      multiple effective treatments, the investigators believe that prolonged disease-free survival
      is achievable in this disease. The investigators goal is to have at least 60-70% of our
      patients in first continuous complete remission 15 years from initiation of treatment.
    

Detailed description: 
      Patients will receive six cycles of combination chemotherapy, C-MOPP-R, typically through a
      subcutaneous PORT. This combination chemotherapy will last six months. After the last dose of
      chemotherapy, patients will have a 2 month treatment holiday prior to undergoing stem cell
      mobilization from peripheral blood with subcutaneous injections of neupogen and mozobil.
      Patients then receive Zevalin radioimmunotherapy, and this is followed after recovery of
      blood counts, typically 3 months later, by an autologous stem cell transplant.
    

Intervention name(s): Combination of treatment modalities
Intervention type(s): Other
Intervention description(s): Intravenous cyclophosphamide, rituximab, and vincristine day 1 and 8 of 28 day cycles for 6 cycles total.
Oral prednisone and procarbazine day 1-14 of every 28 day cycle. Yttrium ibritumomab tiuxetan intravenous injection. Autologous stem cell transplant with intravenous BEAM (BCNU or carmustine, etoposide, ara-C or cytarabine, melphalan) chemotherapy conditioning.
Other intervention name(s): Cytoxan; Rituxan; Oncovin; Matulane; Zevalin
Intervention MeSH terms: Procarbazine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: follicular lymphoma; radioimmunotherapy; rituximab; C-MOPP-R; autologous transplant
HIV-1 Infected Adult Subjects With HIV-associated Neurocognitive Disorders Despite Effective Antiretroviral Therapy
Condition: HIV-1-infection; HIV Associated Neurocognitive Disorder
MeSH terms: Neurocognitive Disorders
Study type: Interventional

Summary: 
      Prospective study in HIV-1 infected adult subjects with HIV-associated neurocognitive
      disorders despite effective antiretroviral therapy in plasma for more than one year,
      analyzing the evolution of cognitive disorders and markers of macrophagic inflammation in
      blood and cerebrospinal fluid, after a change in HIV treatment with an increased of the new
      scale CHARTER score ≥ 3 (total treatment score to be ≥ 9)
    

Detailed description: 
      Neurocognitive disorders are measured using Frascati 3-stage classification and Global
      Deficit Score, after the following 10 standardized battery test: Grooved Pegboard for
      dominant and non-dominant hand, Grefex Verbal Fluency, California Verbal Learning Test
      (CVLT), Digit Span Wechsler Adult Intelligence Scale III, modified Paced Auditory Serial
      Addition Test (60 items), WAIS III Digit Symbol Test, Trail Making Test A&B, recall of CVLT
      and Wisconsin Card Sorting Test; and after the Beck Depression Inventory II (BDI), Inventory
      of Activity Daily Living part II (IADL) and 10-items Cognitive Complaint Questionnaire (CCQ).
      The global CNS Penetration Effectiveness (CPE) score of ARV treatment are the sum of the
      scores of each ARV the patient received, according to the last published scoring. For each
      drug class, we considered treatment intensification only for drugs with CPE score reaching at
      least 3 (no intensification if switch in same drug class with same CPE score). CPE score was
      corrected by drugs resistance status, using cumulative genotype interpreted with the 2012
      ANRS algorithm (www.hivfrenchresistance.org; v.2012) at inclusion (CPE=0 if resistance).
    

Intervention name(s): Validation of Charter score for the CNS diffusion of antiretroviral drugs
Intervention type(s): Other
Intervention description(s): IHFB001 (Neuroplustrois) is a pilot study, phase IV, open-label, multicenter in Ile-de-France region, trying to demonstrate the improvement of cognitive change after treatment characterized by its better diffusion in the central nervous system. The characteristics of the change in treatment are (Cn - Ci) ≥ 3 and Cn ≥ 9, where Cn is the Charter score of the new treatment and Ci the Charter score of the initial treatment.
Intervention MeSH terms: Anti-Retroviral Agents
Intervention model: Single Group Assignment
Intervention model description: Prospective Pilot study, open-label, multicenter in the Ile-de-France
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CNS Penetration Effectiveness; Global Deficit Score; Cytokines; CSF Inflammation
Effects of Regular Brisk Walking in Chronic Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Chronic stroke patients (>6 months) fulfilling including criteria were trained during 3
      months. The physical training program was based on walking.
    

Detailed description: 
      Participants had been evaluated 4 times during a long follow-up period of 7 months. Activity
      limitations were assessed at baseline (enrollment time point), 1 month, 4 months and 7 months
      later.
    

Intervention name(s): physical training
Intervention type(s): Behavioral
Intervention description(s): walking many times a week
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Activity limitations; restriction of participation; chronic stroke survival; physical activity; walking
Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients
Condition: Renal Dialysis
MeSH terms: Tetanus
Study type: Interventional
Phase: Phase 2

Summary: 
      Levamisole as an immunomodulator drug has been demonstrated to improve the immune response to
      Hepatitis B virus (HBV) vaccination in hemodialysis patients. The aim of this study was to
      evaluate the effect of levamisole supplementation on tetanus-diphtheria (Td) vaccine response
      rate in hemodialysis patients.
    

Detailed description: 
      Levamisole as an immunomodulator drug has been demonstrated to improve the immune response to
      HBV vaccination in hemodialysis patients. The aim of this study was to evaluate the effect of
      levamisole supplementation on Td vaccine response rate in hemodialysis patients. In this
      randomized double-blind placebo-controlled trial 40 hemodialysis patients who had not
      received tetanus vaccination in a year before investigation and had unprotective anti-tetanus
      immunoglobulin G (IgG) levels (<0.1 International Unit [IU]/ml) were enrolled. These patients
      were randomized into two equal groups to receive one dose of intramuscular Td vaccine
      supplemented with either levamisole 100 mg or placebo daily, six days before and six days
      after vaccination. The anti-tetanus IgG levels were measured 1 and 6 months after
      vaccination.
    

Intervention name(s): Levamisole; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Levamisole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tetanus; Vaccines; Renal Dialysis; Levamisole
Efficacy of Rituximab For the Treatment of Calcineurin Inhibitors Dependent Nephrotic Syndrome During Childhood
Condition: Childhood Idiopathic Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Nephrosis, Lipoid; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Background

      Idiopathic nephrotic syndrome is a rare disease beginning during childhood and treated with
      immunosuppressants (i.e. steroids, mycophenolate mofetil, cyclophosphamide, cyclosporine).

      Renal function of patients suffering from severe, steroid-dependent nephrotic syndrome with
      failure or toxic side effects of other immunosuppressant treatments is a major matter of
      concern.

      Cyclosporine endangers renal parenchyma (fibrosis) in these patients who must take this
      treatment for years. At the same time, low doses of cyclosporine allow proteinuria to
      reappear, which provokes degradation of renal function by focal segmental glomerulosclerosis.
      Some recent data lead to the conclusion that Rituximab may be effective in such a disease,
      with a cyclosporin sparing effect.

      Purpose

      The aim of the study is to evaluate the efficacy of Rituximab versus placebo in the treatment
      of pediatric patients suffering from severe cyclosporine-dependent nephrotic syndrome.

      Abstract Patients will be included in the study in a period of remission of proteinuria. Two
      infusions of Rituximab - at the dose of 375 mg/m²- or placebo will be administered at one
      week of interval. Other immunosuppressant treatments will be gradually tapered off with the
      same tapering pattern in both groups. In case of relapse of nephrotic syndrome, the blinding
      code will be broken. Rituximab will then be infused to patients having received placebo.
    

Detailed description: 
      After infusions of Rituximab or placebo, patients will be examined by their nephrologist on a
      monthly basis during five months. Follow up will be focused on proteinuria, albuminemia,
      lymphocyte phenotyping and Rituximab pharmacokinetics
    

Intervention name(s): Rituximab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): two infusions - at the dose of 375 mg/m²- will be administered at one week of interval; two infusions - at the dose of 375 mg/m² - will be administrered at one week of interval
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: rituximab; idiopathic nephrotic syndrome; minimal change disease; focal and segmental glomerulosclerosis
VivaSight Left-sided Double Lumen Tube Study
Condition: Intubation, Intratracheal
Study type: Interventional

Summary: 
      The VivaSight™-DLT is a new OLV (one lung ventilation) device that contains an embedded
      camera. Therefore, a potential advantage is the continuous assessment of DLT position through
      continuous monitoring of the camera. The embedded camera of VivaSight™-DLT is positioned at
      the tracheal opening of the double lumen tube. It allows for continuous monitoring of the
      carina and bronchial tube placement.

      The purpose of this study is to determine if a double lumen tube (DLT) with an embedded video
      camera, the VivaSight DLT, can be used in similar fashion to the standard double lumen tube
      with fiberoptic bronchoscopy. More specifically, the investigators would like to know the
      difference in time to optimal position in the left bronchus between the VivaSight DLT and the
      standard DLT with fiberoptic bronchoscopy. In addition, the investigators would like to know
      if the embedded camera on the VivaSight DLT provides a view that will allow for the optimum
      position of the DLT in the left bronchus.
    

Detailed description: 
      The investigators will perform a prospective, randomized study in thoracic surgical patients
      undergoing one-lung ventilation where the patient will receive either the VivaSight DLT or
      standard left-sided DLT. Subjects will be selected and evaluated who are at least 18 years
      old, but no older than 90 years old.

      The investigators will compare the intubation time for the VivaSight™-DLT with the intubation
      time for standard DLT. The intubation time parameters for the VivaSight™-DLT are the passage
      of the tube through the vocal cords and the confirmation of proper tube positioning by the
      embedded camera. Fiberoptic bronchoscopy is performed to reassess the proper tube
      positioning, however, this will not be counted for the intubation time in this group. For the
      standard DLT, the intubation time parameter begins similarly, on the passage of the tube
      through the vocal cords, but ends with the confirmation of the proper placement by fiberoptic
      bronchoscopy. In both groups, C-MAC blade is used to visualize the passage of the tube
      through the vocal cords. These intubation times will be tracked real-time in the operating
      room and will be based upon both observation as well as the verbal confirmation of the
      attending anesthesiologist.

      The intubation time must be within 5 minutes. The intubation time required more than 5
      minutes is considered as unsuccessful intubation.
    

Intervention name(s): intubation with VivaSight double-lumen tube; intubation with standard double-lumen tube; fiberoptic bronchoscopy
Intervention type(s): Device; Device; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: double-lumen endotracheal tube; VivaSight double-lumen tube
Changes and Associations Between Cervical Range of Motion, Pain, TMJ Range of Motion and Quality of Life in Migraineurs Applying Physical Therapy
Condition: Migraine; Temporomandibular Joint Disorders; Myofascial Trigger Point Pain
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of physiotherapy program and review the
      associations between neck movements, pain, temporomandibular joint (TMJ) movements and
      quality of life in individuals with migraine.
    

Detailed description: 
      Migraine is one of the most common type of headaches in the world causing the greatest
      disability in individuals under 50 years of age. Many different health organizations
      (American Headache Society etc.) recommend regular physical activity and exercise for the
      treatment and prevention of migraine. However, the relationship between aerobic exercise and
      migraine is still not completely clear. Unfortunately, a research database to validate the
      benefits of exercise for people with migraine is still being developed.

      The aim of this study is to assess the effects of physiotherapy program and review the
      associations between neck movements, pain, temporomandibular movements and quality of life in
      individuals with migraine.

      The study was approved by Committee on Biomedical Research Ethics of Kaunas Region
      (2020-06-30 No.BEC-SR(M)-266).
    

Intervention name(s): Aerobic exercise and exercise for TMJ; Aerobic exercise at home
Intervention type(s): Other; Other
Intervention description(s): Aerobic exercise; Aerobic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Role of the Gut Sweet Taste Receptor in the Secretion of Satiation Peptides
Condition: Taste Disorder, Secondary, Sweet
MeSH terms: Taste Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the functional significance of sweet taste
      receptors in the secretion of gastrointestinal (GI) satiation peptides by using a specific
      sweet taste receptor antagonist to block sweet taste perception in the gastrointestinal
      tract.
    

Detailed description: 
      There is strong evidence that taste signaling mechanisms identified in the oral epithelium
      also operate in the gut. It is suggested that open-type enteroendocrine cells directly sense
      nutrient via alpha-gustducin coupled taste receptors to modulate the secretion of glucagon
      like peptide-1 (GLP-1) and peptide YY (PYY). Several nutrient responsive G-protein coupled
      receptors have been identified in the human gut, including the sweet taste responsive
      T1R2/T1R3 heterodimer, the amino acid/umami responsive T1R1/T1R3 as well as GPR120 for
      unsaturated long-chain free fatty acids. The functional significance of sweet taste receptors
      in mixed liquid meal-stimulated secretion of GLP-1 and PYY will be determined by intragastric
      infusion of a 500 mL mixed liquid meal with or without lactisole (450 ppm)in a double blind,
      2-way crossover trial including 16 healthy subjects.
    

Intervention name(s): lactisole
Intervention type(s): Dietary Supplement
Intervention description(s): Lactisole-liquid meal: Lactisole (450 ppm) will be mixed with a liquid meal. Liquid meal only: The comparator will be the liquid meal alone.
Other intervention name(s): Dietary supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: T1R2/T1R3; gastric emptying; gut; lactisole; nutrient sensing
A Study to Evaluate the Safety of a Monovalent Vaccine in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety of a vaccine in healthy adults prior to the release of the vaccine
      (FluMist®) containing it.
    

Detailed description: 
      The objective is to assess the safety of a monovalent vaccine of a new 6:2 influenza virus
      reassortant in healthy adults prior to the release of the trivalent vaccine (FluMist®)
      containing it.
    

Intervention name(s): Frozen FluMist®; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Monovalent vaccine is supplied in intranasal sprayers containing 0.5 mL.
Other intervention name(s): Placebo is supplied in intranasal sprayers containing 0.5 mL
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
Condition: Back Pain Without Radiation; Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose: This is a randomized clinical trial comparing the effects of three different
      medications for acute low back pain (LBP):Ketorolac, Ibuprofen, Diclofenac

      Hypothesis: A daily regimen of ketorolac will provide greater relief of LBP than ibuprofen or
      diclofenac 5 days after an emergency department (ED) visit, as measured by the Roland Morris
      Disability Questionnaire (RMQ)
    

Detailed description: 
      More than 2.5 million patients present to US emergency departments (ED) annually with low
      back pain. Up to half of ED patients with acute, new onset low back pain (LBP) report
      persistent moderate or severe pain one week after the ED visit. Non-steroidal
      anti-inflammatory drugs (NSAIDs) are an effective treatment of acute LBP, though their impact
      is only modest.Given the poor pain and functional outcomes that persist beyond an ED visit
      for acute LBP, this clinical trial proposes to determine whether there is a difference in
      efficacy between the NSAIDs ketorolac, ibuprofen, and diclofenac and for the treatment of
      acute, non-traumatic, non-radicular low back pain.
    

Intervention name(s): Ketorolac; Ibuprofen; Diclofenac; Educational Intervention
Intervention type(s): Drug; Drug; Drug; Behavioral
Intervention description(s): Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed; Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed; Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed; Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information
Intervention MeSH terms: Ibuprofen; Diclofenac; Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ketorolac; diclofenac; ibuprofen; low back pain; back pain
Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      Itopride is a compound already marketed in Japan and in some countries of Eastern Europe
      under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients
      suffering from this condition have difficulties digesting food. Patients feel full after
      eating, they have bloating and have stomach pain. The goal of this study is to see if
      Itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.
    

Detailed description: 
      All patients having completed study ITOFD04-01 will be offered to continue to be treated with
      itopride for a period of up to one year in duration. A target of 300 patients will be
      followed up for 6 months. Of these, a target of 100 patients will be kept on treatment for an
      additional 6 months.

      Patients will need to come to the clinic for evaluations every 8 weeks during the trial.
      Evaluations done at these visits will include: lab tests, evaluation of the heartburn
      condition, and a questionnaire needed to be completed by the patient to see if the drug is
      helpful in relieving their symptoms.
    

Intervention name(s): Itopride hydrochloride
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Abdominal Symptom relief; Fullness; Bloating; Indigestion; Functional dyspepsia