bioihbjkbjnl/mcl2 huggingface dataset:
Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients Who Have Chronic Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Combining more than one drug may kill more cancer cells.
      Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing
      substances to them without harming normal cells.

      PURPOSE: Phase II trial to study the effectiveness of fludarabine plus high-dose
      cyclophosphamide and rituximab in treating patients who have previously untreated chronic
      lymphocytic leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response rate in patients with chronic lymphocytic leukemia treated with
           sequential fludarabine, high dose cyclophosphamide, and rituximab.

        -  Survival up to 5 years

        -  Utilize flow cytometry and polymerase chain reaction as sensitive measures of minimal
           residual disease in these patients.

      OUTLINE: This is an open label study.

      Patients receive fludarabine IV once daily for 5 days. Treatment is repeated every 4 weeks
      for 3 or 6 courses.

      Three weeks later, cyclophosphamide is administered intravenously every 2-3 weeks for 3
      courses. Filgrastim (G-CSF) is administered on days 2-10. Beginning 4 weeks after the last
      dose of cyclophosphamide, patients receive rituximab by intravenous infusion once weekly for
      4 weeks.

      Patient are followed every 3 months until death.

      PROJECTED ACCRUAL: This study will accrue 30 patients within 3 years.
    

Intervention name(s): filgrastim; rituximab; cyclophosphamide; fludarabine phosphate
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): Filgrastim (300 μg for patients ≤ 70 kg or 480 μg for patients > 70 kg) will be administered beginning two days after each cyclophosphamide dose and given for a total of eight subcutaneous daily doses.; Approximately four weeks after the completion of the last cyclophosphamide dose, patients will receive rituximab 375mg/m2 as an intravenous infusion once weekly for four doses.; Cyclophosphamide 3000mg/m2 will be given intravenously q 2 - 3 weeks x 3 doses.; Fludarabine will be administered intravenously at a dose of 25 mg/m2 per day x 5 days every 4 weeks.
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine; Fludarabine phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia
Levosimendan Administration in Neonates With Transposition of the Great Arteries
Condition: Low Cardiac Output Syndrome
MeSH terms: Cardiac Output, Low; Transposition of Great Vessels
Study type: Interventional
Phase: Phase 2

Summary: 
      Calcium sensitizer drugs such as Levosimendan may exert anti-ischemic effect in addition to
      positive inotropic and anti-stunning effects mediated by the opening of ATP-sensitive
      potassium (KATP) channels. The aim of the study is to test the myocardial protection effect
      of peri-operative iv infusion of Levosimendan in a cohort of neonates affected by
      transposition of the great arteries undergoing surgical correction by arterial switch.
    

Detailed description: 
      Function of the myocardium of neonates with congenital heart disease may be affected by
      several factors in post operative phase: congenital insufficiency, cardiopulmonary bypass low
      perfusion, ischemima during the cross-clamp phase, low cardiac output syndrome, systemic
      inflammation. Furthermore, neonates have immature molecular mechanisms leading to calcium
      utilization inside myocytes. Calcium sensitizer drugs such as Levosimendan may exert
      anti-ischemic effect in addition to positive inotropic and anti-stunning effects mediated by
      the opening of ATP-sensitive potassium (KATP) channels. The aim of the study is to test the
      inodilator and myocardial protection effect of peri-operative iv infusion of 0.1 mcg/kg/min
      Levosimendan (without previuos bolus) in a cohort of neonates affected by transposition of
      the great arteries undergoing surgical correction by arterial switch.
    

Intervention name(s): levosimendan; placebo
Intervention type(s): Drug; Drug
Intervention description(s): patients enrolled in this group will receive a levosimendan continuous infusion at a rate of 0.1 mcg/kg/min; saline continuous infusion
Other intervention name(s): simdax; saline
Intervention MeSH terms: Simendan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: levosimendan; pediatric cardiac surgery; low cardiac output syndrome; transposition of the great arteries
Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through
      the nose) using the OPTINOSE SUMATRIPTAN Device can reduce the pain and symptoms associated
      with migraine headaches.
    

Detailed description: 
      The primary objective for this study is to compare headache relief (defined as a reduction
      from moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0] or mild [Grade 1] pain) at
      120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute
      treatment of a single migraine attack.
    

Intervention name(s): Sumatriptan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sumatriptan 20mg; Matching placebo
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Headache; Sumatriptan
Analgesic Effect of Trigger Point Injection and EMLA for Shoulder Pain in Laparoscopic Hysterectomy
Condition: Myoma of Uterus
Study type: Interventional

Summary: 
      Laparoscopic operative procedures have revolutionized gynecological surgery. These have
      several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter
      postoperative stay, which cuts down on hospital costs. However, postoperative pain continues
      to be one complication, which results in an unpleasant experience for the patient and at
      times causes a delayed discharge. Trigger point injection removes the pain developing point
      and block the pain signal. EMLA cream shows analgesic effect when being spread on the skin.
      An literature showed that patch of local anesthetics showed the effect of trigger point
      inject. The purpose of this study is to investigate the alleviation of shoulder pain,
      headache, abdominal pain, and back pain after trigger point injection or EMLA cream applying
      on shoulder in patients undergoing total laparoscopic hysterectomy.
    


Intervention name(s): TPI; EMLA cream
Intervention type(s): Drug; Drug
Intervention description(s): Trigger point injection with 25G needle on the shoulder before surgery(0.5% procaine, 0.25~0.5% lidocaine, 0.125% bupivacaine); EMLA cream with occluding dressing on the shoulder before surgery(5% of eutectic mixture with 2.5% lidocaine and 2.5% prilocaine)
Other intervention name(s): Trigger Point Injection
Intervention MeSH terms: Lidocaine, Prilocaine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA
Condition: Vulvovaginal Atrophy; Dyspareunia
MeSH terms: Dyspareunia; Atrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an unblinded study to be conducted at a single research center, San Diego Sexual
      Medicine. Subjects meeting inclusion and exclusion criteria will receive 60 mg ospemifene
      daily for twenty weeks. After the informed consent is signed, a baseline physical
      examination, and vulvoscopy with detailed photography of the vulva, vestibule and vagina,
      will be performed. Physical examination and vulvoscopy with detailed photography of the
      vulva, vestibule and vagina, will be repeated prospectively every 4 weeks for a total of 20
      weeks. Therefore, physical examination and vulvoscopy with detailed photography of the vulva,
      vestibule and vagina will be performed prospectively at baseline (vulvoscopy session 1), 4
      weeks (vulvoscopy session 2), 8 weeks (vulvoscopy session 3), 12, weeks (vulvoscopy session
      4), 16 weeks (vulvoscopy session 5) and 20 weeks (vulvoscopy session 6) following daily
      administration of 60 mg ospemifene.
    

Detailed description: 
      Ospemifene is indicated for post-menopausal women diagnosed with vulvar vaginal atrophy (VVA)
      and dyspareunia. While ospemifene clinically significantly reduces pain associated with
      dyspareunia, there has been little prospective documentation using vulvoscopy with detailed
      photography of the visible changes to the vulva, vestibule and vaginal region with daily
      administration of 60 mg ospemifene in post-menopausal women with VVA and dyspareunia. This
      study will include a total of 6 prospective photographic sessions of the vulva, vestibule and
      vagina over the 20 weeks administration of 60 mg ospemifene in the study. Comparisons will be
      made of baseline photography (vulvoscopy session 0) with photography at 4 weeks (vulvoscopy
      session 1), 8 weeks (vulvoscopy session 2), 12 weeks (vulvoscopy session 3), 16 weeks
      (vulvoscopy session 4) and 20 weeks (vulvoscopy session 5).

      Currently there have been limited prospective studies using vulvoscopy with detailed
      photography demonstrating visible changes to the vulva, vestibule and vagina following oral
      administration of 60 mg ospemifene in post-menopausal women with VVA and dyspareunia.
      Information regarding visible changes to the vulva, vestibule and vagina may be very
      important to the patient and to the health care provider to best understand the beneficial
      effects of ospemifene and to ensure patient compliance with treatment.
    

Intervention name(s): Ospemifene
Intervention type(s): Drug
Intervention description(s): FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia
Other intervention name(s): Osphena
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neural and Physiological Responses to Real-World Experiences
Condition: Gene Expression
Study type: Interventional

Summary: 
      UCLA researchers looking for healthy individuals (aged 35-50) who have a home computer with
      internet access, are not pregnant, planning to become pregnant, or currently breastfeeding
      (if female), to participate in a study investigating whether real-world experiences alter the
      brain and body. This study takes place over an eight week period and involves providing the
      names of 8 close friends or family members, completing a neuroimaging session, providing
      blood and saliva (for genetic analysis), and a 6-week period in which participants login
      twice a week to complete online questionnaires. Compensation is up to $210 for those who
      complete all aspects of the study. Please email realworld.ucla@gmail.com for more
      information.
    


Intervention name(s): Writing about people; Writing about places, objects
Intervention type(s): Behavioral; Other
Intervention description(s): Subjects will be asked to write about other people in their lives once a week for 6-weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level
Condition: Healthy
Study type: Interventional

Summary: 
      The postprandial increase in MDA level following meat meal could cause modification to LDL
      particles in healthy volunteers. Co-consumption of food drived polyphenols with the meat will
      result in a significant decrease in LDL modification.
    


Intervention name(s): frozen meat cutlets meal; meat meals
Intervention type(s): Other; Other
Intervention description(s): 250 g of meat cutlets; 250 g of meat meal for 4 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: meat; LDL; MDA
Short Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure
Condition: Cesarean Section Complications
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology
      Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S
      (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in
      subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies,
      ...) are very important issues. Classically Kerr incision is repaired with continuous locked
      suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in
      turn may reduce short and long term complications. For this reason, the investigators aimed
      to compare two closure techniques.
    

Detailed description: 
      In the clinic, patients undergoing cesarean section that meet the criteria for inclusion into
      the study and agreed to participate in the study will be randomized into two groups
      (computer-assisted randomization method will be used.) In the first group of patients
      classical closure method of Kerr incision (double layered continuously locked suturing) will
      be used. In the second group of patients double layered purse string closure technique will
      be used. The two groups will be compared after 6 weeks in terms of healing, operation time,
      blood loss, incision size and incisional scar defect( if present). A physician who does not
      know the method of closure will evaluate incision size by transabdominal and/or transvaginal
      ultrasound. The length of the incision and myometrial thickness in Kerr incisional line will
      be measured and recorded in longitudinal and transverse axis separately. If any incisional
      scar defect is determined it will be measured and recorded also.
    

Intervention name(s): Purse string closure technique; Continuously locked closure technique
Intervention type(s): Procedure; Procedure
Intervention description(s): Uterine Kerr incision will be closed with purse string suture; Uterine Kerr incision will be closed with continuously locked suturing
Other intervention name(s): Uterine incision in C/S; Uterine incision in C/S
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cesarean section; Kerr incision; Purse string suturing in C/S; Continuous locked suturing in C/S
Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism Spectrum Disorders (ASD)
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      We are studying an investigational drug called intranasal oxytocin (Syntocinon®). Syntocinon®
      has been approved by the U.S. Food and Drug Administration for use in helping women
      breastfeed, but it has not been approved for use in children with ASD. However, there is
      previous research conducted that has indicated that after administration of oxytocin, adults
      with ASD demonstrated improvements in social cognition, and reduced repetitive behaviours and
      anxiety. There is also early research to suggest that children may also benefit in these
      areas. The purpose of this study is to test if oxytocin works to help children and
      adolescents with ASD.
    

Detailed description: 
      Extensive data has been accumulated to suggest that central release of oxytocin is important
      for social cognition and function, as well as likely involved in anxiety modulation and
      repetitive behaviors. The Principal Investigator and Co-Principal Investigator of this study
      have previously documented: 1) an association between ASD and a single nuclear polymorphism
      of the oxytocin receptor gene, 2) ability to measure oxytocin levels in the blood by enzyme
      immunoassay and 3) preliminary data to support safety and efficacy of intranasal oxytocin in
      the treatment of social deficits and repetitive behaviors in adults with autism. A medication
      treatment targeting the core deficits of ASD in childhood is highly valuable because it could
      influence the developmental trajectory and make further psychosocial interventions possible.
      In this context, we propose a randomized placebo controlled trial of intranasal oxytocin in
      children and adolescents with ASD.
    

Intervention name(s): Intranasal Oxytocin; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Social; Functioning; Cognition; Repetitive Behaviors; Anxiety; Quality of Life
Mitochondria and Chronic Kidney Disease
Condition: Hemodialysis-Induced Symptom; Mitochondrial Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Mitochondrial Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The overarching goal of this study is to determine the role of chronic kidney disease and the
      activation of the kallikrein-kinin system during hemodialysis on the development of
      mitochondrial dysfunction; the investigators will measure mitochondrial function using the
      gold standard method, 31-phosphorus magnetic resonance spectroscopy.

      The investigators will test the hypothesis that endogenous bradykinin promotes mitochondrial
      dysfunction in patients undergoing hemodialysis. The investigators will first perform a
      randomized, placebo-controlled, double-blind, cross-over study measuring the effect of
      Icatibant (HOE-140), a bradykinin B2 receptor blocker, on mitochondrial function.
    


Intervention name(s): Icatibant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive either Icatibant or placebo in the first study day. After a washout period of 3 weeks, participant will receive the other treatment. Icatibant (50µg/kg/h) or placebo will be infused for 1 hour prior to the initiation of dialysis and continue through hemodialysis. Hemodialysis session will last approximately 4 hours. Two hours after the end of hemodialysis, The investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy.; Subjects will receive either Icatibant or placebo in the first study day. After a washout period of 3 weeks, participant will receive the other treatment. Icatibant (50µg/kg/h) or placebo will be infused for 1 hour prior to the initiation of dialysis and continue through hemodialysis. Hemodialysis session will last approximately 4 hours. Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy.
Other intervention name(s): HOE-140; placebo infusion
Intervention MeSH terms: Icatibant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate the safety and immunogenicity of a recombinant
      hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at
      4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA
      formulations.
    

Detailed description: 
      All currently licensed influenza vaccines in the United States are produced in embryonated
      hen's eggs. There are several well-recognized disadvantages to the use of eggs as the
      substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could
      be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is
      usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process
      that can be time consuming, is not always successful, and can select receptor variants that
      may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken
      flocks, and that might be an important issue in a pandemic due to an avian influenza virus
      strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore,
      development of alternative substrates for influenza vaccine production has been identified as
      a high-priority objective.

      One potential alternative method for production of influenza vaccine is expression of the
      influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids
      dependence on eggs and is very efficient because of the high levels of protein expression
      under the control of the baculovirus polyhedrin promoter.
    

Intervention name(s): 0.5mL Intramuscular Injection
Intervention type(s): Biological
Intervention description(s): 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Other intervention name(s): rHA; recombinant hemagglutinin; PanBlok
Intervention MeSH terms: Hemagglutinins
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza