bioihbjkbjnl/mcl2 huggingface dataset:
Cytarabine and Clofarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different
      ways to stop the growth of cancer cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when
      given together with cytarabine and to see how well they work in treating patients with
      refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response rate in adult patients with relapsed or refractory acute myeloid
           leukemia or acute lymphoblastic leukemia treated with high-dose cytarabine followed by
           clofarabine.

        -  Document the safety profile and tolerability of this regimen in these patients.

        -  Phase I: Patients receive high-dose cytarabine IV over 3 hours followed by clofarabine
           IV over 2 hours on days 1-5. Treatment repeats for up to 4 courses (1-2 induction
           courses, 2-3 post-remission courses) in the absence of disease progression or
           unacceptable toxicity.

      A cohort of 3-6 patients receives the starting dose of clofarabine. If 1 of 6 patients
      experiences dose-limiting toxicity (DLT), a subsequent cohort of patients receives
      clofarabine at the next higher dose. If ≥ 2 of 6 patients experience DLT, the dose of
      cytarabine is reduced and subsequent cohorts of patients receive cytarabine at reduced doses
      and clofarabine as per the dose-escalation scheme above.

      PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.
    

Intervention name(s): clofarabine; cytarabine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cytarabine; Clofarabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult acute lymphoblastic leukemia; recurrent adult acute myeloid leukemia; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute basophilic leukemia; adult acute eosinophilic leukemia; adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); adult acute megakaryoblastic leukemia (M7); adult acute minimally differentiated myeloid leukemia (M0); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult acute myeloblastic leukemia with maturation (M2); adult acute myeloblastic leukemia without maturation (M1); adult acute myelomonocytic leukemia (M4)
Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of
      icatibant administered to adult Japanese subjects.
    

Detailed description: 
      Icatibant has been studied for the treatment of acute attacks of hereditary angioedema (HAE),
      an autosomal dominant disorder characterized by recurrent and self-limiting episodes of edema
      of the skin, larynx, and gastrointestinal tract. The most serious manifestation of an HAE
      attack is laryngeal edema, causing obstruction of the upper airways that may lead to death by
      asphyxiation if undiagnosed and/or untreated.

      Icatibant has been approved in over 40 countries around the world including the United States
      (US) and Europe for the treatment of acute attacks of hereditary angioedema (HAE) in adults.
      This study is being conducted to evaluate the safety and tolerability of icatibant in a
      Japanese population and to evaluate whether race/ethnicity impacts the pharmacokinetics of
      icatibant after single subcutaneous injection.

      This is an open-label, single-arm study that will enroll at least 12 Japanese subjects (in
      order to have 12 subjects complete the study), age 18-55 years inclusive. All subjects will
      receive a single subcutaneous injection of 30mg icatibant. The study will be conducted at 1
      site in the US. The study will consist of a Screening Period, a Treatment Period, and a
      Follow-Up Period.
    

Intervention name(s): Icatibant (30 mg)
Intervention type(s): Drug
Intervention description(s): On Day 1, subjects will receive a single 30mg subcutaneous injection of icatibant in their abdominal area. Subjects will be discharged from the study on Day 3 after collection of study related assessments
Other intervention name(s): Firazyr
Intervention MeSH terms: Icatibant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Firazyr; Angioedema; Angioedemas, Hereditary; Vascular Diseases; Cardiovascular Diseases; Urticaria; Skin Diseases, Vascular; Skin Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Genetic Diseases, Inborn; Icatibant; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Agents
Burning Mouth Syndrome Mouth Guard Prospective Study
Condition: Burning Mouth Syndrome; Burning Mouth
MeSH terms: Burning Mouth Syndrome; Syndrome; Burns
Study type: Interventional

Summary: 
      This study will seek to test the effectiveness of a nonpharmacologic therapy for burning
      mouth syndrome (BMS). This nonpharmacologic therapy approach will be the fabrication a
      protective acrylic mouthguard for the maxillary arch and palate.
    

Detailed description: 
      The study involves a nonpharmacologic and non-invasive treatment method for BMS which will be
      administered randomly (flipping a coin) to half of the study subjects, (case group) in
      addition to normal condition treatment protocol for BMS.
    

Intervention name(s): Mouthguard
Intervention type(s): Device
Intervention description(s): The mouthguard is a thin clear acrylic protector fabricated from an impression of a patient's upper teeth and palate. The acrylic protector will be trimmed and will fit onto the patient's upper teeth and palate for use during the day, except when eating to minimize trauma to the tongue that exacerbates burning tongue pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact Of Sensory Re-Education Paradigm On Sensation And Quality Of Life In Patients Post-Covid 19 Polyneuropathy
Condition: Post-COVID-19 Syndrome
MeSH terms: COVID-19; Polyneuropathies
Study type: Interventional

Summary: 
      This study will be conducted to investigate the effect of a sensory re-education paradigm on
      sensation and proprioception in patients with post covid-19 neuropathy.
    

Detailed description: 
      The Coronavirus disease has profoundly impacted the world, altering the functioning of the
      population and health system. it is so far affected more than 532 million cases and 6.3
      million confirmed deaths (WHO., 2020). Recent studies documented that COVID-19-associated
      peripheral neuropathy is a common and frequent problem, with neuro-muscular complications.
      This phenomenon is widespread in those with comorbidities, such as diabetes mellitus, which
      may result from immune processes or as side effects of some medications used to manage
      COVID-19 symptoms, such as hydroxychloroquine, clindamycin, and steroids. To a lesser extent,
      prolonged hospitalization may cause entrapment neuropathy (peripheral nerve compression).
      Most physiotherapists focus on motor improvements rather than sensibility improvements though
      the sensory system may have the upper hand in improving motor function. Therefore; the
      sensory re-education paradigm should be assessed in randomized trials with a blinded
      assessment of functional outcomes to evaluate its effectiveness in patients with post
      covid-19 neuropathic patients. Currently, there is not enough research addressing the impact
      of the sensory re-education paradigm on sensation and quality of life in neuropathic patients
      post-covid19. forty patients will be assigned randomly into two equal groups; the study group
      will receive sensory re-education paradigm and traditional treatment while the control group
      will receive traditional treatment only.
    

Intervention name(s): sensory re-education training; traditional treatment
Intervention type(s): Other; Other
Intervention description(s): the patients will receive sensory re-education training in the form of texture discrimination training, limb position sense and tactile object recognition; the Patients in this group will receive traditional treatment in the form of proprioception neuromuscular facilitation (PNF) and graduated active and resisted wrist and hand muscle strengthening exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: sensory re-education and traditional therapy
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: post-covid 19 polyneuropathy; sensory re-education paradigm; sensation; quality of life
Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women
Condition: Cancer Cervix
Study type: Interventional

Summary: 
      Despite the existence of an effective screening test (pap smear), cervical cancer is, every
      year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in
      10 women are not screened or not often enough (nearly 7 millions women). It is therefore
      necessary to develop new strategies to reach these women. The etiological factor of this
      cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV).
      Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with
      HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal
      self-sampling with HPV test is a powerful means to increase the participation rate in
      cervical cancer screening.
    


Intervention name(s): Group 1 remove self sample kit at gp consulting room or perform pap smear; Group 2 perform self sample at home or pap smear
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Selected general practitioners are briefly informed about the study and they receive a package of kits for vaginal self-sampling.
Selected women receive a mail inviting them either to remove a kit for vaginal self-sampling at their general practitioner's consulting room or to perform a pap smear. When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.; Selected general practitioners are briefly informed about the study. Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear.
When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Cervical cancer screening; High Risk Human papillomavirus Infection; vaginal self-sampling; pap smear; general practitioner
Effects of Acupressure and Foot Massage on Pain During Heel Lancing in Neonates
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      Aim: The study was aimed to identifying the effects of foot massage and acupressure on pain
      during heel lancing in neonates.

      Methods: A single-blinded randomized controlled trial was performed in a university hospital
      in Turkey between April-December 2018. Neonates were randomized into three groups as
      acupressure, massage and control groups. Data were obtained by using Information form,
      Neonatal Infant Pain Scale (NIPS), pulse oximeter device and chronometer. Acupressure was
      applied to the neonates in the acupressure group and massage was given to the neonates in the
      massage group for 2 minutes before heel lancing procedure. Pain levels of the neonates in the
      groups were evaluated during and 1 minute after heel lancing procedure. Furthermore, the
      oxygen saturation and heart rate values of the neonates in the groups were measured by pulse
      oximeter device before, during and after heel lancing procedure. Duration of crying and heel
      lancing procedure were recorded by chronometer.
    

Detailed description: 
      Massage is a systematic and scientific procedure applied by using hands or special tools. As
      for acupressure, it is a method applied by stimulating the acupuncture points using hands and
      fingers by applying pressure on the meridians in body.Both methods are reliable, economic and
      easy to learn and apply. Review of the related literature indicates studies on the
      effectiveness of acupressure and foot massage on reducing pain in neonates.
    

Intervention name(s): nonpharmalogocial methods
Intervention type(s): Other
Intervention description(s): neonates received acupressure (acupressure group) or massage (massage group) before heel lancing procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: randomized controlled trial
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: acupressure; massage; pain; neonate; heel lancing
Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders
Condition: Sleep Disorders; Autism Spectrum Disorder
MeSH terms: Sleep Wake Disorders; Parasomnias; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to verify the efficacy of NPC-15 (melatonin 1 mg/d or 4 mg/d)
      versus placebo to sleep latency with electronic sleep diaries.
    

Detailed description: 
      This study will be a multicenter, double-blind, randomized, placebo-controlled parallel group
      trial. The trial has five phases; the pre-screening phase, the screening phase,
      double-blinded treatment phase, open label treatment phase and post-treatment phase. The
      screening phase comprises a screening visit where subject's initial eligibility will be
      evaluated. During double-blinded treatment phase, patients who meet all entry criteria for
      the trial will be randomized into three groups, and they will be assigned NPC-15 1 mg, 4 mg
      or placebo before going to bed for 2 weeks. During open label treatment phase, all patients
      will be administered NPC-15 1 mg, 2 mg or 4 mg on the basis of their doctors' judgements.
    

Intervention name(s): NPC-15 Granules Lower Dose; NPC-15 Granules Higher Dose; NPC-15 Placebo Granule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NPC-15 granule which contains 1mg melatonin; Melatonin granule which contains 4 mg melatonin; Melatonin placebo granule which does not contains melatonin.
Other intervention name(s): Melatonin 1mg; Melatonin 4mg; Placebo
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Melatonin; NPC-15; Sleep disorders; Autism spectrum disorders; DSM-5
A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate safety and immunogenicity of 2 different HIV-1 peptide candidate vaccines, the
      UBI HIV-1 MN PND peptide immunogen and the UBI microparticulate monovalent HIV-1 MN branched
      peptide when administered sequentially by 2 different routes of immunization, parental
      priming followed by oral boosting.
    

Detailed description: 
      After the prescreening, volunteers will be randomized into Group I or Group II. Each group
      will contain 16 volunteers. At least 5 volunteers in each group must be women. At month 0 all
      volunteers will receive multivalent HIV-1 peptide immunogen or the placebo. Group I will
      receive the injection in the deltoid and Group II will receive it in the anterior thigh. At
      months 1, 2 and 8 all patients will receive microparticulate monovalent HIV-1 peptide or the
      placebo. Follow up will be conducted.
    

Intervention name(s): HIV-1 Peptide Vaccine, Microparticulate Monovalent; HIV-1 Peptide Immunogen, Multivalent
Intervention type(s): Biological; Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; HIV-1; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
A Phase 1, Bio-equivalence Study of TAK-536 Pediatric Formulation
Condition: Japanese Healthy Adult Male Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bio-equivalence of a single oral administration
      of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial
      formulation (tablet) in Japanese healthy adult male participants in an open label, 2-period,
      2-treatment, cross-over design.
    

Detailed description: 
      The purpose of this study is to evaluate the bio-equivalence of a single oral administration
      of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial
      formulation (tablet) in healthy adult male participants in an open label, 2-period,
      2-treatment, cross-over design.
    

Intervention name(s): TAK-536; TAK-536
Intervention type(s): Drug; Drug
Intervention description(s): TAK-536 granules.; TAK-536 tablet.
Intervention MeSH terms: Azilsartan medoxomil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
Effect of Anesthesia on Insulin Secretion in Patients With Preoperative Decreased Insulin Sensitivity
Condition: Colorectal Surgery
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Epidural anesthesia has been found to manipulate the hyperglycemic response to surgery. It is
      unclear, however, whether the preoperative metabolic status of the surgical patient plays a
      role in the degree of this hyperglycemic response. For instance, the presence of low insulin
      sensitivity before surgery could predispose the individual to an altered metabolic response
      after surgery. In this case, it would be appropriate to identify adequate interventions that
      attenuate the response to surgical stress and facilitate the recovery process.

      The aims of this research projects are the following:

        1. To determine the extent in which epidural local anesthetics, initiated before surgery
           and continued after surgery, improves insulin secretion in patients with preoperative
           low insulin sensitivity.

        2. To understand which measures of postoperative recovery are sensitive to the restoration
           of insulin secretion in this particular group of patients
    


Intervention name(s): Anesthesia
Intervention type(s): Procedure
Intervention description(s): Patients will be randomized to receive either epidural or general anesthesia for pain management throughout their surgery.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Assessment of the Nociception During Lumbar Surgery
Condition: Lumbar Surgery
Study type: Interventional

Summary: 
      The aim of the study is to assess the accuracy of a new paradigm in measuring the level of
      nociception during lumbar surgery. The paradigm is based the measurement of the baroreflex in
      response to noxious stimuli in anesthetized patients.
    

Detailed description: 
      The study aims at exploring the changes in the baroreflex induced by 3 noxious stimulation in
      anesthetized patients: tracheal intubation, tetanic stimulus, and surgical incision. Patients
      are randomly assigned to one of 2 groups: remifentanil-2 or remifentanil-4, corresponding to
      the target effect site concentration of this drug delivered through a TCI system. Other drugs
      included propofol and cisatracurium.

      The paradigm exploring the baroreflex collects information continuously recorded of the RR
      intervals and the changes in systolic arterial pressure, before and during noxious stimuli.
      The hypothesis is that this paradigm explores nociception as the group with smaller doses in
      remifentanil will have more cardiovascular reactions in response to noxious stimuli.
    

Intervention name(s): remifentanil; remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 2 ng/ml.; anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 4 ng/ml.
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: nociception, intraoperative, baroreflex