bioihbjkbjnl/mcl2 huggingface dataset:
Haploidentical Stem Cell Transplantation for Children With Therapy Resistant Leukemia
Condition: Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Despite substantial progress in the treatment pediatric acute leukemia a significant number
      of children will experience primary or secondary resistance to the treatment. In other words
      it will be not possible to achieve remission using standard chemotherapy (primary resistance)
      or the patients will develop chemotherapy resistant relapse (secondary resistance). Children
      failing to achieve remission or children relapsing after previous allogeneic stem cell
      transplantation have short life expectancy and palliative treatment still remains the most
      reasonable option as the escalation of conventional chemotherapy is not longer effective.

      The role of Graft versus Leukemia effect was postulated as one of the mechanisms contributing
      to the leukemia control/eradication after transplantation of hematopoietic stem cells.

      In this study the investigators combine intensified multiagent Clofarabine containing
      chemotherapy with post-induction treatment intensification using reduced intensity
      conditioning followed by haploidentical hematopoietic stem cell transplantation. Introducing
      a new drug to the treatment of resistant leukemia the investigators want to achieve a
      response which allows us to proceed to immediate haploidentical transplantation. Using a
      haploidentical donor the investigators can avoid time consuming search for an unrelated donor
      and perform the transplantation at the optimal time-point. Combating therapy resistant
      leukemia the investigators would like to evoke and utilize potential Graft-versus-Leukemia
      effect which is much more pronounced in the haploidentical setting, as it is well documented
      that allogeneic transplantation with a matched donor is not effective in resistant disease.
      The use of best KIR mismatch donor and post-transplant donor lymphocyte infusion will be
      implemented in order to develop/intensify graft versus leukemia effect.
    


Intervention name(s): Clofarabine for remission induction; Etoposide for remission induction; Cyclophosphamide for remission induction; Clofarabine in conditioning before transplantation; Thiotepa in conditioning before transplantation; Melfalan in conditioning before transplantation; Haploidentical transplantation of T-cell depleted graft; Donor lymphocyte infusion
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Cyclophosphamide; Thiotepa; Etoposide; Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Haploidentical hematopoietic stem cell transplantation; Graft versus host disease; Donor lymphocyte infusion; Graft versus leukemia effect; Immunological recovery; Bridge to transplant approach; Therapy resistant leukemia; Hematological malignancy
Pilot Study of Olanzapine and Aprepitant to Prevent Nausea and Vomiting in Children Receiving Chemotherapy
Condition: Chemotherapy Induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the feasibility of a larger trial comparing
      olanzapine and aprepitant and to obtain preliminary data on the effectiveness of these two
      medications to treat nausea and vomiting in children receiving chemotherapy. Children
      receiving 2 cycles of chemotherapy with a high risk of causing nausea and vomiting will
      receive olanzapine in one cycle and aprepitant in another cycle. Children will be randomized
      to see which medicine they receive first. The investigators will record the number of extra
      medications used for nausea, the number of times a child vomits, and the amount of nausea the
      child feels each day.
    

Detailed description: 
      This will be a pilot study, designed as a randomized, crossover study comparing olanzapine
      and aprepitant in pediatric oncology patients receiving highly emetogenic chemotherapy (HEC).
      The primary objective is to determine the feasibility of recruitment and data collection for
      conducting a larger trial aimed at comparing olanzapine and aprepitant as antiemetic regimens
      and establishing efficacy of this regimens for pediatric patients receiving HEC. Secondary
      objectives are to obtain preliminary data regarding the effectiveness of olanzapine and
      aprepitant as well as the tolerability of olanzapine in the pediatric oncology population.

      Each patient must be planned to undergo at least 2 cycles of the same cycle of HEC. Each
      patient will be randomized to receive olanzapine or aprepitant in the first cycle of
      chemotherapy, and then will receive the other agent in a second cycle of chemotherapy.
      Patients will also receive ondansetron and dexamethasone with each cycle. Patients with CNS
      tumors will not receive dexamethasone. Response will be measured objectively recording number
      of emesis and use of breakthrough medications. The medications chosen for breakthrough
      medications will be at the treating physicians discretion. A complete response will be no
      episodes of emesis or use of breakthrough medications. A partial response is one or less
      episodes of emesis and one or less use of breakthrough medications. Nausea will be measured
      based on parent and patient scales and will be a separate measure, not included in the
      compete or partial response.
    

Intervention name(s): Olanzapine; Aprepitant
Intervention type(s): Drug; Drug
Other intervention name(s): zyprexa; emend
Intervention MeSH terms: Olanzapine; Aprepitant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: olanzapine; Nausea and vomiting; aprepitant; pediatrics
Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women (P06090)
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 4

Summary: 
      Both tibolone and raloxifene have been demonstrated to prevent postmenopausal bone loss.
      During treatment with tibolone bone mineral density (BMD) of the spine has been shown to be
      increased between 1.8 and 5.8 % above baseline in two years, depending on the population
      studied. Since treatments aimed at prevention should ideally be used long-term, compliance
      with the treatment is crucial. Efficacy of and compliance with the two treatments will be
      measured and evaluated.
    


Intervention name(s): tibolone; raloxifen
Intervention type(s): Drug; Drug
Intervention description(s): 2 years treatment with tibolone (1.25 mg Org OD-14); 2 years treatment with raloxifene (60 mg)
Intervention MeSH terms: Tibolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Stretching and Relaxation Exercises on Anxiety in Individuals With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia is a non-articular, chronic rheumatic disease of unknown etiology characterized
      by widespread musculoskeletal pain, sleep disturbance, fatigue, and the presence of multiple
      tender points.
    

Detailed description: 
      Although the exact etiology cannot be determined in fibromyalgia, it is thought that there
      are many mechanisms that contribute to the formation of Fibromyalgia. Evidence for some
      biochemical, neurohormonal, central nervous system, immunological, psychological and
      environmental factors that may play a role in the disease has been found.
    

Intervention name(s): Cervical Extensor Stretch; Cervical Extensor Stretch
Intervention type(s): Other; Other
Intervention description(s): Fibromyalgia individual: Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.; Healthy volunteers : Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Individuals with fibromyalgia and healthy individuals will be included in the study and the effectiveness of the treatment will be examined. Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.
Masking: Single (Investigator)
Primary purpose: Other
Keywords: exercise
Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate and GW642444 Are Processed by the Body in Healthy Subjects
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being done to look at the absolute bioavailability of fluticasone furoate and
      GW642444 inhalation powder when administered in healthy subjects. Bioavailability is
      determined by measuring the amount of the dose of inhaled medication that reaches the
      circulation; the amount of inhaled fluticasone furoate and GW642444 powder will be compared
      to the medication administered intravenously (where bioavailability is 100%).
    

Detailed description: 
      Fluticasone furoate (FF), a novel glucocorticoid, and GW642444, a potent, inhaled longacting,
      beta2-receptor agonist (LABA), are currently under development in combination for use as a
      once-daily, inhaled treatment for asthma and chronic obstructive pulmonary disease (COPD). FF
      is also being developed as a stand-alone product for asthma and GW642444 is also being
      developed as a stand-alone product and in combination with a novel, long-acting muscarinic
      antagonist for the treatment of COPD. This study is being performed to determine the absolute
      bioavailability of both FF and GW642444 when delivered in combination from the novel dry
      powder inhaler.
    

Intervention name(s): fluticasone furoate//GW642444; fluticasone furoate; GW642444
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder administered in the morning; Single IV dose of FF (250mcg); Single IV dose of GW642444 (55mcg)
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetics; GW642444; absolute bioavailability; healthy subjects; fluticasone furoate; GW685698
Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of RM-493 on mean percent body weight
      loss, and other weight loss parameters as well as Pharmacokinetic (PK) profile, and
      ambulatory blood pressure in obese participants. The study is designed to evaluate the
      efficacy and tolerability of a single dose of RM-493. The study drug (RM-493 and placebo)
      will be administered subcutaneously in a blinded fashion.
    


Intervention name(s): Setmelanotide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Daily subcutaneous infusion; Daily subcutaneous infusion
Other intervention name(s): RM-493
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Overweight
Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d.
      under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.
    


Intervention name(s): PPX ER; PPX ER
Intervention type(s): Drug; Drug
Intervention description(s): PPX ER 0.375mg - 1.5mg for 32 days totally; PPX ER 0.375mg - 1.5mg for 32 days totally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (Pegasys) and Adeforvir Dipivoxil (ADV) in Participants With Lamivudine-Resistant Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in
      participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will
      be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral
      lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine
      for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target
      sample size is 255 individuals.
    


Intervention name(s): Adefovir dipivoxil; Lamivudine; Peginterferon alfa-2a
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ADV will be administered orally at a dose of 10 mg QD for 72 weeks.; Lamivudine tablets will be administered orally at a dose of 10 mg QD for 12 weeks.; Peginterferon alfa-2a injection will be administered at a dose of 180 mcg QW for 48 weeks.
Other intervention name(s): Pegasys
Intervention MeSH terms: Lamivudine; Adefovir; Adefovir dipivoxil; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
Condition: Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate analgesic efficacy and safety of
      hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar
      extraction.
    

Detailed description: 
      Dosing started within 6 hours after completion of third molar extraction. Study drug was
      given once every 6 hours for 12 hours (for a total of 2 doses). Participants were randomized
      to receive placebo or active drug (either experimental drug or comparator). The total dose
      was the same for both groups receiving active drug, but was given as either 1 dose of
      extended-release tablets (experimental drug), or 2 doses of immediate-release tablets (active
      comparator).
    

Intervention name(s): ABT-712 Extended-release; Hydrocodone/Acetaminophen Immediate-release; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ABT-712 extended-release tablet; Hydrocodone/acetaminophen immediate-release tablet; Placebo tablet
Other intervention name(s): Hydrocodone/acetaminophen extended-release; Hydrocodone bitartrate and acetaminophen extended-release
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study
Condition: Renal Failure Chronic Requiring Hemodialysis
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Compare the HeRO Vascular Access Device to a conventional ePTFE graft.
    

Detailed description: 
      The purpose of this study is to compare the HeRO Vascular Access Device to a conventional
      ePTFE graft. It is hypothesized that HeRO patency will be comparable to the conventional
      ePTFE graft control.
    

Intervention name(s): HeRO Vascular Access Device; Conventional ePTFE hemodialysis graft
Intervention type(s): Device; Device
Intervention description(s): HeRO Vascular Access Device; Conventional ePTFE hemodialysis graft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vascular access hemodialysis; ePTFE graft; Graft-eligible; Long-term vascular access for hemodialysis
Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia
Condition: Cardiovascular Disease
MeSH terms: Endotoxemia; Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to better understand the anti-inflammatory benefits of two
      prescription medicines that are currently used to help people with cholesterol problems.

      Fish oil, from eating certain kinds of fish and from supplement pills, has been used to help
      control cholesterol and reduce inflammation (the body's response to injury or sickness).
      Lovaza® is the brand name for prescription strength fish oil pills. In this study, we will be
      looking at how Lovaza® works to help reduce inflammation in healthy volunteers.

      Tricor® is the brand name for prescription fenofibrate pills. Fenofibrate is a prescription
      medicine that many doctors give to people with high triglyceride (fat in the blood) levels.
      In this study, we will be looking at how Tricor® works to help reduce inflammation in healthy
      volunteers.

      Endotoxin or lipopolysaccharide (LPS) is a small part of bacteria (that is no longer living)
      that can cause many of the effects similar to bacterial infections in humans. However, it can
      be administered in very small amounts to produce a mild immune response much the same as a
      'flu' like illness. Within 1 ½ -3 hours after giving LPS by vein, a response consisting of
      fever, chills, headache, nausea and vomiting and generalized aches and pains will occur which
      lasts up to 6-8 hours. In addition to the flu like symptoms, the response causes temporary
      changes in cholesterol, triglycerides and blood sugar. Different people respond differently
      to LPS. We are using LPS in this study to bring on a temporary inflammatory response in the
      body and to compare the responses of people who receive Lovaza® or Tricor® to the responses
      of people who receive a placebo (pill that does not contain medicine).
    


Intervention name(s): Fenofibrate (Tricor) tablets; Placebo; Lovaza
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks; Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks; 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: healthy volunteer
Development and Assessment of a Mobile Phone Based Intervention to Reduce Maternal Depression and Improve Child Health
Condition: Maternal Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The prevalence rate of maternal depression in Pakistani women and its effect on the growth
      and development of young children and child mortality is very high.

      The main objective of this study is to increase access to evidence based psychological
      interventions for mothers who have children of age 0 to 30 months, consistent with her
      values. The study will be a 2 (conditions) into 3 (Time) single blind randomized controlled
      trail. Depressed mothers will be randomized either to intervention arm or control arm.
      Intervention will include text messages based on Learning Through Play Plus (LTP plus CBT).
    

Detailed description: 
      Disturbances in mother-infant relationship in depressed mothers negatively influence the
      child's development. There are a number of efficient treatments for postnatal depression
      including antidepressant medication, psychotherapy and psychosocial interventions.
      Tele-health and mobile health is a novel and emerging field in psychiatric and psychological
      care and treatment of mental health difficulties, it involves the use of telecommunications
      to provide health care, support and intervention from a distance.

      The proposed study will test the efficacy of an innovative, affordable mobile based
      intervention program that can help mothers with postnatal depression in low resource
      countries such as Pakistan.

      Participants will be recruited from maternal and child care centres in Karachi, Pakistan and
      those participants (n = 204) meeting inclusion criteria of the study will be randomized into
      one of the 2 treatment arms, i.e., intervention or control, after completion of baseline
      assessment. Intervention will be comprised of LTP Plus and will be delivered through text
      messages. Momentary Sampling assessment and Momentary Psychological intervention will be part
      of this study. Participants will be assessed again after completion of intervention (i.e.,
      after 12 weeks) and then 3 months post intervention.
    

Intervention name(s): Mobile based intervention
Intervention type(s): Behavioral
Intervention description(s): Learning through Play Plus Intervention delivered through mobile phone
Other intervention name(s): Intelligent Real Time Therapy iRTT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Maternal depression; Mobile phone based intervention; Learning Through Play; CBT; Intelligent Real Time Therapy
Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I study is conducted to determine the maximum tolerated dose (MTD), dose limiting
      toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-516 injection
      on twice-weekly schedule in patients with advanced solid cancers failed to standard therapy.
      The usefulness of the this regimen is evaluated by response rate, progression free survival
      and vascular disruption effect by Dynamic Contrast-Enhanced MRI (DCE-MRI) or DWI.
    

Detailed description: 
      This is an open label, dose escalation study. Patients receive CKD-516 IV over 30 minutes on
      day 1, 4, 8, 11 every 3 weeks in the absence of unacceptable toxicity or disease progression.
      Cohorts of 3~6 patients receive escalating doses of CKD-516 until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
      patients experience dose limiting toxicity.
    

Intervention name(s): CKD-516 inj.
Intervention type(s): Drug
Intervention description(s): CKD-516: 3.3~13mg/m2/day
Other intervention name(s): CKD-516
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Solid Tumor, Tubulin inhibitor