bioihbjkbjnl/mcl2 huggingface dataset:
Study of LY2228820 With Radiotherapy Plus Concomitant TMZ in the Treatment of Newly Diagnosed Glioblastoma
Condition: Adult Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Glioblastomas are extremely resistant to treatment, including radiotherapy and/or
      chemotherapy. Mitogen-activated protein kinase (MAPK) cascades are key signaling pathways
      involved in the regulation of normal cell proliferation, survival and differentiation.
      Activation of p38 MAPK has been associated with a poor prognosis among patients with
      glioblastoma during the temozolomide (TMZ) era and represents a compensatory response by
      tumor cell to environmental stress such as radiation or chemotherapy.

      LY2228820 is a potent and selective inhibitor of p38 MAPK, and reduces phosphorylation of its
      cellular target, MAPK-activated protein kinase 2 (MAPKAPK-2) . LY2228820 is a good candidate
      to target malignant glioma resistance to the gold standard treatment combining radiation and
      TMZ by acting on both tumor and stromal cells.

      The primary objectives of this study were to determine the recommended dose of LY2228820 in
      combination with TMZ and radiotherapy during chemoradiotherapy period (phase I) and to
      estimate the 6-month progression free survival (PFS) rate of patients treated with LY2228820
      when administered at the recommended dose in combination with radiotherapy and concomitant
      TMZ (phase II)
    


Intervention name(s): LY2228820; Temozolomide; radiotherapy
Intervention type(s): Drug; Drug; Radiation
Other intervention name(s): ralimetinib; TMZ
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: newly diagnosed glioblastoma; p38 MAPK inhibitor; temozolomide; radiotherapy
A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)
Condition: Postherpetic Neuralgia; Shingles; Herpes Zoster; Neuropathic Pain
MeSH terms: Herpes Zoster; Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo
      in the treatment of postherpetic neuralgia.
    


Intervention name(s): KD7040 Topical Gel; Placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): KD7040 topical gel; Placebo gel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Influence of Intragastric Fatty Acid Infusion on Behavioral Responses to Positive Emotion Induction in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to test whether intragastrically infused fatty acid will
      interact with positive emotion induction and if this effect is mediated by gut hormones.
    

Detailed description: 
      This study aims at the possible effect of subliminal intragastric administration of fatty
      acids on responses to positive emotion induction, based on our earlier findings that
      subjective administration of fatty acid decreases neural responses to negative mood induction
      (Van Oudenhove et al, J Clin Invest 2011). After screening for exclusion criteria and the
      participants sign the informed consent form, an intravenous catheter is placed in the
      forearm, and a naso-gastric tube inserted through the nose. Then the test subject is
      connected to the equipment in order to record the activity of the autonomic nervous system,
      via three electrocardiogram electrodes. By using the nasogastric tube we serve a fatty acid
      solution (Dodecanoic acid, "fatty acid" condition) or a physiological saline solution (
      "control" condition) intragastrically. The intragastric administration of low doses of this
      food ingredient has already been used in several previous studies by our research group and
      has proven perfectly safe. A positive or neutral emotional state will be induced by the
      combination of looking at emotional facial expressions and listening to classical music
      pieces that were previously validated for this purpose; This combination of incentives has
      already been used in previous studies of our research group. Responses will be measured by
      means of validated self-report scales and measurements of the vagal tone. We also take blood
      samples on a regular basis by the intravenous catheter for determination of gastrointestinal
      hormones, given our hypothesis that this may explain the effect on emotions. After removal of
      the nasogastric tube, the influence of subliminal administration of fatty acids and emotional
      state on food intake measured by means of a validated and previously drink test used in which
      participants "ad libitum" to drink a chocolate milkshake while the emotion-induction by means
      of classical music pieces continue. Finally, the intravenous catheter is removed.
    

Intervention name(s): Dodecanoic acid; Positive emotion; saline; neutral emotion
Intervention type(s): Dietary Supplement; Behavioral; Dietary Supplement; Behavioral
Intervention description(s): The middle chain saturated fatty acid that can be widely found in daily food.; Positive emotion induced by facial expressions and classic music.; saline; Neutral emotion induced by facial expressions and classic music.
Other intervention name(s): Lauric acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Study in Healthy Men to Test How BI 1810631 is Taken up in the Body When Taken With or Without Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the relative bioavailability of a single
      dose of BI 1810631 intended commercial formulation (iCF) under fed (Test treatment, T) and
      fasted (Reference treatment, R) conditions.
    


Intervention name(s): BI 1810631
Intervention type(s): Drug
Intervention description(s): BI 1810631
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: two-way crossover
Masking: None (Open Label)
Primary purpose: Treatment
Metabolic Consequences of CPT-1 Deficiency
Condition: Carnitine Palmitoyl Transferase Type 1A (CPT1A) Deficiency
Study type: Interventional

Summary: 
      The purpose of this study is to learn more about how long children with CPT-1 deficiency can
      wait between meals without developing low blood sugar or symptoms of low blood sugar. The
      other purpose is to learn more about how much fat is stored in the liver of a child with
      CPT-1 deficiency.
    

Detailed description: 
      With the advent of enhanced screening (via tandem mass spectroscopy, MS/MS), the Northwest
      Regional Newborn Screening Program (NWRNSP) has identified a high incidence of carnitine
      palmitoyl transferase type 1A (CPT1A) deficiency in Alaska Native infants. Since October of
      2003 approximately 80 Alaska Native infants have been identified with this condition;
      previously only 30 published cases were known worldwide. All of the infants are homozygous
      for a c.1436C-T sequence variant in the CPT1A gene, which results in the substitution of a
      leucine for proline at amino acid position 479 (P479L), and an approximately 80% reduction of
      CPT1A activity (non-classic CPT1A deficiency) (7). The clinical implications of this very
      restricted level of enzyme activity are not known. However, patients with more severe
      reductions of CPT1A activity (as the result of other mutations) are known to be at high risk
      for hypoketotic hypoglycemia, liver dysfunction, and sudden unexplained death (1).
      Hepatomegaly with micro- and macro-vesicular steatosis is also common (16). Currently the
      treatment of Alaska Native infants and children with CPT1A deficiency is based on data from
      patients with more severe forms of CPT1A deficiency and other fatty acid oxidation (FAO)
      disorders. Our ultimate goal is to establish evidence-based guidelines for treatment of the
      form of CPT1A deficiency prevalent in the Alaska Native population. This pilot study
      addresses two specific questions and will provide the first glimpse of the physiologic
      effects of homozygosity for the c.1436C-T sequence variant in the CPT1A gene. These data will
      aid in the development of strategies for clinical management that can be evaluated in future
      prospective studies, and provide preliminary data required for applications for NIH funding
      for more in-depth characterization of the clinical consequences of this condition.
    

Intervention name(s): Medically supervised fasting
Intervention type(s): Other
Intervention description(s): Metabolic fasting studies will be conducted over an 18-hour period or until blood glucose is < 40 mg/dl. If the YSI reading is 40 mg/dl or less, at any time during the study, then a blood sample will be collected, and the fast terminated by giving D25W IV and then feeding orally.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: CPT1A; steatosis; deficiency; metabolic; response; fasting
Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.
Condition: Hepatitis B Vaccine
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the persistence of immunity to hepatitis B in children
      who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol
      Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    


Intervention name(s): Engerix™-B Kinder
Intervention type(s): Biological
Intervention description(s): Intramuscular injection, 1 dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B vaccine; Challenge dose
Study of a Structured Parent Intervention on Adolescent Weight Loss Modification Program.
Condition: Pediatric Obesity; Impact of Parent Intervention on Adolescent Weight Loss
MeSH terms: Pediatric Obesity; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The study will enroll 110 overweight and obese adolescents ages 11-16 in a lifestyle
      modification program focusing on dietary modification and exercise. Parents will be
      randomized into control and motivational interviewing-based intervention groups. The primary
      hypothesis is that adolescents whose parents are in the intervention group will have improved
      compliance, weight loss and health outcomes compared with adolescents whose parents do not
      receive the intervention.
    

Detailed description: 
      Adolescents will participate in a 6-month intensive lifestyle modification that includes a
      structured exercise program, nutrition education and dietary modification and behavioral
      support, followed by a 6-month maintenance phase with monthly booster sessions. Parents will
      be randomized to participate in 4 dedicated "pre-treatment" parent psychoeducational sessions
      vs. control (no psychoeducational sessions). The sessions will explore parents' feelings
      about participation in a weight management program, explore their reasons for wanting to make
      behavioral changes, and enhance motivation. All parents will participate in monthly parent
      support groups while their adolescents are participating in the intervention phase of the
      study. The 6-month adolescent intervention will include biweekly sessions with a registered
      dietitian for dietary education; biweekly interactive group discussion sessions on topics
      pertaining to motivation, strategies for changing health behaviors, setting and keeping goals
      and dealing with peer pressure; and exercise sessions three times a week with 30 minutes of
      cardiovascular exercise and 30 minutes of strength training each session. Comprehensive
      assessments, including nutrition, behavior and exercise assessments, laboratory work, body
      composition measurements and medical assessments will be conducted at baseline, 6 months and
      12 months.
    

Intervention name(s): Lifestyle Intervention; Parent Motivational Interviewing
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric obesity; motivational interviewing; lifestyle intervention
Nasal Expiratory Positive Airway Pressure for the Treatment of Pediatric Obstructive Sleep Apnea Syndrome
Condition: Organic Pediatric Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will evaluate effectiveness and adherence of the nasal expiratory positive airway
      pressure (NEPAP) device as an an alternate therapy for children with Obstructive Sleep Apnea
      Syndrome (OSAS). NEPAP is currently approved for use only in adults.
    

Detailed description: 
      The nasal expiratory positive airway pressure (NEPAP) device has been used to treat OSAS in
      adults. A disposable device is placed in each nostril at night and attached with adhesive.
      The device acts as a one-way valve, during inspiration the valve opens, with negligible
      resistance to flow. During expiration, the valve closes and airflow is directed through small
      air channels, increasing resistance. The increased resistance helps to maintain the upper
      airway pressure during the critical end-expiratory period when the upper airway has been
      found to be most narrow in the breaths preceding an apnea event. In contrast to Continuous
      Positive Airway Pressure (CPAP) which provides positive pressure during both inspiration and
      expiration, NEPAP creates pressure during expiration. NEPAP is a potential alternative
      therapy which is less cumbersome than CPAP and may increase adherence.
    

Intervention name(s): Nasal Expiratory Positive Airway Pressure Device; placebo sham
Intervention type(s): Device; Device
Intervention description(s): assigned to Nasal Expiratory Positive Airway Pressure arm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: NEPAP; CPAP; alternative; OSAS
Responsive Parenting Program for Infants in Rural Bangladesh
Condition: Child Development
Study type: Interventional

Summary: 
      Children of mothers in the intervention parenting program are expected to show benefits over
      the standard care control group in terms of better cognitive/language development, less
      recent illness, and better height for age. The mothers assigned to the intervention parenting
      program are expected to evidence higher levels of home stimulation, better health prevention,
      and better dietary diversity, along with more accurate knowledge of child development.
    

Detailed description: 
      There are actually two intervention groups: in one the program is delivered by trained peer
      educators from the village, and in the other the program is delivered by trained government
      personnel.
    

Intervention name(s): Responsive parenting; Child Development
Intervention type(s): Behavioral; Behavioral
Intervention description(s): On a monthly basis, mothers meet with the peer educator to learn about ways to provide a hygienic environment (hand-washing), proper diverse diet (family foods, breast milk), play materials and conversation to stimulation their child's cognitive and language development. Mothers practice with their child and are coached by the peer educator.; On a monthly basis, mothers meet with the government worker to learn about ways to provide a hygienic environment (hand-washing), proper diverse diet (family foods, breast milk), play materials and conversation to stimulation their child's cognitive and language development.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: parenting intervention; child development; low and middle income countries
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2 part study designed to provide an initial assessment on the safety, tolerability,
      and PK of rivipansel, following single ascending (Part 1) and multiple ascending dosing (Part
      2) given subcutaneously with rHuPH20, in healthy subjects. Part 1 of the study will be
      conducted using a cross-over design while Part 2 of the study will be conducted using a
      parallel design.
    


Intervention name(s): Rivipansel; Placebo; Rivipansel; Rivipansel; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Rivipansel administered as a single dose subcutaneously with rHuPH20 in cross-over fashion. Each subject may receive up to 4 study treatments (placebo and up to 3 doses of rivipansel). The planned dose levels are 350 mg, 1210 mg, and 4200 mg (these are subject to change based on emerging data).; Matched Placebo administered as single dose subcutaneously with rHuPH20.; Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20. Planned doses are 1400 mg loading and 700 mg maintenance for 12 doses (these are subject to change based on emerging data).; Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20. Planned doses are 2800 mg loading and 1400 mg maintenance for 12 doses (these are subject to change based on emerging data).; Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy subjects; Randomized; Double-blind; Single ascending dose; Multiple ascending dose
Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel
      works in treating patients with persistent, recurrent, or metastatic head and neck cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the response rate in patients with previously treated persistent, recurrent,
           or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and
           docetaxel.

      Secondary

        -  Determine the toxicity of this regimen in these patients.

        -  Determine the duration of response and survival of patients treated with this regimen.

      OUTLINE: Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 60 minutes on
      day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable
      toxicity. Patients achieving complete response (CR) receive 4 additional courses of therapy
      beyond documentation of CR.

      After completion of study treatment, patients are followed for survival.

      PROJECTED ACCRUAL: A total of 17-41 patients will be accrued within 42-49 months.
    

Intervention name(s): docetaxel; Gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.; Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
Other intervention name(s): Taxotere; Gemzar
Intervention MeSH terms: Gemcitabine; Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; metastatic squamous neck cancer with occult primary squamous cell carcinoma; recurrent metastatic squamous neck cancer with occult primary; recurrent squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
Aquatic Sequential Preparatory Approach and Severe Traumatic Brain Injury
Condition: Traumatic Brain Injury; Severe Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      Traumatic brain injury (TBI) is an acquired insult to the brain from an external mechanical
      force. It is considered a major cause of mortality and of long-term disabilities in young
      adults, especially considering high-income countries.

      The TBI can cause a wide range of temporary and/or permanent brain's dysfunctions that can
      involve physical, cognitive, behavioural and emotional functioning limiting everyday life and
      social activities and leading to a lowers quality of life.

      a sequential preparatory approach (SPA), performed in aquatic environment, based on
      increasing difficulty and following a specific sequence of preparatory exercises (from the
      simplest to the most complex) could be an effective complementary training during post-acute
      intensive rehabilitation in patients with severe traumatic brain injury (sTBI).
    


Intervention name(s): Aquatic Training; Conventional Training
Intervention type(s): Other; Other
Intervention description(s): Aquatic Training training consists of a sequential and a preparatory approach aimed at enhancing dynamic postural stability. The exercises follow a specific sequence starting from a kneeling position, proceeding to a sitting position and ending with a supine position. Step exercises preparatory for gait were performed using a step and two floating aids. Gait exercises were performed first with the upper limbs placed on two floating aids and then during a dual motor task (i.e. catching a ball thrown by the therapist). Subjects performed three sessions a week for four weeks and each session lasting 45 minutes. The training was carried out by a physiotherapist who had at least 5 years of experience in aquatic neurorehabilitation.; Conventional land-based therapy consists of customized exercises focused on static and dynamic postural stability improvement. The exercises included the active-assisted mobilization, the muscle stretching the postural transition, the balance and the gait training. The control approach was carried out three times a week for four weeks and each session lasted 45 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment