bioihbjkbjnl/mcl2 huggingface dataset:
Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aimed to investigate the clinical benefit contribution and safety of nimotuzumab
      to the standard combined treatment for patients with newly diagnosed glioblastoma.
    


Intervention name(s): Nimotuzumab; Temozolomide; Radiotherapy
Intervention type(s): Biological; Drug; Radiation
Intervention description(s): Nimotuzumab, 200 mg as 1-hour intravenous infusion once weekly, from first week to last week of RT for a total of 6 times.; Temozolomide, 75 mg/m2/d was administered orally from the first to the last day of RT. After 4-week break, individualized adjuvant TMZ was given based on MGMT status. The standard 5-day schedule every 4 weeks for six cycles was given for patients with negative MGMT expression. Dose was 150mg/m2 for the first cycle and 200 mg/m2 from the second cycle. The 7-day on/7-day off schedule every 2 weeks for 12 cycles was given for patients with positive MGMT expression. The dose was 100 mg/m2 for the first two cycles and 150 mg/m2 starting from the third cycle.; Fractionated 3D conformal RT was given at 2.0Gy per fraction, 5 daily fractions per week for 6 weeks.
Intervention MeSH terms: Temozolomide; Nimotuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glioma; phase 2; nimotozumab; temozolomide; radiotherapy
Stress Reduction: A Pilot Study With Adolescents
Condition: Physiological Stress; Psychological Stress
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      This study will evaluate the feasibility of providing an onsite mindfulness intervention,
      delivered as part of the school health curriculum, to help high school-attending adolescents
      cope with stress.
    

Detailed description: 
      For this study, sophomores who are enrolled in health at Jesuit High School, (n = 320
      students) will be invited to participate in a research study, conducted during health class,
      comparing mindfulness to a wellness or waitlist control. The students will be randomized by
      classroom, to either wellness or mindfulness or waitlist, with approximately 3-4 classes per
      intervention or control. Initially, six classes or sections of health will be randomized to
      one of the two active interventions, with the remaining classes/sections of health on the
      waitlist. Both of the intervention groups will meet weekly, during one of the regularly
      scheduled health classes, and have daily assignments. The students in the waitlisted
      classrooms will receive an intervention at the start of the next term. At the end of the
      study, students will have access to the materials from the other group, if desired.
    

Intervention name(s): Mindfulness; Wellness
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
fMRI in Impulsivity
Condition: Impulse Control Disorders; Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder; Impulsive Behavior; Disruptive, Impulse Control, and Conduct Disorders
Study type: Observational

Summary: 
      This study aims to use resting-state and task based functional Magnetic Resonance Imaging
      (fMRI) as a tool to evaluate trait characteristics of impulsivity in subjects with borderline
      personality disorder.
    


Intervention name(s): Experimental
Intervention type(s): Behavioral
Intervention description(s): with functional imaging and behavioural measurements at baseline and 4 weeks
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        BPD and normal volunteers
Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy
Condition: Progressive Supranuclear Palsy
MeSH terms: Paralysis; Supranuclear Palsy, Progressive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability (maximum tolerated dose (MTD) within the
      specified dosing range) of single intravenous (IV) infusion of C2N-8E12 in patients with
      progressive supranuclear palsy (PSP).
    

Detailed description: 
      This study evaluates the safety, tolerability, pharmacokinetics, and maximum tolerated dose
      (within dosing range) of intravenous (IV) infusion of C2N-8E12 in 32 patients with
      progressive supranuclear palsy (PSP). Four sequential cohorts will receive increasing single
      doses of either C2N-8E12 or placebo. Out of every 4 patients enrolled 3 patients will receive
      drug and 1 will receive placebo. Study participants will be followed for a minimum of 2
      months post-treatment to monitor for the safety, tolerability, pharmacokinetics, and
      immunogenicity of C2N-8E12.
    

Intervention name(s): Single dose C2N-8E12; Single dose placebo
Intervention type(s): Drug; Drug
Intervention description(s): C2N-8E12 is a humanized recombinant anti-human tau antibody.; Subjects will be block randomized to receive a single dose of C2N-8E12 or placebo in two blocks of 4 subjects (3:1, C2N-8E12:placebo) per cohort.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PSP; C2N-8E12; tauopathy; Progressive Supranuclear Palsy; Steele Richardson Olszewski Syndrome; Humanized anti-tau antibody
Assessment of Adenoidal Obstruction in Children : Clinical Signs Versus Flexible Nasal Endoscopy and Roentgenographic Findings
Condition: Obstructive Sleep Apnea; Nasal Obstruction
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Nasal Obstruction
Study type: Observational

Summary: 
      The term adenoids describes lymphoid tissue on the superior and posterior walls of the
      nasopharynx, and their hypertrophy is a common condition of childhood. When enlarged,
      adenoids can obstruct the nasopharyngeal airway and cause mouth-breathing, hyponasal voice,
      and snoring. In more severe cases, obstructive sleep apnea (OSA) may result, which carries
      potential risk of neurocognitive disturbance, growth failure, and heart-lungs disease.
      Adenoid hypertrophy can also be associated with otitis media with effusion, possibly through
      Eustachian tube dysfunction or chronic adenoidal infection.

      Methods for identification of adenoid hypertrophy include the clinical history, examination,
      imaging (eg, plain lateral x-ray), or by nasal endoscopy witch enable direct visualization of
      the nasal cavity with dynamic evaluation of any nasal airway obstruction.

      Objectives :

      The aim of this study is to prospectively examine invasive and non-invasive office procedures
      to assess adenoids hypertrophy, including clinical history, x-ray imaging, and nasal
      endoscopy.

      Methods :

      Prospective, observational study in pediatric patients aged 2-18 that will be referred to the
      otolaryngology pediatric 'Clalit' clinic in Haifa after x-ray imaging and an informed
      consent.

        1. Nasal Obstruction Index (NOI) The NOI questionnaire for history and physical exam will
           be evaluated at the clinic, as described by Paradise grading system.

        2. Plain lateral x-rays Plain lateral X-rays of the patients will be evaluated only if the
           patients had them at the time of referral. Adenoidal obstruction will be assessed by
           Fujioka's Adenoid-Nasopharynx ratio.

        3. Fiberoptic nasal endoscopy (FNE) Fiberoptic analysis will be done as an office procedure
           using a 2.4mm Storz nasal flexible endoscope following an application of Lidocaine gel
           locally into the nostril and on the endoscope distal end. Adenoidal obstruction will be
           assessed by Parikh grading system.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients aged 2-18 with suspected adenoid hypertrophy
      
Keywords: obstructive sleep apnea; pediatric; adenoid hypertrophy
Steroid Nasal Irrigation for Flavor Evaluation and Detection Study
Condition: Olfactory Disorder
Study type: Interventional

Summary: 
      The purpose of this research study is to examine the efficacy of a 12-week smell training
      intervention for participants with olfactory dysfunction following an infection of the upper
      respiratory tract.
    

Detailed description: 
      Olfactory dysfunction affects up to fifteen percent of the general population and can cause
      significant psychosocial distress including decreased appetite, reduced self-hygiene, and
      mood disturbances.

      This study aims to study the efficacy of smell training for patients with olfactory
      dysfunction following a viral upper respiratory tract infection. Eligible participants will
      complete a 30-day course of budesonide nasal saline irrigation. Participants who do not show
      improvement in their olfaction based on composite smell and taste tests will be eligible to
      receive a baseline resting-state fMRI (rs-fMRI) and complete a 12-week smell training
      intervention program. Smell training involves participants smelling 4 odors (phenyl ethyl
      alcohol, eucalyptus, lemon, and eugenol) twice a day for 12 weeks. Following completion of
      smell training, participants will undergo repeat smell and taste tests as well as rs-fMRI to
      ascertain the efficacy of smell training.
    

Intervention name(s): Smell training
Intervention type(s): Behavioral
Intervention description(s): Participants will be provided with 4 vials of essential odors. Participants will sniff each scent for 20-30 seconds, twice daily, for 12 weeks. The participant will take 30 seconds of rest between each scent. All participants will undergo this smell training regimen for 12 weeks.
Other intervention name(s): Olfactory Training
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective cohort, pre- and post-intervention study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anosmia; Hyposmia; Intranasal Steroid Irrigation; Olfactory Neuroplasticity; Olfactory training
Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor
Condition: Pregnancy
Study type: Observational

Summary: 
      This proposal is a pilot study to describe the variations of blood sugar in pregnant women
      with various degrees of glucose intolerance, and how they relate to standardized meals. Blood
      sugar control during pregnancy is important to prevent complications for the newborn. The
      variation and timing of the blood sugar measurements in gestational diabetics and how this
      relates to the baby's outcome is controversial. We will use an FDA approved device called
      Minimed Glucose Continuous Monitor, which is used in clinical practice for certain diabetics.
      It is very small, similar to a beeper, and is connected to the patient through a small
      plastic catheter subcutaneously. This measures blood sugar every five minutes for a total of
      288 readings a day with minimum discomfort. The hypothesis of this study is that use of the
      Minimed glucose monitor will provide information about variations of blood sugar in
      gestational diabetics that is missed by capillary glucose monitors.

      Our conclusions will allow us to compare blood glucose trends among the groups. After the
      data is analyzed in this pilot study, we plan to design a bigger study involving more
      subjects to study the impact of the blood sugar variations in the outcome of the newborn, and
      to obtain generalizable results for the population in general.
    

Detailed description: 
      We will coordinate the study through the CRC. The women will have to come in only twice, to
      have the monitor placed and then taken off three days later. A blood sample will be collected
      at each visit. Meals and snacks will be provided for each day of the study, specially
      packaged, to supply an equivalent amount of calories for each subject. These will meet the
      nutritional requirements for both the mother and the fetus. Women will do separate
      fingerstick blood sugar measurements using a capillary glucometer four times a day, to ensure
      the accuracy of the sensor's readings.
    

Intervention name(s): Continuous ambulatory subcutaneous glucose monitor
Intervention type(s): Device
Observational model: Defined Population
Time perspective: Other
Host-pathogen Interactions During SARS-CoV-2 Infection
Condition: Infection, Coronavirus; Severe Acute Respiratory Syndrome Coronavirus 2
MeSH terms: Infections; Communicable Diseases; Coronavirus Infections; COVID-19; Severe Acute Respiratory Syndrome
Study type: Interventional

Summary: 
      The new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease
      2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory
      infections, responsible for a veritable global health crisis.

      In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii)
      severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate
      severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be
      affected, but are more rarely symptomatic and severe pediatric forms are exceptional.

      Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus
      (MERS-CoV)), these differences in clinical expression could be based on a variability in the
      immunological response, notably either via inhibition of the type I interferon (IFN-I)
      response, or on the contrary an immunological dysregulation responsible for a "cytokine
      storm" associated with the aggravation. Little is known about the impact of these innate
      immune response abnormalities on the adaptive response. In addition, certain genetic factors
      predisposing to a state of "hyper-fragility" and certain viral virulence factors could also
      be predictive of the clinical response.

      In this context, the main hypothesis is that the virological analysis and the initial
      biological and immunological profiles are correlated with the initial clinical presentation
      of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults
      may be linked to a more robust innate immune response, including better production of IFN-I.
    


Intervention name(s): Blood sample; Low or upper respiratory tract sample; Stool collection or fecal swab; phone call
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): blood samples will be taken as below: Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0; Low or upper respiratory tract sample will be collected in order to take virology measurements:
Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0; The stool collection or fecal swab will be collected in order to take virology measurements:
Group E1: / Group E2: At day 0, day 7, day 14 Group E3: At day 0; phone calls will be performed to collect data regarding patients' symptoms at: Group E1: Day 14 Group E3: Day 14
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Severe Acute Respiratory Syndrome Coronavirus 2; COVID-19; immunology; interferon; coronavirus
Influence of Vaginal Lactoferrin on Amniotic Fluid Cytokines to Avoid Pregnancy Complications
Condition: Pregnancy
Study type: Interventional

Summary: 
      Objective: To evaluate the influence of vaginal Lactoferrin administration on amniotic fluid
      concentration of 47 cytokines, chemokines and growth factors.
    

Detailed description: 
      60 women undergoing genetic amniocentesis will be enrolled at the Obstetric Unit, University
      of Ferrara. The selected patients will be randomly assigned to receive 300 mg of vaginal
      Lactoferrin to obtain 3 groups: A, 20 untreated patients; B and C (20 patients each one)
      respectively treated 4 and 12 h before amniocentesis. Cytokines, chemokines and growth
      factors concentrations will be quantified by a magnetic bead Luminex multiplex immunoassays
      panel technology.

      Amniotic fluid samples will be obtained by transabdominal amniocentesis and the sample not
      required for clinical purposes will be centrifuged to remove particulate material and the
      supernatants will be aliquoted and stored at -80°C until assay.
    

Intervention name(s): Lactoferrin
Intervention type(s): Drug
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Amniocentesis
Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease
Condition: Pediatric Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's
      Disease Activity Index (PCDAI) in pediatric patients with moderate to severe Crohn's disease
      after TA-650 administration at a dose of 5 mg/kg at week 0, 2, and 6, then every 8 week after
      week 14 up to week 46, and at a dose of 10 mg/kg if the effect is attenuated. The safety and
      pharmacokinetics are also evaluated.
    

Detailed description: 
      This is an open-label, uncontrolled, multicenter Phase 3 study conducted in Japan.
    

Intervention name(s): TA-650
Intervention type(s): Drug
Intervention description(s): TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Week 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 46. If the criteria for a dosage escalation are met, TA-650 will be administered at a dosage of 10 mg/kg.
Other intervention name(s): Infliximab
Intervention MeSH terms: Infliximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infliximab; REMICADE; TA-650; pediatric Crohn's disease
S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      This is a randomized multicenter controlled study of oxaliplatin, leucovorin calcium , plus
      5-fluorouracil (FOLFOX) compared with S-1 plus oxaliplatin (SOX) as perioperative
      chemotherapy for advanced gastric cancer.

      Hypothesis: SOX is not inferior to FOLFOX as perioperative chemotherapy for advanced gastric
      cancer.
    


Intervention name(s): S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium
Intervention type(s): Drug
Intervention description(s): FOLFOX:
oxaliplatin 130mg/m2 on day 1, CF 400mg/m2 on day 1, 5-Fu 400mg/m2 on day 1; 5-FU 2400 mg/m2 46hr civ regimen repeated every 3 weeks Pre-operative chemotherapy: 2-4 cycles and peri-operative chemotherapy consist of 6 cycles
SOX:
oxaliplatin 130mg/m2 on day 1, S-1 for 14 days regimen repeated every 3 weeks Pre-chemotherapy: 2-4 cycles, totally 6 cycles of perioperative chemotherapy
Intervention MeSH terms: Leucovorin; Oxaliplatin; Calcium; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric Cancer
An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE)
Condition: Eosinophilic Esophagitis (EoE)
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, double- blind extension study of Oral Budesonide Suspension (OBS) in
      adults and adolescents (11 to 55 years of age, inclusive) with Eosinophilic Esophagitis (EoE)
      who have completed participation in the SHP621-301 induction study (NCT02605837). The primary
      objective is to evaluate the maintenance of efficacy of OBS over 36 weeks. Maintenance of
      efficacy will be measured by the peak eosinophilic count and Dysphagia Symptom Questionnaire
      (DSQ) score.
    


Intervention name(s): Oral Budesonide Suspension (OBS); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): OBS 2mg twice daily; Matching Placebo dose
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants
Condition: Vaccines, Pneumococcal Conjugate Vaccine
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the
      13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.
    


Intervention name(s): 13vPnC
Intervention type(s): Biological
Intervention description(s): "First dose during 2 to 6 months of age Second dose at least 28 days after the first dose Third dose at least 28 days after the second dose Forth dose during 12 to 15 months of age"
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
An Open-Label Phase 1/2 Study to Assess the Safety, Efficacy and Dose of Study Drug UX003 Recombinant Human Beta-glucuronidase (rhGUS) Enzyme Replacement Therapy in Patients With Mucopolysaccharidosis Type 7 (MPS 7)
Condition: Mucopolysaccharidosis Type 7
MeSH terms: Mucopolysaccharidoses
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      UX003-CL201 is an open-label Phase 1/2 study to assess the safety, efficacy, and dose of
      UX003 in MPS 7 patients via intravenous (IV) administration every other week (QOW) for 36
      weeks with up to an additional 36 weeks from the optional continuation period. Up to 5
      participants, who are between 5 and 30 years of age inclusive, will be enrolled and treated
      with UX003.

      The initial 12-week treatment period will be followed by a 24-week forced dose titration
      period to assess the optimal dose. Participants who complete both the initial treatment and
      forced dose titration periods will continue treatment in a 36- week continuation period.
    


Intervention name(s): UX003
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mucopolysaccharidosis type 7, MPS 7, Sly syndrome, enzyme replacement therapy, rare disease, lysosomal storage disease, metabolic disorder