bioihbjkbjnl/mcl2 huggingface dataset:
Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants
Condition: Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children with
      refractory or advanced solid tumors who are receiving anticonvulsants.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of irinotecan in children with refractory or
           advanced solid tumors receiving anticonvulsants.

        -  Determine the dose-limiting toxicity of irinotecan in this patient population.

        -  Evaluate the pharmacokinetic behavior of this treatment regimen in these patients.

        -  Determine, preliminarily, the antitumor activity of this treatment regimen in these
           patients.

      OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
      type of concurrent anticonvulsant (enzyme activating anticonvulsants vs valproic acid vs
      other anticonvulsants).

      Patients receive irinotecan IV over 1 hour daily for 5 days. Treatment repeats every 21 days
      in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated
      dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 3
      or 2 of 6 patients experience dose-limiting toxicity.

      Patients are followed every 6 months for up to 4 years and then annually thereafter.

      PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.
    

Intervention name(s): irinotecan hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Irinotecan
Primary purpose: Treatment
Keywords: unspecified childhood solid tumor, protocol specific
To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax
Condition: Hepatic Hydrothorax
MeSH terms: Hydrothorax
Study type: Interventional

Summary: 
      Hepatic hydrothorax is defined with accumulation of transudate fluid (500 ml) in the pleural
      cavity in patients with decompensated liver cirrhosis but without cardiopulmonary and pleural
      diseases. The Prevalence is 5-12% The treatment for hydrothorax is diuretics, repeated
      thoracocentensis, TIPS and liver transplant.. Midodrine increases effective arterial blood
      volume and also increases renal perfusion.It has also been used in Refractory ascitis .It has
      been shown to mobilise ascitis. In patients who are ineligible for TIPS and Liver transplant
      there is no data on Midodrine and its effects on Hydrothorax in cirrhotics.There are also no
      guidelines on the use of albumin during Pleural fluid tapping and the dose to be used. This
      study is being done to assess the safety and efficacy of Midodrine in hydrothorax.
    


Intervention name(s): Midodrine; Albumin; Diuretics
Intervention type(s): Drug; Biological; Drug
Intervention description(s): Midodrine 5 mg thrice daily; Albumin 20g/l; Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg.
Intervention MeSH terms: Midodrine; Diuretics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
Condition: Submental Fat; Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction
      of submental fat.
    

Detailed description: 
      No study medication is administered in this study.
    

Intervention name(s): ATX-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events; Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
The Effects of a Model-based Sensory Stimulation Intervention on Preventing Delirium Among Intensive Care Unit Patients: A Randomised Controlled Trial
Condition: Delirium, Intensive Care Unit, Randomised Controlled Trial
MeSH terms: Delirium
Study type: Interventional

Summary: 
      Delirium is highly associated with adverse clinical outcomes of intensive care unit (ICU)
      patients, including increased cognitive impairment, duration of intubation, ICU length of
      stay, mortality, physical dependence, and health care costs. This randomised controlled study
      will firstly develop a family-supported sensory stimulation package based on the literature
      review as well as the findings of the cross-sectional survey and the in-depth interview. The
      intervention effects than will be evaluated using outcomes including delirium incidence,
      delirium duration, delirium severity, ICU patients' consciousness and cognitive function as
      well as family members' satisfaction and anxiety. This study is expected to provide evidence
      of the effectiveness of family-supported sensory stimulation on preventing delirium among ICU
      patients.
    


Intervention name(s): Sensory stimulation
Intervention type(s): Other
Intervention description(s): Sensory stimulation can be formed in different aspects, and the most important ones are visual stimulation and auditory stimulation. Visual stimulation interventions involved providing a calendar, clock or familiar objects such as photographs of family caregivers; while auditory stimulation included calling the name of patients, helping to orientate the time and location, introducing hospital information, the ICU surrounding and treatment, and communicating with patients, who could not talk due to artificial airway, through a blackboard and use of gestures.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An assessor-blinded two-arm randomised controlled trial (RCT) will be conducted.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Delirium, sensory stimulation, intensive care unit, prevention
The Effects of Intravenous Heme Arginate on Heme Oxygenase-1 Expression (HO-1) and Oxidative Stress in the Human Heart
Condition: Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Ischemia reperfusion injury may be attenuated by HO-1 induction. Our previous data confirmed
      strong HO-1 induction in peripheral blood cells following heme arginate infusion in healthy
      humans. Furthermore, we could demonstrate the amelioration of experimental ischemia
      reperfusion injury in the calf musculature by heme arginate in healthy subjects as measured
      by functional MRI.

      Therefore, we propose that HO-1 induction in the human heart may be a suitable target to
      mitigate cardiac ischemia-reperfusion injury.

      The HO-1 induction will be assessed in a clinical trial by myocardial biopsy prior to and
      after aortic cross-clamping in subjects with or without preceding heme arginate treatment in
      two different dosages. The HO-1 expression will also be measured in the clinical trials in
      peripheral blood mononuclear cells. As additional outcome, levels of myoglobin,
      creatine-kinase and troponin T and reactive oxygen species will be measured in plasma
      according to standard laboratory procedures.
    


Intervention name(s): Heme arginate 3mg/kg; Heme arginate 1mg/kg; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Normosang; Normosang; 0.9% sodium chloride solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: carboxyhemoglobin; neutrophil; reactive oxygen species; reperfusion injury
Local Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional
Phase: Phase 1

Summary: 
      The "dry eye syndrome" DES is a highly prevalent ocular disease, in particular in the elderly
      population. One mainstay of therapy for patients suffering from DES is the use of topically
      administered lubricants. However, despite many efforts, no "ideal" formulation has yet been
      found.

      Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for
      treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with
      favourable biological properties such as high biocompatibility and low toxicity.
      Additionally, the new formulation comprises N-acetylcysteine, which has been used in
      ophthalmology because of its mucolytic properties for several years. Based on theoretical
      considerations, one can hypothesize that the new chitosan derivative may show an increased
      adhesion to mucins of the ocular surface and may therefore be particularly beneficial in
      reducing the symptoms associated with DES. We have recently shown in a phase I trial that
      single instillation of chitosan-N-acetylcysteine eye drops is well tolerated in young healthy
      subjects. However, due to the fact that intraocular pressure has been measured as one of the
      main safety variables, topical anesthesia was necessary. Thus, the data about local ocular
      discomfort after administration are limited. This trial seeks to investigate whether single
      instillation of chitosan-N-acetylcystein leads to ocular discomfort such as burning and
      stinging.
    


Intervention name(s): 0.05% Chitosan-N-Acetylcysteine eye drops; 0.1% Chitosan-N-Acetylcysteine eye drops
Intervention type(s): Device; Device
Intervention description(s): Subjects will be randomized to receive one drop of the medical device in either the right or left eye; Subjects will be randomized to receive one drop of the medical device in either the right or left eye
Intervention MeSH terms: Acetylcysteine; Chitosan; Ophthalmic Solutions; N-monoacetylcystine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dry eye syndromes; Chitosan-N-Acetylcysteine
How Infant Diets Would Affect Growth in Early Childhood
Condition: Growth; Body Composition; Gut Health
Study type: Observational

Summary: 
      The investigators research group conducted a feeding study in 2012 (IRB 07-0003) that
      included breastfed infants consuming different infant solid foods. The investigators results
      showed that different solid foods, especially the protein content of the food, is important
      on infant's gut bacteria profile and growth. Although the first year of life is critical in
      obesity development later in life, data are very limited on the effect of protein from solid
      foods, an important component of infant diet, especially in breast-fed infants. In this
      study, the investigators will re-contact these participants, who are now in their early
      childhood (~5 years old), to evaluate the long-term effect of various macronutrient
      quantities in solid foods, by assessing the participants' growth, body composition, and gut
      bacteria profile.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children 4-6 years of age
      
Biospecimen description: 
      stool samples will be collected for microbiome analysis
Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The present study is the first study designed to evaluate safety, tolerability and
      immunogenicity of the cell culture-derived influenza vaccine in healthy children and
      adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and
      safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to
      enrolling additional children and adolescents 9 to 17 years of age (Cohort 2) and children 3
      to 8 years of age (Cohort 3).
    


Intervention name(s): Cell culture-derived influenza subunit vaccine (cTIV); Egg derived influenza subunit vaccine (eTIV); Cell culture-derived influenza subunit vaccine (cTIV); Egg derived influenza subunit vaccine (eTIV)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): One 0.5 ml injection of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.; One 0.5 ml injection of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.; Two 0.5 mL injections,of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm, administered four weeks apart.; Two 0.5 mL injections of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm,administered four weeks apart.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza; Flu; Cell Culture-Derived; Egg-Derived; Healthy Children; Healthy Adolescents; Safety; Immunogenicity; Trivalent; Inactivated; Vaccination
Effect of Growth Hormone (GH) on Cardiac Echos in GH Deficient Patients After Acromegaly Treatment
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Observational

Summary: 
      The purpose of this research study is to study the effects of growth hormone (GH) replacement
      on the heart. The investigators will study these effects in people who have been cured of
      acromegaly and then have developed growth hormone deficiency (GHD, not enough growth
      hormone).
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men and women between age 18-75 who have developed growth hormone deficiency after history
        of acromegaly with biochemical cure.
      
Biospecimen description: 
      serum and plasma
    
Keywords: acromegaly; growth hormone; growth hormone deficiency
Care for Post-Concussive Symptoms
Condition: Concussion
MeSH terms: Post-Concussion Syndrome
Study type: Interventional

Summary: 
      The proposed study is a pilot randomized trial of a stepped collaborative care intervention
      designed to decrease post-concussive symptoms and improve post-injury functioning among
      sports-injured youth aged 11-17. Participants with persistent post-concussive symptoms
      (symptoms persisting at least two months post-injury) will be recruited from Seattle
      Children's Hospital departments of sports medicine and rehabilitation medicine. Consent and
      assent will be obtained in-person. Participants will be randomized to receive either the
      stepped collaborative care intervention, or treatment-as-usual. Participants will be assessed
      on a range of symptoms and areas of functioning at four time points: 0 months, 1 month, 3
      months, and 6 months after enrollment. The primary hypothesis is that the intervention group
      athletes, when compared to usual care control group athletes, will demonstrate clinically and
      statistically significant reductions in postconcussive, anxiety, and depressive symptoms over
      the course of the 6-month study. Secondary analyses will assess the impact of the
      intervention on functional impairment including missed school days and other academic
      outcomes. Exploratory analyses will examine MRI findings that are characteristic of
      postconcussive neuropathology, if available in medical record, as predictors of treatment
      responses.
    


Intervention name(s): Stepped Care
Intervention type(s): Behavioral
Intervention description(s): Intervention will include : 1) care management; 2) cognitive-behavioral therapy (CBT); 3) psychiatric medication consultation in addition too receiving standard care through their medical team. Care management will include initial consultation to determine participants' and families' concerns and areas of difficulty, followed by brief interventions to connect them with care providers as needed . If participants do not show adequate symptom reduction, they will be engaged in structured CBT. CBT will be delivered in 4 to 12 structured sessions, each ranging from 30-60 minutes in length. Psychiatric medication consultation will be offered on an as-needed basis for participants not adequately responding to prior stepped care interventions. MD providers with expertise in psychopharmacological treatment of youth will provide consultation for participants' primary care provider regarding the prescription of psychiatric medications.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Dentinal Hypersensitivity Reduction
Condition: Dentinal Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this clinical study is to assess the efficacy of a dentifrice containing
      stannous fluoride (Colgate-Palmolive Company, New York, NY, USA) as compared to a
      commercially-available potassium-based toothpaste (Sensodyne Extra Whitening Toothpaste,
      GlaxoSmithKline Co., UK) and a commercially available non-desensitizing toothpaste (Colgate
      Cavity Protection Toothpaste, Colgate-Palmolive Company, New York, NY, USA) in the reduction
      of dentinal hypersensitivity over a seven (7) day period.
    


Intervention name(s): Colgate SNF; Sensodyne Extra Whitening; Colgate Fluoride (CDC)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): toothpaste; toothpaste; toothpaste
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: tactile; airblast; dentin hypersensitivity
Thin Prep Versus Traditional Cytological Procedure for Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      In the diagnosis of lung cancer, the cytological sample obtained during Bronchoscopy (FBS),
      has an increasingly important role in the characterization of malignancy. The cytological
      sample can be harvested during bronchoscopy by bronchial brushing, bronchial lavages or fine
      needle aspiration. Immunocytochemical staining allows not only to discriminate between small
      cell lung cancer versus non-small cell lung cancer (NSCLC), but also to identify the
      expression of specific markers such as TTF-1, CK7, CK20, 4A4, 34βE12 and p63. Thin Prep is a
      technique for cytological assay already validated and largely used in the immunocytochemical
      determination of gynaecologic specimens. Further Studies are required to asses the accuracy
      of this technique compared to conventional smear in cytological airway samples obtained by
      fine needle aspiration.
    

Detailed description: 
      Patients undergoing FBS for lung cancer diagnosis purpose will be enrolled in the study.
      During FBS Fine Need Aspiration (FNA) will be performed. Four samplings by FNA will be
      performed in each patient. Two samplings will be processed with thin prep technique and two
      samplings with the traditional procedure. To avoid sampling procedures-related bias, the
      first harvested sample will be randomly tested with Thin Prep or Traditional technique.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with suspected lung cancer
      
Keywords: Lung Cancer; Bronchoscopy; Fine Need Aspiration; Cytochemical Assays
Reveal LINQ™ In-Office 2 (RIO2) Study International
Condition: Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      The purpose of the RIO 2 International study is to provide clinical and economic evidence to
      support moving the LINQ™ insertion procedure outside these traditional locations within the
      hospital, referred to as "out-of-cathlab".
    

Detailed description: 
      The traditional location of the LINQ™ insertion procedure is the catheterization laboratory,
      electrophysiology laboratory, or operating room. The purpose of the RIO 2 International study
      is to provide clinical and economic evidence to support moving the LINQ™ insertion procedure
      outside these traditional locations within the hospital, referred to as "out-of-cathlab".
    

Intervention name(s): Out of cathlab insertion
Intervention type(s): Other
Intervention description(s): Insertion of the Reveal LINQ device in the "out-of-cathlab" setting (out of the operating room, cardiac catheterization or electrophysiology laboratory).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Relative Bioavailability Study of FOR-6219 in Capsule and Tablet Formulations
Condition: Relative Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomised, open-label, three-way, three-period, crossover relative
      bioavailability study to assess the single-dose pharmacokinetics of FOR-6219 in capsule and
      tablet formulations in postmenopausal women. The effect of high-fat food on the
      pharmacokinetics of the tablet formulation will also be evaluated. A total of twelve,
      post-menopausal women, will be randomised to receive a single oral dose of FOR-6219 in three
      treatment periods: capsule formulation (fasted); tablet formulation (fed); tablet formulation
      (fasted)
    


Intervention name(s): FOR-6219 capsule formulation; FOR-6219 tablet formulation
Intervention type(s): Drug; Drug
Intervention description(s): FOR-6219 capsule formulation will be available as a soft gelatine capsule with a single dose of 50 milligrams, administered orally.; FOR-6219 tablet formulation will be available as a tablet with a single dose of 50 milligrams, administered orally.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HSD17B1 inhibitor; Endometriosis; Food-effect; Bioavailability