bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of
      crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than
      24 months of age with mild-to-moderate AD.
    

Detailed description: 
      Approximately 125 subjects will be enrolled. Subjects must have mild-to-moderate AD involving
      at least 5% treatable %BSA assessed on Baseline/Day 1. Treatable %BSA will be defined as the
      percent of a subject's total body surface area that is AD-involved, excluding the scalp.

      In addition, a cohort of at least 16 of the 125 subjects will be included in a subgroup for
      PK assessment. These subjects must have moderate AD and a minimum of 35% treatable %BSA,
      excluding the scalp, and must complete all PK assessments to be included in the PK analysis.
      Of these subjects, at least 3 subjects who are less than 9 months of age will be enrolled.
      Subjects discontinuing for reasons other than treatment emergent adverse event ( TEAE) may be
      replaced at the discretion of the sponsor to ensure 16 subjects complete the PK assessments.
      Only selected study sites will participate in the PK assessment.

      Scheduled study visits/telephone contacts for all subjects will occur at Screening (up to 28
      days prior to Baseline/Day 1), Baseline/Day 1, Day 8, Day 15, Day 22, Day 29 (end of
      treatment/early termination), Day 36, and Day 57 (end of study).
    

Intervention name(s): Crisaborole ointment 2%
Intervention type(s): Drug
Intervention description(s): Applied BID
Other intervention name(s): Eucrisa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Botox on Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      Botulinum toxin injections are a common form of treatment for children with cerebral palsy to
      help reduce muscle tightness and help them walk without resorting to surgery. While the
      treatment is beneficial, it requires that the therapy be repeated every six months, which can
      be costly and may eventually result in the therapy not being effective over time. The study
      being conducted at Shriners Hospitals for Children, Philadelphia, will examine the effects of
      botulinum toxin injections, not only on walking, but on the changes it causes in the muscle,
      brain and spinal cord. The changes in the muscle, brain and spinal cord, called neuromuscular
      plasticity, have not been extensively examined in response to botulinum toxin, and could
      provide insight into how botulinum toxin works and how to make it more effective. This study
      will focus on children with cerebral palsy between the ages of 4 and 12 years, with only one
      leg involved and who would normally be receiving botulinum toxin injections of the lower leg
      to help improve walking. The children will be asked to come into the hospital for a full day
      before they receive the injection, and then again after four and twelve weeks to look at the
      changes in the muscle, brain and spinal cord. This will involve recording them while they
      walk, measurements of the muscle reflexes, and recording their brain activity while the move
      their ankle (also known as functional magnetic resonance imaging or fMRI). A group of
      children with typical development will also be asked to participate in the study to act as a
      comparison group. The researchers believe that examining the changes in the muscles, brain
      and spinal cord in response to the injection will aid in the understanding how better to use
      botulinum toxin to achieve better or longer lasting changes.
    


Intervention name(s): Botulinum Toxin A
Intervention type(s): Drug
Intervention description(s): Injection into the gastrocnemius/soleus muscles for spasticity
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with spastic hemiplegic or diplegic CP, GMFCS Level I or II
      
Keywords: Cerebral Palsy; Botulinum Toxin; Neuromuscular Function
Comparison of Cardiac Output Measured by Ultrasound Dilution Method and Pulmonary Artery Thermodilution Technique
Condition: Cardiac Disease; Post Surgery Patients
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      Cardiac output (CO) is an important hemodynamic variable in the management of critically ill
      patients. The pulmonary artery catheter (PAC) requires invasive techniques with potential
      complications and there is increasing interest in less invasive methods of measuring CO. This
      study is designed to compare CO values from PAC thermodilution (COTD) and ultrasound dilution
      (COUD).
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Age ≥ 18 years of age Presence of arterial catheter plus central venous pressure monitor
        and pulmonary artery catheter for hemodynamic monitoring.
      
Keywords: Cardiac output; ultrasound dilution; thermodilution
Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Glioblastoma Multiforme or Brain Stem Tumors
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Bone marrow or peripheral stem cell transplantation may be able to
      replace immune cells that were destroyed by chemotherapy used to kill tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by autologous
      bone marrow or peripheral stem cell transplantation in treating patients with glioblastoma
      multiforme or brain stem tumors.
    

Detailed description: 
      OBJECTIVES: I. Estimate the overall survival, progression-free interval, and time to
      progression or recurrence in patients with nondisseminated glioblastoma multiforme or diffuse
      intrinsic brain stem tumors that are nonprogressive following surgery (if feasible) and
      involved-field irradiation and treated with intensive chemotherapy followed by autologous
      peripheral blood stem cell (PBSC) or autologous bone marrow (ABM) rescue. II. Estimate the
      toxicity of myeloablative chemotherapy with thiotepa (TSPA) followed by carboplatin (CBDCA)
      in these patients. III. Evaluate the pharmacokinetic interactions of high-dose CBDCA, TSPA,
      and triethylenephosphoramide (a metabolite of TSPA) and any impact on subsequent toxicity.
      IV. Evaluate the effectiveness of autologous stem cells in restoring hematopoiesis following
      myeloablative therapy.

      OUTLINE: All patients undergo bone marrow or stem cell harvest (investigator option) no later
      than 12 weeks after completion of radiotherapy. The following acronyms are used: ABM
      Autologous Bone Marrow CBDCA Carboplatin, NSC-241240 G-CSF Granulocyte Colony-Stimulating
      Factor (Amgen), NSC-614629 PBSC Peripheral Blood Stem Cells TSPA Thiotepa, NSC-6396 2-Drug
      Myeloablative Chemotherapy followed by Hematopoietic Rescue. TSPA; CBDCA; followed by ABM or
      PBSC; G-CSF.

      PROJECTED ACCRUAL: 60 patients will be entered over 3 years. If more than 5 patients on any
      arm experience treatment-related mortality, accrual will be discontinued.
    

Intervention name(s): filgrastim; carboplatin; thiotepa; autologous bone marrow transplantation; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Carboplatin; Thiotepa
Primary purpose: Treatment
Keywords: adult brain stem glioma; adult glioblastoma; childhood high-grade cerebral astrocytoma; untreated childhood brain stem glioma; adult giant cell glioblastoma; adult gliosarcoma
A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of tirzepatide in participants with obesity. The main purpose is to learn
      more about how tirzepatide affects the number of calories participants burn and the amount of
      food they eat. The study lasted for 28 weeks and will include about 21 visits to the study
      center.
    


Intervention name(s): Tirzepatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY3298176
Intervention MeSH terms: Tirzepatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study of ARQ 197 Monotherapy
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase II open-label study with ARQ 197 administered orally and twice daily as monotherapy
      in patients with previously treated advanced/recurrent gastric cancer. The primary endpoint
      is disease control and the secondary efficacy endpoints include antitumor effect (tumor
      response), progression-free survival and overall survival. The pharmacokinetic profile and
      the safety profile are also evaluated.
    


Intervention name(s): ARQ 197
Intervention type(s): Drug
Intervention description(s): Orally twice daily administration of ARQ 197
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced/recurrent gastric cancer
Effectiveness of Laying-on-of-hands for Sickle Cell Disease
Condition: Sickle Cell Disease; Pain Crisis Recurrent; Anemia; Infection; Death
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the effectiveness of 1-year administration of
      laying-on-of-hands on the morbidity and mortality of patients with sickle cell disease in
      Africa.
    

Detailed description: 
      Patients with sickle cell disease (SCD) have a high risk of premature death in Africa, mainly
      due to insufficient medical services. SCD patients often visit emergency department and need
      hospitalization when they suffer from severe pain; however, they manage most of painful
      episodes at home. Appropriate pain management at home is, therefore, crucial to improve their
      clinical course and quality of life. Laying-on-of-hands may be a good candidate for home care
      management, because family member(s) can become a practitioner of laying-on-of-hands without
      difficulty and administer it to their loved one as an initial treatment whenever necessary.
      There are no reports concerning the effectiveness of laying-on-of-hands for the outcomes of
      SCD patients, as far as we have investigated.
    

Intervention name(s): laying-on-of-hands
Intervention type(s): Behavioral
Intervention description(s): The intervention group received laying-on-of-hands every weekday for 1 year along with conventional medicine. The control group did not undergo any alternatives to OPT.
Other intervention name(s): Okada Purifying Therapy; biofield therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sickle cell disease; laying-on-of-hands; morbidity; mortality
Bupropion for the Treatment of Methamphetamine Dependence - 1
Condition: Amphetamine-Related Disorders
MeSH terms: Amphetamine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of bupropion in reducing
      methamphetamine use in subjects with methamphetamine dependence
    

Detailed description: 
      A double-blind, placebo-controlled, parallel-group design study in which 100 subjects will be
      randomly assigned to placebo or bupropion for 12 weeks with follow-up assessments 4 weeks
      following treatment. Adaptive randomization will be used to balance treatment groups based on
      gender.
    

Intervention name(s): Bupropion
Intervention type(s): Drug
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: amphetamine dependence
Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis
Condition: Spasticity in People With Multiple Sclerosis
MeSH terms: Muscle Spasticity; Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.
    

Detailed description: 
      Single dose escalation followed by multiple fixed dose administrations to assess short term
      safety and to determine whether spasticity improves.
    

Intervention name(s): VSN16R; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Small molecule; dummy tablet
Other intervention name(s): Not yet available
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MS; Spasticity; VSN16R
Laser Therapy for Pediatric Burn Scars
Condition: Cicatrix, Hypertrophic; Burns
MeSH terms: Cicatrix; Cicatrix, Hypertrophic; Burns
Study type: Observational

Summary: 
      A new era of outcomes for pediatric burn patients has begun as burn care continues to
      improve. Unfortunately, complete restoration of burn-injured skin may be limited by the
      development of hypertrophic scarring. Treatment with laser therapy is one of the newest forms
      of scar therapy available. Although laser therapy has only been adopted by burn clinicians
      within the last several years, early evidence suggests that it may offer significant
      benefits. Thus the aim of this study is to investigate the effectiveness of using laser
      therapy to treat hypertrophic burn scars in pediatric patients by using a comprehensive set
      of subjective and objective scar assessment tools.
    


Intervention name(s): Laser Therapy
Intervention type(s): Device
Intervention description(s): Laser therapy is a technology that can be used to treat hypertrophic burn scars.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible participants will be pediatric patients with hypertrophic scars requiring
        treatment.
      
Keywords: Pediatric; Laser; Burn; Scar; Photothermolysis
Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease
Condition: Raynaud's Disease
MeSH terms: Raynaud Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days
      2101 dosing period.
    

Detailed description: 
      1. Number and cumulative duration of Raynaud's attacks.

        2. Adverse events and changes in vital signs.

        3. SLx-2101 pharmacokinetic parameters derived after dosing on Day 1 and Day maximum plasma
           concentration (Cmax), area under the plasma concentration-time curve (AUC0-4), time to
           Cmax (tmax), and accumulation ratio
    

Intervention name(s): SLx-2101; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Captivator EMR Registry
Condition: Barrett's Esophagus
MeSH terms: Barrett Esophagus
Study type: Observational [Patient Registry]

Summary: 
      To confirm performance of the Captivator™ EMR device for resection of early neoplasia in
      Barrett's Esophagus.
    


Intervention name(s): Captivator™ EMR
Intervention type(s): Device
Intervention description(s): The Captivator ™ EMR Device is indicated for endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Barrett's Esophagus patients with early neoplasia.
      
Keywords: EMR; EAC; Barrett's Neoplasia; Multiband Mucosectomy
Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients
Condition: Gout; Arthritis, Gouty; Hyperuricemia; Gout Chronic
MeSH terms: Gout; Arthritis, Gouty; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the serum uric acid lowering effect and safety of AR882 in gout
      patients at two doses compared to placebo over 12 weeks.
    


Intervention name(s): AR882 Dose 1; AR882 Dose 2; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Solid Oral Capsule; Solid Oral Capsule; Matching Solid Oral Capsule Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetic Interaction Between Ritonavir and Prasugrel in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      HIV patients are at particular risk to develop cardiovascular disease (CVD) as they exhibit
      multiple known risk factors for CVD. Of specific concern is the fact that use of the non
      nucleosidic reverse transcriptase inhibitors (NNRTI) and/or protease inhibitors (PI) drug
      classes is associated with dyslipidemia known to increase the risk of coronary heart disease
      particularly among older subjects with normalized CD4 cell counts and suppressed HIV
      replication. HIV patients could thus potentially receive anti-aggregant therapy concomitantly
      with their antiretroviral treatment. Prasugrel is an anti-aggregating agent indicated to
      prevent the recurrence of ischemic events after coronary arteries stenting. It is a pro-drug
      mainly metabolized by cytochromes P450 (CYP) 3A and 2B6 and to a lesser extent by CYP2C9 and
      2C19. Ritonavir is an anti-protease and CYP3A4 and CYP2B6 inhibitor used in anti-HIV therapy.
      The aim of the present study is to assess the potential drug-drug interaction between
      prasugrel and the CYP3A/2B6 inhibitor ritonavir. Ten healthy volunteers will receive
      prasugrel 10mg alone or after 100mg ritonavir. The effect of ritonavir on prasugrel
      pharmacokinetics will be assessed. The two sessions will be separated by a one-week "wash
      out" period. During each session, CYP3A, 2B6, 2C9 and 2C19 activities will be assessed by a
      micrococktail approach with microdoses of midazolam, bupropion, flurbiprofen and omeprazole.
      The pharmacokinetics of prasugrel active metabolite will be assessed during the two sessions.
    


Intervention name(s): Prasugrel; Ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): Assessment of prasugrel metabolic ratio and phenotyping of CYP2B6/2C9/2C19/3A4; Assessment of prasugrel metabolic ratio and phenotyping of CYP2B6/2C9/2C19/3A4 in presence of ritonavir
Intervention MeSH terms: Ritonavir; Prasugrel Hydrochloride
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Framing on Medication Beliefs, Intentions to Take Medication, Adherence, and Asthma Control
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The goal of this study is to examine the effects of framed mobile messages on young adults'
      beliefs about their daily Inhaled Corticosteroids (ICS), intentions to take their ICS,
      adherence, and asthma control. College students (18-29 years) who owned a mobile phone and
      had a diagnosis of asthma with a prescription for an ICS will be recruited. Participants will
      be randomized to receive either gain- or loss-framed mobile messages three times per week for
      eight weeks. Outcomes including beliefs, intentions, adherence, and asthma control will be
      assessed.
    


Intervention name(s): Negatively Framed text messages; Positively Framed text messages
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Negatively Framed text messages delivered to participants three times per week for 8 weeks.; Positively Framed text messages delivered to participants three times per week for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: mHealth; message framing
Impact of Peer Education Program on Headache Disorders
Condition: Headache Disorder
MeSH terms: Headache Disorders; Headache
Study type: Interventional

Summary: 
      Worldwide, headache disorders are among the most common medical conditions. Many people with
      headache need not experience further pain if the diagnosis and treatment are correct. Most
      patients do not have correct diagnosis and treatment. This study tested a model for treatment
      of people with headache disorders at primary health-care level in rural areas of Haryana,
      India.
    


Intervention name(s): Community education programs
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Laryngeal Mask Airway (LMA) Protector for Minimally Invasive Thyroidectomy
Condition: Sore Throat; Dysphagia; Postoperative Pain
MeSH terms: Pharyngitis
Study type: Interventional

Summary: 
      The patients will be allocated to 2 groups: the LMA group and the endotracheal tube (ET)
      group. Airway management will be done with the LMA Protector for the patients of the LMA
      group and with the classic endotracheal tube for the patients of the ET group. The main
      purpose of the study is to determine if the application of the LMA Protector causes less
      laryngopharyngeal symptoms than the endotracheal tube after minimally invasive thyroidectomy.
      The secondary purpose is to confirm that the LMA Protector is a safe alternative airway
      management device for minimally invasive thyroidectomy.
    


Intervention name(s): LMA Protector; Endotracheal tube
Intervention type(s): Device; Device
Intervention description(s): After induction of general anesthesia, the LMA Protector will be applied for airway management. The size of the laryngeal mask will be chosen according to the manufacturer's instructions. Lubricant gel will be applied to the dorsal side of the mask to ease the insertion to the oropharynx. The cuff of the mask will be filled with air by syringe until the indication of the integrated cuff pressure indicator is appropriate according to the manufacturer (green indication). If the indication changes during surgery, air will be added or removed accordingly. If the ventilation of the patient is inadequate at the beginning or anytime during the operation, the mask will be removed and the patient will be intubated.; After induction of general anesthesia, the endotracheal tube be applied for airway management. The size of the tube will be 7.5 for female and 8.5 for male patients. The cuff of of the tube will be filled with 10ml air.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care