bioihbjkbjnl/mcl2 huggingface dataset:
A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the long-term safety and efficacy of TAU-284
      (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks
      administration.
    

Detailed description: 
      This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and
      efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12
      weeks administration.
    

Intervention name(s): Bepotastine besilate
Intervention type(s): Drug
Intervention description(s): Two TAU-284 5mg tablets will be taken orally twice a day
Other intervention name(s): TALION 5mg tablets
Intervention MeSH terms: Bepotastine besilate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TAU-284; Bepotastine besilate; Histamine H1 receptor antagonists; children
Activity Monitoring Assessment of Opiate Withdrawal - 4
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if hyperactivity accompanies abrupt opiate
      withdrawal in heroin addicts, to determine if computerized solid state activity monitors are
      capable of quantifying hyperactivity, and to quantify the physical and affective symptoms
      occurring during abrupt withdrawal in heroin addicts and morphine's capacity to alleviate
      these symptoms.
    


Intervention name(s): Morphine
Intervention type(s): Drug
Intervention MeSH terms: Morphine
Primary purpose: Treatment
Keywords: opioid dependence
Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      Psoriasis is a chronic inflammatory cutaneous disease, affecting 3% of the French population.
      Among psoriatic patients, 80% feel pain or cutaneous discomfort related to their pathology.

      Neurogenic inflammation's role in psoriasis has recently been put forward by a study showing
      that TRPV1 ion channels are necessary to establish psoriasiform inflammation in mice.

      The investigators hypothesize that there is a link between cutaneous sensory neuropathies and
      altered cutaneous microcirculation during psoriasis.

      In order to test this hypothesis, local vasodilators will be delivered to patients by
      iontophoresis and their skin blood flow in response to these molecules will be followed by
      laser Doppler recordings. Two recordings will be performed for each patient, both on a
      psoriasis plaque and on uninvolved skin, in order for the patient to be his own internal
      control.
    


Intervention name(s): Acetylcholine iontophoresis; Sodium Nitroprussiate iontophoresis; ppi water iontophoresis; Laser Doppler recording
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Acetylcholine will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).; Sodium Nitroprussiate will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).; ppi water will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).; Skin blood flow will be recorded by laser Doppler during 2 minutes before iontophoresis, and during 30 minutes following iontophoretic delivery of vasodilators.
Intervention MeSH terms: Acetylcholine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Psoriasis; Microcirculation; TRPV1
Computer-based Attention Training in Patients With Acquired Brain Injury
Condition: Brain Injuries
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Investigates computer based cognitive rehabilitation and training using the N-back task with
      a Visual Search task as an active control. The overall purpose is to provide (further)
      evidence about the efficacy (or lack of efficacy) of the N-back task and to find points of
      convergence and divergence between patients with acquired brain injury and non-impaired
      subjects.
    


Intervention name(s): N-back; Visual Search
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The N-back task required patients to monitor a continuous sequence of stimuli (in this experiment audio and visual stimuli). Press a button if the current stimulus is the same as that shown N back in the sequence. N increases if performance is good and decreases if performance is poor.
Subjects train for 20 days, 12 blocks a day, 20+N trials per block. That is 240 blocks in total. A minimum of 10 blocks per day counts as a successfully trained day.; The Visual Search task consists of a NxN array of shapes. Press the button if a certain target stimulus is present in this array. N increases if performance is good and decreases if performance is poor.
Subjects train for 20 days, 12 blocks a day, 20+N trials per block. That is 240 blocks in total. A minimum of 10 blocks per day counts as a successfully trained day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive training; Cognitive rehabilitation; Acquired brain injury; N-back; Visual Search; Cognitive transfer
Etravirine Plus 2 Analogs in HIV-infected Patients
Condition: HIV-1-infection
MeSH terms: Infections
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the virological and clinical efficacy of etravirine
      plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs) in HIV-infected
      patients. Additionally, the safety of these regimens, specially lipid profiles, will be
      assessed.
    

Detailed description: 
      Methods: prospective, single arm multicenter clinical trial without entry restrictions on
      plasma HIV-RNA (VL) or CD4 with a planned duration of 52 weeks.

      The primary clinical endpoint is the percentage of subjects with therapeutic success on
      etravirine 400 mg/day (200 mg bid or 400 mg qd) plus 2 active NRTIs after 12 months. Efficacy
      data will be analyzed by on-treatment and by intention-to-treat analyses (noncomplete/missing
      equals failure), considering treatment failure as either treatment interruption whatever the
      reason (adverse events, death, or loss to follow-up) or virological failure, defined as
      inability to suppress the VL to less than 50 copies/ml after 24 weeks on treatment or a
      confirmed VL of more than 200 copies/ml in patients who had previously achieved a viral
      suppression or had an undetectable viral load at inclusion.

      Patients missing two consecutive scheduled visits were considered lost to follow-up. The
      safety and tolerability of the studied medications will be evaluated by means of clinical
      adverse events, physical examination and laboratory results.

      NRTIs prescribed as part of HAART were selected by the responsible physicians on the basis of
      previous antiretroviral treatments and/or genotypic resistance testing.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-infected patients who strated an antirretroviral regimen based on etravirine plus 2
        NRTIs between January 2009 and June 2010
      
Biospecimen description: 
      plasma
    
Keywords: HIV-infection; Etravirine; Treatment; Non-nucleoside reverse-transcriptase inhibitor
Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by ANP
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      To evaluate whether ANP as an adjunctive therapy for AMI reduces myocardial infarct size and
      improves regional wall motion.
    

Detailed description: 
      The benefits of percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI)
      are limited by reperfusion injury. In animal models, atrial natriuretic peptide (ANP) reduces
      infarct size, so the Japan-Working groups of acute myocardial Infarction for the reduction of
      Necrotic Damage by ANP(J-WINDANP) designed a prospective, randomized, multicenter study, to
      evaluate whether ANP as an adjunctive therapy for AMI reduces myocardial infarct size and
      improves regional wall motion.

      Twenty hospitals in Japan will participate in the J-WIND-ANP study. Patients with AMI who are
      candidates for PCI are randomly allocated to receive either intravenous ANP or placebo
      administration. The primary end-points are (1) estimated infarct size (Σcreatine kinase and
      troponin T) and (2) left ventricular function (left ventriculograms). Single nucleotide
      polymorphisms (SNPs) that may be associated with the function of ANP and susceptibility of
      AMI will be examined. Furthermore, a data mining method will be used to design the optimal
      combinational therapy for post-MI patients.

      J-WIND-ANP will provide important data on the effects of ANP as an adjunct to PCI for AMI and
      the SNPs information will open the field of tailor-made therapy. The optimal therapeutic drug
      combination will also be determined for post-MI patients.
    

Intervention name(s): ANP(hANP); Control
Intervention type(s): Drug; Drug
Intervention description(s): 0∙025 μg/kg per min for 3 days(intravenous); placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute myocardial infarction; Atrial natriuretic peptide; Data mining; Randomized clinical trial; SNPs
Combination Chemotherapy With or Without Filgrastim in Treating Patients With Advanced Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
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. Colony-stimulating factors such as filgrastim may increase the
      number of immune cells found in bone marrow or peripheral blood and may help a person's
      immune system recover from the side effects of chemotherapy.

      PURPOSE: Phase I trial to study the effectiveness of gemcitabine combined with docetaxel and
      carboplatin with or without filgrastim in treating patients who have advanced solid tumors.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and docetaxel when
      administered with carboplatin with or without filgrastim (G-CSF) in patients with advanced
      solid tumors. II. Determine a safe dose level and schedule for this regimen for phase II
      study in these patients. III. Determine the toxicity of this regimen in these patients.

      OUTLINE: This is a dose-escalation study of docetaxel and gemcitabine. Patients receive
      gemcitabine IV over 30 minutes, docetaxel IV over 1 hour, and carboplatin IV over 30 minutes
      on day 1. Patients also receive gemcitabine IV over 30 minutes on day 8. Treatment repeats
      every 21 days for approximately 6 courses in the absence of disease progression or
      unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine and
      docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
      dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
      (DLT). If the DLT is grade 4 neutropenia, filgrastim (G-CSF) is added to the regimen
      (administered subcutaneously on days 2-7 and 8-14 or until blood counts recover). A new MTD
      is then determined. Patients are followed every 3 months.

      PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
    

Intervention name(s): filgrastim; carboplatin; docetaxel; gemcitabine hydrochloride
Intervention type(s): Biological; Drug; Drug; Drug
Intervention MeSH terms: Carboplatin; Gemcitabine; Docetaxel
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Optical Frequency Domain Imaging for Non-melanoma Skin Cancers
Condition: Non-Melanoma Skin Cancer (NMSC)
MeSH terms: Skin Neoplasms
Study type: Interventional

Summary: 
      The purpose of this research study is to find out if a non-invasive imaging device called
      Optical Frequency Domain Imaging (OFDI) can help doctors to see the tissue and blood vessels
      that are related to non-melanoma skin cancers. OFDI was designed to see microscopic details
      of your skin without needing to use any invasive techniques such as surgery or biopsy.
    

Detailed description: 
      Non-melanoma skin cancer (NMSC) is the most common cancer in the United States, with more
      than 750,000 diagnosed patients treated every year. Its prevalence and incidence have
      significantly increased over the past two decades and it has been estimated that 20% of all
      Americans will develop this type of cancer during their lifetime (Neville et al., 2007).
      Biopsy and surgical resection of NMSC can result in tissue mutilation and scaring. Therefore,
      there is a need for new imaging technologies that can be used to non-invasively guide biopsy
      and surgery.

      Optical Frequency Domain Imaging (OFDI) is a second-generation imaging implementation of
      optical coherence tomography (OCT) developed at the Wellman Center. OFDI provides
      high-resolution three-dimensional imaging in tissue. It uses an interferometric
      depth-sectioning technique and employs a near-infrared light source. Through analysis of
      phase information in the recorded signal. OFDI can detect blood vessels within tissues and
      tumors. Importantly, OFDI-based vascular imaging can be performed without the need for
      exogenous contrast agents, making it relatively easy to deploy in clinical settings.
    

Intervention name(s): OFDI
Intervention type(s): Device
Intervention description(s): Imaging of skin
Other intervention name(s): Optical Imaging; Optical Coherence Tomography; OCT; Optical Frequency Domain Imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: skin cancer; optical imaging; optical coherence tomography; optical frequency domain imaging
Effectiveness of Extended Telephone Monitoring
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effectiveness of extended telephone monitoring
      for alcohol-dependent patients receiving intensive outpatient treatment. It is hypothesized
      that telephone monitoring will produce better alcohol use outcomes relative to treatment as
      usual. It is also hypothesized that adaptive telephone monitoring plus brief counseling will
      produce better alcohol use outcomes over time relative to telephone monitoring plus feedback
      only.
    


Intervention name(s): Telephone Monitoring and Feedback; Telephone Monitoring and Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In addition to attending IOP, participants receive phone contact from our counselors but only to receive a monitoring assessment. There is no feedback or counseling from study staff in this condition.; In addition to attending IOP, participants have phone contact with study counselors, which includes monitoring, feedback, and counseling.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine whether LY2181308 in combination with
      docetaxel is safe and effective treatment for hormone refractory prostate cancer patients.
    


Intervention name(s): docetaxel; LY2181308 sodium; Prednisone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.; LY2181308 sodium (referred to as LY2181308 throughout this record) administered weekly plus docetaxel 75 mg/m² intravenously administered every 21 days. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.; Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy
Intervention MeSH terms: Prednisone; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hormone Refractory Prostate Cancer
A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial will be conducted to evaluate the efficacy and safety of the Centanafadine
      extended release (XR) capsules in adolescent subjects (13 - 17 years, inclusive) with ADHD.
    

Detailed description: 
      The trial will consist of a screening period of up to 28 days (4 weeks), a 42-day (6-week)
      double-blind treatment period, and a 7 (+ 2)-day follow-up period.
    

Intervention name(s): Centanafadine Hydrochloride; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Capsule; Capsule
Other intervention name(s): Centanafadine QD XR; Matching Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Centanafadine; ADHD
A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135
      in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C
    


Intervention name(s): VX-135; ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): 12 weeks of VX-135; 12 weeks of ribavirin
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C; HCV; CHC
Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring and Nonlaboring Patients by Practicing Clinicians
Condition: Pregnancy
Study type: Observational

Summary: 
      This multi-reader multi-case study was designed to evaluate the performance of SureCALL®
      Labor Monitor® (SureCALL®) directly to the standard Tocodynamometer device (TOCO).
    

Detailed description: 
      The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor
      intended to measure uterine activity. It is intended for use on pregnant women, with
      singleton pregnancies, using surface electrodes on the maternal abdomen. The device is
      intended for use by healthcare professionals in a clinical setting.

      This multi-reader multi-case study was designed to evaluate the performance of SureCALL® to
      the predicate Tocodynamometer device (TOCO).

      This study involved 25 women at a Gestational Age of 36 weeks or less and 5 women at a
      Gestation Age of greater than 36 and not in labor at five clinical sites. Each study subject
      was instrumented with two technologies for measuring uterine activity:

        1. Standard tocodynamometer attached to the maternal abdomen,

        2. SureCALL® with a set of abdominal surface electrodes for uterine electromyography
           attached to the maternal abdomen

      An assessment was obtained and quantified from masked, qualified clinical obstetrician
      readers for the evaluation of the equivalence of both labor monitor devices by identifying in
      isolation the individual uterine contraction signals and the peak of each contraction signal
      as recorded by each labor monitor device.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women with uncomplicated singleton pregnancies
Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam
Condition: Safety Issues; Pharmacokinetics; Drug Interaction; Tolerability
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open-label, fixed design, drug-drug-interaction (DDI) study divided in 2
      parts. Part I is designed to evaluate whether concomitant treatment with linaprazan glurate
      and clarithromycin, a strong inhibitor of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein P
      (PgP), leads to an effect on the systemic exposure to linaprazan glurate and linaprazan and
      whether there is an effect on the pharmacokinetics of clarithromycin after a single dose of
      linaprazan glurate. Part II is designed to evaluate the effect of repeated doses of
      linaprazan glurate on the pharmacokinetics (PK) of a sensitive substrate of CYP3A
      (midazolam).
    


Intervention name(s): Linaprazan glurate; Drug drug interaction (DDI) - Clarithromycin (Part I); Drug drug interaction (DDI) - Midazolam (Part 2)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Investigational Medicinal Product: Linaprazan glurate (tablets).
Part I:
Linaprazan glurate in base form, 100 mg once daily Day 1 and Day 10.
Part II:
Linaprazan glurate hydrochloride (HCl), 75 mg twice daily for 13 days.; Index inhibitor (perpetrator drug) Clarithromycin 500 mg twice daily for 9 days (tablets).; Substrate for CYP3A. Midazolam 2.5 mg once daily (2.5 mL oral solution).
Intervention MeSH terms: Clarithromycin; Midazolam
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science