bioihbjkbjnl/mcl2 huggingface dataset:
The Study of Cardiovascular Outcomes in Women With Preeclampsia Using Echocardiography: The SCOPE Study
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      This study will evaluate the differences in cardiovascular parameters between women with
      severe preterm preeclampsia and those without preeclampsia using echocardiography and
      maternal blood. The investigators will also look at associations of abnormal cardiovascular
      findings and immediate complications among a high risk cohort of pregnant African American
      women.
    

Detailed description: 
      This will be a prospective cohort study. Exposed cases will be admitted to the inpatient
      obstetrical unit (labor & delivery or antepartum unit) at the Hospital of the University of
      Pennsylvania with concern for severe preterm preeclampsia. Unexposed controls will be matched
      by gestational age and other clinical factors and will be obtained from the outpatient
      setting (Helen O Dickens clinic or Penn ObGyn Associates at 3701 Market Street). The
      investigators will compare cardiovascular risk factors between these two groups.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will take place on the obstetrical unit at the Hospital of the University of
        Pennsylvania (HUP) as well as in the outpatient setting. The patient population is primary
        from the surrounding urban region. The majority receive prenatal care at our institution.
        Based on fiscal year 2010 at HUP, the mean age was 24 years old and 85% were African
        American.
      
Biospecimen description: 
      Evaluation of angiogenic factors, markers of heart failure, and evaluation of extracellular
      RNAs will specifically be used for discovery. The investigators will not be evaluating DNA.
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 (Andecaliximab) in Adults With Moderate to Severe Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are as follows:

        -  To assess the safety and tolerability of escalating single and multiple doses of GS-5745
           (andecaliximab) in participants with moderate to severe ulcerative colitis (UC) as
           assessed by adverse events (AEs) and laboratory abnormalities

        -  To assess the pharmacokinetics (PK) of GS-5745 (andecaliximab) in participants with
           moderate to severe UC.
    

Detailed description: 
      The study will test the safety of the drug. Participants will be given different
      concentrations of the drug in Cohorts, starting from a lower dose to a higher dose.

      Single-Dose Treatment:

      A thorough assessment of safety and tolerability will be performed before escalating to the
      next higher dose. For example, the first 2 participants will be dosed in a staggered fashion
      24 hours apart. Provided that there are no significant safety signals up to 24 hours
      post-dose for the first 2 participants, the remaining 4 participants will be dosed. A
      thorough assessment of safety and tolerability (through Day 14 post-dose) will be performed
      by the safety review committee before escalating to the next higher dose. Participants
      enrolled in a SAD cohort will be eligible to participate in a MAD or adaptive MAD cohort if
      eligibility criteria are met.

      Multiple-Dose Treatment:

      This design follows the same set-up as the Single-Dose Treatment. Dosing will not commence in
      the first MAD cohort until safety data from the second dose level SAD cohort has been
      reviewed through Day 15. Successive MAD cohorts will only be dosed after safety data from the
      previous, lower dose MAD cohort through Day 43 and the next higher dose SAD cohort through
      Day 15, have been reviewed by the safety review committee. An additional Adaptive MAD cohort
      will explore a subcutaneous dosing of andecaliximab 150 mg prefilled syringe once a week for
      5 weeks.
    

Intervention name(s): Andecaliximab; Placebo to match Andecaliximab
Intervention type(s): Drug; Drug
Intervention description(s): Andecaliximab administered by intravenous (IV) infusion or subcutaneous (SC) injection; Placebo to match andecaliximab administered by IV infusion
Other intervention name(s): GS-5745
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder
Condition: Binge Eating Disorder; Obesity
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the safety and efficacy of sibutramine in preventing
      binge eating episodes. Additionally the study aim is to evaluate the safety and efficacy of
      sibutramine in reducing body weight in subjects with binge-eating disorder.
    


Intervention name(s): sibutramine
Intervention type(s): Drug
Intervention MeSH terms: Sibutramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Sensory Nociceptive Nerve Fibers, Key Regulator of Immune Response Type 2 in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The skin is innervated by a network of nociceptive sensory neurons (nociceptors) whose
      primary function is the transmission of pain and pruritus signals to the central nervous
      system. Their role in atopic dermatitis (AD), characterized by an exacerbated type 2 immune
      response, is only partially understood. Nevertheless, large amounts of neuropeptides,
      including substance P (SP), are found in the serum of patients, their level being correlated
      with the clinical severity of AD. Mast cells (MC) are part of the cells of the immune system
      residing in the skin. MCs have neuro-receptors of the Mas-related G protein-coupled receptors
      family (MRGPR) and in particular MRGPRX2 (the receptor for cationic molecules [including SP]
      for MCs) through which they could communicate in a privileged way. with the nociceptors.
      Preliminary data obtained in mice show that its mouse orthologue "MrgprB2" is absolutely
      necessary for the development of type 2 immunity and the pathological characteristics of a
      preclinical "DA-like" model (manuscript in preparation). The investigators therefore
      hypothesize that the activation of MCs expressing MRGPRX2 by nociceptors producing SP plays a
      key role in the development of type 2 inflammation in AD in humans.
    


Intervention name(s): Clinical examination; Biopsies; Blood test
Intervention type(s): Other; Procedure; Other
Intervention description(s): This is a classic dermatological clinical examination during a classic consultation; 2 skin biopsies on a lesion area selected according to the inclusion criteria (2 punchs of 4 mm) for each experimental group.
The first half of whole cutaneous biopsies (n = 25) will be studied using biphotonic microscopy. This will be performed on whole biopsies in 3-D according to the protocol developed in the laboratory.
The second half of whole skin biopsies (n = 25) will be studied using the technique of single-cell RNA seq.
The skin controls skin-free subjects will be obtained from skin reduction surgery (abdominoplasty) to subjects who have agreed to the use of their skin sample.; A blood test on a tube (2 tubes of 10 mL).An assay of specific IgE and the serum level of IL-4, IL-13 and IL-5 will be carried out by ELISA (Enzyme Linked ImmunoSorbent Assay) from the blood samples.The blood samples will be obtained through the French blood establishment from different donors who have given their consent.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: nociceptors- immune response; atopic prurigo
Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-462206
Condition: Safety; Tolerability; Pharmacodynamics; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      A study of ACT-462206 to evaluate the tolerability, safety, pharmacokinetics, and
      pharmacodynamic of ascending single doses of ACT-462206, a novel dual orexin receptor
      antagonist in healthy male subjects.
    

Detailed description: 
      Each dose level will be investigated in a new group of eight healthy male subjects (six on
      active drug and two on placebo). Each subject will participate in one treatment period, with
      the exception of subjects in the crossover part (i.e., almorexant reference group at the
      fourth dose level), who will participate in two treatment periods. At this dose level
      subjects on active drug (six) will receive in one treatment period ACT-462206 and in the
      other 400 mg of almorexant; subjects on placebo (two) will receive the corresponding placebos
      (double-dummy).
    

Intervention name(s): ACT-462206 5 mg; ACT-462206 25 mg; ACT-462206 100mg; ACT-462206 200mg; ACT-462206 400mg; ACT-462206 1000 mg; ACT-462206 1500mg; Almorexant 400mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: ACT-462206; Selective dual orexin receptor antagonist
Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
      ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
      help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such
      as liposomal doxorubicin, work in different ways to stop the growth of cancer cells, either
      by killing the cells or by stopping them from dividing. Giving rituximab together with
      liposomal doxorubicin may kill more cancer cells.

      PURPOSE: This phase I/II trial is studying the side effects of giving rituximab together with
      liposomal doxorubicin and to see how well they work in treating patients with relapsed or
      refractory B-cell non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the safety, including qualitative and quantitative toxic effects and their
           duration and reversibility, of rituximab and doxorubicin HCl liposome in patients with
           relapsed or refractory, indolent or aggressive CD20-positive B-cell non-Hodgkin's
           lymphoma.

      Secondary

        -  Determine the efficacy, including overall response rate and durability of objective
           response, of this regimen in these patients.

        -  Correlate pretreatment functional, phenotypic, and genotypic characteristics of host
           immune effector cells with response in patients treated with this regimen.

      OUTLINE: This is an open-label, pilot study.

      Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over
      1-3 hours on day 3. Treatment repeats every 21 days for 6 courses in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically for 4 years.

      PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
    

Intervention name(s): rituximab; pegylated liposomal doxorubicin hydrochloride
Intervention type(s): Biological; Drug
Intervention description(s): IV; IV
Intervention MeSH terms: Rituximab; Doxorubicin; Liposomal doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; recurrent small lymphocytic lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma
Radiofrequency Neurotomy In Relieving Chronic Knee Pain
Condition: Osteo Arthritis Knee; Pain, Chronic
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Chronic Pain
Study type: Interventional

Summary: 
      Osteoarthritis (OA) affects aged above 45 years. RF has been used for several painful
      conditions. There have been a few attempts to use RF current for the treatment of painful
      conditions of joints of the extremities. It was also used for the treatment of painful
      conditions of the hip joint.
    

Detailed description: 
      Osteoarthritis (OA) is commonest chronic arthritis affecting patients usually aged above 45
      years. OA decreased health-related quality of life and increased economic costs.
      Radiofrequency (RF), was used for the treatment of chronic pain unresponsive to conservative
      therapies. RF has been used for several painful conditions. There have been a few attempts to
      use RF current for the treatment of painful conditions of joints of the extremities. It was
      also used for the treatment of painful conditions of the hip joint.
    

Intervention name(s): radiofrequency; Paracetamol (conventional); Ketorolac Tromethamine (conventional)
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): radiofrequency done in the three genicular nerves upper medial and upper lateral and lower medial
Intervention MeSH terms: Acetaminophen; Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study to Evaluate the Safety and Efficacy of Zonisamide an Antiepileptic Drug as Monotherapy or Adjunctive Therapy in Treatment of Adult Patients With Partial, Generalized or Combined Seizures.
Condition: Partial, Generalized and Combined Seizures
MeSH terms: Seizures
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of zonisamide in the
      treatment of adult patients with partial, generalized or combined seizures.
    

Detailed description: 
      This is an open labeled non-comparative, multicentric observational post marketing
      surveillance study to comparing the safety and efficacy of zonisamide as adjunctive therapy
      or monotherapy in patients with partial, generalized or combined seizures, in a initiating
      dose of 100mg/day titrated to a maximum of 600mg per day based on the seizure control and
      tolerability over a 24 weeks treatment period. This study will include a total of 900
      patients with partial, generalized or combined seizures across 30 centres in the country. The
      patients will be enrolled based on the inclusion and exclusion criteria and will be evaluated
      for safety and efficacy at every 4 weekly interval for 24 weeks. There will be total 7 study
      visits and the patients will be evaluated for clinically reportable adverse events, safety on
      Patients Global Assessment of Tolerability to Therapy (PGATT) on a 4-point scale and for
      efficacy by evaluation of reduction in seizure frequency as the primary objective of the
      study. For secondary objectives the patients data will be evaluated to determine the
      responder rates (> or = to 50% reduction in seizure frequency from baseline) and seizure
      freedom over the 24 weeks study period.
    

Intervention name(s): zonisamide
Intervention type(s): Drug
Intervention description(s): zonisamide 100mg tablets
Intervention MeSH terms: Zonisamide
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Single Cohort Study involving community patients with epilepsy
An Educational Intervention to Promote Safe Driving
Condition: Driver Sleepiness
MeSH terms: Sleepiness
Study type: Interventional

Summary: 
      The general aim of the study is to promote safe, economic, and environmental-friendly driving
      among long-haul truck drivers. To do this, the investigators will conduct an on-road study on
      i) the relationship of driver sleepiness and stress with driving behaviour and fuel
      consumption and ii) effectiveness of an educational intervention in mitigating sleepiness at
      the wheel. The educational intervention is designed to be employed by occupational health
      care professionals in the future. This solution clearly facilitates the implementation of the
      intervention into practice if it turns out to be effective.

      The investigators specified research questions are the following:

        -  Do truck driver sleepiness and stress at the wheel reach levels that affect driving
           behaviour, fuel consumption and carbon emissions?

        -  What are the sources of sub-optimal arousal at the wheel in truck drivers?

        -  Can truck driver sleepiness be mitigated by an educational intervention, and if yes,
           does it improve driving behaviour and decrease fuel consumption and carbon emissions as
           well?
    


Intervention name(s): Fatigue management training
Intervention type(s): Behavioral
Intervention description(s): Experimental group took part in a single half-day (4 hours) fatigue management training grounded on Problem Based Learning (PBL).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: professional drivers; sleepiness; stress; safe driving; training
A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria
Condition: Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 4

Summary: 
      This multicenter, randomized, double-blind, placebo-controlled study will evaluate the
      efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48
      weeks for treatment of H1 antihistamine refractory chronic idiopathic urticaria (CIU). After
      completing an initial 24-week open-label treatment period with omalizumab 300 milligrams (mg)
      every 4 weeks (Q4W), participants responding to omalizumab will be randomized at a 3:2 ratio
      (omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a
      further 24 weeks.
    


Intervention name(s): Omalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Omalizumab 300 mg administered SC Q4W.; Placebo matched to omalizumab administered SC Q4W.
Other intervention name(s): Xolair; RO5489789
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Concerta in the Treatment of ADHD in Youth and Adults With Bipolar Disorder
Condition: ADHD; Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to investigate the safety and effectiveness of Concerta in the
      treatment of children (ages 5 to 17 years old) and adults (ages 18 to 55 years old) with
      Bipolar I, Bipolar II and Bipolar Spectrum Disorder and comorbid ADHD over 8 weeks. This
      study seeks to study the short-term effectiveness of a long acting formulation of
      methylphenidate (Concerta) in the treatment of children and adults with bipolar disorder and
      comorbid ADHD adequately stabilized on an acceptable and stable regimen of anti-mania agents.
    

Detailed description: 
      A leading source of difficulty in treating youth with Bipolar Disorder is its comorbidity
      with attention deficit hyperactivity disorder (ADHD). Systematic studies of children and
      adolescents show that rates of ADHD range from 60% to 90% in pediatric study participants
      with mania. These findings could not be accounted for by the overlapping symptoms of
      distractibility, talkativeness, and physical hyperactivity, suggesting that affected children
      may suffer from both disorders, which was also consistent with findings of familial
      co-transmission of these two conditions. Considering the well-documented morbidity and
      dysfunction associated with ADHD, a comprehensive treatment approach to the management of the
      bipolar child with comorbid ADHD requires the development of appropriate therapeutic
      strategies for the treatment ADHD symptoms.

      The objective of this study is to investigate the safety and effectiveness of Concerta in the
      treatment of children (ages 5 to 17 years old) and adults (ages 18 to 55 years old) with
      Bipolar I, Bipolar II and Bipolar Spectrum Disorder and comorbid ADHD over 8 weeks. This
      study seeks to study the short-term effectiveness of a long acting formulation of
      methylphenidate (Concerta) in the treatment of children and adults with bipolar disorder and
      comorbid ADHD adequately stabilized on an acceptable and stable regimen of anti-mania agents.
    

Intervention name(s): methylphenidate HCl (Concerta)
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; bipolar disorder; children; Concerta
Pharmacokinetics and Pharmacodynamics of the Interferon Beta-1a Produced by Laboratorio Quimico Farmaceutico Bergamo Compared to Interferon Beta-1a (Rebif - Merck Serono) in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic
      effect of two commercial preparations of interferon beta-1a (IFN Test: Lab Bergamo and IFN
      Comparator: Rebif ® - Merck Serono Lab) after single administration (12.000UI) in healthy
      subjects by modifying the parameters Cmax, Tmax and AUC (pharmacokinetics) and the levels of
      2'5' oligoadenylate synthase and beta-2-microglobulin (pharmacodynamics).
    

Detailed description: 
      Secondly, safety will be observed (tolerability) clinically after administration of a single
      dose in study subjects, by comparing the clinical and laboratory parameters before and after
      study and the incidence of adverse events.
    

Intervention name(s): Interferon beta-1a; Interferon beta-1a
Intervention type(s): Biological; Biological
Intervention description(s): 12.000UI - single dose; 12.000UI - Single dose
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: PHARMACOKINETICS AND PHARMACODYNAMICS OF DRUG INTERFERON BETA-1A