bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Two Different Forms of Marine Oil on Indirect Markers of Muscle Damage and Soreness in Untrained Men
Condition: Inflammation; Muscle
MeSH terms: Myositis; Inflammation
Study type: Interventional

Summary: 
      To evaluate the effects of PCSO-524®, and a blend of PCSO-24® (75%) and krill oil (25%)
      (ESPO-572®), on indirect markers of muscle damage, inflammation and soreness during recovery
      from muscle damaging exercise in untrained men.
    

Detailed description: 
      The study will be conducted as a randomized, parallel group trial over 29 days. A total of 50
      untrained male subjects will participate in this study. Subjects will be classified as
      'untrained' if they exercise less than three times per week for less than 30 min during each
      session. Subjects will be randomly assigned to either a green-lipped mussel oil blend
      (PCSO-524® supplementation group, n = 25) or a 75/25% PCSO-24®/Krill oil blend group
      (ESPO-572® supplementation group, n = 25). Supplementation will begin 26 days before an
      eccentric exercise bout (downhill running, designed to induce muscle damage and continue for
      3 days following the muscle damaging exercise bout).
    

Intervention name(s): ESPO-572®; PCSO-524®
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): ESPO-572® is the same as PCSO-524®, except it has krill oil added to it.; PCSO-524® (Lyprinol®/Omega XL®) is a nutritional supplement containing a patented extract of highly condensed form of stabilized marine lipids from the New Zealand green lipped mussel (Perna canaliculus) that is combined with olive oil and vitamin E. This marine oil lipid and omega-3 polyunsaturated fatty acid (PUFA) blend is a diverse mixture of sterol esters, sterols, polar lipids, triglycerides, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (split between the triacylglycerol and polar lipid classes), and free fatty acids.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled non-inferiority trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: krill oil; DOMS; EIMD (exercise induced muscle damage)
Endothelial Function in Patients With Scleroderma or Cirrhosis With and Without Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension; Scleroderma, Systemic; Scleroderma, Diffuse; Fibrosis
Study type: Observational

Summary: 
      Pulmonary arterial hypertension (PAH) is a condition characterized by an increased pulmonary
      vascular resistance that can lead to right heart failure and death. Several diseases are
      known etiologies of PAH including scleroderma and cirrhosis. The presence of PAH in the
      context of systemic sclerosis or cirrhosis has a dramatic impact on prognosis and survival of
      the connective tissue or liver disease.

      Despite advances in the diagnosis of PAH, echocardiography remains a necessary test for
      screening PAH in patients with scleroderma or cirrhosis. However, echocardiography is less
      than ideal for diagnosing PAH and predicting treatment response. Thus, there is a pressing
      need to identify methodologies that can accurately and non-invasively recognize the presence
      of PAH in patients with scleroderma and cirrhosis.

      Hypothesis:

        1. To measure endothelial function and exhaled gases in patients with scleroderma and
           cirrhosis. To assess whether they correlate with the presence or the development of PAH.

        2. The degree of local (forearm) capillary vasodilation during treprostinil iontophoresis
           identifies patients who will develop PAH and in those already diagnosed PAH predicts
           response to PAH-specific therapies.
    

Detailed description: 
      Patients with scleroderma are known to have endothelial dysfunction and limited data
      suggested an association between the degree of endothelial function in scleroderma and the
      presence of PAH. However, these data is preliminary and has not been used to predict response
      to PAH-specific therapy or the development of PAH. We will test patients with cirrhosis
      because they tend to have PAH in the context of a hyperdynamic instead of a hypodynamic state
      as observed in scleroderma and PAH.

      Aims:

        1. To measure endothelial function and exhaled gases in patients with scleroderma or
           cirrhosis to assess whether they correlate with the presence or the development of PAH.

        2. To evaluate the degree of endothelial response to local treprostinil iontophoresis and
           determine if this test can predict the development of pulmonary hypertension or response
           to PAH-specific therapies.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with scleroderma or cirrhosis. These patients may or may not have known PAH or be
        on treatment of this condition.
      
Keywords: Scleroderma; Cirrhosis
Study on the Difference of Plasma microRNA Expression in Patients With Genetic Susceptibility to Mental Disorders
Condition: Plasma microRNA in Patients With Genetic Susceptibility to Mental Disorders
MeSH terms: Disease Susceptibility; Genetic Predisposition to Disease; Mental Disorders; Psychotic Disorders
Study type: Observational

Summary: 
      Schizophrenia (Schizophrenia,Sc), biphasic affective disorder (Bipolar disorder,BPD), major
      depression (major depressive disorder,MDD), anxiety disorder (Anxiety disorder,An) and other
      mental disorders have obvious family aggregation, with heritability of 60 -90%. This kind of
      common mental illness seriously affects the psychosomatic health and quality of life of
      patients, and places a great mental and economic burden on the society and family. At
      present, the diagnosis of mental illness is mainly based on clinical symptoms. With the
      development of molecular biology, genomics has become a new way to study mental illness.
      MicroRNA (miRNA) is a class of eukaryotic endogenously non-coding single-stranded RNA, which
      can regulate gene expression by binding to specific mRNA or regulating the protein
      translation process of specific mRNA. MiRNA widely exists in plasma and serum, and the type
      and quantity of miRNA in plasma and serum change with different physiological and disease
      conditions. It is reported that the expression profile of miRNA in brain tissue of
      schizophrenia is significantly different from that of normal subjects. In addition, the study
      found that the specific miRNA detected in peripheral blood can directly reflect the condition
      of the disease, which may use miRNA in peripheral blood as a clinical biological marker. In
      order to detect the expression of various miRNA in plasma, high throughput miRNA chip
      detection has become the first choice for primary screening. In this study, the investigators
      intend to detect the difference of miRNA expression in peripheral blood of different types of
      schizophrenia by high throughput miRNA chip, and analyze the correlation between them. It is
      hoped to provide the basis for the diagnosis and occurrence and development of clinical
      psychotic patients.
    


Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        From 2014 to 2016, 28 patients with mental disorders were enrolled in the second affiliated
        Hospital of Zhejiang University, aged 21 -66 years, with an average age of 42.0 years.
IMPaCT (Individualized Management Towards Patient-Centered Targets)
Condition: General Medical Inpatient Conditions
Study type: Interventional

Summary: 
      The investigators propose a pilot randomized controlled trial of a care transitions
      intervention in which trained Community Health Workers will act as supports for
      socioeconomically vulnerable patients who are being discharged from the Hospital of the
      University of Pennsylvania and Presbyterian Hospital. CHWs or IMPaCT Partners will help
      patients to overcome the challenges of transition, including arranging primary care provider
      (PCP) follow-up, filling medication prescriptions and obtaining referrals to community-based
      social services. As our primary outcome, the investigators will examine the effect of the
      IMPaCT intervention on rates of primary care follow-up. The investigators will also examine
      the effect of IMPaCT on secondary outcome variables including patients' satisfaction with the
      experience of transition, quality of discharge communication, medication adherence, self-
      rated health, and inpatient readmission within 30 days after discharge.
    


Intervention name(s): Patient-Centered Transition Intervention
Intervention type(s): Behavioral
Intervention description(s): Community Health Workers will act as PaCT Partners for uninsured/Medicaid patients who are being discharged from the Hospital of the University of Pennsylvania and Presbyterian Hospital. PaCT Partners will help patients to overcome the challenges of transition, including arranging primary care provider (PCP) follow-up, filling medication prescriptions and obtaining referrals to community-based social services.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Acute-phase Response & Periodontal Treatment in Obese Patients
Condition: Periodontal Diseases; Obesity
MeSH terms: Periodontal Diseases; Acute-Phase Reaction
Study type: Interventional

Summary: 
      The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus
      full-mouth treatment (FM-SRP) in terms of acute-phase responses following no surgical
      periodontal treatment in obese patients affected by periodontitis.
    

Detailed description: 
      Periodontal treatment, consisting in both supra- and sub-gingival mechanical instrumentation
      of the root surface (scaling and root planing), will be performed by a single periodontist on
      obese patients with periodontitis.

      The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus
      full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical
      periodontal treatment.

      Treatment will be provided using both hand and ultrasonic instrumentation with ﬁne tips.

      FM-SRP patients will received treatment within 24 h. Q-SRP patients will received four
      quadrants sessions of periodontal treatment with an interval of 1 week between sessions.

      Vital, endothelial function and blood inflammatory parameters will be evaluated at baseline,
      24 hours after the first treatment and after 3 months. Periodontal parameters will be
      evaluated at baseline and after 3 months.
    

Intervention name(s): FM-SRP; Q-SRP
Intervention type(s): Procedure; Procedure
Intervention description(s): Supra- and sub-gingival mechanical instrumentation of the root surface of the whole dentition within 24 hours.; Supra- and sub-gingival mechanical instrumentation of the root surface will be performed in all dentition subdivided in four appointments. Each appointment will be performed in one week interval. In each appointment only a "quadrant" of the dentition will be instrumented.
Other intervention name(s): Full mouth scaling and root planing; Quadrant scaling and root planing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Prospective, Multi-center and Randomized Controlled Trial of Tianyi Revascularization Device in Acute Ischemic Stroke
Condition: AIS; Acute Ischemic Stroke; Large Vessel Occlusion; Thrombectomy
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      This is a prospective, randomized, single blind, concurrent controlled, multi-center study.
      Patients presenting with symptoms of acute ischemic stroke who have evidence of a large
      vessel occlusion in the cerebral circulation.
    

Detailed description: 
      This is a prospective, randomized, single blind, concurrent controlled, multi-center study.
      Patients presenting with symptoms of acute ischemic stroke who have evidence of a large
      vessel occlusion in the cerebral circulation will be assigned to either the Tianyi
      Revascularization Device or Solitaire FR Revascularization Device. Each treated patient will
      be followed and assessed for 3 months after randomization. Up to 238 evaluable patients at up
      to 18 centers presenting with acute ischemic stroke in vessels accessible to the
      Revascularization Device for revascularization within 8 hours of symptom onset. The
      hypothesis to be tested is that the safety and effectiveness of the Tianyi Revascularization
      Device for the revascularization of large vessel occlusion is not inferior to the Solitaire
      FR Revascularization Device.
    

Intervention name(s): Tianyi Revascularization Device; Solitaire FR Revascularization Device
Intervention type(s): Device; Device
Intervention description(s): Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain; Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of Lisdexamfetamine Sulfate to Treat Cognitive Dysfunction in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Amphetamines have been shown to improve cognition but its use is limited due to its side
      effects. Lisdexamfetamine is an amphetamine pro-drug, minimizing these effects and has been
      safely used in children and adults with Attention Deficit Hyperactivity Disorder (ADHD). The
      investigators hypothesize that lisdexamfetamine may improve cognitive abilities in MS
      patients with documented cognitive dysfunction. Because lisdexamfetamine is a stimulant its
      positive effects should be observed primarily in the domains of processing speed and working
      memory. The investigators therefore propose a study in which the primary objective will be to
      assess the efficacy of lisdexamfetamine in improving attention and processing speed in MS.
      The secondary objectives will be (a) the assessment of the safety and tolerability of
      lisdexamfetamine in the MS population, and (b) to test for effects of the drug on other
      cognitive domains, depression, and self and informant reports of cognitive and executive
      function demanding activities and behaviors.
    


Intervention name(s): lisdexamfetamine sulfate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30mg lisdexamfetamine OD, increased to 70mg OD over 4 weeks and continued on 70mg OD for 4 weeks; sugar pill
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Two-Part, Phase 1, Single-Dose Study of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody); in Healthy Subjects and Adults With Atopic Dermatitis
Condition: Healthy Subjects and Atopic Dermatitis Subjects
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine safety and tolerability of IL-31 mAB
    

Detailed description: 
      Healthy Volunteers not acceptable for "Part 2" (Adult subjects with Atopic Dermatitis)

      Enrollment: (both Part 1 and Part 2) Part 2 will consist of up to 42 patients with atopic
      dermatitis
    

Intervention name(s): BMS-981164; Placebo matching with BMS-981164
Intervention type(s): Biological; Biological
Other intervention name(s): IL-31 mAB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Safety Trial to Compare Different Analgesics in Combination With Low Dose Aspirin to Study Their Bleeding Properties and Their Effects on the Stomach
Condition: Analgesics
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare several analgesics given in approved daily doses in
      combination with a daily cardioprotective dose of aspirin (81 mg), to study their bleeding
      properties and their effects on the stomach in healthy volunteers.
    

Detailed description: 
      The purpose of this randomized, multiple-dose, single-blind, parallel-group study is to
      examine in healthy volunteers the effects of analgesics given in approved daily doses in
      addition to daily cardio-protective doses of aspirin (81 mg) on the stomach. All subjects are
      examined endoscopically before receiving study medication, and at the end of treatment on Day
      9. Each subject takes 81 mg of aspirin daily plus one of the following treatments to be taken
      daily on Days 1 through 8: four doses of acetaminophen 1000 mg, three doses of ibuprofen 400
      mg, two doses of naproxen sodium (440 mg in the morning and 220 mg in the evening), four
      doses of aspirin 650 mg, two doses of celecoxib 200 mg, one dose of rofecoxib 25 mg, or no
      additional study medication. On Day 9, one dose of aspirin 81 mg and only one dose of the
      assigned treatment drug are taken prior to having an endoscopy. The primary endpoints of the
      study are the effects of the analgesics on the inhibition of COX-1 activity by aspirin, and
      any injury to the stomach mucosa, as determined by direct endoscopic observation. Safety
      assessments consist of routine monitoring for adverse events, as well as endoscopic
      examination of gastric mucosa for erosions and ulcerations occurring during the treatment
      phase. The study hypothesis is that the effects of acetaminophen on the stomach do not differ
      from the effects of ibuprofen, naproxen, aspirin, celecoxib, or rofecoxib. 81 mg aspirin and
      1of 7 treatments for 8 days: acetaminophen 1000mg 4xday, ibuprofen 400mg 3xday, naproxen
      440mg morning and 220mg evening, no additional study medication, aspirin 650mg 4xday,
      celecoxib 200mg 2xday,rofecoxib 25mg 1xday. On Day 9, 1 dose aspirin & 1 dose study drug
      before endoscopy.
    

Intervention name(s): aspirin, acetaminophen, ibuprofen, naproxen, celecoxib, rofecoxib
Intervention type(s): Drug
Intervention MeSH terms: Aspirin; Acetaminophen; Ibuprofen; Celecoxib; Naproxen; Rofecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: aspirin; analgesics; cyclooxygenase activity; non-steroidal antiinflammatory drugs
Study to Assess the Safety, Tolerance and Efficacy of Tezampanel in Patients With Acute Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effects of a single sc administration of TEZAMPANEL at one of three different
      dosage levels compared to placebo, employing traditional measures of efficacy and safety in
      the treatment of a single episode of acute migraine.
    

Detailed description: 
      Primary:

      • Headache relief (headache response) defined as the percentage of patients in each treatment
      group who experience a decrease in pain from moderate or severe intensity pre-dose (baseline)
      to mild or no pain 2 hours after study drug administration and prior to use of rescue
      medication.

      Secondary:

        -  Percentage of patients in each treatment group who are pain-free two hours after study
           drug administration, prior to the use of any rescue medication

        -  Sustained headache response rate (percentage of patients in each treatment group with
           headache response at Hour 2 and no rescue medication or headache recurrence from 2
           through 24 hours)

        -  Sustained pain-free rate (percentage of patients in each treatment group who are pain
           free at Hour 2 with no rescue medication or headache recurrence from 2 through 48 hours)

        -  Recurrence rate (percentage of patients in each treatment group with an Hour 2 mild
           response or pain-free response who subsequently develop a headache rated as moderate to
           severe in intensity within 2 to 24 hours)

        -  Relapse rate (percentage of patients in each treatment group with an Hour 2 pain free
           response who subsequently develop a headache rated as moderate to severe in intensity
           within 2 to 48 hours
    

Intervention name(s): TEZAMPANEL
Intervention type(s): Drug
Intervention description(s): Single Administration of: TEZAMPANEL 40 mg; TEZAMPANEL 70 mg; TEZAMPANEL 100 mg; Placebo (Sterile Water for Injection)
Other intervention name(s): NGX424MIG2001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Migraine
QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
Condition: CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      AIMS The aims were 1) to describe the quality of life (QoL) of a cohort of children born very
      preterm (<28 weeks of gestation) aged 7 to 9 years; 2) to compare children's QoL to the QoL
      reported by a French general population of reference. 3) to determine whether
      socio-demographic factors, neonatal features and neurocognitive status were impacting their
      QoL.

      METHODS:

        -  Multi-centre study: 6 French level three perinatal care units (Marseille, Montpellier,
           Nantes, Nîmes, Nice and Rouen).

        -  Inclusion criteria: all infants born before 28 weeks of gestation between January 2005
           and December 2007, from 7 to 9 years old of age at the time of evaluation.

        -  Written agreement to participate: collected from parents.

        -  Data collection: reports of children's QoL by children and their parents (using
           standardized validated questionnaires); clinical information about the children,
           obtained through a medical examination; children neurocognitive profile.

        -  Duration of inclusion: over 24 months.

        -  Population: of the six structures, approximately 300 children will be evaluated
           consistent with the active files of the participating centres and an attrition rate of
           30%.

      PERSPECTIVES This is one of the first studies to collect self-reported data on quality of
      life of school-age children (7-9 years) born before 28 weeks of gestation. A better
      understanding of demographic and clinical determinants of QOL of school-age very preterm
      children may help clinicians involved in the care of these children in their ethical and
      medical considerations.
    


Intervention name(s): questionary on quality of life
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other