bioihbjkbjnl/mcl2 huggingface dataset:
Endostatin Serum Levels During Bicycle Stress Test
Condition: Smoking; Cardiac Diseases
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      Endostatin, a 20-kDa cleavage product of collagen XVIII, is a component of the extracellular
      matrix expressed in the basement membrane. As a potent inhibitor of angiogenesis, endostatin
      induces endothelial cell apoptosis and diminishes cell migration, adhesion and proliferation.

      Endostatin may stop the progression of atherosclerosis. Atherosclerotic heart disease
      involves unwanted tissue growth. By cutting off the blood supply from a plaque the likelihood
      of plaque rupture may eventually be reduced. Recent data indicates that the loss of collagen
      XVIII/endostatin is related to the enhancement of neo-vascularization and vascular
      permeability in atherosclerosis. Plaque neo-vascularization strongly correlates with the
      regional content of inflammatory cells. Furthermore, increased vascular permeability enhances
      lipid accumulation in the vessel walls, hence increasing foam cells.

      Therapeutic angiogenesis is a most promising strategy for the treatment of myocardial
      infarction. However, it remains unknown if and how endogenous angiogenesis inhibitors, such
      as endostatin, regulate angiogenesis in myocardial infarction. Rat models showed that after
      myocardial infarction endostatin neutralization displayed adverse left ventricular remodeling
      and severe heart failure compared with controls. Although angiogenesis was increased, tissue
      remodeling and interstitial fibrosis were further exaggerated in post-myocardial infarction
      hearts by endostatin neutralization.

      However, several studies suggest that endostatin may locally modulate coronary collateral
      formation by inhibiting collateral vessel formation in patients with ischemic heart disease.

      During treadmill exercise tests in healthy volunteers a significant increase in circulating
      endostatin levels can be observed. Exercise induces angiogenesis in cardiac and skeletal
      muscles by decreasing endostatin in the muscle tissues to increase blood flow to these
      metabolically active tissues. Thereby endostatin is released into the general circulation.

      In summary, endostatin might be a new weapon to fight against atherosclerotic progression by
      inhibiting neo-vascularization of atherosclerotic plaques.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        200 patients, divided into sub-groups, always both genders will be tested for different
        conditions (smoking, age, CMP, CHD,...)
Influence of Antiviral Therapy on Bone Mineral Density and Metabolism in Patients With Chronic Hepatitis C
Condition: Hepatitis C, Chronic; Liver Diseases; Virus Diseases
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Liver Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      One single study has suggested that bone mineral density (BMD) is reduced in patients with
      non-cirrhotic chronic viral hepatitis C. Antiviral combination therapy with standard
      interferon and ribavirin may further decrease BMD. The aim of this study is to systematically
      investigate the effect of chronic hepatitis C genotype 1 infection alone and current standard
      therapy with peginterferon alfa-2a/ribavirin on BMD and bone metabolism.
    


Intervention name(s): peginterferon alfa-2a and ribavirin
Intervention type(s): Drug
Intervention description(s): standard antiviral therapy with peginterferon alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d
Other intervention name(s): Pegasys; Copegus
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HCV; hepatitis C virus; CHC; chronic hepatitis c; interferon; ribavirin; DEXA; BMD; bone mineral density; osteoporosis; osteopenia; osteodystrophy; osteodensitometry; Bone Density; Hepatitis, Viral, Human; Anti-Infective Agents; peginterferon alfa-2a
GISSI Outliers CAPIRE
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Observational

Summary: 
      The risk of developing clinical manifestations of ischemic heart disease is currently
      assessed by using integrated multifactorial prediction models based on the presence of
      non-modifiable risk factors, such as age, gender and a family history of early ischemic heart
      disease along with risk factors which are defined as conventional, such as arterial
      hypertension, hypercholesterolemia, cigarette smoking and diabetes mellitus.

      However, if the relationship between risk factors and ischemic heart disease clinical
      manifestations shows some limitations, the relation between risk factors and the coronary
      atherosclerosis process underlying most ischemic syndromes seems to be even weaker.

      In fact there is significant individual variability and the limits of such relationship are
      demonstrated by a non negligible number of subjects at the outliers of mean behaviour of the
      prediction model. At one outlier, in the presence of multiple risk factors, these subjects do
      not develop neither coronary events nor coronary atherosclerosis whereas, at the other,
      coronary events and disease occur in the absence of risk factors.This study aims at detecting
      new protection and susceptibility factors, thus enabling to formulate new etiopathogenetic
      hypotheses concerning coronary atherosclerosis and to identify new therapeutic targets.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male and female subjects between 45 and 75 years old who, in the absence of any previous
        clinical manifestations of ischemic heart disease, will undergo coronary arteries study.
      
Biospecimen description: 
      whole blood and serum. Lipid profile Metabolic profile (HbA1c, HOMA index) inflammatory
      profile (CRP, LP-PLA, pentraxine 3, MCP-1, IL-8, IL-10, IL-5, P-selectin, ICAM, VCAM-1,
      CD40L, TIMP-1, MMP Genetic profile: chromosome polymorphism 9 (9p21)
Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
      yet known which regimen of combination chemotherapy is more effective in treating patients
      with recurrent or metastatic colorectal cancer.

      PURPOSE: Randomized phase III trial to study the effectiveness of combining fluorouracil,
      leucovorin, and oxaliplatin in different ways in treating patients with recurrent or
      metastatic colorectal cancer.
    

Detailed description: 
      OBJECTIVES: I. Compare the effects of chronomodulated versus nonchronomodulated infusional
      administration of a 3 drug high-dose chemotherapy regimen on survival in patients with
      locoregionally recurrent or metastatic colorectal cancer. II. Assess the antitumor effect of
      the combination of fluorouracil, leucovorin calcium, and oxaliplatin given as first line
      chemotherapy in these patients. III. Assess the response rate and toxicity of this treatment
      in these patients. IV. Assess the quality of life of patients receiving this treatment.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      performance status (ECOG 0-1 vs 2), extent of liver involvement (none vs less than 25% vs 25%
      or greater), and institution. Patients are randomized into 2 arms: Arm I (chronotherapy):
      Patients receive a 4 day infusion of fluorouracil, leucovorin calcium, and oxaliplatin
      administered via pump using chronomodulated delivery rates. Arm II (fixed infusion rate):
      Patients receive leucovorin calcium and oxaliplatin as 2 hour concurrent infusions followed
      by fluorouracil as a 22 hour infusion on day 1. On day 2, patients receive a 2 hour infusion
      of leucovorin calcium followed by a 22 hour infusion of fluorouracil. For patients on both
      arms, courses repeat every 2 weeks until the occurrence of disease progression, severe
      toxicity, or complete remission for a minimum of 4 months. Quality of life is assessed prior
      to treatment and 2 weeks after courses 4 and 8. Patients are followed for survival.

      PROJECTED ACCRUAL: A total of 554 patients will be accrued for this study.
    

Intervention name(s): FOLFOX regimen; fluorouracil; leucovorin calcium; oxaliplatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Calcium; Levoleucovorin
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum
Evaluation of the Success Rate of Pulpal Anesthesia in Mandibular First Molar Following Infiltration of 4% Articaine Alone and as Supplemental Injection After Inferior Alveolar Nerve Block
Condition: Pulpal Anesthesia
Study type: Interventional

Summary: 
      The purpose of this study is to determine the success rate of pulpal anesthesia in mandibular
      firs molar following infiltration of 4% articaine alone and as supplemental injection after
      inferior alveolar nerve block(IANB).
    

Detailed description: 
      According to inclusion & exclusion criteria, volunteers will be selected and divided into 4
      groups randomly. The clinician who does the injections will not be aware of study purpose.
      Also the person who does the electric pulp test (EPT); the volunteer and the statistical
      analyzer will not be aware of group codes. Intervention in each group will be as follow:
      Group 1-Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine. Group
      2-Buccal infiltration of two 4% Articaine cartridges with 1/100000epinephrine. Group
      3-Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine +
      buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine. Group 4-
      Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine.
      Before injection a control tooth (contralateral canine) will be tested to understand the
      accuracy of patient's response to EPT; also for measuring the base line vitality, each tooth
      will be evaluated by EPT twice before injection. After injection each tooth will be evaluated
      by EPT every 3 minutes; also every minute the anesthesia of lip and tongue will be checked,
      up to 15 minutes. The tooth will be discerned "anesthetized" if the subject will not response
      to 80 reading of EPT in 2 consecutive tests. Finally the information will be recorded and in
      addition to the success rate the mean time for onset of anesthesia and its mean duration time
      will be evaluated.
    

Intervention name(s): Lidocaine(IANB); 1 Articaine(Infiltration); 2 Articaine(Infiltration); Lidocaine(IANB)+1Articaine(Infiltration)
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine; Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine; Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine; Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine
Other intervention name(s): Persocaine E; Septanest; Septanest; Persocaine E + Septanest
Intervention MeSH terms: Lidocaine; Carticaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulp Anesthesia; Articaine; Lidocaine
Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to assess the impact of 13-valent Pneumococcal Conjugate Vaccine
      (13vPnC) on nasopharyngeal colonization with Streptococcus pneumoniae in healthy infants.
    


Intervention name(s): 13-valent Pneumococcal Conjugate Vaccine; 7 valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 1 dose at 2, 4, 6 and 12 months of age; 1 dose at 2, 4, 6 and 12 months of age
Other intervention name(s): 13vPnC; 7vPnC
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Nasopharyngeal Colonization; Streptococcus pneumoniae; Healthy Infants; Vaccines; Pneumococcal Conjugate Vaccine
Effects of Mandala Coloring on Anxiety in Pregnant Women
Condition: Anxiety; Pregnancy Related
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This research was planned as a randomized controlled experimental study in order to reduce
      the anxiety felt by expectant mothers in relation to pregnancy during pregnancy.
    

Detailed description: 
      Pregnancy is an important period in a woman's life in which she experiences different
      spiritual, physical and emotional experiences. While experiencing this process, women may
      face many factors that may affect their mental health, such as stress, anxiety and
      depression. When the literature is examined, it is stated that approximately 10% to 24.2% of
      pregnant women experience anxiety or stress during their pregnancy.It is very important to
      diagnose it in the early stages of pregnancy, as anxiety in pregnancy can have negative
      effects on maternal and newborn health, especially in the birth and postpartum period.

      A number of alternatives have been found to reduce anxiety, one of which is using it in the
      form of art therapy.In the opinion of art psychotherapists, mandala painting is one of the
      main tools of other art psychotherapy techniques that focus on healing.A number of studies
      have been conducted to determine the effect of drawing or coloring a mandala on anxiety.

      Amelia et al conducted research that proved that drawing and coloring mandalas effectively
      reduces students' anxiety levels. In Turkey, a study was conducted by Sezen and Ünsalver on
      the fear of childbirth in pregnant women, including art therapy. In the study, 7 types of art
      therapy were applied to the women, including listening to music and singing, making masks,
      drawing, making mandalas, making dolls, taking photographs and making collages. As a result
      of the research, it was determined that art therapy was effective in reducing anxiety.

      When the studies are examined, there are studies on the application of mandala to reduce the
      anxiety felt by children in cancer patients, but there are no studies on reducing
      pregnancy-related anxiety of women during pregnancy. This research was planned as a
      randomized controlled experimental study in order to reduce the anxiety felt by expectant
      mothers in relation to pregnancy during pregnancy.
    

Intervention name(s): Mandala coloring
Intervention type(s): Other
Intervention description(s): Participants will be asked to choose the pages they want from 12 colored felt-tip pen paint sets and 16 mandala coloring pages given to each participant by the researcher for 1 month, 2 days a week, at any time of the day and for an average of 20-30 minutes each time, and paint them in the colors they want.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: pregnancy; anxiety; mandala coloring
Treximet Early Intervention Adolescent Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study involves approximately 105 adolescent (ages 12-17) subjects to be screened at 4
      sites across the US. All subjects enrolled will treat up to 4 MILD migraines over a 6 month
      period. They will be required to have three office visits during the six months. All subjects
      will be randomized to either Treximet (85mg Imitrex/500mg Naproxen Sodium) or Placebo
      (sugar-pill) in four of the five treatment arms with a 3 to 1 ratio. A fifth treatment arm
      will treat all 4 migraines with active drug, Treximet. The hypothesis is that Treximet will
      prove to be a safe and effective treatment for this population, that has so few treatment for
      migraine. And Treximet will be superior over placebo for pain free endpoints at 2 and 24
      hours.
    

Detailed description: 
      There are two primary treatment comparisons for this study: 1) the percentage of subjects'
      pain free at 2 hours after treatment with TREXIMET versus placebo across attacks, and 2) the
      percentage of subjects who are sustained pain free at 24 hours after treatment with TREXIMET
      versus placebo across attacks.

      The following alternative hypothesis will be tested to see if there is a difference in the
      proportion of subjects who are pain free at 2 hours with TREXIMET versus placebo at all
      attacks, OR there is a difference in the proportion of subjects who are sustained pain free
      at 24 hours with TREXIMET versus placebo at all attacks.
    

Intervention name(s): Treximet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.; Dummy pill comparator
Other intervention name(s): Imitrex and Naproxen Sodium; Sugar Pill
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects
Condition: Shoulder Pain Chronic
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this research study is to investigate safety and gather initial effectiveness
      data for a new implanted device designed to treat chronic shoulder pain in chronic
      post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1" x 0.1". It is
      implanted into the shoulder to stimulate the axillary nerve. Stimulation of this nerve may
      reduce shoulder pain, reduce shoulder subluxation, improve motion, improve function, and
      possibly decrease use of pain medication. CAUTION--Investigational device. Limited by Federal
      law to investigational use.
    

Detailed description: 
      This is a prospective, multi-center, randomized, controlled, double-blinded parallel study
      designed to evaluate feasibility and safety. The primary purpose of this study is to
      demonstrate the clinical feasibility of implanting the BBPM near a peripheral nerve for the
      treatment of chronic, intractable, pain in this case represented by chronic regional shoulder
      pain in hemiplegic stroke patients. This is a 48-week efficacy study with safety data
      collection throughout the study period and up to 2 years for all available subjects. Each
      study arm will receive therapeutic level stimulation for a total of 12 consecutive weeks
      (Weeks 1-12 for Active treatment group and Weeks 24-36 for the sham group) during the 48
      weeks.
    

Intervention name(s): Battery Powered Microneuromodulator (BBPM)
Intervention type(s): Device
Intervention description(s): The Battery Powered Microneuromodulator (BBPM) is programmed to deliver bursts of electrical stimulation to deliver therapeutic stimulation beginning with a frequency of 30Hz, current of 5mA, for 200 microseconds. These settings were applied to deliver greater or lesser intensity based on study arm (active vs placebo).
Other intervention name(s): Bioness Battery Powered Microneuromodulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: shoulder; pain; stroke; subluxation
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives are:

        -  Part I: To investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in
           healthy male subjects following oral administration of single rising doses.

        -  Part II: The relative bioavailability of BI 706321 after administration of tablets and
           capsules under fasted conditions will be compared with each other and the effect of food
           on the tablet bioavailability will be investigated.
    


Intervention name(s): BI 706321; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule or Oral Solution; Capsule or Oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment