bioihbjkbjnl/mcl2 huggingface dataset:
Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation
Condition: Coronary Artery Disease; Coronary Artery Bypass Graft
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The use of platelet aggregation inhibitors, including aspirin and clopidogrel, has become a
      standard management strategy for patients with acute coronary syndrome. On this background,
      an increasing percentage of patients presenting for surgical coronary revascularization is
      the subject to irreversible platelet inhibition.

      Tranexamic acid is a widely used antifibrinolytic agent, and is a promising substitute for
      aprotinin when the latter has been suspended in 2007.The release of plasmin during CPB
      activates fibrinolysis and may contribute to platelet dysfunction. Pharmacological inhibition
      of the fibrinolytic system may therefore ameliorate platelet dysfunction and fibrinolysis
      after CPB and decrease postoperative bleeding. Tranexamic acid prevents plasmin formation and
      inhibits fibrinolysis.

      Many studies and meta-analyses have shown a reduction in postoperative bleeding and
      transfusion requirements of this antifibrinolytic drug in cardium revascularization surgery.
      Unfortunately the preoperative antiplatelet therapy was either neglected or obscure. Few
      studies specify the time between the last clopidogrel ingestion and surgery.Several studies
      were keen on the blood loss and allogeneic transfusion in patients who received their last
      clopidogrel or asprin within 7 days prior to coronary artery bypass grafting. Concerning the
      secession of aprotinin and the increasing proportion of patients with persistence on
      clopidogrel until their surgery, evolutional work is expected, especially in the eastern
      population.

      The purpose of this study is to assess the effect of tranexamic acid in patients with
      clopidogrel and asprin ingestion less than 7 days prior to surgery. The working hypothesis is
      that tranexamic acid would reduce bleeding and transfusion requirements in this specific
      population of patients.
    


Intervention name(s): Tranexamic Acid; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction
Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization; Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction
Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronary Artery Disease; Coronary Artery Bypass Graft; Platelet Aggregation Inhibitors; Tranexamic Acid
A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (150 mg/850 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin IR Tablets (2 x 850 mg) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)
      tablets of canagliflozin and metformin immediate release (IR) in comparison with the
      individual components of canagliflozin and metformin IR.
    

Detailed description: 
      This is an open-label (identity of study drug will be known to volunteer and study staff),
      single-center study to evaluate the bioequivalence of canagliflozin and metformin IR when
      administered orally (by mouth) as individual components (ie, separate tablets of
      canagliflozin and metformin IR) (Treatment A) and when administered as fixed-dose combination
      (FDC) tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment
      B). Healthy volunteers participating in the study will be randomly (by chance) assigned to
      receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a
      period of approximately 15 days between treatments.
    

Intervention name(s): A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets); B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets)
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A: Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use + metformin IR: Type = 2, unit = mg, number = 850, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 150/850, form = tablet, route = oral use. Two canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2; Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 150/850, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment A: Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use + Metformin IR: Type = 2, unit = mg, number = 850, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Bioequivalence; Canagliflozin (JNJ-28431754); Metformin IR
A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking
Condition: Alcoholism
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      This pilot trial has the goal to demonstrate the feasibility of a study to test the effects
      of baclofen in a laboratory experiment using cue-reactivity and alcohol-self administration
      paradigms in non-treatment seeking alcohol-dependent subjects.
    


Intervention name(s): Baclofen; Cyproheptadine
Intervention type(s): Drug; Drug
Intervention description(s): Baclofen 10mg t.i.d.; 'active' placebo
Intervention MeSH terms: Cyproheptadine; Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: baclofen; alcoholism; urge; craving; alcohol drinking; biobehavioral mechanisms of baclofen in alcoholism
Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to assess the image quality of Ablavar-enhanced MR angiography
      of the central veins of the chest, and to determine whether dose reduction can be performed
      while maintaining image quality. This will be a prospective randomized study, in which
      healthy volunteers will be recruited to undergo a central veins magnetic resonance angiogram
      (MRA). They will receive either the FDA-approved dose or a lower dose of Ablavar.
      Quantitative and qualitative analysis will be performed on the images.
    


Intervention name(s): gadofosveset
Intervention type(s): Drug
Intervention description(s): Intravenous administration of the specified dosage of gadolinium contrast agent
Other intervention name(s): Ablavar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: central veins; thorax; superior vena cava; Central vein imaging
A Pilot Study of Hand Function in Children With Cerebral Palsy Undergoing Intensive Neurophysiological Rehabilitation
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      The aim of the study is to observe the effects of Intensive Neurophysiological Rehabilitation
      System on hand function in children with spastic cerebral palsy.
    

Detailed description: 
      Intensive Neurophysiological Rehabilitation System is a novel multimodal rehabilitation
      approach that combines different treatment modalities. The treatment course lasts for 2 weeks
      with daily therapy up to 4 hours. Main treatment programs include biomechanical correction of
      the spine, extremity joint mobilization, physical and occupational therapy, reflexotherapy,
      special massage system, rhythmical group exercises, mechanotherapy and computer games therapy
      and some other.

      Preliminary observational studies indicate an improvement of gross and fine motor functions
      in children with Cerebral Palsy after the treatment course.

      The aim of the study is to observe the effects of Intensive Neurophysiological Rehabilitation
      System on hand function in children with spastic cerebral palsy.

      About 50 patients with spastic forms of cerebral palsy with mild to moderate impairment of
      hand function (Level I to III according to Manual Abilities Classification System) would be
      evaluated before and after the two-week treatment course.

      This study may help to generate the hypothesis of the effects of the Intensive treatment
      course on hand function abilities and to prepare a future randomized controlled trial.
    

Intervention name(s): Intensive Neurophysiological Rehabilitation
Intervention type(s): Procedure
Intervention description(s): Intensive Neurophysiological Rehabilitation System (INRS) is a combination of different treatment modalities that complement and reinforce each other. It includes spinal manipulative therapy, physical therapy, occupational therapy, joints mobilization techniques, special massage therapy, mechanotherapy, computer games therapy and other treatments with daily duration up to 4 hours.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with spastic cerebral palsy aged six to fifteen undergoing Intensive
        Neurophysiological Rehabilitation.
      
Keywords: Cerebral Palsy; Rehabilitation; Hand
Effectiveness of Dry Needling and Ischemic Compression in Sternocleidomastoid, on Cervical Motor Control in Patients With Cervical Pain.
Condition: Cervical Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study will compare the effect of dry needling on the active trigger point on
      sternocleidomastoid versus the effect of dry needling at 1.5 centimeters of active trigger
      point on sternocleidomastoid, both combined with ischemic compression, on cervical pain and
      cervical motor control short and medium term.
    


Intervention name(s): Dry Needling and Ischemic Compression at the Trigger Point; Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger Point
Intervention type(s): Other; Other
Intervention description(s): The intervention consist on dry needling in the active trigger point, and next, do ischemic compression in the same point.; The intervention consist on dry needling at 1.5 centimeters from the active trigger point, and next, do ischemic compression in the same point.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Clinical Trial (RCT) with two groups.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cervical Pain; Motor Control; Sternocleidomastoid; Dry Needling
Reducing the Experience of Menopausal Symptoms Through Temperature
Condition: Hot Flashes; Menopause
MeSH terms: Hot Flashes
Study type: Interventional

Summary: 
      The purposes of this study are to obtain preliminary evidence on the efficacy of a cooling
      mattress pad in reducing subjective hot flashes for peri and postmenopausal women
      experiencing menopausal hot flashes, and to obtain preliminary evidence on the efficacy of a
      cooling mattress pad for improving sleep for peri and postmenopausal women experiencing
      menopausal hot flashes.
    

Detailed description: 
      Women will be recruited from the community through flyers. They will call into a study phone
      line at which time they will be screened for their initial eligibility using a telephone
      screener. Women who are eligible and willing to participate, will either come to the Research
      Center in Winston-Salem to be consented and complete baseline questionnaires or complete
      these by mail or email. After two weeks, women will mail back their diaries and continue to
      record their daily hot flashes until they are notified by study staff of their eligibility,
      within a week of receiving the diary. If they qualify, a cooling mattress pad will be
      provided by study staff to be used for the duration of the intervention phase for
      approximately 8 weeks. The study staff will determine the efficacy of the cooling mattress
      pad through comparing answers to subject questionnaires at baseline and follow up in addition
      to comparing the baseline diaries to the intervention diaries.
    

Intervention name(s): Cooling mattress pad
Intervention type(s): Device
Intervention description(s): The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.
Intervention model: Single Group Assignment
Intervention model description: 24 peri or postmenopausal women aged 45-60 experiencing at least 4 hot flashes/night sweats/day will use a cooling mattress pad nightly for approximately 8 weeks
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hot flashes; menopause; cooling mattress pad
Exercises Associated or Not With Manual Therapy Shoulder Impingement
Condition: Shoulder Impingement
MeSH terms: Shoulder Impingement Syndrome
Study type: Interventional

Summary: 
      Manual therapy combined with a protocol of therapeutic exercises will increase the beneficial
      effects on scapular kinematics, myofascial pain and function in subjects with shoulder
      impingement when compared to exercises only.
    


Intervention name(s): Exercises; Exercises + Manual Therapy
Intervention type(s): Other; Other
Intervention description(s): Strengthening and stretching; Mobilization; massage; post-isometric relaxation; strengthening; stretching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Vitamin D in Vulnerable Adults (VIVA-VA)
Condition: Frail Elderly; Vitamin d Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      Vitamin D insufficiency is a problem of growing concern, given its prevalence in older
      persons and the association of low vitamin D with multiple major health problems, including
      mobility and balance deterioration and falls, cardiovascular disease, diabetes, and certain
      cancers. Sedentary persons are particularly vulnerable for these health problems and
      generally not adherent to prescribed physical activity. This study will investigate if
      treatment with vitamin D will benefit physical performance in male veterans age 65 to 95.
    


Intervention name(s): vitamin D; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): cholecalciferol; placebo tablet
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: aged; vitamin d deficiency
Inguinal Hernia Operation and Postoperative Pain
Condition: Pain, Postoperative; Inguinal Hernia; Quality of Life
MeSH terms: Pain, Postoperative; Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Inguinal hernia is a common disease, which is treated surgically when symptomatic. Pain after
      open inguinal hernia surgery can affect the patient significantly and weaken their quality of
      life. The aim of this study is to find out if the choice of mesh affects postoperative pain
      and therefore causes more contacts to the health care center. Our goal is also to find out
      how the pain affects the patients´ quality of life.
    


Intervention name(s): Adhesix mesh; Progrip mesh
Intervention type(s): Procedure; Procedure
Intervention description(s): Adhesix mesh; Progrip mesh
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Differences in Malaria Infection Levels in HIV-infected Infants and Children Receiving PI- and NNRTI-based HAART
Condition: HIV Infections; Malaria
MeSH terms: Infections; Malaria
Study type: Interventional
Phase: Early Phase 1

Summary: 
      More than 1.5 million deaths of African children under 5 years of age have been due to
      Plasmodium falciparum malaria. When HIV and malaria are present as coinfections, they enhance
      each other's progression. The primary purpose of this study is to compare the malarial
      infection levels in HIV-infected infants and children receiving protease inhibitor (PI)- or
      non-nucleotide reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral
      therapy (HAART).
    

Detailed description: 
      The World Health Organization (WHO) reports 1 to 2 million malaria deaths annually, with most
      malaria-related deaths occurring in children. The malaria burden is compounded by the HIV
      epidemic, which is most prevalent in areas endemic for malaria, notably Sub-Saharan Africa
      where nine in ten children younger than 15 years of age are infected with HIV. The purpose of
      this study is to compare parasitemia levels in HIV-infected infants and children receiving
      PI- or NNRTI-based HAART regimens.

      This study will enroll a total of 140 participants, 35 from each of the 4 groups in IMPAACT
      P1060.

      This substudy will last until 24 weeks after the last P1060 enrollment or until P1060 study
      discontinuation. Participants must meet enrollment criteria for P1060 as well as additional
      criteria for this study. Study visits will occur as a part of P1060 study visits, all of
      which include a physical exam, blood collection, and assessments of HIV-related symptoms.

      Participants are also encouraged to return to the primary clinic site for intercurrent
      illness visits for assessment, thick and thin blood smear, and filter paper blood collection,
      however these visits are not mandatory for study participation.
    

Intervention name(s): Lamivudine; Lopinavir/Ritonavir; Nevirapine; Zidovudine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Taken orally twice daily; Taken orally twice daily; Taken orally twice daily; Taken orally twice daily
Other intervention name(s): 3TC; LPV/r; NVP; ZDV
Intervention MeSH terms: Ritonavir; Lopinavir; Lamivudine; Zidovudine; Nevirapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Coinfection
Supplementation of Alpha-linolenic Acid (ALA)-Rich Oil in Humans
Condition: Overweight; Hypercholesterolemia
MeSH terms: Overweight; Hypercholesterolemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this study is to investigate the accumulation of n-3 LC-PUFA (EPA, DPA and
      DHA) in human lipids by oral supplementation of ALA-rich linseed oil. In addition, the
      accumulation of n-3 LC-PUFA is compared between subpopulations of different age, gender and
      physiological conditions (overweight, increased serum total cholesterol).
    

Detailed description: 
      N-3 PUFA are important for human health and nutrition. Unfortunately, the land-based n-3 ALA
      is a limited precursor for the formation of n-3 LC-PUFA. The conversion of ALA depends on the
      rate-limiting ∆6-desaturation.

      The first objective of this study is to investigate differences of the accumulation of n-3
      LC-PUFA (EPA, DPA and DHA) in human lipids during supplementation of ALA-rich linseed oil
      dependent on age, gender and physiological conditions (overweight, increased serum total
      cholesterol). One study group will receive fish oil with mainly EPA as positive control.

      The second objective is to compare the n-3 LC-PUFA enrichment during the linseed oil
      supplementation (study LSEP H50-KK) with the n-3 LC-PUFA enrichment during the further Echium
      oil supplementation (study LSEP H42-KK). The second study will be the control for the first
      study.

      Therefore, it is planned to recruit the same subjects for the linseed oil supplementation.

      Eighty volunteers will be recruited and allocated into four study groups depending on age and
      BMI. Three groups (each n=20) will receive daily ca. 15 g linseed oil (mean age: 25 and 55
      years; mean BMI < 25; and mean age 55 and BMI > 25). One group (n=20) will receive n-3PUFA
      free olive oil (mean age 25 and 55, BMI < 25). The double-blind, randomized,
      parallel-designed study will start with a two-weeks run-in period, followed by an eight-weeks
      supplementation period. After the run-in period, one week and eight weeks of oil
      supplementation blood will be drawn and 24-h urine will be sampled.

      Altogether, the fatty acid distribution after Echium oil and linseed oil supplementation from
      similar subjects can be statistically analysed.
    

Intervention name(s): n-3 PUFA free olive oil; linseed oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): negative control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Conversion of ALA