bioihbjkbjnl/mcl2 huggingface dataset:
Mechanism of Dipyridamole Action in Platelets: in Vivo Study With Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigation of the mechanism of dipyridamole action in platelets in an in-vivo study with
      healthy volunteers treated Aggrenox in comparison with volunteers treated with Persantin
      Retard or Acetylsalicylic Acid using platelet Vasodilator-Stimulated-Phosphoprotein
      (VASP)-phosphorylation as indication for an action and measurements of dipyridamole plasma
      levels
    


Intervention name(s): Aggrenox; Persantin Retard; Acetylsalicylic acid
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Aspirin; Dipyridamole; Aspirin, Dipyridamole Drug Combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pediatric Epilepsy Study
Condition: Epilepsy; Epilepsies, Partial
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on
      therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.
    


Intervention name(s): oxcarbazepine
Intervention type(s): Drug
Intervention MeSH terms: Oxcarbazepine
Primary purpose: Treatment
Keywords: partial seizures
Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and immunogenicity of VAX161B [STF2.HA5 H5N1], a
      recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of
      doses.
    

Detailed description: 
      The purpose of this study is to test an investigational vaccine known as "VAX161B". VAX161B
      is a vaccine for the influenza A virus subtype H5N1 avian influenza virus (bird flu). In this
      study, the subject will receive the VAX161B vaccine at one of five doses to see which does
      might be the best. VaxInnate want to find out how safe these vaccines are and how well they
      are tolerated by people who receive them. To measure how effective each type of vaccine is,
      VaxInnate will test the ability of the body to develop an immune response, which means how
      well the body recognizes and defends itself against the influenza virus.
    

Intervention name(s): VAX161 [STF2.HA5 H5N1]
Intervention type(s): Biological
Intervention description(s): dose escalating, 2 intramuscular doses given 21 days apart
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Influenza; Vaccines; H5N1
Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking
      some of the enzymes needed for cell growth. Everolimus may also block blood flow to the
      tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib
      mesylate works in treating patients with metastatic or unresectable kidney cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Estimate the proportion of patients with previously treated metastatic or unresectable
           clear cell carcinoma of the kidney who are progression free (complete response [CR],
           partial response [PR], or stable disease [SD]) at 3 months after treatment with
           everolimus and imatinib mesylate.

      Secondary

        -  Estimate median time to progression in patients treated with this regimen.

        -  Determine the proportion of patients whose best overall response are CR, PR, SD, or
           progressive disease.

        -  Evaluate the mean and range of the maximum percent reduction in tumor size.

        -  Describe the toxicities of this regimen in these patients.

      OUTLINE: This is an open-label, multicenter study.

      Patients receive oral imatinib mesylate and oral everolimus once daily beginning on day 1 and
      continuing in the absence of disease progression.

      PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
    

Intervention name(s): Everolimus; imatinib mesylate
Intervention type(s): Drug; Drug
Intervention description(s): 2.5 mg by mouth daily; 600 mg by mouth daily
Other intervention name(s): Afinitor; RAD001; Certican; Gleevec; STI-571
Intervention MeSH terms: Everolimus; Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III renal cell cancer; stage IV renal cell cancer; clear cell renal cell carcinoma; recurrent renal cell cancer
Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of TAK-085, once daily (QD)
      or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in
      participants with hypertriglyceridemia undergoing lifestyle modification.
    

Detailed description: 
      TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085
      contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl
      docosahexaenoic acid (DHA-E)).

      This is a phase 3, open-label, randomized study to evaluate the efficacy and safety of
      TAK-085. In addition, EPA-E is also administered for 52 weeks for reference to evaluate the
      safety of TAK-085 in participants with hypertriglyceridemia who are undergoing lifestyle
      modification.

      The study period is a total of 56 weeks, comprised of a 4- week screening period and 52 weeks
      of treatment.
    

Intervention name(s): omega-3-acid ethyl esters 90 (TAK-085); Eicosapentaenoic acid-ethyl (EPA)
Intervention type(s): Drug; Drug
Intervention description(s): Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.; EPA-E capsules
Other intervention name(s): LOVAZA; Omacor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy
De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma
Condition: Liver Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study investigates whether sirolimus could decrease the rate of hepatoma recurrence
      after liver transplantation in high risk hepatoma patients.
    

Detailed description: 
      A total of 70 patients with HCC (mean age: 54.6 years, female/male: 12/58) received a liver
      transplant and were included in the study. Immunosuppression included de novo sirolimus,
      low-dose calcineurin inhibitor for 6 to 12 months, with short-course (3 months) or no
      steroids.
    

Intervention name(s): Sirolimus
Intervention type(s): Drug
Intervention description(s): Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l
Other intervention name(s): Rapamune
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: liver transplant; hepatocellular carcinoma; sirolimus
A Study of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication (VERSE)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will
      assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains
      uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller
      medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment
      with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo every 4 weeks
      for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a
      52-week double-blind active treatment extension. The anticipated time on study treatment is
      up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study
      drug for all patients.
    


Intervention name(s): lebrikizumab; lebrikizumab; lebrikizumab; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): subcutaneous dose every 4 weeks; subcutaneous dose every 4 weeks; subcutaneous dose every 4 weeks; subcutaneous dose every 4 weeks
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Weight Loss in Patients With COVID-19 and Influenza in Comorbidity With NCDs: a Pilot Prospective Clinical Trial
Condition: Clinical Trial
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The goal of this study was to evaluate the effects of the fast weight loss on clinic and
      laboratory inflammation profile, metabolic profile, reactive oxygen species (ROS) and body
      composition in patients with COVID and Influenza in comorbidity with NCDs.

      Primary endpoints: Clinic/infectious/inflammation tests for COVID and Influenza; weight loss
      during 14 days. Secondary endpoints: fasting blood glucose, HbA1c, blood insulin;
      systolic/diastolic BP; blood lipids; ALT, AST, chest CT-scan.
    

Detailed description: 
      Study Design. A 6-week, open, pilot prospective clinical trial with the intention-to-treat
      principle.

      Participants: The study enrolled 72 adult people (38 women) aged from 25 to 80 years with
      moderate-to-severe cases COVID and Influenza in comorbidity with NCDs as T2D, hypertension,
      and NASH. All patients with the ARDs had in comorbidity with one or more NCDs. All patients
      refused for pharmacology therapy due to: either previous unsuccessful drug results; or an
      antimicrobial resistance profile; or drug allergy; or reluctance to take medication; or
      iatrogenic fear (iatrophobia); or a rich failed experience in drug treatment; and NASH.

      All the patients were admitted into the out-patient department in 3-5 days after illness
      onset. The study was carried out in the Republic of Kazakhstan from November, 2020, through
      July, 2022 at University Medical Center (Astana) and ANADETO medical center.
    

Intervention name(s): "Analimentary detoxication" (ANADETO) weight loss based on very-low-calorie-diet
Intervention type(s): Dietary Supplement
Intervention description(s): calorie restriction to 50-100 kcal/day with fat-free vegetables (tomatoes and cucumbers) with mandatory salt intake to 5-6 gr/day, hot water drinking 1000-1500 ml/day, walking at least 2,000 steps/day after normalized body temperature, and sexual self-restraint. The walking provided to promote of blood circulation and decrease in metabolic intoxication. The weight loss method lasted 14 days. Then the patients followed for 4-week a diet where they ate one meal a day without any food restriction.
Other intervention name(s): very-low-calorie-diet
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: 27 patients with COVID and 35 patients with Influenza
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; Influenza; Non-Communicable Diseases (NCDs); fast weight loss
A Study of Nipocalimab in Healthy Male and Female Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single and multiple
      doses of nipocalimab following subcutaneous (SC) administration compared with intravenous
      (IV) administration in healthy participants.
    


Intervention name(s): Nipocalimab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive IV infusion or SC injection of nipocalimab.; Participants will receive IV infusion or SC injection of placebo.
Other intervention name(s): JNJ-80202135
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Quality of Life 12 Months After Cardiac Surgery
Condition: Quality of Life
Study type: Observational [Patient Registry]

Summary: 
      Cardiac surgical patients entering the hospital for operation were voluntarily recruited to
      participate a 12 month follow- up of health related quality of life (QOL)
    

Detailed description: 
      Cardiac surgical patients entering the hospital for operation were voluntarily recruited to
      participate a 12 month follow- up of health related quality of life based on established QOL
      measurements with EuroQol quality of life 5 dimensional 3 level (EQ-5D-3L) description system
      at preoperative, 6 months and 12 months postoperatively. The study started on May 2013 and
      ended at the end of 2018. The data has been analyzed for publication in 2021. The total
      number of patients reached 1594.
    

Intervention name(s): Cardiac surgical operation (valve, aorta, coronary arteries)
Intervention type(s): Procedure
Intervention description(s): Quality of life assessment using EQ-5D-3L
Other intervention name(s): Quality of life assessment
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All comers for primary or secondary major cardiac surgery (cabg, valve, aorta or combined
        procedures)
      
Keywords: Quality of Life, postoperative
Prasugrel vs. Ticagrelor on Myocardial Injury in STEMI
Condition: ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The investigators propose to perform a randomized clinical trial comparing prasugrel vs.
      ticagrelor in 60 patients with ST elevation acute myocardial infarction (STEMI) undergoing
      primary percutaneous coronary intervention. The principal objective of the study would be
      analyzing the difference in myocardial infarction size measured by cardiac magnetic resonance
      at 6 months
    

Detailed description: 
      Dual antiplatelet therapy consisting of aspirin and one of the P2Y12 receptor inhibitors is
      the mainstay of treatment for patients with ST elevation acute myocardial infarction
      undergoing primary percutaneous coronary intervention. Prasugrel or ticagrelor have actually
      shown to be superior to clopidogrel improving the prognosis of these patients. However, the
      industrial interest has avoided any direct comparison between these two antiplatelets.
      Comparison is of great interest considering that only ticagrelor has shown to significantly
      reduce mortality. As ticagrelor may exert off-target effects through adenosine-related
      mechanisms, the investigators aimed to investigate whether ticagrelor reduces myocardial
      injury to a greater extent than prasugrel in patients with revascularized STEMI.

      Patients with acute STEMI undergoing primary percutaneous coronary revascularization within 6
      hours of chest pain, will be randomized to (1) prasugrel (a 60 mg oral loading and a 10-mg
      dailiy maintenance dose) or to (2) ticagrelor (a 180 mg loading dose and a 90 mg twice daily
      maintenance dose). The predefined primary end point is infarct sieze on magnetic resonance
      imaging at the end of the study (6 months). Magnetic resonance will be performed at day 1,
      day 7 and moth 6. Platelet reactivity, biomarkers and clinical outcomes will also be assesed.
    

Intervention name(s): Prasugrel; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg oral bolus plus oral 10 mg once daily; 180 mg oral bolus plus oral 90 mg every 12 hours daily
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary angioplasty; Prasugrel; Ticagrelor; STEMI; cardiac magnetic resonance; infarct size; infarct injury
A Study of the Effectiveness and Safety of Almotriptan Versus Placebo in the Treatment of Migraine Headache
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate
      (AXERT®) 12.5 milligram tablets compared with placebo for the acute treatment of migraine
      headache at the earliest onset of headache pain. Almotriptan malate (AXERT®) is approved for
      the treatment of migraine headache, with or without aura, in adults. Patients in this study
      will take either almotriptan or placebo oral tablets for 3 consecutive migraine headaches.
    

Detailed description: 
      Almotriptan malate (AXERT®) is approved for the treatment of migraine headache, with or
      without aura, in adults. This is a multicenter, randomized, double-blind, placebo-controlled,
      parallel group study of adult patients with a diagnosis of migraine headache, with or without
      aura. Patients will be randomized (like with the toss of a coin) to receive almotriptan
      malate (AXERT®) or placebo for the treatment of 3 consecutive qualifying migraine headaches.
      After screening, patients will leave the study center with blinded study medication and an
      electronic subject diary (Personal Digital Assistant [PDA]). Patients will self-dose with
      study medication as soon as headache pain of any intensity begins (that resembles their usual
      migraine), but no later than 1 hour after headache pain begins. Patients will use their PDAs
      to record assessments such as pain intensity, symptom severity and ability to function as
      related to the headaches. The primary hypothesis of this study is that the percentage of
      patients who are pain free two hours after taking study drug at the earliest onset of
      headache pain is greater in the almotriptan malate (AXERT®) 12.5mg group than in the placebo
      group and almotriptan malate (AXERT®) is generally well-tolerated.

      Almotriptan malate (AXERT®) 12.5 milligrams or placebo tablets, one by mouth at the beginning
      of migraine pain (within 1 hour) for 3 consecutive migraine headaches
    

Intervention name(s): almotriptan malate
Intervention type(s): Drug
Intervention MeSH terms: Almotriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: aura; Migraine; pain; headache
Muscle Treatment for Management of Pain & Disability in Tension-type Headache
Condition: Tension-type Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effectiveness of treatments (massage therapy or
      ultrasound) directed at skeletal muscle for alleviating pain associated wtih tension
      headache.
    

Detailed description: 
      Chronic or episodic forms of tension-type headache affect a high percentage of the
      population. Pain from tension-type headache (TTH) not only impacts personal well-being, but
      also poses a significant socioeconomic burden in terms of workdays lost and decreased worker
      productivity. Although TTH is the most prevalent of the headache disorders, there is a
      distinct lack of research with regards to specific treatments for this ailment in comparison
      to all other headache classifications, such as migraine. A muscular involvement is associated
      with TTH and is reported in the research literature as elevation in skeletal muscle
      tenderness, increased presence of active myofascial trigger point's, and physical
      abnormalities in cervical and cranial muscles. Thus, a treatment approach that addresses the
      skeletal musculature could be an important component in the management of TTH. The purpose of
      this randomized trial is to determine the effectiveness of two muscle oriented treatments on
      reducing pain and disability associated with TTH: massage therapy and ultrasound.
    

Intervention name(s): ultrasound; massage
Intervention type(s): Other; Other
Intervention description(s): Twice weekly ultrasound sessions for 6 weeks; Twice weekly massage sessions for 6 weeks
Other intervention name(s): myofsacial trigger point therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Easy Peasy: Health Effects of Supplementation With Vegetables
Condition: Health Knowledge, Attitudes, Practice
Study type: Interventional

Summary: 
      The proposed study aims to test the effects of supplementing healthy individuals (with low
      baseline vegetable consumption) with 5 servings of vegetables (80-120g per serving) per day
      for 4 weeks on blood lipids and other cardiometabolic outcomes. Previous studies indicate the
      potential to see significant effects in this population and within this amount of time.
      Importantly, the investigators will also be including a weekly cooking demonstration as part
      of the intervention, which provides an essential hands-on participatory component and allows
      participants to connect with one another in a group setting, which aids in acceptability and
      adherence to dietary interventions. The investigators hypothesize that 4 weeks of daily
      supplementation with 4-5 servings of vegetables will significantly improve LDL-C and other
      cardiometabolic outcomes in healthy adults.
    


Intervention name(s): Vegetables
Intervention type(s): Dietary Supplement
Intervention description(s): 4-5 servings of vegetables daily, per USDA guidelines.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other