bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Hemodilution Methods in Patients Undergoing Primary Debulking Gynaecological Surgery
Condition: Ovarian Neoplasm Epithelial
MeSH terms: Ovarian Neoplasms
Study type: Interventional

Summary: 
      Primary cytoreductive surgery for ovarian cancer is an ideal setting to evaluate endothelial
      function under ANH and AHH, as the procedure is associated with moderately high blood loss.
      As the technique has not yet been described in this setting, investigators designed a pilot
      study to evaluate ANH and AHH in patients planned to undergo primary cytoreduction during
      perioperative period, with the intent of proceeding to a randomized trial if results were
      favorable.
    

Detailed description: 
      Using a computer-generated random number table, patients were randomized to three groups:
      Control Group(n=30), ANH Group(n=30) and AHH Group(n=30). Patients underwent standard
      preoperative preparation for cytoreductive surgery according to institutional standards.All
      patients who underwent a standard anesthesia protocol and similar surgical procedures were
      considered for the analysis. For this purpose, investigators only included patients who
      underwent the following interventions: radical hysterectomy, bilateral adnexectomy, one or
      more bowel resection, peritonectomy, pelvic lymphadenectomy and extended periaortic
      lymphadenectomy. The patient would be ruled out of the experiment when the participant was
      accompanied with any kind of serious complications such as wakening delay and drug allergy.
    

Intervention name(s): acute normovolemic hemodilution (ANH); acute hypervolemic hemodilution (AHH)
Intervention type(s): Other; Other
Intervention description(s): Acute normovolemic hemodilution (ANH) is a medical procedure that involves removing a certain volume of blood from a patient before surgery and replacing it with a volume expander or blood substitute. The goal of ANH is to reduce the need for blood transfusions during or after surgery. During the ANH procedure, a patient's blood is typically withdrawn and replaced with a crystalloid or colloid solution. This dilutes the patient's blood, reducing the concentration of red blood cells. The withdrawn blood is then stored and can be reinfused back into the patient after the surgical procedure is completed.; The purpose of diluting the blood with fluids and removing some of the red blood cells is to decrease the viscosity of the blood. This can improve blood flow and oxygen delivery to tissues, especially in cases of decreased blood flow or oxygenation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Acute normovolemic hemodilution (ANH); Acute hypervolemic hemodilution (AHH); Ovarian cancer
Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)
Condition: Hematologic Neoplasms; Graft-Versus-Host Disease
MeSH terms: Hematologic Neoplasms; Graft vs Host Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine the safety and efficacy of post-transplant
      cyclophosphamide and a post-transplant infusion of donor cells, that have been specially
      processed to remove alpha beta t-cells, in patients undergoing a haploidentical allogeneic
      stem cell transplant to help reduce the risk of relapse without increasing the risk of
      graft-versus-host disease.
    

Detailed description: 
      Transplant patients participating in this clinical trial will receive one of 3 standard
      pre-transplant chemotherapy preparative regimens as appropriate for their specific disease.
      They will then receive a standard non-manipulated donor stem cell infusion on transplant day
      (day 0) followed by cyclophosphamide (days +3 and +4) and an alpha-beta t-cell reduced donor
      stem cell infusion on day +7.
    

Intervention name(s): Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Intervention type(s): Device
Intervention description(s): Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Intervention MeSH terms: Cyclophosphamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stem cell transplant
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of T-614 versus placebo when
      added to ongoing, stable-dose methotrexate therapy in patients with persistently active
      rheumatoid arthritis
    


Intervention name(s): T-614; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): T-614 is administered twice daily in combination with methotrexate. The daily dose of T-614 is 25 mg for the first 4 weeks and 50 mg for subsequent weeks.; Placebo is administered twice daily in combination with methotrexate. In placebo group, patients will receive T-614 after completing 28 weeks of treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Study to Explore Biomarkers for Drug-induced Liver Injury (DILI)
Condition: Healthy
MeSH terms: Chemical and Drug Induced Liver Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has an open-label, one-sequence, multiple drug administration design. The purpose
      of this study is as follows;

        -  To evaluate the change of liver function according to glutathione s-transferase (GST)
           genotype after the multiple administration of amoxicillin/clavulanate.

        -  To evaluate the intrinsic metabolite, human leukocyte antigen (HLA) genotype, and
           microRNA (miRNA) based on liver function change as the candidate biomarker for DILI.
    


Intervention name(s): Augmentin tablet
Intervention type(s): Drug
Other intervention name(s): Experimental: Augmentin; Augmentin 3 tablets (Amoxicilin:clavualanate=2:1) bid, for 14days
Intervention MeSH terms: Amoxicillin-Potassium Clavulanate Combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GST, DILI, biomarker
Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study
Condition: Verruca, Warts
MeSH terms: Warts
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate topical treatment with Veregen™ 15% ointment as a
      single therapeutic agent and compare it to combination therapy with Veregen ™ 15% ointment
      and a single destructive treatment by cryotherapy for non-facial verruca vulgaris in the
      pediatric population. This novel treatment modality may be useful in the pediatric
      dermatology community offering a less invasive, painless option for treatment of non-facial
      verruca vulgaris.
    

Detailed description: 
      The purpose of this study is to investigate topical treatment with Veregen™ 15% ointment as a
      single therapeutic agent and compare it to combination therapy with Veregen ™ 15% ointment
      and a single destructive treatment by cryotherapy for non-facial verruca vulgaris in the
      pediatric population. The investigators will compare the single and combination treatment
      modalities over identical time points in patients with non-facial verruca vulgaris. One of
      the current options for care for non-facial verruca includes cryotherapy, which is a painful
      and destructive method performed in the pediatric dermatology clinic. This study aims to
      establish the safety, non-invasivenature, efficiency, and efficacy of Veregen ™ 15% ointment
      as monotherapyfor non-facial verruca vulgaris in the pediatric population. The investigators
      hypothesize that Veregen ™ 15% ointment monotherapy will non-invasively treat non-facial
      verruca vulgaris with similar efficacy as combination therapy with a single cryotherapy
      treatment followed by topical application of Veregen ™ ointment. This novel treatment
      modality will be useful in the pediatric dermatology community offering a less invasive,
      painless option for treatment of non-facial verruca vulgaris.
    

Intervention name(s): Veregen only; Cryotherapy and Veregen
Intervention type(s): Drug; Procedure
Intervention description(s): Topical application of Veregen 15% ointment on affected areas twice daily; Cryotherapy followed by topical application of Veregen 15% ointment on affected areas twice daily
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Observational Study of Correction of Anaemia With Darbepoetin Alfa at QM Dosing Interval in Patients With CKD Not on Dialysis
Condition: Anaemia; Chronic Kidney Disease (CKD)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Observational

Summary: 
      To describe anaemia correction via haemoglobin measurements taken throughout observation
      period in ESA naive patients with chronic kidney disease initiated on darbepoetin alfa QM
    

Detailed description: 
      Darbepoetin alfa (Aranesp) is a long-acting ESA approved for treatment of anaemia in CKD
      patients, and may be administered once a week (QW), once every two weeks (Q2W) or once a
      month (QM) for correction and for maintenance in CKD patients not on dialysis. Prescribing
      information for darbepoetin alfa was updated in August 2013 (in EU and Australia), to
      incorporate the option for correction at QM dosing frequency in CKD patients not on dialysis.
      There is very little published literature describing QM correction in a real-world setting.

      Data obtained from this study are intended to contribute to filling a literature gap and to
      provide a robust source of information for physicians.
    

Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        The study population comprises CKD patients not on dialysis, ESA-naïve at time of
        initiation of darbepoetin alfa QM, and treated at nephrology clinics in EU and Australia
        from 01 May 2013. Eligible patients will have received at least three consecutive doses of
        darbepoetin alfa for correction of anaemia at a QM dosing interval. At each participating
        study site, all potentially elgible patients are to be considered for enrolment.
      
Keywords: chronic kidney disease,; anaemia correction/maintenance,; non dialysis,
Safety Study of an Oral Vaccine to Prevent Seasonal Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine
      tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded
      trial at a single site. The study was conducted under two separate protocols. Initially
      single administrations at two dose levels (low dose and mid dose) of the oral vaccine was
      tested in a placebo controlled study (37 subjects). And subsequently a single high dose of
      the oral vaccine was tested in a separate placebo-controlled study (24 subjects).
    

Detailed description: 
      Low and mid dose study was conducted under protocol number VXA02-001

      High dose study was conducted under protocol number VXA02-003
    

Intervention name(s): VXA-A1.1 Oral Vaccine; VXA Placebo Tablet
Intervention type(s): Biological; Biological
Intervention description(s): One or two doses of replication incompetent adenovirus oral tablet vaccine; Off-white tablets similarly formulated to the active drug product tablets.
Other intervention name(s): Ad-HA-dsRNA (VXA-A1.1); Placebo Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; H1N1; flu; seasonal
Endotracheal Intubation Using Bonfils Fibrescope Without Neuromuscular Blockade
Condition: Endotracheal Intubation; Hemodynamics; Neuromuscular Blockade
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      We studied intubating conditions and hemodynamic changes during endotracheal intubation
      employing either Bonfils intubating fiberscope or the conventional Macintosh laryngoscopy in
      80 healthy patients candidates for elective surgery requiring endotracheal intubation. We
      omitted neuromuscular blocking drugs from the induction regimen.
    

Detailed description: 
      BACKGROUND:

      Neuromuscular blocking drugs (NMBDs) are believed to be the dominating antigens causing
      bronchospasm and anaphylaxis during anaesthesia. Avoidance of these drugs, however, renders
      compromised intubating conditions and higher morbidity with conventional Macintosh
      laryngoscopy. Thus, we compared Macintosh laryngoscopy with Bonfils intubation fibrescope
      without administering NMBDs.

      METHODS:

      Eighty male and female patients scheduled for elective surgery, aged 15 to 60 years, ASA
      class II or I, non-obese, with lower risk for difficult intubation were enrolled in this
      study. They were randomly allocated into the Bonfils group or the Macintosh group (40 each).
      Following adequate hydration and preoxygenation, midazolam 0.05 mg kg-1 was administered,
      followed by alfentanil 20 µg kg-1, lidocaine 1.5 mg kg-1, and propofol 2 mg kg-1
      intravenously. Tracheal intubation was then carried out using Bonfils intubation fibrescope
      (Bonfils group) or employing conventional Macintosh laryngoscopy (Macintosh group). The
      primary outcome measure was the intubating condition, with mean arterial blood pressure and
      heart rate as secondary outcomes.
    

Intervention name(s): Bonfils; Macintosh
Intervention type(s): Device; Device
Intervention description(s): Endotracheal intubation using Bonfils Intubating Fiberscope; Endotracheal intubation using Macintosh laryngoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intubating conditions; Bonfils intubation fiberscope; Macintosh laryngoscope; neuromuscular blockade
The Clinical Efficacy of Three Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Dental Plaque and Gingivitis
Condition: Dental Plaque; Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this clinical research study is to assess the efficacy of three oral hygiene
      multi-component regimens encompassing the use of a manual toothbrush, toothpaste and a
      mouthwash in controlling established dental plaque and gingivitis.
    


Intervention name(s): triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash; stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash; fluoride toothpaste + fluoride Mouthwash
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.; Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.; Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
Other intervention name(s): Total toothpaste; Total Mouthwash; Crest Pro-Health toothpaste; Crest Pro-Health Multi-Protection Mouthwash; Crest Cavity Protection toothpaste; Crest Pro-Health For Me Breezy Mint mouthwash
Intervention MeSH terms: Triclosan; Cetylpyridinium; Fluorides; Tin Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of a Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus-like Particle (VLP) Vaccine
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, parallel dose assigned, double blind, multi center, Phase II study
      assessing the efficacy, safety, and immunogenicity of VLP vaccine (Authentic and Alpha
      variants) in adults between 18 and 59 years who are healthy or have medically stable chronic
      diseases and who have no known history of SARS-CoV-2 infection
    

Detailed description: 
      The primary objective of the study is to evaluate the humoral and cellular immune response of
      VLP vaccine candidates (harboring M, N, E, and HexaPro S antigens of the virus), as an
      efficacy criteria.

      Approximately 330 subjects will be randomized in a 1:1:1 ratio to receive two doses of 40 mcg
      VLP vaccine for Wuhan (n=110) or 40 mcg VLP vaccine for Alpha (British) variant (n=110) or 40
      mcg VLP vaccine for Wuhan+Alpha variant (n=110) 21 days apart.

      The study will be completed in 14 months.

      All injections will be done subcutaneously.
    

Intervention name(s): SARS-CoV-2 VLP Vaccine-Wuhan; SARS-CoV-2 VLP Vaccine-Alpha (British) variant; SARS-CoV-2 VLP Vaccine-Wuhan+Alpha variant
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus; Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus; Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the Wuhan or Alpha variants
Other intervention name(s): Authentic VLP Vaccine; Alpha Variant VLP Vaccine; Combination of Authentic and Alpha VLP Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Virus-like Particles harboring S, M, N, E antigens; SARS-CoV-2; K3-CpG ODN; Alum
Drug Coated Balloon Versus Stenting in Patients With Symptomatic Vertebral Artery Stenosis：an Observational Clinical Study
Condition: Vertebral Artery Origin Stenosis
MeSH terms: Constriction, Pathologic
Study type: Observational

Summary: 
      There are two arms in our trial, DCB group, BMS group.The investigators are going to
      investigate the safety and efficacy of all groups at 6 months and 12 months.
    


Intervention name(s): drug-coated balloon; bare metal stent
Intervention type(s): Device; Device
Intervention description(s): Orchid and Dahlia DCB; any type of bare metal stent
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients meet all of the inclusion criteria and none of the excusion criteria
      
Keywords: vertebral artery origin stenosis; drug-coated balloon; stenting; medical treatment
Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women
Condition: Microvascular Dysfunction
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      The purpose of this study is to determine if women with chest pain and "clean" heart blood
      vessels have impaired blood flow to the heart due to problems with the small blood vessels
      that provide blood and oxygen to the heart. Impairment in the small blood vessels will be
      tested using ultrasound pictures of the heart, called myocardial contrast echocardiography.
      Since these small blood vessels are not seen in a coronary angiogram, which is an x-ray of
      the heart vessels using a dye containing iodine injected in the heart vessels, the problem
      may remain undiagnosed in women until the heart muscle becomes severely damaged.

      A second purpose is to identify if there is a common trait in the population of women with
      this tiny blood vessel dysfunction, which will be investigated by checking blood levels of
      certain chemical and hormones related to heart disease. Finally, we would like to investigate
      the relationship between depression and stress, and heart disease. We will do this by
      measuring cortisol (a hormone that serves as a measure of stress) and administering
      questionnaires that help to identify depression and stress.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Fifty non-smoking women, between 45 and 75 years of age, with chest pain will be referred
        to this study by clinicians at OHSU. The control group will be fifty non-smoking women with
        no cardiac symptoms, matched with the study group by age and risk factors. Flyers and other
        advertisements may be used to recruit both the study group and the control group. Criteria
        for exclusion from the study are pregnancy, allergy to any component in the drugs used in
        the study, severe asthma, known disease of the heart vessels or heart valves, active
        infection, cancer, uncontrolled hypertension, kidney disease and current smoking status.
      
Keywords: Cardiac disease; vascular dysfunction; women; chest pain; echocardiography