bioihbjkbjnl/mcl2 huggingface dataset:
Sore Throat After Intubation Using Glidescope With Stylet and Bougie
Condition: Postoperative Sore Throat
MeSH terms: Pharyngitis
Study type: Interventional

Summary: 
      This is a prospective double-blinded clinical trial aiming to compare the incidence and
      severity of sore throat after laparoscopic cholecystectomy when using two different
      techniques of intubation using glidescope
    

Detailed description: 
      The first technique is loading the endotracheal tube on a stylet the second technique is
      sliding the endotracheal tube over a bogie that is dragged into the trachea at both
      techniques, the investigators are using glidescope
    

Intervention name(s): a device to facilitate endotracheal intubation
Intervention type(s): Device
Intervention description(s): a device to facilitate endotracheal intubation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery
Condition: Spinal Fusion; Antifibrinolytic Agents; Hemorrhage; Blood Transfusion
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Current evidence regarding the efficacy and safety of perioperative administration of
      tranexamic acid for antifibrinolysis does not suffice to support its use in major spinal
      surgery.

      OBJECTIVES: To evaluate the effectiveness of tranexamic acid for decreasing transfusion
      requirements and bleeding in this patient population. To evaluate the safety of this
      antifibrinolytic agent in the intraoperative and mid-term postoperative period.

      METHODS: Multicenter, randomized, double-blind, placebo-controlled clinical trial with
      parallel groups. The main outcome measure is intraoperative and postoperative transfusion
      requirements; blood loss and safety will also be evaluated. Previous results in other types
      of surgery suggest that tranexamic acid reduces transfusion requirements and blood loss.
      Hence, the hypothesis of this study is that tranexamic acid will significantly reduce blood
      loss in comparison to a placebo in major spine surgery.
    


Intervention name(s): Tranexamic Acid; fisiologic serum
Intervention type(s): Drug; Drug
Intervention description(s): A 10-mg/kg dose of tranexamic acid will be administered as a bolus or as a fast, 20-minute intravenous infusion before performing the incision at the start of surgery, followed by perfusion of 2 mg/kg/hour up to the time the surgical wound is closed at completion of surgery.; The placebo will be administered according to the same regimen and infusion time as the medication in the study arm (bolus or 20-minute fast infusion before the incision at the beginning of surgery followed by perfusion of 2 mg/kg/hour until closure of the surgical wound at completion of surgery)
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal deformity correction; Surgical bleeding; Transfusion practice; Spinal Fusion; Antifibrinolytic Agents; Hemorrhage; Blood Transfusion
A Proof-of-principle Study of HBO-SRS for Brain Metastases
Condition: Brain Metastases
MeSH terms: Neoplasm Metastasis; Brain Neoplasms
Study type: Interventional

Summary: 
      Patients with brain metastases who are candidates for treatment with stereotactic
      radiosurgery (SRS) are potential study participants. SRS delivers high-energy,
      precisely-focused radiation to each brain metastasis to shrink the tumor, and is the
      standard-of-care for patients with these tumors. Oxygen enhances the damaging effects of
      radiation on tumor cells. Hyperbaric oxygen (HBO) therapy increases oxygen levels in all
      kinds of tissues, including tumors. The purpose of this trial is to study whether it is
      feasible to treat patients with HBO just prior to receiving SRS, given the timing constraints
      of treating sequentially with HBO and then SRS. Patients will undergo HBO treatment followed
      by the placement of a Gill-Thomas-Cosman head frame then transported ,via stretcher, to
      receive SRS. The transfer and placement of the head frame needs to be completed within the
      15minute time frame. The trial's secondary objectives are to determine whether it has any
      effects on outcomes and quality of life. As part of study participation patients will be
      asked to complete quality of life questionnaires as well as mini mental status
      questionnaires. These will be done prior to treatment and at follow up appointments
      throughout the next 3 years while participating in the study. Patients will be given the
      option to participate in the optional bio marker blood draw study which would require
      patients to have blood drawn at three time points, pre-treatment, the day after treatment and
      at their first follow up visit.
    


Intervention name(s): Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Demonstrate coordination of HBO with SRS treatments is feasible.; Demonstrate outcomes for patients treated with combination of HBO and SRS are non-inferior .
Dietary Carbohydrate Consumption at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite
Condition: Childhood Obesity; Breakfast
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of carbohydrates of familiar breakfast
      meals on glycemic response, subjective appetite, and food intake in normal weight (NW) and
      overweight or obese (OW/OB) children.
    

Detailed description: 
      Regular breakfast eating NW and OW/OB children, 9-14 years of age, will participate in the
      experiment. Four isocaloric (450 kcal) breakfasts (eggs with a side of French fries, mashed
      potatoes, or beans, and control breakfast of milk, cereal and toast) and breakfast skipping
      will be examined. On five separate mornings, 7 days apart and after a 12 hour overnight fast,
      each participant will receive one of the four breakfasts or skip breakfast, in a randomized
      counterbalanced order. Participants will be given an ad libitum lunch 3 hours after breakfast
      and parents will report the rest of day food record for food intake analysis. Blood glucose
      will be measured via finger-prick at baseline, and 30, 60, 120, and 180 minutes after
      breakfast consumption. Subjective appetite will be measured with a visual analogue scale at
      baseline and every 15 minutes for 1 hour, and every hour for 3 hours.
    

Intervention name(s): Mashed potatoes; Traditional breakfast; Breakfast skipping; French fries; Beans
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Isocaloric (450 kcal) breakfast treatments of eggs with a side of mashed potatoes; Isocaloric (450 kcal) control breakfast treatments of cereal, milk, toast and jam; No breakfast; Isocaloric (450 kcal) breakfast treatments of eggs with a side of French fries; Isocaloric (450 kcal) breakfast treatments of eggs with a side of beans
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: children; dietary carbohydrates; satiety; appetite; blood glucose; solanum tuberosum; obesity; breakfast
Galantamine Effects on Cognitive Function in Marijuana Users
Condition: Memory
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate galantamine's effects on cognitive performance in marijuana users. Galantamine,
      an acetylcholine esterase inhibitor, is approved for treatment of Alzheimer's disease.
      Current marijuana users show impaired cognitive functioning, which predicts poor treatment
      response to behavioral treatments in this population. Whether cognitive impairment in
      marijuana users will improve with medication treatment has not been evaluated. We hypothesize
      that galantamine, compared to placebo, will improve cognitive performance in marijuana
      users.Galantamine, compared to placebo, will improve working memory, verbal learning/memory
      and response inhibition functions in marijuana users.
    

Detailed description: 
      To summarize, marijuana users show impaired cognitive functioning, especially in working
      memory and verbal learning and memory functions. Impaired cognitive functioning predicts poor
      treatment response in marijuana users. Whether the cognitive impairments in marijuana users
      improve with cholinergic enhancers has not been evaluated. In this double-blind,
      parallel-group study, we are proposing to evaluate galantamine's effects on cognitive
      performance in marijuana users. Thirty subjects will first have an adaptation session to
      familiarize them with the study procedures including cognitive assessment. The adaptation
      session will be followed by a 10-day treatment period, in which subjects will be randomized
      to galantamine (8 mg/day) or placebo. On Day 4 or 5 and Day 9 or10 of each treatment phase
      subjects will have test sessions, where a battery of cognitive tests will be administered.
      The cognitive test that will be administered will include the Hopkins Verbal Learning Test
      (HVLT) modules from the Cambridge Neuropsychological Test Automated Battery (CANTAB): the
      Rapid Visual Information Processing (RVIP) and the Stop Signal Test (SST).

      Currently this study is in data analysis with 30 completers. (April 2011)
    

Intervention name(s): Placebo; Galantamine
Intervention type(s): Drug; Drug
Intervention description(s): 8Mg a day of a sugar pill; 8mg of Galantamine
Intervention MeSH terms: Galantamine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: ability to learn, working memory
EC905 Pharmacokinetic Profile Study
Condition: Phase 1; Healthy; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms
MeSH terms: Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to compare the pharmacokinetics of tamsulosin HCl and solifenacin succinate after
      co-administration of single entity tablets and of the combination tablet EC905 under steady
      state conditions at three dose strengths.
    

Detailed description: 
      There will be 3 dose cohorts of 15 subjects each. In Period 1, subjects will be randomized to
      either receive multiple doses of both tamsulosin HCl and solifenacin succinate as single
      entity tablets, or the combination tablet EC905. The alternate treatment will be provided in
      Period 2. The cohorts will be balanced for period effects and first-order carry over effects.
    

Intervention name(s): Tamsulosin HCl; Solifenacin Succinate; EC905
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral; Oral; Oral
Other intervention name(s): Omnic OCAS®; Vesicare®; Vesomni®
Intervention MeSH terms: Tamsulosin; Solifenacin Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bladder outlet obstruction; Overactive bladder; Urinary incontinence; Omnic OCAS®; Vesicare®; Tamsulosin hydrochloride; Solifenacin succinate
Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising
Condition: Ecchymosis
MeSH terms: Ecchymosis; Contusions
Study type: Interventional

Summary: 
      The objective of this study is to assess the comparative utility of topical formulations in
      hastening the resolution of skin bruising. For each subject, four standard bruises of 7 mm
      diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using
      a 595-nm pulsed-dye laser. Randomization was used to assign one topical agent (5% vitamin K,
      1% vitamin K and 0.3% retinol, 20% arnica or white petrolatum) to exactly one bruise per
      subject, which was then treated under occlusion twice a day for 2 weeks. A dermatologist
      rated bruises in standardized photographs immediately after bruise creation and at week 2.
    


Intervention name(s): Petrolatum United States Pharmacopeia (USP); Vitamin K and retinol ointment; Arnica ointment; Vitamin K ointment
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Topical formation applied to bruise twice daily for 2 weeks.; Topical formation applied to bruise twice daily for 2 weeks.; Topical formation applied to bruise twice daily for 2 weeks.; Topical formation applied to bruise twice daily for 2 weeks.
Intervention MeSH terms: Vitamins; Vitamin K; Vitamin A; Petrolatum
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bruising; Topical 20% arnica
Evaluation of the Efficacy of Rosuvastatin in Daily Practice (TARGET)
Condition: Hypercholesterolemia; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Study type: Observational

Summary: 
      In this study the effect of the switch to rosuvastatin from another statin (fluvastatin,
      pravastatin, simvastatin, atorvastatin) was evaluated in high-risk patients with and without
      evident CHD and LDL-C ≥ 3.2 mmol/l. This was done in a large observational study (TARGET)
      representing daily practice. Primary end points analysis was the percentage of patients
      reaching the target of LDL-C < 3.2 mmol/l. Secondary outcomes were the changes of LDL-C,
      HDL-C, TC, Triglycerides (TG) and TC/HDL-C-ratio from baseline.
    


Observational model: Defined Population
Time perspective: Prospective
Keywords: cholesterol; coronary heart disease; rosuvastatin; LDL-C goal; hypercholesterolemia
Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics
Condition: Asthma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with
      the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.
    


Intervention name(s): budesonide and formoterol 200/6 microg; budesonide and formoterol 200/6 microg; budesonide and formoterol 200/6 microg; budesonide and formoterol 200/6 microg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 inhalations as a single dose; 2 inhalations as a single dose; 2 inhalations as a single dose with the concurrent charcoal blockage; 2 inhalations as a single dose with the concurrent charcoal blockage
Other intervention name(s): Budesonide/formoterol Easyhaler 200/6 microg/inhalation; Symbicort Turbohaler 200/6 microg/inhalation; Budesonide/formoterol Easyhaler 200/6 microg/inhalation; Symbicort Turbohaler 200/6 microg/inhalation
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Thrombosis
Study type: Interventional

Summary: 
      Hepatectomy is still the treatment of choice for hepatocellular carcinoma. Part of the
      patients may present portal vein tumor thrombus (PVTT) after resection. PVTT might lead to
      upper gastrointestinal bleeding and worsening of hypersplenism which will endanger the life
      of the patients. PVTT also plays the centre role of recurrence and metastasis of HCC. There
      is no standard treatment for PVTT yet. We aim to compare the effects of TACE and TACE plus
      laser ablation for treating patients with PVTT.
    

Detailed description: 
      Hepatectomy is still the treatment of choice for hepatocellular carcinoma, but the prognosis
      is not agreeable. Part of the patients may present portal vein tumor thrombus (PVTT) after
      resection. PVTT might further increase the pressure of portal vein and lead to upper
      gastrointestinal bleeding and worsening of hypersplenism which will endanger the life of the
      patients. PVTT also plays the centre role of recurrence and metastasis of HCC. There is no
      standard treatment available now for PVTT yet. TACE is mostly often used to treat the PVTT.
      We aim to compare the effects of TACE and TACE plus laser ablation for treating patients with
      PVTT.
    

Intervention name(s): TACE; Laser ablation
Intervention type(s): Drug; Procedure
Intervention description(s): TACE: The chemotherapeutic drugs and 2 to 10 ml lipiodol are given via hepatica propria artery. The chemotherapeutic drugs include 5-Fu 1500 mg, epirubicin 30 mg, cisplatin 30 mg.; Laser ablation is given to the PVTT.
Other intervention name(s): TAE; Microinvasive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; Portal vein tumor thrombus; laser ablation
HIV and Cardiovascular Risk
Condition: HIV Infections; Cardiovascular Disease
MeSH terms: HIV Infections; Cardiovascular Diseases
Study type: Observational

Summary: 
      HIV-infected patients treated with combination antiretroviral therapy demonstrate metabolic
      abnormalities that may predispose them to cardiovascular disease. In HIV-infected patients we
      will investigate progression rates of cardiovascular disease and assess whether these
      progression rates are predicted by increased inflammatory indices.
    

Detailed description: 
      HIV-infected patients treated with combination antiretroviral (ARV) therapy increasingly
      demonstrate metabolic abnormalities, including dyslipidemia, insulin resistance and body
      composition abnormalities that may predispose them to cardiovascular disease (CVD). Initial
      studies suggest increased carotid intima-media thickness (IMT) and endothelial dysfunction in
      this population. Increased carotid IMT over time has been demonstrated in HIV-infected
      patients compared to control subjects. However, traditional risk factors, such as
      dyslipidemia, diabetes mellitus and body composition changes alone do not fully predict
      increased cardiovascular disease in HIV-infected patients. One possible explanation is
      increased inflammation, related directly to effects of ARV therapy or indirectly from changes
      in fat distribution. In preliminary studies, our group has shown that changes in fat
      distribution were highly predictive of TNF and IL-6, as well as adiponectin, and that
      specific inflammatory cytokines were related in cross-sectional studies to increased IMT. In
      the proposed study we will investigate using detailed methodologies the relationship between
      adipocytokine concentrations and subclinical atherosclerosis in both cross-sectional and
      longitudinal studies. We will determine in HIV-infected patients on ARVs for greater than 6
      months, progression rates of IMT and whether progression rates are predicted by increased
      inflammatory indices, controlling for traditional risk factors, and body composition changes.
      We will test the hypothesis that inflammation, more than traditional risk factors and ARV
      use, mediates subclinical atherosclerotic disease in HIV-infected patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Flyers and advertisements regarding this study will be posted in community centers and
        newspapers
      
Biospecimen description: 
      blood will be frozen for end of study analysis for insulin, CRP, adiponectin, TNF-α, sTNFR2,
      IL-6, PAI-1, MCP-1
    
Keywords: HIV Infection; Cardiovascular Disease; Antiretroviral Therapy; Inflammatory Markers; Treatment Experienced
Naltrexone Treatment of Alcohol Dependence
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The long-range goal of this ongoing research program is to find more effective treatments for
      alcohol dependence by combining medication with the appropriate psychosocial support. This
      proposal has three specific aims: (1) to compare the effectiveness of naltrexone (Revia) in
      three types of treatment settings; (2) to assess the effects of psychosocial support on
      medication compliance and treatment retention; and (3) to investigate the individual
      characteristics that may predict who is likely to benefit from additional psychosocial
      support versus simple medication management.
    


Intervention name(s): naltrexone (Revia); Compliance Enhancement Tech.; Cognitive Behavior Therapy
Intervention type(s): Drug; Behavioral; Behavioral
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Stress-MRI Assessment After Right Coronary Artery CTO Recanalization
Condition: Ischemic Heart Disease; Coronary Atherosclerosis; Coronary Artery Disease; Coronary Artery Stenosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Atherosclerosis; Coronary Stenosis
Study type: Interventional

Summary: 
      The hypothesis of this study is that Stress-MRI is a clinically significant method of
      myocardial perfusion assessment after coronary angioplasty with stenting of right coronary
      artery (RCA) chronic total occlusion (CTO) is performed.
    


Intervention name(s): CTO coronary angioplasty; Optimal medicamentous treatment; Stress-MRI
Intervention type(s): Procedure; Drug; Procedure
Intervention description(s): A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Recanalisation of coronary artery CTO is performed by the hydrophilic coronary wire, using the most appropriate technique. Then balloon angioplasty of target lesion is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.; A standard stress-MRI test with adenosine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Coronary stenosis; Drug-eluting stent; Coronary angioplasty with stenting; Ischemic Heart Disease; Chronic total occlusion; Right coronary artery; Stress-MRI