bioihbjkbjnl/mcl2 huggingface dataset:
Treatment Effects of Atorvastatin on Hemostasis and Skin Microcirculation in Patients With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus; Dyslipidemia
MeSH terms: Diabetes Mellitus, Type 1; Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with type 1 diabetes are at increased risk of vascular complications both in the
      micro- and macrocirculation. Hyperglycemia plays a major role in the development of these
      vascular complications, but other factors such increased platelet adhesion and aggregation,
      elevated levels of plasma fibrinogen, altered fibrin network structure, increased thrombin
      generation, dyslipidemia and endothelial dysfunction may contribute.

      Lipid-lowering therapy with statins is effective in prevention of cardiovascular events in
      individuals at increased risk. Statins seem to exert beneficial effects on hemostasis and
      vasculature that are independent of their lipid-lowering properties.

      The aim of the present study was to investigated the effects of intensive
      LDL-cholesterol-lowering therapy with atorvastatin on fibrin network permeability (primary
      variable) and other aspects of hemostasis in patients with type 1 diabetes and dyslipidemia.
      Furthermore, the effects of atorvastatin therapy on skin microvascular function was also
      investigated.
    


Intervention name(s): Atorvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Atorvastatin 80mg once daily for 8 weeks; Placebo tablet once daily for 8 weeks
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study was to compare the efficacy of etanercept (25 mg, twice
      weekly) with that of placebo based on the percentage of patients who achieve the Assessment
      in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20%) at week 12.
    


Intervention name(s): Enbrel (etanercept)
Intervention type(s): Drug
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Smoking Cessation Study In Healthy Adolescent Smokers
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is designed to see if varenicline combined with age appropriate (adolescent)
      smoking cessation counseling will help teens quit smoking.
    


Intervention name(s): Varenicline 1mg BID; Varenicline 0.5mg BID; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52; Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52; Oral placebo for twelve weeks,follow-up through Week 52
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking cessation in adolescents
Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair
Condition: Abdominal Aortic Aneurysm
MeSH terms: Lung Injury; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Study type: Interventional

Summary: 
      To investigate whether limb remote ischemic preconditioning (LRIP) has protective effects
      against intestinal and pulmonary injury in patients undergoing open infrarenal abdominal
      aortic aneurysm (AAA) repair.
    

Detailed description: 
      Remote ischaemic preconditioning may confer the cytoprotection in critical organs. We
      hypothesized that limb remote ischemic preconditioning (RIPC) would reduce intestinal and
      pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA)
      repair.The primary outcomes included the biomarkers reflecting intestinal injury (serum
      intestinal fatty acid binding protein, endotoxin levels and diamine oxidase activity) and the
      variables reflecting pulmonary injury (arterial-alveolar oxygen tension ratio,
      alveolar-arterial oxygen tension difference and respiratory index). In addition, the severity
      of intestinal and pulmonary injury was assessed with different scoring methods, respectively.
      Markers of oxidative stress and systemic inflammation were measured as well.
    

Intervention name(s): Limb remote ischemic preconditioning(LRIP)
Intervention type(s): Procedure
Intervention description(s): LRIP consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated.
Other intervention name(s): LRIP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: aortic aneurysm; ischemia/reperfusion; preconditioning; pulmonary injury; intestinal injury
Yoga Study in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This purpose of this study is to test whether a 6-month yoga program improves quality of life
      and reduces fatigue and weight gain in breast cancer survivors.
    

Detailed description: 
      Women who are overweight or obese have a higher risk of breast cancer than normal weight
      women. Furthermore, women who are overweight or obese or gain weight after diagnosis have an
      increased risk of recurrence or dying from breast cancer compared with normal weight women.
      Yoga has been associated with reduced weight gain and weight loss in persons without cancer.
      However, no studies have tested whether yoga leads to less weight gain or weight loss in
      breast cancer patients. Both obesity and the sequelae of breast cancer therapy can result in
      reduced health-related quality of life and severe fatigue, which may also be favorably
      affected by yoga practice. The specific aims of the proposed trial are to examine, in women
      with Stage 0-IIIa breast cancer who are at least 3 months post primary treatment for their
      disease (other than tamoxifen or aromatase inhibitors), the effects of a 6-month yoga
      intervention on health-related quality of life, fatigue, and body weight.
    

Intervention name(s): Yoga; Delayed yoga classes
Intervention type(s): Behavioral; Other
Intervention description(s): Instructor-led yoga classes 1/time per week + 4 days of home practice; Delayed yoga classes (after 6 months) offered [wait list control group]
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Breast Cancer; Yoga; Quality of Life; Obesity; Fatigue; Weight
Time Serial Analysis on Preemptive Analgesia of Preoperative Topical Diclofenac and Ketorolac in Photorefractive Keratectomy(PRK)
Condition: Myopes Who Have Undergone PRK.
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators performed this study to investigate pain prevention of preoperative topical
      nonsteroidal anti-inflammatory drug (NSAID) in photorefractive keratectomy(PRK) using time
      serial pain scoring.
    


Intervention name(s): topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA); topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)
Intervention type(s): Drug; Drug
Intervention description(s): On operation day, the patients were randomly assigned to one of the following two groups: group KO,preoperative application of topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA) in one eye and topical ofloxacin 0.3% (Ocuflox®, SamilInc, Seoul, Korea)in the other eye; group DO, topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland) in one eye and ofloxacin 0.3% in the other eye. Neither the surgeon nor the participants knew which ophthalmic would go to which eye. A randomly assigned ophthalmic was instilled into right eye first three times by 1 minute interval 30 minutes prior to operation and the other ophthalmic was instilled into left eye with the same manner 10 minute later.; On operation day, the patients were randomly assigned to one of the following two groups: group KO,preoperative application of topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA) in one eye and topical ofloxacin 0.3% (Ocuflox®, SamilInc, Seoul, Korea)in the other eye; group DO, topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland) in one eye and ofloxacin 0.3% in the other eye. Neither the surgeon nor the participants knew which ophthalmic would go to which eye. A randomly assigned ophthalmic was instilled into right eye first three times by 1 minute interval 30 minutes prior to operation and the other ophthalmic was instilled into left eye with the same manner 10 minute later.
Intervention MeSH terms: Diclofenac; Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      High-dose interleukin 2 (Proleukin, Novartis) (IL-2) is approved by the U.S Food and Drug
      Administration (FDA) for the treatment of metastatic kidney cancer and is a standard
      treatment of this disease. At the present time, IL-2 is the only therapy for kidney cancer
      that can produce a remission of disease that lasts after treatment is completed. However,
      most patients who receive IL-2 do not benefit and all patients experience potentially
      dangerous side effects.

      Recent research has suggested that certain patients may respond better to IL-2 than others.
      The Cytokine Working Group is currently conducting a clinical trial that aims to identify and
      confirm this research and narrow the application of IL-2 to those patients most likely to
      benefit.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine, in a prospective fashion, if the response rate to high-dose IL-2 for
           patients with metastatic renal cell carcinoma and "good" pathologic predictive features
           is significantly higher than a historical, unselected patient population.

      Secondary

        -  To determine, in a prospective fashion, the response rate to high-dose IL-2 for patients
           with metastatic renal cell carcinoma and "poor" pathologic predictive features and to
           compare this response rate to the response rate of patients with "good" pathologic
           predictive features.

        -  To determine if components of other predictive and prognostic models (e.g MSKCI or UCLA
           criteria) can help to further define the optimal population to receive high-dose IL2 for
           metastatic renal cell carcinoma.

        -  To identify features of the baseline immune function (arginine, arginase, T cell zeta
           chain) of patients with metastatic renal cell carcinoma that are associated with
           response to high-dose IL-2.

        -  To identify new proteins or patterns of gene expression that might be associated with
           high-dose IL-2 responsiveness in order to further narrow the application of IL-2 therapy
           to those who will benefit the most.
    

Intervention name(s): HD IL2
Intervention type(s): Drug
Other intervention name(s): Proleukin; Aldesleukin
Intervention MeSH terms: Aldesleukin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney; Renal Cell; Metastatic; interleukin-2; select
Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length
Condition: Menorrhagia
MeSH terms: Menorrhagia
Study type: Interventional
Phase: Phase 4

Summary: 
      CavatermTM is a second-generation thermal balloon ablation device in the management of
      menorrhagia. The purpose of this study is to investigate the success (questionnaire) of
      CavatermTM dependent on uterus probe length, especially corpus probe length, which is
      measured during surgery.
    


Intervention name(s): Thermal Balloon Endometrial Ablation
Intervention type(s): Device
Intervention description(s): Thermal Balloon Endometrial Ablation for 10 minutes after curettage
Other intervention name(s): CavatermTM
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: menorrhagia; dysfunctional uterine bleeding; endometrial ablation; cavatermTM; probe
Influence of Data Collection Mode on Self-Report Validity of Asthma Therapy Adherence
Condition: Lung Diseases; Asthma
MeSH terms: Asthma; Lung Diseases
Study type: Interventional

Summary: 
      This study will examine how the assessment mode influences the validity of self-reported
      adherence to asthma therapy. Self-reported adherence to asthma therapy data will be collected
      using one of three randomized assessment modes (interview, computer, or telephone).
    

Detailed description: 
      BACKGROUND:

      Self-reports are a primary source of behavioral data. Studies have highlighted the variable
      validity and reliability of self-report measures of health behaviors such as adherence to
      therapy. Research on self-reports of sensitive information, such as sexual behavior and drug
      use, suggests that the mode of data collection may enhance validity of self-reports. However,
      no studies have determined how the mode of data collection influences self-reports when an
      objective measure of the behavior is available.

      DESIGN NARRATIVE:

      The primary aim of this study is to examine the influence of the mode of data collection on
      the validity of self-reports of inhaled anti-inflammatory medication adherence.

      The key secondary outcomes of the study will attempt to answer the following questions: 1)
      does the assessment mode influence self-reports of commonly used asthma outcome measures of
      disease-related symptoms, self-management behaviors, and quality of life?; 2) does the
      relationship between the assessment mode, the validity of self-reports of adherence, and
      other measures (i.e., asthma symptoms, self-management behaviors, and quality of life) change
      over time?; and 3) does the assessment mode interact with baseline personality
      characteristics and mood to influence the validity of self-reports of adherence and other
      outcome measures (i.e., asthma symptoms, self-management behaviors, and quality of life)?
    

Intervention name(s): Standardized Asthma Education Program
Intervention type(s): Behavioral
Allocation: Randomized
Carbamazepine Treatment of Cocaine Dependence - 1
Condition: Cocaine-Related Disorders; Substance-Related Disorders
MeSH terms: Cocaine-Related Disorders; Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the efficacy of carbamazepine in treatment of
      cocaine-dependence in patients with affective disorders.
    


Intervention name(s): Carbamazepine
Intervention type(s): Drug
Intervention MeSH terms: Carbamazepine
Primary purpose: Treatment
Keywords: Cocaine; Substance Abuse
Closure Method Study Following Tonsillectomy in Children
Condition: Tonsillectomy; Children
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a children's study evaluating the effects of a tonsillectomy with tonsillar fossae
      closure compared to without closure of the operative wound.
    

Detailed description: 
      This is a children's study. Patients experience significant postoperative pain, activity
      limitation and sometimes other significant postoperative complications. We are going to
      compare the effects of closing the tonsil wound versus non-closure. A daily journal will be
      kept (by the patient's parent or legal guardian)to log in measures of morbidity.
      Postoperative telephone calls will be made and scripted questions will be asked regarding any
      tonsillar hemorrhage requiring medical re-evaluation, and dehydration requiring medical
      re-evaluation. The patients will also be examined in the clinic at 10-14 days postoperatively
      to determine if the fossa remained closed or dehisced.
    

Intervention name(s): Closure of the Tonsillar Fossa; Tonsillectomy with open fossa
Intervention type(s): Procedure; Procedure
Intervention description(s): We hypothesize that closure of the tonsillar fossa decreases the morbidity of pain by decreasing exposure of the raw operative bed to oral secretions, mediation, and oral intake, and decreases the morbidity of post-operative hemorrhage by having the operative wound closed.; SOP for a tonsillectomy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tonsillectomy, tonsillar fossa, wound closure
Comparison of Outpatient and Inpatient Spa Therapy
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      In this study, we aimed to compare the effectiveness of inpatient and outpatient physical
      therapy modalities and spa combination treatments on pain and functional status in patients
      with knee osteoarthritis.
    

Detailed description: 
      Osteoarthritis (OA) has an important place in musculoskeletal diseases and is the most common
      rheumatic joint disorder characterized by progressive cartilage degeneration. Osteoarthritis
      of the knee is the most common symptomatic osteoarthritis characterized by chronic knee pain,
      joint stiffness, limited daily activities, and decreased quality of life.

      In this study, it was aimed to compare the effects of inpatient and outpatient applications
      of HP, US, TENS, spa combination treatments on pain and functional status in patients with
      knee osteoarthritis.
    

Intervention name(s): Spa therapy and conventional physical therapy
Intervention type(s): Other
Intervention description(s): HP application +deep heater application + TENS. HP application: A hotpack wrapped in a towel for 20 minutes will be placed on the knee and surrounding soft tissues.
Deep heater application: The application will be performed with a therapeutic ultrasound device at a dose of 1.5watt / cm2 for each string for 6 minutes.
TENS application:TENS device with two electrodes surrounding tendon will be performed for 30 minutes at low-frequency current application.
Spa therapy: A conventional water bath water at 38 ° C will be applied in the pool for 20 minutes a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spa therapy; Electrotherapy; Ultrasound; Hotpack
A Study of LY2409021 Formulations and the Effect of Food
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to compare how much of LY2409021 enters the bloodstream and
      how long the body takes to get rid of the drug when different formulations of LY2409021 are
      given, and when LY2409021 is taken with or without food.

      The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting of
      3 formulations of LY2409021. Participants in each cohort will receive the same all 3
      formulations using a randomized sequence crossover design. There is a washout period of at
      least 14 days between dosing periods.

      There will be an interim analysis after Cohort 1 completes study Period 2. Cohort 2 will not
      begin enrolling until this analysis is complete. The need to enroll Cohort 2 will be
      determined by the outcome of the interim analysis.
    


Intervention name(s): LY2409021 Reference Form; LY2409021 Test-Med Formulation (medium particle size); LY2409021 Test-High Formulation (high particle size); LY2409021 Test-Low Formulation (low particle size)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally; Administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; Bioavailability
Safety and Efficacy of Cariprazine for Mania
Condition: Bipolar Disorder; Mania
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy, safety, and tolerability of
      cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes
      associated with bipolar I disorder.
    


Intervention name(s): Cariprazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine.; Patients who meet eligibility criteria will be administered a once daily oral dose of placebo.
Intervention MeSH terms: Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Mania; Bipolar I Disorder
Use of Electroconvulsive Therapy (ECT) in Chronic, Severe, Treatment Resistant Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Post Traumatic Stress Disorder is a chronic debilitating illness and few treatment options
      have demonstrated effectiveness. The study will look at the use of electroconvulsive therapy
      for the treatment of Post Traumatic Stress disorder in patients who have not responded to
      multiple antidepressants or cognitive behavioral therapy.
    


Intervention name(s): Electroconvulsive Therapy
Intervention type(s): Procedure
Intervention description(s): ECT was administered using the MECTA-SR1 apparatus. The current amplitude was 800 mA, pulse width was 1.5 ms, and pulse frequency was 50 Hz. Stimulus duration was increased as required to elicit an adequate seizure, defined as at least 25 s with EEG monitoring. The ECT course was fixed, and comprised 6 treatments administered with bitemporal electrode placement at a twice-weekly frequency
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: posttraumatic stress disorder; electroconvulsive therapy; medication refractoriness