bioihbjkbjnl/mcl2 huggingface dataset:
Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes
Condition: Hypertension; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the vascular effects of two commonly used blood
      pressure medications, carvedilol and metoprolol in hypertensive patients with type 2
      diabetes.
    

Detailed description: 
      Carvedilol and metoprolol are two commonly used blood pressure medications that have both
      been shown to be effective in controlling hypertension. Although in the same drug class,
      preliminary data have shown that these medications may have different vascular effects. This
      study will assess which medication is better at improving artery health independent of their
      blood pressure lowering effects. Artery health will be assessed non-invasively by ultrasound.
      Certain markers of atherosclerosis found in the blood will also be measured.
    

Intervention name(s): Carvedilol; Metoprolol
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg twice daily for five months.; 200 mg twice daily for five months.
Other intervention name(s): Coreg; Lopressor
Intervention MeSH terms: Metoprolol; Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: beta-blockers; endothelial function
Laparoscopic Colorectal Resection in Elderly
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      This is a nested cohort study of OAMBP-01. Patients over 70 years old were enrolled into the
      data-analysis.

      The purpose of this study was to examine the feasibility and safety of laparoscopic
      colorectal resection in elderly patients from a single center, and to explore if there are
      advantages in laparoscopic surgery.
    

Detailed description: 
      Surgical resection remains the primary treatment for CRC. Despite advancements in surgical
      techniques, treating elderly cancer patients remains challenging for surgeons. Perioperative
      risk increases as elderly patients are susceptible to cardiovascular and respiratory
      diseases. In addition, it has been demonstrated that elderly individuals come with more
      locally advanced tumor and are more likely to have obstructive or disseminated disease at the
      time of presentation. In addition, aging diminishes a person's physiological capacity to
      withstand a major operation. Therefore, surgeons preferred to choose laparotomic colorectal
      resection to reduce surgical duration and morbidity..

      The benefits of laparoscopic colorectal resections over laparotomic surgery have been clearly
      demonstrated in the general population. However, previous clinical trials comparing surgical
      approach between laparoscopy and laparotomy restricted the patient's age <75 years, we have
      limited information on short- and long-term safety and efficacy of elderly patients underwent
      laparoscopic colorectal resection.

      The purpose of this study was to examine the feasibility and safety of laparoscopic
      colorectal resection in elderly patients from a single center, and to explore if there are
      advantages in laparoscopic surgery.

      This is a nested cohort study of OAMBP-01. Patients over 70 years old were enrolled into the
      data-analysis.
    

Intervention name(s): laparoscopic surgery
Intervention type(s): Procedure
Intervention description(s): Patients over 70 years old underwent laparoscopic or laparotomic colorectal resection were enrolled.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This is a nested cohort study of OAMBP-01, patients over 70 years old underwent laparotomic
        surgery were enrolled into the data analysis, compared with the laparotomic colorectal
        resection in the same time period. All eligible patients were identified by searching the
        database of the Gastrointestinal Surgery Centre, Third Affiliated Hospital of Sun Yat-sen
        University.
      
Keywords: laparoscopy; laparotomy; elderly
Timing of Complete Revascularization for Multivessel Coronary Artery Disease in STEMI
Condition: Myocardial Infarction
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The study will compare clinical outcomes between complete revascularization during
      hospitalization for ST elevation myocardial infarction (STEMI) and intervention after 30 days
      and intervention based on outpatient non-invasive ischemia testing in patients with
      multivessel coronary artery disease (MVD) presenting with first ever ST elevation myocardial
      infarction.
    

Detailed description: 
      This study is prospective, randomized, multicentre, open label study in patients with ST
      elevation myocardial infarction (STEMI) with multivessel coronary artery disease (MVD)
      defined as >70% stenosis in a non-culprit vessel, initially treated with culprit only primary
      PCI. The patients will be enrolled in four high volume PCI centers after successful culprit
      only primary PCI and then randomly assigned to one of three treatment arms:1. complete
      revascularization of all non-culprit significant lesions in a single session during initial
      hospitalization; 2. same revascularization in a single session after 30 days;
      3.revascularization or it's deferral based on ischemia testing using Dobutamin stress
      echocardiography. The study will explore differences in occurrence of major adverse
      cardio-cerebral events (cardiac death, repeated myocardial infarction, cerebrovascular
      accident and repeated revascularization) and complications of interventions during 12 months
      follow-up.
    

Intervention name(s): PCI; dobutamine stress echocardiography
Intervention type(s): Procedure; Procedure
Intervention description(s): percutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis; Echocardiographic stress test of provoked myocardial ischemia using dobutamine
Other intervention name(s): percutaneous coronary intervention
Intervention MeSH terms: Dobutamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myocardial infarction; percutaneous coronary intervention; multivessel coronary artery disease; dobutamine stress echocardiography
Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy
Condition: Central Serous Chorioretinopathy
MeSH terms: Central Serous Chorioretinopathy
Study type: Interventional

Summary: 
      The aim of this study was to evaluate safety and therapeutic response to micropulse diode
      810nm laser treatment in patients with chronic central serous chorioretinopathy.
    

Detailed description: 
      Most of the cases of central serous chorioretinopathy (CSC) recur spontaneously within three
      months of disease. After 3 months without resolution of acute CSC or in chronic CSC,
      continuous wave laser photocoagulation or photodynamic therapy should be considered. Direct
      threshold continuous photocoagulation treatment can shorten the duration of the serous
      detachment, but it is not appropriate for juxtafoveal or subfoveal leakage point.Subvisible
      photocoagulation potentially localizes and decreases chorioretinal thermic burn. Subthreshold
      diode micropulse (SDM) laser using a 810nm diode laser may spare the damage to the neural
      retina by raising the temperature of the RPE to just below the protein-denaturation threshold
      so that the thermal wave that reaches the neural retina is insufficient to cause neither
      damage nor clinically visible end-point. This therapeutic laser modality offers the
      possibility to minimize the iatrogenic retinal lesion.
    

Intervention name(s): Subthreshold diode micropulse laser
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vaginal Electrical Stimulation Versus Neuromodulation
Condition: Refractory Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Observational

Summary: 
      This prospective study compares quality of life measures of patients with refractory
      overactive bladder, between two modes of neuromodulation: vaginal electrical stimulation
      (Group A) and sacral nerve stimulation (Group B).

      The specific aims are:

      1. To characterize patient symptom bother score, quality of life, and body image scores in
      patients obtaining sacral nerve stimulation, as compared to vaginal electrical stimulation.

      - Hypothesis 1: Both modes of neuromodulation will impact patients' scores in quality of
      life, patient symptoms, and body image questionnaires.
    

Detailed description: 
      All participants will have a standardized intake history which will include age, weight,
      history of prior treatment for incontinence, medication list, obstetric and gynecologic
      history, medical history, and surgical history, as well as a complete review of systems. The
      physical examination will include vital signs (including BMI), genitourinary exam, including
      Pelvic Organ Prolapse Quantification (POPQ), and neurologic exam. All patients will undergo
      spontaneous uroflowmetry, urine dipstick from catheterized specimen, multichannel
      urodynamics, and 3-day voiding diary. Measurement of post-void residual will also be
      obtained. Completion of the UDI-69, King's Health Questionnaire10, and the Modified Body
      Image Perception Scale (MBIS) will also be part of the initial visit 11,12.

      All participants taking anticholinergics will undergo a 2 week flush-out period prior to the
      intake assessment. After the intake assessment, the provider will determine which treatment
      option is appropriate to the participant, and they will then be assigned to one of the two
      treatment arms: Group A will use vaginal electrical stimulation using the Empi Intravaginal
      Stimulation Unit Minnova (Empi, St. Paul, MN, USA) and participants in Group B will receive
      sacral neuromodulation using InterStim (Medtronic, Minneapolis, MN, USA).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The projected sample size is 48 patients. We anticipate the recruitment of 16 patients for
        the InterStim arm of this study and 32 patients who will undergo vaginal electrical
        stimulation. Participants will be drawn from the University of Oklahoma Urogynecology
        clinics. Our catchment area includes OU Physicians clinic (private clinic) and Presbyterian
        Professional Building (resident clinic). Our referral area includes all of Oklahoma as well
        as the surrounding states. Participants will be recruited by physician referrals as well as
        by campus advertisements.
Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy
Condition: Stomach Neoplasms; Precancerous Conditions
MeSH terms: Stomach Neoplasms; Precancerous Conditions
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether endomicroscopy can improve the detection of
      Early Gastric Cancers (EGC).
    

Detailed description: 
      Endoscopy is proved to be the best method to achieve early diagnosis of gastric cancer (GC).
      Confocal laser endomicroscopy (CLE), a new diagnostic modality, has been shown to be valuable
      in increasing the diagnostic yield of colorectal neoplasias, but it is not clear whether CLE
      is helpful to find out early gastric cancer (EGC).The aim of the study is to investigate the
      value of CLE in improving the detection of EGCs.
    

Intervention name(s): Endomicroscope (Pentax, Tokyo, Japan); Gastroscopes (Pentax, Tokyo, Japan)
Intervention type(s): Device; Device
Intervention description(s): A Pentax EC3870K endomicroscope which can produce conventional white light endoscopic images and confocal images at the same time with a optical slice thickness of 7 μm, a lateral resolution of 0.7 μm, a scanning depth of 0 to 250 μm, a pixel density of 1024×512 pixels (at an image acquisition rate of 1.6 frames/second)，and a field of view of 475 μm×475 μm.; Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)
Other intervention name(s): Pentax EC3870K endomicroscope; Pentax EG-2940 gastroscopes (Pentax, Tokyo, Japan)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Stomach; endoscopy; neoplasms
Drug Interaction Study Between Bosutinib And Dabigatran
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study evaluates the effect of a single oral dose of bosutinib on the single dose
      pharmacokinetics of dabigatran, a p-glycoprotein substrate, in healthy subjects.
    


Intervention name(s): Dabigatran; Bosutinib; Dabigatran
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dabigatran 150 mg orally; Bosutinib 500 mg orally; Dabigatran 150 mg orally
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bosutinib; dabigatran; drug interaction; p-glycoprotein; pharmacokinetics
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
Condition: Pain; Diabetic Neuropathies; Paresthesia
MeSH terms: Diabetic Neuropathies; Paresthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES:

      I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain
      in patients with diabetic neuropathy.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by
      participating institution.

      The first group receives oral mexiletine 3 times a day for 6 weeks. The dose is increased
      after the first week if there are no side effects.

      The second group receives a placebo. Patients cross to the alternate treatment after a 1-week
      washout.
    

Intervention name(s): mexiletine
Intervention type(s): Drug
Intervention MeSH terms: Mexiletine
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: diabetic neuropathy; disease-related problem/condition; neurologic and psychiatric disorders; pain; rare disease
Measurement Algorithm Control and Optimization With Subsequent Performance Evaluation of Sanmina Non-invasive Biosensors During a Standardized Meal Test in Patients With Diabetes Mellitus Type 1 and Type 2
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Measurement algorithm control and optimization with subsequent performance evaluation of
      Sanmina biosensors in monitoring of glucose, heart rate (HR), and SpO2 in patients with type
      1 and type 2 diabetes during a standardized meal experiment.
    

Detailed description: 
      -  This study is a combined, open label, prospective, comparative single-center study.

        -  The study is separated in 3 consecutive study parts. The first 2 study parts include 12
           patients each. In the third study part 36 patients will be enrolled. Study part 1 and 2
           will be used for optimization and control of the measurement algorithms of the Sanmina
           biosensors. During the third study part with enrolment of 36 patients, the precision and
           accuracy of the final Sanmina biosensor algorithm will be demonstrated. The study
           conduct for all 60 participants of all 3 study parts will be exactly the same. In all
           groups of participants, the Sanmina finger clip and wearable non-invasive monitoring
           biosensor will be individually introduced and assigned. During the study visit at the
           study site, a standardized meal will be given to the participants. At eleven time points
           before and after the standardized meal, glucose, heart rate, and pO2 will be measured
           using the Sanmina finger clip and wearable non-invasive monitoring biosensor. The
           measurement time points are -30, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min. The
           measurements will be compared to capillary blood glucose measurements by YSI Stat 2300
           and StatStrip (glucose), and parallel measurements of the heart rate and the pO2 using a
           patient monitor. Further the exact skin colour will be evaluated using a skin colour
           card.
    

Intervention name(s): Sanmina Biosensor
Intervention type(s): Device
Intervention description(s): non-invasive blood glucose measurement using the Sanmina Biosensor referenced with the invasive reference blood glucose device YSI 2400 Plus.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The first 2 study parts include 12 patients each. In the third study part 36 patients will be enrolled. Study part 1 and 2 will be used for optimization and control of the measurement algorithms of the Sanmina biosensors. During the third study part with enrolment of 36 patients, the precision and accuracy of the final Sanmina biosensor algorithm will be demonstrated.
Masking: None (Open Label)
Primary purpose: Other
Intensity Training and Cardiovascular Health in Colombian Adults
Condition: Metabolic Diseases
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      Several studies have shown relationship between exercise intensity and improvement
      cardiometabolic health. It has been suggested that high intensity interval training and also
      moderate training generate positive effects on metabolic risk factors. For these reasons, it
      is necessary to clarify which type of training, is more effective to improve cardiometabolic
      health in latinamerican population.
    


Intervention name(s): High Intensity Interval Training; Moderate Intensity Interval Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.; Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of multiple doses of PF 02545920 administered orally
      to psychiatrically stable subjects with schizophrenia receiving background antipsychotic +/-
      other adjunctive medication.
    


Intervention name(s): PF-02545920; PF-02545920; PF-02545920; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 15 mg (2 mg X 2d, 5 mg X 2d, 8 mg X 3 d, then 15 mg) Q12h; 15 mg (5 mg X 2d, 10 mg X 2d, then 15 mg) Q12h; 15 mg (5 mg BID for 7 days 10 mg BID for 7 days, then 15 mg BID for 4 days) Q12h; Placebo Q12h
Other intervention name(s): Cohort 1; Cohort 2; Cohort 3
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: PF-02545920; safety; schizophrenia
Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to provide aripiprazole to schizophrenic outpatients and
      Community Treated Patients who are currently receiving aripiprazole therapy on another BMS
      sponsored clinical trial.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country
Other intervention name(s): Abilify; BMS-337039
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization
Condition: Periodontitis
MeSH terms: Periodontitis; Disease Progression
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the size of the benefit of an adjunctive empiric
      antibiotic therapy compared to standard mechanical debridement and oral hygiene instructions
      in a representative sample of German periodontitis patients.
    

Detailed description: 
      Periodontitis is an endemic inflammatory disease caused by a mixed bacterial biofilm
      infection that is followed by destruction of tooth supporting tissues. Standard of care
      consists of lifelong mechanical removal of the biofilm. However, outcome is variable.
      According to recent EFP and AAP reviews, adjunctive antimicrobial therapy may be beneficial.
      We plan to conduct a double-blind, parallel group, randomized, placebo-controlled
      multi-center efficacy study that addresses the following objectives:

        1. What is the size of the benefit of an adjunctive empiric antibiotic therapy compared to
           standard mechanical debridement and oral hygiene instructions in a representative sample
           of German periodontitis patients?

        2. Does the administration of the antibiotic therapy delay recurrence of periodontitis in
           the general population and in specific high risk groups (e.g. smokers) under standard
           supportive therapy?

        3. Is the presence of specific microbial complexes a useful predictor of outcome and
           recurrence of periodontitis?

        4. Does the administration of the antibiotic therapy affect the "oral health related
           quality of life"?

      The primary hypothesis tested is: the administered empiric adjunctive antibiotic therapy
      reduces about one half of the proportion of sites with attachment loss compared to
      subgingival debridement alone over a 27.5-month period in a statistical and clinical
      significant manner.

      To test this hypothesis about 500 patients will be enrolled in the clinical trial. According
      to the intention-to-treat principle, the primary efficacy analysis will include all
      randomized subjects. In addition, a per-protocol analysis will be done.
    

Intervention name(s): Amoxicillin and Metronidazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): tablets: Amoxicillin 3H2O 574 mg and 400 mg metronidazole three times daily for 7 days; Placebo tablets (cellulose powder, lactose monohydrate, magnesium stearate, microcrystalline cellulose): three times daily for 7 days
Other intervention name(s): Flagyl® 400 Filmtablette; Amoxicillin-ratiopharm® 500
Intervention MeSH terms: Amoxicillin; Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Periodontitis; Mechanical Debridement; Antibiotics; Attachment loss; Randomized controlled trial