bioihbjkbjnl/mcl2 huggingface dataset:
Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training
Condition: Mild Cognitive Impairment; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this pilot study will be to test whether Kundalini yoga (KY) and Kirtan Kriya
      (KK) yogic meditation is superior to Memory Enhancement Training (MET) for improving
      cognitive functioning, health (including cardiovascular factors), and mood in women with high
      AD risk.
    

Detailed description: 
      Overall, the investigators anticipate recruiting 100 women (50 or older) with MCI and high
      Alzheimer's disease risk. Subjects will either receive: (1) MET class for 60 minutes per
      week; or (2) Kundalini yoga and "Kirtan Kriya" meditation class for 60 minutes per week.
      Assessments will be completed immediately after the interventions at 6 and 12 weeks and
      follow-up visits at week 24 and 48 to monitor the overall benefit of the intervention.
    

Intervention name(s): Memory Training; Kundalini yoga and meditation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will attend a weekly memory training class for 12 weeks as well as receive daily memory homework (12 minute duration) for the 12 weeks.; Participants will participate in a 60 minute yoga and meditation session weekly for 12 weeks and will be assigned a daily Kirtan Kriya meditation (12 minute duration) for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Memory impairment; Meditation; Yoga; Memory Training; Mild Cognitive Impairment; MCI; Geriatric; fMRI; Alzheimer's disease; Cardiovascular risk
Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This clinical trial studies ultrasound tomography using SoftVue in diagnosing women with
      breast cancer. New diagnostic procedures, such as ultrasound tomography using SoftVue, may
      help find and diagnose breast cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine the in-vivo imaging potential of SoftVue through 3-dimensional (3-D) breast
      imaging.

      II. Acquire data for SoftVue evaluation from a cohort of 100 women receiving standard
      ultrasound (US) evaluation as follow-up to mammographic or palpable abnormalities and
      construct reflection, sound speed and attenuation images with SoftVue.

      III. Evaluate the ability of SoftVue to detect dominant breast findings (i.e. major normal
      landmark architecture) or masses previously identified with standard diagnostic evaluation
      (palpation, mammography, standard US) using standard clock position and radial distance
      measurements from the nipple.

      IV. Conduct tomographic (i.e. slice-by-slice) comparison of SoftVue with magnetic resonance
      imaging (MRI) findings from a subgroup of 50 patients.

      OUTLINE:

      Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the
      breast.
    

Intervention name(s): ultrasound tomography; magnetic resonance imaging
Intervention type(s): Other; Procedure
Intervention description(s): Undergo ultrasound tomography using SoftVue; Undergo MRI of the breast
Other intervention name(s): MRI; NMR imaging; NMRI; nuclear magnetic resonance imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Metformin Effect on Fracture Healing in Post-Menopausal Women
Condition: Bone Fracture
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 4

Summary: 
      study the effect of metformin drug on fracture healing of patients with high risk of delayed
      fracture healing or non-union and correlating this to serum irisin myokine level.
    

Detailed description: 
      1. Approval will be obtained from Ethics Committee of general organization of teaching
           hospitals and institutes and Research Ethics Committee of Faculty of Pharmacy, Damanhour
           University.

        2. Getting informed consent from all participants to take part in this study.

        3. Two groups each of 20 post-menopausal women with a bone fracture. One group will be
           treated randomly with metformin Retard 850 mg once daily for two weeks then 850 mg twice
           daily. The other group will be untreated and served as control group.

        4. Venous blood samples will be taken from each patient before fracture stabilization and
           later for determination of serum irisin level with corresponding radiological
           evaluations.

      Inclusion criteria:

      • Age range from 55 to less than 65 years old with bone fracture.

      Exclusion criteria:

        -  Age equal or less than 55 years

        -  Age equal or more than 65 years

        -  Unstable or hospitalized patients with heart failure

        -  Hepatic impairment

        -  Chronic kidney disease with eGFR <45 mL/minute/1.73 m2

        -  Open fractures

        -  Pathological fractures

        -  Diabetic patients Statistical tests appropriate to the study design will be conducted to
           evaluate the significance of the results.

      Methodology:

        -  Active Human Irisin ELISA kit will be used.

        -  Bone-specific Alkaline phosphatase BAP

        -  Serum creatinine, serum albumin, prothrombin time.

        -  Fasting insulin, fasting blood glucose and Calcium level.

        -  BMI, weight, waist, waist-hip ratio, total cholesterol and low-density-lipoprotein
           cholesterol.

        -  radiological scoring system will be used to evaluate the degree of new bone formation in
           the fracture line on anterior-posterior and lateral radiographs will be taken two months
           post stabilization.
    

Intervention name(s): Metformin Retard 850 mg; Placebo
Intervention type(s): Drug; Other
Intervention description(s): tablet; placebo tablet
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 40 post-menopausal women with a bone fracture divided into two groups each of 20, randomly assigned to administration with metformin Retard 850 mg once daily for two weeks then 850 mg twice daily or with placebo.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bone Fracture; Post-Menopausal Women; Metformin; Irisin
Adductor-Canal-Blockade Versus the Femoral Nerve Block Effect on Muscle Strength, Pain and Mobilization After Total Knee Replacement
Condition: Total Knee Arthroplasty
Study type: Interventional

Summary: 
      The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus
      the Femoral Nerve Block on muscle strength, pain and mobilization after total knee
      arthroplasty. We hypothesize that the Adductor-Canal-Blockade has the same effect on pain and
      morphine consumption as the Femoral Nerve Block, but without the same reduction in quadriceps
      muscle strength.
    


Intervention name(s): Adductor-Canal-Blockade; Femoral Nerve Block
Intervention type(s): Procedure; Procedure
Intervention description(s): US-guided Adductor-Canal-Blockade with Ropivacaine; US-guided Femoral Nerve Block with Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adductor-Canal-Blockade; Femoral Nerve Block; Postoperative Pain; Total Knee Arthroplasty
Correlation of Solitary Dilated Duct at Mammography With Ultrasonography and Anatomopathological Findings
Condition: Mammary Duct Ectasia of Unspecified Breast; Mammographic Findings; Female
MeSH terms: Dilatation, Pathologic
Study type: Observational

Summary: 
      Mammograms performed at the Diagnostic Imaging Department of the "Instituto Brasileiro de
      Controle do Câncer" (IBCC - Brazilian Cancer Control Institute) will be prospectively
      evaluated. Patients who present a solitary dilated duct visualized by mammography will be
      submitted to breast ultrasonography. In case of detection of lesion, a percutaneous biopsy
      will be performed.
    

Detailed description: 
      Purpose: To determinate the incidence, pathological significance and risk factors associated
      with the presence of solitary dilated duct visualized at mammography exam.

      Methods: Mammograms performed at the Diagnostic Imaging Department of the "Instituto
      Brasileiro de Controle do Câncer" (IBCC - Brazilian Cancer Control Institute) will be
      prospectively evaluated. Patients who present a solitary dilated duct visualized by
      mammography will be included in the study. These patients will be recalled in order to be
      submitted to an ultrasonography directed to the mammographic finding. Patients who present
      lesions on ultrasonography will undergo method-guided percutaneous biopsy.

      Patients with ductal ectasia, without evident lesions, will be followed for 2 years to
      evaluate stability by means of mammography or ultrasonography every 6-month intervals.
    

Intervention name(s): Follow-up; Ultrasound-guided percutaneous biopsy
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Group "No ductal lesion" will be submitted to follow-up with periodic breast ultrasonography/mammography every 6 months for 2 years.; Group "Ductal lesion" will be submitted to ultrasound-guided percutaneous biopsy and the specimen will be histologically analysed.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women submitted to mammography for breast cancer screening or for diagnosis purposes
      
Keywords: mammography; ductal ectasia; breast neoplasm/diagnostic imaging; mammary Glands, Human/pathology; female
Effect of Food on the Pharmacokinetics of Meloxicam in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate dose-proportionality over the dosage range 7.5 mg to 22.5 mg, and to
      assess the effect of food on the pharmacokinetics of meloxicam after a single p.o.
      administration of 22.5 mg meloxicam oral suspension.
    


Intervention name(s): Meloxicam, low dose; Meloxicam, medium dose; Meloxicam, high dose
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Neural Inspiratory Time and Expiratory Delay in Patient and Health During Spontaneous Breathing and Ventilation
Condition: State Key Laboratory of Respiratory Disease
MeSH terms: Respiratory Aspiration; Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional

Summary: 
      To make these definitions of neural inspiratory time (Ti) and expiratory delay clearly.The
      present study was undertaken to examined the physiological signals of patients and healthy
      subjects during spontaneous breathing and noninvasive mechanical ventilation.
    

Detailed description: 
      In total, 8 chronic obstructive pulmonary disease (COPD) patients, 8 patients with
      interstitial lung disease (ILD) and 8 healthy subjects were recruited.

      The patient was studied at the afternoon in a semirecumbent position. After the application
      of topical anaesthesia (2% xylocaine), the patient was asked to swallow two balloon-tipped
      catheters and the multi-pair esophageal electrode catheter through the nose into the their
      right position.

      At the first period, the stable signals of unassisted spontaneous breathing (about 5min) were
      chosen to be recorded. After this period, the patient was placed on noninvasive pressure
      support ventilation(PSV). The inspiratory positive airway pressure (IPAP) was initially
      titrated by patient's tolerance . The noninvasive ventilation lasted at least 20 minutes
      until the breathing was stable. All the raw signals were recorded. The last 15 minutes of the
      stable computer-stored data were calculated and analyzed. The leaks were monitored by the
      display of the ventilator and the computer during the procedure. When the leak was observed,
      the mask was carefully adjusted to prevent. Esophageal and gastric balloon-catheters were
      used to detect the intra-thoracic and abdominal pressure. Airway pressure was also measured
      simultaneously. EMGdi was recorded from a multipair esophageal electrode .During ventilation
      Airflow and ventilation were measured with pneumotachograph.

      Respiratory rate, tidal volume,the time difference between the initial increase and the
      termination of the diaphragm electromyogram(EMGdi) , time difference between maximal value of
      EMGdi and the end of inspiratory flow,time difference between the point of zero flow between
      inspiration and expiration ,and the time difference between the onset of the upward
      deflection in transdiagramic pressure( Pdi) and the return of Pdi were calculated during the
      unassisted spontaneous breathing and mechanical ventilation.
    

Intervention name(s): noninvasive mechanical ventilation
Intervention type(s): Device
Intervention description(s): To examined the physiological signals of patients and healthy subjects during spontaneous breathing and noninvasive mechanical ventilation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: interstitial lung disease; chronic obstructive pulmonary disease; mechanical ventilation; expiratory delay; neural inspiratory time
The Benefit of 5% IVIG for Patients With Primary Immunodeficiency Disorders Who Experience Adverse Events on 10% IVIG Preparations
Condition: Primary Immunodeficiency
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      Patients with primary immunodeficiency disorders (PID) on intravenous immunoglobulin (IVIG)
      treatment may experience adverse events (AEs). Patients who experience AEs on any 10% IVIG
      solution will be changed to octagam 5% for six infusions to evaluate the potential benefit
      for reduction of AEs on a lower concentration IVIG product.
    

Detailed description: 
      Patients with PID require life long immunoglobulin (Ig) replacement therapy with IVIG being
      the most common form. As more 10% IVIG products are FDA approved, the older and well
      characterized 5% IVIG products are becoming less used. Currently, the standard of care for
      patients who experience AEs on IVIG is to move to a subcutaneous (SCIG) delivery and product.
      This study will evaluate the AEs on a 10% product and octagam 5%. The study will enroll 15
      patients after an AE on any 10% product who will then be infused with octagam 5% for six
      infusions. AEs will be documented and compared to the 10% product along with changes in
      biomarkers. The study data may document another therapeutic option for patients who
      experience AEs - SCIG and octagam 5%.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Diagnosis of PID - specifically common variable immunodeficiency (CVID)
The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      The investigators previously investigated the cardioprotective effect of an
      adenosine-lidocaine cardioplegia with moderate-potassium (K+, 10.0 mmol/L) in pediatric
      cardiac surgery, which was associated with better myocardial protective effects when compared
      with conventional high-potassium cardioplegia. However, this cardioplegia could not be sucked
      back into the cardiopulmonary bypass (CPB) circuit because of excessive hemodilution and
      severe systemic hypotension induced by adenosine. Therefore, the investigators supposed that
      a moderate-potassium (K+, 10.0 mmol/L) blood cardioplegia without adenosine could also arrest
      the heart and have better myocardial protective effects compared with conventional
      hyperkalamic cold blood cardioplegia during cardiac operations without excessive hemodilution
      and systemic hypotension.
    


Intervention name(s): MP (moderate potassium) group; HP (High potassium) group
Intervention type(s): Drug; Drug
Intervention description(s): Hearts were arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L)during cardiac operation; Hearts are arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L)during cardiac operation.
Other intervention name(s): moderate potassium cardioplegia; High potassium cardioplegia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: congenital heart disease; cardiac surgery; cardiopulmonary bypass; cardioplegia
The Effects of Soluble Corn Fiber on Gastrointestinal Tolerance and Fecal Microbiome in Healthy Children
Condition: Gastrointestinal Tolerance
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of PROMITOR® Soluble Corn Fiber versus
      inulin on GI symptoms (tolerance), stool consistency (laxation) and fecal microbiome at
      levels that could contribute to closing the fiber gap. The dose response effects of PROMITOR®
      Soluble Corn Fiber in healthy children will also be compared.
    

Detailed description: 
      After initial site visits and randomization children were given a packet of powdered fiber to
      be mixed into a beverage daily. There were four test arms, described elsewhere. Each study
      arm lasted 10 days with an 18 day washout in between study periods.
    

Intervention name(s): Inulin; soluble corn fiber
Intervention type(s): Other; Other
Intervention description(s): Inulin, a dietary fiber, will be given in a beverage daily in doses 3g, 5g, 6g, or 8g dependent on arm and age of participants.; soluble corn fiber, a dietary fiber, will be given in a beverage daily in doses 3g, 5g, 6g, or 8g dependent on arm and age of participants.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: digestion, fiber, tolerance,
A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps
Condition: Nasal Polyps; Chronic Rhinosinusitis
MeSH terms: Nasal Polyps; Polyps
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of omalizumab compared with
      placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had
      an inadequate response to standard-of-care treatments.

      Study GA39688 (POLYP 1; NCT03280550) was another Phase III study by the Sponsor with
      identical objectives and design and was run in parallel with this study.
    


Intervention name(s): Omalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants received omalizumab as a subcutaneous injection once every 2 weeks (q2w) or once every 4 weeks (q4w). The dose (from 75 mg up to 600 mg) and dosing frequency (q2w or q4w) was determined by serum total IgE level and body weight using the study-drug dosing table.; Participants received matching placebo as a subcutaneous injection once every 2 weeks or once every 4 weeks. The dose and dosing frequency was determined by serum total IgE level and body weight using the study-drug dosing table.
Other intervention name(s): Xolair; IGE025; RO5489789
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery
Condition: Malignant Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant; Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth.

      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with
      pleural malignant mesothelioma that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the 4-month progression-free survival in patients with unresectable
           malignant pleural mesothelioma treated with everolimus.

      Secondary

        -  To determine the response rate (confirmed and unconfirmed, complete and partial
           responses) and disease control rate (response or stable disease) in patients with
           measurable disease by RECIST and modified RECIST criteria.

        -  To determine overall survival of these patients.

        -  To evaluate the frequency and severity of toxicities associated with this treatment
           regimen.

      OUTLINE: This is a multicenter study.

      Patients receive oral everolimus once daily on days 1-28. Courses repeat every 28 days in the
      absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed for 3 years.
    

Intervention name(s): everolimus
Intervention type(s): Drug
Intervention MeSH terms: Everolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent malignant mesothelioma; stage II malignant mesothelioma; stage III malignant mesothelioma; stage IV malignant mesothelioma