bioihbjkbjnl/mcl2 huggingface dataset:
Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The investigators are investigating the benefits of a mind/body intervention, Mindfulness
      Based Stress Reduction, for adults with Mild Cognitive Impairment.
    

Detailed description: 
      We propose a prospective, randomized controlled pilot trial assessing the feasibility and
      safety of a study investigating mindfulness based stress reduction (MBSR) as an intervention
      in adults with Mild Cognitive Impairment (MCI). We are assessing safety and feasibility of
      this intervention, as well as using neuroimaging (fMRI) to assess improved connections in the
      default mode network. We will also be assessing the impact of this intervention on cognitive
      function and measures of well-being.
    

Intervention name(s): Mindfulness Based Stress Reduction (MBSR)
Intervention type(s): Behavioral
Intervention description(s): 8 weekly classes of meditation/yoga
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mild Cognitive Impairment; Alzheimer's disease; Meditation; Default Mode Network
Bioequivalence Study of Donepezil Hydrochloride 10 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose
      crossover study was conducted to compare the relative bioavailability of equal doses of the
      test and reference products under fasted conditions.
    

Detailed description: 
      This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose
      crossover study was conducted to compare the relative bioavailability of equal doses of the
      test and reference products under fasted conditions. The study was conducted with 32 (31
      completing) healthy adults in accordance with Protocol No. 10940307 (Revision 0). In each
      study period, a single 10 mg tablet of donepezil hydrochloride was administered to all
      subjects following an overnight fast of at least 10 hours. The test formulation was donepezil
      hydrochloride 10 mg tablet (OHM Laboratories, Inc., USA a subsidiary of Ranbaxy
      Pharmaceuticals, Inc. USA) and the reference formulation was ARICEPT® (donepezil
      hydrochloride) 10 mg Tablets (Eisai Inc.). The subjects received the test product in one
      study period and the reference product in the other period; the order of administration was
      according to the dosing randomization schedule. Subjects were confined at the clinical
      facility from at least 10 hours prior to dosing until after the 24 hour blood collection.
      Subjects returned to the clinical facility for the 36, 48, and 72 hour blood sample
      collection. There was a 28-day interval between treatments.

      Blood samples were collected pre-dose and at intervals over 72 hours after dosing in each
      period. The plasma samples from all subjects were shipped to Warnex Bioanalytical Services
      for determination of donepezil concentrations.

      Statistical analysis was performed by Ranbaxy Laboratories Limited to compare the
      bioequivalence of the test formulation to the reference product. Bioequivalence was
      determined based on the confidence intervals for the major pharmacokinetic parameters,
      AUC0-72 and Cmax, for donepezil.
    

Intervention name(s): Donepezil
Intervention type(s): Drug
Intervention description(s): 10 mg Tablet
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this clinical study is to asses the effect of ultrasonic periodontal debridement
      associated to locally delivered doxycycline (20%) by PLGA microspheres on chronic generalized
      periodontitis treatment.
    

Detailed description: 
      Thirty patients with chronic periodontitis and a minimum of seven pockets (>5

      mm) in non-molars teeth that bled on probing will be selected. Patients will be randomly

      assigned to ultrasonic periodontal debridement followed by local application of doxycycline

      by PLGA microspheres (DB+DOX) and periodontal debridement followed by administration

      of void PLGA microspheres (DB). Plaque, bleeding on probe, clinical attachment level

      (CAL), and probing depth (PD) will be recorded at baseline, 3 and 6 months. Subgingival

      biofilm samples will be collected from initially moderate (5 to 6 mm) and deep (≥7 mm)

      pockets at baseline, 1, 3 and 6 months. Polimerase chain reaction (PCR) analysis will be

      used to detect the frequency of Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf),

      Treponema denticola (Td), Aggregatibacter actinomycetemcomitans (Aa), and Prevotella

      intermedia (Pi).
    

Intervention name(s): Doxicicline; Full-mouth debridment
Intervention type(s): Drug; Procedure
Intervention description(s): Association of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis.; The patients will be treated by a single-session of periodontal debridement
during 45 minutes, using an ultrasonic instrument (Cavitron, Dentsply, Rio de
Janeiro, Brazil), under irrigation with sterile saline solution 20. After the debridement, local administration of microspheres loading doxycycline (DOX) (test) or empty microspheres (control) was performed.
Other intervention name(s): PLGA microspheres
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic periodontitis; Local doxycycline; Ultrasonic debridement; PLGA microspheres; Microbiologic assessment
Effect of the Steep Trendelenburg Position on Respiratory Gas Heat Content
Condition: Effect of Patient Position on Airway Heat Content
Study type: Observational

Summary: 
      This is a single site, prospective, non-blinded, non-randomized, non-interventional study
      designed to evaluate the effect of changes in patient position on the measurement of
      respiratory heat loss (enthalpy). This study would be carried out on patients whose operation
      requires the use of the steep Trendelenburg position independent of this study.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Elective surgery requiring steep Trendelenberg position.
      
Keywords: Enthalpy; Trendelenberg position; Mechanical ventilation
Vegetable Signature From Human Metabolomics Responses
Condition: Vegetable Signature Documentation With Metabolomic Technique
Study type: Interventional

Summary: 
      The purpose of this study is to perform dietary intervention studies on a variety of
      vegetables.
    

Detailed description: 
      Plant-based foods have always been an important component of a healthy diet. High intake of
      plant foods may not only maintain normal bodily functions through the provision of dietary
      fiber, vitamins, and minerals but also relieve symptoms and prevent diseases. Many studies
      have pointed out that high intake of plant foods may reduce the incidence of non-communicable
      disease. Past research investigating the effect of phytochemicals has usually been limited to
      single substances or single foods. However, a number of researchers have pointed out that
      phytonutrients and dietary components are likely to act synergistically.Health effects and
      mechanisms of phytonutrients in combination have not been carefully studied in population
      settings. The technology of metabolomics has enabled the simultaneous measurement of hundreds
      of small molecules in biological samples. Exploring the change of metabolites after feeding
      can not only help us understand the role of plant foods, but may also provide opportunities
      to assess plant food intake levels.
    

Intervention name(s): Control; Spinach; Celery; Onion; Mixed Vegetables
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): A standardized diet without any vegetables was provided.; A standardized diet with 200g spinach was provided.; A standardized diet with 200g celery was provided.; A standardized diet with 200g onion was provided.; A standardized diet with 200g of mixed vegetables (spinach, celery, and onion) was provided.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: vegetable metabolite signature; human serum/urinary metabolite; liquid chromatography mass spectrometry
Change in Plaque Characteristics With Atorvastatin
Condition: Acute Coronary Syndrome; Atherosclerosis; Dyslipidemia
MeSH terms: Acute Coronary Syndrome; Atherosclerosis; Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      To examine effects of intensive lipid lowering therapy with atorvastatin on stabilization of
      coronary plaque by using optical coherence tomography (OCT) in patients with acute coronary
      syndrome.
    

Detailed description: 
      Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will
      undergo PCI and have at least one atherosclerotic lesion of >25% stenosis other than culprit
      lesions of current ACS are enrolled. Fibrous cap thickness of a target coronary plaque is
      evaluated by optical coherence tomography.
    

Intervention name(s): high-dose atorvastatin; low-dose atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): 20mg/day; 5mg/day
Other intervention name(s): Lipitor20; Lipitor5
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Short Chain Fatty Acid Metabolism and Energy Metabolism
Condition: Type 2 Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Gut microbiota is being increasingly recognized as an important factor in fat distribution,
      insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota
      could play an important role in the development of obesity and type 2 diabetes mellitus. The
      role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by
      microbial fermentation of fibre, is still controversial. At the present time, our
      understanding of the effects of SCFA on human metabolism (in gut or systemically) is still
      limited. The investigators hypothesize that the differential availability of SCFA impacts
      human metabolism differently.

      In this placebo controlled, double-blind, randomized crossover pilot study the investigators
      will validate in overweight/obese healthy male volunteers whether rectal administration of
      SCFA is a good model for studying the acute metabolic effects of SCFA. For this, it will be
      investigated if site of administration (in distal or proximal colon) of SCFA differentially
      affects parameters of substrate and energy metabolism and to test the duration of short-term
      effects of SCFA administration.
    


Intervention name(s): acetate or placebo infusion
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Tranexamic Acid in Pediatric Cardiac Surgery
Condition: Blood Loss; Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital; Hemorrhage
Study type: Interventional

Summary: 
      Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery.
      Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict
      results. The reason why they showed mixed results would be the imbalance of patients
      population with regard to presence of cyanosis. TXA would reduce blood loss in pediatric
      cardiac surgery with well balanced patients population.
    


Intervention name(s): Tranexamic Acid
Intervention type(s): Drug
Intervention description(s): 50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit in TXA group. same volume of normal saline was given in Placebo group.
Other intervention name(s): transamine; antifibrinolytic; lysin analogue
Intervention MeSH terms: Tranylcypromine; Tranexamic Acid; Antifibrinolytic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: pediatric cardiac surgery; bleeding; tranexamic acid; fibrinolysis; blood loss in pediatric cardiac surgery
Metformin to Prevent Metabolic Complications in Glucocorticoid Excess
Condition: Patients With Glucocorticoid Treatment
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate if a treatment with metformin compared to placebo
      reduces metabolic side-effects in patients with glucocorticoid treatment over three months
      time.
    


Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Volunteers will be given Metformin or placebo for 1 month, once daily.; Volunteers will be given Metformin or placebo for 1 month, once daily
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft
Condition: Degenerative Osteoarthritis; Post-traumatic; Arthrosis; Rheumatoid Arthritis & Other Inflammatory Polyarthropathies; Rheumatoid Arthritis of Subtalar Joint
MeSH terms: Arthritis; Osteoarthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to evaluate the outcome of implanting AlloStem® graft
      with appropriate rigid internal fixation hardware as an alternative to autograft bone graft
      with rigid fixation in subtalar arthrodesis procedures. The primary objective of this
      clinical trial is to compare the overall fusion rate of the investigational to the control
      treatment. Fusion will be determined by clinical findings, radiographs and computed
      tomography (CT) of the subtalar joint 24 weeks (6 months) after the trial surgery.
    


Intervention name(s): Subtalar Arthrodesis
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Other Hindfoot Conditions requiring Subtalar Arthrodesis; Post-traumatic Arthritis
Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women: A Randomized Controlled Trial
Condition: Pelvic Pain Syndrome
MeSH terms: Pelvic Pain
Study type: Interventional

Summary: 
      Background: Chronic pelvic pain (CPP) significantly impacts the quality of life in women.
      This study investigated the effects of transdermal neuromodulation in females with CPP.

      Trial Design: Parallel, randomized, single-blind, controlled trial The aim of the study will
      be to examine the effect of posterior tibial nerve stimulation on women with idiopathic
      chronic pelvic pain syndrome.

      Methods: Thirty females with chronic pelvic pain will be randomly allocated 1:1 to receive
      either transdermal neuromodulation of the posterior tibial nerve (intervention group) or
      advice to control posture (control group) for 4 weeks at the Outpatient Physical Therapy
      Clinic at Kafrelsheikh University in Egypt. The primary outcome was pain intensity measured
      by visual analog scale (VAS). Secondary outcomes were serum cortisol level and quality of
      life (QOL) score. Assessments will be done at baseline and after 4 weeks.
    


Intervention name(s): Percutaneous Posterior Tibial Nerve Stimulation; Placebo Percutaneous Posterior Tibial Nerve Stimulation; Home instructions
Intervention type(s): Device; Device; Behavioral
Intervention description(s): 20 minutes of neuromodulation of the posterior tibial nerve of both lower limbs using Physio Go-lite electrical stimulation device (made by ASTAR in Poland, ver 1.0.2 in Poland). Using Transcutaneous Electrical Nerve Stimulation (TENS) current in the device, the positive electrode will be placed posterior to the medial ankle malleolus, and the negative electrode will placed ten centimeters away on the leg along the tibial nerve path. The TENS current parameters will be 200 microsecond pulse width, 10 Hz frequency, and intensity according to participant tolerance ranging between (10 - 50 mA) that increased gradually until visible movement in the big toe or fanning of toes will be noticed. The therapy sessions will be given three times a week, every other day, for a total of twelve sessions.; placebo neuromodulation of the posterior tibial nerve in both lower limbs, much as those in the research group.; they will receive leaflet with information for home instructions on how to properly walk, sleep, maintain good posture, and deal with activities of daily living.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety and Tolerability, PK, and PD Study of Single and Multiple ALXN2080 Doses in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety and tolerability, pharmacokinetics and
      pharmacodynamics of single and multiple doses of ALXN2080 in healthy adult participants.
    

Detailed description: 
      Participants will be assigned to 10 different cohorts (6 SAD cohorts and 4 MAD cohorts), each
      with 8 participants on active treatment with ALXN2080 and 2 participants on placebo. ALXN2080
      will be administered under fasted conditions throughout this study, except for the last SAD
      Cohort 6 in which ALXN2080 will be given with food to evaluate the effect of food on the
      single-dose pharmacokinetics of ALXN2080.
    

Intervention name(s): ALXN2080; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Powder-in-capsule; Powder-in-capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ALXN2080; Complement system; Pharmacokinetics
Evaluation of Visual Outcomes After Myopic LASIK
Condition: Myopia; Astigmatism; Myopic Astigmatism
MeSH terms: Myopia; Astigmatism
Study type: Interventional

Summary: 
      The aim of the study was to evaluate visual outcomes, contrast sensitivity, glare testing and
      high order aberrations induced by different laser technologies and to evaluate differences in
      aberrometer technology. We hypothesized that there will not be differences among conventional
      or wavefront guided treatments.
    

Detailed description: 
      The aim of the study was to evaluate and compare visual outcomes, contrast sensitivity, glare
      testing and induction of high order aberrations by different laser technologies and to
      evaluate differences in aberrometer technology.
    

Intervention name(s): Conventional LASIK; Wavefront-guided LASIK
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Cell Transplant in Spinal Cord Injury Patients
Condition: Chronic Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to assess the safety of autologous bone marrow derived cell transplant
      in chronic spinal cord injury patients. The hypothesis is that the availability of bone
      marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration.
    


Intervention name(s): Autologous bone marrow transplant; Physical therapy
Intervention type(s): Procedure; Procedure
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal cord injury
Bioavailability of Red Wine Anthocyanins
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main aim of this study is to evaluate the bioavailability of table red wine and young
      Port red wine anthocyanins in healthy men.
    

Detailed description: 
      Anthocyanins (ANT) are water soluble pigments found in plants, flowers and fruits that are
      consumed as part of the human diet, many times in higher amounts than other flavonoid
      classes. Red wine is also an important source of anthocyanins, especially Mv3glc.

      Several epidemiological studies have suggested that the consumption of anthocyanin-rich
      foods, including the moderate consumption of red wine, is positively associated with the
      prevention of cardiovascular heart disease.

      It has become clear that the flavonoid bioactive forms in vivo are not necessarily those
      which occur in nature, but metabolites arising after absorption takes place.Therefore,
      studying the bioavailability of red wine ANT is very important to identify which metabolites
      (originated in vivo) can actually reach the target organs (and in which concentrations) and
      may be responsible for the postulated health benefits of red wine.

      Intervention protocol:

      Urine samples and peripheral venous blood (10 ml) will be collected from 10 h-fasting
      subjects. Afterwards, each volunteer will consume 250 ml of table red wine or 150 ml of young
      Port red wine and blood samples will be collected 15, 30, 60 and 120 min after wines
      ingestion. Another urine sample will be collected at 120 min.

      Table red wine 12 % (250 ml) and young Port red wine 20 % (150 ml), two different food
      matrices rich in ANT, provided the same amount of ethanol (24 g of ethanol).

      A thorough screening analysis for ANT will be performed in plasma and urine samples collected
      from the volunteers at different time points.
    

Intervention name(s): Table Red Wine; Young Port Red Wine
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Anthocyanins; Bioavailability; Flavonoids; Port wine; Red wine