bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of a Healthy Diet Containing Flaxseed and Olive Oil on Cardiovascular Disease Risk Markers
Condition: Coronary Artery Disease
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      Flaxseed and olive oil consumption have beneficial effects on cardiovascular risk factors.
      Nonetheless the effects of their simultaneous consumption have not yet been studied.The
      purpose of this study is to investigate the effects of a healthy diet containing flaxseed and
      olive oil compared with healthy dietary advice on cardiovascular disease risk markers in
      patients with coronary artery disease (CAD), in improving flow-mediated dilation, plasma
      lipid profile and fatty acids composition of red blood cells.
    

Detailed description: 
      A randomized controlled clinical trial will be conducted in Rajaie Cardiovascular Center in
      Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the
      design of the study, written consent form will be completed. The participants are 50 eligible
      coronary artery disease patients, aged 30-75 years. Intervention group will be received a
      heart-healthy diet with a specified number of food servings from different food groups
      (including vegetables, fruits, grains, dairy products, meats) + daily consumption of 30 grams
      of flaxseed + 25 mL/day of refined olive oil (equivalent to 4 tablespoons; 2 tablespoons for
      lunch and 2 tablespoons for dinner); and control group will be received recommendations for a
      heart-healthy diet, such as those of the American Heart Association for 3 months. These
      include eating at least 5 servings of vegetables and fruits daily, reduction in the
      consumption of sources of saturated and trans fats by avoiding the consumption of high-fat
      red meats and replacing them with low-fat meat or with poultry and fish, replacing low-fat
      dairy sources with regular or high-fat ones; consumption of regular vegetable oils such as
      canola and sunflower; reduction in salt consumption; and reduction in the consumption of
      simple sugars, for 3 months. Flow mediated dilatation (FMD) in brachial artery via
      ultrasonography, plasma levels of lipids and lipoproteins via enzymatic method, and fatty
      acids composition of red blood cells via gas chromatography method were measured.
    

Intervention name(s): Dietary Intervention
Intervention type(s): Other
Intervention description(s): A heart-healthy diet + daily consumption of 30 grams of flaxseed + 25 mL/day of refined olive oil in adjunct to medical treatment for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh
Condition: Environmental Enteric Dysfunction
Study type: Interventional

Summary: 
      This is a pilot study to assess the feasibility and acceptability of a trial of Enterade
      (VS001) to treat environmental enteric dysfunction in children from a low-income setting.
      Preliminary data on efficacy will also be obtained.
    

Detailed description: 
      Primary Objectives

        1. To determine tolerability of Enterade (VS001) in stunted Bangladeshi children between 1
           and 2 years of age

        2. To assess the efficacy of Enterade (VS001) in treatment of environmental enteric
           dysfunction by comparing improvements in 2-h lactulose mannitol ratio between Enterade
           (VS001) and a placebo.

      Secondary Objectives

        1. To assess the adherence to the regimen of 237ml (8 oz) of Enterade daily in children
           aged 1 to 2 years.

        2. To assess Enterade (VS001) efficacy by comparing improvements in fecal measures of
           intestinal inflammation between Enterade (VS001) and placebo.
    

Intervention name(s): Enterade; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Enterade is a glucose-free, amino acid-based medical food containing specific amino acids (aspartic acid, valine, serine, threonine and tyrosine) in addition to electrolytes and a non-sugar sweetener.; The placebo is an identical product to Enterade except without added amino acids.
Other intervention name(s): VS001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Clinical Evaluation of Fenfuro (Fenugreek Seed Extract) in Type-2 Diabetic Subjects: an add-on Study
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is an open label, two armed trial evaluating the safety and efficacy of Fenfuro
      capsule twice daily for 90 days in 100 patients with type 2 diabetes that will be conducted
      in single center in India. The primary outcome measures will be the determination of decrease
      in plasma glucose levels from baseline to last visit. The secondary outcome will be the
      determination of safety of Fenfuro capsule in type 2 diabetic subjects.
    

Detailed description: 
      Diabetes mellitus, involving rise in blood sugar levels, has shown to be a highly prevalent
      disease. Treatments and treatment regimens include combinations of oral anti-diabetic drugs
      (OADs), anti-hypertensive medications and anti-dyslipidemic agents, but these have been less
      than successful in managing their respective disease targets with clinical goals. Now-a-days,
      the treatment strategies for diabetes mellitus type 2 which are opted by general population
      include natural supplements. This choice is based upon the involvement of very less side
      effects along with high effectiveness of the natural supplements as compared to the synthetic
      medications. One of those natural supplements is fenugreek seeds extract i.e. Fenfuro which
      has been used as a nutraceutical in the present study for the management of type 2 diabetes
      mellitus.

      Fenugreek has been extensively used as a source of anti-diabetic compounds from long time.
      Thus, Fenfuro, prepared from fenugreek seeds extract, is supposed to have anti-diabetic
      properties as well. Previous studies on fenugreek seeds extract have shown effective and safe
      anti-diabetic and anti-hyperlipidemic properties of it. It has shown to decrease blood
      glucose levels as well as lipid profile of the diabetic patients.

      In this proposed study, Fenugreek seed extract will be used as an add-on to the existing
      therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be
      evaluated using standard methodology.
    

Intervention name(s): Fenfuro
Intervention type(s): Drug
Other intervention name(s): Fenugreek seed extract
Intervention MeSH terms: Fenugreek seed meal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: FBS,HbA1C, PPBS
Korean Version of the "Quality of Recovery 15" After General Anesthesia
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Observational

Summary: 
      The aim of this study is to test the Korean version of QoR-15 for its validity and clinical
      acceptability and feasibility.
    

Detailed description: 
      Quality of recovery (QoR) after anesthesia is an important measure of the early postoperative
      health status of patients. The QoR-40 is a widely-used questionnaire for postoperative
      patients and the short-form version of it (QoR-15) was developed in 2013. The validation of
      QoR-15 has been reported in the version of English, Portuguese, Danish, Chinese and Swedish.
      However, the study to validate the Korean version of QoR-15 has not been demonstrated.

      Patients undergoing surgery and general anesthesia are asked by the investigators to complete
      the QoR-15 questionnaire and Korean 36-Item Short Form Health Survey (SF-36) a day before
      surgery. They are then asked to repeat the QoR-15 questionnaire 24 h postoperatively and also
      rate their overall postoperative pain score using 11-point numeric rating scale (NRS).
    

Intervention name(s): QoR-15
Intervention type(s): Other
Intervention description(s): The QoR-15 is the questionnaire to provide an evaluation of the postoperative quality of recovery. Patients undergoing surgery and general anesthesia are asked by the investigators to complete the QoR-15 questionnaire before and 24h after the surgery.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients undergoing elective surgery and general anesthesia in Seoul National
        University Hospital.
Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation
Condition: Lyme Disease
MeSH terms: Lyme Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to prevent
      Lyme disease at early stages of infection after tick bite.
    

Detailed description: 
      In this study two consecutive cohorts will be treated:

        -  Cohort 1: 8 volunteers

        -  Cohort 2: 24 volunteers, divided into 3 groups of 8 subjects each

      The study will be conducted in the following three phases:

        1. Treatment of cohort 1: The aim is to establish the maximal tolerated dose (MTD) for a
           local treatment with azithromycin dermal formulation.

             1. Treatment of cohort 1 with azithromycin dermal formulation and follow up

             2. Assessment of local safety within the 7 days following the first treatment

             3. The maximal tolerated dose (MTD) will be determined

        2. Treatment of cohort 2: The aim is to confirm the local tolerance of the selected doses
           and to evaluate the local skin and plasma concentration of azithromycin after
           application of SHB001 dermal formulation.

             1. Treatment of cohort 2 with azithromycin dermal formulation at maximal tolerated
                dose (MTD), with a dose one or more concentrations lower than maximal tolerated
                dose (MTD) and with placebo

             2. Skin biopsies of treated skin areas will be taken for the PK assessment

        3. Study completion examination
    

Intervention name(s): Application of SHB001
Intervention type(s): Drug
Intervention description(s): Cohort 1: Application of SHB001 on the skin of right thigh
Cohort 2:
Application of SHB001 on the skin of right thigh
punch biopsies of treated skin areas
Other intervention name(s): 0% SHB001 azitrhomycin dermal formulation (placebo); 5% SHB001 azitrhomycin dermal formulation; 10% SHB001 azitrhomycin dermal formulation
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Lyme disease; Borreliosis; Azithromycin
What we Think About the Do-not-resuscitate Order: Survey Study
Condition: Knowledge, Attitudes, Practice
Study type: Observational

Summary: 
      The do not resuscitate (DNR) order is a decision taken by the patient or other people about
      medical care in the end stages of life to withhold CPR in event of respiratory or cardiac
      arrest and allow natural death to occur. There is currently no related article of law to DNR
      order in Turkey. It was aimed to evaluate the health workers(HW) and the non health
      workers'(NHW) knowledge, attitude, and behavior related to the do-not-resuscitate (DNR) order
      in Turkey.
    

Detailed description: 
      The do not resuscitate (DNR) order is a decision taken by the patient or other people about
      medical care in the end stages of life to withhold CPR in event of respiratory or cardiac
      arrest and allow natural death to occur. There is currently no related article of law to DNR
      order in Turkey. A questionnaire with 25 questions has been distributed to health workers and
      non-health workers.

      It was aimed to evaluate the health workers(HW) and the non health workers'(NHW) knowledge,
      attitude, and behavior related to the do-not-resuscitate (DNR) order in Turkey.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Health workers and non health workers who are able to complete the questionnaire
      
Keywords: The do-not-resuscitate order, end of life, medical ethics
Determination of the Optimal Approach to Select the Best Size of BASKA Mask to Use in Male Patients
Condition: Determination of the Best Predictor for Correct Baska Mask Size
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators group has performed a number of studies on novel airway devices, including
      an observational study on the performance of a new supraglottic airway named Baska mask. In
      this new study the investigators wish to determine which criteria best predict the correct
      size of the Baska mask to be used in male patients
    

Detailed description: 
      Our observational study of the performance of the Baska mask suggests that this novel
      supraglottic airway has promise as an alternative to the current standard device, the
      laryngeal mask airway (LMA). Our results indicate that while the manufacturer weight criteria
      work reasonably well in females this may not be the case in males. The investigators wish to
      determine how well the manufacturer recommended sizing criteria for the Baska mask work in
      males.

      This study is designed to determine which criteria best predict the correct size Baska mask
      to use in male patients. In addition the investigators will monitor the performance and
      safety of this device (insertion success rate, seal pressures, time to and ease of insertion,
      failure rate, complications etc)
    

Intervention name(s): Placement and use of Baska mask
Intervention type(s): Device
Intervention description(s): use of Baska mask as component of standard general anaesthetic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mask size; Baska mask; supraglottic airway; airway management
Effect of Food on the Bioavailability of 30 mg Estetrol (E4) Tablet in Healthy Postmenopausal Female Volunteers
Condition: Food-effect
Study type: Interventional
Phase: Phase 1

Summary: 
      Assessment of the effect of a high fat meal on the quantity in blood of a female sex hormone
      called estetrol (E4).

      The study also aims at determining how subject tolerate the study drug and how safe it is for
      them.
    


Intervention name(s): 30 mg estetrol (E4)
Intervention type(s): Drug
Intervention description(s): All subjects received both Treatment A and Treatment B either at the first treatment period (Period 1) or at the second treatment period (Period 2). Approximately half of the subjects was randomized to receive either Treatment A followed by Treatment B (sequence AB), or Treatment B followed by Treatment A (sequence BA).
Other intervention name(s): 30 mg E4 tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Estetrol; Menopausal hormone therapy
A Pharmacokinetic Study to Assess Drug-drug Interaction Between Zanubrutinib and a Cocktail of Substrates in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety and pharmacokinetic interaction of effects of
      multiple doses of zanubrutinib with a "Cocktail" of five probe drugs for cytochrome P450
      (CYP) 3A, CYP2C9, CYP2C19, P-glycoprotein and breast cancer resistance protein (BCRP) in
      healthy subjects
    


Intervention name(s): BGB-3111 and Drug Cocktail
Intervention type(s): Drug
Intervention description(s): BGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin)
Intervention MeSH terms: Zanubrutinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Healthy subjects
PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      -  To evaluate the overall tumor response rate in subjects with metastatic hormone
           refractory prostate cancer

        -  To evaluate PSA (tumor marker) response rate

        -  To evaluate safety
    


Intervention name(s): ARD6562, Docetaxel
Intervention type(s): Drug
Intervention MeSH terms: Docetaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate cancer; HRPC; AIPC; Hormone refractory; Androgen independent; Docetaxel; Taxotere; prednisolone
Autobiographical Memory
Condition: Alzheimer's Disease; Autobiographical Memory; Eye Movement; Memory
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      This study aims at the assessment of eye movement during autobiographical retrieval (i.e.,
      retrieval of personal memories) in patients with Alzheimer's Disease.
    

Detailed description: 
      There is an increased interest in the study of eye movements during the retrieval of
      autobiographical memories and recent research has demonstrated how retrieval of
      autobiographical memory can activate eye movement. This research has been however mainly
      concerned with young adults and, until now, little is known about the relationship between
      eye movement and autobiographical memory in patients with Alzheimer's Disease. The aim of the
      current study is therefore to evaluate eye movements during the retrieval of autobiographical
      memories in patients with Alzheimer's Disease.
    

Intervention name(s): Study of eye movements
Intervention type(s): Behavioral
Intervention description(s): The assessment of eye movement during autobiographical retrieval (i.e., retrieval of personal memories) in patients with Alzheimer's Disease.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with Alzheimer's disease in the mild stage
Influence of Different Ankle Positions on Nerve Conduction Parameters of Deep Peroneal Nerve
Condition: Healthy Subjects
Study type: Observational

Summary: 
      BACKGROUND:

      The deep peroneal nerve arises as a branch of the common peroneal nerve which courses around
      the neck of the fibula. The motor component of deep peroneal nerve is responsible for
      innervating the anterior compartment of the lower leg which includes the tibialis anterior,
      extensor hallucis longus, extensor digitorum longus, and peroneus tertius muscles.

      Nerve conduction velocity shortly known as "NCV" tests are used determine the speed of the
      electrical signals moving along a specific peripheral nerve .This will be helpful in
      localizing the site of entrapment of peripheral nerves and useful for assessing both recovery
      and prognosis of any injury to peripheral nervesthere are numerous aspects that could
      influence nerve conduction study.

      Although changes in joint position have been reported in several studies to affect nerve
      conduction velocity of peripheral nerves. the effect of changing ankle joint position on deep
      peroneal NCV has not been repor Purpose

      This study will investigate the effect of different ankle positions on:

        1. Deep peroneal nerve distal motor latency across ankle joint.

        2. Deep peroneal nerve sensory onset latency across ankle joint
    

Detailed description: 
      31healthy subjects of both genders with age ranging from 20to 40years old were examined for
      motor distal latency and sensory onset latency at three different ankle positions
      :neutral,20degrees dorsiflexion and 40degrees plantar flexion
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        31 healthy subjects of both genders will be recruited to participate in this study
Genetic Influences Between Cognitive Function and BMI
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      In this study the investigators will interrogate an existing data set to examine whether
      genetic variants contribute to an inverse association between weight status and cognitive
      function. Investigators hypothesize that body mass index (BMI) will be inversely related to a
      number of variables measuring cognitive function, and that that this inverse relation will be
      at least partially attributable to genetic variants which influence both BMI and cognition.
    

Detailed description: 
      Investigators will use existing data collected as part of the Texas Twin Project (TTP). TTP
      collected neuropsychological task data on cognition (executive functioning and general
      cognitive abilities) from a computerized test battery, as well as BMI data, on a sample of
      869 twins. Investigators will use information from the known extent of genetic and
      environmental sharing between members of MZ (monozygotic; identical) and DZ (dizygotic;
      fraternal) twin pairs to quantify the genetic correlation between measures of cognition and
      BMI using biometric genetic modeling under the assumptions of the classical twin model. The
      specific aims are:

        -  To examine the association between BMI and executive functioning (EF) in a sample of 869
           twin children, ages 7 to 15 years old, who participated in the Texas Twin Project (TTP)

        -  To gauge the specificity of EF-BMI relations relative to academic achievement and
           general cognitive abilities.

        -  To examine the relative contribution of genetic and environment influences to the
           inverse association between BMI and EF
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals from the Texas twin Project dataset, who were twins and higher-order multiples
        previously recruited from the Houston and Austin Metropolitan areas, via flyers, the
        internet (study website) and contact through public school rosters
      
Keywords: Obesity; BMI; executive functioning; general cognitive ability; twin study; heritability; cognition; GCTA