bioihbjkbjnl/mcl2 huggingface dataset:
Artichoke and Bergamot Phytosome
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      According to WHO data, about 50% of deaths each year are caused by cardiovascular disease.
      One of the strategies for prevention of cardiovascular diseases, in addition to a correct
      lifestyle, is to implement therapies that reduce the level of cholesterol in the blood and at
      the same time control the glycemic levels, which are closely related in the maintenance of
      metabolic homeostasis. The aim of this clinical study is to confirm the potential broader
      activity as hypocholesterolemic agent in bergamot poor-responders subjects with mild
      hypercholesterolemia. The study was a 8-week randomized double-blind placebo-controlled
      trial. Participants were randomized to either the supplement based on dry extract from
      artichoke leaf and bergamot phospholipid (31) or placebo arm (29).
    


Intervention name(s): Combined Bergamot phytosome and Artichoke leaf dry extract; Placebo
Intervention type(s): Dietary Supplement; Combination Product
Intervention description(s): 600 mg of Bergamot Phytosome and 100 mg of Artichoke leaf standardized dry extract. Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.; Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: bergamot; Cynara cardunculus
Study in Healthy Volunteers to Document Safety and Tolerability of Increasing Doses Pemirolast
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-centre, open-label, dose escalation , safety, tolerability and
      pharmacokinetics (PK) study in healthy male and female subjects. The study include a
      screening day and a 5-day dosing period. Subjects will be enrolled in sequential cohorts and
      each cohort will include 8 subjects. there will be 24 subjects total included in the study.
      The duration of the clinical part of the study will be approximately 2 months.
    

Detailed description: 
      Subjects meeting the eligibility criteria at screening will remain in the clinic from the
      evening preceding the first day of dosing (Day - 1) of the investigational medical product
      (IMP) and check out from the clinic 24 hours after the first dose administration of the IMP
      (in the morning of Day 2). Dose administration of the IMP in the evening of Day 2 and morning
      and evening dose for Days 3 and 4 will be performed at home. The subjects will check-in again
      in the morning of Day 5 and receive the last dose administration of the IMP and stay in the
      clinic 12 hours post dose. All subjects within the same cohort will receive the same dose of
      the IMP.

      There will be 3 cohorts (dose-levels) with 8 subjects in each cohort corresponding to 24
      subjects in total. Within a cohort the subjects will be dosed in groups of 4. There will be
      24 hours between the dosing of the groups and 15 minutes between the dosing of the subjects
      in a group.

      There will be an interval of approximately at least 1-week interval between the cohorts to
      allow time for compilation and evaluation of data for the Internal Safety Review Committee
      meeting.

      Subsequent cohorts will be administered increasing doses until either the maximum tolerated
      dose (MTD) or the study maximum dose (SMD) has been reached.
    

Intervention name(s): CRD007
Intervention type(s): Drug
Other intervention name(s): Pemirolast
Intervention MeSH terms: Pemirolast
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Effects of Dietary Nitrate From Vegetable/Fruit Juice on Cerebral Blood Flow Parameters
Condition: Cerebrovascular Circulation; Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Nitrate provides the body with an alternative source of Nitric Oxide which plays a large role
      in promoting blood flow and reducing blood pressure. Nitrate supplementation with
      vegetable/fruit juice has recently been shown to reduce blood pressure and reduce energy
      expenditure during low intensity exercise. Such findings combined with the previously known
      biological effects of nitric oxide would suggest that nitrate supplementation would also
      impact on blood flow. The aim of this study is to examine the effects of dietary nitrate
      supplementation via vegetable/fruit juice drink on cerebral (brain) blood flow (using Near
      Infrared Spectroscopy).
    


Intervention name(s): Vegetable/fruit juice; Placebo juice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 450ml active juice, 45ml no added sugar fruit squash (for flavour); 50 ml No Added Sugar fruit squash, 45 ml Pressed Apple Juice, 405ml with water.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Persistent Pain After CS Delivery
Condition: Persistent Pain After Delivery
Study type: Observational

Summary: 
      Many factors influence the development of persistent pain after CS (chronic pain) as well as
      post-partum depression. We are attempting to use trajectory pain methods in an attempt to
      identify those at risk for the development of persistent pain post delivery using a daily
      method of contact for the determination of pain scores. Assessments are also done evaluating
      satisfaction of pain management and maternal/infant bonding opportunities. Physical activity
      is monitored by subject's wearing a Fitbit with correlation being done with pain scores
      obtained over 60 days postop with eligible subjects..
    

Detailed description: 
      Subjects are contacted on a daily basis after having a cesarean delivery to determine current
      pain, current pain unpleasantness, worst pain, worst pain unpleasantness, average pain, and
      average pain unpleaseantness. Preoperatively subjects complete a psycho-social/depressive
      screening questionnaire. Pain treatments/satisfaction assessments are captured for the first
      24 hours. Mother/baby outcomes are also captured. Physical activity and pain scores are also
      correlated with the subject's wearing of a Fitbit physical activity bracelet with eligible
      subjects for 60 days post-delivery.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        those subjects who are scheduled to have an elective cesarean section (CS) and able to
        complete a preoperative psychosocial/depressive questionnaire and who agree to be contacted
        on a daily basis for 60 days postoperatively
      
Keywords: chronic pain; cesarean section pain
The Effect of Meal Texture on Intake
Condition: Eating Behavior
Study type: Interventional

Summary: 
      In this study the effect of meal texture differences (slow vs fast eating rate) on intake
      will be investigated.
    

Detailed description: 
      Rationale: Food texture modifies eating rate and through that the energy intake of foods. It
      is shown that harder, chunkier, more viscous, and more voluminous foods decrease eating rate
      of foods and thus decrease energy intake. However, most research is done in model foods or
      single foods. So far, little research on food texture and intake has been performed for
      meals. It is not known what the effect of food texture and eating rate is on intake in a wide
      variety of meals. Knowledge on the effect of food texture on intake could be used for
      strategies to drive or limit energy intake.

      Objective: The objective is to determine how a wide range of different food textures
      influence energy intake, food intake, and eating behaviour.

      Study design: All participants receive all twelve different meals (within subject design).
      The meals are either served during breakfast or lunch. The meals have a wide range of
      different food textures. Participants consume the meals ad libitum twice per week for six
      weeks long with at least two days in between.

      Study population: Healthy Dutch speaking adults (n=30) between 18-55 years old with a BMI
      between 18.5-30 kg/m2.

      Intervention: Participants will join twelve test sessions. For the test sessions they will
      visit the eating behaviour lab where they receive ad libitum meals during breakfast or lunch.
      During meal consumption participants are video recorded to determine eating behaviour. The
      participants will receive in total twelve meals. The order in which participants will receive
      the meals will be block randomized (block n = 5).
    

Intervention name(s): Meals served during breakfast with a wide range of different food textures; Meals served during lunch with a wide range of different food textures
Intervention type(s): Other; Other
Intervention description(s): Ad libitum portions of twelve different meals with a wide range of food textures served during breakfast at the eating behaviour lab; Ad libitum portions of twelve different meals with a wide range of food textures served during lunch at the eating behaviour lab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Texture; Eating rate; Food intake; Energy intake
Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death
Condition: Refractory Epilepsy; Arrhythmia; Sudden Death
MeSH terms: Epilepsy; Drug Resistant Epilepsy; Death; Death, Sudden
Study type: Observational

Summary: 
      People with epilepsy are at a higher risk for sudden unexpected death than the general
      population. Sudden unexpected death in epilepsy (SUDEP) is a major cause of death in this
      population, accounting for 10-50% of deaths for those with epilepsy. The risk for SUDEP is
      particularly high for those with refractory epilepsy. Several lines of evidence support a
      cardiac mechanism for SUDEP.

      This study plans to determine:

        1. the frequency and types of cardiac arrhythmias that occur in this population and

        2. whether these are increased above the general population in the same age group.

      Additionally, these data will be correlated to specific clinical data, including seizure
      history, anticonvulsant medications, and any accompanying clinical symptoms.
    

Detailed description: 
      By employing long-term electrocardiographic monitoring, this study plans to determine:

        1. the frequency and types of cardiac arrhythmias that occur in patients with uncontrolled
           seizures and

        2. whether these are increased above the general population in the same age group.

      The specific aims:

        1. Identify the types, frequency, and duration of cardiac arrhythmias that occur in
           patients with refractory epilepsy and compare these data to available normative data.

        2. Correlate abnormal heart rates and rhythms to specific clinical data:

             1. seizure type,

             2. seizure frequency,

             3. probable location of seizure onset in the brain, when such data are available,

             4. duration of seizures, and

             5. type(s) and number of anticonvulsant medications being used.

        3. Correlate cardiac arrhythmias to clinical symptoms
    

Intervention name(s): Medtronic REVEAL
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals with refractory focal or generalized epilepsy.
      
Keywords: Epilepsy
The Effects of COX-inhibiting Drugs on Skeletal Muscle Adaptations to Resistance Exercise in Healthy Adults
Condition: Skeletal Muscle Mass Regulation
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, healthy human subjects (18-35 yrs) are be randomised to consume 1200 mg
      ibuprofen or 75 mg acetylsalicylic acid daily during a training period of 8 weeks. During
      these weeks, subjects perform 2-3 supervised strength training sessions (knee extensions).
      Before and after training, muscle volume is measured by MRI, and muscle strength is assessed
      by isokinetic and isoinertial ergometers. Muscle biopsies are obtained from m. vastus
      lateralis to study gene and protein expression of markers regulating muscle protein turnover
      and prostaglandin synthesis.
    


Intervention name(s): Ibuprofen; Acetylsalicylic acid
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Muscle mass; strength; NSAID; Ibuprofen; resistance exercise
Validation of Ambulatory Sleep Test (WP200/U) Compared In-lab Sleep Testing in Cardiac Subjects
Condition: Sleep Disorders
MeSH terms: Sleep Wake Disorders
Study type: Observational

Summary: 
      Subjects with cardiac disorders will be tested in the sleep laboratory with a conventional
      full-night PSG recording along with WP 200/WP200U ambulatory sleep diagnostic device in a
      synchronized manner.

      The PSG data will be scored manually by a trained polysomnographic scorer, according to
      standard criteria for this clinical routine.

      The data obtained by the WP200/WP200U will be analyzed automatically for RDI, AHI, sleep
      stages, snoring (optional) and body position (optional), in addition to parameters specific
      to cardiac subjects. The analysis will be performed by the WP200/WP200U software (zzzPAT) and
      will be compared to the PSG's manual scoring which serves as a "Gold Standard".
    

Detailed description: 
      Subjects with cardiac disorders, referred to the sleep lab will be offered to participate in
      the study. Subjects will be asked to sign an informed consent form and will be screened for
      inclusion exclusion criteria.

      Subject demographic and medical information will be acquired from the subject himself and/or
      from the subject's medical chart and will be recorded on the appropriate pre-study electronic
      case report forms.

      The subjects will be admitted to the clinical sleep laboratory for one night, during which
      they will undergo conventional full night PSG recording with the standard PSG channels. The
      WP 200/WP200U wrist device, which includes the PAT and pulse oximeter probes will be worn on
      the wrist.

      The investigator will not have access to the WP200/WP200U data while scoring the PSG data.
      During the study recording, the WP200/WP200U data will be recorded inside the device, without
      being displayed on the PSG monitor. Furthermore, the WP200/WP200U analysis is done
      automatically without knowledge of the PSG scoring results.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with cardiac disorder, referred to the sleep lab for a night study, who consent to
        undergo an overnight sleep study in the clinical sleep laboratory.
The Efficacy of Postoperative Analgesia of Gabapentin Plus Nefopam in the Spinal Surgery
Condition: Spinal Fusion
Study type: Interventional

Summary: 
      The acute pain after spinal surgery is serious. The most pain is during 24 hours after
      surgery. The multimodal therapy is a method which is applied to treat the postoperative pain.

      Morphine is main analgesic to treat postoperative pain. However, some the side-effects can
      occur to patients and there are associate with dosage. So, some analgesics usually combinate
      with morphine to postoperative analgesia, include gabapentin, celecoxib, ketamine, ...

      Nefopam is a central analgesic. There are effect prevent hyperalgesia. The effect of the
      combination of gabapentin with nefopam to postoperative analgesia in spinal surgery hasn't
      been reported yet.

      The gabapentin oral with 600 mg combine with continuously intravenous nefopam with 65
      µg/kg/hour during 24 hours after spinal surgery whether to increase the effect of
      postoperative analgesia.

      The investigators hypothesized that the gabapentin oral with 600 mg combine with continuously
      intravenous nefopam with 65 µg/kg/hour during 24 hours after spinal surgery can decrease 40%
      of the consumption of morphine during 24 hours.
    

Detailed description: 
      After enrolled, all participants will randomly assigned into the two groups. The intervention
      group (GAPA-group) will treated preoperative oral 600 mg of gabapentin. After general
      anesthesia, all participants of both groups will continuously transfused 65 µg/kg/hour of
      nefopam during 24 hours. After surgery, all cases will treated analgesia with morphine-PCA (2
      mg of singe dose, 5 minutes of lockout time, and 6 mg of one hour).

      The efficacy of postoperative analgesia will evaluated with the consumption of morphine
      during 24 hours.
    

Intervention name(s): Gabapentin
Intervention type(s): Drug
Intervention description(s): Gabapentin plus nefopam
Other intervention name(s): Nefopam
Intervention MeSH terms: Gabapentin; Nefopam
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The intervention group will treated postoperative analgesia with 600 mg of gabapentin plus 65 mcg/kg/hour during 24 hours of nefopam
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gabapentin; Nefopam; Spinal surgery; Postoperative analgesia
Effects of scFOS on Stool Frequency in People With Functionnal Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the
      frequency and constistency of stools in subjects with functional constipation
    


Intervention name(s): Short-chain fructo-oligosaccharides; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Hypertension and Sleep Disordered Breathing in Pediatrics
Condition: Hypertension; Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension
Study type: Observational

Summary: 
      The primary objective is to determine the prevalence of sleep disordered breathing in
      children with primary hypertension or pre hypertension. The secondary objectives are to
      determine any association factors for children with primary hypertension or prehypertension
      to have sleep disordered breathing be it gender, age, body mass index (BMI), family history
      (hx) or ethnic group.
    

Detailed description: 
      This is an exploratory, cross sectional study involving identification of the children of the
      age between 10 years and 17 years diagnosed with primary hypertension who have not been
      previously diagnosed and or treated for sleep disordered breathing with the revised pediatric
      sleep questionaire (PSQ) for sleep disordered breathing. The subjects that have shown
      interest will be mailed the informed consent/assent form to tbe reviewed. The consent/assent
      form will be handed to the child and all their questions and concerns will be answered in a
      comprehensible manner.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        children aged 10 to 17 years who have been diagnosed with primary hypertension
      
Keywords: hypertension; obstructive sleep apnea; pediatrics
Effects of a Longitudinal Health Literacy Training Program on Family Medicine Residents
Condition: Health Literacy
Study type: Interventional

Summary: 
      1. Briefly describe the purpose of this protocol: This study is designed to evaluate the
           effectiveness of an educational training program on the topic of health literacy for
           Family Medicine residents. The hypothesis being tested is that training residents about
           health literacy will result in improvements in residents' knowledge, skills, and
           attitudes with respect to health literacy.

        2. Briefly summarize how participants are recruited: OHSU Family Medicine Interns attending
           mandatory trainings on the topic of health literacy throughout the three years of the
           residency program will be invited to participate in the study.

        3. Briefly describe the procedures subjects will undergo: Completion of a short
           self-administered anonymous survey before and after a variety of learning sessions on
           the topic of health literacy.

        4. If applicable, briefly describe survey/interview instruments used: A 12-item pre-test
           questionnaire and 13-item post-test questionnaire designed to assess individuals'
           knowledge about health literacy, and intended clinical practices with respect to health
           literacy.

        5. If this is a clinical trial using an experimental drug and/or device, or an approved
           drug and/or device used for an unapproved purpose, briefly describe the drug and/or
           device: n/a

        6. Briefly describe how the data will be analyzed to address the purpose of the protocol:
           Demographics and responses to individual items will be reported as frequencies and
           percentages within the sample. We will use a chi-square analysis to stratify responses
           by demographic groups and t-tests to measure possible changes over time
    


Intervention name(s): educational intervention
Intervention type(s): Other
Intervention description(s): series of lectures and workshops on health literacy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: resident education; health literacy; curriculum