bioihbjkbjnl/mcl2 huggingface dataset:
Glycemic Index and Polyphenol Bioavailability of Potatoes
Condition: Diabetes; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to determine the glycemic index of four varieties of potatoes
      and to determine the bioavailability of polyphenols contained in these potatoes.
    

Detailed description: 
      Ten healthy persons will have a fasting blood sample drawn and asked to randomly consume a
      50g glucose drink (2 occasions), or 50g carbohydrate equivalent of cooked purple, red, yellow
      and white potatoes. Further blood samples will be obtained at 15,30, 45, 60, 90, 120, 180,
      240 mins. Bloods from the first 2 hours will be analyzed for glucose and insulin to determine
      the glycemic response. Hourly blood samples will be analyzed for polyphenol to determine the
      bioavailability of polyphenols from the different potato variety. Urine samples will be
      collected before ingestion of the food items and again at 4 hours, and will be used to
      determine polyphenol bioavailability.
    

Intervention name(s): Glycemic response to different varieties of potatoes
Intervention type(s): Other
Intervention description(s): the glycemic response top 50g available carbohydrates from 4 potato varieties will be compared to a 50g glucose standard
Other intervention name(s): Purple potato; Red potato; White potato; Yellow potaot
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glycemic index; Anthocyanin; Potato; Polyphenol
Evaluation of COPD (Chronic Obstructive Pulmonary Disease) to Longitudinally Identify Predictive Surrogate Endpoints
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      This is a 3 year longitudinal study to identify novel endpoints and compare these with
      standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to
      measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression
      over time. Control subjects (smokers and never smokers) will be recruited as comparators with
      the COPD subjects.
    


Intervention name(s): Novel endpoint determination
Intervention type(s): Other
Intervention description(s): Novel endpoint determination
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        COPD subjects and smoking and non-smoking controls
      
Biospecimen description: 
      Whole blood, serum, plasma, urine sputum
    
Keywords: Chronic Obstructive Pulmonary Disease (COPD); longitudinal; eclipse
Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions
Condition: Dry Mouth
MeSH terms: Xerostomia
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine
      Tablets, 5 mg, to SALAGEN® Tablets, 5 mg (MGI Pharma) under fasting conditions using a
      single-dose, 2-treatment, 2-period, crossover design.
    


Intervention name(s): Pilocarpine
Intervention type(s): Drug
Intervention MeSH terms: Pilocarpine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP)
Condition: Bradycardia
MeSH terms: Bradycardia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of the VIP™ feature (available in dual
      chamber Victory® devices) to reduce unnecessary RV pacing, and to determine if patients with
      implanted SJM pacemakers will benefit by using VIP™ rather than only a programmed AV/PV
      delay.
    


Intervention name(s): Intervention/treatment
Intervention type(s): Device
Intervention description(s): Device: VIP On
Device: VIP Off
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
To Study the Effect of Aprocitentan on the Electrical Activity of the Heart in Healthy Men and Women
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate that multiple-dose administration of oral therapeutic and supratherapeutic
      doses of aprocitentan do not have a clinically relevant effect on the QT interval.
    


Intervention name(s): Aprocitentan 25 mg; Aprocitentan 100 mg; Matching placebo; Moxifloxacin control to establish assay sensitivity
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Repeated administration of a 25 mg oral dose of aprocitentan, once daily from Day 1 to Day 10, followed by 18 days of observation.; Repeated administration of a 100 mg oral dose of aprocitentan, once daily from Day 1 to Day 10, followed by 18 days of observation.; Repeated administration of an oral dose of aprocitentan-matching placebo, once daily from Day 1 to Day 10, followed by 18 days of observation.; Repeated administration of an oral dose of aprocitentan-matching placebo, once daily from Day 1 to Day 9. On Day 10, oral administration of one single 400 mg moxifloxacin tablet open-label, followed by 18 days of observation.
Other intervention name(s): ACT-132577; ACT-132577
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each subject will be randomized immediately prior to first study treatment administration on Day 1 Period 1 to one of 12 treatment sequences following a 3 × 4 × 4 Williams square design. Moxifloxacin will be open-label on Day 10 in one period.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Safety Study for Beta Thalassemia Subjects on PTG-300
Condition: β-thalassemia; Ineffective Erythropoiesis
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study will investigate long term safety and use of the PTG-300 in Beta Thalassemia
      patients.
    

Detailed description: 
      The PTG-300-03 study will study beta thalassemia patients on PTG-300 for two years. The dose
      and dose frequency for each subject enrolling in the PTG-300-03 study will be based on the
      last dose and frequency received by the subject in the previous study PTG-300-02 and the
      subject's response at that dose. Patients dose will be increased in a manner similar to that
      used on PTG-300-02 study. The maximum PTG-300 dose allowed is 80 mg/week.
    

Intervention name(s): PTG-300
Intervention type(s): Drug
Intervention description(s): PTG-300 is a hepcidin Mimetic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic anemia; β-thalassemia
A Safety and Effective Study of Ginkgolides Diterpene Lactone Meglumine Injection in the Treatment of Ischemic Stroke.
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone
      meglumine injection tn the treatment of acute ischemic stroke
    

Detailed description: 
      After randomized to 90 + 7 days mRS 0-1 points is the Primary Outcome Measure,evaluate the
      safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of
      acute ischemic stroke
    

Intervention name(s): Ginkgo diterpene lactone meglumine injection; Ginkgo diterpene lactone meglumine injection simulation
Intervention type(s): Drug; Drug
Intervention description(s): 5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip.; 5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: acute ischemic stroke; safety and effectiveness; Ginkgo diterpene lactone meglumine injection
Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      This study will look at dietary patterns in individuals with chronic spinal cord injuries and
      the relationship between these dietary patterns and cardiovascular disease risk factors. The
      study is a supplement to the Coronary Artery Risk Development in Young Adults (CARDIA) study.
      The dietary history from CARDIA will be used. The investigators' primary hypothesis is the
      following: Greater whole-grain and dietary fiber intake will be favorably associated with
      adiposity (BMI and WC) and metabolic CVD risk factors (fasting glucose, fasting insulin,
      HOMA-IR, diabetes, hsCRP, TC, HDL-C, triglycerides, TC/HDL-C ratio, non-HDL-C, and systolic
      and diastolic blood-pressure) among a sample of individuals with SCI aged 38-50 who have been
      injured >1 year.
    

Detailed description: 
      This study is a cross-sectional study. It will look at dietary patterns in individuals with
      chronic spinal cord injuries and the relationship between these dietary patterns and
      cardiovascular disease risk factors. The study is a supplement to the Coronary Artery Risk
      Development in Young Adults (CARDIA) study. The dietary history from CARDIA will be used. The
      investigators' primary hypothesis is the following: Greater whole-grain and dietary fiber
      intake will be favorably associated with adiposity (BMI and WC) and metabolic CVD risk
      factors (fasting glucose, fasting insulin, HOMA-IR, diabetes, hsCRP, TC, HDL-C,
      triglycerides, TC/HDL-C ratio, non-HDL-C, and systolic and diastolic blood-pressure) among a
      sample of individuals with SCI aged 38-50 who have been injured >1 year.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        100 individuals with chronic spinal cord injuries
      
Keywords: spinal cord injury; cardiovascular disease; dietary patterns
1% Metformin in Moderate and Severe Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study evaluates the efficacy of 1% Metformin gel in treatment of moderate and severe
      periodontitis subject.
    

Detailed description: 
      Metformin (MF) has stimulating effect of osteoblastic lineages. In the present study seventy
      subjects were categorized into two treatment groups: Scaling and root planing (SRP) plus 1%
      MF and SRP plus placebo. Clinical parameters were recorded at baseline, 3, 6 and 9 months;
      they included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD),
      and clinical attachment level (CAL). Radiologic assessment of intra bony defect (IBD) and
      percentage defect depth reduction (DDR%) was done at baseline, 6 months and 9 months interval
      using computer-aided software. PD, CAL and defect depth reduction was evaluated in initial
      pocket depth of ≥5mm and ≥7mm subgroup within placebo and MF group.

      Mean probing depth reduction and mean clinical attachment level gain was found to greater in
      MF group than placebo group at all visits. Significantly greater mean percentage of defect
      depth reduction was found in MF group than the placebo sites in both ≥5mm and ≥7mm of initial
      periodontal pocket depth. In MF group improvement in clinical parameter were similar in both
      the sites, with slightly better improvement in clinical parameters in initial pocket depth
      ≥7mm with respect to CAL, IBD and DDR% while PD was significantly reduced in initial pocket
      depth of ≥7mm.

      There was greater decrease in mSBI and PD and more CAL gain with significant IBD depth
      reduction at the sites treated with SRP plus locally delivered MF in chronic periodontitis
      subjects with intrabony defects as compared to placebo and effect of MF was similar in
      initial moderate periodontal pockets and deep pocket depths.
    

Intervention name(s): Placebo gel; 1% Metformin gel
Intervention type(s): Drug; Drug
Intervention description(s): Placebo gel consist of drug without the active component.; Metformin gel consist of active component.
Other intervention name(s): Placebo group; 1% Metformin group
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Metformin; Pocket depth; moderate periodontitis; severe periodontitis
The Role of Massage in Increasing Total Motile Sperm Count of IUI
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this prospective, randomized study, was to determine if neck and shoulder
      massage performed within 15 minutes of semen sample collection will increase the semen
      volume, and therefore increase the total motile sperm available for insemination as a result
      of decreased stress.
    


Intervention name(s): Massage
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Infertility; Intrauterine insemination; Male factor infertility; Massage; Total motile sperm count
Heart Rate Variability and Hyperthyroidism: Evaluation of the Short-term Effects of Propanolol
Condition: Hyperthyroidism
MeSH terms: Hyperthyroidism
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: The aim of our study was to evaluate the short term effects of Propanolol on heart
      rate variability in patients with hyperthyroidism.

      Design: In ten patients newly diagnosed as having hyperthyroidism and naïve of all treatment
      specific for hyperthyroidism, we evaluated the short term effects of Propanolol on heart rate
      variability (HRV).

      Methods: We measured heart rate variability by power spectral analysis during 2 hours of rest
      and during Ewing's tests before and after the administration of Propanolol 40mg/12 hours
      orally for 72 hours.
    

Detailed description: 
      Objective: The aim of our study was to evaluate the short term effects of Propanolol on heart
      rate variability in patients with hyperthyroidism.

      Design: In ten patients newly diagnosed as having hyperthyroidism and naïve of all treatment
      specific for hyperthyroidism, we evaluated the short term effects of Propanolol on heart rate
      variability (HRV).

      Methods: We measured heart rate variability by power spectral analysis during 2 hours of rest
      and during Ewing's tests before and after the administration of Propanolol 40mg/12 hours
      orally for 72 hours. Other outcomes included mean heart rate, mean R-R interval during 2-hour
      rest.

      The study questions the systematic adjunction of Propanolol early in the treatment of
      hyperthyroidism.
    

Intervention name(s): Propanolol
Intervention type(s): Drug
Intervention description(s): 72-hour propanolol before specific treatment of hyperthyroidism
Other intervention name(s): Avlocardyl
Intervention MeSH terms: Propranolol
Intervention model: Single Group Assignment
Intervention model description: Open label Before and After design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hyperthyroidism; heart rate variability; propanolol; Africa
Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption for Treatment of Glioma
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety of blood-brain barrier (BBB) disruption
      in adult patients with a first presentation of a glioblastoma (GBM) following a maximal safe
      surgical resection and standard chemo-radiation with temozolomide (TMZ) protocol and ready
      for the maintenance phase of the Stupp protocol with TMZ.
    

Detailed description: 
      This is a prospective, single center, single-arm study to establish the safety, feasibility,
      and effectiveness of BBB disruption along the periphery of the tumor resection cavity using
      the ExAblate Neuro Model 4000 Type 2 (220 kHz) system and DEFINITY ultrasound contrast in
      patients with GBM. Adult patients with a first time diagnosis of GBM, whom have undergone
      maximal safe surgical resection and have safely completed the initial phase of concurrent
      chemo-radiation therapy, will be recruited for this study. Twenty patients will undergo up to
      6 treatments with FUS coincident with their standard TMZ cycles.
    

Intervention name(s): Focused Ultrasound (FUS) BBB Disruption
Intervention type(s): Device
Intervention description(s): FUS BBB disruption involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets
Other intervention name(s): Exablate Neuro
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study To Evaluate Safety and Efficacy of Vesatolimod for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Participants
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study are to evaluate the safety, tolerability, and efficacy
      of vesatolimod in participants with chronic hepatitis B (CHB) infection currently being
      treated with oral antivirals (OAV).

      Participants will be randomized in 3 sequential cohorts (Cohorts A, B, and C). Within each
      cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of the doses of
      vesatolimod (1, 2, or 4 mg).
    


Intervention name(s): Vesatolimod; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vesatolimod tablet administered orally; Placebo to match vesatolimod tablet administered orally
Other intervention name(s): GS-9620
Intervention MeSH terms: Vesatolimod
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Hepatitis B; HBV; GS-9620; TLR-7 Agonist
Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
Condition: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiration Disorders; Signs and Symptoms, Respiratory; Syndrome, Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiration Disorders; Syndrome; Signs and Symptoms, Respiratory
Study type: Interventional

Summary: 
      The objective of the study is to determine the safety and preliminary efficacy in patients
      utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
    


Intervention name(s): aura6000 System
Intervention type(s): Device
Intervention description(s): The aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea, neurostimulation, hypoglossal nerve
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      The aim of the project is to investigate the clinical and patient centred outcomes of people
      with Peripheral Arterial Disease (PAD) attending a podiatry led integrated care pathway,
      utilising advice on diet, activity and smoking cessation. The podiatry clinic will be
      delivered from the Move More centre (NCSEM) and participants will be encouraged to access
      these facilities as part of their activity programme which will be agreed with the physical
      activity team. Primary and secondary outcomes will be clinical - claudication pain, distance
      walked at 3 and 6 months, blood pressure and lipid monitoring, weight management, reduced
      BMI, and the success of any smoking cessation. Quality of life and patient satisfaction with
      the programme will also be assessed.
    


Intervention name(s): PAD tailored care
Intervention type(s): Other
Intervention description(s): PAD tailored care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Vasopressor Prophylaxis After Spinal Anesthesia
Condition: Cesarean Section Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean
      delivery with promising results ; However, the optimum dose for efficient prophylaxis with
      the least side effects is not known. In this study, we will compare three doses (0.05, 0.1,
      0.15 mcg/Kg/min) of norepinephrine for prophylaxis against Post-Spinal hypotension during
      cesarean delivery.
    

Detailed description: 
      Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery
      (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal
      hypotension (PSH) during CD.

      Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic
      activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a
      vasopressor with minimal cardiac depressant effect; these pharmacological properties would
      make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used
      vasopressors in obstetric anesthesia).

      Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with
      promising results; However, the optimum dose for efficient prophylaxis with the least side
      effects is not known.

      In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for
      prophylaxis against PSH during CD.
    

Intervention name(s): Norepinephrine 0.05 mcg /Kg/min; Norepinephrine 0.1 mcg /Kg/min; Norepinephrine 0.15 mcg /Kg/min; Bupivacaine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia; Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia; Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia; 10 mg Bupivacaine intra-thecal for spinal anesthesia
Other intervention name(s): noradrenaline infusion; noradrenaline infusion; noradrenaline infusion; marcaine
Intervention MeSH terms: Norepinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention