bioihbjkbjnl/mcl2 huggingface dataset:
Acute Effect of Nitrate From Natural Dietary Sources on Arterial Stiffness and Blood Pressures in Healthy Individuals
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the acute effect of a meal high in dietary nitrates
      on aortic augmentation index, brachial and aortic blood pressures, and subendocardial
      viability ration (SEVR).
    

Detailed description: 
      Hypertension has become a common medical condition worldwide, raising public concern
      regarding the accompanying increase in cardiovascular disease risk and other health risks.
      Targets for optimal blood pressure are often unmet by conventional pharmaceutical therapies;
      consequently, complementary and alternative medicines are increasing in popularity among
      patients wishing to better manage their BP. In the case of hypertension, endothelial
      dysfunction and cardiovascular disease, a decline in the ability of blood vessels to dilate
      in response to shear stress is a major contributor to vascular pathology. At the core of
      these conditions is a decreased ability to synthesize nitric oxide, a potent vasodilatory
      agent. The proposed study will examine whether or not increasing the intake of dietary
      nitrate, which can be converted to nitric oxide endogenously, can improve three indices of
      vascular function that are validated risk factors for CVD: arterial stiffness, as measured by
      aortic augmentation index (AIx), aortic BP and brachial BP.
    

Intervention name(s): Spinach soup; Asparagus soup
Intervention type(s): Other; Other
Intervention description(s): 556 g of high Nitrate spinach soup that is orally consumed as a single dose for 7 days; 556 grams of low nitrate asparagus soup that is orally consumed for a period of 7 days as a single does
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Dietary Nitrates; Arterial Stiffness; Vascular; Blood pressure
Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses of BI 11054 CL Administered With the Respimat® in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, and pharmacokinetics of BI 11054
    


Intervention name(s): BI 11054 CL; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Evaluation of a New Radiotracer (64Cu-DOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography
Condition: Breast Cancer; Prostate Cancer; Urinary Bladder Cancer
MeSH terms: Prostatic Neoplasms; Urinary Bladder Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The primary objective of the study is to test a new radiotracer called 64Cu-DOTA-AE105 for
      PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential
      of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and
      less aggressive tumors. This is a first in human study to test the radiotracer in cancer
      patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging (1,3
      and 24 hours post injection).
    

Detailed description: 
      The primary objective of the study is to test a new radiotracer called 64Cu-DOTA-AE105 for
      PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential
      of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and
      less aggressive tumors. This is a first in human study to test the radiotracer in cancer
      patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging (1,3
      and 24 hours post injection). The primary end points are Biodistribution and dosimetry of
      64Cu-DOTA-AE105. In addition, the quantitative uptake of 64Cu-DOTA-AE105 in tumors and
      expression of uPAR in tumor tissue obtained by surgery or biopsies (either 14 days before
      (only biopsies) or after the PET scans) will be compared to validate the image-derived data
      on UPAR expression
    

Intervention name(s): Injection of 64Cu-DOTA-AE105
Intervention type(s): Other
Intervention description(s): One injection of 64Cu-DOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan 1, 3 and 24 hours post injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Positron Emission Tomography; Uroplasminogen Plasminogen Activator Receptor; Breast cancer; Prostate cancer; Urinary bladder cancer; Biodistribution; Radiation exposure
The neoClose Abdominal Closure vs Carter-Thomason Trial
Condition: Surgical Port Site Hernia
MeSH terms: Hernia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the neoClose abdominal closure to the standard
      Carter-Thomason closure in a bariatric surgery gastric bypass population.
    

Detailed description: 
      Both the neoClose abdominal closure to the standard Carter-Thomason closure will be used to
      close 12 mm camera port sites and 12 mm stapler port sites upon completion of a robotic
      assisted laparoscopic gastric bypass. The procedure requires a 12 mm port site be placed in
      the midline approximately 3 cm cephalad to the umbilicus and a second 12mm port site in the
      right mid abdomen. Port sites will be closed as defined as the inability to palpate a fascial
      defect and the incision being air tight upon carbon dioxide insufflation.
    

Intervention name(s): Neo Close Abdominal Closure; Carter Thomason Device
Intervention type(s): Device; Device
Intervention description(s): Neo Close Abdominal Closure; Carter Thomason Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bioavailability of Avenanthramide-Enriched Oats in Healthy Older Adults
Condition: Healthy
Study type: Interventional

Summary: 
      This is a placebo-controlled, crossover study investigating the pharmacokinetic
      bioavailability of avenanthramides from avenanthramide-enriched oats and their in vivo
      metabolites in a cohort of healthy, older adults.
    


Intervention name(s): Avenanthramide-enriched oats
Intervention type(s): Other
Intervention description(s): Single dose, 24 hour pharmacokinetic trial
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: avenanthramide; enriched; oat; phytochemical; bioavailability
Study of the Clinical Utility of PSMA Imaging in the Evaluation of Men With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      In this study we aim to more precisely define the clinical utility of PSMA imaging across a
      range of clinical indications in men with prostate cancer. To accomplish this, we will make
      the 18F-DCFPyL PET/CT scan available to urologists, medical oncologists, and radiation
      oncologists at Johns Hopkins and survey physicians as to the indication for ordering the
      PET/CT and if a change in management occurred as the result of new information gained from
      the scan. We believe these data will prove critical for planning future studies aimed at
      evaluating the efficacy of this test for improving patient outcomes.
    


Intervention name(s): 18F DCFPyL- Radiopharmaceutica
Intervention type(s): Drug
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adenocarcinoma of the prostate
Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes
Condition: Diabetes Mellitus; Pregnancy Complications
MeSH terms: Pregnancy Complications; Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomised controlled, open-label trial in an unselected cohort of pregnant women with type
      1 or type 2 diabetes allocated to insulin Fiasp® or insulin NovoRapid® during pregnancy and
      lactation.
    


Intervention name(s): Faster-acting Aspart insulin Fiasp; Control (insulin Novorapid)
Intervention type(s): Drug; Drug
Intervention description(s): Randomization to treatment with insulin Fiasp; Randomization to standard treatment with insulin Novorapid
Other intervention name(s): Insulin Fiasp; First generation insulin analog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Continuous Venovenous Hemodiafiltration Versus Sustained Low-efficiency Hemodialysis for Critically Ill Patients With Acute Kidney Injury in Intensive Care Unit
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Interventional

Summary: 
      The investigators conducted a comparison trial between SLED and CRRT in critically ill
      patients to evaluate the outcome for all cause mortality at 30 day . The secondary outcome
      were recovery of renal function, complications during therapy and duration of
      hospitalization.
    

Detailed description: 
      The investigators performed a single center experience accumulated over 12 months since
      February 2009 with a continuous venovenous hemodiafiltration (CVVHDF) and hybrid technique
      named sustained low-efficiency dialysis (SLED). The primary end point was death from any
      cause by day 30. Intensive care unit (ICU) patients were eligible for inclusion when serum
      creatinine was > 2 mg/dL, and renal replacement therapy (RRT) was initiated. The selected
      patients were treated with CVVHDF or SLED.
    

Intervention name(s): Slow efficiency dialysis
Intervention type(s): Procedure
Intervention description(s): Slow dialysis 4 times weekly 8 hours CVVHDF predilution mode
Other intervention name(s): CRRT
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Faba Bean Fractions as Ingredients in Novel Food Products on Glycemia, Appetite and Metabolic Control
Condition: Faba Bean; Post-prandial Blood Glucose; Appetite; Satiety Hormones; Insulin
Study type: Interventional

Summary: 
      To describe the effect and mechanisms of action faba bean powder and fractions (protein,
      starch and fiber) on glucose and insulin homeostasis, food intake, satiety and metabolic
      regulation in young adults (18 to 30 years).
    

Detailed description: 
      The overall objective is to describe the effect and mechanisms of action of faba bean powder
      and fractions (protein, starch and fiber) on glucose and insulin homeostasis, food intake,
      satiety and metabolic regulation in young adults (18 to 30 years). The specific objectives
      are to test the acute effects of different faba bean ingredient smoothie on: 1) post-prandial
      blood glucose, appetite, satiety hormone and insulin for 200 minutes, and 2) food intake 120
      minutes following consumption of the faba bean smoothie. Two short-term acute studies will be
      conducted to meet these objectives. Both acute studies will follow a randomized, double
      blinded, balanced, repeated measures design and the same protocol; except one will have an ad
      libitum pizza meal (study 1), while the other will have a fixed pizza meal (study 2) at 120
      minutes. Half the participants will have blood drawn by IV and the other half will be finger
      prick.
    

Intervention name(s): Faba bean powder smoothie; Faba bean protein concentrate smoothie; Faba bean starch smoothie; Faba bean protein isolate smoothie; Non-pulse smoothie smoothie
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Breakfast smoothie with 32 g whole faba bean powder (300g).; Breakfast smoothie with 32 g faba bean protein concentrate.; Breakfast smoothie with 33 g faba bean starch.; Breakfast smoothie with 32 g faba bean protein isolate.; Control smoothie with 32 g corn maltodextrin without added faba bean fractions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors in Pediatric Patients
Condition: Neuroblastoma; Rhabdomyosarcoma; Lymphoma; Wilm's Tumor; Ewing's Sarcoma
MeSH terms: Vaccinia; Sarcoma; Neuroblastoma; Rhabdomyosarcoma; Sarcoma, Ewing; Wilms Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, dose-escalation trial of JX-594 (Pexa-Vec) in pediatric
      patients with advanced/metastatic, unresectable solid tumors refractory to standard therapy
      and/or the patient does not tolerate standard therapies. Tumors are likely to include
      neuroblastoma, lymphoma, Wilms' tumor, rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma,
      non-rhabdomyosarcoma soft tissue sarcomas, and malignant peripheral nerve sheath tumors.
      Benign tumors are excluded. These tumor types were selected because evidence of biological
      activity was observed in cancer cells lines and ex vivo infected primary human tissue
      samples, specifically pediatric cancer types such as sarcomas and neuroblastomas.
    


Intervention name(s): Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Intervention type(s): Drug
Intervention description(s): Intratumoral Injection Dosage from 1 x 10^6 pfu/kg to 3 x 10^7 pfu/kg is administered once to 1-3 injectable tumors in pediatric patients.
Other intervention name(s): Pexa-Vec
Intervention MeSH terms: Molgramostim; Sargramostim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase I; advanced metastatic pediatric solid tumors; pediatric; vaccinia virus; oncolytic virus; neuroblastoma; rhabdomyosarcoma; lymphoma; Wilm's tumor; Ewing's sarcoma; osteosarcoma; non-rhabdomyosarcoma soft tissue sarcomas; malignant peripheral nerve sheath tumors; Pexa-Vec
Virtual Reality Relaxation to Decrease Dental Anxiety
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The aim is to apply short-term virtual reality relaxation to examine if it is effective in
      reducing pre-operative dental anxiety in primary health care using an RCT.
    

Detailed description: 
      Randomized controlled single-center trial with two parallel arms: Virtual Reality Relaxation
      (VRR) and Treatment As Usual (TAU) in a public oral health care unit. VRR group receiving a
      1-3.5 minute 360° video immersing them in peaceful virtual landscape with audio features and
      sound supporting the relaxing experience. TAU groups remaining seated for 3 minutes in
      similar setting.
    

Intervention name(s): Virtual reality relaxation
Intervention type(s): Device
Intervention description(s): 1-3.5 minute 360° videos
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled single-center trial with two parallel arms
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental anxiety; virtual reality
Effects of Seaweed Extract on Mental Performance Following a High-carbohydrate Meal
Condition: Cognitive Change
Study type: Interventional

Summary: 
      The current study will explore the impact of seaweed extract on cognitive function following
      a high-carbohydrate meal at a number of time-points post-consumption.
    

Detailed description: 
      The current randomised, placebo-controlled, double-blind, parallel groups study will examine
      the impact of a brown seaweed extract (InSea2) on cognitive function post-prandially in 60
      healthy non-elderly adults who self-report post-meal drowsiness. Computerised measures of
      episodic memory, attention and subjective state will be completed at baseline and for 3 hours
      following lunch with either seaweed or placebo consumed 30 minutes prior to a
      carbohydrate-rich meal.
    

Intervention name(s): 500mg brown seaweed powder; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): InSea2®
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will receive either 500mg brown seaweed powder (InSea2) or placebo
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: post-prandial cognition; brown seaweed
Impact of Antenatal Exposure to Pesticides on Neurophysiological Functions (Sleep, Respiration) of Preterm Neonates
Condition: Premature Infants
Study type: Observational

Summary: 
      During pregnancy, the foetus is therefore chronically exposed to a large number of
      substances. A number of studies have started to emphasize the effects of this antenatal
      exposure on the newborn infant's morphological parameters (weight, crown-rump length, etc.).
      However, in addition to these morphological effects, pesticides may also induce various
      effects on physiological functions, as some pesticides act as inhibitors of neurotransmitters
      involved in many nervous system regulation pathways in man. This is particularly the case for
      organophosphates, which act as acetylcholinesterase inhibitors. A previous study conducted by
      the coordinator of the project presented here demonstrated the presence of high levels of
      this type of pesticide in meconium (1st stool) in neonates born in Picardy. This inhibition
      of the enzyme metabolizing ACh could have an impact on neurophysiological functions mediated
      by this neurotransmitter. Sleep or respiratory control, vital functions of the neonate
      particularly in preterm neonates, could therefore be affected.

      The PhysioMéco project is therefore designed to study the possible links between antenatal
      exposure to pesticides and modifications of respiratory control allowed by peripheral
      chemoreceptor in preterm neonates. Antenatal exposure will be determined by pesticide assays
      in the meconium of neonates in combination with an exposure questionnaire to determine the
      sources of these pesticides. Sleep and respiratory control will be studied in these neonates
      nursed in incubators. Hypoxic test will be used in order to assess respiratory control
      involving the peripheral chemoreceptors.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        premature neonates
      
Keywords: pesticide exposure; respiratory control; sleep
Raloxifene in Preventing Breast Cancer in Premenopausal Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. The use of raloxifene may be an effective way to prevent
      breast cancer in premenopausal women.

      PURPOSE: Phase II trial to study the effectiveness of raloxifene in preventing invasive
      breast cancer in premenopausal women.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety and tolerability of raloxifene in premenopausal women at high risk
           of developing invasive breast cancer.

        -  Determine the effect of raloxifene on blood steroid hormone levels (luteinizing hormone,
           estradiol, progesterone) and carotenoid levels during the menstrual cycle in these
           participants.

        -  Determine the effect of raloxifene on the endometrium and ovaries in these participants.

        -  Determine the effect of raloxifene on biochemical markers of bone metabolism, lipid
           profiles, and fibrinogen in these participants.

        -  Determine the effect of raloxifene on health-related quality of life of these
           participants.

        -  Determine the effect of raloxifene on bone mineral density in the spine and hip of these
           participants.

      OUTLINE: This is an open-label study.

      Participants are medically evaluated, followed by an observation period of 1 to 2 menstrual
      cycles. After the observation period, participants receive oral raloxifene once daily for 2
      years.

      Quality of life is assessed 1 week prior to study drug administration and at 6, 12, 24 and 36
      months after study drug administration.

      Participants are followed for 1 year.

      PROJECTED ACCRUAL: A total of 41 participants will be accrued for this study within 3 years.
    

Intervention name(s): raloxifene; evaluation of cancer risk factors
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Raloxifene Hydrochloride
Primary purpose: Prevention
Keywords: breast cancer
Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea
Condition: Acellular Pertussis; Diphtheria; Tetanus; Poliomyelitis; Diphtheria-Tetanus-acellular Pertussis Vaccines
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Tetany
Study type: Observational

Summary: 
      The purpose of this study is to collect safety information following routine vaccination with
      Infanrix-IPV among infants and children in Korea.
    


Intervention name(s): Infanrix-IPV data collection
Intervention type(s): Other
Intervention description(s): Safety monitoring: recording of adverse events using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants and children who receive at least one dose of Infanrix-IPV as a part of routine
        practice at a private clinic or hospital.
      
Keywords: Safety; Infanrix-IPV; Post-marketing surveillance; Diphtheria, tetanus, pertussis and poliomyelitis