bioihbjkbjnl/mcl2 huggingface dataset:
The Role of HNHF to Improve Clinical Outcomes Following Severe AECOPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic Obstructive Pulmonary Disease (COPD) is a common lung disease, affecting 1.2 million
      people in the United Kingdom (UK). COPD patients suffer with episodes of worsening breathing
      symptoms called acute exacerbations (AECOPD). Exacerbations occur more often as the disease
      progresses and are a leading cause of emergency hospitalisation. Patients recovering from
      exacerbations are at high risk of deteriorating, with one quarter readmitted to hospital
      within thirty days. COPD thus imposes immense burdens on the National Health Service and
      patients.

      This research will investigate the effects of using humidified nasal high-flow (HNHF) during
      recovery from severe COPD exacerbations. HNHF delivers warmed, humidified air under flows of
      up to 60 litres per minute through a nasal interface. This has been shown to improve clinical
      outcomes, including exacerbation frequency, hospitalisations, breathlessness and quality of
      life amongst COPD patients with respiratory failure. It is thought to achieve this by
      improving secretion clearance and providing positive airways pressure which supports the
      breathing system.

      Patients admitted to St Thomas' Hospital, London with COPD exacerbations will be recruited.
      Prior to discharge, participants will be randomised to receive either usual care alone or
      usual care plus a HNHF device, which they will be trained to use for a regular period daily.
      Usual care includes inhalers, steroids and may include antibiotics.

      Participants will be followed up for 30-days after hospital discharge using weekly
      assessments, daily symptom diaries and wrist-worn watch-like devices that detect physical
      activity. This will enable evaluation of the clinical effects of HNHF on re-exacerbations,
      readmissions, breathlessness, physical activity and quality of life. Device usage will also
      be quantified. Participants who receive devices will be interviewed to explore their
      experiences. After the 30-day home follow-up period, a sub-group of participants will undergo
      detailed breathing tests during and after exercise to explore the effects of HNHF on the
      respiratory system.
    


Intervention name(s): Humidified nasal high-flow device
Intervention type(s): Device
Intervention description(s): Humidified nasal high-flow device which delivers warmed, humidified air at flow rates of up to 60 litres per minute via a nasal cannula interface. Intended delivery at 30 L/min at 37 degrees Celsius, if tolerated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Neural respiratory drive; Physiology; Respiratory muscles; COPD exacerbation; Ventilation; Nasal high-flow; High-flow nasal cannula
Safety and Efficacy of APD356 in the Treatment of Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c
      receptor agonist, in clinical development as a potential treatment for obesity.

      The purpose of this study is to obtain preliminary assessment of the safety and efficacy of
      APD356, when administered daily for 28 days, in obese subjects who are otherwise healthy.
    

Detailed description: 
      This is a double-blind, placebo-controlled, randomized, parallel group study. Three different
      doses of APD356 or placebo will be administered daily for 28 days, to uncomplicated obese,
      male and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400
      subjects will be enrolled.
    

Intervention name(s): APD356
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Serotonin; 5-HT2c; Satiety; Obesity; Appetite suppressant; Weight Loss; Overweight
Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in OSA
Condition: Obstructive Sleep Apnea; Excessive Sleepiness
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the
      effect of JZP-110 on driving performance in subjects with excessive sleepiness due to
      obstructive sleep apnea.
    


Intervention name(s): JZP-110; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): solriamfetol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Driving
Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      The purpose of this research study is to determine the effect of mechanical vibrations on
      bones of persons with spinal cord injury.
    

Detailed description: 
      One of the major complications in persons with spinal cord injury (SCI) is marked bone loss
      because it greatly predisposes to skeletal fractures, even after minimal trauma. The use of
      low magnitude mechanical stimulation has been shown to be both safe and effective in
      improving bone mass and strength in animal studies. This modality has also been shown a
      beneficial effect in children with disability and in postmenopausal women. The investigators
      are interested in obtaining data to determine the possible benefits that mechanical
      intervention with vibratory stimulation may have on bone in individuals with subacute SCI
      (e.g., >1 month after injury but <1 year). Changes in bone density and mass of the leg and
      arm will be determined by dual energy X-ray absorptiometry (DXA); bone architecture of the
      distal leg and distal arm will be determined by peripheral quantitative computed tomography;
      circulating metabolic markers of bone will also be performed.

      OBJECTIVES

      In persons with subacute spinal cord injury:

        1. To determine differences in bone mineral mass and parameters of bone structural
           integrity of the stimulated tibia versus the unstimulated tibia.

        2. To determine changes in the metabolic markers of bone resorption and formation in
           persons with subacute spinal cord injury.
    

Intervention name(s): Vibration: Right Leg and No Vibration: Left Leg.
Intervention type(s): Device
Intervention description(s): Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Spinal Cord Injuries; Mechanical Stimulation; Vibration Plate
Preterm Infants May Better Tolerate Warmer Feeds
Condition: Prematurity; Feeding Disorder Neonatal
MeSH terms: Premature Birth; Feeding and Eating Disorders
Study type: Interventional

Summary: 
      Feeding intolerance is frequent among preterm infants in neonatal intensive care units
      (NICUs). Although there are many studies about enteral nutrition strategies and content in
      preterm infants, no evidence-based standards exist for the optimal milk temperature for
      preterm infants. Therefore, in this study the investigators aimed to examine the effects of
      feeding temperature and the possible morbidities.
    

Detailed description: 
      Feeding intolerance is one of the most frequent problems among preterm infants. These infants
      are fed with expressed breast milk or preterm formulas of which the temperature is not
      routinely measured. In this study, the investigators aimed to examine the effects of feeds
      with warm versus room temperature milk in preterm infants. Infants with a birth weight of
      ≤1500 g or gestational age of ≤ 34 weeks were included in the study and assigned to two
      different feeding temperature groups (22-24°C and 32-34°C). Some infants in both groups were
      exclusive breast milk fed and some received artificial milk. Feeding tolerance of patients in
      both groups and the consequences were evaluated.
    

Intervention name(s): Room temperature; Warmer temperature
Intervention type(s): Other; Other
Intervention description(s): These infants were fed with room temperature (22-24 °C) so that hypothesizing that they will have more feeding tolerance and therefore more co-existing morbidities.; Fifteen NICU mothers volunteered and expressed their milk for rapid measurement of freshly expressed breast milk. The mean (± SD) temperature of freshly expressed breast milk was found to be 33±1.5 °C in these preliminary measurements. Confirming this finding, the investigators decided to feed these infants with milk at 32 - 34 °C to examine the effects of feeding temperature and the possible comorbidities with a hypothesis that warmer feeding at the temperature of freshly expressed breast milk may be better physiologically.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Prematurity; Enteral nutrition; Feeding tolerance; Temperature
A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic
      (the effect of the investigated drug on the body) and the pharmacokinetic (exposure of the
      trial drug in the body) properties of insulin degludec/insulin aspart 15 in subjects with
      type 1 diabetes.
    


Intervention name(s): insulin degludec/insulin aspart 15; insulin degludec/insulin aspart; insulin degludec; insulin aspart; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW).; Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW).; Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.425 U/kg Body Weight (BW).; Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.075 U/kg Body Weight (BW).; Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.
Other intervention name(s): IDegAsp
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome
Condition: Primary Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2a study to evaluate the efficacy and safety of AMG 557/MEDI5872 in Primary Sjögren's
      Syndrome
    

Detailed description: 
      This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group
      study to evaluate the clinical and biologic efficacy, as well as the safety of SC doses of
      AMG 557/MEDI5872 in adult subjects with Primary Sjögren's Syndrome.
    

Intervention name(s): AMG 557/MEDI5872; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Participants will receive a fixed SC dose of 210 mg MEDI5872 (AMG 557/MEDI5872) QW for 3 weeks (Days 1 to 15) and then Q2W for 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, all participants from double-blind period will receive a fixed SC dose of 210 mg MEDI5872 from Day 99 to Day 183 (QW from Days 99 to 113 for participants from Placebo arm and on Days 99 and 113 for participants from MEDI5872 210 mg arm; and Q2W from Days 127 to 183 for participants from both arms).; The SC dose of placebo every week for 3 weeks (Days 1 to 15) and then every 2 weeks for 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, an additional dose of blinded placebo will be administered on Day 106 for participants who will receive MEDI5872 210mg in double-blinded period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Bevacizumab(BAT1706) and Comparators in Healthy Subjects
Condition: NSCLC
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish PK similarity in the treatment of BAT1706 and
      comparators.
    

Detailed description: 
      This is a Phase I, randomized, double-blind, single-dose, 3-arm parallel group study to
      compare the PK, and to evaluate the safety, tolerability and immunogenicity, of BAT1706,
      EU-Avastin and US-Avastin after a single IV infusion in healthy adult male subjects.

      A total of 129 healthy male subjects who meet the required entry criteria will be randomly
      assigned to one of three treatment groups in a 1:1:1 ratio to receive a single IV infusion of
      either BAT1706, EU-Avastin or US-Avastin. A total of 117 evaluable subjects are required.

      Initially, subjects will be administered the study drug in staggered groups; the first group
      will comprise 3 subjects, the second group 6 subjects and the third group 9 subjects. Within
      each group subjects will be randomized to ensure equal numbers of subjects receive each of
      the three treatments.

      There will be at least 48 hours between administrations of study drug to each group. Prior to
      administration of study drug to the next group, the safety and tolerability findings of the
      preceding group will be reviewed by the Principal Investigator. The next group will be dosed
      provided there are no serious or unexpected drug-related safety issues. Each subject will be
      required to remain in the clinical center for 48 hours after dosing for safety evaluation.

      After the first 3 groups have been evaluated, the Principal Investigator will decide whether
      to proceed with continuous enrolment according to the clinical center capability.
    

Intervention name(s): BAT1706 injection; EU-sourced Avastin; US-sourced Avastin
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1mg/kg, IV on day 1; 1mg/kg, IV on day 1; 1mg/kg, IV on day 1
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparing Delayed Cord Clamping and Umbilical Cord Milking During Elective Cesarean Section for the Neonatal Outcome
Condition: Umbilical Cord Milking
Study type: Interventional

Summary: 
      the study is conducted on the different actions on umbilical cord clamping including
      immediate cord clamping (ICC) , delayed cord clamping (DCC) for 30 seconds and umbilical cord
      milking (UCM) for 10-15 seconds in females that are delivered by elective cesarean section ,
      to assess the neonatal outcomes including Hemoglobin and Hematocrit levels after birth in the
      newborn and the bilirubin level after 72 hrs
    

Detailed description: 
      the benefit of umbilical cord milking for 10-15 seconds maneuver in cesarean section, that
      short time can improve the hemoglobin level and prevent anemia in the newborn with
      improvement of the iron stores for months in infancy without affection on the bilirubin level
      and the need for phototherapy. This is significant because of the rising rate of cesarean
      section all over the world make more children are liable for anemia, and by this simple
      technique it can be prevented.
    

Intervention name(s): Delayed cord clamping for 30 seconds
Intervention type(s): Procedure
Intervention description(s): waiting for 30 seconds after delivery of the fetus or milking of the cord in the direction of the fetus 10 times in time frame 10-15 seconds
Other intervention name(s): Umbilical cord milking
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: cesarean section; umbilical cord milking; hemoglobin
Study Effect of Red Wine Consumption on Endothelial Progenitor Cells and Endothelial Function
Condition: Endothelial Progenitor Cells Numbers; Endothelial Function (FMD)
Study type: Interventional
Phase: Phase 1

Summary: 
      Light-to-moderate alcohol consumption has been associated with a reduction of cardiovascular
      events, and red wine seems to offer more benefits than any other type of alcoholic beverages.
      However, the relationship between red wine consumption and endothelial progenitor cells
      (EPCs) remains unclear. The investigators examine whether intake of red wine could enhance
      the number or functional capacity of circulating EPCs by upregulation of nitric oxide (NO)
      bioavailability.
    

Detailed description: 
      Moderate ethanol intake from any type of beverage has been shown to improve lipoprotein
      metabolism and lower cardiovascular mortality risk, but red wine, with its abundant
      antioxidant contents, seems to confer additional healthy benefits. Previous studies indicated
      that the beneficial effects of red wine are derived from increased endothelium-derived nitric
      oxide (NO), implying that enhanced NO bioavailability may mediate the cardiovascular
      protection provided by red wine.

      Increasing evidence suggests that the injured endothelial monolayer is regenerated partly by
      circulating bone marrow derived-endothelial progenitor cells (EPCs), which accelerate
      reendothelialization and protect against the initiation and progression of atherosclerosis.
      Clinical studies demonstrated that the number of circulating EPCs predicts the occurrence of
      cardiovascular events and death from cardiovascular causes and may help to identify patients
      at increased cardiovascular risk. Although many epidemiologic studies have indicated that
      light-to-moderate consumption of red wine can reduce the incidence of CAD, the multifarious
      effects of red wine on circulating EPCs and endothelial function remain to be determined.
      Therefore, we design this study to test the hypothesis that intake of red wine can enhance
      the number and functional capacity of EPCs through increasing NO bioavailability.
    

Intervention name(s): red wine
Intervention type(s): Other
Intervention description(s): One group (n=20) that consumed red wine (100 ml) daily for 3 weeks Another group (n=20) that consumed beer (250 ml) daily for 3 weeks
Other intervention name(s): The red wine used is "Vin De Pays D'OC" (12.5% ethanol), a cabernet sauvignon from France; The beer used was Taiwan Beer (5% alcohol) from Taiwan.
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives
Condition: Obesity; Hypertension
MeSH terms: Body-Weight Trajectory
Study type: Interventional
Phase: Phase 3

Summary: 
      To study the effect of sibutramine treatment on weight reduction and blood pressure
      improvement in three groups with antihypertensive therapy whose blood pressure was not
      adequately controlled with antihypertensive combination treatment.
    


Intervention name(s): sibutramine; sibutramine; verapamil/trandolapril; metoprolol/HCT; felodipine/ramipril
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 8-wks, sibutramine, 10 mg, capsules, once daily; 8-wks, sibutramine, 15 mg, capsules, once daily; 2 wk Run-in phase, antihypertensive therapy only; 2 wk Run-in phase, antihypertensive therapy only; 2 wk Run-in phase, antihypertensive therapy only
Other intervention name(s): ABT-991; Meridia; Reductil; ABT-991; Meridia; Reductil
Intervention MeSH terms: Sibutramine; Metoprolol; Verapamil; Felodipine; Ramipril; Trandolapril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
High-intensity Interval Training Versus Moderate Continuous Training in Heart Transplant Recipients.
Condition: Heart Transplant Recipients
Study type: Interventional

Summary: 
      The aim of this study was to examine the effects of high intensity aerobic interval training
      (AIT) versus moderate continuous training (CON) in heart transplant recipients.
    

Detailed description: 
      Clinically stable heart transplant recipients > 12 month or more after HTx, age > 18 years,
      willing and capable of giving written informed consent for study participation and
      anticipated to be able to participate in the study for 12 months were included from the Heart
      Centre, Rigshospitalet, Copenhagen University Hospital.

      Patients were excluded due to unstable condition or postoperative complications, recent
      severe rejection episodes (>H1R < 3 month), physical disabilities which prevent participation
      and re-transplantation or multi-organtransplantation.
    

Intervention name(s): high intense interval training; continuous moderate training
Intervention type(s): Other; Other
Intervention description(s): Each AIT session consisted a 10 minute warm-up period followed by 16 minutes of interval training consisting of intervals of 4-3-2 and 1 minutes duration at 85-95% of their peak capacity separated by 2-4 min active rest.; Continued exercise 45 min.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart transplant recipients; Exercise capacity; endothelial function; Quality of life