TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Adverse Drug Events (ADEs) in Hospitalised Older Patients Using STOPP/START Criteria
Brief Summary: The next four decades will see a marked expansion of the elderly population in Ireland, in particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of prescription medicines in Ireland and have the highest prevalence rates of major polypharmacy. Polypharmacy is intimately linked with serious adverse drug events (ADEs) and consequent major morbidity and mortality. Epidemiological data from the United States indicate that ADEs is the fifth most common cause of death nationally. Experts suggest that effective evidence based interventions can be applied to this major public health problem.

Recent research data indicate a cause-and-effect relationship between inappropriate prescription medicines and serious ADEs in older people in hospital. To date, Beers' criteria have been the dominant set of criteria for defining potentially inappropriate medicines (PIMs) in late life. Research data collected by this group show that the recently validated STOPP/START criteria (Screening Tool of Older Persons' Prescriptions and Screening Tool to Alert doctors to Right Treatment) identify ADEs that are causal or contributory to acute hospital admission in older people 2.7 times more frequently than Beers' criteria. Based on these findings, our hypothesis is that STOPP/START criteria have the potential to be used as a regular intervention for the purpose of ADE prevention in older people. A recent single centre randomised control trial (RCT) undertaken at Cork University Hospital showed that prospective application of STOPP/START criteria led to a highly significant improvement in medication appropriateness in older hospitalised patients compared with standard inpatient pharmaceutical care. Significantly, the improvement in medication appropriateness was maintained to the end of the study follow-up i.e. 6 months post-discharge. However, the ability of STOPP/START criteria to significantly reduce ADEs in a prospective RCT has yet to be demonstrated.


Options:
A: Drug Related Problems (DRP) (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Mortality (6-month after inclusion); Average length of the hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Readmissions (6-month after inclusion); Average cost of hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days)
B: Number of patients with probable and definite adverse drug events in hospital (Up to Day 14 of hospital admission)
C: Readmissions (30 days); Admissions (180 days); Emergency Department Visits (180 days); Composite Endpoint, Admissions or Emergency Department Visits (180 days)
D: acute care utilization (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT
Brief Summary: This project a European observational study on the incidence and characteristics of chronic post surgical pain (CPSP).

Research Questions

* What is the incidence of chronic post surgical pain (CPSP) in Europe?
* What are the risk factors of chronic post surgical pain (CPSP) related to surgery, patient and anaesthesia management?
* What are the difference in incidence and risk factors in different European countries?


Options:
A: Morphine consumption (24 hours postoperatively.)
B: Numeric Rating Scale Pain Scores (1 day (PACU pain scores)); OR and PACU Opioid Consumption (up to 1 day, in the OR and PACU)
C: The incidence of chronic post surgical pain (CPSP)12 months after surgery (12 months)
D: Morphine consumption (postoperative first 24 hour)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT
Brief Summary: This project a European observational study on the incidence and characteristics of chronic post surgical pain (CPSP).

Research Questions

* What is the incidence of chronic post surgical pain (CPSP) in Europe?
* What are the risk factors of chronic post surgical pain (CPSP) related to surgery, patient and anaesthesia management?
* What are the difference in incidence and risk factors in different European countries?


Options:
A: The incidence of chronic post surgical pain (CPSP)12 months after surgery (12 months)
B: 11-point Visual Analog Scale for Pain (1-2 weeks)
C: Post-ERCP Pancreatitis (2 weeks)
D: Number of Participants With Level 3 Postoperative Hemorrhage (Data about post-tonsillectomy bleeding will be obtained after the end of a 14-day postoperative period.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT
Brief Summary: This project a European observational study on the incidence and characteristics of chronic post surgical pain (CPSP).

Research Questions

* What is the incidence of chronic post surgical pain (CPSP) in Europe?
* What are the risk factors of chronic post surgical pain (CPSP) related to surgery, patient and anaesthesia management?
* What are the difference in incidence and risk factors in different European countries?


Options:
A: Morphine consumption (24 hours postoperatively.)
B: the patient centred QoR-15 score among ESB and SAP block patients; (1 year)
C: The incidence of chronic post surgical pain (CPSP)12 months after surgery (12 months)
D: Numeric Rating Scale Pain Scores (1 day (PACU pain scores)); OR and PACU Opioid Consumption (up to 1 day, in the OR and PACU)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Life After STroke - the LAST Study. A Norwegian Multi Centre Randomized Controlled Trial
Brief Summary: The LAST study is a Norwegian multi site randomised controlled trial that intends to assess the effect of a long term follow up program after stroke. The program consists of a coordinating physiotherapist who will encourage and motivate included patients to perform at least 60 minutes of intensive motor training every week and 30 minutes of physical activity every day for 18 months after inclusion. The primary hypothesis is that patients receiving a long term follow up program after stroke will have better motor function at end of follow up than patients receiving standard care. A total of 390 home dwelling stroke patients living in the municipality of Trondheim, Asker and Bærum will be included at the out-patient clinic at St. Olavs Hospital or Bærum Hospital three months after their stroke. Included patients will be randomised to an intervention group receiving the long term follow up program or to a control group receiving standard care. Motor function, mental health and physical functioning in daily life will be assessed at inclusion and 18 months later. The LAST study is funded by the Norwegian Research Council, the Norwegian University of Science and Technology and the Central Norway Regional Health Authority and will conclude at the end of 2015.


Options:
A: Glucose area under the curve (0 weeks and 2 weeks)
B: Incident Cancer (12/31/2030); All cause and disease specific mortality (12/31/2030); Chronic diseases (12/31/2030)
C: Adherence (8 weeks)
D: Motor Assessment Scale (18 months after inclusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Life After STroke - the LAST Study. A Norwegian Multi Centre Randomized Controlled Trial
Brief Summary: The LAST study is a Norwegian multi site randomised controlled trial that intends to assess the effect of a long term follow up program after stroke. The program consists of a coordinating physiotherapist who will encourage and motivate included patients to perform at least 60 minutes of intensive motor training every week and 30 minutes of physical activity every day for 18 months after inclusion. The primary hypothesis is that patients receiving a long term follow up program after stroke will have better motor function at end of follow up than patients receiving standard care. A total of 390 home dwelling stroke patients living in the municipality of Trondheim, Asker and Bærum will be included at the out-patient clinic at St. Olavs Hospital or Bærum Hospital three months after their stroke. Included patients will be randomised to an intervention group receiving the long term follow up program or to a control group receiving standard care. Motor function, mental health and physical functioning in daily life will be assessed at inclusion and 18 months later. The LAST study is funded by the Norwegian Research Council, the Norwegian University of Science and Technology and the Central Norway Regional Health Authority and will conclude at the end of 2015.


Options:
A: Motor Assessment Scale (18 months after inclusion)
B: Reaction time (millisecond) (24 hours post intervention)
C: Change of TMS (transcranial magnetic stimulation) measurement of cortical excitability (within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke)
D: JTT (crossover design, four different sessions with four different interventions)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Life After STroke - the LAST Study. A Norwegian Multi Centre Randomized Controlled Trial
Brief Summary: The LAST study is a Norwegian multi site randomised controlled trial that intends to assess the effect of a long term follow up program after stroke. The program consists of a coordinating physiotherapist who will encourage and motivate included patients to perform at least 60 minutes of intensive motor training every week and 30 minutes of physical activity every day for 18 months after inclusion. The primary hypothesis is that patients receiving a long term follow up program after stroke will have better motor function at end of follow up than patients receiving standard care. A total of 390 home dwelling stroke patients living in the municipality of Trondheim, Asker and Bærum will be included at the out-patient clinic at St. Olavs Hospital or Bærum Hospital three months after their stroke. Included patients will be randomised to an intervention group receiving the long term follow up program or to a control group receiving standard care. Motor function, mental health and physical functioning in daily life will be assessed at inclusion and 18 months later. The LAST study is funded by the Norwegian Research Council, the Norwegian University of Science and Technology and the Central Norway Regional Health Authority and will conclude at the end of 2015.


Options:
A: Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE) (before and after 4 weeks intervention)
B: modified Rankin Score (3 months)
C: Motor Assessment Scale (18 months after inclusion)
D: Trunk Impairment Scale Norwegian Version (12 weeks); ActiGraph WgtX-BT (13 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: 1•DAY ACUVUE® TruEye™ Brand Contact Lenses & 1•DAY ACUVUE® MOIST® Brand Contact Lenses With LACREON® TECHNOLOGY Daily Disposable Performance Overview Registry -TEMPO Study
Brief Summary: This study is an observational registry of patients who have recently been prescribed 1•DAY ACUVUE® TruEye® or 1•DAY ACUVUE® MOIST® Brand Contact Lenses with LACREON® TECHNOLOGY.


Options:
A: Incidence of Adverse Events (Self-report at 2 Week, 4 Month or 12 Month surveys)
B: Number of Participants Developing a Corneal Inflammatory Event (CIE) (up to 1 year)
C: Visual acuity on a LogMAR (logarithm of the minimum angle of resolution) scale (Approximately 1 week after lens fitting)
D: Tear film osmolarity (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of CAM and Conventional Mind-Body Therapies for Chronic Back Pain
Brief Summary: Although national expenditures on back pain treatments have increased substantially over the past decade, the health and functional status of persons suffering from back pain has deteriorated. This trial will evaluate the effectiveness, and cost-effectiveness, of a safe and relatively inexpensive "mind-body" therapy that has the potential to provide relief to some of the millions of Americans who continue to suffer from chronic back pain.


Options:
A: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
B: Back pain-related dysfunction (26 weeks); Bothersomeness of back pain (26 weeks)
C: Somatic symptoms as assessed by the Rheumatoid Arthritis Symptom Questionnaire (12 months)
D: Chronic Pain (This was conducted at 21 weeks.); Depression (This was conducted at 21 weeks.); Pain Self Efficacy Scale (This was conducted at 21 weeks.); Pain Medication Use (This was conducted at 21 weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Angiotensin II Blockade for the Prevention of Cortical Interstitial Expansion and Graft Loss in Kidney Transplant Recipients
Brief Summary: Chronic allograft nephropathy continues to be a major cause of kidney transplant loss and return to dialysis. Treatment options are limited and the course of the disease tends to be progressive. This trial is designed to prevent a major mediator of this process, namely the expansion of the cortical interstitial compartment of the kidney where most of the scarring occurs. The drug being studied, Losartan, has proven efficacious in a number of kidney diseases.


Options:
A: left ventricular hypertrophy (3 months)
B: Change in left ventricular ejection fraction, as assessed by cardiac MRI (Baseline and end of study (up to 72 weeks))
C: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
D: Doubling of Interstitium or Any ESRD (Baseline to 5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Ovarian Stimulation Using Recombinant FSH and GHRH Antagonist in Alternate Days on ICSI Outcomes
Brief Summary: The present prospective study was designed to compare the effects of administering a daily dose of gonadotrophin releasing hormone (GnRH) antagonist vs. an alternate-day dosage of GnRH agonist on ovarian response and in vitro fertilization (IVF) outcome in patients stimulated with recombinant follicle-stimulating hormone (FSH) and human chorionic gonadotrophin (hCG) microdose.


Options:
A: The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met. (At completion of ovarian stimulation; maximally after 18 days of recFSH administration.)
B: cost of treatment (One month)
C: ovum pickup rate that took place between Sunday to Thursday without a compromise (a year)
D: To collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian hyperstimulation. (In both cohorts a follow-up pediatric evaluation was scheduled within 6 months post-partum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Xylitol Wipes on Infants in Reducing Bacterial Transmission and Colonization From Mother to Child
Brief Summary: Mutans streptococci (MS) and lactobacillus species (LB) are the two groups of infectious cariogenic (caries-causing) bacteria most strongly associated with dental caries (dental decay). Infants acquire cariogenic bacteria from their mothers early in development via saliva. There have been several studies that have demonstrated a significant reduction in dental caries associated with consumption of the food additive known as xylitol in children and adults. Xylitol is a non-toxic 5 carbon polyol, approved as a food additive by the FDA, that tastes like and behaves like sucrose in humans. Xylitol is used as a sugar substitute to reduce dental caries as it is not fermentable by the caries causing bacteria. In addition, an observed positive beneficial side effect of this sugar substitute is that xylitol has been shown to reduce mother to child bacterial transfer when used by the mother. It is commonly recommended to wipe infants' teeth and gums with a soft cloth to reduce the formation of dental bacterial plaque. Recently wipes have been marketed that contain xylitol to provide a safe sweet sensation for the infant during this cleaning procedure. However, no study has been conducted that assesses the biological effect of applying xylitol directly to the teeth and gums of infants. This study will be conducted to test whether xylitol applied by swab directly to the infant's teeth and gums will effectively reduce bacterial transfer from mother to child. Children age up to two years old whose mothers have high cariogenic bacterial counts will be recruited to use xylitol wipes 3-4 times daily in addition to their normal preventive regimen. This will be a randomized double blinded study where the control group will receive placebo wipes (with no xylitol) and the experimental group will receive the xylitol wipes. The mother-child pair MS and LB bacterial counts and caries score of the children will be measured at baseline, 3 months, 6 months and 1 year. We will contact all patients that were recruited into the study to inquire whether they are willing to return for further follow-up visits at 1, 2, 3, and 4 years post-wipe treatment completion. If successful, this study will support the use of a simple caries preventive measure that could be easily and safely implemented in young children. Ten MS isolates and unique LB colonies will be isolated from each saliva samples to study their genetic diversities and virulence factors.

The investigators will also investigate whether specific MS genes relate to ECC prevention effect of daily xylitol-wipe application using genomic sequencing of MS isolated from current study when the active intervention was applied.


Options:
A: combined root and coronal D2FS (dental caries) increment (3 year)
B: new decayed surfaces (1 year)
C: caries reduction (3 years)
D: MS colonization (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy - A Randomised Controlled Intervention Trial
Brief Summary: The purpose of this randomized intervention study is to investigate the effects and biological mechanisms of a supervised 12-week progressive resistance training on fatigue and immunological and inflammatory biomarkers in breast cancer patients during adjuvant radiotherapy. To determine the effect of the exercise itself beyond potential psychosocial effects due to attention by trainers or the group support, patients in the control group have a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with relaxation training (Jacobsen method).


Options:
A: Fatigue measured by Fatigue Assessment Questionnaire (FAQ) (change between baseline and week 13 (end of intervention))
B: Quality of Life
C: Exercise behavior
D: Menopausal symptoms (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy - A Randomised Controlled Intervention Trial
Brief Summary: The purpose of this randomized intervention study is to investigate the effects and biological mechanisms of a supervised 12-week progressive resistance training on fatigue and immunological and inflammatory biomarkers in breast cancer patients during adjuvant radiotherapy. To determine the effect of the exercise itself beyond potential psychosocial effects due to attention by trainers or the group support, patients in the control group have a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with relaxation training (Jacobsen method).


Options:
A: bone health (baseline, 12 months)
B: Fatigue measured by Fatigue Assessment Questionnaire (FAQ) (change between baseline and week 13 (end of intervention))
C: Cognitive-psychosocial functions (3 and 6 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy - A Randomised Controlled Intervention Trial
Brief Summary: The purpose of this randomized intervention study is to investigate the effects and biological mechanisms of a supervised 12-week progressive resistance training on fatigue and immunological and inflammatory biomarkers in breast cancer patients during adjuvant radiotherapy. To determine the effect of the exercise itself beyond potential psychosocial effects due to attention by trainers or the group support, patients in the control group have a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with relaxation training (Jacobsen method).


Options:
A: HRQOL urinary irritative score (12 month)
B: Change from Baseline Cancer-related fatigue at post-radiotherapy and follow-up (Baseline, post-radiotherapy (~6weeks), follow-up (~8 weeks))
C: Fatigue measured by Fatigue Assessment Questionnaire (FAQ) (change between baseline and week 13 (end of intervention))
D: change in physical activity (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase IIB Evaluation of Weekly Paclitaxel (NSC #673089) Plus Pazopanib (NSC #737754) Versus Weekly Paclitaxel Plus Placebo in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
Brief Summary: This randomized phase II trial studies how well paclitaxel when given together with or without pazopanib hydrochloride works in treating patients with ovarian epithelial, fallopian tube, or peritoneal cavity cancer that is persistent or has come back. Drugs used in chemotherapy, such as paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pazopanib hydrochloride may stop the growth of tumor cells by blocking blood flow to the tumor or by blocking some of the enzymes needed for cell growth. It is not yet known whether paclitaxel is more effective when given with or without pazopanib hydrochloride in treating ovarian epithelial, fallopian tube, and peritoneal cavity cancer.


Options:
A: Progression Free Survival (For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, Up to 5 years)
B: Progression-Free Survival (PFS): Independent Radiologist Review (From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years)
C: Progression free survival (PFS) at 6 months assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (6 months)
D: Peritoneal adhesion ORR (pORR) (3weeks after the last treatment)

Answer: A