TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Linagliptin on Endothelial Function and Global Arginine Bioavailability Ratio in Coronary Artery Disease Patients With Early Diabetes
Brief Summary: This study is planned to evaluate if linagliptin can improve endothelial function in patients with type 2 diabetes mellitus. In addition, the effect of linagliptin on arginine bioavailability ratios and postchallenge glycaemic control will be studied.


Options:
A: Changes in Endothelial Function (FMD - Flow Mediated Dilatation) From Baseline to 12 Weeks (12 weeks)
B: Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks (baseline and 24 weeks)
C: Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period (Median of 1.65 person years for CV follow-up time period)
D: Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment (Baseline and 52 weeks); Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment (Baseline and 76 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Genetically Informed Smoking Cessation Trial
Brief Summary: The investigators' goal is to identify the most appropriate smoking cessation treatments for smokers based on genetic information. Smokers try to quit smoking but relapses are common.


Options:
A: Change From Baseline Smoking Abstinence Rates at 12 Weeks (12 weeks)
B: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
C: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
D: 7-day Point Prevalence Quit Rate (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient Navigation and Financial Incentives to Promote Smoking Cessation
Brief Summary: Cigarette smoking is a significant health threat. To eliminate disparities in cancer burden, smoking rates must be reduced among populations where smoking is disproportionately concentrated: those with low socioeconomic status (SES). The investigators will apply two methods that are being used in the field of health disparities to the challenge of promoting smoking cessation among low SES smokers. These include: 1) Patient navigation; patient navigators are often lay persons, working as paid employees, who guide patients through the health care system and 2) Financial incentives; investigators propose to provide monetary incentives: $250 for smoking cessation within 6 months after study enrollment, and $500 for an additional 6 months of abstinence after the initial cessation. The investigators will recruit/randomize 352 smokers to a randomized controlled trial comparing the combination of Patient Navigation (delivered over 6 months) and Financial Incentives versus Enhanced Traditional Care control condition (smoking cessation brochure/list of cessation resources). The RCT will take place among adult daily smokers seen in the past year at BMC primary care practices, with a primary outcome of smoking cessation at one year. Follow-up by telephone, for both groups, will occur 6, 12, and 18 months after enrollment.


Options:
A: Biochemical verification of smoking status. (15 months)
B: Smoking Status at 6 Months (6 months after enrollment)
C: Smoking abstinence at 12 months post-enrollment (12 months)
D: verified abstinence 6 months (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of the Impact of Offering a Nutrition and Health Intervention to Children Recovered From Moderate Acute Malnutrition
Brief Summary: Children who recover from moderate acute malnutrition in Malawi remain at high risk for relapse or death in the year following recovery. This cluster-randomized trial will evaluate a package of affordable, safe, proven interventions specifically targeted to this population of children in an attempt to decrease their risk of relapse or death following recovery from moderate acute malnutrition. These children will be followed for a year following recovery to assess rates of relapse and mortality.


Options:
A: Number of children who remain well-nourished (Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema) (12 months)
B: Mean (± standard deviation) weight gain (kg) (Change between birth and six months of age)
C: Mean (± standard deviation) weight gain (kg) (from 12 to 24 months of age)
D: Understanding of key findings (30 minutes)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Placebo-Controlled Trial Comparing Opioid-Sparing and Opioid-Containing Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
Brief Summary: A randomized, double-blind, placebo-controlled intervention trial involving 100 treated subjects undergoing endonasal trans-sphenoidal (ENTS) resection of pituitary lesion. Subjects will be randomized into two groups: 50 treated in the opioid-sparing arm and 50 treated in the standard post-operative medication arm.


Options:
A: the amount of morphine administered (during the first 24 hours)
B: Summed Pain Intensity Difference (SPID)-Calculated From the Pain Intensity Scores Recorded on a 100mm Long Scale With Anchors for "no Pain" (0 mm) and "Worst Pain Imaginable" (100 mm). (48 hours after the first dose)
C: Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery (24 Hours)
D: Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour) (mean pain score over 48 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Placebo-Controlled Trial Comparing Opioid-Sparing and Opioid-Containing Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
Brief Summary: A randomized, double-blind, placebo-controlled intervention trial involving 100 treated subjects undergoing endonasal trans-sphenoidal (ENTS) resection of pituitary lesion. Subjects will be randomized into two groups: 50 treated in the opioid-sparing arm and 50 treated in the standard post-operative medication arm.


Options:
A: Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour) (mean pain score over 48 hours)
B: Narcotic Requirement After Surgery (48 hours)
C: Quality of Recovery (24 hours)
D: Integrated Pulmonary Index (IPI) (Change from Beseline IPI values in postoperative first 24 hours.(at 10th minute, 1, 2, 6, 12, and 24 hours post dose))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Experiences for Receiving Auriculotherapy for Osteoarthritis Knee: A Randomised Controlled Feasibility Study.
Brief Summary: Osteoarthritis (OA) is the most common form of arthritis in Hong Kong and a prevalent condition in the ageing population. With disease progression, some clients may develop severe pain and profound limitations in ambulation, which may result in morbidity and impaired physical functions. Among the available treatments, pharmacological therapies primarily focus on musculoskeletal pain relief. However, adverse effects, such as gastrointestinal haemorrhage arising from non-steroidal anti-inflammatory drugs have led to an increasing number of concerns regarding the use of these treatments. Other non-invasive complementary methods for osteoarthritic knee (OA knee) should be explored because of the limitations of pharmacological therapy.

Auriculotherapy (AT) is one of the approaches in traditional Chinese medicine (TCM). It is a therapeutic method by which specific points on the auricle are stimulated to treat various disorders of the body. The present study is a four-arm randomised controlled study to determine the effectiveness of AT using magneto-AT (MAT) and/or laser AT (LAT) to improve the conditions of elderly patients suffering from OA knee. The effectiveness of MAT and LAT in terms of alleviating pain, relieving stiffness and promoting a range of motion, and enhancing functional abilities will be determined.

Subjects in 'Treatment arm 1' will receive MAT on specific auricular points on one side of the ear during each treatment session. A deactivated laser will be used to achieve the effect of subject blinding. Subjects in 'Treatment arm 2' will receive LAT using low-energy laser applied to selected acupoints of the ear, and a plaster centred with a portion of Junci Medulla that mimics MAT treatment will also be given. Subjects in 'Treatment arm 3' will receive a combined approach (both MAT and LAT). Subjects in the 'placebo arm' will serve as placebo controls. Six auricular acupoints that are considered to have an effect on the OA knee will be selected. Only one ear at a time will receive treatment. Thus, the ears will be treated alternately. The total treatment period will be four weeks. The experimental objects will be replaced every other day. Therefore, treatment will be performed thrice a week. Subjects will be assessed at baseline up to 3 months after the therapy. This study could advance the knowledge on the complementary approaches than can be used to improve OA knee conditions in the elderly.


Options:
A: Western Ontario and McMaster Osteoarthritis Index (WOMAC) change assessment. (Base line, through study completion (3 months); and 3, 6 and 12 months follow-up)
B: Numerical rating scale of pain (NRS) : (collected at baseline up to 3 months after therapy)
C: Pain: Numerical pain scale (Baseline, 6 weeks, 3 months, 1 year)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention for Improving Psychological Distress in Dialysis (iDiD) Feasibility Two Arm Randomised Controlled Trial: Online Cognitive Behavioural Therapy (CBT) Intervention With Therapist Support vs Online CBT Intervention Alone (no Therapist Support)
Brief Summary: To explore whether it is feasible to recruit and retain haemodialysis patients into a randomised controlled trial of online cognitive-behavioural therapy to manage distress


Options:
A: Medication Adherence Change from Baseline to 6 Months (6 months); Medication Adherence Change from 6 Months to 12 Months (12 months); Medication Adherence Change from Baseline to 12 Months (12)
B: Knowledge of increased risk donor kidney transplants (1 week)
C: Taking Adherence (12 months); Timing Adherence (12 months)
D: Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7) (Baseline recruitment/screening)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Protein Intake on Preterm Infant Body Composition
Brief Summary: The investigators will compare weight gain based on fat accretion and change in body composition in preterm infants receiving different amounts of enteral protein.


Options:
A: Daily growth velocity (g/kg/day) (From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks))
B: Weight gain due to fat mass (4 weeks)
C: Caloric content of human milk (Daily until 36 weeks corrected gestational age)
D: Weight Gain (Study Day 1 to Study Day 29 (or discharge, whichever happens first))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Protein Intake on Preterm Infant Body Composition
Brief Summary: The investigators will compare weight gain based on fat accretion and change in body composition in preterm infants receiving different amounts of enteral protein.


Options:
A: Caloric content of human milk (Daily until 36 weeks corrected gestational age)
B: Weight gain due to fat mass (4 weeks)
C: Weight gain (29 days)
D: growth (from inclusion at postmentrual age <32 weeks until 36 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Development Of Cortical Metrics Assessment Outcome Measures in Response to Memantine Treatment in Autism Spectrum Disorders
Brief Summary: Specific Aim 1: Obtain proof of concept evidence that cortical metrics will change in response to treatment with Memantine extended release (XR)®, an agent that modulates n-methyl d-asptartate (NMDA) receptor activation, in children with autism spectrum disorders (ASD) who clinically demonstrate treatment response.

Hypothesis1: Children with ASD who have dramatic clinical response to Memantine XR® will exhibit changes in their cortical metrics, which will differ less from neurotypical children. Subjective ratings of improvement will be correlated with the change in cortical metrics.

The completion of these aims will be essential to design a larger federally funded trial to validate cortical metrics as an outcome measure in a more heterogeneous pediatric ASD sample. Specifically, the feasibility data obtained may demonstrate the potential for detecting changes in cortical metrics over time, so that a larger grant could focus on determining how sensitive and clinically relevant changes in cortical metrics are or may indicate the need to explore different interventions to use in a validation study. We have chosen to use Memantine XR® because of its impact on NMDA neurotransmission, its current evaluation in a large multi-site randomized ASD clinical trial whose initial results are expected shortly, and our own observations of clinical improvements and good tolerability in the ongoing trial.


Options:
A: Patients With Any Treatment-emergent Adverse Event (Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit)
B: cortical metrics (a mathematical plot of tactile responsivity in 3 dimensions) (8 weeks)
C: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))
D: Developmental Neuropsychological Assessment (NEPSY) Apraxia and Repetition of Nonsense Words Subtests (Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial)); Expressive Vocabulary Test (EVT) (Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomised Control Trial of Blastocyst Euploidy Assessment and Conditioned Embryo Transfer for Infertility Patients of Advanced Maternal Age
Brief Summary: The study is designed to evaluate the effectiveness of pre-implantation genetic screening (PGS) for infertility patients of advanced maternal age undergoing assisted reproductive treatment. Half of the patients will have their embryos tested by PGS and 1 or 2 chromosomally normal embryos with the highest morphological grading transplanted back to the uterus. The other half of the participants will not have their embryos tested and 1 or 2 untested embryos with the highest morphological grading transplanted back to the uterus.


Options:
A: improvement in ongoing implantation rates (When a fetal heartbeat is detected for each patient. (8 weeks after implantation).)
B: Ongoing pregnancy (Gestational week 20)
C: Ongoing Pregnancy (Gestational Age of 20 Weeks)
D: Live Birth (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Low Glycemic Index Mediterranean Diet on AGEs. A Randomized Clinical Trial
Brief Summary: Advanced glycation end products (AGE) result from a chemical reaction between the carbonyl group of reducing sugar and the nucleophilic NH2 of a free amino acid or a protein; lysine and arginine being the main reactive amino acids on proteins. Following this first step, a molecular rearrangement occurs, rearrangement of Amadori resulting to the formation of Maillard products.


Options:
A: Non-alcoholic Fatty Liver Disease Ultrasonography Score (Six months)
B: improvement in insulin resistance measured by HOMA index (6 months)
C: Advanced glycation end products levels (Six months)
D: Primary Outcome Measures Described Below (December 2011)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Double Blind, Randomised, Placebo Controlled Study To Assess The Efficacy And Safety Of A Single Treatment Of Clostridium Botulinum Toxin Type A To Improve The Appearance Of Moderate To Severe Glabellar Lines
Brief Summary: The purpose of this study was to demonstrate the safety and the efficacy of a single treatment of an injectable liquid form of Clostridium botulinum toxin type A haemagglutinin complex (BTX-A-HAC; hereafter referred to as BTX-A-HAC Next Generation (BTX-A-HAC NG)), used for the improvement in the appearance of moderate to severe glabellar lines (the lines between the eyebrows).


Options:
A: Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales (Week 4)
B: Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales (Week 4)
C: Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown (Week 24); Duration of response assessed by investigator assessment of severity of glabellar lines at maximum frown from the date of injection to when subject reverts to baseline severity (Up to Week 36)
D: The Proportion of Responders at Day 29 in the ILA of Glabellar Lines at Maximum Frown. (Day 29)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Using a Tailored Health Information Technology Driven Intervention to Improve Health Literacy and Medication Adherence in a Pakistani Population With Vascular Disease
Brief Summary: Although most patients admitted with acute coronary syndrome or acute ischemic stroke in South Asian countries receive these evidence-based treatments, their overall continuation in the outpatient phase of care remains low. Patient from Pakistan are uniquely challenged in this respect because the overall literacy rates remain one of the lowest in Pakistan among South Asian Countries. In addition, a great majority of Pakistani patients often do not understand or follow health prescriptions (which are still written in English). Additionally, due to an unregulated health industry, they frequently take multiple opinions and prescriptions from different physicians. The investigators propose to develop a "talking prescription" for patients with stroke or myocardial infarction for secondary prevention. This will enable them to understand their medications better, improve health literacy and adherence. This is an IT enabled health literacy intervention. Physicians will prescribe statin and/or antiplatelet to the selected patients and enter the necessary details on an Optical Mark Recognition (OMR) sheet.Patients will be assigned to either of the 2 arms--either regular care or talking prescriptions. Follow-up will be done at 3 months post recruitment for behavioral knowledge assessment and adherence assessment.


Options:
A: Blood Pressure (12 months)
B: Medication Adherence (3 Months)
C: Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9) (Change in depressive symptoms from baseline to 8 weeks); Caregiving-related negative life changes: Bakas Caregiving Outcomes Scale (BCOS) (Change in caregiving-related negative life changes from baseline to 8 weeks); Unhealthy days: Unhealthy Days (UD) (Change in unhealthy days from baseline to 8 weeks)
D: Blood Pressure (6 months post enrollment into trial); LDL Cholesterol (6 months post enrollment into trial); Use of Anti-thrombotic Medication (6 months post enrollment into trial)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Using a Tailored Health Information Technology Driven Intervention to Improve Health Literacy and Medication Adherence in a Pakistani Population With Vascular Disease
Brief Summary: Although most patients admitted with acute coronary syndrome or acute ischemic stroke in South Asian countries receive these evidence-based treatments, their overall continuation in the outpatient phase of care remains low. Patient from Pakistan are uniquely challenged in this respect because the overall literacy rates remain one of the lowest in Pakistan among South Asian Countries. In addition, a great majority of Pakistani patients often do not understand or follow health prescriptions (which are still written in English). Additionally, due to an unregulated health industry, they frequently take multiple opinions and prescriptions from different physicians. The investigators propose to develop a "talking prescription" for patients with stroke or myocardial infarction for secondary prevention. This will enable them to understand their medications better, improve health literacy and adherence. This is an IT enabled health literacy intervention. Physicians will prescribe statin and/or antiplatelet to the selected patients and enter the necessary details on an Optical Mark Recognition (OMR) sheet.Patients will be assigned to either of the 2 arms--either regular care or talking prescriptions. Follow-up will be done at 3 months post recruitment for behavioral knowledge assessment and adherence assessment.


Options:
A: Heart Failure-specific Quality of Life (twelve-month followup)
B: Medication Adherence Score (2 months)
C: medication adherence (one month)
D: Medication Adherence (3 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Part 1: AVANOVA1 - A Phase I Study to Evaluate the Safety and Tolerability of Bevacizumab-niraparib Combination Therapy and Determine the Recommended Phase 2 Dose (RP2D) in Women With Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Part 2: AVANOVA2 - A Two-arm, Open-label, Phase II Randomized Study to Evaluate the Efficacy of Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer.
Brief Summary: Part 1 (Phase 1): safety and tolerability of bevacizumab-Niraparib combination Part 2 (Randomized Phase 2): to compare Progression-Free Survival (PFS)

PARP inhibitors are active as monotherapy to treat patients with recurrent ovarian cancer; the strongest activity being observed in the platinum sensitive, gBRCAmut subgroup as well as in gBRCAwt, HRD population but also in HRD negative disease.

In the same population there is level one evidence that bevacizumab is beneficial. And a phase two randomized study has indicated that combination of a PARP inhibitor with anti-angiogenic drug is superior to PARP inhibitor alone.

The question is:

Is niraparib combined with bevacizumab superior to niraparib? The comparison of tolerability and efficacy of niraparib-bevacizumab combination against niraparib.


Options:
A: Progression free survival (PFS) (4 months)
B: overall survival (18 months)
C: To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up)); To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up).)
D: Progression free survival (30 months)

Answer: D