TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Adherence Enhancement for Renal Transplant Patients
Brief Summary: Despite significant advances in the care of kidney transplant recipients, long term graft survival after renal transplantation remains suboptimal. Medication nonadherence and clinical inertia are key contributors to graft loss. The purpose of the proposed RCT feasibility study is to evaluate impact of a "bundled" wireless real time medication reminder system and blood pressure monitoring system in combination with a cognitive behavioral adherence skills enhancement program upon medication adherence, therapeutic drug concentration, and blood pressure, in nonadherent kidney transplant recipients with hypertension. We propose to recruit 60 kidney transplant recipients in phase 1 with 20 non-adherent continuing to phase 2 for a 5-month feasibility RCT.


Options:
A: medication adherence (5 months)
B: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)
C: Change in Pain, Sexual Dysfunction, and Depression Symptoms (12 months)
D: Time Specific Interdialytic Weight Gain (Baseline) (Baseline); Time Specific Interdialytic Weight Gain (8 Weeks) (8 weeks); Time Specific Interdialytic Weight Gain (12 Weeks) (12 weeks); Time Specific Interdialytic Weight Gain (16 Weeks) (16 weeks); Time Specific Dietary Sodium Intake (Baseline) (Baseline); Time Specific Dietary Sodium Intake (8 Weeks) (8 weeks); Time Specific Dietary Sodium Intake (16 Weeks) (16 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) (Baseline to 8 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) (Baseline to 16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Controlled, Double-Blind Study of the Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis Patients
Brief Summary: The purpose of this study will be to evaluate the effects of a modified formulation of AquADEKs (AquADEKs-2) on markers of inflammation, antioxidant levels and oxidative stress.

Cystic Fibrosis (CF) is a disease that affects the organs in the body such as the lungs. Some of the damage to the lungs of CF patients may be caused by something called oxidant/antioxidant imbalance and oxidative stress.

Oxidation in the body is kind of what happens to an apple when it turns brown after being cut. And, just as a squeeze of lemon juice stops the oxidation of an apple, antioxidants can stop the rusting (or damage) inside our bodies by unstable oxygen molecules called free radicals. Free radicals can help fight off bacteria and viruses but too many of them do damage instead. Our bodies need antioxidants to keep things in balance so we have the right amount of free radicals.

Many CF patients also have trouble digesting food and absorbing nutrients like vitamins. Many of the vitamins we rely on are antioxidants, like vitamins A, D, E, K and beta-carotene. In some people with CF, even though they take multivitamins and pancreatic enzymes, they still have low amounts of antioxidants. The investigators are looking to see if taking more vitamins and antioxidants will help CF patients.

AquADEKs-2 is an investigational new drug (a drug that has not received approval by the Food and Drug Administration \[FDA\]). This research study is being done with the AquADEKs-2 compared to a control multivitamin. The study drug, AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium. The control multivitamin contains standard amounts of vitamins A, B, D, E, and K without additional antioxidant supplementation.


Options:
A: Time to First Pulmonary Exacerbation (36 weeks)
B: Change in Sputum Myeloperoxidase (MPO) Level (Baseline (Visit 2) to Week 16 (Visit 4))
C: Plasma levels of beta-carotene (12 weeks)
D: Change in FEV1 (in liters) from baseline (At the end of the 14 day treatment period); Adverse events such as gastrointestinal complaints, wheezing, hepatitis or shortness of breath (70 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stepped Care - Optimising Psycho-oncological Care Provision by Structured Screening and Diagnosis
Brief Summary: The study will examine whether the provision of psychosocial support services for cancer patients in acute care can be optimized by the use of a structured combination of screening procedures with physician interviews and structured patient pathways.

There is strong evidence that a third of all cancer patients in acute care are suffering from mental health conditions and that a third expresses the need for professional psycho-oncological support.

However, physicians and nurses do not always identify these patients in need for support. Screening questionnaires are significantly better to identify distressed patients however the use of screenings alone does not necessarily improve the patients' emotional well-being.

Purpose of this study is to evaluate a psychosocial stepped care model which aims to decrease the patients' distress.


Options:
A: Difference in unmet supportive care needs between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in continuity of care between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in quality of life between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline)
B: The primary outcomes to be measured include measures of spiritual well-being (meaning) and psychological distress (depression, hopelessness, optimism quality of life). (16 weeks)
C: The primary effect outcome measurement is the number and type of referred patients with psychosocial problems to psychosocial caregivers and type of referrals with respect to psychosocial problems. (Is measured at three (T3) and twelve (T4) months after first measurement)
D: Mental condition (from baseline until 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Stepped Care - Optimising Psycho-oncological Care Provision by Structured Screening and Diagnosis
Brief Summary: The study will examine whether the provision of psychosocial support services for cancer patients in acute care can be optimized by the use of a structured combination of screening procedures with physician interviews and structured patient pathways.

There is strong evidence that a third of all cancer patients in acute care are suffering from mental health conditions and that a third expresses the need for professional psycho-oncological support.

However, physicians and nurses do not always identify these patients in need for support. Screening questionnaires are significantly better to identify distressed patients however the use of screenings alone does not necessarily improve the patients' emotional well-being.

Purpose of this study is to evaluate a psychosocial stepped care model which aims to decrease the patients' distress.


Options:
A: Mental condition (from baseline until 6 months)
B: Number of patients achieving the internationally recommended level of physical activity of at least 150 minutes per week of moderate-to-vigorous physical activity (intensity ≥3 METs) (6 months)
C: The primary end point of the study was the maximum grade of acute graft versus host (GVH) disease observed in the recipient.
D: Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI) (baseline, 3month, 6month, and 12month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Positive End Expiratory Pressure With A T-piece Resuscitator (Neopuff) For Near-Term and Term Infants With Respiratory Distress: A Randomized, Controlled Trial
Brief Summary: Evaluating the effect of early application of Continuous positive airway pressure (CPAP) via Neopuff in cases of transient tachypnea of the newborn(TTN) and its role in decreasing the duration and complication of TTN.


Options:
A: Assessment of respiratory distress (48 hours)
B: Duration of Respiratory Support (every hour until patient stable without respiratory support, an average of approximately 55 hours and a maximum of 205 hours)
C: Difference in time (min) required to normalize the respiratory distress (modified Silverman score = 0, no need for oxygen, RF < 50 bpm and SaO2 > 92%) between the two ventilatory modes (Within the first 6 hours after birth)
D: Need for admissions to NICU secondary to TTN (24 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Automated SMS Reminders to Parents on Their Cell Phones Can Significantly Improve the on Time Vaccination Rates for Children in Pakistan
Brief Summary: Vaccines are one of the best public health tools available to achieve the Millennium Development Goal (MDG) # 4 of decreasing child mortality. A major reason for poor childhood vaccine coverage is the lack of awareness among parents regarding the need for immunization in children, and the importance of completing the entire series of vaccines. This result in significant drop-out between vaccines delivered at birth and later in the infancy period. New innovative methods involving technologies are needed to be employed to increase the vaccine coverage. This study is being conducted in Karachi, Pakistan and main study objective is

• To assess the effectiveness of SMS reminders on cell phones in improving the compliance of subsequent visits for routine immunization for children.


Options:
A: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)
B: The rate of the Exclusive Breastfeeding (from birth of baby to 6 months post birth)
C: Immunization coverage (12 months); Timeliness of receipt of scheduled immunization (12 months)
D: To assess the effectiveness of SMS reminders on cell phones in improving the compliance of subsequent visits for routine immunization for children in Pakistan (10 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial To Compare The Initial Success Rate of Ultrasound Guided Versus Landmark Approach For Placement of Peripheral Intravenous Access Lines in Emergency Department Patients
Brief Summary: The primary objective of this randomized controlled trial (RCT) is to compare the success rate of obtaining peripheral vascular access with ultrasound guidance versus the traditional, landmark approach among patients with varying degrees of intravenous access difficulty. In addition to comparing overall initial success rates of the two methods, we will also compare the success rates by degree of intravenous access difficulty (3 main subject subgroups) and by operator experience (approximately 20 emergency department technicians).

The main hypothesis is that the initial success rate will be significantly higher (5% or greater) for ultrasound guided peripheral intravenous access compared to landmark approach among patients who are judged to have difficult intravenous access but no significant difference (i.e. \< 5%) among patients judged to have easy intravenous access.


Options:
A: Duration of IV Survival (30 days)
B: Initial success rate (immediatetely after first attempt, average attempt takes 15 minutes)
C: Number of Participants with Successful Securing of Peripheral Vein on First Attempt (60 minutes)
D: Reducing the use of CVC and PVC (through study completion, an average of 7 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Culturally Competent Website on Living Kidney Donation for Hispanics
Brief Summary: The purpose of this study is to increase understanding about living kidney donation (LKD) among Hispanic/Latino patients and public by increasing knowledge and positive attitudes about LKD. Improving Hispanics' understanding about LKD will ensure that Hispanic patients and public are fully informed of the treatment options for End Stage Kidney Disease.


Options:
A: Time Specific Interdialytic Weight Gain (Baseline) (Baseline); Time Specific Interdialytic Weight Gain (8 Weeks) (8 weeks); Time Specific Interdialytic Weight Gain (12 Weeks) (12 weeks); Time Specific Interdialytic Weight Gain (16 Weeks) (16 weeks); Time Specific Dietary Sodium Intake (Baseline) (Baseline); Time Specific Dietary Sodium Intake (8 Weeks) (8 weeks); Time Specific Dietary Sodium Intake (16 Weeks) (16 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) (Baseline to 8 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) (Baseline to 16 weeks)
B: Knowledge about Living Kidney Donation (3 weeks)
C: Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention (1 month)
D: New Advance Care Planning Documentation in the Medical Record at 15 Months (15 months after study enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Culturally Competent Website on Living Kidney Donation for Hispanics
Brief Summary: The purpose of this study is to increase understanding about living kidney donation (LKD) among Hispanic/Latino patients and public by increasing knowledge and positive attitudes about LKD. Improving Hispanics' understanding about LKD will ensure that Hispanic patients and public are fully informed of the treatment options for End Stage Kidney Disease.


Options:
A: Organ Donation Registration (6 months)
B: psychological distress (6 weeks post-donation); somatic/physical health perceptions (6 weeks post-donation); interpersonal relationship quality and distress (6 weeks post-donation); quality of life (6 weeks post-donation); psychological distress (3 months post-donation); somatic/physical health perceptions (3 months post-donation); interpersonal relationship quality and distress (3 months post-donation); quality of life (3 months post-donation)
C: Knowledge about Living Kidney Donation (3 weeks)
D: Number of Participants With Live Kidney Donor Activation Events (24 months post randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Culturally Competent Website on Living Kidney Donation for Hispanics
Brief Summary: The purpose of this study is to increase understanding about living kidney donation (LKD) among Hispanic/Latino patients and public by increasing knowledge and positive attitudes about LKD. Improving Hispanics' understanding about LKD will ensure that Hispanic patients and public are fully informed of the treatment options for End Stage Kidney Disease.


Options:
A: Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period (12 months)
B: medication adherence (5 months)
C: Knowledge about Living Kidney Donation (3 weeks)
D: Knowledge of increased risk donor kidney transplants (1 week)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Kidney Transplant Patients' Informed Consent for Increased Risk Donors
Brief Summary: The objective of this study is to evaluate kidney transplant candidates' comprehension about increased risk donor kidneys necessary for informed consent. We have developed a web-based tool that educates and assesses candidates' comprehension (Inform Me), as a supplement to current informed consent processes. We will then compare the effectiveness of the current informed consent processes supplemented by Inform Me, with the current consent processes alone for kidney transplant.


Options:
A: Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options. (Up to 19 months)
B: Dialysis Within 7 Days (From start of AKI to 7 days later); Death (7 days of randomization); Relative Maximum Change in Creatinine (7 days of randomization)
C: Combined endpoint achievement of target blood pressure and proteinuria (one year); Cumulative duration of hospitalization in short-stay for 1 year (one year); Cumulative duration of unplanned short stay for 1 year (One year); Survival (One Year)
D: Knowledge of increased risk donor kidney transplants (1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Kidney Transplant Patients' Informed Consent for Increased Risk Donors
Brief Summary: The objective of this study is to evaluate kidney transplant candidates' comprehension about increased risk donor kidneys necessary for informed consent. We have developed a web-based tool that educates and assesses candidates' comprehension (Inform Me), as a supplement to current informed consent processes. We will then compare the effectiveness of the current informed consent processes supplemented by Inform Me, with the current consent processes alone for kidney transplant.


Options:
A: Change in Pain, Sexual Dysfunction, and Depression Symptoms (12 months)
B: The difference of rate of estimated glomerular filtration rate (eGFR) decline (30 months)
C: Referral for Kidney Transplantation (One Year)
D: Knowledge of increased risk donor kidney transplants (1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of Dupilumab (REGN668) Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Brief Summary: To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (AD).


Options:
A: Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16 (Baseline to Week 16)
B: proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment (36 months)
C: Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 (Week 16)
D: Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 (Baseline to Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.


Options:
A: To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF. (2 years)
B: Concentrations of immune cells and cytokines of IL-6, IL-10, and IL-12 in infant's blood samples will be measured to evaluate immune functions. (1, 4, and 6 postnatal months)
C: Number of Participants With Weight<10th Percentile for Age (36 weeks post-conceptual age); Number of Participants With Length <10th Percentile for Age (36 weeks post-conceptual age); Number of Participants With Head Circumference <10th Percentile for Age (36 weeks post-conceptual age); Cognitive Development Score (18-22 months corrected gestational age)
D: Total RBC glutathione (0 days, 7 days, 60 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomised, Phase II Study Evaluating the Efficacy and Safety of Addition of Continuous Multiple Line Bevacizumab Treatment to Lomustine in Second (2nd)-Line Followed by Standard of Care (SOC) in Third (3rd)-Line and Beyond Compared to Addition of Placebo, Following First Progression of Disease (PD1) in Patients With Glioblastoma (GBM) After First (1st)-Line Treatment With Radiotherapy, Temozolomide and Bevacizumab
Brief Summary: This multicenter, double-blind, placebo-controlled, randomized study will evaluate the efficacy and safety of the addition of bevacizumab treatment to lomustine (in 2nd-line \[2L\] treatment) and SOC (in 3rd-line \[3L\] and subsequent lines of treatment) following first-line disease progression (PD1) in participants with newly diagnosed glioblastoma. All enrolled participants will receive 1L treatment with radiotherapy, temozolomide, and bevacizumab. At PD1, eligible participants will be randomized (1:1) to receive 2L treatment with either bevacizumab plus lomustine or placebo plus lomustine. After second-line disease progression (PD2), participants will receive 3L treatment and will continue blinded bevacizumab or placebo with the addition of an SOC agent. Following third-line disease progression (PD3), participants will receive subsequent lines of treatment and will either continue blinded bevacizumab or placebo (at the discretion of the investigator), or switch to open-label bevacizumab (at the choice of the participant).


Options:
A: Overall Survival (at 12 months)
B: Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I) (14 days); Progression-free Survival at 6 Months (PFS6) (Phase II) (6 months)
C: Survival 6 mo (Proportion of alive participants at 6 months)
D: Overall Survival (OS) (From randomization at PD1 until death from any cause or end of study (overall approximately 35 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of the Effect of Cranberry-lingonberry Juice on the Occurrence of Urinary Tract Infections, the Gut Microbiota, and the Uropathogenic Escherichia Coli
Brief Summary: Cranberry and cranberry-lingonberry juice prevented urinary tract infections in children and in adults in our earlier clinical trials. The preventive effect was, however, observed late in the follow-up and the next recurrence was not prevented in children. The investigators hypothesize that cranberry-lingonberry juice should be started already during the antimicrobial treatment of acute urinary tract infection in order to maximize the preventive efficacy of the juice. In addition, the investigators aim to find the explanation for the efficacy of cranberry-lingonberry juice by analyzing the concomitant changes in the chemical composition of urine and feces as well as the changes of gut microbiota.


Options:
A: Change of the intestinal and urinary microbiome (3 months to 12 months)
B: Participants With Clinically-diagnosed and Treated UTI's. (From surgery to post-op visit, approximately 6 weeks post surgery)
C: Time to onset of a first UTI within one year of treatment. (one year)
D: UTI Recurrence (Variable for each participant over course of up to one year)

Answer: A