TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation
Brief Summary: Administration of intravascular (IV) fluid is the most common emergency department (ED) procedure. IV fluids are integral to increasing effective blood volume and ensuring organ perfusion in patients with volume depletion and dehydration. There are many options of IV fluids providers can use when treating ED patients. Surveys show physicians do not cite an evidence-based reason for selecting the crystalloid IV fluid used; the decision was likely to be influenced by type and location of practice. A gap exists in the current literature, as there is no evidence for the optimal IV fluid choice for the ED patient requiring IV fluid before discharge.

Normal saline (NS) is commonly used as an IV fluid replacement in ED patients. However, NS has been associated with increased risk of acidosis and acute kidney injury. This study will use a novel approach of a patient-centered outcome in a non-critically ill population to ascertain the optimal IV fluid for patient quality of recovery. The results of this study will inform provider's IV fluid decisions between NS and LR. More importantly, the results of this study will have the power to improve patient's quality of recovery following IV fluid administration and subsequent ED discharge.

ED patients will be recruited, and participants will be randomized to receive one of two IV solutions (Lactated ringer's or normal saline). Participants will answer a survey before and after the intervention to assess their quality of recovery. The post-survey will be administered by phone after ED discharge. Participants will also be contacted by text message one week following their ED visit to gather information on their healthcare utilization.


Options:
A: The primary end point of each phase of this study will be a 6 mmol difference in serum chloride concentration after infusion of the balanced and unbalanced crystalloids and colloids. (Phase A: Times 0, 60, 90, 120, 180 and 240 min and Phase B: Times 0, 30, 60, 120, 180 and 240 min)
B: Incidence of hyperchloremic acidosis during the 2 first days of acute cranial traumatism. (J1 and J2)
C: Quality of Recovery-40 Score at 24 Hours (24 hours after ED visit)
D: Major Adverse Kidney Event Within 30 Days (30 days after enrollment censored at hospital discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Cell-phone Assisted Postpartum Counseling on the Use of Long-acting Reversible Contraceptives: a Randomized Controlled Trial
Brief Summary: Unintended and closely spaced pregnancies are a major public health problem that affects not only the individuals directly involved but also the society indirectly. It increases the risks of infants with adverse outcomes such as preterm, low birth weight and small for gestational age. Pregnancy occurring within six months of the last delivery holds a 7.5-fold increased risk for induced abortion, a 3.3-fold increase in miscarriage and a 1.6-fold increased risk of stillbirth. But, use of contraceptive methods has been shown to reduce unwanted pregnancy, high fertility and maternal mortality rates.


Options:
A: Viral load (6 months post-randomization)
B: Smoking status by collecting an expired carbon monoxide breath sample (3-Month Follow-Up)
C: Proportion of women who received a Pap smear within 6 months from the date when the study randomization began. (6 months after randomization of study)
D: Initiation of Long acting reversible contraception method (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Cell-phone Assisted Postpartum Counseling on the Use of Long-acting Reversible Contraceptives: a Randomized Controlled Trial
Brief Summary: Unintended and closely spaced pregnancies are a major public health problem that affects not only the individuals directly involved but also the society indirectly. It increases the risks of infants with adverse outcomes such as preterm, low birth weight and small for gestational age. Pregnancy occurring within six months of the last delivery holds a 7.5-fold increased risk for induced abortion, a 3.3-fold increase in miscarriage and a 1.6-fold increased risk of stillbirth. But, use of contraceptive methods has been shown to reduce unwanted pregnancy, high fertility and maternal mortality rates.


Options:
A: Smoking Abstinence (3 months)
B: Patient retention in care (12 months)
C: Neonatal death (28 days)
D: Initiation of Long acting reversible contraception method (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Cell-phone Assisted Postpartum Counseling on the Use of Long-acting Reversible Contraceptives: a Randomized Controlled Trial
Brief Summary: Unintended and closely spaced pregnancies are a major public health problem that affects not only the individuals directly involved but also the society indirectly. It increases the risks of infants with adverse outcomes such as preterm, low birth weight and small for gestational age. Pregnancy occurring within six months of the last delivery holds a 7.5-fold increased risk for induced abortion, a 3.3-fold increase in miscarriage and a 1.6-fold increased risk of stillbirth. But, use of contraceptive methods has been shown to reduce unwanted pregnancy, high fertility and maternal mortality rates.


Options:
A: Average number of missed pills per cycle (3 months)
B: Initiation of Long acting reversible contraception method (6 months)
C: Measles vaccination coverage (10 months)
D: Exclusive breastfeeding (6 months postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Cell-phone Assisted Postpartum Counseling on the Use of Long-acting Reversible Contraceptives: a Randomized Controlled Trial
Brief Summary: Unintended and closely spaced pregnancies are a major public health problem that affects not only the individuals directly involved but also the society indirectly. It increases the risks of infants with adverse outcomes such as preterm, low birth weight and small for gestational age. Pregnancy occurring within six months of the last delivery holds a 7.5-fold increased risk for induced abortion, a 3.3-fold increase in miscarriage and a 1.6-fold increased risk of stillbirth. But, use of contraceptive methods has been shown to reduce unwanted pregnancy, high fertility and maternal mortality rates.


Options:
A: Difference in Number and proportion of adults responding to standard appointment versus intense follow up. (2 weeks)
B: Mammogram receipt (1 week)
C: Contraceptive uptake (10 weeks postpartum; 24 weeks postpartum); Facility Delivery (Postpartum); Exclusive Breastfeeding (24 weeks postpartum)
D: Initiation of Long acting reversible contraception method (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Cell-phone Assisted Postpartum Counseling on the Use of Long-acting Reversible Contraceptives: a Randomized Controlled Trial
Brief Summary: Unintended and closely spaced pregnancies are a major public health problem that affects not only the individuals directly involved but also the society indirectly. It increases the risks of infants with adverse outcomes such as preterm, low birth weight and small for gestational age. Pregnancy occurring within six months of the last delivery holds a 7.5-fold increased risk for induced abortion, a 3.3-fold increase in miscarriage and a 1.6-fold increased risk of stillbirth. But, use of contraceptive methods has been shown to reduce unwanted pregnancy, high fertility and maternal mortality rates.


Options:
A: Initiation of Long acting reversible contraception method (6 months)
B: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)
C: 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)
D: The rate of the Exclusive Breastfeeding (from birth of baby to 6 months post birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Cell-phone Assisted Postpartum Counseling on the Use of Long-acting Reversible Contraceptives: a Randomized Controlled Trial
Brief Summary: Unintended and closely spaced pregnancies are a major public health problem that affects not only the individuals directly involved but also the society indirectly. It increases the risks of infants with adverse outcomes such as preterm, low birth weight and small for gestational age. Pregnancy occurring within six months of the last delivery holds a 7.5-fold increased risk for induced abortion, a 3.3-fold increase in miscarriage and a 1.6-fold increased risk of stillbirth. But, use of contraceptive methods has been shown to reduce unwanted pregnancy, high fertility and maternal mortality rates.


Options:
A: Differences in the Screen IVF questionaire between the intervention groups (through study completion, an average of 2 years)
B: Initiation of Long acting reversible contraception method (6 months)
C: Completion of 3 Doses of Pentavalent Vaccine (8 months of age)
D: Neonatal death (28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Controlling Hypertension in Native American and Other Populations
Brief Summary: The study evaluates the use of automated motivational messages, visit reminders, and medication reminders (using interactive voice response technology or text messages) to improve blood pressure control among adults with hypertension that receive their care at the First Nations Community Healthsource clinic in Albuquerque, New Mexico. Half of the participants will receive usual care, while the other half will receive the automated calls or text messages and have the option to receive home blood pressure monitors and/or designate a care partner who will also receive messages. Participants will be followed for 12 months.


Options:
A: Impact of mHealth app on rate of uninsured persons who are at risk and attend a first visit with a health professional at a local government primary care clinic. (6 weeks)
B: Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device (Change from Baseline in objectively monitored physical activity at one year after randomization)
C: Systolic blood pressure (12-months)
D: The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pedometer-based Walking Intervention With and Without Email Counselling in General Practice: a Pilot Randomised Controlled Trial
Brief Summary: A two-arm parallel randomised controlled trial comparing pedometer-based intervention with and without email counselling in a primary care setting. Physically inactive patients from four general practices will be randomised to the pedometer-plus-email group or to the pedometer-alone group. All patients will be instructed to gradually increase the daily number of steps to at least 10,000. Patients in the pedometer-plus-email group will receive 8 counselling emails based on behavioural techniques. The primary outcome will be change in average daily steps measured during 7-day period at baseline and at 12 weeks.


Options:
A: Maximal treadmill walking distance (6 months)
B: Pre and post exercise training CPET (10 wks); Accelerometry-based activity (10 wks); 6 minute walk distance (10 wks); Quality of life and functional measures (10 wks)
C: average daily step count (12 weeks)
D: Changes in MVPA (Moderate-to-Vigorous Physical Activity) bouts of participants from baseline to months 6 and 12 (Baseline, 6 and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mastiha Treatment for Obese With NAFLD Diagnosis
Brief Summary: NAFLD/NASH is one of the most common complications of obesity and diabetes mellitus in Western populations affecting approximately 50% of diabetics and 76% of obese patients. Due to the lack of specialized treatment, many new efforts focus on exploring alternative, non-pharmacologic means for managing the disease, including bioactive substances in fruits, vegetables and plants or their products. Mastiha, a natural product of Greece, consists of a great variety of bioactive phytochemical compounds and demonstrates antioxidant, antiinflammatory, antimicrobial and lipid lowering properties. Taking into account the contribution of oxidative stress and inflammation to NAFLD/NASH pathogenesis, the hypothesis that Mastiha could improve disease aspects is investigated. Thus, design of a multicenter (4 centers across Europe), randomized, double-blind, placebo controlled (parallel arm) clinical trial to assess the effect of Mastiha on clinical course of NAFLD/NASH patients has been conducted. The effectiveness of the proposed intervention will be evaluated via clinical and laboratory markers. MAST4HEALTH aims also at exploring gene-diet interactions and at correlating genetic and epigenetic markers with metabolomic and intestinal microbiota profiles pre- and post- intervention. To this end, patients with confirmed NAFLD/NASH will be allocated to either verum or placebo group. Duration of the intervention will be 6 months and the dosage applied will be 2.1 g daily. NAFLD/NASH diagnosis will be confirmed by MS scanning and the sensitive LiverMultiScan technique. Anthropometric, demographic data, body composition, dietary habits, physical activity, family history and smoking status will be assessed pre- and post- intervention. Biochemical profile, oxidative stress and inflammation, as well as epigenetic and metabolomic profiles will be assessed in blood samples, while the metagenome profile will be examined in stools. Both groups will receive counselling to allow for body weight regulation up to 5%. Compliance will be assessed monthly and side effects will be reported.


Options:
A: Change in Serum ALT (Alanine Aminotransferase) From Baseline to Week 16 (16 Weeks); Change in Liver Stiffness Measurements by Transient Elastography From Baseline to Week 16 (16 Weeks); Number of Treatment Emergent Adverse Events (TEAEs) in Each Treatment Group Leading to Treatment Discontinuation (20 Weeks)
B: Improvement of laboratory markers of inflammation and oxidative stress, such as concentrations of TNF-alpha, lipopolysaccharide (LPS), adiponectin, catepsin D, cytokeratin-18. (4 months); Improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile, transaminases serum levels (4 months)
C: Histological change (9 months)
D: LIF score (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomised Controlled Trial Evaluating the Safety and Efficacy of Antifibrinolytics (Tranexamic Acid) in Patients With Haematological Malignancies With Severe Thrombocytopenia
Brief Summary: The purpose of this study is to test whether giving tranexamic acid to patients receiving treatment for blood cancers reduces the risk of bleeding or death, and the need for platelet transfusions. Patients will be randomised to receive tranexamic acid (given intravenously through a drip, or orally) or a placebo.


Options:
A: Response to Drug Based on Platelet Count at the End of Therapy (21 days and/or 42 days of therapy, 15 and 30 days after the end of therapy)
B: Safety and tolerability parameters including non-hematological laboratory Grade 3/Grade 4 toxicities, change in bone marrow blast counts from baseline and adverse events reporting. (Approximately 46 months)
C: How Many WAS Patients Will Achieve Platelet Counts Above 50,000/ul. (12 weeks)
D: The proportion of patients who die or have bleeding of WHO grade 2 or above by WHO criteria during the first 30 days from the first dose of trial treatment, or planned first dose for those participants who do not receive treatment. (The first 30 days from first dose of trial treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy and Stability of Information and Communication Technology Based Centralized Clinical Trial Monitoring System of Adherence to Immunosuppressive Medication in Kidney Transplant Recipients
Brief Summary: Immunosuppression non-adherence in kidney transplant recipients (KTRs) not only increases the risk of medical intervention due to acute rejection and graft loss but burdens the socioeconomic system in the form of increased healthcare cost. Aggressive preemptive effort by healthcare professionals geared to ensure adherence to immunosuppressants in KTRs is significant and imperative.

This study was designed as a prospective, randomized, controlled, and multicenter study aimed at evaluating efficacy and stability of the information and communication technology (ICT)-based centralized monitoring system in boosting medication adherence in KTRs.

This study is based upon work supported by the Ministry of Trade, Industry \& Energy (MOTIE, Korea) under Industrial Technology Innovation Program ( No. 10059066, 'Establishment of ICT Clinical Trial System and Foundation for Industrialization').


Options:
A: Time to First Occurrence of Acute Rejection, Failure, Death (1 year post-transplant)
B: adherence rate (up to 6 months)
C: 12-week immunosuppression medication adherence (12 weeks)
D: Drug adherence (at 6 months after enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy and Stability of Information and Communication Technology Based Centralized Clinical Trial Monitoring System of Adherence to Immunosuppressive Medication in Kidney Transplant Recipients
Brief Summary: Immunosuppression non-adherence in kidney transplant recipients (KTRs) not only increases the risk of medical intervention due to acute rejection and graft loss but burdens the socioeconomic system in the form of increased healthcare cost. Aggressive preemptive effort by healthcare professionals geared to ensure adherence to immunosuppressants in KTRs is significant and imperative.

This study was designed as a prospective, randomized, controlled, and multicenter study aimed at evaluating efficacy and stability of the information and communication technology (ICT)-based centralized monitoring system in boosting medication adherence in KTRs.

This study is based upon work supported by the Ministry of Trade, Industry \& Energy (MOTIE, Korea) under Industrial Technology Innovation Program ( No. 10059066, 'Establishment of ICT Clinical Trial System and Foundation for Industrialization').


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: Drug adherence (at 6 months after enrollment)
C: Composite clinical outcome (1 year (plus 12 weeks for complete follow-up of technique failure))
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect Of Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration and Blood Flow
Brief Summary: To investigate the effect of pre-operative exercise on

1. Hemodynamics in the fistula artery and vein, pre and post AV fistula formation
2. Suitability of cannulation of AV fistula at 8weeks


Options:
A: Hemodynamics in the fistula artery and vein, pre and post AV fistula formation (22 weeks)
B: Changes in blood flow of AVF draining vein (from Baseline to 3 months)
C: Increasing the diameter of the cephalic vein (8 weeks of training for each patient)
D: Brachial artery flow-mediated dilatation (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Effectiveness-Implementation Trial of SPIRIT in ESRD
Brief Summary: Despite advances in dialysis, only 50% of dialysis patients are alive 3 years after the onset of end-stage renal disease (ESRD). Although withdrawal of dialysis precedes 1 in 4 deaths of patients with ESRD, withdrawal from dialysis and aggressive treatment is rarely discussed by patients and their surrogates with sufficient time to consider alternatives such as hospice or dying at home. Over the last decade, the researchers have developed and iteratively tested a patient and family-centered advance care planning intervention based on the Representational Approach to Patient Education called "Sharing Patient's Illness Representation to Increase Trust" (SPIRIT). SPIRIT is a 6-step, 2-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates.

This study is a multicenter, clinic-level cluster randomized trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics compared to usual care plus delayed SPIRIT implementation. The researchers will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from dialysis clinics in four states. Patients and surrogates will complete questionnaires at baseline and two weeks after the intervention. Surrogates will complete a post-bereavement assessment three months after the death of the patient.


Options:
A: Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days) (From time of hospital discharge up to 60 days)
B: Dyad Congruence on Goals-of-Care Tool (Baseline, Week 2); Patient's Decisional Conflict Scale (DCS) Score (Baseline, Week 2); Surrogate's Decision Making Confidence (DMC) Scale Score (Baseline, Week 2); Composite Outcome of Dyad Congruence and Surrogate DMC Score (Baseline, Week 2)
C: family decision-making self-efficacy (at 8 weeks after the intervention)
D: Mean Patient-centered Communication in Advanced Cancer Score (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: UVX as an Adjuvant in the Treatment of Fungal Keratitis
Brief Summary: In this study, investigators want to find the effect of adjuvant collagen cross-linking in the treatment of fungal keratitis


Options:
A: Maximum Keratometry (12 months)
B: size of infiltrate or scar, corneal structural integrity (6 months)
C: time of complete healing (days) (180 days)
D: Time to Re-epithelialization (Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete)

Answer: C