TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Intensified Chemotherapy and Simultaneous Treatment With Heparin in Out-patients With Pancreatic Cancer.
Brief Summary: Venous thromboembolic events are considered to be a prognostic negative factor and small studies showed astonishing survival advantages using heparin as prophylactic treatment to prevent venous thromboembolic events. Based on these assumptions our Charité - Onkologie (CONKO) study group planned to conduct a randomized trial to investigate the impact of low molecular weight heparin (LMWH) in a prospective setting in patients with advanced pancreatic cancer undergoing first line therapy, the CONKO-004 trial. During the preliminary stages we had to undertake a pilot trial to get information on safety and feasibility of combined chemotherapy with simultaneous treatment of the LMWH Enoxaparin in patients with advanced pancreatic cancer who are at high risk of gastrointestinal bleeding due to local cancer spread.


Options:
A: Progression free survival (5 years)
B: Composite of Recurrent VTE or VTE Death at 36 Months (36 months); Composite of Recurrent VTE or VTE Death at 18 Months (18 months)
C: Incidence of NCI CTC Toxicity III°/IV° and severe bleedings (minimum of 3 months)
D: Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death (From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Intensified Chemotherapy and Simultaneous Treatment With Heparin in Out-patients With Pancreatic Cancer.
Brief Summary: Venous thromboembolic events are considered to be a prognostic negative factor and small studies showed astonishing survival advantages using heparin as prophylactic treatment to prevent venous thromboembolic events. Based on these assumptions our Charité - Onkologie (CONKO) study group planned to conduct a randomized trial to investigate the impact of low molecular weight heparin (LMWH) in a prospective setting in patients with advanced pancreatic cancer undergoing first line therapy, the CONKO-004 trial. During the preliminary stages we had to undertake a pilot trial to get information on safety and feasibility of combined chemotherapy with simultaneous treatment of the LMWH Enoxaparin in patients with advanced pancreatic cancer who are at high risk of gastrointestinal bleeding due to local cancer spread.


Options:
A: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6-, or 12-month study treatment period)
B: Incidence of NCI CTC Toxicity III°/IV° and severe bleedings (minimum of 3 months)
C: Composite of Recurrent VTE or VTE Death at 36 Months (36 months); Composite of Recurrent VTE or VTE Death at 18 Months (18 months)
D: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6- or 12-month study treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Intensified Chemotherapy and Simultaneous Treatment With Heparin in Out-patients With Pancreatic Cancer.
Brief Summary: Venous thromboembolic events are considered to be a prognostic negative factor and small studies showed astonishing survival advantages using heparin as prophylactic treatment to prevent venous thromboembolic events. Based on these assumptions our Charité - Onkologie (CONKO) study group planned to conduct a randomized trial to investigate the impact of low molecular weight heparin (LMWH) in a prospective setting in patients with advanced pancreatic cancer undergoing first line therapy, the CONKO-004 trial. During the preliminary stages we had to undertake a pilot trial to get information on safety and feasibility of combined chemotherapy with simultaneous treatment of the LMWH Enoxaparin in patients with advanced pancreatic cancer who are at high risk of gastrointestinal bleeding due to local cancer spread.


Options:
A: Incidence of venous thromboembolism reduction
B: Composite end-point represented by the time in days from randomisation to the first occurrence of VTE (6 months)
C: Composite of Recurrent VTE or VTE Death at 36 Months (36 months); Composite of Recurrent VTE or VTE Death at 18 Months (18 months)
D: Incidence of NCI CTC Toxicity III°/IV° and severe bleedings (minimum of 3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Goal-directed Resuscitation in High-risk Patients Undergoing Major Cancer Surgery: a Controlled and Randomized Study
Brief Summary: The purpose of this study is to determine whether a goal-directed resuscitation therapy within the first 8 hours after major abdominal cancer surgery reduces postoperative complications compared to a standard therapy.


Options:
A: The primary outcome measure is the duration of postoperative hospital stay. (at days 1,2, and 5, as well as at ICU discharge, and hospital discharge.)
B: Composite endpoint of death or major postoperative complications (30 days after randomization)
C: Composite of morbidity and mortality on day 28 (28 days)
D: Postoperative Complications (30 days post procedure)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Adherence to Sleep Apnea Treatment Through Health Education Among Blacks With Metabolic Syndrome
Brief Summary: This is a randomized controlled Trial to evaluate effect of a culturally and linguistically tailored, telephone-delivered behavioral intervention on adherence to recommended assessment and treatment of sleep apnea in Blacks with Metabolic Syndrome. The investigators believe low awareness of Sleep Apnea and the risk it imposes to an individual health plays an important role in underdiagnosis and low adherence to treatment among Blacks. Hence, culturally and linguistically tailored health education will decrease the knowledge gap and improve adherence to recommended assessment and treatment of sleep Apnea. the investigators believe the effect of adherence to treatment of Sleep apnea is shown to improve the components of Metabolic syndrome and hence promote well control of Hypertension, Diabetes, weight, triglyceride and cholesterol.


Options:
A: Average hours of CPAP use per night: experimental pathway vs. traditional pathway (3 months)
B: Change the knowledge of risk factors for sleep apnea and improve adherence to recommended assessment and treatment for sleep apnea. (6 months)
C: Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure (12 Months)
D: CPAP adherence in minutes used per night (after 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Standard ART Practice vs. Trophectoderm Biopsy, Whole Chromosome Analysis by Next Generation Sequencing, and Replacement of a Single Euploid Embryo
Brief Summary: We propose to perform a clinical randomized trial to evaluate the effect of blastocyst biopsy and whole chromosome analysis by Next Generation Sequencing (NGS) in comparison to standard Assisted Reproductive Technologies (ART) methods on on implantation rates, miscarriage rates, and pregnancy rates.

This will be three studies into one: a) a comparison of treatment (NGS) and no treatment, b) a non-selection study based on the control group for which we will replace without knowing the ploidy of the embryos, but we will know it later, c) a retrospective study about the use of Mitochondrial DNA as a selection tool.


Options:
A: number of patients with positive pregnancy test (2 months)
B: Impact of next generation sequencing on the embryos produced from IVF on implantation rates (2 years)
C: improvement in ongoing implantation rates (When a fetal heartbeat is detected for each patient. (8 weeks after implantation).)
D: PRIMARY OUTCOME MEASURE:IMPLANTATION RATE; (9 MONTHS)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Aim of the study was to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray and paracervical block with ultracaine on curettage procedure.


Options:
A: Subject Perception of Pain and Anxiety During Uterine Aspiration (at time of uterine aspiration (30-60 minutes after premedication))
B: Pain Scores on the Visual Analog Scale (Three months)
C: pain reduction (nine months)
D: Patient Perception of Pain (At time of uterine aspiration (baseline))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation
Brief Summary: The purpose of this study is to learn more about how patients and healthcare providers interact in order to improve shared decision making. The investigators plan to test an intervention with two separate educational components-one for patients and one for providers-designed to encourage patients to ask questions and increase their level of involvement in their own care, while simultaneously training providers to be more receptive to patients' questions and concerns. Patients in the intervention group will receive three short (30-45 minute) trainings focused on developing and asking questions and will be interviewed three times over the course of the intervention to see how it has affected the quality of their care. Providers receiving the intervention will participate in three separate trainings, including a 12-hour group workshop, an additional two hour training, and six hours of individual instruction, including personalized feedback based on three audio-recorded patient visits. Previous studies looking at patient engagement and involvement in decision-making have shown that increased engagement is linked with improved outcomes, but that providers are sometimes not prepared to develop a collaborative relationship with patients. The investigators think that training both patients and providers to work together and communicate more effectively will improve quality of care and increase patient satisfaction more than interventions that focus on only one side of the clinical encounter. One of the major goals in studying patient-provider communication is to improve shared decision-making and see how it contributes to racial and ethnic disparities in mental health care, since minority patients have been shown to be less involved in care and have been shown to be perceived and treated differently by providers.


Options:
A: Shared Decision-Making Coding System (Change in collaborative decision-making behaviors from baseline (month 0) to post-intervention (month 2)); Shared Decision-Making Coding System (Change in collaborative decision-making behaviors from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
B: Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores (Follow-up assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Patient Version) (End-of-intervention Assessment (5 months)); Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version (Follow-up Assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Provider Version) (Follow-up Assessment (2 months)); Perceptions of Care Survey - Global Evaluation of Care Scale (PoC) (End-of-intervention Assessment (5 months)); Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version (End-of-intervention Assessment (5 months))
C: Penn State Worry Questionnaire-Abbreviated (Week 11)
D: Veterans RAND-12 Mental Component Score (VR-12 MCS) (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation
Brief Summary: The purpose of this study is to learn more about how patients and healthcare providers interact in order to improve shared decision making. The investigators plan to test an intervention with two separate educational components-one for patients and one for providers-designed to encourage patients to ask questions and increase their level of involvement in their own care, while simultaneously training providers to be more receptive to patients' questions and concerns. Patients in the intervention group will receive three short (30-45 minute) trainings focused on developing and asking questions and will be interviewed three times over the course of the intervention to see how it has affected the quality of their care. Providers receiving the intervention will participate in three separate trainings, including a 12-hour group workshop, an additional two hour training, and six hours of individual instruction, including personalized feedback based on three audio-recorded patient visits. Previous studies looking at patient engagement and involvement in decision-making have shown that increased engagement is linked with improved outcomes, but that providers are sometimes not prepared to develop a collaborative relationship with patients. The investigators think that training both patients and providers to work together and communicate more effectively will improve quality of care and increase patient satisfaction more than interventions that focus on only one side of the clinical encounter. One of the major goals in studying patient-provider communication is to improve shared decision-making and see how it contributes to racial and ethnic disparities in mental health care, since minority patients have been shown to be less involved in care and have been shown to be perceived and treated differently by providers.


Options:
A: Percentage uptake of PPIUD (Within approximately 24 hours postpartum, before discharge from the hospital.)
B: Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores (Follow-up assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Patient Version) (End-of-intervention Assessment (5 months)); Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version (Follow-up Assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Provider Version) (Follow-up Assessment (2 months)); Perceptions of Care Survey - Global Evaluation of Care Scale (PoC) (End-of-intervention Assessment (5 months)); Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version (End-of-intervention Assessment (5 months))
C: Number of Participants Who Used Dual Contraception or Safer Conception Method (Month 12)
D: Incidence choice for eSET (after embryo transfer)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Maternal Supplementation With DHA During Pregnancy and Lactation on the Development of the Term Newborn
Brief Summary: In the present study, we evaluate the effect of the mother suplementación with DHA during the gestation and lactation on diverse aspects of the development of newborn. The effect on the oxidative stress, inflammatory signaling, bone turnover and piscomotor and visual development was studied. Women will in the sixth month of pregnancy, consume a diet balanced during last 3 months of pregnancy and the whole lactation. In addition the women will divide in two groups: one will receive a supplement of docosahexaenoic acid (DHA) to evaluate the effects on the development of the newborn child; whereas another group will receive a placebo. Different samples of blood of the mother and of mother milk will be taken and we will correlating her lipidic profile with the brain development of the newborn child, evaluated by different tests.


Options:
A: Change of Visual Development of newborn (Change from Baseline at 12 months of life)
B: Occurrence of Early Preterm Birth (<34 weeks gestation) (Baseline to 34 Weeks); Occurrence of Early Preterm Birth (<34 weeks gestation) (Baseline to 34 weeks); Maternal and infant adverse and serious adverse events (Enrollment to 30 days past last birth)
C: Insulin sensitivity (Measured at approximately Month 3)
D: Primary outcome is measuring of infant CNS maturity to 18 months of age (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain.

To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients.

To assess the effect of an intravenous nonnarcotic pain medication on common side effects seen in patients taking other intravenous narcotic pain medication in the neurocritical care unit.


Options:
A: Subjectively-rated pain intensity, using a 0-10 NRS (0=no pain, 10 = unbearable pain) (8 h)
B: Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour) (mean pain score over 48 hours)
C: Narcotic Requirement After Surgery (48 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: C
Please select the outcome measures that correspond to the clinical trial below.
Title: AMICA: Assessing the Fit of Motivational Interviewing by Cultures With Adolescents
Brief Summary: Hispanic adolescents experience more severe alcohol-related consequences due to their alcohol abuse and yet significantly fewer Hispanic adolescents receive alcohol treatment, particularly among justice-involved youth. Despite the level of research that has been conducted on motivational interviewing (MI) with mainstream samples, no published studies have investigated the efficacy of this brief, individual intervention with Hispanic adolescents. The overarching objective of this application is to evaluate the efficacy of a brief individual intervention (MI) for problem drinking behaviors with a sample of justice-involved Hispanic and Caucasian adolescents to determine if this intervention is differentially effective between Hispanic and Caucasian adolescents. Specifically, the first aim is to determine whether an MI intervention targeting alcohol abuse is effective at reducing alcohol use and related risk behavior in a sample of adolescent alcohol abusers. The second aim is to examine whether the effects of MI on problem drinking outcomes (e.g., alcohol problems, quantity of drinking, frequency of binging) are different between Hispanic versus Caucasian adolescents. Because it is important to determine the mechanisms that mediate the effects of MI and determine whether these mechanisms differ between Caucasian and Hispanic adolescents, the third aim is to examine whether group (Hispanic vs. Caucasian) moderates the mediational linkages in the overall model using a cross-groups approach to moderated mediation. To accomplish these aims, 453 Caucasian and Hispanic justice-involved alcohol abusing adolescents (ages 14-17) will be randomized to either two 60 minute MI interventions (one at baseline and a second, one week later) or an education condition. All adolescents will receive behavioral assessments at baseline, 3, 6 and 12 months. The proposed research is expected to take a significant step towards reducing current racial/ethnic health disparities in alcohol treatment for Hispanic adolescents.


Options:
A: past 30 day drug use abstinence (6 months post intervention)
B: Frequency of alcohol use (Change from baseline in frequency of alcohol use at 3 , 6 , & 12 month follow-up)
C: Alcohol-related Problems (assessed at baseline, and 3-, 6-, and 12-month post-treatment follow ups; 12-month follow up reported)
D: Linkage to Alcohol Behavioral Therapy Counseling (i.e., "Aftercare") (1 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of a Polyethyleneimine-coated Membrane (oXiris™) for Hemofiltration Versus Polymyxin B- Immobilized Fibre Column (Toraymyxin™) for Hemoperfusion on Endotoxin Activity and Inflammatory Conditions in Septic Shock- A Randomized Controlled Pilot Study
Brief Summary: Septic shock has a high mortality risk despite the availability of various treatments. Endotoxin, that is present in the cell walls of gram-negative bacteria, is a potent trigger of innate immunity. Endotoxin leads to an activation of a cascade with an overwhelming systemic overflow of pro- and anti- inflammatory mediators at the early phase of sepsis with generalized vascular endothelial damage, tissue injury and multi-organ failure.

Extracorporeal blood purification therapies aim to reduce the circulating level of endotoxin. Different extracorporeal blood purification systems are available. The oXiris™ device comprises a surface treated AN69 membrane capable to adsorb a large spectrum of plasma cytokines, such as IL-6 and HMGB1 protein. The positively charged inner surface of the membrane allows absorbing negatively charged bacterial products such as endotoxin. From an historical perspective, filters containing AN69-based membranes have been the most commonly used products for CRRT in the management of critically ill patients and a substantial volume of published data exist.

Another extracorporeal endotoxin removal therapy is the hemoperfusion with ToraymyxinTM (PMX) filter, which is a cartridge selectively removing blood endotoxin. PMX is composed of polymyxin B covalently bonded to polystyrene-derivative fibres. It is well known that the polarity of the polymyxin B antibiotic binds endotoxin and has bactericidal activity. Therefore, the rationale underlying extracorporeal therapy with PMX is to remove circulating endotoxin by adsorption.

* Trial with medical device


Options:
A: Measurement of the endotoxin activity 72 hours after treatment initiation (72 hours)
B: The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting. (6 hours after starting dialysis)
C: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)
D: To compare the clearance of urea and creatinine by renal replacement therapy (RRT) using continuous venovenous hemofiltration versus continuous venovenous hemodialysis. (48 hours)

Answer: A