TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Does the Type of Drain Influence the Postoperative Pancreatic Fistula Rate After Pancreatic Resection?
Brief Summary: Pancreatic resection is the only potentially curative modality of treatment for pancreatic neoplasm. The mortality associated with this procedure decreased rapidly in the past decades. However, the morbidity associated with pancreatic resection remains high. The main reason for postoperative morbidity is postoperative pancreatic fistula (POPF), which is regarded as the most ominous complication following pancreatic resection. Its reported incidence varies in the surgical literature from 10% to \>30%.

Recently published studies showed that the placement of intraoperative drains, manipulation with the drains, timing of removal of the drain, and especially the type of drain, have significant effect on the postoperative complications, and especially POPF.

Controversy exists regarding the type of intraoperatively placed drain. Nowadays, the two most commonly used systems are closed suction drainage and closed gravity drainage. Open systems have been abandoned in most centers as they are obsolete.

Our hypothesis is that the closed suction drain will have better results as it is more effective than the gravity drainage. However, some surgeons claim that the suction system can actively suck the pancreatic juice through the anastomosis or suture and thus promote the development of POPF.

The aim of this study is to compare closed suction drains and closed gravity drains after pancreatic resection in a randomized controlled study.

The primary end-point is the postoperative pancreatic fistula rate. The secondary end-point is the postoperative morbidity.


Options:
A: To Compare 60-day ≥Grade 3 Pancreatic Complication Rates (Fistula, Leak, and Abscess) as Defined by the MSKCC Surgical Secondary Events System Between Patients Who Receive Perioperative SOM230 and Saline Placebo. (60 days)
B: Postoperative pancreatic fistula (30 days postoperatively)
C: Abdominal Complications (1 month)
D: 60-day ≥ Grade II Complication Rate (60 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, Open-label, 3-arm Parallel Group, Multi-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Apparently Healthy Smokers Switching to the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) or Observing Smoking Abstinence, Compared to Continuing to Use Menthol Conventional Cigarettes, for 5 Days in Confinement and Prolonged by 86 Days in an Ambulatory Setting
Brief Summary: Evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, for 5 days in confinement, and after 86 days in an ambulatory setting, by apparently adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs).


Options:
A: Levels of High Density Lipoprotein C (HDL-C). (26 Weeks); Levels of White Blood Cells (WBC). (26 Weeks); Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1). (26 Weeks); Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1). (26 Weeks); Concentrations of 11-dehydrothromboxane B2 (11-DTXB2). (26 Weeks); Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α). (26 Weeks); Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL). (26 Weeks); Percent Change From Baseline of Carboxyhemoglobin (COHb) (26 Weeks)
B: Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) (5 days); Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) (5 days); Concentration of S-phenylmercapturic Acid (S-PMA) (5 days); Levels of Carboxyhemoglobin (COHb) (5 days)
C: Concentration of Monohydroxybutenylmercapturic Acid (MHBMA) (5 days); Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) (5 days); Concentration of S-phenylmercapturic Acid (S-PMA) (5 days); Levels of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol (Total NNAL) (90 days); Levels of Carboxyhemoglobin (COHb) (5 days)
D: Number of Participants With Smoking Cessation (12 WEEK)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Chlorhexidine Wipe for Prevention of Multidrug-resistant Organisms in Intensive Care Unit Patients
Brief Summary: The purpose of this study is to determine 2% chlorhexidine wipes are effective in preventing of colonization of multi-drug resistant bacteria in intensive care unit patients.


Options:
A: N/A
B: Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
C: Main Outcome: Patients With Nosocomial MRSA Clinical Cultures (The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.)
D: The overall rate of Multidrug resistant bacteria acquisition at 7 days after received 2% chlorhexidine wipe bathing versus with soap bathing (7 days after recieved 2% chlorhexidine wipes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With "No Evidence of Disease" After Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma
Brief Summary: This randomized phase III trial studies sargramostim or vaccine therapy alone to see how well they work compared to sargramostim and vaccine therapy together in preventing disease recurrence in patients with melanoma that has been removed by surgery. Sargramostim may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether yeast derived sargramostim and vaccine therapy are more effective alone or together in preventing recurrence of melanoma.


Options:
A: Pathological response rate (From baseline to 6 weeks)
B: Progression free survival (June 2009)
C: Safety as measured by the frequency of grade 3/4 immune-related adverse events, using CTCAE 4.03 (During the first 12 weeks.); Response rate according to RECIST 1.1 (At 6 weeks); Pathological response according to central pathological revision, according to pathological response criteria (At 6 weeks); Pathologic response rate according to central revision of the marked index lymph node (At 6 weeks, prior surgery); RFS at 24 months in patients achieving pCR or pnCR in their marked index lymph node and did not undergo CLND. RFS will be calculated from date of resection of the marked lymph node. (24 months); RFS at 24 months in patients with pNR and being subsequently treated with adjuvant nivolumab+optional radiotherapy (or dabrafenib/trametinib if BRAFV600E pos. and treatment is approved). RFS will be calculated from day of resection of marked lymph node. (24 months)
D: Overall Survival (assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15); Recurrence Free Survival (assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus
Brief Summary: The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.


Options:
A: Incidence of Poor Graft Function After Kidney Transplant (7 days after transplant)
B: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
C: Weighted mean glucose (24 weeks)
D: Progression of Albuminuria (Up to 3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus
Brief Summary: The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.


Options:
A: Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (Time from randomisation up to end of follow-up (scheduled at week 109))
B: Progression of Albuminuria (Up to 3 years)
C: To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF). (52 weeks)
D: Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) (From randomisation until completion of the planned treatment period, up to 1040 days.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Technological Advances to Prevent Smoking Relapse Among Smokers With PTSD
Brief Summary: The primary goal of the study is to evaluate the use of a new smart phone application in preventing relapse to smoking among people with PTSD. The technology intervention will combine a mobile system to reward non-smoking, smoking cessation counseling, smoking cessation medications, and use of the smart phone app. The primary aim is to evaluate how effective this intervention is in preventing smoking relapse compared to another intervention that does not include the app.


Options:
A: Duration of smoke-free status (8 weeks postpartum); Duration of breastfeeding (8 weeks postpartum)
B: The primary endpoint will be 6M of abstinence measured 18M after enrollment. (18M)
C: Abstinence at 12 months postpartum (through 12 months)
D: smoking, self-report (6 months follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Technological Advances to Prevent Smoking Relapse Among Smokers With PTSD
Brief Summary: The primary goal of the study is to evaluate the use of a new smart phone application in preventing relapse to smoking among people with PTSD. The technology intervention will combine a mobile system to reward non-smoking, smoking cessation counseling, smoking cessation medications, and use of the smart phone app. The primary aim is to evaluate how effective this intervention is in preventing smoking relapse compared to another intervention that does not include the app.


Options:
A: Abstinence at 12 months postpartum (through 12 months)
B: Self Reported Relapse Rate at 2 Months (2 months after joining the groups for the social networking services.); Self Reported Relapse Rate at 6 Months (6-months)
C: evaluate the abstinence of tobacco consumption (12 months)
D: smoking, self-report (6 months follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CareToy - A Modular Smart System for Infants' Rehabilitation at Home Based on Mechatronic Toys
Brief Summary: Stroke and other neurological conditions affect the population of infants in percentages that cannot be considered marginal. Preterm infants are the highest infants at risk for neurological damage. Currently, infants have rehabilitation sessions few times a week in rehabilitation centres but according to basic neuroscience it would be necessary to provide them with an early, intensive and multiaxial intervention. One option to reduce the cost of the entire European Healthcare System while increasing the practice of rehabilitation is to devise therapies and technologies that can be administered at home by caregivers and telemonitored by rehabilitation staff. The aim of this proposal is to promote early intervention in the first year of life and to reinforce therapy by "CareToy": a portable low cost smart system telemonitored thus augmenting the clinical effectiveness of the therapy while reducing the cost. The smart system is based on a common baby gym, composed of different modules: a) an instrumented baby gym with mechatronic hanging toys, so that the infants' actions on the gym can be measured and stimulated, b) a vision module, for measuring and promoting infants' attention and gaze movements and c) a sensorized mat for measuring and promoting postural control. Each module will also incorporate built-in signal processor, memory and wireless communication. A fourth telerehabilitation module completes the system that allows the system to remotely communicate with the rehabilitation staff for monitoring and assessing the rehabilitation techniques. CareToy and the effectiveness of home rehabilitation based on this system will be validated by clinical trials on at least 50 preterm infants. The result of this project could have a large impact. CareToy may become a commercial product, manufactured on a large scale and distributed not only in rehabilitation centres but also at homes, sold or rented by the Health Care System to families as a therapeutic tool for care intensity.


Options:
A: Bonding between primary caregiver and infant (6 months)
B: Length of Stay (From Infant's birth to discharge from NICU)
C: Cognitive and behavioral outcome; Parenting Stress
D: Changes on Infant Motor Profile (IMP) (T0(baseline, 1week before beginning of Study period);T1 (within 1 week after the end of the first training/control period; before the cross-over); T2 (within 1 week after the end of the second training/control 2nd period, after cross-over), T3: 18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CareToy - A Modular Smart System for Infants' Rehabilitation at Home Based on Mechatronic Toys
Brief Summary: Stroke and other neurological conditions affect the population of infants in percentages that cannot be considered marginal. Preterm infants are the highest infants at risk for neurological damage. Currently, infants have rehabilitation sessions few times a week in rehabilitation centres but according to basic neuroscience it would be necessary to provide them with an early, intensive and multiaxial intervention. One option to reduce the cost of the entire European Healthcare System while increasing the practice of rehabilitation is to devise therapies and technologies that can be administered at home by caregivers and telemonitored by rehabilitation staff. The aim of this proposal is to promote early intervention in the first year of life and to reinforce therapy by "CareToy": a portable low cost smart system telemonitored thus augmenting the clinical effectiveness of the therapy while reducing the cost. The smart system is based on a common baby gym, composed of different modules: a) an instrumented baby gym with mechatronic hanging toys, so that the infants' actions on the gym can be measured and stimulated, b) a vision module, for measuring and promoting infants' attention and gaze movements and c) a sensorized mat for measuring and promoting postural control. Each module will also incorporate built-in signal processor, memory and wireless communication. A fourth telerehabilitation module completes the system that allows the system to remotely communicate with the rehabilitation staff for monitoring and assessing the rehabilitation techniques. CareToy and the effectiveness of home rehabilitation based on this system will be validated by clinical trials on at least 50 preterm infants. The result of this project could have a large impact. CareToy may become a commercial product, manufactured on a large scale and distributed not only in rehabilitation centres but also at homes, sold or rented by the Health Care System to families as a therapeutic tool for care intensity.


Options:
A: Peabody Developmental Motor Scales(PDMS-2) (Two years post term age)
B: Cognitive and behavioral outcome; Parenting Stress
C: Compare the costs and effectiveness of the three intervention programs to determine which one is more cost-effective for VLBW preterm infants in Taiwan. (In-hospital, 6, 12, 18 and 24 months of age)
D: Changes on Infant Motor Profile (IMP) (T0(baseline, 1week before beginning of Study period);T1 (within 1 week after the end of the first training/control period; before the cross-over); T2 (within 1 week after the end of the second training/control 2nd period, after cross-over), T3: 18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making
Brief Summary: The objective of this proposal is to test whether a multi-media website (www.prepareforyourcare.org) that is focused on preparing older adults for communication and medical decision making can help people engage in advance care planning.


Options:
A: efficacy of PC-ACP
B: New advance care planning documentation in the medical record (15 months after study enrollment)
C: Efficacy of Motivation and Problem Solving (MAPS) in Cancer Risk Reduction (6 months)
D: Adherence with care (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa- a Randomized Controlled Trial (XACT)
Brief Summary: The purpose of this study is to compare two different methods of intensified tuberculosis (TB) case finding in the community. These methods all involve the use of a mobile clinic to reach people with TB symptoms who are not able to readily access clinic services. A standard diagnostics package consisting of smear microscopy and culture (with smear result available the next day) will be compared with a novel diagnostics package involving point-of-care sputum GeneXpert MTB/RIF performed at a mobile or conventional clinic (with same day result), sputum culture, and lateral flow urinary lipoarabinomannan (LAM) testing (in HIV +ve subjects only). The primary outcome is a comparison between the number of culture +ve subjects on TB treatment in each group at the end of two months. A secondary aim is an evaluation of the accuracy and feasibility of GeneXpert performed in a mobile clinic. Additional study aims include using chest X-rays obtained during the study to develop and validate of an computer-aided diagnosis (CAD) software package for TB (together with collaborators in the Netherlands), as well as establishing whether LAM is detectable at sub-ELISA concentrations in the urine of those with TB.


Options:
A: Comparison of novel intensive-case finding diagnostic tools to standard intensive-case finding strategy (2 months)
B: Retention in care with viral suppression (48 weeks after HIV testing)
C: Time to TB treatment initiation (8 weeks follow up)
D: Number of patients who complete tuberculosis treatment (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa- a Randomized Controlled Trial (XACT)
Brief Summary: The purpose of this study is to compare two different methods of intensified tuberculosis (TB) case finding in the community. These methods all involve the use of a mobile clinic to reach people with TB symptoms who are not able to readily access clinic services. A standard diagnostics package consisting of smear microscopy and culture (with smear result available the next day) will be compared with a novel diagnostics package involving point-of-care sputum GeneXpert MTB/RIF performed at a mobile or conventional clinic (with same day result), sputum culture, and lateral flow urinary lipoarabinomannan (LAM) testing (in HIV +ve subjects only). The primary outcome is a comparison between the number of culture +ve subjects on TB treatment in each group at the end of two months. A secondary aim is an evaluation of the accuracy and feasibility of GeneXpert performed in a mobile clinic. Additional study aims include using chest X-rays obtained during the study to develop and validate of an computer-aided diagnosis (CAD) software package for TB (together with collaborators in the Netherlands), as well as establishing whether LAM is detectable at sub-ELISA concentrations in the urine of those with TB.


Options:
A: Comparison of novel intensive-case finding diagnostic tools to standard intensive-case finding strategy (2 months)
B: To compare the characteristics of subjects with relapsed tuberculosis verses the characteristics of subjects that do not experience relapse disease (Over course of the study)
C: All-cause Mortality (6 months post-HAART initiation)
D: Sensitivity of the lateral-flow urine LAM assay (LF-LAM) (One year); Failure rate of the lateral-flow urine LAM assay (One year); Inter-reader variability of the lateral-flow urine LAM assay (One year); Specificity of the lateral-flow urine LAM assay (LF-LAM) (One year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa- a Randomized Controlled Trial (XACT)
Brief Summary: The purpose of this study is to compare two different methods of intensified tuberculosis (TB) case finding in the community. These methods all involve the use of a mobile clinic to reach people with TB symptoms who are not able to readily access clinic services. A standard diagnostics package consisting of smear microscopy and culture (with smear result available the next day) will be compared with a novel diagnostics package involving point-of-care sputum GeneXpert MTB/RIF performed at a mobile or conventional clinic (with same day result), sputum culture, and lateral flow urinary lipoarabinomannan (LAM) testing (in HIV +ve subjects only). The primary outcome is a comparison between the number of culture +ve subjects on TB treatment in each group at the end of two months. A secondary aim is an evaluation of the accuracy and feasibility of GeneXpert performed in a mobile clinic. Additional study aims include using chest X-rays obtained during the study to develop and validate of an computer-aided diagnosis (CAD) software package for TB (together with collaborators in the Netherlands), as well as establishing whether LAM is detectable at sub-ELISA concentrations in the urine of those with TB.


Options:
A: Survival of newly-diagnosed HIV-infected patients at 1 year (4 years)
B: Comparison of novel intensive-case finding diagnostic tools to standard intensive-case finding strategy (2 months)
C: Difference in TB-related Morbidity (2 months); Difference in TB-related Morbidity (6 months)
D: Notification Rate Ratio (October 2012 (up to 2 years)); Costs Per Detected Case (October 2012 (up to 2 years))

Answer: B