TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Different Arachidonic Acid Supplementation on Psychomotor Development in Very Preterm Infants, a Randomized Controlled Trial
Brief Summary: Long-chain polyunsaturated fatty acids (LCPUFAs), arachidonic acid (AA omega-6; 20:4ω-6), and docosahexaenoic acid (DHA omega-3; 22:6ω-3), are required for the formation of non-myelinated cell membranes in the central nervous system, including in the retina, hence the great importance of them for appropriate visual and cognitive development.

In this study, the investigators assessed anthropometric, visual, auditory, and psychomotor development in very preterm infants who had diets supplemented with different LCPUFA amount of AA to support the importance of sufficient AA values in formula.


Options:
A: Length of stay in ICU and length of stay in the hospital. (2 years)
B: Incidence of new infection during ICU stay (during ICU stay and up to 90 days post-randomization); Duration of ICU dependency (crude stay days and time to alive discharge from ICU) (during ICU stay and up to 90 days post-randomization)
C: Reduction of inflammation (during ICU stay to day 5); duration of dependency on intensive care (days in ICU) (time in ICU)
D: Psychomotor development (From september 2013 to november 2014 (at two years of corrected age))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, Open-label, 2-arm Parallel Group, Single Center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Healthy Smokers Switching to the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) Compared to Continuing to Use Conventional Cigarettes During 5 Days in Confinement.
Brief Summary: The overall goal of the study is to demonstrate the reduction of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) in adult smokers switching for 5 days from conventional cigarette (CC) to Carbon Heated Tobacco Product 1.0 (CHTP 1.0) as compared to smokers continuing to use CC.


Options:
A: Number of Participants With Smoking Cessation (12 WEEK)
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: Change in Urinary Tobacco Exposure Biomarkers from Weeks 0 to 12 (Week 12); Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 12 (Week 12); Change in Markers of Exposure and Potential Harm from Weeks 0 to 12 (Week 12); Change in health status scores from self-administered questionnaires on COPD-related disease from Weeks 0 to 12 (Week 12); Change in tobacco usage diary from Weeks 0 to 4 (Week 4); Change in Urinary Tobacco Exposure Biomarkers from Weeks 0 to 24 (Week 24); Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 24 (Week 24); Change in Markers of Exposure and Potential Harm from Weeks 0 to 24 (Week 24); Change in daily tobacco usage diary from Weeks 4 to 8 (Week 8); Change in daily tobacco usage diary from Weeks 8 to 12 (Week 12); Change in daily tobacco usage diary from Weeks 12 to 16 (Week 16); Change in daily tobacco usage diary from Weeks 16 to 20 (Week 20); Change in daily tobacco usage diary from Weeks 20 to 24 (Week 24); Change in health status scores from self-administered questionnaires on COPD-related disease from Weeks 0 to 24 (Week 24)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study of Safety, Tolerability and Evidence of Activity of Intravitreal APL-2 Therapy in Patients With Geographic Atrophy (GA)
Brief Summary: The primary objectives of the study are to assess the safety, tolerability and evidence of activity of multiple intravitreal (IVT) injections of pegcetacoplan in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD).


Options:
A: Growth rate of geographic atrophy (GA) lesion area from baseline (Month 18)
B: Least Square (LS) Mean Change From Baseline in Square Root GA Lesion Size in the Study Eye at Month 12 (Baseline (screening) and Month 12.); Number of Subjects With Treatment Emergent Adverse Events (TEAEs) in the Study Eye, Including by Severity (From the time of first study drug administration (Day 1) up to Month 12 (Data cut-off date).)
C: Least Squares (LS) Mean Change From Baseline to Week 16 in Hemoglobin (Hb) Level During the RCP (Baseline and Week 16)
D: The Change in Best-corrected Visual Acuity (BCVA) From Baseline to Year 2 for All Participants. (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Pieda Study: A Phase 3b Investigation Of Erythropoietin Drugs Using A Specified Dosing Algorithm: A Randomized Open Label Dosing Study In Adult Chronic Kidney Disease Subjects On Hemodialysis
Brief Summary: A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira Epoetin and Standard of Care Epogen.


Options:
A: Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL) (Week 17 up to Week 24)
B: Composite renal outcome of chronic dialysis, kidney transplantation, eGFR 6 mL/min/1.73m2 or less, or eGFR less than 50% of initial value. (96 weeks)
C: Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First (Baseline up to approximately 8.5 years)
D: Local pain due to s.c. injection (by VAS). (After each injection)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Injection Technique for Infant Vaccination
Brief Summary: Vaccine injections are a significant source of pain for infants. Altering the injection speed when administering vaccines may be an effective intervention and is feasible (cost neutral). At present, there are no data regarding impact of injection speed on vaccine injection pain in infants. The aim of this study is to address this knowledge gap and to compare the impact of slow and fast vaccine injection speeds on pain during routine infant vaccinations.


Options:
A: To measure analgesic effectiveness of the 5 S's (swaddling, side/stomach position, shushing, swinging, and sucking) alone and combined with sucrose, during routine immunizations at 2 and 4 month well child visits. (every 15 sec)
B: Pain Process Outcomes (pain assessment) (T1 (Baseline)); Factors Influencing Sustainability: The Alberta Context Tool (ACT) (T1 (Baseline)); Pain Process Outcomes (pain assessment) (T2 (12 months following the implementation of the Booster)); Pain Process Outcomes (pain assessment) (T3 (24 months following the implementation of the Booster)); Factors Influencing Sustainability: The Alberta Context Tool (ACT) (T2 (12 months following the implementation of the Booster)); Factors Influencing Sustainability: The Alberta Context Tool (ACT) (T3 (24 months following the implementation of the Booster)); Pain Process Outcomes (pain management) (T1 (Baseline)); Pain Process Outcomes (pain management) (T2 (12 months following the implementation of the Booster)); Pain Process Outcomes (pain management) (T3 (24 months following the implementation of the Booster))
C: Cortical oxy-haemoglobin increase (During the procedure)
D: Infant Behavioural Pain Score (up to 1 minute post-vaccinations)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Default Palliative Care Consultation for Seriously Ill Hospitalized Patients
Brief Summary: This is a large pragmatic, randomized controlled trial to test the real-world effectiveness of inpatient palliative care consultative services in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The investigators hypothesize that improved patient-centered outcomes can be achieved without higher costs by simply changing the default option for inpatient palliative care consultation for eligible patients from an opt-in to an opt-out system. To test this hypothesis the investigators will conduct a clinical trial at 11 hospitals using the same electronic health record within Ascension Health, the largest non-profit health system in the U.S.


Options:
A: Relapse by Study Week 32 (0-16 weeks in Phase B (16-32 weeks in study))
B: Change in scores from baseline to week 26 on measuring cognition Severe Impairment Battery test and the Minimum Data Set Activities of Daily Living test.
C: Composite Measure: Length of Stay and In-Hospital Mortality (Duration of hospital stay, an expected average of 8 days)
D: Change From Baseline in the Mini-Mental State Examination (MMSE) Score (Baseline, Month 24); The Number of Deaths Reported in Participants (Up to 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Novel Brief Therapy for Attempted Suicide: Two Year Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP)
Brief Summary: Objective

Attempted suicide is the main risk factor for repeated suicidal behavior. However, evidence of the effectiveness of follow-up treatments for these patients is limited. The authors evaluated the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP), a novel brief therapy based on a patient-oriented model of suicidal behavior. The ASSIP consists of three sessions followed by regular letters for 24 months.

Method

In this treatment study, 120 patients were randomly assigned to either the ASSIP intervention or a control group that received a one-session clinical assessment. Both groups received in- and outpatient treatment as usual. Study participants also completed a set of psychosocial and clinical questionnaires every 6 months during a 24-month follow-up period.


Options:
A: The Zanarini Rating Scale for Borderline Personality Disorder (Weeks 0, 2, 4, 6, 8, 10, 12); Borderline Evaluation of Severity over Time (BEST) (Weeks 0,2,4,6,8,10,12)
B: Impact of omega-3 HUFA supplementation on suicidal behaviors and thinking among adults. (6 months)
C: Suicidal behaviour (2-year follow-up); Suicidal behaviour (1-year follow-up)
D: suicidal act frequency (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Novel Brief Therapy for Attempted Suicide: Two Year Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP)
Brief Summary: Objective

Attempted suicide is the main risk factor for repeated suicidal behavior. However, evidence of the effectiveness of follow-up treatments for these patients is limited. The authors evaluated the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP), a novel brief therapy based on a patient-oriented model of suicidal behavior. The ASSIP consists of three sessions followed by regular letters for 24 months.

Method

In this treatment study, 120 patients were randomly assigned to either the ASSIP intervention or a control group that received a one-session clinical assessment. Both groups received in- and outpatient treatment as usual. Study participants also completed a set of psychosocial and clinical questionnaires every 6 months during a 24-month follow-up period.


Options:
A: Suicidal behaviour (2-year follow-up); Suicidal behaviour (1-year follow-up)
B: Change in Beck Scale for Suicide Ideation (BSS) score (Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3))
C: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23). (Baseline and up to 12 months after inclusion.)
D: Suicide repetition (or death by suicide) (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Novel Brief Therapy for Attempted Suicide: Two Year Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP)
Brief Summary: Objective

Attempted suicide is the main risk factor for repeated suicidal behavior. However, evidence of the effectiveness of follow-up treatments for these patients is limited. The authors evaluated the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP), a novel brief therapy based on a patient-oriented model of suicidal behavior. The ASSIP consists of three sessions followed by regular letters for 24 months.

Method

In this treatment study, 120 patients were randomly assigned to either the ASSIP intervention or a control group that received a one-session clinical assessment. Both groups received in- and outpatient treatment as usual. Study participants also completed a set of psychosocial and clinical questionnaires every 6 months during a 24-month follow-up period.


Options:
A: Suicidal behaviour (2-year follow-up); Suicidal behaviour (1-year follow-up)
B: Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task (At 2 weeks after group completion); Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task (At 2 weeks after group completion); Baseline activation when viewing angry vs. neutral faces during an implicit emotional visualization task (At 3 months after therapy)
C: Patient Satisfaction Questionnaire ((baseline) Assessment taking place immediately after completion of intervention)
D: The number of contacts with mental health services appropriate to the patient's needs. (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Novel Brief Therapy for Attempted Suicide: Two Year Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP)
Brief Summary: Objective

Attempted suicide is the main risk factor for repeated suicidal behavior. However, evidence of the effectiveness of follow-up treatments for these patients is limited. The authors evaluated the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP), a novel brief therapy based on a patient-oriented model of suicidal behavior. The ASSIP consists of three sessions followed by regular letters for 24 months.

Method

In this treatment study, 120 patients were randomly assigned to either the ASSIP intervention or a control group that received a one-session clinical assessment. Both groups received in- and outpatient treatment as usual. Study participants also completed a set of psychosocial and clinical questionnaires every 6 months during a 24-month follow-up period.


Options:
A: N/A
B: Suicidal behaviour (2-year follow-up); Suicidal behaviour (1-year follow-up)
C: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)
D: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Young Child Undernutrition Through an Integrated Agricultural Project With Women's Groups: A Cluster-randomized Trial in Rural Bangladesh
Brief Summary: The aim of this study is to evaluate the potential of reducing young child undernutrition in low-income countries through an integrated program that trains women's groups in agriculture, nutrition, child care and hygiene.


Options:
A: Incidence of Diarrhea (2 weeks)
B: Growth (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months); Hemoglobin (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months)
C: Food security as measured by the value of food consumption through a household questionnaire (6 months); Dietary diversity as measured by dietary diversity index and food consumption score through a household questionnaire (6 months)
D: Linear growth in children below 3 years of age (Measured 50 months after randomization (endline survey 2019))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Young Child Undernutrition Through an Integrated Agricultural Project With Women's Groups: A Cluster-randomized Trial in Rural Bangladesh
Brief Summary: The aim of this study is to evaluate the potential of reducing young child undernutrition in low-income countries through an integrated program that trains women's groups in agriculture, nutrition, child care and hygiene.


Options:
A: Change from Baseline in nutritionally related biochemical measures at 22 months (At baseline and 22 months)
B: Sexually Transmitted Infections (18 months); Schooling (12 months/24 months)
C: Linear growth in children below 3 years of age (Measured 50 months after randomization (endline survey 2019))
D: Growth (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months); Hemoglobin (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing the Efficacy of Intranasal Oxytocin for the Prevention of Postpartum Depression and PTSD
Brief Summary: The purpose of this study is to test a new treatment for preventing childbirth-related mental illness in postpartum mothers. The treatment is aimed at enhancing maternal bonding, reducing postpartum depression (PPD) and anxiety in mothers at risk, and promoting child development. To this end, the investigators will test the clinical utility of intranasal (IN) oxytocin (OXT) administered to mothers during the first postpartum days.


Options:
A: Diagnostic Interview Schedule for Children and Adolescents (DICA) - Parent (Baseline to Week 24); Diagnostic Interview for Children and Adolescents (DICA) - Child (Baseline to Week 24)
B: Treatment Effect on Mother-infant Bonding (5 days and 2 months postpartum (on average))
C: Primary Objective (24 months)
D: Symptoms of Acute Stress Disorder; Symptoms of Posttraumatic Stress Disorder

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Comparison of the Trans-obturator Mid-urethral Sling and the Single-incision Sling in Women With Stress Urinary Incontinence
Brief Summary: Mid-urethral slings (MUS) now represent a gold standard in the treatment of female stress urinary incontinence (SUI). Second generation trans-obturator slings (TOT) have proven to be as effective as retropubic tension-free vaginal tape (TVT) with fewer major complications. A third generation of the MUS inserted through a single vaginal incision (SIS) has become a means to overcome significant post-operative groin pain. Novel types of SIS with a more robust and adjustable anchoring mechanism can assure adequate long-lasting attachment to the obturator membrane (OM). Objective of this study was to compare an inside-out TOT with an innovative fixation SIS in randomized controlled trial on patients undergoing their primary surgery for urodynamic SUI.


Options:
A: Percentage of Participants With Negative Cough Stress Test (CST) (four years); Patient Global Impression of Improvement (PGI-I) Score (four years)
B: • Feasibility of the single incision sub-urethral tape to be done under local anaesthesia (1 year)
C: Standardised pad test: "cure" is defined as less than 1g gain in pad weight over the duration of the test (12 months following surgery)
D: The absence of stress incontinence at 6 weeks ascertained by direct questioning and from the Kings Quality of life questionnaire and the absence at 6 months by the same criteria and by urodynamics. (6 weeks and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial to Determine the Nutritional Requirement for Vitamin D for Prevention of Deficiency During Pregnancy and in the Early Neonatal Period (D-MAT)
Brief Summary: Randomised, placebo-controlled dose-response intervention study with vitamin D3 in pregnant women.


Options:
A: Number of Participants with D- deficiency or access (at 40 (+/-2 weeks) PMA (postmenstrual age)); Number of Participants with D- deficiency or access (at 4 weeks of age); Number of Participants with D- deficiency or access (At 35 (+/-2 weeks) PMA (postmenstrual age)); Number of Participants with D- deficiency or access (At 52 (+/-2 weeks) PMA (postmenstrual age))
B: Prevalence in plasma 25OHD and parathyroid hormone at birth (at birth (baseline))
C: Persistent wheeze (0 to 3 years of age)
D: Serum 25-hydroxyvitamin D in pregnant women and cord blood (Change from 1st through 2nd trimester and at delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial to Determine the Nutritional Requirement for Vitamin D for Prevention of Deficiency During Pregnancy and in the Early Neonatal Period (D-MAT)
Brief Summary: Randomised, placebo-controlled dose-response intervention study with vitamin D3 in pregnant women.


Options:
A: Asthma or Recurrent Wheeze in First 3 Years of Life (First 3 years of life.); Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. (32-38 weeks gestation)
B: Infant Length-for-Age Z-Scores with Prenatal Supplementation (1 year of age); Infant Length-for-Age Z-Scores with Postpartum Supplementation (1 year of age)
C: Serum 25-hydroxyvitamin D in pregnant women and cord blood (Change from 1st through 2nd trimester and at delivery)
D: The proportions of women who will reach the IOM defined desirable 25(OH)D level ≥20ng/ml. (At delivery); Infant bone mineral content (BMC) (one to six weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial to Determine the Nutritional Requirement for Vitamin D for Prevention of Deficiency During Pregnancy and in the Early Neonatal Period (D-MAT)
Brief Summary: Randomised, placebo-controlled dose-response intervention study with vitamin D3 in pregnant women.


Options:
A: 25-hydroxyvitamin D concentration (6 scheduled timepoints during supplementation period); Serum calcium concentration (albumin-corrected) (6 scheduled timepoints during supplementation period); Urine calcium: creatinine ratio (7-8 scheduled timepoints during supplementation period)
B: Persistent wheeze (0 to 3 years of age)
C: Prevention of adverse pregnancy outcome, viz preeclampsia, small for gestational age (SGA), preterm labor (18 months)
D: Serum 25-hydroxyvitamin D in pregnant women and cord blood (Change from 1st through 2nd trimester and at delivery)

Answer: D