TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Shortened Time Interval to Postpartum Visit in Improving Postpartum Attendance
Brief Summary: Due to potential to improve family planning, clinicians are increasingly interested in shortening the time to postpartum visits, but lack an evidence base to change policy.There are no studies that have examined the effectiveness of shortened interval to postpartum visit on attendance rate, contraception use, and rapid repeat of pregnancy (RROP). With this research, the investigators propose to conduct a randomized controlled trial (RCT) to examine the effect of reduced time interval to postpartum visit (3-4 weeks rather than 6-8 weeks) on postpartum visit attendance rate, contraceptive use, and RROP.


Options:
A: Child Emergency Room Presentation Rates (Program enrollment until 24 months of Child Age.); Mother Emergency Room Presentation Rates (Program enrollment until 24 months postnatal.); Child Hospital Admissions (Program enrollment until 24 months postnatal.); Mother Hospital Admissions (Program enrollment until 24 months postnatal.)
B: Postpartum Clinic Attendance (assessed at 12 weeks postpartum)
C: Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (3 years)
D: Quality of life assessed by World Health Organization Quality of Life Assessment Instrument (WHOQOL-Bref) (3 months); Fatigue assessed by Visual Analogue Scale for Fatigue (3 months); Sleep quality assessed by Pittsburg Sleep Quality Index (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: NMDA Receptor Modulation for Hyperarousal in PTSD
Brief Summary: This Phase 1b study examines the safety and efficacy of parenterally-administered lanicemine in a parallel-arm, randomized, double-blind, placebo-controlled trial in adult patients (N=24) with significant PTSD symptoms and elevated anxiety potentiated startle (APS). Investigator hypothesize that lanicemine (100 mg) displays a normalization of APS following three infusions over 5 non-consecutive days. If target engagement is demonstrated and the drug is safe and tolerable in this patient population, investigator will proceed to a larger POC study.


Options:
A: Post-traumatic Stress Disorder (chronic) by CAPS scores. (Four months, seven months, 14 moths, two years)
B: Primary Objective (24 months)
C: Treatment Effect on Mother-infant Bonding (5 days and 2 months postpartum (on average))
D: 28 day mortality in all the non-responders to ACTH (< or = 9 mcg/dl or 250 nmol/L post ACTH) (28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Novel Smartphone Application on Postpartum Weight Loss and Breastfeeding Rates Among Low-income, Urban Women
Brief Summary: Breastfed babies have significant health benefits extending beyond infancy, including lower rates of childhood obesity and infection. Mothers who breastfeeding also have health benefits, including increased rates of postpartum weight loss. Low-income women are less likely to breastfeed comparatively; this disparity may be due to misconceptions about breastfeeding benefits or poor social support. Based on survey results and focus groups of low-income women, the investigators designed a novel smart-phone application to confront barriers women perceived prevented them from breastfeeding and propose the first-ever randomized controlled trial describing the impact a smart phone app has on postpartum weight loss and breastfeeding rates among low-income women.


Options:
A: Infant Feeding Questionnaire (4 weeks)
B: Number of Participants Breastfeeding Without Formula Supplementation (Postpartum day number 2)
C: Breastfeeding self-efficacy (Change from Baseline Breastfeeding self-efficacy at 6 months.)
D: Reduction in the prevalence and degree of obesity at age 3 years (3 years); Improvement in infant diet composition (1-3 years); Improvement in infant lifestyle behaviors associated with increased risk of obesity. (1-3 years); Improvement in parent feeding knowledge, attitudes, styles and practices (1-3 years); Reduction in infant and child excess weight gain (1-3 years); Additional Outcome Measures for the Expanded Starting Early Program: Preschool intervention (2-5 years); Additional Outcome Measures for the Expanded Starting Early Program: Prenatal Intervention (2-5 years); Feasibility process measures: (2-5 years); Participant engagement (2-5 years); Participant satisfaction (2-5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrating Counseling to Transform HIV Family Planning Services
Brief Summary: This 3-arm cluster randomized controlled trial (RCT) will compare (1) a comprehensive family planning (FP) program that incorporates a structured, multi-component safer conception counseling (SCC) intervention (SCC1) versus (2) a SCC training workshop for FP nurses (SCC2; less intensive and mimics approach used by Ugandan Ministry of Health (MoH) to integrate new services), and (3) existing FP services (usual care) at 9 HIV clinics (3 per arm) operated by The AIDS Support Organization (TASO) Uganda.


Options:
A: Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling (6 &12-month follow-up)
B: Medication start/stop, knowledge, and patient involvement. (Baseline and at 6 months)
C: Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes (Measured at the end of the study period (approximately 2 years))
D: Number of Participants Who Used Dual Contraception or Safer Conception Method (Month 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intensive Cognitive Rehabilitation in Subacute Stroke Patient
Brief Summary: Early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications. However, there was no consensus of proper amount of cognitive rehabilitation in stroke patients. In this study, the investigators assess the effects of the intensive cognitive rehabilitation during subacute phase to improve cognitive function at 6 months after onset in patients with first-ever strokes.


Options:
A: Change from Baseline: behavioral Inattention Test (BIT) (up to 21 days post baseline and up to 90 days follow-up)
B: Changes at Behavioral Inattention Test (BIT) (Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training); Changes at KF-NAP scale (Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training)
C: Korean-Montreal Cognitive Assessment (K-MoCA) (Change of K-MoCa after intensive cognitive rehabilitation for 4 weeks)
D: Change in excitability of fronto-parietal connectivity (Participants will be assessed at baseline and 30 minutes later)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intensive Cognitive Rehabilitation in Subacute Stroke Patient
Brief Summary: Early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications. However, there was no consensus of proper amount of cognitive rehabilitation in stroke patients. In this study, the investigators assess the effects of the intensive cognitive rehabilitation during subacute phase to improve cognitive function at 6 months after onset in patients with first-ever strokes.


Options:
A: Change response time during a novel motor task. (Baseline, After Intervention (2 weeks), 30-day follow-up); Wolf Motor Function Task Rate (Baseline, After Intervention (2 weeks), 30-day follow-up)
B: maximum voluntary isometric strength of knee extensors (2 hours)
C: Ambulatory function measured by the Six Minute Walk Test (Rehabilitation discharge (average 4-5 weeks post admission))
D: Korean-Montreal Cognitive Assessment (K-MoCA) (Change of K-MoCa after intensive cognitive rehabilitation for 4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Closed-loop Automatic Control of the Inspiratory Fraction of Oxygen (FiO2-C) on Outcome of Extremely Preterm Infants - a Randomized Controlled Parallel Group Multicenter Trial for Safety and Efficacy
Brief Summary: Extremely low gestational age neonates (ELGANs), i.e. those born at \<28 weeks, frequently experience intermittent hypoxemic/hyperoxemic episodes. Observational data indicate that severe and prolonged hypoxemic episodes are associated with retinopathy of prematurity (ROP), impaired long-term development and death. Closed-loop automated control of the inspiratory fraction of oxygen (FiO2-C) reduces time outside the oxygen target range, decreases number and duration of hypo- and hyperoxemic episodes, and reduces caregivers' workload. The proposed observer-blinded randomized controlled trial was designed and will be powered to compare the effect of FiO2-C in addition to manual adjustments, in comparison with manual adjustments of FiO2 only, on death and severe complications of prematurity thought to be related to hypoxia/hyperoxia and neurodevelopmental impairment in ELGANs. The results of this trial may help to improve the quality of life of ELGANs and reduce the burden of significant morbidity as well as costs for health care and society


Options:
A: proportion of time spent in extreme saturation ( less than or equal to 80%) (Through study completion, an average of 8 weeks)
B: Percent time in target range for oxygen saturation by pulse oximetry (24 hrs)
C: Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment (6 hours or 1 hour after cessation of oxygenation)
D: Primary outcome I: composite outcome of death, severe retinopathy of prematurity (ROP), chronic lung disease of prematurity (BPD), necrotizing enterocolitis (NEC) (until/at post-menstrual age (PMA) 36 weeks (death, BPD and NEC) and at latest at PMA 44 weeks for severity of ROP); Primary outcome II: composite of death or neurodevelopmental impairment (NDI) (at 24 months of age corrected for prematurity)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Scale Down: A Randomized, Controlled Weight Management Intervention for Women With Endometrial Cancer
Brief Summary: This proposal will pilot a weight management program for patients with endometrial cancer, the cancer most associated with obesity. If successful, this pilot could be expanded to include obese women with other gynecologic cancers (ovarian and cervical) and could be expanded and adapted for use not only upon completion of treatment, but during chemotherapy or radiation. Furthermore, other obstetricians and gynecologists could use this strategy for obese women as a practical cancer prevention strategy for obesity-associated cancers.


Options:
A: Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Weight loss as measured by weight, body mass index (BMI), waist circumference, Weight Efficacy Life Style Questionnaire, Three Factor Eating Inventory Questionnaire, and Leisure Score index at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36) (baseline, 3, 6, and 12 months); Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months)
B: Change in Weight (kilograms) (Change from Baseline Weight at 6 months); Serum biomarker: Change in levels of Insulin-like growth factor-binding protein 1 (IGFBP-1), in ng/mL (Change from Baseline IGFBP-1 at 6 months); Serum biomarker: Change in levels of Adiponectin, in ug/mL (Change from Baseline Adiponectin at 6 months); Serum biomarker: Change in levels of Vascular Endothelial Growth Factor (VEGF), in pg/mL (Change from Baseline VEGF at 6 months); Serum biomarker: Change in Interleukin 1-beta (IL1-beta), in pg/mL (Change from Baseline IL1-beta at 6 months); Serum biomarker: Change in Interleukin 2 (IL2), in pg/mL (Change from Baseline IL2 at 6 months); Serum biomarker: Change in Interleukin 6 (IL6), in pg/mL (Change from Baseline IL6 at 6 months); Serum biomarker: Change in Interleukin 7 (IL7), in pg/mL (Change from Baseline IL7 at 6 months); Serum biomarker: Change in Interleukin 8 (IL8), in pg/mL (Change from Baseline IL8 at 6 months); Serum biomarker: Change in C reactive protein (CRP), in mg/L (Change from Baseline CRP at 6 months)
C: Mean weight loss compared between the two arms (Up to 12 months)
D: Weight loss (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Melanomas Excised in Primary Care vs Secondary Care Excision
Brief Summary: Melanoma is the most dangerous skin cancer and is becoming commoner, largely due to increased foreign holidays and use of sun-beds. Melanoma usually begins as a new or changing mole. If it is picked-up quickly enough it can be removed in a simple operation and effectively cured. GPs can do this operation and many are highly experienced and skilled in minor skin surgery. However, guidelines written by hospital specialists insist that all patients who might have a melanoma should not be treated by GPs, but should be referred to hospital. This contrasts with Australia, where melanoma is commoner and initial treatment by GPs is standard practice. This creates several potential problems. First, melanoma can be difficult to diagnose. Many moles that do not look concerning based on checklists do turn out to be melanoma, and the opposite frequently occurs too, moles that look worrying at initial examination are not melanoma. Second, people are becoming more skin aware and GPs are checking moles much more often. Sensibly many of these patients are being sent to hospital for a check, although most will not have melanoma. Third, as a result hospital skin clinics and minor surgery lists are becoming very busy and waiting times are ever increasing. Fourth, the many people who have a melanoma that is not clinically obvious are waiting an increasingly long time to have it diagnosed and treated in hospital, and this could actually mean that melanoma has more chance to spread while they wait. The investigators conducted studies on 1200 people diagnosed with a melanoma in Northeast Scotland between 1991 and 2008 and found that 20% of these people had had their melanoma diagnosed and first treated by their GP. These patients were no more likely to receive improper treatment than those that had been referred to hospital. Also people who had had their melanoma cut out by a GP were no more likely to die from melanoma, and they actually required less hospital visits afterward. This suggests that the guidelines could be changed to allow GPs to treat suspicious moles. The investigators think this will be better for patients and the NHS in the long-run. However, the investigators cannot recommend changes to the guidelines on the basis of local research. For this reason, the investigators wish to extend the study using data from 18,000 patients diagnosed with melanoma from across Scotland. The results of this inclusive study will inform how the health service should deal with the growing problem of suspicious moles in the future.


Options:
A: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)
B: Absence of local recurrence at 3 years after start of treatment
C: Sensitivity and Specificity (Within 120 days of Data Lock)
D: All-cause mortality (Until December 2015)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Melanomas Excised in Primary Care vs Secondary Care Excision
Brief Summary: Melanoma is the most dangerous skin cancer and is becoming commoner, largely due to increased foreign holidays and use of sun-beds. Melanoma usually begins as a new or changing mole. If it is picked-up quickly enough it can be removed in a simple operation and effectively cured. GPs can do this operation and many are highly experienced and skilled in minor skin surgery. However, guidelines written by hospital specialists insist that all patients who might have a melanoma should not be treated by GPs, but should be referred to hospital. This contrasts with Australia, where melanoma is commoner and initial treatment by GPs is standard practice. This creates several potential problems. First, melanoma can be difficult to diagnose. Many moles that do not look concerning based on checklists do turn out to be melanoma, and the opposite frequently occurs too, moles that look worrying at initial examination are not melanoma. Second, people are becoming more skin aware and GPs are checking moles much more often. Sensibly many of these patients are being sent to hospital for a check, although most will not have melanoma. Third, as a result hospital skin clinics and minor surgery lists are becoming very busy and waiting times are ever increasing. Fourth, the many people who have a melanoma that is not clinically obvious are waiting an increasingly long time to have it diagnosed and treated in hospital, and this could actually mean that melanoma has more chance to spread while they wait. The investigators conducted studies on 1200 people diagnosed with a melanoma in Northeast Scotland between 1991 and 2008 and found that 20% of these people had had their melanoma diagnosed and first treated by their GP. These patients were no more likely to receive improper treatment than those that had been referred to hospital. Also people who had had their melanoma cut out by a GP were no more likely to die from melanoma, and they actually required less hospital visits afterward. This suggests that the guidelines could be changed to allow GPs to treat suspicious moles. The investigators think this will be better for patients and the NHS in the long-run. However, the investigators cannot recommend changes to the guidelines on the basis of local research. For this reason, the investigators wish to extend the study using data from 18,000 patients diagnosed with melanoma from across Scotland. The results of this inclusive study will inform how the health service should deal with the growing problem of suspicious moles in the future.


Options:
A: Sensitivity and Specificity (Within 120 days of Data Lock)
B: Absence of local recurrence at 3 years after start of treatment
C: All-cause mortality (Until December 2015)
D: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Sequential Imagery Rehearsal Therapy and Cognitive-Behavioural Therapy in Sexual Assault Victims With Posttraumatic Stress Disorder: a Randomized Control Trial
Brief Summary: Sexual assault victims (SAV) have an elevated risk of developing posttraumatic stress disorder (PTSD). Trauma-focused cognitive-behavioural therapy (CBT) is an effective first-line treatment for this pathology. However, although sleep disturbances are a common complaint in SAV with PTSD, trauma-focused CBT does not directly address this symptom. Posttraumatic nightmares are widespread among SAV. Trauma-related sleep disturbances are associated with significant impairment in general functioning and quality of life (mental and physical health), and contribute to the maintenance of PTSD symptoms. This study evaluates the efficacy of sequential nightmare therapy (imagery rehearsal therapy; IRT) and trauma-focused CBT, in comparison to CBT alone. Forty-two SAV suffering from PTSD and sleep difficulties were recruited and randomly assigned to the experimental (IRT+CBT) or control condition (waiting period followed by CBT alone). Participants were administered a clinical interview and a series of questionnaires assessing PTSD symptoms, general functioning and quality of life.


Options:
A: Change in Pittsburgh Sleep Quality Index total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU); Change in Modified PTSD Symptom Scale - Self Report total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU)
B: PTSD Checklist (PCL) (Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment)
C: Clinician Assessed Severity of PTSD (Baseline, 16, 24 and 32 weeks)
D: Change in Number of Health Risks (Two months); Change in Number of Health Risks (Four months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Sequential Imagery Rehearsal Therapy and Cognitive-Behavioural Therapy in Sexual Assault Victims With Posttraumatic Stress Disorder: a Randomized Control Trial
Brief Summary: Sexual assault victims (SAV) have an elevated risk of developing posttraumatic stress disorder (PTSD). Trauma-focused cognitive-behavioural therapy (CBT) is an effective first-line treatment for this pathology. However, although sleep disturbances are a common complaint in SAV with PTSD, trauma-focused CBT does not directly address this symptom. Posttraumatic nightmares are widespread among SAV. Trauma-related sleep disturbances are associated with significant impairment in general functioning and quality of life (mental and physical health), and contribute to the maintenance of PTSD symptoms. This study evaluates the efficacy of sequential nightmare therapy (imagery rehearsal therapy; IRT) and trauma-focused CBT, in comparison to CBT alone. Forty-two SAV suffering from PTSD and sleep difficulties were recruited and randomly assigned to the experimental (IRT+CBT) or control condition (waiting period followed by CBT alone). Participants were administered a clinical interview and a series of questionnaires assessing PTSD symptoms, general functioning and quality of life.


Options:
A: Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013) (Baseline, changes from baseline at 1 week post-treatment, 3 months post-treatment, and 6 months post-treatment)
B: Number of Participants Who Engage in Mental Health Treatment (Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.); Center for Epidemiological Studies Depression Scale (Baseline (pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.)
C: PTSD Symptom Scale- I (PSS) (Measured 4 and 12 weeks post-trauma)
D: Change in Pittsburgh Sleep Quality Index total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU); Change in Modified PTSD Symptom Scale - Self Report total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU)

Answer: D