TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention Trial of Family Focused Treatment in Youth at Risk for Psychosis
Brief Summary: Preventing psychotic disorders such as schizophrenia and associated functional disability could relieve an enormous burden of personal and family suffering and economic losses to society. This project aims to conduct a pilot randomized trial to determine the efficacy of a family-focused treatment in comparison with treatment-as-usual in enhancing functional outcomes, stabilizing symptoms, and preventing or delaying the onset of full psychosis in transitional age youth with prodromal symptoms. The results of this study will be crucial for the development of cost-effective, evidence-based psychosocial approaches to psychosis prevention and thus will have major implications for public health.


Options:
A: Cognitive performance (20 weeks)
B: Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint
C: number of relapses (Change from baseline to 1 -year follow-up and 2 years follow-up)
D: Change in subthreshold psychotic (positive and negative) symptoms (Change from pretreatment (assessed for the 3 months prior to randomization) to 12 month reassessment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention Trial of Family Focused Treatment in Youth at Risk for Psychosis
Brief Summary: Preventing psychotic disorders such as schizophrenia and associated functional disability could relieve an enormous burden of personal and family suffering and economic losses to society. This project aims to conduct a pilot randomized trial to determine the efficacy of a family-focused treatment in comparison with treatment-as-usual in enhancing functional outcomes, stabilizing symptoms, and preventing or delaying the onset of full psychosis in transitional age youth with prodromal symptoms. The results of this study will be crucial for the development of cost-effective, evidence-based psychosocial approaches to psychosis prevention and thus will have major implications for public health.


Options:
A: Psychotic Symptoms (two years)
B: Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (6 months (for Phases 1 and 2) after completion of intervention); Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (12 months (for Phases 1 and 2) after completion of intervention); Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (24 months (for Phase 2 only) after completion of intervention); Coping style (42-item Revised Ways of Coping Checklist) (6 months (for Phases 1 and 2) after completion of intervention); Coping style (42-item Revised Ways of Coping Checklist) (12 months (for Phases 1 and 2) after completion of intervention); Coping style (42-item Revised Ways of Coping Checklist) (24 months (for Phase 2 only) after completion of intervention)
C: Change in subthreshold psychotic (positive and negative) symptoms (Change from pretreatment (assessed for the 3 months prior to randomization) to 12 month reassessment)
D: Psychotic symptoms at one and two year follow-up; Negative symptoms at one and two year follow-up

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections
Brief Summary: This trial is a pilot study to determine the feasibility of a randomized clinical trial comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid molecular viral diagnostics, and serum procalcitonin testing to standard of care for directing antibiotic use in patients with non-pneumonic lower respiratory tract infection. The reduction in antibiotic use in those subjects randomized to the treatment algorithm compared to those randomized to standard care will be determined.


Options:
A: the risk of disease specific failure (within 1 month COPD)
B: N/A
C: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
D: Antibiotic days (Total antibiotic days within 30 days after randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level: a Cluster Randomized Trial
Brief Summary: This study aims to test directly by means of a cluster randomized controlled trial, the impact of the introduction of RDTs for malaria on dispensing behaviour of chemical sellers, the main non-formal outlet for drugs locally, at community level.


Options:
A: Number of Children Who Received Early and Appropriate Treatment for Pneumonia. (one year); Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) (one year)
B: Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups (28 days)
C: The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms (Until the estimated sample size is obtained or up to 2 yrs whichever comes first)
D: Proportion of cases correctly treated (Outcomes measured during consultation - approximately 30-40 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Phase IV Trial Evaluating the Palliative Benefit of Either Continuing Pamidronate or Switching to Second-line Zoledronic Acid in Breast Cancer Patients With High-risk Bone Metastases.
Brief Summary: Metastatic breast cancer patients with bone involvement who are at high-risk of subsequent skeletal related event (SRE), defined as radiotherapy or surgery to the bone, pathological fracture, spinal cord compression, or hypercalcemia (as reflected through: elevated sCTX or bone pain or a prior SRE despite receiving standard bisphosphonate therapy) should experience a decrease in the surrogate marker, sCTX, at week 12 if switched to zoledronic acid compared with those patients who continue on intravenous pamidronate (i.e. current standard of care). The investigators propose that a drop in sCTX will correlate with improved pain, quality of life and a reduced incidence of further SREs.


Options:
A: sCTX values (baseline, 1 week post treatment, week 4, week 8, week 12)
B: Increase in apoptotic index between diagnostic core biopsy and repeat core biopsy taken on day 5 (Repeat biopsy on day 5 (+/- day 21))
C: Disease Free Survival. (8 years)
D: Evaluate the impact of Zometa (zoledronic acid) on the clearance of bone marrow micrometastases (Prior to therapy initiation, after completion of neoadjuvant chemotherapy, and 12-15 months from registration); Evaluate the protective effect of Zometa (zoledronic acid) on chemotherapy-induced loss of bone mineral density (Prior to therapy initiation and 12-15 months from registration)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Systemic lidocaine infusion may improve the patients' recovery quality and chronic post surgical pain after robot-assisted thyroidectomy


Options:
A: The primary outcome will be postoperative pain, measured by an NRS, the quality of recovery score (QoR) and a Self Assessment Diary in the first 24h postoperative period. (24 hours)
B: VAS and McGill PRI(R)2 scores for phantom and stump pain are recorded 48 and 24 hours before, and 4 and 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity are the endpoints of the study. (six months)
C: opiate consumption (hospital discharge/ days 0-7)
D: Quality of recovery 40(QoR-40) score (24hours after operation day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Systemic lidocaine infusion may improve the patients' recovery quality and chronic post surgical pain after robot-assisted thyroidectomy


Options:
A: To estimate the immediate postoperative analgesic effect of the association ketamine IV-thoracic epidural with regard to the use of the only epidural (24 months)
B: Evaluation of chronic postsurgical pain. (After 3 and 12 months of surgery.)
C: Quality of recovery 40(QoR-40) score (24hours after operation day)
D: 30% decrease in VAS score on mobilization on the day of surgery (patients will be followed during all the duration of hospital stay and 2 months after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Systemic lidocaine infusion may improve the patients' recovery quality and chronic post surgical pain after robot-assisted thyroidectomy


Options:
A: Quality of Recovery 40 Score (24 hours post surgery)
B: Quality of recovery 40(QoR-40) score (24hours after operation day)
C: Postoperative pain measuring using Visual analogue scale at postoperative 2hour (Post op 2 hour)
D: Length of hospital stay; Total opioid use at 48 hours postoperatively

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based Intervention Package for Polio Eradication in Pakistan
Brief Summary: The objective of the projects is to Develop and implement a Package of interventions that will comprise of an augmented communication and counseling strategy coupled with private sector involvement and a combined Oral Polio Vaccine and Inject able Polio Vaccine approach during the Polio campaigns followed by the evaluation of this project for acceptability, feasibility and effectiveness of the intervention Package.


Options:
A: Change from baseline in number of child maltreatment protective factors available to caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Caregivers Assessment of Protective Factors" (t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later); Change from baseline in number and amount of income supports available to and accessed by caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Self-Report Family Inventory" + supplementary questions on $ value (t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later); Change from baseline in social capital available to caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Social Network Grid" (t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later); Change from baseline in parental stress at 6 months, as measured by the "Parenting Stress Index (PSI) - long form" (t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later); Change from baseline in parenting and child-rearing attitudes of child's caregiver at 6 months, as measured on the "Adult-Adolescent Parenting Inventory(AAPI-2)" (t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later)
B: Receipt of influenza vaccine during pregnancy (Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.)
C: Improved immunization coverage (At the completion of all recruitment and follow ups which will take an average time of 1 year)
D: 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm (efficient or participatory), 11-12 year olds (Baseline, month 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based Intervention Package for Polio Eradication in Pakistan
Brief Summary: The objective of the projects is to Develop and implement a Package of interventions that will comprise of an augmented communication and counseling strategy coupled with private sector involvement and a combined Oral Polio Vaccine and Inject able Polio Vaccine approach during the Polio campaigns followed by the evaluation of this project for acceptability, feasibility and effectiveness of the intervention Package.


Options:
A: Initiation of Long acting reversible contraception method (6 months)
B: Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate (1 year); Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations (1 year); Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month (1 year)
C: Improved immunization coverage (At the completion of all recruitment and follow ups which will take an average time of 1 year)
D: To assess the effectiveness of SMS reminders on cell phones in improving the compliance of subsequent visits for routine immunization for children in Pakistan (10 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Double-dummy, Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Twice-daily Aclidinium Bromide/Formoterol Fumarate Compared With Twice-daily Salmeterol/Fluticasone Propionate for 24 Weeks Treatment in Symptomatic Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)


Options:
A: Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 (At Week 24)
B: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) (Baseline and Week 24)
C: Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE) (Up to study Week 56 ± 3 days)
D: Identifying new patient subtypes and endpoints for COPD (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Double-dummy, Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Twice-daily Aclidinium Bromide/Formoterol Fumarate Compared With Twice-daily Salmeterol/Fluticasone Propionate for 24 Weeks Treatment in Symptomatic Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)


Options:
A: Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period
B: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Baseline (BL) and Day 85)
C: Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 (At Week 24)
D: Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84 (Baseline (Day 1) and Day 84)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Double-dummy, Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Twice-daily Aclidinium Bromide/Formoterol Fumarate Compared With Twice-daily Salmeterol/Fluticasone Propionate for 24 Weeks Treatment in Symptomatic Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)


Options:
A: Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Week 12 (Visit 4)); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Day 1 (baseline) and week 12)
B: Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 (At Week 24)
C: Adjusted Rate of Moderate or Severe Exacerbations (52-week treatment period)
D: Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Forced Expiratory Volume Over 1 Second (FEV1) at Day 84 (Baseline and Day 84)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Double-dummy, Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Twice-daily Aclidinium Bromide/Formoterol Fumarate Compared With Twice-daily Salmeterol/Fluticasone Propionate for 24 Weeks Treatment in Symptomatic Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)


Options:
A: Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Forced Expiratory Volume Over 1 Second (FEV1) at Day 84 (Baseline and Day 84)
B: Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Non-inferiority of QVA149 110/50 μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d (26 weeks)
C: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
D: Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 (At Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism
Brief Summary: We are studying an investigational drug called intranasal oxytocin (Syntocinon®). Syntocinon® has been approved by the U.S. Food and Drug Administration for use in helping women breastfeed, but it has not been approved for use in children with ASD. However, there is previous research conducted that has indicated that after administration of oxytocin, adults with ASD demonstrated improvements in social cognition, and reduced repetitive behaviours and anxiety. There is also early research to suggest that children may also benefit in these areas. The purpose of this study is to test if oxytocin works to help children and adolescents with ASD.


Options:
A: Child Autism Rating Scale score (day 0 to day 90)
B: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale (6 Weeks)
C: Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment. (Baseline; Week 4)
D: Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function (12 and 24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism
Brief Summary: We are studying an investigational drug called intranasal oxytocin (Syntocinon®). Syntocinon® has been approved by the U.S. Food and Drug Administration for use in helping women breastfeed, but it has not been approved for use in children with ASD. However, there is previous research conducted that has indicated that after administration of oxytocin, adults with ASD demonstrated improvements in social cognition, and reduced repetitive behaviours and anxiety. There is also early research to suggest that children may also benefit in these areas. The purpose of this study is to test if oxytocin works to help children and adolescents with ASD.


Options:
A: Buss-Durkee Hostility Inventory; Barratt Impulsiveness Scale
B: Percentage of Patients Relapsing by Week 16 (From end of Phase 1 (Date of randomization) to Week 16 of Phase 2 and end of treatment)
C: Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function (12 and 24 weeks)
D: Children's Psychiatric Rating Scale (Weekly)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism
Brief Summary: We are studying an investigational drug called intranasal oxytocin (Syntocinon®). Syntocinon® has been approved by the U.S. Food and Drug Administration for use in helping women breastfeed, but it has not been approved for use in children with ASD. However, there is previous research conducted that has indicated that after administration of oxytocin, adults with ASD demonstrated improvements in social cognition, and reduced repetitive behaviours and anxiety. There is also early research to suggest that children may also benefit in these areas. The purpose of this study is to test if oxytocin works to help children and adolescents with ASD.


Options:
A: Clinical Global Impression-Improvement Scale (CGI-I) (Baseline to 12 weeks)
B: Nonverbal Developmental Quotient (NVDQ) (Baseline and 12 months)
C: Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function (12 and 24 weeks)
D: Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents (week 10); Percentage of Participants Who Were Autism Spectrum Disorder Respondents (week 10)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The ACTonHEART Study: a Randomized Controlled Clinical Trial of Acceptance and Commitment Therapy in Cardiac Patients
Brief Summary: The study will determine whether a brief intervention program based on Acceptance and Commitment Therapy can be effective for the reduction of modifiable risk factors and improvement of psychological well-being in patients referred to cardiac rehabilitation


Options:
A: Re-hospitalization and death rates (Measured at Month 12); Total hospitalizations (Measured at Month 12); HF-specific quality of life (Measured at Months 6 and 12)
B: The cumulative incidence of new cardiological events and the occurrence of new medical pathologies (5 years)
C: Low-density lipoprotein (LDL)cholesterol (Baseline and 12 months); Blood pressure (baseline and 12 months); Body Mass Index (baseline and 12 months); Psychological Well-Being (Baseline and 12 months)
D: Levels of proinflammatory cytokines (IL-1 and IL-6) (at baseline and after 8 weeks (at the completion of the intervention)); The soluble receptor for IL-6 (sIL-6) (at baseline and after 8 weeks (at the completion of the intervention)); Inflammatory markers c-reactive protein (CRP and sICAM-1) (at baseline and after 8 weeks (at the completion of the intervention))

Answer: C