TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: International Register of Open Abdomen
Brief Summary: To evaluate the different indications to Open Abdomen, the different techniques used to perform it, it's management, it's definitive closure and mortality rates linked to the different variables. Moreover to evaluate the 1 month and 1 year follow up in patients underwent to Open Abdomen.


Options:
A: Systemic inflammatory marker levels and peritoneal fluid inflammatory marker levels (admission to dicharge, expected average of hospital stay 4 weeks.)
B: Indications to open abdomen (Enrollment); Techniques to perform open abdomen (Enrollment); Management of open abdomen (Visit 2); Definitive closure techniques (Visit 4)
C: Fascial Closure Rate (Until hospital discharge Aprox 60 days)
D: The numbers of participants who are survival in hospital stay (90 days after participants enrolled in the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimization of the Flare Management in Rheumatoid Arthritis (RA) by Implementing Patient-driven Systematic Changes to the RA Ambulatory Care Stream
Brief Summary: The purpose of this study is to determine how best to monitor for flares in patients with rheumatoid arthritis (RA).


Options:
A: UWQOL v4 QoL (Post-Treatment 1 Year Review Clinic)
B: Heart Failure-specific Quality of Life (twelve-month followup)
C: Flare Occurrence (Anticipated length of study is two years.); Flare-to-visit Time (Anticipated length of study is two years.)
D: Occurrence of Discussion About Goals of Care at Target Visit (2 weeks after target visit)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of Pazopanib and Weekly Paclitaxel in Patients With Platinum Resistant/Refractory Ovarian Cancer Who Relapse During Bevacizumab Maintenance
Brief Summary: Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance.


Options:
A: Progression Free Survival (2 years)
B: To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer (every 8 weeks)
C: Progression free survival (PFS) (4 months)
D: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of Pazopanib and Weekly Paclitaxel in Patients With Platinum Resistant/Refractory Ovarian Cancer Who Relapse During Bevacizumab Maintenance
Brief Summary: Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance.


Options:
A: Progression Free Survival (PFS) (Assessed frequently during the trial until observation of 586 PFS events or three years after Last Patient In, whichever occurs earlier)
B: Progression free survival (PFS) (4 months)
C: Progression free survival (up to 18 months)
D: Progression-free survival (Apr 2013)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of Pazopanib and Weekly Paclitaxel in Patients With Platinum Resistant/Refractory Ovarian Cancer Who Relapse During Bevacizumab Maintenance
Brief Summary: Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance.


Options:
A: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018)
B: Progression free survival (PFS) (4 months)
C: ORR (Up to 2 years); PFS (Up to 2 years)
D: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Incorporating PROMIS Symptom Measures Into Primary Care Practice
Brief Summary: The purpose of this study is to determine the effectiveness of providing PROMIS Profile Scale scores (e.g., sleep, pain, anxiety, depression, energy/fatigue) to physicians on patients' symptoms.


Options:
A: Flare Occurrence (Anticipated length of study is two years.); Flare-to-visit Time (Anticipated length of study is two years.)
B: To evaluate patient willingness to use STAR (Symptom Tracking and Reporting for Patients), an Internet-based system for cancer patients to self-report common toxicity symptoms, performance status, and quality of life. (conclusion of study); To evaluate the impact of STAR on clinical outcomes (2 years)
C: Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up (baseline and 3 month follow up)
D: Risky drinking (6, 12, 18, 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder
Brief Summary: This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old inclusive with Autism Spectrum Disorder. The trial is six months long, and each participant will receive a series of tests at both the beginning and end of the study. The researchers hope to show improvements in language and social deficits.


Options:
A: Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I) (Baseline and 7 days.)
B: Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (Least Mean Squares Double-blind phase: change from baseline to week 24); Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (Least mean squares for Open Label: Change between weeks 24-48)
C: Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function (12 and 24 weeks)
D: Change in Mullen Scales of Early Learning - Expressive Language Raw Score (From baseline visit to six-month visit); Change in Mullen Scales of Early Learning - Combined Age Equivalent Score (From baseline visit to six-month visit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Bimodal Pre-habilitation Program to Improve Symptom Control After Treatment for Head and Neck Cancer
Brief Summary: The purpose of this study is to explore whether early initiated physical exercise concurrent with a swallowing and mouth opening exercise program will have a positive effect on swallowing function and other quality of life aspects in patients treated with radiotherapy for head and neck cancer. The investigators hypothesize that patients who complete the program will have improved swallowing function and physical function one year after completing their treatment compared to patients who do not participate in the training program.


Options:
A: Fatigue (immediately before and after the intervention)
B: Swallowing function measured by penetration aspiration scale (PAS) during a Fiber Endoscopic Evaluation of Swallowing (FEES). (Baseline, 14 weeks and 58 weeks. Participants will be followed up till 12 months after they finalize their radiotherapy, an expected average of 58 weeks from baseline.)
C: Change from Baseline Cancer-related fatigue at post-radiotherapy and follow-up (Baseline, post-radiotherapy (~6weeks), follow-up (~8 weeks))
D: Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex. (10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia
Brief Summary: Vitreoretinal surgery is associated with a considerable incidence of postoperative nausea and vomiting (PONV), which is reported to be as high as 60%. Reasons for this high incidence may be the long duration of surgery and anesthesia and the high degree of manipulation of the eye. Postoperative vomiting after vitrectomy is an important risk factor for the onset of several complications, such as suprachoroidal hemorrhage, with disastrous visual consequences.

To date there is no evidence as to the possible protective effect of anti-emetic therapy with regard to interventions of vitrectomy performed under local anesthesia.

In this prospective, randomized, multicenter, double blind study, we evaluated the efficacy of Ondansetron alone, Dexamethasone alone and in combination in controlling nausea and vomiting in patients undergoing vitrectomy under local anesthesia.


Options:
A: Effect of Granisetron and Ondansetron on QTc interval Prolongation at various time intervals after administration (0 mins (before injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours)
B: Prevention of PONV in the 24 hours following end of surgery; Tolerability (24 hours)
C: pain during coughing (day 1)
D: • Proportion of patients with Complete Response (no nausea, no vomiting, no retching, and no use of rescue medication) during the first 24 hours after surgery (1-24 hours post-operatively)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ISIS 396443 Delivered Intrathecally to Subjects With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy
Brief Summary: The primary objective of the study is to examine the efficacy of multiple doses of Nusinersen administered intrathecally in preventing or delaying the need for respiratory intervention or death in infants with genetically diagnosed and presymptomatic spinal muscular atrophy (SMA). Secondary objectives of this study are to examine the effects of Nusinersen in infants with genetically diagnosed and presymptomatic SMA.


Options:
A: Percentage of Motor Milestones Responders (assessed at the later of the Day 183, Day 302, or Day 394 study visits); Time to Death or Permanent Ventilation (Day 91, Day 182, Day 273, Day 364, Day 394)
B: Time to death or respiratory intervention (Up to Day 2891)
C: Manual Muscle Test (Medical Research Council scale-MRC), the Hammersmith Motor Ability Score (one year)
D: To assess safety and tolerability of VPA in SMA patients greater than 2 years of age

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ISIS 396443 Delivered Intrathecally to Subjects With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy
Brief Summary: The primary objective of the study is to examine the efficacy of multiple doses of Nusinersen administered intrathecally in preventing or delaying the need for respiratory intervention or death in infants with genetically diagnosed and presymptomatic spinal muscular atrophy (SMA). Secondary objectives of this study are to examine the effects of Nusinersen in infants with genetically diagnosed and presymptomatic SMA.


Options:
A: To assess safety and tolerability of VPA in SMA patients greater than 2 years of age
B: Time to death or respiratory intervention (Up to Day 2891)
C: Safety Labs (-4 wks, 0, 2 wks, 3 mo, 6 mo, 9 mo, 12 mo for safety labs; throughout for AEs); Efficacy, Measured Through Motor Function Assessments (-4wks, 0, 3 mo, 6 mo, 12 mo); Modified Hammersmith Change From Baseline to 6 Months (0 months, 6 months)
D: Number of Participants That Experienced One Grade III or Higher Unanticipated, Treatment-related Toxicity That Presents With Clinical Symptoms and Requires Medical Treatment (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Pharmaceutical Care Intervention to Improve Adherence of Inhaled Medication in Asthma and COPD Patients
Brief Summary: Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among asthma and COPD patients is high and patients may be frequently hospitalized due to exacerbations. Reasons for uncontrolled disease are manifold, but are frequently associated with poor inhalation technique and non-adherence to the prescribed treatment plan which may cause substantial mortality, morbidity, and cost to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase respectively maintain treatment adherence, particularly in chronic diseases, is of major clinical importance.

The aim of this study was to investigate the impact of an acoustic reminder and a close supervision on adherence to inhaled medication and on course of disease and quality of life (Qol) in asthma and COPD patients.

In this single-blinded trial, asthma and/or COPD patients were randomly assigned either to the intervention or the control group. Adherence to inhaled medication was monitored using electronic data capture devices, recording date and time of each inhalation device actuation. Follow-up was six months. Primary outcome was defined as "time to next exacerbation". Secondary outcomes included number of exacerbations, number of exacerbations with hospitalization, taking/timing adherence, and Qol during follow-up. Adherence was measured using electronic data capture devices which saved date and time of each inhalative device actuation. Patients are randomly assigned to an intervention, respectively control group. Patients assigned to the intervention group will receive audio reminder and support calls in case medication is not been taken as prescribed or if rescue medication is used more frequently than prespecified in the study protocol. During the study, participants are assessed every two months.


Options:
A: Time to Next Asthma or COPD Exacerbation up to 182 Days (182 days)
B: Medicines adherence (Change in adherence from 6 weeks to 10 weeks and 26 weeks); Cost effectiveness (6 months); Operation of the NMS (1 year from first recruited patient)
C: Mean Number of Exacerbations Per Year: Negative Binomial Model (Baseline through Week 52); Mean Number of Exacerbations Per Year: Poisson Model (Baseline through Week 52)
D: Adverse events (Evaluation at 12 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Pharmaceutical Care Intervention to Improve Adherence of Inhaled Medication in Asthma and COPD Patients
Brief Summary: Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among asthma and COPD patients is high and patients may be frequently hospitalized due to exacerbations. Reasons for uncontrolled disease are manifold, but are frequently associated with poor inhalation technique and non-adherence to the prescribed treatment plan which may cause substantial mortality, morbidity, and cost to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase respectively maintain treatment adherence, particularly in chronic diseases, is of major clinical importance.

The aim of this study was to investigate the impact of an acoustic reminder and a close supervision on adherence to inhaled medication and on course of disease and quality of life (Qol) in asthma and COPD patients.

In this single-blinded trial, asthma and/or COPD patients were randomly assigned either to the intervention or the control group. Adherence to inhaled medication was monitored using electronic data capture devices, recording date and time of each inhalation device actuation. Follow-up was six months. Primary outcome was defined as "time to next exacerbation". Secondary outcomes included number of exacerbations, number of exacerbations with hospitalization, taking/timing adherence, and Qol during follow-up. Adherence was measured using electronic data capture devices which saved date and time of each inhalative device actuation. Patients are randomly assigned to an intervention, respectively control group. Patients assigned to the intervention group will receive audio reminder and support calls in case medication is not been taken as prescribed or if rescue medication is used more frequently than prespecified in the study protocol. During the study, participants are assessed every two months.


Options:
A: Appropriate use of asthma controller medications (Measured at Year 1); Number of asthma symptom days (Measured at Year 1)
B: Asthma Exacerbations (12 months)
C: Time to Next Asthma or COPD Exacerbation up to 182 Days (182 days)
D: MDI use Competence in Clinic (1 day); MDI use Competence at home (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dialectical Behaviour Therapy for Chronically Self-harming Individuals With BPD: Evaluating the Clinical and Cost Effectiveness of a 6-month Treatment
Brief Summary: Standard one-year dialectical behaviour therapy (DBT), which has four components, is an effective treatment for people with borderline personality disorder. However, such DBT programs are in short supply and costly, resulting in long wait lists. In practice, DBT is often reduced in length or intensity. This study will determine whether shorter DBT treatment is clinically effective and cost-effective. In total, 240 self-harming BPD patients will be randomly assigned to receive either 1 year or 6 months of DBT, with follow-up lasting two years. Rates of suicidal and self-harm behaviours, use of health care and general psychological functioning will be examined.


Options:
A: Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII) (Administered pre-treatment and every three months until 24 months)
B: Changes in score of Affective Lability Scale (Baseline and then weekly for 12 weeks); Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder (Baseline and then weekly for 12 weeks)
C: CAPS-5 (Clinician Administered PTSD Scale) (12 months)
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: Dialectical Behaviour Therapy for Chronically Self-harming Individuals With BPD: Evaluating the Clinical and Cost Effectiveness of a 6-month Treatment
Brief Summary: Standard one-year dialectical behaviour therapy (DBT), which has four components, is an effective treatment for people with borderline personality disorder. However, such DBT programs are in short supply and costly, resulting in long wait lists. In practice, DBT is often reduced in length or intensity. This study will determine whether shorter DBT treatment is clinically effective and cost-effective. In total, 240 self-harming BPD patients will be randomly assigned to receive either 1 year or 6 months of DBT, with follow-up lasting two years. Rates of suicidal and self-harm behaviours, use of health care and general psychological functioning will be examined.


Options:
A: Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII) (Administered pre-treatment and every three months until 24 months)
B: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)
C: Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010) (12 weeks); Self-harm and related hospital use as reported in National Health Service patient records (12 weeks)
D: The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 40 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 10 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 20 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 30 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dialectical Behaviour Therapy for Chronically Self-harming Individuals With BPD: Evaluating the Clinical and Cost Effectiveness of a 6-month Treatment
Brief Summary: Standard one-year dialectical behaviour therapy (DBT), which has four components, is an effective treatment for people with borderline personality disorder. However, such DBT programs are in short supply and costly, resulting in long wait lists. In practice, DBT is often reduced in length or intensity. This study will determine whether shorter DBT treatment is clinically effective and cost-effective. In total, 240 self-harming BPD patients will be randomly assigned to receive either 1 year or 6 months of DBT, with follow-up lasting two years. Rates of suicidal and self-harm behaviours, use of health care and general psychological functioning will be examined.


Options:
A: Number of days with hospital admission (Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively)
B: Change in self-injury attentional bias as measured by a Dot Probe Paradigm (The Dot Probe Paradigm will be administered immediately preceding the mindfulness or control conditions and immediately following the mindfulness or control conditions)
C: Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII) (Administered pre-treatment and every three months until 24 months)
D: Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6 (Baseline, Week 1, Week 2, Week 3, Week 4, Week 5)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dialectical Behaviour Therapy for Chronically Self-harming Individuals With BPD: Evaluating the Clinical and Cost Effectiveness of a 6-month Treatment
Brief Summary: Standard one-year dialectical behaviour therapy (DBT), which has four components, is an effective treatment for people with borderline personality disorder. However, such DBT programs are in short supply and costly, resulting in long wait lists. In practice, DBT is often reduced in length or intensity. This study will determine whether shorter DBT treatment is clinically effective and cost-effective. In total, 240 self-harming BPD patients will be randomly assigned to receive either 1 year or 6 months of DBT, with follow-up lasting two years. Rates of suicidal and self-harm behaviours, use of health care and general psychological functioning will be examined.


Options:
A: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23). (Baseline and up to 12 months after inclusion.)
B: Suicide ideation (12 month)
C: Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII) (Administered pre-treatment and every three months until 24 months)
D: Suicide Attempt Self-Injury Interview (SASII) (4 months, 8 months and 12 months)

Answer: C