TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy in a Private Practice Setting - A Large Prospective Randomized Trial
Brief Summary: Narrow Band Imaging (NBI) with high-definition (HDTV) visualization has been implemented into GI endoscopy with the purpose to better highlight endoluminal pathological structures by improving their contrast. Previous studies from referral centers could not show significant differences in terms of colonoscopic adenoma detection rate, but either very high adenoma rates or some numerical differences suggested that some benefit may exist which may become evident with average adenoma rates and/or large case numbers.

In a prospective randomized trial performed exclusively in a multicenter private practice setting involving 6 examiners with substantial life-time experience (\>10.000 colonoscopies) 1200 patients will undergo HDTV screening colonoscopy with either NBI or conventional imaging technique on instrument withdrawal. Primary outcome measure is the adenoma detection rate (ADR; i.e. number of adenomas per patient).


Options:
A: The primary outcome is whether the patient is a responder or not after 8 weeks treatment.; The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.; The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe).
B: adenoma detection rate (number of polyps/number of patients examined) (6 months)
C: Neoplasm Miss Rate (same day)
D: The prevalence of adenomas in the three arms of the study. (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Stress Reduction on Surgical Wound Healing: A Randomised Controlled Trial
Brief Summary: The purpose of this study is to investigate whether a stress reduction intervention prior to surgery can improve wound healing and recovery.The investigators hypothesise that patients who receive a psychological stress reduction intervention prior to surgery will report lower stress and higher perceived control, have lower stress hormones, better wound healing and better self-reported recovery than patients who receive standard care alone.


Options:
A: Change Eating behaviours (This co-primary outcome will be assessed, first, one week before the start of the 10 weeks intervention, and second, 1 week after the termination of the 10-weeks intervention. In addition a 1 and 4 year follow-up have been performed); Change Affective symptoms (This co-primary outcome will be assessed, first, one week before the start of the 10 weeks intervention, and second, 1 week after the termination of the 10-weeks intervention. In addition a 1 and 4 year follow-up have been performed)
B: Change from baseline state anxiety via the State Trait Anxiety Scale (STAI) (Ten days)
C: Incidence of spontaneous dreams and recallable dreams while using different general anaesthesiological methods? (2009 - 2011)
D: expanded polytetrafluoroethylene (ePTFE) tubes assessed for hydroxyproline deposited per unit length of the tube as well as total protein (7 days following surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors
Brief Summary: The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on treatment. Those in which it is unclear will be randomized to continue or withdraw treatment to determine whether that benefit is related to brivanib


Options:
A: Overall survival (After follow-up is complete (year 3-4 of the trial))
B: Radiographic imaging and clinical evaluation will be used for tumor assessment (every 6 weeks)
C: Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)); Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months))
D: Primary objective: Determination of the progression-free survival (PFS) of patients treated with topotecan and sorafenib versus topotecan and placebo (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors
Brief Summary: The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on treatment. Those in which it is unclear will be randomized to continue or withdraw treatment to determine whether that benefit is related to brivanib


Options:
A: Progression-free survival (Apr 2013)
B: Primary objective: Determination of the progression-free survival (PFS) of patients treated with topotecan and sorafenib versus topotecan and placebo (18 months)
C: Radiographic imaging and clinical evaluation will be used for tumor assessment (every 6 weeks)
D: Progression Free Survival (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Personality disorders are life-long maladaptive behavioral patterns. Borderline personality disorder (BPD) is the leading personality disorder encountered in clinical settings, often associated with tremendous distress. It is characterized by impulsivity, emotional lability, unstable interpersonal relationships, with particular sensitivity to abandonment. BPD patients are prone to self destructive behaviors and all too frequently attempt suicide. When in emotional turmoil, persons with BPD may also develop brief, transient psychotic states.

Psychotherapy for BPD is a common treatment option, but it requires considerable time and specific personnel training, and is therefore not always feasible. Medical treatment is an efficacious alternative, however there is no concensus on drug selection. Some experts have suggested that medical treatment should be selected individually according to the subject's dominant clinical symptom. Several psychopharmacological groups have been proposed: Antidepressants, mood stabilizers, and several novel antipsychotic drugs. The latter are particularly promising since they may produce symptomaic improvement with fewer adverse effects. Risperidone has been shown in a few preliminary studies to be promising in the treatment of various BPD symptoms, but no controlled study has tested it yet. We propose to test the efficacy of risperidone in the treatment of BPD in a double-blind crossover design using both clinical and phsysiological measure.The main hypothesis is that risperidone will be efficient in alleviating BPD core and secondary symptoms.


Options:
A: 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))
B: treatment adherence, defined as outpatient mental health clinic attendance (6-month, and 12-month)
C: Clinical Global Improvement Scale (0, 1, 5, 10 week)
D: Change in Beck Scale for Suicide Ideation Score (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Suicide Attempt Index (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Index of Spouse Abuse Score (Baseline, Week 10, Post-treatment Months 6 and 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Personality disorders are life-long maladaptive behavioral patterns. Borderline personality disorder (BPD) is the leading personality disorder encountered in clinical settings, often associated with tremendous distress. It is characterized by impulsivity, emotional lability, unstable interpersonal relationships, with particular sensitivity to abandonment. BPD patients are prone to self destructive behaviors and all too frequently attempt suicide. When in emotional turmoil, persons with BPD may also develop brief, transient psychotic states.

Psychotherapy for BPD is a common treatment option, but it requires considerable time and specific personnel training, and is therefore not always feasible. Medical treatment is an efficacious alternative, however there is no concensus on drug selection. Some experts have suggested that medical treatment should be selected individually according to the subject's dominant clinical symptom. Several psychopharmacological groups have been proposed: Antidepressants, mood stabilizers, and several novel antipsychotic drugs. The latter are particularly promising since they may produce symptomaic improvement with fewer adverse effects. Risperidone has been shown in a few preliminary studies to be promising in the treatment of various BPD symptoms, but no controlled study has tested it yet. We propose to test the efficacy of risperidone in the treatment of BPD in a double-blind crossover design using both clinical and phsysiological measure.The main hypothesis is that risperidone will be efficient in alleviating BPD core and secondary symptoms.


Options:
A: EPs during BART (Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS)
B: Transition to PANSS defined first-episode psychosis (Baseline, 1, 2, 3, 4, 8, 12 weeks, 6, and 12 months)
C: Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS) (At 2 years after the intervention)
D: Clinical Global Improvement Scale (0, 1, 5, 10 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial of Intubation With the McGrath Series 5 Video Laryngoscope vs the Macintosh Laryngoscope
Brief Summary: The simplicity of use and intuitive function of the McGrath video-laryngoscope suggests it may have a bigger role than as a back-up to conventional direct laryngoscopy and could possibly be the first-line laryngoscope for situations where difficult intubations are more likely or more hazardous. The incidence of difficult or failed intubation for an individual anaesthetist is related to their experience, decreasing as experience increases. The purpose of this trial is to evaluate the McGrath laryngoscope when used by relatively inexperienced anaesthetists, who are those most likely to encounter difficulties.

The null hypotheses to be tested is that there is no difference between the Macintosh and McGrath laryngoscope in terms of ease and success in intubation.


Options:
A: First Pass Success in Patients Undergoing Emergency Intubation, Intubated With Either Direct Larynogoscopy or Video Laryngoscopy Using a C-MAC Device. (During intubation procedure up to 1 hour); Time to Intubation (From the time the first device entered the patients mouth until successful intubation up to 1 hour)
B: Difficult intubation (until to 10 minutes)
C: Peak forces during intubation (Intraoperatively)
D: Intubation Time (At intubation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial of Intubation With the McGrath Series 5 Video Laryngoscope vs the Macintosh Laryngoscope
Brief Summary: The simplicity of use and intuitive function of the McGrath video-laryngoscope suggests it may have a bigger role than as a back-up to conventional direct laryngoscopy and could possibly be the first-line laryngoscope for situations where difficult intubations are more likely or more hazardous. The incidence of difficult or failed intubation for an individual anaesthetist is related to their experience, decreasing as experience increases. The purpose of this trial is to evaluate the McGrath laryngoscope when used by relatively inexperienced anaesthetists, who are those most likely to encounter difficulties.

The null hypotheses to be tested is that there is no difference between the Macintosh and McGrath laryngoscope in terms of ease and success in intubation.


Options:
A: Intubation Time (At intubation)
B: risk of failure on the first attempt of endotracheal intubation
C: CERVICAL MOTIONS (January 2011 and December 2012)
D: Time to intubation (seconds) (Immediate)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism
Brief Summary: The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)


Options:
A: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
B: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
C: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))
D: Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation (Day 1 up to 12 Months); Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation (Day 1 up to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism
Brief Summary: The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)


Options:
A: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
B: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
C: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (6- or 12-month study treatment period)
D: Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation (Day 1 up to 12 Months); Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation (Day 1 up to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism
Brief Summary: The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)


Options:
A: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
B: Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method] (Baseline to final visit (Day 14-21))
C: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
D: Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation (Day 1 up to 12 Months); Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation (Day 1 up to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism
Brief Summary: The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)


Options:
A: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))
B: Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment (Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early))
C: Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation (Day 1 up to 12 Months); Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation (Day 1 up to 12 months)
D: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6- or 12-month study treatment period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing HIV Risk in Female Teens: A Tailored Approach
Brief Summary: The Horizons Program will test the efficacy of a multi-session HIV prevention program for African American female teens attending reproductive health clinics in Atlanta, GA.


Options:
A: Cohort I: 12 month experience of intimate partner violence; Cohort II: Condom use with last non-spousal partner; Cohort III: Condom use with last non-spousal partner; Cohort III: HIV incidence
B: Combined HIV/STI 12-month Incidence Rates of HIV, Syphilis, Chlamydia, Gonorrhea and Trichomonas Vaginalis. (12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline)
C: HIV incidence
D: Proportion of condom protected vaginal sex acts over the last 60 days (6 and 12 months post-randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing HIV Risk in Female Teens: A Tailored Approach
Brief Summary: The Horizons Program will test the efficacy of a multi-session HIV prevention program for African American female teens attending reproductive health clinics in Atlanta, GA.


Options:
A: Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study (Up to 4 years); Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Long-term Follow-up (LTFU) Study (Up to 14 years since Vaccine Dose 1); Incidence of the Composite Endpoint of HPV16/18-related CIN 2 or Worse in the Long-term Follow-up (LTFU) Study (up to 22 years post Vaccination Dose 1)
B: Proportion of condom protected vaginal sex acts over the last 60 days (6 and 12 months post-randomization)
C: HIV sero-incidence (24 months post-baseline)
D: Re-infection with a non-viral sexually transmitted infection (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Determine the Impact of Lymphedema Therapy on Quality of Life and Disease Severity in Patients With Post-Thrombotic Syndrome
Brief Summary: The purpose of this study is to determine if complex lymphedema therapy is effective in decreasing disease severity and improving quality of life in patients with post thrombotic syndrome.


Options:
A: To determine if complex lymphedema therapy improves the quality of life in patients with post-thrombotic syndrome (1 and 3 months); To determine if complex lymphedema therapy reduces disease severity in patients with post thrombotic syndrome (1 and 3 months)
B: Difference in the average number of muscle cramps per week between magnesium and placebo treatments (3 weeks)
C: Number of documented episodes of NLC (4 weeks)
D: Improvement in QOL questionnaires (3 months); Lack of deterioration in portal hypertension (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: D-Cycloserine Enhancement of Exposure in Social Phobia
Brief Summary: The purpose of this study is to test a drug called d-cycloserine to see if it can help people with a condition called social phobia. Social phobia is also called "social anxiety disorder." Social phobia is a constant fear of social or performance situations. Social situations include group gatherings of any kind. Performance situations might include times when a person would have to do something in public, such as speak up in class or at a meeting. A person with this condition worries about being embarrassed, or about other people's opinions. People with social phobia usually feel extremely anxious (nervous and worried) about being the focus of attention. They often avoid social and performance situations. This behavior can have a negative effect on the quality of their lives and relationships.

In this study, we want to find out if d-cycloserine can help control social phobia when the drug is added to the standard treatment for this condition. The standard treatment is cognitive-behavior therapy (CBT). CBT is a form of talk therapy involving discussion with a therapist, along with practicing the feelings or events that the person finds frightening.


Options:
A: Snake Questionnaire (SNAQ) (2 weeks)
B: Clinician-Administered PTSD Scale (CAPS) (Baseline); Clinician-Administered PTSD Scale (CAPS) (Posttreatment, 8 weeks); Clinician-Administered PTSD Scale (CAPS) (Month 3); Clinician-Administered PTSD Scale (CAPS) (Month 6); Clinician-Administered PTSD Scale (CAPS) (Month 12)
C: Liebowitz Social Anxiety Scale (LSAS) (Week 13); CGI - Clinical Global Impression of Improvement (Week 13)
D: Child PTSD Symptom Scale (CPSS) (After 12 therapy sessions, up to 28 weeks.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
Brief Summary: This study investigates the hypothesis that instability in mood in patients with borderline personality disorder will respond the mood stabilizing medication lamotrigine.


Options:
A: 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)
B: The number of contacts with mental health services appropriate to the patient's needs. (3 months)
C: Client Satisfaction Questionnaire (Immediately following Brief Intervention)
D: Suicidal thoughts or attempts (Measured at Year 2)

Answer: A