TrialPanorama/Dataset huggingface dataset:
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: To assess the efficacy of olanzapine therapy (5.0-10.0 mg/day) compared with placebo in patients with BPD,as defined by DSM-IV-TR criteria,; in improving overall symptomatology as measured by the last observation carried forward (LOCF) mean change from baseline to endpoint in the ZAN-BPD total score for up to 12 weeks of double-blind treatment.
B: Change From Baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score (Baseline (Day 0) to Week 10)
C: 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)
D: CAPS-5 (Clinician Administered PTSD Scale) (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Inhaled Hypertonic Saline (7%) Versus Normal Saline (0.9%) on the Lung Clearance Index in Patients With Cystic Fibrosis
Brief Summary: This study is examining the effect of hypertonic saline compared to placebo on the Lung Clearance Index in Cystic Fibrosis patients.


Options:
A: Change in Mucociliary Clearance Rate (Baseline versus after completion of 4 week treatment period)
B: Interview #1 (to be conducted at the time of enrollment (post SIMPLIFY study)); Interview #2 (to be conducted 4 months following the date of the first interview)
C: Computed Tomography Evidence of Less Sinus Disease (baseline and 1 year); Improvement in Appearance of Nasal Passages/Sinuses (baseline and 1 year)
D: Change in LCI from baseline to end of treatment in hypertonic saline treated patients versus patients receiving placebo (isotonic saline) (Duration of patient's involvement in study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Inhaled Hypertonic Saline (7%) Versus Normal Saline (0.9%) on the Lung Clearance Index in Patients With Cystic Fibrosis
Brief Summary: This study is examining the effect of hypertonic saline compared to placebo on the Lung Clearance Index in Cystic Fibrosis patients.


Options:
A: Change in FEV1 (in liters) from baseline (At the end of the 14 day treatment period); Adverse events such as gastrointestinal complaints, wheezing, hepatitis or shortness of breath (70 weeks)
B: Lung function (FEV1, FVC, FEF25-75)
C: Lung Clearance Index (90 minutes post treatment)
D: Change in LCI from baseline to end of treatment in hypertonic saline treated patients versus patients receiving placebo (isotonic saline) (Duration of patient's involvement in study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Inhaled Hypertonic Saline (7%) Versus Normal Saline (0.9%) on the Lung Clearance Index in Patients With Cystic Fibrosis
Brief Summary: This study is examining the effect of hypertonic saline compared to placebo on the Lung Clearance Index in Cystic Fibrosis patients.


Options:
A: The rate of protocol-defined pulmonary exacerbations requiring treatment with oral, inhaled or intravenous antibiotics between subjects randomized to HS and IS (during the 48 week treatment period)
B: Change in FEV1 (in liters) from baseline (At the end of the 14 day treatment period); Adverse events such as gastrointestinal complaints, wheezing, hepatitis or shortness of breath (70 weeks)
C: Lung Clearance Index (90 minutes post treatment)
D: Change in LCI from baseline to end of treatment in hypertonic saline treated patients versus patients receiving placebo (isotonic saline) (Duration of patient's involvement in study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Inhaled Hypertonic Saline (7%) Versus Normal Saline (0.9%) on the Lung Clearance Index in Patients With Cystic Fibrosis
Brief Summary: This study is examining the effect of hypertonic saline compared to placebo on the Lung Clearance Index in Cystic Fibrosis patients.


Options:
A: Lung function (FEV1, FVC, FEF25-75)
B: Changes in the Sino-nasal-outcome test SNOT-20 adapt CF (days 1, 29, 57 and 85)
C: Change in LCI from baseline to end of treatment in hypertonic saline treated patients versus patients receiving placebo (isotonic saline) (Duration of patient's involvement in study)
D: The rate of protocol-defined pulmonary exacerbations requiring treatment with oral, inhaled or intravenous antibiotics between subjects randomized to HS and IS (during the 48 week treatment period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1/2, Open-Label, Adaptive, Randomized Study of Liposomal Doxorubicin With or Without M200 (Volociximab) for the Treatment of Subjects With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer That Have Relapsed After Prior Therapy With a Platinum/Taxane-Based Chemotherapy
Brief Summary: This is an open-label study of liposomal doxorubicin with or without volociximab for the treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer relapsed after prior therapy with Plat/Taxane-based chemo. Volociximab is an anti-angiogenic integrin inhibitor being developed for the treatment of solid tumors. Preclinical data with a surrogate volociximab antibody administered as monotherapy indicate encouraging efficacy in terms of tumor reduction and anti-angiogenic effects in mouse ovarian cancer xenograft models. In clinical studies, volociximab has been evaluated in several solid tumor types, including pancreatic, renal, and melanoma, with many subjects who entered the studies with progressive disease remaining progression-free for several months. In all studies in solid tumors, volociximab has shown a favorable safety profile when administered at 10 mg/kg q2wks and more recently at 15 mg/kg qwk. A study of volociximab in combination with liposomal doxorubicin in subjects with ovarian cancer or primary peritoneal cancer who have relapsed after prior platin/taxane therapies is warranted to further evaluate the drug's efficacy and safety. The investigators have thus far activated stage 2 of this study at 11/25 sites. Worldwide, the study aims to enroll 150 subjects.


Options:
A: Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011); Progression Free Survival (PFS; Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011)
B: To evaluate the efficacy of volociximab in combination with liposomal doxorubicin in advanced epithelial ovarian cancer or primary peritoneal cancer. To evaluate the safety and tolerability of volociximab in combination with liposomal doxorubicin. (50-57 days)
C: Progression-free survival (Apr 2013)
D: Progression Free Survival (PFS) (Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During an Initial Encounter
Brief Summary: The primary objective outcome is the proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation. Proportion will be calculated using the cumulative number of hours on therapy divided by the total number of days of the investigation for each participant. The mean and standard deviation of these mean therapy hours will then be calculated for each arm of the investigation. Participants with compliance of at least four hours will be classified as "compliant" and those with less than four hours will be classified as "non-compliant". The null hypothesis will be rejected if the mean of the primary objective outcome for all participants in the BiPAP® Auto with Bi-Flex® therapy arm is significantly greater than that for all participants in the CPAP therapy arm.

Secondary Measures

The secondary measures used to evaluate potentially improved adherence to BiPAP® Auto with Bi-Flex® therapy compared to CPAP therapy will include:

* Hours of use per night, for all nights
* Hours of use per night, for nights with therapy use
* Device derived AHI
* Heart Rate Variability
* Functional Outcomes of Sleep Questionnaire (FOSQ),
* 10 cm Visual Analog Scale (VAS) for mask comfort and satisfaction with therapy,
* Epworth Sleepiness Scale (ESS) questionnaire
* Psychomotor Vigilance Task
* Attitudes toward use
* Actigraphy (sleep continuity) and sleep diary
* Fatigue Severity Scale
* Daytime Functioning Scale


Options:
A: subjective sleepiness and other OSAS symptoms (3 months, 1 year, 2 years); quality of life (3 months, 1 year, 2 years); percentage of withdrawal and cross-over to other CPAP mode (3 months, 1 year, 2 years); objective vigilance (3 months, 1 year, 2 years); blood pressure (3 months, 1 year, 2 years); cost/utility ratios (3 months, 1 year, 2 years)
B: Apnea-Hypopnea Index (Baseline and 180 Days)
C: proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation. (90 days)
D: Clinical blood pressure (Before treatment, 4 months after treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Three Dosages of [Vortioxetine] Lu AA21004, in Acute Treatment of Major Depressive Disorder
Brief Summary: The purpose of the study is to evaluate the efficacy and the tolerability of three fixed doses of Vortioxetine in order to establish the appropriate clinical effective dose range in the treatment of Major Depressive Disorder (MDD).


Options:
A: Change From Baseline in MADRS Total Score After 8 Weeks of Treatment (Baseline and Week 8)
B: Change From Baseline in MADRS Total Score at Week 8 (Baseline and Week 8)
C: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Baseline and Week 8)
D: Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment (Baseline and Week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Three Dosages of [Vortioxetine] Lu AA21004, in Acute Treatment of Major Depressive Disorder
Brief Summary: The purpose of the study is to evaluate the efficacy and the tolerability of three fixed doses of Vortioxetine in order to establish the appropriate clinical effective dose range in the treatment of Major Depressive Disorder (MDD).


Options:
A: Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation (Baseline and Week 8 or FOT)
B: Change From Baseline in MADRS Total Score After 8 Weeks of Treatment (Baseline and Week 8)
C: Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
D: Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment (Baseline and Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Immediate Post-placental Insertion of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean Delivery vs. 4-8 Week Post-delivery Interval Insertion: A Randomized Controlled Trial
Brief Summary: The study is a randomized controlled trial comparing outcomes of immediate postplacental insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled cesarean delivery.

Our primary hypothesis is that the proportion of women using the LNG-IUS for contraception at 12 months after delivery will be higher in the group randomized to immediate post-placental insertion.


Options:
A: Implant utilization as measured by the proportion of women using LNG contraceptive implants at 6 months after delivery in women randomized to insertion within 5 days of delivery (immediate insertion) or 6-8 weeks after delivery (delayed insertion). (6 months)
B: IUD Usage Rate at 6 Months (6 months after delivery)
C: IUD Use (6 months postpartum)
D: Use of the LNG-IUS for Contraception (12 months after cesarean delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Immediate Post-placental Insertion of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean Delivery vs. 4-8 Week Post-delivery Interval Insertion: A Randomized Controlled Trial
Brief Summary: The study is a randomized controlled trial comparing outcomes of immediate postplacental insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled cesarean delivery.

Our primary hypothesis is that the proportion of women using the LNG-IUS for contraception at 12 months after delivery will be higher in the group randomized to immediate post-placental insertion.


Options:
A: 6 month IUD usage rates (6 months)
B: Use of the LNG-IUS for Contraception (12 months after cesarean delivery)
C: IUD Usage Rate at 6 Months (6 months after delivery)
D: Time (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Neuromuscular Electrical Stimulation on Muscle Metabolism of Major Abdominal Surgical Patients
Brief Summary: Skeletal muscle atrophy is associated with catabolic conditions such as major surgical interventions and leads to reduced muscle strength, increased clinical complications and prolonged convalescence. Several studies revealed immobilisation as a major stimulus for muscle wasting in severely ill patients. This study investigates the potency of neuromuscular electrical stimulation on skeletal muscle growth factors and degradation processes in major abdominal surgery patients.


Options:
A: Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks (Baseline and 12 weeks post-intervention); Change From Baseline in Quadriceps Strength at 12 Weeks (Baseline and 12 weeks following the intervention)
B: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)
C: mRNA level of IGF-1Ea
D: Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively (Baseline through 3.5 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers
Brief Summary: A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.


Options:
A: Stunting in Children at 18 mo (18 months of age)
B: Increase physical activity (2010); Increase the intake of fiber (2010); Decrease fat intake (2010); Decrease television and other screen time (2010); Decrease obesity (2010)
C: BMI z-score (via measured weight and height) of preschooler (~2 years post baseline)
D: Exclusive Breastfeeding at Four Months of Age (Six months after the beginning of the study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers
Brief Summary: A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.


Options:
A: Exclusive Breastfeeding at Four Months of Age (Six months after the beginning of the study)
B: Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards) (6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years)
C: Mean weight-for-length z-score at 15 months of age (15 months of age)
D: Exclusive breastfeeding (EBF) among children 0-6 months of age (4 years after baseline); Child anthropometry (height, weight) among children 24-48 months of age (4 years after baseline); Complementary feeding among children 6-23.9 months of age (4 years after baseline); Anemia among children 6-23.9 months (4 years after baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers
Brief Summary: A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.


Options:
A: Increase physical activity (2010); Increase the intake of fiber (2010); Decrease fat intake (2010); Decrease television and other screen time (2010); Decrease obesity (2010)
B: Change from baseline in energy dense food consumption at 12 months (12 months); Change from baseline in nutrient dense food consumption at 12 months (12 months)
C: Change from baseline in Total Kilocalorie intake at 16 weeks (16 weeks); Change from baseline in reported levels of household food security at 16 weeks (16 weeks); Change from baseline in Healthy Eating Index (HEI) Score at 16 weeks (16 weeks); Change from baseline in daily servings of fruits and vegetable (added together) at 16 weeks (16 weeks); Change from baseline in daily total, in grams, of added sugars at 16 weeks (16 weeks)
D: Exclusive Breastfeeding at Four Months of Age (Six months after the beginning of the study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers
Brief Summary: A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.


Options:
A: Exclusive Breastfeeding at Four Months of Age (Six months after the beginning of the study)
B: Serum 25OH-vitamin D levels (90 days after start of treatment)
C: Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards) (6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years)
D: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers
Brief Summary: A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.


Options:
A: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)
B: Exclusive Breastfeeding at Four Months of Age (Six months after the beginning of the study)
C: Reduction in the 2-year caries increment (dmfs/DMFS index); final follow-up at 24 months.
D: changes in frequencies of dental brushing and flossing (changes from baseline, two weeks after the intervention and six months follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Acceptability of the NuvaRing Among College and Graduate Students
Brief Summary: The ACCEPT study is a Phase IV trial in which women are randomized to either the NuvaRing® vaginal contraceptive ring or a low dose oral contraceptive to assess compliance, side effects, overall acceptability and intent to continue use of the method. The study is focused on the acceptability of the vaginal ring among female undergraduate or graduate students.


Options:
A: Adherence Rate (Rate of Perfect Method Use) (For the first 3 months)
B: contraceptive continuation (6 months)
C: Contraceptive Use (24 months)
D: Use of a Effective Contraceptive Method at Four-months Post-abortion (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Acceptability of the NuvaRing Among College and Graduate Students
Brief Summary: The ACCEPT study is a Phase IV trial in which women are randomized to either the NuvaRing® vaginal contraceptive ring or a low dose oral contraceptive to assess compliance, side effects, overall acceptability and intent to continue use of the method. The study is focused on the acceptability of the vaginal ring among female undergraduate or graduate students.


Options:
A: N/A
B: Adherence Rate (Rate of Perfect Method Use) (For the first 3 months)
C: continuation into the fourth cycle (four months)
D: Pregnancy (AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year)

Answer: B