TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III in Partial and Null Responders
Brief Summary: The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.


Options:
A: Percentage of Participants With Virologic Response at Week 12 (End of treatment (EOT) (up to Week 48))
B: Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants (Baseline, Day 7)
C: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 24 weeks)
D: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (12 Weeks After the Planned End of Treatment (EOT: Week 48))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Burst, Tonic and Sham Spinal Cord Stimulation. A Verification of the Best Treatment Protocol
Brief Summary: Recently a novel stimulation design was developed, called burst stimulation. In a non-placebo controlled pilot study burst stimulation seemed superior to tonic stimulation over a period extending more than 2 years, and even though an incidental finding, this design seemed capable of suppressing pain without mandatory induction of paresthesias. This permits for the first time to scientifically prove that spinal cord stimulation is better than placebo stimulation. A study was therefore initiated to find out whether spinal cord stimulation is indeed capable of suppressing neuropathic limb pain in a placebo controlled way.


Options:
A: To investigate if typical abdominal pain of IBS can be ameliorated by SCS? (According to protocol for 26 weeks)
B: Visual Analogue Scales for pain back, pain limb, pain general and paresthesia
C: Onset meaningful pain reduction
D: Nerve conduction measurements; Pain scores from patient diaries

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Burst, Tonic and Sham Spinal Cord Stimulation. A Verification of the Best Treatment Protocol
Brief Summary: Recently a novel stimulation design was developed, called burst stimulation. In a non-placebo controlled pilot study burst stimulation seemed superior to tonic stimulation over a period extending more than 2 years, and even though an incidental finding, this design seemed capable of suppressing pain without mandatory induction of paresthesias. This permits for the first time to scientifically prove that spinal cord stimulation is better than placebo stimulation. A study was therefore initiated to find out whether spinal cord stimulation is indeed capable of suppressing neuropathic limb pain in a placebo controlled way.


Options:
A: Visual Analogue Scales for pain back, pain limb, pain general and paresthesia
B: Change in Multidimensional Pain Inventory (MPI)-SCI average activity score (Baseline, 9 months); Motor recovery as measured by EMG (Up to 9 months); Motor recovery as measured by dynamometry (Up to 9 months)
C: Difference between treatment groups in responder rates. (3 Months)
D: Composite of Safety and Effectiveness (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Burst, Tonic and Sham Spinal Cord Stimulation. A Verification of the Best Treatment Protocol
Brief Summary: Recently a novel stimulation design was developed, called burst stimulation. In a non-placebo controlled pilot study burst stimulation seemed superior to tonic stimulation over a period extending more than 2 years, and even though an incidental finding, this design seemed capable of suppressing pain without mandatory induction of paresthesias. This permits for the first time to scientifically prove that spinal cord stimulation is better than placebo stimulation. A study was therefore initiated to find out whether spinal cord stimulation is indeed capable of suppressing neuropathic limb pain in a placebo controlled way.


Options:
A: Evaluation of pain (28 days)
B: To investigate if typical abdominal pain of IBS can be ameliorated by SCS? (According to protocol for 26 weeks)
C: Visual Analogue Scales for pain back, pain limb, pain general and paresthesia
D: Pain intensity measured on a weighted NRS according to Jensen and a PGIC for pain measured on a 7-point Likert scale. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application
Brief Summary: The purpose of this study is evaluate the effects and safety of Traditional Chinese medicine for prevention and management of mild/moderate chronic obstructive pulmonary disease (COPD).


Options:
A: pulmonary function（FEV1） (Change from Baseline in FEV1 at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase); the frequency of exacerbation (Change from Baseline in the frequency of exacerbation at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase)
B: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)
C: Physical activity (Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)); Physical activity (Change between T1 and T2: 3 months follow up)
D: Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks (Week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application
Brief Summary: The purpose of this study is evaluate the effects and safety of Traditional Chinese medicine for prevention and management of mild/moderate chronic obstructive pulmonary disease (COPD).


Options:
A: Change in physical activity (Baseline and 12 months follow-up)
B: pulmonary function（FEV1） (Change from Baseline in FEV1 at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase); the frequency of exacerbation (Change from Baseline in the frequency of exacerbation at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase)
C: Improvement tolerance capacity (4 months and 6 months)
D: COPD Assessment Test (CAT) (1 Year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Identifying and Overcoming Barriers to Diabetes Management in the Elderly: A Cost-effective Intervention Study
Brief Summary: The purpose of this study is to find ways to identify barriers that affect self care in older adult with diabetes and to provide cost effective coping strategies to improve clinical, functional and psychosocial measures.


Options:
A: Hemoglobin A1c (6 and 12 months)
B: glycemic control (All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians); lipid control (All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians)
C: Change in Glycosylated Hemoglobin (Hba1c) (From date of randomization every 3 months, up to one year)
D: Proportion of Participants that Receive Annual Eye Exam (Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Identifying and Overcoming Barriers to Diabetes Management in the Elderly: A Cost-effective Intervention Study
Brief Summary: The purpose of this study is to find ways to identify barriers that affect self care in older adult with diabetes and to provide cost effective coping strategies to improve clinical, functional and psychosocial measures.


Options:
A: Self-Care Behaviors; Glycemic control (HbA1c); fitness
B: Hemoglobin A1c (6 and 12 months)
C: Change in HbA1c from baseline to 12 months (Baseline, 3, 6, 9 and 12 months)
D: % of patients reaching goal HbA1C (<7) (2 years after enrollment); % of patients with BP goal (<130/80) (Two years after enrollment); % of patients with LDL at goal (<100) (2 years after enrollment); % of patients at goal for all three parameters (HbA1C <7, BP <130/80, LDL <100) (2 years after enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Gabapentin in Treating Overactive Bladder
Brief Summary: Overactive bladder (OAB) syndrome as defined by International Continence Society is a pathological condition characterized by irritative symptoms: urinary urgency, with or without incontinence, urinary frequency and nocturia. The syndrome often seriously compromises the quality of life of the patients. The etiology of the OAB is considered multifactorial. Neural plasticity of bladder afferent pathways is one of the proposed mechanisms of OAB. The detrusor muscle itself has for many years been the target for drug treatment such as antimuscarinics. However, depression of detrusor contractility, may results in a reduced ability to empty the bladder and lead to some sympathetic adverse effects, which limits the treatment of OAB. Currently the focus of OAB treatment has changed to other bladder structures/mechanisms, such as afferent nerves and urothelial signaling as targets for intervention. C-fiber bladder afferents nerves may be critical for symptom generation in pathologic states such as OAB because these fibers demonstrate remarkable plasticity. Up-regulation of bladder C-fiber afferent nerve function may also play a role in urge incontinence, overactive bladder (OAB) and sensory urgency. The mechanism of Gabapentin's action for neuropathic pain has not been fully elucidated but is appears to have inhibitory activity on afferent C-fibers nerve activity; moreover, several studies had established the safety of Gabapentin in its treatment of different conditions. Due to the proposed mechanism, the investigators suggest that Gabapentin may be a new alternative for treating OAB.


Options:
A: improvement of symptom domain means decreased frequency to less than 8 micturitions per 24 hours, no urgency noted per 24 hrs and less that 3 wakening at bedtime for micturation. (12 weeks)
B: Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.
C: N/A
D: Patient Perception of Bladder Condition at 12 weeks of treatment compared to placebo.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Umbilical Cord Milking on Hemodynamic Status of Preterm Infants: a Randomized Controlled Trial
Brief Summary: Very preterm babies frequently develop problems with their blood circulation during the first few days after birth. These circulation problems could affect the oxygen and blood flow to their brain and lead to effects such as bleeding in the head or delayed developmental milestones later in life. Currently the care for such problems may include transfusion of intravenous fluids or blood to the baby and/or giving the baby medications that can help circulation.

The current practice at the delivery of these babies is to immediately clamp their umbilical cords after birth. Recent research studies have shown that giving more of the baby's own blood to them at birth by delayed cord clamping (waiting for clamping the cord for about 30-90 seconds) or by milking the cord, may reduce the number of blood transfusions that these babies may need later on. It may also improve their initial blood pressure and reduce the chances of bleeding in their heads.

More research is needed to prove if either delayed cord clamping or milking the cord at birth will be better in terms of improving these babies' health.

The aim of this study is to find out if adding some blood to these babies' circulation, through milking the cord at birth, could prevent or reduce the possible problems with blood circulation and the reduced blood flow to the brain that some of these babies may have after birth.

The investigators will also investigate if milking the cord at birth could improve their long-term developmental outcome.

Hypothesis: In preterm infants less than 31 weeks' gestation, milking the umbilical cord 3 times prior to clamping, compared to immediate clamping after birth will improve systemic blood flow (as assessed by improving superior vena cava flow measured by heart ultrasound in the first 24 hours after birth)


Options:
A: To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation. (2 years)
B: Hematologic status at 6 months of age; Iron status at 6 months of age
C: Very low birth weight (VLBW) infants in the delayed cord clamping (DCC) group will have less intraventricular hemorrhage (IVH) compared to VLBW infants in the immediate clamped (ICC) group (December, 2012); Very low birth weight infants in the delayed cord clamping group will have less late onset sepsis than those in the immediate clamping group (December 2012)
D: Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 4-6 hours after birth. (at 4-6 hours of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema
Brief Summary: The purpose of this study is to compare the morphological and visual acuity outcomes associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for treatment of diabetic macular edema.


Options:
A: Change from Baseline in Visual Acuity (VA) to Month 12 (Baseline, Month 12); Change from Baseline in Visual Acuity (VA) to Month 24 (Baseline, Month 24)
B: N/A
C: Central subfield macular thickness (CSFT) change (Monthly from baseline to Week 48)
D: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema
Brief Summary: The purpose of this study is to compare the morphological and visual acuity outcomes associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for treatment of diabetic macular edema.


Options:
A: visual acuity; central macular thickness
B: Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year (Baseline to 1-year); Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69 (Baseline to 1-year); Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69 (Baseline to 1-year)
C: Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year (Baseline, Year 1)
D: Central subfield macular thickness (CSFT) change (Monthly from baseline to Week 48)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the Effect of Two Different Types of Telephone Counselling Respectively and a Web-based Smoking Cessation Programme Among Adult Daily Cigarette Smokers.
Brief Summary: The primary objective of the study is to compare the efficacy of four different smoking cessation programmes, including a proactive telephone counseling intervention, a reactive telephone counseling a and an interactive web-based intervention and (as control) written self-help material.


Options:
A: Presence of a total home smoking ban (Change from baseline in reported total home smoking bans at 3-month and 6-month follow-up)
B: 30 days prolonged abstinence (6-months postpartum)
C: Biochemically confirmed 7-day point prevalent smoking abstinence (52 weeks)
D: Smoking cessation (14 months post baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the Effect of Two Different Types of Telephone Counselling Respectively and a Web-based Smoking Cessation Programme Among Adult Daily Cigarette Smokers.
Brief Summary: The primary objective of the study is to compare the efficacy of four different smoking cessation programmes, including a proactive telephone counseling intervention, a reactive telephone counseling a and an interactive web-based intervention and (as control) written self-help material.


Options:
A: Change in tobacco smoking (6 months); Change in level of physical activity (6 months); Change in diet quality (6 months)
B: 7-day point prevalence (3 months and 6 months post treatment)
C: Smoking cessation (14 months post baseline)
D: Abstinence for 7 consecutive days and 24 hours at 1, 3, and 6 months

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the Effect of Two Different Types of Telephone Counselling Respectively and a Web-based Smoking Cessation Programme Among Adult Daily Cigarette Smokers.
Brief Summary: The primary objective of the study is to compare the efficacy of four different smoking cessation programmes, including a proactive telephone counseling intervention, a reactive telephone counseling a and an interactive web-based intervention and (as control) written self-help material.


Options:
A: Smoking cessation (14 months post baseline)
B: smoking abstinence (12 months); smoking abstinence (12 months); smoking abstinence (12 months)
C: smoking quit rate change from baseline at 3-month follow-up (3-month follow-up); smoking quit rate change from baseline at 6-month follow-up (6-month follow-up)
D: Self-reported 7-day Point Prevalence Abstinence From Smoking That Was Sustained at 60 Days After the Quit Date (60 days after quit date)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the Effect of Two Different Types of Telephone Counselling Respectively and a Web-based Smoking Cessation Programme Among Adult Daily Cigarette Smokers.
Brief Summary: The primary objective of the study is to compare the efficacy of four different smoking cessation programmes, including a proactive telephone counseling intervention, a reactive telephone counseling a and an interactive web-based intervention and (as control) written self-help material.


Options:
A: Reduction in number of cigarettes smoked as measured by the Timeline Follow-back. (Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24)
B: Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During 90-session intervention period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During 90-session intervention period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During 90-session intervention period); Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During the 6-month follow-up period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During the 6-month follow-up period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During the 6-month follow-up period)
C: Smoking cessation (14 months post baseline)
D: Quit Attempt(s) (Any time within 26 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Life Goals Collaborative Care to Improve Health Outcomes in Mental Disorders
Brief Summary: Persons with serious mental illness (SMI) are at increased risk of cardiovascular disease (CVD). The goals of this study are to test a treatment, Life Goals Collaborative Care to help promote health behavior change and improve mental health and physical health-related quality of life, as well as to get feedback from patients and providers on what is needed to help better coordinate the physical and mental health care of these patients.


Options:
A: SF-12 MCS (6-Month Follow-up)
B: Physical Health-related Quality of Life (12 months)
C: Reduction in symptoms of major depression (Measured at Months 12, 18, and 24)
D: Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline (6- and12-month follow-ups)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Strengthening the Midwife Service Scheme With Community Focused Interventions: Evidence From a Randomized Controlled Field Trial in Nigeria
Brief Summary: The objective of this cluster randomized controlled trial is to assess the impact of several community-based interventions that address the key factors underlying the high maternal mortality, as well as neonatal mortality and morbidity in northern Nigeria. The interventions, include:

1. a Voluntary Health Worker Program (VHW)
2. the VHW program with provision of a safe birth kit
3. the VHW program with community folk media activities.


Options:
A: control of postpartum hemorrhage (within 20 minutes of administration)
B: Change in hemoglobin measurement of >2 g/dL pre- to -post-delivery. (Before delivery (at onset of labor), after delivery (2 to 4 days after delivery))
C: Maternal Mortality Ratio (42 days post delivery)
D: Hb of greater than or equal to 2 g/dl from pre- to post-delivery (3-5 days after delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV, Randomized, Single Center, Parallel Group Trial of Human Fibrinogen Concentrate (Haemocomplettan) in the Treatment of Dilutional Coagulopathy During Major Pediatric Surgery
Brief Summary: The purpose of this study is to compare two different thromboelastometry (ROTEM) trigger levels for administration of human fibrinogen concentrate (Haemocomplettan P) in the treatment of perioperative dilutional coagulopathy during major pediatric surgery. The study hypothesis is that administration of fibrinogen concentrate triggered by a ROTEM FibTEM MCF \< 13 mm might reduce the total amount of transfused red cell concentrate during 24 hours after start of surgery as compared to a trigger level of ROTEM FibTEM MCF \< 8 mm.


Options:
A: Total amount of transfused red cell concentrate (24 hours after start of surgery)
B: The primary outcome is death from haemorrhage (within 5 days of randomisation)
C: The primary outcome is the proportion of women who die or undergo hysterectomy. The primary cause of death will be described. (up to 42 days after randomisation)
D: To determine whether fibrinogen concentrate infusion reduces perioperative blood loss. (within 12 hours.)

Answer: A