TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study
Brief Summary: Medical literature about awareness during general anesthesia is rare in China, and some small sampled studies in China showed a significantly higher incidence (1.5～6%) of intra-operative awareness compared with western countries. The investigators sponsored this multicenter, large sampled, prospective study to determine the incidence of intra-operative awareness in China, and the preservation effect of BIS monitor on the incidence of awareness.


Options:
A: The incidence of explicit recall of events during the surgical and anesthetic periods. (30 days)
B: Bispectral index (BIS) monitoring in abdominal surgery patients (six months)
C: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
D: evaluation of intra-operative awareness in all the patients investigated (within 4 days after the general anesthesia)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing Activity in Peripheral Arterial Disease
Brief Summary: Lower extremity peripheral arterial disease (PAD) is a disease in which fatty build-up, or plaque, accumulates in the arteries of the legs. People with lower extremity PAD often experience leg pain while walking, which is caused by reduced blood flow to the legs. Regular walking has significant benefits for people with blood flow problems in their legs, but previous studies have shown that most men and women with PAD do not walk for exercise on a regular basis. A group home-based walking program may help people with PAD to walk more often and improve their lower extremity functioning. This study will evaluate the effectiveness of a home-based group mediated cognitive behavioral (GMCB) exercise program in helping people with lower extremity PAD to increase their walking frequency and improve their lower leg functioning.


Options:
A: 24 hour blood pressure (12 weeks)
B: Change of intrahepatic triglyceride contents (12 months)
C: 6-minute walk test at 6 month follow-up (Measured at baseline and Month 6 follow-up)
D: Blood pressure at 6 months (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing Activity in Peripheral Arterial Disease
Brief Summary: Lower extremity peripheral arterial disease (PAD) is a disease in which fatty build-up, or plaque, accumulates in the arteries of the legs. People with lower extremity PAD often experience leg pain while walking, which is caused by reduced blood flow to the legs. Regular walking has significant benefits for people with blood flow problems in their legs, but previous studies have shown that most men and women with PAD do not walk for exercise on a regular basis. A group home-based walking program may help people with PAD to walk more often and improve their lower extremity functioning. This study will evaluate the effectiveness of a home-based group mediated cognitive behavioral (GMCB) exercise program in helping people with lower extremity PAD to increase their walking frequency and improve their lower leg functioning.


Options:
A: maximal walking distance
B: 6-minute walk test at 6 month follow-up (Measured at baseline and Month 6 follow-up)
C: Quality of Life (1 year)
D: MWD change score (Measured at 6 months); MWD change score (Measured at 6 months); MWD change score (Measured at 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing Activity in Peripheral Arterial Disease
Brief Summary: Lower extremity peripheral arterial disease (PAD) is a disease in which fatty build-up, or plaque, accumulates in the arteries of the legs. People with lower extremity PAD often experience leg pain while walking, which is caused by reduced blood flow to the legs. Regular walking has significant benefits for people with blood flow problems in their legs, but previous studies have shown that most men and women with PAD do not walk for exercise on a regular basis. A group home-based walking program may help people with PAD to walk more often and improve their lower extremity functioning. This study will evaluate the effectiveness of a home-based group mediated cognitive behavioral (GMCB) exercise program in helping people with lower extremity PAD to increase their walking frequency and improve their lower leg functioning.


Options:
A: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain (3 months)
B: Treadmill maximum walking distance (2 weeks); EACH-Q walking questionnaire score (2 weeks)
C: Change in Six-Minute Walk Performance at 12-week Follow-up (change from baseline to week 12)
D: 6-minute walk test at 6 month follow-up (Measured at baseline and Month 6 follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Veterans Walk to Beat Back Pain
Brief Summary: The objective of this study was to assess whether an Internet-mediated pedometer based intervention would increase walking and improve function among individuals with chronic back pain.


Options:
A: The Roland Morris Disability Questionnaire (RDQ) Score (12 months)
B: Change in pain Intensity (Baseline and 6 weeks after beginning treatment.); Change in functional disability (Baseline and 6 weeks after beginning treatment.)
C: The primary outcome measure is actual LBP, as measured with an "11 point box scale". (10 weeks and 12 months)
D: Pain VAS

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Veterans Walk to Beat Back Pain
Brief Summary: The objective of this study was to assess whether an Internet-mediated pedometer based intervention would increase walking and improve function among individuals with chronic back pain.


Options:
A: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months
B: Change in catastrophizing cognitions (T1: At the start of in-house rehabilitation T2: At the end of in-house rehabilitation - begin situational feedback intervention T3: End of situational feedback intervention T4: 6 month after T1 T5: 12 months after T1)
C: The Roland Morris Disability Questionnaire (RDQ) Score (12 months)
D: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants
Brief Summary: The purpose of this study is to assess whether an instrument, the Laser Doppler Imager, is able to measure the effect of pain related changes in skin blood flow in newborn infants. The study will also determine whether the use of sucrose (sugar water) when given by mouth has any effect on pain related skin blood flow changes.


Options:
A: skin blood flow response (perfusion units, PU) (immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points))
B: Premature Infant Pain Profile (PIPP) scale rate (0-21) (15 seconds before and Within 30 seconds after heel lance)
C: - Infant pain score during the newborn screening test, assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP (facial grimace, heart rate, oxygen saturation)
D: Pain reaction (first 14 days of life)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants
Brief Summary: The purpose of this study is to assess whether an instrument, the Laser Doppler Imager, is able to measure the effect of pain related changes in skin blood flow in newborn infants. The study will also determine whether the use of sucrose (sugar water) when given by mouth has any effect on pain related skin blood flow changes.


Options:
A: Painful response as assessed by PIPP Scale (Pre procedure,Intra procedure,post 30 sec,post 1 min,post 2 minutes)
B: Pain scores assessed by the PIPP score (The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.)
C: Premature Infant Pain Profile (PIPP) (At the moment of painful procedure)
D: skin blood flow response (perfusion units, PU) (immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy of 6% Hydroxyethyl Starch (HES, 130/0.4) in Normal Saline Compared to Ringer's Lactate Solution for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section
Brief Summary: The aim of the study is to evaluate the efficacy of Voluven® in the prevention of maternal hypotension in women undergoing spinal anesthesia for cesarean section


Options:
A: Number of Participants with Adverse Events as a Measure of Safety and Tolerability" (day 1)
B: The time required to remain sitting after spinal anesthesia (start with 3 minutes after completion of spinal then we ll go up or down)
C: Early Profound Fetal Bradycardia (Within 30 minutes of combined spinal epidural (CSE) placement)
D: Incidence of hypotension (Time between induction of spinal anesthesia until delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy of 6% Hydroxyethyl Starch (HES, 130/0.4) in Normal Saline Compared to Ringer's Lactate Solution for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section
Brief Summary: The aim of the study is to evaluate the efficacy of Voluven® in the prevention of maternal hypotension in women undergoing spinal anesthesia for cesarean section


Options:
A: The time required to remain sitting after spinal anesthesia (start with 3 minutes after completion of spinal then we ll go up or down)
B: Early Profound Fetal Bradycardia (Within 30 minutes of combined spinal epidural (CSE) placement)
C: Incidence of hypotension (Time between induction of spinal anesthesia until delivery)
D: Frontal lobe cerebral oxygenation (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour); Foetal heartrate (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy
Brief Summary: The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy.

The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.


Options:
A: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)
B: Proximal deep vein thrombosis(DVT) diagnosed by compression ultrasound (28 days from randomization)
C: Event free survival for all patients (January 2014); GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage) (January 2014)
D: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy
Brief Summary: The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy.

The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.


Options:
A: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)
B: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)
C: disease response (up to day 1 of cycle 6)
D: Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) (Up to Day 180); Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH) (From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy
Brief Summary: The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy.

The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.


Options:
A: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)
B: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)
C: Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis (one year)
D: Percent Change in D-dimer Value (Baseline, 56 Day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy
Brief Summary: The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy.

The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.


Options:
A: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)
B: Overall survival
C: DVT/TVE event rate (After 12 events and after 24 events or after 540 pts recruited)
D: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy
Brief Summary: The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy.

The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.


Options:
A: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)
B: Progression free survival (5 years)
C: Incidence of venous thromboembolism reduction
D: Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) (20 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy
Brief Summary: The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy.

The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.


Options:
A: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)
B: Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy (Events occurring during the four months of treatment plus 10 days)
C: Incidence of NCI CTC Toxicity III°/IV° and severe bleedings (minimum of 3 months)
D: symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria in Tanzanian Children.
Brief Summary: This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important

1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania
2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever.

Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite.

The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.


Options:
A: Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42. (42 days)
B: Parasitological failure by day 28 (Within 28 days of treatment.)
C: Parasitological failure rates; Parasite clearance time; Fever clearance times; Incidence rate of adverse events
D: Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population (Day 28); Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population (Day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia
Brief Summary: This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.


Options:
A: Time to Relapse During the Double-Blind Phase (Approximately Week 60)
B: Change in the PANSS Total Score From Baseline to the Last Postrandomization Assessment in the Double-blind Period of the Study. (6 weeks)
C: Change From Baseline to Week 6 in the PANSS Total Score (Baseline to Week 6)
D: Time From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse in Phase C. (From randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia
Brief Summary: This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.


Options:
A: Efficacy of combined risperidone and quetiapine groups versus placebo based on change in psychotic symptoms scale from baseline to two weeks.
B: Change From Baseline to Week 6 in the PANSS Total Score (Baseline to Week 6)
C: Positive and Negative Syndrome Scale (PANSS) total score (Change from baseline to Day 28)
D: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline, Week 6)

Answer: B