TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Sulphadoxine-pyrimethamine and Amodiaquine Alone or in Combination as Intermittent Preventive Treatment in Pregnancy in the Kassena-Nankana District of Ghana: a Randomized Controlled Trial
Brief Summary: In areas of stable transmission, pregnant women, especially during the first and second pregnancies, have an increased susceptibility to Plasmodium falciparum malaria, malaria-related anaemia and an increased risk of having low birthweight babies. Intermittent Preventive Treatment in pregnancy(IPTp) with sulphadoxine-pyrimethamine has been shown to be effective in reducing the effects of malaria in pregnancy. This has mainly been in areas of perennial transmission and there is a need to study this effect in intense seasonal transmission settings. The emergence and spread of resistance to SP is likely to undermine its useful lifespan and it is important that other antimalarials that are safe and effective are identified for use in IPTp. The options are however limited. Amodiaquine has been shown to be effective in treatment of clinical cases of malaria, even in areas where chloroquine resistance is prevalent, and its combination with SP has been associated with favourable results. Both are affordable. However, there is limited data on their use in pregnancy. This study aims to assess the efficacy of SP in an area of intense seasonal transmission, and evaluate the safety and efficacy of amodiaquine and a combination of sulphadoxine-pyrimethamine and amodiaquine as possible alternatives to SP for use as IPTp.


Options:
A: Prevalence of severe maternal anaemia (Hb < 8g/dl) at 34 to 36 weeks of gestation. (At 34 to 36 weeks of gestation)
B: • Prevalence of placental malaria infection; • Prevalence of maternal peripheral parasitemia
C: mean birthweight (April 2004-Jan 2007); prevalence of low birthweight (April 2004 - Jan 2007)
D: HB at delivery (with inseven 7days of delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Trial of Rapid Diagnostic Tests in the Diagnosis of Non-Severe Malaria at Different Transmission Intensities of Plasmodium Falciparum in Tanzania
Brief Summary: There is clear evidence diagnosis of malaria in much of Africa is sub-optimal and this has a negative impact on patient care. Many of those treated for malaria do not have it. Rapid diagnostic tests (RDTs) are dipsticks which diagnose malaria rapidly and accurately. The main objective of this trial is to determine by means of a randomised trial the impact of introducing RDTs into a standard outpatient setting in Tanzania has on the appropriate prescription of antimalarials. Other objectives are:

1. To compare at high, moderate and low P.falciparum transmission intensity the sensitivity and specificity of malaria diagnosis using hospital slide results and RDTs, using research quality slides as the reference.
2. To estimate the specificity of clinical diagnosis of malaria at high, moderate and low transmission intensity of P. falciparum.
3. To compare the proportion of cases reported as slide-negative who are treated for malaria with the proportion of RDT-negative cases treated for malaria.
4. To evaluate the cost effectiveness of introducing RDTs compared to current diagnostic practice in facilities with microscopic diagnosis of malaria at different levels of transmission of P.falciparum.


Options:
A: N/A
B: Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups (28 days)
C: N/A
D: The proportion of RDT test-negative patients who are prescribed an antimalarial in two settings: where there is microscopy and where diagnosis is on clinical basis (Two years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Trial of Rapid Diagnostic Tests in the Diagnosis of Non-Severe Malaria at Different Transmission Intensities of Plasmodium Falciparum in Tanzania
Brief Summary: There is clear evidence diagnosis of malaria in much of Africa is sub-optimal and this has a negative impact on patient care. Many of those treated for malaria do not have it. Rapid diagnostic tests (RDTs) are dipsticks which diagnose malaria rapidly and accurately. The main objective of this trial is to determine by means of a randomised trial the impact of introducing RDTs into a standard outpatient setting in Tanzania has on the appropriate prescription of antimalarials. Other objectives are:

1. To compare at high, moderate and low P.falciparum transmission intensity the sensitivity and specificity of malaria diagnosis using hospital slide results and RDTs, using research quality slides as the reference.
2. To estimate the specificity of clinical diagnosis of malaria at high, moderate and low transmission intensity of P. falciparum.
3. To compare the proportion of cases reported as slide-negative who are treated for malaria with the proportion of RDT-negative cases treated for malaria.
4. To evaluate the cost effectiveness of introducing RDTs compared to current diagnostic practice in facilities with microscopic diagnosis of malaria at different levels of transmission of P.falciparum.


Options:
A: N/A
B: Incidence of malaria (fever + any level of parasite density) in < 48 month-old children (Stage 2, Component A) (Three years)
C: the proportion of study children receiving prescriptions of antimalarial drugs in the respective arms (Day 0)
D: The proportion of RDT test-negative patients who are prescribed an antimalarial in two settings: where there is microscopy and where diagnosis is on clinical basis (Two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Post Traumatic Stress Disorder by Early Treatment
Brief Summary: To prospectively evaluate the effect of early treatment (cognitive therapy (CT), cognitive-behavioral therapy (CBT) and escitalopram (SSRI) in preventing the occurrence of post-traumatic stress disorder in recent survivors of traumatic events.


Options:
A: Psychopathology: improvement on PANSS positive scale (PANSS 'Positive and Negative Syndrome Scale') (12 weeks)
B: Post-traumatic Stress Disorder (chronic) by CAPS scores. (Four months, seven months, 14 moths, two years)
C: Change in PTSD Symptom Scale, Interview Version (PSS-I) following treatment (Baseline to 6-month follow-up (approximately 34 weeks for Spaced PE and PCT, 26 weeks for Massed PE)
D: Change in PTSD symptom severity with the PSS-I the Post-traumatic Stress Disorder Scale- Interview (PSS-I) post-treatment at 6- and 12-month follow-up (8, 18 and 25- month follow-up); Change in Attraction to violence with the Appetitive Aggression Scale (AAS) post-treatment at 6- and 12-month follow-up (8, 18 and 25- month follow-up); Change in Methylation Pattern of the Glucocorticoid Receptor promoter region via saliva samples (8, 18 and 25- month follow-up); Change in Self-committed violence with the AAS offense list (8, 18 and 25- month follow-up); Influence of Social Acknowledgement with Social Acknowledgement Questionnaire (SAQ) (8, 18 and 25- month follow-up); Influence of drug abuse related to violence on number of offenses with the offense checklist (from the AAS) (8, 18 and 25- month follow-up); Change in Epigenetic Markers (methylation patterns) of violence in the androgen receptor promoter region via saliva samples (8, 18 and 25- month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Post Traumatic Stress Disorder by Early Treatment
Brief Summary: To prospectively evaluate the effect of early treatment (cognitive therapy (CT), cognitive-behavioral therapy (CBT) and escitalopram (SSRI) in preventing the occurrence of post-traumatic stress disorder in recent survivors of traumatic events.


Options:
A: Post-traumatic Stress Disorder (chronic) by CAPS scores. (Four months, seven months, 14 moths, two years)
B: Symptoms of Acute Stress Disorder; Symptoms of Posttraumatic Stress Disorder
C: Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) (30 days postoperatively)
D: Cumulative opioid morphine equivalent dose (The first 24 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Post Traumatic Stress Disorder by Early Treatment
Brief Summary: To prospectively evaluate the effect of early treatment (cognitive therapy (CT), cognitive-behavioral therapy (CBT) and escitalopram (SSRI) in preventing the occurrence of post-traumatic stress disorder in recent survivors of traumatic events.


Options:
A: The Number of Feasibility Criteria Successfully Met (3-6 months post discharge from PICU)
B: Hospital Anxiety and Depression Scale - Depression Scale at Baseline (Baseline); Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up (Six-months follow-up); Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up (Twelve-months follow-up); Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline (Baseline); Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up (Six-months follow-up); Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Total Score at Baseline (Baseline); Impact of Events Scale-Revised - Total Score at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Total Score at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Intrusiveness Scale at Baseline (Baseline); Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Avoidance Scale at Baseline (Baseline); Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Event Scale-Revised Hyperarousal Scale at Baseline (Baseline); Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up (Six-months follow-up); Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up (Twelve-months follow-up); Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline (Baseline); Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up (Six-months follow-up); Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up (Twelve-months follow-up)
C: Post-traumatic Stress Disorder (chronic) by CAPS scores. (Four months, seven months, 14 moths, two years)
D: PTSD Symptom Scale- I (PSS) (Measured 4 and 12 weeks post-trauma)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Corticosteroid Therapy of Septic Shock - Corticus. A Multi-National, Prospective, Double-Blind, Randomized, Placebo-Controlled Study
Brief Summary: The purpose of the study is to determine whether steroids decrease 28-day mortality in patients with septic shock.


Options:
A: Safety and Tolerability (6-9 months); Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for PTSD (2-3 years); Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for early Acute Stress Disorder (ASD) (2-3 years); Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for prolonged Acute Stress Disorder (ASD) (2-3 years)
B: Physiological Posterior Probability of Posttraumatic Stress Disorder (PTSD) as Determined From Psychophysiologic Responses During Script-Driven Mental Imagery at Month 1 (Month 1); Physiological Posterior Probability of PTSD as Determined From Psychophysiologic Responses During Script-Driven Mental Imagery at Month 3 (Month 3)
C: 28 day mortality in all the non-responders to ACTH (< or = 9 mcg/dl or 250 nmol/L post ACTH) (28 days)
D: Clinician Administered PTSD Scale (CAPS) (Up to 7 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Corticosteroid Therapy of Septic Shock - Corticus. A Multi-National, Prospective, Double-Blind, Randomized, Placebo-Controlled Study
Brief Summary: The purpose of the study is to determine whether steroids decrease 28-day mortality in patients with septic shock.


Options:
A: Time to clinical stability (30 days)
B: 28-day Mortality (28 days)
C: Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria (28 days)
D: 28 day mortality in all the non-responders to ACTH (< or = 9 mcg/dl or 250 nmol/L post ACTH) (28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Corticosteroid Therapy of Septic Shock - Corticus. A Multi-National, Prospective, Double-Blind, Randomized, Placebo-Controlled Study
Brief Summary: The purpose of the study is to determine whether steroids decrease 28-day mortality in patients with septic shock.


Options:
A: 28 day mortality in all the non-responders to ACTH (< or = 9 mcg/dl or 250 nmol/L post ACTH) (28 days)
B: Length of stay in ICU and length of stay in the hospital. (2 years)
C: Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock
D: length of hospital stay (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension
Brief Summary: This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.


Options:
A: Peak 6-minute Walk Distance (12 weeks)
B: Change from baseline to all assessed time points in 6MWT, in Borg dyspnea index, and in modified NYHA functional class.
C: Change in 6-minute walk distance (Baseline to End-of-Period 1)
D: Time to tumor progression (TTP) or death (progression free survival) after initiation of treatment. Tumor progression is defined per RECIST criteria. (6 weekly)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension
Brief Summary: This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.


Options:
A: Six Minute Walk Distance (6MWD) (Baseline and Week 12)
B: 6-minute Walk Distance (6MWD) (Baseline and 16 weeks)
C: Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake (Up to 7 days after end of double-blind treatment (maximum: 4.3 years))
D: Peak 6-minute Walk Distance (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension
Brief Summary: This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.


Options:
A: Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake (Up to 7 days after end of double-blind treatment (maximum: 4.3 years))
B: Number of Patients Reaching a 6-Minute Walk Test (6MWT) Distance ≥ 380 Meters (at 16 weeks and at 28 weeks of a stepped approach to therapy)
C: Peak 6-minute Walk Distance (12 weeks)
D: Pulmonary hemodynamics (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension
Brief Summary: This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.


Options:
A: Peak 6-minute Walk Distance (12 weeks)
B: Improvement in six minute walk distance (16 weeks)
C: Change in 6-minute walk distance (Baseline to End-of-Period 1)
D: 6 minutes walking distance

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Safety of Campath-1H as an Induction Agent in Combination With Tacrolimus Monotherapy for Prevention of Graft Rejection Compared to Tacrolimus in Combination With MMF and Steroids in Cadaveric Kidney Transplantation
Brief Summary: The purpose of this study is to determine whether Campath following Tacrolimus monotherapy is more effective in the prevention of renal graft rejection (considering an acute rejection rate of 5% for Campath-1H/Tacrolimus and of 22% for Tacrolimus/MMF/Steroids).


Options:
A: Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months (6 months)
B: Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function (During first 7 days after kidney transplantation)
C: Incidence and severity of biopsy-confirmed acute rejection (First six months after transplantation)
D: Biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification) (Month 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis
Brief Summary: The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily \[BID\]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).


Options:
A: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
B: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)
C: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 (Baseline, Month 3); Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 (Month 6)
D: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 (Week 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis
Brief Summary: The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily \[BID\]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).


Options:
A: ACR 20% response (Week 14)
B: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 (Week 6)
C: EULAR individual response (12 months)
D: Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score (76 and 91 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis
Brief Summary: The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily \[BID\]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 (Week 12)
B: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)
C: Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24 (Baseline to Week 24)
D: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 (Week 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis
Brief Summary: The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily \[BID\]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).


Options:
A: Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 16 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 16); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 8 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 8); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 4 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 4); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 2 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 2); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 1 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 1)
B: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 (Week 6)
C: Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4 (Week 78)
D: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)

Answer: B