TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine GSK580299 in Healthy Female Subjects Aged 10-25 Years.
Brief Summary: Cervical cancer is the second most common cancer among women worldwide. Approximately 500 000 new cases are reported each year worldwide, from which 83% occur in developing countries. The incidence of cervical cancer varies depending on the region of the world. Africa has some of the highest age-standardized incidence and mortality rates in the world (Eastern Africa 42.7 and 34.6 per 100 000; Southern Africa 38.2 and 22.6 per 100 000; Western Africa 29.3 and 23.8 per 100 000; Middle Africa 28.0 and 23.0 per 100 000).

As in the majority of developing countries, organization of cervical cancer screening programs in Africa is difficult to manage, especially in rural areas. HPV prophylactic vaccination could therefore clearly and efficiently decrease the incidence of cervical cancer. The current study is designed to assess the immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 AS04 vaccine in female subjects enrolled from multiple countries in Africa.

Ideally, HPV vaccination should be performed before onset of sexual activity, since studies have shown that acquisition of high-risk HPV occurs soon after sexual debut. This study will therefore be performed in subjects aged 10 to 25 years of age.


Options:
A: Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) (Throughout the study period (up to Month 24))
B: Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies (At Month 7); Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies (At Month 7)
C: Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies (At Month 7)
D: Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies (At Month 7)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled Dose-Range Finding Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Brief Summary: A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control of their blood sugar.


Options:
A: To asses the effectiveness of MK0431 compared to placebo (over 12 weeks)
B: Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]) (Baseline to Week 24)
C: Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia. (From week 0 to week 52.)
D: ß-cell Function parameter (From the signature of the Informed Consent Form (ICF) up to the end of study); Glucose Homeostasis and glycemic control status (From the signature of the Informed Consent Form (ICF) up to the end of study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy of PR OROS Methylphenidate Followed by Open-Label Extension, in Swedish Male Prison Inmates With ADHD
Brief Summary: The purpose of this study is to evaluate the efficacy and effectiveness of methylphenidate in treatment of ADHD in Swedish adult male prison inmates diagnosed with ADHD.


Options:
A: Primary Outcome Measure (3 years)
B: Efficacy of PR OROS methylphenidate on ADHD-symptoms in adult male prison inmates with ADHD, as measured by changes from baseline until endpoint in the observer-rated CAARS. (Changes from baseline until endpoint at week 5)
C: N/A
D: prevalence of non-users of street opioid after one year of treatment will be compared between arms. (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy of PR OROS Methylphenidate Followed by Open-Label Extension, in Swedish Male Prison Inmates With ADHD
Brief Summary: The purpose of this study is to evaluate the efficacy and effectiveness of methylphenidate in treatment of ADHD in Swedish adult male prison inmates diagnosed with ADHD.


Options:
A: Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed). (These must be the last three weeks (7,8,9) of the trial.)
B: Time-to-Relapse: XRNTX vs. ETAU Following Release From Jail (up to 24 weeks)
C: Service Cascade: % Referred to Substance Use Treatment (120 weeks); Staff Perception: Value of Evidenced Based Substance Use Treatment (120 weeks)
D: Efficacy of PR OROS methylphenidate on ADHD-symptoms in adult male prison inmates with ADHD, as measured by changes from baseline until endpoint in the observer-rated CAARS. (Changes from baseline until endpoint at week 5)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy of PR OROS Methylphenidate Followed by Open-Label Extension, in Swedish Male Prison Inmates With ADHD
Brief Summary: The purpose of this study is to evaluate the efficacy and effectiveness of methylphenidate in treatment of ADHD in Swedish adult male prison inmates diagnosed with ADHD.


Options:
A: Monitoring adverse events, blood pressure, pulse, and weight throughout the study; ECG at Screening, Baseline, 1 week after upward dose titration, Months 3, 6, 9, 12 or Early Termination; Laboratory tests Screening, Month 6, Month 12 or Early Termination
B: N/A
C: Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment (Baseline 1 to End of Period 1 (Week 9)); Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment (Baseline 1 to End of Period 1 (Week 9)); Percentage of Participants With Treatment Failures During Period 3 (Baseline Period 1 (Baseline 1) and Baseline Period 3 (Baseline 2) to End of Week 40)
D: Efficacy of PR OROS methylphenidate on ADHD-symptoms in adult male prison inmates with ADHD, as measured by changes from baseline until endpoint in the observer-rated CAARS. (Changes from baseline until endpoint at week 5)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
Brief Summary: The purpose of this study is to compare the antinociceptive effect of 1 ml of 30% sucrose solution vs breastfeeding on neonatal screening heel lance


Options:
A: Premature Infant Pain Profile (PIPP) scale rate (0-21) (15 seconds before and Within 30 seconds after heel lance)
B: - 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)
C: Pain-specific event related potential (Isolated within the one-minute window post-procedure.)
D: The primary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R). (Change from baseline 30 seconds post painful procedure)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
Brief Summary: The purpose of this study is to compare the antinociceptive effect of 1 ml of 30% sucrose solution vs breastfeeding on neonatal screening heel lance


Options:
A: 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.)
B: Cortical oxy-haemoglobin increase (During the procedure)
C: N/A
D: Premature Infant Pain Profile (PIPP) scale rate (0-21) (15 seconds before and Within 30 seconds after heel lance)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
Brief Summary: The purpose of this study is to compare the antinociceptive effect of 1 ml of 30% sucrose solution vs breastfeeding on neonatal screening heel lance


Options:
A: - 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)
B: The University of Wisconsin Children's Hospital Pain Scale will measure the primary outcome acute behavioral pain response. Measure will be recorded at baseline, immediately after immunizations and 3 minutes following immunizations
C: Premature Infant Pain Profile (PIPP) scale rate (0-21) (15 seconds before and Within 30 seconds after heel lance)
D: Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP) (before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
Brief Summary: The purpose of this study is to compare the antinociceptive effect of 1 ml of 30% sucrose solution vs breastfeeding on neonatal screening heel lance


Options:
A: Premature Infant Pain Profile (two hours)
B: Premature Infant Pain Profile (PIPP) scale rate (0-21) (15 seconds before and Within 30 seconds after heel lance)
C: 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.)
D: Painful response as assessed by PIPP Scale (Pre procedure,Intra procedure,post 30 sec,post 1 min,post 2 minutes)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Study of Temozolomide and Short-Course Radiation Versus Short-Course Radiation Alone In The Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether radiation therapy and temozolomide are more effective than radiation therapy alone in treating glioblastoma multiforme.

PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared with radiation therapy alone in treating patients with newly diagnosed glioblastoma multiforme.


Options:
A: Progression Free Survival (PFS) (Baseline at 6 weeks and then every 6 weeks to discontinuation)
B: Overall survival (From the date of randomization to 18 months or to the date of death from any cause)
C: Survival 6 mo (Proportion of alive participants at 6 months)
D: Overall Survival (7 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Study of Temozolomide and Short-Course Radiation Versus Short-Course Radiation Alone In The Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether radiation therapy and temozolomide are more effective than radiation therapy alone in treating glioblastoma multiforme.

PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared with radiation therapy alone in treating patients with newly diagnosed glioblastoma multiforme.


Options:
A: N/A
B: median overall survival (1 year)
C: Overall Survival (OS) Time (Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012))
D: Overall Survival (7 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Study of Temozolomide and Short-Course Radiation Versus Short-Course Radiation Alone In The Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether radiation therapy and temozolomide are more effective than radiation therapy alone in treating glioblastoma multiforme.

PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared with radiation therapy alone in treating patients with newly diagnosed glioblastoma multiforme.


Options:
A: Overall Survival (7 years)
B: N/A
C: Overall Survival (2.5 years)
D: Survival

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Risk Factors for Diabetes Complications in Primary Care
Brief Summary: The purpose of this study is to test an intervention in primary care clinics to improve three risk factors for diabetes complications: glucose control, blood pressure and cholesterol. Subjects in the study will be clinic staff and clinicians, not patients. The intervention is Practice Facilitation. Practice facilitation occurs when a trained facilitator meets with a team of staff and clinicians in each practice over a period of several months. Facilitation meetings create time for learning and reflection by members of the team and improves their communication so that they can adopt and implement a strategy to improve patient care


Options:
A: Reach (Entire 6 month early or delayed implementation phase); Effectiveness - Ask (6 month early implementation phase); Effectiveness - Goal Setting (6 month early implementation phase); Effectiveness - Assistance (6 month early implementation phase); Effectiveness - Referred (6 month early implementation phase)
B: Increased linkages between low income families and established services in their communities (Baseline, 12-month, 24-month, 36-month follow-up)
C: glycosylated hemoglobin (36 months)
D: Change in Body Mass Index (3 and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin
Brief Summary: The randomized controlled trial is conducted among antiretroviral naive co-infected HIV and tuberculosis patients who receiving rifampicin-based antituberculous regimen fro at least 4 weeks butt not exceed 16 weeks before enrolment. All patients receive the same backbone regimen of stavudine (30 mg/40 mg twice daily)+ lamivudie 150 mg twice daily. They are randomized to receive nevirapine 400 mg/day twice daily vs efavirenz 600 mg/day at bed time. All patients are followed through 144 weeks after initiation of antiviral therapy. The primary objective are to compare the proportion of patient who achieve undetectable plasma HIV-1RNA\<50 copies/ml at week 48. The previous reports demonstrated that the standard doses of both nevirapine and efavirenz coulde be used among co-infected HIV and tuberculosis patients who receiving rifampicin even though plasma levels are somewhat reduced by rifampicin. However, there have been not been a randomized control trial to compare these two regimens. Thus, this trial will provide the efficacy data between these two regimens.


Options:
A: To compare proportion of patients who achieved undetectable plasma HIV-1RNA< 50 copies/mL at 48 weeks after initiation of antiretroviral treatment between the 2 groups (48 weeks)
B: Virological suppression at 48 weeks. (5 years)
C: Viral load measure (Virological failure will be defined after 2 consecutive measures as : More than 1 log10 increase in plasma HIV-1 RNA concentration for patients with detectable viral load (> 50 copies/mL) at the previous dosage.) (3, 6 and 12 months)
D: Suppression of Viral load to < 400 copies/ml or a two log reduction in viral load from the baseline value at the end of 6 months and a viral load <400 copies/ml at 24 months of antiretroviral therapy (Dec 2008)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and Pharmacogenetic Study of Attention Deficit With Hyperactivity Disorder (ADHD)
Brief Summary: Attention deficit with hyperactivity disorder (ADHD) is a very common behavioral problem during childhood. It is estimated that up to 80% of this disorder could be related to genetic factors. The most common treatment for ADHD is psychostimulants. In this study, the researchers investigate the effect of genetic variants in increasing the risk for behaviours pertinent to ADHD or in modulating the response of these behaviours to methylphenidate. Response to methylphenidate is evaluated through a double blind placebo controlled one week study.


Options:
A: Change in ADHD and ODD symptoms (Every week for six weeks); Change in attention, motor activity and executive functioning (The neuropsychological tests are administered once on each type of medication during the six week trial); Change in side-effects (Once every week through the six week trial)
B: Conners' Global Index - Parent Version (CGI-P) (Once weekly during the medication trial); Conner's Global Index - Teacher Version (CGI-T) (Once weekly during the medication trial)
C: Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose (Pre-dose to 10, 11, and 12 hours post-dose)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and Pharmacogenetic Study of Attention Deficit With Hyperactivity Disorder (ADHD)
Brief Summary: Attention deficit with hyperactivity disorder (ADHD) is a very common behavioral problem during childhood. It is estimated that up to 80% of this disorder could be related to genetic factors. The most common treatment for ADHD is psychostimulants. In this study, the researchers investigate the effect of genetic variants in increasing the risk for behaviours pertinent to ADHD or in modulating the response of these behaviours to methylphenidate. Response to methylphenidate is evaluated through a double blind placebo controlled one week study.


Options:
A: Abstinence from smoking in the past 30 days at 6 months and 1 year
B: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
C: Conners' Global Index - Parent Version (CGI-P) (Once weekly during the medication trial); Conner's Global Index - Teacher Version (CGI-T) (Once weekly during the medication trial)
D: Reduction in number of cigarettes smoked as measured by the Timeline Follow-back. (Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and Pharmacogenetic Study of Attention Deficit With Hyperactivity Disorder (ADHD)
Brief Summary: Attention deficit with hyperactivity disorder (ADHD) is a very common behavioral problem during childhood. It is estimated that up to 80% of this disorder could be related to genetic factors. The most common treatment for ADHD is psychostimulants. In this study, the researchers investigate the effect of genetic variants in increasing the risk for behaviours pertinent to ADHD or in modulating the response of these behaviours to methylphenidate. Response to methylphenidate is evaluated through a double blind placebo controlled one week study.


Options:
A: Efficacy outcome was change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T) (at 16 weeks)
B: Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose (Pre-dose to 10, 11, and 12 hours post-dose)
C: Postoperative pain - VAS (24 hours); Postoperative pain - PCA (24 hours)
D: Conners' Global Index - Parent Version (CGI-P) (Once weekly during the medication trial); Conner's Global Index - Teacher Version (CGI-T) (Once weekly during the medication trial)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Telephone Follow-Up on Outcome After Mild TBI
Brief Summary: The purpose of this study is to see whether providing education and counseling after a mild traumatic brain injury will help in preventing symptoms from becoming chronic over the first six months after injury.


Options:
A: Beck Depression Inventory - II (Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.)
B: Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status (Six months)
C: Remission of depression (DSM-IV diagnosis no longer met) (baseline); Remission of depression (DSM-IV diagnosis no longer met) (one week after treatment completion); Remission of depression (DSM-IV diagnosis no longer met) (six months after treatment completion); Remission of depression (DSM-IV diagnosis no longer met) (one year after treatment completion)
D: Hamilton Rating Scale for Depression (HAM-D) (16 weeks, 24 weeks); Symptom Checklist-20 (SCL-20) (16 weeks, 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Maximizing Opportunity: HIV Prevention in Hospitalized Russian Drinkers
Brief Summary: The objective of this study is to test in a randomized controlled trial the effectiveness of a US secondary HIV prevention program to reduce HIV risk behaviors, STD acquisition, and alcohol consumption among HIV-infected Russians with risky drinking.


Options:
A: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)
B: Fruit and vegetable intake (Up to one year)
C: Rearrest
D: Number of unprotected sex acts, unclean drug injections, and sexually transmitted infections (by urinalysis) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Maximizing Opportunity: HIV Prevention in Hospitalized Russian Drinkers
Brief Summary: The objective of this study is to test in a randomized controlled trial the effectiveness of a US secondary HIV prevention program to reduce HIV risk behaviors, STD acquisition, and alcohol consumption among HIV-infected Russians with risky drinking.


Options:
A: Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline. (Baseline and 6 months post-baseline)
B: Number of unprotected sex acts, unclean drug injections, and sexually transmitted infections (by urinalysis) (12 months)
C: Alcohol use (12 months); HIV viral load (12 months)
D: Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative (3-, 6-, and 9-month post-baseline)

Answer: B