TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Natural History Study of Multidrug-Resistant Tuberculosis Strains and Host Susceptibility Genes in Korean Patients With Pulmonary Tuberculosis
Brief Summary: This study, conducted in Korea, will examine why some people are more susceptible to tuberculosis (TB) than others and why some strains of M tuberculosis (the bacteria that causes TB) are more difficult to treat or become resistant to drug treatments. The study will compare blood samples and other medical information from patients with different kinds of tuberculosis and with healthy volunteers to identify patient and bacterial characteristics that contribute to disease susceptibility, treatment failure, disease recurrence and multi-drug resistance.

Healthy volunteers and patients with tuberculosis who are 20 years of age or older may be eligible for this study. Subjects are recruited from among patients receiving treatment for tuberculosis at the National Masan Tuberculosis Hospital in the Republic of Korea and from healthy people visiting government health care centers for annual medical checkups. The latter include people who have had TB but are cured; people who have been exposed to TB, but currently have no signs of disease; and those who have not been exposed to TB.

Participants with tuberculosis undergo the following tests and procedures:

* Medical history, including past treatments for TB, and review of medical records
* Interview about home and work
* Sputum collection to test for the kind of TB bacteria present and for genetic studies of the bacteria
* Drug treatment for TB
* Blood draws as part of regular patient care, for HIV testing, and for genetic studies
* Chest x-rays as part of routine patient care
* In patients with recurrent disease, examination of the strains from both bouts of disease to determine if it is a recurrence of the same organism or infection with a new strain.

Healthy volunteers undergo the following tests and procedures:

* Brief medical history
* Blood draw to look for exposure to TB and for genetic studies
* Review of previous x-ray to look for active TB


Options:
A: All-cause mortality (8 weeks)
B: Sensitivity of the lateral-flow urine LAM assay (LF-LAM) (One year); Failure rate of the lateral-flow urine LAM assay (One year); Inter-reader variability of the lateral-flow urine LAM assay (One year); Specificity of the lateral-flow urine LAM assay (LF-LAM) (One year)
C: Sensitivity of the lateral-flow urine LAM assay (LF-LAM) (One year); Failure rate of the lateral-flow urine LAM assay (One year); Inter-reader variability of the lateral-flow urine LAM assay (One year); Specificity of the lateral-flow urine LAM assay (LF-LAM) (One year)
D: To compare the characteristics of subjects with relapsed tuberculosis verses the characteristics of subjects that do not experience relapse disease (Over course of the study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Natural History Study of Multidrug-Resistant Tuberculosis Strains and Host Susceptibility Genes in Korean Patients With Pulmonary Tuberculosis
Brief Summary: This study, conducted in Korea, will examine why some people are more susceptible to tuberculosis (TB) than others and why some strains of M tuberculosis (the bacteria that causes TB) are more difficult to treat or become resistant to drug treatments. The study will compare blood samples and other medical information from patients with different kinds of tuberculosis and with healthy volunteers to identify patient and bacterial characteristics that contribute to disease susceptibility, treatment failure, disease recurrence and multi-drug resistance.

Healthy volunteers and patients with tuberculosis who are 20 years of age or older may be eligible for this study. Subjects are recruited from among patients receiving treatment for tuberculosis at the National Masan Tuberculosis Hospital in the Republic of Korea and from healthy people visiting government health care centers for annual medical checkups. The latter include people who have had TB but are cured; people who have been exposed to TB, but currently have no signs of disease; and those who have not been exposed to TB.

Participants with tuberculosis undergo the following tests and procedures:

* Medical history, including past treatments for TB, and review of medical records
* Interview about home and work
* Sputum collection to test for the kind of TB bacteria present and for genetic studies of the bacteria
* Drug treatment for TB
* Blood draws as part of regular patient care, for HIV testing, and for genetic studies
* Chest x-rays as part of routine patient care
* In patients with recurrent disease, examination of the strains from both bouts of disease to determine if it is a recurrence of the same organism or infection with a new strain.

Healthy volunteers undergo the following tests and procedures:

* Brief medical history
* Blood draw to look for exposure to TB and for genetic studies
* Review of previous x-ray to look for active TB


Options:
A: Sensitivity of the lateral-flow urine LAM assay (LF-LAM) (One year); Failure rate of the lateral-flow urine LAM assay (One year); Inter-reader variability of the lateral-flow urine LAM assay (One year); Specificity of the lateral-flow urine LAM assay (LF-LAM) (One year)
B: All-cause mortality (8 weeks)
C: To compare the characteristics of subjects with relapsed tuberculosis verses the characteristics of subjects that do not experience relapse disease (Over course of the study)
D: Comparison of novel intensive-case finding diagnostic tools to standard intensive-case finding strategy (2 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study (ATBC Study) Population
Brief Summary: The project is a passive follow-up of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study cohort. Originally, this was a large, randomized, double-blind, placebo-controlled, 2x2 factorial primary prevention trial testing the effects of alpha-tocopherol and beta-carotene supplementation on cancer incidence and mortality. The study was conducted in Finland as a collaboration between the U.S. National Cancer Institute (NCI) and the National Public Health Institute of Finland. NCI has maintained passive surveillance of the cohort through Finnish national registries, including the cancer registry.

The primary purpose of the ATBC cohort follow-up is to use the existing risk factor data and biological specimens (i.e., serum, whole blood, DNA, red blood cells, and toenails) to test hypotheses relevant to cancer etiology, survival, early detection, and prevention. These data and biospecimens continue to provide an invaluable resource for the study of biochemical, nutritional, genetic, and molecular hypotheses. These analyses are made all the more informative and powerful by the addition of cases identified annually during the follow-up period, and the research benefits from a longer pre-diagnosis period (now over 30 years).


Options:
A: Cancer (Annually)
B: A combination of CVD mortality non fatal MI and Stoke at a 4 year follow up.
C: Cardiovascular disease; Cancer
D: Cellular and Humoral Immune Response (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pivotal Phase 3 Observer-Blind, Randomized Clinical Trial of the Efficacy and Safety of APF530 Compared to Aloxi For The Prevention of Acute-Onset and Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Following The Administration of Either Moderately or Highly Emetogenic Chemotherapy Regimens
Brief Summary: This randomized phase III trial is studying APF530 and dexamethasone to see how well they work compared with palonosetron and dexamethasone in preventing nausea and vomiting in patients receiving chemotherapy for cancer.


Options:
A: Patient diary recording nausea, emesis, food ingestion, and rescue therapy (From initiating administration of anticancer agents to day 6 (120 hours))
B: Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1 (0-24 Hours); Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1 (24-120 Hours)
C: Effect of aprepitant on cyclophosphamide and 4-hydroxycyclophosphamide pharmacokinetics as measured by plasma AUC (05/2005 to 10/2010)
D: Complete Response. (Participants were evaluated from start of treatment through day 8 of cycle 2.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Triple Dummy, Placebo-controlled, Randomised, Parallel Group Positron Emission Tomography Study to Investigate the Effects of a 8 Week Administration of GW597599 and Paroxetine Either Alone or in Combination on Regional Cerebral Blood Flow During a Public Speaking Test in Subjects Affected by Social Phobia.
Brief Summary: This six-arm study is being conducted to measure the effect of a combination of paroxetine and vestipitant on the arousal induced by public speaking in Seasonal Effective Disorder (SAD) patients, using functional brain imaging readouts (i.e., WAT(Wave Analysis Technology) PET(Positron Emission Tomography)), after one or eight weeks of treatment. The effect of paroxetine alone after one or eight weeks of treatment will also be measured.


Options:
A: Superiority is defined as a statistically greater reduction of the mean change from baseline to endpoint (after 12 weeks of treatment) in the Liebowitz Social Anxiety Scale (LSAS) total score.
B: Change in Liebowitz Social Anxiety Scale (LSAS) - total score (Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks)
C: Personal Report of Confidence as a Speaker (PRCS)
D: To assess, by mean of Positron Emission Tomography, the degree of regional Cerebral Blood Flow in different brain regions involved in the emotional brain circuit during public speaking task before treatment and after eight weeks of treatment.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Randomised, Double-blind, Double Dummy Study Comparing the Efficacy and Safety of Chlorproguanil-dapsone-artesunate Versus Artemether-lumefantrine in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children and Adolescents in Africa.
Brief Summary: Chlorproguanil-dapsone has been approved for the treatment of uncomplicated Plasmodium falciparum malaria in a number of countries across sub-Sahara Africa, and by the UK's Medicines and Healthcare products Regulatory Agency.

CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a public-private partnership with the Medicines for Malaria Venture (MMV), World Health Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P. falciparum malaria.

The combination of chlorproguanil-dapsone-artesunate (CDA) is being developed to supersede chlorproguanil-dapsone for the same indication, but the addition of an artemisinin derivative, artesunate, should provide additional population benefits over chlorproguanil-dapsone alone. The artemisinins have been demonstrated to rapidly reduce parasite load and have activity against the sexual stages of the P.falciparum lifecycle. The addition of a second agent to the chlorproguanil-dapsone combination should also protect against the selection of resistant strains of P.falciparum.

Artemether-lumefantrine is the only available fixed-dose Artemisinin-based Combination Therapy actually available and is considered as the gold standard for the treatment of P. falciparum malaria. This study will therefore aim to demonstrate the non-inferiority of the combination of CDA to artemether-lumefantrine in terms of efficacy at 28-days. The key secondary objectives will compare the Parasite Clearance Times (PCT) and the Fever Clearance Times (FCT) between CDA and artemether-lumefantrine.


Options:
A: Parasitological cure rate, PCR corrected, at day 28 in the PP population The ITT population is a key supportive analysis.
B: Parasitological cure rate, PCR-corrected, at day 28, in the per-protocol population. Parasitological cure rate is defined as the clearance of the initial malaria infection by day 7 and remaining free of this infection to the day of assessment.
C: Prevalence of P. falciparum gametocyte carriers (QT-NASBA) (Day 7)
D: Cure rate (63 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Randomised, Double-blind, Double Dummy Study Comparing the Efficacy and Safety of Chlorproguanil-dapsone-artesunate Versus Artemether-lumefantrine in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children and Adolescents in Africa.
Brief Summary: Chlorproguanil-dapsone has been approved for the treatment of uncomplicated Plasmodium falciparum malaria in a number of countries across sub-Sahara Africa, and by the UK's Medicines and Healthcare products Regulatory Agency.

CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a public-private partnership with the Medicines for Malaria Venture (MMV), World Health Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P. falciparum malaria.

The combination of chlorproguanil-dapsone-artesunate (CDA) is being developed to supersede chlorproguanil-dapsone for the same indication, but the addition of an artemisinin derivative, artesunate, should provide additional population benefits over chlorproguanil-dapsone alone. The artemisinins have been demonstrated to rapidly reduce parasite load and have activity against the sexual stages of the P.falciparum lifecycle. The addition of a second agent to the chlorproguanil-dapsone combination should also protect against the selection of resistant strains of P.falciparum.

Artemether-lumefantrine is the only available fixed-dose Artemisinin-based Combination Therapy actually available and is considered as the gold standard for the treatment of P. falciparum malaria. This study will therefore aim to demonstrate the non-inferiority of the combination of CDA to artemether-lumefantrine in terms of efficacy at 28-days. The key secondary objectives will compare the Parasite Clearance Times (PCT) and the Fever Clearance Times (FCT) between CDA and artemether-lumefantrine.


Options:
A: P.falciparum parasitaemia detected by PCR on days 3,7 and 14. (14 days from start of treatment)
B: Cure rate (63 days)
C: Parasitological cure rate, PCR corrected, at day 28 in the PP population The ITT population is a key supportive analysis.
D: Mean number of days to gametocyte clearance (gametocyte clearance time, GCT) (14 days); Mean (+/- SD) maximal fall in Hb (g/dL) from enrollment to day 28 of follow-up (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Randomised, Double-blind, Double Dummy Study Comparing the Efficacy and Safety of Chlorproguanil-dapsone-artesunate Versus Artemether-lumefantrine in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children and Adolescents in Africa.
Brief Summary: Chlorproguanil-dapsone has been approved for the treatment of uncomplicated Plasmodium falciparum malaria in a number of countries across sub-Sahara Africa, and by the UK's Medicines and Healthcare products Regulatory Agency.

CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a public-private partnership with the Medicines for Malaria Venture (MMV), World Health Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P. falciparum malaria.

The combination of chlorproguanil-dapsone-artesunate (CDA) is being developed to supersede chlorproguanil-dapsone for the same indication, but the addition of an artemisinin derivative, artesunate, should provide additional population benefits over chlorproguanil-dapsone alone. The artemisinins have been demonstrated to rapidly reduce parasite load and have activity against the sexual stages of the P.falciparum lifecycle. The addition of a second agent to the chlorproguanil-dapsone combination should also protect against the selection of resistant strains of P.falciparum.

Artemether-lumefantrine is the only available fixed-dose Artemisinin-based Combination Therapy actually available and is considered as the gold standard for the treatment of P. falciparum malaria. This study will therefore aim to demonstrate the non-inferiority of the combination of CDA to artemether-lumefantrine in terms of efficacy at 28-days. The key secondary objectives will compare the Parasite Clearance Times (PCT) and the Fever Clearance Times (FCT) between CDA and artemether-lumefantrine.


Options:
A: Parasitological cure rate, PCR corrected, at day 28 in the PP population The ITT population is a key supportive analysis.
B: Parasitological outcome after 28 days follow-up (28 days)
C: Parasitological cure rate, PCR-corrected, at day 28, in the per-protocol population. Parasitological cure rate is defined as the clearance of the initial malaria infection by day 7 and remaining free of this infection to the day of assessment.
D: P.falciparum parasitaemia detected by PCR on days 3,7 and 14. (14 days from start of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IIIb, Double-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV-16/18 VLP/AS04 Vaccine Administered Intramuscularly at 0, 1, 6 Months in Healthy Indian Female Subjects Aged 18-35 Yrs
Brief Summary: Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immune response induced by the HPV-16/18 L1/AS04 vaccine and the safety of the vaccine.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Number of Seroconverted Subjects for Anti-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity (At Month 7 (i.e. one month after the last dose of study vaccine)); Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the ATP Cohort for Immunogenicity (At Month 7 (i.e. one month after the last dose of study vaccine)); Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the Total Vaccinated Cohort (TVC) (At Month 7 (i.e. one month after the last dose of study vaccine))
B: 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)
C: Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies (One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).); Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms (Within 7 days (Day 0-6) after vaccination.); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (Within 7 days (Day 0-6) after vaccination.)
D: Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. (25 months); Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. (25 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Abbreviated Post-partum Magnesium Sulfate Seizure Prophylaxis in Preeclampsia: A Comparison of 12 and 24 Hour Regimens
Brief Summary: Magnesium sulfate is used for seizure prophylaxis in pregnancies complicated by preeclampsia. There is debate as to how long to continue this therapy after delivery of the pregnancy. Different schemes have been offered to shorten the exposure to magnesium sulfate after delivery, with little data. We seek to investigate the effect of shortened magnesium sulfate therapy on the post-partum recovery phase of mild preeclampsia. Our hypothesis was that shortened therapy (12 hours versus the traditional 24 hours post-partum) has no effect on disease course, and will result in significantly shorter exposure to magnesium sulfate.


Options:
A: Eclampsia (24 hours postpartum)
B: Time of magnesium sulfate therapy (minutes); Blood pressure; Maternal symptoms (headaches, blurred vision, chest pain, shortness of breath)
C: completed course of treatment (24 hours postpartum)
D: Need to continue therapy for another 12 hours. (24 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Optical Coherence Tomography (OCT) Imaging of Patients With Neovascular Age-Related Macular Degeneration (AMD) Treated With Intra-Ocular Lucentis™ (Ranibizumab): PrONTO Study
Brief Summary: The PrONTO Study was designed to evaluate the response of neovascular age-related macular degeneration (AMD) patients to intravitreal Lucentis using Optical Coherence Tomography (OCT) imaging. OCT was then used to determine the need for retreatment after 3 monthly injections of Lucentis. Patients would be followed for 2 years.


Options:
A: Mean Visual Acuity; Total number of treatments
B: N/A
C: N/A
D: Preservation of 5Ve isopter Goldmann visual field versus baseline at 1 year (12 and 24 months); Estimate the % of subjects progressing to neovascular glaucoma requiring pan-retinal photocoagulation or glaucoma surgery after treatment with ranibizumab (comparing 0.3mg to 0.5mg doses) (12 and 24 mponths)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A New School-based Drug Prevention Programme for Teenagers: Interventions That Target Personality Risk for Substance Abuse and Mental Illness
Brief Summary: Personality targeted cognitive behavioural interventions have been shown to be effective in reducing alcohol and drug misuse in adult substance abusers (Conrod et al., 2000) and adolescent drinkers (Conrod et al, in press). As these interventions target personality traits linked to risk for addictive and non-addictive mental disorders, the aim of this study is to examine the extent to which this approach can prevent and/or reduce alcohol and drug misuse as well as have an impact on the onset or severity of emotional and behavioural problems in young people.


Options:
A: Fruit and vegetable intake (Up to one year)
B: Change in Body Mass Index Percentage (BMI%) (Change from Baseline to 12-Month Post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 12-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 15-Week Post intervention); Social Skills (15-Week Post); Academic Performance (15-Week Post); Change in Body Mass Index Percentile (%) (Change from Baseline to 6-Month post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 12-Month Post intervention)
C: Time to onset and severity of drug use (2 years); Frequency and Quantity of Drinking (2 years); Problem drinking symptoms (2 years)
D: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)

Answer: C