TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow-up Management of Peripheral Arterial Intervention With Clopidogrel MIRROR-Study
Brief Summary: The Mirror Study is a randomized, double-blinded mono-centre trial the access the periinterventinal and postinterventional administration of clopidogrel in patients with peripheral vascular disease.


Options:
A: Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose (At 2 hours after first dose of study drug); Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug (4 to 72 Hours after last dose of study drug)
B: Platelet activation during and after the intervention (6-12 hours)
C: Vein graft patency examined by CT scan (three months after surgery)
D: Primary Outcome The composite of cardio-vascular death, MI, stent thrombosis, TVR and bleeding (minor or major) following randomly assigned DES implantation (12 months after stent implantation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-term Asthma Control
Brief Summary: The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.


Options:
A: Subject's height measured w. standard stadiometry techniques. 4 acceptable serial measurements taken at each visit on same equipment by a qualified technician.Median of 4 measurements used the subject's stadiometer height data
B: Change from baseline to Week 12 in FEV1
C: time until the first severe asthma exacerbation occurs; number of poorly controlled asthma days.
D: Change From Baseline in Morning Peak Expiratory Flow (PEF) (Baseline and Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients
Brief Summary: The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Options:
A: time to first moderate or severe asthma exacerbation. (24 weeks)
B: Number of Participants With a Severe Asthma Exacerbation Event (From randomization up to a discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.)
C: Rate of Asthma Exacerbations Per Year (monthly through study completion an average of 15 months)
D: Number of exacerbations (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients
Brief Summary: The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Options:
A: N/A
B: time to first moderate or severe asthma exacerbation. (24 weeks)
C: Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period (Last 10 weeks of the treatment period (Weeks 16-26))
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients
Brief Summary: The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Options:
A: Subject's height measured w. standard stadiometry techniques. 4 acceptable serial measurements taken at each visit on same equipment by a qualified technician.Median of 4 measurements used the subject's stadiometer height data
B: Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy (Measured during the 44-week treatment period)
C: time to first moderate or severe asthma exacerbation. (24 weeks)
D: Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period (At the end of treatment, 4-6 years from baseline assessment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients
Brief Summary: The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Options:
A: time to first moderate or severe asthma exacerbation. (24 weeks)
B: The proportion of upper respiratory tract infections (URTIs) in each group requiring treatment with systemic corticosteroids as confirmed by review of medical records and pharmacy records of prescriptions dispensed.
C: Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy (Measured during the 44-week treatment period)
D: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre Randomised Controlled Trial Comparing the Current Standard Diagnostic Strategy for Invasive Aspergillosis to the New Diagnostic Strategy for Invasive Aspergillosis in High-Risk Haematology Patients in Order to Determine Which Strategy Results in the Lower Rates of Use of Empiric Antifungal Therapy
Brief Summary: Aspergillus is a fungus found in soil, on farms and on construction sites. In those whose immune system is impaired it causes severe infection. The people who are particularly at high-risk of infection with Aspergillus (which is called Invasive Aspergillosis)are those with acute leukaemia who are having chemotherapy and those post bone marrow transplantation. Currently 15% of those at high-risk develop Invasive Aspergillosis and 60-90% of those with Invasive Aspergillosis die.

The main reason for this high death rate is that our current diagnostic tests are not good at detecting infection or often only detect the infection at advanced stages when treatment is ineffective. Because of the limitations of current diagnostic tests the current practice is to give empiric antifungal therapy (EAFT) early to treat suspected Invasive Aspergillosis. However studies have demonstrated that this therapy has only resulted in a minor reduction in the mortality rates and it also causes significant drug toxicity. It is a suboptimal treatment modality.

New tests have recently been developed to diagnose Invasive Aspergillosis. These tests are for the detection of an Aspergillus protein in blood and for the detection of Aspergillus DNA in blood. Available data suggests that these new tests make an early diagnosis and seem to be able to monitor responses to treatment. However no study has been reported to date which demonstrates that the use of these tests can impact on important patient outcomes. This trial is being performed to determine whether the use of the new diagnostic tests to guide antifungal therapy will help improve treatment of Invasive Aspergillosis, reduce drug toxicity and reduce the death rate in the high-risk patients as compared with the current standard method of diagnosis and treatment with EAFT.


Options:
A: The proportion of patients treated with at least 1 course of empiric antifungal therapy as per protocol definition at 26 weeks following randomisation (26 weeks of follow-up)
B: Calculation of sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio (3 months)
C: Prevention of possible, probable or proven fungal infection. (Completion of Induction Chemotherapy or successful recovery of ANC > 1000/mm3)
D: Efficacy of PCR technique for detection of Aspergillus DNA versus the standard technique for the determination of galactomannan Antigen (AGA) in serum (18-20 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Trauma Reception and Resuscitation Project - 'Time for a New Approach'
Brief Summary: Test the hypothesis that the implementation of real-time, computer-prompted algorithms in the first half hour of trauma management will result in a measurable reduction in management errors associated with the reception and resuscitation of major trauma patients.

Demonstrate that a reduction in management errors will translate into a reduction in morbidity and mortality.


Options:
A: Change in rate of potentially inappropriate prescribing (Baseline, 8 weeks, 16 weeks)
B: Error rate per patient treated demonstrated by deviation from the algorithms
C: Proportion of patients screened for alcohol (One year); Proportion receiving Brief Intervention among those who screen positive to screener. (One year.); Proportion of patients referred to treatment (one year)
D: Intervention acceptance (6 months (May 2010-Nov2010))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Nitrous Oxide In the Gas Mixture for Anaesthesia: a Randomised Controlled Trial
Brief Summary: We aim to investigate the effectiveness and safety of nitrous oxide (N2O) in anaesthesia.

Hypothesis In patients undergoing anaesthesia for major surgery, avoidance of N2O will reduce hospital length of stay when compared with otherwise identically managed surgical patients receiving N2O as a component of their anaesthesia.


Options:
A: The primary endpoint is hospital length of stay (LOS), defined from the start of surgery until actual hospital discharge. Patients transferred to another hospital will be tracked until final discharge to home (or other final destination). LOS is likely
B: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
C: electroencephalographic (BIS) and functional cognitive recovery (24h)
D: systolic arterial pressure fluctuation (intraoperative)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Nitrous Oxide In the Gas Mixture for Anaesthesia: a Randomised Controlled Trial
Brief Summary: We aim to investigate the effectiveness and safety of nitrous oxide (N2O) in anaesthesia.

Hypothesis In patients undergoing anaesthesia for major surgery, avoidance of N2O will reduce hospital length of stay when compared with otherwise identically managed surgical patients receiving N2O as a component of their anaesthesia.


Options:
A: Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil. (during anesthesia)
B: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
C: The primary endpoint is hospital length of stay (LOS), defined from the start of surgery until actual hospital discharge. Patients transferred to another hospital will be tracked until final discharge to home (or other final destination). LOS is likely
D: The incidence of explicit recall of events during the surgical and anesthetic periods. (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Nitrous Oxide In the Gas Mixture for Anaesthesia: a Randomised Controlled Trial
Brief Summary: We aim to investigate the effectiveness and safety of nitrous oxide (N2O) in anaesthesia.

Hypothesis In patients undergoing anaesthesia for major surgery, avoidance of N2O will reduce hospital length of stay when compared with otherwise identically managed surgical patients receiving N2O as a component of their anaesthesia.


Options:
A: Surgical site infection (2 weeks)
B: The primary endpoint is hospital length of stay (LOS), defined from the start of surgery until actual hospital discharge. Patients transferred to another hospital will be tracked until final discharge to home (or other final destination). LOS is likely
C: Surgical wound infection (14 days after surgery)
D: The Primary Endpoint is a Composite of Death and Cardiovascular Events (Clinical and Silent MI, Cardiac Failure, Cardiac Arrest, Pulmonary Embolism, and Stroke) Measured at 30 Days After Surgery. (30 days post op)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
Brief Summary: This is a randomized, blinded, two-arm comparative trial of continued versus limited isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.


Options:
A: to compare the compliance; to compare the side effects
B: Incident tuberculosis (During enrolment)
C: COMPLETE RATE OF LTBI TREATMENT (1.5 year)
D: Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children (Through to week 96); Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children (Through to week 96)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Collaborative Injection Drug Users Study III/Drug Users Intervention Trial (CIDUS III/DUIT)
Brief Summary: The purpose of this study is to test whether a six-session behavioral intervention for HIV and HCV seronegative injection drug users is effective in reducing sexual and injection risk behaviors that could lead to primary HIV and HCV infection.


Options:
A: 1. decrease in the number and proportion of times participants practiced vaginal or anal sex without a condom.; 2. decrease in the overall number of persons participants shared syringes or injection equipment with.; 3. decrease in the number and proportion of injections done with a syringe previously used by another person.; 4. decrease in the number and proportion of times participant used another person's equipment to prepare or divide drugs before injecting.
B: Opiate abstinence
C: prevalence of non-users of street opioid after one year of treatment will be compared between arms. (one year)
D: Hepatitis C seroconversion

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: HIP: HIV Intervention for Providers
Brief Summary: The purpose is to encourage Provider participants to evaluate high risk HIV transmission behaviors and offer prevention messages to their HIV+ patients which will, in turn, reduce rates of unprotected anal and/or vaginal sex with partners of known HIV sero-negativity or unknown HIV serostatus. It is hypothesized that patients of providers participating in the HIP intervention will report higher reduction in sexual risk practices, when compared to the patients of the providers who were randomized into the control condition.


Options:
A: General practitioners'adherence to treatment recommendations (3-6 months after end of intervention)
B: Number of LTC residents on vitamin D (16 months)
C: Proportion of febrile patients receiving treatment as recommended in clinical guidelines for uncomplicated malaria (As patients exit the health facility)
D: Self-reported, unprotected (without condoms) anal or vaginal sex with HIV-negative and unknown-status persons.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Episodic Acyclovir Therapy on Ulcer Duration and HIV Shedding From Genital Ulcers Among Men in South Africa
Brief Summary: The purpose of this study is to determine if acyclovir episodic treatment has an effect in ulcer healing and if it should be added to the syndromic management of genital ulcer disease.


Options:
A: Serologically confirmed HIV infection (Throughout study)
B: Sequence-verified HIV-transmission from index to partner participant (March 2009)
C: Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation (4 weeks)
D: Ulcer healing

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Tools for Health Promotion and Disease Prevention
Brief Summary: The study will evaluate the effect of familial risk assessment and prevention prompts tailored to familial risk on health behaviors and use of preventive services among adults who are members of primary care practices in the U.S.


Options:
A: Receipt of mammography screening (six month post intervention)
B: Change in stage of adoption of health behaviors and referral for additional screening and follow up for high risk participants at 6 month post evaluation
C: Receipt of CRC screening (12 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Legacy for Children, The CDC Parenting Research Projects
Brief Summary: The purpose of this study is to determine if an intervention focused on promoting parent-child interaction, parental responsibility, parental commitment of time and energy, and sense of community results in better developmental outcomes for low-income children.


Options:
A: Change in Child Behavior Problems (baseline, first follow-up (up to 2 years))
B: Parenting behavior (Measured post-intervention and at 6- and 12-month follow-ups); Child disruptive behaviors (Measured post-intervention and at 6- and 12-month follow-ups)
C: The Parenting Sense of Competence scale (PSOC) (measured when child is 9 months)
D: child behavior (1yr, 2 yr, 3 yr, 4 yr, 5 yr); child social skills (1yr, 2 yr, 3 yr, 4 yr, 5 yr); child cognition (1 yr, 3 yr, 5 yr); child language/communication (2 yr, 4 yr, 5 yr); child attachment (2 yr); child peer relationships (5 yr); child academics (4 yr, 5 yr); parent-child interaction (6 months, 5 yr)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health
Brief Summary: This is a comparative clinical trial among HIV-infected women and their infants to determine:

1. the benefit of nutritional supplementation given to women during breastfeeding
2. the benefit and safety of antiretroviral (ARV) medications given either to infants or to their mothers to prevent HIV transmission during breastfeeding
3. the feasibility of exclusive breastfeeding followed by early, rapid breastfeeding cessation


Options:
A: weight-for-height in children 6 to 60 mo of age (8 months)
B: Postpartum weight loss between delivery and 28 weeks (between delivery and 28 weeks); Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.) (birth to 28 weeks); Exclusive breastfeeding and breastfeeding cessation by 28 weeks (birth to 28 weeks)
C: Cumulative wasting incidence, hemoglobin concentration (monthly)
D: Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 6-23 months of age (After 24 months of program implementation); Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 6-23 months) (monthly from study inclusion at 6 months to 23 months of age and at study endline); Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm (Monthly from study inclusion at 6 months to 23 months of age); Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted) (monthly from study inclusion at 6 months to 23 months of age and at study endline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health
Brief Summary: This is a comparative clinical trial among HIV-infected women and their infants to determine:

1. the benefit of nutritional supplementation given to women during breastfeeding
2. the benefit and safety of antiretroviral (ARV) medications given either to infants or to their mothers to prevent HIV transmission during breastfeeding
3. the feasibility of exclusive breastfeeding followed by early, rapid breastfeeding cessation


Options:
A: Change in length-for-age Z-score (LAZ, based on WHO 2005 MGRS) between enrollment and 18 months of age (Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)); Incidence of serious adverse events during the study period (12 months after enrollment (age 18 months))
B: Postpartum weight loss between delivery and 28 weeks (between delivery and 28 weeks); Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.) (birth to 28 weeks); Exclusive breastfeeding and breastfeeding cessation by 28 weeks (birth to 28 weeks)
C: Maternal primary outcome is child length at birth (0 - 48 hr after birth); Child primary outcome is child length-for-age Z-score (LAZ, based on WHO 2006 growth standards) at 18 months of age (18 months after birth)
D: Birth weight (approx 20 weeks after enrollment (within 48 hours)); Newborn length (At 1 week of age); Length for age Z-score (LAZ) at 18 months of age (12 months after enrollment (age 18 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health
Brief Summary: This is a comparative clinical trial among HIV-infected women and their infants to determine:

1. the benefit of nutritional supplementation given to women during breastfeeding
2. the benefit and safety of antiretroviral (ARV) medications given either to infants or to their mothers to prevent HIV transmission during breastfeeding
3. the feasibility of exclusive breastfeeding followed by early, rapid breastfeeding cessation


Options:
A: Infant HIV infection status (At Months 6 and 12)
B: Number of Participants With Virologic Suppression (Throughout study, including breastfeeding, assessed up to 24 months); Number of HIV+ Infants (Throughout study, including breastfeeding, assessed up to 24 months)
C: HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study (At Month 6); Frequency and Severity of Adverse Reactions Among Participating Infants (6 weeks through 18 months)
D: Postpartum weight loss between delivery and 28 weeks (between delivery and 28 weeks); Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.) (birth to 28 weeks); Exclusive breastfeeding and breastfeeding cessation by 28 weeks (birth to 28 weeks)

Answer: D