TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: VA Low Vision Intervention Trial (LOVIT) II
Brief Summary: This study will determine if the interdisciplinary team low vision rehabilitation program is more effective than basic low vision care provided by an optometrist working alone in improving visual reading ability in veterans with macular diseases and best corrected visual acuity of 20/50 to 20/200.


Options:
A: activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS)) (5 and 17 weeks); distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ)) (5 and 17 weeks)
B: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)
C: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)
D: Comparison of Changes in Visual Reading Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire (changes from baseline to 4 months later)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-blinded Single-site Control Study Comparing Blood Loss Prevention of Tranexamic Acid (TXA) to Epsilon Aminocaproic Acid (EACA) for Corrective Spinal Surgery
Brief Summary: Tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) have been reported to reduce blood loss in the cardiac surgery literature but they have not been reported in use head-to-head in the orthopedic surgery literature. In a randomized, double-blind, prospective study we believe that TXA will be more effective than both EACA and placebo at reducing blood loss for corrective spinal surgery.


Options:
A: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell (between the begining of surgery (day 1) and the eighth post-operative day (day 8))
B: Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge) (1 Week)
C: Number of allogenic blood units transfused (Measured through the 8th postoperative day)
D: 24 hours postoperative drainage blood loss; incidence of allogeneic blood transfusion

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Stroke Family Caregiver Support Across the Care Continuum by Improving the Timing of Intervention Delivery
Brief Summary: About 50% of stroke survivors have limitations in their activities of daily living on return to the community. Family caregivers provide invaluable support to these individuals during their recovery and rehabilitation. Unfortunately, there is no standard clinical practice to prepare caregivers for this role and, as a result, many experience stress and poor health that can compromise stroke survivor recovery and threaten the sustainability of the care needed to thrive in their home. To address this gap, the investigators have developed the Timing it Right Stroke Family Support Program that aims to meet the evolving needs of caregivers. The objective of this multi-province randomized controlled trial is to determine if this program delivered across the stroke care continuum improves caregivers' sense of being supported and emotional well-being. Ultimately this program could be used by stroke care programs from across Canada.


Options:
A: Motor Activity Log - Quality Of Movement (MAL-QOM) and Wolf Motor Function Test - Performance Time (WMFT-PT) (4 weeks (post-treatment) relative to baseline performance)
B: Fugl Meyer (FM) Assessment (Baseline, post intervention and 3 month follow-up)
C: Jette Late Life Functional and Disability Instrument (LLFDI) (3 months)
D: The primary outcome, caregiver's perceived social support, will be assessed by Medical Outcomes Study Social Support Scale. (Baseline, 3, 6 and 12-months post-stroke)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Telecommunication Enhanced Asthma Management
Brief Summary: The primary aim of this project is to conduct a randomized practical clinical trial within a large health maintenance organization to test a telephone intervention designed to improve adherence to daily asthma medications and thereby improve asthma outcomes. The investigators hypothesize that adherence with inhaled corticosteroid medications in the TEAM intervention group will be greater than in the usual care group.


Options:
A: Change in Asthma Control Test Scores (Baseline and Six months)
B: Emergency Department Visit (12 months)
C: Medication Adherence (12 months)
D: Asthma-related morbidity (Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Telecommunication Enhanced Asthma Management
Brief Summary: The primary aim of this project is to conduct a randomized practical clinical trial within a large health maintenance organization to test a telephone intervention designed to improve adherence to daily asthma medications and thereby improve asthma outcomes. The investigators hypothesize that adherence with inhaled corticosteroid medications in the TEAM intervention group will be greater than in the usual care group.


Options:
A: Medication Adherence (12 months)
B: Change in baseline asthma self efficacy after 3 weeks (participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.)
C: Adherence rate to daily inhaled steroids, reported as the ratio of the sum of number of recorded over prescribed activation per day during the 28 days following the index visit.
D: Modified Medication Possession Ratio (Measured over 19 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Brazilian Intervention to Increase Evidence Usage in Practice - Acute Coronary Syndromes
Brief Summary: Phase 1: An observational study (registry) will be conducted which will objectively document the ACS clinical practice in Brazilian public hospitals, and identify the important barriers for the evidence usage incorporation in the clinical practice.

Phase 2: A Cluster randomized clinical trial in which public hospital will be randomized to receive or not a multifaceted strategy in order to increase evidence based therapy in clinical practice.


Options:
A: Phase 1: patient who've received interventions based on evidence proportion informed by the indicators (9 months); Phase 2: increase of prescription of evidence based treatment in clinical practice (6 months)
B: Computed tomography ordering proportions (January 2009)
C: Cardiac Medication Use (3 and 12 months)
D: Urinary catheter day (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Brazilian Intervention to Increase Evidence Usage in Practice - Acute Coronary Syndromes
Brief Summary: Phase 1: An observational study (registry) will be conducted which will objectively document the ACS clinical practice in Brazilian public hospitals, and identify the important barriers for the evidence usage incorporation in the clinical practice.

Phase 2: A Cluster randomized clinical trial in which public hospital will be randomized to receive or not a multifaceted strategy in order to increase evidence based therapy in clinical practice.


Options:
A: cardiovascular mortality; non fatal re-MI; angina requiring hospitalization; urgent revascularization procedures; hospitalization for heart failure; non fatal stroke
B: Phase 1: patient who've received interventions based on evidence proportion informed by the indicators (9 months); Phase 2: increase of prescription of evidence based treatment in clinical practice (6 months)
C: The reduction of systolic blood pressure in the nurse administered intervention will be 5 mm hg lower than those patients randomized to an education control group over 12 months of follow-up (12 months)
D: Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: (Baseline, 6 and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.
Brief Summary: The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.


Options:
A: The primary efficacy endpoint of this study is the relative efficacy of CAIV-T; compared to TIV against the incidence of culture-confirmed symptomatic influenza infection caused by community-acquired wild-type strains antigenically similar to those contained in the vaccine, occurring during the; influenza surveillance period and at least 14 days after the last required vaccination
B: Laboratory-confirmed influenza infection. (up to 3 years)
C: Geometric Mean Titer 30 Days After the Last Study Vaccination (30 days after the last study vaccination); Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination (30 days after the last study vaccination)
D: Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. (At Day 42.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pseudo-randomised, Double-blinded Placebo-controlled Trial of Chloroquine or Sulphadoxine-pyrimethamine Alone or in Combination With Primaquine or Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Pakistan
Brief Summary: This study is an evaluation of the benefit of adding artesunate to existing first and second line antimalarial therapies in Pakistan.

A placebo controlled trial was carried out to assess two potential benefits of Artesunate Combination Therapy (ACT): efficacy and potential for transmission reduction.


Options:
A: Parasitological outcome after 28 days follow-up (28 days)
B: mosquito infectivity assessed through membrane feeding (7 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: Development of sexual stages of P.falciparum (42 days post treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pseudo-randomised, Double-blinded Placebo-controlled Trial of Chloroquine or Sulphadoxine-pyrimethamine Alone or in Combination With Primaquine or Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Pakistan
Brief Summary: This study is an evaluation of the benefit of adding artesunate to existing first and second line antimalarial therapies in Pakistan.

A placebo controlled trial was carried out to assess two potential benefits of Artesunate Combination Therapy (ACT): efficacy and potential for transmission reduction.


Options:
A: Parasitological outcome after 28 days follow-up (28 days)
B: malaria morbidity by active and passive case detection. (during the entire study period); asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA (monthly during the entire study period); gametocyte prevalence and density by QT-NASBA and microscopy (monthly during the entire study period); transmission intensity quantified by entomologic inoculation rate (continuously during the study period); human infectious reservoir (prior to the intervention and several months after the intervention)
C: Cure rate (63 days)
D: Primary Efficacy Variable: Proportion with relapse(s) of P. vivax in 12 months of follow-up. (2004-March 2007)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pseudo-randomised, Double-blinded Placebo-controlled Trial of Chloroquine or Sulphadoxine-pyrimethamine Alone or in Combination With Primaquine or Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Pakistan
Brief Summary: This study is an evaluation of the benefit of adding artesunate to existing first and second line antimalarial therapies in Pakistan.

A placebo controlled trial was carried out to assess two potential benefits of Artesunate Combination Therapy (ACT): efficacy and potential for transmission reduction.


Options:
A: Parasitological outcome after 28 days follow-up (28 days)
B: 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)
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: Development of sexual stages of P.falciparum (42 days post treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pseudo-randomised, Double-blinded Placebo-controlled Trial of Chloroquine or Sulphadoxine-pyrimethamine Alone or in Combination With Primaquine or Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Pakistan
Brief Summary: This study is an evaluation of the benefit of adding artesunate to existing first and second line antimalarial therapies in Pakistan.

A placebo controlled trial was carried out to assess two potential benefits of Artesunate Combination Therapy (ACT): efficacy and potential for transmission reduction.


Options:
A: malaria morbidity by active and passive case detection. (during the entire study period); asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA (monthly during the entire study period); gametocyte prevalence and density by QT-NASBA and microscopy (monthly during the entire study period); transmission intensity quantified by entomologic inoculation rate (continuously during the study period); human infectious reservoir (prior to the intervention and several months after the intervention)
B: Parasitological outcome after 28 days follow-up (28 days)
C: 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)
D: 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.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of LMWH (Enoxaparine) With or Without Aspirin in the Prevention of Habitual Abortion; Special Attention to the Thrombophilic Status of the Mother
Brief Summary: 1 % of all pregnancies end in habitual/recurrent abortion. In about half of women with habitual abortions (HAB) hereditary or acquired (antiphospholipid antibodies) thrombophilia are observed. The investigators wanted to test whether antithrombotic treatment (Low-Molecular Weight Heparin, LMWH, ASA or both combined)would prevent these women from a subsequent abortion. Depending on thrombophilic status the women included in one of the three sub-studies: HABENOX 1 (mild, single thrombophilia), HABENOX 2 (no known thrombophilia), HABENOX 3 (moderate to severe thrombophilia, with combined thrombophilia or moderate to high titer antiphospholipid antibodies).

Study design: Randomised placebo controlled multicenter study.

Number of patients per study: 90 patients per group, 270 altogether.

Timetable: Starting 2/2002, finishing 31.12.2007.

Time frame: \>37 weeks of gestation and \>24, but \<37 weeks of gestation (premature)

Treatment started before 7. gw.

HABENOX 1 and 2:

Study groups:

Group 1 : Enoxaparin 40 mg+ placebo, Group 2: Enoxaparin 40 +ASA 100 mg, Group 3: ASA.

HABENOX 3:

Study groups:

Group 1: Enoxaparin 40 twice daily+ placebo o.d., Group 2: Enoxaparin 40 mg twice daily +ASA 100 mg o.d.

Primary end-points:

Pregnancy outcome: livebirths ( ≥37 weeks of gestation), premature livebirths (≥24, but \<37 weeks of gestation)

Secondary end-points: Bleeding complications, intrauterine growth retardation (\<-2SD), pre-eclampsia, abruptio placentae,

Ending: In the group of combined medication, tablets will be stopped at 36 weeks of gesta-tion. LMWH will be started in all patients after delivery and continued 6 weeks postpartum.


Options:
A: To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone. (Duration of pregnancy)
B: The difference in the subsequent livebirth rate among patients with secondary recurrent miscarriage who, during the trial, receive intravenous immunoglobulin or placebo, respectively, without any exclusions (ITT analysis) (August 2008 to June 2011)
C: Pregnancy outcome: livebirths (>37 weeks of gestation), premature livebirths (> 24, but <37 weeks of gestation) (gestational weeks >37 and gestational weeks > 24, but <37)
D: Study Feasibility: Mean Recruitment Rate Per Center Per Month (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of LMWH (Enoxaparine) With or Without Aspirin in the Prevention of Habitual Abortion; Special Attention to the Thrombophilic Status of the Mother
Brief Summary: 1 % of all pregnancies end in habitual/recurrent abortion. In about half of women with habitual abortions (HAB) hereditary or acquired (antiphospholipid antibodies) thrombophilia are observed. The investigators wanted to test whether antithrombotic treatment (Low-Molecular Weight Heparin, LMWH, ASA or both combined)would prevent these women from a subsequent abortion. Depending on thrombophilic status the women included in one of the three sub-studies: HABENOX 1 (mild, single thrombophilia), HABENOX 2 (no known thrombophilia), HABENOX 3 (moderate to severe thrombophilia, with combined thrombophilia or moderate to high titer antiphospholipid antibodies).

Study design: Randomised placebo controlled multicenter study.

Number of patients per study: 90 patients per group, 270 altogether.

Timetable: Starting 2/2002, finishing 31.12.2007.

Time frame: \>37 weeks of gestation and \>24, but \<37 weeks of gestation (premature)

Treatment started before 7. gw.

HABENOX 1 and 2:

Study groups:

Group 1 : Enoxaparin 40 mg+ placebo, Group 2: Enoxaparin 40 +ASA 100 mg, Group 3: ASA.

HABENOX 3:

Study groups:

Group 1: Enoxaparin 40 twice daily+ placebo o.d., Group 2: Enoxaparin 40 mg twice daily +ASA 100 mg o.d.

Primary end-points:

Pregnancy outcome: livebirths ( ≥37 weeks of gestation), premature livebirths (≥24, but \<37 weeks of gestation)

Secondary end-points: Bleeding complications, intrauterine growth retardation (\<-2SD), pre-eclampsia, abruptio placentae,

Ending: In the group of combined medication, tablets will be stopped at 36 weeks of gesta-tion. LMWH will be started in all patients after delivery and continued 6 weeks postpartum.


Options:
A: Fetal loss (From 12 weeks to 42 weeks gestational age)
B: Venous thromboembolism (40 days after delivery)
C: Study Feasibility: Mean Recruitment Rate Per Center Per Month (24 months)
D: Pregnancy outcome: livebirths (>37 weeks of gestation), premature livebirths (> 24, but <37 weeks of gestation) (gestational weeks >37 and gestational weeks > 24, but <37)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of LMWH (Enoxaparine) With or Without Aspirin in the Prevention of Habitual Abortion; Special Attention to the Thrombophilic Status of the Mother
Brief Summary: 1 % of all pregnancies end in habitual/recurrent abortion. In about half of women with habitual abortions (HAB) hereditary or acquired (antiphospholipid antibodies) thrombophilia are observed. The investigators wanted to test whether antithrombotic treatment (Low-Molecular Weight Heparin, LMWH, ASA or both combined)would prevent these women from a subsequent abortion. Depending on thrombophilic status the women included in one of the three sub-studies: HABENOX 1 (mild, single thrombophilia), HABENOX 2 (no known thrombophilia), HABENOX 3 (moderate to severe thrombophilia, with combined thrombophilia or moderate to high titer antiphospholipid antibodies).

Study design: Randomised placebo controlled multicenter study.

Number of patients per study: 90 patients per group, 270 altogether.

Timetable: Starting 2/2002, finishing 31.12.2007.

Time frame: \>37 weeks of gestation and \>24, but \<37 weeks of gestation (premature)

Treatment started before 7. gw.

HABENOX 1 and 2:

Study groups:

Group 1 : Enoxaparin 40 mg+ placebo, Group 2: Enoxaparin 40 +ASA 100 mg, Group 3: ASA.

HABENOX 3:

Study groups:

Group 1: Enoxaparin 40 twice daily+ placebo o.d., Group 2: Enoxaparin 40 mg twice daily +ASA 100 mg o.d.

Primary end-points:

Pregnancy outcome: livebirths ( ≥37 weeks of gestation), premature livebirths (≥24, but \<37 weeks of gestation)

Secondary end-points: Bleeding complications, intrauterine growth retardation (\<-2SD), pre-eclampsia, abruptio placentae,

Ending: In the group of combined medication, tablets will be stopped at 36 weeks of gesta-tion. LMWH will be started in all patients after delivery and continued 6 weeks postpartum.


Options:
A: Study Feasibility: Mean Recruitment Rate Per Center Per Month (24 months)
B: Pregnancy outcome: livebirths (>37 weeks of gestation), premature livebirths (> 24, but <37 weeks of gestation) (gestational weeks >37 and gestational weeks > 24, but <37)
C: pregnancy loss (during first 20 weeks of gregnancy)
D: Cumulative outcome measure will be incident acute thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleeding, or death. (up to 4 years)

Answer: B