TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation and the Natural History of HIV-Associated Emphysema
Brief Summary: People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.


Options:
A: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
B: A significant percentage of surgical patients will be receptive to smoking cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52 weeks after starting the treatment. (2 years)
C: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
D: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation and the Natural History of HIV-Associated Emphysema
Brief Summary: People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.


Options:
A: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
B: Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date). (52 weeks after starting the treatment)
C: Quit Rate (4 months)
D: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation and the Natural History of HIV-Associated Emphysema
Brief Summary: People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.


Options:
A: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
B: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
C: Point Prevalence Abstinence (52-week); Week 24 Point Prevalence Abstinence (24-week)
D: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation and the Natural History of HIV-Associated Emphysema
Brief Summary: People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.


Options:
A: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
B: Smoking behavior (after 5 hrs abstinence)
C: Weight Gain in Treatment Completers (baseline and 12 weeks)
D: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation and the Natural History of HIV-Associated Emphysema
Brief Summary: People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.


Options:
A: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
B: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
C: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
D: Smoking Abstinence (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Clinical Study on the Effect of Home-based Treatment of Patients With COPD. Improved Cooperation Between Hospital and Primary Healthcare System.
Brief Summary: We want to improve the treatment of patients suffering from COPD (3-4) by early medical intervention in the patients home. A close cooperation between the hospital and the primary healthcare system will hopefully reduce hospitalisation, drug consumption and improve quality of life. Following up from the hospital and the primary healthcare in cooperation may lead to earlier detection and treatment of exacerbations in COPD.

The main outcome variable will be number of hospitalizations assessed simply by counting. The second objective will be Quality of life and activation assessed by different questionnaires included in St.George´s Respiratory Questionnaire.


Options:
A: Hospital admissions per patient (maximum 2 years)
B: Sensitivity, Specificity and Positive Predictive Value of Simple Case Finding tools (12 months)
C: Number of hospitalizations (2011)
D: Hospital Readmission (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Clinical Study on the Effect of Home-based Treatment of Patients With COPD. Improved Cooperation Between Hospital and Primary Healthcare System.
Brief Summary: We want to improve the treatment of patients suffering from COPD (3-4) by early medical intervention in the patients home. A close cooperation between the hospital and the primary healthcare system will hopefully reduce hospitalisation, drug consumption and improve quality of life. Following up from the hospital and the primary healthcare in cooperation may lead to earlier detection and treatment of exacerbations in COPD.

The main outcome variable will be number of hospitalizations assessed simply by counting. The second objective will be Quality of life and activation assessed by different questionnaires included in St.George´s Respiratory Questionnaire.


Options:
A: Total cost of hospitalization, $ (Day of admission to day of discharge)
B: Number of hospitalizations (2011)
C: Self-management and Activation (6 Months)
D: Death (30 days, 3 months, 6 months); readmission (30 days, 3 months, 6 months); need for additional Prednisolone, additional antibiotics , NIV or life support machine (respirator) (30 days, 3 months, 6 months); Self-efficacy (3 days); Cognitive function (3 days and six weeks after discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Clinical Study on the Effect of Home-based Treatment of Patients With COPD. Improved Cooperation Between Hospital and Primary Healthcare System.
Brief Summary: We want to improve the treatment of patients suffering from COPD (3-4) by early medical intervention in the patients home. A close cooperation between the hospital and the primary healthcare system will hopefully reduce hospitalisation, drug consumption and improve quality of life. Following up from the hospital and the primary healthcare in cooperation may lead to earlier detection and treatment of exacerbations in COPD.

The main outcome variable will be number of hospitalizations assessed simply by counting. The second objective will be Quality of life and activation assessed by different questionnaires included in St.George´s Respiratory Questionnaire.


Options:
A: Percentage of patients who completed the program (3 months)
B: 6 minute walk test (measured at week 8)
C: Change in impact of COPD in daily life (Baseline and 3 months after baseline)
D: Number of hospitalizations (2011)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardioselective Beta-Blockade Using Bisoprolol in Patients With Chronic Heart Failure (CHF) and Coexistent Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) With or Without Significant Reversibility.
Brief Summary: The principal research objectives are to demonstrate cardioselective beta-blockade using bisoprolol is not inferior to placebo with regard to pulmonary function and improves quality of life in patients with heart failure and coexistent moderate or severe chronic obstructive pulmonary disease with or without significant reversibility. Patients will be followed up for 4 months during which bisoprolol will be up-titrated to the maximum clinically tolerated dose. Health status will be assessed using a generic and two disease specific questionnaires, and pulmonary function by spirometry, body box plethysmography, and cardiopulmonary exercise testing.


Options:
A: Oxygen Desaturation Index 4% (ODI4%) (Overnight, up to 8 hrs on nights 1 and 2)
B: Exercise Capacity (6 minute)
C: Plasma concentration levels over time of biomarkers of oxidative stress, apoptosis, inflammation and platelet aggregation (Within 8hours from baseline)
D: Forced expiratory volume 1 second (FEV1) (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 38819
Brief Summary: To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), in order to estimate the cumulative pregnancy rate for each treatment group.


Options:
A: Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate) (Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial)
B: Number of cumulus-oocyte-complexes retrieved (1 cycle)
C: Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate) (From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)); Number of Expectant Mothers Experiencing Adverse Events (AEs) (From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)); Number of Expectant Mothers Experiencing Serious AEs (SAEs) (From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)); Number of Infants Experiencing AEs (Up to 12 weeks after birth); Number of Infants Experiencing SAEs (Up to 12 weeks after birth)
D: Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate) (Assessed at least 10 weeks after embryo transfer (up to 1 year)); Mean Number of Oocytes Retrieved (Up to 36 hours after administration of hCG (up to 1 year))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-method Study of a Low-salt Dietary Approach to Control Blood Pressure in the Bangladeshi Chronic Kidney Disease Population.
Brief Summary: The aim of this study is to assess the benefits of using low-salt and healthy eating educational programme, designed specifically for Bangladeshi kidney patients, compared to the usual diet advice given by the clinic dietitians.


Options:
A: Reduction in blood pressure (Six months)
B: Time Specific Interdialytic Weight Gain (Baseline) (Baseline); Time Specific Interdialytic Weight Gain (8 Weeks) (8 weeks); Time Specific Interdialytic Weight Gain (12 Weeks) (12 weeks); Time Specific Interdialytic Weight Gain (16 Weeks) (16 weeks); Time Specific Dietary Sodium Intake (Baseline) (Baseline); Time Specific Dietary Sodium Intake (8 Weeks) (8 weeks); Time Specific Dietary Sodium Intake (16 Weeks) (16 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) (Baseline to 8 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) (Baseline to 16 weeks)
C: C-reactive protein (up to 16 weeks); interleukin-6 (up to 16 weeks); alpha tumor necrosis serum concetrations (up to 16 weeks)
D: Net Change in Urinary Albumin-to-Creatinine Ratio (ACR) (Assessed twice at baseline, once at week 12, and twice at week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-method Study of a Low-salt Dietary Approach to Control Blood Pressure in the Bangladeshi Chronic Kidney Disease Population.
Brief Summary: The aim of this study is to assess the benefits of using low-salt and healthy eating educational programme, designed specifically for Bangladeshi kidney patients, compared to the usual diet advice given by the clinic dietitians.


Options:
A: 24-hourly urinary sodium excretion (up to 9 months)
B: ∆Albuminuria by 24-hour Urine Protein Excretion (changes from week 8 at week 16 (week 8 - week 16))
C: Reduction in blood pressure (Six months)
D: Weight in kgs will be obtained using a single, calibrated scale (Change from baseline in weight at 6 months); Serum phosphorus will be evaluated from a venipuncture sample (Change from baseline in Serum Phosphourous at 6 months); Urinary sodium will be determined from a time 24-hour urine sample (Change from baseline in Urinary sodium at 6 months); Weight in kgs will be obtained using a single, calibrated scale (Change from baseline in weight at 12 months); Serum phosphorus will be evaluated from a venipuncture sample (Change from baseline in Serum phosphorus at 12 months); Urinary sodium will be determined from a time 24-hour urine sample (Change from baseline in Urinary sodium at 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-wk, Rand., Double-blind, Double Dummy, Multi-ctr., Phase IV Study Comparing Efficacy and Safety of SYMBICORT® pMDI 160/4.5 ug x 2 Actuations Twice Daily Versus Pulmicort® (Budesonide Inhalation Powder DPI) 180 ug x 2 Inhalations Twice Daily, in Adult and Adolescent African American Subjects With Asthma
Brief Summary: To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.


Options:
A: Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy (Week 0 and 12 visits)
B: Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period (Baseline to 12 weeks)
C: 12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation (FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period)
D: Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) (From Day 1 up to 26 weeks); Number of Participants Experiencing at Least One Asthma Exacerbation (From Day 1 up to 26 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Ovulation Induction in Clinical Trial 107010 for the Development of Org 36286 (Corifollitropin Alfa)
Brief Summary: The objective of follow-up study P05713 is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of monofollicular growth in women who underwent ovulation induction (OI) in base study P05693 (NCT00697255) is safe for pregnant participants and their offspring.


Options:
A: Number of cumulus-oocyte-complexes retrieved (1 cycle)
B: Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) (Up to one day following delivery (up to 1 year)); Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs) (Up to one day following delivery (up to 1 year)); Number of Infants Born in Current Follow Up Trial Experiencing AEs (Up to 12 weeks following delivery (up to 1 year)); Number of Infants in Current Follow Up Trial Experiencing SAEs (Up to 12 weeks following delivery (up to 1 year)); Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial. (At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)); Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer. (At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year))
C: Pregnancy status at 20 weeks of gestation (one pregnancy period); Take-home baby rate (one pregnancy period)
D: Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)); Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)); Number of Mothers With Adverse Events (AEs) During Follow-up (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)); Number of Mothers With Serious AEs (SAEs) During Follow-up (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)); Number of Infants With AEs During Follow-up (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study); Number of Infants With SAEs During Follow-up (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38833 for Org 36286 (Corifollitropin Alfa)
Brief Summary: The objective of this trial is to evaluate whether corifollitropin alfa (MK-8962, Org 36286) treatment for the induction of multifollicular growth in women undergoing Controlled Ovarian Stimulation (COS) prior to in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) is safe for pregnant participants and their offspring.


Options:
A: Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate) (From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)); Number of Expectant Mothers Experiencing Adverse Events (AEs) (From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)); Number of Expectant Mothers Experiencing Serious AEs (SAEs) (From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)); Number of Infants Experiencing AEs (Up to 12 weeks after birth); Number of Infants Experiencing SAEs (Up to 12 weeks after birth)
B: Pregnancy status at 20 weeks of gestation (one pregnancy period); Take-home baby rate (one pregnancy period)
C: Number of Expectant Mothers Experiencing Adverse Events (AEs) (Up to 1 Year); Number of Expectant Mothers Experiencing Serious AEs (SAEs) (Up to 1 Year); Number of Infants Experiencing AEs (Up to 1 Year); Number of Infants Experiencing SAEs (Up to 1 Year); Take-Home Baby Rate (Birth of a one or more live babies (Up to 1 year))
D: Number of cumulus-oocyte-complexes retrieved (1 cycle)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 for the Development of Org 36286 (Corifollitropin Alfa).
Brief Summary: The objective of this trial was to evaluate whether Org 36286 treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) is safe for pregnant subjects and their offspring.


Options:
A: Pregnancy status at 20 weeks of gestation; Take-home baby rate (one pregnancy period)
B: Pregnancy status at 20 weeks of gestation (one pregnancy period); Take-home baby rate (one pregnancy period)
C: Percentage of Participants With Clinically Relevant Immunogenicity (Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle); Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles (30 minutes post dose in each treatment cycle); Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles (30 minutes post dose in each treatment cycle); Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles (30 minutes post dose in each treatment cycle); Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles (30 minutes post dose in each treatment cycle); Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles (30 minutes post dose in each treatment cycle); Number of Participants With AEs (Up to approximately 26 months after first dose of corifollitropin alfa); Number of Participants With Serious AEs (SAEs) (Up to approximately 26 months after first dose of corifollitropin alfa); Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS) (Up to approximately 1 month after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle)
D: Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate) (From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)); Number of Expectant Mothers Experiencing Adverse Events (AEs) (From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)); Number of Expectant Mothers Experiencing Serious AEs (SAEs) (From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)); Number of Infants Experiencing AEs (Up to 12 weeks after birth); Number of Infants Experiencing SAEs (Up to 12 weeks after birth)

Answer: B