TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Observation of the Initial Procalcitonin Values and the Clinical Course of Patients With Acute Respiratory Tract Infections at General Medical Practices in Greater Hannover
Brief Summary: Observation of the initial Procalcitonin values and the clinical course of consecutively included patients with Acute Respiratory Tract Infections at general medical practices in greater Hannover.


Options:
A: Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx
B: N/A
C: the antibiotic prescribing rate (within the first 2 weeks after first consultation)
D: days with significant impairment due to acute respiratory tract infection (14 to 28 days after infection)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Observation of the Initial Procalcitonin Values and the Clinical Course of Patients With Acute Respiratory Tract Infections at General Medical Practices in Greater Hannover
Brief Summary: Observation of the initial Procalcitonin values and the clinical course of consecutively included patients with Acute Respiratory Tract Infections at general medical practices in greater Hannover.


Options:
A: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
B: N/A
C: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)
D: days with significant impairment due to acute respiratory tract infection (14 to 28 days after infection)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Observation of the Initial Procalcitonin Values and the Clinical Course of Patients With Acute Respiratory Tract Infections at General Medical Practices in Greater Hannover
Brief Summary: Observation of the initial Procalcitonin values and the clinical course of consecutively included patients with Acute Respiratory Tract Infections at general medical practices in greater Hannover.


Options:
A: overall rate of antibiotic prescribing (2 years)
B: N/A
C: Total Antibiotic Exposure Days (30 days); Number of Participants With Any Adverse Outcome (30 days)
D: Serious infection (1 year); Immediate antibiotic prescribing rates (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Observation of the Initial Procalcitonin Values and the Clinical Course of Patients With Acute Respiratory Tract Infections at General Medical Practices in Greater Hannover
Brief Summary: Observation of the initial Procalcitonin values and the clinical course of consecutively included patients with Acute Respiratory Tract Infections at general medical practices in greater Hannover.


Options:
A: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
B: All cause mortality (28 days)
C: days with significant impairment due to acute respiratory tract infection (14 to 28 days after infection)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Intravenous Erythromycin on Gastric Emptying in Patients Undergoing Rapid Sequence Intubation for Full Stomach - A Randomised, Placebo-controlled, Double-blind Study
Brief Summary: In this study the investigators want to investigate the effect of a short intravenous infusion of Erythromycine on gastric emptying on patients considered "full stomac" and scheduled for Emergency operation. A gastroscopy will be done after intubation to controll the effect of the perfusion.


Options:
A: Immediately after intubation an upper GI endoscopy will be done. The following primary endpoint will be recorded: Stomach clear from any content: yes or no (dichotomous). (10 minutes)
B: Reduction in number of exacerbations (1 year)
C: Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Measured monthly through 13 months)
D: Estimation of crude mortality by any reason of each study group; Estimation of attributable mortality by VAP of each study group; 7-day mortality rate of each group; 28-mortality rate of each group; Rate of progression to multiple organ failure and septic shock (and number of failing organs) of each study group; Time to progression to multiple organ failure and septic shock of each study group; Days of resolution of VAP; Days in ICU after diagnosis of VAP

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multinational Study to Evaluate the Efficacy and Safety of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Brief Summary: The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full, etc.)


Options:
A: Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo
B: Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone (Baseline, Week 8)
C: Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks (Baseline, 12 weeks)
D: Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) (Baseline, 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Adjuvant Zoladex Plus Tamoxifen on Breast Density in Pre- or Peri-menopausal Women With Early-stage Breast Cancer
Brief Summary: The purpose of this study is to compare Zoladex plus tamoxifen with tamoxifen alone as adjuvant hormonal therapy in pre- or perimenopausal women with early-stage breast cancer in terms of breast density, estrogen levels, lipidemia, endometrial thickness and ultrasonographic abnormalities.


Options:
A: Mammographic percentage density at 18months (18months after enrolled)
B: Disease-free Survival (5-year estimate reported at a median follow-up of 72 months)
C: Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) (Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.); Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) (Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.)
D: Disease-free Survival (5-year estimates, reported at a median follow-up of 67 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Contraception and Ovarian Suppression in Women With Different Weights
Brief Summary: This study proposes a double blind randomized clinical trial to include normal weight and obese women who have normal ovulatory function at baseline; the investigators will randomize women to 2 widely used OCs and evaluate ovarian follicle development and circulating progesterone to assess ovarian suppression during OC use.


Options:
A: Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment (Baseline, Cycle 7)
B: Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression. (Up to 8 biweekly visits from start of OCP therapy)
C: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles)); Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles))
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Contraception and Ovarian Suppression in Women With Different Weights
Brief Summary: This study proposes a double blind randomized clinical trial to include normal weight and obese women who have normal ovulatory function at baseline; the investigators will randomize women to 2 widely used OCs and evaluate ovarian follicle development and circulating progesterone to assess ovarian suppression during OC use.


Options:
A: Pearl Index up to 3 Years (Up to 3 years); Pearl Index for LCS16 up to 5 Years (Up to 5 years)
B: Pregnancy (AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year)
C: Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression. (Up to 8 biweekly visits from start of OCP therapy)
D: To describe the pharmacokinetic profile of Implanon (etonogestrel) among obese women. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Can we improve diabetes outcomes through 1) report card mailings to patients 2) point of care distribution of report cards to patients and 3) provider performance feedback with patient level data?


Options:
A: Percent of patients with HgA1c < 7 (january 2009); Percent of patients with LDL < 100 mg/dL (january 2009); Percent of patients with BP < 130/80 (january 2009)
B: The following dependant variables were measured in this study;; Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and; LDL-cholesterol levels and test rates in the 12 months post-intervention.
C: colorectal cancer screening (15 months)
D: Percentage of participants with controlled blood pressure, as defined by the following criteria: less than 130/80 mm Hg for participants with diabetes or chronic kidney disease; less than 140/90 mm Hg for all other participants (Measured at Year 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Paliperidone ER Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia: a Randomized, Open-label, Controlled Trial
Brief Summary: Primary objective: To examine whether the switch to paliperidone ER from risperidone improves cognitive function in stabilized patients with schizophrenia.

Secondary objectives: To compare the general clinical outcomes (efficacy and safety) after switching to paliperidone ER from risperidone


Options:
A: Neurocognitive function (12 weeks)
B: The change in total Positive and Negative Syndrome Scale (PANSS) score from baseline at week 14 of Phase 2.
C: Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine
D: Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine.; The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Tobacco Quitline for Cancer Survivors
Brief Summary: The proposed study is a two-armed randomized controlled clinical trial examining the long-term (one-year) efficacy of telephone intervention conditions for smoking cessation in a high risk medical population; namely, cancer survivors: Proactive telephone recruitment through the Childhood Cancer Survivors Survey (CCSS) St. Jude Life Study, After Completion of Therapy (ACT) Clinic and face to face recruitment at the local West Clinics will serve as the primary methods of recruitment.

The specific aims of the study :

(1) To recruit nationally a cohort of approximately 1242 smokers who are cancer survivors(621 childhood cancer survivors and 621 adult cancer survivors); 2) To determine the long-term (one year) efficacy of the intervention condition for participants randomly assigned to the Counselor-initiated versus a Self-paced QL; and (3) to find out whether treatment outcomes vary as a function of survivors' age of cancer diagnosis (survivors who diagnosed while adults vs. childhood cancer survivors who diagnosed before the age of 21).


Options:
A: 7-Day Point Prevalence Smoking Quit Rates 1 Month Post Quit Date (Assessed 1 month after quit date); 7-Day Point Prevalence Smoking Quit Rates 3 Months Post Quit Date (Assessed 3 months after quit date); 7-Day Point Prevalence Smoking Quit Rates 6 Months Post Quit Date (Assessed 6 months after quit date); 7-Day Point Prevalence Smoking Quit Rates 12 Months Post Quit Date (Assessed 12 months after quit date)
B: 7-day point prevalence abstinence from smoking (6 months after enrollment)
C: Self-reported prolonged abstinence and cotinine-validated point-prevalence abstinence at 1 year follow-up (1 year)
D: 7-day point-prevalence abstinence at 2 weeks and 6 month follow-up

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Tobacco Quitline for Cancer Survivors
Brief Summary: The proposed study is a two-armed randomized controlled clinical trial examining the long-term (one-year) efficacy of telephone intervention conditions for smoking cessation in a high risk medical population; namely, cancer survivors: Proactive telephone recruitment through the Childhood Cancer Survivors Survey (CCSS) St. Jude Life Study, After Completion of Therapy (ACT) Clinic and face to face recruitment at the local West Clinics will serve as the primary methods of recruitment.

The specific aims of the study :

(1) To recruit nationally a cohort of approximately 1242 smokers who are cancer survivors(621 childhood cancer survivors and 621 adult cancer survivors); 2) To determine the long-term (one year) efficacy of the intervention condition for participants randomly assigned to the Counselor-initiated versus a Self-paced QL; and (3) to find out whether treatment outcomes vary as a function of survivors' age of cancer diagnosis (survivors who diagnosed while adults vs. childhood cancer survivors who diagnosed before the age of 21).


Options:
A: 7-day point prevalence abstinence (Measured at Months 3, 6, and 12)
B: Self-reported prolonged abstinence and cotinine-validated point-prevalence abstinence at 1 year follow-up (1 year)
C: 30-day point prevalence tobacco abstinence (6 months); Change in weight (6 months)
D: Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Strength at Home Couples Program (Formerly: PTSD-Focused Relationship Enhancement Therapy for Returning Veterans and Their Partners)
Brief Summary: The purpose of the project is to develop and test a couples-based relationship enhancement group intervention for married or partnered Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF)/Operation New Dawn (OND) veterans to prevent the perpetration of intimate partner aggression (IPA) among participants.


Options:
A: CAPS for PTSD symptoms and ASI for substance use (pre, mid treatment, post, 3-month follow-up, 6-month follow-up)
B: Drug abstinence
C: Evidence of change in incidence and frequency of intimate partner physical assault and psychological aggression assessed by questionnaires and clinical interviews. (Change determined by assessments pre and post treatment, 6 months, 12 months, and 18 months following treatment)
D: Severity of mental health symptoms (previous 4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Populationbased Screening for Urogenital Chlamydia Trachomatis Infections by Use of Home-Obtained and Mailed Samples: A Randomized Study
Brief Summary: 30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two groups. The intervention group received an invitation to be tested for urogenital Chlamydia trachomatis by use of home-obtained and mailed sample (9,000 individuals). The control group received no intervention (21,000 individuals). Outcome measures: Number of tested individuals, number of detected infections, number of women developing PID, ectopic pregnancy or infertility, number of women giving birth to a child, number of women receiving IVF treatment and number of men developing epididymitis.

The hypothesis was that more individuals would be tested and treated for infections and that number of long term fertility complications would decline in the intervention group compared to control group.


Options:
A: mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit (approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)); mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit (3 weeks (allowable window 2-5))
B: chlamydia and gonorrhea tests completed; chlamydia and gonorrhea infections detected
C: Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups. (12 months)
D: Long term infertility complications (2008)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Populationbased Screening for Urogenital Chlamydia Trachomatis Infections by Use of Home-Obtained and Mailed Samples: A Randomized Study
Brief Summary: 30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two groups. The intervention group received an invitation to be tested for urogenital Chlamydia trachomatis by use of home-obtained and mailed sample (9,000 individuals). The control group received no intervention (21,000 individuals). Outcome measures: Number of tested individuals, number of detected infections, number of women developing PID, ectopic pregnancy or infertility, number of women giving birth to a child, number of women receiving IVF treatment and number of men developing epididymitis.

The hypothesis was that more individuals would be tested and treated for infections and that number of long term fertility complications would decline in the intervention group compared to control group.


Options:
A: Percent of women rescreened for chlamydia
B: Yield ratio tested for uro-genital C.trachomatis infection; Yield ratio diagnosed for uro-genital C.trachomatis infection; Yield ratio treated for uro-genital C.trachomatis infection
C: Long term infertility complications (2008)
D: chlamydia and gonorrhea tests completed; chlamydia and gonorrhea infections detected

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Tolerability of Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)
Brief Summary: Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of luteal support (S.C.) to an approved comparator (vaginal gel).


Options:
A: Number of Bleeding Episodes (Up to year)
B: Ongoing Pregnancy Rate at the End of the Study (10 weeks after treatment start)
C: Ongoing pregnancy rate (12 weeks)
D: Clinical pregnancy (8 weeks after IUI)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction.EXAMINATION Study
Brief Summary: This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study.

Patient randomization will be to one of the two treatment arms: Everolimus arm or Non drug eluting stent arm. The objective of this study is to assess the safety and performance of the Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable stent in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction.


Options:
A: Composite of death, myocardial infarction or stroke occurring in the time window from 31 days and up to 24 months after intervention. (24 months)
B: Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year. (1 year)
C: Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA) (6 months)
D: First occurrence of all-cause mortality and non-fatal myocardial infarction (composite) (After five years of follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Varenicline Treatment for Smoking Cessation
Brief Summary: This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.


Options:
A: Weight Gain in Treatment Completers (baseline and 12 weeks)
B: Number of cigarettes smoked per day (End of 6 week intervention)
C: Change in Metabolic Syndrome Prevalence (Changes in the prevalence of Metabolic Syndrome from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years)
D: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Varenicline Treatment for Smoking Cessation
Brief Summary: This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.


Options:
A: tobacco abstinence (6 months)
B: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)
C: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
D: Weight Gain in Treatment Completers (baseline and 12 weeks)

Answer: B