TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: WebQuit Online Smoking Cessation Study
Brief Summary: Would you like to quit smoking?

Seattle's Fred Hutchinson Cancer Research Center is launching a new study that may be able to help. Participants who enroll in this study will be randomly assigned by computer (like flipping a coin) to one of two online programs. The goal of this study is to learn which of these programs is the most effective at helping people stop smoking. Findings from this study will be used to help build more effective online smoking cessation programs in the future.

Participants in both of the smoking cessation programs used in this study will receive:

* Interactive tools for dealing more effectively with urges to smoke
* Step-by-step guides for quitting smoking
* Personalized plans for quitting and remaining smoke-free
* Electronic links for reaching one-on-one expert help for quitting

Participants will be asked to complete online questionnaires, including a brief three-month follow-up survey.

There is no cost for participating in this study.

To enroll in this study or for more information, please visit www.webquit.com.

This study is being conducted by Seattle's Fred Hutchinson Cancer Research Center (www.fhcrc.org), a world leader in advancing the prevention, diagnosis and treatment of cancer. The principal investigator for the WebQuit smoking cessation study is Dr. Jonathan Bricker, a faculty member at both the Hutchinson Center and at the University of Washington in Seattle.


Options:
A: 7-day point prevalence (3 months and 6 months post treatment)
B: Our primary outcome measures are patient-reported provider delivered tobacco screening and tobacco cessation advice. (Baseline, 8-months post-intervention, and 24-months post-intervention)
C: Number of smokers referred to tobacco cessation website (12 months)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: WebQuit Online Smoking Cessation Study
Brief Summary: Would you like to quit smoking?

Seattle's Fred Hutchinson Cancer Research Center is launching a new study that may be able to help. Participants who enroll in this study will be randomly assigned by computer (like flipping a coin) to one of two online programs. The goal of this study is to learn which of these programs is the most effective at helping people stop smoking. Findings from this study will be used to help build more effective online smoking cessation programs in the future.

Participants in both of the smoking cessation programs used in this study will receive:

* Interactive tools for dealing more effectively with urges to smoke
* Step-by-step guides for quitting smoking
* Personalized plans for quitting and remaining smoke-free
* Electronic links for reaching one-on-one expert help for quitting

Participants will be asked to complete online questionnaires, including a brief three-month follow-up survey.

There is no cost for participating in this study.

To enroll in this study or for more information, please visit www.webquit.com.

This study is being conducted by Seattle's Fred Hutchinson Cancer Research Center (www.fhcrc.org), a world leader in advancing the prevention, diagnosis and treatment of cancer. The principal investigator for the WebQuit smoking cessation study is Dr. Jonathan Bricker, a faculty member at both the Hutchinson Center and at the University of Washington in Seattle.


Options:
A: Alcohol consumption (12 weeks); Time to lapse (12 weeks); amount of alcohol consumption (12 weeks)
B: Hamilton Depression Scale, Timeline Follow-back (substance measure) (18 months)
C: 7-day point prevalence (3 months and 6 months post treatment)
D: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: WebQuit Online Smoking Cessation Study
Brief Summary: Would you like to quit smoking?

Seattle's Fred Hutchinson Cancer Research Center is launching a new study that may be able to help. Participants who enroll in this study will be randomly assigned by computer (like flipping a coin) to one of two online programs. The goal of this study is to learn which of these programs is the most effective at helping people stop smoking. Findings from this study will be used to help build more effective online smoking cessation programs in the future.

Participants in both of the smoking cessation programs used in this study will receive:

* Interactive tools for dealing more effectively with urges to smoke
* Step-by-step guides for quitting smoking
* Personalized plans for quitting and remaining smoke-free
* Electronic links for reaching one-on-one expert help for quitting

Participants will be asked to complete online questionnaires, including a brief three-month follow-up survey.

There is no cost for participating in this study.

To enroll in this study or for more information, please visit www.webquit.com.

This study is being conducted by Seattle's Fred Hutchinson Cancer Research Center (www.fhcrc.org), a world leader in advancing the prevention, diagnosis and treatment of cancer. The principal investigator for the WebQuit smoking cessation study is Dr. Jonathan Bricker, a faculty member at both the Hutchinson Center and at the University of Washington in Seattle.


Options:
A: Smoking Abstinence (12 months)
B: 7-day point prevalence (3 months and 6 months post treatment)
C: Biochemically confirmed continuous 30-day abstinence from smoking (12 weeks post-Target Quit Day (TQD))
D: Number of Participants With Smoking Abstinence (4 weeks post quit day (one week following the end of treatment)); Smoking Abstinence (26 weeks post quit day); Smoking Abstinence (4 weeks post quit day (one week following the end of treatment))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term Effectiveness Of Sacrospinous Ligament Fixation vs Uterosacral Ligament Suspension With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training: Extended Operations & Pelvic Muscle Training Of Apical Support Loss Study
Brief Summary: Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study and no new study treatment interventions will be given. Rather an enrollment intervention will be investigated with potential E-OPTIMAL participants randomly assigned to watch a standardized video prior to consent or undergo the standard informed consent process. The standardized video will review the rationale for women's health research, the importance of long-term follow-up and a detailed invitation to participate in E-OPTIMAL. The video has undergone review by potential subjects, coordinators and physician researchers to ensure that the relevance and importance of issues potentially impacting on long-term participation in studies such as E-OPTIMAL are covered. Participation in E-OPTIMAL will occur up to three additional years. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.

We propose to test the following null hypotheses:

1. There will be no difference in time to surgical failure between uterosacral vaginal vault ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) up to 5 years after surgery.
2. The addition of a standardized video detailing the importance of long-term follow-up studies for POP to the informed consent process will not improve enrollment or retention in E-OPTIMAL.


Options:
A: Mesh attachment interval (Intraoperatively)
B: Mesh Attachment Time (Assessed at one time point, during the participants surgery.)
C: Surgical Success (24 months); Anatomic Failure (24 months); Urinary Distress Inventory at 6 Months (6 months)
D: Surgical Failure (6 months and 1, 2, 3, 4, and 5 years); Recruitment Into E-OPTIMAL (At 24 Months post OPTIMAL Treatment); Retention in E-OPTIMAL (3, 4, and 5 Years Post OPTIMAL Treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term Effectiveness Of Sacrospinous Ligament Fixation vs Uterosacral Ligament Suspension With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training: Extended Operations & Pelvic Muscle Training Of Apical Support Loss Study
Brief Summary: Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study and no new study treatment interventions will be given. Rather an enrollment intervention will be investigated with potential E-OPTIMAL participants randomly assigned to watch a standardized video prior to consent or undergo the standard informed consent process. The standardized video will review the rationale for women's health research, the importance of long-term follow-up and a detailed invitation to participate in E-OPTIMAL. The video has undergone review by potential subjects, coordinators and physician researchers to ensure that the relevance and importance of issues potentially impacting on long-term participation in studies such as E-OPTIMAL are covered. Participation in E-OPTIMAL will occur up to three additional years. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.

We propose to test the following null hypotheses:

1. There will be no difference in time to surgical failure between uterosacral vaginal vault ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) up to 5 years after surgery.
2. The addition of a standardized video detailing the importance of long-term follow-up studies for POP to the informed consent process will not improve enrollment or retention in E-OPTIMAL.


Options:
A: Surgical Failure (6 months and 1, 2, 3, 4, and 5 years); Recruitment Into E-OPTIMAL (At 24 Months post OPTIMAL Treatment); Retention in E-OPTIMAL (3, 4, and 5 Years Post OPTIMAL Treatment)
B: FIT Completion (Completed FIT kits sent back within 12 months)
C: Change in dietary and physical activity behavior (self-report) (Baseline to 8 weeks later)
D: Women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out. (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Impact of Botulinum Toxin A Versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence
Brief Summary: Urinary incontinence is a prevalent condition that markedly impacts quality of life and disproportionately affects women. Overactive Bladder syndrome (OAB) is defined as symptoms of urgency and frequency with urge urinary incontinence (OAB-wet) and without urge incontinence (OAB-dry). Conservative first line treatments for urge incontinence combined with other OAB symptoms (OAB-wet) include behavioral therapy, pelvic floor training +/- biofeedback, or the use of anticholinergic medications. These treatment modalities may not result in total continence and often drug therapy is discontinued because of lack of efficacy, side effects and cost or because of not wanting to take a pill. Behavioral therapy and pelvic muscle exercises require consistent, active intervention by the patient which is often not sustained. Thus, the objective of the Anticholinergic vs Botox Comparison Study (ABC) is to determine whether a single intra-detrusor injection of botulinum toxin A (Botox A®) is more effective than a standardized regimen of oral anticholinergics in reducing urge urinary incontinence. The null hypothesis is that there is no difference in the change from baseline in average number of urge urinary incontinence episodes over 6 months between groups.


Options:
A: Change From Baseline in mean number of micturitions per 24 hours (12 weeks)
B: Change in Urge Urinary Incontinence (UUI) Episodes (Baseline through 6 months)
C: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (Baseline, Week 12)
D: Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours (Baseline and EoT (up to 12 weeks)); Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours (Baseline and EoT (up to 12 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Examining a Text Message Intervention for Smoking Cessation
Brief Summary: The primary goal of this study is to use qualitative interviews and focus groups to aid us in adapting a face-to-face smoking cessation intervention for delivery through text messaging. After design is completed, the intervention will be pilot tested with a sample of young adults (ages 18-35) who smoke. Final assessments will be conducted at 7 weeks (end of treatment) and both 3 and 6 month follow up.


Options:
A: Point prevalence abstinence at 6 months (6 months after beginning treatment)
B: Carbon Monoxide-verified Continuous Abstinence at 12 Weeks (12-weeks post-quit day)
C: 30 day point prevalence of abstinence (6 months)
D: Smoking abstinence (Six months post-treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Examining a Text Message Intervention for Smoking Cessation
Brief Summary: The primary goal of this study is to use qualitative interviews and focus groups to aid us in adapting a face-to-face smoking cessation intervention for delivery through text messaging. After design is completed, the intervention will be pilot tested with a sample of young adults (ages 18-35) who smoke. Final assessments will be conducted at 7 weeks (end of treatment) and both 3 and 6 month follow up.


Options:
A: 30 day point prevalence of abstinence (6 months)
B: Point prevalence abstinence at 6 months (6 months after beginning treatment)
C: Smoking abstinence (Six months post-treatment)
D: Point prevalence abstinence of 7 days (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Late Clinical Events After Drug-eluting Versus Bare-metal Stents in Patients at Risk: BAsel Stent Kosten Effektivitäts Trial - PROspective Validation Examination Part II (BASKET-PROVE II)
Brief Summary: Background:

Retrospective analyses of long-term BASKET findings identified patients with large drug-eluting stents (DES) (\>2.5mm Stents) as patients at risk for late cardiac death/nonfatal myocardial infarction. In view of new DES with absorbable polymers and new bare metal stents BMS) with thin struts and biocompatible polymers, BP-II will be launched to test their comparative clinical safety up to 12 years if treated with an aspirin/prasugrel combination, since prasugrel halved stent thrombosis rates compared to clopidogrel in a large ACS trial.

The primary objective is to demonstrate non-inferiority of the Nobori DES stent compared to the Xience Prime DES stent on safety and e cacy in patients requiring stents \>=3.0mm in diameter on the background of contemporary dual antiplatelet therapy (DAPT) with prasugrel and aspirin

Set-up:

Multicenter open-label randomized trial.

Patient inclusion:

Unselected series of patients in need of large (\>3mm) stents only in native vessels irrespective of clinical indication.

Patient exclusion:

In-stent restenosis, Left-main disease, cardiogenic shock, planned surgery \<12months, increased bleeding risk, no compliance expected, History of stroke or transient ischemic attack (TIA).

Randomization:

By centre using sealed envelopes 1:1:1: Nobori:Xience Prime:Prokinetik-stent.


Options:
A: Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vesselpost-procedure. (1 and 6 months and at 1, 3, 4, and 5 years post-procedure.)
B: Ischemia Driven Target Lesion Failure (TLF) (1 year)
C: MACE (composite endpoint including cardiac death, myocardial infarction (MI) and target-vessel revascularization (TVR) (2 years)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
Brief Summary: It is still not clear whether a positive AGO-score just selects patients with less aggressive biologic tumor behavior who as well would have had a positive outcome by chemotherapy only, or , if it is a score selecting patients who really benefit from surgery. Nevertheless, the AGO-score was confirmed to select patients with a less than 30% risk of ending with residual tumor after surgery for recurrent disease. This could avoid including patients into the present surgical protocol who could not benefit from an operationThe goal of this third DESKTOP study is to evaluate in a prospectively randomized multicentre setting, whether maximum effort of cytoreductive surgery followed by platinum based combination chemotherapy can improve overall survival as compared to platinum based combination chemotherapy alone in AGO-score positive patients.


Options:
A: Overall survival (Approximately 36 months after last patient randomized and observation of 244 events)
B: Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS) (Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.)
C: Efficacy: Progression Free Survival (PFS) (An average of 30 months for each participant); Safety: Number of Evacuations Per Day (Evacuation were collected daily for the first four weeks of treatment of experimental drugs)
D: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: COMPARISON OF CLINICAL EFFICACY OF COMBINATION Amoxycillin Plus Clavulanic Acid and Oxacillin Plus Ceftriaxone for HOSPITAL TREATMENT OF COMMUNITY Acquired PNEUMONIA IN CHILDREN : A Randomized Clinical Study
Brief Summary: Objective: To compare the clinical effectiveness and hospital costs, the initial empirical treatment, Oxacillin / Ceftriaxone and Amoxicillin / Clavulanate in children with Community Acquired Pneumonia (CAP) severe.

Methods: Clinical prospective randomized study in children aged two months to five years of age with a diagnosis of severe CAP, according to criteria of World Health Organization (WHO), admitted to the Pediatrics Ward of the Hospital of the Medical School of Botucatu- UNESP. We excluded children with comorbid disorders (primary and secondary immunodeficiency) with acute or chronic kidney disease, referred patients receiving antibiotics proposal and history of allergy to antibiotics proposed. We included 104 children who were randomized into two groups to receive: Oxacillin / Ceftriaxone IV (GCO, n = 48) and Amoxicillin / Clavulanate IV (GAA, n = 56). Patients of the GAA, after clinical improvement, has been receiving the same oral antibiotic, and maintaining clinical stability, were discharged from hospital, the GOC received any IV treatment. The outcomes analyzed were time to clinical improvement (fever and tachypnea), duration of oxygen therapy, hospitalization time, need to expand the antimicrobial spectrum progression to pleural effusion / empyema (DP / E) and hospital costs. Treatment failure was determined by the need to expand the antimicrobial spectrum after 48 hours of hospitalization.


Options:
A: length of stay at pediatric ward. (3 years)
B: Clinical cure rate (cured or not cured) at 10-17 days after the last dose of study medication.
C: The development of clinical treatment failure at day 6 among those children initially evaluated for ARI needing assessment (ANA) by a LHW at the domiciliary level. (At day 6)
D: Primary outcome:; Clinical Cure: Respiratory rate below age specific cut-off (<50 bpm in infants <12 months and <40 bpm in 12 - 59 months of age).

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Controlled Study Comparing EKOS EkoSonic Ultrasound Accelerated Thrombolysis to Anticoagulation in the Treatment of Sub-massive Pulmonary Embolism
Brief Summary: The ULTIMA study is intended to prove that in patients with pulmonary embolism and a right ventricular end diastolic diameter to left ventricular end diastolic diameter ratio ≥1 (RV/LV ratio) will benefit from treatment with ultrasound accelerated thrombolysis (rt-PA) as compared to unfractionated heparin anticoagulation. Specifically, at 24 hours the RV/LV ratio will be significantly reduced in the treatment arm compared to the control arm.


Options:
A: Clinical composite endpoint of all-cause mortality or haemodynamic collapse within 7 days (Day 7); Haemodynamic collapse is defined as: need for cardiopulmonary resuscitation; or systolic blood pressure < 90 mm Hg for at least 15 min or drop of syst (Day 7)
B: Clinically relevant reduction of RVD (24 hours from Tenecteplase or Placebo injection)
C: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)
D: Reduction of RV/LV Ratio (24 hours); Major Bleeding and Intracranial Bleeding at 30 Days. (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Controlled Study Comparing EKOS EkoSonic Ultrasound Accelerated Thrombolysis to Anticoagulation in the Treatment of Sub-massive Pulmonary Embolism
Brief Summary: The ULTIMA study is intended to prove that in patients with pulmonary embolism and a right ventricular end diastolic diameter to left ventricular end diastolic diameter ratio ≥1 (RV/LV ratio) will benefit from treatment with ultrasound accelerated thrombolysis (rt-PA) as compared to unfractionated heparin anticoagulation. Specifically, at 24 hours the RV/LV ratio will be significantly reduced in the treatment arm compared to the control arm.


Options:
A: Reduction of RV/LV Ratio (24 hours); Major Bleeding and Intracranial Bleeding at 30 Days. (30 days)
B: The improvement of the right ventricular function , perfusion defect score on lung V/Q scans or quantitative computed tomographic pulmonary angiography (CTPA) score. (14d)
C: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)
D: Clinically relevant reduction of RVD (24 hours from Tenecteplase or Placebo injection)

Answer: A