TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Chewing Gum on Small Bowel Transit Time: a Prospective Randomized Trial.
Brief Summary: The purpose of this study is to see if chewing sugarless chewing gum alters the time it takes for a capsule endoscopy to travel through the stomach and small bowel, and to see if more/less capsule endoscopes reach the large bowel.


Options:
A: Time to flatus (30 days)
B: Small bowel transit time (6 hours)
C: Time to return to active bowel movements (participants will be followed for the duration of hospital stay)
D: Time to first bowel movement (patients postoperative in hospital stay (mean 6 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of Using Video Images in Advance Care Planning in Patients With Advanced Cancer
Brief Summary: To compare the decision making of subjects with advanced cancer having a verbal advance care planning discussion compared to subjects using a video.


Options:
A: Test if Chest Pain Choice Safely Improves Patient Knowledge. (Directly following intervention (on day 1))
B: preferences for CPR (within one hour after oncology visit)
C: Mean Number of Skin Examinations Without Partner Over 4 Months (4 months); Mean Number of Skin Examinations With Partner Over 4 Months (4 months); Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months (4 months)
D: Proportion of patients reporting a decision for "immediate antibiotics." (After index consultation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of Using Video Images in Advance Care Planning in Patients With Advanced Cancer
Brief Summary: To compare the decision making of subjects with advanced cancer having a verbal advance care planning discussion compared to subjects using a video.


Options:
A: Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp. (Three months after enrollment.)
B: Prevalence of Conversations about ICD Deactivation (after 1st clinical encounter after enrollment for intervention group); Prevalence of Conversations about ICD Deactivation (3rd clinical encounter after enrollment for intervention group); Prevalence of Conversations about ICD Deactivation (3 months after enrollment for control group); Prevalence of Conversations about ICD Deactivation (9 months after enrollment for control group)
C: preferences for CPR (within one hour after oncology visit)
D: Number of Patients With Accurate Understanding of Chemotherapy Benefits (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Esophageal Stent is More Effective Than Tamponade Controlling Refractory Esophageal Variceal Bleeding: a Randomized Controlled Trial
Brief Summary: In the last years, important advances have been done in the treatment and prevention of esophageal variceal bleeding. Experts agree that the combination of pharmacological and endoscopic therapy should be the first line therapy in the acute bleeding episode; whereas TIPS (transjugular intrahepatic portosystemic shunt) is considered a rescue therapy. Nevertheless, some patients would require different therapies to act as a "bridge" until definitive therapy can be instituted. Balloon tamponade (using the Sengstaken tube) represents, up to now, the most widely used temporary "bridge" to TIPS. However, balloon tamponade is associated with a high incidence of serious adverse events. Recently, the use of self-expanding metal stents have been introduced in the treatment of acute variceal bleeding showing a very high hemostatic efficacy with no adverse events. The present study is directed to compare the efficacy free of adverse events and mortality of self-expanding metal stents vs balloon tamponade in patients with variceal bleeding refractory to medical and endoscopic therapy.


Options:
A: Survival (10 years)
B: N/A
C: Combined: bleeding + absence of severe adverse events + survival (15 days)
D: Haemostasis (24 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice
Brief Summary: This quality improvement trial aims to evaluate whether giving patients information about their coronary heart disease risk via a computer kiosk in the doctors waiting room and providing primary care doctors with a personal digital device with a decision support tool to help with cholesterol management will improve cholesterol management compared to usual care.


Options:
A: Net Difference in Proportion Treated with Low-dose Diuretics (baseline and at one year)
B: %patients at ATP III goals (one year after intervention)
C: Framingham Risk Score (15 months)
D: Multiple CVD risk factor control targets (42 months after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice
Brief Summary: This quality improvement trial aims to evaluate whether giving patients information about their coronary heart disease risk via a computer kiosk in the doctors waiting room and providing primary care doctors with a personal digital device with a decision support tool to help with cholesterol management will improve cholesterol management compared to usual care.


Options:
A: Systolic blood Pressure (Baseline and 12 months); Glycated haemoglobin (HbA1c) (Baseline and 12 months)
B: %patients at ATP III goals (one year after intervention)
C: Count of Initiating BUP in the ED With Referral for Ongoing MOUD With User-centered CDS Compared With Usual Care (Upon discharge (Up to 1 day))
D: Degree of evidence-based guideline-concordant care for CKD (up to 3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor
Brief Summary: Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour.


Options:
A: Spontaneous delivery before 34 completed weeks (Each 6 months)
B: Spontaneous Delivery Before 34 Completed Weeks (Between 24 and 34 weeks)
C: Preterm delivery before 37 weeks (2 years)
D: Children's survival without neurodevelopmental disability at the age of 3 years (assessment of the newborn at age of 3 years (corrected age for prematurity))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy
Brief Summary: The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of CDP6038 treatment in adult subjects with active rheumatoid arthritis who have had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapy.


Options:
A: Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) (At baseline); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA (Baseline to Day 113); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis (Baseline to Day 113)
B: Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo (Baseline, Week 12)
C: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 (Week 6)
D: Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 (Week 24); Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 (Baseline and Week 52)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy
Brief Summary: The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of CDP6038 treatment in adult subjects with active rheumatoid arthritis who have had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapy.


Options:
A: Number of patients who achieve a DAS28 < 3.2 (0, 1, 3, 6, 9, 12 and 24 months (DAS28))
B: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)
C: Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24 (Baseline to Week 24)
D: Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo (Baseline, Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy
Brief Summary: The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of CDP6038 treatment in adult subjects with active rheumatoid arthritis who have had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapy.


Options:
A: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
B: Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score (76 and 91 weeks)
C: Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24 (Baseline to Week 24)
D: Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo (Baseline, Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Quit and Fit: Exploring the Effects of Physical Activity on Teen Smoking Cessation
Brief Summary: The long term goal of the study entitled "Quit \& Fit" was to revise, evaluate, and disseminate the American Lung Association´s (ALA) teen smoking cessation program called Not On Tobacco (N-O-T), with an added physical activity module. The physical activity module was intended to encourage youth to adopt a more physically active lifestyle. Research showed that physical activity may increase the odds of smoking cessation. The general N-O-T program goals are to help adolescents quit smoking; reduce cigarette use (for participants who are unable to completely quit); increase healthy lifestyle behaviors; and improve life skills such as stress management, decision making, communication, and interpersonal skills. The primary aim of the current research project was to reduce smoking among West Virginia teens. A two-prong secondary aim was to (a) increase participants´ physical activity behavior by supplementing the intervention with a physical activity component and (b) assess the mediating/moderating impact of physical activity on cessation outcomes. If participants quit smoking, the likelihood that they will develop smoking-related diseases is diminished. Participating in this project may aid smoking cessation and therefore improve participants´ health. Research was conducted among 19 of the 123 West Virginia public high schools. 236 teens were recruited to participate in the study over 3 years. This study is a clinical behavioral trial using a 3-group design, with subsequent random assignment.


Options:
A: Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day (End of treatment (10 weeks post quit day) and 30-week follow-up)
B: Smoking cessation: quit and reduction rates (6 months)
C: Salivary Cotinine (12 months posttreatment)
D: Smoking Cue Reactivity on Quit Day (4-weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Quit and Fit: Exploring the Effects of Physical Activity on Teen Smoking Cessation
Brief Summary: The long term goal of the study entitled "Quit \& Fit" was to revise, evaluate, and disseminate the American Lung Association´s (ALA) teen smoking cessation program called Not On Tobacco (N-O-T), with an added physical activity module. The physical activity module was intended to encourage youth to adopt a more physically active lifestyle. Research showed that physical activity may increase the odds of smoking cessation. The general N-O-T program goals are to help adolescents quit smoking; reduce cigarette use (for participants who are unable to completely quit); increase healthy lifestyle behaviors; and improve life skills such as stress management, decision making, communication, and interpersonal skills. The primary aim of the current research project was to reduce smoking among West Virginia teens. A two-prong secondary aim was to (a) increase participants´ physical activity behavior by supplementing the intervention with a physical activity component and (b) assess the mediating/moderating impact of physical activity on cessation outcomes. If participants quit smoking, the likelihood that they will develop smoking-related diseases is diminished. Participating in this project may aid smoking cessation and therefore improve participants´ health. Research was conducted among 19 of the 123 West Virginia public high schools. 236 teens were recruited to participate in the study over 3 years. This study is a clinical behavioral trial using a 3-group design, with subsequent random assignment.


Options:
A: Time Line Follow Back and urine screen (Pre and post-treatment, 3 and 6 month follow-ups)
B: Time to onset and severity of drug use (2 years); Frequency and Quantity of Drinking (2 years); Problem drinking symptoms (2 years)
C: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)
D: Smoking cessation: quit and reduction rates (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Case-Management & Environmental Support to Sustain Weight Loss & Reduce CHD Risk
Brief Summary: Physician-based primary care has thus far failed to address the obesity epidemic. In this randomized clinical trial of 200 obese patients with heart disease risk factors, the investigators will evaluate the impact of nurse and dietitian case management on weight loss and weight maintenance, as an adjunct to physician care. In addition, the investigators will test the incremental benefit of an environmental support strategy using community health workers to help patients navigate their home and neighborhood environments to achieve weight loss. The innovative intervention model developed and evaluated in this project has the potential to provide a blueprint for successful primary care-based obesity services


Options:
A: The relative effectiveness of two physical activity programs in affecting glucose metabolism, lipid metabolism and stress-related hormone production (2 years)
B: The primary outcome is improvement in metabolic control (HbA1c). (The primary outcome was evaluated at 4- and 12-months following randomization.)
C: body mass index (24 months)
D: Systolic Blood Pressure (SBP) (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Case-Management & Environmental Support to Sustain Weight Loss & Reduce CHD Risk
Brief Summary: Physician-based primary care has thus far failed to address the obesity epidemic. In this randomized clinical trial of 200 obese patients with heart disease risk factors, the investigators will evaluate the impact of nurse and dietitian case management on weight loss and weight maintenance, as an adjunct to physician care. In addition, the investigators will test the incremental benefit of an environmental support strategy using community health workers to help patients navigate their home and neighborhood environments to achieve weight loss. The innovative intervention model developed and evaluated in this project has the potential to provide a blueprint for successful primary care-based obesity services


Options:
A: body mass index (24 months)
B: HbA1c level (Final (before 2 years follow-up))
C: body weight (12 months)
D: Body Mass Index (Baseline, 3-, 6- and 15- month follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization'(IVF) Treatment Cycle
Brief Summary: BACKGROUND: Despite the numerous advances in the field of in vitro fertilisation/intracytoplasmic sperm injection (IVF/ICSI), there still exists a maximum implantation rate per embryo transferred of about 30%. Next to the physiological and physic burden that comes with every IVF treatment cycle, implantation failure also adds up to the considerable costs associated with ART. Studies have shown, that minor intrauterine abnormalities can be found in 11-40% of the infertile women with a normal transvaginal sonography. Detection and treatment of these abnormalities by office hysteroscopy have led to a 9-13% increase in pregnancy rate. Therefore, it is increasingly advocated to screen all infertile women on intracavitary pathology prior to the start of IVF/ICSI.

OBJECTIVE: The aim of the proposed study is to assess whether diagnosing and treating unsuspected intrauterine abnormalities by saline infusion sonography and/or routine office hysteroscopy prior to a first IVF/ICSI treatment cycle improves the cost-effectiveness of the fertility treatment.

STUDY DESIGN: Multicenter randomized intervention study. POPULATION: Asymptomatic women, indicated for a first IVF/ICSI treatment cycle and a normal transvaginal ultrasonography.

INTERVENTION: Participants will be randomized for a (SIS and) hysteroscopy with treatment-on-the spot of predefined intrauterine abnormalities versus no diagnostic work-up. In both groups standard IVF/ICSI treatment will be initiated.

PRIMARY OUTCOME MEASURE:

Cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)

SECONDARY OUTCOME MEASURE:

* Cumulative implantation rate achieved within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)
* Cumulative miscarry rate within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)
* Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment
* Patient preference and tolerance of a SIS and diagnostic/therapeutic hysteroscopy procedure
* Prevalence of unexpected intrauterine abnormalities
* Diagnostic accuracy of SIS in diagnosing intrauterine abnormalities


Options:
A: The time taken for polyp removal (at the time of surgery (day 1 intraoperatively))
B: Clinical pregnancy rate (10 month)
C: Visual analogue scale for pain; Patient satisfaction
D: Ongoing pregnancy (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Double-dummy, Randomized, Positive- Controlled Study Comparing the Efficacy and Safety of Lacosamide (200 to 600 mg/Day) to Controlled Release Carbamazepine (400 to 1200 mg/Day), Used as Monotherapy in Subjects (≥ 16 Years) Newly or Recently Diagnosed With Epilepsy and Experiencing Partial-onset or Generalized Tonic-clonic Seizures.
Brief Summary: Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).


Options:
A: Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject (6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject); Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject (6 consecutive months (26 consecutive weeks) of treatment); Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) (Duration of the Treatment Phase (up to 113 weeks)); Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) (Duration of the Treatment Phase (up to 113 weeks)); Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks) (Duration of the Treatment Phase (up to 113 weeks))
B: Rate of seizure-free patients (in the first 6 weeks of the trial)
C: Serum neuron-specific enolase (NSE) and S100B (Change from baseline over 4 weeks)
D: Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase (Week 31 through Week 109)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The Objective of this study is to introduce a practically feasible multifaceted intervention in the preadmission clinic to help reduce smoking in preoperative surgical patients. The investigators aim to study the effectiveness of such a program in promoting positive change in smoking behavior among patients before surgery. The forced abstinence enforced on patients during hospital stay for their surgery can also be used to help smokers remain tobacco free long term. 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.


Options:
A: Rate of Smoking Abstinence (18 months & 24 months post study enrollment)
B: 7-day point prevalent CO validated smoking cessation. (Three months after lung screening)
C: 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)
D: Continuous abstinence (Russell Standard) (Six months post quit date)

Answer: C