TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Dental Tobacco Control.Net:Improving Practice
Brief Summary: This is a randomized, controlled trial (RCT) to test the efficacy of an internet continuing dental education intervention designed to increase tobacco cessation counseling in dental practices. The intervention involves surveying practices regarding preventive care, surveying adult patients about their tobacco habits and preventive care provided by dental practice and training/educating the dentist and office staff on tobacco cessation. With patients who smoke and indicate that they have quit, we followed up with testing their saliva for the presence of cotinine. We have enrolled general dentists and periodontists who practice in the Southeastern United States.


Options:
A: N/A
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: 7-day point prevalence abstinence at 3 months (3 months post baseline); 7-day point prevalence abstinence at 6 months (6 months post baseline); 7-day point prevalence abstinence at 12 months (12 months post baseline)
D: Physician performance on refering patients that smoke cigarettes to the web intervention (pre-intervention, 6 months, 12 months and 24 months); Of the smokers who are referred to the web intervention, the number who go to the site (preintervention, 6 months, 12 months, 24 months); Point prevalence smoking cessation (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Dental Tobacco Control.Net:Improving Practice
Brief Summary: This is a randomized, controlled trial (RCT) to test the efficacy of an internet continuing dental education intervention designed to increase tobacco cessation counseling in dental practices. The intervention involves surveying practices regarding preventive care, surveying adult patients about their tobacco habits and preventive care provided by dental practice and training/educating the dentist and office staff on tobacco cessation. With patients who smoke and indicate that they have quit, we followed up with testing their saliva for the presence of cotinine. We have enrolled general dentists and periodontists who practice in the Southeastern United States.


Options:
A: 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)
B: Knowledge about hazards of smokeless tobacco (6 months)
C: Patient report (Within 3 days of the dental encounter)
D: Change in Body Mass Index (Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dental Tobacco Control.Net:Improving Practice
Brief Summary: This is a randomized, controlled trial (RCT) to test the efficacy of an internet continuing dental education intervention designed to increase tobacco cessation counseling in dental practices. The intervention involves surveying practices regarding preventive care, surveying adult patients about their tobacco habits and preventive care provided by dental practice and training/educating the dentist and office staff on tobacco cessation. With patients who smoke and indicate that they have quit, we followed up with testing their saliva for the presence of cotinine. We have enrolled general dentists and periodontists who practice in the Southeastern United States.


Options:
A: Validated smoking cessation (6 months)
B: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)
C: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Fear of Food in Anorexia Nervosa
Brief Summary: This study will compare the effectiveness of two types of psychotherapy, a relapse prevention program and cognitive behavioral therapy, in reducing relapse and fear of eating situations in people with anorexia nervosa.


Options:
A: Percent Ideal Body Weight (%IBW) (9-months and 21-months)
B: Eating Disorder Interview (change from baseline to one month post-intervention); Eating Disorder Inventory (Change from baseline to one month post-intervention); Eating Disorder Interview (Change from baseline to 6 mos post-intervention); Eating Disorder Interview (Change from baseline to 12 months post-intervention); Eating Disorder Inventory (Change from baseline to 6 mos post-intervention); Eating Disorder Inventory (Change from baseline to 12 mos post-intervention)
C: Scores on the Eating Disorders Examination (Measured at Year 1 of treatment and Year 1 of follow-up)
D: Diet Energy Density and Variety score (Measured before treatment and at Months 1, 2, 3, 4, 5, and 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomised Study to Evaluate the Effect of Triggering Ovulation With GnRHa (Buserelin) and Low Dose hCG (Pregnyl) as Compared to the Use of Conventional Doses of hCG (Pregnyl)
Brief Summary: The purpose of this study is to possibly further improve the clinical outcome and explore the incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in GnRH antagonist IVF/ICSI cycles


Options:
A: Frequency of Moderate to Severe OHSS. (From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test)
B: Ongoing pregnancy rate beyond 20 weeks
C: Ongoing pregnancy rate (12 weeks)
D: Number of cumulus-oocyte-complexes retrieved (1 cycle)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Avaulta Plus for Anterior Repair. A Multicenter Randomised Prospective Controlled Study
Brief Summary: Summary:

Vaginal prolapse is a well-known disease and is observed in approximately 11% of all postmenopausal women and tending to increase with age. Consequently, many surgical procedures have been developed in order to ensure sufficient support for the bladder, rectum or vaginal vault depending on the site of the defect. However, many procedures are associated with a high recurrence rate up to 40 % even within one to two years after the surgical procedure.

Due to the high recurrence rate new methods include the use of mesh, either biologically or synthetic. The latter is a permanent implant and therefore theoretically may result in a long-lasting anatomically correct position of the prolapse.

Although the recurrence rate may be lower using a mesh such surgical procedures may be associated with adverse events such as erosions of the vaginal mucosa. Others have observed shrinkage of the vaginal mucosa. However, in these studies large prolene mesh have been used. In contrast the recurrence rate is lowered up to 25%.

The above-mentioned advantage of synthetic mesh is however, mostly based on few non-randomised studies. We therefore find it of importance to evaluate whether a surgical procedure using a mesh implant is superior to conventional surgical techniques. The present study is a clinical controlled study where patients with anterior vaginal prolapse are randomised to either a mesh technique or a standard anterior procedure.

The present study includes only two more visits at the outpatient clinic after the surgical procedure. Furthermore the patients have to fulfil questionnaires regarding urinary and faecal leakage and sexual habits.

Any participation in the study is totally voluntary and the patient may at any time withdraw herself. In any case the patient will receive our standard treatment.

The study is performed in all the Scandinavian countries.


Options:
A: Recurrent Stage II or Greater Anterior Vaginal Prolapse (three years)
B: Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery (4 years)
C: Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis (2 years)
D: Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr. (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Avaulta Plus for Anterior Repair. A Multicenter Randomised Prospective Controlled Study
Brief Summary: Summary:

Vaginal prolapse is a well-known disease and is observed in approximately 11% of all postmenopausal women and tending to increase with age. Consequently, many surgical procedures have been developed in order to ensure sufficient support for the bladder, rectum or vaginal vault depending on the site of the defect. However, many procedures are associated with a high recurrence rate up to 40 % even within one to two years after the surgical procedure.

Due to the high recurrence rate new methods include the use of mesh, either biologically or synthetic. The latter is a permanent implant and therefore theoretically may result in a long-lasting anatomically correct position of the prolapse.

Although the recurrence rate may be lower using a mesh such surgical procedures may be associated with adverse events such as erosions of the vaginal mucosa. Others have observed shrinkage of the vaginal mucosa. However, in these studies large prolene mesh have been used. In contrast the recurrence rate is lowered up to 25%.

The above-mentioned advantage of synthetic mesh is however, mostly based on few non-randomised studies. We therefore find it of importance to evaluate whether a surgical procedure using a mesh implant is superior to conventional surgical techniques. The present study is a clinical controlled study where patients with anterior vaginal prolapse are randomised to either a mesh technique or a standard anterior procedure.

The present study includes only two more visits at the outpatient clinic after the surgical procedure. Furthermore the patients have to fulfil questionnaires regarding urinary and faecal leakage and sexual habits.

Any participation in the study is totally voluntary and the patient may at any time withdraw herself. In any case the patient will receive our standard treatment.

The study is performed in all the Scandinavian countries.


Options:
A: Recurrence of anterior vaginal wall prolapse
B: Objective assessment of prolapse. "Cure" is defined as point Ba (on POP-Q) of -1 or above (i.e., more negative) (12 months postoperatively)
C: Recurrent Stage II or Greater Anterior Vaginal Prolapse (three years)
D: Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr. (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Avaulta Plus for Anterior Repair. A Multicenter Randomised Prospective Controlled Study
Brief Summary: Summary:

Vaginal prolapse is a well-known disease and is observed in approximately 11% of all postmenopausal women and tending to increase with age. Consequently, many surgical procedures have been developed in order to ensure sufficient support for the bladder, rectum or vaginal vault depending on the site of the defect. However, many procedures are associated with a high recurrence rate up to 40 % even within one to two years after the surgical procedure.

Due to the high recurrence rate new methods include the use of mesh, either biologically or synthetic. The latter is a permanent implant and therefore theoretically may result in a long-lasting anatomically correct position of the prolapse.

Although the recurrence rate may be lower using a mesh such surgical procedures may be associated with adverse events such as erosions of the vaginal mucosa. Others have observed shrinkage of the vaginal mucosa. However, in these studies large prolene mesh have been used. In contrast the recurrence rate is lowered up to 25%.

The above-mentioned advantage of synthetic mesh is however, mostly based on few non-randomised studies. We therefore find it of importance to evaluate whether a surgical procedure using a mesh implant is superior to conventional surgical techniques. The present study is a clinical controlled study where patients with anterior vaginal prolapse are randomised to either a mesh technique or a standard anterior procedure.

The present study includes only two more visits at the outpatient clinic after the surgical procedure. Furthermore the patients have to fulfil questionnaires regarding urinary and faecal leakage and sexual habits.

Any participation in the study is totally voluntary and the patient may at any time withdraw herself. In any case the patient will receive our standard treatment.

The study is performed in all the Scandinavian countries.


Options:
A: Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr. (one year)
B: Anatomical success rates 1 year after surgery to correct pelvic organ prolapse with the Avaulta synthetic mesh kit (1 year post operatively)
C: Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence (3 months post-surgery); Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery (12 months post-surgery)
D: Stress urinary continence (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Tolerability of Oral Once-Daily Prucalopride (R108512) Solution in Constipated Elderly Subjects Living in a Nursing Facility
Brief Summary: The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of constipation in elderly subjects living in a nursing facility.

Hypothesis:

Prucalopride up to a dose of 4 mg once daily is safe and well tolerated in in elderly subjects living in a nursing facility.


Options:
A: Colonic Transit at 24 Hours (24 hours post-radiolabeled meal)
B: Patient's Global Assessment of severity of constipation and efficacy of treatment evaluated (for exploratory reasons only). (4 weeks)
C: Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency (Change from Baseline to Week 4)
D: Proportion of subjects with an average of 3 or more SCBM per week (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind , Randomized, Placebo Controlled Study of N-Acetyl Cysteine in Autism.
Brief Summary: The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism. NAC is a compound that increases the levels of Glutathione, the body's main antioxidant. Glutathione is a compound in the blood that is part of a natural defense system (the antioxidant system). Anti-oxidants protect the body from damage caused by internal toxins called "free radicals." It is possible that children with Autism tend to have lower levels of glutathione, an important compound in our bodies that helps combat the effects of toxic free radicals.

We hope that by studying the antioxidant system in more detail, we will increase our understanding of the reasons why people develop Autism so that we can design better ways to treat individuals with this condition. This study is meant to test the safety tolerability of NAC and its effectiveness in the treatment of behavioral difficulties in children with autism. It will also examine the possible benefit of this agent in improving the core deficits in autism such as social deficits.


Options:
A: Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) (4, 8, and 12 weeks); The Clinical Global Rating Scale (CGRS) Improvement Subscale Score (12 weeks); Glutathione (GSH) Levels in Peripheral Blood, Measured by State-of-the-art High-performance Liquid Chromatography (HPLC) (12 weeks); Irritability Subscale of the Aberrant Behavior Checklist (ABC) (baseline and 12 weeks)
B: Number of Participants Reporting Improvement on the Clinical Global Impression (Baseline to end of study (week 15)); Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores (Baseline and End of Study (week 15))
C: Home Situations Questionnaire (Week 24); Vineland Daily Living Skills Scale (Week 24)
D: Mean Conners' Teacher ADHD Index T Score by Dose (Measured at each dosing week of the drug trial (placebo, low, medium, high)); Mean Continuous Performance Test (CPT)-Commission Errors by Dose (Measured at each dosing week of the drug trial (placebo, low, medium, high))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C
Brief Summary: A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).


Options:
A: Proportion of Participants With Sustained Virologic Response 12 (SVR-12) (12 weeks post-therapy)
B: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))
C: Proportion of Subjects Achieving Undetectable HCV RNA at Week 12 (12 weeks after first dose of study drug)
D: Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1 (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3 (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1 (Up to 5 days); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3 (Up to 5 days); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a (Up to 5 days); Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5 (Up to 5 days); Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event (Up to 5 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C
Brief Summary: A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).


Options:
A: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))
B: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)
C: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)
D: Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12) (12 weeks post-treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C
Brief Summary: A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).


Options:
A: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Baseline to Week 12)
B: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))
C: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) (Post-treatment Week 24); Percentage of Participants Who Experienced Adverse Events (Baseline (Day 1) to post-treatment Day 30)
D: Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population. (At Follow-up Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C
Brief Summary: A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).


Options:
A: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))
B: Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population. (At Follow-up Week 24)
C: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)
D: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)

Answer: A