TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Sequential Open-Label Study to Evaluate the Efficacy and Safety of Sorafenib Followed by Sunitinib Versus Sunitinib Followed by Sorafenib in the Treatment of First-Line Advanced / Metastatic Renal Cell Carcinoma
Brief Summary: Primary:

To evaluate if progression-free survival from first treatment to progression or death during second-line therapy (total PFS) of sorafenib followed by sunitinib is superior compared to sunitinib followed by sorafenib.

Secondary:

1. Time from first treatment to progression during second-line therapy (total TTP)
2. Time to first-line treatment failure (progression, death, discontinuation due to toxicity) descriptively in each arm
3. PFS in first-line and second-line treatment, descriptively
4. Overall survival, descriptively (data cut-off same as for primary endpoint)
5. Disease Control Rate (DCR); Response rates in first-line and in second-line (CR, PR, SD according to RECIST criteria)
6. Cardiotoxicity analysis by means of echocardiography and NT-pro BNP with an interim analysis after 100 patients of each arm have completed the study
7. Safety and tolerability


Options:
A: Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death) (12 months)
B: total Progression Free Survival (Last patient last visit (LPLV) to October 2013)
C: Percentage of Participants With Disease Progression Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Via Independent Review Committee (IRC) Assessment or Death in Intent-to-Treat (ITT) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Progression-Free Survival (PFS) Per RECIST v1.1 Via IRC Assessment in ITT Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Immune Cell 1/2/3 (IC1/2/3) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); PFS Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years))
D: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: IVC CLAMP: Infrahepatic Inferior Vena Cava Clamping During Hepatectomy - A Randomized Controlled Trial
Brief Summary: Intraoperative blood loss is a major concern during hepatic resection, as it has been shown to adversely affect patients' perioperative outcome. Reduction of central venous pressure during parenchymal transection has been shown to effectively lower liver hemorrhage. While CVP reduction is mainly achieved via fluid restriction and diuretics, dehydration may impair organ function. Moreover, it may lead to hemodynamic instability, particularly in case of severe bleeding. For this reason the technique of infrahepatic inferior vena cava clamping has been suggested which is able to lower CVP without the need for fluid restriction.

In the present study the two strategies to reduce CVP and by this intraoperative bleeding, namely fluid restriction and inferior vena cava clamping are compared with intraoperative blood loss as primary endpoint.


Options:
A: Intraoperative blood loss (End of operation)
B: N/A
C: Proportion of patients with hemostasis 3 minutes after application of the haemostat product (3 minutes)
D: Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS). (Intra-operative)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost-effectiveness of Multidisciplinary Management of Tinnitus at a Specialised Tinnitus Centre
Brief Summary: Background: Tinnitus is a common chronic health condition that affects 10% to 20% of the general population. Among severe sufferers it causes disability in various areas. As a result of the tinnitus quality of life is often impaired. At present there is no cure or uniformly effective treatment, leading to fragmentized and costly tinnitus care. Evidence suggests an integral multidisciplinary approach in treating tinnitus is effective. The main objective of this study is to examine the effectiveness, costs, and cost-effectiveness of an integral treatment provided by a specialized tinnitus center versus usual care. This paper describes the study protocol.

Methods/Design: In a randomized controlled clinical trial 198 tinnitus patients will be randomly assigned to a specialized tinnitus care group or a usual care group. Adult tinnitus sufferers referred to the audiological centre are eligible. Included patients will be followed for 12 months.

Primary outcome measure is generic quality of life (measured with the Health Utilities Index Mark III). Secondary outcomes are severity of tinnitus, general distress, tinnitus cognitions, tinnitus specific fear, and costs. Based on health state utility outcome data the number of patients to include is 198. Economic evaluation will be from a societal perspective.

Discussion/ Conclusion: This is, to our knowledge, the first randomized controlled trial that evaluates an integral treatment of tinnitus that includes a full economic evaluation from a societal perspective. If this intervention proves to be effective and cost-effective, implementation of this intervention is considered and anticipated.


Options:
A: N/A
B: Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3) (At baseline and 3, 8 and 12 months follow-up)
C: Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007) (18 months); MINI-Tinnitus Questionnaire (Mini-TQ; Hiller & Goebel, 2004) (18 months)
D: Change in tinnitus complaints as measured by the German version of the Tinnitus Questionnaire (TQ)(Baseline versus week 9) (Baseline to Week 9)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost-effectiveness of Multidisciplinary Management of Tinnitus at a Specialised Tinnitus Centre
Brief Summary: Background: Tinnitus is a common chronic health condition that affects 10% to 20% of the general population. Among severe sufferers it causes disability in various areas. As a result of the tinnitus quality of life is often impaired. At present there is no cure or uniformly effective treatment, leading to fragmentized and costly tinnitus care. Evidence suggests an integral multidisciplinary approach in treating tinnitus is effective. The main objective of this study is to examine the effectiveness, costs, and cost-effectiveness of an integral treatment provided by a specialized tinnitus center versus usual care. This paper describes the study protocol.

Methods/Design: In a randomized controlled clinical trial 198 tinnitus patients will be randomly assigned to a specialized tinnitus care group or a usual care group. Adult tinnitus sufferers referred to the audiological centre are eligible. Included patients will be followed for 12 months.

Primary outcome measure is generic quality of life (measured with the Health Utilities Index Mark III). Secondary outcomes are severity of tinnitus, general distress, tinnitus cognitions, tinnitus specific fear, and costs. Based on health state utility outcome data the number of patients to include is 198. Economic evaluation will be from a societal perspective.

Discussion/ Conclusion: This is, to our knowledge, the first randomized controlled trial that evaluates an integral treatment of tinnitus that includes a full economic evaluation from a societal perspective. If this intervention proves to be effective and cost-effective, implementation of this intervention is considered and anticipated.


Options:
A: N/A
B: Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3) (At baseline and 3, 8 and 12 months follow-up)
C: Tinnitus Handicap Questionnaire (4 weeks)
D: THI (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Lumbosacral radiculopathy is one of the leading of cause of disability in the U.S. and worldwide. Among recent reviews evaluating epidural steroid injections, some 1 but not all 2 concluded them to be effective in the long-term. In our own double-blind, placebo-controlled study evaluating epidural etanercept, the results showed significant benefit in favor of the etanercept group, but no subject was included with a duration of pain \> 9 months, and the results of this study have yet to be replicated.

Currently, epidural steroid injections are the most frequently performed procedures in pain clinics across the U.S. However, epidural steroids may benefit only a select group of patients. The literature on treating sciatica is notable for a lack of randomized comparative studies involving various treatments. The objective of this project is to conduct a 3-arm study to determine the efficacy of 1) transforaminal epidural corticosteroids; and 2) transforaminal epidural etanercept, in patients with lumbosacral radiculopathy.


Options:
A: Radicular Pain Visual Analogue Scale (VAS) Score change from baseline (Baseline, 4 weeks, 8 weeks, 12 weeks post injection)
B: To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids. (Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.)
C: Roland Morris (6 weeks)
D: Numerical Rating Leg Pain Score (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure
Brief Summary: The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnea. Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control group is 35% in the first year. It is assumed that the hazard rate is constant over time.


Options:
A: Global Rank Endpoint (Baseline, 6 months)
B: apnea-hypopnea index (at 6 weeks)
C: All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation (time to first event, assessed for up to 70 weeks)
D: Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure
Brief Summary: The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnea. Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control group is 35% in the first year. It is assumed that the hazard rate is constant over time.


Options:
A: improvement of isovolumetric relaxation time (30 minutes)
B: Left ventricular ejection fraction confirmed by echocardiography (three months)
C: Global Rank Endpoint (Baseline, 6 months)
D: All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation (time to first event, assessed for up to 70 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure
Brief Summary: The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnea. Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control group is 35% in the first year. It is assumed that the hazard rate is constant over time.


Options:
A: The Proportion of Participants Experiencing a Reduction in Apnea-hypopnea Index (AHI) (6 months); Freedom From Related Serious Adverse Events Within 12 Months (12 months)
B: Changes in Apnea-Hypopnea Index as compared to baseline (0 month to 3 months)
C: exercise capacity (1 week); Quality of Life (1 week)
D: All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation (time to first event, assessed for up to 70 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-Blinded Randomized Multi-Center Trial to Evaluate the Efficacy and Durability of Myofascial Tissue Manipulation in Women With Interstitial Cystitis/Painful Bladder Syndrome
Brief Summary: There are many different treatments that doctors recommend for patients with IC/PBS. Only a few research studies have been done to evaluate treatments given to patients. Treatment choices can be of two types: drug therapy and non-drug therapy. The two treatments used in this study will be of the non-drug therapy type. One of the treatments being used in this study is called Myofascial Tissue Manipulation. This is a kind of physical therapy that is designed to work on specific muscles and tissue layers in a particular part of the body. In this study, this treatment will focus on the areas around the pelvis and the pelvic floor. The treatment will involve the physical therapist's use of hands and fingers to target specific muscles and tissues located within your pelvis, rectum, and/or vagina (the pelvic floor) as well as muscles and layers of tissue in your abdomen and legs. The other treatment being used in this study is Global Therapeutic Massage. This treatment involves the physical therapist's use of classic Western body massage techniques on the muscles of your arms, legs, hands, neck, shoulders, back, stomach, buttocks, and feet to create an overall feeling of well being.

The purpose of this research study is to find out if Pelvic Physical Therapy is safe and effective on treating symptoms in women with interstitial cystitis as compared to a full body therapeutic massage. This study will also measure the lasting effects of the treatment up to 3 months after your last study treatment.


Options:
A: Proportion of responders moderately or markedly improved on a 7-point global response assessment (GRA) scale (12 Weeks)
B: Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2 (12 weeks)
C: Change of the O'Leary-Sant symptom score (OSS, including ICSI and ICPI) (Baseline and 1 month)
D: Change of the O'Leary-Sant symptom score (Baseline and 1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders
Brief Summary: The purpose of this study is to determine whether there is increased oral contraceptive pill (OCP) adherence in women receiving daily text messaging reminders to take their OCP, compared to women who do not receive reminders. The investigators hypothesize that women who receive daily text messaging reminders to take their OCP will have increased pill adherence compared to women who do not receive reminders.

The investigators also hope to determine whether there is a difference in OCP adherence as measured by electronic monitoring device and wireless real-time data collection versus traditional patient pill diaries. The investigators hypothesize that electronic monitoring device and wireless real-time data collection will demonstrate lower adherence compared to traditional patient pill diaries.


Options:
A: Acceptability of at least one method of effective contraception (4 months)
B: Average number of missed pills per cycle (3 months)
C: Initiation of highly effective contraception, as defined by the World Health Organization. (3 months after initial enrollment)
D: Smoking status by collecting an expired carbon monoxide breath sample (3-Month Follow-Up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders
Brief Summary: The purpose of this study is to determine whether there is increased oral contraceptive pill (OCP) adherence in women receiving daily text messaging reminders to take their OCP, compared to women who do not receive reminders. The investigators hypothesize that women who receive daily text messaging reminders to take their OCP will have increased pill adherence compared to women who do not receive reminders.

The investigators also hope to determine whether there is a difference in OCP adherence as measured by electronic monitoring device and wireless real-time data collection versus traditional patient pill diaries. The investigators hypothesize that electronic monitoring device and wireless real-time data collection will demonstrate lower adherence compared to traditional patient pill diaries.


Options:
A: Immunization coverage (12 months); Timeliness of receipt of scheduled immunization (12 months)
B: Average number of missed pills per cycle (3 months)
C: Acceptability of at least one method of effective contraception (4 months)
D: Vaccines received (Electronic Health Record) (up to a year of follow up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders
Brief Summary: The purpose of this study is to determine whether there is increased oral contraceptive pill (OCP) adherence in women receiving daily text messaging reminders to take their OCP, compared to women who do not receive reminders. The investigators hypothesize that women who receive daily text messaging reminders to take their OCP will have increased pill adherence compared to women who do not receive reminders.

The investigators also hope to determine whether there is a difference in OCP adherence as measured by electronic monitoring device and wireless real-time data collection versus traditional patient pill diaries. The investigators hypothesize that electronic monitoring device and wireless real-time data collection will demonstrate lower adherence compared to traditional patient pill diaries.


Options:
A: Measurement of contraceptive adherence (12 months); Measurement of dual method use (12 months); Measurement of pregnancy rates and sexually transmitted diseases (STDs) (12 months)
B: N/A
C: Average number of missed pills per cycle (3 months)
D: Contraceptive Use (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders
Brief Summary: The purpose of this study is to determine whether there is increased oral contraceptive pill (OCP) adherence in women receiving daily text messaging reminders to take their OCP, compared to women who do not receive reminders. The investigators hypothesize that women who receive daily text messaging reminders to take their OCP will have increased pill adherence compared to women who do not receive reminders.

The investigators also hope to determine whether there is a difference in OCP adherence as measured by electronic monitoring device and wireless real-time data collection versus traditional patient pill diaries. The investigators hypothesize that electronic monitoring device and wireless real-time data collection will demonstrate lower adherence compared to traditional patient pill diaries.


Options:
A: contraceptive continuation (6 months)
B: Adherence to ART and HIV RNA suppression (6,12 months)
C: Average number of missed pills per cycle (3 months)
D: Use of a Effective Contraceptive Method at Four-months Post-abortion (4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders
Brief Summary: The purpose of this study is to determine whether there is increased oral contraceptive pill (OCP) adherence in women receiving daily text messaging reminders to take their OCP, compared to women who do not receive reminders. The investigators hypothesize that women who receive daily text messaging reminders to take their OCP will have increased pill adherence compared to women who do not receive reminders.

The investigators also hope to determine whether there is a difference in OCP adherence as measured by electronic monitoring device and wireless real-time data collection versus traditional patient pill diaries. The investigators hypothesize that electronic monitoring device and wireless real-time data collection will demonstrate lower adherence compared to traditional patient pill diaries.


Options:
A: MEMS Adherence (12 months follow up)
B: Linkage to care for HIV infected persons not on treatment following a point-of care CD4 count compared to referral to clinic for CD4 testing (Up to 12 Months); Uptake of male circumcision referral among HIV-uninfected men with either promotion at point of HIV testing, SMS follow-up or lay-counselor follow-up visits (Up to 9 months); Linkage to care for HIV infected persons after lay counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinic referral (Up to 12 months)
C: Average number of missed pills per cycle (3 months)
D: Complications detected (3 days after delivery); Successful referrals (10 days after delivery (survey and administrative records)); Care Seeking Behavior around complications and well baby check-up (10 days after delivery (survey)); Knowledge of danger signs (10 days after delivery (survey)); Breastfeeding (10 days and 9 weeks after delivery (survey))

Answer: C