TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Telehealth Intervention Combining Structured Self-Monitoring of Blood Glucose and Nurse Care Coordination Among People With Type 2 Diabetes Noninsulin-Treated
Brief Summary: Telehealth remote patient monitoring is a means of using communications technology - such as telephones, computers, and the Internet - to connect patients remotely with their healthcare team from their homes. The investigators hope to learn more about improving healthy behaviors and blood glucose among persons with diabetes using telehealth remote patient monitoring technology to connect directly with nurse care coordinators.

The purpose of this study is to evaluate a process for improving blood glucose and healthy behaviors among people with type 2 diabetes using telehealth remote patient monitoring technology with nurse care coordinators. Some of the people in this study will work with a nurse care coordinator who will review your blood glucose weekly and call you at home every month for 3 months, while some of the people in this study will simply receive their normal care. At the end of the study, every participant will be asked questions about how they feel about their health care.


Options:
A: Diabetes Control (Baseline, 3months, 6months)
B: Outcome and process measures from the danish diabetes guideline (1/3 2007-1/6 2008)
C: Multiple CVD risk factor control targets (42 months after randomization)
D: Hemoglobin A1c (Change from baseline to 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder
Brief Summary: The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD


Options:
A: N/A
B: Montgomery and Asberg Scale for Depression (8 weeks)
C: Change in a depression rating scale at endpoint
D: Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period (Baseline (Week 8)); Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period (Baseline (Week 8) to Week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravenous Administration of Autoserum-cultured Autologous Mesenchymal Stem Cells in Ischemic Stroke: A Single Center, Randomized, Open Label, Prospective, Phase 3 Study
Brief Summary: The objectives of this study was to test hypothesis that ischemic stroke patients having moderate to severe persistent neurologic deficit will have better outcomes with intravenous transplantation of autologous mesenchymal stem cells (MSCs) expanded with autologous serum that is obtained at acute phase of stroke than patients receiving standard treatment.


Options:
A: Barthel index score (six month post randomization)
B: Absence of new neurological deficits and adverse effects during the timeframe. (Duration of study)
C: Functional Independence Measure (6 months)
D: Categorical shift in modified Rankin scale (mRS) (90 days after the cell treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: In recent years medicine has been enhanced by the incorporation of technological innovations from areas as diverse as cell biology, biochemistry, genetics, biophysics and bioengineering. One of the few exceptions in this rapid process of implementing technological advances occurs in clinical medicine, where its penetration is much less effective than in other scientific and professional fields, or even in everyday life. Attempts to tackle this problem have given rise to various initiatives in the US and Europe, including Spain.

There is a surprising paucity of telemedicine systems in clinical practice, especially with respect to sleep-related breathing disorders, and most particularly obstructive sleep apnea (OSA), where protocols are urgently needed to alleviate this healthcare problem represented by its under-diagnosis and comorbidity, as well as the long waiting lists for treatment. In others words, the growing awareness of sleep disorders, especially OSA, has not been accompanied by strategic changes in the cost-effective diagnosis and/or treatment of these diseases.

CPAP therapy compliance is not always appropriate. Helping patients during the first two months usually determines compliance. Therefore, the development of strategies to support the patient during the first weeks is essential. However, this "collides" with reality, where it is difficult to properly care all patients because of congested sleep units. It is therefore necessary to implement new and imaginative control schemes especially at the beginning of the treatment. Patients' follow-up performed by telemedicine technology is an option that aims to substitute the face-to-face visits or at least reduce them considerably. In a future context, the idea is that the professional in charge of CPAP patients monitoring has on his/her agenda face-to-face visits and televisits (at distance) and information which patient will provide through online questionnaires with a certain frequency.

In this sense, this project aims to analyze whether CPAP treatment compliance of OSA patients monitored by telemedicine techniques (website and televisits) is similar to that achieved by standard monitoring but more cost-effective. The study design is a multicenter randomized trial with parallel groups and blind final evaluation after CPAP treatment following two different strategies: one through conventional monitoring in the hospital (face-to-face visiting) and another by telemedicine monitoring (non-contact visiting and website).


Options:
A: proportion using CPAP within 48-hours of stroke onset (72 hours)
B: CPAP adherence at 3 months (3 months)
C: CPAP compliance (6 months); Cost-effectiveness (6 months); Quality of life (6 months)
D: Home Arterial Blood Pressure (Home arterial Blood Pressure is assessed at week 1); Home Arterial Blood Pressure (Home arterial Blood Pressure is assessed at week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of NCI Supplied Cabozantinib (NSC #761968) Versus Weekly Paclitaxel (NSC #673089) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Brief Summary: This randomized phase II trial studies how well giving cabozantinib-s-malate or paclitaxel works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether cabozantinib-s-malate or paclitaxel is more effective at treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer.


Options:
A: Event Free Survival (The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks)
B: Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)); Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months))
C: overall survival (18 months)
D: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of NCI Supplied Cabozantinib (NSC #761968) Versus Weekly Paclitaxel (NSC #673089) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Brief Summary: This randomized phase II trial studies how well giving cabozantinib-s-malate or paclitaxel works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether cabozantinib-s-malate or paclitaxel is more effective at treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer.


Options:
A: Overall Survival (Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.)
B: overall survival (ten years)
C: To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin (Once 244 planned pts. received at least 2 cycles of study treatment(s))
D: Event Free Survival (The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of NCI Supplied Cabozantinib (NSC #761968) Versus Weekly Paclitaxel (NSC #673089) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Brief Summary: This randomized phase II trial studies how well giving cabozantinib-s-malate or paclitaxel works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether cabozantinib-s-malate or paclitaxel is more effective at treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer.


Options:
A: Event Free Survival (The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks)
B: 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 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018)
C: Complete response rate (average 24 months)
D: Radiographic imaging and clinical evaluation will be used for tumor assessment (every 6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen MK-5172 and MK-8742 ± Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection
Brief Summary: This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the treatment arms.


Options:
A: Percentage of Participants Achieving Sustained Virologic Response (SVR)12 (Posttreatment Week 12); Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 12)
B: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12) (12 weeks after end of therapy (up to 30 weeks)); Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days (From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)); Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days (From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks))
C: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate (12 weeks after last dose of study drug)
D: Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2 (Follow-up Week 24); Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3 (Follow-up Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen MK-5172 and MK-8742 ± Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection
Brief Summary: This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the treatment arms.


Options:
A: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12) (12 weeks after end of therapy (up to 30 weeks)); Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days (From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)); Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days (From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks))
B: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 12 weeks)
C: Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication (Up to Week 72)
D: Percentage of Participants With Sustained Viral Response (SVR) at Week 72 (Week 72)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Basilar Artery International Cooperation Study
Brief Summary: Rationale: Recently our study group reported the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic basilar artery occlusion (BAO). Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely. Furthermore, the often-held assumption that intra-arterial thrombolysis (IAT) is superior to intravenous thrombolysis (IVT) in patients with an acute symptomatic BAO is challenged by our data. The BASICS registry was observational and has all the limitations of a non-randomised study. Interpretation of results is hampered by the lack of a standard treatment protocol for all patients who entered the study.

Objective: Evaluate the efficacy and safety of IAT in addition to best medical management (BMM) in patients with basilar artery occlusion.

Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial.

Study population: Patients, aged 18 years and older, with CTA or MRA confirmed basilar occlusion.

Intervention: Patients will be randomised between BMM with additional IAT versus BMM alone. IAT has to be initiated within 6 hours from estimated time of BAO. If treated with as part of BMM, IVT should be started within 4.5 hours of estimated time of BAO.

Main study parameters/endpoints: Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.


Options:
A: Rate of patients with intracranial hemorrhagic complications (Scan performed between 24 and 36 hours after thrombectomy)
B: Rate of Good Functional Outcomes Measured by Modified Rankin Score (mRS) (90 days)
C: Level of disability (90 days (3 months))
D: Favourable outcome (day 90)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Basilar Artery International Cooperation Study
Brief Summary: Rationale: Recently our study group reported the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic basilar artery occlusion (BAO). Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely. Furthermore, the often-held assumption that intra-arterial thrombolysis (IAT) is superior to intravenous thrombolysis (IVT) in patients with an acute symptomatic BAO is challenged by our data. The BASICS registry was observational and has all the limitations of a non-randomised study. Interpretation of results is hampered by the lack of a standard treatment protocol for all patients who entered the study.

Objective: Evaluate the efficacy and safety of IAT in addition to best medical management (BMM) in patients with basilar artery occlusion.

Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial.

Study population: Patients, aged 18 years and older, with CTA or MRA confirmed basilar occlusion.

Intervention: Patients will be randomised between BMM with additional IAT versus BMM alone. IAT has to be initiated within 6 hours from estimated time of BAO. If treated with as part of BMM, IVT should be started within 4.5 hours of estimated time of BAO.

Main study parameters/endpoints: Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.


Options:
A: Modified Rankin Scale 0-1 (90 days after stroke onset)
B: Favourable outcome (day 90)
C: Rate of Good Functional Outcomes Measured by Modified Rankin Score (mRS) (90 days)
D: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimal Prevention of Overdose Deaths and Opioid Relapse Following Discharge: A Multi-Center RCT of Naltrexone Versus Buprenorphine in Norway
Brief Summary: Persons dependent on opioids like heroin, morphine, or codeine have a high risk of relapse, overdose and overdose death. This risk is elevated even further following discharge from treatment or correctional institutions where patients have been detoxified. At the moment, state-of-the-art treatment is based on maintaining the dependence on opioids by daily intake of opioid medications like methadone or buprenorphine. Recently, a medication containing the blocking agent naltrexone was approved in the US; this does not maintain dependence but instead blocks heroin and other opioids for 28 days after intramuscular administration. This study will conduct a 12-week randomized comparison of naltrexone intramuscular suspension (XL-NTX) with daily buprenorphine-naloxone in OMT. Medication will start preceding discharge from a treatment or correctional facility to participating catchment regions in Norway. The main hypotheses are that XL-NTX will do equally well as - or better than - OMT on the proportion of biological samples negative for opioids, retention, self-reported use of alcohol and illicit drugs. Following the 12-week randomized period, there will be a 36-week period where participants can receive the study medication of their choice. After the end of the study, data from national registry databases can be collected for a further 12 months on outcomes such as recidivism, mortality and morbidity.


Options:
A: unmet need (past 6 months); abstinent from alcohol and opioid use, past 30 days (past 30 days); negative consequences related to substance use (past 3 months); Functioning (past 4 weeks); Engagement (30 days of initiation); initiation (Within 14 days of index visit); heavy alcohol use (6 months)
B: Number of biological samples negative/positive for opioid agonists (Week 1-12 post discharge); Retention (Week 1-12 post discharge); Days of use or abstinence from opioids (Week 1-12 post discharge)
C: Opiate abstinence
D: The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 (12 weeks); The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment (12 weeks in Phase 2 period (i.e., 24 weeks into the study))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of Macronutrient Diet Composition on Maternal and Infant Metabolic Outcomes in Gestational Diabetes
Brief Summary: A better understanding of the optimal diet for women with gestational diabetes is fundamental to the management of this rapidly growing problem in pregnancy. Careful comparison studies of the current low- carbohydrate, higher-fat diet versus a diet higher in complex carbohydrate but lower in fat is critical in order to determine which diet results in a more favorable maternal 24-hour glucose, lipid, and inflammatory profile, all of which directly effect optimal fetal growth and may influence the future health of the offspring.


Options:
A: 3rd trimester glycated hemoglobin (3rd trimester of pregnancy); total maternal weight gain (during pregnancy); severe maternal hypoglycemia (from enrollment to delivery); preeclampsia (during pregnancy or puerperium); cesarean section (at the end of pregnancy); gestational age at birth (at birth); preterm birth (at birth); birthweight (at birth); macrosomia (at birth); large-for-gestational age newborn (at birth); small-for-gestational age newborn (at birth); neonatal hypoglycemia (in the neonatal period); perinatal mortality (in the perinatal period); insulin treatment (from enrollment to delivery)
B: Need of insulin treatment for GDM (Day of delivery)
C: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
D: Glucose area-under-the-curve (During 3 days of each diet treatment)

Answer: D