TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: For cancer patients with inadequate pain relief, a switch to an alternative opioid is the preferred option for symptomatic improvement. However, multiple opioids are often simultaneously administered for anecdotal reasons.

The present study isdesigned to assess the analgesic profiles of two different strategies in chronic cancer pain: the opioid rotation from oxycodone to transdermal fentanyl and the combination of oral oxycodone and transdermal fentanyl.


Options:
A: Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale (within 15 days)
B: Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5. (5 days)
C: Change in pain score and treatment success
D: Proportion of Non-Responder (NR) Participants (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: For cancer patients with inadequate pain relief, a switch to an alternative opioid is the preferred option for symptomatic improvement. However, multiple opioids are often simultaneously administered for anecdotal reasons.

The present study isdesigned to assess the analgesic profiles of two different strategies in chronic cancer pain: the opioid rotation from oxycodone to transdermal fentanyl and the combination of oral oxycodone and transdermal fentanyl.


Options:
A: Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale (within 15 days)
B: Proportion of Non-Responder (NR) Participants (28 days)
C: Efficacy variable: Bowel Function Index (BFI) score. Amount of laxative medication use recorded at each assessment visit (4 weeks and a 6 month open label); Efficacy variable: Brief Pain Inventory Short-Form (BPI-SF) (Cleeland, 1991). Amount of analgesic rescue medication used (4 weeks and a 6 month open label)
D: Change in pain score and treatment success

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Parallel-Group Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease
Brief Summary: The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with moderate to severe Alzheimer's disease.


Options:
A: Change From Baseline to Week 24 in SIB Total Score (Baseline and Week 24); Overall Change From Baseline in Modified CIBIC+ to Week 24 (Baseline and Week 24)
B: Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain. (6 months)
C: Change in cognition and function after 24 weeks.
D: Polysomnography parameters: sleep structure, respiratory, limb movements (onset, 3 and 6 months of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Parallel-Group Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease
Brief Summary: The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with moderate to severe Alzheimer's disease.


Options:
A: Change From Baseline to Week 24 in SIB Total Score (Baseline and Week 24); Overall Change From Baseline in Modified CIBIC+ to Week 24 (Baseline and Week 24)
B: Change in the Paced Auditory Serial Addition Test and the California Verbal Learning Test II (multivariate end-point) after 15 weeks of treatment.
C: to assess the efficacy of Memantine in improving memory deficit in MS patients using the SRT scale (6 months)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Cross-over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome
Brief Summary: The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than the current standard agent, clomifene citrate in anovular infertile women with polycystic ovarian syndrome.


Options:
A: Pregnancy rate (14 moths)
B: Ovulation Rate (3 months)
C: Live Birth (as few as 5 months, up to 16 months)
D: Live birth rate (Up to 18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Cross-over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome
Brief Summary: The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than the current standard agent, clomifene citrate in anovular infertile women with polycystic ovarian syndrome.


Options:
A: Live Birth (as few as 5 months, up to 16 months)
B: Live birth rate (Up to 18 months)
C: Live birth rate (Up to 14 months)
D: Pregnancy rate (14 moths)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Gilles de la Tourette Syndrome by Bilateral Stimulation of the Internal Part of the Globus PALLIDUS
Brief Summary: The aim of this study is to evaluate the efficacy and safety of bilateral pallidal stimulation in patients with a severe form of Gilles de la Tourette syndrome.


Options:
A: To evaluate the therapeutic effect of the high frequency bilateral stimulation of GPI in severe forms and invalidating MGT, in a protocol randomized as a double blind man in parallel groups. (during the 44 months); The assumption tested is that of the frank improvement (> 60% on scale YGTSS) of the symptoms of the MGT by the bilateral stimulation of GPI in its former part. (at the end of 44 months)
B: Severity of tics
C: Change in Yale Global Tic Severity Scale (Three months after stimulation switched ON v three months after stimulation switched OFF)
D: Number of Participants With a 40% Reduction in Total Tics on the Yale Global Tic Severity Scale (YGTSS) With CDBS (Period 1) (Baseline to 6 months post-surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intraoperative Fluid Management Based on Arterial Pulse Pressure Variation During High-Risk Surgery
Brief Summary: Hypovolaemia and tissue hypoperfusion can pass undetected during and after major surgery. The resulting systemic inflammatory response and organ dysfunction, often not clinically apparent for several days, may lead to increased morbidity and mortality and prolonged hospital stay.

In this regard, intraoperative optimization of circulatory status by volume loading has been shown to improve the outcome of patients undergoing high-risk surgery.

Indeed, several reports (1-7) have shown that monitoring and maximizing stroke volume by volume loading (until stroke volume reaches a plateau, actually the plateau of the Frank-Starling curve) during high-risk surgery decreases the incidence of post-operative complications and the length of hospital stay.

Unfortunately, this strategy has required so far the measurement of stroke volume by a cardiac output monitor, as well as a specific training period for the operators (8), and hence is not applicable in many institutions as well as in many countries.

The arterial pulse pressure variation (∆PP) induced by mechanical ventilation is known to be a very accurate predictor of fluid responsiveness, i.e. of the position on the preload/stroke volume relationship (Frank-Starling curve) (9).

By increasing cardiac preload, volume loading induces a rightward shift on the preload/stroke volume relationship and hence a decrease in ∆PP. Patients who have reached the plateau of the Frank-Starling relationship can be identified as patients in whom ∆PP is low (9).

Therefore, the clinical and intraoperative goal of "maximizing stroke volume by volume loading" can be achieved simply by minimizing ∆PP.

We designed the present study to investigate whether monitoring and minimizing ∆PP by volume loading during high-risk surgery may improve post-operative outcome and decrease the duration of post-operative hospital stay.


Options:
A: Composite of morbidity and mortality on day 28 (28 days)
B: The primary outcome measure is the duration of postoperative hospital stay. (at days 1,2, and 5, as well as at ICU discharge, and hospital discharge.)
C: incidence of intraoperative hypovolemia (intraoperative)
D: The volume of crystalloid solutions administered intraoperatively. (Start of Anesthesia until the doppler is removed at the end of surgery, approximately 8 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Study of Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm
Brief Summary: Combined the chemoembolization and Radiofrequency ablation for the hepatocellular carcinoma greater than 3 cm,the ablation volume of coagulation necrosis can be significantly increased,which may be enable effective treatment of patients with HCC greater than 3 cm.


Options:
A: overall survival (5 years)
B: Time to Progression (TTP). (Patients will be followed over a 2 years period.)
C: Overall Survival (OS) (from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment); Time to Symptomatic Progression (TTSP) (from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment)
D: Time to Progression (TTP) - Independent Radiological Review (Primary Analysis) (From randomization of the first participant until 28 months later (cut-off date))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Dementia Home Care Project: a Randomised Controlled Trial to Evaluate the Effectiveness of a Home Care Program for Supporting Caregivers of Persons With Dementia in Developing Countries: a Randomised Controlled Trial From Goa, India
Brief Summary: The aim of this trial was to apply a home based, flexible, stepped-care intervention designed to improve the awareness and knowledge of family caregivers regarding dementia, to maximise their caregiving resources and to improve their caregiving skills. A Randomized Controlled Trial (RCT) will be used to evaluate the same wherein the intervention group will get the services immediately and the control arm would receive the same after a period of 6 months.


Options:
A: Feasibility as assessed through the John Hopkins Implementation and Dissemination Science Scale (Immediately after the intervention); Acceptability as assessed through the John Hopkins Implementation and Dissemination Science Scale (Immediately after the intervention)
B: Change from baseline Mental health distress at 18 months (Baseline and 18 months post baseline)
C: Primary Outcome Measure(s) evaluate the efficacy and cost-effectiveness of the intervention in reducing carer burden, improving behaviour problems in elderly persons with dementia and reducing the costs of illness. (by the end of the study)
D: Psychiatric diagnosis at 6-month follow-up (6-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Dementia Home Care Project: a Randomised Controlled Trial to Evaluate the Effectiveness of a Home Care Program for Supporting Caregivers of Persons With Dementia in Developing Countries: a Randomised Controlled Trial From Goa, India
Brief Summary: The aim of this trial was to apply a home based, flexible, stepped-care intervention designed to improve the awareness and knowledge of family caregivers regarding dementia, to maximise their caregiving resources and to improve their caregiving skills. A Randomized Controlled Trial (RCT) will be used to evaluate the same wherein the intervention group will get the services immediately and the control arm would receive the same after a period of 6 months.


Options:
A: Neuropsychiatric Inventory; Cornell Depression in Dementia Scale; Activities of Daily Living
B: Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI) (24 months)
C: 1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);; 2. performance scores in daily activities of the patients on the Interview of Deterioration in Daily Activities in Dementia (IDDD);; 3. Sense of competence scores of the primary caregivers on the Sense of Competence Questionnaire (SCQ).
D: Primary Outcome Measure(s) evaluate the efficacy and cost-effectiveness of the intervention in reducing carer burden, improving behaviour problems in elderly persons with dementia and reducing the costs of illness. (by the end of the study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Dementia Home Care Project: a Randomised Controlled Trial to Evaluate the Effectiveness of a Home Care Program for Supporting Caregivers of Persons With Dementia in Developing Countries: a Randomised Controlled Trial From Goa, India
Brief Summary: The aim of this trial was to apply a home based, flexible, stepped-care intervention designed to improve the awareness and knowledge of family caregivers regarding dementia, to maximise their caregiving resources and to improve their caregiving skills. A Randomized Controlled Trial (RCT) will be used to evaluate the same wherein the intervention group will get the services immediately and the control arm would receive the same after a period of 6 months.


Options:
A: Change in Health of Nations Outcomes Scale (HoNOS) score from baseline (Baseline, 6 months and 12 months); Change in Clinical Interview Schedule Revised (CIS-R) score from baseline (Baseline, 6 months and 12 months)
B: Rate of Maternal HIV Viral Suppression (Two months post pregnancy); Mean Maternal Antiretroviral (ART) Adherence (Past 6 months, assessed at 2 months after the completion of pregnancy); Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention (through study completion, an average of 48 weeks); Rate of Delivery in Health Facility (two months post pregnancy); Rate of Infant Use of ART (First 6 weeks of life)
C: Post Traumatic Stress Disorder- Reaction Index (RI) (Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.)
D: Primary Outcome Measure(s) evaluate the efficacy and cost-effectiveness of the intervention in reducing carer burden, improving behaviour problems in elderly persons with dementia and reducing the costs of illness. (by the end of the study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of Extended-release (ER) Niacin/Laropiprant in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia.
Brief Summary: This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.


Options:
A: Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.
B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12 (Baseline and 12 Weeks)
C: N/A
D: Antioxidative Properties of Endothelial Progenitor Cells (3 months); FDD (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multi-centre, Randomised, Double-blind Comparison of Intravenous Dexmedetomidine With Propofol for Continuous Sedation of Ventilated Patients in Intensive Care Unit
Brief Summary: Patients in the ICU who need help with their breathing are put onto a machine called a ventilator and are also given a medicine, called a sedative, which helps them to sleep and makes them more comfortable. Propofol is a sedative that is routinely used for these purposes.

For most patients the aim of sedation is to make them sleepy but still able to respond to nursing staff (light sedation).

Dexmedetomidine is a new sedative for use in intensive care and in this clinical study,dexmedetomidine is compared to propofol. It is thought that dexmedetomidine might be slightly better at allowing patients to be sleepy but still respond to people around them. It also does not appear to affect patient's breathing. The purpose of this study is to test whether dexmedetomidine really does have these advantages compared to propofol.

In this study, we hope to show that: dexmedetomidine is at least as good as propofol in helping patients to sleep better and making them more comfortable, and that they are able to communicate and cooperate better with the staff treating them, and that patients treated with dexmedetomidine require a shorter time on the ventilator than those treated with propofol.


Options:
A: Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion (During study drug administration (6 to 24 hours))
B: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required. (2 hourly and before each rescue treatment dose during the treatment period and the 48-hour follow-up); Duration of mechanical ventilation (Start and stop times of mechanical ventilation while the patient is treated in the ICU)
C: Percent of Subjects Requiring Rescue Midazolam for Sedation (During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).)
D: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required (RASS score will be assessed approximately 2 hourly during the treatment period and during the 48-hour follow-up period); Duration of mechanical ventilation the number of days the patient receives mechanical ventilation will be recorded (This variable will be dependent on the individual patient and the number of days they require mechanical ventilation .)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multi-centre, Randomised, Double-blind Comparison of Intravenous Dexmedetomidine With Propofol for Continuous Sedation of Ventilated Patients in Intensive Care Unit
Brief Summary: Patients in the ICU who need help with their breathing are put onto a machine called a ventilator and are also given a medicine, called a sedative, which helps them to sleep and makes them more comfortable. Propofol is a sedative that is routinely used for these purposes.

For most patients the aim of sedation is to make them sleepy but still able to respond to nursing staff (light sedation).

Dexmedetomidine is a new sedative for use in intensive care and in this clinical study,dexmedetomidine is compared to propofol. It is thought that dexmedetomidine might be slightly better at allowing patients to be sleepy but still respond to people around them. It also does not appear to affect patient's breathing. The purpose of this study is to test whether dexmedetomidine really does have these advantages compared to propofol.

In this study, we hope to show that: dexmedetomidine is at least as good as propofol in helping patients to sleep better and making them more comfortable, and that they are able to communicate and cooperate better with the staff treating them, and that patients treated with dexmedetomidine require a shorter time on the ventilator than those treated with propofol.


Options:
A: PONV During the First 24 Hours After Bariatric Surgery (24 hours)
B: administered doses of propofol and of remifentanil during anesthesia (end of anesthesia)
C: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required (RASS score will be assessed approximately 2 hourly during the treatment period and during the 48-hour follow-up period); Duration of mechanical ventilation the number of days the patient receives mechanical ventilation will be recorded (This variable will be dependent on the individual patient and the number of days they require mechanical ventilation .)
D: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required. (2 hourly and before each rescue treatment dose during the treatment period and the 48-hour follow-up); Duration of mechanical ventilation (Start and stop times of mechanical ventilation while the patient is treated in the ICU)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multi-centre, Randomised, Double-blind Comparison of Intravenous Dexmedetomidine With Propofol for Continuous Sedation of Ventilated Patients in Intensive Care Unit
Brief Summary: Patients in the ICU who need help with their breathing are put onto a machine called a ventilator and are also given a medicine, called a sedative, which helps them to sleep and makes them more comfortable. Propofol is a sedative that is routinely used for these purposes.

For most patients the aim of sedation is to make them sleepy but still able to respond to nursing staff (light sedation).

Dexmedetomidine is a new sedative for use in intensive care and in this clinical study,dexmedetomidine is compared to propofol. It is thought that dexmedetomidine might be slightly better at allowing patients to be sleepy but still respond to people around them. It also does not appear to affect patient's breathing. The purpose of this study is to test whether dexmedetomidine really does have these advantages compared to propofol.

In this study, we hope to show that: dexmedetomidine is at least as good as propofol in helping patients to sleep better and making them more comfortable, and that they are able to communicate and cooperate better with the staff treating them, and that patients treated with dexmedetomidine require a shorter time on the ventilator than those treated with propofol.


Options:
A: Time From Study Drug Initiation to Tracheal Extubation (Duration of ICU stay, for up to 24 weeks)
B: Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target range; Time from ICU admission to discharge
C: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required. (2 hourly and before each rescue treatment dose during the treatment period and the 48-hour follow-up); Duration of mechanical ventilation (Start and stop times of mechanical ventilation while the patient is treated in the ICU)
D: The percentage of time spent within the protocol specified sedation range (Richmond Agitation-Sedation Scale [RASS] range of -2 to +1) (Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion)

Answer: C