TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Rheumatologists are discussing, whether rehabilitation of patients with low back pain (LBP) can be improved. At present patients with LBP start treatment as soon as possible, this also applies for patients with chronic low back pain (CLBP) - pain lasting over 12 weeks. At Glostrup University Hospital department of Physical Medicine/rheumatology we use a method (method A) where an interdisciplinary team gives the patients a treatment composed of various topics. This includes among other things education, physical team training, exercises in swimming pool, stretching exercises, and occupational therapy. A different method (method B) originates from the Rehabilitation centre in Karlslunde led by Teddy Oefeldt. Here they focus strictly on dynamic training of muscles in the back and the buttocks. A therapist, who in the beginning partly carries the patient through the exercises, assists this training.

In both methods, individually considerations are taken, but to a greater extend in method B. The treatment will extend over a three months period.

A few earlier investigations have compared these two methods, but they have not been systematized to such a degree, that they gave any final conclusions. Therefore, we initialized an investigation including a larger number of patients, where the two methods are compared from the results the patients achieve after 3, 6, 12 and 24 months.

286 consecutive patients were included and randomized to one of the two methods. Those, who did not wish to participate in the investigation, were treated according to the department's normal procedure (Method A)


Options:
A: Muscle activity onset in transversus abdominal muscle (1 year)
B: Pain VAS
C: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)
D: Pain Intensity (2 months after randomisation); Disability (2 months after randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Rheumatologists are discussing, whether rehabilitation of patients with low back pain (LBP) can be improved. At present patients with LBP start treatment as soon as possible, this also applies for patients with chronic low back pain (CLBP) - pain lasting over 12 weeks. At Glostrup University Hospital department of Physical Medicine/rheumatology we use a method (method A) where an interdisciplinary team gives the patients a treatment composed of various topics. This includes among other things education, physical team training, exercises in swimming pool, stretching exercises, and occupational therapy. A different method (method B) originates from the Rehabilitation centre in Karlslunde led by Teddy Oefeldt. Here they focus strictly on dynamic training of muscles in the back and the buttocks. A therapist, who in the beginning partly carries the patient through the exercises, assists this training.

In both methods, individually considerations are taken, but to a greater extend in method B. The treatment will extend over a three months period.

A few earlier investigations have compared these two methods, but they have not been systematized to such a degree, that they gave any final conclusions. Therefore, we initialized an investigation including a larger number of patients, where the two methods are compared from the results the patients achieve after 3, 6, 12 and 24 months.

286 consecutive patients were included and randomized to one of the two methods. Those, who did not wish to participate in the investigation, were treated according to the department's normal procedure (Method A)


Options:
A: Pain (6 weeks); Functional Disability (6 weeks)
B: Selfrated function, symptoms and pain-rating (8 weeks, 6 month, 12 month)
C: Pain VAS
D: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Rheumatologists are discussing, whether rehabilitation of patients with low back pain (LBP) can be improved. At present patients with LBP start treatment as soon as possible, this also applies for patients with chronic low back pain (CLBP) - pain lasting over 12 weeks. At Glostrup University Hospital department of Physical Medicine/rheumatology we use a method (method A) where an interdisciplinary team gives the patients a treatment composed of various topics. This includes among other things education, physical team training, exercises in swimming pool, stretching exercises, and occupational therapy. A different method (method B) originates from the Rehabilitation centre in Karlslunde led by Teddy Oefeldt. Here they focus strictly on dynamic training of muscles in the back and the buttocks. A therapist, who in the beginning partly carries the patient through the exercises, assists this training.

In both methods, individually considerations are taken, but to a greater extend in method B. The treatment will extend over a three months period.

A few earlier investigations have compared these two methods, but they have not been systematized to such a degree, that they gave any final conclusions. Therefore, we initialized an investigation including a larger number of patients, where the two methods are compared from the results the patients achieve after 3, 6, 12 and 24 months.

286 consecutive patients were included and randomized to one of the two methods. Those, who did not wish to participate in the investigation, were treated according to the department's normal procedure (Method A)


Options:
A: Pain VAS
B: Oswestry Disability Index; Cost-effectiveness (full economic analysis)
C: N/A
D: Days with pain (Change from baseline to follow-up after 16 weeks); Physical functioning (Change from baseline to follow-up after 16 weeks); Role physical (Change from baseline to follow-up after 16 weeks); Bodily pain (Change from baseline to follow-up after 16 weeks); General health (Change from baseline to follow-up after 16 weeks); Vitality (Change from baseline to follow-up after 16 weeks); Social functioning (Change from baseline to follow-up after 16 weeks); Role emotional (Change from baseline to follow-up after 16 weeks); Mental health (Change from baseline to follow-up after 16 weeks); Disability (Change from baseline to follow-up after 16 weeks); Stress (Change from baseline to follow-up after 16 weeks); Well-being (Change from baseline to follow-up after 16 weeks); Use of prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of non-prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of conventional care (Change from baseline to follow-up after 16 weeks); Use of complementary care (Change from baseline to follow-up after 16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: LabAlert: Enhancing Medication Safety Through Electronic Interventions to Improve Medication Safety
Brief Summary: Errors and preventable adverse events associated with medication prescription and dispensing are common, and the difference between guideline recommendations and the actual frequency of laboratory monitoring is substantial. This study evaluates three interventions to improve laboratory monitoring at initiation of medication therapy: an electronic medical record reminder to the prescribing clinician (EMR), an automated voice message to the patient (AVM), and a pharmacy team outreach (Pharmacy) compared to usual care (UC).


Options:
A: rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period (after 30 days)
B: The number of patients that complete recommended laboratory monitoring within one week and twenty five days after intervention.; The study will evaluate the time to completion of the recommended labs.; The study will also evaluate PCP and patient experiences with the interventions in order to refine the interventions in the future.
C: Proportion of older ED patients who receive a potentially inappropriate medication (During discharge home from the ED)
D: rate of potentially inappropriate psychotropic medication (September 2008-July 2010)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: LabAlert: Enhancing Medication Safety Through Electronic Interventions to Improve Medication Safety
Brief Summary: Errors and preventable adverse events associated with medication prescription and dispensing are common, and the difference between guideline recommendations and the actual frequency of laboratory monitoring is substantial. This study evaluates three interventions to improve laboratory monitoring at initiation of medication therapy: an electronic medical record reminder to the prescribing clinician (EMR), an automated voice message to the patient (AVM), and a pharmacy team outreach (Pharmacy) compared to usual care (UC).


Options:
A: Usual Gait Speed (Baseline); Usual Gait Speed (3 month); Usual Gait Speed (12-month); Rapid Gait Speed (Baseline); Rapid Gait Speed (3-month); Rapid Gait Speed (12-month)
B: Proportion of women who exclusively breastfeed to 6 months (The outcome will be measured when the infant is 6-7 months old.)
C: The number of patients that complete recommended laboratory monitoring within one week and twenty five days after intervention.; The study will evaluate the time to completion of the recommended labs.; The study will also evaluate PCP and patient experiences with the interventions in order to refine the interventions in the future.
D: Child BMI

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: LabAlert: Enhancing Medication Safety Through Electronic Interventions to Improve Medication Safety
Brief Summary: Errors and preventable adverse events associated with medication prescription and dispensing are common, and the difference between guideline recommendations and the actual frequency of laboratory monitoring is substantial. This study evaluates three interventions to improve laboratory monitoring at initiation of medication therapy: an electronic medical record reminder to the prescribing clinician (EMR), an automated voice message to the patient (AVM), and a pharmacy team outreach (Pharmacy) compared to usual care (UC).


Options:
A: Blood pressure control (Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months)
B: Adherence to hypertension guidelines (Measured for two 6 month periods: the first is prior to the participant's enrollment in the study and the second is while the participant is enrolled in the study)
C: Medication adherence; Exacerbation of heart failure; Health-related quality of life
D: The number of patients that complete recommended laboratory monitoring within one week and twenty five days after intervention.; The study will evaluate the time to completion of the recommended labs.; The study will also evaluate PCP and patient experiences with the interventions in order to refine the interventions in the future.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Carbohydrate Portfolio or "Eco-Atkins" Diet
Brief Summary: Exchange of the butter, eggs, cheese and meat in the Atkins diet for soy protein foods, other vegetable proteins including gluten and vegetable fats, nuts, avocado, olive and canola oil will result in dramatic rather than modest reductions in blood lipids with weight loss. In effect this will represent an exchange of saturated fat and animal protein for healthy monounsaturated and polyunsaturated fats and vegetable proteins with significant effects on blood lipids while still encouraging weight loss.


Options:
A: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
B: total and low-density lipoprotein (LDL) cholesterol; LDL:HDL cholesterol ratio; weight reduction
C: hemoglobin A1C (diabetes management) (assessment at baseline (0 weeks)); hemoglobin A1C (diabetes management) (assessment at 10 weeks); hemoglobin A1C (diabetes management) (assessment at 20 weeks); hemoglobin A1C (diabetes management) (assessment at one-year follow-up); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assessment at baseline (0 weeks)); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assessment at 10 weeks); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assesment at 20 weeks); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assessment at one-year follow-up); body weight (assessment at baseline (0 weeks)); body weight (assessment at 10 weeks); body weight (assessment at 20 weeks); body weight (assessment at one-year follow-up); indices of renal function (serum creatinine, microalbumin) (assessment at baseline (0 weeks)); indices of renal function (serum creatinine, microalbumin) (assessment at 10 weeks); indices of renal function (serum creatinine, microalbumin) (assessment at 20 weeks); indices of renal function (serum creatinine, microalbumin) (assessment at one-year follow-up)
D: Hemoglobin A1c (22 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Metastatic (Stage IV) NSCLC
Brief Summary: This is a randomized, open label, parallel group, multi-centre, phase II study of progression free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.


Options:
A: To compare ZD1839 and vinorelbine in terms of progression free survival
B: Median Progression Free Survival (PFS) in Months (Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).)
C: To compare overall survival between ZD1839 and docetaxel
D: Progression Free Survival (PFS) by Investigator Assessment (RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Metastatic (Stage IV) NSCLC
Brief Summary: This is a randomized, open label, parallel group, multi-centre, phase II study of progression free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.


Options:
A: Progression-Free Survival (PFS) Time (Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression)
B: Progression Free Survival (12 months)
C: Progression free survival (12 months)
D: To compare ZD1839 and vinorelbine in terms of progression free survival

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma
Brief Summary: This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)


Options:
A: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1) (Up to 28 days in Cycle 1); Number of Participants Who Experienced an Adverse Event (AE) (Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)); Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)); ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015))
B: Disease Free Survival (Up to 2 years)
C: Arm C: Number of Participants With the Pathologic Response Rate (up to 2 years)
D: overall survival (August 2010)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients
Brief Summary: This study will test whether addition of imiquimod to standard antimony therapy provides a significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our previous results, we hypothesize that lesions in patients who receive the combined treatment of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and produce less scarring than treatment with pentavalent antimony alone.


Options:
A: Change of Lesion size (6 months)
B: Time to healing; Reduction of scaring
C: Occurrence of dose-limiting toxicity; Adverse events
D: Definitive cure (3 months after treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia
Brief Summary: The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.


Options:
A: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) (Baseline and Week 4)
B: Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Following First Treatment Cycle (Baseline and Week 4)
C: Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score (Cycle 1 - Baseline and week 4); Patient Global Impression of Change using the 7-point Likert scale (Cycle 1 - Baseline and week 4)
D: Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4. (4 weeks post-treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study Of Pitavastatin 1 Mg Vs. Pravastatin 10 Mg, Pitavastatin 2 Mg Vs. Pravastatin 20 Mg And Pitavastatin 4 Mg Vs. Pravastatin 40 Mg (Following Up-Titration) In Elderly Patients With Primary Hypercholesterolemia Or Combined Dyslipidemia
Brief Summary: The purpose of this study is to compare the efficacy and safety of pitavastatin with that of pravastatin in elderly patients


Options:
A: Thiobarbituric acid reactive substance; high sensitive C-reactive protein (12 weeks)
B: Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks (12 weeks minus baseline)
C: Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir (12 weeks)
D: Percent Change From Baseline in LDL-C (Baseline to 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of Dysphagia Therapies for Swallowing Disorders Following Stroke.
Brief Summary: Swallowing dysfunction after stroke is common, but there is no reliable evidence for how it should be managed other than perhaps by nasogastric tube. This study compared the effectiveness of standardised, low and high intensity behavioral intervention for dysphagia with that of "usual care".


Options:
A: survival free of an abnormal diet at 6 months
B: To detect a significant difference in energy intake of 48kJ/200 kcal between the groups at 5% significance level and with 80% power. (5 days to 3 weeks intervention)
C: Protein intake measured on an individual level over 24h (3 days (hospital), 3 weeks (rehabilitation home))
D: Assessment of nutritional status with the Mini nutritional Assessment (MNA) (Baseline and every 4 weeks, up to 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy
Brief Summary: The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.


Options:
A: Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 (Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]))
B: Scores in the SNAP-IV (ADHD); Scores in the Young Mania Rating Scale (BD); Weight
C: Change from baseline to endpoint in a mania rating scale
D: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4 (Baseline and Week 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Prospective, Double-blinded, Randomized, Multicenter Study of Low Dose and Medium Dose Botulinum Toxin Type A (Dysport® ) Injection for Migraine Prophylaxis.
Brief Summary: The purpose of this study is to determine whether 120 Unit, and 240 unit of botulinum toxin A are effective in the treatment of migraine without aura prophylaxis.


Options:
A: Change in Frequency of Headache Days (Baseline, Week 24)
B: Mean change from baseline of Area undercurve of headache diary ( total headache score).; Mean change from baseline of total duration of migraine attack( hours) in 4 weeks.; Mean change from baseline of migraine frequency
C: Change in Frequency of Headache Episodes (Baseline, Week 24)
D: Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period (4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase)

Answer: B