TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Osteoarthritis (OA), a common disabling condition, is the commonest type of arthritis worldwide.Pain is the leading symptom and is often chronic in na. Current treatment options have had limited symptomatic effect and are associated with significant side effects. Duloxetine, a selective serotonin norepinephrine reuptake inhibitor has been demonstrated to have, besides its antidepressant properties, a centrally acting analgesic effect.

The aim of the present study was to investigate the efficacy of duloxetine in reducing pain in older adults with knee OA.

288 patients aged 65 years and above with ACR clinical and radiographic criteria of primary knee OA attending the outpatient clinic of our institution were enrolled in this study. All patients underwent a physical examination and where questioned about the number of flares. Exclusion criteria included any inflammatory, autoimmune, psychiatric illness and morbid obesity. Patients were randomized 1:1. One hundred and forty four received 60mg/day of duloxetine HCL and 144 received placebo together with their usual therapy for 16 weeks. The primary outcome measure was pain reduction. Secondary outcome measures included improvements in physical functioning scores. Pain was assessed using the Brief Pain Inventory (BPI) and Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment using the self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores and the Geriatric Depression Scale (GDS) was conducted. Alterations in dosage of analgesic/NSAID drugs used were recorded. Safety and tolerability were also assessed. Data was collected at baseline and at monthly intervals for 4 months. All staff involved in data collection was blinded to the treatment assignment groups.


Options:
A: Mechanical and Heat Hyperalgesia (2 week intervals)
B: Pressure Pain Threshold. (Difference between baseline (prior to treatment) compared with 10 weeks of 60 mg/daily duloxetine compared with placebo)
C: Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item (Day 1 of Week 1 to Day 1 of Week 6)
D: Pain reduction (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Osteoarthritis (OA), a common disabling condition, is the commonest type of arthritis worldwide.Pain is the leading symptom and is often chronic in na. Current treatment options have had limited symptomatic effect and are associated with significant side effects. Duloxetine, a selective serotonin norepinephrine reuptake inhibitor has been demonstrated to have, besides its antidepressant properties, a centrally acting analgesic effect.

The aim of the present study was to investigate the efficacy of duloxetine in reducing pain in older adults with knee OA.

288 patients aged 65 years and above with ACR clinical and radiographic criteria of primary knee OA attending the outpatient clinic of our institution were enrolled in this study. All patients underwent a physical examination and where questioned about the number of flares. Exclusion criteria included any inflammatory, autoimmune, psychiatric illness and morbid obesity. Patients were randomized 1:1. One hundred and forty four received 60mg/day of duloxetine HCL and 144 received placebo together with their usual therapy for 16 weeks. The primary outcome measure was pain reduction. Secondary outcome measures included improvements in physical functioning scores. Pain was assessed using the Brief Pain Inventory (BPI) and Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment using the self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores and the Geriatric Depression Scale (GDS) was conducted. Alterations in dosage of analgesic/NSAID drugs used were recorded. Safety and tolerability were also assessed. Data was collected at baseline and at monthly intervals for 4 months. All staff involved in data collection was blinded to the treatment assignment groups.


Options:
A: Pain reduction (16 weeks)
B: Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks (Baseline, 8 weeks (blinded endpoint))
C: Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary (Over 13 Weeks)
D: Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score (baseline, 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Open Label, Study of Safety and Effectiveness of GRALISE™(Gabapentin) Tablets in the Treatment of Patients With Postherpetic Neuralgia in Clinical Practice
Brief Summary: Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice


Options:
A: The primary study objective is to assess the relative efficacy of G-ER versus placebo in reducing the mean daily pain score from the baseline week to end of efficacy treatment period (Treatment Week 4) in patients with DPN. (4 weeks)
B: Change in pain and symptoms (Up to 14 weeks)
C: Change From Baseline to End of Study in LOCF VAS (8 weeks (Baseline and Week 8))
D: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data (Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)); Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period (Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multi-national, Multi-centre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Women Undergoing an ART Programme
Brief Summary: This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.


Options:
A: Number of patients obtaining 5-12 oocytes during COH (2 years)
B: Number of Oocytes Retrieved Per Participant (34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU))
C: Number of metaphase II oocytes retrieved during the course of one treatment cycle (2 years)
D: Number of Oocytes Retrieved (Day of oocyte retrieval (up to Day 18 after start of stimulation))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multi-national, Multi-centre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Women Undergoing an ART Programme
Brief Summary: This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.


Options:
A: Number of Oocytes Retrieved Per Participant (34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU))
B: Number of Oocytes Retrieved (Day of oocyte retrieval (up to Day 18 after start of stimulation))
C: Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set (10-11 weeks after embryo transfer at the blastocyst stage); Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set (10-11 weeks after embryo transfer at the blastocyst stage)
D: Number of metaphase II oocytes retrieved during the course of one treatment cycle (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Interventions to Teach Respiratory Inhaler techNique (E-TRaIN)
Brief Summary: The purpose of this study is to evaluate the relative effectiveness of two different ways to teach subjects while hospitalized how to use respiratory inhalers and to follow-up after discharge home from the hospital to determine durability of the education.

Teach-to-Goal (TTG) education employs instruction followed by patient "teach-back," then repeated cycles of learning and assessment until a skill is mastered. By contrast, Brief Intervention (BI) education only consists of providing the patient with verbal and written instruction.

The investigators hypothesize that hospital-based TTG compared to BI increases a patient's ability to retain instructions on respiratory inhaler technique. The investigators will test this hypothesis separately for the MDI and Diskus® devices after discharge.


Options:
A: Adherence rate (at three months)
B: medication adherence (on year)
C: Change in inhaler, turbuhaler, and diskus technique (Baseline and 1-month follow-up)
D: Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Interventions to Teach Respiratory Inhaler techNique (E-TRaIN)
Brief Summary: The purpose of this study is to evaluate the relative effectiveness of two different ways to teach subjects while hospitalized how to use respiratory inhalers and to follow-up after discharge home from the hospital to determine durability of the education.

Teach-to-Goal (TTG) education employs instruction followed by patient "teach-back," then repeated cycles of learning and assessment until a skill is mastered. By contrast, Brief Intervention (BI) education only consists of providing the patient with verbal and written instruction.

The investigators hypothesize that hospital-based TTG compared to BI increases a patient's ability to retain instructions on respiratory inhaler technique. The investigators will test this hypothesis separately for the MDI and Diskus® devices after discharge.


Options:
A: Readmission rate (6 month)
B: Mean Number of Exacerbations Per Year: Negative Binomial Model (Baseline through Week 52); Mean Number of Exacerbations Per Year: Poisson Model (Baseline through Week 52)
C: Lung function after 2 weeks of treatment
D: Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: 18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study
Brief Summary: The purpose of this study is to examine differences in the long-term effects of immediate versus delayed cord clamping at birth on developmental outcomes of our study infants at 18-22 months corrected age.


Options:
A: Very low birth weight (VLBW) infants in the delayed cord clamping (DCC) group will have less intraventricular hemorrhage (IVH) compared to VLBW infants in the immediate clamped (ICC) group (December, 2012); Very low birth weight infants in the delayed cord clamping group will have less late onset sepsis than those in the immediate clamping group (December 2012)
B: Motor function (18-22 months)
C: Superior Vena Cava Flow (<12 hours of life)
D: To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation. (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Trial Investigating the Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer
Brief Summary: Study participants with primary breast cancer will receive a standard chemotherapy with an anthracycline and a taxane as well as trastuzumab in case of HER2-positive tumors at doses and duration in concordance to current treatment guidelines. Patients will be receive and benefit in addition currently not in the neoadjuvant setting registered medication as lapatinib or bevacizumab of which significant increases of cure (pCR) rates have been reported in previous phase III studies. Patients randomized to carboplatin will receive in addition to the described backbone therapies a potentially active agent which suggested synergy of efficacy with chemotherapies as well as targeted agents. Patients might have the risk of an increase in toxicities due to the added agents and will have additional burden due to investigations required for study participation. However, due to the severity of the underlying disease and the high risk of relapse and death due to the stage of disease, this increase in toxicity and burden appears less relevant compared to the potential higher efficacy and finally cure rate by the incorporated treatments.


Options:
A: Comparison of the pCR rates in patients with HER2+/HR+ breast cancer treated by preoperative T-DM1 with or without standard endocrine therapy or trastuzumab with endocrine therapy. (After 12 weeks); Evaluation of dynamic testing (based on proliferation/apoptosis changes in serial biopsy and imaging by MRI) after three weeks of treatment as a surrogate parameter for response. (after 3 weeks of treamtment)
B: Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11 (8 years)
C: Rate of Pathologic Complete Response (pCR) (3 years)
D: Pathological complete response of breast and lymph nodes (ypT0 ypN0; primary endpoint) (24 weeks (time window -3 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension (CSRPH)
Brief Summary: The purpose of this study is to study the differential short-term effect of nocturnal oxygen, acetazolamide tablets and nocturnal non-invasive positive pressure ventilation on symptoms, exercise capacity and nocturnal breathing disturbances in subjects with pulmonary hypertension and sleep related breathing disorders

* Trial with medicinal product


Options:
A: exercise capacity (1 week); Quality of Life (1 week)
B: 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)
C: The Central Apnea-hypopnea Index (one night); Respiratory Arousal Index (one night)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery
Brief Summary: Pulmonary dysfunction after cardiac surgery with CPB remains to be a problem complicating the postoperative course of the patients. The investigators hypothesized that RIPCcom, combined intervention of remote ischemic preconditioning and remote ischemic postconditioning, would confer beneficial influence on inflammatory response and resultant postoperative pulmonary dysfunction after CPB in patients undergoing complex valvular heart surgery who are at increased risk of postoperative pulmonary dysfunction.The aim of this study was to evaluate the lung-protective effect of combined remote ischemic pre- and post-conditioning in patients undergoing complex valvular heart surgery.


Options:
A: Allogenic Blood Product Transfusion Risk (Patients were followed for the duration of hospital stay, an average of 6 days)
B: Mortality at 30 days (30 days post-randomization); Composite (30 days post-randomization)
C: Endothelial Progenitor Cells (EPCs) Count (Cells/µl) (Postoperative 6th hours)
D: Comparison of postoperative PaO2/FiO2 (at 10 minutes after anesthetic induction)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery
Brief Summary: Pulmonary dysfunction after cardiac surgery with CPB remains to be a problem complicating the postoperative course of the patients. The investigators hypothesized that RIPCcom, combined intervention of remote ischemic preconditioning and remote ischemic postconditioning, would confer beneficial influence on inflammatory response and resultant postoperative pulmonary dysfunction after CPB in patients undergoing complex valvular heart surgery who are at increased risk of postoperative pulmonary dysfunction.The aim of this study was to evaluate the lung-protective effect of combined remote ischemic pre- and post-conditioning in patients undergoing complex valvular heart surgery.


Options:
A: Decrease of tissue oxygen saturation below 95 % of baseline (4 hours)
B: Comparison of postoperative PaO2/FiO2 (at 10 minutes after anesthetic induction)
C: Area Under the Curve of CK - MB release (baseline to 72h since admission)
D: Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated. (February 2012)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Technologically Enhanced Community Health Worker (CHW) Delivery of Personalized Diabetes Information
Brief Summary: Two of AHRQ 's consumer-focused guides, "Pills for Type 2 Diabetes" and "Premixed Insulin for Type 2 Diabetes" could be of great use to underserved ethnic and racial minority adults. The presentation of content and delivery mechanisms of these Guides, however, needs to be modified to increase their use and impact among these difficult-to-reach populations.

To achieve this goal, a long-standing collaboration among African American and Latino community organizations, health care centers and systems, public health organizations, and academics (the REACH Detroit Partnership) is joining with leading experts in the development of personally and culturally tailored health decision aids (University of Michigan's Center for Health Communications Research \[CHCR\] and Center for Behavioral and Decision Sciences in Medicine \[CBDSM\]).

The investigators will develop and evaluate a computer tailored online diabetes medication decision aid that will enable community health workers (CHWs) to provide personalized patient education materials to underserved diabetic African American and Latino adults in Detroit, Michigan.


Options:
A: Blood Pressure, Health-Related Quality of Life(Medical outcome Study Short Form-36) (Baseling, 12month, 24month)
B: Hemoglobin A1c (Change in Baseline in HbA1c at 6 Months)
C: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months
D: Changes in decisional conflict (baseline and 3 month post intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Technologically Enhanced Community Health Worker (CHW) Delivery of Personalized Diabetes Information
Brief Summary: Two of AHRQ 's consumer-focused guides, "Pills for Type 2 Diabetes" and "Premixed Insulin for Type 2 Diabetes" could be of great use to underserved ethnic and racial minority adults. The presentation of content and delivery mechanisms of these Guides, however, needs to be modified to increase their use and impact among these difficult-to-reach populations.

To achieve this goal, a long-standing collaboration among African American and Latino community organizations, health care centers and systems, public health organizations, and academics (the REACH Detroit Partnership) is joining with leading experts in the development of personally and culturally tailored health decision aids (University of Michigan's Center for Health Communications Research \[CHCR\] and Center for Behavioral and Decision Sciences in Medicine \[CBDSM\]).

The investigators will develop and evaluate a computer tailored online diabetes medication decision aid that will enable community health workers (CHWs) to provide personalized patient education materials to underserved diabetic African American and Latino adults in Detroit, Michigan.


Options:
A: Change in Hemoglobin A1c (3 months, 6 months, 12 months)
B: Blood Pressure Control (blood pressure (SBP/DBP) <140/90 mmHg)) (At 1 year from the time of initiation of the intervention); Mean HbA1c (At 1 year from the time of initiation of the intervention)
C: Changes in decisional conflict (baseline and 3 month post intervention)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Technologically Enhanced Community Health Worker (CHW) Delivery of Personalized Diabetes Information
Brief Summary: Two of AHRQ 's consumer-focused guides, "Pills for Type 2 Diabetes" and "Premixed Insulin for Type 2 Diabetes" could be of great use to underserved ethnic and racial minority adults. The presentation of content and delivery mechanisms of these Guides, however, needs to be modified to increase their use and impact among these difficult-to-reach populations.

To achieve this goal, a long-standing collaboration among African American and Latino community organizations, health care centers and systems, public health organizations, and academics (the REACH Detroit Partnership) is joining with leading experts in the development of personally and culturally tailored health decision aids (University of Michigan's Center for Health Communications Research \[CHCR\] and Center for Behavioral and Decision Sciences in Medicine \[CBDSM\]).

The investigators will develop and evaluate a computer tailored online diabetes medication decision aid that will enable community health workers (CHWs) to provide personalized patient education materials to underserved diabetic African American and Latino adults in Detroit, Michigan.


Options:
A: Knowledge, risk perception, stigma, perceived control (immediately post intervention and 1 month post intervention)
B: Changes in decisional conflict (baseline and 3 month post intervention)
C: Deceased Donor Kidney Transplant (DDKT) and Living Donor Kidney Transplant (DDKT) Knowledge (9 months)
D: Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores (Follow-up assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Patient Version) (End-of-intervention Assessment (5 months)); Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version (Follow-up Assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Provider Version) (Follow-up Assessment (2 months)); Perceptions of Care Survey - Global Evaluation of Care Scale (PoC) (End-of-intervention Assessment (5 months)); Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version (End-of-intervention Assessment (5 months))

Answer: B