TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementing Tobacco Control in Dental Practice
Brief Summary: Our goal is to test a dentist-hygienist team intervention to help dental patients quit smoking and determine if it can be effectively and cost-effectively implemented and sustained.

Staff in half of the HMO's 14 large dental facilities will be trained to provide brief cessation advice and assistance and to encourage smokers to talk by phone with a tobacco counselor before they leave the dental office. Phone counselors will provide brief counseling, assess stage, and offer a full list of cessation services. The Active Referral intervention strategy is both practical and innovative, as it takes advantage of available resources; efficiently distributes intervention activities between dentists, hygienists, and counseling specialists; and could be delivered in individual, small, or large dental practices. This intervention is provided as part of routine care to all patients seen for annual dental and periodontal exams.Consented patients will receive a short phone survey shortly after the exam to assess smoking status, satisfaction with delivery of support services,and satisfaction with intervention. Consented patients in treatment and control facilities will be surveyed by phone at one year to re-assess smoking status and satisfaction with services.


Options:
A: Tobacco-cessation rates (30-day point prevalence) at one year.
B: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
C: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)
D: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinson's Disease Patients With Stable Motor Function and Depressive Symptoms
Brief Summary: Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the brain (nerve cells) to control and harmonize muscle movements. Consequently, the main manifestations of the disease affect movement and include tremor, muscular rigidity, slowness in performing movements and loss of balance.

However, the disease affects also other, non motor functions and may cause other disorders, such as depression. Depression may be a reaction to the disability caused by the disease, but many studies show that depression is more common in PD than in other chronic debilitating illnesses. Moreover, there is also a biological explanation for the phenomenon: dopamine is also used in brain circuits involved in the experience of pleasure, and loss of pleasure in daily physical or social activity is one of the key manifestations of depression.

The objective of the study is to assess whether pramipexole, at doses approved for the treatment of PD symptoms, is more effective than placebo in resolving depressive symptoms in PD patients.

Also data on the safety of the product in the disease will be collected.


Options:
A: Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12 (Baseline and Week 12)
B: Canadian Occupational Performance Measure (COPM) (3 months)
C: UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment (6 months)
D: Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline (12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.
Brief Summary: COLOR II is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Halifax, Canada. Quality of life and costs will be assessed on a national basis.


Options:
A: locoregional recurrence rate (3 years post operatively)
B: Primary endpoint is cancer free survival at three years.
C: Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay (1 month)
D: Disease free survival (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.
Brief Summary: COLOR II is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Halifax, Canada. Quality of life and costs will be assessed on a national basis.


Options:
A: Local recurrence (2 years)
B: locoregional recurrence rate (3 years post operatively)
C: 3-Year Disease-free Survival (Up to 3 years)
D: Recurrence free at 3 year follow-up (3 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Assisted Decision Support to Increase the Safety of Prescribing to Older Emergency Department Patients
Brief Summary: The subjects in this study are physicians working in the Wishard Emergency Department. The purpose of this study is to measure the extent to which information technology (i.e.-computers) improves emergency department care. The objective of our study is to evaluate the use of informatics in the emergency department and specifically to determine if computer reminder systems: 1) reduce the number of unsafe medications prescribed to older adults, 2) assist in more safely dosing of medications to adults of all ages, and 3) increase influenza immunization of eligible older patients in the emergency department.

Interventions: The interventions in this study are computer reminders. When releasing patients from the emergency department, physicians currently write all release orders, including prescriptions, on a computer order entry system that is linked to the Regenstrief Medical Record System. The computerized order entry system will be programmed so that physicians randomized (randomly placed) into the intervention group, the group that will receive the intervention, they will receive one of three types of reminders:

1. The medication prescribed is generally considered unsafe for use in older patients. The reminder will then list appropriate alternatives for this medication.
2. The dose of the prescribed medication is excessive and should be adjusted for the patient's creatinine clearance (or kidney function).
3. This patient may be eligible for influenza vaccination.

The physician will then choose to order or disregard the recommendation. The computer system will automatically record what the physician selected to do. The general outcome of interest is the extent to which the electronic reminders successfully improved physician practice in the emergency department setting. This outcome will be compared to physicians who were randomized to the group that did not receive the reminders (the control group).


Options:
A: Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score (24 weeks)
B: Proportion of older ED patients who receive a potentially inappropriate medication (During discharge home from the ED)
C: Rate of HPV vaccination among girls actively cared for at participating sites (Monthly, up to 1 year)
D: Adherence to tobacco use treatment guidelines (4-6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Assisted Decision Support to Increase the Safety of Prescribing to Older Emergency Department Patients
Brief Summary: The subjects in this study are physicians working in the Wishard Emergency Department. The purpose of this study is to measure the extent to which information technology (i.e.-computers) improves emergency department care. The objective of our study is to evaluate the use of informatics in the emergency department and specifically to determine if computer reminder systems: 1) reduce the number of unsafe medications prescribed to older adults, 2) assist in more safely dosing of medications to adults of all ages, and 3) increase influenza immunization of eligible older patients in the emergency department.

Interventions: The interventions in this study are computer reminders. When releasing patients from the emergency department, physicians currently write all release orders, including prescriptions, on a computer order entry system that is linked to the Regenstrief Medical Record System. The computerized order entry system will be programmed so that physicians randomized (randomly placed) into the intervention group, the group that will receive the intervention, they will receive one of three types of reminders:

1. The medication prescribed is generally considered unsafe for use in older patients. The reminder will then list appropriate alternatives for this medication.
2. The dose of the prescribed medication is excessive and should be adjusted for the patient's creatinine clearance (or kidney function).
3. This patient may be eligible for influenza vaccination.

The physician will then choose to order or disregard the recommendation. The computer system will automatically record what the physician selected to do. The general outcome of interest is the extent to which the electronic reminders successfully improved physician practice in the emergency department setting. This outcome will be compared to physicians who were randomized to the group that did not receive the reminders (the control group).


Options:
A: rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period (after 30 days)
B: Proportion of older ED patients who receive a potentially inappropriate medication (During discharge home from the ED)
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: 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: Computer-Assisted Decision Support to Increase the Safety of Prescribing to Older Emergency Department Patients
Brief Summary: The subjects in this study are physicians working in the Wishard Emergency Department. The purpose of this study is to measure the extent to which information technology (i.e.-computers) improves emergency department care. The objective of our study is to evaluate the use of informatics in the emergency department and specifically to determine if computer reminder systems: 1) reduce the number of unsafe medications prescribed to older adults, 2) assist in more safely dosing of medications to adults of all ages, and 3) increase influenza immunization of eligible older patients in the emergency department.

Interventions: The interventions in this study are computer reminders. When releasing patients from the emergency department, physicians currently write all release orders, including prescriptions, on a computer order entry system that is linked to the Regenstrief Medical Record System. The computerized order entry system will be programmed so that physicians randomized (randomly placed) into the intervention group, the group that will receive the intervention, they will receive one of three types of reminders:

1. The medication prescribed is generally considered unsafe for use in older patients. The reminder will then list appropriate alternatives for this medication.
2. The dose of the prescribed medication is excessive and should be adjusted for the patient's creatinine clearance (or kidney function).
3. This patient may be eligible for influenza vaccination.

The physician will then choose to order or disregard the recommendation. The computer system will automatically record what the physician selected to do. The general outcome of interest is the extent to which the electronic reminders successfully improved physician practice in the emergency department setting. This outcome will be compared to physicians who were randomized to the group that did not receive the reminders (the control group).


Options:
A: Medication adherence (One month after patients receive intervention materials)
B: Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 3 months); Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 6 months); Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 12 months); Change from baseline in fall rate (Change from baseline in fall rate at 3 months); Change from baseline in fall rate (Change from baseline in fall rate at 6 months); Change from baseline in fall rate (Change from baseline in fall rate at 12 months)
C: Proportion of older ED patients who receive a potentially inappropriate medication (During discharge home from the ED)
D: Adherence to blood pressure medications; Blood pressure control

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group, Fixed Dose, Clinical Trial of Quetiapine 600 mg/Day vs 1200 mg/Day for Patients With Treatment-Resistant Schizophrenia or Schizoaffective Disorder
Brief Summary: This study will investigate the safety and efficacy of quetiapine in sub-optimally responding patients with DSM-IV schizophrenia using a double blind, randomized 12-week trial comparing oral doses of 1200 mg/d to 600 mg/d of quetiapine.


Options:
A: To determine the proportion of subjects (%) experiencing emergent or a worsening of EPS following treatment of quetiapine 800mg or higher than 800 mg/day in schizophrenic or schizoaffective subjects.
B: To see if mean extrapyramidal symptoms measure will change significantly from baseline to endpoint for the whole group and if the mean change in EPS measure is significantly different between quetiapine 1200mg daily group and quetiapine 600mg daily group (8 weeks)
C: Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients (Weeks 0, 3, 4, 6, 8, 12)
D: Time to Relapse of Psychotic Symptoms During 6 Weeks (6 Weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Rifaximin 550 mg BID For 6 Months In Preventing Hepatic Encephalopathy
Brief Summary: The purpose of this study is to determine if the study drug is safe and effective in preventing hepatic encephalopathy (HE).


Options:
A: The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. (24 weeks)
B: Time To The First Breakthrough Overt HE Episode (Baseline up to 6 Months (168 days))
C: Alaninaminotransferase (ALT) (28 weeks); Liver fibrosis (28 weeks)
D: Liver Enzymes(ALT) (7 days after probiotics)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Umbilical Cord Clamping and Infant Iron Status
Brief Summary: The aim of the study was to determine whether delayed umbilical cord clamping, as compared to early umbilical cord clamping, improves infant iron status at 6 months of age.


Options:
A: Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 4-6 hours after birth. (at 4-6 hours of age)
B: Hemoglobin (8 months plus/minus one month)
C: Hematologic status at 6 months of age; Iron status at 6 months of age
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Umbilical Cord Clamping and Infant Iron Status
Brief Summary: The aim of the study was to determine whether delayed umbilical cord clamping, as compared to early umbilical cord clamping, improves infant iron status at 6 months of age.


Options:
A: Hematologic status at 6 months of age; Iron status at 6 months of age
B: The primary outcome is a comparison of area under the curve (AUC) for change in serum iron for each intervention adjusted for diurnal variation. The use of AUC will provide a single outcome for each participant. (3 weeks)
C: Hemoglobin (February 2007-February 2008)
D: Birth weight; 3-month infant mortality

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomised Clinical Trial to Investigate the Management of Headache Disorders. Study to Identify Prognostic Patient Characteristics and to Investigate the Additional Value of Physio-/Manual Therapy
Brief Summary: The management of headache disorders is too often based upon trial and error or on personal beliefs and opinions. Seldom it is based on scientific arguments. Therefore the identification of prognostic patient characteristics is mandatory as this will lead to a more precise referral of headache patients.A prospective cohortstudy is designed to identify these prognostic patient characteristics. After testing, 186 headache patients (migraine, tension type headache and cervicogenic headache) will be randomly allocated to one of two treatment groups. Testing includes the fulfillment of questionnaires (Headache Diagnosis Questionnaire, Headache Inventory Questionnaire and the Headache Impact Test) and physical tests (Thermal Stimuli, Cervical Spine examination and Pressure Algometry). Treatment groups are a usual care group (administered by a medical doctor) and a usual care plus physio-/ manual therapy treatment. After six weeks of treatment subjects will complete the headache inventory list and the Headache Impact Test a second time. The perceived effect will be registered allowing the distinction between responders (positive effect) and non-responders (no effect or worse). Logistic regression-analysis will be used to identify the specific patient characteristics of the responders and the non-responders. Secondly the additional value of the physio-/ manual therapy intervention will be examined. Follow-up measurements up to 52 weeks are provided.


Options:
A: Patient-rated pain (0-11 box scale) (short term = 12 weeks; long term = 52 weeks)
B: Neck Disability Index (4 weeks, 6 months)
C: Patient-rated neck and back disability (9 months)
D: Manual Examination of the Cervical Spine; Pressure algometry; Thermal stimulation; Perceived effect; HIT-6

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Tolerability and Safety of Rituximab When Given in Combination With Methotrexate and Etanercept (Enbrel) or Methotrexate and Adalimumab (Humira) in Subjects With Active Rheumatoid Arthritis
Brief Summary: The primary objective of this study was to evaluate the tolerability and safety of rituximab in combination with methotrexate (MTX) and etanercept or adalimumab in participants with active rheumatoid arthritis (RA). The secondary objective was to explore the efficacy of rituximab in combination with MTX and etanercept or adalimumab in participants with active RA.


Options:
A: Proportion of patients with an ACR20 response (24 weeks)
B: Percentage of Patients Developing a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the First Course of Rituximab Treatment (From first treatment with rituximab (Day 1) through Week 24)
C: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)
D: Proportion of Participants With at Least One Serious Infection Through Week 24 (Through Week 24); Number of Participants With Any Infections or Any Grade 3/4 Infections Through Week 24 (Through Week 24); Maximum Duration of Infections Through Week 24 (Week 24); Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Week 24 (Through Week 24); Number of Participants With Clinically Significant Immunological and Laboratory Assessment Findings (Through Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An RCT to Evaluate the Effect of Home-Based Peer Support on Maternal-Infant Interaction, Infant Health Outcomes, and Postpartum Depression
Brief Summary: The objective of this study is to examine the impact of a home-based peer support intervention for mothers affected by postpartum depression (PPD) and for their infants.


Options:
A: The rate of exclusive breastfeeding at 3 months post-birth. (3 months post birth)
B: Parents breastfeeding self efficacy (7 days post partum)
C: DSS Investigated and Substantiated Child Maltreatment Rates (0 - 12 Years of Child Age)
D: maternal-infant interaction (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An RCT to Evaluate the Effect of Home-Based Peer Support on Maternal-Infant Interaction, Infant Health Outcomes, and Postpartum Depression
Brief Summary: The objective of this study is to examine the impact of a home-based peer support intervention for mothers affected by postpartum depression (PPD) and for their infants.


Options:
A: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)
B: Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (3 years)
C: maternal-infant interaction (12 months)
D: Child Emergency Room Presentation Rates (Program enrollment until 24 months of Child Age.); Mother Emergency Room Presentation Rates (Program enrollment until 24 months postnatal.); Child Hospital Admissions (Program enrollment until 24 months postnatal.); Mother Hospital Admissions (Program enrollment until 24 months postnatal.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The aim of the study is to find out if allergic diseases can be prevented buy giving probiotic bacteria to pregnant mothers and their newborn infants


Options:
A: Reduction of the onset of gaseous colic, regurgitation and of constipation. (one year)
B: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
C: N/A
D: Presence of probiotic in the stool (weeks 0-12); Adverse events (duration of study - through study completion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The aim of the study is to find out if allergic diseases can be prevented buy giving probiotic bacteria to pregnant mothers and their newborn infants


Options:
A: N/A
B: days with diarrhoea (January 2011 to June 2011)
C: N/A
D: Incidence of infectious diseases

Answer: A