TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Chemoprophylaxis With Sulfadoxine-pyrimethamine to Prevent Recurrence of Severe Anaemia in Gambian Children Aged 3 Months to 9 Years
Brief Summary: Severe anaemia is a frequent cause of admission to hospitals in tropical Africa and about 10% of such children die. In endemic countries, anaemia has multiple causes such as nutritional deficiencies, infections and haemoglobinopathies. However, Plasmodium falciparum infection is believed to be the major contributory factor to the aetiology of severe anaemia. Severe anaemia is usually treated by blood transfusion although transfusion carries the attendant risk of transmission of HIV and other blood-borne infections. Thus, there is a need to explore novel strategies to reduce the incidence of severe anaemia in high-risk groups such as children with suboptimal haemoglobin levels because these children are at increased risk of developing severe anaemia if they develop a malaria infection before their haemoglobin level has normalized. Therefore, it is proposed to study whether monthly chemoprophylaxis with sulphadoxine/pyrimethamine (S/P) given during malaria transmission season can protect Gambian children from developing severe anaemia. After receiving treatment from the hospital, 1200 children admitted to the hospital with a haematocrit of less than 21% were randomised to receive either monthly S/P or placebo during the rest of the malaria transmission season. Morbidity was monitored throughout the rainy season. Study subjects were seen at the end of the dry season to document morbidity and mortality.


Options:
A: incidence rate of clinical malaria; in vivo adequate clinical and parasitological response of P. falciparum to SP
B: Proportion of children with moderate anaemia (hemoglobin [Hb] <7 g/dl (at end of the malaria transmission season); haemoglobin concentration (At the end of malaria transmission season); hemoglobin concentration (at the end of malaria transmission season)
C: Incidence of clinical malaria (2008-2009)
D: 1. Incidence of clinical malaria: [(history of fever during previous 2 days or axillary temperature >37.5ºC) + parasitaemia of any density + absence of any other obvious causes of fever] during the period of 3-11 months of age (3-11 months of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Therapy Versus Supportive Therapy in Borderline Personality Disorder
Brief Summary: This is a randomised trial comparing cognitive therapy and supportive therapy administered along one year in borderline personality disorder. The follow-up is one year after treatments end.

The therapists were the same in the two groups. Patients received one session a week during six months and one session every two weeks during the next six months


Options:
A: The acceptability of the intervention to patients (within 6 months of study completion); The feasibility of intervention delivery at the ER setting (within 6 months of study completion); Patient recruitment (Baseline); The proportion of participating patients who can be reached by telephone contact at the 3-month follow-up. (3 months); The proportion of participating patients who can be reached by telephone contact at the 6-month follow-up. (6 months); The proportion of participating patients who can be traced from the hospital record at the 3-month. (3 months); The proportion of participating patients who can be traced from the hospital record at the 6-month. (6 months); The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 6-month. (6 months); The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 3-month. (3 months); Change in scores on a self-report suicidal behaviors assessment from baseline to 3 months (Baseline, 3 months); Change in scores on a self-report suicidal behaviors assessment from baseline to 6 months (Baseline, 6 months); Number of repeat self-harm episodes per person in 3 months after intervention based on hospital records (3 months); Number of repeat self-harm episodes per person in 3 months after intervention recorded in the nationwide self-harm registry (3 months); Number of repeat self-harm episodes per person in 6 months after intervention based on hospital records (6 months); Number of repeat self-harm episodes per person in 6 months after intervention recorded in the nationwide self-harm registry (6 months); Time to next self-harm repetition (in days) following randomization (6 months)
B: Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10 (The change from baseline at Week 10 in the total ZAN-BPD score was calculated using the MMRM model which is a longitudinal analyses and it incorporates ZAN-BPD measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.)
C: Beck scale for suicidal ideation (six months)
D: Clinical Global Impression (CGI): Improvement (1-7): score 3 ( a little better) associated with a hopelessness scale score < 8 (this means that the suicide risk is low)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Therapy Versus Supportive Therapy in Borderline Personality Disorder
Brief Summary: This is a randomised trial comparing cognitive therapy and supportive therapy administered along one year in borderline personality disorder. The follow-up is one year after treatments end.

The therapists were the same in the two groups. Patients received one session a week during six months and one session every two weeks during the next six months


Options:
A: scl-90-R, IIP-C, GAF (before and after therapy,follow-up and every 3 months during therapy)
B: Change in Recovery Assessment Scale (Change from baseline in Recovery Assessment Scale at 12th meeting (6 up to 12 weeks))
C: Clinical Global Impression (CGI): Improvement (1-7): score 3 ( a little better) associated with a hopelessness scale score < 8 (this means that the suicide risk is low)
D: episodes of parasuicide, alcohol intoxication, institutional care (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Therapy Versus Supportive Therapy in Borderline Personality Disorder
Brief Summary: This is a randomised trial comparing cognitive therapy and supportive therapy administered along one year in borderline personality disorder. The follow-up is one year after treatments end.

The therapists were the same in the two groups. Patients received one session a week during six months and one session every two weeks during the next six months


Options:
A: Clinical Global Impression (CGI): Improvement (1-7): score 3 ( a little better) associated with a hopelessness scale score < 8 (this means that the suicide risk is low)
B: Suicidal behaviour (3 and 6 months); Suicidal behaviour (3 and 6 months)
C: N/A
D: level of depression (Baseline to 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Therapy Versus Supportive Therapy in Borderline Personality Disorder
Brief Summary: This is a randomised trial comparing cognitive therapy and supportive therapy administered along one year in borderline personality disorder. The follow-up is one year after treatments end.

The therapists were the same in the two groups. Patients received one session a week during six months and one session every two weeks during the next six months


Options:
A: Clinical Global Impression (CGI): Improvement (1-7): score 3 ( a little better) associated with a hopelessness scale score < 8 (this means that the suicide risk is low)
B: change from baseline in borderline symptoms after a 10 week intervention (10 weeks)
C: The primary outcome will be the composite outcome of the number of in-patient psychiatric hospitalisations, the number of A& E contacts, and the number of suicidal acts. (At both 12 and 24 months post randomisation.)
D: Functioning Assessment Scale Test (FAST) (up to three years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Electronic Integration of Care for Better Vascular Outcomes: The Compete III Study Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness (COMPETE III)
Brief Summary: Vascular diseases (cardiac events, strokes, peripheral vascular disease) remain the number one killer in Canadian society as well as the leading cause of hospitalization and days spent in the hospital. A 1996 estimate placed Ontario's vascular disease financial burden at $5.5 billion in total. Any intervention which lowers vascular risk, will have a direct impact on the quantity and quality of life and costs of health care. Further integration of health professionals in teams focused on chronic disease management in individuals and populations is also ripe for further evaluation. Increased collaboration between family physicians, physician specialists, nurse practitioners, and pharmacists are generally thought to be beneficial for patient outcomes, but the literature is inconclusive and their cost-effectiveness is unproven. In addition, combining centralized electronic up-to-date information on the patient's status with evidence-based recommendations and the ability to communicate either electronically or by phone is expected to result in improved access to care, quality of care, continuity of care and increase cost-effectiveness of chronic disease management.

COMPETE III builds on the researchers' previous work to study an electronic vascular tracking and decision support system shared by patients and their physicians, combined with a clinical care coordinator and automated telephone support system. The researchers are evaluating its impact on vascular risk processes and outcomes, perceived usefulness, ease of use, need for improvement, medication adherence, quality of life and patient goals and motivation.

Study hypothesis: Patients at increased risk of vascular events, if connected with their family physicians, medical specialists and care coordinator via an electronic network (Web, fax and telephone) sharing an intensive tracking, advice and support program, will lower their vascular risk more than those in usual care.


Options:
A: The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups. (6 months to 1 year)
B: Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein (12 months)
C: HbA1c (18 months)
D: Diabetic nephropathy (Four years); Combined cardiovascular endpoint (Eight years); Total mortality (13 years); Years of life years gained (21 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Electronic Integration of Care for Better Vascular Outcomes: The Compete III Study Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness (COMPETE III)
Brief Summary: Vascular diseases (cardiac events, strokes, peripheral vascular disease) remain the number one killer in Canadian society as well as the leading cause of hospitalization and days spent in the hospital. A 1996 estimate placed Ontario's vascular disease financial burden at $5.5 billion in total. Any intervention which lowers vascular risk, will have a direct impact on the quantity and quality of life and costs of health care. Further integration of health professionals in teams focused on chronic disease management in individuals and populations is also ripe for further evaluation. Increased collaboration between family physicians, physician specialists, nurse practitioners, and pharmacists are generally thought to be beneficial for patient outcomes, but the literature is inconclusive and their cost-effectiveness is unproven. In addition, combining centralized electronic up-to-date information on the patient's status with evidence-based recommendations and the ability to communicate either electronically or by phone is expected to result in improved access to care, quality of care, continuity of care and increase cost-effectiveness of chronic disease management.

COMPETE III builds on the researchers' previous work to study an electronic vascular tracking and decision support system shared by patients and their physicians, combined with a clinical care coordinator and automated telephone support system. The researchers are evaluating its impact on vascular risk processes and outcomes, perceived usefulness, ease of use, need for improvement, medication adherence, quality of life and patient goals and motivation.

Study hypothesis: Patients at increased risk of vascular events, if connected with their family physicians, medical specialists and care coordinator via an electronic network (Web, fax and telephone) sharing an intensive tracking, advice and support program, will lower their vascular risk more than those in usual care.


Options:
A: Change in serum LDL-cholesterol level (at 6 months post disclosure of CAD risk)
B: percentage of participants with increase of the adequacy of lipid-lowering prescription (up to 24 months)
C: Low-density Lipoprotein Cholesterol (Measured at 1 year); Systolic Blood Pressure (Measured at 1 year); HbA1c (Measured at 1 year)
D: The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups. (6 months to 1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Electronic Integration of Care for Better Vascular Outcomes: The Compete III Study Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness (COMPETE III)
Brief Summary: Vascular diseases (cardiac events, strokes, peripheral vascular disease) remain the number one killer in Canadian society as well as the leading cause of hospitalization and days spent in the hospital. A 1996 estimate placed Ontario's vascular disease financial burden at $5.5 billion in total. Any intervention which lowers vascular risk, will have a direct impact on the quantity and quality of life and costs of health care. Further integration of health professionals in teams focused on chronic disease management in individuals and populations is also ripe for further evaluation. Increased collaboration between family physicians, physician specialists, nurse practitioners, and pharmacists are generally thought to be beneficial for patient outcomes, but the literature is inconclusive and their cost-effectiveness is unproven. In addition, combining centralized electronic up-to-date information on the patient's status with evidence-based recommendations and the ability to communicate either electronically or by phone is expected to result in improved access to care, quality of care, continuity of care and increase cost-effectiveness of chronic disease management.

COMPETE III builds on the researchers' previous work to study an electronic vascular tracking and decision support system shared by patients and their physicians, combined with a clinical care coordinator and automated telephone support system. The researchers are evaluating its impact on vascular risk processes and outcomes, perceived usefulness, ease of use, need for improvement, medication adherence, quality of life and patient goals and motivation.

Study hypothesis: Patients at increased risk of vascular events, if connected with their family physicians, medical specialists and care coordinator via an electronic network (Web, fax and telephone) sharing an intensive tracking, advice and support program, will lower their vascular risk more than those in usual care.


Options:
A: extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (two years)
B: systolic blood pressure (change from baseline to 12-month of follow-up)
C: Net Difference in Proportion Treated with Low-dose Diuretics (baseline and at one year)
D: The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups. (6 months to 1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Patients With Chronic Functional Disorders. A Randomized Controlled Trial of Specialized Treatment Compared to Usual Care.
Brief Summary: The purpose of this study is to determine the effect of specialized treatment (including cognitive therapy, social counselling and a recommendation letter to the patients' primary care physician) on the functional level, emotional problems, and use of health care in patients with chronic medically unexplained symptoms.


Options:
A: Whitely Index (Measured immediately post-treatment and at Months 6 and 12 post-treatment)
B: General Self-Efficacy Scale (GSE) (Baseline, 8 Weeks, 12 Months)
C: Perceived quality of life (Change from baseline in quality of life at 12 months after the intervention)
D: Physical health measured with The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) (aggregate score of the scales physical functioning, bodily pain and vitality) (Measured at baseline and months 4 (end of treatment), 10 and 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Intervention to Reduce Injury in Minorities
Brief Summary: The purpose of this study is to evaluate the effectiveness and ethnic differences of a brief alcohol intervention for injured patients.


Options:
A: alcohol intake (six months and one year); injury recidivism (six months and one year)
B: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
C: Change in number of patients with alcohol-related negative consequences from baseline to 4, 8, and 12 months post-randomization (Change from baseline in alcohol-related negatve consequences at 4, 8, and 12 months)
D: Reduction of 25% in self reported alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the intervention group. In the control group we expect that 10% will reduce their consumption equivalent. (6 and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #555 - Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
Brief Summary: In the proposed study 450 veterans with a primary diagnosis of schizophrenia who had at least one psychiatric hospitalization for schizophrenia in the previous 2 years would be randomly assigned at 16 VA medical centers to long-acting injectable risperidone or doctor's choice of oral antipsychotic medication (i.e., excluding other long-acting injectable medications, but not specifying any particular oral agents or dosages). Recruitment would take 27 months to complete, and the study would continue for a third year to allow 9 months of follow-up for the last patient recruited. All patients would be treated from the time of entry up to the end of the three-year study period. Follow-up assessments would continue quarterly. Treatments would not be blinded since giving placebo injections to the comparison group would interfere with the goal of comparing the acceptability of two different methods of medication administration. However, end points will be blindly rated.


Options:
A: Hospitalization-free Survival - Time to Event (From randomization until date of first re-hospitalization, assessed up to 24 months); Hazard Ratio for Hospitalization (24 months)
B: Time to Relapse (Day 1 to relapse); Time in Remission (Day 1 to last PANSS measurement)
C: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia (Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks))
D: Risperidone effectiveness is measured by time to relapse within the 52 week period.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Self-collected Vaginal Swabs as an Innovative Approach to Facilitate Testing for Repeat Chlamydia Infection
Brief Summary: The purpose of this study is to determine if, among women who were treated for a prior chlamydial infection, home-based, self-collected vaginal swabs can increase rescreening for chlamydia in comparison with rescreening in the clinic. The study design is two randomized trials with enrollment at multiple family planning clinics and sexually transmitted disease (STD) clinics following a common protocol.


Options:
A: chlamydia and gonorrhea tests completed; chlamydia and gonorrhea infections detected
B: Yield ratio tested for uro-genital C.trachomatis infection; Yield ratio diagnosed for uro-genital C.trachomatis infection; Yield ratio treated for uro-genital C.trachomatis infection
C: Percent of women rescreened for chlamydia
D: Number of tests received

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Summary

This study will look at physical exercise after acute ischaemic stroke. It is called the ExStroke Pilot Trial.

Physical activity is associated with a lower risk of first-time stroke. It remains unknown if physical activity also is associated with a lower risk of recurrent stroke. Patients with ischaemic stroke have a 30% to 40% risk of a recurrent stroke during a 5 year follow-up. The risk of acute myocardial infarction (MI) and death from vascular disease is approximately 15% each. The impact of lifestyle factors on risk for these events is insufficiently covered in the international scientific literature.

Purpose:

The purpose of the trial is to examine whether the level of physical activity increases in patients who have had an ischemic stroke, when they are informed about physical activity and instructed in a physical training program. The occurrence of new cerebro- and cardiovascular events in the patients will be registered. The patients are randomised to receive oral and written information by a physician and a physiotherapist about physical exercise; or to a control group with no instruction regarding physical exercise. Both groups will receive the best available therapy with regard to secondary stroke prevention and will be informed about lifestyle factors.

Irrespective of which group the patients are randomised to, all patients will receive the best possible established treatment with regard to prevention of thromboses; blood pressure control; lipid lowering agents, if necessary; and information about diet, tobacco smoking, and vitamin supplements.

Study Design:

The patients will be randomised centrally within 90 days after stroke onset, and they will be re-examined at 3, 6, 9, 12, 18, and 24 months. Inclusion criteria are patients with ischaemic stroke, aged 40 years or older. In the pilot trial a number of 300 included patients is wanted.


Options:
A: Blood Pressure (6 months and 1 year)
B: physical scale of the Stroke Impact Scale 3.0 (before discharge from acute care, four weeks after discharge from the hospital or rehabilitation (in case of referral to a medical rehabilitation) immediately before randomization (baseline assessment), and 12 months after randomization)
C: Self-efficacy in performing stroke self-management behaviors (One month after the program)
D: Difference in physical activity scale for the elderly (24 months)

Answer: D