TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Center Prospective Randomized Control Trial on Negative Pressure Wound Therapy for Primarily Closed Groin Incisions Following Lower-limb Re-vascularization to Reduce Surgical Site Infection
Brief Summary: The purpose of this study is to investigate the current standard of wound care following vascular operations compared to to a negative pressure wound therapy (vacuum dressing) and the rate of surgical site infections (SSIs) in patients undergoing surgery to restore blood flow to the lower limb(s).

Negative pressure wound therapy consists of a closed, sealed system that produces negative pressure (vacuum) to the wound surface. The device itself consists of open-cell foam that is sealed with an occlusive adhesive dressing (covers and sticks to the incision) and suction is maintained by connecting suction tubes to a vacuum pump and waste collector.

The investigators objectives are to determine whether there will be any reduction in surgical site infection and this potential reduction will influence length of hospital stay, emergency room visits, antibiotic use and need for re-operation.


Options:
A: Number of Participants With Wound Complication (Day of surgery to 30 days postoperative); Number of Participants With Classification of Wound Morbidity (Day of Surgery to 30 days postoperative)
B: Surgical Site Infection (30 days)
C: Time to Complete Wound Closure (42 days)
D: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Integrated Care to Decrease Hospitalization and Institutionalization in Community Dwelling Frail Elderly, With Care Coordination Between Physicians, Home Nursing Services and a Community Geriatrics Unit.
Brief Summary: Introduction: Care of frail and dependent elders with multiple chronic conditions is a major challenge for health care systems. The objective of this study is to evaluate the effect of coordinating the existing structures in the private and public sector for the care of frail and dependent persons over age 60, and susceptible of presenting complex bio-psycho-social issues. This approach is aimed at improving the coordination, continuity, quality and efficacy of care in this population, which presents a high risk of hospitalization, emergency room visits, institutionalization and mortality.

Methods: Three-year cluster randomised controlled trial. A control group receiving usual care (follow up by primary care physician and home nursing service) will be compared to an intervention group that will be provided, in addition, in-home multidimensional geriatric assessment with access to a 24h/7 day a week call service, and coordinated long-term follow-up. Survival analyses will be conducted to compare the outcomes between groups.

Primary outcome:

- Hospitalizations: rates of first hospitalization, number, cause and length of stay.

Secondary outcomes:

* Emergency room visits: rates of first visit, number and cause
* Institutionalization: number of patients
* Mortality: rate and number of deaths and place of death (home versus hospital)


Options:
A: Hospitalizations: rates of first hospitalization, number and reason (Three years)
B: Functional performance (independent) activities of daily living measured using Groningen Activity Restriction Scale (3 months); Mental health using subscale mental health MOS-20 (3 months); Informal caregiver burden using Zarit Burden Interview (3 months)
C: Overall functioning (18 months); Incremental cost-effectiveness ratio (ICER) (18 months)
D: Health Care Consumption (1 year); Dependence in Activities of Daily Living (1 year); Satisfaction With Health and Social Care (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Integrated Care to Decrease Hospitalization and Institutionalization in Community Dwelling Frail Elderly, With Care Coordination Between Physicians, Home Nursing Services and a Community Geriatrics Unit.
Brief Summary: Introduction: Care of frail and dependent elders with multiple chronic conditions is a major challenge for health care systems. The objective of this study is to evaluate the effect of coordinating the existing structures in the private and public sector for the care of frail and dependent persons over age 60, and susceptible of presenting complex bio-psycho-social issues. This approach is aimed at improving the coordination, continuity, quality and efficacy of care in this population, which presents a high risk of hospitalization, emergency room visits, institutionalization and mortality.

Methods: Three-year cluster randomised controlled trial. A control group receiving usual care (follow up by primary care physician and home nursing service) will be compared to an intervention group that will be provided, in addition, in-home multidimensional geriatric assessment with access to a 24h/7 day a week call service, and coordinated long-term follow-up. Survival analyses will be conducted to compare the outcomes between groups.

Primary outcome:

- Hospitalizations: rates of first hospitalization, number, cause and length of stay.

Secondary outcomes:

* Emergency room visits: rates of first visit, number and cause
* Institutionalization: number of patients
* Mortality: rate and number of deaths and place of death (home versus hospital)


Options:
A: Hospitalizations: rates of first hospitalization, number and reason (Three years)
B: Functional status; health status; hospitalization and nursing home placement
C: Health care utilization including EMR, hospital admissions, care days, out patient hospital or primary care (Change from 1 year before inclusion to 1 year follow up)
D: Progress attaining health goals (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing and Linkage to HIV Care in China: A Clustered Randomized Trial
Brief Summary: This study will evaluate the effects of a comprehensive approach (One4All) to increase the percentage of patients that receive their HIV testing results and counseling.

Primary Hypothesis: The One4All approach will increase the proportion of individuals who have completed all tests to confirm HIV diagnosis and received counseling within 30 days of screening HIV+, given they have screened HIV+ on the initial test, from 40% to 60%.


Options:
A: Death (all-cause), or severe HIV-related disease (AIDS-defining diseases, non-AIDS-defining malignancies, and non-AIDS-defining invasive bacterial diseases) (30 months); prevalence of HIV resistance (ANRS12253 associated study) (30 month after ARV initiation)
B: Receipt of post-test results and counseling following testing completeness (30 days)
C: Survival, recurrence of presenting OI/bacterial infection (BI) or incidence of new AIDS-defining events, and HIV-1 plasma viral load at Week 48
D: Linkage to care (90 days); Viral suppression (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Ketorolac Tromethamine 0.4% and Nepafenac 0.1% for the Prevention of Cystoid Macular Edema After Phacoemulsification: Prospective Randomized Double-masked Study
Brief Summary: To compare the anti-inflammatory efficacy of ketorolac of tromethamine 0.4% and nepafenac 0.1% eye drops for prophylaxis of cystoid macular edema (CME) after small-incision cataract extraction.


Options:
A: Percentage of patients who develop macular edema within 90 days following cataract surgery (Time to event)
B: Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery (3 Months)
C: The incidence of CME was evaluated by retinal foveal thickness on optical coherence tomography (OCT) (After 1 week, 4 weeks, 12 weeks after surgery)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Community Trial to Measure the Effect of Individual Prenatal Education With Mobile Phone Consultations Offered to Pregnant Women in Masindi and Kiryandongo, Western Uganda
Brief Summary: Introduction There is compelling evidence for scheduled home visits to improve newborn health. There is also a growing wealth of evidence to support the use of mobile phones as a public health tool in low and middle-income countries. UNICEF and WHO have recommended implementation of home visits for newborn care improvement. In sub Saharan Africa the evidence for a combined scheduled home visit and mobile phone technology to improve neonatal health is lacking. In this study the investigators aim to determine the effect of scheduled home visits by Community Health Workers (hereafter referred to as Village Health Teams-VHTs) combined with mobile phone consultations on newborn care in Masindi, Uganda.

Methods This is a community intervention trial to be conducted in Masindi and Kiryandongo in Uganda from May 2013 to June 2014. A mixed method data collection technique will be used. Our overarching hypothesis is that survival of the newborn requires a continuum of care from pregnancy to the newborn period. Eight health centres each will be randomly allocated to the intervention arm and a control arm. Five villages will be randomly selected from each of the catchment areas of the intervention health centres and one VHT purposively selected from each of the villages. Intervention arm will receive VHTs equipped with mobile phones making four scheduled home visits to women while the control arm will receive the standard care for prenatal and immediate newborn education. VHTs will discuss care for the pregnancy, danger signs in pregnancy, birth preparation, acquiring needed items for delivery and recommended newborn care practices. VHTs can also make instant telephone consultations with the midwife for a second opinion. A closed caller group for the mobile telephone consultation is already negotiated with Mobile Telephone Network (MTN) a mobile phone service provider to allow lower tariff rates. Our primary outcome variables of interest are hygienic cord care (specifically application of substances on the cord), thermal care (specifically delayed bathing of the baby soon after birth), initiation of breastfeeding within one hour and avoiding pre-lacteal feeds. Secondary outcomes like completed four antenatal visits, institutionalized delivery were also assessed.


Options:
A: Perinatal mortality (12 months)
B: delayed bathing of baby (24 months)
C: Neonatal mortality rate (deaths within 28 days of birth)
D: % of mothers who know at last 3 danger signs (2 years); % of VHSG who know 6 danger signs (2 years); % of families who seek care from an appropriate facility (2 years); Time between onset of suspected danger signs and referral to appropriate facility (2 years); Improved hygiene behavior by family (2 years); Improved infection control behavior among HC staff (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Community Trial to Measure the Effect of Individual Prenatal Education With Mobile Phone Consultations Offered to Pregnant Women in Masindi and Kiryandongo, Western Uganda
Brief Summary: Introduction There is compelling evidence for scheduled home visits to improve newborn health. There is also a growing wealth of evidence to support the use of mobile phones as a public health tool in low and middle-income countries. UNICEF and WHO have recommended implementation of home visits for newborn care improvement. In sub Saharan Africa the evidence for a combined scheduled home visit and mobile phone technology to improve neonatal health is lacking. In this study the investigators aim to determine the effect of scheduled home visits by Community Health Workers (hereafter referred to as Village Health Teams-VHTs) combined with mobile phone consultations on newborn care in Masindi, Uganda.

Methods This is a community intervention trial to be conducted in Masindi and Kiryandongo in Uganda from May 2013 to June 2014. A mixed method data collection technique will be used. Our overarching hypothesis is that survival of the newborn requires a continuum of care from pregnancy to the newborn period. Eight health centres each will be randomly allocated to the intervention arm and a control arm. Five villages will be randomly selected from each of the catchment areas of the intervention health centres and one VHT purposively selected from each of the villages. Intervention arm will receive VHTs equipped with mobile phones making four scheduled home visits to women while the control arm will receive the standard care for prenatal and immediate newborn education. VHTs will discuss care for the pregnancy, danger signs in pregnancy, birth preparation, acquiring needed items for delivery and recommended newborn care practices. VHTs can also make instant telephone consultations with the midwife for a second opinion. A closed caller group for the mobile telephone consultation is already negotiated with Mobile Telephone Network (MTN) a mobile phone service provider to allow lower tariff rates. Our primary outcome variables of interest are hygienic cord care (specifically application of substances on the cord), thermal care (specifically delayed bathing of the baby soon after birth), initiation of breastfeeding within one hour and avoiding pre-lacteal feeds. Secondary outcomes like completed four antenatal visits, institutionalized delivery were also assessed.


Options:
A: antiretroviral treatment (primary) (6 months)
B: delayed bathing of baby (24 months)
C: Proportion of mothers and infants non-retained in care at 6 months (6 months)
D: healing time for leg ulcer and/or diabetes related foot ulcer (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Exploratory, 12 Week, Randomised, Partially Double-blinded, Placebo-controlled Parallel Group Trial to Explore the Effects of Once Daily Treatments of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination or Tiotropium (Both Delivered by Respimat® Inhaler), Supervised Exercise Training and Behavior Modification on Exercise Capacity and Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD


Options:
A: Physical activity in daily life (measuremet unit: number of steps per day) (four years)
B: Chronic Respiratory Disease Questionnaire (6, 12, and 18 months); 6-minute walk (6, 12, and 18 months)
C: Dyspnea (Change from baseline to 12 months)
D: Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks (Week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Exploratory, 12 Week, Randomised, Partially Double-blinded, Placebo-controlled Parallel Group Trial to Explore the Effects of Once Daily Treatments of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination or Tiotropium (Both Delivered by Respimat® Inhaler), Supervised Exercise Training and Behavior Modification on Exercise Capacity and Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD


Options:
A: Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks (Week 8)
B: FEV1 AUC0-3h Response (baseline and 12 weeks); Trough FEV1 Response (Change From Baseline) (baseline and 12 weeks); St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study (12 weeks treatment); St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352 (12 weeks treatment)
C: Change From Baseline in Morning Pre-dose Trough FEV1 (At Week 24)
D: Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168 (Baseline (BL) to Day 168); Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169 (Baseline to Day 169)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Exploratory, 12 Week, Randomised, Partially Double-blinded, Placebo-controlled Parallel Group Trial to Explore the Effects of Once Daily Treatments of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination or Tiotropium (Both Delivered by Respimat® Inhaler), Supervised Exercise Training and Behavior Modification on Exercise Capacity and Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD


Options:
A: Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment. (day 1 and week 6)
B: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7 (Baseline, Day 7)
C: Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks (Week 8)
D: Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 (Week 26)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Telemedicine Training and Counselling After Hospitalization in Patients With Severe Chronic Obstructive Pulmonary Disease: A Feasibility Study
Brief Summary: Chronic obstructive pulmonary disease (COPD) is a widespread disease that can have a major impact on the lives of individuals. An essential element in the treatment of COPD is rehabilitation of which supervised training is an important part. However, not all individuals with severe COPD can participate in the rehabilitation provided by hospitals and municipal training centres due to distance to the training venues and transportation difficulties. The aim of the feasibility study was to evaluate an individualised home based training and counselling programme via video conference to patients with severe COPD after hospitalization with regard to safety, clinical outcomes, patients' perception, organisational aspects and economic aspects.


Options:
A: Training time (3 month)
B: Clinical COPD Questionnaire (CCQ) (Up to 3 weeks); Timed Up & Go test (TUG) (Up to 3 weeks); The five time sit to stand test (FTSST) (Up to 3 weeks); Patients' falls during training (Up to 3 weeks); Need for acute contact to the general practitioner (Up to 3 weeks); Patient subjective perception (Up to 3 weeks); Costs per patient participating in the telemedicine rehabilitation (Up to 3 weeks); Reimbursement to the hospital (Up to 3 weeks); Focus Group interview (Up to 3 weeks)
C: Change in 6-minute walk test (Baseline, 8 weeks and 12 months)
D: 6 Minutes Walk Test (9 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Telemedicine Training and Counselling After Hospitalization in Patients With Severe Chronic Obstructive Pulmonary Disease: A Feasibility Study
Brief Summary: Chronic obstructive pulmonary disease (COPD) is a widespread disease that can have a major impact on the lives of individuals. An essential element in the treatment of COPD is rehabilitation of which supervised training is an important part. However, not all individuals with severe COPD can participate in the rehabilitation provided by hospitals and municipal training centres due to distance to the training venues and transportation difficulties. The aim of the feasibility study was to evaluate an individualised home based training and counselling programme via video conference to patients with severe COPD after hospitalization with regard to safety, clinical outcomes, patients' perception, organisational aspects and economic aspects.


Options:
A: Functional performance (12 weeks)
B: Improvement in physical activity (1 month)
C: Diabetes Self-efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at Baseline (Baseline); Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF) (3 months); Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at 9-months (9-months)
D: Clinical COPD Questionnaire (CCQ) (Up to 3 weeks); Timed Up & Go test (TUG) (Up to 3 weeks); The five time sit to stand test (FTSST) (Up to 3 weeks); Patients' falls during training (Up to 3 weeks); Need for acute contact to the general practitioner (Up to 3 weeks); Patient subjective perception (Up to 3 weeks); Costs per patient participating in the telemedicine rehabilitation (Up to 3 weeks); Reimbursement to the hospital (Up to 3 weeks); Focus Group interview (Up to 3 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Telemedicine Training and Counselling After Hospitalization in Patients With Severe Chronic Obstructive Pulmonary Disease: A Feasibility Study
Brief Summary: Chronic obstructive pulmonary disease (COPD) is a widespread disease that can have a major impact on the lives of individuals. An essential element in the treatment of COPD is rehabilitation of which supervised training is an important part. However, not all individuals with severe COPD can participate in the rehabilitation provided by hospitals and municipal training centres due to distance to the training venues and transportation difficulties. The aim of the feasibility study was to evaluate an individualised home based training and counselling programme via video conference to patients with severe COPD after hospitalization with regard to safety, clinical outcomes, patients' perception, organisational aspects and economic aspects.


Options:
A: Identifying new patient subtypes and endpoints for COPD (3 years)
B: Clinical COPD Questionnaire (CCQ) (Up to 3 weeks); Timed Up & Go test (TUG) (Up to 3 weeks); The five time sit to stand test (FTSST) (Up to 3 weeks); Patients' falls during training (Up to 3 weeks); Need for acute contact to the general practitioner (Up to 3 weeks); Patient subjective perception (Up to 3 weeks); Costs per patient participating in the telemedicine rehabilitation (Up to 3 weeks); Reimbursement to the hospital (Up to 3 weeks); Focus Group interview (Up to 3 weeks)
C: COPD Assessment Test, CAT, to assess symtoms of COPD (Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
D: Combined number of hospitalizations and emergency department presentations (Two years)

Answer: B