TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementing Comprehensive PMTCT and HIV Prevention for South African Couples
Brief Summary: This study will test the effectiveness of a behavioral intervention to increase Prevention of Mother-to-Child Transmission of HIV (PMTCT) protocol uptake among South African HIV positive pregnant women. This study will also determine whether the participation of male partners will have additional positive impact on PMTCT uptake. The intervention will utilize a combination of both gender-concordant groups and individual or couples counseling strategies, before and after birth. During antenatal care, the intervention will use a gender-concordant group format to address PMTCT information, HIV disclosure, coping with stigma, intimate partner violence, and adherence to the overall PMTCT protocol. Just prior to birth and following birth, the intervention will shift to individual or couples-based counseling, targeting medication adherence, safer infant feeding, and family planning. It is hypothesized that women attending the intervention will be more likely to properly take HIV medication before birth and provide it to their infants. Additionally, it is hypothesized that male partner involvement will further increase the likelihood that mothers will take their HIV medication as prescribed and provide it to their infants.


Options:
A: Dried Blood Spot Analysis of Medication Adherence- Mother and Infant (32 weeks gestation); Infant HIV Seroconversions (12 months postpartum)
B: Psychiatric diagnosis at 6-month follow-up (6-month follow-up)
C: Remission (i.e. recovery from depression) (6 months post child birth)
D: EPDS (3 and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation by Telephone. Effectiveness and Cost-effectiveness of Proactive and Reactive Services at the Swedish National Tobacco Quitline (SNTQ).
Brief Summary: The purpose of this study was to compare the effectiveness of the high-intensity proactive service with the low-intensity reactive service at the Swedish National Tobacco Quitline (SNTQ). Our hypothesis was that the effectiveness is about 5% higher in proactive than in reactive service.

The structured treatment protocol is a mixture of motivational interviewing (MI), cognitive behavior therapy, and pharmacological consultation.The standard process at the SNTQ is to offer the client a choice of callback (proactive service) or no callback (reactive service). In the present study clients were not offered a choice, but were randomized to proactive service on even dates and to reactive service on odd dates. Data are collected through postal questionnaires, one baseline and one follow-up after 12 months.


Options:
A: Biochemically confirmed 7-day point prevalent smoking abstinence (52 weeks)
B: Treatment Satisfaction (End of treatment (seven weeks after baseline))
C: Point prevalence abstinence (12 months)
D: The primary endpoint will be 6M of abstinence measured 18M after enrollment. (18M)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Does the Use of Ropivacaine Facilitates Cholecystectomy by Laparoscopy in Ambulatory Surgery?
Brief Summary: Since the recommendations of the French Society of Digestive Surgery 2010, cholecystectomy can be performed as outpatient surgery. This approach is difficult in many centers because of post operative pain and nausea/vomiting.

The use of postoperative morphine may be responsible for the state of nausea. The use of ropivacaine allows a reduction of the morphine consumption and thus may allow the patient to have their surgery as an outpatient.

Currently, ropivacaine is used randomly during the investigators surgeries. Initially, it was used for the infiltration holes trocar. In recent years, ropivacaine is used for the reduction of intra-abdominal postoperative pain. Its use is made of parietal surgery ( hernia ) in cholecystectomy and colonic surgery. This mode of administration is allowed to view the many publications made on this subject. Its use in the investigators daily surgery, however, has not been evaluated in ambulatory surgery.


Options:
A: Pain at 6 and 24 hours after surgery measured using the Visual Analogue Scale [VAS] [score 0 to 10, 0 = no pain, 10 = unbearable pain], (6 and 24 hours after surgery)
B: Abdominal Pain in Visual Analogue Scale (VAS 0-100mm) (24 h postoperatively)
C: Postoperative pain measuring using Visual analogue scale at postoperative 2hour (Post op 2 hour)
D: Time to discharge patient after surgery (6 hours postoperative)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Pilates Compared to Pelvic Floor Muscle Training Associated With Electrical Stimulation in the Recovery of Post-prostatectomy Urinary Incontinence: a Randomized Clinical Trial.
Brief Summary: The purpose of this study is to compare the efficacy between a Pilates exercise program and a Pelvic Floor Muscle Training (PFMT) protocol combined with anal electrical stimulation (AES) in the recovery of urinary continence (UI) after radical prostatectomy.

There are no studies that evaluate Pilates mat exercises for incontinence in men although it can be assured that this method has the pelvic floor contractions as a principle for practice. If this new therapeutic approach proves to be as effective as described treatment in improving urinary complaints, it will be an option for patients who prefer a non-invasive treatment.


Options:
A: Effects of transcutaneous perineal stimulation compared to anal stimulation (Baseline, 6 and 10 weeks)
B: Subjective report of urinary continence at 12 months; Incremental cost per quality-adjusted year
C: improves muscle strength of the pelvic floor at 3 months (baseline and 3 months)
D: Change in the number of pads used per day at 3 months (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Transitional Palliative Care Model on Patients With End-stage Heart Failure
Brief Summary: Palliative care for end-stage organ failure patients has been included as one of the key programs to be implemented in 2011-2012 in the Hospital Authority, Hong Kong. Among all the disease groups, end-stage heart failure patients have the highest mortality rate. Patients at the end stage of heart failure have health concerns shared by other end-stage patients including cancer patients. Many guidelines, local and world-wide, have advocated a palliative approach of care for those heart failure patients who are at end stage. Studies have shown that end-stage heart failure patients tend to have frequent emergency room visits and repeated hospital admissions. Also, these patients suffer from a number of health problems that adversely affect their Quality Of Life.

There is scarcity of experimental studies informing practitioners which models work best for palliative patients in Hong Kong. There were randomized controlled trials conducted outside Hong Kong which suggest multidisciplinary approach of palliative care is possible to reduce readmissions but evidence is not present for other outcomes such as symptom control and carer burden.

In an attempt to fill knowledge gap and inform practice using evidence, this study is launched to compare the effects of a customary hospital-based palliative heart failure care and an interventional Home-based Palliative heart failure Program.

Hypothesis

* there is no difference in health care utilization for end-stage heart failure patients between the customary hospital-based group and the Home based palliative heart failure program group
* there is no difference in evaluated health outcomes (functional status, symptom intensity, and satisfaction with care) between the customary hospital-based group and the Home based palliative heart failure program group
* there is no difference in perceived health outcomes (quality of life, caregiver burden) between the customary hospital-based group and the Home based palliative heart failure program group
* there is no difference in cost effectiveness between the customary hospital-based group and the Home based palliative heart failure program group
* there is no difference In patients' lived experiences between the customary hospital-based group and the Home based palliative heart failure program group


Options:
A: Healthcare utilization (up to 12 months)
B: Change in Score on the Edmonton Symptom Assessment for patients (At baseline and 1- and 2- months following baseline); Change in Score on Hospital Anxiety and Depression Scale (HADS) for patients (At baseline and 1- and 2- months following baseline)
C: Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp. (Three months after enrollment.)
D: changes from baseline values of symptom scores on the the Edmonton assessment scale (ESAS) after intervention of 4, 12 and 24 weeks (baseline and after 4, 16 and 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Transitional Palliative Care Model on Patients With End-stage Heart Failure
Brief Summary: Palliative care for end-stage organ failure patients has been included as one of the key programs to be implemented in 2011-2012 in the Hospital Authority, Hong Kong. Among all the disease groups, end-stage heart failure patients have the highest mortality rate. Patients at the end stage of heart failure have health concerns shared by other end-stage patients including cancer patients. Many guidelines, local and world-wide, have advocated a palliative approach of care for those heart failure patients who are at end stage. Studies have shown that end-stage heart failure patients tend to have frequent emergency room visits and repeated hospital admissions. Also, these patients suffer from a number of health problems that adversely affect their Quality Of Life.

There is scarcity of experimental studies informing practitioners which models work best for palliative patients in Hong Kong. There were randomized controlled trials conducted outside Hong Kong which suggest multidisciplinary approach of palliative care is possible to reduce readmissions but evidence is not present for other outcomes such as symptom control and carer burden.

In an attempt to fill knowledge gap and inform practice using evidence, this study is launched to compare the effects of a customary hospital-based palliative heart failure care and an interventional Home-based Palliative heart failure Program.

Hypothesis

* there is no difference in health care utilization for end-stage heart failure patients between the customary hospital-based group and the Home based palliative heart failure program group
* there is no difference in evaluated health outcomes (functional status, symptom intensity, and satisfaction with care) between the customary hospital-based group and the Home based palliative heart failure program group
* there is no difference in perceived health outcomes (quality of life, caregiver burden) between the customary hospital-based group and the Home based palliative heart failure program group
* there is no difference in cost effectiveness between the customary hospital-based group and the Home based palliative heart failure program group
* there is no difference In patients' lived experiences between the customary hospital-based group and the Home based palliative heart failure program group


Options:
A: Is there a change in patient understanding of prognosis with the addition of a palliative care intervention? (6 months)
B: knowledge (5 minutes after survey); preferences (5 minutes after survey)
C: Healthcare utilization (up to 12 months)
D: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) (Baseline, 6 months); Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal) (Baseline, 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Using IT to Improve Access, Communication and Asthma in African American and Hispanic/Latino Adults
Brief Summary: Background: Asthma morbidity is high in inner-city minority adults, despite the existence of efficacious therapy. Tailored, patient-centered interventions are needed to improve access to care and patient-provider communication. Access and communication increasingly rely on information technology (IT) as new incentives arise to use the Electronic Health Record (EHR). The EHR patient portal (PP) gives patients web-based communication with providers and practices. How the poor and those with limited educational opportunities can take advantage of these is unclear. In contrast, the investigators have found that home visits (HVs) by community health workers (CHWs) can improve access to care for children and promote caretaker-clinician communication. The investigators also found many inner-city adults have internet access and are willing to learn to use the PP.

Objective: to examine the benefits for adults of using the PP with and without HVs by CHWs who will encourage/facilitate PP use, understand patients' social context, and enhance communication with the medical team. The investigator hypothesize all patients will benefit from PPs, and that the addition of HVs will be particularly helpful for those with low literacy or language barriers. Specific Aims test if the 1-year interventions result in 1) better within-group asthma outcomes, 2) better outcomes in one group over the other, 3) more communication (use of PP) and access (appointments made and kept) which mediate the interventions' effects on asthma outcomes, and 4) effect modification by literacy level, primary language, and convenience of internet access.

Methods: In a randomized controlled trial, 301 adults, predominantly African American and Hispanic/Latino, with uncontrolled asthma recruited from low income urban neighborhoods will be assured internet access and taught to use the PP, with and without HVs from a CHW. CHWs will 1) train patients to competency in PP use, 2) enhance care coordination, 3) transmit a view of the complex social circumstances of patients' lives to providers, and 4) make up for differences in patients' health literacy skills.

Patient Outcomes are asthma control, asthma-related quality of life, emergency department (ED) visits, and hospitalizations for asthma or any cause. Together asthma and other health conditions affect patients' ability to perform their daily tasks and care for their families. Potential benefits of the intervention are enhanced patient-clinician communication, access to care, improved health, and ability to use IT.


Options:
A: Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI) (12 months)
B: Systolic blood pressure (9 months); Diastolic blood pressure (9 months)
C: Severity and duration of symptom distress (At baseline and at 2, 4, 6, 8 and 12 months); Anxiety and depression (At baseline an at 2, 4, 6, 8 and 12 months)
D: Score of Asthma Control Questionnaire (baseline and over a year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Using IT to Improve Access, Communication and Asthma in African American and Hispanic/Latino Adults
Brief Summary: Background: Asthma morbidity is high in inner-city minority adults, despite the existence of efficacious therapy. Tailored, patient-centered interventions are needed to improve access to care and patient-provider communication. Access and communication increasingly rely on information technology (IT) as new incentives arise to use the Electronic Health Record (EHR). The EHR patient portal (PP) gives patients web-based communication with providers and practices. How the poor and those with limited educational opportunities can take advantage of these is unclear. In contrast, the investigators have found that home visits (HVs) by community health workers (CHWs) can improve access to care for children and promote caretaker-clinician communication. The investigators also found many inner-city adults have internet access and are willing to learn to use the PP.

Objective: to examine the benefits for adults of using the PP with and without HVs by CHWs who will encourage/facilitate PP use, understand patients' social context, and enhance communication with the medical team. The investigator hypothesize all patients will benefit from PPs, and that the addition of HVs will be particularly helpful for those with low literacy or language barriers. Specific Aims test if the 1-year interventions result in 1) better within-group asthma outcomes, 2) better outcomes in one group over the other, 3) more communication (use of PP) and access (appointments made and kept) which mediate the interventions' effects on asthma outcomes, and 4) effect modification by literacy level, primary language, and convenience of internet access.

Methods: In a randomized controlled trial, 301 adults, predominantly African American and Hispanic/Latino, with uncontrolled asthma recruited from low income urban neighborhoods will be assured internet access and taught to use the PP, with and without HVs from a CHW. CHWs will 1) train patients to competency in PP use, 2) enhance care coordination, 3) transmit a view of the complex social circumstances of patients' lives to providers, and 4) make up for differences in patients' health literacy skills.

Patient Outcomes are asthma control, asthma-related quality of life, emergency department (ED) visits, and hospitalizations for asthma or any cause. Together asthma and other health conditions affect patients' ability to perform their daily tasks and care for their families. Potential benefits of the intervention are enhanced patient-clinician communication, access to care, improved health, and ability to use IT.


Options:
A: Patient Adherence to Inhaled Corticosteroids (ICS) (1 year)
B: Asthma control - as measured by the Asthma Control Test (Measured at Year 1)
C: Average Number of Days Without Asthma Symptoms (Symptom Free Days) (Average number of days, over 2 weeks, during peak winter season (November-March), assessed over 4 years.)
D: Score of Asthma Control Questionnaire (baseline and over a year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Clinical Feasibility Study of Red Cell Transfusion Goals in Patients With Acute Leukemias
Brief Summary: The purpose of this study to determine if a lower hemoglobin transfusion threshold, 7 g/dL, has a safety profile similar to that of the current standard transfusion threshold of 8 g/dL.


Options:
A: Incidence of death or major neurodevelopmental impairment (24 months of age corrected for prematurity)
B: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)
C: Physical Fatigue (on day 3 postpartum)
D: A Composite of In-hospital Postoperative Morbidity and Mortality (After surgery until hosptal discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Clinical Feasibility Study of Red Cell Transfusion Goals in Patients With Acute Leukemias
Brief Summary: The purpose of this study to determine if a lower hemoglobin transfusion threshold, 7 g/dL, has a safety profile similar to that of the current standard transfusion threshold of 8 g/dL.


Options:
A: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)
B: Adherence to the study protocol (up to 28 days)
C: Incidence of Blood Stream Infection (1 week after randomization and weekly thereafter through discarge from hospital)
D: Amount of FFP (Fresh Frozen Plasma) transfusion in both groups (42 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Clinical Feasibility Study of Red Cell Transfusion Goals in Patients With Acute Leukemias
Brief Summary: The purpose of this study to determine if a lower hemoglobin transfusion threshold, 7 g/dL, has a safety profile similar to that of the current standard transfusion threshold of 8 g/dL.


Options:
A: FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status (Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion)
B: Randomization Rate (12 months)
C: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
D: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Clinical Feasibility Study of Red Cell Transfusion Goals in Patients With Acute Leukemias
Brief Summary: The purpose of this study to determine if a lower hemoglobin transfusion threshold, 7 g/dL, has a safety profile similar to that of the current standard transfusion threshold of 8 g/dL.


Options:
A: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)
B: Number of severe complications (grade 3 or more) (up to 1 month after the last day of hospitalization)
C: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
D: The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion (30 days after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Clinical Feasibility Study of Red Cell Transfusion Goals in Patients With Acute Leukemias
Brief Summary: The purpose of this study to determine if a lower hemoglobin transfusion threshold, 7 g/dL, has a safety profile similar to that of the current standard transfusion threshold of 8 g/dL.


Options:
A: Composite end-point of mortality and severe complication (30 days)
B: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)
C: Physical Fatigue (on day 3 postpartum)
D: Mortality at the 45th day (45 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Clinical Feasibility Study of Red Cell Transfusion Goals in Patients With Acute Leukemias
Brief Summary: The purpose of this study to determine if a lower hemoglobin transfusion threshold, 7 g/dL, has a safety profile similar to that of the current standard transfusion threshold of 8 g/dL.


Options:
A: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)
B: Postoperative Functional mobility; Restricting factors for functional mobility
C: Overall adherence to the transfusion strategies defined as adherence to the transfusion strategies in 90% of patients in more than 90% of their days in hospital. (Day of surgery through to hospital discharge.)
D: Mortality at the 45th day (45 days)

Answer: A