TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Mimi - mHealth to Increase Measles Immunization. A Randomized Controlled Trial.
Brief Summary: The question that this project seeks to answer, is whether mobile phones can be used to increase the measles vaccination coverage and timeliness in Guinea-Bissau. The intervention will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating evidence that could help policy makers making informed decisions about implementing mHealth interventions at a national level.

The intervention takes the form of a randomized controlled trial in which text messages (SMS) as well as voice calls are scheduled and delivered to mo thers to remind and encourage them to have their children timely vaccinated against measles. In addition, the messages will include relevant information about opening hours and availability of the measles vaccine at the mothers' local health facilities thus improving coordination. The trial will include three different randomization groups with approx. 350 participants in each group. The first group will receive SMS messages, the second group will receive a voice call in addition to the SMS messages, and the third group is a control group that does not receive any intervention.

Study participants will be enrolled following birth at one of three health centers in different rural regions of Guinea-Bissau. Before the measles vaccine is scheduled to be given, at 9 months of age, mothers will receive the intervention message depending on their assigned randomization group. When the measles vaccine is administered, the child will be registered as having received the measles vaccination.

A follow-up phone interview will be conducted at 12 months of age for all children participating regardless of randomization group and whether or not they received the measles vaccine. All participating children, who at that time still have not received the measles vaccine, will be offered the vaccine at the expense of the project.


Options:
A: Contraceptive uptake (10 weeks postpartum; 24 weeks postpartum); Facility Delivery (Postpartum); Exclusive Breastfeeding (24 weeks postpartum)
B: MV Coverage at 12 months of age (12 months of age)
C: The primary outcome will measure the number of children who got vaccinated for routine immunization scheduled at 6, 10 and 14 weeks of life (Vaccination status at 20th week of life of the particpants)
D: Increase in immunization coverage in intervention versus control (The outcome will be measured after at least 9 months of follow up of the last participant enrolled); Increase in timeliness of immunization in intervention versus control (The outcome will be measured after at least 9 months of follow up of the last participant enrolled)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mimi - mHealth to Increase Measles Immunization. A Randomized Controlled Trial.
Brief Summary: The question that this project seeks to answer, is whether mobile phones can be used to increase the measles vaccination coverage and timeliness in Guinea-Bissau. The intervention will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating evidence that could help policy makers making informed decisions about implementing mHealth interventions at a national level.

The intervention takes the form of a randomized controlled trial in which text messages (SMS) as well as voice calls are scheduled and delivered to mo thers to remind and encourage them to have their children timely vaccinated against measles. In addition, the messages will include relevant information about opening hours and availability of the measles vaccine at the mothers' local health facilities thus improving coordination. The trial will include three different randomization groups with approx. 350 participants in each group. The first group will receive SMS messages, the second group will receive a voice call in addition to the SMS messages, and the third group is a control group that does not receive any intervention.

Study participants will be enrolled following birth at one of three health centers in different rural regions of Guinea-Bissau. Before the measles vaccine is scheduled to be given, at 9 months of age, mothers will receive the intervention message depending on their assigned randomization group. When the measles vaccine is administered, the child will be registered as having received the measles vaccination.

A follow-up phone interview will be conducted at 12 months of age for all children participating regardless of randomization group and whether or not they received the measles vaccine. All participating children, who at that time still have not received the measles vaccine, will be offered the vaccine at the expense of the project.


Options:
A: Clinic attendance for pills pick up (six months.)
B: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))
C: MV Coverage at 12 months of age (12 months of age)
D: Recent HIV Testing (past 6 months); Condom Use with Clients (Past 1 month); Condom Use with boyfriend/husband/romantic partner (Past 1 month); Contraceptive Prevalence Rate (Past 1 month); Abortion Rate (Past 6 months); Workplace Alcohol Consumption (Past 6 months); Gender-Based harassment rate (Past 6 months); Gender-based violence rate (Past 6 months); STI Screening (Past six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Precision Medicine Guided Treatment for Cancer Pain
Brief Summary: Pain is one of the most burdensome symptoms associated with cancer and its treatment, and opioids are the cornerstone of clinical pain management in cancer patients. Yet, individual patient responses to opioids vary widely, and the patient's genotype contributes to this variability. Specifically, cytochrome P450 2D6 (CYP2D6) genotype has important relevance for response to opioid analgesics that depend on CYP2D6 for bioactivation. Poor metabolizers (PMs) have lower concentrations of active metabolites of codeine (morphine), tramadol (O-desmethyltramadol), oxycodone (oxymorphone), and hydrocodone (hydromorphone), compared to extensive metabolizers (EMs). Morphine and O-desmethyltramadol have 200-fold greater affinity for the µ-opioid receptor than the parent compound, whereas oxymorphone and hydromorphone have 40-fold and 10-fold higher receptor affinity compared to their parent compounds, respectively. Consequently, PMs may fail to derive pain relief from these opioids compared to EMs. Interestingly, the occurrence of side effects may not differ between PMs and EMs so that while PMs may get little to no pain relief from certain opioid analgesics, they may still experience troublesome adverse effects. Intermediate metabolizers (IMs) are also expected to have reduced analgesic response based on their significant reduction in enzyme activity. Conversely, individuals with the UM phenotype may have toxic concentrations of active opioid metabolites, with reports of life-threatening toxicity and death. The µ-opioid receptor gene (OPRM1) is the primary binding site for endogenous opioid peptides and opioid analgesics, and may have additional contributions to opioid response. The investigators propose to examine the effect of CYP2D6 genotype-guided pain management on cancer pain control in study participants and the additional effect of the OPRM1 genotype on response to opioids.


Options:
A: Efficacy variable: Bowel Function Index (BFI) score. Amount of laxative medication use recorded at each assessment visit (4 weeks and a 6 month open label); Efficacy variable: Brief Pain Inventory Short-Form (BPI-SF) (Cleeland, 1991). Amount of analgesic rescue medication used (4 weeks and a 6 month open label)
B: Proportion of Non-Responder (NR) Participants (28 days)
C: Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5. (5 days)
D: Brief Pain Inventory-Short Form (BPI-SF) will be used to evaluate pain management and interference between the groups. (Change in baseline, weeks 2, 4, 6 and 8.); MD Anderson Symptom Inventory (MDASI) will be used to evaluate symptom interference between the groups. (Change in baseline, weeks 2, 4, 6 and 8.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Compared Efficacy of Nurse-led and GP-led Geriatric Assessment in PrImary Care: A Pragmatic Three-arm Cluster Randomized Controlled Trial
Brief Summary: Older patients account for around 10% of the population, of which 57% have a long-term illness, and 33% were admitted in the past year.

Geriatric assessment (GA) is a multidimensional assessment of general health status that can help identifying deficiencies and followed by a personalized care plan.

Assessment and management of elderly patients is a daily concern for the general practitioner (GP) but conflicting results have been reported so far relating to the clinical impact of GA when applied in the primary care setting.

This study protocol aims to assess the effect on morbi-mortality of a complex intervention in patients aged ≥70 years with chronic conditions in primary care. It aims to demonstrate that a GA adapted to primary care, followed by a personalized care plan and combined with successful interprofessional collaboration can improve clinically relevant outcomes in elderly patients with chronic conditions such as one-year overall mortality, unplanned hospital admission, emergency visits, or institutionalization.

The CEPIA study will also help addressing the issue of whether an improved benefit could be achieved from a systematic nurse-led or a case-by-case GP-led GA.


Options:
A: Predicted 10-year CHD risk (4-month follow-up)
B: Medication Adherence - Pill Count (6 months after Baseline); Medication Adherence - Proper Use (6 Months after Baseline); Medication Adherence - ASK12 (6 Months after Baseline)
C: Combined Emergency Department Visits and Inpatient Readmissions (30 days after discharge from hospital); Combined Emergency Department Visits and Inpatient Readmissions (90 days after discharge from hospital); Combined Emergency Department Visits and Inpatient Readmissions (180 days after discharge from hospital)
D: Primary composite endpoint combined with: - Percentage of all-cause mortality - Percentage of Unplanned hospital admission - Percentage of Emergency visits. - Percentage of Institutionalization (At 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioural Group Therapy Versus Individual Supportive Therapy for the Prevention of Repeat Suicide Attempts: a Multicentre, Assessor-blinded, 2-parallel-group, Randomised, Superiority Trial
Brief Summary: The primary objective of this study is to evaluate the efficacy of a program of 6 sessions of Cognitive Behavioural Group Therapy (CBGT) (as compared to 6 sessions of Individual Supportive Therapy (IST)) designed for preventing repeat suicide attempts at 12 months post-psychotherapy in adults admitted to inpatient care for suicide attempts.


Options:
A: Changes in score of Affective Lability Scale (Baseline and then weekly for 12 weeks); Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder (Baseline and then weekly for 12 weeks)
B: Columbia Suicide-Severity Rating Scale (C-SSRS; Posner et al., 2006; Posner et al. 2008). (Baseline and 1, 3, and 6 month follow-up assessments)
C: The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period (12 months)
D: The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 40 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 10 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 20 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 30 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioural Group Therapy Versus Individual Supportive Therapy for the Prevention of Repeat Suicide Attempts: a Multicentre, Assessor-blinded, 2-parallel-group, Randomised, Superiority Trial
Brief Summary: The primary objective of this study is to evaluate the efficacy of a program of 6 sessions of Cognitive Behavioural Group Therapy (CBGT) (as compared to 6 sessions of Individual Supportive Therapy (IST)) designed for preventing repeat suicide attempts at 12 months post-psychotherapy in adults admitted to inpatient care for suicide attempts.


Options:
A: The number of contacts with mental health services appropriate to the patient's needs. (3 months)
B: Suicide behavior defined by self poisoning or other suicidal attempts in the emergency departments of the region. Death by suicide will be identified by the examination of information obtained from the national death statistics office (INSERM). (2 years)
C: The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period (12 months)
D: Changes in scores on Beck's Scale for Suicide Ideation (BSSI) (From baseline to 6 and 12 months after patient is included in the study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioural Group Therapy Versus Individual Supportive Therapy for the Prevention of Repeat Suicide Attempts: a Multicentre, Assessor-blinded, 2-parallel-group, Randomised, Superiority Trial
Brief Summary: The primary objective of this study is to evaluate the efficacy of a program of 6 sessions of Cognitive Behavioural Group Therapy (CBGT) (as compared to 6 sessions of Individual Supportive Therapy (IST)) designed for preventing repeat suicide attempts at 12 months post-psychotherapy in adults admitted to inpatient care for suicide attempts.


Options:
A: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)
B: The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period (12 months)
C: Completion of follow-up (End of treatment at 12 weeks); The fraction of eligible participants who consent to inclusion and randomization (End of treatment at 12 weeks); Compliance (End of treatment at 12 weeks); Non-suicidal self-injury as explorative primary clinical outcome (End of treatment at 12 weeks)
D: Suicidal behavior and ideation (Weeks 4, 12, and 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: State Key Laboratory of Respiratory Disease
Brief Summary: Tai-Chi may be a beneficial form of rehabilitation which is acceptable to the Chinese population but no data exist concerning metabolic responses to Tai-Chi in COPD patients. Investigators conduct an Randomized controlled trial to evaluate the synergistic effect of a Long acting β2-agonists with Tai-Chi as a culturally acceptable form of PR in the Asian population. Classical western style pulmonary rehabilitation will serve as a comparator Investigators propose a prospective randomized controlled trial in which 120 bronchodilator naïve participants (Age 40-80 with GOLD II-IV COPD (post-bronchodilator FEV1 ≥ 25% and \<80 % of the predicted normal, and a post-bronchodilator FEV1/FVC \< 0.70) are randomized to receive a 26 weeks course of Indacaterol with either Tai-Chi or conventional Pulmonary Rehabilitation. Only participants who are residents in Xingning city (Guangdong Province, China) will be recruited.

Both Tai-Chi and pulmonary rehabilitation will be given by qualified instructors at a rural location in southern China (Xingning). A qualified UK Physiotherapist will also be involved in the management of pulmonary rehabilitation program to further make sure the high quality of pulmonary rehabilitation has been applied. Both arm participants will also receive in an open label fashion Indacaterol 150µg qd. for 6 months giving 2 therapy groups (Tai-Chi/Indacaterol, pulmonary rehabilitation/Indacaterol). The primary endpoint of this study is change in SGRQ between Tai-Chi/Indacaterol and pulmonary rehabilitation/Indacaterol at 14 weeks after entry and the secondary endpoints are change in FEV1% and six minute walk distance. the planned recruitment will be 120 with a view to obtaining 100 completers. The investigators propose the study starts on 31 Dec 2014 and completes on 30 June, 2016.


Options:
A: Maximal oxygen consumption (Baseline)
B: change in St. George's Respiratory Questionnaire (SGRQ) (14 weeks after intervention)
C: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)
D: Change From Baseline in Endurance Time (Seconds) (Week 3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Methocarbamol and Orphenadrine for Acute, Non-traumatic, Non-radicular Low Back Pain: A Randomized, Placebo Controlled, 3-armed Study
Brief Summary: Low back pain is a common cause of visit to emergency department. It is not clear if skeletal muscle relaxants are of benefit for patients with acute low back pain. This is a randomized study to determine if skeletal muscle relaxants, when combined with naproxen, improve outcomes more than naproxen alone


Options:
A: Time to First Perceptible Relief (Confirmed by Meaningful Relief) (Baseline (time of wrap application or oral treatment administration) up to 4 hours)
B: Change from Baseline in numerical rating scale of back pain (Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment.)
C: Functional Impairment as Measured on the Roland Morris Disability Questionnaire (1 week)
D: Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake) (Baseline and Day 2)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet-based Versus Face-to-face Clinical Care for Tinnitus: A Multi-study Randomised Control Trial
Brief Summary: The purpose of this study is to compare the effectiveness of a CBT-based internet intervention with face to face standard clinical care for adults with tinnitus in the United Kingdom.


Options:
A: Tinnitus Functional Index (TFI) (Change will be assessed at 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2). The change will be assessed at every test moment.)
B: N/A
C: The Tinnitus Functional Index (At baseline and at 8 weeks post-intervention)
D: Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3) (At baseline and 3, 8 and 12 months follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-Blind, Randomized Control Trial of Adjunctive Transcranial Direct Current Stimulation (tDCS) for Chronic Pain Among Patients Receiving Specialized, Inpatient Multi-Modal Pain Management
Brief Summary: Transcranial direct current stimulation (tDCS) is an investigational device that has not been approved for the treatment of any medical condition by the FDA but is allowed to be used for research purposes. In clinical trials tDCS has been associated with pain relief by decreasing the intensity and duration of chronic pain. tDCS potentially works by stimulating the brain by delivering an extremely low-level electrical current to areas below the forehead - areas associated with chronic pain. It is anticipated that this current will increase brain activity or the likelihood of brain activity in these areas, affecting individual's ability to regulate pain.

The purpose of this study is to compare eligible participants in the Pain Management Program at The Menninger Clinic receiving adjunctive real transcranial Direct Current Stimulation (tDCS) versus those receiving sham tDCS in the resolution of chronic pain. The primary objectives are: (1) improving pain tolerance and (2) improving subjective pain experience. Secondary objectives are: (1) improving subjective experience of sleep quality and (2) increasing physical activity.


Options:
A: Change From Baseline in Visual Analogue Scale (VAS) for Pain Change From Baseline (On a weekly basis: 1) Day 1 (first day of tDCS). 2) Day 8 (after first week with post 5 consecutive sessions of tDCS followed by 2 consecutive days without tDCS). 3) Day 15 (after second week post another 5 sessions of tDCS followed by 2 consecutive days)
B: Change in pain Scores as measured by the Visual Analog Scale (2 months)
C: Changes in the Visual Analog Scale for Phantom Limb Pain (4 weeks)
D: Average Pain (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up); THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up); THE HAMILTON DEPRESSION RATING SCALE (HRDS) (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up)

Answer: A