TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Developing and Scaling a Text Messaging Tool to Help Pregnant Smokers
Brief Summary: The goal of this project is to evaluate the effectiveness (Phase II) of a text-based program to be called Quit4Baby to support smoking cessation efforts of pregnant women who smoke.

In Phase II, Dr. Abroms will conduct a randomized clinical trial among 500 pregnant smokers who have been recruited from users of text4baby - the first large scale mobile health application in the United States. Developed and operated by Voxiva and Healthy Mothers, Healthy Babies (HMHB)-collaborators in this program -text4baby is a free national service that has enrolled more than 800,000 pregnant women and mothers of infants 0-1 nationwide and delivered more than 150 million health messages to them including messages encouraging them not to smoke during pregnancy and referring them to quit lines.

Hypothesis 1: Pregnant smokers who receive quit4Baby + text4Baby will demonstrate higher levels of knowledge about the dangers of second hand smoke and the benefits of smoking cessation for mothers and their infants than text4baby only users.

Hypothesis 2: Pregnant smokers who receive quit4baby + text4baby will report significantly higher rates of calling a quit line, discussions with their health provider and/or use of cessation counseling than those who receive Text4baby alone.

Hypothesis 3: Pregnant smokers who receive quit4baby + text4baby will have significantly more favorable quitting outcomes compared with text4baby alone.


Options:
A: Biometrically confirmed abstinence (3-6 months); Quitline call rates (1-6 months); Knowledge as measured by survey items (1-6 months)
B: Immunization Rate (12 months)
C: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)
D: Measles vaccination coverage (10 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Developing and Scaling a Text Messaging Tool to Help Pregnant Smokers
Brief Summary: The goal of this project is to evaluate the effectiveness (Phase II) of a text-based program to be called Quit4Baby to support smoking cessation efforts of pregnant women who smoke.

In Phase II, Dr. Abroms will conduct a randomized clinical trial among 500 pregnant smokers who have been recruited from users of text4baby - the first large scale mobile health application in the United States. Developed and operated by Voxiva and Healthy Mothers, Healthy Babies (HMHB)-collaborators in this program -text4baby is a free national service that has enrolled more than 800,000 pregnant women and mothers of infants 0-1 nationwide and delivered more than 150 million health messages to them including messages encouraging them not to smoke during pregnancy and referring them to quit lines.

Hypothesis 1: Pregnant smokers who receive quit4Baby + text4Baby will demonstrate higher levels of knowledge about the dangers of second hand smoke and the benefits of smoking cessation for mothers and their infants than text4baby only users.

Hypothesis 2: Pregnant smokers who receive quit4baby + text4baby will report significantly higher rates of calling a quit line, discussions with their health provider and/or use of cessation counseling than those who receive Text4baby alone.

Hypothesis 3: Pregnant smokers who receive quit4baby + text4baby will have significantly more favorable quitting outcomes compared with text4baby alone.


Options:
A: Biometrically confirmed abstinence (3-6 months); Quitline call rates (1-6 months); Knowledge as measured by survey items (1-6 months)
B: Use of long acting and reversible contraceptive at 4 months (4 months)
C: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))
D: Immunization Rate (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Quit4Baby: Reaching Pregnant Smokers With Health Information Via Text
Brief Summary: Despite the great health benefits associated with smoking cessation in pregnancy to both mother and baby, few studies to date have examined the applications of text messaging or other communication technologies for smoking cessation in this population. This project is the first step in developing a new dissemination strategy for reaching pregnant smokers. This research will explore how a state-of -the-art, interactive and intensive, text messaging program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers. This program may have the potential to reach pregnant smokers who are not currently being reached with traditional smoking cessation services. The study Aims are: 1) to elicit qualitative feedback from pregnant smokers and recent quitters (in the past month) about the concept of SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed messages in SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of SmokefreeMoms which is consistent with Clinical Practice Guidelines (Phase 2), and 3) To conduct a formative evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent quitters (Phase 3). 4) To measure the likelihood that pregnant women who smoke cigarettes will join an SMS program by responding to different types of recruitment messages.


Options:
A: Smoking Abstinence (3 months)
B: ART Adherence at 20 Weeks as Determined by VAS, Viral Load (20week [End of study]); ART Adherence at 20 Weeks as Determined by Pill Counts, ACTG Adherence Questionnaire, and VAS Scores (20week [End of study]); ART Adherence at 20 Weeks as Determined by Viral Load Count (20 week [End of study]); ART Adherence at 20 Weeks as Determined by Log of Viral Load Count (20week [End of study])
C: Number of Participants Who Report Starting Any Modern Method of Contraception Since the Start of the Study (4-months post-encouragement)
D: Measles - 2 Completion (When the participants reach 2 years of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Quit4Baby: Reaching Pregnant Smokers With Health Information Via Text
Brief Summary: Despite the great health benefits associated with smoking cessation in pregnancy to both mother and baby, few studies to date have examined the applications of text messaging or other communication technologies for smoking cessation in this population. This project is the first step in developing a new dissemination strategy for reaching pregnant smokers. This research will explore how a state-of -the-art, interactive and intensive, text messaging program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers. This program may have the potential to reach pregnant smokers who are not currently being reached with traditional smoking cessation services. The study Aims are: 1) to elicit qualitative feedback from pregnant smokers and recent quitters (in the past month) about the concept of SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed messages in SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of SmokefreeMoms which is consistent with Clinical Practice Guidelines (Phase 2), and 3) To conduct a formative evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent quitters (Phase 3). 4) To measure the likelihood that pregnant women who smoke cigarettes will join an SMS program by responding to different types of recruitment messages.


Options:
A: Attendance for Early infant diagnosis (EID) of HIV (1 year); Early identification of HEI at Reproductive and Child Health (RCH) Clinic (1 year); Antenatal care (ANC) visits (1 year); Facility delivery (1 year); Post natal care (PNC) visits (1 year); Nevirapine (NVP) at delivery (1 year)
B: Smoking Abstinence (3 months)
C: Use of long acting and reversible contraceptive at 4 months (4 months)
D: Proportion of Patients Who Receive a Pap Test at End of Follow up (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Quit4Baby: Reaching Pregnant Smokers With Health Information Via Text
Brief Summary: Despite the great health benefits associated with smoking cessation in pregnancy to both mother and baby, few studies to date have examined the applications of text messaging or other communication technologies for smoking cessation in this population. This project is the first step in developing a new dissemination strategy for reaching pregnant smokers. This research will explore how a state-of -the-art, interactive and intensive, text messaging program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers. This program may have the potential to reach pregnant smokers who are not currently being reached with traditional smoking cessation services. The study Aims are: 1) to elicit qualitative feedback from pregnant smokers and recent quitters (in the past month) about the concept of SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed messages in SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of SmokefreeMoms which is consistent with Clinical Practice Guidelines (Phase 2), and 3) To conduct a formative evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent quitters (Phase 3). 4) To measure the likelihood that pregnant women who smoke cigarettes will join an SMS program by responding to different types of recruitment messages.


Options:
A: Difference in Number and proportion of adults responding to standard appointment versus intense follow up. (2 weeks)
B: Smoking Abstinence (3 months)
C: Vaccines received (Electronic Health Record) (up to a year of follow up)
D: Excessive weight gain (0-6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Quit4Baby: Reaching Pregnant Smokers With Health Information Via Text
Brief Summary: Despite the great health benefits associated with smoking cessation in pregnancy to both mother and baby, few studies to date have examined the applications of text messaging or other communication technologies for smoking cessation in this population. This project is the first step in developing a new dissemination strategy for reaching pregnant smokers. This research will explore how a state-of -the-art, interactive and intensive, text messaging program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers. This program may have the potential to reach pregnant smokers who are not currently being reached with traditional smoking cessation services. The study Aims are: 1) to elicit qualitative feedback from pregnant smokers and recent quitters (in the past month) about the concept of SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed messages in SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of SmokefreeMoms which is consistent with Clinical Practice Guidelines (Phase 2), and 3) To conduct a formative evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent quitters (Phase 3). 4) To measure the likelihood that pregnant women who smoke cigarettes will join an SMS program by responding to different types of recruitment messages.


Options:
A: Smoking Abstinence (3 months)
B: Exhaled Carbon Monoxide Levels (1 month)
C: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Quit4Baby: Reaching Pregnant Smokers With Health Information Via Text
Brief Summary: Despite the great health benefits associated with smoking cessation in pregnancy to both mother and baby, few studies to date have examined the applications of text messaging or other communication technologies for smoking cessation in this population. This project is the first step in developing a new dissemination strategy for reaching pregnant smokers. This research will explore how a state-of -the-art, interactive and intensive, text messaging program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers. This program may have the potential to reach pregnant smokers who are not currently being reached with traditional smoking cessation services. The study Aims are: 1) to elicit qualitative feedback from pregnant smokers and recent quitters (in the past month) about the concept of SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed messages in SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of SmokefreeMoms which is consistent with Clinical Practice Guidelines (Phase 2), and 3) To conduct a formative evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent quitters (Phase 3). 4) To measure the likelihood that pregnant women who smoke cigarettes will join an SMS program by responding to different types of recruitment messages.


Options:
A: Smoking Abstinence (3 months)
B: Overall MEMS Adherence to Antiretroviral Medication (6 weeks); MEMS Adherence to Antiretroviral Medication Based on Dose Timing (6 weeks)
C: Exclusive breastfeeding (0-6 months following delivery); Immediate breastfeeding (1 hour following delivery)
D: Proportion of women who received a Pap smear within 6 months from the date when the study randomization began. (6 months after randomization of study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More? Randomized Controlled Trial to Evaluate Patient Satisfaction and Cost-effectiveness of a Reduced Follow-up Schedule
Brief Summary: Background: It has often been hypothesized that the frequency of follow-up for patients with early-stage endometrial cancer could be decreased. However, studies evaluating effects of a reduced follow-up schedule among this patient group are lacking.

Objective: Assess patient satisfaction and cost-effectiveness of a less frequent follow-up schedule compared to the schedule according to the Dutch guideline.

Study design: Dutch multicentre randomized controlled trial with a 5 year follow-up. Patients (n=282) are randomized in an intervention group with 4 follow-up visits during 3 years, and a control group with 10-13 follow-up visits during 5 years, according to the Dutch guideline. Patients are asked to fill out a questionnaire at baseline, 6, 12, 36 and 60 months. Patient inclusion will take two years (if 60% of the patients participate).

Outcomes: Primary: Patient satisfaction with follow-up care and cost-effectiveness.

Secondary: health care use, adherence to schedule, health-related quality of life, fear of recurrence, anxiety and depression, information provision, recurrence, survival

Patients: Stage 1A and 1B low-risk endometrial cancer patients, for whom adjuvant radiotherapy is not indicated

Statistics: linear regression analyses to assess differences in patient satisfaction with follow-up care between intervention and control group adjusted for potential pre-defined confounders.

Expected results: Patients in the intervention arm have a similar satisfaction with follow-up care and overall outcomes, but lower health care use and costs than patients in the control arm. No effects are expected on QALY differences (losses) and satisfaction, but the reduced schedule is expected to save 144.000 per year in the Netherlands.


Options:
A: Change in FACIT-TS questionnaire score (Baseline, 6 months)
B: Overall Survival (OS) (5-year OS); Health Related Quality of Life (Yearly assessment over 5 years)
C: Subscale quality of life of the questionnaire: EORTC QLQ C30 (After each treatment completion, during follow up; first year every 3 months, second year every 6 months)
D: Patient satisfaction with follow-up care (up to 60 months after completion of primary treatment); Costs-effectiveness (assessed at 60 months after completion of primary treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in Critical Care Unit
Brief Summary: The aim of this study is to demonstrate that the rate of successful orotracheal intubation at first laryngoscopy will be higher in patients intubated with McGrath Mac videolaryngoscope compared to patients intubated with classical Macintosh laryngoscope in patients requiring an orotracheal intubation in ICU.


Options:
A: Required dose of opioid to counteract nociceptive stimulation (1 hour)
B: Classification of Glottis Visualization (At intubation)
C: Proportion of successful orotracheal intubation at first laryngoscopy (intubation procedure, an expected average of 15 minutes)
D: risk of failure on the first attempt of endotracheal intubation

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Controlled, Cross-over Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy
Brief Summary: This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of the new amino acid-based formula in infants and children aged\< 12 years with documented cow's milk protein allergy (CMPA).


Options:
A: Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height² (At age 11 years and 18 years)
B: Weight (14 days of age to 112 days of age)
C: The primary outcome is growth velocity for first 28 days of life calculated as: weight gain, head circumference, length
D: Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula (14 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children
Brief Summary: Children hospitalized with severe illness in sub-Saharan Africa are at high risk of morbidity and mortality following discharge from hospital. These children represent an accessible high-risk population in which targeted interventions to prevent morbidity and mortality could have dramatic impact. A large cluster randomized trial of azithromycin delivered in a mass drug administration program within trachoma endemic areas in sub-Saharan Africa demonstrated an almost 50% mortality benefit in children 1-9 years of age in treated communities. However, mass drug administration of azithromycin leads to the rapid emergence of macrolide resistance within treated communities and is expensive. The targeted delivery of azithromycin to children at hospital discharge may be a novel and practical intervention to maximize benefit while minimizing risk of antibiotic resistance. This is a randomized, double-blind, placebo-controlled trial to determine the efficacy of azithromycin provided at discharge, compared to placebo, in reducing mortality and re-hospitalization rates in children age 1-59 months in Kenya. The study will also investigate potential mechanisms by which azithromycin may reduce morbidity and mortality in this population and will assess the emergence of antibiotic resistance among treated individuals and their primary caregivers. A cost-effectiveness analysis of the intervention will also be conducted.


Options:
A: Exacerbation Frequency; Airway Inflammation
B: Immediately after intubation an upper GI endoscopy will be done. The following primary endpoint will be recorded: Stomach clear from any content: yes or no (dichotomous). (10 minutes)
C: Re-hospitalization or Death (6 months)
D: Diary card summary symptom score (10 days after randomisation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of a Brief Intervention for Medically Hospitalized Suicide Attempt Survivors
Brief Summary: The current study proposes to study the feasibility and acceptability of a brief psychosocial intervention delivered to suicide attempt survivors hospitalized on a medical/surgical floor or inpatient psychiatry unit at Vanderbilt University Medical Center. The proposed study will involve training of care providers affiliated with Vanderbilt University Medical Center to deliver the brief intervention. Additionally, the participants will complete baseline, 1, 3, and 12-month assessments on outcomes of interest, including readiness to change problematic behaviors, engagement in outpatient mental health services, suicidal ideation, self-harming behavior, and reasons for living.


Options:
A: Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008) (one year); Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010) (one year); Coping Styles and Strategies Scale (COPE) (Crespo 1997) (one year)
B: EPs during BART (Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS)
C: Client Satisfaction Questionnaire (Immediately following Brief Intervention)
D: Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale (Weeks 1-12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of a Brief Intervention for Medically Hospitalized Suicide Attempt Survivors
Brief Summary: The current study proposes to study the feasibility and acceptability of a brief psychosocial intervention delivered to suicide attempt survivors hospitalized on a medical/surgical floor or inpatient psychiatry unit at Vanderbilt University Medical Center. The proposed study will involve training of care providers affiliated with Vanderbilt University Medical Center to deliver the brief intervention. Additionally, the participants will complete baseline, 1, 3, and 12-month assessments on outcomes of interest, including readiness to change problematic behaviors, engagement in outpatient mental health services, suicidal ideation, self-harming behavior, and reasons for living.


Options:
A: 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)
B: suicide/attempted suicide (12 months)
C: Client Satisfaction Questionnaire (Immediately following Brief Intervention)
D: Deliberate Self-harm Inventory (DSHI; Gratz, 2001) and Lifetime Suicide Attempt Self-Injury interview (LSASI; formerly Lifetime Parasuicide Count, Linehan MM, Comtois KA, unpublished manuscript, 1996) (baseline; 10 weeks; 20 weeks; 3 month follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of a Brief Intervention for Medically Hospitalized Suicide Attempt Survivors
Brief Summary: The current study proposes to study the feasibility and acceptability of a brief psychosocial intervention delivered to suicide attempt survivors hospitalized on a medical/surgical floor or inpatient psychiatry unit at Vanderbilt University Medical Center. The proposed study will involve training of care providers affiliated with Vanderbilt University Medical Center to deliver the brief intervention. Additionally, the participants will complete baseline, 1, 3, and 12-month assessments on outcomes of interest, including readiness to change problematic behaviors, engagement in outpatient mental health services, suicidal ideation, self-harming behavior, and reasons for living.


Options:
A: Occurrence of suicidal event assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (6 months)
B: Client Satisfaction Questionnaire (Immediately following Brief Intervention)
C: Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6 (Baseline, Week 1, Week 2, Week 3, Week 4, Week 5)
D: Suicide Attempt Self Injury Interview SASII (Change in scores from baseline to 12th months)

Answer: B