TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial to Compare Antenatal Preparation and Postnatal Counseling Strategies for Improving Breastfeeding Rates
Brief Summary: This is a randomised controlled trial to compare antenatal preparation and postnatal counseling strategies for improving breastfeeding rates.

The objectives are:

1. to study the effect of a standard two-encounter postnatal lactation counseling protocol on the initiation and maintenance of exclusive breastfeediing in mothers
2. to compare the effect of a standard two-encounter postnatal lactation counseling protocol with a single-encounter antenatal breastfeeding education protocol on the initiation and maintenance of exclusive breastfeeding in mothers.


Options:
A: The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at baseline); The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at 3 weeks postpartum); The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at 3 months postpartum); The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at 6 months postpartum)
B: Percent of infants sleeping 5 consecutive hours at night at 2 months of age (2.5 years)
C: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)
D: Study the effect of a standard two-encounter postnatal lactation counseling protocol on the initiation and maintenance of exclusive breastfeeding in mothers

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Combined Intervention After Traumatic Injury
Brief Summary: This study will evaluate the effectiveness of patient-centered collaborative care that combines behavioral therapy and drug therapy as compared to usual care in reducing symptoms of post-traumatic stress disorder in people who have survived a traumatic injury.


Options:
A: Hospital Anxiety and Depression Scale - Depression Scale at Baseline (Baseline); Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up (Six-months follow-up); Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up (Twelve-months follow-up); Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline (Baseline); Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up (Six-months follow-up); Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Total Score at Baseline (Baseline); Impact of Events Scale-Revised - Total Score at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Total Score at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Intrusiveness Scale at Baseline (Baseline); Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Avoidance Scale at Baseline (Baseline); Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Event Scale-Revised Hyperarousal Scale at Baseline (Baseline); Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up (Six-months follow-up); Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up (Twelve-months follow-up); Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline (Baseline); Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up (Six-months follow-up); Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up (Twelve-months follow-up)
B: Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. (Change from baseline at weeks 2, 6 and 12)
C: Feasibility - enrollment of 1-2 participants per month (One year)
D: PTSD ratings (Measured at Year 1); Substance use (Measured at Year 1); General functioning reports (Measured at Year 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ATLAS: Ambulatory Treatments for Leakage Associated With Stress, A Randomized Trial of Pelvic Muscle Exercise Versus Incontinence Pessary Versus Both for Women With Stress or Mixed Urinary Incontinence
Brief Summary: Stress urinary incontinence is the uncontrollable leakage of urine with physical effort or stress, such as coughing, sneezing, or exercise. Treatment for stress incontinence can be surgical or non-surgical. Different non-surgical treatments include pelvic muscle exercises and pessary use. Pelvic muscle exercises (often known as "Kegel" exercises) train and strengthen the pelvic muscles and improve incontinence. A pessary is a medical device that fits inside the vagina to give the urethra and bladder extra support and prevent or reduce urinary incontinence. Exercises and pessary use can help women with stress incontinence but it is not known which treatment is better, or if a combination of the two treatments at the same time is best. This study will determine whether pelvic muscle training and exercises, pessary use, or a combination of both exercises and pessary is most effective at improving incontinence in women. The study's primary hypothesis is that pessary use is more effective than pelvic muscle exercises after 3 months of treatment.


Options:
A: urgencyepisodes (after 2 month (end of study)); urgeincontinence (after 2 month (studyend)); VAS score from ICI_OAB_Q (after 2 month (studyend))
B: Difference in the % of patients maintaining persistence between no intervention and HEI group (6 months)
C: "Much Better" or "Very Much Better" on PGI-I at 3 Months (Outcome was measured at three months following randomization.); No Bothersome Stress Incontinence Symptoms at 3 Months (Outcome was measured at three months following randomization.)
D: Overactive bladder-validated 8-questions (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: ATLAS: Ambulatory Treatments for Leakage Associated With Stress, A Randomized Trial of Pelvic Muscle Exercise Versus Incontinence Pessary Versus Both for Women With Stress or Mixed Urinary Incontinence
Brief Summary: Stress urinary incontinence is the uncontrollable leakage of urine with physical effort or stress, such as coughing, sneezing, or exercise. Treatment for stress incontinence can be surgical or non-surgical. Different non-surgical treatments include pelvic muscle exercises and pessary use. Pelvic muscle exercises (often known as "Kegel" exercises) train and strengthen the pelvic muscles and improve incontinence. A pessary is a medical device that fits inside the vagina to give the urethra and bladder extra support and prevent or reduce urinary incontinence. Exercises and pessary use can help women with stress incontinence but it is not known which treatment is better, or if a combination of the two treatments at the same time is best. This study will determine whether pelvic muscle training and exercises, pessary use, or a combination of both exercises and pessary is most effective at improving incontinence in women. The study's primary hypothesis is that pessary use is more effective than pelvic muscle exercises after 3 months of treatment.


Options:
A: Vaginal infections (60 weeks)
B: Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains. (baseline and 2-12 weeks after treatment (at time of surgery))
C: "Much Better" or "Very Much Better" on PGI-I at 3 Months (Outcome was measured at three months following randomization.); No Bothersome Stress Incontinence Symptoms at 3 Months (Outcome was measured at three months following randomization.)
D: Patient satisfaction (At 6 months from study enrollment); Patient satisfaction (At 12 months from study enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Naltrexone in Women's Smoking Cessation
Brief Summary: The purpose of the proposed study is to conduct a randomized, double-blind clinical trial to compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard smoking cessation treatment with nicotine patch and counseling.

Hypotheses:

1. Naltrexone will improve smoking cessation quit rates, as measured at the end of active treatment (3 months) and during long term follow up (1 year).
2. Weight and smoking-related variables (i.e., less weight gain, as well as reduced craving and withdrawal) will be important factors by which naltrexone improves smoking cessation outcome.
3. These effects are predicted to be stronger in women compared to men.


Options:
A: Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date (4 Weeks Following Smoking Quit Date (Study week 7)); Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date (12 Weeks Following Smoking Quit Date (Study week 15)); 7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date (4 Weeks Following Smoking Quit Date (Study week 7)); 7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date (12 Weeks Following Smoking Quit Date (Study week 15)); 7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date (26 Weeks Following Smoking Quit Date (Study week 29)); 7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date (52 Weeks Following Smoking Quit Date (Study week 55))
B: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
C: Summarization of safety data in smokers treated with either varenicline or placebo.
D: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse
Brief Summary: The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.


Options:
A: To evaluate the ability of the VCM to treat pelvic organ prolapse as demonstrated by improvement of cystocele as measured by a comparison of POP-Q scores pre and post surgery (2 years)
B: Anatomical success rates 1 year after surgery to correct pelvic organ prolapse with the Avaulta synthetic mesh kit (1 year post operatively)
C: Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months (12 months)
D: Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery (4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse
Brief Summary: The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.


Options:
A: Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr. (one year)
B: Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence (3 months post-surgery); Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery (12 months post-surgery)
C: Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery (4 years)
D: Anatomical success rates 1 year after surgery to correct pelvic organ prolapse with the Avaulta synthetic mesh kit (1 year post operatively)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)
Brief Summary: Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. The purpose of the REVERSE clinical trial is to determine whether pacing in both the left and right ventricles using Cardiac Resynchronization Therapy (CRT) can help slow the progression of heart failure in people who have mild or previous symptoms and poor heart pumping function. This kind of therapy has previously been shown to reduce symptoms and improve exercise capacity in people with more advanced forms of heart failure.


Options:
A: Incidences of Appropriate Therapies (ATP and Shocks) and ICD-Related Complications (3-year)
B: Percentage of Patients Worsened for Clinical Composite Response (12 Months)
C: N/A
D: All cause mortality (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal Opioid Treatment: Human Experimental Research
Brief Summary: Children born to women who abuse drugs have a high risk of being born with birth defects and developmental problems. Methadone is a drug that is commonly used for treating opioid dependence. However, its use by a pregnant woman can cause severe withdrawal symptoms in a newborn because of the prenatal exposure. The purpose of this study is to evaluate the effectiveness of buprenorphine, another drug, versus methadone in reducing withdrawal symptoms in children born to opioid-dependent women.


Options:
A: Number of Participants Administered Morphine Treatment (Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days); Cumulative Pharmacological Treatment- Morphine Dose (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Hospitalization Length of Stay (Day of life infants discharged home, which is an expected mean of 21 days.); Hospitalization Length of Stay for Untreated Infants (Day of life untreated infants discharged home, which is an expected mean of 21 days.); Hospitalization Length of Stay for Treated Infants (Day of life treated infants discharged home, which is an expected mean of 21 days.); Length of Pharmacological Treatment-Duration (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Trajectory of Symptom Severity Among Treated Infants (Day of life infant started morphine treatment); Velocity of Weight Gain (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Neurobehavioral Outcomes Assessment (6 month and 12 months of life)
B: Length of treatment (From initiation of medical treatment through last dose of medication given, up to 100 days)
C: Length of Hospital Stay (assessed at hospital discharge, approximately 7-30 days)
D: Child's Head Circumference Measurement (Measured at Birth) (birth); Child's Length of Hospital Stay (delivery until hospital discharge (min=2 days, max=79 days)); Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) (From birth until hospital discharge (min=4 days, max=10, depending on site)); Child's Peak Daily Total NAS Score (minimum twice daily from birth until NAS no longer measured (min=10 days)); Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS (Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal Opioid Treatment: Human Experimental Research
Brief Summary: Children born to women who abuse drugs have a high risk of being born with birth defects and developmental problems. Methadone is a drug that is commonly used for treating opioid dependence. However, its use by a pregnant woman can cause severe withdrawal symptoms in a newborn because of the prenatal exposure. The purpose of this study is to evaluate the effectiveness of buprenorphine, another drug, versus methadone in reducing withdrawal symptoms in children born to opioid-dependent women.


Options:
A: Number of Participants Administered Morphine Treatment (Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days); Cumulative Pharmacological Treatment- Morphine Dose (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Hospitalization Length of Stay (Day of life infants discharged home, which is an expected mean of 21 days.); Hospitalization Length of Stay for Untreated Infants (Day of life untreated infants discharged home, which is an expected mean of 21 days.); Hospitalization Length of Stay for Treated Infants (Day of life treated infants discharged home, which is an expected mean of 21 days.); Length of Pharmacological Treatment-Duration (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Trajectory of Symptom Severity Among Treated Infants (Day of life infant started morphine treatment); Velocity of Weight Gain (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Neurobehavioral Outcomes Assessment (6 month and 12 months of life)
B: Duration of treatment (0 to 42 days)
C: Child's Head Circumference Measurement (Measured at Birth) (birth); Child's Length of Hospital Stay (delivery until hospital discharge (min=2 days, max=79 days)); Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) (From birth until hospital discharge (min=4 days, max=10, depending on site)); Child's Peak Daily Total NAS Score (minimum twice daily from birth until NAS no longer measured (min=10 days)); Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS (Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days))
D: Sublingual Buprenorphine safety and tolerability in the neonate (Index hospitalization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal Opioid Treatment: Human Experimental Research
Brief Summary: Children born to women who abuse drugs have a high risk of being born with birth defects and developmental problems. Methadone is a drug that is commonly used for treating opioid dependence. However, its use by a pregnant woman can cause severe withdrawal symptoms in a newborn because of the prenatal exposure. The purpose of this study is to evaluate the effectiveness of buprenorphine, another drug, versus methadone in reducing withdrawal symptoms in children born to opioid-dependent women.


Options:
A: Number of Participants Retained in Treatment (6 months)
B: Time to resumption of heroin use; Time to relapse; Maximum consecutive weeks of opiate abstinence; Reduction of HIV risks
C: Child's Head Circumference Measurement (Measured at Birth) (birth); Child's Length of Hospital Stay (delivery until hospital discharge (min=2 days, max=79 days)); Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) (From birth until hospital discharge (min=4 days, max=10, depending on site)); Child's Peak Daily Total NAS Score (minimum twice daily from birth until NAS no longer measured (min=10 days)); Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS (Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days))
D: Opiate abstinence

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal Opioid Treatment: Human Experimental Research
Brief Summary: Children born to women who abuse drugs have a high risk of being born with birth defects and developmental problems. Methadone is a drug that is commonly used for treating opioid dependence. However, its use by a pregnant woman can cause severe withdrawal symptoms in a newborn because of the prenatal exposure. The purpose of this study is to evaluate the effectiveness of buprenorphine, another drug, versus methadone in reducing withdrawal symptoms in children born to opioid-dependent women.


Options:
A: methadone concentrations in breast milk (1-30 days after delivery); methadone concentrations in maternal plasma (1-30 days after delivery)
B: combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. (corrected age of 18 months)
C: Child's Head Circumference Measurement (Measured at Birth) (birth); Child's Length of Hospital Stay (delivery until hospital discharge (min=2 days, max=79 days)); Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) (From birth until hospital discharge (min=4 days, max=10, depending on site)); Child's Peak Daily Total NAS Score (minimum twice daily from birth until NAS no longer measured (min=10 days)); Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS (Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days))
D: Change in Infant Movement between Mattress ON and Mattress OFF (control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.); Change in Infant Breathing between Mattress ON and Mattress OFF (control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.); Change in Infant Heart Rate between Mattress ON and Mattress OFF(control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis
Brief Summary: The effect of long term inhalation of hypertonic saline in subjects with cystic fibrosis on lung function, incidence of respiratory tract infections, quality of life, quantitative microbiology and sputum cytokine profile. The hypothesis is that regular inhalation of nebulised hypertonic saline will have a beneficial effect on lung function and other clinical outcomes with no adverse effects on infection and inflammation in adults and children with cystic fibrosis.


Options:
A: Chest CT (48 weeks)
B: Change in Mucociliary Clearance Rate (Baseline versus after completion of 4 week treatment period)
C: Change in Lung Clearance Index (LCI) (48 weeks)
D: Lung function (FEV1, FVC, FEF25-75)

Answer: D