TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Propess® Versus Double Balloon for Cervical Ripening of Prolonged Pregnancies: a Randomised Controlled Trial
Brief Summary: A pregnancy is considered ''prolonged'' from 41 weeks of gestation. Prolonged Pregnancies (PP) are associated with increased maternal morbidity: emergency caesarean, 3rd and 4th degree perineal lesions and postpartum haemorrhage. Foetuses are at increased risk of oligohydramnios, meconium-staining and Fetal Heart Rate (FHR) anomalies. Around 15% of all pregnancies are prolonged.

A Cochrane review on induction of labour showed that a policy of labour induction at or beyond 41 weeks was associated with significantly fewer perinatal deaths. Thus the French College of Obstetricians and Gynaecologists stated, "induction of labour can be proposed to patients between 41+0 and 41+6 weeks of gestation". In cases where labour is induced and cervix is unfavourable, cervical ripening is advised. Methods of cervical ripening include pharmacological (prostaglandins) and mechanical (Foley catheter or trans-cervical double balloon) methods. Those two methods were compared in the PROBAAT trial among women with term pregnancies (beyond 37+0). The rates of caesarean section with these two strategies were identical, however uterine hyper stimulation with FHR anomalies occurred less when cervical ripening was mechanical.

Considering pharmacological cervical ripening is associated with more uterine hyper stimulation and more FHR anomalies, it may not be the most appropriate in cases of fragile foetuses that include cases of prolonged pregnancies. Considering prolonged pregnancies are associated with a risk of FHR anomalies and that cervical ripening with a pharmacological method is another factor which increases this risk: women with prolonged pregnancies could benefit from a more "gentle" cervical ripening.

At present, no particular method is recommended in cases of cervical ripening and prolonged pregnancies. We hypothesise that, in cases of prolonged pregnancies, mechanical cervical ripening, with less uterine hyperstimulation and fewer FHR anomalies, could be more appropriate and could reduce the rate of caesarean section for suspicion of fetal distress.


Options:
A: Delivery rate (proportion) (Within 24 hours)
B: induction delivery interval (time from starting induction to delivery) (48hours)
C: The Time Interval From Induction to Delivery: All Participants (Day 1); Time (Hours) From Induction to Delivery: Nulliparous (Day 1); Time (Hours) From Induction to Delivery: Multiparous (Day 1); Time From Induction to Delivery: VD (Day 1); Time From Induction to Delivery: CD (Day 1); Per Treatment Protocol: Time (Hours) From Induction to Delivery (day 1)
D: Caesarean section rate for non-reassuring fetal status. (Up to 2 days after cervical ripening)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Strengthening the Evidence Base on Effective scHool Based intErventions for pRomoting Adolescent Health (SEHER)
Brief Summary: SEHER Plus- Strengthening Evidence base on scHool-based intErventions for pRomoting adolescent health, seeks to evaluate a school based adolescent health promotion intervention delivered by two different delivery agents viz. teacher-as-SEHER Mitra (TSM) and lay school counsellor called as SEHER Mitra (SM) in government- run secondary schools in Bihar, India. SEHER Plus will be implemented in the same randomly assigned 74 schools wherein, the SEHER trial (ClinicalTrials.gov ID: NCT02484014)-a three armed clustered randomised trial (CRT) was implemented to evaluate the effectiveness and cost-effectiveness of these two models compared with the Tarang-Adolescence Education Programme (usual care) implemented by the State Government of Bihar.

The SEHER trial hypothesised that both interventions, compared to the control arm, would lead to a greater impact on school climate (school connectedness and relationship with teachers and fellow students). In addition, the interventions would increase the knowledge, attitude and awareness, and promoting healthy behaviours in youth on reproductive and sexual health outcomes, mental health and substance use, and gender related attitudes and violence. The SEHER trial also hypothesized that the addition of more resource intensive component (the SM arm) would be associated with the best outcomes. The hypothesis for the SEHER Plus is that students who will have exposure to the SEHER intervention activities in two academic years (Class IX and X) will show greater benefits on the primary, secondary and exploratory outcomes than students who have exposure to the SEHER intervention activities in one academic year (Class IX).


Options:
A: Developmental Disorders- Children Disability Assessment Schedule (DD-CDAS) (Change in DD-CDAS score at 6 months post-intervention)
B: Depression - Patient Health Questionnaire (1 week post-intervention)
C: School Climate (Up to 7 months)
D: Mental health state (anxiety) (Before intervention begins and through intervention completion on average of 15 days); Mental health state (Depression) (Before intervention begins and through intervention completion on average of 15 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Milk Protein Intake in Young Children on Early Growth and Later Obesity Risk: a Multicentre Randomized Clinical Trial
Brief Summary: To assess growth of children (enrolled between 11.5 and 13.5 months) fed with two iso-energetic, young-child formulas with different protein content during the second year of life


Options:
A: BMI-for-age z-score (Age 24 months)
B: Change in weight (Baseline to 4 months of age)
C: Infant weight gain (Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks))
D: Weight Gain Velocity (up to 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM2) - A Randomised Clinical Trial
Brief Summary: ILCOR guidelines recommend Target Temperature Management (TTM) to between 32°C and 36°C after out-of-hospital cardiac arrest, based on low quality evidence. In a previous trial, TTM at 33°C did not confer a survival benefit or improved neurological function, compared to TTM at 36°C. A lower target temperature might be beneficial compared with normothermia and early treatment of fever. Therefore the primary purpose of the TTM2-trial will be to study any differences in mortality, neurological function and quality of life between a target temperature of 33°C and standard care avoiding fever.


Options:
A: all cause mortality at 6 months (6 months)
B: Mortality (180 days)
C: Number of Participants With Death or Poor Neurologic Outcome at 6 Months (Six months)
D: Neurological outcome assessed with Cerebral Performance Category scale (Day 90)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioural Therapy for Anxiety Disorder in Children With Co-morbid Autism Spectrum Disorder
Brief Summary: Children with Autism Spectrum Disorder (ASD) often have other difficulties as a result of the disorder. Up to half of the children with ASD are thought to suffer with anxiety in a way that interferes with their wellbeing and every day functioning. In this project the investigators will study the effect of the group program The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD) - an anxiety treatment program specific developed for children with ASD. The investigators expect a decrease in the overall anxiety level together with an increase in the ability of handling anxiety.


Options:
A: Evidence of therapy effects on anxiety symptoms are established by assessments of clinical status, symptoms, affective style, sleep,parent-child interactions using rating scales, self-report measures, and behavioral observations. (16 weeks)
B: Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP). (Change from baseline interview results at 14 weeks); Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP). (Change from baseline interview results at 3 months)
C: Anxiety Disorders Interview Schedule - Child/Parent Version (Post Treatment (16 weeks))
D: Pediatric Anxiety Rating Scale (After an average of 16 weeks (Post-treatment))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Early Postoperative Decline
Brief Summary: The purpose of this trial is to determine whether using a brain training program in the time leading up to as well as after heart surgery will reduce confusion and cognitive loss that can occur after surgery.


Options:
A: postoperative delirium (2 MONTHS)
B: Participant Reduced Symptom Burden (From Baseline to 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion))
C: Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment (Enrollment was assessed after enrollment was completed.); Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence (To be evaluated at the conclusion of the study. Adherence was assessed in 3 separate periods: pre hospital, in hospital, and post discharge (typically at the 4 week follow up clinic visit).)
D: Delirium incidence (% participants) (Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Early Postoperative Decline
Brief Summary: The purpose of this trial is to determine whether using a brain training program in the time leading up to as well as after heart surgery will reduce confusion and cognitive loss that can occur after surgery.


Options:
A: Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment (Enrollment was assessed after enrollment was completed.); Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence (To be evaluated at the conclusion of the study. Adherence was assessed in 3 separate periods: pre hospital, in hospital, and post discharge (typically at the 4 week follow up clinic visit).)
B: Delirium incidence (% participants) (Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
C: Participant Reduced Symptom Burden (From Baseline to 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion))
D: Recruitment rate (Up to 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Weight reduction is the most important treatment target when polycystic ovary syndrome (PCOS) is linked to obesity. Liraglutide (LIRA) in dose of 3 mg was recently approved as an anti-obesity drug. Metformin could enhance weight lowering potential of liraglutide.

We investigates short term interventions with low dose liraglutide in combination with metformin and high dose liraglutide alone influence on significant weight reduction in obese women with PCOS.


Options:
A: The main outcome was change in body weight. (Patient's body weight was measured at the base point and after 12 weeks of clinical trial.)
B: Glucose infusion rate (M value) below euglycaemic hyperinsulinaemic clamp (comparing baseline with 4 months)
C: Clinical pregnancy (within 6 calendar months of randomisation)
D: Clinical Pregnancy Rate (up to 18 weeks - in average, two weeks after the end of the in vitro fertilization cycle)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus (ENGAGE-DM): A 12-month Study of the Impact of Combined Shared-decision Making and Brief Negotiated Interviewing on Disease Control and Medication Adherence in Patients With Diabetes
Brief Summary: The purpose of this study is to evaluate whether a combination of pharmacist-delivered patient engagement techniques improves disease control and medication adherence among patients with poorly-controlled diabetes compared with usual care. These engagement techniques include shared decision-making and brief negotiated interviewing and are delivered telephonically.


Options:
A: HbA1c (Last measurement within 12 months before - and 15 months after nurse participation in the course)
B: Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg (4 months)
C: Clinical inertia (12 month post intervention)
D: Glycosylated Hemoglobin (HbA1c): (baseline and at the end of 12 months post index date)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus (ENGAGE-DM): A 12-month Study of the Impact of Combined Shared-decision Making and Brief Negotiated Interviewing on Disease Control and Medication Adherence in Patients With Diabetes
Brief Summary: The purpose of this study is to evaluate whether a combination of pharmacist-delivered patient engagement techniques improves disease control and medication adherence among patients with poorly-controlled diabetes compared with usual care. These engagement techniques include shared decision-making and brief negotiated interviewing and are delivered telephonically.


Options:
A: Glycosylated Hemoglobin (HbA1c): (baseline and at the end of 12 months post index date)
B: Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching (30 months)
C: Patient Adherence (Test Completion) (12 months post-intervention)
D: Reach of Intervention (Baseline 2 (post-education: average 3 days after enrollment)); Effectiveness of Intervention: Knowledge (Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment)); Adoption of Intervention (At time of intervention phase start); Implementation of Intervention (Baseline 2 (post-education: average 3 days after enrollment)); Maintenance of Intervention (6 months after study enrollment end date); Effectiveness of Intervention: Values-Choice Concordance (Baseline 1 (enrollment) and 1 Month Follow-Up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Features and Prevalence of Asymptomatic Peripheral Artery Disease in Patients With Type 1 Diabetes Mellitus
Brief Summary: AIMS: Determining the clinical features and prevalence of peripheral artery disease (PAD) in asymptomatics patients with type 1 diabetes mellitus (T1DM) and checking the validity of the current recommendations regarding for PAD screening in T1DM.

METHODOLOGY: An observational and cross-sectional prevalence study. The whole group of patients (sample size calculated: 299 patients) will make the Edinburgh Questionnaire for detecting classic symptoms of intermittent claudication, and after verifying the absence of symptoms and exclusion criteria, they will be included in the study. All patients will undergo assessment of clinical parameters related to T1DM and classic cardiovascular risk factors, as well as, an analytical assessment of the lipid profile, HbA1c level, proinflammatory profile and oxidative stress status. They will also undergo a comprehensive anthropometric assessment including office blood pressure (BP) monitoring and ambulatory 24-hours BP monitoring in patients with an indication as routine clinical practice, assessment of cardioautonomic function, and lastly an ankle-brachial index (ABI) by Doppler ultrasound, in the context of routine clinical practice in patients with clinical indication, or as an extraordinary procedure for participating in the study in patients who do not meet criteria for screening according to current recommendations.


Options:
A: Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke (From randomization to PACD, an average of 2.5 years)
B: Diagnostic Accuracy (1 hour; all tests will be performed on the same day of presentation.)
C: Prevalence of PAD in asymptomatic patients with T1DM assessed by ankle-branchial index. (2 years)
D: Changes in TcPO2 (30 minutes); Correlation of stimulation TcPO2 parameters with the type of peripheral arterial flow (30 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Introduction of a Uterine Balloon Tamponade for Postpartum Hemorrhage in Three Low Income Countries: a Stepped Wedge Cluster Randomized Trial
Brief Summary: This study is a prospective, systematic evaluation to assess the effectiveness and safety of introduction of UBT into PPH care at secondary level and district hospitals in 3 low-resource countries. The first component of the evaluation is a prospective stepped wedge cluster randomized design to assess the potential reduction in PPH-related mortality and invasive procedures (blood transfusion, arterial ligation, hysterectomy and uterine arterial embolization) for PPH performed at participating facilities following introduction of UBT. The second component is a nested cohort analysis to assess the safety and acceptability of UBT among women diagnosed with PPH.


Options:
A: Frequency of mortalities and frequency of severe morbidities combined as extreme adverse outcomes (during hospital stay)
B: Number of patients who need surgical intervention to stop the bleeding (1 year)
C: Maternal death due to PPH or invasive procedures due to PPH (After delivery and before discharge from facility (usually within 48 hours after delivery)); Treatment of postpartum infection among women diagnosed with PPH (Within 4 weeks after delivery)
D: Proportion of women who received at least 3 RBC units for the treatment of PPH and /or who had a calculated peripartum blood loss > 1000 ml. (1 day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Intervention With Potassium and/ or Magnesium-enriched Salt on Neurological Performance of Stroke Patients
Brief Summary: Cerebrovascular disease is the second leading cause of death in Taiwan. Although stroke incidence and mortality decline steadily in Taiwan, its impact on medical cost, quality of life and neurological deficits remains extraordinary. Stroke incidence and mortality are also rising in the developed countries presumably due to a world-wide increase in prevalence of obesity and metabolic syndrome. Negative associations have been observed between high blood pressure, hyperglycemia and two major dietary cations in vegetables and dairy products: potassium and magnesium. Mean levels of dietary potassium and magnesium intake in Taiwan are much lower than those of dietary reference intake. Short term supplementation studies have demonstrated their effects in reducing blood pressure and degree of insulin resistance. However, long-term studies on cardiovascular events are lacking. Our previous long-term intervention trial in elderly veteran home showed a 41% reduction in cardiovascular mortality by simply switching regular cooking salt to potassium-enriched salt in kitchens. The investigators have previously observed an annual reduction of medical cost around $ 15,000 NT in the aforementioned veteran home trial. A multi-centered randomized controlled trial was carried out with three arms: (1) regular salt (Na salt), (2) potassium-enriched salt (K salt), and (3) potassium and magnesium-enriched salt (K/Mg salt). The objectives of this study was to investigate whether potassium and magnesium-enriched salt would improve the neurological performance of the stroke patients.The investigators anticipate to observe beneficial effect from consuming potassium and magnesium enriched salt for neurological improvement in stroke patients.


Options:
A: Change in Baseline Mean Systolic Blood Pressure (mmHg) at 6 months ((Baseline compared to 6 months after start of intervention))
B: Systolic/diastolic blood pressure (mmHg) (Three years)
C: Systolic Blood Pressure (three months)
D: The modified Rankin scale (mRs) (6 months); The National Institute of Health Stroke Scale (NIHSS) (6 months); The Barthel index (BI) (6 months); The "good neurological performance" (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese Polycystic Ovary Syndrome Women; A Quasi Experimental Study
Brief Summary: RCT to investigate whether metformin co-treatment would improve IVF outcomes in overweight and obese women with PCOS.


Options:
A: To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic sperm injection) will increase clinical pregnancy rate in normal weight PCOS-women (Vaginal ultrasound in pregnancy week 7)
B: Rate of cancellation due to low ovarian response (one month)
C: Total number of retrieved oocytes (Two weeks Metformin treatment)
D: Rate of OHSS (one month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Latinas LEarning About Density (LLEAD Study)
Brief Summary: This study will examine behavioral and psychological outcomes of breast density notification using a 3-group randomized design comparing usual written notification to two educationally enhanced approaches.


Options:
A: New Advance Care Planning Documentation in the Medical Record at 15 Months (15 months after study enrollment)
B: Beck Depression Inventory- II (Assessed at every session and at the 1-month follow-up)
C: Anxiety Short Term (Change from baseline anxiety at 1 month); Breast density knowledge (Total knowledge scores at 1 month); Anxiety Longer Term (Change from baseline anxiety at 1 year)
D: Health literacy levels (Measured at Week 6 and Months 6, 12, 18, and 24); Blood pressure control (Measured at Week 6 and Months 6, 12, 18, and 24); Reduction in blood pressure (Measured at Month 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Cross-Over Trial of Ketamine Therapy Plus or Minus Naltrexone in Treatment Resistant Depression (TRD)
Brief Summary: The primary objective is to determine if the opioid properties of ketamine are responsible for its antidepressant effects. Since naltrexone can block opiate actions, the investigators will determine if naltrexone can effectively block ketamine's effects.


Options:
A: Level of Depression as assessed by the HAM-D (Day 1-7)
B: 17-item Hamilton Depression Rating Scale (week 0, 2, 4, 6); Remission rate (week 0, 2,4, 6); GAF(Global Assessment of Function) (Week 0, 2, 4, 6)
C: Change in 24 item Hamilton Depression Rating Scale (HAMD) scores. Safety measures: UKU scale, vital signs assessments, laboratory parameters (SMA-20, CBC, UA) (6 weeks); Change in Hamilton Rating Scale for Anxiety (HAMA) scores. (6 weeks)
D: Montgomery-Asberg Depression Rating Scale (MADRS) (24 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Cross-Over Trial of Ketamine Therapy Plus or Minus Naltrexone in Treatment Resistant Depression (TRD)
Brief Summary: The primary objective is to determine if the opioid properties of ketamine are responsible for its antidepressant effects. Since naltrexone can block opiate actions, the investigators will determine if naltrexone can effectively block ketamine's effects.


Options:
A: 17-item Hamilton Depression Rating Scale (week 0, 2, 4, 6); Remission rate (week 0, 2,4, 6); GAF(Global Assessment of Function) (Week 0, 2, 4, 6)
B: Level of Depression as assessed by the HAM-D (Day 1-7)
C: Montgomery-Asberg Depression Rating Score (MADRS) (Baseline & week 8)
D: Change in Montgomery Asberg Depression Rating Scale (MADRS) (From baseline to Week 6)

Answer: B