TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized Controlled Trial of Aerobic Exercise in Rectal Cancer Patients During and After Neoadjuvant Chemoradiotherapy
Brief Summary: This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.


Options:
A: Measurement of Cardio Pulmonary exercise test related parameters (VO2 at AT) pre and post neoadjuvant chemoradiotherapy in rectal cancer patients. (2 years)
B: Patient perception and pattern of change (3 months of training followed by 6 and 12 months of no formal training)
C: Change in Cardiorespiratory fitness (pre-NACRT (baseline), post-NACRT (an average of 6 weeks))
D: psychosocial well-being (as assessed by the EORTC-QLQ C30 Quality of life core questionnaire by the European Organization of Research and Treatment in Cancer (EORTC-QLQ C30) and the Profile of Mood States Short form (POMS-SF) (baseline, 1 month follow-up, 6 month follow-up, 12 month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized Controlled Trial of Aerobic Exercise in Rectal Cancer Patients During and After Neoadjuvant Chemoradiotherapy
Brief Summary: This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.


Options:
A: Change in Cardiorespiratory fitness (pre-NACRT (baseline), post-NACRT (an average of 6 weeks))
B: The change of 6MWD observed between pre-and post radical treatment (12 weeks); between post radical treatment and after a 12 week resistance training (12 weeks)
C: Menopausal symptoms (6 months)
D: To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. (Baseline); To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. (8 weeks); To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. (16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Topical Magnesium Supplementation for the Treatment of Muscle Cramps in Dialysis Patients
Brief Summary: Oral magnesium supplementation has been widely used in the treatment of muscle cramps. Muscle cramps are common in dialysis patients but are not satisfactorily prevented by oral magnesium. Transdermal administration of magnesium has been promoted as a potential treatment for muscle cramps but this has not been investigated rigorously. We aim to evaluate the effectiveness of transdermal magnesium supplementation in reducing cramp frequency and severity. We will recruit current haemodialysis patients who suffer from muscle cramps into a randomised, placebo-controlled, cross-over design trial. Each intervention period will last 8 weeks with a 4-week washout period in between. We will measure muscle cramp frequency, duration and severity as the primary outcomes.


Options:
A: Physical fitness (six weeks); ADL performance (six weeks); Well being (six weeks); Nocturnal cramps (Six weeks)
B: Difference in the average number of muscle cramps per week between magnesium and placebo treatments (3 weeks)
C: Improvement in QOL questionnaires (3 months); Lack of deterioration in portal hypertension (3 months)
D: Number of documented episodes of NLC (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
Brief Summary: Nighttime agitation in persons with Alzheimer's disease causes patient suffering, distresses caregivers, and often results in prescriptions for harmful antipsychotics. Effective treatments are lacking because of limited knowledge of the etiology of nighttime agitation. The investigators propose a clinical trial to better elucidate whether a sleep disorder, restless legs syndrome, may be a mechanism for nighttime agitation, and if treatment with gabapentin enacarbil (Horizant®) reduces nighttime agitation, improves sleep, reduces restless legs syndrome behaviors, and reduces antipsychotic medications.


Options:
A: To measure the differences between galantamine and donepazil for sleep and attention, explore methods of measuring sleep in patients with Alzheimer's Disease (AD)and their caregivers and attention in AD patients; GI tolerance
B: Mean Nighttime Total Sleep Time as determined by actigraphy. (Week 1)
C: Nighttime Agitation - Cohen Mansfield Agitation Inventory (CMAI) - Direct Observation (Change from baseline at 2 and 8 weeks)
D: Sleep Efficiency (Post-intervention, up to 3 weeks); Sleep Minutes (post-intervention, up to 3 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Study of Salvational Intervention With ICS/LABA for Reducing Chronic Obstructive Pulmonary Disease Exacerbation Under Severe Air Pollution (SIRCAP) in Beijing
Brief Summary: This is a multi-center, prospective, randomized and standard treatment parallel control clinical trial.A total of 764 stable COPD patients according to GOLD will be recruited and equally divided into two parallel groups, salvational intervention group (SI group) and control group (CT group).On the foundation of basic medicine, inhaled ICS/LABA will be used as an intervention drug for patients in SI group on severe air pollution days. It is aimed to evaluate whether this novel treatment strategy will decrease the frequency of AECOPD per year.


Options:
A: Asthma control using the asthma control diary (After 1 month); Severe asthma exacerbations (1 year & preliminary analysis after 1 month); Moderate asthma exacerbations (1 year & preliminary analysis after 1 month)
B: the frequency of exacerbation of COPD per year (3 year)
C: Comparison of Asthma Control Test (ACT) questionnaire score between the no intervention group and the intervention groups in asthmatic children during the high DDS period of 2019 (4 months); Comparison of Asthma Control Test (ACT) questionnaire score between the no intervention group and the intervention groups in asthmatic children during the high DDS period of 2020 (4 months); Comparison of the number and duration of high atrial frequency episode between the no intervention group and the intervention groups in adults with AF during the high DDS period of 2019. (6 months); Comparison of the number and duration of high atrial frequency episode between the no intervention group and the intervention groups in adults with AF during the high DDS period of 2020. (6 months)
D: Myocardial ischaemic burden determined using continuous electrographic monitoring (During 2 hour walk and subsequent 24 hour period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Randomized Controlled Trial of a Web-based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression: the eMotion Study.
Brief Summary: Physical activity has many potential mood enhancing benefits, and may be as effective as anti-depressants and psychological therapies for treating depression and low mood. However, getting people with depression to become more active is challenging. Behavioural Activation (BA) is an evidenced based psychotherapeutic treatment that focuses on increasing exposure to positive environmental stimuli which could provide an effective delivery mechanism for increasing physical activity for people who are more sedentary than the general population. The purpose of this study is to examine the feasibility of delivering a theory informed online intervention combining physical activity and BA (eMotion) to people with depression, and to examine its effects on depressive symptoms and physical activity.


Options:
A: Patient Health Questionnaire (PHQ-9)- Change from baseline (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment); Beck Depression Inventory (BDI)- Change from baseline (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment)
B: Recruitment and retention rates, data completion, and resource utilization. (Baseline, Week 18)
C: Depression (Two months)
D: depression symptom severity (3-6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Changes in Biomarkers Associated With Use of Electronic Cigarettes Among African American Menthol and Nonmenthol Smokers
Brief Summary: The objective of this clinical trial was to compare the effects of e-cigarettes with and without nicotine on patterns of combustible cigarette use and biomarkers of exposure to tobacco toxicants among African American smokers.


Options:
A: Change in Biomarker Concentrations: Nicotine Equivalents (Baseline, Week 6); Change in Biomarker Concentrations: NNAL (Baseline, Week 6)
B: effectiveness (2 years)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
D: Cigarette use (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Changes in Biomarkers Associated With Use of Electronic Cigarettes Among African American Menthol and Nonmenthol Smokers
Brief Summary: The objective of this clinical trial was to compare the effects of e-cigarettes with and without nicotine on patterns of combustible cigarette use and biomarkers of exposure to tobacco toxicants among African American smokers.


Options:
A: Weight Gain in Treatment Completers (baseline and 12 weeks)
B: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
C: Change in Biomarker Concentrations: Nicotine Equivalents (Baseline, Week 6); Change in Biomarker Concentrations: NNAL (Baseline, Week 6)
D: Proportion of participants with verified continuous smoking abstinence (Six months post-quit date)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Changes in Biomarkers Associated With Use of Electronic Cigarettes Among African American Menthol and Nonmenthol Smokers
Brief Summary: The objective of this clinical trial was to compare the effects of e-cigarettes with and without nicotine on patterns of combustible cigarette use and biomarkers of exposure to tobacco toxicants among African American smokers.


Options:
A: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)
B: Change in pulmonary health (dry cough, breath shortness, mouth irritation) index (baseline, 6 months, 12 months)
C: Change in Biomarker Concentrations: Nicotine Equivalents (Baseline, Week 6); Change in Biomarker Concentrations: NNAL (Baseline, Week 6)
D: Continuous smoking abstinence rate (Weeks 9 to 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Lung Cancer Screening: Integrated Digital/Clinical Approach
Brief Summary: This study will evaluate the impact of a proactive, EHR-supported enrollment strategy that links LDCT-eligible smokers with an evidence-based intervention comprised of a web-based program and integrated text messaging. The goal is to provide actionable findings about how to most effectively and cost efficiently promote abstinence in LDCT clinics.


Options:
A: smoking abstinence (12 months); smoking abstinence (12 months); smoking abstinence (12 months)
B: smoking quit rate change from baseline at 3-month follow-up (3-month follow-up); smoking quit rate change from baseline at 6-month follow-up (6-month follow-up)
C: Child Urine Cotinine (3 months and 12 months); Cigarettes/Day (3 months and 12 months)
D: Carbon Monoxide-verified Continuous Abstinence at 12 Weeks (12-weeks post-quit day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Project EAT: Eating and Attitudes in Teens
Brief Summary: Research suggests there is a connection between mood and weight. People who feel stressed or depressed are more likely to be overweight than people who don't have these feelings. Some individuals turn to food to cope, which can lead to gaining too much weight over time. Adolescence is an important time to understand these connections. Patterns of handling stress learned during adolescence set the stage for stress management in adulthood. This study is a randomized controlled pilot study with 60 adolescents who are at-risk for future, chronic obesity. The investigators will test if taking part in a 6-week group program to lower stress and improve mood will be helpful to teens at-risk.


Options:
A: Student: SSB Change From Baseline to 7-months (All Participants) (Baseline and 7-months)
B: Feasibility of study (3 years); Acceptability of program (6 weeks); Acceptability of study participation (6 weeks)
C: Change in Body Mass Index (Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months)
D: Change From Baseline in Percent Students Eating the School Breakfast Per School (Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Atopic Dermatitis by a Full-Body Blue Light Device
Brief Summary: Multicentric, placebo-controlled, double-blinded, three-armed, prospective, randomized controlled trial.150 patients diagnosed with atopic dermatitis will be randomized to arm 1 (irradiation for 30min at 415nm wavelength), arm 2 (irradiation for 30min at 450nm wavelength), and arm 3 (irradiation for 30min at low-dose (placebo)). Irradiation will be scheduled 3 times a week for 8 weeks. Patients will be followed up for four weeks after the last irradiation.


Options:
A: Clinical improvement during UVA1/NB-UVB phototherapy using a validated; SCORAD index
B: Change in Eczema Area Severity Index (EASI) at end of treatment (week 8)
C: Proportion of eligible families screened who are willing and able to be randomised. (Before birth)
D: The incidence of atopic dermatitis (Measure will be reported annually by year from 2008-2018); The prevalence of atopic dermatitis (Measure will be reported annually by year from 2008-2018); The prevalence of diagnosed co-morbidities in people with and without atopic dermatitis (Prevelence reported annually by year from 2008-2018); Annual rates of service utilisation (number of primary and secondary care visits) in people with atopic dermatitis (Measures will be reported annually by year from 2008-2018); Annual prescription rates for atopic dermatitis related treatments (Measures will be reported annually by year from 2008-2018)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Prospective, Randomized Study to Assess the Effect of Metformin Supplementation on IVF Outcome and Intrafollicular Environment in Patients With Polycystic Ovarian Syndrome Undergoing In Vitro Fertilization/Embryo Transfer
Brief Summary: This study was performed to investigate the effects of metformin on controlled ovarian stimulation (COS), in vitro fertilization (IVF) outcomes, pregnancy outcomes, and comparison of serum and follicular fluid cytokines and hormones in patients with polycystic ovary syndrome (PCOS) undergoing IVF using gonadotropin-releasing hormone(GnRH) antagonist protocol.


Options:
A: Pregnancy rates (1 year)
B: Number of mature(MII) oocyte (Day1(from the day of oocyte retrieval to fertilization confirmation))
C: 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)
D: Clinical pregnancy rate (4 weeks after embryo transfer)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus. A 30-week Randomised, Double-blind, Placebo-controlled Trial
Brief Summary: This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.


Options:
A: Adjusted Mean Change in HbA1c Levels (Baseline to Week 24); Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit (Baseline to week 24)
B: Change in HbA1c (Week 0, week 30)
C: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. (From randomisation to individual end of observation, up to 4.6 years)
D: Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study) (Up to approximately 6 years); Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study) (Baseline); Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study) (Baseline and Week 18); Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) (Baseline); Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) (Baseline and Week 18); Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) (Baseline); Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin With Sulfonylurea Add-on Glycemic Sub-study) (Baseline and Week 18)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Quality of Life Through the Routine Use of the Patient Concerns Inventory for Head and Neck Cancer Patients (PCI-QoL)
Brief Summary: The Patient Concerns Inventory (PCI) for head and neck cancer (HNC) patients has been developed and used largely within the confines of a single clinic setting and has not been used routinely with patients in the first year following treatment. Research so far suggests it is popular with patients, they would like to continue to use it in clinic and it is feasible. Benefits of its routine repeated use is untested, notably its impact on improving QOL and in reducing emotional distress, especially within the first year after treatment when patients are more likely to benefit from repeated use of the PCI.

The overarching aim of the proposed research is to explore whether the routine use of the PCI in review clinics during the first year following head and neck cancer treatment can improve patients quality of life.

The primary outcome is an improvement in QOL. Secondary outcomes are:

social-emotional scale, distress thermometer and health economics.

This will be a pragmatic cluster randomised control trial with consultants randomised to either 'using or 'not using' the PCI at clinic. It will involve two centres. 416 patients from at least 10 consultant clusters are required to show a clinically meaningful difference in the primary outcome.

Intervention; Patient completion of the PCI and its inclusion into the regular review clinic consultation is the 'intervention' and is compared to standard out-patient follow-up. The pre-consultation questionnaires and PCI will be used from the first post-treatment clinic (i.e. baseline) onwards for one year. Completion of all pre-consultation questionnaires and the PCI is by computer (IPAD).


Options:
A: Overall and cancer-specific mortality (5 years)
B: UWQOL v4 QoL (Post-Treatment 1 Year Review Clinic)
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: Overall Survival (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Quality of Life Through the Routine Use of the Patient Concerns Inventory for Head and Neck Cancer Patients (PCI-QoL)
Brief Summary: The Patient Concerns Inventory (PCI) for head and neck cancer (HNC) patients has been developed and used largely within the confines of a single clinic setting and has not been used routinely with patients in the first year following treatment. Research so far suggests it is popular with patients, they would like to continue to use it in clinic and it is feasible. Benefits of its routine repeated use is untested, notably its impact on improving QOL and in reducing emotional distress, especially within the first year after treatment when patients are more likely to benefit from repeated use of the PCI.

The overarching aim of the proposed research is to explore whether the routine use of the PCI in review clinics during the first year following head and neck cancer treatment can improve patients quality of life.

The primary outcome is an improvement in QOL. Secondary outcomes are:

social-emotional scale, distress thermometer and health economics.

This will be a pragmatic cluster randomised control trial with consultants randomised to either 'using or 'not using' the PCI at clinic. It will involve two centres. 416 patients from at least 10 consultant clusters are required to show a clinically meaningful difference in the primary outcome.

Intervention; Patient completion of the PCI and its inclusion into the regular review clinic consultation is the 'intervention' and is compared to standard out-patient follow-up. The pre-consultation questionnaires and PCI will be used from the first post-treatment clinic (i.e. baseline) onwards for one year. Completion of all pre-consultation questionnaires and the PCI is by computer (IPAD).


Options:
A: Number of participants compliant with endocrine therapy as assessed by Morisky Green Levine (MGL) scale (12 months after the onset of endocrine therapy)
B: Change in the Patient Safety Climate Synthetic Index (At pre-intervention and after 12 months follow-up)
C: Comorbidities treatment (6 months later); Auto-DAS: Patient education to calculate his Disease Activity Score (6 months after)
D: UWQOL v4 QoL (Post-Treatment 1 Year Review Clinic)

Answer: D