TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: INVESTIGATION of FLOW ALTERED, SHORT TRANSCERVICAL CAROTID ARTERY STENTING in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE With Filter.
Brief Summary: The purpose of this study is to obtain and establish the safety and efficacy of The MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) for providing cerebral embolic protection during angioplasty and stenting procedures in carotid arteries. The MICHI NPS+f also facilitates access to the carotid and neuro anatomy for the introduction of therapeutic or diagnostic endovascular devices and/or agents. It will be used in conjunction with a FDA approved carotid artery stent for the treatment of carotid artery disease.


Options:
A: Any stroke or death within 30 days of the procedure (during de study)
B: Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days. (0 to 365 days)
C: Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery. (First 24 hours after implantation of carotid stent)
D: Hierarchical Composite of Stroke, Myocardial Infarction, and Death (30-day post-procedure)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas
Brief Summary: The aim of the study is to determine whether the application of a glyceryl trinitrate patch (GTN patch) helps arteriovenous fistulas, created for renal dialysis access, mature so that they can be used.


Options:
A: Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events (6 months)
B: N/A
C: Change to diameter of vein (Initial assessment and 6 weeks after surgery)
D: To assess the safety of a single topical dose of PRT-201. (Day of AVG creation and 4 weeks After surgery.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Fexinidazole Compared to Nifurtimox-Eflornithine Combination Therapy (NECT) in Patients With Late-stage Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: Pivotal, Non-inferiority, Multicentre, Randomised, Open-label Study
Brief Summary: This clinical trial is designed to prove the efficacy and safety of Fexinidazole as an oral treatment for human african trypanosomiasis in advanced stage. The Fexinidazole is compared to reference treatment NECT. The trial will try to demonstrate that Fexinidazole is not inferior to NECT treatment.


Options:
A: success or failure at 18 months FU visit (18 months after treatment)
B: N/A
C: Outcome (success or failure) at the test of cure (ToC) visit 12 months after the end of treatment (EOT). (12 months after end of treatment (day 11))
D: Proportion of patients discharged alive from the hospital or the treatment center

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.
Brief Summary: The primary objective is to determine the efficacy of a strategy of biomarker-guided therapy compared with usual care in high risk patients with left ventricular systolic dysfunction.


Options:
A: Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group. (minimum of one year)
B: Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events (One year)
C: Prevalence and severity of LVD (5 year)
D: CV Death or Heart Failure Hospitalization (24 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.
Brief Summary: The primary objective is to determine the efficacy of a strategy of biomarker-guided therapy compared with usual care in high risk patients with left ventricular systolic dysfunction.


Options:
A: Prevalence and severity of LVD (5 year)
B: Heart failure rehospitalisation rate;; combined endpoint death or heart failure rehospitalisation;
C: To use the Triage touch to determine the optimal frequency of home BNP testing and the changes in BNP concentrations that correlate with clinical HF decompensations and related adverse events in at-risk HF patients. (Day 5, Day 30 and Day 60)
D: CV Death or Heart Failure Hospitalization (24 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomised Clinical Trial of Mirena® ± Metformin ± Weight Loss Intervention in Patients With Early Stage Cancer of the Endometrium
Brief Summary: Currently the standard treatment for early stage endometrial cancer or endometrial hyperplasia with atypia is a total hysterectomy (an operation to remove the uterus) and removal of both ovaries. While highly effective, this surgery carries significant side effects for:

* young women who still wish to have children and would lose fertility; and
* women with one or more disorders (or diseases) in addition to the early stage endometrial cancer or endometrial hyperplasia with atypia and/or morbid obesity who are at risk for surgical complications making surgery unsafe.

This study will access a new approach to the treatment of endometrial cancer to spare women of having to undergo major surgery that may be unwanted or unnecessary.

Mirena is approved in Australia for contraception, to treat heavy bleeding, and to prevent thickening of the lining of the uterus (endometrial hyperplasia) during oestrogen replacement therapy (HRT). However it is not approved to treat early stage endometrial cancer or endometrial hyperplasia with atypia. This research project will test to see if Mirena is an effective treatment for early stage endometrial cancer and endometrial hyperplasia with atypia.

Metformin is approved in Australia to treat Diabetes. However it is not approved to treat early stage endometrial cancer or endometrial hyperplasia with atypia. Therefore, it is an experimental treatment for early stage endometrial cancer and endometrial hyperplasia with atypia. This means that it must be tested to see if it is an effective treatment for early stage endometrial cancer and endometrial hyperplasia with atypia.

Weight loss interventions are feasible and safe, and already being implemented by gynaecologic oncologist to make women eligible for surgery. Weight loss of 7% body weight induces a large biological effect (for example reduces incidence of diabetes by 58%, and hypertension by 26%).


Options:
A: Weight loss (2 years)
B: Weight loss (2 years)
C: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
D: Pathological complete response (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized Study on Oral 8-methoxypsoralen Plus UVA With or Without Maintenance Therapy in Mycosis Fungoides EORTC/ISCL Stage IA to IIB
Brief Summary: The purpose of the study is to determine whether psoralen plus UVA (PUVA) photochemotherapy maintenance treatment prolongs disease-free survival of cutaneous T cell lymphoma (mycosis fungoides) patients.


Options:
A: Recurrence after complete remission within 12 months post therapy (12 months after end of therapy)
B: Response (complete clinical [CCR] and partial resp. [PR]) rate by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 wks during treatment and then every 12 wks until progression
C: Overall Response Rate (ORR) (2 years)
D: Progression-free survival

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group, Multicenter Study of Fluticasone Furoate/Vilanterol 200/25 mcg Inhalation Powder, Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, and Fluticasone Furoate 100 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents
Brief Summary: This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study with three active comparators in subjects with moderate to severe persistent asthma. The study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and a follow up contact period of one week. The total duration of the study is 17 weeks. 990 subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF 100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects will be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for acute asthma symptoms throughout the entire study. Subjects will attend four on-treatment visits at Weeks 2, 4, 8, and 12 (Visits 4 through 7).


Options:
A: Change From Baseline in Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population (Baseline and Week 24); Change From Baseline in PM FEV1 Using Per Protocol (PP) Population (Baseline and Week 24)
B: Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12)
C: FEV1 peak0-3 Change From Baseline (Baseline and 24 weeks)
D: Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period (Baseline and Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group, Multicenter Study of Fluticasone Furoate/Vilanterol 200/25 mcg Inhalation Powder, Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, and Fluticasone Furoate 100 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents
Brief Summary: This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study with three active comparators in subjects with moderate to severe persistent asthma. The study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and a follow up contact period of one week. The total duration of the study is 17 weeks. 990 subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF 100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects will be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for acute asthma symptoms throughout the entire study. Subjects will attend four on-treatment visits at Weeks 2, 4, 8, and 12 (Visits 4 through 7).


Options:
A: Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period (Baseline and Week 12)
B: Mean Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline (pre-dose at Day 1) and Week 24)
C: Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period (Baseline and Week 12)
D: Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus QMF149 at Week 26 (26 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of the Collaborative Life Skills Program
Brief Summary: This study tests the effectiveness of a newly developed integrated school-home behavioral intervention for behaviors related to Attention Deficit Hyperactivity Disorder (ADHD). The intervention is implemented by school-based mental health professionals within school settings.


Options:
A: Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe (measured at week 12 (endpoint))
B: Post-treatment ADHD symptoms (Post-treatment (after receiving 3 month treatment)); Post-treatment functional impairment (Post-treatment (after receiving 3 month treatment))
C: Rule Violations During Direct Classroom Observation at Endpoint (Week 8) (Endpoint (Week 8))
D: Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V. (change from baseline on ADHD symptoms at 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Morphine Versus Ibuprofen for Post-operative Pain Management in Children: a Randomized Controlled Study
Brief Summary: Children 5-17 years of age who have undergo orthopedic day surgical procedures for definitive management of fractures, tendon release, etc. will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for 48 hours post-operatively at home. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in significantly lower pain scores on the Faces Pain Scale Revised (FPS-R) compared to ibuprofen. It is hoped that the results of this trial will create a new option for post-operative pain management in children.


Options:
A: The incidence of chronic post surgical pain (CPSP)12 months after surgery (12 months)
B: The visual analog scale (VAS) was used to measures levels of pain. (8 hours-time)
C: Change in faces pain score pre and post intervention (48 hours from the time of discharge from hospital.)
D: Safety (1.5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of Selective Laser Trabeculoplasty (SLT) in Open Angle Glaucoma Who Had Been Previously Treated With Complete SLT
Brief Summary: Lasers are important therapy in glaucoma. They are a pivotal point in treatment between medical and surgical care. Over the last 10 years a new laser has emerged as the usual laser treatment: Selective laser trabeculoplasty (SLT). SLT works as well as the older laser used: argon laser trabeculoplasty (ALT). However SLT has many theoretical benefits over ALT including causing less damage to the tissue it affects. One of the potential patient centered benefits of this laser is that it may be repeatable. It is even possible that the old laser ALT may be useable after an SLT treatment. This study aims to uncover whether repeat laser is possible after SLT and if so which laser is more effective (ALT vs SLT). The potential of repeating laser therapies may delay surgical treatment and its complications. Also understanding which laser to use will help eye doctors know how to treat their patients at this point of the disease.


Options:
A: Intraocular Pressure (12 months post operatively)
B: Change of circadian intraocular pressure (Six weeks after recieving treatment)
C: Intraocular pressure reduction
D: The difference between the two treatment groups between the mean baseline IOP and the mean IOP after the treatment (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Home Visiting for Low Income, Pregnant Women
Brief Summary: In the Pico-Union/Koreatown community of Los Angeles investigators are designing a preventive health care model that increases the opportunities for families to make healthy choices -- in their homes, schools \& communities. The project's key element is: Lay community health workers (paraprofessionals) - Mentor Mothers (MM) (promotoras) - who make home visits to pregnant mothers \& newly-delivered mothers who have agreed to participate in the research study.

Investigators hope to achieve the following outcomes: 1) lower maternal BMI at 6 months post-birth; 2) longer duration of breastfeeding; 3) less alcohol, smoking, and drug use during pregnancy; and 4) increased and consistent prenatal and postnatal healthcare adherence.

Investigators will implement the study with 6 MMs, who will maintain an average caseload of 16 women each across an 18-month period. Each participant will be visited (or receive the intervention by telephone) twice per month.

Separate Assessment Team members will conduct assessments at: Baseline, within a week of birth of the target child, and 6 months from birth.


Options:
A: proportion of patients with breastfeeding completed at 6 months (6 months)
B: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)
C: Exclusive breastfeeding (Six months post-birth); Maternal BMI (Six months post-birth)
D: Neonatal death (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment
Brief Summary: Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A open-label randomized controlled trial. 249 participants will be included. Three arms: acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list.


Options:
A: number of days with migraine (4 weeks); frequency of migraine attacks (4 weeks)
B: Mean monthly number of headache days with moderate or severe intensity (3 months)
C: N/A
D: frequency of migraine attacks (16th week after inclusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Aldosterone receptor blockers reduce cardiac-related morbidity and mortality. Recently, we demonstrated that long-term low-dose spironolactone is clinically safe in many hemodialysis (HD) patients. In the present study, we assess whether low-dose spironolactone treatment reduces the high incidence of cardio- and cerebrovascular (CCV) morbidity and mortality in HD patients. The investigators' hypothesis is that aldosterone receptor blockade by spironolactone reduces the risk of both CCV morbidity and death among HD patients.


Options:
A: cardio- and cerebrovascular events
B: residual renal function of peritoneal dialysis patients (From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.)
C: Peritoneal fibrosis (6 months)
D: Safety - Number of Participants With Serum Potassium >6.5 mEq/L (0 - 40 weeks); Safety - Participants With Serious Hypotension (0 - 40 weeks); Study Drug Tolerability (0 - 36 weeks); Efficacy - Change in Mitral Annular E' Velocity (Baseline to 36 weeks); Feasibility of Conducting a Full-scale Mortality-powered Trial (0 - 40 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Denervation in Treatment Resistant Hypertension
Brief Summary: In patients with treatment resistant hypertension renal nerve ablation emerged as an effective interventional approach of treating hypertensive disease with a progressively increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is one of the major underlying pathogenetic mechanism of the fall in blood pressure but the precise mechanisms that causes the fall in blood pressure in the short-term and, in particular, long-term remains elusive. The objective of the study is to understand the pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic nervous system. In 100 hypertensive patients most advanced technology will be applied, before and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labeling technique), local activity of the renin angiotensin system in the kidney (urinary angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24 hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall in blood pressure after renal denervation may help to identify those hypertensive patients that profit most from renal nerve ablation in terms of blood pressure reduction.

The investigators propose the following hypotheses why a progressive decrease in blood pressure happens, in addition to the decreased activity of the central nervous system, after renal nerve ablation:

Short term effects:

A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the kidney C)Exaggerated sodium excretion immediately after renal nerve ablation

Long term effects:

D)Decrease of total sodium content after 6 and 12 months E)Improvement of vascular wall properties after 6 and 12 months


Options:
A: office BP (baseline, 6 months); 24-ABPM (baseline, 6 months); Magnetic resonance imaging (MRI) (baseline, 3 and 6 months); Albuminuria (baseline, 6 months); Systemic RAS activity (baseline, 6 months); Vascular structure and function of large and small arteries (baseline, 6 months); Local RAS activity (baseline, 6 months)
B: Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline (3 months post-randomization)
C: To document that renal denervation achieved via the delivery of RF energy is safe, and not associated with clinically significant adverse events, in patients with refractory hypertension. (3 years)
D: Change in Systolic Blood Pressure From Baseline to 6 Months on 24-h Ambulatory Measurement (Follow-up Minus Baseline Measurement) (The primary endpoint has been assessed 6 months after randomization.); Change in Glomerular Filtration Rate (This endpoint has been assessed 6 months after randomization.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Longitudinal Trial About the Effects of Music on Fear of Childbirth and Outcome of Delivery
Brief Summary: The aim of this trial is to find out if active music listening during pregnancy and delivery reliefs fear of childbirth, pain in delivery, need for analgesia during delivery and if there is an effect on delivery complications. Also we try to find out if there is any influence on mother-baby relationship.


Options:
A: Change in Fear of labor (childbirth self-efficacy and pain catastrophizing) (Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth)); Perceived labor pain (Postpartum (average of 6 weeks post-birth)); Pain medication use during labor (Labor (during childbirth)); Childbirth satisfaction (Postpartum (average of 6 weeks post-birth)); Change in Depression (Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth))
B: spontaneous vaginal delivery (day of delivery)
C: Pregnancy-Related Anxiety Questionnaire (In the end of second session of intervention- up to 4 weeks from screening)
D: Scores for the Wijma Delivery Expectancy Questionnaire (W-DEQ) (Change in W-DEQ scores measured at entry to the study (approximately gestational weeks 20 to 31) and again at gestational week 36.)

Answer: B