TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial
Brief Summary: The purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.


Options:
A: Patient satisfaction (At 6 months from study enrollment); Patient satisfaction (At 12 months from study enrollment)
B: Vaginal infections (60 weeks)
C: 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))
D: "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.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Centre, Randomized, Double-blind, Dose Ascending, Placebo-controlled Study, in Two Parts, to Evaluate the Safety, Tolerability and Pharmacokinetics of Escalating Single and Repeat Inhaled Doses of GSK573719 and Placebo Formulated With the Excipient Magnesium Stearate, in Healthy Subjects and in a Healthy Population of Cytochrome P450 Isoenzyme 2D6 Poor Metabolisers.
Brief Summary: This study is to look at a new formulation of GSK573719 to see if it is safe and tolerated in healthy volunteers


Options:
A: Change From Baseline in Trough FEV1 on Day 85 (Baseline (BL) and Day 85)
B: General safety and tolerability endpoints: Adverse Events (AE), HR, BP, 12- lead ECG and lung function (FEV1) and clinical laboratory safety tests (Various)
C: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Baseline and Day 85)
D: Composite of Pharmacokinetic (PK) Parameters as a measure of systemic exposure. (PK Blood samples will be collected at Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose on Day 1 of each treatment period); Systemic exposure of FF and UMEC and VI following single inhaled doses (four inhalations) of FF/UMEC/VI 100mcg /62.5mcg /25mcg compared with FF/VI 100mcg /25mcg and UMEC/VI 62.5mcg /25mcg (PK Blood samples will be collected at Day 1 Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Urodynamic Testing Before Stress-Incontinence Surgery
Brief Summary: Although no reliable and specific figures are available for the total expenditure on UDS, UDS is commonly performed for patients with urinary incontinence (UI) regardless of gender and age. UDS is typically performed prior to incontinence surgery. Urodynamic studies are expensive, time-consuming, and uncomfortable diagnostic investigations. The 3rd ICI reported insufficient evidence with which to answer the following key research questions related to UDS: 1) Do physicians alter clinical decision-making based on results of UDS?, and 2) Do alterations in clinical decisions made in response to UDS results improve the clinical outcomes?


Options:
A: To assess the utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra.
B: Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and "Very Much" or "Much" Better on the Patient Global Impression of Improvement Measure at 12 Mos. (12 Months)
C: Non inferiority among the two groups as far as the improvement in the UDI at two years after treatment is concerned.
D: Non inferiority of the improvement of the urinary distress inventory one year after treatment. (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Pregnant Women Education in Case of Overweight or Obesity on Risk of Child Overweight and Pregnancy Outcome
Brief Summary: Metabolic environment of the foetus during pregnancy in obese women is altered and the child exposed at an increased risk of obesity. Rapid infancy and childhood weight gain is associated with subsequent obesity.

The purpose of the study is to test the efficacy of an educational intervention during pregnancy in obese or overweight women, on the reduction of rapid infancy weight gain in the two first years of life.


Options:
A: 30 per cent reduction of rapid infancy weight gain at two years defined as > +0,67 change in weight SD score. The 0,67 SD represents the difference between the displayed centile lines on standard infant growth charts. (30 Months)
B: Gestational Weight Gain (delivery); Postpartum Weight Change (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Percent of Participants Meeting Postpartum Weight Goals (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Fasting Glucose (FG) (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Fasting Insulin (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Hemoglobin A1c (HbA1c) (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Adiponectin (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Total Leptin (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Total Cholesterol (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Low Density Lipoprotein Cholesterol (6 weeks postpartum, 6 months postpartum, 12 months postpartum); High Density Lipoprotein Cholesterol. (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Triglycerides (6 weeks postpartum, 6 months postpartum, 12 months postpartum); High Sensitivity C-Reactive Protein (6 weeks postpartum, 6 months postpartum, 12 months postpartum); Compliance With IOM Weight Gain Guidelines for Pregnancy. (delivery); Child Waist Circumference (delivery); Child Head Circumference (delivery); Child Skinfold Thicknesses - Subcapsular and Triceps (delivery); Fetal Growth (delivery); Ponderal Index (delivery); Birthweight (delivery); Child Length (delivery)
C: Cesarean Section (At delivery); Preeclampsia/Pregnancy Induced Hypertension (Delivery); Gestational Diabetes Mellitus (Delivery); Large for Gestational Age (Delivery); Neonatal Intensive Care Unit (Within 1 month postpartum); Gestational Weight Gain (Gestational week 35)
D: The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups. (3 - 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Pregnant Women Education in Case of Overweight or Obesity on Risk of Child Overweight and Pregnancy Outcome
Brief Summary: Metabolic environment of the foetus during pregnancy in obese women is altered and the child exposed at an increased risk of obesity. Rapid infancy and childhood weight gain is associated with subsequent obesity.

The purpose of the study is to test the efficacy of an educational intervention during pregnancy in obese or overweight women, on the reduction of rapid infancy weight gain in the two first years of life.


Options:
A: number of gestational diabetes cases diagnosed with OGTT (24-28th weeks gestation); difference in HOMA values (from first trimester to OGTT)
B: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)
C: Maternal Weight Change (baseline to 2 weeks post partum)
D: 30 per cent reduction of rapid infancy weight gain at two years defined as > +0,67 change in weight SD score. The 0,67 SD represents the difference between the displayed centile lines on standard infant growth charts. (30 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation
Brief Summary: Compared with chronic dialysis treatment, kidney transplantation generally offers a longer life span, a better quality of life, and lower health care costs for the over 500,000 Americans with End Stage Renal Disease. Despite Medicare funding of virtually all kidney transplants, minority, female, and poor patients with End Stage Renal Disease have decreased access to kidney transplantation. In prior work, the investigators identified the steps in the transplant process that are responsible for creating these disparities. These include medical suitability, interest in receiving a transplant, referral to a transplant center for a pre-transplant workup, placement on a waiting list or identification of a living donor, and receipt of a kidney from a deceased or living donor. The investigators now propose to train transplant recipients to act as transplant navigators and then test the value of using transplant navigators to help patients and providers complete these steps.

The proposed community-based randomized controlled trial will involve approximately 75-100 adult hemodialysis patients at intervention dialysis facilities and approximately 75-100 patients at control facilities to compare a transplant navigator intervention with usual care over a 24 month interval. Baseline evaluation will include sociodemographic and medical characteristics, specific steps completed in the transplant process, and barriers to moving forward in the transplant process. At periodic intervals, the navigator will provide tailored information and assistance to patients and their nephrologists to help them complete the tasks required at each step. The major outcome will be completion of additional steps in the transplant process. Secondary analyses will examine impediments to successful intervention among subjects who fail to move forward in the transplant process despite assistance from a navigator.

The proposed project will test a novel intervention that targets patients and nephrologists as they together make transplant-related decisions. Future work will involve determining the impact of navigators on disparities in transplant rates, examining the cost-effectiveness of transplant navigators, and disseminating the intervention for use across the country. Helping patients complete steps in the transplant process may lead not only to improved access to kidney transplantation but also to better patient survival, decreased health care costs, and increased quality of life.


Options:
A: Change in blood pressure measurement at baseline and at one year follow-up (Baseline and one year follow-up)
B: Self-Reported physical activity (Baseline, 3 months, and 6 months)
C: Behavior change (6 month -12 months post-partum)
D: Number of Steps Completed in Transplant Process (18-24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation
Brief Summary: Compared with chronic dialysis treatment, kidney transplantation generally offers a longer life span, a better quality of life, and lower health care costs for the over 500,000 Americans with End Stage Renal Disease. Despite Medicare funding of virtually all kidney transplants, minority, female, and poor patients with End Stage Renal Disease have decreased access to kidney transplantation. In prior work, the investigators identified the steps in the transplant process that are responsible for creating these disparities. These include medical suitability, interest in receiving a transplant, referral to a transplant center for a pre-transplant workup, placement on a waiting list or identification of a living donor, and receipt of a kidney from a deceased or living donor. The investigators now propose to train transplant recipients to act as transplant navigators and then test the value of using transplant navigators to help patients and providers complete these steps.

The proposed community-based randomized controlled trial will involve approximately 75-100 adult hemodialysis patients at intervention dialysis facilities and approximately 75-100 patients at control facilities to compare a transplant navigator intervention with usual care over a 24 month interval. Baseline evaluation will include sociodemographic and medical characteristics, specific steps completed in the transplant process, and barriers to moving forward in the transplant process. At periodic intervals, the navigator will provide tailored information and assistance to patients and their nephrologists to help them complete the tasks required at each step. The major outcome will be completion of additional steps in the transplant process. Secondary analyses will examine impediments to successful intervention among subjects who fail to move forward in the transplant process despite assistance from a navigator.

The proposed project will test a novel intervention that targets patients and nephrologists as they together make transplant-related decisions. Future work will involve determining the impact of navigators on disparities in transplant rates, examining the cost-effectiveness of transplant navigators, and disseminating the intervention for use across the country. Helping patients complete steps in the transplant process may lead not only to improved access to kidney transplantation but also to better patient survival, decreased health care costs, and increased quality of life.


Options:
A: Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options. (Up to 19 months)
B: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)
C: Number of Steps Completed in Transplant Process (18-24 months)
D: efficacy of PC-ACP

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I Trial of Conditionally Replication-Competent Adenovirus (DNX-2401, Formerly Known as Delta-24-RGD-4C) for Recurrent Malignant Gliomas
Brief Summary: The goal of this clinical research study is to find the highest tolerable dose of DNX-2401 that can be injected directly into brain tumors and into the surrounding brain tissue where tumor cells can multiply. A second goal is to study how the new drug DNX-2401 affects brain tumor cells and the body in general.


Options:
A: Maximum Tolerated Dose (MTD) DNX-2401 (Assessed during 14 day waiting period between doses (every 28 days).)
B: Overall Survival (at 12 months)
C: Overall survival (From the date of randomization to 18 months or to the date of death from any cause)
D: Overall survival (From date of study entry until the date of death from any cause (up to 10 years))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole as Adjunctive Therapy to Mechanical Treatment of Patients With Chronic Periodontitis
Brief Summary: The purpose of this study is to assess the clinical and microbiological effectiveness of the moxifloxacin compared with the combination ciprofloxacin - metronidazole, when used as adjunctive therapy to scaling and root planning for the treatment of advanced chronic periodontitis.


Options:
A: Probing Depth (six months period (two measurements))
B: The Primary Outcome Variable Was Probing Depth. (6-months)
C: Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months (12 months)
D: Change in probing pocket depth (PD) (baseline, 4weeks, 8weeks and 12weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole as Adjunctive Therapy to Mechanical Treatment of Patients With Chronic Periodontitis
Brief Summary: The purpose of this study is to assess the clinical and microbiological effectiveness of the moxifloxacin compared with the combination ciprofloxacin - metronidazole, when used as adjunctive therapy to scaling and root planning for the treatment of advanced chronic periodontitis.


Options:
A: probing depth (six months)
B: Probing Depth (six months period (two measurements))
C: The Primary Outcome Variable Was Probing Depth. (6-months)
D: Change in probing pocket depth (PD) (baseline, 4weeks, 8weeks and 12weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in Polycystic Ovarian Syndrome (PCOS) Patients
Brief Summary: This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Each study center will follow its standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.


Options:
A: Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3 (weeks 1-3)
B: Pituitary Response to GnRH (Peak hormone level within 2 hours post GnRH doses); Effect of Estrogen on Pituitary Response to GnRH (Peak hormone level within 2 hours post GnRH doses)
C: Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. (Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks)
D: A difference in the term (37 completed weeks of gestation), singleton live birth rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. (Approximately 9 months after completion of the last procedure of the last study participant.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Metabolic Parameters of Antipsychotic Child Treatment (IMPACT)
Brief Summary: This study will test the effectiveness of two different treatments for children and adolescents who have gained weight on their antipsychotic medications.


Options:
A: Body Mass Index (BMI) Z-score Change (Change from baseline to 24 weeks)
B: The Fagerstrom Test for Nicotine Dependence, expired CO level, and urine cotinine will be used to determine if bupropion SR, when used as an adjunct to antipsychotic medication, is superior to placebo for helping patients with schizophrenia improve their (Expired CO weekly, Fagerstrom baseline and end of study, Urine cotinine baseline, week 2 and week 8); Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function. (Beginning and end of study)
C: Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score (Baseline (Day 8) to Day 92 (end of study Part A))
D: Change from baseline in weight at week eight (Baseline and week eight)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Phosphate Binding With Sevelamer Carbonate Improve Cardiovascular Structure and Function in Patients With Early Chronic Kidney Disease?
Brief Summary: The purpose of this study is to determine whether lowering phosphate in patients with early chronic kidney disease with the phosphate binder sevelamer has beneficial effects on cardiovascular structure and function.


Options:
A: Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels (Week 0 - 12); Percentage Changes in Parathyroid Hormone (PTH) Levels (Week 0 - 12)
B: Composite end-point of Ca, P, Ca*P within K/DOQI recommendation (12 months)
C: Total phosphorus bound and entrapped per piece of chewing gum (60 minutes)
D: Change in left ventricular mass (36 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Local Steroid Injection in the Treatment of Idiopathic Carpal Tunnel Syndrome: A Randomized Double-blind Placebo-controlled Trial Among Patients Planned for Surgical Treatment
Brief Summary: The aim of this study is to assess the efficacy of injecting steroid into the carpal tunnel in relieving symptoms of carpal tunnel syndrome for at least 1 year with outcomes measured with patient evaluated symptoms score.Out of the patients referred by primary care, those with a clinical diagnosis of CTS who have tried wrist splint and whose symptom severity is judged by the examining surgeon to warrant surgery are offered to be put on the waiting list for carpal tunnel release. This means a waiting time of approximately 3 months. Patients who give informed consent will be asked to attend the outpatient clinic for a physical examination followed by allocation to one of the three trial groups. Immediately following the allocation the patients will receive the assigned treatment.


Options:
A: Percentage of Participants Achieving Sustained Remission Rate At Week 104 (Week 104)
B: Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand (5 to 7 years); Symptom Severity Score (5-7 years)
C: The CTS symptom severity score after treatment. (10 weeks); Rate of surgery (52 weeks)
D: Changes in the intensity of pain symptoms between baseline and follow-up periods (Baseline and 1, 3, 6 and 12 months after the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC
Brief Summary: This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.


Options:
A: Length of survival
B: Progression-free survival (Event driven)
C: Survival (Up to 5 years); Grade 4 or 5 toxicities assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Up to 5 years)
D: Progression Free Survival (PFS) Rate at Month 6 (Month 6)

Answer: B