TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Safety and Effectiveness of the Hydrus Aqueous Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery, A Prospective, Multicenter, Randomized, Controlled Clinical Trial
Brief Summary: This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.


Options:
A: Mean IOP at 6 months (6 months); Surgical complication rates (intraoperative and postoperative up to 12 months)
B: Change in Intraocular Pressure (Baseline to 5 years); Rate of Complications (5 years)
C: Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure (12 months); Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure (24 months)
D: Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. (Baseline and 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Therapy to Prevent Sexual Pain in Menopausal Survivors of Breast Cancer
Brief Summary: The purpose of this protocol is to determine whether pain with sexual intercourse can be reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain.

The investigators hypothesize that the pain arises in the vulvar vestibule. The investigators predict that the localized use of lidocaine will be more efficacious than use of placebo liquid.


Options:
A: patients' views three months after intervention; use of booklet with others between intervention and three month follow up; change in reported social support between recruitment and three month follow up; change in anxiety and depression between recruitment and three month follow up
B: To assess whether MBSR favorably influences psychological status (anxiety, perceived stress, depression), quality of life, and immune status (among post-treatment breast cancer survivors) (6 weeks)
C: Sexuality problems (Baseline); Intimacy problems. (Baseline); Sexuality problems (T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group)); Sexuality problems (T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group)); Sexuality problems (T3: 3 months after T2 (intervention group)); Intimacy problems. (T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group)); Intimacy problems. (T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group)); Intimacy problems. (T3: 3 months after T2 (intervention group)); Sexuality problems (T4: 6 months after T3 (intervention group)); Intimacy problems (T4: 6 months after T3 (intervention group))
D: Prevention of Entry Dyspareunia With Non-hormonal Therapy (During Phase II (0-4 weeks) and during Phase III (5-12 weeks)); Location of Pain in Postmenopausal Dyspareunia (Enrollment visit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
Brief Summary: Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.


Options:
A: Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.) (Day 8 from first misoprostol dose)
B: Success rate of abortion (24 hours); Interval to abortion (24 hours)
C: Complete abortion without recourse to surgical intervention (follow up visit 7 days after initial treatment)
D: Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment. (Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done); Gestational Sac Expulsion by the Second Follow-up Visit at Day 8 (Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)); Gestational Sac Expulsion by the 30-day Telephone Call (30 Days); Uterine Asperation (30 Days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
Brief Summary: Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.


Options:
A: Complete abortion without recourse to surgical intervention (follow up visit 7 days after initial treatment)
B: Complete abortion without recourse to surgical intervention. (follow up visit 7 days after initial treatment)
C: Cervical Dilation in Women Following Exposure to Either Ripening Agent (3-4 hours after placement of ripening agent)
D: Number of surgical evacuation in each group (during de study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
Brief Summary: Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.


Options:
A: doxycycline side effects (24 hours)
B: Complete abortion without recourse to surgical intervention. (follow up visit 7 days after initial treatment)
C: Number of surgical evacuation in each group (during de study)
D: Complete abortion without recourse to surgical intervention (follow up visit 7 days after initial treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia
Brief Summary: This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.


Options:
A: Progression-Free Survival (Up to 17 months)
B: Arm A: Percentage of Complete Responses (7 months); Arm B: Treatment-free Survival at 18 Months (18 months)
C: Overall response rate (ORR) (84 days after first dose of last induction cycle)
D: Overall Response Rate (ORR) (Disease evaluated on Cycle 2 day 22 (Restage end of cycle 2), Cycle 10 day 1 (Final Restage 2 months after end of ofa therapy) and off treatment prior to cycle 10. Treatment duration is median 243 days with range of 9-620 days.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Immediate Postplacental Insertion of Intrauterine Devices at Time of Cesarean Delivery: A Randomized Clinical Trial
Brief Summary: This is a randomized controlled trial among women who deliver by cesarean at UNC Women's Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8 week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months later than women who plan on receiving an IUD 4-8 weeks after delivery.


Options:
A: 6 month IUD usage rates (6 months)
B: Time to Lactogenesis Stage II (5 days postpartum)
C: Use of the LNG-IUS for Contraception (12 months after cesarean delivery)
D: IUD Use (6 months postpartum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Parallel Group, Placebo Controlled Research of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis
Brief Summary: The efficacy measure of hUC-MSC in the treatment of proliferative lupus nephritis on remission of lupus nephritis (combined partial and complete remission) in terms of stabilization and improvement in renal function.


Options:
A: Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period (Day 1 (randomization) to 12 months.)
B: To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ,Ⅴ, Ⅲ+Ⅴand Ⅳ+Ⅴ LN. (24 weeks)
C: Induction Phase: Number of Patients Showing Treatment Response (24 weeks); Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval (From the start of the Maintenance Phase to Month 36)
D: Efficacy and Safety (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Open-labelled, Controlled, Parallel Group Study to Assess the Efficacy and Safety of MUTAFLOR in 3 Weeks Treatment for Immunity Improvement in Preterm Infants With 1 Year Follow-up Period
Brief Summary: EcN has been registered as a medical drug under the brand name Mutaflor® SUSPENSION in Ukraine in 2010. Indications for its clinical use are acute diarrhea in infants and toddlers including those on tube feeding tube, diarrhea in children, prophylactics of pathological colonization in newborns including premature newborns, and improvement of immunity in newborns (mature and premature).

The aim of this trial was to observe efficacy and safety of Mutaflor® SUSPENSION use for immunity improvement in preterm newborn infants


Options:
A: The Number (Rate) of Patients With Acute Respiratory Infections (first 28 days of life)
B: Natural killer cell activity (At baseline); Natural killer cell activity (At 12-week follow-up); Change from baseline natural killer cell activity at 12-week (At baseline and 12-week follow-up)
C: N/A
D: Interleukin-8 (IL-8) (72 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness-based Therapy For the Treatment of Chronic Tinnitus: A Randomized Controlled Pilot Study
Brief Summary: In the present randomized waiting-list-controlled study the investigators examined a specific manualized mindfulness-based therapeutic approach in the treatment of chronic tinnitus.


Options:
A: Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007) (18 months); MINI-Tinnitus Questionnaire (Mini-TQ; Hiller & Goebel, 2004) (18 months)
B: Tinnitus Functional Index (TFI) (Change will be assessed at 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2). The change will be assessed at every test moment.)
C: Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005) (Last session)
D: Change in tinnitus complaints as measured by the German version of the Tinnitus Questionnaire (TQ)(Baseline versus week 9) (Baseline to Week 9)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence
Brief Summary: During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in pressure was observed in the external urethral sphincter along with an increase in bladder capacity. In a subsequent study it was demonstrated that Transcutaneous Mechanical Nerve Stimulation (TMNS) in women could induce pressure increment of the external urethral sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33 women suffering from urinary stress incontinence were able to contract their pelvic floor muscles and had become free of symptoms. Another pilot study has shown promising effect on the overactive bladder syndrome. Furthermore pilot studies in men who are incontinent after a radical prostatectomy have shown promising results. A randomized investigation of TMNS applied in the immediate period after a radical prostatectomy to investigate effects on both continence and erectile function is on going.

The present study aims to treat urinary incontinence in men who are still incontinent more than 1 year after a radical prostatectomy. A medical vibrator is used daily for a period of 6 weeks and the results of the treatment is then evaluated. The participants will be randomized to 2 groups. Group 1 starts vibration treatment at base line and group 2 starts after 6 weeks when group 1 is done. The groups are compared at baseline, at 6 weeks and at 12 weeks.

The stimulation will be performed at the frenulum of the glans penis every day for 6 weeks with an amplitude of 2 mm and a frequency of 100 Hz. Results will be evaluated on the basis of questionnaires, micturition diaries and diaper tests.

If the investigators are able to demonstrate a significant reduction in the incontinence symptoms in the subjects the investigators asses that vibration can be a way of reestablishing normal continence in men after a radical prostatectomy.


Options:
A: 24 hour Diaper test (weight in grams) at 6 weeks (Assessment at baseline and again after 6 weeks)
B: urinary incontinence (august/2013 to December/2013 (4 months))
C: Amount of Urinary Leakage (Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment); Frequency of Daily Urinary Leakage (Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment)
D: Effects of transcutaneous perineal stimulation compared to anal stimulation (Baseline, 6 and 10 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Medication Adherence in Kidney Transplant Recipients Using Automated Reminders and Provider Notification
Brief Summary: Novel wireless technology has created inexpensive tools that allow both accurate monitoring of adherence to pills as well as real-time interventions such as automated reminders in the event of a missed dose. In this study, the investigators will use Vitality GlowCaps, an electronic pill bottle. These pill bottles provide an unbiased assessment of pill bottle opening and a valid approach to verifying self-administered pill taking, reflecting not only daily use but also patterns of drug use and timing. At the prescribed times, bottle will electronically transmit whether a subject opened the pill cap to take the immunosuppressant medication via a built-in transmitter to the central server. The investigators will randomize participants to usual care, customized reminders, and customized reminders paired with provider notification in the event of low adherence.

The investigators' aim: To improve immunosuppression (IS) medication adherence in kidney transplant recipients.

The investigators' hypotheses: a) Automated reminders will improve adherence to immunosuppression compared to usual care, and b) Automated reminders, paired with provider notification about patients with poor adherence, will improve adherence to immunosuppression compared to usual care.


Options:
A: 12-week immunosuppression medication adherence (12 weeks)
B: Immunosuppression (Tacrolimus) Adherence (90 days)
C: Comparison of Variability in Tacrolimus Levels by Group Assignment (3 months ( to 12 Months Post-Transplantation)
D: Medication adherence (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Blood Pressure Control and Compliance to Treatment in Hypertensive Patients With Metabolic Syndrome: a Study Based on Home Blood Pressure Telemonitoring
Brief Summary: The purpose of this study is to assess whether, in patients at high cardiovascular risk (hypertension with metabolic syndrome), long-term (1-year) blood pressure control is most effective when based on home blood pressure telemonitoring and on the feedback to the patient by the doctor between visits, or when based only on blood pressure determination during quarterly office visits.


Options:
A: Brain Natriuretic Peptide values (Baseline, 6 months); Self-care practices measured through Self-Care of Heart Failure Index scores and interviews (baseline, 6 months); Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews (baseline, 6 months)
B: Time between emergency call and therapy decision
C: Weight (Measured at Month 24)
D: Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg (6 months); Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Blood Pressure Control and Compliance to Treatment in Hypertensive Patients With Metabolic Syndrome: a Study Based on Home Blood Pressure Telemonitoring
Brief Summary: The purpose of this study is to assess whether, in patients at high cardiovascular risk (hypertension with metabolic syndrome), long-term (1-year) blood pressure control is most effective when based on home blood pressure telemonitoring and on the feedback to the patient by the doctor between visits, or when based only on blood pressure determination during quarterly office visits.


Options:
A: Medication Adherence (12 months after intervention); Mean Proportion of Days Covered Relative to Usual Care (12 months)
B: Adherence to ART and HIV RNA suppression (6,12 months)
C: Proportion of people who respond to text messages and are persistently hypertensive (3 weeks)
D: Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg (6 months); Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Blood Pressure Control and Compliance to Treatment in Hypertensive Patients With Metabolic Syndrome: a Study Based on Home Blood Pressure Telemonitoring
Brief Summary: The purpose of this study is to assess whether, in patients at high cardiovascular risk (hypertension with metabolic syndrome), long-term (1-year) blood pressure control is most effective when based on home blood pressure telemonitoring and on the feedback to the patient by the doctor between visits, or when based only on blood pressure determination during quarterly office visits.


Options:
A: Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg (6 months); Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg (12 months)
B: The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. (1 year)
C: Changes in mean SBP (From baseline (T1) to 12 months (T3))
D: Target goal of HbA1c (< 7.0%) without hypoglycemia (24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicentre Study to Assess Efficacy and Safety of Expanded Allogeneic Adipose-derived Stem Cells (eASCs) for the Treatment of Perianal Fistulising Crohn's Disease Over a Period of 24 Weeks and an Extended Follow-up Period up to 104 Weeks.
Brief Summary: The current multicentre phase III study is proposed to confirm in an add-on therapy design compared to a placebo-control group, the efficacy of adipose-derived stem cells (eASCs) from healthy donors for the treatment of complex anal fistulas in patients with Crohn's disease over a 24-week period and an extended follow-up period up to 104 weeks.


Options:
A: Combine remission of perianal fistulising Crohn's (24 weeks)
B: Safety and efficacy (fistula closure) (12 weeks)
C: Clinical response to MSC: Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy (Six weeks)
D: Closure of fistulas defined as absence of suppuration and re-epithelization of the external opening and absence of collections>2 cm directly related to the fistula tract treated, as measured by MRI (healing) (weeks 1, 4, 12 and 24. Week 26 in patients with a second dose)

Answer: A