TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: TRON: A Randomised, Double Blind, Placebo-controlled Study of RAD001 (Everolimus) in the Treatment of Neurocognitive Problems in Tuberous Sclerosis
Brief Summary: This is a single centre, two-arm, individually randomised, Phase II, double- blind, placebo-controlled trial of RAD001 (Everolimus) versus placebo in the treatment of neurocognitive problems in patients with tuberous sclerosis (TSC). The IMP is a licensed medicine in this patient group but for a different target of effect. The current trial is a proof of principle study for memory and executive function outcomes.

Following an eligibility visit, patients will be scheduled for baseline visit and randomization. They will then be followed up for 6 months undergoing both safety and neurocognitive assessments whilst taking either the placebo or study drug.

48 patients aged 16 to 60 years with tuberous sclerosis (TSC) who have IQ \> 60 and a significant deficit in one or more primary outcome measures will be randomly allocated in a ratio of 2:1 to either RAD001 (Everolimus) or Placebo.


Options:
A: Rapamycin level (6 months); Complete blood count (6 months); Total cholesterol (6 months); Dermatologic sensitivity at site of application (pain, erythema, edema, pruritis) (6 months)
B: List Learning test (from the BIRT Memory and Information Processing Battery) (6 months); Complex Figure test (from the BIRT Memory and Information Processing Battery) (6 months); CANTAB - Stockings of Cambridge (SOC) (6 months); CANTAB - Spatial Working Memory (SWM) (6 months); Telephone search dual task (from the Test of Everyday Attention) (6 months)
C: Core Phase: European Medicine Agency (EMA): Seizure Frequency Response Rate (Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)); Core Phase: Food & Drug Administration (FDA): Percentage Change From Baseline in Partial Onset-seizure Frequency (Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase))
D: Change From Baseline in the Facial Angiofibroma Grading Scale (AGS) Score (baseline, 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of the Efficacy of Methylnaltrexone in Resolving Constipation Induced by Different Opioid Subtypes, Combined With Laboratory Analysis of Immunomodulatory and Antiangiogenic Effects of Methylnaltrexone
Brief Summary: Methylnaltrexone for the treatment of opioid-induced constipation in the setting of palliative or hospice care, is significantly more effective than placebo (1). However, in both the randomized and the open-label phase of the multi center trial showing this favorable outcome, the drug produced rescue-free laxation in only about half of the patients (2). There may be several reasons for this result, since constipation in palliative care patients often has multiple simultaneously occurring causes.

Assuming that constipation of the non-responders is still opioid-induced, one of the possible reasons for not responding to methylnaltrexone could be that central actions of opioids contribute to constipation by reducing motility of the intestines through direct actions in the spinal dorsal horn (2). However, as methylnaltrexone is a µ-receptor antagonist and not all opioids are solely µ-receptor agonists another reason may well be that successful laxation is determined by the receptor-profile of the specific opioid the patient is using.

Opioids do not only influence bowel functioning, but also immune system functioning and angiogenesis. Methylnaltrexone possibly antagonizes these changes, therefore this study will also investigate the influence of methylnaltrexone on immunologic and angiogenic parameters.


Options:
A: Rescue-free laxation response (Within 4 hours after at least 2 of the first 4 doses (the first week of treatment).)
B: Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone (4 hours after the dose of subcutaneous methylnaltrexone)
C: Efficacy of SC MNTX compared with placebo in inducing laxation (29 days)
D: Assess the efficacy of Targinact® treatment (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of the Efficacy of Methylnaltrexone in Resolving Constipation Induced by Different Opioid Subtypes, Combined With Laboratory Analysis of Immunomodulatory and Antiangiogenic Effects of Methylnaltrexone
Brief Summary: Methylnaltrexone for the treatment of opioid-induced constipation in the setting of palliative or hospice care, is significantly more effective than placebo (1). However, in both the randomized and the open-label phase of the multi center trial showing this favorable outcome, the drug produced rescue-free laxation in only about half of the patients (2). There may be several reasons for this result, since constipation in palliative care patients often has multiple simultaneously occurring causes.

Assuming that constipation of the non-responders is still opioid-induced, one of the possible reasons for not responding to methylnaltrexone could be that central actions of opioids contribute to constipation by reducing motility of the intestines through direct actions in the spinal dorsal horn (2). However, as methylnaltrexone is a µ-receptor antagonist and not all opioids are solely µ-receptor agonists another reason may well be that successful laxation is determined by the receptor-profile of the specific opioid the patient is using.

Opioids do not only influence bowel functioning, but also immune system functioning and angiogenesis. Methylnaltrexone possibly antagonizes these changes, therefore this study will also investigate the influence of methylnaltrexone on immunologic and angiogenic parameters.


Options:
A: Efficacy of SC MNTX compared with placebo in inducing laxation (29 days)
B: Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period. (2 weeks)
C: Rescue-free laxation response (Within 4 hours after at least 2 of the first 4 doses (the first week of treatment).)
D: Efficacy variable: Bowel Function Index (BFI) score. Amount of laxative medication use recorded at each assessment visit (4 weeks and a 6 month open label); Efficacy variable: Brief Pain Inventory Short-Form (BPI-SF) (Cleeland, 1991). Amount of analgesic rescue medication used (4 weeks and a 6 month open label)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of Virtual Therapy by Means of Reinforced Feedback in Virtual Environment on Upper Limb Function in Post-stroke Patients.
Brief Summary: The aims of the study is to explore whether the rehabilitation of the upper extremity performed in interaction with a virtual environment could improve motor function in post-ischemic and post-haemorrhagic stroke subjects with hemiparesis, in comparison to the traditional neuromotor rehabilitation treatment.


Options:
A: Length of outpatient rehab stay (LOS) (From admission to discharge, an expected average of 5 weeks.)
B: Fugl_Meyer Upper Extremity scale (F-M UE) (20 min)
C: Fugl-meyer assessment_upper extremity (Change from baseline in Fugl-Meyer assessment at 4 weeks after intervention)
D: Rating Scale Score (1 day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Efficacy and Safety of FE 999049 With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme
Brief Summary: This trial investigates the effects of FE 999049 compared to GONAL-F.


Options:
A: Ongoing Pregnancy Rate (10-11 weeks after blastocyst transfer); Ongoing Implantation Rate (10-11 weeks after blastocyst transfer)
B: Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set (10-11 weeks after embryo transfer at the blastocyst stage); Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set (10-11 weeks after embryo transfer at the blastocyst stage)
C: Number of patients obtaining 5-12 oocytes during COH (2 years)
D: Number of oocytes retrieved (End of stimulation (max 16 days after investigational medicinal product (IMP) start))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Efficacy and Safety of FE 999049 With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme
Brief Summary: This trial investigates the effects of FE 999049 compared to GONAL-F.


Options:
A: Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set (10-11 weeks after embryo transfer at the blastocyst stage); Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set (10-11 weeks after embryo transfer at the blastocyst stage)
B: Number of Oocytes Retrieved (Day of oocyte retrieval (up to Day 18 after start of stimulation))
C: Ongoing Pregnancy Rate (10-11 weeks after blastocyst transfer); Ongoing Implantation Rate (10-11 weeks after blastocyst transfer)
D: Number of metaphase II oocytes retrieved during the course of one treatment cycle (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Evaluating the Immunogenicity of FE 999049 in Repeated Cycles of Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme
Brief Summary: This trial investigates the immunogenicity of FE 999049 in repeated cycles.


Options:
A: Live birth rate (12 months)
B: Ongoing Pregnancy Rate (10-11 weeks after transfer)
C: Number of oocytes retrieved (End of stimulation (max 16 days after investigational medicinal product (IMP) start))
D: Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles (Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Fall Risk Reduction in Multiple Sclerosis: Exercise Versus Behavior
Brief Summary: Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, \& head injuries). The effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. Despite the importance of falls in persons with MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear. The purpose of this investigation is to determine whether exercise based or educational based interventions are more suited for fall prevention in older adults with MS.


Options:
A: Difference in mean change in total falls between intervention and control arms (5 months)
B: Fall incidence (3 months)
C: Change from Baseline in Functional Mobility at Completion of Training and the Following Three Months (At baseline, 1 week after completion of training, 3 months later); Change from Baseline in Falls at Completion of Training and the Following Three Months (First week of training, last week of training, 3 months later); Change from Baseline in Functional Neural Connectivity (fMRI) at Completion of Training (At baseline, 1 week after completion of training)
D: Clinical assessment procedures: - Berg Balance Scale (BBS) - Activities-specific Balance Confidence Scale (ABC) Instrumental assessment procedures: - Stabilometric assessment (At recruitment, after treatment (5 weeks) and in the follow-up (1 month))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Fall Risk Reduction in Multiple Sclerosis: Exercise Versus Behavior
Brief Summary: Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, \& head injuries). The effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. Despite the importance of falls in persons with MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear. The purpose of this investigation is to determine whether exercise based or educational based interventions are more suited for fall prevention in older adults with MS.


Options:
A: Falls events (6-months)
B: Quality of life (1 year)
C: Fall incidence (3 months)
D: rate of falls (12 months); proportion of fallers (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency. A Randomized Clinical Trial.
Brief Summary: At 3 months, crenobalneotherapy session is superior to waiting list for patients with chronic venous insufficiency.


Options:
A: number of patient with 20% improvement of CIVIC scale at 3 months (3 months)
B: Occurrence of a leg ulcer within the year following the inclusion. The ulcer will be classified C5 of CEAP (healed ulcer) or C6 (non healed ulcer)at the follow up visit. (1 year)
C: The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20) (12 months); Photoplethysmograph (PPG) (12 months)
D: Feasibility as Measured by Number of Participants Who Meet Study Eligibility Criteria at Baseline (Baseline); Number of Screened Subjects Who Provided Consent at Baseline (Baseline); Mean Number of Participants Who Adhered to the Assigned Physical Activity During 8-week Period (Intervention Arm -FitBit Arm ) (8 weeks); Mean Physical Activity Questionnaire Score at 3 Months (Standard of Care Arm Only) (3 months); Mean Physical Activity Questionnaire Score at 6 Months (Standard of Care Arm Only) (6 months); Mean Physical Activity Questionnaire Score at 9 Months (Standard of Care Arm Only) (9 months); Proportion of Subjects Who Complete Post-randomization (Within 24 months of trial initiation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II - Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult Male Circumcision Programs in Zimbabwe (Comparative Study)
Brief Summary: The protocol, approved by the Medical Research Council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in Zimbabwe


Options:
A: Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing (Up to 30 minutes)
B: Procedure time (9 weeks)
C: The study's primary goal is to compare the PrePex™ circumcision procedure with one of the approved WHO methods of surgical circumcision. (9 weeks)
D: HIV acquisition; safety of circumcision

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility of Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease (COPD) Who Decline Pulmonary Rehabilitation
Brief Summary: The feasibility study will involve mixed methods, this means interviews as well as assessment of treatment with inspiratory muscle training therapy (IMT). There are two pathways within the study depending on whether people want to have inspiratory muscle training. People who accept to have inspiratory muscle training will have assessments before training, after 8 weeks of training and at 6 month follow up in addition to interviews before and after the study (at 6 months). For those who choose not to have the inspiratory muscle training the investigators will offer them an interview so that the investigators can find out more about what might have made the study more appealing or what treatments they would have preferred. The investigators will also ask if they wish to be followed up with baseline assessments for the study period and if the investigators can access health records.

Interviews

Semi-structured interviews lasting approximately an hour will be performed at the beginning of the study with participants who accept the IMT pathway and those who decline IMT until no knew themes are raised. These interviews will be used to provide information on reasons for declining pulmonary rehabilitation, attitudes to exercise, attitudes to IMT, treatment preferences and opinions regarding study design and outcome measures (see Interview Topic guide). The interviews will be taped and transcribed verbatim. A follow up interview with study participants who have received IMT will be conducted at 6 months addressing attitudes to IMT and study design and whether they have decided that they wish to engage with other services (such as pulmonary rehabilitation and smoking cessation).

Inspiratory Muscle Training (IMT) method

Participants will perform 8 weeks of IMT strength training using the Powerbreathe Kinetic device (Powerbreathe). Training will progress to 60% maximum inspiratory pressure (PiMax). This means that each breath in through the device is set at 60% of the maximum force you are able to create when you breathe in rather than at full force. 30 breaths are performed at high velocity (paced initially over a period of 15 minutes to allow recovery between each breath through the device). Once established it is anticipated that each training session should take no more than five minutes. Training is performed twice a day, 5 days per week for the first 8 weeks. Training will be titrated (set to a level suitable for the participant) and supervised weekly for the first 8 weeks by a physiotherapist. After 8 weeks training the participants are advised to continue training unsupervised, twice a day, 3 times per week for a further 18 weeks.


Options:
A: Dyspnea measure (21 - 4 days / +7 jours)
B: Sustained Maximal Inspiratory Pressure (SMIP) (Change from baseline to 8 weeks and 24 weeks)
C: Recruitment (4 months)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Purpose and rationale: Acute pulmonary embolism (PE) is a common and often fatal disease, with an approximately 30% mortality rate without treatment. Treatment is important to reduce mortality and recurrence in acute PE. Therapeutic options for PE include subcutaneous low molecular weight heparin (SC LMWH), intravenous unfractionated heparin (IV UFH), subcutaneous unfractionated heparin and subcutaneous fondaparinux with or without thrombolysis. In the treatment of acute PE, SC LMWH has been shown, at least, as effective and safe as IV UFH \[4\]. Compared to IV UFH, SC LMWH associated with lower mortality, fewer recurrent thrombotic events and less major bleeding. Current guidelines recommend use of SC LMWH for most hemodynamically stable patients with PE and they say that SC LMWH have not been tested in the setting of acute massive PE.

The purpose of this study is to demonstrate that SC LMWH is as safe as IV UFH in the treatment of acute PE in combination with thrombolytic treatment.


Options:
A: Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))
B: The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))
C: The primary aim of the study is to compare the major hemorrhage risk between the use of LMWH plus thrombolytic treatment and UFH plus thrombolytic in the treatment of acute massive PE. (7 day)
D: Symptomatic Venous Thromboembolism; Major Bleeding; Death

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD) -Study 1
Brief Summary: After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide \[UMEC\] \[62.5 mcg\] administered once daily via a DPI; OR UMEC \[125 mcg\] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.


Options:
A: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85 (Day 85)
B: Change From Baseline in 24-hour Weighted-mean Serial FEV1 on Treatment Day 84 (Baseline and Day 84)
C: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
D: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer
Brief Summary: This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.


Options:
A: Overall Survival Time (3 years)
B: Radiographic Progression-Free Survival (PFS) (Up to 44 months); Overall Survival (OS) (Up to 66 months)
C: Overall Survival (From randomization (Day 1) up to end of study (Month 60)); Radiographic Progression-free Survival (rPFS) (From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18))
D: Survival (7.5 years after the first inclusion); Survival (9.5 years after the first inclusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Development of a Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
Brief Summary: Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The Wisepill Study).


Options:
A: Confirmed HBV and HCV test uptake (enrollment - 4 weeks after enrollment)
B: Exclusive breastfeeding duration (Six months)
C: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)
D: Antiretroviral Therapy (ART) Adherence Levels (real time (for 9 months))

Answer: D