TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre, Double Blind, Randomised Sham-Controlled Trial of 10kHz High-Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (Modulate-LBP)
Brief Summary: Multicentre, randomised, double-blinded, sham-controlled trial with parallel economic evaluation. Patients will be allocated 1:1 to activated 10kHz SCS plus usual care (intervention) or sham 10kHz SCS plus usual care (control) and followed up to 6 months.


Options:
A: Difference between treatment groups in responder rates. (3 Months)
B: Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET) (PET is performed at study day 0 (baseline), day 14 and day 35.)
C: Mean VAS Back Pain (7 Day Subject VAS Pain Diary) (6 months post randomisation)
D: Completion of EQ-5D5L Health questionnaire (1 hour); Numeric Rating Scale (NRS) recording pain severity (1 hour)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme
Brief Summary: Multiple sclerosis (MS) is a central nervous system inflammatory disease that causes a chronic and progressive physical handicap. Though primarily considered as a motor disease, it may, in 40 to 65% of cases, cause cognitive function deficits, concerning mainly attention, information processing speed, executive functions and memory. The impairment of these various functions may significantly impair the patients' social, professional and family lives. As such, the presence of cognitive difficulties is more frequently associated with the onset of anxio-depressive psychiatric symptoms and with reduced quality of life to the extent that it can be estimated via psychometric scales, or by a more qualitative approach. Recent research has focused, not on demonstrating the existence of cognitive disorders in MS, but rather on attempting to reduce their daily impact through cognitive rehabilitation programmes. While encouraging, the available results are relatively discordant and further work is required to demonstrate the actual efficacy of such programmes applied to daily life and of their long-term effects.

The main objective of this work is to evaluate, in patients suffering from MS and presenting with cognitive disorders and/or with complaints, the effect of an innovative computerised, semi-autonomous at-home cognitive rehabilitation programme, following care, on quality of life. The secondary objective is to estimate the improvement, or even stabilisation over time, of patients' cognitive performance and psycho-affective sphere.

In this randomised trial, the investigators plan to include 40 patients suffering from the RR and SP forms of MS, distributed to two groups paired by age, gender and socio-cultural level, one of which will benefit from computerised management, along with at-home support from a psychologist, while the other receives only the support.

This work is expected to provide two types of benefits. Firstly, to enable patients to better understand their cognitive function via daily management and as such to improve their quality of life and self-esteem. Secondly, to eventually allow more appropriate patient management by combining the quasi-systematic use of this programme with follow-up consultations with referring practitioners (neurologists, psychologists, etc.).


Options:
A: Neuropsychological Assessment (Baseline assessment, and Week 3)
B: Efficacy of cognitive rehabilitation on quality of life at short term. (10 weeks); Efficacy of cognitive rehabilitation on quality of life at long term. (34 weeks)
C: A composite derived from a standardized battery of neuropsychological tests (12weeks)
D: Neurotrophic Factor BDNF (3-weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate GLPG2737 in Orkambi-treated Subjects With Cystic Fibrosis Homozygous for the F508del Mutation
Brief Summary: This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate GLPG2737 administered orally b.i.d. for 28 days to adult male and female subjects with a confirmed diagnosis of cystic fibrosis homozygous for the F508del CFTR mutation and on stable treatment with Orkambi.


Options:
A: Safety and Tolerability Based on Adverse Events (AEs) (Up to 14 days after last dose (last dose = Day 28))
B: Absolute Change From Baseline (Day 1) in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24 (Day 1, Through Week 24)
C: Change of Sweat Chloride Content From Baseline (Baseline, at day 14 and day 28 in study part 1)
D: Change from baseline in sweat chloride concentration compared to placebo (Between day 1 pre-morning dose and Day 28.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate GLPG2737 in Orkambi-treated Subjects With Cystic Fibrosis Homozygous for the F508del Mutation
Brief Summary: This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate GLPG2737 administered orally b.i.d. for 28 days to adult male and female subjects with a confirmed diagnosis of cystic fibrosis homozygous for the F508del CFTR mutation and on stable treatment with Orkambi.


Options:
A: Changes in adverse events (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal laboratory (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal vital signs, ECG or physical examination (at screening and at each study visit up to day 43 which is the final FU visit)
B: Number of Participants With Treatment-Emergent Adverse Events (First administration (Day 1) through Follow-up (Day 43))
C: Change from baseline in sweat chloride concentration compared to placebo (Between day 1 pre-morning dose and Day 28.)
D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 12 (Baseline, Through Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III, Multicenter, Open-Label, Randomized Study of Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India
Brief Summary: This study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific anti-rotavirus IgA antibodies by these vaccines. The study will also evaluate lot-to-lot consistency in the manufacture of LBRV-PV by demonstrating equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots.


Options:
A: Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml (6, 10, 14 and 18 weeks)
B: Occurrence of RV GE
C: Seroprotection for each polio serotype 1 month after the 3rd dose.
D: Immunogenicity of rotavirus vaccine (28 days post dose 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis
Brief Summary: The current standard management strategy for drug-sensitive pulmonary tuberculosis (TB) is to treat with multiple drugs for 6 months, although patients often fail to adhere to the long treatment, leading to poor clinical outcomes including drug resistance, which is expensive and difficult to treat.

The TRUNCATE-TB trial evaluates an alternative strategy (the TRUNCATE-TB Management Strategy) comprising treatment for 2 months (8 weeks, extended to 12 weeks if inadequate clinical response) with a regimen predicted to have enhanced sterilising activity ("boosted regimen") and monitoring closely after treatment cessation. Those who relapse (predicted to be always drug sensitive and likely to occur early) will be retreated with a standard 6 month regimen.

The trial is a randomized, open-label, multi-arm, multi-stage (MAMS) trial to test the hypothesis that the TRUNCATE-TB Management Strategy is non-inferior to the standard management strategy in terms of longer-term outcomes (clinical status at 96 weeks). If non-inferiority is demonstrated then the advantages/disadvantages of implementing the strategy will be explored in secondary outcomes (from patient and programme perspective).

The trial will evaluate the TRUNCATE-TB Management Strategy with 4 potential boosted regimens (180 per arm, total 900 with the standard TB management strategy arm). The boosted regimens include new drugs (licensed drugs, repurposed from other indications) and optimized doses of standard drugs, selected based on consideration of maximal sterilising effect, absence of drug-drug interactions, as well as safety and tolerability over a period of 2 months


Options:
A: Healing without surgical intervention (one year)
B: healing without recurrence and without excision surgery (12 months after start of treatment)
C: healing without recurrence and without debridement surgery at 12 months follow-up after start of treatment (12 months follow-up after start of treatment)
D: Unsatisfactory clinical outcome at week 96 after randomisation (96 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Internet-Based Intervention for Occupational Stress Among Medical Professionals: A Randomized Controlled Trial
Brief Summary: The aim of this study is to assess the efficacy of internet intervention for reduction of occupational stress and its negative consequences (job burnout, depression) among medical professionals through the enhancement of the resources that are critical for coping with stress: self-efficacy and perceived social support.


Options:
A: Change in scores on Caregiver Distress (HADS) from baseline (Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].); Change in scores on Caregiver Burden (ZBI-12) from baseline (Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].)
B: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
C: Change on Perceived Stress Scale 14 (PSS-14) (Change from baseline on PSS-14 (3 or 6 weeks depending on the study condition)); Change on Perceived Stress Scale 14 (PSS-14) (Change from baseline on PSS-14 (6 months)); Change on Perceived Stress Scale 14 (PSS-14) (Change from baseline on PSS-14 (12 months)); Change on Oldenburg Burnout Inventory (OLBI) (Change from baseline on OLBI (3 or 6 weeks depending on the study condition)); Change on Oldenburg Burnout Inventory (OLBI) (Change from baseline on OLBI (6 months)); Change on Oldenburg Burnout Inventory (OLBI) (Change from baseline on OLBI (12 months))
D: level of depression (Baseline to 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tranexamic Acid for the Prevention of Postpartum Bleeding in Women With Anaemia: an International, Randomised, Double-blind, Placebo Controlled Trial.
Brief Summary: Postpartum haemorrhage (PPH) is responsible for about 100,000 maternal deaths every year, almost all of which occur in low and middle income countries. When given within three hours of birth, tranexamic acid reduces deaths due to bleeding in women with PPH by almost one third. However, for many women, treatment of PPH is too late to prevent death and severe morbidities. Over one-third of pregnant women in the world are anaemic and many are severely anaemic. We now want to do the WOMAN-2 trial to see if giving tranexamic acid can prevent PPH and other severe outcomes in women with moderate and severe anaemia.


Options:
A: Estimated blood loss (EBL) during cesarean delivery (during the operation)
B: Blood Volume Loss (24 hours postpartum.)
C: The amount of blood loss in the third and fourth stages (the fourth stage of labor begins with delivery of the placenta and ends 2 hours after delivery) of labor. (2 hours)
D: Postpartum Haemorrhage (cause will be described) (24 hours after administration of the trial medication or at discharge from hospital, whichever is earlier)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of a Long-lasting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE in Patients With Advanced Metastatic Neuroendocrine Tumors
Brief Summary: This is a prospective study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluate response to 177Lu-DOTA-EB-TATE in patients with advanced metastatic neuroendocrine tumors. Different groups with doses of 0.37GBq-0.74GBq (10-20 mCi) and 1.85GBq (50 mCi)of 177Lu-DOTA-EB-TATE, 3.7GBq (100 mCi)of 177Lu-DOTA-TATE will be injected intravenously. Besides, we evaluated the safety and dosimetry of 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE with and without amino acid infusion. All patients will undergo 68Ga-DOTATATE PET/CT scans before and after the treatment.


Options:
A: Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks (Baseline and 12 Weeks); Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period (First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.6 Weeks)); Number of Participants With TEAEs in the Open-Label Extension Period (First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 54.3 Weeks))
B: Change of standardized uptake value of 68Ga-DOTA-TATE before and after the treatment in metastatic neuroendocrine tumors (1 year); the safety of 3.7GBq of 177Lu-DOTA-EB-TATE with and without amino acid infusion. (1 year)
C: Proportion of Patients Alive and Progression-free at 6 Months (6 months)
D: Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review (Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mixed-Methods Approach to Evaluate a mHealth Intervention to Increase Adherence to Triage of HPV+ Women Who Have Performed Self-collection
Brief Summary: Background: Cervical cancer is one of the leading causes of cancer death among women worldwide, with more than 85% of cases occurring in low- and middle-income countries. Human papillomavirus (HPV) screening allows for self-collection with the potential to increase coverage, but still requires triage to identify which HPV+ women need diagnostic and treatment procedures. However, achieving high levels of triage adherence can be challenging, especially among socially vulnerable women. The ATICA protocol (Application of Communication and Information Technologies to Self-Collection, for its initials in Spanish), aimed at evaluating the implementation strategy and the effectiveness of a multi-component mobile health (mHealth) intervention to increase adherence to triage among women with HPV+ self-collected tests. Methods: Researchers will use an effectiveness-implementation hybrid type I trial with a mixed-methods evaluation approach. A cluster randomized trial design including 200 community health workers (CHWs) will evaluate whether the mHealth intervention increases adherence to triage among HPV+ women who self-collected at home during a CHW visit within 120 days after a positive result. The intervention includes an initial mobile phone text message (SMS) alert and subsequent reminders sent to HPV+ women. For those who do not adhere to triage within 60 days of a positive HPV test, an email and SMS will be sent to the CHWs to promote contact with these women during home visits. Reserchers will use the Consolidated Framework for Implementation Research (CFIR) as an organizing and analytic framework to evaluate the implementation of the intervention while also drawing on Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM). Researchers will conduct a self-administered, semi-structured survey of CHWs, semi-structured interviews with local health authorities, and a survey of HPV+ women.


Options:
A: Confirmed HBV and HCV test uptake (enrollment - 4 weeks after enrollment)
B: Attendance at Cervical Cancer Screening at clinics included in Trial (within 60 days from recruitment into study)
C: Percentage of Women With Triage Pap Smears at 120 Days After HPV Results (120 days)
D: Smoking status by collecting an expired carbon monoxide breath sample (3-Month Follow-Up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mixed-Methods Approach to Evaluate a mHealth Intervention to Increase Adherence to Triage of HPV+ Women Who Have Performed Self-collection
Brief Summary: Background: Cervical cancer is one of the leading causes of cancer death among women worldwide, with more than 85% of cases occurring in low- and middle-income countries. Human papillomavirus (HPV) screening allows for self-collection with the potential to increase coverage, but still requires triage to identify which HPV+ women need diagnostic and treatment procedures. However, achieving high levels of triage adherence can be challenging, especially among socially vulnerable women. The ATICA protocol (Application of Communication and Information Technologies to Self-Collection, for its initials in Spanish), aimed at evaluating the implementation strategy and the effectiveness of a multi-component mobile health (mHealth) intervention to increase adherence to triage among women with HPV+ self-collected tests. Methods: Researchers will use an effectiveness-implementation hybrid type I trial with a mixed-methods evaluation approach. A cluster randomized trial design including 200 community health workers (CHWs) will evaluate whether the mHealth intervention increases adherence to triage among HPV+ women who self-collected at home during a CHW visit within 120 days after a positive result. The intervention includes an initial mobile phone text message (SMS) alert and subsequent reminders sent to HPV+ women. For those who do not adhere to triage within 60 days of a positive HPV test, an email and SMS will be sent to the CHWs to promote contact with these women during home visits. Reserchers will use the Consolidated Framework for Implementation Research (CFIR) as an organizing and analytic framework to evaluate the implementation of the intervention while also drawing on Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM). Researchers will conduct a self-administered, semi-structured survey of CHWs, semi-structured interviews with local health authorities, and a survey of HPV+ women.


Options:
A: Percentage of Women With Triage Pap Smears at 120 Days After HPV Results (120 days)
B: Highly-effective contraceptive use (6 months postpartum)
C: Exclusive breastfeeding duration (Six months)
D: Exhaled Carbon Monoxide Levels (1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mixed-Methods Approach to Evaluate a mHealth Intervention to Increase Adherence to Triage of HPV+ Women Who Have Performed Self-collection
Brief Summary: Background: Cervical cancer is one of the leading causes of cancer death among women worldwide, with more than 85% of cases occurring in low- and middle-income countries. Human papillomavirus (HPV) screening allows for self-collection with the potential to increase coverage, but still requires triage to identify which HPV+ women need diagnostic and treatment procedures. However, achieving high levels of triage adherence can be challenging, especially among socially vulnerable women. The ATICA protocol (Application of Communication and Information Technologies to Self-Collection, for its initials in Spanish), aimed at evaluating the implementation strategy and the effectiveness of a multi-component mobile health (mHealth) intervention to increase adherence to triage among women with HPV+ self-collected tests. Methods: Researchers will use an effectiveness-implementation hybrid type I trial with a mixed-methods evaluation approach. A cluster randomized trial design including 200 community health workers (CHWs) will evaluate whether the mHealth intervention increases adherence to triage among HPV+ women who self-collected at home during a CHW visit within 120 days after a positive result. The intervention includes an initial mobile phone text message (SMS) alert and subsequent reminders sent to HPV+ women. For those who do not adhere to triage within 60 days of a positive HPV test, an email and SMS will be sent to the CHWs to promote contact with these women during home visits. Reserchers will use the Consolidated Framework for Implementation Research (CFIR) as an organizing and analytic framework to evaluate the implementation of the intervention while also drawing on Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM). Researchers will conduct a self-administered, semi-structured survey of CHWs, semi-structured interviews with local health authorities, and a survey of HPV+ women.


Options:
A: Percentage of Women With Triage Pap Smears at 120 Days After HPV Results (120 days)
B: Measles vaccination coverage (10 months)
C: Neonatal death (28 days)
D: Change in Exclusive Breastfeeding Rate (2 weeks after birth); Change in Exclusive Breastfeeding Rate (3 months after birth); Change in Exclusive Breastfeeding Rate (6 months after birth)

Answer: A