TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Triple Therapy Versus Sequential Therapy Versus Concomitant Therapy as First Line Treatment for Helicobacter Pylori Infection
Brief Summary: Triple therapy (TT) comprising proton pump inhibitor (PPI), amoxicillin 1g and clarithromycin 500mg twice daily has long been considered one of the standard treatment for H. pylori infection as initial studies demonstrated success rates of \> 90% on per protocol analysis (PP) and \> 80% on intention to treat (ITT) analysis. However increasing bacterial resistance, especially to clarithromycin, has been reported and there are concerns that the efficacy of TT has decreased. Sequential therapy (ST) is an alternative first line therapy that consists of 5 days of treatment with a PPI and amoxicillin followed by 5-day treatment with the PPI and clarithromycin and metronidazole. The rationale for this approach is that amoxicillin may weaken the bacterial cell wall in the initial phase of treatment, and prevent the development of drug efflux channels that inhibit clarithromycin from binding to ribosomes and thus help to improve the efficacy of clarithromycin in the second phase of treatment. A recent meta-analysis based on mainly European studies showed that the success rate of ST compared to TT was 92.8 - 96% vs. 76.2 - 78.8%. Concomitant therapy (CT) is another alternative first line treatment that consists of 10 days of PPI, amoxicillin, clarithromycin and metronidazole. The rationale for using CT as a first line treatment option is to address the possibility of clarithromycin resistance which is increasingly encountered in clinical practice. Currently there are no randomized controlled studies that compared TT with ST in Singapore, although both regimens are being used in routine clinical practice. The hypothesis is that ST is superior to TT as first line treatment for H. pylori infection.

The study aim to compare 10-day TT versus 10-day ST versus 10-day CT as first line treatment for H. pylori infection in Singapore.


Options:
A: Number of Participants With Complete Eradication of Helicobacter Pylori (at the 6th week after the end of anti- H. pylori therapy)
B: Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis (6 weeks after eradication therapy)
C: 13C urea breath test, upper endoscopy, histology, rapid urease test assessment
D: H pylori eradication rate (at least 4 weeks up to 24 weeks after finishing course of antibiotics)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) Community Study
Brief Summary: The Southeastern Kidney Transplant Coalition is an academic-community collaboration between partners in the kidney disease community who share the common goal of eliminating health disparities in access to kidney transplantation among African American End Stage Renal Disease living in Georgia, North Carolina, and South Carolina. Volunteer members of this community-based coalition include patients with kidney disease, dialysis facility staff and providers, transplant centers, quality improvement organizations, and patient advocacy organizations. The burden of kidney disease is highest in the Southeast, and yet the rate of kidney transplantation is the lowest in the nation. Further, the investigators research suggests that racial disparities in access to kidney transplantation are concentrated in the Southeast, where African Americans are less likely to access each step in the transplant process. The long-term goal of the investigators Coalition is to use community- based participatory research approaches to develop, test, and disseminate sustainable, community interventions improve access to transplant for African American patients with kidney disease. The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) community study proposes to use community-based participatory research methods to develop a multilevel intervention to reduce racial disparities in access to kidney transplantation. The long-term impact of this application will be to reduce racial disparities in the kidney disease community.


Options:
A: Referral for Kidney Transplantation (One Year)
B: Change from baseline in the level of patient-centredness at one year (one year)
C: Rate of First or Only Clinical Episode of Plasmodium Falciparum (P. Falciparum) Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD) (From Month 2.5 to Month 14); Rate of First or Only Clinical Episode of P. Falciparum Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD) (From Month 2.5 to Month 14)
D: Change in Body Mass Index (3 and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) Community Study
Brief Summary: The Southeastern Kidney Transplant Coalition is an academic-community collaboration between partners in the kidney disease community who share the common goal of eliminating health disparities in access to kidney transplantation among African American End Stage Renal Disease living in Georgia, North Carolina, and South Carolina. Volunteer members of this community-based coalition include patients with kidney disease, dialysis facility staff and providers, transplant centers, quality improvement organizations, and patient advocacy organizations. The burden of kidney disease is highest in the Southeast, and yet the rate of kidney transplantation is the lowest in the nation. Further, the investigators research suggests that racial disparities in access to kidney transplantation are concentrated in the Southeast, where African Americans are less likely to access each step in the transplant process. The long-term goal of the investigators Coalition is to use community- based participatory research approaches to develop, test, and disseminate sustainable, community interventions improve access to transplant for African American patients with kidney disease. The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) community study proposes to use community-based participatory research methods to develop a multilevel intervention to reduce racial disparities in access to kidney transplantation. The long-term impact of this application will be to reduce racial disparities in the kidney disease community.


Options:
A: Number of patients that start home-based dialysis. (1 year)
B: Systolic Blood Pressure (SBP) (one year)
C: Referral for Kidney Transplantation (One Year)
D: Taking Adherence (12 months); Timing Adherence (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) Community Study
Brief Summary: The Southeastern Kidney Transplant Coalition is an academic-community collaboration between partners in the kidney disease community who share the common goal of eliminating health disparities in access to kidney transplantation among African American End Stage Renal Disease living in Georgia, North Carolina, and South Carolina. Volunteer members of this community-based coalition include patients with kidney disease, dialysis facility staff and providers, transplant centers, quality improvement organizations, and patient advocacy organizations. The burden of kidney disease is highest in the Southeast, and yet the rate of kidney transplantation is the lowest in the nation. Further, the investigators research suggests that racial disparities in access to kidney transplantation are concentrated in the Southeast, where African Americans are less likely to access each step in the transplant process. The long-term goal of the investigators Coalition is to use community- based participatory research approaches to develop, test, and disseminate sustainable, community interventions improve access to transplant for African American patients with kidney disease. The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) community study proposes to use community-based participatory research methods to develop a multilevel intervention to reduce racial disparities in access to kidney transplantation. The long-term impact of this application will be to reduce racial disparities in the kidney disease community.


Options:
A: Physical activity CHAMPS (Baseline, 3 and 6 months); Glycemic control - HbA1c (Baseline, 3 and 6 months); Dietary adherence (Baseline, 3 and 6 months)
B: Referral for Kidney Transplantation (One Year)
C: Change in Anxiety and Depression (HADS) scores from baseline (Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
D: The difference of rate of estimated glomerular filtration rate (eGFR) decline (30 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Texting 2 Initiate: A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department (T2I)
Brief Summary: The objective of this study is to develop and test an emergency department (ED)-based intervention which uses text messages to facilitate contraception initiation.


Options:
A: Initiation of highly effective contraception, as defined by the World Health Organization. (3 months after initial enrollment)
B: Adherence to cervical cancer screening (step1) (Up to 20 months)
C: Clinic attendance for pills pick up (six months.)
D: Unprotected sex, no contraceptive (6-week post-baseline (in the past 6 weeks)); Unprotected sex, no highly effective contraceptive (6-week post-baseline (in the past 6 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Texting 2 Initiate: A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department (T2I)
Brief Summary: The objective of this study is to develop and test an emergency department (ED)-based intervention which uses text messages to facilitate contraception initiation.


Options:
A: Initiation of highly effective contraception, as defined by the World Health Organization. (3 months after initial enrollment)
B: Adherence to PrEP (Baseline to Week 48)
C: Measles vaccination coverage (10 months)
D: Rate of Enrollment (Month 12); Acceptability of the mHealth application (Month 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Texting 2 Initiate: A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department (T2I)
Brief Summary: The objective of this study is to develop and test an emergency department (ED)-based intervention which uses text messages to facilitate contraception initiation.


Options:
A: Measles - 2 Completion (When the participants reach 2 years of age)
B: Confirmed HBV and HCV test uptake (enrollment - 4 weeks after enrollment)
C: Initiation of highly effective contraception, as defined by the World Health Organization. (3 months after initial enrollment)
D: Vaccines received (Electronic Health Record) (up to a year of follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1b, Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Subjects
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of multiple subcutaneous administrations of DX-2930 across a range of doses in HAE participants.


Options:
A: The mean acute angioedema attack rate (12 weeks)
B: The Mean Time Normalized Number of HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1 (13 weeks)
C: Time-Normalized Number of Hereditary Angioedema (HAE) Attacks Per Month During Treatment Period (First injection up to 6 months)
D: Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) (From Day 1 up to final follow-up (Day 123))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Decrease in Cholesterol Levels Induced by a Statin on Sperm Quality
Brief Summary: Recently, concerns about the effect of atorvastatin intake on men fertility have been raised. However, this statin has never been investigated regarding its influence on male fertility, notably sperm quality.

The aim of this pilot study is to evaluate the efficacy and the safety of a decrease of cholesterol blood levels, induced by taking atorvastatin, on sperm quality of normocholesterolaemic and healthy men without confounding factors.


Options:
A: Observations of all modifications on semen quality after 5 months of atorvastatin treatment (at month 5); Observations of all modifications on semen quality after 5 months of atorvastatin treatment and after 3 months after its withdrawal (at month 8)
B: N/A
C: Thrombin generation (8 weeks)
D: C-peptide after a liquid mixed meal stimulation (at randomization, after 12 months, and after 18 months of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Auditory Games for Tinnitus Benefit: Interactive Versus Reactive Auditory Discrimination Games
Brief Summary: Tinnitus refers to a the perception of a ringing, hissing or buzzing sound despite there being no such sound in the external world. It is prevalent and for many individual is a distressing condition. Recent advances in the understanding of changes in the hearing brain and their relation to tinnitus perception has led to a focus on forms of active auditory training which might provide effective techniques for tinnitus management. Our recent trial of auditory training provided evidence that training using sounds where there is no hearing loss has benefit in terms of reduced tinnitus intrusiveness, above training at where there is some level of hearing loss. Our next challenge is to build on this finding in ways that might maximize the benefits we observe.

The training software we used previously was developed for use with children. Past participants have given mixed reviews of this software. While some enjoyed the training or found it soporific, others reported that they found it too monotonous and un-motivating. We therefore wish to explore the impact of different game mechanics in the delivery of auditory training and have designed two different interactive games in the context of training for tinnitus benefit. These games will deliver the same type of auditory training as the software we currently use, but should be intrinsically motivating, i.e. be a game that the people are motivated to play irrespective of any potential benefit for tinnitus. The game we previously used is reactive, i.e. the sounds play and the player selects what they think is the correct answer (odd one out).

The two new games we wish to test can be described as interactive, i.e. players control the sound delivery and actively seek the correct answer: this may have additional benefit for tinnitus.


Options:
A: Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3) (At baseline and 3, 8 and 12 months follow-up)
B: N/A
C: Tinnitus Handicap Questionnaire (4 weeks)
D: THI (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomised Study Comparing the Tolerance of PICC Line (Peripherally Inserted Central Catheter) and Implanted Port for Adjuvant Chemotherapy in HER2-negative Early Breast Cancer
Brief Summary: Adjuvant chemotherapy is frequently proposed to patients presenting early breast cancer, in case of high risk of recurrence (large tumors, node involvement, high grade...). Due to its toxicity toward veins, chemotherapy must be administered through a central venous device. Today, one can use either an implanted port or a PICC line (Peripherally Inserted Central Catheter). A PICC line is easier to implant and to explant, but has to be flushed every week and may impact daily life (no swimming, some clothes may not fit). On the other hand, a port is subcutaneous and lets patients lead a normal life, but its implant and explant require a cutaneous incision with possible complications (bleeding, pain, infection). For both venous devices, complications such as thrombosis or infection may happen. Published data comparing the two devices are heterogeneous and do not often distinguish patients treated for different diseases at various stages. Empirically in daily practice, for long term use (\>6 months) a port is usually preferred, whereas for short-term treatments (\<6 weeks) a PICC line is used. In the case of Her2 negative early breast cancer, adjuvant chemotherapy usually lasts 4 to 5 months. There is no scientific evidence for preferring one device to the other for these patients.

The aim of this study is to prospectively compare the patients' satisfaction and tolerance of each of the two devices.


Options:
A: Probability of occurrence of a significant adverse event related to the central venous device (37 weeks)
B: Post insertion failure rates (Duration of catheter dwell time (up to 168 hours)); Overall utility (Up to 168 hours (1 week))
C: Grade 1 and Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique (9 months after patient recruitment begins)
D: First pass success (1 day); Number of attempts (1 day); Overall success (1 day); Time to completion (1 day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
Brief Summary: The aim of this project is to clinically evaluate a novel robot-assisted therapeutic approach to train sensorimotor hand function after stroke. It combines the profound experience of the clinic Hildebrand in neurocognitive therapy - involving brain and mind in the task and training both the motor and the sensory system - with the advanced haptic robotic technology of the Rehabilitation Engineering Lab at the Swiss Federal Institute of Technology Zurich (ETH Zurich), allowing unmet interaction with the hand through the simulation of virtual objects with various mechanical properties. In a randomized controlled clinical trial, 10 sub-acute stroke patients will receive four weeks of robotic therapy sessions, integrated seamlessly into their daily rehabilitation program, while 10 other patients will receive conventional therapy. The investigators will assess baseline performance in an initial clinical and robotic assessment, with another assessment at the end of the four-week period, and in follow-ups four weeks and six months later. The contents of the patient-tailored robotic therapy sessions will match those of the conventional therapy as closely as possible. This study will demonstrate the feasibility of including robotic therapy of hand function into the daily rehabilitation program, and investigate the acceptance from patients and therapists. The investigators expect increased training intensity during the robotic therapy session compared to conventional sessions with similar contents, as well as novel insights into the recovery process of both the motor and the sensory system during the four weeks of therapy, through advanced robotic assessments integrated into the training sessions. This project is a first step towards making such robotic therapy available to patients as integration into the conventional individual therapy program (e.g. for self-training), and towards transferring this technology to the home environment.


Options:
A: Social Functioning: Total Social Behavior (6 weeks)
B: Change scores of Montreal Cognitive Assessment (MoCA) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Memory Scale - Third Edition (WMS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Useful Field of View (UFOV) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop Color-Word test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
C: Motor impairment of the upper limb (Change from Baseline in motor impairment of the upper limb at 4 weeks)
D: Frontal Assessment Battery (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nitrous Oxide for Pain Management of First Trimester Surgical Abortion
Brief Summary: The purpose of this research is to study the effect of nitrous oxide on pain felt by women having a surgical termination at less than 11 weeks compared to pain felt by women receiving oral pain medications.


Options:
A: Aspiration Pain (Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds))
B: Visual Analog Pain Score for Mean Maximum Procedural Pain (Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure)
C: Pain reported with cervical dilation (1 Year)
D: pain reduction (nine months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Transcutaneous Electrical Acupoint P6 Stimulation vs. Tropisetron Both in Combination With Dexamethasone to Prevent Postoperation Nausea and Vomiting in Women
Brief Summary: The purpose of this study is to access the effect of TEAS of P6 in the prevention of PONV in women scheduled for gynecologic laparoscopic surgery with general anesthesia.


Options:
A: N/A
B: Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively (within 24h after operation)
C: Pain score by numeric rating scale (At 8 hours postoperatively)
D: Experienced Post-operative Nausea or Vomiting (24 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn's Disease
Brief Summary: This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54.


Options:
A: Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice. (24 months)
B: Sustained clinical remission for the precision dosing group vs. the conventional IFX maintenance dosing group (52 weeks)
C: Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76 (Baseline up to Week 76)
D: The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 (at Week 6)

Answer: D