TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Childhood Immunization: Reducing Immunization Distress (RID) Using Multi-Modal Distraction
Brief Summary: The purpose of this study is to compare the effectiveness of a more feasible method for reducing the pain and distress of childhood immunization with the standard method in use at the Pediatric Medical Group. A secondary aim is to evaluate the impact of parental involvement on the parent and child satisfaction with the immunization experience.

Study Hypotheses: In the standard, pre-kindergarten, two- or three vaccine sequence, there will be no statistically significant group differences between PPT and ST with respect to:

1. Child self-reported pain using the Faces Pain Scale-Revised (FPS-R) scale13 (primary outcome);
2. Parent report of child pain using the FPS-R;
3. Observer-rated child distress and pain using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale14;
4. Parent and child satisfaction with pain management during immunization measured by a 5-point Likert type scales;
5. Time required for completion of immunization from initiation of ST or PPT to 2 minutes after completion of the last injection.


Options:
A: Child pain intensity (2 minutes after completion of the immunization series.)
B: Faces Pain Scale-Revised (FPS-R) (5 minute)
C: Venham's clinical rating scale (Within 1 hour of procedure)
D: Observation Scale of Behavioral Distress-Revised (OSBD-R)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III International, Randomized Study of Trabectedin Plus Pegylated Liposomal Doxorubicin (PLD) Versus Carboplatin Plus PLD in Patients With Ovarian Cancer Progressing Within 6-12 Months of Last Platinum
Brief Summary: The objective of this multicentric, randomised, Phase III study is to demonstrate superiority, in terms of survival, of trabectedin and Pegylated Liposomal Doxorubicin (PLD) versus carboplatin and PLD in partially-platinum sensitive ovarian cancer patients.


Options:
A: Recommended Phase 2 Dose (RP2D) - Part 1 (Phase 1b) (Cycle 1 (21-days)); Objective Response Rates (ORR) - Part 2 (Phase 2a) (12 months); Measure the Progression Free Survival (PFS)- Part 3 ( Phase 3) (12 Months)
B: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.); Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.)
C: Overall survival (OS) (This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled)
D: Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)); Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens (REMEMBER)
Brief Summary: People with HIV have a high chance of becoming infected with TB, especially when they live in areas where TB infection is common. It can be difficult to diagnose TB in people who need to start HIV treatment right away. Within about 6 months after starting HIV treatment, some of these people can become very sick with TB and can even die from it.

This study was being done in people who were starting HIV treatment and who lived in areas where the TB infection rate is high. The purpose of this study was to test an experimental approach to TB treatment to see if it is better than the usual approach. The experimental approach was to start TB treatment at the same time as HIV treatment, even when TB infection had not been found. The usual approach was to start TB treatment only if TB infection was found.

In this study, half of the people started TB treatment at the same time as they started their HIV treatment. The other half started TB treatment only if TB infection was found.

The study also tested how safe and effective it was to start TB treatment at about the same time as HIV treatment even when TB infection had not been found. The study collected information about diet, whether (and when) people in the study became sicker or died, how well their HIV was controlled, how they were feeling, how they were taking their medications, whether it mattered where they lived or what kind of HIV and TB care was standard, how many people were diagnosed with TB while in the study, and how the cost of the two treatment options on a national level could be compared.


Options:
A: Comparison of novel intensive-case finding diagnostic tools to standard intensive-case finding strategy (2 months)
B: TB diagnostic sensitivity among adults (>12 years old). Sensitivity proportions will be estimated using laboratory data on TB diagnoses (see "Description" below). (Patients will be followed for an average of about 6 months each, and TB diagnostic sensitivity will be estimated at each clinical visit where the patient tests culture-positive for TB, with clinic visits occuring every one to 3 months.); All-cause mortality (Patients will be followed for an average of about 6 months each, with vital status assessed across the 6 month follow-up period.)
C: Cumulative Probability of Death or Unknown Vital Status by Week 24 (From study entry to week 24)
D: Time to TB treatment initiation (8 weeks follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy With UVADEX for the Treatment of Patients With Moderate to Severe Chronic Graft-versus-Host Disease (cGvHD)
Brief Summary: Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after transplants. The transplanted cells seem to fight with the patient's own cells.

Extracorporeal photopheresis (ECP) is a fairly new procedure for cGVHD. The participant gets a port to hook up to a machine. The machine removes the white blood cells, mixes them with a light-sensitive drug, shines light on it, and puts all the blood back in.

This study will find out if patients respond better if they get ECP with methoxsalen, in addition to the pills normally used to treat cGVHD.


Options:
A: Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy (2 years)
B: Number of Participants With an Overall Response at Week 28 (Week 28)
C: Overall survival (3 years); Time to discontinuation of immunosuppression (3 years); Functional impairments (3 years)
D: To estimate the response rate (CR and PR) of pentostatin when used to treat refractory-chronic GVHD in children. (To end of study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2a Randomized, Double-Blind, Placebo-Controlled, Dose Range Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 42-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and 4
Brief Summary: The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat dosing for 42 days.


Options:
A: Hemoglobin level (24 weeks)
B: Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) (Baseline, Week 6)
C: Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42) (Day 1 to Day 42)
D: Number of subjects with adverse events (15 days); Vital signs and 12 lead ECGs (15 days); Cmax (maximum concentration) (15 days); tmax (time to reach maximum concentration) (15 days); t1/2 (elimination half-life) (15 days); AUC (area under the concentration-time curve) (15 days); AR (accumulation ratio) (15 days); RBC (red blood cell) count (15 days); Hgb (hemoglobin) (15 days); TSAT (transferrin saturation) (15 days); serum ferritin (15 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Transarterial RAdioembolization Versus ChemoEmbolization for the Treatment of HCC: A Multicenter Randomized Controlled Trial (TRACE Trial)
Brief Summary: Hepatocellular carcinoma (HCC) is a primary malignant tumor of the liver that accounts for an important health problem worldwide. In only 10% - 15% of all patients with HCC, tumors are considered resectable at presentation. In contrast to metastatic liver disease, there is no role for systemic chemotherapy in the treatment of HCC. Today only evidence is available for Sorafenib, a tyrosine kinase inhibiting agent. The arsenal of non-surgical therapies can roughly be divided into local ablative, transarterial and systemic therapies. In well selected patients, local ablative therapy can offer favorable long term results.

For patients with disease confined to the liver, but locally more advanced, transarterial treatment modalities are proposed. These therapies exploit the dual blood supply to the liver. HCC derives its blood supply almost entirely from the hepatic artery, while liver parenchyma derives \> 75% of its blood supply from the portal vein. Antitumoral agents, such as cytotoxic drugs or radionuclides, can be delivered in close proximity of the tumor.

Examples of transarterial therapies are: transarterial chemoembolization (TACE), bland transarterial embolization (TAE), transarterial chemoembolization with drug eluting beads (TACE-DEB) and transarterial radioembolization with Iodine-131 or Yttrium-90.

TACE is currently the gold standard for treatment of patients with intermediate stage HCC, with a reported median survival of around 17 months. A novel development in the TACE treatment for HCC is the drug-eluting bead (DEB). Recently performed small clinical trials reported the efficacy of DEBs in the treatment of intermediate stage HCC, which is substantially higher compared to conventional TACE.

Yttrium-90 radioembolization (90Y-RE) is a relatively recently developed technique which implements transarterial administration of minimally embolic microspheres loaded with Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor.

In this study the investigators want to prospectively compare TACE-DEB and 90Y-RE, two novel treatments that both have theoretical and/or proven advantages compared to the use of conventional TACE, in patients with intermediate stage HCC.


Options:
A: Time to Progression (TTP) - Independent Radiological Review (Primary Analysis) (From randomization of the first participant until 28 months later (cut-off date))
B: overall survival (5 years)
C: Overall Survival (OS) (from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment); Time to Symptomatic Progression (TTSP) (from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment)
D: Time to Progression (TTP). (Patients will be followed over a 2 years period.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Full Title Interactive Computer Game Exercise Regime, Effects on Balance Impairment in Frail Community-Dwelling Older Adults. A Randomized Controlled Trial
Brief Summary: Due to the many problems associated with reduced balance and mobility, providing an effective and engaging rehabilitation regimen is essential to progress recovery from impairments and to help prevent further degradation of motor skills. The purpose was to examine effects of physical therapy based on the task-oriented approach delivered in an engaging, interactive video game paradigm. The intervention focused on performing targeted dynamic tasks, which included reactive balance controls and environmental interaction. Thirty community dwelling and ambulatory older adults attending the Day hospital for balance and mobility limitation treatment participated in this study. Participants were randomly assigned to either a control group or experimental group. The control group received the typical rehabilitation program provided at the Day Hospital, consisting of strengthening and balance exercises. The experimental group received a program of dynamic balance exercises coupled to video game play, using a centre of pressure (COP) position signal as the computer mouse. The tasks were performed while standing on a fixed floor surface with progression to a compliant sponge pad. Each group received 16 sessions, scheduled two per week, each lasting 45 minutes. Balance performance measures and spatial-temporal gait variables were obtained pre- and post-treatment Findings demonstrated significant improvements for both groups in balance performance scores post-treatment, and change scores were significantly greater in the experimental compared to control group. No significant treatment effect was observed in either group for the spatial-temporal gait variables. In conclusion dynamic balance exercises on fixed and compliant sponge surfaces were feasibly coupled to interactive game-based exercise. This in turn resulted in a greater improvement in dynamic standing balance control compared to the typical exercise program. However there was no transfer of effect to gait function.

Key Words: Balance, Postural; Rehabilitation; Therapy, computer-assisted; Video Games; Center of Pressure.


Options:
A: Balance (Baseline=june; Endline=september); Muscle strength (Baseline=june; Endline=september); Motivation (Baseline=june; Endline=september)
B: Improvement in formal balance score (4 weeks and 12 weeks following the exercise intervention)
C: Falls incidence rate (6 months)
D: Standing Balance (5 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine When Administered According to Alternative 2-dose Schedules in 9 - 14 Year Old Females
Brief Summary: This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals' HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and 0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule (0,1,6 months) in 15-25 year old females.


Options:
A: Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies (At Month 7)
B: Incident cervical infection with HPV-16 and/or HPV-18
C: Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 (At Month 24); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 (At Month 48); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 (At Month 57); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 (At Month 72)
D: Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7 (At Month 7 (i.e. one month after the last dose of study vaccine)); Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7 (At Month 7 (i.e. one month after the last dose of study vaccine))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomized, Crossover, Multicenter Study to Evaluate the Effect of JNJ-28431754 (Canagliflozin) on Post-Meal Glucose in Subjects With Type 2 Diabetes Mellitus
Brief Summary: The purpose of this study is to evaluate the effect of canagliflozin on post-meal glucose blood levels in patients with Type 2 Diabetes Mellitus.


Options:
A: HbA1c Change From Baseline at Week 12 (Baseline and Week 12)
B: Plasma concentrations of glucose (Up to Day 44)
C: Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population) (Up to 5 years); Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population) (Up to 5 years)
D: Ischemic Foot Ulcer (Until hospitalization for ischemic foot ulcer or until 31 December 2011)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of AlcoholEdu: A Randomized Multi-Campus Trial
Brief Summary: The study examined whether an online course for college freshmen (AlcoholEdu) had an effect on alcohol misuse and related problems, using a randomized controlled design with 30 universities.


Options:
A: Binge drinking (30 days)
B: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)
C: frequency of consumption; drinks per occasion; number of drinks in a typical week; frequency of 5+ consumption; highest number of drinks on one occasion.
D: proportion of negative breath samples submitted (Week 4)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Pulsed Electromagnetic Field Therapy for Management of Post-operative Pain Following Cesarean Delivery: a Randomised, Double-blind, Placebo-controlled Study
Brief Summary: Pain following Cesarean delivery remains the most common post-operative complaint, and the provision of effective and safe analgesia is very important. Pain can impede the mother's ability to mobilise, and to care for and breastfeed her newborn baby.

Pulsed electromagnetic field (PEMF) devices have been used in various clinical settings, especially after plastic surgeries, to reduce postoperative swelling and pain, as well as to accelerate wound repair. PEMF therapy is simple to use, cost-effective and has no known side effects.

Despite advances in post-operative analgesia, pain relief and maternal satisfaction remain inadequate in some patients. Improving the quality of post-Cesarean analgesia while limiting undesirable side effects will enhance maternal satisfaction and reduce the risk of post-operative complications.

The investigators hypothesize that the continuous use of a PEMF device for 48 hours after Cesarean delivery will result in decreased post-operative pain scores on movement at 48 hours.


Options:
A: Pain, assessed by patients using a pain scale (72 hours or hospital stay)
B: Number of Subjects Who Achieved 50% Sustained Pain Reduction (12 days)
C: Pain score by visual analogue scale (VAS) on movement at 48 hours postoperatively (48 hours)
D: Intensity of pain after cesarean (after TENS application)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nuevo Amanecer: Promoting the Psychosocial Health of Latinas
Brief Summary: The purpose of this study is to test whether a new program Nuevo Amanecer (A New Dawn), improves the quality of life of Latinas diagnosed with breast cancer. Trained Latina counselors who have had breast cancer provide support to recently diagnosed women. The investigators call these counselors peer support counselors.


Options:
A: Changes in depressive symptoms (Pre-treatment (at recruitment; about 2 weeks before starting the experimental condition of 8 weeks), post-treatment (immediately after the experimental condition of 8 weeks), 3-month follow-up and 6-month follow-up)
B: Physical wellbeing: emotion regulation ability (heart rate, relaxation, quality of life,...) (Change from baseline in heart rate and relaxation ability at 6 (T2) and 12 months (T3)); Psychological wellbeing: emotional state, emotional adjustment, social adjustment, quality of life,... (Change from baseline in emotional state, emotional adjustment, social adjustment and quality of life at 6 (T1) and 12 (T2) months.)
C: 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)
D: Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment); Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment); Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment); Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment); Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment); Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial (RCT) to Compare Adenoma Detection Rate of Combined Chromoendoscopy (Indigo Carmine) With Water Infusion in Lieu of Air Insufflation (Water Method) vs. Water Method Alone in Screening Colonoscopy
Brief Summary: In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a dilute solution of Indigocarmine (IC) delivered by the water method (study method) will improve adenoma detection rate compared with the water method with plain water alone (control method).


Options:
A: adenoma detection rate (number of polyps/number of patients examined) (6 months)
B: Detection Rates for Adenomas and for Total Polyps (Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.)
C: The primary outcome is whether the patient is a responder or not after 8 weeks treatment.; The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.; The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe).
D: Diagnosis of adenoma (24 months)

Answer: D