TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Redirected Autologous T Cells Transduced to Express A CD20-Specific Chimeric Immunoreceptor in Patient With Chemotherapy Resistant or Refractory CD20+ Leukemia and Lymphoma
Brief Summary: RATIONALE: Placing a gene that has been created in the laboratory into white blood cells may make the body build an immune response to kill cancer cells.

PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with B-cell leukemia or lymphoma that is resistant or refractory to chemotherapy.


Options:
A: Percentage of Participants With Cytokine Release Syndrome (CRS) Adverse Events Grade ≥ 3 (From first dose to 90 days following first dose (up to approximately 90 days)); Percentage of Participants With Neurotoxicity (NT) Adverse Events Grade ≥ 3 (From first dose to 90 days following first dose (up to approximately 90 days)); Percentage of Participants With Infection Adverse Events Grade ≥ 3 (From first dose to 90 days following first dose (up to approximately 90 days)); Percentage of Participants With Grade ≥ 3 Prolonged Cytopenia at Day 29. (At Day 29 after first treatment)
B: Percentage of Participants With Overall Remission Rate (ORR) as Determined by Independent Review Committee (IRC) Assessment. (during the 3 months after tisagenlecleucel administration)
C: Occurrence of study related adverse events (Until week 24)
D: Phase I - Identification of the dose limiting toxicity (DLT) (4 weeks after CAR T cell infusion); Phase II - Efficacy (4 weeks after CAR T cell infusion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial
Brief Summary: Hemi spatial neglect, or the tendency to ignore stimuli originating in a portion of the environment contra lateral to a cerebral lesion, can be a major source of functional handicap after stroke. The currently available treatments for unilateral neglect are scanning training, visual cuing approaches, limb activation strategies, visual imagery, tactile stimulation, prisms and sustained attention training.Mirror therapy improves the hand function in sub-acute stroke.

Hypothesis: To evaluate the effectiveness of Mirror therapy in the management of stroke patients with unilateral neglect.


Options:
A: Behavioural Inattention Test (BIT) (Change in BIT score between the baseline sessions average and score measured at week 11)
B: Will include the accuracy (defined as the difference between the straight line connecting the origin and the target and the line followed by the subject) during reaching. One of the additional outcomes is the time to complete a reaching task.
C: Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months (Baseline, 1,3 and 6 months); Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months (Baseline, 1,3 and 6 months); Change From Baseline in Picture Identification Task at 1,3, and 6 Months (Baseline, 1,3 and 6 months)
D: Change scores of Fugl-Meyer Assessment (FMA) (Baseline, 2 weeks, 4 weeks, 16 weeks, and 28 weeks); Change scores of Wolf Motor Function Test (WMFT) (Baseline, 2 weeks, and 4 weeks); Change scores of Motor Activity Log (MAL) (Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks); Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0) (Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks); Change scores of Revised Nottingham Sensory Assessment (rNSA) (Baseline, and 4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Artemisinin-resistant Plasmodium Falciparum Malaria in Cambodia
Brief Summary: Background:

- Artemisinin-based combination therapies (ACTs) are the first-line treatments for malaria. ACTs are highly effective, but malaria caused by the Plasmodium falciparum parasite is becoming resistant to some ACTs. ACT-resistant malaria has shown up in some parts of Cambodia, but not yet in other parts of the country. This has been shown by treating patients with ACTs, checking the amount of parasites in the patient s blood every 6 hours, and calculating the rate of parasite clearance. The parasite clearance rate in response to ACTs is getting slower in western Cambodia and may be the first sign of ACT resistance. Researchers want to study how effective ACTs are in different regions of Cambodia. This study will look at the extent of ACT resistance and how widespread ACT-resistant malaria has become.

Objectives:

- To compare the prevalence of ACT-resistant malaria in western, northern and eastern Cambodia.

Eligibility:

- Individuals between 2 and 65 years of age who have uncomplicated Plasmodium falciparum malaria and have not taken any antimalarial drugs for their symptoms in the previous 7 days.

Design:

* Participants will be recruited from clinics and hospitals in three Cambodian provinces.
* Participants will be informed about the study and their consent to participate in the study will be obtained.
* A venous blood sample will be obtained from patients before treatment and used for laboratory experiments to measure parasite and patient factors that might affect the parasite clearance rate.
* Participants with malaria will be treated with dihydroartemisinin-piperaquine (DHA-PPQ), the standard first-line treatment for malaria in Cambodia.
* Treatment will be monitored with frequent blood samples obtained from a finger prick. The amount of malaria parasites in each blood sample will be counted and followed until they are no longer detectable.
* Participants will have weekly follow-up visits for up to 9 weeks. Finger-prick blood samples will be taken at each visit to see if the parasites reappear after treatment with ACT.


Options:
A: Maternal malaria at delivery (Delivery)
B: N/A
C: Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants (6 to 24 months of age); Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants (Randomization to 24 months of age)
D: Incidence of symptomatic malaria (due to any Plasmodium species) from 3 - 15 months of age (15 months); Incidence of symptomatic P. falciparum malaria from 3 - 15 months of age (15 months); Incidence of symptomatic P. vivax malaria from 3-15 months of age (!5 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Artemisinin-resistant Plasmodium Falciparum Malaria in Cambodia
Brief Summary: Background:

- Artemisinin-based combination therapies (ACTs) are the first-line treatments for malaria. ACTs are highly effective, but malaria caused by the Plasmodium falciparum parasite is becoming resistant to some ACTs. ACT-resistant malaria has shown up in some parts of Cambodia, but not yet in other parts of the country. This has been shown by treating patients with ACTs, checking the amount of parasites in the patient s blood every 6 hours, and calculating the rate of parasite clearance. The parasite clearance rate in response to ACTs is getting slower in western Cambodia and may be the first sign of ACT resistance. Researchers want to study how effective ACTs are in different regions of Cambodia. This study will look at the extent of ACT resistance and how widespread ACT-resistant malaria has become.

Objectives:

- To compare the prevalence of ACT-resistant malaria in western, northern and eastern Cambodia.

Eligibility:

- Individuals between 2 and 65 years of age who have uncomplicated Plasmodium falciparum malaria and have not taken any antimalarial drugs for their symptoms in the previous 7 days.

Design:

* Participants will be recruited from clinics and hospitals in three Cambodian provinces.
* Participants will be informed about the study and their consent to participate in the study will be obtained.
* A venous blood sample will be obtained from patients before treatment and used for laboratory experiments to measure parasite and patient factors that might affect the parasite clearance rate.
* Participants with malaria will be treated with dihydroartemisinin-piperaquine (DHA-PPQ), the standard first-line treatment for malaria in Cambodia.
* Treatment will be monitored with frequent blood samples obtained from a finger prick. The amount of malaria parasites in each blood sample will be counted and followed until they are no longer detectable.
* Participants will have weekly follow-up visits for up to 9 weeks. Finger-prick blood samples will be taken at each visit to see if the parasites reappear after treatment with ACT.


Options:
A: incidence rate of clinical malaria; in vivo adequate clinical and parasitological response of P. falciparum to SP
B: Mortality rate in children aged 2-11 months (estimated by birth history questioning) (Up to 12 months of age); Incidence of severe adverse drug reactions following IPTi (as detected by spontaneous, passive reporting system) (All age groups, particular attention in under 2 year olds)
C: N/A
D: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of KRX-0502 (Ferric Citrate) in Managing Serum Phosphorus and Iron Deficiency in Anemic Subjects With Stage III to V Chronic Kidney Disease Not on Dialysis
Brief Summary: The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of treatment is approximately 12 weeks.


Options:
A: Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment (12 Weeks); Change in Serum Phosphorus Levels From Baseline to End of Treatment (12 Weeks)
B: The Change in Serum Phosphorus From Week 12 to Week 16 (4 weeks (Week 12 to Week 16))
C: N/A
D: Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels (Week 0 - 12); Percentage Changes in Parathyroid Hormone (PTH) Levels (Week 0 - 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2/3, Multi-Center, Open Label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (BAX 855) Administered for Prophylaxis and Treatment of Bleeding in Previously Treated Patients With Severe Hemophilia A
Brief Summary: To assess efficacy and safety, including immunogenicity of BAX 855 administered as prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of BAX 855.


Options:
A: Annualized Bleeding Rate (ABR) (9 months)
B: Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized) (Up to 26 weeks for on-demand regimen, and between 1 and 17 months for prophylaxis regimen.); Number of Subjects Developing Inhibitors Against Factor IX (FIX) (Up to 27.7 months (maximum))
C: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (up to 52 weeks ± 1 week); Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (up to 52 weeks + 30 days ± 1 week); Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Incidence Rate of FIX Inhibitor Development (up to 52 weeks ± 1 week); Annualized Bleeding Rate (up to 52 weeks ± 1 week (efficacy period as defined in description)); Comparison of Annualized Bleeding Rates (up to 52 weeks ± 1 week (efficacy period as defined in description))
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2/3, Multi-Center, Open Label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (BAX 855) Administered for Prophylaxis and Treatment of Bleeding in Previously Treated Patients With Severe Hemophilia A
Brief Summary: To assess efficacy and safety, including immunogenicity of BAX 855 administered as prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of BAX 855.


Options:
A: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (up to 52 weeks ± 1 week); Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (up to 52 weeks + 30 days ± 1 week); Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Incidence Rate of FIX Inhibitor Development (up to 52 weeks ± 1 week); Annualized Bleeding Rate (up to 52 weeks ± 1 week (efficacy period as defined in description)); Comparison of Annualized Bleeding Rates (up to 52 weeks ± 1 week (efficacy period as defined in description))
B: Annualized Bleeding Rate (ABR) (9 months)
C: Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized) (Up to 26 weeks for on-demand regimen, and between 1 and 17 months for prophylaxis regimen.); Number of Subjects Developing Inhibitors Against Factor IX (FIX) (Up to 27.7 months (maximum))
D: To assess the safety of systemic administration of a novel self-complementary AAV vector in adults with severe hemophilia B at up to four different dosage levels. (15 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Psycho-educational Intervention to Improve Family Mental Health and Child Educational Outcomes Following Admission to PICU: A Pilot Study
Brief Summary: 1. Evaluate the feasibility and acceptability of an information based intervention delivered to parents following their child's admission to paediatric intensive care;
2. Evaluate the feasibility and acceptability of the study design and procedures;
3. Explore the effects of the intervention on parent and child psychological outcomes 3-6 months post discharge from PICU;
4. Explore the effects of parental stress experienced during PICU admission on the effectiveness of the intervention;
5. To provide data that, combined with results from other studies, could inform the sample size for a future multi-site RCT.


Options:
A: Post-traumatic Stress Disorder (chronic) by CAPS scores. (Four months, seven months, 14 moths, two years)
B: The Number of Feasibility Criteria Successfully Met (3-6 months post discharge from PICU)
C: Diagnosis of Post Traumatic Stress Disorder (3 months post critical illness)
D: PTSD ratings (Measured at Year 1); Substance use (Measured at Year 1); General functioning reports (Measured at Year 1)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Investigation for Fractures of the Proximal Humerus in Elderly Patients. A Randomized Study of Two Surgical Treatments: Reverse Total Shoulder Arthroplasty Versus Angular Stable Device Philos
Brief Summary: To investigate the assumption that reversed shoulder prosthetic replacement will give a better functional outcome compared to open reduction and internal fixation with an angular stable plate in displaced proximal humeral fractures. Short name: The DelPhi trial.


Options:
A: Constant Shoulder Score (5 years)
B: Shoulder function (score /100) (Pre-intervention: 1 to 3 weeks post fracture (T1) and Post-intervention: after the 8-week intervention (T2))
C: Quick-DASH (2 years)
D: DASH (6 months); DASH (1 year); DASH (2 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Proactive Outreach for Smokers in VA Mental Health
Brief Summary: Veterans with a mental health diagnosis have higher a prevalence of smoking and higher rates of smoking-related morbidities compared to the general Veteran population. Smoking cessation treatment delivery in the VA typically depends on a visit from a health care provider. In this study, investigators will use information within the electronic medical record to identify all smokers with a mental health diagnosis at a VA health care facility and proactively reach out to enroll them in an intensive tobacco cessation treatment program. This approach could be generalized to other behaviors and provides a novel method to improve the health of an entire population of patients.


Options:
A: Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment (12 months)
B: Continuous Abstinence (Measured at Year 1)
C: Number of Participants With Cotinine-Validated Abstinence From Smoking (12 months)
D: Percentage of Participants With 30-day Abstinence (6-months post enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage (FMRICH): a Randomised Placebo-controlled Trial
Brief Summary: This is a randomized, double-blind, placebo-controlled, multicenter clinical trial that will be carried out in Mexico. The purpose of this study is to test whether a 3-month treatment with fluoxetine enhances motor recovery in non-depressed patients with acute intracerebral hemorrhage.


Options:
A: Progression in the Fugl-Meyer Motor Scale (M3 (3 months))
B: Peak treadmill speed (4 weeks)
C: Functional status, measured with the modified Rankin scale. (6 months)
D: Fugl Meyer Motor Scale score (Baseline and 90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage (FMRICH): a Randomised Placebo-controlled Trial
Brief Summary: This is a randomized, double-blind, placebo-controlled, multicenter clinical trial that will be carried out in Mexico. The purpose of this study is to test whether a 3-month treatment with fluoxetine enhances motor recovery in non-depressed patients with acute intracerebral hemorrhage.


Options:
A: Peak treadmill speed (4 weeks)
B: Fugl Meyer Motor Scale score (Baseline and 90 days)
C: Incidence of depressive disorders in the study population (Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18)
D: Occurrence rate of depression (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Two-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-Controlled Study of Safety and Efficacy of Microporous, Fractionated, Protonated Zirconium Silicate in Mild to Moderate Hyperkalemia
Brief Summary: Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 - 6.5 mmol/l versus no difference between ZS and placebo control (null hypothesis).

Subacute Phase (randomized withdrawal): It is hypothesized that ZS once daily is more effective than placebo control (alternative hypotheses) in maintaining normokalemic levels (3.5 - 4.9 mmol/l) among subjects completing the Acute Phase versus no difference between each ZS dose and respective placebo controls (null hypotheses).


Options:
A: Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. (Through 48 hours acute phase); Exponential Rate of Change in S-K Levels in the Subacute Phase. (Through 12 days subacute phase (Day 3 through Day 15))
B: Change in Serum Potassium From Part A Baseline to Part A Week 4 (Part A Baseline to Part A Week 4); Change in Serum Potassium From Part B Baseline (Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L)
C: Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population). (22 Days; Maintenance Phase Days 8 - 29, inclusive.)
D: Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group (Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Two-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-Controlled Study of Safety and Efficacy of Microporous, Fractionated, Protonated Zirconium Silicate in Mild to Moderate Hyperkalemia
Brief Summary: Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 - 6.5 mmol/l versus no difference between ZS and placebo control (null hypothesis).

Subacute Phase (randomized withdrawal): It is hypothesized that ZS once daily is more effective than placebo control (alternative hypotheses) in maintaining normokalemic levels (3.5 - 4.9 mmol/l) among subjects completing the Acute Phase versus no difference between each ZS dose and respective placebo controls (null hypotheses).


Options:
A: Percentage of Responders (Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15.); Percentage of Responders When Accounting for Missing Central Laboratory Serum Potassium Data (Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15.)
B: Number of Participants Remaining on Spironolactone at Week 12 (At week 12)
C: Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. (Through 48 hours acute phase); Exponential Rate of Change in S-K Levels in the Subacute Phase. (Through 12 days subacute phase (Day 3 through Day 15))
D: Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 (21 to 28 Days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
Brief Summary: This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

At least 250 subjects will participate. The study is going to be conducted in approximately 50 sites in the United States and Canada.


Options:
A: Wound Closure (16 Weeks)
B: Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline (Weekly, over 12 Weeks or until wound closure, which ever occurred first)
C: Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline (12 Weeks)
D: The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. (Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first)

Answer: A