TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


Options:
A: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28-30 (Baseline and End of treatment (Day 28-30))
B: Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal (Day 0 (baseline), Week 4)
C: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
D: Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab (From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


Options:
A: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
B: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
C: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)
D: Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization (Measured over the 18 month study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
C: MRSA Culture Status (Day 28)
D: Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture (Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocol)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


Options:
A: Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 (Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days))
B: Number of Participants With Treatment-Emergent Adverse Events (56 days)
C: Clinically Significant Laboratory Abnormalities. (28 Days)
D: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


Options:
A: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
B: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)
C: Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization (Measured over the 18 month study)
D: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
C: Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 (Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days))
D: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


Options:
A: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: MRSA Culture Status (Day 28)
D: Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture (Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocol)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Study of SOX vs. COX in Patients With Advanced Colorectal Cancer
Brief Summary: Primary objective :

To compare the combination of S-1 and oxaliplatin(SOX) to the combination of capecitabine and oxaliplatin(COX) therapy for advanced or metastatic colorectal carcinoma.

Secondary objectives :

1. To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups.
2. To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups.


Options:
A: Overall survival (Assessed until 1.5 years after the last patient enrolment)
B: Disease-free Survival in Stage III Cancer Patients - Time to Event (From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).); Disease-free Survival in Stage III Cancer Patients - Number of Events (From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).)
C: Overall Survival: Time From Randomization to Death From Any Cause (within 6.5 years)
D: To compare the combination of S-1 and oxaliplatin to the combination of capecitabine and oxaliplatin in terms of progression free survival in patients previously untreated by systemic therapy for advanced or metastatic colorectal carcinoma. (9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Usefulness of Gluten-free Diet in Gluten-genetically Predisposed Subjects Positive to Intestinal-mucosa Anti-transglutaminase Antibodies
Brief Summary: Undetected or untreated CD may cause severe complications later in life, such as autoimmune disorders.

It is recommended for subjects with autoimmune diseases or at risk for CD to be screened for CD and to repeat serological screening about every three years to detect cases of clinically silent, late-onset CD.

Celiac disease (CD) auto-antibodies against tissue transglutaminase (anti-tTG) are produced in the intestinal mucosa even when not measurable in serum. By using the phage display libraries technique it is possible to investigate in vivo (intestinal biopsy) early antibody responses in autoimmune disease. In particularly, this technique demonstrated that the humoral response against tissue transglutaminase occurs at the intestinal mucosal level, and that the human VH5 gene is the commonly used variable region by the celiac patients to build the anti-tTG. The intestinal mucosa production of IgA anti-tTG could be important in the diagnostic work-up of early-stage CD, when mucosal histology is not yet diagnostic.

The investigators propose to 1) first degree relatives of CD patients, 2) subjects with autoimmune disease, 3) symptomatic subjects (genetically predisposed to gluten intolerance) tested negative for CD related autoantibodies and with apparently normal intestinal mucosa a prospective study to uncover early-stage of gluten intolerance by measuring the mucosal VH5 restricted gene family anti-tTG clones in two biopsies: before and after one year of gluten free-diet (GFD).

Aims of this clinical trial are:

1. to measure by means of phage display libraries the gluten dependent humoral immune response (anti-tTG) of the intestinal mucosa in subjects with high risk of untreated CD, without CD-related intestinal lesions.
2. to demonstrate the mucosal gluten-dependent immune response before and after 12 months of gluten-free diet
3. to demonstrate that dietary intervention might modify the clinical condition (e.g improvements of the gastrointestinal complaints or extra-gastrointestinal symptoms) of the enrolled patients and the improvement of the intestinal inflammation with the disappearance of the mucosal anti-tTG.
4. to evaluate the specificity of the double staining technique for detecting IgA antitransglutaminase mucosal deposit with the phage display antibodies assay


Options:
A: Small-bowel mucosal morphology and inflammation (One year)
B: Identification of FODMAP intollerance in IBS subjects (4 weeks); Identification of NCGS in IBS subjects who responded to low FODMAPs diet (3 weeks)
C: The extent of autistic symptoms based on the Autism Diagnostic Observation Schedule - 2 (ADOS-2) (Change over time - 6 months)
D: Intestinal mucosal gluten-dependent immune response before and after a gluten-free diet (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Cardiovascular Risk With Dietary Flavonoids in Post Menopausal Women With Type 2 Diabetes
Brief Summary: The purpose of this placebo controlled trial is to determine whether a year long intervention with flavonoids (found in cocoa and soy) is more effective in reducing the risk of cardiovascular disease in postmenopausal women with type 2 diabetes, than standard therapy (statins). A range of markers of cardiovascular disease risk are being studied and volunteers are also providing urine and blood samples. 152 postmenopausal women, from the locality, will be recruited for this study.


Options:
A: Change in cardiovascular disease risk indictaors - including carotid intima-media thickness (CIMT), total plaque volume (TPV) (at the carotid bifurcation), pulse wave velocity (PWV) and biomarkers of risk in blood samples . (6 months - 1 year)
B: Vascular function (Measured at weeks 4 and 12)
C: changes in systolic and diastolic blood pressure
D: Blood lipids (after 4 weeks intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Text Message Reminders on Contraceptive Continuation, a Randomized Controlled Trial
Brief Summary: Teen girls and young women taking birth control pills may forget to take their pills or may stop taking them altogether. This places them at risk for unintended pregnancies. Most young women own cell phones and use them for text messaging. We will test whether contraceptive continuation is affected after six months of daily text message reminders.


Options:
A: Differences in the Screen IVF questionaire between the intervention groups (through study completion, an average of 2 years)
B: Effect of SMS intervention on attendance rate to follow-up screening appointment (up to 14 months)
C: contraceptive continuation (6 months)
D: Average number of missed pills per cycle (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Text Message Reminders on Contraceptive Continuation, a Randomized Controlled Trial
Brief Summary: Teen girls and young women taking birth control pills may forget to take their pills or may stop taking them altogether. This places them at risk for unintended pregnancies. Most young women own cell phones and use them for text messaging. We will test whether contraceptive continuation is affected after six months of daily text message reminders.


Options:
A: Intention to treat analysis (13 months)
B: Measles - 2 Completion (When the participants reach 2 years of age)
C: contraceptive continuation (6 months)
D: Contraceptive uptake (10 weeks postpartum; 24 weeks postpartum); Facility Delivery (Postpartum); Exclusive Breastfeeding (24 weeks postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Text Message Reminders on Contraceptive Continuation, a Randomized Controlled Trial
Brief Summary: Teen girls and young women taking birth control pills may forget to take their pills or may stop taking them altogether. This places them at risk for unintended pregnancies. Most young women own cell phones and use them for text messaging. We will test whether contraceptive continuation is affected after six months of daily text message reminders.


Options:
A: Average number of missed pills per cycle (3 months)
B: contraceptive continuation (6 months)
C: Contraceptive use at time of last sexual intercourse (18 months)
D: Assessment of acceptability of Implanon in comparison to the TCu380A IUD and the LNG-IUS (Participants will receive counseling before admission and at 12 months after)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Text Message Reminders on Contraceptive Continuation, a Randomized Controlled Trial
Brief Summary: Teen girls and young women taking birth control pills may forget to take their pills or may stop taking them altogether. This places them at risk for unintended pregnancies. Most young women own cell phones and use them for text messaging. We will test whether contraceptive continuation is affected after six months of daily text message reminders.


Options:
A: contraceptive continuation (6 months)
B: Use of a Effective Contraceptive Method at Four-months Post-abortion (4 months)
C: Average number of missed pills per cycle (3 months)
D: Adherence to ART and HIV RNA suppression (6,12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Text Message Reminders on Contraceptive Continuation, a Randomized Controlled Trial
Brief Summary: Teen girls and young women taking birth control pills may forget to take their pills or may stop taking them altogether. This places them at risk for unintended pregnancies. Most young women own cell phones and use them for text messaging. We will test whether contraceptive continuation is affected after six months of daily text message reminders.


Options:
A: Measurement of contraceptive adherence (12 months); Measurement of dual method use (12 months); Measurement of pregnancy rates and sexually transmitted diseases (STDs) (12 months)
B: contraceptive continuation (6 months)
C: Unprotected vaginal and anal sex (Baseline); Unprotected vaginal and anal sex (6 month follow-up); Unprotected vaginal and anal sex (12-month follow-up)
D: Choice of contraceptive method on day of enrollment. (Day of enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Text Message Reminders on Contraceptive Continuation, a Randomized Controlled Trial
Brief Summary: Teen girls and young women taking birth control pills may forget to take their pills or may stop taking them altogether. This places them at risk for unintended pregnancies. Most young women own cell phones and use them for text messaging. We will test whether contraceptive continuation is affected after six months of daily text message reminders.


Options:
A: MEMS Adherence (12 months follow up)
B: Exclusive breastfeeding duration (Six months)
C: Immunization Rate (12 months)
D: contraceptive continuation (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Text Message Reminders on Contraceptive Continuation, a Randomized Controlled Trial
Brief Summary: Teen girls and young women taking birth control pills may forget to take their pills or may stop taking them altogether. This places them at risk for unintended pregnancies. Most young women own cell phones and use them for text messaging. We will test whether contraceptive continuation is affected after six months of daily text message reminders.


Options:
A: Pregnancy (AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year)
B: Discontinuation rate by treatment group (at 12 months)
C: contraceptive continuation (6 months)
D: Adherence Rate (Rate of Perfect Method Use) (For the first 3 months)

Answer: C