TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to compare the effects on visual development, growth, cognitive development, tolerance, and blood chemistry parameters in term infants fed one of four study formulas containing various levels of DHA and ARA.


Options:
A: visual development
B: change of weight from day 30 to day 120 (postnatal age 30 to 120 days)
C: Percentage of Total Fatty Acids by Weight (at time of birth); Gestational Age (at time of birth); Birth Weight (at time of birth); Birth Length (at time of birth)
D: time of achieving the four gross motor development milestones (4, 8 and 12 months of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed With Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen (Including Those in The MA.17 Study)
Brief Summary: RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating in women with breast cancer who have already received 5 years of aromatase inhibitor therapy.

PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating women with primary breast cancer who have received 5 years of aromatase inhibitor therapy.


Options:
A: Hot flash frequency and intensity (Baseline, 8 weeks, 24 weeks)
B: SCL-90r Depression and anxiety subscales (baseline - 12 months)
C: Disease-free Survival (DFS) (Unitil the end of study with a median follow up of 75 months)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Trial of Depression Care Management by Electronic Secure Messaging
Brief Summary: This study will test whether an electronic system that monitors and sends messages to help people with depression could be feasible, acceptable, and potentially effective as a treatment.


Options:
A: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months
B: 20-Item Symptom Checklist Depression Scale (Measured at baseline and after 6 months of treatment)
C: EPDS (3 and 6 months)
D: Generic Mental Health-Related Quality of Life (Measured 8 months post-CABG)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Trial of Depression Care Management by Electronic Secure Messaging
Brief Summary: This study will test whether an electronic system that monitors and sends messages to help people with depression could be feasible, acceptable, and potentially effective as a treatment.


Options:
A: Pill count (18 months)
B: 20-Item Symptom Checklist Depression Scale (Measured at baseline and after 6 months of treatment)
C: proportion of patients who successfully complete TB treatment and achieve cure.
D: Blood Pressure and Hemaglobin A1c

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee
Brief Summary: The purpose of this study is to determine if the traditional Chinese herbal compound (Huo-Luo-Xiao-Ling Dan, or HLXL) is effective in treating OA of the knee in addition to participants current OA of the knee treatment(s) and also to determine the best dosage of HLXL that is safe and well tolerated.


Options:
A: ‡Pain Normalized Score (8 weeks)
B: Lequesne Index
C: Average change from baseline through Week 12 for WOMAC pain subscale score. Average change from baseline through Week 12 for WOMAC physical function subscale score. Subject's average global assessment of response to therapy through Week 12.
D: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Study of the Effect of a Peritoneal Dialysis Solution Containing Glucose (1.5%) and L-carnitine (0.1%) on Insulin Sensitivity in Patients on Continuous Ambulatory Peritoneal Dialysis
Brief Summary: The current study is initiated in order to assess the impact of a PD solution containing L-carnitine on insulin sensitivity measured by a hyperinsulinemic euglycemic clamp.


Options:
A: Resistance index to erythropoietin (during de study); Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo. (during the study)
B: To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by euglycemic hyperinsulinemic clamp (time 0, 4 months)
C: lipid profile (at sixteen weeks after admission)
D: Change in weight (Baseline and 6 months); Change in fat free body mass (Baseline and 6 months); Change in serum albumin concentration (Baseline and 6 months); Change in serum prealbumin concentration (Baseline and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study Proposal - A Randomized Double-blinded Study Comparing Adding Etoricoxib Versus Placebo to Female Patients With Fibromyalgia-analysis of Organic and Psychiatric Measures
Brief Summary: The main of the proposed study is to assess whether the use of the Cox-2 inhibitor Etoricoxib is beneficial for the use in fibromyalgia. We intend to seek whether this medication may improve psychiatric and rheumatologic parameters of the disease.


Options:
A: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)
B: Brief pain inventory (6 weeks)
C: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
D: Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline (Baseline (Day 1)); Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12 (Month 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of the Preoperative Oral Carbohydrate Attenuating Immediate Postoperative Insulin Resistance on PI3K Dependent Signaling Pathway
Brief Summary: The purpose of this study is to delineate the effects of preoperative oral carbohydrate on immediate postoperative insulin resistance (PIR) in patients undergoing elective open colorectal cancer resection, and to further clarify the hypotheses that preoperative oral carbohydrate treatment attenuates PIR in patients by enhancing insulin signaling to PI3K-dependent pathway.


Options:
A: Change in Insulin Sensitivity (Percent) (Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM).)
B: PTK activity and PI3K, PKB, GLUT4 expression in rectus abdominis muscle samples by the end of operation (1 month (postoperative period))
C: Safety parameters reflecting pathophysiological functions of the liver (day -1, 0, 1, and 7); Gastrointestinal tolerance (day 0 before and 6-8h after surgery); Metabolic parameters in serum, liver and muscle tissue (on day -1, 0, 1, and 7)
D: insulin resistance (Homa-IR will be assessed in two time points: baseline (2-3 h before operatio) and 24h after operation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of PGL4001 (Ulipristal) Versus Placebo for Pre-Operative Treatment of Symptomatic Uterine Myomas
Brief Summary: This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.


Options:
A: Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13) (Week 13 visit); Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit) (Week 13)
B: Shrinkage of Fibroids - Size of Fibroids (3 months (baseline to end of treatment))
C: Myoma size (2004 to 2007)
D: Efficacy endpoints (From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.); Number and proportion of subjects experiencing open label treatment-emergent adverse events (From baseline to end of PGL4001 treatment (3months treatment))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of PGL4001 (Ulipristal) Versus Placebo for Pre-Operative Treatment of Symptomatic Uterine Myomas
Brief Summary: This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.


Options:
A: Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13) (Week 13 visit); Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit) (Week 13)
B: Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit) (3 months); Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist (Week 13 visit); Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist (Up to week 17)
C: Shrinkage of Fibroids - Size of Fibroids (3 months (baseline to end of treatment))
D: Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses (18 months study duration per subject (4 3-month intermittent treatment courses))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An 8 Week Multicenter, Open-label, Observational Study to Evaluate the Effectiveness of Adding Montelukast Sodium 10 mg Per Day to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma
Brief Summary: The purpose of this study is to evaluate the effectiveness of adding Montelukast Sodium (singulair®) 10 mg per day to inhaled corticosteroids in adult subjects with uncontrolled asthma.


Options:
A: Symptom-free days; Quality of Life Questionnaire (AQLQ, PAQLQ); Rate of asthma-related hospitalizations over 18 months of enrollment; Rate of asthma-related emergency room (ER) visits over 18 months of enrollment
B: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)
C: To describe the percentage of patients with asthma who will be controlled after 8 weeks of treatment with montelukast used in combination with inhaled corticosteroids (8 weeks)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Short Versus Long IVF-treatment. A Prospective, Consecutive and Randomized Comparative Study
Brief Summary: Purpose: Comparing a GnRH agonist and an antagonist protocol for IVF/ICSI with regard to

1. frequency of ovarian hyperstimulation syndrome (OHSS) (1. outcome measure)
2. quality of life (2. outcome measure)
3. live birth rate (2. outcome measure)
4. gene expression profiles of granulosa and cumulus cells, and concentrations of estradiol and vascular endothelial growth factor in follicular fluid(not only compared between GnRH agonist and antagonist protocol, but also between patients with OHSS and no OHSS and patients becoming pregnant and not becoming pregnant (2. outcome measure), and
5. number of oocytes removed per treatment, number of embryo transfers per treatment and number of spontaneous abortions per treatment (these three parameters are tertiary outcome measures).

In addition to the above mentioned efficacy outcome measures the safety outcome measure "frequency of known side-effects" will be compared between the two protocols.


Options:
A: Live birth rate (12 months)
B: Frequency of Ovarian Hyperstimulation Syndrome (OHSS) (3 years)
C: Number of Oocytes Retrieved Per Participant (34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU))
D: Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles (Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Short Versus Long IVF-treatment. A Prospective, Consecutive and Randomized Comparative Study
Brief Summary: Purpose: Comparing a GnRH agonist and an antagonist protocol for IVF/ICSI with regard to

1. frequency of ovarian hyperstimulation syndrome (OHSS) (1. outcome measure)
2. quality of life (2. outcome measure)
3. live birth rate (2. outcome measure)
4. gene expression profiles of granulosa and cumulus cells, and concentrations of estradiol and vascular endothelial growth factor in follicular fluid(not only compared between GnRH agonist and antagonist protocol, but also between patients with OHSS and no OHSS and patients becoming pregnant and not becoming pregnant (2. outcome measure), and
5. number of oocytes removed per treatment, number of embryo transfers per treatment and number of spontaneous abortions per treatment (these three parameters are tertiary outcome measures).

In addition to the above mentioned efficacy outcome measures the safety outcome measure "frequency of known side-effects" will be compared between the two protocols.


Options:
A: Frequency of Ovarian Hyperstimulation Syndrome (OHSS) (3 years)
B: Number of Oocytes Retrieved (Day of oocyte retrieval (up to Day 18 after start of stimulation))
C: Number of patients obtaining 5-12 oocytes during COH (2 years)
D: Number of metaphase II oocytes retrieved during the course of one treatment cycle (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Short Versus Long IVF-treatment. A Prospective, Consecutive and Randomized Comparative Study
Brief Summary: Purpose: Comparing a GnRH agonist and an antagonist protocol for IVF/ICSI with regard to

1. frequency of ovarian hyperstimulation syndrome (OHSS) (1. outcome measure)
2. quality of life (2. outcome measure)
3. live birth rate (2. outcome measure)
4. gene expression profiles of granulosa and cumulus cells, and concentrations of estradiol and vascular endothelial growth factor in follicular fluid(not only compared between GnRH agonist and antagonist protocol, but also between patients with OHSS and no OHSS and patients becoming pregnant and not becoming pregnant (2. outcome measure), and
5. number of oocytes removed per treatment, number of embryo transfers per treatment and number of spontaneous abortions per treatment (these three parameters are tertiary outcome measures).

In addition to the above mentioned efficacy outcome measures the safety outcome measure "frequency of known side-effects" will be compared between the two protocols.


Options:
A: cost of treatment (One month)
B: Frequency of Ovarian Hyperstimulation Syndrome (OHSS) (3 years)
C: To collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian hyperstimulation. (In both cohorts a follow-up pediatric evaluation was scheduled within 6 months post-partum)
D: The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met. (At completion of ovarian stimulation; maximally after 18 days of recFSH administration.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Short Versus Long IVF-treatment. A Prospective, Consecutive and Randomized Comparative Study
Brief Summary: Purpose: Comparing a GnRH agonist and an antagonist protocol for IVF/ICSI with regard to

1. frequency of ovarian hyperstimulation syndrome (OHSS) (1. outcome measure)
2. quality of life (2. outcome measure)
3. live birth rate (2. outcome measure)
4. gene expression profiles of granulosa and cumulus cells, and concentrations of estradiol and vascular endothelial growth factor in follicular fluid(not only compared between GnRH agonist and antagonist protocol, but also between patients with OHSS and no OHSS and patients becoming pregnant and not becoming pregnant (2. outcome measure), and
5. number of oocytes removed per treatment, number of embryo transfers per treatment and number of spontaneous abortions per treatment (these three parameters are tertiary outcome measures).

In addition to the above mentioned efficacy outcome measures the safety outcome measure "frequency of known side-effects" will be compared between the two protocols.


Options:
A: Frequency of Ovarian Hyperstimulation Syndrome (OHSS) (3 years)
B: FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS (2 weeks)
C: Proportion of mature oocytes retrieved (day of intervention)
D: Number of retrieved oocytes per procedure (through study completion, 9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Low Molecular Weight Heparin in Hemodiafiltration
Brief Summary: Low molecular weight heparin (LMWH) is injected in the dialysis circuit at the start of the session. In the present study we compare 3 different methods of injection of LMWH: parameters of dialysis efficiency and clotting are measured. The study lasts 3 sessions for each patient.


Options:
A: The change from baseline in the cumulative dose of heparin anticoagulation used during conventional HD (2 weeks after CD exposure, 2 weeks after AD exposure)
B: anticoagulation efficacy as evaluated by clotting score of dialyser; anticoagulation efficacy as evaluated by occurrence of major and minor clotting events; anticoagulation efficacy as evaluated by instantaneous blood clearances
C: Anti-Xa activity at the end of the session (240 min after start)
D: clinical patency of the hemodialysis extracorporeal circuit (4 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial of Surgical Masks vs N95 Respirators to Prevent Influenza in Health Care Workers
Brief Summary: The goal of this study is to compare the efficacy of the surgical mask to the N95 respirator in protecting nurses from influenza in the hospital setting. The investigators propose a non-inferiority randomized controlled trial whereby nurses are randomized to either a surgical mask or an N95 respirator when caring for patients with febrile respiratory illness during the influenza season. The hypothesis is that the surgical mask offers similar protection against influenza to that of the N95. The specific objective of the study is to assess whether the rates of influenza (laboratory-confirmed by PCR and HAI assay), as well as secondary outcomes (influenza-like illness, work-related absenteeism, physician visits for respiratory illness, and lower respiratory infection), are similar among nurses using a surgical mask compared to those using an N95 respirator.


Options:
A: the episodes due to respiratory tract infections (8 moth); The episodes due to gastroenteritis (8 month)
B: Number of laboratory confirmed cases of Influenza (8 weeks, including the 6 weeks of intervention and two weeks post-intervention)
C: the incidence rates of influenza infection (Until 3 months gargling)
D: Laboratory-confirmed Influenza Infection (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial of Surgical Masks vs N95 Respirators to Prevent Influenza in Health Care Workers
Brief Summary: The goal of this study is to compare the efficacy of the surgical mask to the N95 respirator in protecting nurses from influenza in the hospital setting. The investigators propose a non-inferiority randomized controlled trial whereby nurses are randomized to either a surgical mask or an N95 respirator when caring for patients with febrile respiratory illness during the influenza season. The hypothesis is that the surgical mask offers similar protection against influenza to that of the N95. The specific objective of the study is to assess whether the rates of influenza (laboratory-confirmed by PCR and HAI assay), as well as secondary outcomes (influenza-like illness, work-related absenteeism, physician visits for respiratory illness, and lower respiratory infection), are similar among nurses using a surgical mask compared to those using an N95 respirator.


Options:
A: Absenteeism rate due to gastrointestinal or respiratory illness during the study period. (8 weeks)
B: Laboratory-confirmed Influenza Infection (one year)
C: Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm (At the end of the entire study period (16 months)); Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm (At the end of the study period (16 months))
D: secondary influenza infection (7 days)

Answer: B