TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Harnessing the Power of Text Messaging to Invigorate AMSM HIV Preventive Behavior
Brief Summary: The purpose of this study is to examine whether Guy2Guy (G2G), a text messaging-based healthy sexuality and human immunodeficiency virus (HIV) prevention program intervention for 14-18 year gay, bisexual and queer men, is associated with HIV preventive behavior (e.g., condom use) compared to an attention-matched control group.


Options:
A: Exclusive breastfeeding (0-6 months following delivery); Immediate breastfeeding (1 hour following delivery)
B: Intention to treat analysis (13 months)
C: Adherence to cervical cancer screening (step1) (Up to 20 months)
D: The Number of Condomless Sex Acts at 3-months Post-intervention (3-months post-intervention); Percent of Boys Reporting Abstinence at 3-months Post-intervention (3-months post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1b, Randomized, Double-blind (Sponsor Open), Placebo Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf 04447943, Co-administered With And Without Hydroxyurea, In Subjects With Stable Sickle Cell Disease
Brief Summary: This study is being conducted to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of an investigational drug, PF-04447943, in subjects with stable sickle cell disease with and without co-administration with hydroxyurea. This study will also aid in selecting the doses for future studies and evaluation of substances in the blood which may help access the effectiveness of the drug.


Options:
A: Distribution of the Density of Hemoglobin SC Red Cells (measured 2 months after initiation of treatment)
B: Number of Malaria Episodes (12 months)
C: Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Vital Signs (Baseline up to 30 days post last dose on Day 29); Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Neurologic Function (Baseline up to Day 29); Number of Participants With Potentially Clinically Important (PCI) Change in Physical Examination Findings (Baseline up to 30 days post last dose on Day 29); Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings (Baseline up to 30 days post last dose on Day 29); Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Symptoms of Sickle Cell Disease (Baseline up to 30 days post last dose on Day 29); Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Day 1 to 30 days post last dose on Day 29); Number of Participants With Laboratory Test Abnormalities (Baseline up to 30 days post last dose on Day 29)
D: Change in Soluble Vascular Cell Adhesion Molecule-1 (sVCAM) (baseline to eight weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: REVITIVE for the Treatment of Patients With Venous Insufficiency
Brief Summary: To investigate the efficacy of an electrical stimulation (using the REVITIVE IX device) in treating patients with venous insufficiency.


Options:
A: Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV (0 and 6 weeks)
B: The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20) (12 months); Photoplethysmograph (PPG) (12 months)
C: Feasibility as Measured by Number of Participants Who Meet Study Eligibility Criteria at Baseline (Baseline); Number of Screened Subjects Who Provided Consent at Baseline (Baseline); Mean Number of Participants Who Adhered to the Assigned Physical Activity During 8-week Period (Intervention Arm -FitBit Arm ) (8 weeks); Mean Physical Activity Questionnaire Score at 3 Months (Standard of Care Arm Only) (3 months); Mean Physical Activity Questionnaire Score at 6 Months (Standard of Care Arm Only) (6 months); Mean Physical Activity Questionnaire Score at 9 Months (Standard of Care Arm Only) (9 months); Proportion of Subjects Who Complete Post-randomization (Within 24 months of trial initiation)
D: number of patient with 20% improvement of CIVIC scale at 3 months (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of the Immunogenicity and Descriptive Safety of a Live Attenuated Herpes Zoster Vaccine and the Glaxo Smith Kline (GSK) Herpes Zoster Recombinant HZ/su Candidate Vaccine in 50-59 Year Old and 70-85 Year Old Vaccine Recipients
Brief Summary: This study will compare the two vaccines that have been developed to prevent and/or lessen the effects of shingles. One vaccine is live (Zostavax, licensed by FDA) and the other, herpes zoster subunit (HZ/su), contains a piece of the shingles virus (not live) and an ingredient that may enhance the body's immune response to the vaccine, and is currently investigational. The vaccines are being compared to assess their ability to stimulated protection against shingles. The study will provide an opportunity to determine the safety profile of each vaccine in a single trial. The study will also look at the effect of age on the immune response to the two vaccines and on the persistence of these responses.


Options:
A: Changes in Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number (Measured up to Day 730)
B: Number of Subjects With Vaccine Response to Anti-gE Antibodies (At one month post-dose 2 (Month 3)); Vaccine Response for Anti-gE Humoral Immunogenicity (At one month post-dose 2 (Month 3)); Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies (At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)); FLU Haemagglutination Inhibition (HI) Antibody Titers (At Day 21 post vaccination)
C: Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3))
D: Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group (At 1 month post-Dose 2 (Month 3)); Antibody Concentrations Against Glycoprotein E (Anti-gE) (At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group)); Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens (At 1 month post-Dose 1 (Month 1)); Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens (At 1 month post-Dose 1 (Month 1))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of the Immunogenicity and Descriptive Safety of a Live Attenuated Herpes Zoster Vaccine and the Glaxo Smith Kline (GSK) Herpes Zoster Recombinant HZ/su Candidate Vaccine in 50-59 Year Old and 70-85 Year Old Vaccine Recipients
Brief Summary: This study will compare the two vaccines that have been developed to prevent and/or lessen the effects of shingles. One vaccine is live (Zostavax, licensed by FDA) and the other, herpes zoster subunit (HZ/su), contains a piece of the shingles virus (not live) and an ingredient that may enhance the body's immune response to the vaccine, and is currently investigational. The vaccines are being compared to assess their ability to stimulated protection against shingles. The study will provide an opportunity to determine the safety profile of each vaccine in a single trial. The study will also look at the effect of age on the immune response to the two vaccines and on the persistence of these responses.


Options:
A: Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3))
B: Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Anti-glycoprotein E (gE) Antibody Concentrations (One month after the second vaccination (Month 3)); Anti-VZV Antibody Concentrations (One month after the second vaccination (Month 3))
C: Reduce burden of illness due to herpes zoster (HZ) (Incidence of postherpetic neuralgia (PHN), where PHN is defined as HZ-associated pain greater than or equal to 3 persisting or appearing more than 30 days after the onset of the HZ rash)
D: Changes in Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number (Measured up to Day 730)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [HPV] [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old Men
Brief Summary: Primary objective

To demonstrate that administration of V503 induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to 26-year-old men


Options:
A: Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen. (From Month 6 up to Month 48)
B: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18 (4 weeks postdose 3 (Month 7))
C: Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline) (Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline) (at Month 48)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: INTERACTIVE SECTIONS OF AN INTERNET-BASED INTERVENTION INCREASE PATIENT EMPOWERMENT: A RANDOMIZED CONTROLLED STUDY WITH CHRONIC BACK PAIN PATIENTS
Brief Summary: The aim of the study is to study how to improve patients' management of chronic back pain, particularly their management of prescription medication, through increasing health literacy and patient empowerment through an internet based intervention. We do this by designing both patient education materials and physician communication strategies to increase literacy and volitional components of patients. We will test two conditions using a website called Oneself: one providing only information (literacy-only control) and a second providing relational communications designed to increase both literacy and volitional empowerment. To test the self-management enhancing effects of empowerment and health literacy, we will conduct a longitudinal experiment with 51 chronich back pain patients over two months. This span of time is the minimum necessary to achieve a systematic change in self-management and literacy skills, increasing also the range of possible decisions to be made and actions to be real-ized by the patients.


Options:
A: Roland Morris Disability Questionnaire (change from baseline to 3 months)
B: Empowerment level (psychological measure) (8 weeks)
C: Primary Endpoint: WOMAC Pain Score (Likert Scale Version) at 4 Weeks (4 Weeks)
D: Change in Disability: Change in the Roland-Morris Questionnaire (five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).); Change in Pain measured by Numerical Rating Scale (NRS) (five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PRimary Prevention Of Depression in Offspring of Depressed Parents
Brief Summary: The purpose of this randomised controlled trial is to see whether a group-based psychological intervention for families can reduce the inflated risk of depression in children and adolescents who have at least one parent who suffers from depression (or who has suffered from depressed in the child's lifetime).


Options:
A: Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4) (Time to a score of 4 or higher between baseline and 9 months using survival analysis)
B: use of Internet site (2 months)
C: N/A
D: Presence or absence of a depressive episode (child) (T4 (9 months after completion of the programme))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Biomechatronic System Using Voluntary Motor Effort (VME)-Driven Neuromuscular Electrical Stimulation (NMES) for Upper Limb Rehabilitation
Brief Summary: The purpose of this study is to investigate the combined training effectiveness of mechanical robot and neuromuscular electrical stimulation on upper limb rehabilitation after stroke.


Options:
A: Gait Velocity (6 months); Stroke Impact Scale (SIS) Composite Score (6 months); Device Related Serious Adverse Events (6 months)
B: Change in Fugl-Meyer Assessment Scale after training (1) up to 7 weeks, 2) 3 months after participants finish the training); Change in Modified Ashworth Scale after training (1) up to 7 weeks, 2) 3 months after participants finish the training)
C: Ten Meter Walk Test (10mWT) (Week 30)
D: Change in Action Research Arm Test (ARAT) Score (Baseline and 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Counseling to Reduce Children's Secondhand Smoke Exposure: A Trial With Maternal Smokers
Brief Summary: The goal of this study is to reduce infant and toddlers' secondhand smoke exposure (SHSe) in a high risk, medically underserved population of maternal smokers. The program is called "Philadelphia FRESH (Family Rules for Establishing Smokefree Homes)". Participants are recruited from low-income urban neighborhoods in Philadelphia, Pennsylvania. After determining study eligibility via telephone screen, all participants complete an in-home pre-intervention interview that includes self-reported smoking history, current smoking and exposure patterns, and factors that relate to maternal smoking (such as depressive symptoms, weight concerns, nicotine dependence,) as well as collection of child urine cotinine (a biomarker used to detect SHSe).

Participants are randomized after baseline to receive either (a) a moderately intensive (up to 2 in-home sessions, 8 phone sessions) Behavioral Counseling intervention (BC) delivered over a 16-week period by counselors trained and supervised by investigators, or (b) an enhanced Self-Help Control (SHC) that uses brief advice and a detailed self-help manual for SHSe-reduction and smokingcessation. Post intervention assessments include self-reports of intervention process, factors associated with intervention effects, and intervention outcomes that include child urine cotinine (to measure level of SHSe) and participant saliva cotinine (to verify self-reported smoking quit status). Interviewers and data management staff remain blind to the treatment assignment. All procedures are implemented after signed informed consent and were approved by Temple University's Institutional Review Board.


Options:
A: child urine cotinine (baseline to 16 weeks)
B: Percentage of Days Used Drugs or Alcohol (intake to delivery, an average of 21 weeks); Percentage of Days Used Drugs or Alcohol (delivery to 3 months post-delivery); Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol (intake to delivery, an average of 21 weeks); Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol (Delivery to 3 months post-delivery); Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol (intake to delivery, an average of 21 weeks); Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol (Delivery to 3 months post-delivery)
C: evaluate the abstinence of tobacco consumption (12 months)
D: 7-day point prevalence (3 months and 6 months post treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Counseling to Reduce Children's Secondhand Smoke Exposure: A Trial With Maternal Smokers
Brief Summary: The goal of this study is to reduce infant and toddlers' secondhand smoke exposure (SHSe) in a high risk, medically underserved population of maternal smokers. The program is called "Philadelphia FRESH (Family Rules for Establishing Smokefree Homes)". Participants are recruited from low-income urban neighborhoods in Philadelphia, Pennsylvania. After determining study eligibility via telephone screen, all participants complete an in-home pre-intervention interview that includes self-reported smoking history, current smoking and exposure patterns, and factors that relate to maternal smoking (such as depressive symptoms, weight concerns, nicotine dependence,) as well as collection of child urine cotinine (a biomarker used to detect SHSe).

Participants are randomized after baseline to receive either (a) a moderately intensive (up to 2 in-home sessions, 8 phone sessions) Behavioral Counseling intervention (BC) delivered over a 16-week period by counselors trained and supervised by investigators, or (b) an enhanced Self-Help Control (SHC) that uses brief advice and a detailed self-help manual for SHSe-reduction and smokingcessation. Post intervention assessments include self-reports of intervention process, factors associated with intervention effects, and intervention outcomes that include child urine cotinine (to measure level of SHSe) and participant saliva cotinine (to verify self-reported smoking quit status). Interviewers and data management staff remain blind to the treatment assignment. All procedures are implemented after signed informed consent and were approved by Temple University's Institutional Review Board.


Options:
A: child urine cotinine (baseline to 16 weeks)
B: The level of exposure to SHS in the babies by means of questionnaire and nicotine hair analysis. (6 months at the beginning of intervention)
C: Smoking Status (2 months after the end of home visits; after the end of the phone calls (4 months). The 6 month follow-up occurred approximately 2 months after the four month assessment and the 12 month assessment occurred 6 months after the 6 month assessment.)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial Comparing Transepithelial Corneal Cross-linking Using Iontophoresis and Standard Corneal Cross-linking for the Treatment of Keratoconus
Brief Summary: The purpose of the present Randomized Clinical Trial (RCT) is to compare the efficacy and safety of transepithelial corneal cross-linking using iontophoresis (T-ionto CL) to treat progressive keratoconus in comparison with standard cross-linking (standard CL).


Options:
A: Best corrected visual acuity (at six months after surgery)
B: Best corrected distant visual acuity (BCDVA) (One year)
C: K-max (Changes from baseline in Kmax at 12 months); Corneal Endothelial Cell Density (Changes from baseline in ECD at 12 months)
D: evaluation of depth of demarcation line (1 month postoperative)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Comparison of Coronary Bypass Grafting With Minimal Extracorporeal Circulation System (MECC) Versus Off-pump Coronary Surgery. New Insights Into Inflammatory Cytokines.
Brief Summary: The investigators aimed to evaluate the clinical results and the inflammatory response of the minimal extracorporeal circulation system (MECC) Compared with off-pump coronary revascularization (OPCABG).

This is a randomized and prospective study in 230 patients with indications for coronary surgery, with 113 patients in the OPCABG group and 117 in the MECC group. The endpoints were the clinical and biochemical results, intra-operative outcomes and the determination of 19 inflammatory circulating markers, 17 of them for the first time analyzed comparing both techniques.


Options:
A: Evolution of pro-inflammatory and anti-inflammatory cytokines [TNF-alfa, IL-1, IL-6, IL-8 and IL-10 (1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb); Evolution of complement C5a (1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb); Evolution of CD 64 and CD 163 markers (1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb); Evolution of miRNA (1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb); Evolution of PON1, HDL and LDL (1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb)
B: Clinical outcomes (within the first 30 days (plus or minus 3 days) after surgery)
C: Mortality at 30 days (30 days post-randomization); Composite (30 days post-randomization)
D: Endothelial Progenitor Cells (EPCs) Count (Cells/µl) (Postoperative 6th hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Connective Tissue Graft Associated or Not With Low Intensity Laser Therapy: A Randomized Clinical Trial
Brief Summary: The purpose of this study was to evaluate the 6-month outcomes of applying low-intensity laser therapy associated with connective tissue grafts to treat gingival recession.


Options:
A: percentage of root coverage (6 month)
B: Percentage of root coverage (6 months)
C: Percentage of root coverage (6 months)
D: Percentage of Defect Coverage (6 months)

Answer: B