TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double Blind, Placebo Controlled, Phase IIb Dose Ranging Study (With Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate.
Brief Summary: This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid Arthritis (RA) and if so how it compares to placebo (a substance which does not have any action) and etanercept (a medicine already available to treat Rheumatoid Arthritis) when added to treatment with methotrexate. The purpose of this study is also to find out which dose of AZD5672 is the most effective at treating RA and to find out how well the body tolerates AZD5672 when taken for up to 12 weeks.


Options:
A: American College of Rheumatology 20 Response (ACR20) (12 weeks)
B: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 (Month 3); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 (Month 3)
C: Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 (Week 24); Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 (Baseline and Week 52)
D: Percentage of patients with ACR 20 response (Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Genetic Counseling for Individuals With Mental Illness: Impact on Knowledge, Risk Perception, Perceived Control and Internalized Stigma.
Brief Summary: People who have experienced mental illnesses like schizophrenia, bipolar disorder or schizoaffective disorder often have a poor understanding of the causes of their illness, and that they are often very worried about how the illness affects their families. In particular, affected individuals worry that there is a high chance that any children that they have will become affected with the same illness. Often, because of this fear, affected individuals choose not to have children.

Genetic counseling is a process where information about the causes of illnesses, and about chances for family members of individuals with these illnesses to become similarly affected is provided in a supportive environment by a specially trained healthcare professional. This study will investigate whether genetic counseling can reduce perceptions of risk and stigma, and increase perceived control and knowledge about the causes of the illness, amongst individuals who have a major mental illness.


Options:
A: Change in PTSD Symptom Scale, Interview Version (PSS-I) following treatment (Baseline to 6-month follow-up (approximately 34 weeks for Spaced PE and PCT, 26 weeks for Massed PE)
B: Depression (Baseline, t2, t3)
C: Knowledge, risk perception, stigma, perceived control (immediately post intervention and 1 month post intervention)
D: Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale) (3 months, 6 months and 1 year after completion of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Genetic Counseling for Individuals With Mental Illness: Impact on Knowledge, Risk Perception, Perceived Control and Internalized Stigma.
Brief Summary: People who have experienced mental illnesses like schizophrenia, bipolar disorder or schizoaffective disorder often have a poor understanding of the causes of their illness, and that they are often very worried about how the illness affects their families. In particular, affected individuals worry that there is a high chance that any children that they have will become affected with the same illness. Often, because of this fear, affected individuals choose not to have children.

Genetic counseling is a process where information about the causes of illnesses, and about chances for family members of individuals with these illnesses to become similarly affected is provided in a supportive environment by a specially trained healthcare professional. This study will investigate whether genetic counseling can reduce perceptions of risk and stigma, and increase perceived control and knowledge about the causes of the illness, amongst individuals who have a major mental illness.


Options:
A: Percentage uptake of PPIUD (Within approximately 24 hours postpartum, before discharge from the hospital.)
B: Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes (Measured at the end of the study period (approximately 2 years))
C: Knowledge, risk perception, stigma, perceived control (immediately post intervention and 1 month post intervention)
D: Glycosylated Hemoglobin (HbA1c): (baseline and at the end of 12 months post index date)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Manual Therapy and Physical Therapy in Patients With Subacute and Chronic Non-specific Neck Pain. A Randomized Controlled Trial.
Brief Summary: Background of the study: Manual Therapy applied to patients with non-specific neck pain has been investigated several times, both internationally and nationally. In the Netherlands different types of manual therapy treatment exist. Manual Therapy, as practiced under the Utrecht School, has not been subject of a randomized controlled trial. There is a need to evaluate the effectiveness of this type of manual therapy.

Objective of the study: This trial will investigate the effectiveness of Manual Therapy in the short and long-term up to 52 weeks in patient with (sub) acute (minimal two weeks) and chronic (maximum 52 weeks) since last episode of neck pain. Functional state, pain and global perceived effect are the outcome variables.

Study design: The study is a single blind randomized controlled trial.

Study population: Men and women aged 18 to 70 years old with neck pain for at least two weeks.

Intervention: The experimental group will be treated with manual therapy for a period of six weeks. The control group will be treated with physical therapy (usual care) also for a period of six weeks.

Primary study parameters / outcome of the study: Global Perceived Effect (GPE) and the Neck disability index (NDI-DV ) will be applied.

Secondary study parameters / outcome of the study: Visual Analogue Scale (VAS) for pain and SF36 (Quality of life). The Multidimensional Health Locus of Control(MHLC ), Credibility/Expectancy Questionnaire, Fear Avoidance Beliefs Questionnaire (FABQ-DLV) will also be measured.


Options:
A: Pain intensity (week 8)
B: Global Perceived Effect (GPE), Neck disability index (NDI-DV ) (0-3-7-13-26-52 weeks)
C: Neck Disability Index (NDI) (baseline and post intervention 2 weeks)
D: Headache days change from baseline for cervicogenic headache (0, 6, 12, 24, 39, 52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Manual Therapy and Physical Therapy in Patients With Subacute and Chronic Non-specific Neck Pain. A Randomized Controlled Trial.
Brief Summary: Background of the study: Manual Therapy applied to patients with non-specific neck pain has been investigated several times, both internationally and nationally. In the Netherlands different types of manual therapy treatment exist. Manual Therapy, as practiced under the Utrecht School, has not been subject of a randomized controlled trial. There is a need to evaluate the effectiveness of this type of manual therapy.

Objective of the study: This trial will investigate the effectiveness of Manual Therapy in the short and long-term up to 52 weeks in patient with (sub) acute (minimal two weeks) and chronic (maximum 52 weeks) since last episode of neck pain. Functional state, pain and global perceived effect are the outcome variables.

Study design: The study is a single blind randomized controlled trial.

Study population: Men and women aged 18 to 70 years old with neck pain for at least two weeks.

Intervention: The experimental group will be treated with manual therapy for a period of six weeks. The control group will be treated with physical therapy (usual care) also for a period of six weeks.

Primary study parameters / outcome of the study: Global Perceived Effect (GPE) and the Neck disability index (NDI-DV ) will be applied.

Secondary study parameters / outcome of the study: Visual Analogue Scale (VAS) for pain and SF36 (Quality of life). The Multidimensional Health Locus of Control(MHLC ), Credibility/Expectancy Questionnaire, Fear Avoidance Beliefs Questionnaire (FABQ-DLV) will also be measured.


Options:
A: Global Perceived Effect (GPE), Neck disability index (NDI-DV ) (0-3-7-13-26-52 weeks)
B: Patient-rated neck and back disability (9 months)
C: N/A
D: Patient-rated pain (0-11 box scale) (short term = 12 weeks; long term = 52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B: a Comparison Between Skin-to-Skin Contact, Glucose 25% and Both of Them
Brief Summary: Acute procedural pain in neonates may be alleviated by non-pharmacological procedures. This study objective is to test the efficacy regarding pain attenuation of 3 interventions (skin-to-skin contact versus glucose 25% versus skin to skin associated to glucose 25) versus control in healthy newborn infants submitted to intra-muscular vaccination for Hepatitis B at 48-72 hours of life.


Options:
A: recovery after inguinal hernia surgery = time to restore normal activities after surgery (one week)
B: Physiological and behavioral parameters were assessed by Brazelton's neonatal behavior assessment scale, and the pain was evaluated by NFCS scale. The mean of Brazelton's scale was reduced after the procedures from 5,88 ± 0.35 to 1,38 ± 0.74, p < 0.001. (At two years)
C: pain response to vaccination with Prevnar and Pentacel, as measured by The Modified Behavioral Pain Scale (MBPS) and the Visual Analogue Scale (VAS) (Immediately after vaccination)
D: Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP) (before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B: a Comparison Between Skin-to-Skin Contact, Glucose 25% and Both of Them
Brief Summary: Acute procedural pain in neonates may be alleviated by non-pharmacological procedures. This study objective is to test the efficacy regarding pain attenuation of 3 interventions (skin-to-skin contact versus glucose 25% versus skin to skin associated to glucose 25) versus control in healthy newborn infants submitted to intra-muscular vaccination for Hepatitis B at 48-72 hours of life.


Options:
A: Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP) (before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection)
B: Premature Infant Pain Profile (PIPP) scale rate (0-21) (15 seconds before and Within 30 seconds after heel lance)
C: - Infant pain score during the newborn screening test, assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP (facial grimace, heart rate, oxygen saturation)
D: The University of Wisconsin Children's Hospital Pain Scale will measure the primary outcome acute behavioral pain response. Measure will be recorded at baseline, immediately after immunizations and 3 minutes following immunizations

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B: a Comparison Between Skin-to-Skin Contact, Glucose 25% and Both of Them
Brief Summary: Acute procedural pain in neonates may be alleviated by non-pharmacological procedures. This study objective is to test the efficacy regarding pain attenuation of 3 interventions (skin-to-skin contact versus glucose 25% versus skin to skin associated to glucose 25) versus control in healthy newborn infants submitted to intra-muscular vaccination for Hepatitis B at 48-72 hours of life.


Options:
A: To measure analgesic effectiveness of the 5 S's (swaddling, side/stomach position, shushing, swinging, and sucking) alone and combined with sucrose, during routine immunizations at 2 and 4 month well child visits. (every 15 sec)
B: Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP) (before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection)
C: recovery after inguinal hernia surgery = time to restore normal activities after surgery (one week)
D: Pain response(Premature Infant Pain Profile (PIPP) (Baseline until completion of heelstick)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study.
Brief Summary: The purpose of this study is to assess the efficacy of add-on therapy with repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of major depressive disorders compared to venlafaxine only (the optimal medication) and to rTMS only.


Options:
A: Subjects self-report of alcohol use, measured by the Timeline Followback (TLFB), and depressive symptoms measured by scores on the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HRSD). (14 weeks)
B: The primary outcome measure is remission. It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)and Montgomery Asberg Depression Rating Scale (MADRS) (2 to 6 weeks)
C: Primary outcomes were MADRS (depression), HAM-A (anxiety), CERAD (cognitive test) and alcohol consumption (time line follow backup).
D: Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17) (From baseline visit to Week 12 (or early discontinuation visit)); Total Drinking Days on the Alcohol Timeline Followback (TLFB) (From Baseline visit to Week 12 (or early discontinuation visit)); Total Drinks Consumed Per Week on the TLFB (From Baseline visit to Week 12 (or early discontinuation visit)); Total Drinks Consumed Per Drinking Day on the TLFB (From Baseline visit to Week 12 (or early discontinuation visit))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of a Stepped-care Approach to Long-term Weight Loss
Brief Summary: The number of overweight and obese adults in the United States is increasing at a rapid rate. A "stepped-care" weight loss program, which at key times increases the frequency of contact between an individual trying to lose weight and the program staff, may be beneficial for achieving long-term weight loss. This study will compare a standard behavioral weight loss program with a "stepped-care" weight loss program in their abilities to help people who are overweight or obese to lose weight.


Options:
A: Weight Loss (Measured at Month 18)
B: 1: Differences in Change in Weight between Groups - Body Weight (kg) (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Weight between Groups - waist circumference (cm) (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Kcal intake (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Weekly minutes moderate or greater intensity activity (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Pressure (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Lipids (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months)
C: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
D: body mass index (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Adolescent Smoking Cessation Programs
Brief Summary: The purpose of this study was to determine if a school-based multi-session group smoking cessation program is more effective than a single session group program.


Options:
A: Self reported quit status (Student identifies self as non-smoker and no smoking for 30 days) (End of program and 1, 3, 6 and 12 months later)
B: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
C: 6-months prolonged smoking abstinence at age 19 and at age 25 (6 months)
D: Abstinence from smoking in the past 30 days at 6 months and 1 year

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate GSK 2115160A in Adults.
Brief Summary: The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.


Options:
A: the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay (21 days after each vaccination)
B: CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection (2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009)
C: Adverse Pregnancy Outcomes (0-28 days postpartum)
D: Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. (At Day 0 and Day 21)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized-Controlled Trial of Transference-Focused Psychotherapy vs. Treatment by Experienced Community Psychotherapists for Borderline Personality Disorder
Brief Summary: The purpose of this study is to find out whether Transference-Focused Psychotherapy (TFP) is effective in the treatment of Borderline Personality Disorder.


Options:
A: Drop-out (1 year); Suicidality (Suicide Attempts) (1 year)
B: Changes in score of Affective Lability Scale (Baseline and then weekly for 12 weeks); Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder (Baseline and then weekly for 12 weeks)
C: assessing change in number of suicide attempts/self-harming acts (baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment)
D: CGI scale for use in borderline personality disorder (CGI-BPD) (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized-Controlled Trial of Transference-Focused Psychotherapy vs. Treatment by Experienced Community Psychotherapists for Borderline Personality Disorder
Brief Summary: The purpose of this study is to find out whether Transference-Focused Psychotherapy (TFP) is effective in the treatment of Borderline Personality Disorder.


Options:
A: Drop-out (1 year); Suicidality (Suicide Attempts) (1 year)
B: N/A
C: Borderline Symptoms (6 weeks)
D: scl-90-R, IIP-C, GAF (before and after therapy,follow-up and every 3 months during therapy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized-Controlled Trial of Transference-Focused Psychotherapy vs. Treatment by Experienced Community Psychotherapists for Borderline Personality Disorder
Brief Summary: The purpose of this study is to find out whether Transference-Focused Psychotherapy (TFP) is effective in the treatment of Borderline Personality Disorder.


Options:
A: Client Satisfaction Questionnaire (Immediately following Brief Intervention)
B: Change in Autonomous and Controlled Motivation (From baseline until 3 months following the completion of the 1-day intervention (i.e., average of 3 months))
C: Drop-out (1 year); Suicidality (Suicide Attempts) (1 year)
D: Change in BPD (Borderline Personality Disorder) behaviors (8-weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized-Controlled Trial of Transference-Focused Psychotherapy vs. Treatment by Experienced Community Psychotherapists for Borderline Personality Disorder
Brief Summary: The purpose of this study is to find out whether Transference-Focused Psychotherapy (TFP) is effective in the treatment of Borderline Personality Disorder.


Options:
A: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
B: Drop-out (1 year); Suicidality (Suicide Attempts) (1 year)
C: Change in the Intensity of Suicidal Ideation Between Intake and End of Treatment (16 weeks (end of treatment)); Change in the Severity of Depression Symptoms Between Intake and End of Treatment (16 weeks (end of treatment))
D: Suicidal behaviour (2-year follow-up); Suicidal behaviour (1-year follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized-Controlled Trial of Transference-Focused Psychotherapy vs. Treatment by Experienced Community Psychotherapists for Borderline Personality Disorder
Brief Summary: The purpose of this study is to find out whether Transference-Focused Psychotherapy (TFP) is effective in the treatment of Borderline Personality Disorder.


Options:
A: Changes in scores on Beck's Scale for Suicide Ideation (BSSI) (From baseline to 6 and 12 months after patient is included in the study)
B: Drop-out (1 year); Suicidality (Suicide Attempts) (1 year)
C: Functioning Assessment Scale Test (FAST) (up to three years)
D: Connor-Davidson's Resilience Scale (CDRISC; Connor and Davidson, 2003) (Up to 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized-Controlled Trial of Transference-Focused Psychotherapy vs. Treatment by Experienced Community Psychotherapists for Borderline Personality Disorder
Brief Summary: The purpose of this study is to find out whether Transference-Focused Psychotherapy (TFP) is effective in the treatment of Borderline Personality Disorder.


Options:
A: Drop-out (1 year); Suicidality (Suicide Attempts) (1 year)
B: Suicidal thoughts or attempts (Measured at Year 2)
C: Suicidal behavior and ideation (Weeks 4, 12, and 24)
D: Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS) (At 2 years after the intervention)

Answer: A