TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Once Daily Indacaterol in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment (after 12 weeks of treatment)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (after 12 weeks)
C: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85) (24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85))
D: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85) (24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome
Brief Summary: The risk of venous thromboembolism increases in pregnancy. Thrombophilia whether genetic or acquired, is a hypercoagulable disorder that may increase the risk of venous thromboembolic events. Clinically, these events are presented as maternal deep vein thrombosis and pulmonary emboli. Thrombophilias are also associated with adverse fetal outcomes including intrauterine growth restriction, intrauterine fetal death, severe preeclampsia, placental abruption and recurrent abortions.

Pregnant women who experienced one or more of the above complications are advised to be examined for the presence of the genetic or the acquired form of thrombophilia.

Low molecular weight heparin prophylaxis, an anticoagulant, is advised for pregnant women with a history of thromboembolism, and many experts recommend prophylaxis for pregnant patients with a known thrombophilia and history of adverse pregnancy outcomes associated with these hypercoagulable states.

Physiologic changes in normal pregnancy, including weight gain, increased renal clearance and volume of distribution, may decrease the availability of low molecular weight heparin (Enoxaparin or Dalteparin), or produce a less predictable response in pregnant women compared with nonpregnant women. There are no clear recommendations for use of prophylactic low molecular weight heparin in pregnancy. Clinicians tend to use doses suggested for nonpregnant patients. Regarding pregnant patients taking enoxaparin or dalteparin, the American College of Obstetricians and Gynecologists states that "because of the lack of data regarding adequate dosing during pregnancy, anti-factor Xa levels may be monitored".

Two recently published studies demonstrated that plasma anti-factor Xa levels during pregnancy were lower than expected, indicating that many pregnant patients may receive a subprophylactic dosing.

Our objective is to check pregnancy outcome among thrombophilic women treated with an adjusted enoxaparin thromboprophylaxis dosage according to anti-factor Xa plasma levels compared to women with fixed dosage.


Options:
A: To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone. (Duration of pregnancy)
B: placental syndrome or thromboembolic event (9 months)
C: Pregnancy continuation beyond twelve weeks gestation (ONE YEAR)
D: Pregnancy outcome (During the treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome
Brief Summary: The risk of venous thromboembolism increases in pregnancy. Thrombophilia whether genetic or acquired, is a hypercoagulable disorder that may increase the risk of venous thromboembolic events. Clinically, these events are presented as maternal deep vein thrombosis and pulmonary emboli. Thrombophilias are also associated with adverse fetal outcomes including intrauterine growth restriction, intrauterine fetal death, severe preeclampsia, placental abruption and recurrent abortions.

Pregnant women who experienced one or more of the above complications are advised to be examined for the presence of the genetic or the acquired form of thrombophilia.

Low molecular weight heparin prophylaxis, an anticoagulant, is advised for pregnant women with a history of thromboembolism, and many experts recommend prophylaxis for pregnant patients with a known thrombophilia and history of adverse pregnancy outcomes associated with these hypercoagulable states.

Physiologic changes in normal pregnancy, including weight gain, increased renal clearance and volume of distribution, may decrease the availability of low molecular weight heparin (Enoxaparin or Dalteparin), or produce a less predictable response in pregnant women compared with nonpregnant women. There are no clear recommendations for use of prophylactic low molecular weight heparin in pregnancy. Clinicians tend to use doses suggested for nonpregnant patients. Regarding pregnant patients taking enoxaparin or dalteparin, the American College of Obstetricians and Gynecologists states that "because of the lack of data regarding adequate dosing during pregnancy, anti-factor Xa levels may be monitored".

Two recently published studies demonstrated that plasma anti-factor Xa levels during pregnancy were lower than expected, indicating that many pregnant patients may receive a subprophylactic dosing.

Our objective is to check pregnancy outcome among thrombophilic women treated with an adjusted enoxaparin thromboprophylaxis dosage according to anti-factor Xa plasma levels compared to women with fixed dosage.


Options:
A: Study Feasibility: Mean Recruitment Rate Per Center Per Month (24 months)
B: Number of steps (48 hours)
C: placental syndrome or thromboembolic event (9 months)
D: Anti Xa Level (3.5-4 hours after the third dose of Lovenox (enoxaparin))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, 12-week, Double-blind, Randomised, Parallel-group, Active-controlled, Multinational, Efficacy and Safety Study of Symbicort® Turbuhaler® 160/4.5 μg 2 Inhalations Twice Daily (Bid) Compared to Oxis® Turbuhaler® 4.5 μg 2 Inhalations Twice Daily (Bid) in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.


Options:
A: First Occurrence of (Moderate or Severe) COPD Exacerbation (52 weeks)
B: Pre-dose Forced Expiratory Volume in One Second (FEV1) (Before randomization, 0, 4, 8 and 12 weeks after randomization)
C: All cause mortality at 3 years
D: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, 12-week, Double-blind, Randomised, Parallel-group, Active-controlled, Multinational, Efficacy and Safety Study of Symbicort® Turbuhaler® 160/4.5 μg 2 Inhalations Twice Daily (Bid) Compared to Oxis® Turbuhaler® 4.5 μg 2 Inhalations Twice Daily (Bid) in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.


Options:
A: Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168 (Baseline (BL) to Day 168); Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169 (Baseline to Day 169)
B: Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168 (Baseline (BL) to Day 168); Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169 (Baseline to Day 169)
C: Post-study medication FEV1 (1 hour after medication)
D: Pre-dose Forced Expiratory Volume in One Second (FEV1) (Before randomization, 0, 4, 8 and 12 weeks after randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, 12-week, Double-blind, Randomised, Parallel-group, Active-controlled, Multinational, Efficacy and Safety Study of Symbicort® Turbuhaler® 160/4.5 μg 2 Inhalations Twice Daily (Bid) Compared to Oxis® Turbuhaler® 4.5 μg 2 Inhalations Twice Daily (Bid) in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.


Options:
A: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
B: Pre-dose Forced Expiratory Volume in One Second (FEV1) (Before randomization, 0, 4, 8 and 12 weeks after randomization)
C: the frequency of exacerbations compared to a control group
D: All cause mortality at 3 years

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluid Lavage of Open Wounds (FLOW): A Multi-Center, Blinded, Factorial Pilot Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures
Brief Summary: The purpose of this trial is to investigate whether irrigation solution (soap vs. saline solution), or irrigation pressure (high vs. low) will decrease the rate of infection among patients with open fracture wounds.


Options:
A: Surgical site infection (30 days)
B: Drainage volume (7 days)
C: changes in acute pain intensity from the baseline (at 2,4,6,12,24,36 and 48 hour postoperatively)
D: The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion). (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label, Randomized Study of the Impact of Diet on Gut Microbiota, Inflammageing and Oxidative Stress in Elderly People. Potential Benefits of Dietary Advices Alone or Associated to Nutraceutical Food Supplements Argan Oil, VSL#3 Probiotic Blend, 5203-L Fruit Extract Terpene. French Part of a Multicentric European Study
Brief Summary: Ageing of the population is a major event in the world. Gerontological/geriatric literature unanimously indicate that physical exercise and diet are at present the two available fundamental approaches to contrast/prevent most of the age associated alterations. In the elderly the inflammageing, the oxidative stress and the alteration of the intestinal microbiota can be influenced by nutritional status and possibly corrected by an appropriate dietetic intervention:

Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve the quality of individual diet for specific needs This study will focus on the development of a specific dietary approach through an E-Health dietary service, associated or not to nutraceutical food supplements intake, to modulate the oxidative stress, inflammageing and gut microflora in the elderly people.


Options:
A: Liver Enzymes(ALT) (7 days after probiotics)
B: The primary beneficial effect parameter is hsPCR (high-sensitivity C-reactive protein) (2 months)
C: High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk) (2 months)
D: Evaluate the effects of VSL#3 on metabolic, endocrine, lipidomic, metabolomic and inflammatory markers and microbiota variation of pediatric patients with BMI>90° (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Postpartum Pelvic Floor Muscle Training in Women With Injured and Non-injured Pelvic Floor Muscles. A Single Blind Randomized Controlled Trial
Brief Summary: Although pregnancy and childbirth are associated with happiness and a positive life change for most women, it can also be considered as risk periods for injuries to the pelvic floor and development of pelvic floor dysfunction. This may leed to devastating loss of function and quality of life (Ashton-Miller \& DeLancey 2007).

The aim of this study is to evaluate the effect of postpartum pelvic floor muscle training for primiparous women with and without pelvic floor muscle injury.


Options:
A: Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire (Week 10-14 gestation (baseline), week 36-39 (after intervention))
B: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)
C: Urinary Incontinence (Prevalence) (6 months postpartum (end of intervention))
D: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Postpartum Pelvic Floor Muscle Training in Women With Injured and Non-injured Pelvic Floor Muscles. A Single Blind Randomized Controlled Trial
Brief Summary: Although pregnancy and childbirth are associated with happiness and a positive life change for most women, it can also be considered as risk periods for injuries to the pelvic floor and development of pelvic floor dysfunction. This may leed to devastating loss of function and quality of life (Ashton-Miller \& DeLancey 2007).

The aim of this study is to evaluate the effect of postpartum pelvic floor muscle training for primiparous women with and without pelvic floor muscle injury.


Options:
A: Placental weight (At delivery); Fetal birth weight (At delivery); Change from baseline in maternal gestational weight (38-42 weeks of gestation)
B: Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity. (Baseline and 3 months)
C: Change in life impact of pelvic floor dysfunction (5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.); Change in symptoms and quality of life (5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.); Change in pelvic floor muscle strength (5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.); Change in pelvic floor muscle characteristics (5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.); Change in pelvic floor muscle strength (5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.)
D: Urinary Incontinence (Prevalence) (6 months postpartum (end of intervention))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Postpartum Pelvic Floor Muscle Training in Women With Injured and Non-injured Pelvic Floor Muscles. A Single Blind Randomized Controlled Trial
Brief Summary: Although pregnancy and childbirth are associated with happiness and a positive life change for most women, it can also be considered as risk periods for injuries to the pelvic floor and development of pelvic floor dysfunction. This may leed to devastating loss of function and quality of life (Ashton-Miller \& DeLancey 2007).

The aim of this study is to evaluate the effect of postpartum pelvic floor muscle training for primiparous women with and without pelvic floor muscle injury.


Options:
A: Maternal gestational weight gain (40-42 weeks)
B: UI reduction (12 months)
C: Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire (Week 10-14 gestation (baseline), week 36-39 (after intervention))
D: Urinary Incontinence (Prevalence) (6 months postpartum (end of intervention))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Multifaceted Intervention on the Preventability of Infections in Residents of French Nursing Homes: Cluster-randomised Controlled Trial (ENLIL Study)
Brief Summary: STUDY HYPOTHESIS : An infection prevention program adapted for the nursing home context can reduce by 5% the number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes.

STUDY DESIGN : The proposal is for an interventional cluster (nursing home) study comprising 2 randomized groups: group 1 (interventional), comprising 25 nursing homes implementing a specific infection prevention program; and group 2 (control), 25 nursing homes continuing to implement their routine prevention measures.


Options:
A: Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes (every month)
B: To test the efficacy of a handwashing promotion intervention for prevention of intrahousehold transmission of influenza virus in a rural setting in Bangladesh (17 months)
C: the incidence rates of influenza infection (Until 3 months gargling)
D: Laboratory-confirmed Influenza Infection (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Multifaceted Intervention on the Preventability of Infections in Residents of French Nursing Homes: Cluster-randomised Controlled Trial (ENLIL Study)
Brief Summary: STUDY HYPOTHESIS : An infection prevention program adapted for the nursing home context can reduce by 5% the number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes.

STUDY DESIGN : The proposal is for an interventional cluster (nursing home) study comprising 2 randomized groups: group 1 (interventional), comprising 25 nursing homes implementing a specific infection prevention program; and group 2 (control), 25 nursing homes continuing to implement their routine prevention measures.


Options:
A: Incidence of Skin and Soft Tissue Infection (SSTI) (At the end of the 20 month study); Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI (At the end of the 20 month study)
B: Protective Effects of N95 Respirators vs Medical Masks (MM) as Assessed by Number of Influenza A and B Events (60 weeks)
C: Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes (every month)
D: Absenteeism rate due to gastrointestinal or respiratory illness during the study period. (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo
Brief Summary: This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.


Options:
A: Change in left ventricular mass (36 weeks)
B: Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment (6 weeks)
C: serum phosphorus (weeks 5-24)
D: Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline (baseline and end of the chewing treatment during three week treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Multicenter, Randomized Controlled Trial of Endovascular Aneurysm Repair Using a Bilateral Percutaneous Approach (PEVAR) vs. Standard Approach (SEVAR) Using the IntuiTrak Endovascular AAA Delivery System and the Prostar XL or Perclose ProGlide Suture-Mediated Closure System
Brief Summary: To determine the safety and effectiveness of PEVAR.


Options:
A: Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. (20 minutes, 1 hour and at discharge, pooled)
B: Time to Hemostasis (TTH) (From when the introducer sheath was removed to the time hemostasis was first observed); Time to Ambulation (TTA) (From when the introducer sheath was removed to 30 days post-procedure); Percentage of Patients Who Experience Any Vascular Closure Related Major Adverse Events During the 30 Days Post-procedure (From post-procedure to 30 days follow up)
C: Composite of arterial access related complications (30 days)
D: Treatment Success as Defined as the Composite of Procedural Technical Success, Absence of Vascular Complications, and Absence of Major Adverse Events as Determined by the Independent Clinical Events Committee (CEC). (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial
Brief Summary: Background:

According to the WHO, major depressive disorder is the second largest healthcare problem worldwide in terms of disability caused by illness. It afflicts an estimated 17% of individuals during their lifetimes at tremendous costs. A number of depressive patients are treated with antidepressant medication. The efficacy of antidepressant medication has been studied in a number of systematic reviews, and in recent years some of these reviews have shown that the efficacy is questionable for many patients. So are there other effective treatments for this serious illness?

Cognitive- and psychodynamic therapies are probably both significantly more effective for depression than no treatment, but only limited comparisons have been made between the two interventions. A Cochrane review shows that cognitive therapy has a preventive effect against recurrent depression, and that this effect may surpass the preventive effect of antidepressant medication. Mindfulness training may be an effective technique in preventing relapse in patients who have had at least 3 previous depressive episodes. But efficacy in treating currently depressed patients has not been studied.

Objective To perform a randomised clinical trial with blinded assessment of efficacy variables in order to study the effects of mindfulness based behavioral therapy (cognitive therapy and mindfulness) versus psychodynamic therapy in depressive patients.

Methods

A randomised clinical trial of 84 consecutive patients diagnosed with major depressive disorder, referred to the day clinic, Roskilde psychiatric services. The patients will be randomised to one of two interventions:

1. MIBT (mindfulness-based behavioural therapy)
2. PT (psychodynamic therapy)


Options:
A: Zanarini Rating Scale for Borderline Personality Disorder (Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up)
B: 17 item Hamilton rating scale for depression (score at the end of 18 weeks of day- treatment) (0 weeks, 18 weeks, and 1 year)
C: Borderline Symptoms (6 weeks)
D: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23). (Baseline and up to 12 months after inclusion.)

Answer: B