TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention Study to Examine the Effectiveness of Lifestyle Counseling Using the "Stage of Change" Model Versus Conventional Physical Therapy on Chronic Low Back Pain
Brief Summary: Background:

Low back pain is the leading cause of disability, affecting the quality of life and work productivity.

It is the most common reason for seek medical help and advice. Low back pain creates huge economical burden worldwide. To date, most ( 90%) of low back pain cases are not clinically defined with no preferred medical treatment

1. Study objectives:

   To prove that consulting using the "Stage of change" model for daily physical activity will lead to long term improvement of pain, disability and well-being parameters of those suffering from chronic low back pain, people age 25-55, when compared to conventional Physical Therapy.
2. Study hypotheses:

   The intervention groups vs. Physical Therapy group will demonstrate that the following parameters will improve after: 3 months, one, two and five years.
   1. Pain reduction.
   2. Less disability - improvement in daily activities.
   3. Better feeling of health and well-being.
   4. Increased and better compliance to daily sport activities.
   5. BMI reduction.
   6. Reduction of cigarette smoking.
   7. Reduction of usage of anti-analgesics and anti-inflammatory medications.
   8. Reduction in number of visits to Physical Therapy clinics due to low back pain.
3. Methods:

The present Randomized intervention study that will include 220 healthy individuals, males and females aged 25-55 years old suffering from chronic or recurrent low back pain, with or without radiation to the legs that were referred to Maccabi Healthcare Services Physical Therapy clinics in the Sharon district in Israel.

These individuals will be randomized to one of the following two groups:

1. Conventional Physical Therapy.
2. Physical Therapy focused on healthy lifestyle using the "Stage of Change" model.

Non-dependent observer will follow-up on the outcome parameters via phone calls and filling the questionnaire's with the relevant study participants following 3 months, 1 year, 2 and 5 years.


Options:
A: Selfrated function, symptoms and pain-rating (8 weeks, 6 month, 12 month)
B: Muscle activity onset in transversus abdominal muscle (1 year)
C: Change from baseline of Disability using the Roland Morris Disability Questionnaire at 3 months, 1, 2 and 5 years (3 months, 1, 2 and 5 years)
D: Five Times Sit-to-stand (5XSTS) (Change from Baseline sit-to-stand at 3 and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Minor mental health problems, MMHP, like mild depression and anxiety, and medically unexplained symptoms, MUS, symptoms with no known underlying organic disease, are strongly associated to each other. MMHP and MUS have an impact on well-being and quality of life, lead to impaired social and cognitive function and could result in reduced work capacity. The investigators have designed the present study as a pragmatic trial to investigate the effectiveness of an integrative treatment model, therapeutic acupuncture, versus conventional treatment in patients with MMHP or MUS in primary care. The investigators examined whether the effects of the integrative treatment model differed from those achieved with therapeutic acupuncture or conventional treatment. Primary endpoints were anxiety and depression (assessed with the Hospital Anxiety and Depression scale), health-related quality of life (SF-36) and coping with stress, sense of coherence (SOC) during the eight weeks of treatment interventions.

Statistical power was calculated based on an expected 50% reduction in HAD anxiety and depression scores after eight weeks of integrative treatment; a 30% reduction in acupuncture; and 20% in conventional care. A total of 120 (40/arm) were needed to achieve a power of 83% at p \<0.05. Treatment effects were calculated as the difference between values at baseline, after four weeks and after the complete intervention period, i.e. after eight weeks. Nonparametric analyses were carried out to test differences between independent samples (Kruskal-Wallis and Mann-Whitney U) and related samples (Wilcoxon).


Options:
A: HAMD-17, GDS , BI and CGI (28-day (course of treatment))
B: Pre-post treatment change in anxiety as assessed with the Hospital Anxiety and Depression scale (HAD) (Baseline and after eight weeks of treatment completion)
C: Self-rated sleep quality score measured by Insomnia Severity Index questionnaire (Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.); Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy (Baseline, 1-week posttreatment, and 4-week posttreatment.); Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log. (Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.)
D: MDI depression score (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
Brief Summary: The prevalence of maternal overweight and obesity has nearly doubled in the United States since 1976. In 2004-2005, 42% of pregnant women had body mass index (BMI) above 25 versus 23% in 1993. Most American women are overweight/ obese (OW/OB) at conception, especially within certain racial, ethnic, and lower socioeconomic groups leading to increased adverse maternal and birth outcomes. This study will recruit, randomize and test in 300 ethnically diverse OW/OB pregnant women a behavioral intervention aimed at controlling gestational weight gain (GWG) through recommended diet, activity and lifestyle changes that are to be maintained postpartum. Outcomes include anthropometric (height, weight, percent body fat) metabolic (blood pressure, fasting glucose, insulin, HbA1c, lipids and C-reactive protein) and behavioral measures (diet. physical activity, sleep and stress). In addition, babies will be measured for length, weight and percent body fat. The goal is to limit excessive gestational weight gain through improved maternal lifestyle that can be maintained and modelled for the family post partum and beyond.


Options:
A: Gestational Weight Gain (GWG) (14-37 weeks)
B: Gestational weight gain (36 weeks)
C: Gestational Weight Gain (Delivery)
D: Weight gain and nutritional status in mothers (36-40 weeks of gestation); Weight retention (12 months post-partum); Glycaemic control (At 20-24 weeks of pregnancy); Lactation rates (At 12 months post-partum); Initiation and duration of breastfeeding (exclusive and total) (Birth-12 months); Weight, length and BMI growth in infants (During the first year of life); Psychomotor development (based on abbreviated scale) (During the first year of life)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Long Term Follow-Up Study of the Safety and Exploratory Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Brief Summary: This is a long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD.


Options:
A: Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls. (during infusions: first 18 postnatal days)
B: To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner (Longitudinal database currently funded through 3/31/2030)
C: To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner (Longitudinal database currently funded through 3/31/2016)
D: Number of subjects with Adverse Drug Reaction (at corrected age of 21 months (±3 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Sumatriptan on the Postoperative Quality of Recovery After Elective Minimally Invasive Craniotomy
Brief Summary: Postoperative migrainous headache following craniotomy is distressing and may cause significant morbidity and often delay discharge from the hospital. The mechanism of this post craniotomy migraine is multifactorial. Possible causes include the intraoperative loss of cerebrospinal fluid leading to stretching of the dura, traction on intracranial vessels and meningeal irritation. There are two groups of patients who undergo elective minimally invasive craniotomies and yet have considerable postoperative migraine headache postoperatively. These are patients who have a craniotomy for clipping of an unruptured cerebral aneurysm and patients who require a microvascular decompressive craniotomy for cranial nerve pain such as trigeminal neuralgia. Their postoperative migrainous headache often impairs the quality of their recovery and may even delay discharge from hospital. Opioid analgesics are not always effective and may also worsen the postoperative nausea and vomiting and in turn postoperative quality of their recovery. Sumatriptan is a drug that has been used for decades for the treatment of migraine headaches. It acts on 5hydroxytryptophan receptors, which are located in the dura mater (lining of the brain) and are also located around the cranial trigeminal nerve ganglion. Thus sumatriptan may be an effective to improve postoperative migraine , nausea and vomiting and overall quality of recovery. We plan to do a randomized double blind placebo controlled trial on the effect of Sumatriptan for postoperative migraine on the postoperative quality of recovery after elective minimally invasive craniotomies. A total of 92 patients scheduled to undergo minimally invasive craniotomy for either clipping of an unruptured aneurysm or microvascular decompression for cranial nerve neuralgias will be included in this study. Patients within the 2 surgical groups with postoperative migraine will then be block randomized to receive either 6mg of sumatriptan subcutaneously or placebo following assessment in the post operative care unit (PACU). The primary outcome measure will be quality of recovery at 24 hours using Quality of recovery 40 Questionnaire (QoR-40). Our secondary outcome will be postoperative pain, analgesic consumption, side effects and hospital discharge times.


Options:
A: Narcotic Requirement After Surgery (48 hours)
B: Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour) (mean pain score over 48 hours)
C: Morphine consumption in 24 hour period. (24 hours after surgery)
D: Quality of Recovery (24 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis
Brief Summary: The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS


Options:
A: Confirmed Annualized Relapse Rate (up to 12 months)
B: Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24 (24 months)
C: The Number of T1-Gadolinium Enhancing Lesions During Months 7-9 (9 months)
D: Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24. (Part I (Week 24)); Incidence of treatment-emergent adverse events and serious adverse events (Part II (Up to 4.5 years))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis
Brief Summary: The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS


Options:
A: ARR - PDEs (Baseline to Month 36)
B: Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale (Month 12)
C: Confirmed Annualized Relapse Rate (up to 12 months)
D: Number of Participants With Treatment-emergent Adverse Events (AEs) (Up to 72 weeks); Number of Participants With Abnormalities in Vital Signs (Up to Week 72); Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities (Up to 72 Weeks); Number of Participants With Abnormalities in Blood Chemistry Laboratory Data (Up to 72 Weeks); Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline (Up to 72 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Immunogenicity of Three Doses of Bivalent, Trivalent or Type One Monovalent Oral Poliovirus Vaccines Provided at 2 or 4 Week Intervals
Brief Summary: This randomized clinical trial will assess the immune response in infants following administration of three types of oral poliovirus vaccine trivalent OPV (tOPV), monovalent OPV type 1 (mOPV1), bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short schedule with administration at two week intervals and the usual schedule at four week intervals. The results of this study will guide the Global Polio Eradication Program in the implementation of new strategies that may: 1) improve the quality of the response to outbreaks following importation of wild poliovirus type 1 by shortening the interval at which several OPV doses are provided; 2) prevent alternate outbreaks of type 1 and type 3 poliovirus by using bOPV in outbreak responses in countries with weak routine immunization systems; and 3) prevent the emergence of type 2 vaccine-derived poliovirus through the replacement of tOPV with bOPV in immunization campaigns and routine immunization programs.


Options:
A: Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea (Within the 15-day solicited follow-up period after any dose)
B: Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.
C: Immunogenicity (7 months)
D: Percentage of seroconversion (anti-rota serum IgA) in children, after two doses of HRV vaccine versus two doses of placebo.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Immunogenicity of Three Doses of Bivalent, Trivalent or Type One Monovalent Oral Poliovirus Vaccines Provided at 2 or 4 Week Intervals
Brief Summary: This randomized clinical trial will assess the immune response in infants following administration of three types of oral poliovirus vaccine trivalent OPV (tOPV), monovalent OPV type 1 (mOPV1), bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short schedule with administration at two week intervals and the usual schedule at four week intervals. The results of this study will guide the Global Polio Eradication Program in the implementation of new strategies that may: 1) improve the quality of the response to outbreaks following importation of wild poliovirus type 1 by shortening the interval at which several OPV doses are provided; 2) prevent alternate outbreaks of type 1 and type 3 poliovirus by using bOPV in outbreak responses in countries with weak routine immunization systems; and 3) prevent the emergence of type 2 vaccine-derived poliovirus through the replacement of tOPV with bOPV in immunization campaigns and routine immunization programs.


Options:
A: Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml (6, 10, 14 and 18 weeks)
B: Immunogenicity (7 months)
C: Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] (42 days after vaccination 3 (up to 185 days))
D: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains (From Month 1 ½ to Month 21)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Immunogenicity of Three Doses of Bivalent, Trivalent or Type One Monovalent Oral Poliovirus Vaccines Provided at 2 or 4 Week Intervals
Brief Summary: This randomized clinical trial will assess the immune response in infants following administration of three types of oral poliovirus vaccine trivalent OPV (tOPV), monovalent OPV type 1 (mOPV1), bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short schedule with administration at two week intervals and the usual schedule at four week intervals. The results of this study will guide the Global Polio Eradication Program in the implementation of new strategies that may: 1) improve the quality of the response to outbreaks following importation of wild poliovirus type 1 by shortening the interval at which several OPV doses are provided; 2) prevent alternate outbreaks of type 1 and type 3 poliovirus by using bOPV in outbreak responses in countries with weak routine immunization systems; and 3) prevent the emergence of type 2 vaccine-derived poliovirus through the replacement of tOPV with bOPV in immunization campaigns and routine immunization programs.


Options:
A: Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.
B: To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule (up to 7 months)
C: Immunogenicity (7 months)
D: Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®. (14-18 weeks of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Does CMV Reactivation Cause Functional Impairment of CMV Specific CD4+ T-cells? The Potential for Valaciclovir to Prevent CMV-mediated Adverse Modulation of the Immune System in Patients With ANCA-associated Vasculitis
Brief Summary: The purpose of this study is to determine whether Cytomegalovirus (CMV) reactivation in ANCA-associated vasculitis (AAV) patients can be effectively and safely reduced using an antiviral agent (valaciclovir) and whether this in turn improves the function of the immune system thereby also improving the body's ability to fight other infections.

The primary hypothesis is that repeated episodes of CMV reactivation in AAV patients drive the expansion and functional impairment of CMV-specific T-cells, with increased susceptibility to infection. Inhibition of CMV replication with valaciclovir will block further stimulation of CMV specific T-cells and increase the functional capacity of the immune system.


Options:
A: Renal recovery (Three months)
B: Number of major relapse (BVAS>10) in each group at the end of the maintenance treatment (18 months treatment + 10 months follow-up) (28 months)
C: Time to First Relapse (Approximately up to 4 years)
D: Proportion of patients with CMV reactivation and time to CMV reactivation (Over 12 month period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Advanced Mechanical Circulatory Support in Patients With ST Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock. The Danish Cardiogenic Shock Trial
Brief Summary: Cardiogenic shock a serious complication of a heart attack (myocardial infarction). Despite rapid invasive treatment, circulatory support using positive inotropes and mechanical support with intra-aortic balloon counterpulsation (IABP), and evaluation of several new treatments during the last decade, the mortality in patients with cardiogenic shock still exceeds 50%. An alternative to current management is restoration of the volume of blood pumped by the heart (cardiac output) using a ventricular assist device. In the acute setting this is difficult but can be done using the Impella device which is a catheter-based, axial flow pump that pumps blood directly from the left ventricle into the circulation thereby restoring blood flow to the failing organs. In 2012 a more powerful Impella has been introduced that is able to deliver 3.5l/min (approximately 75% of a normal cardiac output). The hypothesis of the current study is to reduce mortality and morbidity of patients with cardiogenic shock using the Impella CP. The study will be carried out as a randomized multicenter study where eligible patients will be randomized to receive conventional circulatory support or support with the Impella device and inotropic support if needed. A total of 360 patients are planned to be enrolled, and the primary endpoint will be death.


Options:
A: Death (up to 6 months)
B: To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size. (3-5 days)
C: Left ventricular ejection fraction (LVEF) on day 30 (30 days)
D: Responder Analysis - Peak Oxygen Uptake (Peak VO2) (Baseline to 6 months); Responder Analysis - Six (6) Minute Walk (6MW) Distance (Baseline to 6 months); Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score (baseline to 6 months); Number of Participant Deaths (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Culturally Targeted and Individually Tailored Smoking Cessation Intervention for LGBT Smokers
Brief Summary: For the approximately 4.6 million LGBT persons in the U.S., smoking rates among those living in urban areas are roughly twice that of heterosexuals. Targeted interventions have shown great promise in reducing health risk behaviors across a variety of behaviors and population groups by enhancing the relevance of the health information. The primary aim of this study is to test the efficacy of a culturally targeted group-based smoking cessation intervention (vs. a non-targeted intervention) on smoking outcomes among lesbian, gay, bisexual, and transgender (LGBT) smokers. The investigators anticipate that the culturally targeted intervention will be more effective at helping LGBT smokers to successfully stop smoking than will the non-targeted intervention.


Options:
A: 7-day point prevalence abstinence from smoking (6 months after enrollment)
B: 7-Day Point Prevalence Abstinence From Smoking for 6 Months (6 months)
C: 7-Day Point Prevalence Smoking Quit Rates 1 Month Post Quit Date (Assessed 1 month after quit date); 7-Day Point Prevalence Smoking Quit Rates 3 Months Post Quit Date (Assessed 3 months after quit date); 7-Day Point Prevalence Smoking Quit Rates 6 Months Post Quit Date (Assessed 6 months after quit date); 7-Day Point Prevalence Smoking Quit Rates 12 Months Post Quit Date (Assessed 12 months after quit date)
D: N/A

Answer: C