TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Depression and/or Anxiety - a Randomized Clinical Trial of the Tree Theme Method® (TTM) as an Intervention
Brief Summary: Depression and anxiety are among our most common diseases and the prevalence is increasing. When suffering from depression or anxiety, the individual's ability to cope with everyday life occupations is decreased, as well as the ability to relate to others. The Tree Theme Method® (TTM) is a treatment method. The purpose is to enhance the ability to develop strategies for occupations in everyday life and relationships with others. The method involves using creative activities to create a life story focusing on everyday occupations and to create an imagination of future possibilities/goals. The TTM is a short-term therapy with five sessions. The treatment also implies that the patient is asked to identify various homework tasks to perform between the sessions.

The aim of the project is to investigate the effects of the TTM compared to a control group for people with depression and anxiety diagnosis. The intention is to examine the effect on outcome measures regarding psychological symptoms, everyday occupations and health. The study has been approved by the Regional Ethical Review Board.

The project is a randomized multicenter study with an intervention group and a control group. A total of 130 patients will be included. Inclusion criteria are patients with depression and/or anxiety in the age of 18-65 years and who have problems with their everyday occupations. Exclusion criteria are individuals with a severe somatic illness or psychosis and/or who have difficulties to understand and fill out self-rating questionnaires.

The project implies that doctors will refer appropriate patients to the occupational therapist. After informed consent each patient will be drawn to the TTM or control. Before and after the treatment, as well as 3 and 12 months after finished treatment the patient will meet a project assistant in order to respond to questionnaires regarding psychological symptoms, everyday occupations and health.

The study is a collaborative project involving the Region Skåne, Kronoberg County Council, and Jönköping County Council. Doctors will recruit patients and occupational therapists will perform the treatment. The research team comprise of researchers from Kronoberg County Council (B Gunnarsson and K Hedin), Lund University (C Håkansson) and School of Health Sciences in Jönköping (P Wagman).


Options:
A: Psychological symptoms (Change from baseline to after treatment (6-9 weeks), 3 and 12 months)
B: Competitive employment or education (24 months)
C: Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation (Baseline and Week 8 or FOT)
D: Labor Market Participation in Ordinary Paid Employment, or Education. (1 year (2016))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Get Quit-Stay Quit Study: a Randomized Trial of Health Risk Feedback and Relapse Prevention for Treatment-seeking Smokers
Brief Summary: Narrative: Tobacco smoking remains the single biggest cause of premature death in the United States and the leading cause of cancer and death from cancer. There is therefore an urgent need to find effective but practical ways of helping smokers to quit and stay quit. This randomized trial aims to evaluate two promising methods of helping smokers to quit and to stay quit.

Design: This is a randomized controlled smoking cessation trial with two stages.

In Stage 1, 225 smokers will be recruited and at assessment they will be randomly allocated to receiving feedback on their "Lung Age" as estimated by their Forced Expiratory volume of air from lungs in one second (FEV1), and exhaled carbon-monoxide (CO) (Intervention group 1) or to have these measured but not fed back in a manner designed to enhance motivation to quit (Control group 1). All participants will be provided with group counseling (6 weekly sessions, with the target Quit Date on the day of the second group meeting), and transdermal nicotine patches.

Main outcome measure: Stage 1, Past week tobacco abstinence biochemically validated by exhaled CO \< 10 ppm at visit 7 (4 weeks after Target Quit Date).

In Stage 2 (starting visit 7), all participants attending visit 7 (28 days after their Target Quit Date), will be randomly allocated to receiving either the Forever Free relapse prevention materials (Intervention 2) http://www.smokefree.gov/pdf.html or the Surgeon General's Guide "How Tobacco Smoke Causes Disease" (Control 2) http://www.cdc.gov/tobacco/data_statistics/sgr/2010/consumer_booklet/index.htm.

All randomized participants will receive a follow-up phone call a week later to remind them to read and use the materials they have been given, and will attend a follow up visit (8), 6 months after their initial Target Quit Date.

Main outcome measure: Stage 2. Among those who have not smoked in the previous week at visit 7, sustained tobacco abstinence (including no tobacco use in prior 7 days), validated by exhaled CO \< 10 ppm at the 6 month visit(8) AND not smoking for any 7 consecutive days during the prior 5 months (definition of a relapse in this study).

Hypothesis: Smokers who are provided with lung age feedback at assessment will have higher quit rates 28 days after the target quit date.


Options:
A: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)
B: Preoperative Carbon Monoxide Levels (the morning of surgery); Exhaled CO Level Measured Immediately Prior to Surgery (The median time from study assessment at POE to surgery was 1 day with an interquartile range of 1 to 3 days.)
C: Number of Participants Reporting no Tobacco Use in the Past 7 Days and Have a Validated CO <10ppm (28 days post quit date); Sustained Tobacco Abstinence (6 months)
D: smoking abstinence: self reported abstinence (12 or more months) (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Effect Size of an Educational Intervention in the Home and Compliance With a Smartphone-based Reminder on People Who Suffer From Stroke: a Protocol Study.
Brief Summary: Background. Cognitive, communication and physical weakness combined with environmental changes frequently cause changes in roles, routines and daily occupations. The educational intervention combines the best choice for teaching new behaviours since it involves the active participation of the patient in learning.

Methods. Design. Randomized clinical trial. Participants. Total sample: 80 adults who have suffered a stroke with moderate severity and who have been discharged to their homes.Outcome variables. BI, FIM, MMSE, CNS, SIS-16, TCT, MRS, MSPSS, QLSF, FRT, RT, TUG, TST, a portable dynamometer and a sociodemographic questionnaire. Data analysis. Descriptive analyses will include mean and 95% CI of the values for each variable. The Kolmogov-Smirnov (KS) test and a 2x2 mixed model ANOVA will be used. Intergroup effect sizes will be calculated (Cohen's d).


Options:
A: The family caregiver's burden of care analyzed by Caregiver Burden Scale (2 months)
B: Barthel Index (Change from Baseline to 2, 4, 12 and 22 weeks)
C: Rate of recruitment to the studies (12 weeks (pilot study))
D: Blood Pressure (6 months and 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Effect Size of an Educational Intervention in the Home and Compliance With a Smartphone-based Reminder on People Who Suffer From Stroke: a Protocol Study.
Brief Summary: Background. Cognitive, communication and physical weakness combined with environmental changes frequently cause changes in roles, routines and daily occupations. The educational intervention combines the best choice for teaching new behaviours since it involves the active participation of the patient in learning.

Methods. Design. Randomized clinical trial. Participants. Total sample: 80 adults who have suffered a stroke with moderate severity and who have been discharged to their homes.Outcome variables. BI, FIM, MMSE, CNS, SIS-16, TCT, MRS, MSPSS, QLSF, FRT, RT, TUG, TST, a portable dynamometer and a sociodemographic questionnaire. Data analysis. Descriptive analyses will include mean and 95% CI of the values for each variable. The Kolmogov-Smirnov (KS) test and a 2x2 mixed model ANOVA will be used. Intergroup effect sizes will be calculated (Cohen's d).


Options:
A: Change scores of Montreal Cognitive Assessment (MoCA) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Memory Scale - Third Edition (WMS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Useful Field of View (UFOV) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop Color-Word test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
B: Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time (Baseline, rehabilitation discharge, month 3, month 6)
C: Barthel Index (Change from Baseline to 2, 4, 12 and 22 weeks)
D: Paced auditory Serial Attention Test (PASAT) (change from baseline after each 3 treatment sessions, change from baseline after 20 hours of training, change from baseline after 6 months and change from baseline after 1 year); Work Ability Index (WAI) (change from baseline after 20 hours of training, change from baseline after 3 months and change from baseline after 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Mindfulness Based Application for Smoking Cessation
Brief Summary: Cigarette smoking is the leading cause of preventable death and disability in the world. Although over 70% of smokers want to quit, fewer than 5% achieve this goal annually. Additional effective, safe, and accessible treatments for nicotine dependence are needed due to the low abstinence rates (20-30%) achieved in behavioral therapies, the unappealing side effects of pharmacotherapy, and the frequent lack of accessibility to treatment. Recent evidence supports the central role of craving in maintaining nicotine dependence, and neither behavioral nor replacement therapies directly target the relationship between cravings and smoking. Mindfulness therapy has been found to be effective in teaching strategies to decouple the association between craving and smoking. Mindfulness based smoking therapy (MT) has preliminary support for reducing consumption in smokers, and Dr. Judson Brewer has recently translated this program into a mobile device application (app) for smoking cessation. With Dr. Brewer's consultation, we propose to assess the feasibility of implementation of a MT mobile application in local hospital and community clinics and the effectiveness of the MT mobile application compared to a National Cancer Institute (NCI) QuitPal behavioral change group. We will examine smoking results at end of treatment and 2 and 6 month follow-up as well as the role of craving. If MT smoking cessation is determined to be effective in a mobile phone application, this finding will be a significant step in providing an additional effective and safe treatment for smokers wishing to quit or cut down on their intake, and will be especially important in providing treatment options for marginalized or hard-to-access individuals wishing to reduce cigarette intake.


Options:
A: Smoking Abstinence Rate (Baseline up to 6 weeks)
B: Change in the maintenance of abstinence from Cessation of tobacco use through assessment interviews (self-report and CO monitor will be used), and the point prevalence (baseline and twelve months)
C: Smoking behavior (6 months)
D: Number of Participants Who Stopped Smoking by 12 Month Post Treatment (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Compare Efficacy of the Angiotensin Converting Enzyme Inhibitor (ACEi) Lisinopril With Angiotensin II Receptor Antagonist Losartan (ARB) for the Cardiomyopathy of Duchenne Muscular Dystrophy
Brief Summary: This trial is a double-blind randomized clinical trial of lisinopril versus losartan for the treatment of cardiomyopathy in Duchenne Muscular Dystrophy (DMD). Both drugs are known to be effective for the treatment of dilated cardiomyopathy. ACEi have been reported to delay the onset and progression of left ventricle dysfunction in children with DMD. Multiple studies show therapeutic efficacy of losartan in animals with cardiomyopathy related to muscular dystrophy and in patients with cardiomyopathy from diverse causes. ARBs are often reserved for patients in whom heart failure is not adequately treated or where side effects preclude the use of an ACEi. However, in DMD, losartan might be a better choice as a first line drug because of studies demonstrating a potential benefit for skeletal muscle in the mdx mouse. Considering that both skeletal and cardiac muscles are major contributors of the disability of DMD, a drug that could improve both heart and skeletal muscles simultaneously would need consideration as the drug of choice for the cardiomyopathic DMD patient.


Options:
A: To assess the efficacy of 2 different dosing regimens of subcutaneous GSK2402968 administered over 24 weeks in ambulant subjects with DMD (48 weeks)
B: Change in the Number (%) of Dystrophin Positive Fibers (After 12 weeks for 4 patients who received 50 mg/kg and 2 patients who received placebo. After 24 weeks for 4 patients who received 30 mg/kg and 2 patients who received placebo.)
C: 12-month Change in Myocardial Strain (baseline and 12 months)
D: Cardiac Ejection Fraction as Measured by Echocardiogram (12 month visit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Smartphone Intervention on Quitting Smoking in a Young Adult Population of Smokers: A Randomized Controlled Trial
Brief Summary: The primary aim of this study will be to determine the effectiveness of a smartphone delivered app for young adult smokers on quitting smoking.


Options:
A: 24-hour Point-prevalence tobacco abstinence (3 months)
B: Smoking Abstinence (12 months); Treatment Utilization for Smoking Cessation (12 months)
C: Change in smoking status and maintenance in smoking cessation (the outcome measure is studied at 6 and 12 months)
D: 30 day point prevalence of abstinence (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Smartphone Intervention on Quitting Smoking in a Young Adult Population of Smokers: A Randomized Controlled Trial
Brief Summary: The primary aim of this study will be to determine the effectiveness of a smartphone delivered app for young adult smokers on quitting smoking.


Options:
A: Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day) (12 weeks); Sustained Abstinence at the 12-week Follow up (12 weeks); Number of Days of Varenicline Use (12 weeks); Number of Active Smoking Cessation Activities Used (12 weeks)
B: 30 day point prevalence of abstinence (6 months)
C: Self-reported 7-day Point Prevalence Abstinence From Smoking That Was Sustained at 60 Days After the Quit Date (60 days after quit date)
D: Carbon Monoxide-verified Continuous Abstinence at 12 Weeks (12-weeks post-quit day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Smartphone Intervention on Quitting Smoking in a Young Adult Population of Smokers: A Randomized Controlled Trial
Brief Summary: The primary aim of this study will be to determine the effectiveness of a smartphone delivered app for young adult smokers on quitting smoking.


Options:
A: smoking abstinence (12 months); smoking abstinence (12 months); smoking abstinence (12 months)
B: The primary outcome will be self-reported and biologically verified continuous smoking abstinence. (Six month)
C: Longest duration of abstinence (Week 24)
D: 30 day point prevalence of abstinence (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Psychological Distress Among Critical Illness Survivors and Their Caregivers
Brief Summary: Patients who receive life support in intensive care units commonly suffer from persistent depression, anxiety, and post-traumatic stress disorder (PTSD) symptoms after discharge. We are trying to learn which is a better way to manage this distress: a telephone-based adaptive coping skills training program or an educational program.


Options:
A: Diagnosis of Post Traumatic Stress Disorder (3 months post critical illness)
B: Quality of Life (12 months)
C: Hospital Anxiety and Depression Scale Score (3 & 6 months post-randomization)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Psychological Distress Among Critical Illness Survivors and Their Caregivers
Brief Summary: Patients who receive life support in intensive care units commonly suffer from persistent depression, anxiety, and post-traumatic stress disorder (PTSD) symptoms after discharge. We are trying to learn which is a better way to manage this distress: a telephone-based adaptive coping skills training program or an educational program.


Options:
A: Diagnosis of Post Traumatic Stress Disorder (3 months post critical illness)
B: PTSD ratings (Measured at Year 1); Substance use (Measured at Year 1); General functioning reports (Measured at Year 1)
C: Hospital Anxiety and Depression Scale Score (3 & 6 months post-randomization)
D: Quality of Life (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Transcranial Direct Current Stimulation Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery
Brief Summary: The aim of this study is to determine whether noninvasive brain stimulation in form of active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) offers an additional benefit as compared with sham tDCS combined with CIMT in patients with stroke. Furthermore the purpose is to highlight changes in GABA activity more than 3 months after stroke and its importance for effect of tDCS and CIMT combined with tDCS.


Options:
A: Motor Function of the Affected Upper Extremity (Change from baseline after 5 days (immediately after intervention)); Motor Function of the Affected Upper Extremity (change from baseline after 3 months)
B: Change in Upper Limb function (Baseline and posttest (an average of 2 weeks from baseline))
C: Jebsen Taylor test (5-15-30 days)
D: Upper Extremity Fugl-Meyer-Assessment (UEFMA) (1-7 days after the end of the intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Transcranial Direct Current Stimulation Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery
Brief Summary: The aim of this study is to determine whether noninvasive brain stimulation in form of active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) offers an additional benefit as compared with sham tDCS combined with CIMT in patients with stroke. Furthermore the purpose is to highlight changes in GABA activity more than 3 months after stroke and its importance for effect of tDCS and CIMT combined with tDCS.


Options:
A: Change from baseline in Upper Extremity Fugl Meyer Assessment (Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks)
B: Upper Extremity Fugl-Meyer-Assessment (UEFMA) (1-7 days after the end of the intervention)
C: Change in Upper Limb function (Baseline and posttest (an average of 2 weeks from baseline))
D: Upper Extremity Fugl-Meyer (2 weeks); Upper Extremity Fugl-Meyer (3 months); Upper Extremity Fugl-Meyer (1 year after stroke)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Endometrial Biopsy on in Vitro Fertilization Pregnancy Rates - a Randomized, Multicenter Study
Brief Summary: Animal and clinical studies have suggested that local tissue trauma can promote the process of an embryo implanting in the uterine cavity. The clinical studies have been performed in patients with a history of previously failed treatments using in vitro fertilization; a process of stimulating many eggs from a women and removing them from the body, to allow fertilisation with sperm to occur in a laboratory setting. The embryos are then replaced into the uterine cavity.

This study questions whether endometrial biopsy (placing a small straw like catheter through the cervix and into the uterine cavity to take a sample of tissue via suction into the bore of the catheter), within 5-10 days of starting a cycle of in vitro fertilization, will improve pregnancy outcome for patients in the first or second cycle of treatment. The hypothesis is that endometrial biopsy will improve pregnancy outcome.

The study is a randomized multicentre study involving 3 Canadian fertility centres.


Options:
A: Rate of clinical pregnancy (5 weeks after the embryo implantation in an IVF procedure)
B: Ongoing pregnancy rate (10-12 weeks gestation)
C: Clinical Pregnancy Rate (Five weeks gestation, as dated from the egg retrieval)
D: Pregnancy Rate (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study: a Prospective Randomised Control Trial(REDIRECT)
Brief Summary: Endovascular therapy is increasingly used for patients with moderate-to-severe acute ischemic stroke.This study will compare the efficacy and safety of RECO(a novel, self-expanding stent retriever) with Solitaire FR within 8 hours of stroke onset caused by the large vessel occlusion.


Options:
A: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
B: To assess whether IA thrombolysis, as compared to IV rt-PA, increases survival free of disability (modified Rankin score of zero or 1) at 3 months. (3 months)
C: 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS). (90 days)
D: Revascularization Status (Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Proton Pump Inhibitors on CF Exacerbations
Brief Summary: Gastroesophageal reflux disease (GERD) is a common problem in cystic fibrosis (CF). It may lead to worsening lung function and more respiratory infections for a person with CF. This study will look at treating GERD with a medication, esomeprazole. The medication stops stomach acid from being made. The study will see if there are fewer respiratory infections and improved lung function in patients with CF when taking esomeprazole.


Options:
A: Change in FEV1 (in liters) from baseline (At the end of the 14 day treatment period); Adverse events such as gastrointestinal complaints, wheezing, hepatitis or shortness of breath (70 weeks)
B: Plasma levels of beta-carotene (12 weeks)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Time to First Pulmonary Exacerbation (36 weeks)

Answer: D