cyrilzakka/clinical-trials huggingface dataset:
Evaluating Motivational Interviewing and Habit Formation to Enhance the Effect of Activity Trackers on Physical Activity

Wearable fitness monitors are increasingly popular but the actual utility of these devices for promoting physical activity behavior is unknown. The purpose is to examine the efficacy of the Fitbit monitor for previously inactive individuals when used alone or following brief training in behavior change strategies and techniques. Psychosocial factors will be assessed and changes in physical activity will be monitored over three months to determine the efficacy of this intervention and to better understand individual differences in effectiveness.

The objective for this pilot study is to determine the efficacy of the Fitbit Charge wearable fitness monitor alone or in combination with additional behavior change strategies for increasing physical activity in inactive adults. A secondary objective is to assess the influence of psychosocial factors (e.g. self-efficacy, self-regulation, habit formation) on the effectiveness of this type of behavior change intervention. The central hypothesis is that use of the Fitbit will increase physical activity from baseline and that adding additional strategies will enhance this effect. This hypothesis is based on previous research demonstrating that continuous self- monitoring (using wearable technology) is effective in promotion of weight-loss in overweight and obese adults. This objective will be addressed through pursuing the following specific aims.

Aim 1: To determine the efficacy of using the Fitbit to increase physical activity behaviors and improve health markers in inactive adults. The working hypothesis is that wearing a Fitbit for 3 months will increase physical activity and improve health markers from baseline to follow-up in inactive adults.

Aim 2: To compare the efficacy of the Fitbit alone to the Fitbit in combination with behavior change strategies for increasing physical activity and improving psychosocial factors in inactive adults. The working hypothesis is that using the Fitbit along with behavior change strategies will lead to greater improvements in physical activity and psychosocial factors (self- motivation, self-regulation, self-efficacy, and social support) than using the Fitbit alone.

Aim 3: To assess the influence of individual differences in psychosocial variables on changes in physical activity over the intervention. The working hypothesis is that higher levels of self- motivation, self-regulation, self-efficacy, and social support at baseline will be predictive of greater improvements in physical activity over the intervention, regardless of group assignment.

Eligibility Criteria:
Inclusion Criteria:

* Not meeting physical activity guidelines

Exclusion Criteria:

* Meeting physical activity guidelines
* Injury or condition that limits mobility
To Evaluate the Efficacy and Safety of JLP-2002 on Symptoms of Overactive Bladder

Overactive bladder (OAB) is a clinical condition characterized by urgency (i.e., urinary urinary urinary urgency that is difficult to delay and unbearable) with or without urge incontinence, usually associated with frequency and nocturia. The main drug class used is antimuscarinics, and the clinical utility of antimuscarinic drugs is limited due to its mild efficacy and poor tolerability due to side effects of mechanisms such as dry mouth and constipation. In addition to poor tolerability and mild efficacy, recent literature suggests that long-term use of anticholinergics is associated with cognitive impairment and dementia. Therefore, the purpose of this study was to evaluate the treatment effect of overactive bladder symptoms through the change in the average number of urination per day after administration of JLP-2002, a beta 3-adrenergic receptor (β3-AR) agonist with an effective alternative mechanism, for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Those who are fully informed of this study and then completely understand its contents, voluntarily decide to participate in this study, and give written consent to follow instructions
2. Males or females aged 19 years or older at the time of written consent
3. Those who have already experienced symptoms of overactive bladder (OAB)\* for 6 months or more at the time of screening
4. Those who are able to read, understand, and write in a voiding diary and a questionnaire
5. Those who are able to go to the toilet on foot without other's help

Exclusion Criteria:

1. Those who have a history of malignancies within 3 years before screening
2. Those who were previously or are currently diagnosed with urinary malignancies (e.g., bladder cancer)
3. Males who were previously or are currently diagnosed with prostate cancer or whose prostate-specific antigen (PSA) level is ≥ 4ng/mL within 1 year before screening or at screening
4. Those with a history of allergy to β-adrenergic receptor agonists, intolerant or clinically significant adverse events, or abnormal clinical laboratory values
5. Pregnant or lactating women
6. Those whose systolic blood pressure (SBP) is ≥160mmHg; diastolic blood pressure (DBP) is ≥100 mmHg; or pulse is ≥110 bpm at the time of screening and randomization
7. Those who received other investigational products or investigational devices within 30 days before screening
8. Those who are determined by the investigator to be not eligible for this study due to clinically significant abnormal findings of screening tests
Mental Health Literacy and Academic Performance

The goal of this clinical trial is to test the effectiveness of an intervention designed to promote mental health literacy in adolescents. The main questions it aims to answer are:

1. Whether this intervention can have an impact on mental health
2. Whether this intervention can have an impact on fostering academic performance, particularly in disadvantaged students (i.e., academic resilience)
3. Whether this intervention will have differential effectiveness as a function of the delivery format (psychoeducational materials only versus blended)

Participants will receive either an online, automated intervention consisting of psychoeducational materials delivered at predetermined intervals (automated), or the same but with the addition of synchronous or asynchronous psychoeducational sessions held by a licensed psychologist (i.e., blended).

These two conditions will also be compared to a Waitlist, to test if the interventions perform better than no treatment.

A Randomized Clinical Trial was designed, involving comparisons at three time-points (pre-intervention, post-intervention, and follow-up) between: (a) Automated delivery of the intervention, (b) Blended format of the intervention, (c) Waitlist (matched control group). Participants will be randomly allocated to one of these three arms, with randomization done at the classroom level.

Appropriate methods for two-level-designs were used to determine sample size requirements for a cRCT with 4 cluster groups (i.e. classrooms) per experimental condition, 22 participants per cluster. For a linear mixed-effects model, a sample size of approximately 88 participants per experimental condition for a total sample size of 264 was sufficient to achieve 80% power to detect an effect size of Cohen's d = 0.4 at an alpha level of 0.05.

Mental health symptomatology (screening items, Attention Deficit/Hyperactivity Disorder (ADHD), depression, anxiety, social anxiety, Posttraumatic Stress Disorder (PTSD), eating disorders), adverse childhood experiences, bullying, social support, mental health stigma, help-seeking, social media engagement, digital addiction, and academic performance will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in High School

Exclusion Criteria:

* Younger than 14 or older than 18
Perforator Artery Changes During Suprafascial Pre-expansion of the Perforator Flaps

Tissue expansion methods have been recommended as a means of improving the clinical results with perforator flaps but in plastic surgery literature there are few clinical trials supporting this opinion. The purposes of this clinical study are to address the ''preexpanded perforator flap concept'' by demonstrating a case series of relevant reconstructive procedures and to evaluate the perforator vessel changes that happen during the expansion periods of various perforator flap donor sites.


Eligibility Criteria:
Inclusion Criteria:

* patients with broad scars and contracture bands
* patients with esophagocutaneous fistula
* patients with ambiguous genitalia

Exclusion Criteria:

* none
Prognostic and Predictive Markers of Treatment Response in Patients With PAC.

The objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy,...) in patients with pancreatic adenocarcinoma. The effectiveness and tolerance of these treatments in current practice is also evaluated.

The modest efficacy of current therapies for pancreatic cancer calls for the development of prognostic factors to guide patient selection and clinical decision-making based on tumor aggressiveness and risk of death.

The aim of this study is to identify prognostic and predictive factors of response to treatments administered in pancreatic adenocarcinoma, based on a multicenter cohort established on a population derived from current clinical practice. By accurately stratifying patients according to their estimated survival, prognostic tools could aid therapeutic decisions and optimize patient selection in future clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically confirmed pancreatic adenocarcinoma.
* Disease at a resectable, borderline, locally advanced, initially metastatic, or recurrent stage after surgery
* Diagnosis between January 1, 2003, and December 31, 2030.
* First-line treatment with chemotherapy and/or radiotherapy and/or clinical trials.
* Age ≥ 18 years.
* Written informed consent

Exclusion Criteria:

* Patient under guardianship, curatorship, or judicial protection.
* Pregnant or breastfeeding women.
* Any medical, psychological, or social situation that could prevent compliance with the protocol as assessed by the investigator.
* Refusal to participate in the study
Individualizing Pharmacotherapy for African American Smokers

Improving cessation outcomes for African American smokers through the use of novel, empirically-based strategies is a national health priority. In the vast majority of smoking cessation studies and in clinical practice, when smokers are provided a medication to help them quit, they are expected to continue that medication regardless of how well it is working. This study will assess whether African Americans smokers respond better if they continue with a single treatment or if their treatment is changed when that treatment is not working.

The objective of this study is to examine the efficacy of optimized (OPT) versus enhanced usual care (UC) treatment for smoking cessation. African American smokers randomized to OPT (n=196) will receive high intensity smoking cessation counseling, nicotine patch (NP), and up to two pharmacotherapy optimizations \[varenicline (VAR), bupropion (BUP) plus NP, \] based on verified smoking status at Weeks 2 and 6. African American smokers randomized to enhanced UC (n=196) will receive the same high intensity counseling and NP with no optimizations in pharmacotherapy. Pharmacotherapy and counseling in both groups will last for 18 weeks with long-term follow-up through Week 26. The primary outcome is biochemically-verified smoking status at Week 12.

Eligibility Criteria:
Inclusion Criteria:

* Non-Hispanic African American
* ≥ 18 years of age
* Smoke 5-30 cigarettes per day (CPD)
* Daily cigarette smoker
* Smoked at current rate for \> 6 months
* Verified smoker (CO \> 5 ppm)
* Functioning telephone
* Interested in quitting smoking
* Willing to take NP, VAR , and/or BUP+NP for 18 weeks and complete all study visits

Exclusion Criteria:

* Use of non-cigarette tobacco products in past 30 days
* Medical contraindications to NP, BUP, or VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; medications contraindicated ; history of clinically significant allergic reactions; history of epilepsy, seizure, head trauma, psychosis, bipolar disorder, eating disorder; unstable panic disorder or depression; active suicidal ideation; treatment for alcohol or drug dependence in the past year
* Use of pharmacotherapy in the month prior to enrollment
* Pregnant, contemplating getting pregnant, or breastfeeding
* Unstable housing (e.g., street, shelter)
* Plans to move from Kansas City during the treatment and follow-up phase
* Another household member enrolled in the study
Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study

To investigate the efficacy of Mindfulness-based Stress Reduction (MBSR),to improve HRQoL, cognition, and mood, as well as to determine the longevity of the treatment response in individuals with Parkinson's disease (PD).

Eligible study participants will be randomly assigned to one of two interventions: 1) Mindfulness Based Stress Reduction for Parkinson's disease; MBSR-PD or 2) Creative Education Care (CEC). Study visits may be held remotely, via online video format (Webex). Interventions are held within a group format consisting of approximately 6-10 individuals with PD. Groups will meet once per week for over a 9-week period. All participants will be administered a battery of neuropsychological tests to measure HRQoL, cognition (e.g., executive function, attention, memory), and mood (i.e., anxiety, depression, and apathy), as well as motor symptoms, disease severity, and mindfulness engagement/practice. Tests will be administered at baseline, 9 weeks (post-treatment), and 6- and 12-months (follow-up assessments) by an examiner blinded to group assignment.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of PD based on UK Brain Bank Criteria
2. \>40 years of age

Exclusion Criteria:

1. Secondary causes of Parkinsonism (e.g. corticobasal degeneration, progressive supranuclear palsy, drug-induced parkinsonism)
2. Other neurological conditions (e.g. stroke)
3. Clinical diagnosis of dementia based on any previous neuropsychological testing
4. Psychosis, antipsychotic treatment or treatment for substance abuse
5. Uncorrected vision or hearing to adequately participate in the intervention
6. Prior formal training in MBSR or regular current MBSR practice
7. Recent or new participation in a psychological/behavioral treatment, such as Cognitive Behavioral Therapy (CBT)
8. Active/current suicidal ideation
Artificial Intelligence Versus Maunal Planning in Robot Assisted Spinal Surgery

The goal of this clinical trial is to learn if the artificial intelligence technology helps to improve the efficiency in robot assited spinal surgery. The main questions it aims to answer are:

Does the AI technology shorter the mannual planning time of screw trajectories？ Does the AI technology affect the surgical accuracy？ Researchers will compare the artificial intelligence technology to the conventional mannual planning in robotic surgery.

Participants who met inclusion criteria and do not have any exclusion criterion will be randomized to artificial intelligence or mannual planning group.

Study design:

multicenter, non-inferiority, open-label, randomized controlled trial in patients undergoing robotic spinal surgery.

Monitoring:

Monitoring of patient's safety and effectiveness data is performed by a designated independent Data Safety and Monitoring Board (DSMB). The DSMB watches over the ethics of conducting the study in accordance with the Declaration of Helsinki.

Sample Size Calculation:

Group size calculation is focused on demonstrating non-inferiority. Assuming that the percentage of clinically acceptable screws would be 90% in the artificial intelligence planning group and 95% in the manual planning group, with a non-inferiority margin of 10% and a one-sided significance level of 2.5%, we calculated that a sample of 79 screws per treatment group would give the trial approximately 95% power to show noninferiority of artificial intelligence planning group to manual planning group with regard to the primary end point.

Eligibility Criteria:
Inclusion Criteria:

* Admission to one of the participating centers；
* Need for and start of robotic spinal surgery
* Patients had complete medical records and imaging data;

Exclusion Criteria:

* Age less than 18 years;
* Patients with severe comorbidities;
* Patients diagnosed with tumor diseases;
* Inability to carry out the intervention (mental of physical conditions that limited participation);
* Patients with morbid obesity (body mass index \> 40);
* Missing medical records and imaging data;
* Patients with suspected or confirmed pregnancy;
* Patients participating in another RCT with the same clinical endpoint, or interventions possibly compromising the primary outcome;
* No informed consent.
Replication Of An Early Evaluation Of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin In The U.S

The overall objective of this proposal is to execute a real-world database analysis to evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (NVAF) patients in the U.S.


Eligibility Criteria:
Inclusion Criteria:

* Have a primary or secondary diagnosis of AF identified by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes from the Cerner Health Facts hospital database between January 1, 2012 and August 31, 2014
* Age 18 years or older as of initial hospitalization with AF diagnosis

Exclusion Criteria:

* Have any primary or secondary diagnosis code or procedure code for valvular disease during the study period. This exclusion criterion is consistent with that used in other previous BMS Health Economics and Outcomes Research (HEOR) studies and is used to ensure that the study populations are NVAF patients
* Received multiple types of NOACs during the index hospitalization. Preliminary analysis showed that very few patients receive multiple types of NOACs during the same hospitalization. This exclusion criterion will allow to cleanly group patients into the different New oral anticoagulant (NOAC) usage groups
Mucosal Innate Immune Activation in Chronic Intestinal Disorders

Crohn's disease and ulcerative colitis are types of chronic intestinal disorder called inflammatory bowel diseases (IBD) that can affect the small and large bowel causing symptoms of abdominal pain, diarrhea, blood in the stool, and weight loss. Irritable bowel syndrome (IBS) is a milder form of IBD, with symptoms of abdominal pain, bloating, diarrhea or constipation, and blood in the stool. It is not known what causes diseases such as IBD and IBS. This study will look at the events in the gut that leads to leaky gut and inflammation in patients with IBD and IBS. The study will also see if medications such as rifaximin and mesalamine may reduce the amount of leaky gut.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18-years old and older
* Presenting at the University of Arkansas for Medical Sciences (UAMS) Endoscopy center to undergo endoscopy with biopsy for surveillance, screening or diagnosis.

Exclusion Criteria:

* Subjects classified in an anesthesia risk group , American Society of Anesthesiologists Class (ASA) ≥ 4,
* history of bleeding diathesis or coagulopathy
* stroke or transient neurological attack within the last 6 months
* pregnancy
* currently on blood thinners (excepting aspirin)
* subject is unable to consent themselves
Does the Fecal Microbiome Influence Rotarix Immunogenicity

This is a proposal for a nested case-control study within an ongoing rotavirus vaccine immunogenicity clinical trial Karachi, Pakistan. The primary study aim is to compare the fecal microbiota composition and diversity of infants who do (control) and do not (case) demonstrate immune seroconversion to rotavirus vaccination. The infants will be matched for vaccination dose, age and breast-feeding practices.


Eligibility Criteria:
Inclusion Criteria:

* 6 weeks 0 days to 7 weeks 6 days age at the time of enrollment.
* Healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study.
* Written informed consent obtained from the parents or guardians.
* Availability of baseline fecal sample collected before Rotarix vaccination
* Written informed consent obtained from the parents or guardians for nested study

Exclusion Criteria:

* Hypersensitivity to any of the vaccine components
* Use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study.
* Use of any immunosuppressive drugs.
* Previous intussusceptions or abdominal surgery.
* Enrollment in any other trial (besides NCT01199874).
* Birth weight less than 1500 grams; or if birth weight is unknown, weight less than 2000 grams on or before 28 days.
* Immunoglobulin and/or blood products use since birth or during the study period. Nested study additional exclusion criteria:
* Positive serum anti-rotavirus Immunoglobulin A (\> 20 U/ml) at 6 weeks of age, indicative of prior rotavirus infection
Assessment of Stability of Mail-in Capillary Hemoglobin A1c Test Kit

The purpose of this study is to determine the stability of capillary HBA1c blood samples collected by the participant with this kit and mailed to the laboratory at Children's Mercy Hospital.

Participants are given home lab kit for obtaining HbA1c by capillary blood and shipping it to Children's Mercy Hospital and Clinics. They will mail in sample before their next visit and this result will be compared to the HbA1c performed during this visit.

Eligibility Criteria:
Inclusion Criteria:

* Male or female diabetic patients ages 1-17 years who have an A1c test drawn within 24 hours
* Participants receiving medical care in the Endocrine Clinic at Children's Mercy Hospital

Exclusion Criteria:

* Not meeting above inclusion criteria
Prostaglandin and Cannabinoid Receptors in EoE

The purpose of this study is to investigate prostaglandin and cannabinoid receptors and their endogenous ligands in eosinophilic esophagitis (EoE). A prostaglandin D2 receptor antagonist has been shown to improve disease symptoms suggesting a regulatory role for bioactive lipids in EoE. Prostaglandin D2 and E2, and endocannabinoids are lipid mediators that govern the functional and inflammatory behavior of immune cells critical for EoE development. The prostaglandin D2 and E2 receptor axis, and the components of the endocannabinoid may be involved in the pathogenesis of EoE.

Prostaglandin D2 and E2 receptors, and components of the endocannabinoid system (cannabinoid receptors and endocannabinoid-metabolizing enzymes) are examined in mucosal esophageal biopsies and blood leukocytes from EoE patients (acute and in remission), individuals with gastroesophageal reflux and from individuals with no esophageal disease. Expression of these components are compared between all cohorts by polymerase chain reaction, Western blots, flow cytometry and immunohistochemical methods. EoE disease activity is evaluated by determining a symptom score and the number of eosinophils per high-power field (hpf) in histologic sections of mucosal biopsies. Additionally, an Endoscopic Reference Score (EREFS) is used. Disease activity is correlated with cannabinoid/prostaglandin D2 and E2 receptor expression. Blood is collected and immediately processed for flow cytometric experiments. Prostaglandins and endocannabinoids are measured in plasma and esophageal mucosal biopsy samples of all cohorts by mass spectrometry.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed or suspected EoE or GERD
* without esophageal diseases
* with signed informed consent

Exclusion Criteria:

* viral or parasitic diseases (e.g. herpes, candidiasis)
* eosinophilic gastroenteritis, hypereosinophilic syndrome, Crohn's disease
* autoimmune diseases
* unable to give informed consent
* immunosuppressive therapy