cyrilzakka/clinical-trials huggingface dataset:
Pain and Medication Use Following Surgery

Patients will be randomized to one of two interventions intended to facilitate safe disposal of opioids after cessation following surgery. For pragmatic reasons, participants will be randomized by day to either the information sheet or the disposal bag using a block randomization schedule. To ensuring adequate sample size, patients will be enrolled for a \~4-week period following the 2-week usual care run in period. In the event that the sample size estimate has not been reached after the 4-week intervention period, additional patients will be enrolled accordingly.

The lack of evidence-based guidelines for postoperative opioid prescribing has contributed to a surplus of opioid pills within our patients' homes and communities, increasing the potential for diversion and nonmedical use. A recent study suggests that for outpatient general surgery procedures, roughly 72% of prescribed opioids go unused. Current opioid disposal options are limited to DEA-authorized opioid collectors, including select law enforcement agencies, pharmacies, or organized pill drop events, and many patients remain unaware of these avenues. Several studies have found that few patients have knowledge about opioid disposal options and even fewer dispose of their unconsumed opioids.

Unconsumed opioids pose a diversion risk. In the 2011 National Survey on Drug Use and Health, 70.8% of those who used a prescription medication non-medically obtained the medication from a friend or relative, with or without their knowledge. Additionally, nonmedical prescription opioid use is a common pathway to heroin use. Importantly, over 80% of young intravenous drug users report initiation of prescription opioid misuse prior to heroin.

Considering that 40% of the prescriptions written by surgeons are for opioids and patients frequently have excess opioids and limited options for and/or knowledge of opioid disposal, the present study will provide patients with information and novel options for opioid disposal as part of the surgical care pathway.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for surgery at Michigan Medicine's East Ann Arbor Ambulatory Surgery \& Medical Procedures Center

Exclusion Criteria:

* Unable to speak English
* Inability to understand or complete the surveys
* Other conditions that preclude meaningful participation in the study
Serial FLT PET Imaging in Cancer Patients for Monitoring of Response to Therapy

The purpose of this study is to see if PET/CT scans that use a radioactive substance called \[18F\] fluorothymidine (FLT), can detect and monitor changes in the tumor. Radioactive substances are used with PET/CT scans to "see" cancer cells, and are also called radiotracers. FLT is a new radiotracer that has been given to people in prior studies. FLT PET/CT is an experimental scan unlike FDG (fluorodeoxyglucose) PET scan which is a standard clinical scan and is commonly used. The investigators would like to know if there is any evidence of early treatment response by obtaining FLTPET/ CT scans before and after treatment.

This protocol is an "umbrella" or "companion" protocol to be used in conjunction with other protocols that are evaluating treatment response in solid or hematologic malignancies. The aim of this protocol is to determine if PET imaging with the proliferation marker 18FFLT can monitor changes in FLT uptake parameters, in particular changes in the standardized uptake value (SUV), within tumor target lesions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically-confirmed (confirmation done at MSKCC) malignancies.
* Patients who have consented to a therapeutic protocol for the treatment of their cancer.
* Patients must be ≥ 18 years old.

Exclusion Criteria:

* Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia).
* Women who are pregnant or breast-feeding.
Does an Occupational Therapy Program Enhance Mental Health Outcomes for Veterans Who Scuba Dive

The purpose of the study is to investigate whether an occupational therapy program could enhance mental health outcomes for veterans who SCUBA dive. SCUBA diving requires modified breathing techniques and has been found to provide calming effects to individuals who engage in this activity. Occupational therapy interventions such as mindfulness, journaling, and deep breathing techniques can also provide similar calming effects. Therefore, this study will explore whether occupational therapy can provide additional benefits to overall mental health of veterans who SCUBA dive.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 95 years of age
* Participation in WAVES Project for at least 3 months
* Completion of 3 open water dives
* Proficient in written and verbal English

Exclusion Criteria:

* Younger than 18 years of age or older than 95 years of age
* Not a member of WAVES Project within 3 months of study recruitment
* Has not completed 3 open water dives
* Not proficient in written and verbal English
Association Between CytochromeP4501A2 and CytochromeP4502E1 Gene Polymorphisms and Metabolism of Theophylline

The aim of this study is to determine whether common CYP1A2 and CYP2E1 gene polymorphisms effect metabolism of theophylline in chronic obstructive pulmonary disease patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years,COPD patients, male or female;
* regularly visiting our hospital;
* taking a sustained-release preparation of theophylline continuously for at least 2 weeks

Exclusion Criteria:

* patients with renal or hepatic dysfunction;
* patients with congestive heart failure;
* patients with hypothyroidism or hyperthyroidism;
* patients currently taking drugs likely to affect theophylline metabolism or who had taken such drugs in the preceding week;
* patients with extreme obesity
* patients with very severe Chronic Obstructive Pulmonary Disease(COPD)
An International Survey of the Occurrence of Cardiovascular Disease Among Patients With Type 2 Diabetes

The purpose of the study is to register the occurrence of cardiovascular disease among type 2 diabetes patients across ten countries across the world. Participants will be asked to give information about their health. Participants will continue their normal way of life and will not get any medication other than prescribed to them by their doctor. Participants' participation will be one day/one visit at their doctor. The study will last for about 6 months in total.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
* Male or female, age more than or equal to 18 years at the time of signing informed consent (in Algeria more than or equal to 19 years; in Japan more than or equal to 20 years).
* Diagnosed with T2DM more than or equal to 180 days prior to the day of signing the informed consent

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Diagnosed with Type 1 diabetes
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Patients with known congenital heart disease/malformation
NICU Parent Education Program

The purpose of this study is to adminster one of two education programs to parents of preterm infants in the NICU to evaluate language and cognitive outcomes of their infants.

The long term goal of this research is to determine the language environment necessary in the NICU for very preterm infants to optimize their long-term language and cognitive development. This study will pilot an early language intervention with parents of preterm infants in the NICU the purpose of which is to provide a structured curriculum for the family to guide their language interactions with their infant. The aim is to increase the adult word counts and conversational turns in the NICU and to improve Bayley III language and cognitive scores at 12 months and 24 months corrected age.

The hypotheses is that increasing early language exposure in the NICU will result in improved lanugage and cognitive scores. The investigators plan on testing the hypothesis by the following specific aims.

1. Determine the effectiveness of a structured language curriculum with parents of preterm infants in the NICU on increasing the amount of early language exposure.
2. Test the the hypothesis that increased early language exposure will result in higher Bayley III language and cognitive scores.

Eligibility Criteria:
Inclusion Criteria:

* Receiving care at Women \& Infants' Hospital NICU,
* Providence RI gestational age 23 - 32 weeks,
* RI resident

Exclusion Criteria:

* Unable to understand or speak English,
* congenital or chromosomal disorder likely to affect cognitive or speech development,
* parental loss of custody
Cognitive Control of Negative Stimuli in BPD

Borderline personality disorder (BPD) is characterized by impairments in the cognitive control of negative information. These impairments in cognitive control are presumably due to blunted activity of the dorsolateral prefrontal cortex (dlPFC) along with enhanced activations of the limbic system. However, the impact of an excitatory stimulation of the dlPFC still needs to be elucidated. In the present study, we therefore assigned 50 patients with BPD and 50 healthy controls to receive either anodal or sham stimulation of the right dlPFC in a double-blind, randomized, between-subjects design.


Eligibility Criteria:
Inclusion Criteria Borderline Personality Disorder:

* Diagnosis of borderline personality disorder

Exclusion Criteria Borderline Personality Disorder:

* Diagnosis of current or previous bipolar disorder
* Diagnosis of current substance dependency
* Diagnosis of current major depression
* Diagnosis of current or previous neurological disorders (e.g., epilepsy)
* Tattoos or scarred skin on the left shoulder or scalp (i.e. F4)

Inclusion Criteria Control Participants:

* No current or previous diagnosis of a mental disorder

Exclusion Criteria Control Participants:

* More than 2 criteria of borderline personality disorder are met
* Diagnosis of current or previous neurological disorders (e.g., epilepsy)
* Intake of psychotropic medication
* Tattoos or scarred skin on the left shoulder or scalp (i.e. F4)
QuitAid Pilot Feasibility Trial

Adult smokers were recruited through an independent pharmacy in rural Appalachia and were randomized to 1 of 8 treatments, including medication and/or therapy from the pharmacist, to help quit smoking.

24 adult smokers were recruited through an independent pharmacy in rural Appalachia were randomized to 1 of 8 treatments: (1) pharmacist delivered QuitAid intervention (Yes vs. No), (2) Combination NRT Gum + NRT Patch (vs. NRT patch), and/or (3) 8 weeks of NRT (vs. standard 4 weeks). All participants received 4 weeks of NRT patch in addition to the components to which they were assigned. Participants completed baseline and 3-month follow-up assessments. The primary outcomes were feasibility of recruitment and randomization, retention, treatment adherence and fidelity.

Eligibility Criteria:
Inclusion Criteria:

* smokers must have smoked at least 5 cigarettes per day for the past 6 months
* be willing to set a quit date in the next 30 days
* own a cell phone
* be over 18 years of age
* not be pregnant or planning to become pregnant in the next 6 months
* not have any medical contraindications to using NRT

Exclusion Criteria:

* Those who are pregnant or plan to be
* Those under 18 years of age
* Those with a medical contradiction
* Those who do not own a cell phone
* Those who have not smoked 5 cigarettes per day for the last 6 months
* Those who are unwilling to set a quit date within 30 days
CardioMEMS European Monitoring Study for Heart Failure

The purpose of this study is to characterize the use of the CardioMEMS™ HF System when used in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Indicated to receive a CardioMEMS sensor implant per the CardioMEMS™ HF System User's Manual
* ≥ 18 years of age
* Diagnosis of New York Heart Association (NYHA) Class III Heart Failure at the time of sensor implantation
* Hospitalization for worsening HF, as defined in the protocol, within 12 months prior to the CardioMEMS HF System implant
* Subjects with reduced Left Ventricular Ejection Fraction (LVEF) must be on stable Guideline Directed Medical Therapy (GDMT) as tolerated
* Written informed consent obtained from subject

Exclusion Criteria:

* Known coagulation disorders or inability to take two types of blood thinning medications for one month after the sensor is implanted
* Subjects deemed a candidate for transplant, Ventricular Assist Device, or hospice care in the next 12 months or are otherwise not expected to be able to complete the study follow up
Vitamin D Status and Immune Function

The purpose of this study is to examine the relationship between Vitamin D status and immunity.

Vitamin D is mainly obtained from the sun and follows a seasonal pattern, with Vitamin D levels peaking in summer and reaching a trough during winter. Vitamin D deficiency is associated with impaired immunity. However, knowledge of Vitamin D deficiency with in vivo immunity is limited. This observational study aims to investigate the relationship between Vitamin D status and the in vivo immunity.

Eligibility Criteria:
Inclusion Criteria:

* Passed medical assessment by medical doctor
* Passed audio test (this is part of medical assessment)
* Met physical fitness requirements

Exclusion Criteria:

• Medically deferred by medical doctor
Factors Increasing Air Burden in Intravenous Tubing

There is widespread acceptance that air in intravenous (IV) fluid tubing (lines) can pose a significant risk to patients.1 A rigorous literature search regarding sources of this air identified only anecdotal and non-clinical work regarding the presence and sources of air in IV tubing. Most published case studies have focused on air entrainment from accidental or inadvertent sources - empty IV fluid bags, incomplete priming of the tubing prior to infusion, and air-detection device failures, as examples.

The sources (and volume) of air inside IV tubing during common surgical procedures or interventions have yet to be studied prospectively. Understanding the frequency and magnitude of the presence of unintended air in IV tubing is the first step in devising potential avoidance strategies for eliminating unintended air in IV tubing. This study was designed to identify both the sources and magnitude of air that occurs in IV tubing during routine surgical procedures.

Methods:

An observational prospective trial was conducted in operating room settings across multiple study sites. 120 surgical patients undergoing a variety of interventional and surgical procedures were selected, representing multiple patient populations, case types and anesthesia setups. The ClearLine IV, a device that detects and removes air from IV tubing, was inserted into the IV circuit. Clinicians followed standard protocols. Blood warmers were used at the practitioner's discretion. IV fluid was administered at a constant flow rate or through a bolus given over 30-60 seconds per standard of care. The volume and duration of fluid administration was recorded, along with the frequency, duration and amount of air captured by ClearLine IV.

Eligibility Criteria:
Inclusion Criteria:

* Any age - both pediatric and adult
* Weight equal to or greater than 5kg
* Surgical procedures
* Cardiac catherization procedures
* Minimum two hours procedure time

Exclusion Criteria:

* Patient weight less than 5 kg
* Procedures not involving surgery or cardiac catherization
* Procedures less than two hours
A Family-based Primary Care Intervention to Enhance Older Men's Depression Care

Despite the public health importance of clinical depression, more than 50% of depressed adults receive inadequate or no treatment, with even higher rates of under-treatment in men and minorities. Family members and/or friends often assist older adults in their health care and may help overcome barriers to formal care, yet there is a lack of primary care-based interventions that mobilize family members and friends to improve depression treatment. In partnership with a community-based clinic, this research will address this scientific gap by developing and then testing the feasibility and acceptability of a family-based intervention that can be delivered pragmatically in a primary care setting serving large numbers of older minorities.

The family-based intervention will be tested in a 6 month randomized controlled trial of 24 depressed older men-family member dyads (18 intervention and 6 controls). The purpose of the RCT is to test the acceptability of the intervention, as well as the feasibility of the study methods. Patients from the RCT will be identified from a family practice clinic based on their scores on the PHQ-9 as well as additional inclusion and exclusion criteria. Once they and their family member have agreed to participate, patients will be randomized either to the family based intervention or a usual care control condition augmented by family psychoeducation. The investigators will recruit English and Spanish speaking age 60 and above older men from SJGH who have 1) significant depressive symptoms (i.e. PHQ \> 15, 2) have at least one criteria A symptom (depressed mood or anhedonia), 3) depression-related functional impairment) and 4) an adult family member willing to participate in the study. We have chosen a higher cut-off to minimize false positives. We will exclude psychotic, demented or institutionalized men. After enrollment, 24 dyads (i.e. older man and family member) will be randomized one of two groups: intervention or usual care augmented by written psychoeducational materials on depression. Dyads will be randomized to achieve a 2:1 ratio of intervention versus usual care dyads (i.e. 18 intervention and 6 control dyads). To ensure adequate numbers of ethnic minority patients in each arm of the trial, we will conduct a stratified randomization such that each arm of the RCT is 50% English language preferring and 50% Spanish language preferring (i.e. 3 in control and 9 in intervention arm). The research assistant will conduct subject assessment at baseline, 1-month, 3-months and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Men, age 50 and above
* English or Spanish speaking
* Score of \>9 on the PHQ-9
* Non-demented
* Have an adult family member or close friend who can participate

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Bowel Dysfunction After Rectal Cancer Treatment

Bowel dysfunction after rectal cancer treatment may significantly affect the quality of life. Our study aimed to estimate the incidence and characterize the Low Anterior Resection Syndrome(LARS). We performed a prospective evaluation of patients treated with anterior resection for rectal cancer at two hospitals. Assessment was performed at baseline, after neoadjuvant treatment, and 1, 6 and 12 months after bowel transit reconstruction using the following scores: Bristol scale, LARS score, MSK-BFI, FIQL, EORTC-QLQ30 and a visual analogue scale.

Low anterior resection syndrome (LARS) refers to wide-ranging symptoms including evacuatory dysfunction, fecal urgency and incontinence. The assessment of bowel dysfunction after rectal cancer treatment has improved since the development of the LARS score. This score has widely been used with a meta-analysis reporting a pooled prevalence of "major LARS" of 41%. However, several studies have found a large proportion of patients with major LARS in the general population without rectal cancer raising questions about the specificity of this score. Moreover, most studies on the prevalence of LARS do not include a baseline evaluation and, therefore, may not allow establishing whether the dysfunctions appeared after the treatment. Consequently, we considered that a prospective study including a baseline evaluation and multiple validated questionnaires was required. The present study aimed to estimate the incidence and characterize bowel dysfunction after rectal cancer treatment. The results of this study will be useful to improve the preoperative information given to the patient and the shared decision-making process.

Eligibility Criteria:
Inclusion Criteria:

Patients with anterior resection for rectal adenocarcinoma with curative intention, with or without neoadjuvant chemoradiotherapy, total or partial excision of the mesorectum, colorectal or coloanal anastomosis.

Exclusion Criteria:

* disseminated disease
* surgery with palliative intent
* refusal to participate in the study
* intellectual difficulty to answer the questionnaires
Acuity Functional Impact and Implementation Outcomes Evaluation

This study will test feature enhancements to a behavioral therapy data collection software (Motivity) that will add a new clinical decision support module, called Acuity. Acuity is a Quality Improvement (QI) intervention targeted at Behavior Analysts (BAs) and Behavior Technicians (BTs) that aims to improve the delivery of autism behavioral therapy. Subjects will be staff recruited from existing Motivity customers.

Acuity is intended to provide significant improvements in treatment planning, progress tracking, trend monitoring, and dosage management. If successful, Acuity will provide Applied Behavior Analysis (ABA) practitioners with a higher level of real-time insight into their clinical data, enabling more efficient and productive treatment. Research has shown that first-generation systems fall short in supporting overworked BAs who are overwhelmed with data. Acuity will address critical shortfalls by enabling more agile corrective actions and data-driven planning across multiple aspects of treatment, providing practitioners with new levels of rigorous, real-time insight into their clinical data. Acuity will help BAs establish and adhere to realistic treatment timelines, and will proactively alert the BA to noteworthy trends in the data as they occur, such as learner performance issues, missed dosages, and significant changes in tracked behaviors. In doing so, Acuity will support more responsive and effective treatment.

Eligibility Criteria:
Inclusion Criteria:

* Behavior Analysts and Behavior Technicians treating kids with autism
* Must be employed by one of the autism treatment clinics that have agreed to participate in the study.
* Must be employed by Experiad customers who are using Motivity software as part of their practice.

Exclusion Criteria:

* All people not listed above
The Prevalence of Sarcopenia in a Cohort of Haemodialysis Patients and Its Correlation With Mortality

The study aims to explore the correlation between the prevalence of sarcopenia and one year mortality amongst patients on maintenance hemodialysis

In our study , we aim to explore the correlation between the prevalence of sarcopenia and one year mortality among patients on maintenance hemodialysis The lean muscle mass was measured using bio-impedance analysis (BIA ). The hand-grip test was used to measure the function .

Sarcopenia was defined using European Working Group on Sarcopenia in Older people (EWGSOP) definition which involves reduced muscle function and reduced muscle mass

Eligibility Criteria:
Inclusion Criteria:

* Patients with End stage kidney disease on maintenance dialysis

Exclusion Criteria:

* unable to consent or terminal malignancy