cyrilzakka/clinical-trials huggingface dataset:
Postoperative Opt-In Narcotics Treatment in Breast

In a recent study, researchers let patients choose what medications to go home with after endocrine surgery. This has not been done in outpatient breast surgery, though several institutions have moved towards avoiding opioids altogether after breast surgery. These institutions only prescribed rescue opioids upon request.

The aim of this study is to compare a similar "opt-in" protocol for narcotics to usual care (where patients are routinely discharged with opioids) for outpatient breast surgery.

This study will be designed as a randomized, controlled trial. When adult patients consent for outpatient breast surgery, the patients will be asked to participate in the study. Patients who are currently using narcotics would be excluded. The investigators would then randomize participants to the "opt-in" protocol versus being provided with a standard opioid prescription after surgery. Patients in the opt-in protocol will be recommended a pain treatment regimen with over-the-counter medications, acetaminophen or ibuprofen. These patients will be reassured that if their pain is uncontrolled after discharge, a narcotic prescription will be called in to their pharmacy if requested.

The investigators will assess patient pain scores and medication use in the recovery area using the electronic medical record. The investigators will collect data on patient pain scores and medication use after discharge on a daily basis via phone call or electronically transmitted survey. The investigators will also evaluate patients at the time of their follow-up visits. Any patient phone calls will be routed to study personnel who will fill narcotic prescription requests if requested. Finally, among patients who do receive an opioid prescription, the investigators will track their opioid consumption.

Due to the current opioid epidemic, there has been increased focus on the prescribing patterns of physicians and greater incentive to reduce the amount of narcotic pain medication prescribed.

A recent publication in Journal of American Medical Association Surgery conducted by researchers from the same institution found that giving patients the option of choosing to receive a narcotic prescription or not following endocrine surgery significantly reduced opioid prescriptions and waste without increased pain or worse quality of life. No patients called in to request narcotic pain medication after discharge.

Significance:

Given the current health care and political climate, there has been increasing focus on reducing the amount of narcotics prescribed by health care providers. Based on the results of the above cited study, the investigators believe implementing an opt-in program at University of California at Los Angeles will also significantly decrease the amount of opioids prescribed for postoperative pain following outpatient breast surgery as well.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing outpatient breast surgery (less than 24 hour stay)
* Understands written English

Exclusion Criteria:

* Current ongoing opioid use
* Increased complexity of surgery requiring longer hospital stay
Feasibility Study to Develop Sentinel Lymph Node Mapping in Rectal Cancer Patients

The purpose of this study is to see if investigators can develop a technique to identify sentinel lymph nodes in the rectum for rectal cancer patients with the use of a radiotracer (Tc-sulfur colloid), a dye (Spot), and imaging, both pre- and intraoperatively. Eligible patients are those with stage I-III rectal cancer undergoing standard low anterior resection or abdominoperineal resection.

Investigators hypothesize that use of a unique intraoperative lymphatic mapping technique using a mobile gamma camera will identify the sentinel lymph node in patients with rectal cancer with greater than 80% sensitivity.

Subjects will receive injections of the tracer and dye prior to surgery, have preoperative SPECT/CT imaging to be used as a guide to the rectal lymphatic system and then proceed to their scheduled surgery. During surgery, images of the rectum will be taken with a unique mobile gamma camera prior to removal and upon resection.

If surgeons are able to identify the sentinel lymph nodes surrounding the rectal tumor, the hope is to combine this technique with a less invasive surgery called transanal endoscopic microsurgery (TEM) for early stage rectal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with stage I,II, or III rectal cancer undergoing standard trans- abdominal low anterior resection or abdominoperineal resection surgery at the University of Virginia
* Willing and able to give written informed consent

Exclusion Criteria:

* Patients less than 18 years of age
* Women who are pregnant and/or breastfeeding
* Prisoners
* Unable to give written informed consent
* Participants with medical contradictions or have potential problems complying with the requirements of the protocol, in the opinion of the investigator
Retrospective of Children With ADHD and Cardiac Symptoms

There is some evidence suggesting ADHD medication interaction could result in mild myocardial ischemia/infarct.

Children with no previous cardiac history who have been on Adderall for ADHD, have developed acute cardiac symptoms after the addition of Straterra for the treatment of ADHD.

We wish to do a study of the medication interactions of Straterra and other ADHD medications focusing on the cardiac manifestations.

We will collect the following information on each patient: Medical Record Number, Account number, Dates of Admission, Discharge, Treatment or Death, Information Regarding Cardiac Signs and Symptoms, Medication Information, Age, Weight, Diagnoses

Eligibility Criteria:
Inclusion Criteria:

* ADHD
* myocardial ischemia/infarct
* no previous cardiac history
* added Straterra
* already taking Adderall

Exclusion Criteria:

* those who do not meet inclusion criteria
The Influence of Inhaled CorticoSteroids Adherence on Treatment Response to Mepolizumab in Severe Eosinophilic Asthma

The study aim is to look at the effect of the regular use of inhaled corticosteroids on the response and received from mepolizumab treatment which you are receiving or had received before.

Examine the outcomes of 250 patients who have been treated with mepolizumab within BRSAS and compare the adherence to ICS in the responders and non-responder groups. If confirmed that non-adherence to ICS was related to poor response to mepolizumab, steps then will be undertaken to better monitor and enhance adherence to ICS to improve patients outcomes and response to mepolizumab treatment.

This study will rely on retrospective analysis of medically existing data within the service ,the adherence to ICS treatment will be measured using the prescription possession ratio "PPR" Data is available in the patients' GP records and forms part of the routine clinical practice of the severe asthma clinic to monitor adherence to ICS treatment.

For a significant number of patients ,such data will be already available within patient medical records held at University Hospitals Birmingham NHS Foundation Trust (UHB), however missing data is expected and in such cases GP surgeries will be contacted to obtain the PPR. Patients will be asked to agree to access to GP records as part of the informed consent process.

Eligibility Criteria:
Inclusion Criteria:

* Patients of 18 years of age or higher
* Patients commenced on mepolizumab within the BRSAS network
* Patients who have at least 1 mepolizumab injection and with at least 3 months follow-up data from the time of treatment initiation
* Patients must be able and willing to give informed consent to participate in the study . An Interpreter will be provided for those patients where English is not their first language.

Exclusion Criteria:

* Refusal or inability to provide informed consent
The Use of Aging Biomarkers to Predict Adverse Outcomes After Cardiac Surgery

Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI. The development of CSA-AKI is independently associated with an increased risk of in-hospital death. There are currently no biomarkers that could identify patients at higher risk for AKI and current risk predictor scores that are based on clinical and demographic information are inadequate. Therefore, a diagnostic test for predicting AKI risk in this clinical context would assist clinicians to optimize surgical strategy and postoperative care to prevent CSA-AKI occurrence and improve patient outcomes.

The primary purpose of this study is to measure the association between baseline expression of senescence markers in blood using SenesceTest and the occurrence of CSA-AKI post surgery.


Eligibility Criteria:
Inclusion Criteria:

Patients must fulfill all criteria to be eligible for this study:

* Adult patients (\>18 yo) undergoing non-emergency cardiac surgery using cardiopulmonary bypass (CABG, combined CABG/valve, or valve surgery).

Exclusion Criteria:

Patients who fulfill any of the following criteria will be excluded:

* Emergency surgery.
* Off-pump coronary bypass grafting.
* Aortic aneurysm repair.
* Congenital heart disease repair.
* Heart transplant or LVAD patient.
* Severe heart failure (LVEF\<25%).
* Hemodynamic instability or requiring preoperative vasopressors or IABP.
* Pre-existing end-stage kidney disease (eGFR\< 15 mL/min/1.73 m2) or renal transplantation.
* Presence of major active infection (chronic or acute, e.g. sepsis, HIV, pneumonia).
* Chronic liver disease /cirrhosis.
Behaviour of Intravenous Solutions in Obese Patients Under General Anesthesia

There is no objective evidence of how long intravenous solutions remain inside venous blood vessels after they have been administered, therefore there is no definite guideline of how to administer them in the preoperative setting. Besides, obese patients represent a particular group of subjects as they theoretically with-hold a constant inflammatory response and that would modify the way solutions behave intravenously, that is how long they remain inside.

Having said this, we wish to describe the way colloid solutions behave in this group of patients by taking serial blood samples in 12 obese patients after a colloid infusion, to calculate plasma dilution curves based on hemoglobin dilution and therefore infer the time it remains intravascularly.

All this in the hope this information will help, in the near future, to establish a more objective way to use these solutions and avoid possible complications due to over-administration.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of obesity (IMC \>35kg/m2) that will be treated with gastrojejunal laparoscopic bypass

Exclusion Criteria:

* Renal failure KDOQI \>3
* Cardiac failure NYHA III-IV
* Sepsis
* Allergy to tetrastarch
* Allergy to any of the anesthetic medication that is to be used in the protocol previously established
* Patients in which vasoactive drugs are used
* Patients in which the blood samples are completed.
Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed

Subjects with Fibromyalgia who respond to Duloxetine have specific nerve fiber characteristics. This can be used to predict which future patients will respond to Duloxetine.

Subjects will have skin biopsies taken and evaluated for specific pathologies. All subjects will undergo a treatment period with Duloxetine. The analysis will correlate treatment effectiveness with pathological skin biopsy findings to predict future treatment success.

Eligibility Criteria:
Inclusion Criteria: Treatment Arm

* Fibromyalgia Diagnosis
* Female
* Over the age of 18, under the age of 70
* Understands English
* Not Pregnant/planning to become pregnant

Exclusion Criteria:

* No major psychiatric disorders
* No major unconrolled systemic diseases which may require hospitalization in the next 6 months
* Pregnant

Inclusion Criteria: Control Arm

* Female
* Over the age of 18, under the age of 70
* Understands English
* Not Pregnant/planning to become pregnant

Exclusion Criteria: Control Arm

* No major psychiatric disorders
* No major unconrolled systemic diseases which may require hospitalization in the next 6 months
* Pregnant
Muscle Strength and Exercise Capacity in Sarcoidosis Patients

The aim of this study is to examine exercise capacity, muscle strength and fatigue in sarcoidosis. In this longitudinal study the changes in prevalence of exercise intolerance, reduced muscle strength and fatigue will be established in a two-year follow-up. Also the relation between these physical impairments in time and other clinical parameters, such as QOL, will be established.

The aim of this study is to examine exercise capacity, muscle strength and fatigue in sarcoidosis. In this longitudinal study the changes in prevalence of exercise intolerance, reduced muscle strength and fatigue will be established in a two-year follow-up. Also the relation between these physical impairments in time and other clinical parameters, such as QOL, will be established.

Study design: sarcoidosis patients referred to the ild care team of outpatient clinic of the department of Respiratory Medicine of the MUMC and also participated in the baseline study between November 2008 and September 2009 will be included in this longitudinal study. A six-minute walk test and peripheral muscle strength measurements (included in the regular clinical work-up of sarcoidosis patients) will be performed under supervision of a physical therapist at the department of physical therapy of the MUMC. Moreover, the patients will be asked to complete the WHOQOL-bref questionnaire and the Fatigue Assessment Scale. A maximum of 124 patients will be included.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed sarcoidosis according to WASOG/ATS/ERS guidelines

Exclusion Criteria:

* not being able to walk
Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

Using quantitative and qualitative data, this study will assess the impact of community accompaniment with supervised antiretrovirals (CASA) on HIV-positive individuals and community members in Lima, Peru.

Community-based accompaniment with directly observed antiretroviral therapy (DOT-HAART) may improve adherence and clinical outcomes among impoverished individuals starting HAART in resource-poor settings. Furthermore, the utilization of community health workers may build social capital. This is cluster-randomized trial, with randomization at the level of health centers. Individuals in both intervention and control clusters will receive community-based adherence support (monthly adherence visits) and standard care. In addition, individuals residing in intervention clusters will receive 12 months of community-based DOT-HAART. We will enroll patients as well as community members (health providers, treatment supporters, and community health workers) to assess individual and community-level outcomes.

Eligibility Criteria:
Inclusion Criteria for Patient Cohort:

* Age greater than or equal to 18;
* Diagnosis if HIV and meeting criteria for HAART;
* Lives in poverty;
* EITHER: 1) HAART naïve or 2) starting salvage therapy due to virologic failure;
* Documentation of baseline CD4 cell count and HIV load;
* Residence and receipt of HIV healthcare within the study catchment area

Exclusion Criteria for Patient Cohort:

- Imprisoned or cannot give informed consent.

Inclusion Criteria for Community Cohort:

* Working in a health establishments in study region;
* If health personnel, contracted employee caring for people living with HIV/AIDS.

Exclusion Criteria for Community Cohort:

- Cannot give informed consent
SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications

Prospective multi-center single-blinded randomized controlled trial (RCT) investigating the safety and feasibility of the SELUTION SLR™ (Sustained Limus Release) 018 drug eluting balloon (DEB) for the treatment of failed AV fistula in renal dialysis patients. Patients will be randomised to either SELUTION SLR or POBA.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-90 years
* Patient is able and willing to provide written informed consent
* A Dialysis Access that has performed at least 1 successful dialysis session
* Stenosis \>50% at the outflow vein (by visual estimation) with clinical circuit dysfunction
* Lesion of ≤7mm in diameter
* Lesion of up to the 70mm in length

Exclusion Criteria:

* Life expectancy \<1year
* Lower extremity AVG
* Infected AVG
* Uncontrolled systemic infection
* Aneurysm or pseudoaneurysm in proposed target lesion
* Presence of previous CS or BMS
* ≥2 lesions present within the circuit
* Unable to perform protocol prescribed pre-dilation of the lesion
* Patient is female and is pregnant, or planning to become pregnant during the course of the study.
Childhood Adiposity and Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes (CONCEPTT Kids)

This is a follow-up study of children born to mothers who participated in the CONCEPTT Trial. CONCEPTT (a multicentre randomized controlled trial of continuous glucose monitoring (CGM) in women with Type 1 diabetes during pregnancy).

The purpose of this study is to examine the association of maternal glycemic measures on childhood intelligence quotient (IQ), behavioural outcomes, language scores and weight measures. The children of the women who participated in CONCEPTT will be assessed.

The assessments will occur between the children's ages of 3-7 years. The assessment will include obtaining consent and child measurements including weight, height, waist circumference and skinfold thickness (at the triceps, subscapular, flank and quadriceps). Body mass index (BMI) and Waist-Height ratio will be calculated.

The other procedures will include:

1. the Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition (1);
2. ADHD Rating Scale IV (2) and ADHD Rating Scale-IV Preschool Version (3);
3. Social Responsiveness Scale-2 for ASD behaviours (4);
4. Children's performance on the Speed Naming and Phonological Processing subscales of the NEPSY-II (5)
5. Parent reported language development on the Children's Communication Checklist-2 for children over four years of age (6) or the Language Use Inventory (LUI) for children 36 to 47 months of age (7).

Basic demographic questions will be asked regarding the child's mother and father including age, ethnicity, education, occupation, family arrangement, presence of major illnesses, and diabetes complications. Questions regarding maternal diabetes, maternal and paternal family history of diabetes and risk factors for heart disease will be collected at the clinic visit.

Eligibility Criteria:
Inclusion Criteria:

* Children of women who participated in the CONCEPTT trial at selected recruiting sites.

Exclusion Criteria:

* Children (of women who participated in the CONCEPTT trial) with major congenital anomalies will be assessed on a case by case basis to determine eligibility.
The Treatment of Lenalidomide in Patients With POEMS Syndrome

Lenalidomide is a immunomodulatory drug derived from thalidomide, without neurotoxicity. Lenalidomide blocks the increased secretion of interleukin-6, tumor necrosis factor alpha and vascular endothelial growth factor (VEGF). The association with dexamethasone increased Lenalidomide response rate.

More recently the efficacy of Lenalidomide has been reported in a patient with POEMS (POEMS:polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome with improvement of clinical condition and reduction of vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6) level.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of POEMS syndrome based on published diagnostic criteria

Exclusion Criteria:

* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
Validation of a Questionnaire for Allodynia in Migraine.

Migraine is very frequent (15% of the general population). During attacks, many subjects with migraine have allodynia (pain induced by normally non-painful stimuli), photophobia (hypersensitivity to light), phonophobia (hypersensitivity to sound) or osmophobia (hypersensitivity to odours). The goal of the present study is to validate a new questionnaire made of 4 parts evaluating the presence of these 4 types of hypersensitivity, both during or between migraine attacks. It will allow to look for associations of these 4 symptoms and association of hypersensitivity with patients' or migraine's characteristics.

The prevalence of migraine is around 15% worldwide (GBD 2016, Lancet Neurol 2018). During attacks, and even between attacks, especially when migraine frequency is high, many subjects with migraine present with photophobia, phonophobia, osmophobia or allodynia. These symptoms are though to correspond to central sensitization and can be found in animal models of migraine (Boyer et al., Pain 2017; Dallel et al., Cephalalgia 2018).

These 4 symptoms have been studied separately in previous studies but to date, there is no overall questionnaire evaluating these 4 sub-types of hypersensitivity. The investigators have constituted a questionnaire based on previous validated questionnaires that have been translated into French (Lipton et al., 2008 for cutaneous allodynia; Choi et al., 2009 for photophobia), a previous questionnaire validated in French (Khalfa et al, 2002 for phonophobia) and created a few questions for each of the 4 symptoms, including osmophobia.

Eligibility Criteria:
Inclusion Criteria:

* Subjects fulfilling 2018 international headache society criteria for migraine.
* Age \> 17 years.
* Written consent.

Exclusion Criteria:

* Presence of neurological comorbidities that could lead to sensorial or sensitive abnormalities
* Presence of dermatological comorbidities that could lead to sensorial or sensitive abnormalities
* Presence of ENT comorbidities that could lead to sensorial or sensitive abnormalities
* Significant cognitive dysfunction precluding proper completion of the self-administered questionnaire
Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia

The investigators planned to research the effect of vitamin D supplementation as an adjuvant therapy for patients with hypercholesterolemia.

Vitamin D is primarily generated in the skin, in response to direct absorption of ultraviolet B radiation. Vitamin D can also be obtained through fortified foods and oral supplements. Lipid abnormalities are common in the general population, and are regarded as a modifiable risk factor for cardiovascular disease. Recently low vitamin D status has been shown to be associated with increased risk of developing hyperlipidemia. Statins are normally the first-line therapy for hypercholesterolemia. It is also reported that vitamin D can improve serum lipid levels. However, its effects on hypercholesterolemia patients remain unclear. The investigators planned to determine the efficacy of combination therapy with statins and vitamin D in a cohort of hypercholesterolemia patients. This study may shed light as to whether oral vitamin D supplementation can be an adjunct therapy in hypercholesterolemia patients.

Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria were for hypercholesterolemia patients with the treatment of statins.

Exclusion Criteria:

The exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders. Patients were also excluded if they were taking vitamin D3 tablets or other lipid-regulating drugs.