cyrilzakka/clinical-trials huggingface dataset:
Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study

Chronic pain (pain that is that is present for a long period of time) is very common among people with spinal cord injury (SCI). Unfortunately, chronic pain is very difficult to treat. Many treatments reduce chronic pain only partially. As a result, many people with SCI must find ways of accomplishing daily activities even though they have pain.

The purpose of this research study is to determine how well two different kinds of education programs reduce the extent to which chronic pain interferes with daily life and well-being.

Pain is a highly prevalent and disabling condition among persons with spinal cord injury (SCI). Unfortunately, current pain treatments offer incomplete relief, produce side effects, and/or involve significant cost. Low-risk, low-cost treatments capable of addressing residual pain and pain-related disability are greatly needed. A number of research studies have associated educational interventions with improvements in pain-related outcomes.

The overall goal of the proposed pilot study is to evaluate the feasibility, acceptability, and potential benefits of two types of educational programs for people with chronic pain and spinal cord injury. This study aims to identify a low-cost, low-risk treatment option that empowers people with pain and SCI to improve their functioning and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury for at least one year
* Chronic pain for at least three months that is moderate to severe (rated at or above 4/10 on a scale of 0 to 10 where 0 = "no pain" and 10 = "pain as bad as you can imagine")
* Fluent in English
* Not currently starting a new pain treatment or changing a previous pain treatment

Exclusion Criteria:

* Cancer or conditions that may worsen over time (such as multiple sclerosis, Parkinson Disease, Alzheimer's disease) and may affect my physical or mental functioning
* Significant difficulties with learning or memory
* Previous participation in a health and function education program specifically designed for people with chronic pain and SCI
* Inability to understand English
* Presence of other conditions not related to SCI that cause pain (such as fibromyalgia)
ACEi ARB Withdrawal in CKD Patients

The American Heart Association guidelines for high blood pressure (BP) currently recommend using angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs) as first-line therapy for patients with chronic kidney disease (CKD) stage 3 or above. However, the prevalence of ACEi and ARB use in patients with CKD stage 4 or 5 is low, and current BP guidelines acknowledge the lack of solid evidence to support the benefit of using these agents in advanced CKD.This study seeks to conduct a pilot trial to determine the safety and feasibility of ACEi and/or ARB continuation (intervention) versus withdrawal (control) in patients with advanced CKD.


Eligibility Criteria:
Inclusion Criteria:

* adults ≥18 years of age who meet the eGFR eligibility criteria, which will be determined based on whether participants have at least two eGFR in the last three months that are \< 25 mL/min/1.73m2 or prior diagnosis of CKD (per electronic chart review) and at least one eGFR \< 25 mL/min/1.73m2 in the past six months
* receiving at least one antihypertensive medication at the time of the screening visit.

Exclusion Criteria:

The investigators will exclude those who:

* are or are planning to become pregnant, due to inability to take multiple classes of anti-hypertensive agents
* are marginally housed, due to concerns regarding routine follow-up
* are actively participating in a different interventional trial that may affect blood pressure
* are unwilling to consent to participate
* institutionalized individuals or prisoners
* are actively abusing illicit drugs or alcohol
* have a history of poor or doubtful compliance (e.g., frequently missed appointments)
* have cognitive impairment prohibiting participation in the study
* on dialysis at time of recruitment
Weight Maintenance With Dipeptidyl Peptidase 4 (DPP4) Inhibitor Sitagliptin in Combination With Metformin After Liragludite Induced Weight Loss

Weight reduction is the most important treatment target in obese women with polycystic ovary syndrome (PCOS), yet it is usually hardly achievable with lifestyle intervention alone. Glucagon-like peptide 1 (GLP-1) receptor agonist (RA) liraglutide was recently approved as an anti-obesity drug but with some limitations, which include high cost and the lack of long-term efficacy and safety data regarding weight reduction. In addition, weight loss achieved with liraglutide is often non-sustainable after treatment cessation. Although DPP-4 inhibitors are weight neutral, they reduced weight regain in animals previously treated with GLP-1 RAs if they were switched to DPP-4 inhibitor rather than placebo. The aim is to evaluate whether DPP-4 inhibitor sitagliptin in combination with metformin reduce body weight regain more effectively than metformin alone in obese PCOS who had been previously treated with liraglutide.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary syndrome (NICHD criteria)
* BMI of 30kg/m2 or higher

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* history of carcinoma
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* personal or family history of multiple endocrine neoplasia type 2
* significant cardiovascular, kidney or hepatic disease
* the use of statins, within 90 days prior to study entry
Patient Worries Previous to Dental Treatment

This is a multicenter cross-sectional study that aims to provide a snapshot of the experience of patients before starting dental treatment.

Although the information is of limited duration, it could represent a descriptive view of a particular context of the dental profession in Spain. This qualitative information on patients' concerns may help the clinician to categorize patients' concerns, facilitate communication, and manage their expectations before initiating treatment.

Patients attending 6 different clinics in Spain consecutively for two years constitute the study sample. Questionnaires will be given to patients who consented to participate in the study, prior to the start of treatment. In addition to the questionnaire, additional demographic data will also be recorded.

The data will be analyzed statistically and appropriate conclusions will be drawn.

Eligibility Criteria:
Inclusion Criteria:

* All patients who are going to receive dental treatment.

Exclusion Criteria:

* None
Medical Students' Evaluation of Dyslipidemia and LIPoprotein(a) Study

This cross-sectional study aims to determine the prevalence of elevated Lp(a) levels among volunteer medical students at the Faculty of Medicine, University Hospital of Ioannina, Greece. Data collected will include demographic information, family and medical history, as well as lifestyle habits, and the study aims to provide valuable insights into the prevalence of elevated Lp(a) among Greek medical students.

Lipoprotein(a) \[Lp(a)\] has emerged as a prevalent monogenetic cardiovascular risk factor globally. Despite its significance, clinical attention for elevated Lp(a) is suboptimal. This cross-sectional study aims to determine the prevalence of elevated Lp(a) levels among volunteer medical students at the Faculty of Medicine, University Hospital of Ioannina, Greece, as well as gather data on the demographic characteristics and medical history of this population. Statistical analysis will assess Lp(a) levels, prevalence, and associations with demographic and cardiovascular risk factors. The study aims to provide valuable insights into the prevalence of elevated Lp(a) among Greek medical students, emphasizing the importance of awareness, early diagnosis, and management of this cardiovascular risk factor.

Eligibility Criteria:
Inclusion Criteria:

* Medical students at the Faculty of Medicine, University Hospital of Ioannina, Greece.

Exclusion Criteria:

* Inability/unwillingness to give informed consent
Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents

The investigators propose to deliver a 4-week sleep extension intervention to adolescents to evaluate feasibility of the protocol and obtain preliminary data on intra-individual changes in metabolic parameters induced by sleep extension.

The specific aims of this feasibility study are to 1) examine the feasibility of recruitment and retention of adolescents with overweight/obesity, pre-diabetes, and inadequate sleep into a sleep extension intervention; 2) assess adherence of a sleep extension intervention to increase total sleep time in adolescents with overweight/obesity, pre-diabetes, and inadequate sleep; 3) determine estimates of mean and variability of potential intervention outcomes including metabolomic, body composition, and substrate oxidation. The investigators propose to deliver a 4-week sleep extension intervention to adolescents to evaluate feasibility of the protocol and obtain preliminary data on intra-individual changes in metabolic parameters induced by sleep extension.

This proposal is the first step to demonstrate feasibility in delivering the intervention in a research setting, measure the effect of the intervention on changing sleep duration, and examine changes in obesity-related IR metabolites that would lead to improved IR in an adolescent population with pre-diabetes. The long-term goal is to disseminate an effective and feasible T2D prevention program that can be sustainably implemented in clinical weight management settings.

Eligibility Criteria:
Inclusion Criteria:

1. High school students between the age of 13-19 years
2. BMI \>85th percentile for age and sex
3. Prediabetes defined as a HbA1c 5.7-6.4%
4. Tanner Stage 4-5 (based on breast development for girls and testicular size for boys)

Exclusion Criteria:

1. Any medications that affect insulin resistance or sleep (e.g., metformin, stimulants, atypical antipsychotics, current use of oral steroids)
2. Regular use of melatonin or other sleep aids
3. A prior diagnosis of a sleep disorder (e.g. insomnia, delayed sleep phase syndrome, obstructive sleep apnea) or abnormal scores on sleep disorders screening measures
4. Type 2 diabetes (HbA1c ≥ 6.5%)
5. IQ\<70 or severe mental illness that may impact sleep or ability to consent/assent (e.g., schizophrenia, psychotic episodes), verified through chart review
6. Teens not enrolled in a traditional high school academic program (e.g., home school students)
7. Schedules that would preclude participants from adhering to the sleep extension protocol (e.g. night shift employment)
8. Travel across more than two time zones in the 2 weeks prior to the study
Peripheral Physiological Measures as Determinants of Pain Risk

This study evaluates peripheral nervous system function using Multiple Excitability Measures (MEM) to obtain "electrophysiological pain phenotypes"

Using MEM for peripheral sensory and motor axons we want to identify a set of excitability measures that:

1. Correlate with parameters of clinical pain and of pain processing in existing pain patients (cross sectional study), with the aim to obtain an objective Pain Biomarker.
2. Predict development of neuropathic pain in susceptible patients (longitudinal study). Neuropathic Pain Predictor for patients:

i. Undergoing surgical procedures associated with a relatively high risk of developing neuropathic pain such as thoracotomy and hernia repair ii. Planning to start chemotherapy with potentially neurotoxic agents such as vincristine

Eligibility Criteria:
Inclusion Criteria:

* Chronic peripheral neuropathic pain
* Painless Patient with risk to develop neuropathic pain (post-surgery, chemotherapy-induced)

Exclusion Criteria:

* Minors
Metformin and Muscle in Insulin-resistant Older Veterans

Sarcopenia is the loss of muscle mass, strength and function with aging and is associated with increased disability, falls and fractures. Older adults with diabetes and prediabetes are insulin resistant and have a higher risk of developing sarcopenia. This study examines the use of metformin, an antidiabetic drug, for preventing the development of sarcopenia in older adults with prediabetes.

The proposed study utilizes clinical and translational research approaches to study sarcopenia. Sarcopenia is common in older adults and is associated with decreased strength, increased disability, falls and fractures. There are currently few interventions to prevent or treat sarcopenia and a poor understanding of the mechanisms for sarcopenia. Given the growing number of Veterans over the age of 65, studies to prevent sarcopenia and resulting disability are important for the health, independence and well-being of this population. The investigators' preliminary studies have shown that older adults with diabetes have an accelerated loss in muscle mass and gait speed, except when treated with metformin. Older adults with prediabetes also have a greater decline in muscle mass and higher incidence of disability. Therefore, this study further investigates these findings by addressing the following aims: (1) to determine whether metformin can prevent the loss in muscle mass and physical performance and (2) to examine changes in muscle histologic characteristics associated with metformin treatment in older adults with prediabetes.

Eligibility Criteria:
Inclusion Criteria:

* The investigators will enroll 120 sedentary, weight-stable, ambulatory Veterans aged 65 years and older with prediabetes identified with fasting glucose values 100 mg/dL or greater but under 126 mg/dL with no use of diabetes medications.
* Participants must demonstrate that they are able to ambulate 400 meters without assistance.

Exclusion Criteria:

* Chronic medical conditions affecting muscle mass or function like active non-skin cancer and hypogonadism
* Medications affecting muscle mass or function like glucocorticoids and androgen/antiandrogens
* Contraindications to metformin such as renal dysfunction defined as creatinine \>= 1.5 mg/dL for men or \>=1.4 mg/dL for women or estimated glomerular filtration rate (eGFR)\<60 mL/min; liver dysfunction defined as alanine aminotransferase (ALT)\>48 U/L, aspart aminotransferase (AST)\>41 U/L or alkaline phosphatase (AlkPhos)\>141 U/L; B12 deficiency defined as B12 level \<180 pg/dL; congestive heart failure; known hypersensitivity to metformin; excessive alcohol intake (average of 2 or more alcoholic beverages/day over a month)

For the muscle biopsy substudy, additional exclusion criteria include:

* Conditions that include bleeding risk such as the use of warfarin, clopidogrel/ticlopidine, aggrenox, dabigatran or anagrelide; laboratory results showing platelets\<150 billion/L or international normalized ratio (INR)\>1.2 or activated partial thromboplastin time (aPTT)\>36 seconds
* Allergy to lidocaine
Microcirculation and Inflammatory Markers in Patients With Resistant, Stages 1/2 Hypertension and Normal Blood Pressure

Nailfold videocapillaroscopy (NVC), Venous occlusion Plethysmography (VOP) and inflammatory biomarkers have been used to study endothelial function in patients with resistant hypertension, stages 1 and 2 hypertension and normotensive. This was a cross-sectional study.

Microcirculation determines peripheral resistance contributing to increased blood pressure. The nailfold videocapillaroscopy (NVC), Venous occlusion Plethysmography (VOP) and biomarkers can be used to evaluate the microcirculation in arterial hypertension (AH). The objective of this study is to analyze the behavior of serum inflammatory markers and study the microcirculation by nailfold videocapillaroscopy (NVC) and Venous Occlusion Plethysmography in patients with resistant hypertension (RH), with stages 1 and 2 hypertension (MMH ) and normotensive (CG). A cross-sectional study with 75 patients has been performed: 25 with resistant hypertension (RH), 25 with stages 1 and 2 hypertension (MMH) and 25 normotensive (CG). All underwent anamnesis, dosage serum markers and conducting NVC, VOP. Hypertensive patients without statin use and with controlled or uncontrolled blood pressure were also analyzed. For the statistical analysis were used: Kruskal -Wallis ANOVA, Dunn test and ANCOVA for correction of confusion factors such as age and BMI.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of controlled High Blood Pressure stages 1 and 2 (blood pressure levels from 140/90 mmHg to 179/109 mmHg) .
* Resistant Hypertension (uncontrolled hypertension, with values ≥140/90 mmHg, using three or more antihypertensive drugs of different classes, including a diuretic, or controlled hypertension with four or more drugs).
* Normal Blood Pressure.

Exclusion Criteria:

* Diabetes Mellitus, Types 1 or 2.
* Heart Failure.
* Myocardial infarction or stroke with less than three months of the event.
* Chronic kidney disease.
* Use of hormonal or non-hormonal anti-inflammatory drugs.
* Recent trauma (less than three months).
* Autoimmune diseases.
* Infectious processes in activity.
* Neoplasia.
* Aspirin use (anti-inflammatory dose).
* Obesity grade III (Body Mass Index\>40 kg/m2).
Impact of Hyperbilirubinemia Among HIV Patients Treated With Atazanavir

The purpose of this study is to determine whether HIV patients on Atazanavir who have Hyperbilirubinemia have different outcomes from those without Hyperbilirubinemia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Human immunodeficiency virus
* Treatment with Atazanavir
* 18 yrs and older
SPECS: Safe Pediatric Euglycemia in Cardiac Surgery

Critically ill children, including children undergoing heart surgery, commonly develop elevated blood glucose (also known as "blood sugar") levels during their illness, which can lead to poor health outcomes and an increased risk of death. This study will examine the effectiveness of maintaining normal blood glucose levels at decreasing infections and improving recovery in young children undergoing heart surgery.

Children undergoing heart surgery are under significant bodily stress, which can lead to higher than normal or lower than normal blood glucose levels. A synthetic form of insulin, a naturally occurring hormone in the body, can be injected into people to normalize blood glucose levels. Insulin is most commonly used to treat people with diabetes, but it is also used in hospitals to control blood glucose levels in patients. Previous studies of adult intensive care unit (ICU) patients have shown that patients whose blood sugar levels are maintained at normal levels with the use of insulin contract fewer infections and are released more quickly from the ICU than patients who do not maintain normal blood glucose levels. This study will use a continuous blood glucose monitoring system to detect changes in blood glucose levels. Intravenous insulin infusions will be used to then safely maintain normal blood glucose levels. The purpose of this study is to determine if maintaining normal blood glucose levels during an ICU stay will help decrease the incidence of infections and improve surgical recovery in young children following heart surgery.

This study will enroll children who are undergoing heart surgery that requires a cardiopulmonary bypass procedure. Participants will be randomly assigned to either a control group or the treatment group. All participants will receive usual care while in the ICU and will undergo continuous glucose monitoring. Participants in the treatment group will receive intravenous insulin infusions to keep their blood glucose within the normal range. While in the ICU, blood will be collected from all participants once a day for the first 3 days and then once a week to monitor glucose levels, hormone levels, and measurements of nutrition and immune function. On days 1 and 5 following surgery, participants who are on a ventilator will have their breath measured to monitor heart function and energy use. Thirty days and 1 year following surgery, study researchers will contact the participant's parent or doctor to collect information on health status and any new infections at the surgical site. Children who enroll in the study will be asked to participate in follow-up neurodevelopmental evaluations at 1 and 3 years of age to assess longer term cognitive effects of tight glycemic control in the ICU.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing heart surgery with cardiopulmonary bypass
* Recovering in the Cardiac ICU

Exclusion Criteria:

* Enrolled in another interventional clinical trial with related study outcomes
Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis

The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with generalized Myasthenia Gravis (gMG). Subjects will be randomized in a 1:1:1 ratio to receive daily SC doses of 0.1 mg/kg RA101495, 0.3 mg/kg RA101495, or matching placebo for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of gMG \[Myasthenia Gravis Foundation of America (MGFA) Class II-IVa\] at Screening
* Positive serology for acetylcholine receptor (AChR) autoantibodies
* QMG score ≥ 12 at Screening and Randomization
* No change in corticosteroid dose for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period
* No change in immunosuppressive therapy, including dose, for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period

Exclusion Criteria:

* Thymectomy within 6 months prior to Randomization or scheduled to occur during the 12 week Treatment Period
* History of meningococcal disease
* Current or recent systemic infection within 2 weeks prior to Randomization or infection requiring intravenous (IV) antibiotics within 4 weeks prior to Randomization
Open Label Phase III Duloxetine Study for Stress Urinary Incontinence

The purpose of this study is to monitor the long term safety of duloxetine in the treatment of stress urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Female out patients
* Are ambulatory and are able to use a toilet independently and without difficulty.

Exclusion Criteria:

* Use of monoamine oxidase inhibitors (MAOIs)