cyrilzakka/clinical-trials huggingface dataset:
Electronic Medical Record Reminders and Panel Management to Improve Primary Care of Elderly Patients

The investigators conducted a controlled trial to assess the effectiveness of electronic medical record (EMR) reminders, with or without a panel manager, on completion of health care proxy, osteoporosis screening, and influenza and pneumococcal vaccinations for patients age 65 or older. The investigators hypothesized that EMR reminders would improve adherence to practice guidelines and that benefits would be enhanced with the support of a panel manager.


Eligibility Criteria:
Inclusion Criteria:

* All practicing faculty primary care physicians at Beth Israel Deaconess Medical Center General Medicine \& primary care ambulatory clinic

Exclusion Criteria:
Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions

Percutaneous radiofrequency ablation of liver lesions causes patients acute pain during and after the procedure. During the procedure patients need deep sedation and cannot be collaborative. Furthermore post-operative analgesia is necessary. The aim of this study is to evaluate if the ultrasound-guided paravertebral block (TPVB)with a single injection can provide anesthesia and post-operative analgesia in these patients.

The purpose of this study is to evaluate if single injection TPVB, ultrasound guided, ENS assisted, is advantageous compared to deep sedation (DS)in patients undergoing percutaneous radiofrequency ablation of liver lesions with respect to post-operative analgesia (at rest and in movement)and vomiting. Furthermore we collect data on operator and patient satisfaction.

In this study patients are randomly divided into two groups (20 patient each): TPVB and DS. In TPVB group the block is performed in lateral position at level of T7 with bupivacaine 5mg/ml. In DS group the procedure is conducted under local and intravenous anesthesia, and a post-operative analgesia is assigned. Data on patient, on procedures (duration, number and position of lesions etc.), complications with the anesthesiological technique are collected. The intensity of post-operative pain is assessed at 3-6-12 and 24 hours after procedure in both group using VRS pain scale at rest and in movement. Any concomitant event like nausea, vomiting, respiratory complications etc are recorded.

Eligibility Criteria:
Inclusion Criteria:

* written consent ASA I-III

Exclusion Criteria:

* allergy to local anesthetic infection in the site of planned injection
Bilateral Oophorectomy Versus Ovarian Conservation

This is a pilot study to assess the feasibility of conducting a randomized, blinded, controlled trial of bilateral salpingo-oophorectomy (BSO, removal of the ovaries and fallopian tubes) versus ovarian conservation among premenopausal women age 40 years and greater who plan to undergo hysterectomy for a benign gynecologic condition. Subjects will be randomized to BSO or ovarian conservation concomitant with hysterectomy and remain blinded to group assignment. The primary goal of this pilot is to determine the feasibility of recruiting and retaining study participants in anticipation of conducting a larger, multi-centered trial. However, the investigators will also obtain baseline data and follow-up measures at 6 weeks and 6 months after surgery. Outcomes will be assessed in several domains that the investigators hypothesize may be effected by oophorectomy: cardiovascular health, skeletal health, sexual functioning, and health-related quality-of-life.


Eligibility Criteria:
Inclusion Criteria:

1. Plans to undergo hysterectomy for any non-cancerous gynecologic condition, including symptomatic fibroids, abnormal bleeding, pelvic pain, or pelvic organ prolapse. Hysterectomy may be done abdominally, vaginally or laparoscopically
2. Premenopausal defined as having at least one menses in the 3 months prior to surgery
3. Age \> or = 40 years
4. Speaks English or Spanish

Exclusion Criteria:

1. Personal or family history of breast and/or ovarian cancer (at least one first degree relative with a diagnosis of breast or ovarian cancer) or a known BRCA mutation
2. Known or suspected adnexal mass by physical exam or radiologic imaging study
3. Gynecologist recommends BSO for treatment of pelvic pain and/or endometriosis
4. Known history of coronary heart disease defined as any of the following: prior myocardial infarction, history of angioplasty, history of angina, admission to the hospital for evaluation of chest pain, or use of nitroglycerin to treat angina
5. History of stroke
6. History of osteoporosis
Evaluation of SCOUT DS in Subjects With Type 2 Diabetes

The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes.

Previous studies have excluded subjects with Type 2 diabetes. The primary objective of this study is to correct an imbalance in the disease prevalence of the data set used to develop the SCOUT DS diabetes screening algorithm.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years
2. Self-reported diagnosis of type 2 diabetes

Exclusion Criteria:

* Not diagnosed with type 2 diabetes

  * Diagnosed with type 1 diabetes
  * Known to be pregnant (Self Reported)
  * Receiving dialysis or having known renal compromise
  * Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
  * Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation

Recent research reveals intriguing results concerning the role of exogenous lactate and the ketone body 3-hydroxybutyrate (3-OHB) as therapeutic tools to combat obesity and related conditions. Thus, oral administration of lactate and 3-OHB have separately been shown to suppress appetite sensations and slow gastric emptying while administered orally. Both seem to inhibit lipolysis while oral 3-OHB administration have shown direct insulin sensitizing effects. Furthermore, both substrates can be used as fuel for the heart.

The goal of this placebo-controlled randomized crossover design is to test exogenous lactate and the ketone body 3-hydroxybutyrate (3-OHB) in healthy, non-diabetic, obese adults.

The main questions it aims to answer are if chronic administration of LaKe ester affect or improve the following endpoints:

* Insulin sensitivity
* Appetite sensations
* Gastric emptying
* Lipolysis
* Cardiac output
* Left Ventricular Ejection Fraction
* Global Longitudinal Strain and other echocardiographic measures listed below

Participants will ingest a combined lactate and ketone body ester (LaKe ester) or placebo twice a day for 28 days before experimental days.


Eligibility Criteria:
Inclusion Criteria:

* Age between 30-60 years
* BMI range 30-40
* Glycated haemoglobin (HbA1c) \< 48 mmol/mol
* Otherwise 'healthy'
* Written and oral consent

Exclusion Criteria:

* Medication that affect energy or glucose metabolism, eg metformin, insulin or Glucagon-like peptide-1 receptor (GLP-1) agonists
* Specific diets (eg practicing ketogenic diets)
* Cardiac arrhythmias (eg atrial fibrillation)
* Ongoing acute/chronic serious diseases (eg, anemia, chronic kidney or liver disease)
* Inability to understand Danish or English
Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure

The purpose of this study is to evaluate how safe and effective a remote, virtual, cardiology program is that provides heart failure education to patients, monitors for worsening heart failure, and quickly adjusts heart failure medications, compared to usual care medication use and adjustment, in participants with decompensated heart failure that are recently hospitalized.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years of age
* Acute decompensated HF as a primary cause of hospitalization. Hospitalizations for acute decompensated HF will be determined by local clinician-investigators but should include findings of acute HF (i.e., symptoms, signs, and/or laboratory/imaging abnormalities) and treatments aimed at acute HF (e.g., intravenous diuretics, vasodilators, or inotropes). Participants with a new diagnosis of HF may be enrolled. The enrollment will be monitored to ensure no more than 2/3 of the total cohort has new-onset HF.
* Fluent in written and spoken English

Exclusion Criteria:

* Optimized or nearly optimized on evidence-based medical therapies for HF as determined by local investigator
* Current pregnancy
* Chronic use of intravenous inotropic medications including milrinone, dobutamine, or dopamine
* eGFR of \<20 mL/min/1.73m2 ongoing chronic dialysis at screening. The eGFR should be estimated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (2021 CKD-EPI) creatinine equation.
* History of prior heart transplant or currently listed for heart transplant
* Current left ventricular assist device or planned left ventricular assist device in the next 6 months
* Currently receiving hospice care
* Chronically resides in an assisted living or skilled nursing facility where medications are managed by facility personnel
* Terminal illness other than HF with a life expectancy of \<1 year as determined by the enrolling clinician-investigator
Treatment of Peripheral Neuropathy in Patients With Diabetes

The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have type I or type II Diabetes Mellitus.
* Have been clinically diagnosed with neuropathy.
* Have an HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be on insulin therapy.
* Must be 18 years or older.
* Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study.

Exclusion Criteria:

* History of significant liver problems.
* Have poor kidney function.
* Drink an excess of alcohol or abuse drugs.
* Have recently participated in or are currently participating in a Medical study in which you receive an experimental drug.
* Are a woman and are pregnant or breastfeeding, intending to become pregnant within the next 2 years, or are a woman not using an effective method of birth control.
Psychometric Validation of a French-language Version of the PERMA-Profiler: Tools for Assessing Multidimensional Subjective Well-being

The main objective of this study is to carry out the psychometric validation of the PERMA-Profiler in a population representative of the general French population and in comparison with the reference questionnaire The PERMA-Profiler.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years).
* Person able to read and understand French
* Person willing to participate in this study

Exclusion Criteria:

* The person does not understand the French language
* Person has a history of traumatic brain injury
* The person refuses to participate in the study
Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates

The purpose of this study is to demonstrate the effectiveness of oral glucose administration during MRI for imaging of newborns and compare with midazolam sedation.

Motion artefacts affect the quality of MRI and in order to overcome this problem procedures are performed under sedation or general anaesthesia. The safety profile of these methods for newborns is unclear. Alternative non-pharmacological interventions are changeable and might be time consuming. Oral glucose/sucrose administration has been the most frequently studied non-pharmacologic intervention in term and preterm neonates during painful procedures. In this study investigators aimed to compare oral 30% glucose and intravenous midazolam their efficiency on sedation during MRI.

Eligibility Criteria:
Inclusion Criteria:

* Neonates requiring MR imaging for diagnosis

Exclusion Criteria:

* Patients with fever, cold symptoms, suspicion of difficult airway, hypovolemia, cardiac, renal, lung disease, malformations
The Efficacy of Pulsed Dye Laser in Dermatophytosis

The purpose of this study is to determine whether Pulsed Dye Laser therapy are effective in the treatment of Cutaneous Dermatophytosis.

This study was conducted to determine the efficacy of Pulse Dye Laser in skin fungal infection, if this study showed that Laser could be effective, this would be introduced as a new treatment modality.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Positive KOH Smear skin plaques

Exclusion Criteria:

* Tinea Capitis,Onychomycosis
* Pregnancy and feeding
A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (SUI)

This study will evaluate the effectiveness of the pessary device by assessing reduction in urine leakage in approximately 80 women with SUI. Efficacy will be assessed by pad weight gain, frequency of stress urinary incontinence events, and a quality of life questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* be female 18 years or older;
* provide written informed consent prior to study participation and receive a signed copy;
* be in generally good health as determined by the Investigator;
* have a ≥ 3 month history of experiencing SUI (self reported);
* be willing to use the pessary investigational device to control stress urinary incontinence;
* be willing to comply with study requirements and instructions;

Exclusion Criteria:

* pregnant, lactating or planning to become pregnant during the study;
* within 3 months post partum;
* intrauterine device (IUD) placement of less than 6 months;
* has self-reported difficulty emptying her bladder;
* a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS;
* experience difficulty inserting or wearing an intra-vaginal device, including a tampon;
* vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months;
* has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator which could impact the safety of the subject or the outcome of the study;
* for any reason, the Investigator decides that the subject should not participate in the study.
Blood Changes After Exercise in Restless Legs Syndrome

The goal of this clinical trial is to learn how exercise changes molecules in the blood in people with restless legs syndrome (RLS) to better understand the cause(s) of RLS. The main questions the investigators aim to answer are:

How does long-term exercise change proteins in the blood?

How does a single exercise session change proteins in the blood?

The investigators will compare long-term exercise to no exercise to see if the changes in proteins are specific to exercise.

Participants will complete an exercise test and provide blood samples before and after the exercise test. Participants will be randomized (like the flip of a coin) in to either the exercise or no-exercise group for 12 weeks and then complete the exercise test and blood samples again at the end.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older;
* diagnosis of RLS;
* presence of moderate-to-severe RLS (IRLS score\>15);
* currently untreated RLS;
* being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous six months;
* ability to walk without assistance (does not use a cane/walker/wheelchair for mobility;
* willing to complete outcome measures and complete the exercise program

Exclusion Criteria:

* present with a condition that can mimic RLS or cause secondary RLS (e.g., iron deficiency anemia, radiculopathy, peripheral edema, peripheral neuropathy, diabetes);
* are at moderate or high risk for undertaking strenuous or maximal exercise
Diabetic Ketoacidosis: Brain Morphology and Cognition

The purpose of this study is to assess brain and memory changes in patients with uncontrolled diabetes (a condition called diabetic ketoacidosis (DKA))

Diabetic ketoacidosis (DKA) is a common and serious medical problem. Most cases occur when patients forget or stop insulin injections. Some patients require frequent admissions to the hospital with DKA after stopping insulin. Many patients do not know why they stop insulin therapy. The investigators will test if patients with one or more episodes of DKA have poor memory and brain changes that may lead to poor management.

In this study, the investigators will perform memory testing and brain images in subjects with initial DKA episode and subjects with more than 3 episodes of DKA. The results will be compared to subjects with diabetes and no history of DKA and healthy (non-diabetic) subjects. Each subject with DKA will have an MRI and cognitive testing done shortly after hospital discharge, 1 month, and 3 months after hospital discharge. Diabetic subjects without DKA and healthy controls will only come in for a single baseline visit and have a MRI and cognitive testing done.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes with diabetic ketoacidosis (DKA)
* Age 18-50 years
* Newly diagnosed or history of noncompliance with insulin therapy as precipitating cause of DKA
* No significant medical or surgical illness as precipitating cause of DKA

Exclusion Criteria:

* Significant medical/surgical illness as precipitating cause of DKA (i.e. myocardial infarction, major surgery)
* Associated significant medical or surgical condition within 6 months history
* History of hypoglycemia unawareness
* History of seizures, ischemic stroke or hemorrhage, and severe head trauma
* History of symptomatic stenosis of major intracranial vessels
* Dementia (mini-mental state examination (MMSE) score (r ≤ 24) or inability to cooperate)
* Liver or renal failure or transplant
* Severe hypertension (systolic blood pressure (BP) \>160 mm Hg and/or diastolic BP \>100 mm Hg or subjects taking ≥ 2 antihypertensive medications)
* Malignancy
* Current recreational drug or alcohol abuse
* Magnetic resonance imaging (MRI) exclusions: any metal and bio-implants not compatible with 3 Tesla MRI, claustrophobia
Analgesic Effect of Ketamine Vs Ketamine Magnesium Infusion and Their Effect on Postoperative Morphine Consumption

Ketamine and magnesium-ketamine are two analgesics that are being studied for use as adjuvants. They were shown to have anaesthetic and analgesic properties, and as a consequence of this finding, it has been postulated that they may have a role in minimising the requirement for analgesic drugs during the postoperative period. The major objective of the research was to examine the pain-relieving effects of ketamine vs ketamine magnesium infusion, as well as their influence on postoperative morphine consumption following nephrectomy; the secondary goal is to assess hemodynamic effects and pain severity.

Renal necrosis factor (RN) therapy, which includes ipsilateral adrenalectomy, was first utilized to treat renal cortical tumours in 1969. A radical nephrectomy is a surgical surgery in which the whole kidney, as well as the surrounding fat and, in some cases, the adrenal gland and lymph nodes, are removed. This operation is carried out as an inpatient .

Opioid use, on the other hand, can result in considerable side effects and adverse events, which can result in much longer hospital stays and higher postsurgical hospital costs. Although opioid-based analgesia is essential for postoperative pain management, opioid usage may have serious adverse effects .

Finding techniques to limit opioid intake in the postoperative period is essential because cases that got increased opioid dosages are more likely to have the negative effects. Using non-opioid analgesics alongside opioid analgesics, known as analgesia of multi-modes, to enhance post-operative pain management while reducing the usage of the opioids. .

Ketamine, also and magnesium-ketamine are two analgesics wich are non-opioid that are being studied for use like opioid analgesic adjuvants. They were discovered to have anaesthetic and analgesic properties, and it has been proposed that as a result of this discovery, they may have a great contribution in reducing the need for postoperative analgesic medications .

Eligibility Criteria:
Inclusion Criteria:

* Patients with elective nephrectomy

Exclusion Criteria:

* Pregnant women
* Cases with severe chronic disease as liver cell failures, CHF
* cases with allergies to ketamine and magnesium sulphate
* cases with a history of current regular use of (analgesic, anticonvulsant, antidepressant)
* chronic pain.
* mental illness.
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of KP104

The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of KP104 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of KP104 and Part 2, multiple ascending dose (MAD).


Eligibility Criteria:
Inclusion Criteria:

* Weight of \> 40 kilograms (kg) and \< 120 kg at Screening.
* In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, physical examination, 12-lead ECG, clinical laboratory findings, and vital signs at Screening and Check-in.
* Hemoglobin, hematocrit, white blood cell count, absolute neutrophil count, and platelet count results within the normal range at the Screening Visit; participants with Gilbert's disease with associated abnormalities of liver function tests are eligible for enrollment. Tests may be repeated at the discretion of the Investigator to confirm abnormalities.
* Creatinine clearance based on the Cockcroft-Gault equation of \>= 80 milliliters per minute (ml/min).
* Females of childbearing potential and males must practice effective contraception from Screening until 28 days after the end of study (EOS) visit.
* Females of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to dosing of study drug; for post-menopausal subjects, a blood sample will also be tested for follicle stimulating hormone to confirm post-menopausal status.

Exclusion Criteria:

* Any clinically significant underlying illness in the opinion of the Investigator.
* Any history or sign of significant chronic active or recurrent infection, or screening laboratory evidence consistent with a significant chronic active or recurrent infection requiring treatment with antibacterials, antivirals, or antifungals.
* Treatment of any infection with IV (within 30 days of Screening) or oral (within 14 days of Screening) antibacterials, antivirals, or antifungals.
* History of clinically significant hematologic or bone marrow disease or blood dyscrasias.
* History of meningococcal infection.
* History of tuberculosis.
* History of asplenia (functional or anatomical).
* Prior exposure to KP104.
* Known allergy to penicillin antibiotics or history of allergy or contraindication to required prophylactic antibiotic therapy to be used during the study.
* Known or suspected complement deficiency during screening.
* Positive serology for Hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) at Screening.
* History of drug or alcohol abuse within 1 year of Screening in the opinion of the investigator, or a positive test for drugs of abuse or alcohol at Screening or Check-in.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.