cyrilzakka/clinical-trials huggingface dataset:
Familial Hypercholesterolemia Amongst Patients With Acute Coronary Syndrome

Familial hypercholesterolemia (FH) is a most prevalent genetic disorder, defines as high cholesterol level and premature death. The prevalence of FH has been reported in few countries however unknown in Iran. Thus recognize the FH patients, determine the diagnostic strategies and appropriate treatments are important.

Also acute coronary syndrome (ACS) is a group of conditions which arises from reduction of blood flow in coronary arteries. Three specific conditions are included: ST elevation myocardial infarction, non ST elevation myocardial infarction and unstable angina. Premature ACS defined by occurrence of ACS\<55 for men and ACS\<60 for women. Studies demonstrated direct connection between familial hypercholesterolemia and occurrence of premature ACS. Investigators intent to detection of FH amongst patients with acute coronary syndrome.

Familial hypercholesterolemia (FH) is a genetic disorder, defines as high cholesterol levels, particularly very high levels of low-density lipoprotein (LDL), in the blood and early cardiovascular events and premature death. FH is an autosomal dominant disease with a prevalence of 1:500 (new study in Netherlands demonstrated 1:244) in population more frequent than Cystic fibrosis, mellitus diabetes or neonatal hypothyroidism. Canadian registry demonstrated FH is more common among some specific population such as French Canadian, Christian Lebanese, and Afrikaner descent. The Major causes of FH are pathogenic variant in the LDL-receptor (LDLR) gene or the Apo lipoprotein B (APOB) gene. The clinical signs of FH are high level of Cholesterol (between 350-550 mg/dL in heterozygous), Yellow deposits of cholesterol-rich fat in various places on the body such as around the eyelids (known as xanthelasma palpebrarum), the outer margin of the iris (known as arcus senilis corneae), and in the tendons of the hands, elbows, knees and feet, particularly the Achilles tendon (known as a tendon xanthoma).FH is a hidden syndrome which leads to cardiovascular disease.

Acute coronary syndrome is a term used to describe a range of conditions associated with sudden, reduced blood flow to the heart.

A study in Switzerland has shown that 50% of patients with premature ACS have FH. Thus Investigators can screen FH with high probability amongst patients with acute coronary syndrome.

After introducing the statins total mortality have reduced significantly in these patients. Thus screening and identification of patients and treatment with the most effective therapies will decrease the risk of premature death.

Also, most of patients require an appropriate lipid-lowering medication. Although the genetic problem is the most important factor to expression of FH, other factors like environmental and metabolic factor can be effective in CVD and premature death.

Following scoring of patients, a one-year and 30-day survival model were created in order to assess the effect of elevated cholesterol on survival,.

Eligibility Criteria:
Inclusion Criteria:

* Patients experienced premature cardiac events.

Exclusion Criteria:

* Previously registered FH.
Comprehensive Esophageal Diagnostics Study

The prospective clinical trial will study muscle fibrosis in relation to lower esophageal sphincter (LES) measurements on Functional Lumen Imaging Probe (FLIP) Topography (the novel technology that utilizes impedance planimetry) after pharmacologic challenge. A better understanding of achalasia will allow intervention at an earlier stage.

Achalasia is a disease characterized by inadequate opening of the lower esophageal sphincter. Achalasia is presumed to be due to neuronal dysfunction (active), however there are other variables such as muscle layer fibrosis (passive) that may contribute, particularly in milder or earlier achalasia variants. A new technology, impedance planimetry, may be able to measure active vs passive features of the lower esophageal sphincter (LES).

The prospective clinical trial will study muscle fibrosis in relation to lower esophageal sphincter (LES) measurements on Functional Lumen Imaging Probe (FLIP) Topography (the novel technology that utilizes impedance planimetry) after pharmacologic challenge. A better understanding of achalasia will allow intervention at an earlier stage.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, age 18 and above.
2. Evaluated by Emory Digestive Diseases Clinic, Emory Motility Lab, the Emory Endoscopy Unit, or Emory Surgery Department from October 1, 2020, to September 30, 2024.
3. Has a diagnosis of achalasia or an esophageal motility disorder with confirmed evaluation by one of the following modalities: functional lumen imaging probe (FLIP) or high-resolution esophageal manometry (for Aim 1)
4. Undergoing a diagnostic Functional Lumen Imaging Probe (FLIP) study at Emory University Hospital with anesthesia assistance (for Aim 1)
5. Undergoing Heller myotomy or per oral endoscopic myotomy for the treatment of their esophageal motility disorder (for Aim 2)

Exclusion Criteria:

1. Patients younger than 18 years old
2. Pregnant women
3. Prisoners
4. Non-English speaking - the rationale is that the symptom characterization and outcome data are measured on detailed and fairly lengthy (5-7 pages) of questionnaires written in English with some medical terms. These are standardized questionnaires and do not have short forms available.
5. Cognitively impaired adults unable to provide informed consent
6. Cardiac disease in the form of - arrhythmia requiring ICD or pacemaker, baseline bradycardia with HR \<60 or tachycardia with HR \> 90, congestive heart failure with ejection fraction \<35%, history of myocardial infarction, baseline MAP \<65 or systolic BP \>140, asthma or chronic obstructive pulmonary disease, urinary retention requiring the use of foley catheterization (including intermittent use), narrow-angle glaucoma, myasthenia gravis, GFR \<60 \[exclusions for Aim 1 only\]
Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT

This is a single institution phase II study of a reduced intensity conditioning (RIC) followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with diagnosis of hematologic malignancy. Conditioning will consists of fludarabine, cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI) \>3. This study uses a two-stage phase II design with accrual goal of 84 patients, using 28 patients separately for arms A, C and D


Eligibility Criteria:
Inclusion Criteria:

* Karnofsky performance status of ≥70% or Lansky play score ≥ 70%
* A related haploidentical bone marrow donor with up to 2 or 3 HLA locus-mismatches
* The donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1.
* Adequate liver and renal function
* Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%
* Diffusion capacity corrected (DLCOcorr) \> 40% predicted, and absence of O2 requirements
* \> 6 months after prior autologous transplant (if applicable)
* Agrees to use contraception during study treatment
* Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate)
* Patients who are HIV+ must have undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation

Exclusion Criteria:

* \< 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
* Pregnancy or breastfeeding
* Current active and uncontrolled serious infection
* Acute leukemia in morphologic relapse/persistent disease defined as \> 5% blasts in normocellular bone marrow OR any % blasts if blasts have unique morphologic markers (e.g. Auer rods).
* CML in blast crisis
* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressive on salvage therapy.
* stable non-bulky disease is acceptable.
* Active central nervous system malignancy

Criteria For Donor Selection:

* Donors must be HLA-haploidentical relatives of the patient, defined as having a shared HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1.
* Eligible donors (14-70 years old) include biological children, siblings or half siblings, or parents, able and willing to undergo bone marrow harvesting.
* For donors \<18 years, the maximum recipient weight (actual body weight) should not exceed 1.25 times the donor weight (actual body weight)1 In addition, bone marrow product volume should be limited to 20 ml/kg donor weight for donors \<18 years.
GrOup-based Physical Activity for oLder Adults Trial

Regular physical activity is associated with a diverse range of physical and mental health outcomes, with the effects being particularly pronounced among older adults. Despite these health benefits, involvement in physical activity has been found to decline over the course of adulthood with older adults in particular risk of inactivity. A growing body of evidence, however, suggests that group-based settings that are sensitive to both the age-composition and gender-composition of their constituent members may represent an opportune means of supporting the improved adoption and maintenance of older adults in physical activity programs. The overall purpose of this feasibility trial is to test the effectiveness of a group-based physical activity program for older adults that is sensitive to both age-congruent and gender-congruent contextual factors, in supporting their sustained involvement in physical activity.

The results of prominent meta-analytic reviews suggest that when people exercise in groups they tend to sustain their involvement to a greater extent than when they exercise on their own. Despite the potential for groups to sustain long-term physical activity behaviours, there appears to be an important caveat that comes with exercising with others: if people perceive themselves to be similar to other members of a given group, in terms of salient underlying qualities, this corresponds positively with their attraction to, and level of involvement within, that group. If, however, people perceive themselves to be distinctly different from others within their social group, this is likely to undermine their attraction to, and involvement in that group. Recent research by Dr. Beauchamp and his team suggests that across the adult age spectrum people report a positive preference for exercising within groups that are comprised of others their own age, and when they participate in such classes they display higher levels of adherence to the group. In a similar regard, people report comparable positive preferences for same-gender rather than mixed-gender physical activity group settings. However, to date, research has yet to examine these effects using an experimental (RCT) design. This constitutes the purpose of this present trial.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 65 years of age or older (both males and females), be able to speak and read English, and not experience any contraindication which might prevent that person from participating in moderate-intensity physical activity. Participants will be required to complete PAR-Q+, and where necessary ePARmed-X.

Exclusion Criteria:

* The only exclusionary criteria is that participants must be 65 years of age or older (both males and females), be able to speak and read English, and not experience any contraindication which might prevent that person from participating in moderate-intensity physical activity.
Effects of Protein and Fiber at Breakfast on Appetite, Blood Sugar, and Cholesterol

The objectives of the research are to assess the effects of increased protein and fiber intake at breakfast on neural activation in brain regions associated with appetitive drive and reward-driven eating, measures of subjective appetite, and ingestive behavior in overweight adults. Additional outcomes of interest include the effects of the breakfast intervention on blood sugar and cholesterol profiles.

The objectives of the research are to assess the effects of increased protein and fiber intake at breakfast on neural activation in brain regions associated with appetitive drive and reward-driven eating, measures of subjective appetite, and ingestive behavior in overweight adults. Additional outcomes of interest include the effects of the breakfast intervention on 24-hour glucose profile as well as fasting and postprandial glycemic and lipemic regulation. The investigators will test the effects of consuming breakfasts with normal protein/normal fiber (NPNF), normal protein/high fiber (NPHF), high protein/normal fiber (HPNF), and high protein/high fiber (HPHF) for two weeks in a randomized cross-over study.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* age 21 - 45 years
* BMI 25-29.9 kg/m2

Exclusion Criteria:

* Irregular menstrual cycles
* current smoker
* medications or supplements that affect appetite
* pregnant or lactating
* not weight stable
* acutely ill
* diabetic
* claustrophobic
* any implantation unsafe in magnetic resonance imaging (MRI) environment
Allis Clamp Versus Single-tooth Tenaculum

This study aims to determine whether an Allis clamp is an effective clamp for cervical stabilization compared to a single-tooth tenaculum.


Eligibility Criteria:
Inclusion Criteria:

* Obtaining IUD

Exclusion Criteria:

-
Opioid Sparing Effect of an ISP Nerve Block on Post-Op Pain Control in Posterior Cervical Spine Surgery

Participants who have a surgical procedure called Posterior Cervical (neck) Spine Surgery will normally need pain medication to relieve post operative pain. This usually includes opioid medications. In this study, the consented participant may receive a nerve block procedure, in addition to the pain relieving medication. There is a fifty-fifty chance to receive the nerve block. The goal is to see if the nerve block group needs less opioid medication, has lower pain scores and is discharged from the hospital sooner.

The purpose of this research study is to evaluate the opioid-sparing effect of the use of an Inter-semispinalis plane (ISP) block after posterior cervical spine surgery.

Posterior cervical fusion (PCF) is a painful procedure that often requires the use of high doses of opioids to minimize postoperative pain. Uncontrolled pain can result in a delay in recovery and discharge. Additionally, high doses of opioids carry the risk of opioid dependence, and other side effects, include nausea, vomiting, sedation, and, in rare cases, respiratory depression. For all of the above reasons, reducing the use of opioids is of utmost importance.

Nerve blocks are one alternative to opioid use. The ISP block is a procedure described in 2017; it is a relatively simple procedure that entails injecting local anesthetic between two muscles in the back of the neck, bilaterally, to block the nerves that run in this plane. It is done under ultrasound guidance and, although a limited number of studies have shown promise, more data on its safety and efficacy are needed. The addition of Dexamethasone to local anesthetics, in nerve blocks, resulted in significant prolongation of the analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Having Posterior Cervical Spine Surgery from C2 - C7, which may extend to the upper thoracic vertebrae, inclusive to T3.
* Capacity to provide informed consent

Exclusion Criteria:

* Fusion and decompression due to trauma
* Emergent procedures
* Patient is on a medication-assisted treatment, e.g., buprenorphine, naltrexone or methadone.
* There is an infection near or in the area of neck where the block will be placed.
* The patient is having a complicated surgery or a revision surgery
* Female patient with a positive pregnancy test on the day of surgery (hospital standard-of-care).
* Patient has Diabetes
* Patients who have had a prior adverse reaction to bupivacaine or dexamethasone
* Patients with Glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia
Distribution of Topical Nasal Medication Within the Nasal Cavity and Sinuses by Radiographic Comparison

The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used.

The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used. The study hypothesizes that nasal drops will reach the frontonasal region more often than nasal sprays.

Eligibility Criteria:
Inclusion Criteria:

* adult able to perform activities of daily living

Exclusion Criteria:

* signs or symptoms of acute or chronic paranasal sinus disease
* history of sinus surgery
* symptomatic deviated septum
* active seasonal allergies
* allergies to contrast
* history of nasal polyposis
* pregnant or breast feeding women
* neck or back problems that would prevent a subject from kneeling on the floor and crouching over
* currently taking metformin or amiodarone
* students or stff under the direct supervision of the investigators
* cognitive impairment
* terminal illness
Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery

Obese patients have increased cardiovascular risk and target organ damage (TOD) as compared to people with normal weight. Weight loss reduces cardiovascular risk and TOD. These changes have been associated mainly to changes in inflammatory and pro-atherogenic markers. Office peripheral blood pressure (BP) appears to decrease after bariatric surgery, but information on changes in 24h-ambulatory-BP-monitoring (24h-ABPM) and central-BP(cBP), or about the possible role of renin-angiotensin-aldosterone (RAAS), serotonin(STS) and endocannabinoid(ECS) systems is scarce. Our hypothesis is that the hemodynamic changes mediated by alterations in the RAAS, STS and ECS after weight loss are also responsible for the reduction of TOD.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 - 65 years,
2. who have medical indication for treatment with bariatric surgery and agreeing to undergo the intervention,with
3. given informed consent

Exclusion Criteria:

1. Unmeeting the above Inclusion Criteria.
An Observational Study in Patients With Mild to Moderate COVID-19

The purpose of this study was to observe real-world disease progression in mild-moderate COVID-19 patients with at least one risk factor for serve COVID-19 illness or death.

Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures.

The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.

The following is the general sequence of events during the 28-day evaluation period:

Completion of baseline procedures Participants were assessed for 28 days and completed all safety monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have a positive SARS-CoV-2 test result.
* Participants who have one or more mild or moderate COVID-19 symptoms.
* Participants who have one or more of the following requirements: ≤7 days from the first positive test for SARS-COV-2 virus infection to Day 1; ≤5 days from the first onset of COVID-19 symptoms to Day 1.
* Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death.
* Participants who understand and agree to comply with planned study procedures.
* Participants or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site.
* Capable of giving signed informed consent, including of compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

* Participants who are judged by the investigator as likely to progress to severe/critical COVID-19 prior to randomization.
* Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute.
* Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation.
* Participants who have received or plan to receive a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment).
* Participants who have received convalescent COVID-19 plasma treatment.
Gemcitabine and Oxaliplatin in the Management of Metastatic Pancreatic Cancers With Low Expression of ERCC1

The goal of this clinical trial is to improve and personalize pancreatic cancer care to deliver the most effective therapy while avoiding unnecessary exposure to potential side effects. Excision repair cross-complementation group 1 (ERCC1) protein and mRNA expression predicts response to oxaliplatin - patients whose cancers make small amounts of ERCC1 are much more likely to respond to cisplatin than those whose tumors produce large amounts. The hypothesis is that the combination of gemcitabine and oxaliplatin is a uniquely effective regimen for patients with metastatic pancreatic cancer whose tumors have a low expression of ERCC1.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma
* Patients must not have had prior chemotherapy or biologic therapy for metastatic pancreatic cancer
* Prior adjuvant chemotherapy for completely resected disease or chemoradiotherapy for locally advanced disease is allowed but must have been administered \> 6 months prior to registration
* ECOG Performance Status of 0, 1, or 2
* Adequate hematologic, hepatic and renal function

Exclusion Criteria:

* Pregnant or nursing women
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years
* Patients must not have known brain metastases
* Any other condition that in the opinion of the Investigator may render the patient at excessive risk for treatment complications