cyrilzakka/clinical-trials huggingface dataset:
Impact of Nurse-led Programme With Carotid Ultrasound on Addressing Cardiovascular Risk in Patients With Arthritis

Elevated CVD risk is a significant public health problem that contributes greatly to the increased morbidity and shortened lifespan of individuals with RA and PsA. Over the past decades, there has been great progress into the understanding of the severity of CVD risk in these patients but these risk factors are not well managed. The development of the high-risk strategy is therefore necessary, with more intensive therapy reserved for patients identified as high-risk, e.g. because they have high-risk FRS. However, these risk scores under-estimated CV risk in patients with RA and PsA. An intermediate approach is to use quantification of preclinical vascular disease to further identify high-risk patients. Results from this study will provide clinical implications in terms of detecting and managing cardiovascular morbidity in patients with RA and PsA.

Objectives This study investigates the impact of a nurse-led programme on cardiovascular (CV) risk screening with and without carotid ultrasound for carotid plaque on CV risk factor control in asymptomatic rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients.

Hypothesis The investigators hypothesize that CV risk stratification and management in RA and PsA may be improved by incorporation of carotid ultrasound to assess for carotid plaque.

Eligibility Criteria:
Inclusion Criteria:

* Patients with RA fulfilled the 2010 ACR/EULAR classification criteria or PsA fulfilled the Classification of Psoriatic Arthritis (CASPAR) criteria
* aged between 18 and 75 will be recruited.

Exclusion Criteria:

* had a history of overt CVD (ie, symptomatic coronary artery disease \[CAD\] or ischemic stroke or transient ischemic attack or peripheral vascular disease)
* had significant co-morbidities including severe renal impairment or severe deranged liver function
* female of childbearing potential who are unwilling to use adequate contraception, pregnant or breastfeeding women
* patients who are already taking lipid lowering therapy.
Urinary Retention Following taTME VS laTME Total Mesorectal Excision for Rectal Cancer

A comprehensive study with prospectively collected data. These patients were assigned to either the taTME group or the laTME group according to the surgery procedure received

Transanal total mesorectal excision has emerged as a potential solution to certain limitations associated with laparoscopic total mesorectal excision in rectal cancer patients. Differences in surgical approaches have raised questions regarding their impact on the risk of postoperative urinary retention, with limited data available from large scale study.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 18 to 65 years,
* Diagnosed with rectal cancer at clinical tumor node metastasis stages II or III.
* Palpable tumor determined by digital rectal examination or proctoscopy
* The distal border of the tumor located within 12 cm from the anal verge

Exclusion Criteria:

* Patients presenting clear indications of pelvic side wall involvement or distant metastasis
* Uncontrolled hypertension or cardiovascular disease
* Patients with synchronous colon cancer
* History of other malignancies within the past 5 years
Investigation of The Effects of Different Exercise Methods on Swallowing Function in Stroke Patients

The aim of this study is to examine the effects of PNF (proprioceptive neuromuscular facilitation) and CTAR (Chin Tuck Against Resistance) exercises on swallowing rehabilitation in stroke patients. In addition another aim is to examine the effects of these exercises on the swallowing function, quality of life, functional independence and functional oral intake of individuals, and to investigate the superiority of the exercises to each other in line with these features.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older,
* Who have been diagnosed with stroke
* At least one month has passed since the diagnosis of stroke
* Voluntarily participated in the research,
* Cooperative, able to take instructions (Mini Mental Test score of 24 and above) and
* Individuals with a score of 2 or higher on the Penetration Aspiration Scale will be included.

Exclusion Criteria:

* Lack of long-term sitting balance, unable to maintain an upright position with or without support,
* Have tumors or neoplastic disease in the head and neck region,
* Radiotherapy applied to the neck, swallowing disorders caused by radiotherapy applied to the head and neck region,
* With additional musculoskeletal disease that may cause swallowing disorders,
* With non-stroke neurological disease (Traumatic Brain Injury, Parkinson's, Dementia, ALS, MS, etc.),
* Individuals who have previously received dysphagia treatment will be excluded from the study.
Observing People With Desmoid-Type Fibromatosis

The purpose of this study is to closely observe people with desmoid-type fibromatosis over 1 months.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of desmoid fibromatosis, either new or newly recurrent. Both patients with sporadic and FAP-associated disease will be eligible for inclusion. Patients with clinical diagnosis of desmoid (as assessed by MSK physician) but without pathologic diagnosis may be enrolled on the study to facilitate acquisition of appropriately protocoled baseline scans and allow for biospecimen collection; these patients will be replaced for purposes of analysis if pathology does not confirm clinical diagnosis.
* At least 18 years of age.
* Able to undergo cross-sectional imaging by either MRI or CT with intravenous contrast
* Disease detectable on cross-sectional imaging with target lesion measuring \>/= 1 cm
* Eligible for management by active observation as assessed by primary MSK care provider
* Willing and able to sign an informed consent document

Exclusion Criteria:

* Symptomatic desmoid fibromatosis requiring narcotic pain control, resulting in intestinal fistulization, or requiring inpatient admission during the 3 months prior to enrollment
* Patients with intraabdominal desmoids greater than 7cm in diameter or localized within 1cm of the central mesenteric vessels and those with tumors in the head and neck
* KPS performance status \</= 70 if performance status is limited due to tumor. Patients with low KPS performance status related to co-morbidities but without symptoms related to the tumor will be eligible for enrollment.
* Age less than 18 years old
* Strict contraindication for both cross-sectional MRI and CT imaging with intravenous contrast (e.g., as per standard institutional protocols regarding renal insufficiency or MRI incompatible implanted devices; patients requiring pre-medication to prevent contrast reactions will be eligible for study)
* Unable to grant reliable informed consent
* Ongoing systemic treatment for desmoid fibromatosis
The Role of Immune Semaphorins in Steatotic Liver Disease and Sepsis

The impact of the complex liver immunological network on sepsis outcome is largely unknown. Steatotic liver disease (SLD) is the most common chronic liver disease with prevalence of 25% in European countries. The question remains whether patients with SLD are more prone to bacterial infections and what is the impact of persistent liver inflammation to the systemic response to infection, sepsis course and outcomes. Semaphorins are a large family of secreted and membrane-bound biological response modifiers present in many organ systems that are associated with SLD and development of fibrosis, but also might regulate systemic immune responses in sepsis. This study will investigate the association of semaphorins with sepsis outcomes in patients with SLD.

The liver, with its ability to produce acute phase proteins, complement and cytokines, plays a central role in regulating inflammation. A balanced pro- and anti-inflammatory liver response results in bacterial clearance and resolution of inflammation. Steatotic liver disease (SLD) is the most common chronic liver disease associated with systemic changes in immune response. Although there are numerous immunological links between sepsis and SLD, there is a significant gap in knowledge regarding the role of SLD in sepsis. Semaphorins were recently recognized as one of the key regulators of immune responses; while some suppress immune cells activation, proliferation and production of inflammatory cytokines, others stimulate immune responses. Semaphorins were recently shown to be associated with pathogenesis of viral hepatitis, SLD and progression of fibrosis. However, their role in sepsis is unknown. The hypothesis of this project is that semaphorins are regulators of inflammation in patients with SLD that have impact on sepsis outcome.

Eligibility Criteria:
Inclusion Criteria:

* 2 or more SIRS (Systemic Inflammatory Response Syndrome) criteria (1. Hyperthermia \>38.3°C or Hypothermia \<36°C; 2. Tachycardia \>90 bpm; 3. Tachypnea \>20 bpm; 3. Leukocytosis (\>12,000 μL-1) or Leukopenia (\<4,000 μL-1))
* clinical suspicion of sepsis
* enrolled within 24 hours of hospital admission

Exclusion Criteria:

* no consent
* immunosuppression
* malignancies
* immune diseases
* pregnancy
* HIV infection
* presence of chronic liver disease
* consumption of alcohol \> 20 g/day
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea

This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

Subjects selected to participate in the study are treated either with cadazolid or vancomycin for 10 days. At the end of treatment, clinical cure is assessed; subjects are then followed-up to assess any disease recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent.
* Male or female ≥ 18 years of age. Females of childbearing potential must agree to use an adequate and reliable method of contraception.
* Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with \> 3 liquid or unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to randomization.

Exclusion Criteria:

* More than one previous episode of CDAD in the 3-month period prior to randomization.
* Evidence of life-threatening or fulminant CDAD.
* Likelihood of death within 72 hours from any cause.
* History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea.
* Antimicrobial treatment active against CDAD administered for \> 24 hours except for metronidazole treatment failures (MTF)
* Known hypersensitivity or contraindication to study drugs, oxazolidinones, or quinolones.
* Unable or unwilling to comply with all protocol requirements.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Austrian Wearable Cardioverter Defibrillator Registry

Background: The wearable cardioverter defibrillator (WCD) is an established treatment option for patients at high risk for ventricular tachycardia / ventricular fibrillation (VT/VF), either in whom this risk may only be temporarily present, or in patients at high risk for sudden cardiac death (SCD) or after VT/VF in whom an implantable cardioverter defibrillator (ICD is currently not possible for other reasons (infection, recent MI \<40days, recent PCI/CABG \< 3months etc.).

Methods: Comprehensive registry including all patients in Austria who received a WCD in 2010-2016.

Observational study to describe WCD indications, event rates, inappropriate shock rates and follow up (including ICD rate, shock rate, morbidity and mortality) in all Austrian WCD patients

Eligibility Criteria:
Inclusion Criteria:

* patients, with a prescribed WCD according to guidelines in an austrian center
Diagnosis and Treatment of CAD in Severe PAD After Lower Extremity Revascularization

Peripheral artery disease, lack or blood flow to the legs, has a high prevalence in the Veteran population. In patients with severe peripheral artery disease that requires an endovascular or surgical intervention for lower leg revascularization, the long-term mortality of approximately 50% is worse that most cancers. The goal of this study is to develop a management strategy to improve cardiovascular outcomes in this high-risk peripheral artery disease population after lower extremity revascularization.

This study will be to conduct a randomized, controlled, multi-center clinical trial to evaluate a non-invasive management strategy of a computed topography (CT) scan of the coronary arteries and computational analysis of coronary perfusion with selective coronary revascularization plus optimal medical therapy compared to optimal medical therapy. Therefore, this study will provide the opportunity for Veterans to participate in a clinical trial to reduce the very high cardiac-related mortality rate in this population.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 50 to 85
* Severe intermittent claudication with ABI \< 0.6 or monophasic waveform if non-compressible and TBI \< 0.6
* Chronic limb threatening ischemia (CLTI) with pain at rest (Rutherford Category 4) with ABI \< 0.5 or TBI \< 0.6
* CLTI with minor tissue loss (Rutherford Category 5) with ABI \< 0.5 or TBI \< 0.6
* Completed Lower Extremity Revascularization and enrolled within 45 days
* The patient or legal representative will provide informed written consent
* The patient has a life expectancy of at least 1 year

Exclusion Criteria:

* Major tissue loss of the ischemic limb (Rutherford Category 6)
* Uncompensated congestive heart failure (NYHA class IV)
* Myocardial infarction or stroke within the past 90 days
* Prior coronary artery bypass graft (CABG) revascularization surgery
* Prior percutaneous coronary intervention (PCI) with angioplasty or stenting
* Presence of a pacemaker
* Congestive heart failure with Ejection Fraction \< 30%
* Elevated liver function tests more than twice the upper limit of normal
* Severe Chronic renal disease (Glomerular Filtration Rate, GFR \< 30) or on hemodialysis
* Pregnancy, Human Immunodeficiency Virus, or organ transplant recipients
* Current malignancy or malignancy within the last two years unless the treating oncologic physician provides prognosis of an anticipated 2- year survival (i.e., adequately treated non-melanoma skin cancer or adequately treated prostate cancer without metastatic disease)
* Any condition the review panel determines would make the patient unsuitable for participation in the study
Post Acute Sequelae of COVID-19

COVID-19, a novel coronavirus, has caused widespread mortality and morbidity since it emerged in 2019. There is ongoing research and growing literature describing severe acute respiratory syndrome (SARS-COV-2). There is a growing population of individuals who have recovered from acute SARS-COV-2 infection. The long-term effects of COVID-19 are unknown. There are growing reports of sequelae after acute SARS-CoV-2 not limited to fatigue, dyspnea, reactive airway disease, organizing pneumonia, pulmonary fibrosis, pulmonary hypertension, pulmonary emboli, and tracheal disease. The incidence and natural history of these findings is unstudied.

COVID-19 is a leading cause of death worldwide. The long-term effects of the virus are unknown. There is lack of reliable information about the natural history of post acute sequelae. Although there are limited evidence-based treatment guidelines, many patients receive unproven therapies. Given the mortality and morbidity associated with the illness and the growing number of patients who have survived COVID-19 the long-term effects are a growing area of inquiry. This study is designed to better understand the effects of SARS-CoV-2 that develop over time. This study will characterize the recovery process, epidemiology, and natural history of post-acute sequelae. This includes the clinical spectrum of recover and subsets of patients who have symptoms outside the standard course. Factors studied will include the individual, clinical context, severity of disease, duration of symptoms and the impact of treatment for acute SARS-CoV-2. This study will include a breadth of severity from those treated as outpatients, those requiring hospitalization, and those requiring critical care.

Key personnel will extract data recorded in the electronic health record (EHR) as part of routine clinical care in the evaluation in treatment of COVID-19 and its sequelae. Data such as incidence, prevalence, demographics, comorbidities, duration of illness, severity, level of medical care, measures of organ function, drug treatments, laboratory values, pulmonary function tests, computed tomography images, and other data from clinical care will be retrospectively entered into electronic data capture (REDCap).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* COVID-19 diagnosis
* Seen in a Vanderbilt clinic or affiliated health facility

Exclusion Criteria:

* none
Hardwins - Squamous Cell Carcinoma Head & Neck (Surgery/RT)

This study is examining the effects of increasing the dose of radiation given to treat head and neck cancer. Radiation doses to the primary cancer are higher than usually given; lymph glands of the neck will also be treated at a lower dose. Surgery on the lymph glands my be necessary in the future. Radiation treatments given in small fractions twice a day allows a higher dose to be delivered than if the treatment was given once a day. This study will enroll patients at three sequential increasing dose levels. Approximately 40 patients will be enrolled at each dose level.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous cell carcinoma
* Larynx \& pharynx (except Nasopharyngeal carcinoma)
* Stage III \& IV, but any stage hypopharynx
* Informed Consent

Exclusion Criteria:

-
A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)

The goal of this study is to understand the safety, tolerability and immunogenicity of the Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef

Vaccine (MRKAd 5 HIV-1 gag/pol/nef) vaccine in healthy human volunteers compared to placebo. The study will also evaluate a number of dose levels and the necessity for and timing of booster injections.

The study will proceed in four stages. Following stages I, II and III, all subjects will have the Postdose 1 (PD1) clinical and laboratory safety data reviewed by the Safety Evaluation Committee (SEC). If these data are acceptable, the next stage will be initiated.

* In Stage I, participants will be randomized to receive 3 doses of the 3x10\^9vp/dose level Trivalent vaccine or placebo.
* In Stage II, participants will be randomized to receive 2 or 3 doses of the 3x10\^10vp/dose level Trivalent vaccine or placebo.
* In Stage III, participants will be randomized to receive 3 doses of the Trivalent vaccine with titers of 1x10\^11vp/dose, 3x10\^6vp/dose, 3x10\^7vp/dose, or 3x10\^8vp/dose or placebo.
* In Stage IV, participants will be randomized to all treatment groups. In addition, some participants will be randomized to an MRKAd 5 HIV-1 gag Monovalent vaccine. In this stage, participants will be pre-stratified by baseline Ad5 titers (=\<200, and \>200), to ensure an even distribution of participants with high and low Ad5 titers across the various treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 Years to 45 Years in Stages I-III and 18 Years to 50 Years in Stage IV.
* Subject is in good general health
* Subjects of reproductive potential agree to use acceptable method of birth control through study
* Subject tests negative for Hepatitis B, Hepatitis C, and HIV

Exclusion Criteria:

* Subject has a recent history of fever at time of vaccination
* Subject has received immune globulin or blood product 3 months prior to injection
* Subject has been vaccinated with live virus vaccine 30 days prior to receipt of first dose
* Subject has been vaccinated with inactivated vaccine with 14 days prior to receipt of first dose
* Subject has a chronic medical condition that is considered progressive
* Subject has history of malignancy
* Subject weighs less than 105 lb.
* Female subject is pregnant or breast feeding, Male subject is planning to impregnate during the first year of study
* Subject has contraindication to intramuscular injection
* Subject has a tattoo on the deltoid region of the arm or the injection of Depo-Provera
* Subject is unlikely or unwilling to adhere to lower risk sex practices during the course of the study
Risk Factors and Risk Grading Prediction of Perioperative Respiratory Adverse Events in Children

to explore the risk factors of perioperative respiratory adverse events in children, and to establish a risk prediction model of perioperative respiratory adverse events in children

600 children undergoing elective surgery under general anesthesia were selected. Age, sex, weight, height, allergy history, past history, snoring, passive smoking, abnormal laboratory examination and chest X-ray before operation, upper respiratory tract infection 14 days before operation, Operation Site, working years of anesthesiologist, anesthesia method, Operation Duration, anesthesia duration, perioperative vital signs and respiratory adverse events were collected. The risk prediction model of perioperative respiratory adverse events in children was established by using LASSO (least absolute shrinkage and selection operator) algorithm and gradient boosting machine (GBM) algorithm to screen the relevant data collected during routine diagnosis and treatment, such as demographic characteristics, physical conditions, airway sensitivity, environmental sensitivity and anesthesia management

Eligibility Criteria:
Inclusion Criteria:

* （1）Children aged 1 month to 12 years, （2） ASA Class I or II, （3）scheduled for surgery under general anesthesia

Exclusion Criteria:

-（1）Children and guardians declined to participate in the study (2) children with severe chronic respiratory, cardiovascular, central nervous system, liver and kidney diseases; (3) on the day of operation, the patients had active URTI and pulmonary infection, such as severe nasal obstruction, large amount of airway secretion, severe cough, fever (body temperature \> 37.5 ° C) , in addition to the above symptoms, signs of pulmonary consolidation and/or wet Rales, or peripheral white blood cells \> 10 × 109/L or \< 4 × 109/L with or without left shift of the nucleus, and chest X-ray showed new patchy, patchy infiltrative shadows or interstitial changes.

(4) the child had severe anaphylaxis to narcotic drugs