cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Algorithm for Appendizitis (DIALAPP)

The diagnosis of acute appendicitis remains a challenge in daily clinical practice. The high incidence of appendicitis drives the need to reduce morbidity and unnecessary costs due to negative appendectomies. The aim of the present observation study is to evaluate a diagnostic and therapeutic algorithm for suspected acute appendicitis.

The investigators believe that this diagnostic algorithm helps to simultaneously avoid unnecessary operations, costs and radiation exposure.

This prospective observation study will be performed in the university hospital Frankfurt with a 24-h emergency service, with surgery and radiology readily available. The data will be compiled on patients older than 18 years who will be admitted to the emergency unit with suspected appendicitis.

During the study period, the clinical workflow is standardized. In all cases a resident of surgery and/or consultant surgeon clinically evaluate and perform an ultrasound scan on all patients with suspected appendicitis. With the use of clinical and laboratory results the physician (surgeon) will calculate the Alvarado Score and depending on the result the next diagnostic steps or the treatment will be chosen. Additionally, the department of gynecology of the university hospital routinely evaluate all women of childbearing age. Upon other terms following variables will be collected: age, gender, white blood cells (WBC), C-reactive protein (CRP), Alvarado Score, visuell pain scale, CT scan results, pathologic findings, time between admission and operation, operation procedure, treatment and diagnosis of patients without operation, length of hospital stay, and 30-day complication rate. Furthermore, there will be a follow-up of all patients (with and without operation) after 30 days and 6 months.

The investigators assume that the use of a diagnostic and therapeutic algorithm reduces unnecessary negative appendectomies and optimizes the duration of the hospital stay and the costs.

Eligibility Criteria:
Inclusion Criteria:

* complete evaluation, examination and diagnostic pathways of the patients with suspected appendicitis in our University Hospital

Exclusion Criteria:

* appendectomy during other operations
E-MAX 2nd Gen Vit E Poly On BIOLOX Delta Ceramic Heads

The purpose of this study is to monitor outcomes of total hip arthroplasties performed with E-MAX polyethylene and BIOLOX Delta Ceramic head. Polyethylene has been used as a bearing surface in total joint replacements for half of a century. Radiation, the most common form of sterilization, unfortunately it results in the creation of free radicals (atoms or molecules that cause chemical reactions with other substances) within the materials which cause the breakdown of the polyethylene. Second generation antioxidant polyethylene, Renovis E-MAX, mechanically blends in Vitamin E as an antioxidant. This helps eliminate free radicals while maintaining mechanical strength. The theory is that E-MAX will be a safe and long lasting bearing surface in total hip arthroplasty that meets or exceeds current wear rates after being placed in a patient.


Eligibility Criteria:
Inclusion Criteria:

* Patient is under 65 years of age
* Patient's health status qualifies as ASA 1 or ASA 2
* Patient is willing to commit to long term follow (study duration is 10 yrs)

Exclusion Criteria:

* Allergy to any materials used in hip implant
* Unwillingness to participate in long term follow-up
* Diagnosis of inflammatory arthritis
* Simultaneous bilateral total hip arthroplasty is recommended.
* Patient's health status qualifies as ASA 3 or greater.
* Patient is over the age of 65 of age
AnalyST & Brugada Syndrome - Feasibility Study

Brugada syndrome is characterized by a ST shift on the surface ECG, and a specific morphology of the Twave. This ECG abnormality is called a type 1-ECG, and is variable in time. Patients presenting a Brugada syndrome are exposed to sudden cardiac death, although it's difficult to predict patients at high risk. It is suspected that the type 1-ECG burden might be correlated to the ventricular fibrillation risk of these patients, but there is no mean to record the ECG over a long period of time.

The objective of the study is to evaluate the correlation between ST elevation on the electrocardiogram (ECG) and ST shift on the intracardiac electrograms (EGM) recorded with the AnalyST ICD, to assess the ability of the device to detect the type 1-ECG. Patients enrolled in the study are patients already implanted with a defibrillator for their Brugada syndrome. During an Ajmalin test, which unmasks the type 1-ECG, both intracardiac EGM and surface ECG will be compared to assess the detection of the typical ST-shift by the ICD.

To evaluate the correlation between ST elevation on the ECG and ST shift on the intracardiac EGM recorded with the AnalyST ICD, patients enrolled will have to be already diagnosed as presenting the Brugada Syndrome. They will undergo an ajmaline test, to unmask the type 1-ECG, characteristic from the Brugada syndrome.During the test, both surface ECG and intracardiac signal will be continuously recorded; then the signals will be compared in terms of amplitude of the ST shift, duration of the shift, and recovery period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Brugada syndrome and previous positive Ajmalin test
An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects

A multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 Injection in Healthy Subjects.

This is a Phase 1, single-center, prospective, randomized, double-blind study of multiple ascending doses (MAD) of CD101 Injection administered IV to healthy adult subjects. In this study, subjects in 3 cohorts of 8 subjects each will be randomized to receive multiple IV doses of CD101 Injection or placebo infusions. Dose levels of CD101 Injection to be assessed will follow an ascending multiple-dose regimen.

Eligibility Criteria:
Inclusion Criteria:

* Men must be surgically sterilized or using contraception,
* No significant findings on physical exam, ECG, clinical laboratory tests,
* Body mass index (BMI) between 18.5 and 32.0 kg/m2, inclusive
* Must provide written informed consent

Exclusion Criteria:

* Females of child bearing potential
* Signs and or symptoms of acute illness or chronic disease
* Use of prescription medications within 28 days
* Use of OTC, supplements, and herbals within 14 days
* Current smoker
* Previous participation in a clinical study within 28 days
Neutrophil Gelatinase-associated Lipocalin VS Vascular Calcification in Maintenance Hemodialysis Patients

The goal of this observational study or clinical trial is to learn about the effect of neutrophil gelatinase-associated lipocalin (NGAL) on vascular calcification in maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT). The main question it aims to answer is: the predictive effects of blood NGAL level on the efficacy of palicalcitol in the treatment of SHPT and the adverse reactions of vascular calcification progression. Participants will be treated with palicalcitol, followed up and undergo routine series of Chronic Kidney Disease-Mineral and Bone Disorder associated tests before and after treatment.

1. Sample size calculation: Because there was no previous study on the change of blood NGAL level in MHD patients with palicalcitol; refer to the NGAL changes before and after parathyroidectomy :N=12 NGAL715.84(578.73, 988.14)ng/mL before and 688.42(660.00, 760.26)ng/mL 4-7 days after surgery (p=0.071, paired T-test). According to the 20% loss rate; The sample size is finally determined to be 80 cases.
2. Patients: maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT).
3. Palicalcitol injection
4. Follow-up The patients are followed up for 1 year.
5. Statistical methods All statistical tests are conducted by two-sided test, and the first type of error is 0.05 (α value) to determine the statistical significance of the difference. Quantitative data includ efficacy, laboratory test indicators, such as the number of cases, mean, median, standard deviation and range description. Qualitative data includ comorbidities, described in terms of frequency, composition or percentage. Statistical test: The parameter test method is preferred. If the data distribution differs greatly from the requirements of testing the hypothesis, the non-parameter test method will be used. Patients will be divided into two groups according to circulating NGAL levels before treatment; the clinical characteristics, changes of NGAL level, the efficacy of palicalcitol (changes of iPTH) and the main adverse reactions (increased blood calcium and phosphorus, progress of vascular calcification) are compared between two groups. T test or rank sum test are used for difference test. The correlation between blood NGAL level, VC score and CKD-MBD assay indexes is analyzed by pair-wise correlation and logistic multivariate regression.

Eligibility Criteria:
Inclusion criteria:

* Chronic kidney disease (CKD) maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT), iPTH\>300pg/ml
* Age 18-65 years old
* Haven't used anti-PTH agents within 3 months
* Signed informed consent

Exclusion criteria:

* Allergic to vitamin D or similar drugs
* Vitamin D poisoning
* Expected survival is less than one year
* Acute inflammations, active liver disease, tumor, hospitalization within 3 months
* Fractures, major trauma or operations within 3 months.
Effect of Pre-operative Virtual Visits on Patients With Head and Neck Cancer Undergoing Surgery

Patients with head and neck cancer often undergo complex surgeries requiring significant care post-operatively. This presents considerable psychosocial challenges in addition to their need to physically recover from a large surgery.

The study team will interview patients who have undergone virtual visits before their surgical procedures. The study aims to explore patients' experiences, satisfaction, and perceptions of virtual visits for informing and preparing them for surgery and their postoperative care needs.

The study team will also analyze the effects of the virtual visits on financial costs and patient outcomes such as length of hospital stay, delayed discharges due to social issues, and whether the virtual visits identified any significant medical concerns, etc. The study team will compare these to a randomly selected cohort of patients who also underwent surgical resection and reconstruction for head and neck cancer that did not get pre-operative virtual visits.


Eligibility Criteria:
Inclusion Criteria (Pre-operative Visit Arm)

* Patients \> 18 years
* Underwent surgery for head and neck cancer with free flap reconstruction at the University of Michigan
* Underwent a pre-operative virtual visit.

Inclusion Criteria (NO Pre-operative Visit Arm)

* Patients \> 18 years
* Underwent surgery for head and neck cancer with free flap reconstruction at the University of Michigan

Exclusion Criteria (Pre-operative Visit Arm)

* Patients who died within 60 days of surgery for head and neck cancer with free flap reconstruction at the University of Michigan.

Exclusion Criteria (NO Pre-operative Visit Arm)

* Patients who died within 60 days of surgery for head and neck cancer with free flap reconstruction at the University of Michigan.
* Patient underwent a pre-operative virtual visit.
Omega-3 Fatty Acid for Critically Ill Patients.

Sepsis is the most common reason for intensive care unit (ICU) admission. Sepsis flares up the systemic inflammatory response with its mediators. Sepsis treatment protocols have been established in many centres with immune nutrient as adjuvant treatment. Omega-3 fatty acid and other anti-oxidants formulae have been found to improve sepsis outcome. In most of the studies, immune nutrients were giving parenterally, however, nowadays the preferable route of feeding in critically ill patients is enterally. The present study was done to investigate the effect of enteral Omega-3 fatty acid in septic critically ill patients.

A hundred and ten critically ill septic patients were included in the study. Patients were divided into two groups fifty-five patients each. Group A received enteral nutrition supplemented with Omega-3 fatty acid and group B received enteral nutrition without Omega-3. Demographic data, sepsis characteristics, number of patients required invasive ventilation, ventilation days, ICU sequential organ failure assessment score (SOFA), organ failure free-days, haemodynamic failure free-days, ICU stay, ICU and hospital outcomes were recorded.

Eligibility Criteria:
Inclusion Criteria:

* All septic patients who could receive enteral nutrition were included in the study

Exclusion Criteria:

* Patients with end stage liver or renal disease, haemodynamic instability, immunosuppression, gastrointestinal comorbidity, allergic to omega-3, received omega-3 a week prior to ICU admission, patients who expected to live less than 24 hours, and patients who were mechanically ventilated on ICU admission were excluded from the study.
Marwo-D Research -Need for Vitamin D in Different Population Groups

Insufficient intake of vitamin D is a public health problem, affecting about 40% of the Finnish population in the winter. Vitamin D has a wide range of health effects: in addition to its effect on bone, it is known to affect inflammatory response among other things. The sources of vitamin D are the synthesis in the skin as well as diet and dietary supplements. In Finland and in Northern Europe vitamin D is formed in the skin only from March to October. This alone is not sufficient to cover the need for year-round, because vitamin D storage is used in a few months. During the winter months the only sources of vitamin D are diet and vitamin preparations. Current vitamin D recommendations are usually based on studies in white population. However, there can be a difference in the need of vitamin D and in vitamin D metabolism between different population groups. More research evidence is needed from the northern countries. The aim of this study is to evaluate the vitamin D need in Somali immigrant population and in original Finnish population. The hypothesis is that the Somalis need more vitamin D to exceed the serum 25(OH)D concentration of 50 nmol/L than the original Finnish population.


Eligibility Criteria:
Inclusion Criteria:

* woman between 21-66 years of age
* belongs to original Finnish population or to Somali immigrant population
* healthy (= no disease requiring medication)
* lives in the metropolitan area

Exclusion Criteria:

* pregnant or breastfeeding
* has traveled to a sunny destination or destination near the equator during the previous month
* plans to travel to a sunny destination or destination near the equator in the next 6 months
* has used a tanning bed during the previous month
* plans to use a tanning bed in the next 6 months
* the subject's blood 25-hydroxy-vitamin D level (25 (OH) D), exceeds 100 nmol / L or is less than 30 nmol / L at baseline in the screening phase.
University of Delaware Parkinson's Disease Registry

The purpose of this Parkinson's Disease Registry is to assist with recruitment of willing participants into future Parkinson's disease research studies at the University of Delaware.

There is an urgent need for Parkinson's Disease research due to its increasing global prevalence. Participant recruitment is a significant challenge to the success of Parkinson's disease research and we need your help more than ever in moving the field forward and improving the lives of people who have Parkinson's disease. Recruitment of study participants can be facilitated by maintaining registries of people who agree to be contacted for future studies.

The purpose of the University of Delaware Participant Recruitment Registry for Parkinson's Disease Research is to create a registry that includes the contact information and basic health information pertaining the participant's diagnosis of Parkinson's disease. The registry will streamline recruitment and enrollment in a variety of research studies focusing on topics such as, but not limited to: brain changes in Parkinson's disease, balance and gait in Parkinson's disease, exercise and its effect on motor function.

To be in the registry individuals must have a clinical diagnosis of Parkinson's Disease and have an interest in participating in research studies.

To become a member of this registry, primary information including contact information and some general medical information are needed.

Eligibility Criteria:
Inclusion Criteria:

* Individual 21 years old or older
* A clinical diagnosis of Parkinson's disease
* Interest in participating in one or more investigator-led research studies at the University of Delaware

Exclusion Criteria:

* Individuals with a clinical diagnosis of parkinsonism that is not considered primary (e.g. vascular parkinsonism) or an atypical parkinsonian syndrome (e.g., progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration etc.)
* Clinical diagnosis of dementia
Non-Invasive EndoPAT Increases Diagnostic Yield of CAD by Coronary Angiography

The purpose of this study is to assess the non-invasive, Peripheral Arterial Tonometry (PAT) testing as another way of predicting potential coronary artery blockages in the heart.

We are conducting a 16 minute, non-invasive EndoPAT test on patients coming to our cath lab for a first-time angiogram. The angiogram results will be compared to the EndoPAT results to determine if the EndoPAT test, which generates a score, is successful in predicting who may have blockages in their coronary arteries.

Eligibility Criteria:
Inclusion Criteria:

* Patients without known coronary disease who are referred for coronary angiography.
* Adults 18 years and older.

Exclusion Criteria:

* Patients with known coronary disease, acute coronary syndrome, cardiac transplantation, and severe connective tissue disease.
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Only patients successfully completing study CLAF237A2305 are eligible
* Written informed consent
* Ability to comply with all study requirements

Exclusion Criteria:

* Premature discontinuation from study CLAF237A2305
* Other protocol-defined exclusion criteria may apply
Per-procedural Concentration of Direct Oral Anticoagulants

Background: Peri-procedural management of direct oral anticoagulants (DOAC) is challenging. The optimal duration of pre-procedural discontinuation that guarantees a minimal DOAC concentration (\[DOAC\]) at surgery is unknown. The usual 48-hour discontinuation might not be sufficient for all patients.

Objectives: To investigate the factors associated with per-procedural \[DOAC\]. To test the hypothesis that a 48-hour DOAC discontinuation is not sufficient to ensure a minimal perprocedural \[DOAC\], defined as \[DOAC\] \< 30 ng/mL.

Methods: Patients treated with DOAC, and requiring any invasive procedure will be included in this multicentre, prospective, observational study. \[DOAC\], will be measured during invasive procedure.


Eligibility Criteria:
Inclusion Criteria:

* patient over 18 years-old
* undergoing invasive procedure
* treated with DOAC

Exclusion Criteria:

* none
Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women

RATIONALE: Studying mammograms for breast density changes over time may help doctors predict breast cancer risk.

PURPOSE: This natural history study is looking at changes in breast density and gathering health information over time to assess breast cancer risk in women with breast cancer and in healthy women.

OBJECTIVES:

* Characterize each woman's individual mammographic density (MD) longitudinal change trajectory in women with breast cancer and in healthy female participants to assess within-individual MD longitudinal change and breast cancer risk.
* Examine whether these patients or healthy participants manifest different patterns of within-individual change in MD and evaluate predictors of across-individual differences.
* Determine whether the developmental profile of MD differs systematically between these patients and healthy participants.

OUTLINE: This is a prospective, retrospective, controlled study. Patients and healthy participants are frequency-matched by age (± 2 years) and ethnicity.

* Questionnaire: Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.
* Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.

PROJECTED ACCRUAL: A total of 1500 patients and 1500 healthy participants will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Patient at the University Hospitals Breast Center and primary care clinics within the University Hospitals system
* Have at least 3 screening mammograms since 1994
* for cases, diagnosis with breast cancer between 2004-2006

Exclusion criteria:

* having had irregular screening (less than 3 mammorgrams since 1994)
* Having breast implants
* Known carriers of BRCA1/BRCA2 genes
* Unable to give written consent
CSAPG Early Warning Score

The Early Warning Score (EWS) has been shown in previous studies to be correlated with mortality and mean hospital stay, but it is unknown whether the implementation of the scale improves mortality and mean hospital stay.

This trial aims to study whether the implantation of the EWS in a regional hospital reduces the mean hospital stay (primary objective), mortality and complications (secondary objectives).

For this, an open clinical trial will be carried out in which the hospitalization floors of the hospital will be administratively divided into two sections (two study branches); the EWS scale will be implemented in the computer equipment of one of the sections of each floor, acting the another section as a control branch.

All the patients admitted to the participating hospital floors during one year will be included in the study. The mean stay, mortality and complications will be compared between study branches.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted during study period to the participant hospital units.

Exclusion Criteria:

* None