cyrilzakka/clinical-trials huggingface dataset:
Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

The main objective is to investigate two types of antibacterial catheters regarding their antibacterial efficacy. The study will investigate if silver added to the coating of a urinary catheter exerts antibacterial activity that will have an impact on bacteria quantity in the urine bladder among users of intermittent catheterization.

The study was designed as a prospective, randomized, double-blind, single-site study of 24 hours use of a silver coated antibacterial catheter, and 24 hours follow up, in subjects practicing intermittent catheterization.

Twenty male and female subjects using intermittent catheterization, having a confirmed significant bacteriuria were included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Female/male aged 18 years and over
* Practicing intermittent catheterization at least 4 times daily for at least 6 weeks
* A minimum of 104 CFU of bacteriuria

Exclusion Criteria:

* Ongoing, symptomatic UTI at enrollment
* Known urethral stricture
* Basic tumorous disease
* Previous prostate surgery
* Subjects known to be immunocompromised e.g. HIV or diabetes
* Treatment with antibiotics and/or intravesical antiseptics for the past 30 days before study start
* Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
* Pregnancy or breast feeding
* Previous enrolment or randomisation of treatment in the present study
* Participation in a clinical study that possibly might interfere with the present study, as deemed by the investigator
* Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
Comparison Between Combined ALLR With Single Bundle and Double Bundle Anterior Cruciate Ligament Reconstruction

The goal of this clinical trial is to test and compare different surgical techniques in patients with anterior cruciate ligament (ACL) injuries. The main questions it aims to answer are:

* What are the optimal criteria for selecting between single-bundle ACL reconstruction combined with anterolateral ligament (ALL) reconstruction versus double-bundle ACL reconstruction combined with ALL reconstruction?
* How do these two surgical techniques compare in terms of post-operative knee stability, functional outcomes, and reducing re-tear rates?

Participants will:

* Undergo pre-operative MRI imaging, ligament stability testing, and motion analysis evaluations
* Be randomly assigned to either:

  * Single-bundle ACL + ALL reconstruction
  * Double-bundle ACL + ALL reconstruction
* Receive the assigned surgical procedure
* Participate in post-operative follow-ups, ligament stability testing, and motion analysis at 6 months and 1 year

Researchers will compare the single-bundle ACL + ALL group and the double-bundle ACL + ALL group to see if one technique demonstrates superior knee stability, functional outcomes (e.g. return to sport ability), and lower ACL re-tear rates.

Anterolateral ligament(ALL) combined with anterior cruciate ligament reconstruction(ACL) has become more and more popular in recent years, as ALL could protect the ACL graft in tibial internal rotation, and prevent the ACL graft from rupture. Cottet et al. proposed a minimal invasive method with Y-figure construct of ALL, without acquiring additional graft from the patient. Their data showed significant lower graft re-rupture rate and faster return-to-sport(RTS). There are many different techniques of ACL combined ALL reconstruction. While these methods mostly are single bundle ACL combined ALL reconstruction. Previous cadaver studies told that the anterior cruciate ligament is composed of anteromedial and posterolateral bundle. It had been debated between single bundle and double bundle ACL reconstruction for years. As a result, it is meaningful to compare the clinical outcomes between ALL combined with single bundle or double bundle ACL reconstruction. Our studies included MRI image, arthrometer measurement and optical motion capture system. We hope to compare the clinical outcomes and sports function between A: single bundle ACL combined ALL reconstruction and B: double bundle ACL combined ALL reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Patients plan to receive ACL surgery
* at least 18 years old

Exclusion Criteria:

* Presented history of the injured leg or congenital abnormality
Nutritional Status and Patient Characteristics Upon Length of Stay, Clinical Outcome, and Survival in Older Hospitalized Patients

Disease-related malnutrition (DRM) describes undernutrition or imbalances in energy, protein, or other nutrient-needs, caused by a concomitant disease. Nutritional status plays a vital role in the fate of hospitalized patients, and DRM is associated with loss of function and decreased survival.

DRM is a common condition in patients with acute illnesses, approximately 30% among medical inpatients are malnourished when admitteed to the hospital, and rise higher among the older or critically ill. Physiologically malnutrition is associated with a) poorer tissue healing and restitution after severe disease, b) suppressed immune function and resistance towards infections, c) poorer metabolic defense towards critical disease, d) delayed and poorer progress of chronic diseases. In addition, inadequate nutrition is coupled to a prolonged hospital stay, resulting in more readmissions, and overall higher mortality in hospital patients. Yet, nutritional status of patients upon hospital admittance is seldom systematically assessed and the consequences of DRM in older acutely admitted patients still needs to be understood.

This project will provide a detailed description of nutritional, physiolgical, and biochemical status of 1500 acutely admitted patients. In relation, the study will investigate the relation between patient characteristics and disease progression. The obtained data will also be coupled to patient registers to investigate the link between length of hospital stay, readmissions and acute contact, and mortality.


Eligibility Criteria:
Inclusion Criteria:

* Acutely admitted adults aged 65 years and above.
* Be able to comply with the study information, as assessed by the research personnel.
* Be able to understand Danish.

Exclusion Criteria:

* \<24 hours admission
* Terminal illness in end stage of life
* Patients with temporary civil person registration number (CPR)
Deep Learning to Summarize Findings in Dental Panoramic Radiographs

In this work, the investigators study the application of artificial intelligence systems on dental panoramic images for dental findings. An artificial intelligence system will be learned on an publicly available panoramic image dataset, and test against the investigators' local patient cohort as external test data. The investigators hypothesize the performance would be similar, if not identical to on the public data, and that the investigators' AI system is generalizable.


Eligibility Criteria:
Exclusion Criteria:

* patients under 20 or with primary teeth
* patients with non-removable metal accessory above neck, such as tongue ring, nose ring etc.
* patients with mandible or maxilla deformation
Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control

This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo for pain control in subjects with pancreatic cancer.

Thi is a study of pain control in subjects undergoing surgery for pancreatic or bile duct cancer.

Subjects undergoing surgery will be randomized to surgery plus celiac plexus neurolysis with ethanol injection versus surgery plus placebo injection. Subjects will be followed every three months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. The primary endpoint of pain control will be determined at one year post surgery. Subjects are not required to undergo any additional diagnostic testing procedures that are not part of their routine follow-up care.

Eligibility Criteria:
Inclusion Criteria:

This study will be offered to all patients scheduled to undergo open or laparoscopic operative resection of a presumed pancreatic (any location; i.e., head, body, or tail) or distal biliary tract cancer.

* Physiologic suitability for major abdominal surgery
* Aged 18 years and older
* Written informed consent
* Ability to understand and comply with study guidelines.

Exclusion Criteria:

* Pregnancy
* Previous, preoperative celiac nerve block
* Neoadjuvant chemotherapy or radiation therapy
* Incomplete tumor resection (R2 resection, grossly positive resection margin)
* Presumed ampullary or duodenal cancer based on preoperative work-up or intraoperative findings
* Benign tumors, neuroendocrine tumors, soft tissue tumors based on preoperative work-up or intraoperative findings
* Known metastatic disease
Incurable Ill Patients Attitudes Towards Euthanasia and Assisted Suicide

Euthanasia and assisted dying are of growing interest for patients with incurable diseases. The possible methods are widely discussed by patient-societies, physicians, lawyers, theologians and philosophers. During the last years several opinion-polls were conducted with healthy people or medical stuff, but no surveys were conducted to get the attitude of incurable ill patients.

The hypothesis of the investigators' study is: "Palliative Care Medicine is a better option for incurable ill patients than an assisted suicide."


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Incurable illness
* Mental state thet allows to answer a questionnaire

Exclusion Criteria:

* Somnolence
* Low mental state
* Curable disease
* Depression with danger of acute suicide
Testicular Function After Testicular Torsion

The purpose of this study is to evaluate testicular function measured as testosterone level and semen quality.

Men having undergone surgery for testicular torsion between 01.01.2003 - 12.31.2012 will receive a invitation to participate in this study. It is expected that 110 patients can be identified and about 65% of them will participate. These men will undergo a andrological evaluation, deliver a semen sample, have a blood sample taken and undergo a testicular ultrasound.

Control group:

Men attending the fertility counseling at Herlev hospital will be offered participation in this study. The fertility counseling demands that men who contact the clinic have never had their sperm analyzed, have not tried to get pregnant with their partner for more than a year and that they have no prior knowledge of their fertility.

Primary endpoint:

* Semen quality measured as sperm concentration
* Total testosterone level

Secondary endpoint:

Semen parameters

* Semen volume (ml)
* Sperm concentration (x 106/ml)
* Sperm motility (%) (både klasse AB og ABC)
* sperm morphology
* IgA-bound spermatozoa (%)
* IgG-bound spermatozoa (%)

Hormones

* FSH
* LH
* PRL
* Testosterone
* Estradiol
* Inhibin B
* Insulin-like peptide 3
* SHBG

Data points:

* Paternity
* Time to pregnancy
* Partner (yes/no)
* Any fertility treatment?
* Pain? (VAS score)
* Symptoms of testesterone deficiency symptoms
* Andrological evaluation
* Testicular ultrasound
* Testicular torsion events in the family
* Date of surgery
* Date of follow up meeting
* Surgery details

Eligibility Criteria:
Inclusion Criteria:

* Men with a verified testicular torsion operated at Herlev and Gentofte hospital between 01.01.2003 and 12.31.2012

Exclusion Criteria:

* Retentio testis
* Varicocele
* Previous treatment with chemo- or radiation therapy
* Genetic disposition for infertility
* Anejculation
* Retrograde ejaculation
COmparison and Modification in Neointimal Pattern Assessed by Optical Coherence Tomography With High Versus Moderate Efficacy Statin Treatment After Drug Eluting Stent Implantation: COMPASS Trial

This study is a prospective randomized trial to evaluate and compare the quantitative and qualitative characteristics of neointimal formation between high and low efficacy statin treatment after drug eluting stent (DES) implantation, in patients with homogeneous or heterogeneous neointimal pattern accessed by Optical Coherence Tomography (OCT). The investigators postulate that high efficacy statin could have superior effect on modification of neointimal pattern, compared with lower efficacy statin. Our main hypothesis is that Atorvastatin 40mg, high efficacy statin might have superior effect on modification of neointimal pattern evaluated by serially followed OCT, compared with pravastatin 20mg in patients with DES implantation.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 20 years old
* Patients who received OCT related to clinical needs or the end point of other study
* Patients who received DES within 1 year before OCT evaluation
* Patients with homogenous or hetero neointimal pattern by OCT
* Non-statin user and moderate or low efficacy statin user

Exclusion Criteria:

* Refuse to participate
* Contraindication to statin treatment
* Women with current or potential childbearing
* Life expectancy \<1 year
* High efficacy statin user (Atorvastatin 80mg or Rosuvastatin 20mg)
Effects of High-intensity Interval Training in Patients in Hemodialysis

The purpose of this study is to evaluate the effects of high intensity interval training compared to moderate exercise training and a control group on exercise capacity and quality of life in patients with end stage renal disease on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients on hemodialysis ≥ 3 months

Exclusion Criteria:

* Acute infection
* Systolic BP\>180 mmHG or diabolic BP\>105 mmHG
* Unstable angina pectoris
* Serious rhythm disturbances
* Hyperkalemic (\> 6 mmol/L),
* Unstable diabetes mellitus
* Wheelchair
* Dialyses access on lower extremities
* Haemoglobin \< 9 g/dl
Acupuncture to Reduce Anxiety in Alzheimer's Disease (AD) and AD Related Dementias

The purpose of this study is to investigate the influence of acupuncture on heart rate variability, skin conductance (sweating), and rated behavioral expression of agitation, irritability, and anxiety and mood in qualifying adults with a diagnosis of cognitively unimpaired, or probable Alzheimer's Disease, Frontotemporal Dementia or Dementia with Lewy Bodies. Study subjects will all receive one real acupuncture treatment; mood scales will be assessed before and after.

Massachusetts General Hospital is paying for this research to be done.

Acupuncture is a system of integrative medicine that involves pricking the skin or tissues with needles, used to alleviate pain and to treat various physical, mental, and emotional conditions. Originating in ancient China, acupuncture is now widely practiced globally.

Eligibility Criteria:
Inclusion Criteria:

* Ages 55-95 inclusive, male or female.
* Diagnosis of CU, or probable AD, FTD or DLB as determined by established clinical criteria at screening14.
* For the AIA symptomatic groups, a score of \> 2 for Severity on at least 1 of the AIA-relevant items on the NPI-Q, i.e., Anxiety, Irritability/Lability, Agitation or Aggression.
* For the CU and no neuropsychiatric symptoms group, NPI-Q score must be 0 for AIA-relevant items, i.e., Anxiety, Irritability/Lability, Agitation or Aggression.
* No concurrent use of therapies with prohibitive effects on interpretation of HRV and SC measurements, e.g., those with major direct adrenergic or anticholinergic activities.
* Stable doses (\>2 weeks) of concurrent dementia or psychiatric drugs for those applicable.

Exclusion Criteria:

* Atrial or junctional arrhythmias or other cardiac conditions, including pacemakers or other implantable devices that affect RR intervals or their measurement.
* AIA symptoms or dementia so severe that subject cannot assent and cooperate with all study procedures or requires immediate rescue medication for behavioral control.
* Seizure disorders or other potentially confounding medical, neurological or longstanding psychiatric illnesses.
Epidemiology and Genomic Surveillance of Staphylococcus Aureus in ICU Neonatology

Newborns hospitalized in Neonatology are particularly vulnerable to infections, in particular healthcare associated infection (HAI). Staphylococcus aureus represents the 2nd microorganism responsible for sepsis, this infection is particularly serious and like any HAI, it increases the length of hospitalization of newborns and neonatal morbidity.

In September 2020, the CDC published recommendations for the prevention and control of Staphylococcus aureus infections in neonatal intensive care unit/ICU. They specify the indications for implementing a MSSA surveillance strategy as well as the screening and management methods.

Despite the absence of a defined strategy at the national level, our establishment chose to initiate management measures several years ago following serious infections and MSSA epidemics in neonatal intensive care unit/ICU.

With the aim of improving the efficiency of care and evaluating the strategy chosen at the establishment, it is necessary to describing

* the epidemiology of MSSA carriage and infections
* cross-transmission of MSSA strains between patients
* the success rate of decolonization
* the sensitivity of detection of digestive carriage by stool swabbing in order to limit the number of samples from newborns.


Eligibility Criteria:
Inclusion Criteria:

* newborns hospitalized in neonatal ICU
* MSSA carrier

Exclusion Criteria:

* none
OPTIMIZE IDE for the Treatment of ACS

Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.25 mm - 4.00 mm


Eligibility Criteria:
Inclusion Criteria:

* Subject is an eligible candidate for percutaneous coronary intervention (PCI);
* Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
* Subject is an acceptable candidate for coronary artery bypass grafting (CABG);
* Subject has up to 3 de novo target lesions in up to 2 native coronary artery vessels, with no more than 2 lesions in a single vessel, each meeting the angiographic criteria and none of the exclusion criteria.
* Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.25 mm and ≤ 4.00 mm;

Exclusion Criteria:

* The subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina;
* The subject's target lesion(s) is located in the left main artery;
* The subject's target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate;
* The subject's target lesion(s) is located within a saphenous vein graft or arterial graft;
* The subject's target lesion(s) will be accessed via a saphenous vein graft or arterial graft;
Atrial Fibrillation Data Linkage Non-Interventional Study

The purpose of this study is to understand temporal changes in clinical features and functions, and the relationship with outcomes of atrial fibrillation (AF). AF is a problem with speed or pattern that the heart beats. It is the most common type of arrythmia. The study will use data linkage of a single center patient data and national claims database in Korea. This study does not include an actual patient enrollment process.


Eligibility Criteria:
Inclusion Criteria:

* Patients had incident AF diagnosis (International Classification of Diseases 10th Revision \[ICD-10\]; I48) in an inpatient or outpatient setting at SNUH between 1 Jan 2010 and 31 Dec 2020
* Patients aged 18 years or older on the index date

Exclusion Criteria:

* Medical claims indicating a diagnosis code indicative of rheumatic mitral valvular heart disease, mitral valve stenosis, or prosthetic heart valve during 12 months period prior to first AF diagnosis
Analysis of Tumor Mutations and Tumor Microenvironment Using Archival Paraffin-embedded Tumor Specimens

Genomic alterations have long been recognized as an important factor in tumor formation and drive tumor cell growth. However, the degree of genomic mutation (tumor mutation load, TMB) varies widely between tumors. In addition to gene mutations in tumor cells, the extent of immune cell infiltration in tumor tissues and the type and nature of immune cells (tumor microenvironment, TME) also play an important role in controlling tumor growth.

In recent years, more and more clinical studies have shown that the degree of genomic alteration (TMB) and tumor microenvironment (TME) have great potential in predicting a cancer patients' response to immunotherapy. Therefore, understanding the interaction and correlation between genomic alteration and tumor immune environment will not only deepen our understanding of tumor biology but also provide an important reference for developing immunotherapy treatment strategies for solid tumors.

This is a non-interventional, mono-centric retrospective study to be carried out in Chi Mei Medical Center (CMMC) in order to determine the association between the genomic alterations and gene expression level of immune-related genes in cancer. Samples in paraffin-embedded block of biopsies or surgical pieces (either primary tumor or metastases) will be analyzed. For each sample, clinically relevant data associated with treated cancer and needed for characterization of tumor microenvironment will be documented. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.

This trial is, through accessing to archival tumor materials, to establish the relationship between tumor mutation burden and tumor immune microenvironment for future immunotherapy strategy.

Eligibility Criteria:
Inclusion Criteria:

* Sample from patients with histologically documented cancer in target population.

Exclusion Criteria:

* Unusable sample or biologically deteriorated.
MicroMatrix® Flex in Tunneling Wounds

To evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features.

The purpose of this study is to evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features. Prospective data will be collected to assess the rate of wound area/volume reduction (progression toward closure) and post-operative complications at 12 weeks, and rate of skin graft take, when applicable, up to 16 weeks follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥ 22 years at the time of consent
2. Patient with a diagnosis of pressure injury, venous ulcer, diabetic ulcer, necrotizing soft tissue infection associated wound, dehiscing and/or draining wounds associated with open abdominal procedures, or any indication per the Instructions For Use
3. Patient is willing and able to adhere to protocol requirements and comply with the study follow-up regimen
4. Patient has reviewed the IRB/IEC-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB/IEC-approved consent form

Exclusion Criteria:

1. Burn as etiology of wound
2. Unmanaged infection and/or osteomyelitis as determined pre-operatively
3. Known allergy, hypersensitivity, or objection to porcine materials, due to religion, culture, or other
4. Patient report of concurrent participation in another clinical trial that would interfere with this study
5. Any condition, concomitant medication, or concomitant treatment that, in the opinion of the investigator, would preclude the use of the study device or preclude the patient from completing the follow-up requirements