cyrilzakka/clinical-trials huggingface dataset:
Pathogenesis of Postoperative Infections and Biomarkers for Early Diagnosis of it

Infections remain a prevalent complication after major abdominal surgery. The common belief that most surgical site infections (SSIs) following elective surgery with modern antiseptic techniques are due to intraoperative contamination is still not confirmed. Therefore, alternative mechanisms for SSI development, such as the Trojan Horse theory-which suggests that pathogens from distant sites like the gastrointestinal tract may cause postoperative infections-should be explored. This study aims to analyze the preoperative microbiome of surgical patients' gut and oral cavities and assess whether microorganisms found there are present at the infection site. Additionally, this study will investigate a panel of biomarkers for predicting postoperative infections.

Infections remain a significant concern following major abdominal surgery. The prevailing notion that most surgical site infections (SSIs) after elective surgery with modern antiseptic techniques are solely caused by intraoperative contamination remains unconfirmed. Therefore, alternative mechanisms for SSI development, such as the Trojan Horse theory-which suggests that pathogens from distant sites like the gastrointestinal tract may contribute to postoperative infections-require thorough investigation. This longitudinal observational study aims to either support or challenge the Trojan Horse theory.

This study will enroll patients undergoing major abdominal surgery for confirmed or suspected cancer. Biological samples from stool, the oral cavity, and infection sites will be collected for sequencing and microbiome analysis to evaluate the presence of pathogens potentially responsible for postoperative infections originating from the gastrointestinal tract. Additionally, blood samples will be collected to identify predictive biomarkers associated with the development of postoperative infections.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is scheduled to undergo a major resection-type abdominal surgery due to cancer of the esophagus, stomach, pancreas, liver, bile ducts, colon or rectum.
2. Patient is willing to participate.
3. Age ≥ 18 years.

Exclusion Criteria:

1. Pregnancy.
2. Previous surgical resection of the digestive tract, excluding appendectomy and/or cholecystectomy.
3. Anticipated operation with preventive ileostomy.
4. The operation is planned to be performed as a matter of urgency.
5. Antibiotic therapy ≤1 month. before surgery.
6. Chronic inflammatory bowel disease (non-specific ulcerative colitis, Crohn's disease) or radiation or other colitis of origin.
7. During the last year, the patient suffered from Cl. difficile colitis or was Cl. difficile carrier, had salmonellosis or others intestinal infections.
8. During the last year, the patient used (\> 3 months) pre-/pro-/(syn)biotics.
9. During the last year, the patient has been taking proton pump inhibitors continuously (\> 6 months).
Earliest Lung Ultrasound Time for Predicting the Need of Surfactant

Lung ultrasonography (LUS) is fast and easy technique. it also has high reliability, so it has started to be used more in evaluating respiratory distress in the neonatal period. The most important feature of LUS is being radiation-free. Three LUS findings that show respiratory distress syndrome were described. They were white lung appearance, lack of preserved areas and loss of pleural integrity. The sensitivity of these findings was found to be 98-100% and the specificity 92-100%. A few studies have shown that surfactant need can be determined by LUS.

It was observed that lung findings were more severe in LUS performed in the early period because of non-completed fetal lung fluid clearence, but the findings could be improved during follow-up. Therefore, it is not known when the earliest time of LUS shows the actual clinical condition and course of the patient.

This study was planned to find the most reliable and earliest US time. Evaluation with LUS was done at 30 minutes and repeated at 1, 2, 4 and 6 hours of life. The LUS findings would be compared with x-ray findings and the correlation of surfactant need with LUS findings would also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* preterm babies with a gestational age 32 weeks or less
* babies treated with CPAP

Exclusion Criteria:

* If a baby was intubated in delivery room because of the responsiveness to face-mask ventilation, he/she was excluded.
* congenital heart diseases
* complex congenital malformations
* chromosomal abnormalities.
EMDR Treatment of Conditioned Nausea and Vomiting in Cancer Survivors

To explore the effectiveness of EMDR therapy treatment in reducing symptoms of chemotherapy-induced conditioned nausea and vomiting in (former) patients with cancer.

Conditioned nausea and vomiting is a common side effect of anti-cancer treatment, and while strategies like antiemetics exist, their effectiveness is limited. Conditioned nausea and vomiting can possibly be addressed through Eye Movement Desensitization and Reprocessing (EMDR) therapy. EMDR therapy is a therapeutic intervention, proven to be effective in the treatment of post-traumatic stress disorder (PTSD), and promising in treating a range of other conditions. At the UMCG, EMDR therapy is used on a small scale to treat conditioned nausea with positive results, although more rigorous research is needed to fully establish its efficacy. This study aims to explore the effectiveness of EMDR therapy treatment in reducing symptoms of chemotherapy-induced conditioned nausea and vomiting in (former) patients with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Previously pathologically confirmed diagnosis of cancer
* Previously treated with systemic cancer therapy
* Persistent complaints (more than 2 months) of conditioned nausea and/or vomiting
* Able to understand spoken and written Dutch
* 18 years or older

Exclusion Criteria:

* Ongoing psychiatric treatment
* EMDR therapy contraindications (dissociative disorders, personality disorders or severe somatic disorders (e.g. cardiac arrhythmias))
* Complex type 2 trauma
* Known with recent conditions / non-anti-cancer medication which can elicit nausea (e.g. pregnancy or alcohol abuses)
Evaluation of Patellar Crepitus Following Total Knee Arthroplasty

Analyze clinical data for a group of subjects implanted with a new surgical device designed to reduce the incidence of patellar crepitus following PCL-substituting TKA and compare that to a control group of subjects implanted with a TKA design known to have an incidence of patellar crepitus of approximately 5%.

Patellar crepitus and clunk following posterior cruciate substituting total knee arthroplasty is a persistent problem with a reported incidence as high as 14%. The development of this complication necessitates additional surgery in some patients. Numerous etiologies have been reported including design of the femoral component. Due to a higher than desired incidence of patellar crepitus with the PFC Sigma PS TKA, design modifications of the trochlear groove of the femoral component were introduced with the release of the PFC Sigma HP PS femoral component. The purpose of the proposed study is to evaluate the incidence of patellar crepitus after posterior cruciate substituting TKA utilizing the PFC Sigma vs. the PFC Sigma HP PS femoral components.

Eligibility Criteria:
Inclusion Criteria:

* subjects that received primary total knee replacement

Exclusion Criteria:

* Did not return for follow - up appointments Required any post operative manipulation
Modified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML)

A phase II clinical trial evaluating the efficacy and tolerability of induction and consolidation chemotherapy comprising Fludarabine, cytarabine and attenuated-dose Idarubicin (modified-FLAI) in the elderly patients with acute myeloid leukemia.


Eligibility Criteria:
Inclusion Criteria:

* previously untreated AML (excluding acute promyelocytic leukemia)
* age greater than 60 years old
* ECOG PS (Eastern Cooperative Oncology Group Performance scale) less than 2
* adequate hepatic/ renal/ cardiac function

Exclusion Criteria:

* acute promyelocytic leukemia
* significant cardiac disease
* combined non-hematologic malignancy
* aleukemic leukemia (only granulocytic sarcoma)
* CNS (Central Nervous system) involvement
* significant comorbidity/ uncontrollable bleeding tendency
Ultra - Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI)

To address the critical need in crisis intervention for children and adolescents at suicidal risk the investigators developed an ultra-brief acute crisis intervention, based on Interpersonal Psychotherapy (IPT). The current adaptation of IPT-A is comprised of five weekly sessions, followed by monthly follow-up caring email contacts to the patients and their parents, over a period of three months.

In recent years, suicidal behaviors have shown substantial increase worldwide. This trend is also prominent in Israel and has led to a dramatic increase in mental health treatment demand resulting in long wait times and low treatment acceptance rate. To address the critical need in crisis intervention for children and adolescents at suicidal risk, the investigators developed an ultra-brief acute crisis intervention, based on Interpersonal Psychotherapy (IPT). IPT is an evidence-based intervention for various psychopathologies among different age groups. The current adaptation of IPT-A is comprised of five weekly sessions, followed by monthly follow-up caring email contacts to the patients and their parents, over a period of three months.

Eligibility Criteria:
Inclusion Criteria:

* depression symptoms
* suicidal behavior

Exclusion Criteria:

* acute medical condition
* intellectual disability
* cognitive impairment
* linguistic limitation
FREEDOM - First Real-Life Evaluation of Enablex Done in ZA Overactive Bladder Patients During a 3 Months Period

Patient perspective on Overactive Bladder and symptoms experienced after administration of Darifenacin


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients \> 18 years with symptoms of overactive bladder.

Exclusion Criteria:

* Contraindications for the treatment with Darifenacin prolonged-release tablets according to the registered package insert.
* Pregnancy and lactation. Women of childbearing potential have to use an acceptable method of contraception.
* Concomitant treatment with drugs known to affect mainly the urinary bladder function (e.g. anticholinergics, antispasmodics) at any time during the study. Concomitant treatment with botulinum toxin, capsaicin or resiniferatoxin at any time during the study and treatment with botulinum toxin, capsaicin or resiniferatoxin in the last 6 months prior to Visit 1.
Blood Flow Restriction on Functional Mobility in Pre-frail Older Adults

This study investigates the effect of blood flow restriction with resistance exercise on functional mobility in pre-frail older adults. It is hypothesized that receiving resistance exercise with blood flow restriction will exhibit better improvement on functional mobility than only receiving resistance exercise in pre-frail older adults.

Participants aged over 65 years old with less than two items positive of Fried frailty phenotype assessment result will be recruited. The participants will be randomly assigned to two training groups, blood flow restriction resistance exercise and traditional resistance exercise. Both groups will receive the training 30 minutes/session, two sessions/week for six weeks. Muscle strength of the lower extremities and functional mobility tests will be used to assess outcomes at pre-training, 3-week after training, post-training, and one-month and two-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 65 years old
* Fried frailty index fulfill 1-2 criteria
* Able to walk 6 meters independently
* Able to understand and follow ≥ 3 instructions

Exclusion Criteria:

* Severe hypertension (\>180/110mmHg)
* Peripheral neuropathy
* History of deep-vein thrombosis (DVT)
* Cardiovascular diseases (i.e. Heart failure NYHA Classification III or IV, myocardial infarction, pulmonary hypertension, coronary artery stenosis)
* Neuromuscular diseases (i.e. Stroke, Parkinsons' disease)
* History of resisted exercise training program within the last 6 months before screening
Relation Between Dose and Time to Reinjection of Botulinum Toxin-A in Patient With Poststroke Spasticity From a Real-world Healthcare Insurance Database.

Determining the mean/median time between botulinum toxin-A injection within the treatment of patients with spasticity after stroke in relation to the botulinum toxin dose from a healthcare insurance database in the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

* A patient will be included if he has a diagnosis stroke within the rehabilitation setting and has received at least two injections of botulinum toxin-A: Dysport or Botox

Exclusion Criteria:

* A patient will be excluded if he has been only treated with Xeomin
Effect of Exercise Training on Fine Motor Skills

Despite the importance of physical activity for adolescent physical development, the specific impact of different types of exercise training on fine motor skills and testosterone concentration is unknown. A primary aim of this study was to analyze the benefits of cardiovascular and coordinative exercise training on fine motor skills in an adolescent population. A second aim of our study was to determine the testosterone concentration after physical stress of cardiovascular and coordinative exercise training and if testosterone was related to fine motor skills among adolescents following an exercise training intervention.

We assigned 135 adolescents (68 girls, 12-15 years of age) from Lithuania. Adolescents were assigned to one of three groups: control group (CON) (n = 46; 23 girls), coordinative exercise (CE) (n = 41; 22 girls), and cardiovascular exercise (CVE) group (n = 48; 23 girls). Participants performed all necessary tests according to the study protocol one week before the intervention. Adolescents were familiarized with the tests on a separate day before the first assessment. A second set of tests was performed one week after the 10-week exercise intervention.

The exercise intervention period was 10 weeks. Exercises were led by a Physical Education teacher. Experimental groups had common physical education classes twice per week for 45 minutes each, and additional exercise sessions were held three times per week for 45 minutes after school.

Eligibility Criteria:
Inclusion Criteria:

* absence of physical impairment (e.g. traumatic injury)
* absence of mental impairment (e.g. mental retardation)
* no consumption of psychotropic medications

Exclusion Criteria:

• restrictions to do exercises (based on Medical certificate issued by the Physician)
Multichannel tDCS to Reduce Hypertonia in Patients With Prolonged DOC

Previous studies showed that transcranial direct current stimulation (tDCS) transiently improves performance of motor function in stroke patients, as well as decrease muscle hypertonia. In severely brain injured patients with disorders of consciousness (DOC), a single stimulation over the left dorsolateral prefrontal cortex has shown to improve patients' sign of consciousness. Nevertheless, other brain areas could be stimulated in order to manage other symptoms occurring in this population of patients, such as muscle hypertonia. In this study, investigators will assess the effects of bilateral fronto-central tDCS on spasticity as measured with the Modified Ashworth Scale (MAS) and on the Coma Recovery Scale-Revised (CRS-R) scores in patients with DOC in a double-blind sham-controlled experimental design.

Following severe brain damage and coma, some patients may remain in a vegetative state (VS) or minimally conscious state (MCS). At present, there are no evidence-based guidelines regarding the treatment of patients with disorders of consciousness (DOC). A previous study showed that a single stimulation (using transcranial direct current stimulation - tDCS) of the left prefrontal cortex induces an behavioral improvement in some patients in DOC. Nevertheless, patients with DOC suffer from other invalidating dysfunctions such as spasticity (muscle hypertonia). In sroke patients, the inhibition of the motor cortex through cathodes placed over the motor region showed to reduce spasticity.

In this study, investigators aim to assess the effect of single session of transcranial direct current stimulation (tDCS) over right and left fronto-central areas (using 2 anodes and 2 cathodes), on the level of hypertonia and the level of consciousness of patients with DOC, in a double blind randomized sham controlled study. The anodes will be placed over F3 and F4, and the cathodes over C3 and C4.

tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability under the electrodes, via weak polarizing currents. It has been reported that anodal tDCS transiently improves motor functions in healthy subjects and patients with stroke or Parkinson's disease.

By reducing the activity of the motor cortex (cathodes) and increasing the activity of the prefrontal cortex (anodes) we expect to observe a better motor function in patients with DOC.

Eligibility Criteria:
Inclusion Criteria:

* post comatose patients
* patients in minimally conscious state
* patients with stable condition
* patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

Exclusion Criteria:

* premorbid neurology antecedent
* patients in coma
* patients \< 28 days after the acute brain injury
* patients with a metallic cerebral implant
* cranioplasty
* shunt
68Ga-PSMA PET/MRI in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk

The goal of this observational study is to learn if Ga-68 PSMA PET/MRI can better diagnose prostate cancer than mpMRI in males between 40 to 85 years old who is naive to prostate biopsy and is suspicious for prostate cancer by elevated PSA or lower urinary tract symptoms. The main questions it aims to answer are:

1. Does PSMA PET/MRI have better PPV and NPV than mpMRI to diagnose prostate cancer?
2. Does lesion location concordance in PSMA PET and MRI effect diagnosis accuracy?

Participants will:

1. Undergo a Ga-68 PSMA PET/MRI scan and keep followed up for 2 years to check if prostate cancer is diagnosed after the scan.
2. Between the follow-up period, visit the clinic once every 6 months for checkups and blood tests.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who indicated MRI of pelvis due to clinical suspicion of prostate cancer based on elevated PSA (4\~20 ng/mL), abnormal digital rectal examination or lower urinary tract syndromes.
2. Males aged between 40 and 85 years with a life expectancy greater than two years.
3. Naïve to prostate biopsy in the past.
4. Assessment of daily physical status graded 0 to 2 based on the Eastern Cooperative Oncology Group (ECOG) criteria.
5. Willing to sign the informed consent.

Exclusion Criteria:

1. Unable to tolerate the PET/MRI scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable, or having MRI unsafe metallic implants or devices.
2. With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.
3. High risk to conduct examination after evaluations of PI
4. Patient had previous malignancy history
Autoimmunity Contributes to the Severe Progression of COVID-19

Although elderliness and chronic comorbidities such as hypertension, diabetes, cardiovascular diseases and respiratory diseases, are known risk factors for severe progression of COVID-19, it still remains puzzling on why younger patients without any comorbidity advance to severity and even more rapidly, the underlying mechanisms for severe progression of COVID-19 still needs to be elucidated. Based on current picturing of the COVID-19, similar to SARS, besides direct viral toxicity, immune-mediated attack derived from either the release of pro-inflammatory cytokine perpetual cascade, or secondary pathogen-induced autoimmunity response may also play important roles on disease progression and partly account for the multi-system injuries related with COVID-19. Virus infection has been implicated in the initiation of autoimmunity, which can attack multiple systems. With the knowledge of characteristics of SARS, high level of autoimmune activity was shown to make severe injuries to lungs or other organs, leading to poor outcome including multi-system failure9. COVID-19 may also get autoimmunity involved which is of obviously younger and female population predominance during the pathogenesis, no matter pre-existing or secondary to viral infection. Particularly strong immune response to SARS-CoV-2 infection might not be protective, but perhaps, be harmful to the host, contributing to disease severe progression.


Eligibility Criteria:
Inclusion Criteria:

1. Adult inpatients from two centers, Zhongnan Hospital of Wuhan University and Thunder God Mountain Hospital, Wuhan, China.
2. Experimental confirmed COVID-19 patients.
3. Patients tested with autoimmunological detections including either ANA+ENA (Antinuclear antibody + Anti-extractable nuclear antigen antibody), Anti-cardiolipin antibody (ACA), Rheumatoid factor (RF), or Anti-streptolysin O antibody (ASO) detection.

Exclusion Criteria:

1. Minors.
2. Experimental un-confirmed COVID-19 patients.
3. Patients without autoimmunological detections.
An Open-label, Non-comparative Study to Document the Tolerability to Ramipril in Patients With at Least One High Risk for Developing a Major Cardiovascular Event

Primary Objective:

To document the tolerability of patients receiving study medication at 12-week of therapy in terms of the scoring system assessed by the investigator.

Secondary Objectives:

* To document drug safety at 12-week of treatment in terms of number of Adverse Drug Reaction or Serious Adverse Drug Reaction reported.
* To describe the population treated as per the HOPE study indication in current clinical practice (demographics, cardiovascular risk-factors at treatment initiation, concomitant treatments patterns).

The duration of the study period is 8-12 weeks.

Eligibility Criteria:
Inclusion criteria :

* Man or woman, age 55 years old or more.
* Presence of a high risk of developing a major cardiovascular event, defined as at least one of the following underlying conditions:
* Clinical evidence of coronary artery disease (examples: previous myocardial infarction \[MI\], positive stress test or significant stenosis at coronary angiography, previous Percutaneous Trans-Luminal Coronary Angioplasty \[PTCA\], previous Coronary Arterial Bypass Grafting \[CABG\]);
* Clinical evidence of peripheral vascular disease (examples: history of intermittent claudication with positive Doppler or angiography, previous limb bypass surgery, previous percutaneous trans-luminal angioplasty, previous limb or foot amputation);
* Previous stroke;
* Diabetes (insulin-dependent or non-insulin dependent) with at least one of the following cardiovascular risk factors:
* hypertension (blood pressure \[BP\] \>140/90 mmHg, or patients on antihypertensive treatment);
* hypercholesterolemia (total cholesterol \> 5.2 mmol/L \[\>200 mg/dL\]);
* low HDL cholesterol (\< 0.9 mmol/L \[\<3.5 mg/dL\]);
* current cigarette smoking;
* documented microalbuminuria (30-300 mg/24 hours);
* Evidence of previous vascular disease.

Exclusion criteria:

* Patients with contraindications to ramipril use (as per the local Ramipril Product Information)
* hypersensitivity
* pregnancy, lactation
* bilateral renal stenosis
* Patients with clinically relevant concomitant disease that could compromise the patient's safety or follow up.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.