cyrilzakka/clinical-trials huggingface dataset:
THE EFFECT OF ONLINE TRAINING ON FOOT CARE

The aim of this study is to determine the effect of online trainings on diabetic foot care on foot care behavior and self-efficacy attitudes of individuals with type II diabetes.

Purpose in accordance with the patient's Diagnostic Information Form, diabetic foot care self-efficacy Scale(DABOO), foot care Behavior Scale(ABDO) and diabetic foot risk screening forms are available in the data collection tools; education and Research Hospital Internal Medicine outpatient clinic with Deeply Izmit Seka state hospital, inpatient or outpatient treatment for persons with Type II diabetes who agree to volunteer to participate in research 90 shall apply. After that, the groups will be divided into two groups by randomization, and one of the groups will be given training sessions consisting of min 20 max 40 minutes for diabetic foot care in 5 sessions for nine weeks. After the training, the scales will be applied to the groups again. The data obtained before and after the training will be compared statistically in a computer environment


Eligibility Criteria:
Inclusion Criteria:

* Patients who were applied the Dietetic Foot Risk Screening form during the physician's examination and who were in the low and medium risk groups after the physician's examination.
* To be able to read and write.
* Being between the ages of 18-65.
* Being on oral antidiabetic (OAD) and/or insulin therapy.
* No restriction of access to the Internet.
* To be able to use the Zoom program or WhatsApp video conversation with or without support.
* Having computer and/or telephone skills.
* Volunteering to participate in the study (Informed consent form will be signed by the participants during the application)
* Not having sensory loss such as speech and hearing that prevents communication and no psychiatric problems.

Exclusion Criteria:

outside the inclusion criteria.
Should we Avoid Performing Invasive Coronary Angiography Before Cardiac Surgery in ACHD Patients?

The goal of this observational study is to compare two pre-operative methods, that is the Invasive Coronary Angiography (ICA), an actual standard diagnostic method, with the Coronary Computer Tomography (CCT) to undestand if the only CCT is sufficent to confirm the presence of a significative coronary disease and so to identify possible lesions in the coronary ematic circle, for example: stenosis and narrowing of coronary vessels. This observational study included people who have a congenital heart desease with indication of cardiac surgery and, why this disease, who had already performed these two diagnostic methods and/or who will perform them. The main question it aims to answer is: Should we avoid performing invasive coronary angiography (ICA) before cardiac surgery in people who have congenital heart desease (ACHD patients)?

The primary aim is to verify the diagnostic reliability of coronary CCT to confirm or exclude the presence of significant coronary artery disease in ACHD patients who are candidates for cardiac surgery compared to ICA, the current gold standard.

the Secondary objectives is to measure the occurrence of side effects and/or complications secondary to ICA and CCT procedures. To measure the frequency with which each of the two methods is able to identify the presence of coronary anomaly and the correct anatomical relationships between the anomalous coronary artery and the adjacent structures. To compare the waiting times of coronary CCT and coronarography, in order to assess their actual availability in daily clinical practice.

The primary outcomes of the study are:

* non-significant lesions of the coronary tree (stenosis \< 50%)
* significant lesions (stenosis ≥ 50%)
* limited to CCT investigation: coronary tree partially or completely unassessable due to artefacts or extensive calcifications preventing proper assessment.

Eligibility Criteria:
Inclusion Criteria:

* Adult congenital heart disease patient who is a candidate for cardiac surgery for correction of defect valve, or who performed the surgery after 01.01.2010
* Clinical indication for preoperative ICA and CCT performed less than 12 months apart within 12 months of planned cardiac surgery
* Age ≥ 18 years
* Obtaining written informed consent

Exclusion Criteria:

* Inability to perform ICA for any reason (e.g., poor vascular access or anatomical difficulty in reaching the coronary arteries)
* Patient with severe renal failure on dialysis therapy
* Patient with previous cerebri stroke
Metabolic and Psychological Changes Associated With Menopause Among Women With HIV

This study will investigate the prevalence and extent of both metabolic and psychosocial changes associated with the menopause transition over 1 year among women with HIV compared to women without HIV of similar age, weight, menstrual status, and ethnic background. It is hypothesized that HIV positive women will demonstrate increased abdominal fat, abnormal cholesterol and blood sugar levels, reduced bone density, and greater psychosocial challenges than HIV negative women during the menopause transition.

Treatment with combination antiretroviral therapy (ART) has resulted in substantial improvement in survival among women living with HIV in the United States, many of whom have entered or will soon enter the menopause transition. Significant changes are seen across the menopause transition among women without HIV including increased abdominal fat and waist circumference, reduced muscle mass, and changes in lipids, glucose metabolism and bone density. HIV and potentially ART use have been associated with similar manifestations such as reduced bone density, changes in lipid and glucose metabolism, and body composition, though little is known regarding how the virus may influence or exacerbate such changes across the menopause transition. In addition to metabolic factors, menopause has been associated with changes in mood state, decreased quality of life, and presence of vasomotor symptoms among women without HIV. Psychosocial indices, such as depression and decreased quality of life are common among women with HIV, and may manifest or worsen during the menopause transition. However, research investigating the presence and acuity of these symptoms among women with HIV during menopause is limited.

Eligibility Criteria:
Inclusion Criteria:

1. Females age 45 -52.
2. Females in the perimenopausal transition characterized by the presence of abnormal menstrual function, defined as less than 3 periods in the past 3 months, 1 cycle \>60 days in length in the prior 6 months, or irregular menses in 2 or more cycles within the past 6 months. Women who have been amenorrheic for \>12 months will not be eligible. 3. Women with HIV must have previously documented HIV and be receiving a stable treatment regimen for \> 3 months.

Exclusion Criteria:

1. Use of estrogen, combination hormone replacement therapy, oral contraceptive pills/patches, Depo Provera, glucocorticoids, testosterone, growth hormone or other anabolic steroids within the past 6 months.
2. Diabetes and current use of insulin, or medications known to affect glucose or insulin levels.
3. Positive pregnancy test or recently pregnant within the past year or lactating.
4. Presence of active cancers.
5. Current use of bisphosphonates, or a diagnosis of Paget's disease or other illnesses known to affect bone (Use of calcium and Vitamin D will be permitted).
6. Opportunistic infection within 3 months of study participation (HIV positive subjects).

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Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection

Fecal microbiota transplantation (FMT) is a treatment that restores the balance of gut bacteria and is the most effective treatment for patients who suffer from recurrent Clostridioides difficile infection (CDI) brought on by antibiotic use. Although highly effective, we do not understand how FMT actually works.

Freeze-dried or lyophilized fecal microbiota transplant (LFMT) has been shown to be effective. Recently, filtered fecal slurry, free of any live bacteria, has also been shown to cure 5 such patients. The advantage of the filtered fecal slurry is that it may be safer to patients as it does not contain any live bacteria. We have conducted a pilot study comparing LFMT to lyophilized sterile fecal filtrate (LSFF) in 9 patients, and found that the success rate of treatment was 80% vs 75% in these 2 groups.

Therefore we need to perform a larger multicenter study to compare LFMT to LSFF to determine the success rate of curing these patients.

This prospective double blind randomized study will enroll 248 patients with recurrent Clostridium difficile infection (RCDI) in a 1:1 ratio to receive either LFMT or LSFF by capsules.

Patients will receive 15 capsules at week 0 and be assessed at weeks 1, 4, 8 and 24. Blood, stool and urine samples will be collected. If the first treatment fails, patients will be given open label LFMT from the same donor. If treatment fails again, FMT will be offered in the form and route at the treating physician's discretion.

Eligibility Criteria:
Inclusion Criteria:

* at least 3 episodes of recurrent CDI with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile test, each occurring within 3 months of each other.
* CDI infection under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
* Ability to provide informed consent
* Females and males must agree to effective contraception for the duration of the study

Exclusion Criteria:

* Severe or fulminant colitis
* Chronic diarrheal illnesses such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission 3 months prior to enrollment.
* Those taking or planning to take an investigational drug within 3 months of enrollment
* Chemotherapy or radiation therapy
* Oropharyngeal or significant esophageal dysphagia
* Ileus or small bowel obstruction
* Pregnant or planning to become pregnant within 3 months
* Breastfeeding or planning to breastfeed during the trial
* Active infection requiring antibiotics
* Life expectancy \<6 months Those with history of total colectomy
Comparison of ESP Block and STAP Plane Block

In order to effectively manage postoperative analgesia in patients planned to undergo elective laparoscopic cholecystectomy, patients will be divided into 2 (two) groups and informed consent forms will be obtained after the necessary information is provided so that both groups can be included in the study. In the group planned to undergo erector spinae plane block, erector spinae plane block will be performed after monitoring and sedation in the operating room block unit before being taken to the surgical table preoperatively and postoperative PCA analgesia will be applied. In patients who will undergo subcostal transversus abdominis plane block, subcostal tap block will be performed after monitoring and sedation in the operating room block unit before being taken to the surgical table preoperatively and postoperative PCA analgesia will be applied. The patients' perioperative pain will be monitored with NOL (nociception level) monitor. Remifentanil dose will be adjusted to keep the NOL level between 10 and 25. After the patients are followed up for 24 hours postoperatively, their additional analgesia needs and amounts during this process will be compared. In this way, it is aimed to show that the analgesic method can be used effectively in the follow-up of pain management by comparing the Erector Spina Plane block and the Subcostal Transversus Abdominis Plane block as an effective analgesic application in laparoscopic cholecystectomy operations.


Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo laparoscopic cholecystectomy:
* 18-75 years old
* ASA I-II-III patients

Exclusion Criteria:

* Use of anticoagulant drugs
* Known allergy to drugs to be used
* Infection in the area where the block will be performed
* Patient's reluctance
Biomarkers and Outcome 1 and 10-15 Years After Severe Traumatic Brain Injury

After written consent from next-of-kin patients with severe traumatic brain injury was included from the neurointensive care unit (NICU) at Sahlgrenska university hospital, Gothenburg. Blood and CSF samples were collected during the initial 3 weeks after trauma. 1 year after trauma patients were assessed according to Glasgow outcome scale (GOS), NIHSS and Barthels. 10-15 years after trauma a repeated evaluation according to GOS was performed by telephone. Different biomarkers such as Neurofilament light, Glial fibrillary acidic protein and Tau among others, was analyzed from serum and CSF samples. Further patients were explored Apolipoprotein-E genetype (APOE). The investigators hypothesize that higher biomarkers concentrations and positive test for this gene relate to worse outcome 1-year and 10-15 years after trauma. Further that these biomarkers and genetic marker further have prognostic value on outcome 1-year and 10-15 years after trauma. Finally, the investigators want to explore the concentrations dynamics of these biomarkers in serum and CSF in the acute phase after trauma.

Patients with a severe traumatic brain injury (sTBI) were included after written consent from next-to kin. The injury was considered as severe if having a Glasgow coma scale of 8 or less. Within 48h of trauma patients were included from the neurointensive care unit at Sahlgrenska university hospital, Gothenburg during 2000-2004. Patients were intubated and had a ventricular catheter. All patients were treated in accordance with the Lund Concept. Samples from ventricular cerebrospinal fluid (CSF) and blood was collected, during the first 3 weeks, then prepared for storage and later analyzed. Samples were stored in -70 degrees Celsius until analyzed. 1 year after trauma patients were assessed according to Glasgow outcome scale (GOS), NIHSS and Barthels Index. 10-15 years after trauma an evaluation of GOS by phone was repeated. Biomarkers such as Neurofilament light, Glial fibrillary acidic protein, Tau among others is analyzed in serum and CSF. Further, patients APOE genotype was explored. The investigators hypothesizes that higher concentrations of these biomarkers both in serum and CSF relate to worse 1-year and 10-15 year outcome after a severe traumatic brain injury. Further, patients that have the gene APOE4 is predisposed to worse 1 year and 10-15 year outcome after a sTBI. The investigators further want to explore the dynamics of these biomarkers in serum and CSF in the acute phase after trauma and if these biomarkers gave any prognostic value to on outcome (mortality and functional) 1-year and 10-15 years after trauma.

Eligibility Criteria:
Inclusion Criteria:

* Reaction level scale \>3, corresponding to a Glasgow coma scale \<9
* A therapeutic indication for intracranial pressure monitoring
* Need for ventilator treatment

Exclusion Criteria:

* Not residing in Sweden
Study to Identify the Reduction of Exacerbations Resulting in Hospital Admission in Patients With COPD.

identification of the reduction of exacerbations resulting in hospital admission in COPD patients after the use of the Breath Detect telemedicine platform.


Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosed in GOLD II state or higher

Exclusion Criteria:

* Can´t read and talk in spanish
Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection

Adjuvant whole-brain radiation therapy (WBRT) after resection of single brain metastasis is considered as a standard associated with side effects leading to decreased neurocognitive function. The Investigators addressed the question whether stereotactic radiotherapy of the resection cavity impairs neurological status and/or cognitive functions in compare to adjuvant WBRT.

Patients with surgically removed single brain metastasis are randomly allocated to control or experimental arm. Before treatment the MRC Neurological Status Scale is used for assessing neurological status, the EORTC QLQ-C30 and QLQ-BN20 for quality of life and Mini-Mental State Examination to assess cognitive functioning. The control group receive 30Gy in 10 fractions of 3Gy over 12 days to the whole brain. The patients in the experimental arm are treated with stereotactic radiotherapy to the resection cavity. The dose to the tumor bed is 15-18Gy in one fraction or 25Gy in 5 fractions. The study hypothesis is that the difference in the 5-months failure free survival rate isn't higher than 25% in experimental arm compared to control arm.

Eligibility Criteria:
Inclusion Criteria:

* Patients with surgically removed histologically proven metastatic cancer
* Subtotal or total resection of single brain metastasis
* Presence of single brain metastasis in MRI
* Karnofsky Performance Status ≥ 70
* Life expectancy \> 6 months (minimal extracranial disease or availability of effective oncology treatment)
* No previous history of cranial irradiation
* Availability of MRI
* Starting radiotherapy within six weeks after neurosurgery
* Negative pregnancy test for woman
* Written informed consent

Exclusion Criteria:

* Dementia and central nervous system diseases leading to higher risk of radiation toxicity
* Contraindications for MRI and/or no patient's tolerance and acceptance of cranial MRI
* Altered level of consciousness
* Histologically proven metastatic small cell lung cancer
Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule

There is no randomized controlled trial (RCT) comparing Conformal Radiotherapy (3DCRT) versus the Intensity Modulated Radiotherapy (IMRT) in terms of toxicity and disease control. Data from retrospective studies show that IMRT reduces the risk of severe late complications. More recently, the results from the RTOG 0126 study have also confirmed the benefit from IMRT in reducing acute toxicity for prostate cancer treated with conventional dose escalation. Therefore, to investigate the real clinical benefit of the IMRT over 3DCRT using a hypofractionated schedule in prostate cancer, the investigators developed a RCT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of prostate cancer
* With age between 18-75 years classified in low
* Intermediate and high-risk group according to their Gleason score
* T stage and initial PSA (iPSA).
* Low risk group included patients with Gleason score \<7 / stage T1-T2a, and iPSA \<10 ng/mL.
* Intermediate risk included Gleason score \< 7, or Stage T1-T2b, or iPSA level of 10-20 ng/mL
* High-risk patients with Gleason score \>7, or Stage \> T2b, or iPSA \>20 ng/mL.
* All patients classified as high risk was submitted to the bone scans.

Exclusion Criteria:

* Patients with metastases
* Prior history of prostatectomy
* Pelvic radiotherapy treatment
* Chemotherapy treatment were excluded of this trial.
A Novel Approach Utilizing Organ Specific Age Proteomics

This study compares changes in P16INK4A expression and plasma proteomic signatures of specific organ age pre- and post-chemotherapy in women treated with adjuvant chemotherapy for early-stage breast cancer. It aims to determine if biological and accelerated immune aging, assessed using T cells from peripheral blood, represents aging in different organs.

Patients receiving chemotherapy, especially adjuvant regimens that include anthracyclines and taxanes, often experience late development of cardiac toxicity, functional loss, and cognitive decline. Comparing baseline characteristics with organ aging before therapy might identify patients at the highest risk for chemotherapy complications. For example, this is clinically significant for patients whose therapy includes taxanes or other drugs known to cause peripheral neuropathy. Identifying aging in the neurological or vascular systems before treatment might lead to changes in regimens.

Determining accelerated aging in specific organs allows for investigating interventions to mitigate organ damage. For instance, identifying patients at the highest risk of cardiac aging after treatment could lead to testing the effects of exercise, senolytics, and other strategies to reduce the risk of long-term heart disease.

Chemotherapy has revolutionized cancer treatment, significantly improving relapse-free and survival rates for many cancers. However, these advances have come with a downside, and nowhere is this more evident than in childhood cancer. Despite the significant advances in the curability of most childhood cancers, up to 20% of patients die of comorbidity and secondary cancers by the age of 35 years.

Recent research shows that a plasma proteomic measure of protein abundance and expression can provide a" global" proteomic signature that accurately predicts chronologic age in the general population. It was shown that accelerated organ aging conferred a 20-50% higher mortality risk, and this was pronounced for those with accelerated cardiac and brain aging.

Previous studies have shown that p16INK4a, a robust biomarker of cell senescence measured in peripheral blood T cells, rises dramatically and likely irreversibly after adjuvant therapy for breast cancer. For anthracycline regimens, p16INK4a changes suggest 10 to 20 years of accelerated aging shortly after treatment. Additionally, in murine models, changes in P16INK4A are seen in all organs as mice age, but not all organs age at the same rate.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥22years and \<66 years
* Diagnosed with early-stage breast cancer (The American Joint Committee on Cancer stages I-III).
* Understand and read English.
* Receive care at the study site.
* Able to understand and participate in study procedures for length of study.

Exclusion Criteria:

* Unable to provide consent, unable to communicate verbally.
* Unable to understand or read English.
* Enrolled in hospice care.
Study on the Postoperative Complications and Changes in Posterior Cervical Muscle Volume After Cervical Single Open-door Expansive Laminoplasty With Preservation of Muscular Ligament Complex

In 2006, our hospital improved and began to use cervical expansive open-door laminoplasty preserving the unilateral ligament with muscle complex.The effect of recent follow-up, postoperative complications and their effects on posterior cervical muscle volume were also studied.However, there are few reports about medium and long-term follow-up.

Expansive laminoplasty of posterior cervical canal has been widely used for the treatment of cervical spondylotic myelopathy with cervical spinal stenosis and ossification of the posterior longitudinal ligament since Hirabayashi et al. described it in the 1970s. Traditional single-door surgery requires extensive dissection of both paravertebral muscles and ligaments, and resect part of the spinous process. Postoperative complications (axial neck pain, stiffness, cervical kyphosis, reduced range of motion, etc.) are also related to that in degree. In order to reduce the damage to the posterior cervical structure and reduce the associated complications, in the 1990s, Yoshihiko Oshima et al. introduced the expansive laminoplasty of the spinal canal with one side of the posterior ligamentwith muscle complex attached to the spinous process. In 2006, our hospital improved and began to use cervical expansive open-door laminoplasty preserving the unilateral ligament with muscle complex.The effect of recent follow-up, postoperative complications and their effects on posterior cervical muscle volume were also studied.However, there are few reports about medium and long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* From 2006 to 2018, the patients admitted to the orthopedic department of our hospital for posterior cervical open-door expansive spinal canal laminoplasty with one side muscle-ligament complex reserved.Complete preoperative and postoperative diagnosis and treatment data of our hospital were available, and the follow-up time was ≥2 years.

Exclusion Criteria:

* Patients with incomplete preoperative and postoperative diagnosis and treatment data or less than 2 years of follow-up