cyrilzakka/clinical-trials huggingface dataset:
Mycoplasma Species and the Genitourinary System

The purpose of this study is to determine if the presence of Mycoplasma hominis bacteria is associated with Bacterial vaginosis (BV), non-gonococcal urethritis (NGU) or vaginitis in patients attending sexual health clinic. Patients were participants of the MYCO WELL D-ONE study. Ethics for this follow-on pathway-to-portfolio study (IRAS:253889) is now approved by NRES and HCRW.

The important primary aim of this study is to determine if Mycoplasma hominis (M.hominis) is associated with BV, NGU and vaginitis in the genitourinary system of patients or if they are bacterial commensals. This is important proof of concept work. The secondary aim for this research is to determine if there are clinical and social parameters that are associated with Mycoplasma infection.

Preliminary analysis of 100 patients yielded pilot data suggesting M.hominis is strongly associated with BV, NGU and vaginitis. We aim to consolidate these findings by expansion to 1000 patients from our completed MYCOWELL D-ONE study.

The clinical study site is The Department of Sexual Health, Dewi Sant Hospital, Cwm Taf University Health Board. This study will retrospectively examine the clinical notes of consented participants (IRAS project ID:253889) in the MYCO WELL D-ONE study (IRAS project ID:230693).

Notes will be identified by the sexual health clinic number. The clinic proforma records the following parameters:

1. Gender the patient identifies with
2. Age of the patient when the MYCO WELL D-ONE study sample collected
3. Symptoms and signs that were recorded in the patient notes e.g. BV/NGU
4. Previous sexually transmitted infections diagnosed
5. Drug history
6. Treatments the patient received
7. Sexual history e.g. type of sexual activity On completion, he parameters associated with positive M.hominis result; bacteria load quantification/antimicrobial resistance) and statistical analysis will be examined as below. I Statistical analysis This will be performed on anonymised data. The primary outcome measure of this study is to determine if M.hominis is associated with BV, NGU and vaginitis in the genitourinary system of patients or if it is a bacterial commensal. The secondary outcome for this research is to determine if there are clinical and social parameters that are associated with M.hominis infection.

Eligibility Criteria:
Inclusion Criteria:

* Sexually active participants aged 18 to 100 years
* Participants can give informed consent in writing.

Exclusion Criteria:

* Patients who have been sexually assault.
* Participants who cannot give informed consent in writing.
Multi-Center Project: Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure

This study will test an automated, electronic health record (EHR-)embedded alert to improve prescribing of guideline-directed medical therapy for patients with heart failure and reduced ejection fraction (HFrEF). The investigators have previously tested and implemented this alert at NYU Langone Health (NYULH), and will now test and implement this alert across three other health systems.


Eligibility Criteria:
Inclusion Criteria:

* Patient with an encounter visit at participating cardiology practice during the study period
* Patient with EF of less than or equal to 40% on most recent echocardiogram at the time of visit
* Patient ages 18-90

Exclusion Criteria:

* Pregnancy
* Ventricular assist device
* Hospice
* Cardiac amyloid
* Medication-specific exclusion for MRA: most recent systolic blood pressure less than 105 mm Hg, most recent potassium \< 5.1, any potassium \> 5.5, most recent glomerular filtration rate \< 30 (using MDRD equation), or a documented MRA allergy.
Prediction of Coronary Artery Disease Severity by Epicardial Adipose Tissue Thickness

is to test the hypotheses that epicardial adipose tissue can be a marker of severity of coronary artery disease in myocardial infarction patients

epicardial adipose tissue is defined as the adipose tissue between the visceral pericardium and the outer margin of the myocardium which can be considered an endocrine organ that secretes pro-inflammatory and anti-inflammatory cytokines and chemokines including adiponectin.as investigators know, inflammatory response is an important factor in the coronary atherogenesis. Therefore,epicardial adipose tissue is likely to be connected with the severity of coronary artery disease.Recent studies showed that the thickness of the epicardial adipose tissue in patients with coronary artery disease was greater than that with normal coronary arteries.

epicardial adipose tissue will be assessed using transthoracic echocardiography and cardiac magnetic resonance which allows for an accurate volumetric quantification of epicardial fat.

Eligibility Criteria:
Inclusion Criteria

1. Normal thoracic shape
2. Sinus rhythm
3. without severe respiratory diseases

Exclusion Criteria:

1. contraindication for cardiac magnetic resonance.
2. Patients who previously underwent coronary artery bypass grafting or percutaneous coronary angiography prior to admission
3. history of chronic kidney disease with glomerular filtration rate \<30 mL/min
4. pericardial and/or pleural effusion.
Genetics of Prostate Cancer in Young Patients

The aim of the study is to identify genetic variants in genes responsible or potentially responsible for the etiology of prostate cancer in a population of patients with early onset of the malignancy.

The data collected from the study will provide a preliminary picture of the prevalence and type of germline pathological variants in the context of early-onset prostate cancer in the Italian population. In addition, alterations in DNA repair genes other than BRCA1-2 and ATM, including any genes yet undescribed as causative or predisposing, have yet to be explored in detail: in many cases the significance of variants is not well defined in terms of pathogenicity, prognostic value, and predictive indicator of response to different treatments. Therefore, an extensive mutational analysis-even if performed on a limited number of patients-can generate a large number of variants for evaluation, bringing knowledge about the relationship between these variants and the onset of malignancy The information obtained, although merely exploratory, may indicate the desirability of conducting systematic genetic investigations in this particular patient population in the future, especially in view of the new therapeutic strategies available such as immunotherapy or PARP inhibitors

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologic or cytologic diagnosis of prostate cancer
* Age ≥18 years and ≤55 years at first diagnosis of prostate carcinoma
* Availability of clinical and instrumental data related to prostate cancer
* Patients who knowingly express willingness to participate in the study after signing written informed consent

Exclusion Criteria:

* None
The Effects of "Workplace Health Promotion Program" on Pain, Fatigue, Stress in Nurses

Pain, fatigue, and stress lead to decrease on their work performance with biopsychosocial functioning disorders on nurses. This study was conducted to examine the effects of the "Workplace Health Promotion Program" (WHPP) on pain, fatigue, stress, professional quality of life (Pro-QoL) and coping skills for nurses.

The investigators conducted a randomized control trail in 30 nurses admitted to their Hospital. Progressive relaxation training, posture and breath exercises and ergonomic suggestion as a WHPP was applied to the intervention group (n=15) during the five weeks. Visual Analogue Scale (VAS) was used to determine the pain, fatigue and stress levels of the nurses. Brief COPE and the Professional Quality of Life Scale, Version 4 (Pro-QoL) were used to evaluate the coping skills and quality of life. The evaluations were performed three times on all the participants as; before and after training and the one-year follow-up.

Inclusion criteria of this study were working actively and at least 40 hours working in a week. Participants who have psychiatric illnesses with or without medication, prior training or current use of relaxation therapy and participants without consent were excluded.

Eighty nurses aged between 18 and 65, working in a hospital have been informed about the study. Forty-three nurses who met the criteria and signed consent forms were included in this study. WHPP was PMR training, posture and breath exercises, and ergonomic suggestions.

Eligibility Criteria:
Inclusion Criteria:

* Working actively and at least 40 hours working in a week,
* Working as a nurse.

Exclusion Criteria:

* Have psychiatric illnesses with or without medication,
* Have prior training or current use of relaxation therapy and participants without consent.
The Effect of Obesity on Oral Peri-implant Health - A Cross-Sectional Study

In recent years, greater emphasis has been placed on the link between oral and systemic health. Obesity, a growing medical problem worldwide, has been associated with multiple chronic inflammatory diseases such as diabetes mellitus and cardiovascular disease. With respect to the effect of obesity on periodontal health, it has been shown that obese subjects exhibit higher inflammation around natural teeth and are at increased risk of tooth loss than individuals with normal weight. Peri-implantitis, an inflammatory condition of bacterial origin that occurs around oral implants and resembles periodontal disease, has become a serious concern for the dental profession given its increasing prevalence and challenging treatment. There is also strong evidence that individuals with a history of periodontitis are also at risk for peri-implantitis. However, knowledge about the pathogenesis and treatment of peri-implantitis is scarce. Hence, it is extremely important to understand the implications of excessive body fat on peri-implant health. Based on the current understanding on the effect of obesity on systemic and local inflammation around natural teeth, the investigators hypothesize that obesity will have a significant impact on peri-implant health by inducing an increased inflammatory response as measured by clinical as well as molecular markers of inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older)
* Currently non-smokers
* Subjects in maintenance care with adequate dental plaque control (\<20% plaque index according to O'Leary et al. 1972)
* Subjects with at least one rough surface titanium oral implant in function for at least 6 months.

Exclusion Criteria:

* Edentulous subjects or subjects presenting with blade-type implants and/or implants with smooth surface.
* Pregnant or nursing women
* Subjects who have taken medications that are known to alter the oral inflammatory status, such as antibiotics and anti-inflammatory agents, for 3 months prior to the study.
* Subjects with a history of aggressive periodontitis (As defined by the American Academy of Periodontology).
Impact of Duration Of Absolute Voice Rest on Voice Outcome After Phonomicrosurgery

Absolute voice rest is commonly prescribed after vocal fold surgery, also known as phonomicrosurgery, for benign vocal fold lesions. This is thought to decrease scarring of vocal folds, which could result in increasing tissue stiffness and limitations in optimal vocal outcome. Unfortunately there is no standardized protocol as to how long patients should rest their voice after phonomicrosurgery. To date, there are no studies in the literature directly comparing the impact of short-term and long-term voice rest on vocal fold healing and voice outcome after phonomicrosurgery.

The purpose of this study is to determine whether 3 days versus 7 days of absolute voice rest will result in different voice outcomes in patients who have undergone phonomicrosurgery for benign vocal fold lesions.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with benign mid membranous vocal fold lesions such as the following:

   1. Polyps
   2. Cysts
   3. Sub-epithelial fibrous mass
2. Undergoing elective phonomicrosurgery for vocal fold lesions, which involves microflap excision +/- truncation +/- steroid injection into the vocal folds.
3. Age 18 and older

Exclusion Criteria:

Patients with any of the following will be excluded from the study:

1. Reinke's edema
2. Active smokers
3. Ligamentous mid membranous vocal fold lesions
4. RRP (Recurrent Respiratory Papillomatosis)
5. Dysplasia
6. CIS (Carcinoma-in-situ)
7. SCC (squamous cell carcinoma)
8. Extent of surgery exceeds what is mentioned in the inclusion criteria (e.g., CO2 laser, balloon dilatation, vocal fold augmentation in addition to phonomicrosurgery)
9. Previous vocal fold surgery
10. Systemic steroids
11. History of systemic illness that could affect wound healing
The Microbiome of Infertile Couples and Its Effect on Their Reproductive Outcomes

A prospective cohort study in IVF patients at 5 IVF centres in Denmark. The primary aim is to include patients positive for abnormal vaginal microbiota to an RCT (EUDRACT 2016-002385-31). Secondary aims are the prevalence of abnormal vaginal microbiota in women undergoing IVF treatment, intimate hygiene and relations to the vaginal microbiota, basic fertility work up in relation to vaginal microbiota.

At the time of the interim stage of the RCT (EUDRACT 2016-002385-31), we plan to make a first cross-sectional investigation of the intimate hygiene questionnaire at baseline as compared to abnormal vaginal microbiota. We plan to make focused interview of N=30 patients to cover any additional female hygiene details not covered in the original questionnaire. After this investigation we may include new questions after the interim analysis - given that the study proceeds. In this case we plan to publish the first results of the intimate hygiene habits of the patients enrolled until interim stage.

Eligibility Criteria:
Inclusion Criteria:

* First, second or third IVF stimulation cycle at the involved clinic.
* BMI\<35.
* Written informed consent.
* 18-42 years old

Exclusion Criteria:

* HIV, Hepatitis B or C positivity.
* Intrauterine malformations (Vaginal ultrasound)
* Hysterosalpinx
* Known severe renal or hepatic impairment.
* HPV CIN 2 or higher.
* Patients treated with vitamin K antagonists (warfarin)
* Known or suspected hypersensitivity to clindamycin or any other antibiotic.
* Myastenia Gravis
* Former or current inflammatory bowel disease, including Mb. Crohn and Colitis ulcerosa
* Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)
Treatment of Patients With Acute Sinusitis

For each patient, an initial visit and at least one follow-up visit at the end of treatment should be documented by the treating physician in the case report form.


Eligibility Criteria:
Inclusion Criteria:

* Any patient with a diagnosis of acute bacterial sinusitis treated with Avelox® - in accordance with the local production information.

Exclusion Criteria:

* Those specified in the local product information - contraindications and precautions must be considered.
Therapeutic Monitoring of Antibiotics in Intensive Care Patients: a Cohort Study PopTDM-ICU

Intensive care patients are exposed to serious infections. Mortality linked to these infections remains high and antibiotic therapy treatment optimization is one of the key points of therapeutic success . Pharmacokinetic therapeutic monitoring and dosage adjustments are recommended for large families of antibiotics such as glycopeptides and aminoglycosides for a long time, but to this day still insufficiently practiced. Concerning Beta-Lactamines this practice is recommended by french society of pharmacology and therapeutic (SFPT) and french society of anesthesiology and intensive care (SFAR) since 2018.

The main goal of the POP-TDM-ICU study is to find the predictive factors of clinical therapeutic efficacy of antibiotic therapy in sepsis or septic shock in intensive care, among which the use of the dosage pharmacokinetics of antibiotic therapy (TDM = Therapeutic Drug Monitoring).

This study is a non-interventional study. Patients bacterial samples already collected in standard care and additional plasma samples will be collected as part of a biological collection with the consent of the patient or family member.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 year-old.
* Patient hospitalized in intensive care,
* Patient receiving an antibiotic for sepsis or septic shock
* Patient or family member who does not object to participating in the study

Exclusion Criteria:

Patient at risk of death, for a cause other than infectious, within 48 hours following the introduction of antibiotic therapy.

* Patient receiving antibiotic treatment for antibiotic prophylaxis.
* Patients benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.
* Pregnant and / or lactating women.
A Trial of a Modified Cystoscopy Method to Reduce Pain Perception

The goal of this project is to improve patient experience of cystoscopy using a non-pharmacologic modification of procedure. Cystoscopy is a common outpatient procedure for urology patients and is usually performed without sedation. However, there is limited research into reduction of patient discomfort throughout this procedure. The proposed modification technique was selected based on a well-documented psychological phenomenon in which only particular moments over the course of an aversive event determine the resultant perception of the experience. It is hypothesized that implementation of the technique will decrease the recalled pain intensity of the cystoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 undergoing cystoscopy for the first time for diagnostic investigation will be approached to participate in this study.

Exclusion Criteria:

* Cystoscopies involving other interventions concurrently (e.g. biopsy, urethral dilation, removal of ureteral stent, etc.) will be excluded.
* Patients currently taking medication for chronic pain (e.g. opioids, Tricyclic antidepressants (TCAs)) will be excluded from the study.
* Patients less than 18 years of age will be excluded.
* Patients who have received a cystoscopy previously will be excluded.
Technology-assisted Index on Improving Hand Hygiene of Registered Nurses

In 2009, the World Health Organization (WHO) recommended the use of a multi-faceted, multi-modal hand hygiene strategy (Five Moments for Hand Hygiene) to improve hand hygiene compliance among healthcare staff. The outbreak of coronavirus disease 2019 (COVID-19) has rapidly spread globally. The novel coronavirus is characterized by rapid human-to-human transmission. Hand washing is a part of measures recommended by the World Health Organization (WHO) to avoid contracting COVID-19.The purpose of this study was to use adenosine triphosphate (ATP) testing and direct observation for improving hand hygiene and compliance in nurse.

The purpose of this study was to use adenosine triphosphate (ATP) testing and direct observation as technology-assisted index on improving hand hygiene and compliance in nurse.

Eligibility Criteria:
Inclusion Criteria:

* (1)Day shift nurse on cancer ward,(2)who speak in Taiwanese and Mandarin,(3)and are willing to participate in the study.

Exclusion Criteria:

* (1)There is any wound or scar on hand.
MIBG Scintigraphy and Strain Echocardiography in the Detection of Subclinical Cardiovascular Effects One Year After (Neo)Adjuvant Breast Cancer Treatment With Docetaxel, Doxorubicin and Cyclophosphamide (TAC): a Pilot Study

Many patients with breastcancer in the past, were treated with TAC. These last years, there is more and more focus on the effects of chemotherapy, particularly in children treated with this. One of these effects is damage to the heart muscle, which ultimately might affect the pump-function of the heart . In adults, the effect of treatment with TAC on the heart, has not been previously investigated. The possibility exists that the adverse reactions in children are found in adults also could occur. Therefore we have initiated this trial.

Given the lack of data on the incidence of subclinical cardiotoxicity after treatment with TAC we want to assess whether subclinical cardiovascular damage is present in adult patients with breast cancer who have completed treatment with (neo)adjuvant TAC one year previously, using MIBG (meta-iodobenzylguanidine) scintigraphy, novel echocardiographic techniques and blood biomarkers. Following the study by Lipshultz et al. we expect to find at least in 25% of the patients signs of subclinical cardiovascular damage with at least one of the three techniques.(11) If at least 10% is observed we will conclude that it is useful to further pursue the use of these techniques for the detection of subclinical cardiotoxicity in a next clinical study which will be powered to assess the predictive value of these techniques for the development of clinical heart failure. If a lower percentage is observed we will conclude that it is not useful to further pursue the use of these techniques for the detection of subclinical cardiotoxicity.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with breast cancer, ≥ 18 years old at the time of breast cancer diagnosis
* (Neo)adjuvant treatment with docetaxel, doxorubicin and cyclophosphamide (TAC) completed one year before inclusion

Exclusion Criteria:

* Evidence of breast cancer recurrence or metastatic disease
* Evidence of heart disease at the time of breast cancer diagnosis
* Evidence of renal failure at the time of cardiac evaluation
* Pregnant or lactating
* Participation in a research protocol with ionizing radiation within one year before inclusion.
* Evidence of diabetes mellitus or Parkinson's disease
* Evidence of an MIBG-accumulating tumor (pheochromocytoma, paraganglioma, chemodectoma, ganglioneuroma, neuroblastoma, carcinoid, medullary thyroid cancer, neurofibromatosis, retinoblastoma, esthesioneuroma, schwannoma, merkelcel-tumor, pancreatic islet cell tumors, small cell lung carcinoma, melanoma