cyrilzakka/clinical-trials huggingface dataset:
Risk Factors for Bacterial Stent Colonization in Patients With a Double J Ureteral Stent

The goal of this prospective study is to identify the risk factors associated with bacterial colonization of DJS and report the common microorganisms isolated and drug susceptibility pattern.

This was a hospital-based prospective observational study performed at a tertiary academic center from March 2022 to August 2023.

All patients coming to TUTH OPD and ER for urological surgery were assessed for the placement of a DJS (polyurethane). Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures. All patients received prophylactic antibiotic therapy with levofloxacin for 2 to 3 days at the time of DJS insertion. The DJS was in situ until the duration allocated according to the procedure. The DJS was removed in 2 weeks postoperatively with aseptic precaution under local anesthesia (2% lignocaine jelly) with the help of a 30-degree Karl Storze scope with cystoscope sheath 19/21 and alligator forceps following the standard technique. The equipment was sterilized with a 2.45% Cidex solution for 12 minutes prior to all DJS removal. Then the patient was positioned in the lithotomy position, with proper cleaning of the external genitalia with povidone-iodine 10%, complete separation of the labia in the female, and proper cleaning of the prepuce and glans in the male. Then sterile xylocaine jelly 2% was instilled in the urethra, a cystoscope was inserted into the bladder, alligator forceps were inserted, and a DJS was removed. After removal of the DJS with sterile technique, the tips of both ends (renal end and bladder end) of the stent were cut with surgical blade number 10 and collected in a plastic screw-capped container, and sent for bacterial evaluation.

The report of the culture and sensitivity pattern were collected and treated according to the sensitivity pattern with appropriate antibiotics correlating with the symptoms. Colonization is defined as the growth of microorganisms in the tip culture of either end or both ends of DJS. All the demographic data with other study variables were recorded in proforma. Any amount of preoperative urine albumin from trace amounts and above (+,++, etc.) was considered in this study.

Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing DJ stent placement

Exclusion Criteria:

* Positive urine culture before stenting
* Taking antibiotics during DJS removal
* Presence of yeasts in urine culture
* Declining informed consent
Clinical Trials for Elderly Patients With Multiple Disease

The CHROMED project focuses its investigation on the applicability of an integrated solution for a pathological condition which: a) is very prevalent in ageing patients and b) severely impairs quality of life: COPD with other typical comorbidities such as congestive heart failure and sleep disordered breathing. A specific ICT platform in combination with a set of innovative devices will be used to collect and process useful clinical data at the patient's home and used to optimize their medical treatment. To evaluate the impact of this solution, an international multi-centric randomized control trial will be implemented in five European regions: United Kingdom, Sweden, Estonia, Spain and Slovenia, representing different social and organizational contexts in Europe.


Eligibility Criteria:
Inclusion Criteria:

* COPD GOLD grade II or higher with a prior history of exacerbations and/or an hospitalization for COPD in the previous year with one or more documented non-pulmonary chronic conditions such as:
* CHF due to left ventricular systolic dysfunction (LVSD) confirmed on echocardiography
* SDB identified by respiratory sleeping studies or polysomnography
* current or prior smoking history of \>= 10 pack/years
* subjects capable of providing signed written informed consent
* subjects capable of perform study procedures and use the RESMONPRO at home
* subjects with reliable mobile phone coverage at home

Exclusion Criteria:

* Any disease that, in the opinion of the investigator, put the subject at risk
* subjects with significant vision disturbance and mental diseases
* subjects with a planned prolonged absence from home
Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of HL301 on Radiation Pneumonitis in Non-small Cell Lung Cancer Patients

The purpose of this clinical trial is to evaluate the safety when HL301 is administered to unresectable non-small cell lung cancer patients who receive chemoradiotherapy with Paclitaxel and Carboplatin and to search for a clinically appropriate dose by evaluating the efficacy by comparing the radiation pneumonia incidence rate with the control group.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, age ≥ 19 years
* Stage III non-small cell lung cancer(NSCLC) patient who without surgical treatment
* Patients scheduled for curative concurrent chemoradiotherapy

  * chemotherapy : paclitaxel and carboplatin
  * radiation therapy : IMRT, total 60\~70Gy
* Eastern Cooperative Oncology Group(ECOG) performance status of 0 to 2 at the screening visit
* Subject whose remaining life expectancy is more than 6 months according to the judgment of investigator
* Volunteer, be willing and able to provide written informed consent for the trial

Exclusion Criteria:

* Subjects with pleural effusion
* Subjects with a weight loss of 10% or more within the last 6 months from the screening visit
* Subjects with a history of thoracic or neck radiotherapy or chemotherapy prior to screening visit
* Subjects with distant metastases
* Subjects with liver/renal dysfunction according to the following criteria on the screening test

  * Total Bilirubin \>1.5 mg/dL
  * ALT or AST level is 2.0 times higher than the upper limit of normal (based on the institution)
  * Serum Creatinine \>1.5 mg/dL
* Subjects with serious cardiovascular disease within 3 months prior to the screening visit (ex. arrhythmia, congestive heart failure, infarction, unstable angina etc)
* Subjects with serious systemic infection (≥ Grade 3, evaluated by CTCAE v5.0)
* Patients with chronic or interstitial lung disease (excluding patients with chronic obstructive pulmonary disease (COPD)), patients with chronic bronchitis, patients with pneumonia
* Subjects with thyroid dysfunction as present illness at the screening visit
* Subjects who administered systemic steroids within 4 weeks prior to the date of randomization (except for cases when administered to prevent hypersensitivity reaction of paclitaxel)
* Subjects who are hypersensitive to investigational products and standard anticancer treatments
* Subjects who participate in other clinical trials within 30 days prior to the screening visit and administer investigational drugs or apply clinical trial medical devices
* Women of childbearing age or men who do not agree to use a medically accepted method of contraception during the clinical trial
* Pregnant or breast-feeding
* Subjects who have clinical significance that is considered inappropriate for this clinical trial as judged by the investigator
First Study to Evaluate the Capacity of Maraviroc Drug to Protect Against HIV Infection in Samples of Rectal Mucosa From Healthy Volunteers

Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV. This study will assess the potential of MVC as a "on demand" pre-exposure prophylaxis, within a strategy for the prevention of HIV infection in men who have sex with men (MSM).

Several clinical trials are currently under way evaluating the safety and effectiveness of ARV-based PrEP for preventing HIV infection. The results of the first efficacy trials of ARV-based PrEP showed fewer HIV infections among study participants receiving the study drugs compared to those receiving placebo. Although the results are promising, concerns about adherence, pharmacokinetics, and toxicity still needs further exploration so new and more effective preventive pharmacological approaches should be evaluated. This trial will evaluate the safety, pharmacokinetics and efficacy of ex vivo HIV infection of rectal mucosa by the CCR5 antagonist drug maraviroc (Selzentry) administered to healthy volunteers. This trial will last approximately one year. Twenty-one volunteers will receive MVC 300 mg orally in a single dose. Study visits will occur at enrollment and at days 0, 7, 9, 14 and 16. All study visits will include a physical examination, blood collection and storage and in the basal visit and a day 7 or 9 the participants will undergo a colonoscopy. Ex vivo HIV infectivity in rectal mucosa biopsies and plasma/mucosa MVC levels will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Men who have sex with men (MSM)
2. Age 18 years or above
3. HIV negative at the time of inclusion 4. Signed informed consent

Exclusion Criteria:

1. Existence of sexually transmitted infection (STI) or active systemic infection
2. Submit a contraindication to rectal biopsy
3. Take any drugs concomitantly with interactions with the MVC
4. Subject unable to follow protocol
Patient-centered Mobile Health Intervention to Improve Self-care in Patients With Chronic Heart Failure

Approximately 6.5 million people have heart failure (HF) in the United States, and 960,000 new cases are reported each year. HF is one of the most common hospital diagnosis among older adults. About 40% of patients are readmitted within 1-year following their first admission for HF and hospitalization accounts for approximately 80% of the costs of HF management. This pilot study aims to assess the feasibility, acceptability, and preliminary efficacy of a patient-centered mobile health (mHealth) technology intervention in older adults with chronic heart failure.

This is a single site, two-arm, pilot randomized controlled trial that aims to examine the feasibility, acceptability and preliminary efficacy of a mobile phone-based intervention compared to usual care in older adult patients with HF (≥50 years). Forty (n=40) patients from the University of Illinois Hospital \& Health Sciences system will be enrolled in the study, randomly assigned to the intervention or usual care group, and followed for 60 days. Patients in the intervention group will receive the Heart Failure Health Storylines mobile app developed by Self Care Catalysts in collaboration with the Heart Failure Society of America, three connected health devices from Fitbit and Nokia that interface with the mobile app, and tailored text-messages targeting health beliefs, self-care efficacy, and knowledge about HF. The control group will receive standard care which involves patient education and outpatient follow up with physical and laboratory examinations as needed. The primary study outcome is change in self-care and quality of life. Secondary outcomes include hospital re-admissions and emergency room visits.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients or outpatients with a diagnosis of HF as defined by the International Classification of Diseases (ICD-10) codes
* Stage C, NYHA I, II or III
* ≥ 40 years of age
* Own a smartphone with text-messaging and internet plan
* Ability to speak and read English
* Live within 30 miles from UI Health

Exclusion Criteria:

* On an active waiting list for implanted ventricular assist device or heart transplant
* Advanced renal disease (dialysis or creatinine \>4.0mg/dL)
* End-stage HF (hospice candidate)
* Active cancer
* Individuals who are not their own primary caregiver
* Discharge to a setting other than home
* Patients with baseline Montreal Cognitive Assessment (MoCA) score of \< 22
Observational Study of Hunner's Ulcer in Patient With Interstitial Cystitis/Bladder Pain Syndrome

The purpose of this study is to observe change of distribution pattern of Hunner's ulcer in patient with interstitial cystitis/bladder pain syndrome

This is observational, 12 months study

Eligibility Criteria:
Inclusion Criteria:

1. must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study
2. Pain VAS ≥4
3. O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2)
4. PUF score ≥ 13
5. cystoscopic record within 2 years
6. Hunner ulcer lesion in cystoscopic finding

Exclusion Criteria:

1. Scheduled for or use of intravesical therapy (eg, bladder distention,transurethral resection of bladder ulcer, instillation) during or within 6months prior to the study and use of pentosan polysulfate sodium within 1 months prior to the study
2. Patients who are pregnancy or, childbearing age without no contraception
3. Patients with voided volume \<40 or, \> 400ml
4. Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination
5. Patients with urine culture showing evidence of urinary tract infection 1month prior to the study
6. Accompanied medical problem below

   * Tuberculosis in urinary system
   * Bladder cancer, urethral cancer, prostate cancer
   * Recurrent cystitis
   * Anatomical disorder
7. Patients had prior surgery (eq, bladder augmentation, cystectomy
8. Patients with neurologic disorder
9. Patients with indwelling catheter or intermittent self-catheterization
10. Patients with psychologic problem
Obstructive Sleep Apnea and Bronchoscopy

The prevalence of sleep-disordered breathing in Republic of Korea is 27% and 16% in men and women aged 40-69 years. Up to 93% of women and 82% of men with obstructive sleep apnea (OSA) remain undiagnosed. Polysomnography, the gold standard, is time consuming and costly. Patients with undiagnosed OSA may experience obstructive episodes during procedures with conscious sedation.

STOP-Bang questionnaire is the validated questionnaire to screen patients for undiagnosed OSA in the preoperative setting. It has high sensitivity (92.9%) for predicting patients with moderate to severe OSA.

Previous studies reported that STOP-Bang questionnaire predicted cardiopulmonary events during advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound. However, there have been no studies regarding the risk for sedation-related cardiopulmonary events in patients with undiagnosed OSA undergoing bronchoscopy. Thus, we aimed to evaluate the prevalence of high-risk patients for OSA by a screening questionnaire, and to determine whether the questionnaire could predict patients who are at risk for cardiopulmonary events during bronchoscopy with conscious sedation.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are18 years or order undergoing bronchoscopy with conscious sedation in the bronchoscopy center

Exclusion Criteria:

* Previous diagnosis of OSA
* American Society of Anesthesiologists Physical Status Classification System score \> 3
* Baseline SpO2 \< 90% or need for supplemental oxygen before the procedure
* Tracheostomy tubes
* An inability to provide informed consent
* Undergoing the procedure based on an outpatient clinic
* Undergoing BAL, EBUS-TBNA, and interventional bronchoscopy
* Allergies or sensitivities to sedative medications
* Pregnant
Psychological Wellbeing in Chronic Fatigue Syndrome

Objectives: Chronic Fatigue Syndrome (CFS) is a medically unexplained condition characterized by severe and disabling fatigue. To date much research has focused on finding out whether CFS is caused by mainly physical or psychological factors. Perhaps as a result of this, few studies have examined the relationship between CFS and quality of life, in particular, more positive aspects of mental health, such as an individual's sense of purpose, autonomy and close relationships.

This study will address these limitations by examining Ryff's (1989) six domains of psychological well-being (PWB), and other aspects of well-being including positive emotions, in CFS. It will also examine the relationship between measures of symptomology, emotional distress and PWB.

Method: This is a cross-sectional, questionnaire-based study with a clinical sample of adults with CFS. Participants will complete valid measures of well-being and symptomology.

Results: We expect to find that compared to general population norms, individuals with CFS score lower on measures of PWB. Secondly, we expect PWB dimensions will be related to symptom measures. There are however, no grounds for making strong predictions.

Implications: This study will advance our understanding of quality of life in CFS. Clinically, it has the potential to enrich and inform therapeutic interventions.


Eligibility Criteria:
Inclusion Criteria:

1. Chronic Fatigue Syndrome as defined by NICE (2007).
2. Aged 18 or over
3. English speaking

Exclusion Criteria:

1. Insufficient English language skills to participate without the use of an interpreter.
2. Insufficient ability to read and write independently.
3. Incapacity to consent to the study as defined by the Mental Capacity Act (2005).
Assessment of Subject Use of the Rebiject II Injection Device According to Nurse Examination of Subject Accuracy in 10 Steps as a Dummy Demonstration

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults. Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3 times per week by subcutaneous injection. The Rebiject II device is an autoinjector which allows patients easier administration of their Rebif injections.

Prior to treatment, patients receive training on the use of the device and its maintenance. Currently, all treatments for MS are injectable and require long term patient commitment. Rebiject has been developed to improve patient convenience and comfort but does require multiple steps to be carried out in order for the injection to be delivered correctly. Reports from our local call centre and nurse advisors suggest that inaccuracies of use with the Rebiject device are common. By raising awareness of the level of inaccuracy and determining which steps patients are most likely not to complete correctly, modified training programs or modifications to current subject training may be put into place to address these issues. It is also important to demonstrate the link between poor use of the medication device and increased relapse rates or increased injection site reactions.


Eligibility Criteria:
Inclusion Criteria:

* Have relapsing remitting multiple sclerosis and currently receiving Rebif treatment and using the Rebiject II injection device
* Be under regular review by a MS nurse
* Be aged 18 or above
* Be willing and able to participate in the trial and to have provided written informed consent

Exclusion Criteria:

* Receiving disease modifying therapy other than Rebif
* Receiving Rebif but not using the Rebiject II injection device
* Do not self inject
* Are unable or unwilling to provide informed consent
The Effect of Nature Images Accompanied by Music on Breastfeeding, Breastfeeding Satisfaction and Maternal Attachment"

The study was planned as a randomized controlled study to evaluate the effect of using natural landscape pictures accompanied by music during breastfeeding for lactating mothers on breastfeeding, breastfeeding satisfaction and maternal attachment.

This research is planned as a randomized controlled study to evaluate the effect of using natural landscape pictures accompanied by music during breastfeeding on breastfeeding, breastfeeding satisfaction, and maternal attachment in lactating mothers.

The research will be conducted with primiparous mothers who apply to Adıyaman University Training and Research Hospital Gynecology clinics between January 2024 and August 2024 and meet the inclusion criteria. The study will include a total of 90 participants, divided into one intervention group and one control group.

As a pre-test, the Socio-Demographic Data Survey, LATCH Breastfeeding Diagnosis and Evaluation Scale, Visual Analogue Scale for Satisfaction Evaluation, and Maternal Attachment Scale will be administered to mothers who have just given birth at the clinic. Both groups will receive breastfeeding education.

For the intervention group, mothers will watch nature scene pictures accompanied by music prepared by the researcher. This will be done once in the hospital, once during a home visit after discharge, and then daily at home, with the researcher checking in by phone to ensure the mothers watch the scenes eight more times. The intervention will be conducted a total of 10 times.

Finally, the data collection phase will be completed by administering the post-test surveys to both groups.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily agreeing to participate in the research
* Being over 18 years old
* Being at least a primary school graduate
* Not having a diagnosed psychiatric disease
* Without mental disability
* Turkish speakers and those who do not have communication problems
* Primiparous mothers
* The mother does not have any problems that would prevent her from breastfeeding (e.g., nipple cracks)
* The child is not premature
* Mothers who gave birth at term
* The baby is not low birth weight
* Mothers who do not have any problems that would prevent the baby from breastfeeding

Exclusion Criteria:

* Being illiterate
* Being under 18 years old
* Having a diagnosed psychiatric illness
* Having mental disability and communication problems
* Those who do not speak Turkish and have communication problems
* Non-primiparous mothers
* The mother has any problems that may prevent her from breastfeeding (e.g., nipple cracks)
* Having a premature baby
* Mothers who did not give birth at term
* Low birth weight of the baby
* Mothers who have any problems that may prevent the baby from breastfeeding
Post-instrumentation Pain After Use of the Fanta and M3 Pro Gold Systems

Comparing the intensity of post-operative pain following endodontic treatment of posterior teeth with Fanta (Pepsi gold) (FPG) and M3-pro+ Gold (assorted) (MPG) rotary files.


Eligibility Criteria:
Inclusion Criteria:

* 20-50 years old
* No systemic diseases
* Mandibular first molar
* Asymptomatic tooth
* Normal periapical film
* Restorable teeth
* Periodontal scoring index \<2

Exclusion Criteria:

* Age \<20 and \>50
* Systemic disorders
* Articaine Allergy
* Inability to take paracetamol.
* Pregnancy or Nursing
* Symptomatic pulpitis.
* Pulp necrosis
* PDL is widening.
* Periapical radiolucency
* The sinus tract
* Periapical abscesses.
* Existence of resorption
* Tooth malposition.
* Fixed partial dentures.
* Analgesics intake in the last 12 hours.