cyrilzakka/clinical-trials huggingface dataset:
PHMB-based Antiseptic Use in Full-thickness Surgical Wounds

To study the effect of applying a PHMB-based antiseptic solution to tie-over dressings in full-thickness surgical wounds in dermatologic surgery in order to minimise the development of surgical site infections. The bacterial dynamics in wounds pre-,intra-, and postoperatively will be examined in order to understand the pathogenesis of surgical site infections better.

40 patients with suspected skin cancer in the face planned for full-thickness surgery will be randomised into two groups: One will receive a traditional tie-over dressing saturated with NaCl and the other group will receive a tie-over dressing saturated with a PHMB-based antiseptic. A quantitative and qualitative bacterial analysis of wounds by using a modified Levine's swabbing technique will be carried out pre-,intra-,and postoperatively. The effect of nasal colonisation with S.aureus on the development of surgical site infections will be investigated. All wounds will be followed a week after surgery to assess development of infections.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned for full-thickness skin grafting in the face

Exclusion Criteria:

* Patients with no diabetes
* Patients with no current/previous/recent antibiotic therapy
An Observational Study of Mircera in Patients With Chronic Renal Anemia on Dialysis (CKD Stage V) or Not on Dialysis (CKD Stage III-IV)

This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis. Patients will be followed during 12 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Patients with chronic renal anemia with stage III-IV CKD not on dialysis and who are, in the opinion of the treating physician, not expected at baseline to require dialysis within 12 months
* Patients with chronic renal anemia with stage V CKD on dialysis
* No contraindication to ESA treatment

Exclusion Criteria:

* Uncontrolled hypertension
* Hypersensitivity to the active substance or any other of the excipients of Mircera and other ESAs
Efficacy and Safety of Dexamethasone Prevention for Patients of Ovarian Hyperstimulation Syndrome

This prospective, randomized, controlled clinical trial will evaluate the effect and security of dexamethasone prevention for Patients of Ovarian Hyperstimulation Syndrome.

Ovarian hyperstimulation syndrome (OHSS) is a iatrogenic complication of ovarian stimulation,which in its severe form is associated with significant morbidity and can be life threatening. It is characterized by cystic enlargement of the ovaries and rapid fluid shifts from the intravascular compartment to the third space. It is thought that increased vascular permeability is the pivotal mechanism of OHSS pathophysiology. The administration of human chorionic gonadotrophin results in the release of vasoactive substance such as vascular endothelial growth factor that causes vasodilation and leakage of fluids. Glucocorticoids and their synthetic derivatives have an inhibitory effect on the VEGF gene expression in vascular smooth muscle cells. By reducing leukocytic infiltration and the release of inflammatory mediator, inhibiting vasodilation and preventing increases in vascular permeability, these agents can dampen the inflammatory response and prevent edema formation ,thus offering a potential therapeutic intervention for OHSS. Investigators have observed more than a hundred patients in clinical practice that low-dose dexamethasone has prevention action for patients in IVF cycles at high risk of OHSS. This clinical trial is designed to evaluate the effect and security of dexamethasone prevention for patients of Ovarian Hyperstimulation Syndrome. There are two groups: bromocriptine group, dexamethasone group .After followed-up for 7 days , Clinical OHSS parameters will be collected at oocyte retrieval and at the 4rd d and 6th d of treatment .

Eligibility Criteria:
* Inclusion Criteria:

  * Women of reproductive age
  * Women having controlled ovarian hyperstimulation as part of any assisted reproductive technique
  * Women at risk of severe OHSS(serum estradiol levels were\>3000pg/ml on the day of HCG trigger ; there was retrieval of 20 or more oocytes)
* Exclusion Criteria:

  * Unwillingness to comply with the study protocol.
  * Attending other clinical trials in the same period.
  * Chronic glucocorticoid their synthetic derivatives intake.
  * History of allergic to study medications.
  * The patients who cannot take dexamethasone.： hypertension, diabetes,gastric ulcer; abnormal renal or hepatic function and so on.
Compliance of Long-term Home Non-invasive Ventilation for Patients With Chronic Obstructive Pulmonary Disease

Background : Long-term home non-invasive ventilation (NIV) can be proposed as treatment for acute respiratory failure with severe alveolar hypoventilation. The aim of NIV is to correct both daytime and night-time hypoventilation and associated symptoms and to provide the patient with adequate night-time oxygen saturation. The benefits of long-term NIV in the management of chronic obstructive pulmonary disease (COPD) patients in a stable state remain controversial. This highlights the importance of identifying the predictive factors for good compliance to the NIV, defined as a use of more than 4 hours per day.

Aim of the study: The main objective is this observational study is to monitor the home NIV compliance over a period of 1 year under real conditions of treatment in patients with COPD newly initiated onto NIV (with telemonitoring or not) in order to specify the predictive criteria for good compliance. The secondary objectives are to assess the evolution of functional respiratory data, NIV parameters and changes in prescription, occurrence of acute exacerbations of COPD, hospitalizations and death, patient outcomes (quality of life and acceptability of NIV).

Study design: a cohort of 120 patients with COPD newly initiated onto home-NIV (with telemonitoring or not), either in a stable state or following an acute exacerbation will be enrolled in the study and follow-up over 1 year. Data will be collected by lung specialists and home health care provider teams at 1-month post-initiation of NIV, 6 months and 1 year. The study is conduct in France.


Eligibility Criteria:
Inclusion Criteria:

* COPD patients who require the initiation of a home-NIV (in case of previous equipment: NIV interrupted for more than 6 months).
* Life expectancy greater than 1 year.
* Patient who has agreed to participate in the observational study after receiving clear information from the investigator and signing the consent form.

Exclusion Criteria:

* NIV indicated for the treatment of chronic respiratory failure other than COPD.
* Patient with overlap syndrome (COPD associated to OSA).
* Patient with limitations who do not allow proper use of the NIV device.
* Simultaneous participation in a health intervention research.
Cortical Visual Impairment and Visual Attentiveness

This study will investigate the effect of enhanced visual and cross-modal environments upon the visual attentiveness of multiply handicapped children diagnosed with Cerebral Palsy (CP) and Cortical Visual Impairment (CVI).

Research Hypothesis

1. Adapted visual environments which present controlled auditory, tactile, proprioceptive or contrasting visual background stimulation will enhance the visual attentiveness to a given visual stimulus of children diagnosed with CP and CVI.
2. Systematic, repetitive, visual stimulation over time, improves the visual attentiveness and/or visual-motor responses of CP-CVI children.
3. The analysis of additional behavioral responses to visual stimuli is a critical component in evaluating the perceptual development of visual attention in CP-CVI children.

Use of Noldus: The Observer, an advanced objective computerized observation program, will enable precise detection of the neurobehavioral responses of the participants. Both overt and covert responses will be observed, analyzed and correlated to identify the level of attention of each participant.


Eligibility Criteria:
Inclusion Criteria:

* two to twelve years of age
* diagnosis of: CP, mental retardation (MR) and CVI (Control group participants without visual disability)

Exclusion Criteria:

* N/A
Comparison of Pain Levels in Fusion Prostate Biopsy and Standard TRUS-Guided Biopsy

The aim of this study was to compare the pain levels in transrectal ultrasound (TRUS)-guided standard 12-core prostate biopsy (SPB) and multiparametric prostate magnetic resonance imaging (MpMRI)-guided fusion prostate biopsy (FPB).

The study included patients that underwent prostate biopsy under local anesthesia (intrarectal 2% lidocaine gel + periprostatic nerve block) due to suspected prostate cancer. Patients detected with a Prostate Imaging Reporting and Data System score (PIRADS) ≥3 lesion on MpMRI underwent MpMRI-guided FPB (Group I) and the patients who had no suspected lesions or had a PI-RADS \<3 lesion on MpMRI underwent TRUS-guided SPB (Group II). Pain assessment was performed using Visual Analog Scale (VAS) 5 min after the procedure. Following the procedure, the patients were asked to indicate the most painful biopsy step among the three steps (1: insertion of the probe into the rectum, 2: probe manipulation, 3: the piercing of the biopsy needle).

Eligibility Criteria:
Inclusion Criteria:

* Elevated blood prostate specific antigen (PSA) levels according to patients age. PSA \>2ng/ml for whom aged between 50-60, and PSA \>4ng/ml for whom were above 60 years old
* Having suspicious digital rectal examination
* having multi-parametric prostate MRI before prostate biopsy
* Having MRI defined lesions which were PIRADS - 3 -4-5

Exclusion Criteria:

* PSA \> 50 ng/ml
* previous negative biopsy
* neurological disorders that could affect the pain level such as paraplegia or hemiplegia, analgesics use for any reason on the day of or the day before the procedure,
* patients underwent biopsy under general anesthesia,
* having such diseases as anal fissure or hemorrhoidal disease that could alter the pain threshold
Dietary Protein Requirements on Unbalanced Diets

The objective of this study is to determine ad libitum daily energy and protein intake, energy balance and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive days, also as a function of age, gender, BMI and FTO polymorphisms.

Following the protein leverage hypothesis, energy intake may be a derivative of protein intake. Therefore, in response to an unbalanced menu relative to the usual daily intake target, protein intake should be prioritized. Individuals may over-consume carbohydrate and fat of a menu containing a lower ratio of protein to carbohydrate and fat until the daily intake target amount of protein is ingested, and not the target of total energy intake because of a deficit of protein intake. In contrast, individuals may under-consume energy when the menu has an increased protein to carbohydrate and fat ratio. The protein leverage hypothesis requires evidence for why protein intake is more important than carbohydrate or fat in relation to food intake regulation.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18-35 kg/m2
* age between 18-70 years
* healthy
* non-smoking
* not using a more than moderate amount of alcohol (\> 10 consumptions/wk)
* weight stable (weight change \< 3 kg during the last 6 months)
* not using medication or supplements except for oral contraceptives in women

Exclusion Criteria:

* not healthy
* smoking
* using a more than moderate amount of alcohol
* not being weight stable
* using medication or supplements except for oral contraceptives in women
* do not meet the criteria for BMI and age
* pregnant or lactating
* allergic for the used food items
Comparison of Percutaneous Coronary Intervention Optimization With Fractional Flow Reserve Versus Intravascular Ultrasound in the Treatment of Long Coronary Artery Lesions

A single center, prospective, observational study to compare fractional flow reserve (FFR) and intravascular ultrasound (IVUS) percutaneous coronary intervention (PCI) optimization strategies on the functional PCI result (assessed with FFR) immediately post PCI and at 9-12 months after the treatment of long coronary artery lesions.


Eligibility Criteria:
Inclusion Criteria:

* Chronic coronary syndrome (stable angina; staged PCI to other lesions after acute myocardial infarction with ST segment elevation);
* Acute coronary syndrome without ST segment elevation (unstable angina or myocardial infarction without ST segment elevation);
* Functionally significant (FFR ≤ 0.8) lesion requiring a stent length of ≥ 30 mm and amenable for percutaneous coronary intervention.

Exclusion Criteria:

* Patient's age ≤ 18 years;
* Acute myocardial infarction with ST segment elevation;
* Treatment with dual antiplatelet therapy contraindicated;
* Survival expectancy ≤ 1 year;
* Known allergy to sirolimus, everolimus or zotarolimus.
Functional Brain Imaging and Psychological Testing in Women With Chronic Pelvic Pain

Functional magnetic resonance imaging in women with chronic pelvic pain using arterial spin labelling, functional connectivity, diffusion tensor imaging and magnetic resonance spectroscopy.

Multimodal magnetic resonance neuroimaging will be utilised. Arterial spin labelling is tightly coupled with cerebral metabolism and can be used as a marker of neural activity. Resting state magnetic resonance imaging which measures synchronous activity across the brain, allows detection of functional connectivity of intrinsic brain network. Diffusion tensor imaging detects the anisotropic water diffusion in axonal fibres can provide information on connectivity and fibre tracts. Magnetic resonance spectroscopy would enable the levels of neurotransmitter to be elucidated.

Eligibility Criteria:
Inclusion Criteria:

* Chronic pelvic pain
* Endometriosis

Exclusion Criteria:

* Contraindication to magnetic resonance imaging
ESP Block for Post Cesarean Analgesia

The purpose of this pilot study is to assess the analgesic efficacy of Erector Spinae Plane block (ESPB) with liposomal bupivacaine in women undergoing cesarean delivery and receiving a postoperative multimodal analgesic regimen as assessed by the dose of rescue postoperative opioids compared to a historical control group of women receiving the same multimodal regimen but with no truncal blocks. This will be a case control study with a prospective and a retrospective component. Women undergoing elective cesarean delivery under spinal or combined spinal epidural anesthesia will be approached to participate in the prospective open label component of the study. Cases will be matched in a 1:4 ratio by age, race, history of prior cesarean delivery, and insurance status with historical controls who received the same multimodal analgesic regimen but no truncal blocks. We plan to enroll 30 subjects for the prospective arm of the study and 120 for the retrospective arm.

This will be a case control study with a prospective and a retrospective component. Women undergoing elective cesarean delivery under spinal or combined spinal epidural anesthesia will be approached to participate in the prospective open label component of the study. Those women will receive the standard of care intraoperative and postoperative analgesic regimen used at Duke university incorporating 100 mcg intrathecal morphine, intraoperative acetaminophen 975 mg PR and ketorolac 15 mg IV and postoperative scheduled oral acetaminophen 975 mg every 6 hours, scheduled 15 mg IV ketorolac for 3 doses every 6 hours followed by oral ibuprofen 600 mg every 6 hours. At the end of surgery, a bilateral ESPB will be performed under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side.

Cases will be matched in a 1:4 ratio by age, race, history of prior cesarean delivery, and insurance status with historical controls who received the same multimodal analgesic regimen but no truncal blocks.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age with a term pregnancy of 37 to 42 weeks and American Society of Anesthesiologists Physical Status Classification II or III scheduled to undergo elective CD.

Exclusion Criteria:

* ≥3 prior CDs, pre-pregnancy body mass index \>40 kg/m2, planned concurrent surgical procedure other than tubal ligation, chronic pain or chronic opioid therapy, any clinically significant event or condition uncovered during surgery (eg, excessive bleeding, acute sepsis) that might render the patient medically unstable or complicate the patient's postsurgical course, or allergy or contraindication to any component of the multimodal analgesic regimen.
Which Markers of Musculoskeletal Health Can Explain Complications in Spinal Surgery?

The present study is related to the project "ORTHOSPINE FITNESS: WHICH MARKERS OF MUSCULOSKELETAL HEALTH CAN EXPLAIN COMPLICATIONS IN SPINE SURGERY?", winner of the Ministry of Health Call, financed by the European Union, "M6/C2_CALL 2023", Project Code " PNRR- MCNT2-2023-12378098", Call section "Non-chronic chronic diseases transmissible diseases (MCnT2) with a high impact on health systems".

Complications of spinal surgery still represent a significant and unsolved problem. Their incidence is between 7 and 20%, with a high percentage of mechanical complications observed in patients operated on for degenerative pathologies. Readmissions, re-operations and subsequent rehabilitation treatments have a heavy impact on patients and the entire healthcare system.

The study proposed, financed through the "PNRR-MCNT2-2023-12378098" call, is a multicenter study on a large cohort of patients undergoing spinal surgery for degenerative pathologies of the thoraco-lumbar spine, which has as its general objective to establish a comprehensive preoperative screening of bone health and the musculoskeletal system, combining advanced imaging and modeling (HRpQCT images of bone microstructure at peripheral sites and related computational assessment of bone mechanical properties), assessment of physical fragility (including muscle strength and assessment of proprioception/fall risk), cellular and molecular analyzes of bone fitness and bone-muscle cross-talk, and assessment of nutritional status.

The results of the project will allow us to: (i) define a concept of "surgical suitability" to evaluate patients candidates for elective spinal surgery and possibly improve the surgical decision-making process (for example the choice of fixation and instrumentation); (ii) identify a minimum set of significant and independent markers to monitor in future interventional studies aimed at reducing the risk of adverse events in spinal surgery, (iii) allow patient-specific preoperative interventions (such as nutritional supplementation, physical pre-habilitation or administration of bone anabolic agents)

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years;
* diagnosis of degenerative pathology of the spinal column of the thoraco-lumbo-sacral tract;
* patients candidates for surgical treatment for the aforementioned pathology during the study period;
* willingness to participate in the study and sign the specific informed consent

Exclusion Criteria:

* presence of tumors or infections in the spinal column;
* presence of degenerative pathology of the spine without surgical indication;
* presence of degenerative pathology of the spinal column at the cervical level.
Stress Management for Irritable Bowel Syndrome

The primary goal of this study is to test the efficacy of emotional awareness and expression training (EAET), a novel emotional processing intervention that the investigators have developed, for people with IBS. In this randomized, controlled trial, the investigators will compare EAET to a standard intervention that teaches the conceptually opposite approach-relaxation training (RT)-and test how both of these interventions compare to a wait-list control condition. The investigators hypothesize that individuals in the EAET group will demonstrate greater improvement in their IBS symptom severity, psychological functioning, quality of life, and health care utilization at 4 and 12-week follow-up time points, compared to individuals in the wait-list control group. It is also expected that both of the active interventions (EAET and RT) will be more efficacious than the wait-list control condition.


Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate, individuals must meet the Rome III criteria for IBS. That is, they must report that they have had:

* recurrent abdominal pain or discomfort, or
* a change in stool frequency or form,
* at least three days per month, in the last three months, and
* that they have been given this diagnosis by a physician. They must also report having pain and discomfort of at least two days per week at time of screening.

Exclusion Criteria:

* Individuals who report having post-infectious IBS,
* organic gastrointestinal diseases (e.g., inflammatory bowel disease), immunodeficiency,
* a current psychotic disorder,
* drug or alcohol dependence within the past two years, and
* those who are unable to communicate in English will be excluded.
Metacognitive Therapy for Comorbid Insomnia

The purpose of this study is to determine the effect of meta-cognitive therapy for insomnia.

This study is a randomized controlled trial with 50 patients with a psychiatric disorder and insomnia. The patients will be randomized into two groups of 25 patients. The first group receives meta-cognitive therapy, whereas the second group will be assigned to a waiting list control.

Eligibility Criteria:
Inclusion Criteria:

* Insomnia secondary to a primary psychiatric disorder

Exclusion Criteria:

* substance abuse, psychotic symptoms, suicidal intentions, severe organic disorder or psychiatric disorder where sleep restriction is not advised, organic sleep disorder.
Evaluation of Sarcopenia and Related Factors in Patients Diagnosed With Psoriatic Arthritis

The purpose of the study is identify the prevalence of sarcopenia and its associated factors in patients with psoriatic arthritis. Furthermore, we aimed to investigate the predictive contribution of USG in diagnosing sarcopenia by assessing the thickness of the rectus femoris, vastus intermedius, and quadriceps muscles in patients with psoriatic arthritis.

After being informed about study and potential risk, all patient and giving written informed consent will undergo screnneing determite eligibility for study entire. Participants who agree to take part in the study and sign the informed consent form will be divided into two groups: patients and healthy volunteers. The patients will undergo a rheumatological examination, and sarcopenia screening will be conducted for both groups. Additionally, the quadriceps muscle thickness of both groups will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with psoriatic arthritis according to CASPAR criteria at least 1 year ago
* Between 18 and 65 years old
* Normal cognitive functions
* Agrees to participate in the study
* No changes in medical treatment for psoriatic arthritis in the last 3 months

Exclusion Criteria:

* Those with neurological diseases
* Those with hip dysplasia
* Those with upper and lower extremity deformities
* Those with upper and lower extremity joint arthroplasty
* Those with arthritis and deformities in the hands
* Those with lumbar stabilization
* Those with cognitive impairment preventing participation in the study
* Those with body weight beyond the device\&#39;s measurement capacity
* Those who do not agree to participate in the study