cyrilzakka/clinical-trials huggingface dataset:
Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery

Postoperative endophthalmitis, a possible severe complication of cataract surgery, is an infection of the anterior chamber of the eye caused by bacterial contamination and colonization through surgical incisions. Bacteria are thought to originate mainly from the patient's skin and studies show that bacteria are commonly found in the anterior chamber following surgery. However, innate immune defences are usually able to control and eliminate bacterial growth before postoperative endophthalmitis occurs. Also, due to the low incidence of postoperative endophthalmitis, it is difficult to accurately evaluate preventative methods. This study will examine the efficacy of topical preoperative administration of gatifloxacin (a new fourth generation fluoroquinolone antibiotic) on reduction of bacterial contamination of the anterior chamber following cataract surgery. If the antibiotic is shown to lower bacteria count in cultures from anterior chamber fluid, it has the potential to lower the incidence of postoperative endophthalmitis.

Patients undergoing cataract surgery will be notified and asked to participate in the study by the physician in advance of the surgery, provided they do not possess any exclusion criteria. The participants will be randomly split into two groups; one group will receive topical application of gatifloxacin prior to surgery, while the other group will receive no eye drops. During surgery, a small sample of anterior chamber fluid will be removed from the eye and cultured in both broth and enrichment media for all subjects. Bacterial growth, i.e., colony forming units (CFUs), will be used as an indicator of the bacterial contamination of the fluid.


Eligibility Criteria:
Inclusion Criteria:

* Cataract surgery on first eye (i.e., first cataract surgery.

Exclusion Criteria:

* uveitis,
* herpetic eye disease,
* corneal ulceration,
* severe blepharitis,
* past trauma to the eye,
* complicated cataract surgery (e.g., posterior capsule rupture),
* previous intraocular surgeries.
Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude

This study involves a breathing motion assessment in healthy subjects before and after continuous positive airway pressure (CPAP) administration using MRI images.

The hypothesis for this study is that CPAP administration will significantly reduce breathing motion. This may help cancer patients who are undergoing proton radiotherapy, so they possibly will not have to hold their breath during the procedure.

Minimally invasive techniques for tumor motion reduction that involve free-breathing patients have significant relevance in the context of radiation therapy, in particular proton radiotherapy. Tumor motion reduction has favorable implications for reduction of radiation doses to adjacent healthy organs, radiation plan robustness (accuracy/quality) and for treatment efficiency (reduction of treatment times). Using non-ionizing MRI with volunteers, the investigators will determine the extent to which continuous positive airway pressure (CPAP) reduces breathing motion (diaphragmatic excursion). The researchers will also investigate the parameter space associated with breathing motion reduction versus the amount of pressure applied, as well as timing of initiation of CPAP in relation to the imaging time point (to address whether an initial transient breathing state exists).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult female and males
2. Subject meets routine MRI safety criteria

Exclusion Criteria:

1. Age \<18
2. Known history of chronic obstructive pulmonary disease (COPD), asthma, or other chronic pulmonary illness
3. Pregnancy
4. Any safety risk identified via MRI safety screening
Body Image and Self-esteem in Adolescence

To evaluate the difference between body image and self-esteem scores during and at the end of the medical. Hypothesis: body image and self-esteem changes during the oncological treatments.

Body image and self-esteem represent important variables linked to adolescents' development. These two variables are the most affected in patients with the oncological disease.

The consequences of a visible difference may have a significant impact on behaviour and mood, causing relevant impairments in individuals well-being and quality of life. Among different personal attributes, self-esteem may be the one with the greatest impact on body image (Cash, 2002). Indeed previous studies have investigated different features of body image and self-esteem (Webster \& Tiggemann, 2003), showing that they have a significant influence on the overall well-being (Cash \& Fleming, 2002), and that those aspects are also significantly influenced by age and gender. The patients are evaluated at T0 (within the first week of hospitalization after diagnosis), T1 (within 3 months after diagnosis), T2 (within 6 months after diagnosis), T3 (within 12 months after diagnosis, at the end of cancer treatment), according to a follow-up study design. Data analysis: r Pearson's correlation, repeated measure ANOVA and regression analysis will be carried out to investigate relations between studied variables and eventual changes over time. Analyses are performed using SPSS software (Chicago, S. P. S. S. SPSS Inc; 2008. SPSS Statistics, 17.)

Eligibility Criteria:
Inclusion criteria for patients:

* Age between 12 and 19 years
* Adequate knowledge of the Italian language
* Consent to participation
* First diagnosis for oncological pathology of leukaemia or bone cancer

Exclusion criteria for pediatric patients:

* Patients under the age of 12 or over 19 years
* Not adequate knowledge of the Italian language
* Patients who have a relapse with respect to the pathology already treated
* Patients with previous oncological diseases
* Cognitive disability
* Patients with brain tumours
* Patients with gender dysphoria
* Absence of informed consent
* Previous diagnosis of Anxiety or Depression
* Diagnosis of an eating disorder
Metacarpophalangeal Joint Reconstruction Using a Vascularized Cartilage and Bone Graft

Traumatic cartilage loss of the joint is central to the development of joint failure in arthritis. The study on the use of a bone graft for reconstruction of metacarpophalangeal joint defects.

The metacarpophalangeal joint is vital for hand function. Cartilage loss of the joint is central to the development of joint failure in arthritis. Although various treatments have been proposed, the management remains a challenging problem.Previous anatomical studies have shown that, at the base of the metacarpal, there were nutrient arteries inserting into the dorsum of the metacarpal. The nutrient arteries arise from the distal and middle dorsal carpal arches that run distally to the first to fourth dorsal metacarpal arteries (DMAs. These studies prompt us to use a reverse vascularized cartilage and bone graft based on the DMA. The metacarpal consists of a widened proximal base. The joint surface to the capitate is convex anteriorly and dorsally concave, where it extends to the styloid process on the dorsolateral aspect of the metacarpal base. The unique contour stimulates our imagination and creativity to use a portion of the joint surface for reconstruction of metacarpophalangeal joint defects. The purpose of this study is to report the novel technique and to evaluate the effectiveness of the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. a cartilage defect at either proximal or distal MCP joint;
2. either an acute or old injury;
3. loss of 1/4 of joint entire surface that seen on plain radiographs, CT scan, and intraoperative finding;
4. and with or without MCP joint subluxation.

Exclusion Criteria:

1. large defects involved double joint surfaces;
2. the size of the defect involving less than 1/4 of the joint surface;
3. associate with infection or other diseases that restrict to use the technique.
Structured Non-operative Treatment of Knee Osteoarthritis

The purpose of this study is to test whether an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, non steroidal anti inflammatory drugs (NSAIDs) and Pantoprazole provides further improvement in pain, function and quality of life than standard non-surgical treatment (information on the disease and how to treat it) in patients with knee osteoarthritis.

The H1-hypothesis is that the treatment algorithm results in a greater increase in quality of life and functional capacity and greater reduction in pain than standard treatment at the primary endpoint, which is follow-up 12months after the start of the treatment.

See statistical analysis plan available under "Links" for further description of the study.

Knee osteoarthritis (OA) is the degenerative joint disease that most often requires treatment and at the same time the one associated with the greatest social costs. In addition, the disease has many personal costs and is greatly contributing to reduced functionality and autonomy of older adults.

It is recommended both nationally and internationally that the treatment of knee osteoarthritis should include multiple treatment modalities. Clinical guidelines recommend that exercise, weight loss and patient education is the first step in treatment and that insoles and pharmacological treatment can be included as a supplement.

However if the patient is not a candidate for total knee replacement, the patient most often receives only information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. This postponement of treatment can lead to a worsening of pain and function and a worse outcome after treatment. Therefore, the current treatment strategy for the patient group is problematic.

The current practice may be due to the lack of studies with high level of evidence that have examined the optimal non-operative treatment approach and compared it with the current standard treatment for this group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Knee-OA detected by x-ray (Kellgren \& Lawrence grade 1 or greater)
* KOOS4 of ≤ 75
* Considered not to be a candidate for Total Knee Replacement (TKR) by the orthopedic surgeon.
* The participant is \> 18 years of age.
* The participant can provide relevant and adequate, informed consent.

Exclusion Criteria:

* Prior TKA ipsilateral
* Rheumatoid arthritis
* Mean VAS \> 60mm the last week on a 0-100mm scale
* Possible pregnancy or planning pregnancy;
* Inability to comply with the protocol;
* Inadequacy in written and spoken Danish.
China Inherited Ventricular Arrhythmias Registry

This is an observational, prospective, multi-center registry, aiming at building a risk stratification for malignant inherited ventricular arrhythmias, including Brugada syndrome(Brs)、Long QT syndrome(LQTS)、Short QT syndrome(SQTS)、Early repolarization syndrome(ERS) and Catecholaminergic polymorphic ventricular tachycardia(CPVT). 500 participants will be recruited from 10 centers in China, with clinical data to be abstracted from medical records, and blood samples to be collected for finding related genes and promising risk indicators. The follow-up should be made every 6 months.

In China, the prevalence and risk factors of malignant ventricular arrhythmias remain unclear. In addition, mainstream treatment relies on implantable devices and medication. China Malignant Ventricular Arrhythmias Study is a nation-wide complex consisting of several interrelated studies, with the aim of building a risk stratification as well as an efficient and economic strategy for early prevention and treatment.

Inherited Ventricular Arrhythmias Registry, as a part of China Malignant Ventricular Arrhythmias Study, is an observational, prospective, multi-center registry, aiming at exploring the correlation between genotype and phenotype for inherited structural ventricular arrhythmias, thus helping molecular diagnosis and risk stratification of these conditions. 500 patients with definitive diagnosis will be recruited consecutively from 10 major arrhythmia centers distributed in 6 areas in China. At study entry, participants will be interviewed and asked to sign the informed consent. Demographic characteristics, medical history, clinical features, laboratory tests, imaging pictures, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well-trained staffs. At the same time, blood samples will be collected to detect biological markers, like genes, inflammatory factors ,etc. Once enrolled, the participants will receive follow up every 6 mouths about condition of arrhythmia, medication, clinical events, etc.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as Brugada syndrome(Brs)、Long QT syndrome(LQTS)、Short QT syndrome(SQTS)、Early repolarization syndrome(ERS) or Catecholaminergic polymorphic ventricular tachycardia(CPVT).

Exclusion Criteria:

* patients were enrolled by other clinical trials.
Assessment of Safety Distance of Far-Infrared Therapeutic Device to Human Skin

Abstract The equipment "infrared therapeutic device" is widely used in various medical institutions in Taiwan. The infrared therapeutic device improves the blood circulation, relieves muscle stiffness and pain by the heat energy radiated by the infrared light, and has a significant relief effect on patients with joint pain, muscle soreness, and back discomfort. However, the principle of the infrared therapeutic device is thermal energy, and there is no complete literature on the parameters such as treatment intensity and time and the full distance. In addition, the literature on the damage that can be caused is not based on clinical evidence, and there is no standardization study on the use of equipment, so it is hoped that this test will explore the safety distance of infrared therapeutic devices.

The project is expected to recruit 50 people from 20 years old to 75 years old in the Chinese Medicine Clinic of Tainan Hospital of the Ministry of Health and Welfare, which is included in the diagnosis of osteoarthritis, degenerative arthritis, osteoporosis and other related Chinese medicine clinics. In patients with diseases, the main complaint must include patients with lower back pain and back pain. Subjects should exclude diseases that may be affected by chemoradiotherapy, cardiovascular disease, anemia, hypertension, etc., and exclude dermatitis, skin irritation, and erythema. Skin diseases such as lupus. The test site is the TCM clinic of Tainan Hospital of the Ministry of Health and Welfare. The air conditioner is fixed at a constant temperature of 28 degrees. The output power is calculated by the wattage meter, and the distance and temperature of the infrared lamp are measured. Finally, the appropriate temperature and distance of the infrared lamp to the human skin are estimated through calculation.

Keywords: Infrared, Far- infrared, Burn


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults over the age of 20 are not excluded from patients with lower back pain.

Exclusion Criteria:

1. Exclude cardiovascular diseases, anemia, high blood pressure and other diseases that may affect circulation.
2. People with skin diseases, skin allergies, and skin abnormalities.
3. Patients who are clinically diagnosed with cancer or other major injuries.
4. Excluded conditions are alcoholics, diabetic patients (blood sugar greater than or equal to 200 mg/dL), and severe or life-threatening complications (determined by the trial host based on medical history).
5. Women who are pregnant or breastfeeding (positive urine pregnancy test).
6. The moderator decides that it is not suitable to participate in this research.
Seri Surgical Scaffold Support of the Lower Pole of the Breast

Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help shape and hold the breast up on the chest preventing re-stretching and bottoming out of the breast in breast reduction or augmentation-mastopexy patients? The amount of stretch will be measured manually as well as percent of breast tissue measured with the Canfield Vectra 3-D Imaging system reporting the amount of breast tissue above and below the nipple level.

Patients having augmentation mastopexy or breast reduction will be informed about Seri Scaffold and allowed to have Seri support included in their surgery or not. If the choose the scaffold will be placed under the skin in the lower pole of the breast as an internal hammock to help take weight off of the breast and potentially help prevent future stretch of the lower pole.

Eligibility Criteria:
Inclusion Criteria:

Age =\>18 years

* requesting procedure
* No active cancer or infection

Exclusion Criteria:

* Known allergy to silk
* Pregnant or lactating
Simulation-based Comparative Study on Efficiency of Ventilation During Paediatric Cardiopulmonary Resuscitation

The aim of this study is to gather data to support beginning the pediatric cardiopulmonary resuscitation (CPR) with 5 initial breaths. The group of health care professionals and the group lay rescuers will be asked to perform cardiopulmonary resuscitation (CRP) on 2 pediatric simulation mannequins (the 3-month-old infant, 5 kg, and the 5-year-old child, 25 kg) and the effectiveness of initial ventilation attempts will be evaluated.

There is a lack of knowledge on the efficiency of ventilation during simulated and real cardiopulmonary resuscitation of children and infants. The ventilations should be an integral part of pediatric resuscitation as recommended by European Resuscitation Council (ERC) because the respiratory and other secondary causes with oxygen depletion are common causes of cardiac arrest in children. However, the effectiveness and quality of ventilation are rarely studied and ERC guidelines to start ventilation with 5 initial breaths in pediatric CPR are based on the experts´ opinion. This study evaluates ventilation efficiency during simulated pediatric cardiopulmonary resuscitation performed by 2 different groups of potential rescuers - physicians, nurses- representing the advanced life support and lay rescuers- representing the basic life support algorithm. The primary aim of this study is to evaluate the number of effective breaths (define as a visible chest rise) during 5 initial breaths attempts of simulated pediatric cardiopulmonary resuscitation. Secondary outcomes include subanalysis of the effectiveness of two initial breaths attempts, defined as a visible chest rise, time to first effective breath, breath volume delivered during 5 initial breaths, and breaths during CPR. The appropriate volume would be considered 6-10 mL/kg (i.e. 30 - 50 mL in infant and 125- 250 mL in the child). The data will be obtained before and after standardized simulation training in both groups. For lay rescuers, the dispatcher-assisted CPR will be simulated. For the health care professionals, basic equipment will be available and expected to be used (correct size mask and bag-mask ventilation).

Eligibility Criteria:
Inclusion Criteria:

* Volunteer participants - lay rescuers
* Health care professionals performing simulated CPR

Exclusion Criteria:

* not willing to participate
Is the Use of Blood Platelets Effective in the Treatment of Difficult Fistulas Related to the Anal Sphincter?

Rationale:

Closure of the internal opening is the most accepted standard procedure in the treatment of peri-anal fistulas. The mucosal advancement flap is considered as golden standard. In one out of the three patients mucosal flap repair fails. Possible causal factors are incomplete clearance of pus and debris, incomplete closure of the internal opening, inappropriate host response in patients with risk factors like smoking or diabetes. Platelet derived growth factors may facilitate closure of the internal opening, especially in patients with impaired wound healing.

Objective:

The use of autologous platelet rich plasma (PRP) as an adjunct to the staged mucosal advancement flap to achieve a better closure rate of complex peri-anal fistula's.

Study design:

Randomized, multicenter trial.

Study population:

Patients with complex cryptoglandular peri-anal fistula's.

Intervention:

Injection of PRP in the curretted fistula track under the mucosal flap.

Main study parameters/endpoints:

* Recurrence rate
* Post-operative pain
* Continence
* Quality of life.

Nature and extent of the burden and risks associated with participation, group relatedness:

Because autologous blood is used, no extra risk are expected.


Eligibility Criteria:
Inclusion Criteria:

* Complex peri-anal fistula.
* Able to understand informed consent.

Exclusion Criteria:

* Pregnancy
* Local malignancy
* Crohn's disease or Ulcerative colitis
* Traumatic or iatrogenic lesion
* Thrombocytopenia
* Splenomegaly
* Bleeding disorders
* Hematologic malignancies
RhabdomYolyse in Intensive caRe

Analysis of the outcome of patients \< 18 years old, treated in an intensive care unit for severe rhabdomyolysis, regardless of etiology (renal failure rate, death rate, organ replacement rate)


Eligibility Criteria:
Inclusion Criteria:

* CPK \> 5000 UI/L
* Care in Pediatric Intensive Care Unit
* Age \< 18 years old

Exclusion Criteria:

* Parental refusal
A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan

This is a national, multicenter, retrospective/prospective, observational study in Taiwan designed to assess effectiveness, safety, and usage of efanesoctocog alfa prophylaxis treatment in hemophilia A participants. The data related to efanesoctocog alfa effectiveness, safety and usage will be recorded prospectively during routine visits for up to 5 years following enrollment initiation and the retrospective data will be collected at least 12 months and up to 24 months prior to efanesoctocog alfa initiation. Joint imaging data will be collected in centers performing Joint U/S and/or MRI (≥6 years old). At least 12 months of retrospective data will also be collected from medical records, as available. Prospectively collected data will be recorded at routine clinical visits during a five-year follow-up period. The end of study is defined as the last participant's last visit. No intervention will be administered, and no study related visits are required.


Eligibility Criteria:
Inclusion Criteria:

* Participants with all ages and diagnosis of moderate-severe hemophilia A without current and/or at least three years of un-detectable inhibitor (\<0.6 BU)
* Participants with moderate to severe hemophilia A as defined by FVIII level ≤ 5%
* Participants starting efanesoctocog alfa prophylaxis treatment as per standard of care no more than three months prior to the enrollment date
* Participants aged 6 years and older are able to undergo MRI examinations (sedation given, if necessary, and per investigator discretion)
* Participants are able to undergo joint examinations
* Physician's decision to treat the participant with efanesoctocog alfa is made prior to and independently of participation in the study
* Signed and dated informed consent provided by the participant, or by the participant's legally acceptable representative for participants under the legal age before any study-related activities are undertaken. Assent should be obtained for pediatric participants according to local regulations

Exclusion Criteria:

* Participants with coagulation disorders other than hemophilia A
* Participants diagnosed with other known bleeding disorder
* Participants currently receive factor therapy and have signs of decreased response to FVIII therapy
* Participants with a baseline PS score of greater than 6 in both ankles for each joint
* Enrollment in another concurrent clinical interventional study, or intake of an Investigational Medicinal Product within 3 months prior to inclusion in this study
* Pregnant female participants

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