cyrilzakka/clinical-trials huggingface dataset:
Antibiotic Elution After Two-stage Knee Revision

The goal of this observational study is to monitor the eluted antibiotic concentrations of gentamicin and vancomycin by a static knee cement spacer in patients being treated for periprosthetic infections of the knee. The main question aims to answer if eluted antibiotics are in a therapeutic range for treatment at sight of infection. Secondarily, local antibiotic concentrations are compared with systemic blood levels, as are systemically applied antibiotics compared to intra-articular concentrations. Intra-articular samples are collected over a 72 hour postoperative period.

The present study moinitors antibiotic concentrations eluted by a static cement knee spacer as two-stage revision treatment of a knee PJI. The static cement spacer consists of COPAL G+V cement containing 2g of vancomycin and 0.5g of gentamicin. Microdialysis is used as a technique for continuous extra cellular sample collection directly from the knee joint cavity. It is implemented guided by a drainage tube during the surgery to remove the infected prosthesis and implement the spacer. Over a 72 hour period samples directly from the knee joint are generated continiously. These are analyzed for the eluded antibiotic concentrations of gentamicin and vancomycin from the knee spacer. Once every 24 hours venous blood samples were collected as well and analyzed for gentamicin and vancomycin and also systemically applied antibiotics (a.e. cefuroxim, clindamycin).

Eligibility Criteria:
Inclusion Criteria:

* clinical indication for a two-staged revision of a knee PJI
* approval for surgery by the orthopedic and anesthesiologic departments
* being over 18 years of age
* written, informed consent after detailed patient information about the study protocol and possible study-dependent risks

Exclusion Criteria:

* known allergies to the antibiotics gentamicin and vancomycin contained in the spacer
Novel Imaging Tools in Newly-diagnosed Patients with Cardiac AL Amyloidosis

This will be a systematic, combined, prospective assessment of the novel echographic, CMR, and PET imaging tools in newly-diagnosed patients with cardiac AL amyloidosis at baseline and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* age more than 18;
* histological diagnosis of AL amyloidosis;
* measurable cardiac involvement as per current response criteria (i.e. NT-proBNP \>650 ng/L);
* measurable hematologic disease (dFLC \>20 mg/L);
* adequate renal function (eGFR \>30 mL/min) in order to be safely administered gadolinium;
* absence of atrial fibrillation with uncontrolled heart rate;
* absence of implantable cardiac devices;
* absence of pulmonary amyloidosis histologically documented;
* plan to start anti-plasma cell chemotherapy;
* plan to assess response at the Pavia center after 6 months;
* have given written informed consent to participate.

Exclusion Criteria:

* non-AL amyloidosis;
* NYHA class IV;
* PS-ECOG \>3;
* severe allergy to paramagnetic tracer;
* severe claustrophobia;
* pregnant or nursing women;
Preventing Lymphedema in Axillary Lymph Node Dissection

The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm.

All subjects will undergo an axillary lymph node dissection (ALND). Cluster randomization will determine which of these subjects will have the ARM with LVB and which subjects will have the ALND without this technique. As a baseline, all subjects will have the circumference of their arms measured and complete a questionnaire about lymphedema. Performing the measurements and answering a questionnaire will be repeated at 6, 12, 24, and 36 months after surgery.

Eligibility Criteria:
Inclusion Criteria

* Patients scheduled to undergo an axillary lymph node dissection
* Patients who in the surgeon's judgement are at high risk to convert to an axillary lymph node dissection based intraoperative findings
* English speaking

Exclusion Criteria

* Prior ipsilateral axillary lymph node dissection
* Prior ipsilateral axillary radiation
* Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an axillary lymph node dissection in the surgeon's judgement
* Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema.
* Pregnant patients cannot participate in the substudy
Use of Portable Technology in Patient Education of Shave/Punch Biopsies

The investigators investigated the use of portable MP3 technology in patient education and informed consent of shave and punch biopsies. Eighty patients were divided randomly into a control and experimental group. Control patients received the standard of care in patient education and informed consent. Experimental patients watched a short 80-second video on shave or punch biopsies. All patients were given pre- and post-education questionnaires to assess the efficacy of each method.


Eligibility Criteria:
Inclusion Criteria:

* English speaker
* Receiving shave or punch biopsy

Exclusion Criteria:

* Under 18 years of age
Oral Rinse to Reduced Expelled Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) During COVID-19 Infection

Prospective, cross-sectional study evaluating the effect of commercially available mouthwashes on expelled/exhaled SARS-CoV-2 viral load using face mask sampling.

The study will consist of a Control Phase to optimize procedures for measuring expelled/exhaled viral load, and a Evaluation phase comparing different commercially available mouthwashes.

In the Control Phase. up to 20 COVID-19 patients will be asked to undergo a sequence of face mask sampling and saliva collections prior to and after an oral rinse with (i) water and (ii) a commercially-available cetylpyridinium chloride (CPC) mouthwash.

Based on outcomes of the Control Phase, the study will proceed into the Evaluation Phase, which will randomize approximately 40 COVID-19 patients to receive 1 of 4 commercially available Colgate mouthwashes following standard package instructions. Face mask sampling and saliva will be collected prior to and after the mouth rinse to assess impact on SARS-CoV-2 viral load.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Able to provide consent
3. Polymerase chain reaction (PCR)-confirmed SARS-CoV-2 within previous 48 hours.

Exclusion Criteria:

1. Clinical contraindication or poor feasibility to complete study procedures
2. Unwilling or unable to produce saliva or face mask samples
3. Unable to produce at least 500 microliters of saliva.
4. Eaten within past 30 minutes
5. Known allergy to mouthwash products
An Internet-administered, Mindfulness Training Program for the Treatment of Anxiety

The purpose of this study is to examine the effects of a 10 week mindfulness training program -- without therapist-support -- as treatment of anxiety. Effects on depression, quality of life, and insomnia symptoms will also be studied.

Previous research has provided evidence for the thesis that training in mindfulness can decrease symptoms of anxiety and depression. This study will examine the effects of a 10 week mindfulness training program -- without therapist-support -- as treatment of anxiety. Effects on depression, quality of life, and insomnia symptoms will also be studied.

Eligibility Criteria:
Inclusion Criteria:

* Satisfy DSM-IV criteria for an anxiety disorder
* Living in Sweden and being able to read Swedish
* Access to computer with internet connection

Exclusion Criteria:

* Currently receiving other psychological treatment
* Non-stable use of psychoactive medication
* Deemed suicidal
* Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.
A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Chinese Healthy Male Subjects

This is a phase I clinical study to evaluate the pharmacokinetics (PK) similarity of single dose subcutaneous injection of Ebronucimab with different production processes in Chinese healthy male subjects.

This is a randomized, parallel controlled, phase I clinical study to evaluate the pharmacokinetics (PK) similarity of single dose subcutaneous injection of Ebronucimab with different production processes in Chinese healthy male subjects. This study consists of two parts: pre-trial part and formal-trial part, with a planned enrollment of approximately 180 healthy male participants from China.

Eligibility Criteria:
Key Inclusion Criteria:

* Weight: 60\~80kg; Body mass index (BMI) ≥ 19 and ≤ 26 kg /m2 for healthy Chinese male subjects.
* Subjects fully understand the purpose, content, process, and potential adverse events of the trial, voluntarily participate in the trial, and sign an informed consent form before any trial procedure begins.
* Low density lipoprotein cholesterol (LDL-C) levels ≥ 1.8mmol/L and ≤ 4.9mmol/L during screening.
* Subjects are able to communicate well with the investigator and understand the requirements of the study.

Key Exclusion Criteria:

* 12 months prior use of PCSK9 inhibitors treatment.
* Allergic to the components of Ebronucimab and any monoclonal antibodies.
* History of important organ transplantation (such as heart, lung, liver, kidney, etc.).
* Abnormal vital signs during screening period and before randomization.
* Drug abuse prior to screening.
Artificial Intelligence in Depression - Medication Enhancement

This study will determine the safety and potential effectiveness of a digital health platform aimed at improving treatment outcomes for patients with depression by assisting physicians with clinical decision making about depression treatment.


Eligibility Criteria:
Patient Inclusion Criteria:

* diagnosed with major depressive disorder by a physician using DSM-V criteria
* able to provide informed consent
* patients must confirm that they are comfortable being treated for depression by their physician, who may propose a range of treatment options, such as medications or psychotherapies, consistent with best practice guidelines for depression which are included in the application. Physicians will be required, as in usual practice, to explain treatments to patients and patients will be able to give and withdraw consent for treatment in general or for specific treatments as in usual practice.

Patient Exclusion Criteria:

* bipolar disorder of any type
* inability or unwillingness of the individual to give informed consent
* inability to manage patient in an outpatient setting (i.e. imminent suicidality)
* active major depression is not the main condition being treated (i.e. the patient has depressive symptoms in the context of severe substance abuse or a psychotic disorder, but a primary diagnosis of major depressive episode (MDE) cannot be made or would result in inappropriate care).
* inability to use the tool (i.e. patient cannot interface with a mobile phone or computer due to delirium, or another medical condition)\* \*Note that for patients who do not have access to mobile or desktop devices but are able to use them or to be trained to use them, these will be provided to them at no cost.

Physician Inclusion Criteria:

* any family doctor/primary care physician or psychiatrist accredited in Canada or the USA who treats patients with depression on at least a monthly basis, as well as residents from these specialities supervised by a participating physician
* able to provide informed consent
* comfortable prescribing the range of potential treatments which could have probabilities provided for them by the CDA

No Physician Exclusion Criteria
Cardiac Surgery Neuroprotection Study in Elders

The goal of this study is to determine the potential ability of intranasal insulin to prevent post-operative cognitive decline and post-operative delirium in an elderly cardiac surgery population.

Nearly half of all intensive care unit (ICU) admissions consist of adults \> 65 years old, an age group that is at high risk for developing cognitive decline and delirium in the ICU. Over 50% and 70% of critically ill cardiac surgery patients develop post-operative delirium (POD) and post-operative cognitive decline (POCD), respectively. These two forms of acute cognitive dysfunction are associated with increased mortality and poor functional recovery. While distinct conditions, POD has been associated with the subsequent development of POCD, suggesting a mechanistic link.

No proven pharmacologic treatments targeting the prevention of both POD and POCD in elderly patients exist to date. Recent data suggest that insulin administered into the central nervous system via intranasal delivery improves cognitive function in elderly patients with Alzheimer's disease and mild cognitive impairment. However, its utility in preventing POD and POCD in elderly critically ill patients has not been investigated.

The hypothesis of this study is that intranasal insulin can prevent POD and POCD in elderly critically ill patients admitted to the intensive care unit after undergoing cardiac surgery. To test this hypothesis, this randomized, placebo-controlled, double-blinded Phase II study will enroll 60 patients \>= 65 years old undergoing elective coronary artery bypass graft and/or valve surgery requiring cardiopulmonary bypass, and will treat them with either 40 IU of aspart insulin or placebo intranasally before surgery and then four times a day for 7 days or until hospital discharge (whichever occurs first).

Eligibility Criteria:
Inclusion Criteria:

1. elderly patients (\>=65 years old)
2. undergoing elective coronary artery bypass graft and/or valve surgery requiring cardiopulmonary bypass
3. English or Spanish-speaking

Exclusion Criteria:

1. severe dementia, neurodegenerative, or psychiatric disease that prevents patient from living independently at baseline
2. emergent surgery
3. inability to perform cognitive testing (i.e. difficulty hearing or inability to speak)
4. contraindications to intranasal administration of medication
Is the Nerve Growth Factor (NGF) a Useful Biomarker in Neurogenic Bladder Dysfunction After Spinal Cord Injury?

Spinal cord injury (SCI) almost always affects bladder function as well. As a result of this bladder dysfunction, individuals with SCI have to undergo regular invasive examination of their bladder function (urodynamic examination).

The nerve growth factor (NGF) is released from smooth muscle cells of the bladder, and there are reports, that the concentration of NGF is elevated in the urine of patients with bladder dysfunction. The NGF concentration can also be measured in the blood. The concentration of NGF in the blood and urine of SCI individuals has not yet been investigated. These concentrations may correlate with the severity of bladder dysfunction, and may thus be used to replace or at least reduce the number of the more invasive urodynamic examinations.

The hypothesis that urine and blood NGF concentrations in individuals with SCI are higher compared to individuals with healthy bladder function will be tested.


Eligibility Criteria:
Control Group

Inclusion Criteria:

* physiologic bladder function

Exclusion Criteria:

* no signed consent form
* age \<18 / \>80 years
* urinary tract infection
* bladder surgery
* radiation therapy of the pelvic area
* pregnancy
* bleeding disorder

Study Group

Inclusion Criteria:

* neurogenic detrusor overactivity
* presentation for urodynamic examination

Exclusion Criteria:

* no signed consent form
* age \<18 / \>80 years
* urinary tract infection
* bladder augmentation
* bladder evacuation by permanent catheterization
* radiation therapy of the pelvic area
* pregnancy
* bleeding disorder
PROState Cancer Patients Initiating Hormone Therapy: Effect of Exercise on CARDIOvascular Health (PROSCARDIO)

This study evaluates whether exercise can reduce treatment-related adverse effects in prostate cancer patients initiating androgen deprivation therapy. Half of recruited participants completed a 3-month exercise intervention, while the other half did not perform any supervised exercise. It was anticipated that exercise would have a positive effect on body composition, cardiorespiratory fitness and quality of life.

Androgen deprivation therapy (ADT) is routinely used as first-line treatment for locally advanced and metastatic prostate cancer. However, it is associated with many side effects such as increased fat mass and reduced skeletal muscle mass, cardiorespiratory fitness and metabolic health. Ultimately, these negative changes induced by ADT contribute to reduced health-related quality of life (HRQoL). This study evaluates whether 3-months of exercise can mitigate treatment toxicity in prostate cancer patients initiating ADT.

In a parallel groups, prospective, randomised controlled design, participants were randomly allocated to a standard care control group or standard care plus exercise group. The exercise group completed 3-months of combined aerobic and resistance training. The standard care group did not receive any supervised exercise or specific physical activity recommendations. Outcomes were assessed at baseline, 3-month (post-intervention), and 6-month (follow-up) endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged 50 to 80 years
* Histologically confirmed stage I-IV prostate cancer
* Scheduled for treatment with a luteinizing hormone-releasing hormone (LHRH) agonist either alone or combined with radiotherapy
* Anticipated to remain on androgen deprivation therapy (ADT) for at least the next 6 months
* Willing and able to give written informed consent.
* Understand written and verbal instructions in English
* World Health Organisation (WHO) performance status 0 to 1

Exclusion Criteria:

* Previously treated with ADT
* Diagnosed or suspected metastatic bone disease
* Absolute contraindications to exercise testing and training as defined by the American College of Sports Medicine (ACSM, 2010)
* Prior myocardial infarction or heart failure
* Chronic obstructive pulmonary disease (COPD)
* Poorly controlled hypertension (≥ 200/110 mmHg)
* Uncontrolled supraventricular tachycardia (≥ 100 bpm)
* Pre-existing severe musculoskeletal, neurological or psychiatric condition that may affect their ability to complete the testing battery or exercise training, as determined by the patient's physician
* Involvement in any other clinical trial or exercise trial
The Johns Hopkins Transplant Infectious Diseases Prospective Cohort Study

The Transplant Infectious Diseases Prospective Cohort Study facilitates the prospective identification and collection of data of infectious disease complications in order to determine the epidemiology, risk factors, and outcomes of patients who receive solid organ or stem cell or plastic surgery transplants at Johns Hopkins and other transplant centers. It is essential for the care and treatment of this population to employ a mechanism for investigators to centralize these datasets, using standardized definitions of infectious complications. This protocol outlines the procedures to be utilized in order to prospectively follow the diagnosis and treatment of infectious complications in transplant patients.

Patients are approached at their transplant screening visit, if possible, or during their hospital stay (before or after transplant) in order to introduce the study and obtain informed consent for participation. A letter to transplant physicians will introduce this study. Data collection will begin immediately upon consent and continue for up to five years. The informed consent form specifically requests permission to contact the subject in the future to verify information or if the subject is lost to follow up by Transplant services.

The Day of transplant will be considered day 0 for enrollment in this observational study. Data will be collected on clinical template forms completed by study team members, as infectious complications become apparent in either outpatient ID clinics or on the inpatient service. A member of the research team will complete data collection in the registry, maintained on the REDCap platform. In addition, patient electronic records will be reviewed every 3 months to identify and record infectious complications, treatments administered, and outcomes. During these intervals, subjects will be contacted by phone to review the same outcomes.

Creation of the registry relies on use of standardized definitions to define infections. An electronic database has been constructed in the REDCap system, documenting subject demographics, transplant variables, infection variables, treatments administered, and overall outcomes, during each interim time period.

Eligibility Criteria:
Inclusion Criteria:

Hematopoietic stem cell (bone marrow) and solid organ transplant patients -

Exclusion Criteria:

-
MYND&CO: Studio Pilota Dell'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza

To evaluate an integral approach to the maternal-fetal diad.

A randomized non farmacological monocentric trial.

400 women with single spontaneous pregnancies are randomized.

200 recieve standardized traditional obstetrical care

200 recieve nutritional advice, osteopathic treatment, yoga classes, mindfulness classes and coaching as well as regular obstetrical care.

We evaluate the psychological status at recruitment, at the end of pregnancy and 40 days after birth.

The first international scientific research project focusing on a holistic approach to pregnancy is starting now at the Clinica Mangiagalli in Milan.

This innovative model aims to the gold standard of a "positive pregnancy", which supports both the somatic and psychological component of the mother-newborn unit, and thus organically and proactively prevents the main issues arising during pregnancy and delivery due to unhealthy lifestyles.

A team of experts will take comprehensive care of the mother, first by means of an accurate evaluation of her nutritional profile, and then of her biomechanic (osteo-skeletal) state.

Then, the experts will lead an "academic" path, which will initiate a development of her biochemistry (through nutrition), respiration (through yoga), physical wellbeing (through osteopathy and yoga); and strengthen her sense of self, removing her self-doubt (through mindfulness and yoga).

The women will be supported up until childbirth, so as to attempt to prevent the main complications of pregnancy and of delivery.

This model does not aim to substitute the allopathic one which is currently in place (ultrasounds, ob-gyn appointments, tests, etc.), but to enhance its nature in a more effectively THERAPEUTIC manner, increasing the mother-newborn unit's potential of health.

In summary:

* Weekly mindfulness meet-ups
* Weekly yoga meet-ups
* Nutritional screening and further check-ups, if needed
* Osteopathic screening
* Five motivational meetings with a coach
* Four obstetrical appointments
* Obstetrical screening and check-ups up until childbirth

The team in charge of the project is made up of gynaecologists, midwives, psychologists, osteopaths, nutritionists and yoga teachers, who all collaborate on a regular basis with the Clinica Mangiagalli.

The project is offered to women free of charge.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancies
* spontaneous pregnancies
* no maternal medical conditions
* no language barrier

Exclusion Criteria:

* maternal or fetal medical conditions
* age \<18 or \<45
* ivf
* language barrier
* multiple pregnancies