cyrilzakka/clinical-trials huggingface dataset:
Personalised Modeling and Simulations for the Differential Diagnosis of Dynapenia: Study on Patients With Osteoarthritis

The ForceLoss study aims to develop personalised modeling and simulation procedures to enable the differential diagnosis for the loss of muscle force, namely dynapenia. The primary causes of dynapenia can be identified in a diffuse or selective sarcopenia, a lack of activation (inhibition), or suboptimal motor control. Each of these causes requires different interventions, but a reliable differential diagnosis is currently impossible. While biomedical instruments and tools can provide valuable information, it is often left to the experience of the single clinican to integrate such information into a complete diagnostic picture. An accurate diagnosis for dynapenia is important for a number of pathologies, including neurological diseases, age-related frailty, diabetes, and orthopaedic conditions.

The hypothesis is that the use of mechanistic, subject-specific models (digital twins) to simulate a maximal isometric knee extension task, informed by experimental measures may be employed to conduct a robust differential diagnosis for dynapenia.

In this study, on patients candidate for knee arthroplasty, the investigators will expand (i) the experimental protocol previously developed and tested on healthy volunteers with a measure of involuntary muscle contraction (superimposed neuromuscular electrical stimulation, SNMES), a hand-grip test, measures of bio-impedance and clinical questionnaires, and (ii) the modeling and simulation framework to include one additional step (to check for muscle inhibition).

Medical imaging, electromyography (EMG) and dynamometry data will be collected and combined to inform a digital twin of each participant. Biomechanical computer simulations of a Maximal Voluntary Isometric Contraction (MVIC) task will then be performed. Comparing the models' estimates to in vivo dynamometry measurements and EMG data, the investigators will test one by one the three possible causes of dynapenia, and, through a process of hypothesis falsification will exclude those that do not explain the observed loss of muscle force.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Primary Arthrosis at the knee (according to the American College of Rheumatology criteria), subjects elected for tota knee arthroplasty
* Body Mass Index between 18.5 and 30 kg/m2
* Health status (according to the American Society of Anesthesiology classification) equal to 1 or 2
* Suspected systemic sarcopenia due to aging or localized sarcopenia due to disuse

Exclusion Criteria:

* Neurological, rheumatic or tumoral diseases
* Inguinal or abdominal hernia
* Diabetes
* Severe Hypertension (Level 3)
* Severe Cardio-pulmonary insufficiency
* Diagnosis of Osteonecrosis in the lower limb joints
* Pathologies or physical conditions incompatible with the use of magnetic resonance imaging and electrostimulation (i.e., active and passive implanted biomedical devices, epilepsy, severe venous insufficiency in the lower limbs)
* Previous interventions or traumas to the joints of the lower limb
Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age

The main purpose of this study is to assess the efficacy of early oseltamivir treatment (started within 24 hours of the onset of influenza symptoms) in preventing the development of acute otitis media as a complication of influenza in children aged 1-3 years.


Eligibility Criteria:
Inclusion Criteria:

* Age 1-3 years
* Fever = or \> 38.0 C and at least one respiratory symptom OR fever = or \> 38.0 C and a positive influenza rapid test

Exclusion Criteria:

* Confirmed infection with any other respiratory virus than influenza.
* Suspicion of invasive bacterial infection requiring immediate admission to hospital
* Evidence of a poorly controlled underlying medical condition
* Known immunosuppression (malignancy, transplant, drugs)
* Known allergy to oseltamivir or paracetamol
* Received oseltamivir within 4 weeks
* Participation in another clinical trial with an investigational drug
Use of a Hand-held Digital Cognitive Aid in Simulated Cardiac Arrest.

Cardiac arrest is one of the most stressful situations to be managed. Our first study (MAX, accepted for publication BJA) clearly showed that it could not be compared to other urgent and stressful situations (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia) whose management was significantly improved with the help of a digital cognitive aid.

The present study exclusively deals with the management of cardiac arrest (recovery ward, or in the delivery room.) with the second generation of our digital cognitive aid, and explores new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand of the leader.

" Errare humanum est ", to err is human. This Latin saying attributed to Seneca shows that since the dawn of time, human beings are aware that managing complex situations will always be an inexhaustible source of mistakes. This is particularly true in anesthesia and intensive care in which situations are often complex and stressful, thus leading to mistakes or inadequate management. Improvement might arise from the use of cognitive aids.

In a first study (MAX, accepted for publication BJA) the investigators designed a smartphone application including 5 scenarios of anesthesia and intensive care crises (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia, ventricular fibrillation), designed to be used in the hand of the leader managing the crises. Technical and non technical skills were improved in 4 out of 5 scenarios. Cardiac arrest (ventricular fibrillation) clearly happened to be a different situation compared to other crises, and no improvement could be measured with our cognitive aid.

The present study exclusively deals with the management of cardiac arrest (man in recovery ward, pregnant woman in the delivery room) with the second generation of our digital cognitive aid, and explores new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand of the leader.

Eligibility Criteria:
Inclusion Criteria:•

* Resident Physicians training in Anesthesia/Intensive care (same specialization in France), year 1 to 5 (out of 5)
* to be familiar with our simulation centre (at least passed once as a resident)

Exclusion Criteria:

* no experience in simulation training
Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism

The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24 weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a 6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268 subjects.


Eligibility Criteria:
Inclusion Criteria:

* Adult male subject aged 18 to 65 years inclusive
* BMI \> 30 kg/m2 and \< 50 kg/m2
* Serum total testosterone concentration below the normal range
* LH levels below the upper limit of normal
* Oestradiol levels within or above the normal range of approved assay
* At least two symptoms of androgen deficiency present for at least 2 months prior to the first Screening Visit, with at least one of these being a sexual dysfunction

Exclusion Criteria:

* Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessments
* Other types of hypogonadotropic hypogonadism or primary hypogonadism
* Any other pituitary or hypothalamic disease
iSTART: A Campus & Community Initiative for Services in Tec-health

The iSTART intervention is a 30-day substance prevention web-app whereby students complete five weekly interactive modules using a smart device or computer. Each module is approximately 15 minutes long, and focuses on a select substance: (i) alcohol, (ii) marijuana, (iii) nicotine, (iv) prescription drugs, and (v) illicit drugs. The modules are based on key theoretical constructs, behavior change strategies, and practical module components: attitudes (knowledge), perceived susceptibility (risk perceptions), subjective norms (normative re-education), and self-efficacy (refusal skills). This intervention will be evaluated via a time series design using a sample of 600 students randomly assigned to either the intervention, comparison, or control condition at a public institution in southern California.


Eligibility Criteria:
Inclusion Criteria:

* Current Cal State Northridge (CSUN) matriculated students
* Age 18-30

Exclusion Criteria:

* Not currently a CSUN student
* Not 18-30 years of age
* Identified as having an alcohol or substance use disorder (AUD or SUD) as determined by the brief DSM-5 screener
Effects of Different Surgical Methods to Treat Obesity

Obese patients have an increased risk for developing severe metabolic disorders. This risk can only partly be reduced by weight reduction. The investigators have in a pilot study investigated if removal of abdominal fat (visceral) in addition to weight loss has additional beneficial effects on the metabolic profile and weight loss. This study aims to further investigate if removal of abdominal fat (major omentum) leads to beneficial metabolic effects.


Eligibility Criteria:
Inclusion Criteria:

Body mass index over 40 kg/m2

Body mass index over 35 kg/m2 with obesity associated co-morbidities such as type 2 diabetes and/or additional cardiovascular risk factors -

Exclusion Criteria:

-
A Study to Evaluate Safety and Efficacy of TTP273 for 12 Weeks in Subjects With Type 2 Diabetes

This trial is a multi-center, randomized, double-blind, placebo-controlled parallel group, Phase 2 study in subjects with Type 2 diabetes mellitus on a stable dose of metformin to evaluate the safety and efficacy of TTP273 versus placebo glucose control and body weight following administration for 3 months.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a 6 month diagnosis of Type 2 diabetes mellitus prior to screening and meets the American Diabetes Association (ADA) guidelines for Type 2 diabetes mellitus.
* On a stable regimen of metformin monotherapy equivalent to at least 1000 mg/day for the last 3 months prior to screening.
* Males. Females of non-childbearing potential.
* Generally stable health without a history of major surgery or significant injuries within the last year and without an active infection.

Exclusion Criteria:

* Diagnosis of Type 1 diabetes mellitus, maturity-onset diabetes of the young, insulin-requiring Type 2 Diabetes, other unusual or rare forms of diabetes mellitus, or history of diabetic ketoacidosis.
* Participation in a clinical trial and receipt of an investigational product within 30 days.
* Participation in any formal weight loss program, or fluctuation of \> 5% in body weight, or having received medications approved for weight loss within 3 months prior to screening or contemplating such therapy during the trial.
* Previous surgical treatment of obesity.
* Have a history of hypoglycemic episode requiring glucose, glucagon, or orange juice administered by someone other than the patient within 6 months prior to screening.
* Use of other diabetic agents except metformin within 3 months prior to Screening.
* History of pancreatitis.
* Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to screening.
* History of hemolytic anemia, chronic transfusion requirement or other condition rendering HbA1c results unreliable.
* History of MEN-2 or family history of medullary thyroid cancer.
* History or presence of clinically significant disease (other than Type 2 diabetes mellitus).
Prospective Assessment Project About Cardiac Arrest Resuscitation

In case of a cardiac arrest it is very important to quickly provide high quality cardiopulmonary resuscitation (CPR). For reasons of patient safety the investigators want to assess the frequency, the quality and the outcome of cardiopulmonary resuscitations in the Inselspital Bern.


Eligibility Criteria:
Inclusion Criteria:

* Every patient for which the alarm button for a cardiopulmonary arrest gets triggered

Exclusion Criteria:

* None
Periodontal Therapy in Coronary Artery Patients

Gingival inflammation has been associated with cardiovascular diseases, including heart attack and stroke, because of elevation of blood risk markers such as cholesterol, glucose and C reactive protein. The treatment of gingival diseases decreases the concentration of these risk factors in the blood of cardiovascular patients.


Eligibility Criteria:
Inclusion Criteria:

* 35 years and older
* coronary artery disease
* more than 10 teeth
* chronic periodontitis defined as 2 non-adjacent teeth with probing depth 5+mm and periodontal attachment loss 4+mm

Exclusion Criteria:

* use of antibiotics in the last 6 months
* periodontal therapy in the last 12 months
A VX-680 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Cancer (0457-002)

The purpose of this study is to assess the safety and tolerability of MK-0457(VX-680), an Aurora kinase inhibitor, in participants with advanced solid tumors. Bioavailability of the oral formulation will also be assessed. The primary study hypothesis is that administration of MK-0457 is sufficiently safe and tolerated to permit further study.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least 18 years of age with recurrent or non-responsive solid tumors, or cancers for which standard therapy does not exist.

Exclusion Criteria:

* Patients who have had treatment with any investigational therapy within the past 30 days.
* Patients who have certain types of blood cancers such as leukemia or lymphoma.
* Patients who have uncontrolled congestive heart failure (CHF), chest pains, or had a heart attack within the past 3 months, or have undergone bone marrow or stem cell transplantation.
* Patient is pregnant or nursing.
Prospective Evaluation of Breast Cancer at Brazilian Institutions - Project AMAZONA III

The principal goal of this study is to describe the epidemiology of breast cancer in the Brazilian population

The principal goal of this study is to describe the epidemiology of breast cancer in the Brazilian population. Other specific goals are:

* To evaluate the demographic and socio-demographic profile, comorbidities and reproductive risks, anthropometric profile and family history.
* Characterize the breast tumors immunophenotype through anatomopathological data, such as: tumor grade, estrogen receptor, progesterone receptor, HER2, Ki67.
* Describe the screening tests, main symptoms and cancer stage in the moment of the diagnosis.
* Describe the initial cancer treatment and locally advanced such as surgery, radiotherapy, chemotherapy and endocrine therapy.
* Describe palliative treatment for recurrent or metastatic breast cancer: chemotherapy, radiotherapy, biphosphonate, and others.
* Evaluate the clinical outcomes such as: local or diffuse relapse, period of time until progression to metastatic cancer, global lifespan and specific breast cancer lifespan.
* Evaluate clinical complications of the metastatic disease, such as: brain metastasis, spinal cord compression, skeletal related events.
* Analyze the demographical and socio-economical characteristics, clinical-pathological characteristics of the tumor, treatment, clinical outcomes, type of institution (private/public), and other factors that may impact clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Woman ≥ 18 years old
* Invasive breast cancer stage I to IV proven by histology or cytology
* Patients with new pathological diagnosis of invasive primary BC after the site activation date
* Pathological diagnosis of invasive breast cancer during recruitment (6 months before center activation or until 3000 patients included)
* New primary cancer on the same breast or contralateral breast.
* Patient's medical chart is available and adequate for data collection
* Patient properly signed the informed consent form
In Vitro Study of the Effect of Gadolinium Contrast on Fibrocytes

Gadolinium contrast agents are frequently administered for MRI imaging. Very little is known of its toxicity outside of patients with reduced renal function.

Gadolinium contrast is administered to patients during MRI imaging. Recently, the investigators have observed potential gadolinium toxicity in some patients. To investigate this, the investigators propose to collect clinical data and lab data obtained as a part of clinical care. The investigators also plan to obtain 25 cc of peripheral blood at 2-4 weeks, 4-6 weeks and again at 3 months to identify unique monocyte signatures, gene polymorphisms, and to quantitate circulating fibrocytes (in fresh blood and after culture). Plan to enroll 15 patients with kidney, pancreas or liver transplant and exposed to gadolinium contrast agents, 15 non-transplant patients exposed to gadolinium contrast and 30 age- and sex-matched healthy controls not exposed to gadolinium contrast.

Eligibility Criteria:
Inclusion Criteria:

* Renal, pancreas or liver transplant OR those without organ transplant OR controls
* Age 18-70
* Both gender
* Exposure to gadolinium contrast agents (no exposure in controls)
* Have had a transplant, have had a contrast dye with an MRI
* Have not had a transplant and have had a contrast dye with an MRI
* Healthy person who has not had an MRI or gadolinium for any other reason.

Exclusion Criteria:

* End stage kidney disease or Stage 5
* Previous diagnosis of Nephrogenic Systemic Fibrosis
Evaluation of Therapeutic Management in ESBL-infected Patients or Carriers by Providing and Sharing a Free Tool - the "ESBL toolKIT"and Interventional Study of a Prospective Cohort of HIV+ Patients Searching for Possible Sexual Transmission Factors in ESBL Carriers

Bacterial resistance to antibiotics is a major public health problem. The epidemiology of enteric bacteria including E. coli is changing rapidly with the global spread of a resistance mechanism type beta-lactamase extended spectrum (ESBL), responsible for resistance to almost all penicillins and cephalosporins. The resistance is up to 75% for Quinolones, 67% for Cotrimoxazole and 30-50% for Aminoglycosides.

The main phenomena causing this problem are:

* The selection pressure by antibiotics, in their use in humans or animals
* The hand transmission via the digestive reservoir (faeces)
* Easy spread of resistance mechanism in Enterobacteriaceae due to transferable genetic support (plasmid)

In this context, we decided to implement a cross-border study to improve and accelerate the management, diagnosis and treatment of patients with ESBL in close collaboration between medical and paramedical staff in hospitals, laboratories and private medical offices.

The objective of this study is to standardize diagnostic and therapeutic measures allowing a better and rapid treatment of patients and thus prevent the appearence of ESBL bacteria in the PACA region and Liguria by providing a tool : The "Kit ESBL".

The " ESBL ToolKIT" (also translated into Italian) includes:

* Information on epidemiological data
* A checklist edited for extra-hospital use (private practitioners, health care units other than hospitals)
* A checklist edited for hospital use
* A leaflet BMR for the patient explaining the problematic as well as hygiene measures
* Therapeutical protocols for hospital use and extra hospital use
* An sample letter for the attending physician

The objective of this prospective multicenter cohort study is to evaluate the use of this kit, and to measure its impact on:

* The prescription of appropriate antibiotics
* The measures taken to prevent man to man transmission
* The quality of information provided to the patient

In this context we are also performing a multicentre prospective interventional cohort of HIV+ patients searching for possible sexual transmission factors in ESBL (extended-spectrum ß-lacatamase-producing bacteria) carriers.

We will also try to determine if other sexually transmitted infections associated (syphilis, gonorrhea and chlamydia) are contributing factors to ESBL carriage.

So far there is no data documented on ESBL-carriage in a population of HIV-positive patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* HIV+ patient of the hospital's outpatient clinic
* Signature of informed consent
* Affiliation of the Social Security system

Exclusion criteria

* Vulnerable Persons: minor patient, wardship (tutelage), no liberty to act and speak
* Pregnancy and lactation: a urine pregnancy test will be performed for women of childbearing age. Results will be reported by the physician selected by the patient
Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors

This study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that can be given without causing severe side effects. This study will also test the safety of this combination and see what effects (good or bad) it has on participants and their cancer.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically or cytologically proven advanced, metastatic non-squamous non-small cell lung cancer, pleural malignant mesothelioma, bladder or urethral cancer, ovarian cancer, primary peritoneal cancer, thymoma and thymic cancer and uterine cervical cancer.
* Measurable disease
* Life expectancy of greater than 3 months.
* Ability to take folic acid, vitamin B12, and dexamethasone according to protocol.

Exclusion Criteria:

- Untreated or symptomatic brain metastases.
A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection

The purpose of this clinical research study is to find out whether a combination of entecavir (ETV) plus tenofovir (TNF) works better against Hepatitis B virus than adefovir (ADV) added to continuing lamivudine (LVD) therapy in patients whose Hepatitis B virus (HBV) is resistant against lamivudine. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HBV infection
* History of lamivudine (LVD) treatment, and lamivudine resistance (LVDr), receiving LVD at screening visit
* Compensated liver function
* HBV DNA ≥ 172,000 IU/mL
* Hepatitis B e-antigen (HBeAg)-positive or HBeAg-negative

Exclusion Criteria:

* Evidence of decompensated cirrhosis
* Coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis D virus (HDV)
* Recent history of pancreatitis
* Serum alpha fetoprotein \> 100 ng/mL
* Except lamivudine, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B