cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Physical Exercise to Prevent Functional Deterioration During Hospitalization (EFFAPRO)

This is a randomized study that will measure the possible benefit of supervised training during the hospitalization of patients with stage IV neoplasms in active treatment.

The trial is not going to be runned

Eligibility Criteria:
Inclusion Criteria:

* Patients with stage IV neoplasms.
* Active treatment: chemotherapy, hormone therapy, immunotherapy or targeted therapies.
* Hospitalization at Medical Oncology Departmentof the Hospital Puerta de Hierro.
* Reason for hospitalization is expected to be solved in less than two weeks.

Exclusion Criteria:

* Patients who do not wish to participate.
* Cognitive impairment.
* Hospitalization due to progression of oncological disease.
* Acute coronary syndrome or bone fracture in limbs during the previous three months.
Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients

The purpose of this study is to to assess if the new diet with a low-FODMAP(Fermented Oligo-, Di-, Monosaccharides And Polyols) -content yields a milder symptom picture in IBS patients compared to traditionally dietary advice in IBS. The study also aim to investigate patients compliance to either dietary advices. Further, the investigators aim to find out if IBS patients with different symptoms are alleviated in different ways, to be able to individualize the dietary advices to result in a more optimal symptom relief in each patient in the future.


Eligibility Criteria:
Inclusion Criteria:

* IBS diagnosis
* Adult (over 18 years)
* Be able to read/understand/write swedish

Exclusion Criteria:

* Severe heart failure
* Severe liver disease
* Severe neurologic disease
* Severe psychological disease
* Severe gastrointestinal disease (i.e. celiac disease, IBD (inflammatory bowel disease) e.g.)
Prospective Registry on Intravascular Lithotripsy

multicenter, international, all-comers registry aims to provide insights in the current application of IVL technology in patients with calcified coronary lesions undergoing PCI using IVL technology.

The primary objectives are:

1. To analyze the trends of IVL use overall and according to clinical/anatomical indications
2. To evaluate the rates of procedural success, defined as success in facilitating stent delivery with \<30% residual stenosis and without in-hospital
3. To describe the cumulative hierarchical incidence of MACE defined as: cardiac death, non-fatal target vessel myocardial infarction (MI), or clinically driven target lesion revascularization (TLR) at 30-days following the index procedure

The secondary objectives are:

1. To describe the rate of MACE at 3-, 6- and 12-months following the index procedure
2. To assess the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis at any time point, any type of angina at 30-days, 3-, 6- and 12-months following the index procedure
3. To describe the rates of target lesion failure (TLF) (see end-points definitions section)
4. To describe the rates of device crossing success (see end-points definitions section)
5. To describe the rates of serious angiographic complications (see end-points definitions section)
6. To assess predictors of clinical outcomes based on patient and procedural characteristics
7. To analyze current standards of practice regarding IVL technology in a real-world multinational cohort (technique, training, local protocols).

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years-old
* Ability to provide written informed consent

Exclusion Criteria:

* Patient has any comorbidity or condition that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent
* Patient belongs to a vulnerable population Subject is a member of a vulnerable population , including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure

The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.) compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under hemodialysis treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients research that agree to participate in the study and sign the informed consent form;
* Patients aged over 18 years, both sexes, regardless of color or social class;
* Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system;
* Patients with laboratory results within specified acceptance criteria.

Exclusion Criteria:

* Patients who are taking part or took part in another clinical investigational study within 12 months;
* Hypersensitivity to heparin sodium and/or benzyl alcohol;
* History of active hemorrhage with alteration of blood coagulation, such as genetic disorders of coagulation system;
* History of disease that could aggravate or terminate the clinical manifestations, such as active peptic or gastric ulcer;
* Severe liver disease;
* Patients in cancer treatment;
* Pregnant and lactating women;
* Use of glucocorticoids over physiological dose;
* Use of other anticoagulants;
* Patients undergoing any surgery performed less than 15 days;
* History of non response or exacerbated response to heparin sodium;
* Patients who do not adapt to 150 UI/kg dose.
Influence of Data Collection Mode on Self-Report Validity of Asthma Therapy Adherence

This study will examine how the assessment mode influences the validity of self-reported adherence to asthma therapy. Self-reported adherence to asthma therapy data will be collected using one of three randomized assessment modes (interview, computer, or telephone).

BACKGROUND:

Self-reports are a primary source of behavioral data. Studies have highlighted the variable validity and reliability of self-report measures of health behaviors such as adherence to therapy. Research on self-reports of sensitive information, such as sexual behavior and drug use, suggests that the mode of data collection may enhance validity of self-reports. However, no studies have determined how the mode of data collection influences self-reports when an objective measure of the behavior is available.

DESIGN NARRATIVE:

The primary aim of this study is to examine the influence of the mode of data collection on the validity of self-reports of inhaled anti-inflammatory medication adherence.

The key secondary outcomes of the study will attempt to answer the following questions: 1) does the assessment mode influence self-reports of commonly used asthma outcome measures of disease-related symptoms, self-management behaviors, and quality of life?; 2) does the relationship between the assessment mode, the validity of self-reports of adherence, and other measures (i.e., asthma symptoms, self-management behaviors, and quality of life) change over time?; and 3) does the assessment mode interact with baseline personality characteristics and mood to influence the validity of self-reports of adherence and other outcome measures (i.e., asthma symptoms, self-management behaviors, and quality of life)?

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma
* Under a provider's care for asthma
* Prescribed daily inhaled corticosteroids (by metered dose inhaler \[MDI\]) at least 2 times a day
* Speaks English
* Otherwise in good general health

Exclusion Criteria:

N/A
MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach

The proposed study is a phase II, single arm, open-label trial of MR-guided radiation therapy (RT) with risk stratified RT dose selection in patients with anal cancer. Based on previous data, a risk adaptive treatment approached is proposed in 4 groups: Low risk, standard risk, intermediate risk, and high risk. Human papillomavirus (HPV) DNA will be analyzed to identify novel biomarkers that predict chemoradiotherapy (CRT) response and toxicity.

After being informed about the study and potential risks, all patients giving written informed consent will undergo a risk-stratified dose of treatment (radiation dose and chemotherapy number of cycles) based on predefined clinical and biological biomarkers for anal squamous cell carcinoma (SCC). Radiotherapy will be delivered on the MR-Linac for image-guided-radiation therapy (IGRT). Patients will be followed for up to 5 years after radiotherapy and be required to complete questionnaires and clinic visits. Patients have the option to complete blood and tissue samples during the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically proven diagnosis of anal SCC. This may include tumors of non-keratinizing histology such as basoloid or cloacogenic histology. Individuals with squamous cell carcinoma of the anal margin are eligible.
* Clinical stage T1-4 N0-1 M0 (the Union for International Cancer Control (UICC) / the American Joint Committee on Cancer (AJCC) 8th Ed)
* Patients must be eligible for definitive RT or CRT
* Must be ≥ 18 years of age
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

* Previous chemotherapy, RT or curative-intent surgical treatment (i.e. APR) for anal cancer.
* Any previous RT to the abdomino-pelvic region that would result in overlap of RT volume for the current study.
* Individuals with a history of a different malignancy except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
Quantitative Ultrasound for Diagnosing Hepatic Steatosis in Nonalcoholic Fatty Liver Multicenter Study

To evaluate the diagnostic performance of quantitative ultrasound parameters for assessing hepatic steatosis in non-alcoholic fatty liver disease using histologic results as reference standard


Eligibility Criteria:
Inclusion Criteria:

* Clinically suspected or proven nonalcoholic fatty liver disease (NAFLD)
* Patients who are scheduled hepatic parenchymal biopsy for suspected liver disease or hepatectomy for living donor liver donation
* aged ≥ 18 years who are willing and able to complete all procedures

Exclusion Criteria:

* excessive alcohol consumption within 2 years (40g/day for men, 20g/day for women)
* clinical, laboratory, or histologic evidence of a liver disease other than NAFLD, including viral hepatitis, autoimmune hepatitis, or genetic or acquired disorders
* use of steatogenic or hepatotoxic medication
* evidence of decompensated liver disease
* history of liver surgery
* any other condition believed by investigator to affect a patients' compliance, or completion of the study
Predictive Models on Pain and Severity in FM Patients

The primary goal of this research project is to develop different prediction models in fibromyalgia disease through the application of machine learning techniques and to assess the explainability of the results.

As specific objectives the research project intends: to predicting Fibromyalgia severity of patients based on clinical variables; to assess the relevance of social-psycho-demographic variables on the fibromyalgia severity of the patients; to predict the pain suffered by the patients as well as the impact of the fibromyalgia on patient's life; to categorize fibromyalgia group of patients depending on their levels of Fibromyalgia severity.

Fibromyalgia (FM) is a condition characterized by chronic musculoskeletal pain whose pathophysiology is still unclear. Furthermore, this pathology is frequently associated with sleep disturbances, pronounced fatigue, morning stiffness, poor quality of life, cognitive disturbances (mainly memory problems) and psychological problems (depression, anxiety and stress).

FM is associated with greater negative affect, which implies a general state of anguish composed of aversive emotions such as sadness, fear, anger and guilt. Patients with FM commonly suffer from high rates of anxiety, depression, pain catastrophizing, and stress levels, which are associated with a worsening of symptoms, including own cognitive.

Machine learning (ML) and data mining had been successfully applied, over the past few decades, to build computer-aided diagnosis (CAD) systems for diagnosing complex health issues with good accuracy and efﬁciency by recognizing potentially useful, original, and comprehensible patterns in health data. Thus, machine learning provides useful tools for multivariate data analysis allowing predictions based on the established models and hence offering a suitable advantage for risk assessment of many diseases including heart failure. Machine learning offers advantages not only for clinical prediction but also for feature ranking improving the interpretation of the outputs by clinical professionals.

Explainable ML models, also known as interpretable ML models, allow healthcare experts to make reasonable and data-driven decisions to provide personalized treatment that can ultimately lead to high quality of service in healthcare. These models fall into eXplainable Artificial Intelligence (XAI) field, defined as suite of ML techniques that 1) produce more explainable models while maintaining a high level of learning performance, and 2) enable humans to understand, appropriately trust, and eﬀectively manage the emerging generation of artiﬁcially intelligent partners.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* Fullfilled the 2010 American Collegue of Rheumathology criteria for fibromyalgia.
* Understanding of spoken and written Spanish.

Exclusion Criteria:

* Diagnosed psychiatric pathology.
* Rheumatic pathology not medically controlled.
* Neurological pathologies that make evaluations difficult.
First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.

The study is comparing the new medicine NNC9204-1513 with a standard therapy of glucagon (GlucaGen®). This is the first time NNC9204-1513 is given to humans.

Participants will either receive NNC9204-1513 or GlucaGen® - which treatment you get is decided by chance (like flipping a coin). Neither the participant nor the study doctor will know which study medicine (NNC9204-1513 or GlucaGen®) the participant is receiving (double -blinding). In case of emergency, this information will be readily available.

NNC9204-1513 is a new medicine for rescue treatment of severe low blood sugar and currently not available on the market (doctors cannot prescribe this medicine). The participant will receive two or three single injections below the skin. One injection will contain NNC9204-1513 or GlucaGen®. The other injection will include placebo - this is a product that looks like the actual study drug but without any active ingredients. If a third injection is given, this will contain NNC9204-1513 or placebo. NNC9204-1513 and GlucaGen® will be given using different devices and volumes. In order to mask these external differences, a "double dummy" approach will be used, that means when you get either of the study medicine (NNC9204-1513 or GlucaGen®) you will get another injection which contains no medicine called 'placebo' (it will not have any effect on the body). Dependent on the injection volume to be administered, injections are given by either syringe with needle or an injection pen (NovoPen Echo®). The study will last for up to 39 days.


Eligibility Criteria:
Inclusion Criteria:

* Male, aged 18 -55 years (both inclusive), at the time of signing informed consent
* Body mass index (BMI) between 18.5 and 28.0 kg/sqm (both inclusive)
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
* Smoker (defined as a subject who is smoking at least one cigarette or equivalent daily) who is not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
* Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
Pilot Study of Haloperidol to Treat Critical Illness Delirium

The goal of this study is to determine whether haloperidol reduces the time on the breathing machine in critically ill patients with delirium.

Delirium is a frequent end-organ complication of critical illness and is an independent predictor of mortality in mechanically ventilated patients. However, management of delirium is a major therapeutic challenge and it is unknown if current therapies are disease modifying or function only as symptom management. Haloperidol has been demonstrated to reduce delirium in retrospective studies.

This study is a pilot prospective randomized clinical trial in the Denver Health Medical ICU to determine if haloperidol in addition to an evidence-based standard-of-care sedation protocol for the management of delirium results in a shortened duration of intubation and improvements in post-extubation cognitive status. The haloperidol dose is administered using titration-protocol guided by nursing assessment of delirium using the confusion assessment method for the ICU (CAM-ICU). The primary outcome is ventilator-free days out of the first 28, and secondary outcomes include duration of delirium, length and cost of hospitalization, 28-day mortality, usage of other sedatives, serum markers of delirium (neuron-specific enolase and protein S-100B), and cognitive-function scores at the time of ICU discharge, hospital discharge, and six-month follow-up.

The goal of the 20-patient pilot is demonstrating safety of the haloperidol protocol, as evaluated by an independent data-safety monitoring board. Following approval of the DSMB, 122 more patients will be enrolled in the full RCT to achieve power for an 80% chance of detecting a 40% decrease in duration of intubation with P \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated within 24 hours of arrival to the ICU
* Delirium as assessed by CAM-ICU within 24 hours of arrival to the ICU
* Age \> 18

Exclusion Criteria:

* Known allergy to haloperidol or other neuroleptics
* Neurological injury or trauma
* \< 24 hours after a major operation
* History of Axis I psychiatric disorder or significant dementia
* Baseline QTc of \> 500 msec or a pacemaker which makes the QTc uninterpretable
* History of seizure disorder
* Morbid obesity (\> 1kg/cm body weight)
* Hepatic failure (Child's Class C)
* Neuromuscular disease (C5 or higher spinal cord injury, ALS, Guillain-Barre Syndrome, and myasthenia gravis)
* Malignancy or other irreversible disease or condition for which 6 month mortality is estimated to be ≥ 50%
* Pregnancy (negative pregnancy test required for women of child-bearing potential)
Study with an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children

This phase II trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and children with full-thickness Skin defects.

This multicentre phase II clinical trial will target adults and children with fullt-thickness skin defects to elucidate the benefit of a tissue-engineered autologous skin substitute. Particular emphasis, apart from safety, will be placed on efficacy, e.g. scar quality, in comparison to meshed STSG.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥1 years of age
* Large full-thickness defects that require coverage after excision of: Scars, Benign skin tumors (e.g. neurofibroma), Melanocytic nevus (e.g. giant nevus), Gender reassignment surgery, Soft tissue defect after trauma, Soft tissue defect after infection and debridement (e.g necrotizingn fascitis, hidadentitis suppurativa, purpura fulminans), Flap donorsite (e.g. radial forearm flap)
* Minimal areas requiring coverage (not counting the head and neck area for study patients in The Netherlands): 1-5 years: minimum 9cm2, 6-16 years: minimum 25cm2, \>16 years: minimum 45cm2
* Signed Informed consent

Exclusion Criteria:

* Patients tested positive for HBV, HCV, syphilis or HIV
* Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing)
* Severe drug and alcohol abuse
* Pre-existing coagulation disorders as defined by INR outside its normal value, PTT \>ULN and fibrinogen \<LLN prior to the current hospital admission and / or at the Investigator's discretion
* Patients with known allergies to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen
* Previous enrolment of the patient into the current phase II study
* Participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study
* Patients expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
* Pregnant or breast feeding females
* Intention to become pregnant during the clinical course of the study (12 months)
* Enrolment of the Investigator, his/her family members, employees and other dependent persons
Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy

Hypothesis: Ventilator associated pneumonia (VAP) in critically ill patients may be prevented by continuous lateral rotation therapy (CLRT) using specially designed, motor driven beds.

Patients are randomized to CLRT or supine position if mechanically ventilated and not suffering from pneumonia or ARDS within 48 hours after intubation. Prophylaxis of VAP is standardized in both groups. Primary endpoint is incidence of VAP, secondary endpoints are length of ventilation, length of stay and mortality.


Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated
* Intubated not longer than 48 h
* Medical cause for ICU admission
* Expected to be ventilated for \> 48 hours

Exclusion Criteria:

* Pneumonia or ARDS present
* Postoperative patient