cyrilzakka/clinical-trials huggingface dataset:
Skeletal Muscle Wasting in SARS-CoV-2

The SARS-CoV-2 pandemic causes a major burden on patient and staff admitted/working on the intensive care unit (ICU). Short, and especially long admission on the ICU causes major reductions in skeletal muscle mass (3-4% a day) and strength. Since it is now possible to reduce mortality on the ICU, short and long-term morbidity should be considered another principal endpoint after SARS-CoV-2 infection. Cachexia is defined as 'a complex metabolic syndrome associated with underlying illness and characterized by loss of muscle mass'. Its clinical features are weight loss, low albumin, anorexia, increased muscle protein breakdown and inflammation. There is strong evidence that cachexia develops rapidly in patients hospitalized for SARS-CoV-2 infection, especially on the ICU. Several mechanisms are believed to induce cachexia in SARS-CoV-2. Firstly, the virus can interact with muscle cells, by binding to the angiotensin converting enzyme 2 (ACE-2). In vitro studies have shown the virus can cause myofibrillar fragmentation into individual sarcomeres, in addition to loss of nuclear DNA in cardiomyocytes. Similar results were found during autopsies. On a cellular level, nothing is known about the effects of SARS-CoV-2 infection on skeletal muscle cells. However, up to 19.4% of patients present with myalgia and elevated levels of creatine kinases (\>200U/l), suggesting skeletal muscle injury. Moreover, patients with SARS-CoV-2 infection are shown to have elevated levels of C-reactive protein and other inflammatory cytokines which can all affect skeletal muscles. The above mentioned factors are not the only mediators by which skeletal muscle mass might be affected in SARS-CoV-2. There are other known factors to affect skeletal muscle mass on the ICU, i.e. immobilization and mechanical ventilation, dietary intake (anorexia) and inflammatory cytokines. SARS-CoV-2 infection in combination with bed rest and mechanical ventilation can lead to severe muscle wasting and functional decline resulting in long-term morbidity.

Until know there are no studies investigating acute skeletal muscle wasting in patients infected with SARS-CoV-2 and admitted to the ICU. As a result, there is a need of more in-depth understanding the effects of SARS-CoV-2 infection on muscle wasting. An optimal characterization of these effects may lead to improvement in morbidity and even mortality in the short and long term by the establishment of evidence-based rehabilitation programs for these patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* SARS-CoV-2 infection
* Expected stay to ICU of \> 7 days

Exclusion Criteria:

* Spinal cord injury
* Chronic use of corticosteroids before hospital admission
Daily Living Activities and Exercise Capacity in Lipid Storage Diseases

Lipid Storage Diseases (LSD) is a group of metabolic diseases that are manifested by exercise intolerance or muscle weakness, sometimes accompanied by systemic findings, which develop in some stages of muscle contraction due to necessary lipid transfer or destruction pathways. Exercise intolerance in LSD can limit not only physical activity but also daily activities. In the literature, no study evaluated the activities of daily living in patients with LSD. The aim of this study was to investigate the effect of exercise capacity and daily living activities on the clinical features of LSD patients.

Pulmonary functions are affected negatively in Lipid Storage Diseases (LSD). It was shown that respiratory muscle strength and peak cough flow decreased in these cases. Other respiratory system problems can be listed as; diaphragmatic dysfunction, hypoxemia, and hypercapnia. Routine evaluation of respiratory function in LSD is recommended. A limited number of studies have shown that exercise tolerance is limited by the blockage of fat oxidation on the basis of muscle weakness and fatigue in LSD. Although the assessment of exercise capacity is also an important indicator of heart-lung capacity monitoring, exercise capacity is not routinely measured in patients with LSD. Exercise intolerance can limit not only physical activity but also daily activities. In the literature, the investigator's did not find any study evaluating the activities of daily living in patients with LSD. The aim of this study was to investigate the effect of exercise capacity and daily living activities on the clinical features of LSD patients.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Lipid storage disease clinically and histopathologically.

Exclusion Criteria:

* Severe pulmonary parenchymal disease,
* Cardiac problems
* Renal or hepatic dysfunction
* Uncontrolled hypothyroidism
* Acute infection
* Malignancy
Qualitative Research for Stage 4 Liver Cancer Patients and Their Caregivers

This is opinion based, experiential research and is NOT a drug trial.


Eligibility Criteria:
Inclusion Criteria:

* stage 4 liver cancer patients and caregivers

Exclusion Criteria:

* loved ones passed away
Artificial Intelligence in Colonoscopy

Colorectal cancer is the second most common malignancy in the countries of the European Union. Colonoscopy is the primary method for detecting and preventing the development of colorectal cancer is endoscopic examination. This study aims to evaluate the impact of artificial intelligence on the detection rate of polyps and early stages of colorectal cancer.

Colorectal cancer is the second most common malignancy in the countries of the European Union. The primary method for detecting and preventing the development of colorectal cancer is endoscopic examination-colonoscopy, during which precancerous lesions such as adenomas and serrated polyps can be removed. The effectiveness of colonoscopy depends on the adenoma detection rate, which varies among endoscopists and is influenced by their skills and experience. It has been proven that high-quality colonoscopy prevents the omission of colorectal cancer, which might develop in the future as so-called interval cancer. A breakthrough in machine learning in recent years has enabled the development of commercial artificial intelligence systems. These systems aim to improve the detection rates of precancerous polyps and, consequently, potentially reduce the risk of developing colorectal cancer. Artificial intelligence is also expected to help standardize performance across endoscopic procedures of varying quality, thereby contributing to a reduction in colorectal cancer incidence in the future. This study aims to evaluate the impact of artificial intelligence on the detection rate of polyps and early stages of colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Consent to participate in the study,
* Age between 50 and 65 years,
* Scheduled outpatient colonoscopy.

Exclusion Criteria:

* Previous colonoscopy,
* History of colorectal surgery,
* Ongoing biological therapy for any indication,
* Primary sclerosing cholangitis,
* Familial polyposis syndrome,
* Chronic diarrhea,
* Ulcerative colitis,
* Crohn's disease.
Effect of Pioglitazone Versus Metformin on Bone Health in Postmenopausal Women With Type 2 Diabetes

The study tests whether pioglitazone (PIO)as compared to metformin (MET)affects bone health including bone mineral density, bone turnover markers, and osteocyte biomarker in patients with type 2 diabetes (T2DM).

Women with T2DM exhibit normal or higher bone mineral density (BMD) for their age, but with approximately twice the overall risk of bone fragility compared with nondiabetic subjects. Known the apparent association between T2DM and the risk of bone fragility, examining the effects of commonly used oral antidiabetic agents; such as MET and thiazolidinediones (TZDs; for example rosiglitazone \[ROS\] or PIO), on BMD and/or bone turnover is of great clinical relevance for both diabetic patients and their treating physicians. Recent clinical trials, showed that women treated with ROS had higher risk of bone fragility and self-reported adverse events. Similarly, women on long-term treatment with PIO for T2DM experienced higher incidence of distal extremity fractures. TZDs are agonists of the nuclear transcription factor peroxisome proliferator- activated receptor-γ (PPAR-γ) which increase insulin sensitivity and improve glycemic control in T2DM. PPAR (γ) acts also as a molecular factor that favours adipogenesis over osteoblastogenesis of mesenchymal stem cells. The latter was suggested as a potential mechanism for the effects of TZDs on bone among others. In humans, TZDs decrease BMD and increase bone fragility risk. This study tests whether pioglitazone as compared to MET (both are commonly used in the treatment of T2DM in Saudi Arabia and other countries) affects bone health including bone mineral density, bone turnover markers, and osteocyte biomarker in patients with T2DM.

Eligibility Criteria:
Inclusion Criteria:

* BMD T-score greater than -2.5 at the total hip, femoral neck, and lumbar spine;
* No prior antidiabetic therapy;
* Drug-naïve with glycosylated hemoglobin A1c (HbA1c) ≥ 7.0 to ≤ 10.0%. 53.2 mmol/mol to 88.2 mmol/mol);
* Body-mass index of 40 Kg/m2 and less;
* Stable body weight for at least 4 months.

Exclusion Criteria:

* Type 1 diabetes mellitus (presence of GAD auto antibodies);
* History of diabetes or uncontrolled hypertension;
* Treatment with antidiabetic agents including TZDs;
* Chronic diseases known to affect bone;
* Previous treatment with estrogens and other medications known to affect bone ;
* Creatinine clearance less than 60 ml/min
Best End-Expiratory and Driving-pressure for Individualized Flow Controlled Ventilation in Patients With COPD

Patients with chronic obstructive pulmonary disease (COPD) have a significantly increased risk of postoperative pulmonary complications (PPC). Protective ventilation of the lungs could reduce the rate of PPC in patients with COPD. It has been suggested that flow controlled ventilation (FCV) may be less invasive and more protective to the lungs than conventional ventilation in patients with COPD.

The primary aim of this study is to determine a optimal individual ventilation setting for FCV in ten participants with COPD.

The estimated worldwide chronic obstructive pulmonary disease (COPD) mean prevalence is 13.1%. In 2015, 3.2 million people died from COPD worldwide, and estimates show that COPD will be the third leading cause of death in 2030. Patients with COPD are at high risk for postoperative pulmonary complications (PPC). It has been proposed that FCV might be less-invasive and more protective for the lungs than conventional ventilation in patients with COPD. The pathophysiology of COPD is multifactorial, with the collapse of the central airways having a major impact on the symptoms. Minimizing the expiratory flow could prevent this airway pathology, and thus be beneficial in the ventilation of patients with COPD.

In the operation theater participants will be ventilated with flow controlled ventilation (FCV). Arterial blood gas analysis and electrical impedance tomography (EIT) will be measured.

The aim of the study is to determine the best end-expiratory pressure and driving pressure (assessed after anesthesia induction based on compliance and EIT parameters).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery with endotracheal intubation
* Age ≥ 18
* Verified COPD (preoperative spirometry)

Exclusion Criteria:

* Pregnant woman
* Laparoscopic surgery
* Surgery that might interfere with EIT measurement
* Cardiac Implantable Electronic Devices
Effects of Omega-3 Fatty Acids and Menaquinone-7 on Thrombotic Tendency

Omega-3 fatty acids are notably present in fish oil and krill oil, and are known to have beneficial effects on the vasculature. Vitamin K2 is known for preventing vascular calcification. In this study we investigate a potential synergy between the effects of either fish or krill oil and menaquinone-7, which is one of K2 vitamins.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects - BMI \< 30
* written informed consent

Exclusion Criteria:

* Use of oral anticoagulants
* Coagulation disorders
* Use of multivitamin supplements
* Use of corticosteroids, anticonceptives
* hypertriglyceridemia, hypercholesterolemia
Trigeminus-evoked Somatosensory Potentials in Patients Undergoing Carotid Surgery

Hypothesis: Trigeminus-evoked somatosensory potentials (TRI-SEP) may be used as an alternative technique to medianus-evoked somatosensory potentials (MED-SEP) in patients undergoing elective carotid surgery.

For CNS-monitoring somatosensory-evoked responses ba electrical stimulation of the contralateral median nerve are established: A reduction of amplitude and a delay in latency may represent a sensible marker of imminent cerebral ischemia. This study will evaluate a new concept by using trigeminal nerve evoked somatosensory evoked potentials in comparison to the established MED-SEP. Beside the comparison of two methods of neuromonitoring, this study will investigate the neurological long-term outcome (90-day evaluation) with different neuropsychological tests for the detection of cognitive deficits.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Agreement with study procedure
* Elective carotid surgery

Exclusion Criteria:

* Inability to take somatosensory potentials
* Inability to respond to neuropsychological tests
* Severe preoperative neurological deficit
Relapse Patterns in Female Cocaine Users - 4

The purpose of this study is to pilot a relapse questionnaire and examine relapse patterns in female cocaine users.

The objectives of this study were to determine the most important antecedent factors in relapse episodes and difference in the use of coping skills between relapses and "close calls"

Eligibility Criteria:
Inclusion Criteria:

Female, cocaine abuse or dependency by SCIS, at least 7 days of current abstinence, cocaine use of 8 out of 30 days prior to current abstinence, ages 18-60.

Exclusion Criteria:

Inability to participate in a 90 day longitudinal study
Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma

For patients with glioblastoma,postoperative radiotherapy combined with concurrent and adjuvant temozolomide (Stupp regimen) has long been considered a standard treatment approach.The treatment outcomes, however, are still dismal, with a median overall survival time of 8-12 months. As a novel small molecule multi-target tyrosine kinase inhibitor, anlotinib hydrochloride has been found to be able to inhibit both tumor angiogenesis and cell growth.Previous studies on recurrent glioblastoma have demonstrated its effectiveness in tumor control with manageable toxicities. The current study is designed to evaluate the efficacy and feasibility of the additional anlotinib hydrochloride to the Stupp regimen for newly diagnosed glioblastoma.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed and histological proven glioblastoma
* Complete gross resection or subtotal resection
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Adequate bone marrow, liver and renal function
* Written informed consent

Exclusion Criteria:

* Meningeal carcinomatosis or spinal compression
* Patients who have previously received chemotherapy, targeted therapy, or anti-angiogenesis
* Active, known, or suspected autoimmune disease
* Severe allergy to anlotinib or temozolomide
* Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases
* Uncontrolled mental disorders
* High risk of bleeding
* Severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms), according to NYHA criteria; grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) \<50%
* Contraindicated for MRI examination
* Recipient of live vaccine prior to the first dose of anlotinib
* Ready for or previously received organ transplantation
High Protein Weight Loss Diet, High Sensitivity C-Reactive Protein and Cardiovascular Risks Among Obese Women

The investigators aimed to determine the effects of HP diet on CVD risk factors and hs-CRP among overweight and obese women.

Background: Studies regarding the effects of high protein (HP) diet on cardiovascular (CVD) risk factors have reported contradictory results.

Objective: In present study, we aimed to determine the effects of HP diet on CVD risk factors and hs-CRP among overweight and obese women.

Design: In this randomized controlled trial, we recruited 60 overweight and obese women, aged 20-65 years into HP or control energy restricted diets for three months (protein, carbohydrate, fat: 25%, 45%, 30% vs. 15%, 55%, 30%, respectively). Total protein amount, divided to animal and plant sources in 50%-50% and animal sources distributed (half/half) between meats and dairy products. Fasting blood samples, hs-CRP, lipid profile, systolic and diastolic blood pressure and anthropometric measurements were measured based on the standard guidelines.

Eligibility Criteria:
Inclusion Criteria:

* women aged between 20-65 years
* BMI \> 25 kg/m2
* were no smoker
* no history of renal, liver, metabolic diseases or type 1 or 2 diabetes

Exclusion Criteria:

* had gastrointestinal, respiratory, cardiovascular, metabolic, liver and renal -diseases
* had macroalbuminuria
* were pregnancy or lactating
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients with Advanced Metastatic Castration Resistant Prostate Cancer

This is a Phase 1a, first-in-human, open-label dose-escalation study to determine the RDR and/or MTD, and to assess the DLT of INV-9956. The safety, tolerability, PK/PD, and preliminary antitumor activity of INV-9956 will be assessed in adult patients with advanced mCRPC.

This is a Phase 1a, first-in-human, open-label dose-escalation study to determine the RDR and/or MTD, and to assess the DLT of INV-9956. The safety, tolerability, PK/PD, and preliminary antitumor activity of INV-9956 will be assessed in adult patients with advanced mCRPC. The study will be conducted in 3 stages: Stage 1: dose escalation; Stage 2: dose expansion; Stage 3 (optional): Dose escalation beyond the optimal dose.

The total number of patients enrolled will depend upon the number of dose-escalation cohorts and the number of doses evaluated in Stage 2.

The investigational drug will be co-administered with dexamethasone and fludrocortisone acetate as corticosteroid replacement therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained.
2. Male aged ≥ 18 years.
3. Histologically confirmed adenocarcinoma of the prostate.
4. Castration resistant prostate cancer with serum testosterone \<50 ng/dL.
5. Metastatic disease.
6. Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy.
7. Received at least one prior line of taxane-based chemotherapy and at least one line of hormonal AR targeted therapy (eg, abiraterone, enzalutamide). Patients who have refused or were intolerant to taxane-based chemotherapy may be enrolled.
8. ECOG performance status 0-1.
9. Adequate marrow, liver and kidney function.
10. INR ≤1.5.
11. Able to swallow study treatment.
12. Has a life expectancy of \> 3 months.

Exclusion Criteria:

1. Have a medical condition such as Crohn's disease or have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption.
2. History of pituitary or adrenal dysfunction.
3. Poorly controlled diabetes mellitus.
4. Clinically significant abnormality in serum potassium and sodium.
5. Have a serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
6. Active or unstable cardio-/cerebro-vascular disease, including thromboembolic events.
7. History of congestive heart failure; cardiac disease, myocardial infarction within 6 months prior to enrollment.
8. Prolonged QTcF interval.
9. Active infection or other medical condition that would make corticosteroid contraindicated.
European Survey of Cardiovascular Disease Prevention, Diabetes and Chronic Kidney Disease (EUROASPIRE VI)

The goal of this observational study is to provide a unique European picture of preventive action by cardiologists, other specialists and primary care physicians looking after patients with coronary heart disease (CHD), individuals at high cardiovascular disease risk and all those with hypertension, dyslipidaemia (including familial hypercholesterolaemia), diabetes and dysglycaemia and chronic kidney disease (CKD) and determine whether the European guidelines on cardiovascular disease prevention, hypertension, lipids, diabetes and chronic kidney disease are being followed.

EUROASPIRE is a multicentre European study in coronary patients and individuals at high risk of developing cardiovascular disease (CVD), describing their management through lifestyle and use of drug therapies and providing an objective assessment of clinical implementation of current scientific knowledge. Five EUROASPIRE surveys have been carried out by the European Society of Cardiology so far: EUROASPIRE I in 1995-1997 in nine countries, EUROASPIRE II in 1999- 2000 in 15 countries, EUROASPIRE III in 2006-2009 in 22 countries, EUROASPIRE IV in 2012-2015 in 26 countries and EUROASPIRE V in 2016-2018 in 27 countries.

This sixth EUROASPIRE survey will investigate the cardiometabolic and renal continuum in both secondary and primary cardiovascular disease prevention in 2023-2025 under the auspices of the European Society of Cardiology, Global Registries And Surveys Programme (GRASP). As in the previous EUROASPIRE surveys this survey will be focused on hospital patients with CHD, with and without diabetes mellitus, and apparently healthy individuals in primary care at high risk (hypertension, dyslipidaemia, diabetes) of developing CVD.

Eligibility Criteria:
Inclusion Criteria:

* Patients having signed an informed Consent
* Patients aged from 18 years old at the time of identification
* At least six and at most 24 months elapsed between the index event (the recruiting diagnostic or treatment criteria below) and the date of interview
* Patients meeting the recruiting diagnostic or treatment criteria:
* Coronary patients: Acute coronary events (acute coronary syndrome {STEMI or NSTEMI}, unstable angina) or an emergency or elective revascularisation for coronary artery disease (CABG, PCI)
* High cardiovascular disease (CVD) risk patients: patients free of CVD, who have been prescribed one or more of the following treatments: blood pressure and/or lipid-lowering and/or glucose lowering (diet and/or hypoglycaemic agents and/or insulin)

Exclusion Criteria:

* Patients living outside defined geographical areas
* Patients admitted to hospital from outside the geographical area or under the care of cardiologists in hospitals that do not participate in EUROASPIRE VI