cyrilzakka/clinical-trials huggingface dataset:
Prospective Cohort Study in Patients With NAFLD

To assess the importance of intracellular signalling pathways and its deregulation in adiposity and diabetes-related insulin resistance, liver tissue samples of patients suffering from non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)will be analyzed prospectively from a liver tissue bank.

Patients with suspected fatty liver disease will be screened (and excluded in the presence) of alternative clinical condition associated with NAFLD (see exclusion criteria). Of all patients fulfilling inclusion criteria, relevant baseline characteristics (incl. epidemiological, physiological and biochemical data) will be obtained. In addition, radiological examination will be performed using sonography and fibroscan to assess non-invasively the individual extent of hepatic fat deposition, liver stiffness (fibrosis) and amount of visceral fat mass. In case of high clinical, laboratory and radiological suspicion for NAFLD, a diagnostic liver biopsy will be performed. A part of the liver tissue is used for histological confirmation of NAFLD and subsequent grading and staging according established criteria. Parts of the remaining liver tissue will be stored for later molecular and histological analysis. In addition, several serum samples are collected of patients and stored for future analysis. All patients will be followed up annually (incl. physical examination, metabolic characterisation, clinical chemistry and liver sonography) and additional serum samples will be collected for future analysis. Liver biopsy is not repeated after defined time period, but in case of clinical evidence for disease progression.

Eligibility Criteria:
Inclusion criteria:

* Patients with histologically confirmed fatty liver disease

Exclusion criteria:

* History of significant alcohol consumption
* Viral hepatitis
* Autoimmune hepatitis
* Metabolic diseases (e.g. hemochromatosis, M. Wilson, alpha 1-antitrypsin deficiency)
* Hepatotoxic medication (e.g. amiodarone).
Glucose Study, Spinal Cord Injury

The purpose of this research study is to find out how blood sugar levels change during the day and night in people living with spinal cord injuries (SCI) and then to compare that with people who do not have a spinal cord injury.

As people with SCI get older they become more likely to develop health problems, just like everyone else. However, SCI increases the risk of certain problems. The amount of time post-SCI can also increase the risk of certain problems. This research project will focus on identifying the patterns of changes in blood sugar levels after SCI. Sugar in the blood is the important source of energy for the body. Too much sugar in the blood is known as hyperglycemia and not enough sugar in the blood is known as hypoglycemia. Under healthy conditions, the amount of sugar in the blood is automatically regulated so that a steady level is maintained. After SCI, however, this automatic regulation is damaged. The likelihood of experiencing too much or too little blood sugar is increased. Over time, having too much blood sugar can lead to the development of diabetes. In just the opposite situation, individuals with SCI can begin to experience more frequent episodes of too little blood sugar, which can lead to acute emergency situations.

The pattern of how blood sugar levels change during a typical 24-hour time period in persons with SCI is not known. There may be unknown factors that affect blood sugar levels. In order to find out that information, this study will involve continuously monitoring blood sugar over a 3-day period in a variety of persons with SCI. A non-invasive, wireless monitoring system will be attached to the abdomen. This system records blood sugar levels every 5 minutes. The information gathered from this observational study is vital to the understanding of how SCI alters the regulation of sugar levels in the blood and to the subsequent medical management of this population.


Eligibility Criteria:
Inclusion Criteria:

1. Must be greater than 1 year post-injury.
2. Must be 18-65 years of age.
3. Must have detectable neurologic impairment resulting from a spinal cord lesion.
4. Must not have any current pressure sores.
5. Must be cognitively competent and have no concomitant brain damage.
6. Must pass a medical examination by the study physician.
7. Must be healthy.
8. Must not have any physical ailments.
9. Must be cognitively competent.
A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis

The goal of this study is to test a new vitamin D compound for its ability to reduce parathyroid hormone levels in patients who are on hemodialysis.

This is a randomized, double-blind, placebo-controlled study of the vitamin D analog 2-methylene-19-nor-20S-1α,25-dihydroxyvitamin D3 (DP001) in patients with end-stage renal disease (ESRD). The effect of 12 weeks of oral administration of DP001 on serum parathyroid hormone (PTH) levels will be evaluated in ESRD patients who have secondary hyperparathyroidism.

Eligibility Criteria:
Inclusion Criteria:

* Men and non-pregnant women ≥18 years of age
* Patient is diagnosed with ESRD and must be on hemodialysis 3 times per week for at least 3 months prior to Screening Phase
* Patient is currently being treated with pharmaceutical vitamin D for the treatment of secondary hyperparathyroidism
* Serum iPTH value ≤500 pg/mL at first screening visit
* Total serum calcium (corrected for albumin) ≤10.5 mg/dL at first screening visit
* Serum phosphorus ≤7.0 mg/dL at first screening visit

Exclusion Criteria:

* Currently taking any of the following: drugs affecting vitamin D metabolism, digitalis, glucocorticoids, cyclosporine or other immunosuppressants, aluminum-based phosphate binders
* A daily intake \>4000 IU vitamin D (D3 + D2)
* Any investigational drug use within 10 half-lives of the drug (or within the previous 30 days if the half-life of the drug is unknown)
* History of any of the following: ventricular dysrhythmias, severe congestive heart failure, angina pectoris, myocardial infarction, coronary angioplasty, coronary artery bypass grafting, multiple myeloma, calciphylaxis, active malignancy, end-stage liver disease, active infections, clinically significant renal/urinary tract stones, sarcoidosis, tuberculosis, parathyroidectomy
* Major surgery within the past 3 months
Overeating Different Fats and Influence on Muscle Mass and Body Fat Accumulation

To investigate metabolic and molecular response to fatty acid-specific overfeeding in overweight subjects, in relation to changes in ectopic fat, lean tissue mass and insulin sensitivity


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 25-32

Exclusion Criteria:

* Type 2 diabetes
* Type 1 diabetes
* Kidney disease
* Liver disease
* Abnormal clinical chemistry at screening
* Intense physical exercise \> 2 hours per week
* Use of statins or drugs affecting energy metabolism
* Use of extreme diets
Anti-inflammatory Effect of Aerobic Exercise in Individual With Increased Cardiovascular Risk

Aerobic physical activity attenuates systemic inflammatory activity in individuals with cardiovascular risk.

Background: Observational studies suggest that exercise has anti-inflammatory effect, however this idea has not been definitively confirmed by randomized clinical trials.

Objective: To test the hypothesis that aerobic exercise attenuates systemic inflammatory activity in individuals with cardiovascular risk.

Methods: Randomized controlled trial, which included 68 sedentary individuals, with at least two risk factors for coronary heart disease or established cardiovascular disease. The volunteers were randomized to 3 months of supervised aerobic training or just advice when healthy lifestyles. C-reactive protein (CRP) was measured by the method of high sensitivity before and after 3 months of intervention.

Eligibility Criteria:
Inclusion Criteria:

- Individuals with are between 40 to 70 years, no regular exercise, and at least two risk factor for cardiovascular disease (diabetes, hypertension, dyslipidemia, smoking) or documented cardiovascular disease.

Exclusion Criteria:

- Incapacity to exercise.
The Optimization of Medications in Chronic Heart Failure Using a Website

Heart failure (HF) is the most common hospital discharge diagnosis among older adults in the United States. Strikingly, 2 in 5 patients are readmitted within 1-year following their first HF admission. This results in significant potentially avoidable costs to our already strained healthcare system since hospitalizations result in 70% of yearly HF management costs. One of the most common causes of readmission is lack of medication optimization. This study will determine the effectiveness of a medication optimization website.

In a prospective design, 100 patients will be randomized to the intervention or usual care in a 1:1 fashion. Patients randomized to the intervention will receive an evidence-based medication recommendation intervention. Outcome measures will be collected at baseline and at 2 weeks post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* left ventricular ejection fraction (LVEF) \</= 40%

Exclusion Criteria:

* pregnancy
* active cancer with a life expectancy less than 12 months
* hospice
* chronic inotropic therapy
Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection

Considering the relatively high incidence of surgical site infection (SSI) in colorectal surgery, this trial will compare rates of SSI in patients undergoing colorectal resections followed by surgical wound irrigation with povidone-iodine versus the group of patients undergoing surgical wound irrigation with saline solution. The trial will be conducted in a large university hospital in Southern Brazil.

Patients will be randomized to one of the following intervention groups:

Group 1: intraoperative irrigation/washing of the surgical incision with povidone-iodine (PVP-I); Detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of povidone-iodine solution (PVP-I). The exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues. " Group 2: intraoperative irrigation/washing of the surgical incision with saline solution (NaCl 0.9%); Detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of saline solution (NaCl 0.9%). The exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues.

NOTE: other care routines for participating patients will not be changed by this study. Patients will receive mechanical colon preparation and antibiotic prophylaxis according to routines already in place by the assistant team.

Randomization: the block randomization method will be used (blocks of 4 patients each).

Groups 1 and 2 will be compared with each other regarding the outcomes.

Eligibility Criteria:
Inclusion Criteria:

Patients older than 18 years of age diagnosed with benign or malignant colorectal diseases undergoing elective open or video-assisted colectomy or proctectomy (resection) at the Hospital de Clinicas de Porto Alegre - Division of Coloproctology.

Exclusion Criteria:

* age under 18;
* surgery classified as dirty;
* urgent/emergency surgery;
* patients undergoing multi-visceral resections (pelvic exenteration or partial resection of any adjacent organ);
* known allergy to iodine.
Beta-lactam Therapeutic Drug Monitoring in Singapore

This is a prospective cohort study to evaluate clinical utility and feasibility of beta-lactam therapeutic drug monitoring in Singapore. The investigators hypothesise that conventional beta-lactam dosing regimens based on manufacturer's recommendations (derived from Phase I studies on healthy volunteers) will produce sub-optimal levels in at least half of the patients. Hence, beta-lactam therapeutic drug monitoring and dose individualisation will be required for optimal clinical outcomes. The investigators' secondary aims include correlating various therapeutic targets with clinical outcomes to identify a suitable therapeutic target for clinical use and to characterise beta-lactam pharmacokinetics in sub-group of patients with complex pharmacokinetics so that local empirical dosing regimens can be formulated.

Despite widespread use, conventional beta-lactam dosing regimens, derived from healthy volunteers, are sub-optimal clinically as patients display variable pharmacokinetics. This problem is further confounded by rising antimicrobial resistance and the need for high dose beta-lactams, exceeding licensed recommendations. In order to optimise beta-lactam therapy, dose individualisation using therapeutic drug monitoring (TDM) has been suggested. However, experience with beta-lactam TDM is limited with varying practices worldwide. Therapeutic targets are also variable and have not been extensively validated. Hence, this study primarily aims to establish clinical feasibility and utility of beta-lactam TDM. The investigators hypothesise that conventional beta-lactam dosing will produce sub-optimal levels in at least half of the patients, justifying need for TDM and dose individualisation to improve clinical outcomes. The secondary aims include correlating various therapeutic targets with clinical outcomes to identify a suitable therapeutic target for clinical use and to characterise beta-lactam pharmacokinetics and recommend local empirical dosing regimens.

The investigators propose a prospective cohort study on adult patients (≥21 years) admitted to SGH. Four blood samples will be obtained over a dosing interval and assayed using liquid chromatography with tandem mass spectrometry. Levels and dose adjustment recommendations will be reported to physicians by infectious disease pharmacists.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (21 years and above)
* Admitted to Singapore General Hospital
* Receiving beta-lactam therapy for documented or suspected infection
* Indication for beta-lactam therapeutic drug monitoring: critically ill, altered pharmacokinetics (burns, obese, on extracorporeal therapy, dialysis), immunocompromised, resistant pathogens, deep-seated infections, suspected or at risk for adverse effects

Exclusion Criteria:

* Expected mortality within next 24 hours
* Pregnancy
Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial

The pathophysiological implications of various cancer diseases and anti-cancer therapies is the occurrence of a cardiac disease-like phenotype with cardiac dysfunction, cardiac wasting, and cardiac homeostasis changes (incl. fibrosis and apoptosis) in end-stage cancer patients, causing heart failure like syndrome with development of congestion, dyspnoea and severely reduced physical functioning. The present trial aims to evaluate, if a heart failure medication improves the self-care ability and self-reported health care status of patients with pre-terminal cancer in palliative care.


Eligibility Criteria:
Inclusion criteria:

Basic Criteria:

* Patients with solid cancer in Union internationale contre le cancer (UICC) stage 4 (in palliative care)
* 3-6 months expected survival (minimum 4 weeks) as assessed according to local standards
* Patients under optimised analgetic therapy

Group 1 Criteria:

* Heart rate \>70 bpm
* NT-proBNP \>600 pg/ml
* Elevated high-sensitive troponin (\>99th percentile of respective test)
* LVEF \<55%
* Heart failure with preserved ejection fraction (HFpEF) likelihood medium or large
* Evidence of left ventricular (LV) mass reduction \>15% since start of cancer
* Iron deficiency (ID) with transferrin saturation (TSAT) \<20%

Group 2 Criteria:

* 4 m walking time (\>=6.0 secs for 4m - test will be performed twice and the average time is calculated) or not able to walk 4m at all.
* Not being able to wash oneself in at least 3 of the last 7 days
* Presence of shortness of breath (SoB) (NYHA IV)

Requirement for inclusion:

At least two fulfilled criteria of Group 1 PLUS at least one fulfilled criterion of Group 2

Exclusion criteria:

* Previous participation in this trial. Participation is defined as randomised
* Ongoing haemodialysis
* Patients currently on intravenous iron
* Acute sepsis with at least 2 points at the quick sequential organ failure assessment (qSOFA) score. The use of i.v.-antibiotics is permitted in patients with a lower qSOFA score.
* Ongoing acute exacerbation of chronic obstructive pulmonary disease (COPD) Acute ST elevation myocardial infarction (STEMI) or severe pulmonary embolism (PE) or severe deep vein thrombosis (DVT) (currently or in last 4 weeks)
* Current uncontrolled cerebral metastasis
* Impaired neurological status, precluding the ability to walk
* Unable or unwilling to give written informed consent
* Participation in other interventional trials using investigational products in randomised settings
Creation of a Clinical Database on Primary Nervous System Tumors

the creation of a clinical database including data for all PCNST patients is of high interest. This database will allow us to develop clinical studies on:

* The clinical, radiological and biological presentation of tumors, the impact of oncological treatments and the evaluation of survival for the different subtypes of Primary central nervous system tumors (PCNST). This is particularly important for rare histological subtypes of PCNST for which the current knowledge is scarce;
* Clinical, radiological and biological factors predictive of tumor response to treatments;
* Prognostic factors.

Primary central nervous system tumors (PCNST) correspond to all primitive tumors involving central nervous system structures, meninges and the origin of the cranial and paraspinal nerves. They have a malignant, benign, or borderline evolution. TPSNC represent a heterogeneous group of tumors, with more than 140 subtypes described in the WHO classification. The causes, prognostic factors, and therapeutic management differ according to the histological subtype.

The incidence of all of TPSNCs ranges from 17.6 to 22.0/105 in North American and European studies. However, because of the high number of different histological subtypes, most of them must be considered as rare tumors. Moreover, they represent a major public health problem due to high morbidity \[8\] and mortality.

In this context, the creation of a clinical database including data for all PCNST patients is of high interest. This database will allow us to develop clinical studies on:

* The clinical, radiological and biological presentation of tumors, the impact of oncological treatments and the evaluation of survival for the different subtypes of PCNST. This is particularly important for rare histological subtypes of PCNST for which the current knowledge is scarce;
* Clinical, radiological and biological factors predictive of tumor response to treatments;
* Prognostic factors.

The database will also allow us to develop or participate in multicentric clinical studies, at the national or international level, as well as to facilitate the identification of patients for inclusion in translational studies

Eligibility Criteria:
Inclusion Criteria:

* Adult patient aged ≥ 18, no age limit;
* Diagnosis of Primary central nervous system tumors ;
* Patient treated at the Montpellier Cancer Institute, whatever the treatment received (systemic treatment, radiotherapy or exclusive supportive care);
* For the retrospective part of the study, patient first treated at the Montpellier Cancer Institute between January 1rst, 2004 and the beginning of the prospective part;
* Patient information for the retrospective (patient still alive at the beginning of the study) and prospective study.

Exclusion Criteria:

* Secondary lesions of the central nervous system;
* Patient not affiliated to a social protection scheme;
* Subject under tutelage, curatorship or safeguard of justice.
A Study to Evaluate GSK1325760A - a Long-Term Extension Study

The primary objective of this study is to evaluate the safety of long-term administration of GSK1325760A in patients with PAH.

The secondary objectives of this study are to evaluate long-term administration of GSK1325760A on:

* Improvement in exercise capacity (six-minutes walk distance: 6MWD), change in WHO Functional Classification and time to clinical worsening of PAH
* Change in the Borg Dyspnea Index (assessed immediately following the six-minute walk test \[6MWT\])
* Change in plasma brain natriuretic peptide (BNP) levels
* Cardiopulmonary hemodynamics parameters (as measured by echocardiography)


Eligibility Criteria:
Inclusion Criteria:

* Subjects who complete the 24-week administration of the Phase II/III study (Study No.AMB107816)
* Subjects who are assessed that the long-term extension administration of GSK1325760A is appropriate in the judgement of the investigator or subinvestigator
* Subjects who request the long-term extension administration of GSK1325760A, and agree to newly sign the informed consent form

Exclusion Criteria:

* Subjects who have been withdrawn from the Phase II/III study.
* Female subjects who wish to become pregnant.
* Treatment with other PAH medication is needed.
* A worsening of 2 or more levels of the WHO Functional Classification (see Appendix 2.1) comparing with the baseline of Phase II/III study (Study No.AMB107816).
* Worsening of right ventricular failure (e.g. as indicated by increased jugular venous pressure, new/worsened hepatomegaly, ascites, or peripheral edema) during Phase II/III study (Study No.AMB107816).
* Rapidly progressing cardiac, hepatic or renal failure during Phase II/III study (Study No.AMB107816).
* Participation to the long-term extension study is considered as inappropriate in the judgment of the investigator or subinvestigator.
Effects of Naproxen on Physical Performance

The purpose of this study is to determine the effect of daily use of Naproxen (a commonly used over-the-counter NSAID) on the physical performance of athletes, as measured by maximum oxygen consumption.


Eligibility Criteria:
Inclusion Criteria:

1. Age equal to or greater than18 years of age
2. No history of allergy or adverse reaction to any NSAID
3. No use of any NSAID in past 2 weeks
4. No history of peptic ulcer disease (PUD), gastroesophageal disease (GERD), or gastritis
5. No major medical history including but not limited to diabetes, hypertension, asthma, kidney disease and coronary artery disease
6. Currently not taking any medication including oral contraceptives

Exclusion Criteria:

1. Age \< 18 years of age
2. History of allergy or adverse reaction to any NSAID
3. Use of any NSAID in past 2 weeks
4. History of a bleeding disorder
5. History of PUD, GERD, or gastritis
6. Pregnant
7. A medical history of diabetes, hypertension, asthma, kidney disease or coronary artery disease
8. Taking any medication including oral contraceptives