cyrilzakka/clinical-trials huggingface dataset:
Nutritional Interventions in Patients With Alcohol-associated Hepatitis

Alcohol-associated hepatitis (AH) is a life-threatening condition with high 90-days mortality (up to 40%) and limited treatment options. Previous studies have shown that decreased nutritional intake (less than 21 kcal/kg/day) is associated to a higher mortality compared to patients with a higher caloric intake. Additionally, it has been suggested that subjects with severe AH, should receive a high-protein diet, however, no specific trials have been carried out to address these questions. Thus, the investigators aim to compare nutritional interventions through a randomized controlled trial to assess if a strategy of peripheral parental nutrition (PPN) plus oral nutritional supplementation (ONS) improves outcomes in patients with severe AH. The investigators will compare standard oral intake, enhanced oral intake with IV fluid supplementation, and PPN plus ONS in patients admitted to hospital with severe AH. These results potentially will help guide practitioners on caloric benchmarks targets for patients with severe AH. This study will also assess specific risks and benefits of different nutritional interventions.


Eligibility Criteria:
Inclusion criteria:

* Adult (\>18 years) patients admitted with acute severe AH based clinical diagnosis according to NIAAA criteria
* Excessive alcohol consumption for more than 5 years in a row or interrupted
* No more than 60 days of abstinence before the onset of jaundice
* Bilirubin levels \>3 mg/dL (\>50 umol/L), AST\>50 IU/mL, AST/ALT ratio \> 1.5
* Abstinence of other causes of liver disease
* MELD score ≥ 20

Exclusion criteria:

* Age \< 18 years
* Pregnancy or lactation.
* Allergy or intolerance to the enhanced oral intake formulation or PPN formulation.
* Expected length of stay less than 48 hours.
* Contraindications to IV fluid or PPN administration (fluid overload, suspected bacteremia).
* Presence of drug-induced liver injury (DILI), ischemic hepatitis, biliary duct obstruction, viral hepatitis, autoimmune hepatitis, or Wilson's disease.
* Extrahepatic neoplasia with a life expectancy of less than 6 months.
* History of severe extrahepatic disease (e.g., chronic kidney failure requiring hemodialysis, severe heart disease (NYHA class ≥3), severe chronic lung disease (class ORO ≥3) that confers a survival of less than 6 months.
Mechanisms of Exercise Intolerance in Heart Failure With Preserved Ejection Fraction

The global objective of this study is to determine the mechanisms of exercise intolerance and dyspnea on exertion (DOE) in patients with HFpEF and based on this pathophysiology, test whether specific exercise training programs (whole body vs single leg) will result in improved exercise tolerance.

This will be a randomized, non-blinded prospective intervention testing the effects of two types of exercise training, whole body and isolated single leg, on HFpEF patients with either central or peripheral limitations to exercise training. Subjects will undergo baseline maximal exercise testing and invasive right heart catheterization to define exercise tolerance and pulmonary and cardiac pressures during exercise. Based on the results of baseline testing, subjects will be divided into either centrally limited, defined as excessive rise in pulmonary capillary wedge pressure more than 25 mmHg that decreases after administration of sub-lingual nitroglycerin resulting in improved exercise tolerance, or peripherally limited, defined as no improvement in exercise tolerance despite reduction in pulmonary capillary wedge pressure after sublingual nitroglycerin. After baseline testing, subjects will be randomized to either whole body cycle exercise supplemented with sublingual nitroglycerin to improve training responsiveness or isolated single leg exercise training for 4 months. After 4 months, subjects will repeat maximal exercise testing and invasive right heart catheterization to assess responses to 4 months of exercise training.

Eligibility Criteria:
Inclusion Criteria:

* signs and symptoms of heart failure
* an ejection fraction \> 0.50
* objective evidence of diastolic dysfunction

Exclusion Criteria:

* age \< 60 years
* BMI \> 50 kg/m2
* PDE5 inhibitor use
* Severe valvular disease
* Severe COPD
* CKD 4 or higher
* Contra-indication to MRI.
Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia

Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia caused by P. aeruginosa.

This is a double-blind, randomized, placebo-controlled study of the human monoclonal antibody (mAb) AR-105 for the adjunctive therapeutic treatment of P. aeruginosa pneumonia in mechanically ventilated subjects. Subjects who are randomized will be treated with either standard of care (SOC) antibiotics plus placebo or SOC antibiotics plus AR-105. The study is being conducted at approximately 100 clinical sites across 17 countries. Subjects who meet all of the inclusion criteria and none of the exclusion criteria are screened by the microbiological culture test and/or rapid diagnostic test of an endotracheal aspirate to confirm the presence of an active P. aeruginosa infection. Following eligibility confirmation, the subject will be randomized in a 1:1 ratio to one of two treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* ≥18 years of age, ≥ 20 years of age (Taiwan only),≥ 19 (S. Korea only)
* pneumonia due to P. aeruginosa
* mechanically-ventilated
* intubated
* APACHE II score between 10 and 35

Exclusion Criteria (main criteria):

* being moribund
* effective antibiotic therapy ≥48 hours
* immunocompromised
* underlying pulmonary disease that may preclude the assessment of a therapeutic response
Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical.

This is a randomized, prospective clinical trial. The aim of the project is to assess the clinical performance of three types of tooth-supported crowns; monolithic high translucent colored zirconia, crowns of high-translucent colored zirconia with a mini-veneer buccally and crowns of lithium-disilicate glass-ceramic. Crowns will be placed on posterior teeth and evaluated from an esthetic and functional point of view, to identify if there are any differences between the materials.

90 monolithic tooth-supported crowns are planned to be included in the study; 30 crowns of high translucent zirconia (BruxZir, Glidewell), 30 crowns of high translucent zirconia (BruxZir, Glidewell) with a mini-veneer of porcelain and 30 crowns of lithium-disilicate glass-ceramic (IPS e.max CAD, Ivoclar Vivadent AG, Schaan, Liechtenstein).

Patients with indications for single crowns will be recruited from three general dental clinics. Inclusion criteria for participating in this study are patients in need of crowns in the posterior dentition, premolars and molars. Exclusion criteria are patients with high caries activity/risk for caries and/or advanced periodontal disease. Patients who meet the criteria will be offered the opportunity to participate in the study. They will receive written information about the study design, clinical procedures and the materials and methods to be used. Patients who are interested will confirm their participation by a written consent. The patients will be offered an extended warranty for the crowns in case of failure.

The study has been approved by the Regional Ethical Board in Lund, Sweden

Eligibility Criteria:
Inclusion criteria:

* need of one or more dental crowns in the posterior dentition, premolars and molars

Exclusion criteria:

* high caries activity/risk for caries and/or advanced periodontal disease
Core Stabilization Exercises on Shoulder Impingement Syndrome

The objective of this retrospective study was to look into the effects of core stabilization exercises applied in conjunction with classic physiotherapy program on pain, muscle strength, disability, and posture in SIS.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 35 and 60 who were diagnosed by a Physical Therapy and Rehabilitation doctor with at least ten years of experience, whose SIS was confirmed by MRI, and who had shoulder complaints for at least three months, patients with positive signs, a positive Hawkins-Kennedy test, significant loss of active and passive shoulder movements or painful range of motion (ROM), and patients whose treatment and evaluation methods were appropriate for the study design were enrolled in the study

Exclusion Criteria:

* Patients who had upper extremity surgery, patients with a history of shoulder trauma and corticosteroid application to the shoulder region in the previous year, a history of shoulder dislocation, infection, tumor, adhesive capsulitis, reflex sympathetic dystrophy, congenital anomaly, rheumatic disease, and chronic severe systemic disease, as well as professional athletes and patients whose evaluations were missing in the previous month were excluded
Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery

The aim of the current study is to evaluate, in a prospective cross-over, randomized study, the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficits and cognitive impairment after anterior skull base meningioma tumor removal.


Eligibility Criteria:
Inclusion Criteria:

* Post intracranial meningioma removal surgery 3-12 months prior to the inclusion in the study.
* All patients have to have persistent cognitive or neurological complaints regarding without noticeable improvement during the last month prior to their enrolment.
* Age 18 years or older.

Exclusion Criteria:

* Dynamic neurologic/cognitive improvement or worsening during the past month;

  * Evidence of dynamic cognitive/neurological improvement in the last month.
  * Previous brain radiotherapy and/or radiosurgery.
  * Steroids dependence
  * Seizures 1 month previous to inclusion
  * Had been treated with HBOT for any other reason 1 month prior to inclusion;
  * Have any other indication for HBOT;
  * Chest pathology incompatible with pressure changes;
  * Inner ear disease;
  * Patients suffering from claustrophobia;
  * Inability to sign written informed consent;
  * Smoking patients will not be allowed to smoke during the study and if they would not comply with this demand they will be excluded.
TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study

TransitionCHF aims to recruit a unique cohort of patients with asymptomatic left ventricular dysfunction (NYHA I) to study the progression to symptomatic (\>NYHA I) HF and to identify parameters/ biomarkers promoting and predicting the individual risk of transition. Results from TransitionCHF Cohort Study will inform and refine current treatment guidelines. The implementation of common patient data sets and biobanking standards will enable data and biomaterial sharing with other study groups of the German Center for Cardiovascular Research (DZHK). This study will set the standard for a unique DZHK heart failure database and Biobank for innovative preclinical and clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic systolic dysfunction (defined as: ejection fraction \< 40% by echocardiography or MRI; documented within the last 3 months prior to baseline visit)
* A maximum of one hospitalization for heart failure (defined as hospitalization with signs and symptoms of heart failure requiring intravenous loop diuretic therapy within 48 hours after hospital admission) at least 2 years prior to the baseline visit
* No heart failure symptoms (NYHA II, III or IV) upon inclusion
* 6MWD ≥ 80% of reference values
* Written informed consent
* Age ≥ 18 years

Exclusion Criteria:

* Symptomatic heart failure (NYHA\>I) at baseline visit
* Any significant valvular disease (\> 2nd degree)
* Severe pulmonary disease (e.g. FEV1/FVC \<0.7 and FEV1\<50%)
* Severe renal disease (GFR \< 15 ml/min)
* ejection fraction at baseline visit ≥ 50% by echocardiography or MRI
* Life expectancy \< 1 year
* Pericardial disease
* Hypertrophic cardiomyopathy
* Myocardial infarction within the last 3 months
* Planned cardiac surgical intervention within 3 months after inclusion
* Geographical reasons (e. g. patients living outside Germany or planning to move abroad)
* Inability to give informed consent (e. g. mental disorders)
* Therapy with loop diuretics (e.g. torasemide, furosemide, piretanide) within 4 weeks prior to inclusion/baseline visit
A Study of LY8888AX in Participants Using a Connected Insulin Management Platform

The main purpose of this study is to assess participant adherence and glucose control while using a connected insulin management platform. Approximately 50 participants will be enrolled in each country.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed (clinically) with T1D for at least 1 year or are patients with T2D on basal bolus insulin therapy for at least 6 months
* HbA1c ≥8% as confirmed by point-of-care test at screening
* Are currently using the Dexcom G6 CGM or agree to start using the Dexcom G6 during the study and agree to switch to Glooko RMA
* Are currently using Humalog ® insulin or another rapid acting insulin analogue (e.g., Apidra® , or Novorapid ® ) and agree to switch to study-provided Humalog mealtime insulin for duration of trial
* Have been prescribed ≥3 doses of bolus insulin per day
* Must be taking a stable insulin dose regimen (per investigator's judgement) for at least 3 months preceding study screening
* Have in-home refrigeration for storage of insulin

Exclusion Criteria:

* Previously used the Glooko RMA and/or Dexcom G6 CGM and were judged by the investigator to be non-adherent
* Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
* Have previously used or have been using an approved or investigational connected pen system within the 3 months prior to screening
* Are currently breastfeeding, pregnant, or plan to become pregnant during the next 4-6 months
* Are on ultra-rapid insulin (e.g., Fiasp or Lyumjev) or rapid acting human insulin (i.e., Humulin) for previous 3 months, at the time of screening
* Are currently undergoing dialysis treatment or have any other medical condition which may preclude them from participating in this trial as per the investigator's judgement
* Have vision loss or vision impairment that does not allow recognition of Glooko RMA screen features
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)

This study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 (\[18F\]FNP-59) to image the adrenal gland. Some participants are healthy normal subjects but have undergone interventions to manipulate hormones while other participants have known adrenal pathology.

Groups 2 \& 3 used hormone manipulation using information gathered from Group 1 which identified radiation dosimetry and optimal uptake time.

Group 4 (added to the study later) includes participants with known adrenal pathology. They will not have study associated hormone manipulation.

All groups will be given a radio-tracer and PET/CT scans.

The researchers believe that a fluorine-18 analogue of NP-59, \[18F\]FNP-59, would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry, and improved localization / sensitivity / specificity without concern of thyroid exposure.

Eligibility Criteria:
Inclusion Criteria (Groups 2 \& 3):

* Participants without any known adrenal pathology as normal controls for undergoing endocrine manipulation

Exclusion Criteria (Groups 2 \& 3):

* Pregnancy
* Unable to do imaging
* Body weight greater than 400 lbs (181 Kg)
* Prisoners are not eligible
* Subjects unable to provide own consent are not eligible
* Current use of steroids, Oral contraceptives (OCP), spironolactone, estrogen, androgen, progesterone, Angiotensin-converting enzyme (ACE inhibitors)/ Angiotensin II receptor blockers (ARBs), or supplements that are hormone analogues.
* Known adrenal pathology

Inclusion Criteria (Group 4):

* Abnormal adrenal cortical hormone secretion

Exclusion Criteria (Group 4):

* Pregnant
Synek Score to Predict Poor Neurological Outcome Post Resuscitated Cardiac Arrest

Resuscitated cardiac arrest (CA) is a frequent cause of admission in intensive care unit (ICU). Neurological state of postanoxic comatose patients can evolve either towards the absence of awakening or towards a more or less altered state of consciousness, ranging from the vegetative state to the full recovery of cognitive functions. Most of the deaths result from active withdrawal of life-sustaining treatment, based on poor neurological outcome prediction. Neurological prognostication needs therefore a multimodal approach based on reliable parameters, which should be easy to access and available at the early stage of care, in attempt to limit false poor outcome prognostication and help to not prolong futile active care in patient with severe post anoxic cerebral lesions. Nowadays the prediction of neurological outcome relies on a multimodal strategy including clinical examination, biomarkers and electroencephalography (Guidelines ESICM 2015). Early standard electroencephalography (EEG) is currently recommended and some features, notably absence of reactivity, status epilepticus or burst suppression after rewarming are strongly predictive of poor outcome. But those features require a precise analyze of the EEG usually performed by specialist. EEG patterns can be simplified and classified in five grades according to the Synek classification, ranging from dominant reactive alpha activity (grade 1) to isoelectric encephalogram (grade 5). Grade 1 and two are considering as good prognostic, grade 3 as intermediate and grade 4 to five as poor prognostic. Nevertheless, few data are available on the performance of this classification since generalization of TTM use.

We hypothesize that a multimodal strategy combining clinical examination, NSE concentration and the Synek score would bring a high degree of prediction. We aimed to assess the performances of the combination of clinical examination, NSE analysed at 48-72h and the Synek score to predict hard outcome defined by a cerebral performance category (CPC) 3-5, in postanoxic comatose patients treated with induced hypothermia


Eligibility Criteria:
Inclusion Criteria:

* patients admitted in our ICU following a resuscitate cardiac arrest between November 1, 2013 to November 1, 2017
* treated with 33° induced hypothermia for 24 h
* having at least one early EEG rated according to Synek score
* available dosage of NSE performed within 48-72h post CA

Exclusion Criteria:

* moribund patients
* awoke within the first 48 hours of admission
* neurologic causes of CA
* patients with missing data
Continous Quadratus Lumborum Block for Hepatic Surgery With Right Subcostal Incision

This prospective, randomized study, control study aims to compare the analgesic effect, opioids consumption, quality of recovery, length of hospital stay and et al. between unilateral continuous quadratus lumborum block (QLB) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal incision.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo hepatectomy with right J-shape subcostal incision
* Informed consent

Exclusion Criteria:

* A known allergy to the drugs being used
* Coagulopathy, on anticoagulants
* Analgesics intake, history of substance abuse
* Participating in the investigation of another experimental agent
* Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
Association Analysis for Chronic Diseases Based on Resident Health Records by Using Big Data Methods

This is an observational study to analysis the association factors for common diseases, including chronic obstructive pulmonary disease, coronary artery disease, hypertension, diabetes etc, based on resident healthcare records. More than 10 million resident healthcare records should be collected for the associations study by using big data methods.


Eligibility Criteria:
Inclusion Criteria:

* Survey Chinese residents aged 20 - 100 years, were included in this study.

Exclusion Criteria:

* Serious hepatic or renal dysfunctions.
Multicentric Study Comparison Between Erythropoietin and Erythropoietin Associated to Differentiating Therapy With Acid 13-cis-retinoic and Dihydroxyvitamin D3 in Myelodysplastic Syndromes Without Excess of Blasts

This is a prospective, randomized multicenter phase III clinical trial designed to evaluate the safety and activity of comparison between Erythropoietin and Erythropoietin Associated to Differentiating Therapy With Acid 13-Cis-Retinoic and Dihydroxyvitamin D3 in Myelodysplastic Syndromes Without Excess of Blasts


Eligibility Criteria:
Inclusion Criteria:

1. Age higher than 18;
2. Confirmed diagnosis by osseous biopsy and bone marrow cyto-morphologic counts of blast cells, of Myelodysplastic syndrome without excess of blasts: "refractary anemia", "refractary anemia with rings sideroblasts", "refractary citopenya with multilineage dysplasia", " refractary citopenya with multilineage dysplasia and rings sideroblasts" or "5q-syndrome" without excess of blasts based on WHO classification (appendix).
3. Low or intermediate-1 IPSS (appendix).
4. Hb \< 11g/dl.
5. rEPO serum level \< 500mU/L.
6. Women in menopause from at least one year.
7. Informed consent

Exclusion Criteria:

1. Myelodisplastic syndrome with excess of blasts (RAEB).
2. IPSS score intermediate-2 or high (appendix).
3. Forecasted allogeneic bone marrow transplant within 1 year after diagnosis(patients younger than 60 years, transfusion dependents or with serious leuko/thrombocytopenia and HLA compatible family donor).Considering the time needed to perform this procedure, the indication of a transplant from non-consanguineous donor has no contraindication to the inclusion in this protocol of the response to rEPO therapy ± differentiating therapy.
4. Renal failure with creatininemia value greater than 3 times the normal limit.
5. Chronic hepatophaty with bilirubinemia value greater than 3 times the normal limit and/or AST or ALT or ALP values greater than 5 times the normal limit.
6. Presence of second tumor or other serious pathology with life expectancy lower than one year.
7. Presence of neurologic or psychiatric pathologies that make the patient unreliable in the acquisition of drugs.
8. Allergy/intolerance known to use drugs.
9. Pregnant women.
10. Women of childbearing age or in menopause from less than one year.
11. Age \< 18 years old.
12. HIV positive.