cyrilzakka/clinical-trials huggingface dataset:
Effect of Statin Preloading in STEMI in Improving PCI Outcomes

To compare the effect of a single high dose of atorvastatin versus rosuvastatin preloading on microvascular coronary perfusion as determined by CTFC in patients with ST-segment elevation myocardial infarction (STEMI) undergoing PCI.

Acute myocardial infarction (MI) indicates irreversible myocardial injury resulting in necrosis of a significant portion of myocardium which is caused mostly by coronary plaque rupture or erosion. It could result in several clinical complications and impact cardiac prognosis .

Worldwide, ischemic heart disease is the single most common cause of death and its frequency is increasing, now Accounts for almost 1.8 million annual deaths.

Cholesterol reduction with HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase inhibitors or statins has been shown to improve mortality and cardiovascular morbidity in patients with established coronary artery disease (CAD).

Previous evidence suggests that statins have various favorable effects on vascular system that are not directly related to their impact on lipid metabolism. Beyond lowering lipids, statins have favorable effects on platelet adhesion, thrombosis, endothelial function, plaque stability, and inflammation. . As with ACS, the vascular injury from coronary angioplasty and stent placement induces platelet activation, thrombosis, and inflammation within the vessel wall and the distal microvasculature. Therefore, in addition to a long-term benefit associated with lipid lowering, statin therapy might play a beneficial role early after PCI.

Conventional TIMI flow grading (Thrombolysis In Myocardial Infarction) is a predictor of cardiac outcome after acute myocardial infarction and PCI, but it has several limitations.

The CTFC (corrected TIMI frame count) another approach to grade flow impairment, is an objective, quantitative, reproducible, and sensitive index for coronary blood flow\[9\].

TIMI flow may appear normal visually, but may correlate to abnormal CTFC. The CTFC has been proposed to have incremental prognostic accuracy in predicting survival outcome with reperfusion therapy . Higher CTFC values after PCI have also been found to be associated with poor clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* The Presence of symptoms (\<12h).
* ST-segment elevation of at least 0.1Mv in two contiguous leads of electrocardiogram or new onset left bundle branch block.
* Patients age 18 to 80 years.

Exclusion Criteria:

* Previous (within 3 months) or current treatment with statins.
* Known allergy to heparin, aspirin, clopidogrel, or abciximab.
* Active severe bleeding.
* Pregnancy.
* History of major surgery or trauma.
* Significant gastrointestinal or genitourinary bleeding (\<6 weeks).
* History of cerebrovascular attack (within 2 years) or cerebrovascular attack with a significant residual neurological deficit.
* Cardiogenic shock with mechanical ventilation.
Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction.

EUS-guided drainages has been largely widespread during the last 10 years, even thanks to the advent of dedicated devices, such as lumen apposing metal stents (LAMSs).

Above all, EUS-guided choledochoduodenostomy (EUS-CD) is to date considered a valuable option of treatment in case of distal malignant biliary obstruction in case of failure of endoscopic retrograde cholangiopancreatography (ERCP) due to the presence of a gastric or duodenal obstruction, unreachable papilla in case of altered anatomy, infiltrated papilla or failure of deep cannulation of the common bile duct. This modality of drainage demonstrated satisfying results, with high rate both of technical and clinical success with acceptable rate of adverse events.

When the distal malignant biliary obstruction is associated to signs and symptoms of gastric outflow obstruction (GOO) due to the presence of a gastric or duodenal stenosis, a concomitant or subsequent palliation of the stenosis may be required.

Recently, EUS-guided gastroenterostomy (EUS-GEA) has been introduced for the palliation of GOO, showing good results although technically challenging.

To date, endoscopic treatment in case of GOO, enteral stenting and EUS-GEA are possible alternatives. However, available data demonstrated that EUS-GEA seems to be superior to enteral stenting in terms of rate of reinterventions during long-term follow-up, especially when life expectancy is superior to 6 months.

However, data are lacking regarding which is the best strategy when GOO is associated to distal malignant biliary obstruction, especially when EUS-CD is performed. This is an hot topic, as it has been supposed that EUS-CD has higher rate of adverse events, especially food impaction, when a duodenal stenosis is present.

The aim of our study, therefore, is to perform a retrospective multicenter study collecting all consecutive patients affect by distal malignant biliary obstruction drained using EUS-CD, with associated GOO treated with concomitant or subsequent duodenal stenting or EUS-GEA, in order to evaluate clinical efficacy, long term outcomes and severity of adverse events.


Eligibility Criteria:
Inclusion Criteria:

- patients undergoing affected by distal malignant biliari obstruction and gastric outflow obstruction undergone EUS-CD and EUS-GEA or enteral stenting drainage between January 2016 to September 2021

Exclusion Criteria:

* Age under 18
* Enteral stenting or EUS-GEA performed before EUS-CD
* Provide an estimate of number of records you plan to review and time period that it will be covered.January 2016 to September 2021
* If the number of records you plan to exceeds 500, please provide the following:

N/A

- Provide an estimate of how long it will take you to complete the study, including the time for data analysis.

3 month for data collection and 3 weeks for data analysis
Does Rehabilitation After Total Hip and Knee Arthroplasty Work

Background: Total hip- and knee arthroplasty (THA and TKA) is recommended for relieving pain and restoring function for end-stage osteoarthritis, when non-surgical treatment has failed to relieve symptoms. Following THA and TKA post-discharge physical rehabilitation is common practice, but vary significantly regarding content, duration, intensity and mode of delivery. Recent systematic reviews have found home-based rehabilitation to be as good as outpatient rehabilitation in terms of pain and physical function. Additionally, no long-term benefits seem to persist compared to minimal or no intervention following THA or TKA; questioning the true effectiveness of postoperative rehabilitation. However, a true "no intervention" (e.g. no prescribed exercises) has never been investigated following total THA or TKA. The purpose of this present trial is to compare the effectiveness of telerehabilitation, unsupervised rehabilitation and no rehabilitation to enhance recovery following THA and TKA.

Methods: This pragmatic, randomised controlled trial will include 168 patients following discharge after THA or TKA. Patients will be randomized into one of the three 6-week interventions: telerehabilitation, unsupervised rehabilitation or no intervention. The trial is designed as a superiority trial to test the hypothesis that rehabilitation (telerehabilitation and unsupervised rehabilitation) is superior to no rehabilitation. The primary outcome will be the difference between intervention groups in terms of the mean score of the Hip disability and Osteoarthritis Outcome Score (HOOS)/ the Knee injury and Osteoarthritis Outcome Score (KOOS)-subscale: function of daily living at first follow-up (end of the 6-week intervention). Additional follow-up are scheduled at 3 and 12 months. Outcome assessors and data analysts are blinded to group allocation.

Discussion: As the number of THA and TKA procedures are expected to increase, the need to find effective postoperative rehabilitation strategies are warranted. Knowledge on the effectiveness of the three investigated rehabilitation strategies will help guide the future direction of post-discharge rehabilitation following THA and TKA.


Eligibility Criteria:
Inclusion Criteria:

* Patients having had primary, unilateral THA or TKA due to osteoarthritis.
* Patients being referred to receive postoperative rehabilitation at our institution.
* Patients being able to speak, read and understand Danish language.
* Patients aged ≥ 18 years.

Exclusion Criteria:

* Patients not able to comply with exercise instructions.
* Patients who are discharged to a nursing-home facility or receiving in-home rehabilitation by home care.
Electrical Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation

Comparison of (i) catheter ablation, (ii) electrical cardioversion and (iii) pacemaker implantation with AV node ablation for patients over 65 years of age with persistent Atrial Fibrillation.

the National Institute for Health and Care Excellence (NICE) suggest the following treatments options can be considered for patients with recurrent persistent atrial fibrillation:

1. Direct current cardioversion (DCCV) with concomitant anti-arrhythmic treatment.
2. Permanent pacemaker implantation (PPM) and atrio-ventricular (AV) node ablation.
3. Left atrial catheter ablation.

These treatment options have not been directly compared and each has their own advantages and disadvantages.

1. DC cardioversion is highly successful at restoring sinus rhythm and is a relatively cheap intervention. There is however a high recurrence rate of AF and cardioversion may need to be repeated multiple times.
2. Permanent pacemaker implantation and AV node ablation, 'ablate and pace' therapy provides rapid relief of symptoms and improved quality of life. Patients remain in atrial fibrillation but have a regular heart rhythm and controlled rate and avoid potential side-effects of medications. Following AV node ablation patients are dependent on the pacemaker and as such this treatment option is usually reserved for those over 65 years or age. Costs are modest and both the pacemaker insertion and AV node ablation procedures take less than 1 hour to perform.
3. Catheter ablation for atrial fibrillation aims to restore and sustain sinus rhythm. Procedural success rates are 50-60% after a single procedure and 80-85% after repeat procedures and it can take several months for all procedures in an ablation strategy to be performed. Procedural costs are high due to the equipment used and time taken for each ablation, usually 1.5-4 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic persistent atrial fibrillation of less than 1-year duration.
* Patients must be over 65 years old.
* Patients give informed consent prior to participating in this study.

Exclusion Criteria:

* Paroxysmal atrial fibrillation.
* Long-standing persistent or permanent atrial fibrillation.
* Previous pacemaker implantation.
* Previous atrial ablation.
* Patient is unable to take warfarin or other oral anti-coagulant medication.
* Patient is suffering with unstable angina in last one week.
* Patient has had a myocardial infarction within last two months.
* Patient is expecting or has had major cardiac surgery within last two months.
* Patient is participating in a conflicting study.
* Patient is unable to perform exercise testing.
* Patient is mentally incapacitated and cannot consent or comply with follow-up.
* Patient has New York Heart Association (NYHA) class III/IV heart failure.
* Patient has left ventricular ejection fraction (LVEF) less than 35% not secondary to tachycardia.
* Pregnancy.
* Patient suffers with other cardiac rhythm disorders.
* Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings).
Resident Supervision Index: Assessing Feasibility and Validity

OBJECTIVES: To develop, assess feasibility, and test the validity of the Resident Supervision Index (RSI), a survey tool for medical residents designed to measure quantitatively the level of supervision the resident received while caring for an outpatient during a patient care encounter.

RESEARCH DESIGN: This is a prospective trial assessing the Residency Supervision Index (Index) applied to outpatient care encounters for content validity, test-retest reliability, and construct validity.

OBJECTIVES: To develop, assess feasibility, and test the validity of the Resident Supervision Index (RSI), a survey tool for medical residents designed to measure quantitatively the level of supervision the resident received while caring for an outpatient during a patient care encounter.

RESEARCH DESIGN: This is a prospective trial assessing the Residency Supervision Index (Index) applied to outpatient care encounters for test-retest reliability and construct validity.

METHODOLOGY: Trained interviewers administered the Index during face-to-face and in-clinic interviews with 60 consenting resident physicians and their 37 consenting attending physicians to descsribe the care they provided to 143 patients at the outpatient clinics involving 148 clinical encounters at the Loma Linda VA Medical Center.

For each encounter, data comes from administering the Resident Supervision Index to the resident and attending. Baseline data describing each subject (attending physicians and resident physicians) came from face-to-face interviews.

Test-retest reliability is assessed by re-administering the Index to residents for within 24 hours of the encounter. Concurrent validity is assessed by re-administering the Index to the attending physician responsible for the patient's care.

CLINICAL RELATIONSHIPS: The study will help our understanding of how residents at VA medical centers receive training and are supervised for the purpose of both education and patient outcomes.

IMPACT/SIGNIFICANCE: The instrument is planned for future studies to assess the association between resident supervision and training outcomes, clinical workload, patient outcomes, quality of care, and care costs.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Ages 18 and older

Exclusion Criteria:

* None
Study of Oral Ixazomib in Adult Participants With Relapsed or Refractory Light Chain Amyloidosis

This study will include participants with previously treated systemic relapsed or refractory light-chain (AL) amyloidosis who require further therapy and will be aimed at determining the safety profile and the maximum tolerated dose/recommended phase 2 dose of MLN9078 (Ixazomib) administered orally.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants 18 years or older
* Biopsy-proven systemic relapsed or refractory light-chain (AL) amyloidosis, which after at least 1 prior therapy, in the investigator's opinion, requires further treatment
* If received stem cell transplant, must be at least 3 months posttransplantation and recovered from side effects
* Must have measurable disease defined as serum differential free light chain concentration ≥ 40 mg/L
* Must have objective measurable organ (heart or kidney) amyloid involvement
* Must have cardiac biomarker risk stage I or II disease
* Must have adequate hematologic, hepatic, and renal function
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Female participants who are postmenopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse
* Male participants who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
* Voluntary written consent

Exclusion Criteria

* Peripheral neuropathy that is greater or equal to Grade 2
* Cardiac status as described in protocol
* Severe diarrhea (≥ Grade 3) not controllable with medication or requires administration of total parenteral nutrition
* Known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption of tolerance of MLN9708
* Uncontrolled infection requiring systematic antibiotics
* Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
* Presence of other active malignancy with the exception of nonmelanoma skin cancer, cervical cancer, treated early-stage prostate cancer provided that prostate-specific antigen is within normal limit, or any completely resected carcinoma in situ
* Female participants who are lactating or pregnant
* Major surgery within 14 days before the first dose of study drug
* Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
A Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)

The aim of the study is to assess the efficacy and tolerability of the low-volume supplement. The investigators randomized critically ill patients to receive Intestamin plus Fresubin or Fresubin alone.

To compare early supplementation with antioxidants and glutamine using an enteral pharmaconutrition supplement (Intestamin®) to an energy adjusted standard elementary diet and to investigate its affect on clinical efficacy and tolerability in critically ill patients with sepsis/SIRS.

Methods: This was a prospective controlled randomized study in 58 critically ill patients. They received either Intestamin or a diluted Fresubin solution. After 10 or 14 days inflammatory parameters, catecholamine need, and maximal enteral delivery were determined.

Eligibility Criteria:
Inclusion Criteria:

* sepsis or SIRS (APACHE score 10-30),
* no severe gastrointestinal tract or metabolic diseases,
* enteral feeding within 48 h of admission,
* age 18-75 years,
* written consent by patient or next of kin. -

Exclusion Criteria:

* participation in a drug trial within the last 4 weeks before inclusion in this study,
* previous participation in this study,
* expected patient survival of less than 6 days,
* pregnancy or lactation,
* patients with unstable vital signs that would probably cause incidents that would make participation impossible or would lead to discontinuation,
* severe liver disease with cytolysis (ASAT \>10 N) or impaired detoxification (ammonia \>50 mmol/L, bilirubin \> 50 μmol/L),
* gastrointestinal surgery in the last 4 weeks,
* severe enteritis/colitis,
* short intestine syndrome,
* gastrointestinal bleeding that requires intervention,
* patients who could not be enterally fed
Effect of Physical ACtivity in Fingolimod Treated patiEnts (PACE) With Relapsing-remitting Multiple Sclerosis

This study evaluated the effect of an individualized web-based physical training in fingolimod -treated patients.

In this study, it was planned to randomize 226 participants. However, only 178 participants were randomized during a timeframe of 2 years and 8 months. Therefore, the study was terminated due to slow enrollment and low participant compliance to the physical training schedule.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria
* Patients with Expanded Disability Status Scale (EDSS) score of 0-3.5 (including)
* Immunomodulatory treatment with prescribed fingolimod for at least one month prior to baseline
* Fatigue score assessed by mFIS of equal or greater than 14 at screening
* Neurologically stable with no evidence of relapse within 30 days prior to inclusion date

Exclusion Criteria:

* Patients who have been treated with:

  * systemic corticosteroids or immunoglobulins within 1 month prior to randomization;
  * immunosuppressive medications such as azathioprine, cyclophosphamide, or methotrexate within 3 months prior to randomization;
  * monoclonal antibodies (including natalizumab) within 3 months prior to randomization;
  * mitoxantrone within 6 months prior to randomization
  * cladribine at any time.
* Patients with any medically unstable condition, as assessed by the primary treating physician at each site.
* Patients with any of the following cardiovascular conditions :

  * history of cardiac arrest;
  * history of myocardial infarction or with current unstable ischemic heart disease;
  * history of angina pectoris due to coronary spasm or history of Raynaud syndrome
  * Heart failure (NYHA III-IV) or any severe cardiac disease as determined by the investigator;
  * history or presence of a second-degree AV block, Type II or a third-degree AV
  * block
  * patients receiving Class Ia (ajmaline, disopyramide, procainamide, quinidine) or
  * III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide,
  * dofelitide);
  * proven history of sick sinus syndrome or sino-atrial heart block;
  * uncontrolled hypertension
* Clinically relevant internal disease (e.g. uncorrected anemia) or orthopedic diseases (e.g. scoliosis) that might interfere with physical training
* Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator's discretion

Other protocol-defined inclusion/exclusion criteria may apply.
Brain Network Connectivity of Patients With Metabolic Diseases

The global prevalence of metabolic diseases, including hypertension, type 2 T2DM mellitus (T2DM), gout and obesity, has risen over the past two decades. Brain controls human behavior and metabolism in organisms. It will be very interesting to explore whether there are similarities or relations among different metabolic diseases and how brain might be involved in the progression of different metabolic diseases.

We analyzed the PET-CT images and clinical biological markers of 112 cases of hypertension, 56 cases of T2DM, 11 cases of obesity, 14 cases of gout, and 497 cases without the above diseases. Standardized uptake value ratios (SUVRs) were extracted from different brain regions according to AAL brain atlas using Spatial-Normalization-of-Brain-PET-Images. Partial correlation analysis was used to analyze the correlation of the SUVRs of different brain regions with clinical biological markers by controlling sex, age and BMI. Brain network metabolic connectivity was analyzed using Permutation_IHEP software and visualized using BrainNet Viewer.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent brain PET-CT in Sun Yat-sen Memorial Hospital from January 2018 to June 2024

Exclusion Criteria:

* Brain lesions, including patients with brain atrophy, cerebral ischemia and trauma, epilepsy, brain tumors, brain trauma, and psychiatric disorders; Patients with missing medical history or brain imaging data; Patients with tumor.
A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.

To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma


Eligibility Criteria:
Inclusion Criteria:

* Cytokine refractory metastatic renal cell carcinoma with clear cell component
* Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
* Prior nephrectomy

Exclusion Criteria:

* Prior treatment with any systemic therapy other than 1 cytokine therapy
* History of or known brain metastases
* Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start