cyrilzakka/clinical-trials huggingface dataset:
Slow and Accelerated Rehabilitation Protocols

Latissimus dorsi transfer is an established treatment option with favorable results in massive, irreparable rotator cuff tears, however, it is controversial if earlier motion is detrimental or beneficial to the postoperative goal of reduced pain and improved clinical outcomes. Therefore, the aim of this study is to compare the effects of slow and accelerated rehabilitation protocols after latissimus dorsi transfer in massive, irreparable rotator cuff tears.

A variety of surgical options are proposed in the treatment of massive cuff tears. The treatment options include acromioplasty and tuberoplasty, partial repair with or without soft tissue augmentation, latissimus dorsi transfer (LDT), superior capsular reconstruction (SCR), and reverse total shoulder arthroplasty. Among these options, LDT is a well-recognized technique that aims to rebalance the soft tissue tension around the shoulder joint in order to prevent superior escape of the humeral head and loss of function. From a biomechanical standpoint, the transferred tendon is theorized to function as a humeral head depressor by means of a tenodesis effect, as well as by increasing the active external rotation through the transfer vector. It is an established treatment option with favorable results, however, it is controversial if earlier motion is detrimental or beneficial to the postoperative goal of reduced pain and improved clinical outcomes. Therefore, the aim of this study is to compare the effects of slow and accelerated rehabilitation protocols after latissimus dorsi transfer in massive, irreparable rotator cuff tears.

Eligibility Criteria:
Inclusion Criteria:

* being in the age range of 18-65 years
* being diagnosed with massive, irreparable rotator cuff tears based on magnetic resonance imaging and clinical continuity tests
* symptoms are unresponsive to conservative care including steroid injections and physiotherapy for at least 6 months
* having a good command of the Turkish language
* scoring above 24 in the Mini Mental State Test
* ≥80% compliance in completing the post-ARCR Phase 1 trainings
* volunteering to participate in the study

Exclusion Criteria:

* diabetes mellitus
* neurological problems
* cervical disc herniation
* visual, verbal, and/or cognitive defects (aphasia, unilateral neglect, etc.)
* systemic inflammatory problems
* hypermobility, trauma, and/or inflammation that could be a contraindication for mobilization
* former shoulder fractures on the affected side
* advanced glenohumeral arthritis (Hamada grade 3),
* deltoid muscle dysfunction,
* irreparable subscapularis tears,
* active infection,
* shoulder stiffness,
* a history of previous shoulder surgery
Blueberry Effects on Dark Vision and Glare Recovery

Clinical evidence for effects of plant anthocyanins on vision, and particularly night vision is controversial. Two clinical trials were conducted to investigate whether blueberry juice consumption affected visual dark adaptation, functional night vision, and recovery after photo-bleaching of the retina. One trial (S2) employed a 3 week intervention and washout period, and two doses of blueberries plus a placebo. The other trial (L1) employed a 12 week intervention plus an 8 week washout and tested one blueberry juice dose against a juice placebo.

Vision Tests: 1. Dark adaptometry, 2. scotopic visual acuity, 3. scotopic contrast sensitivity, 4. rod/cone conversion, 5. recovery after retinal photobleaching

Eligibility Criteria:
Inclusion Criteria:

* visual acuity better than 6/7.5 on EDTRS acuity chart at 2.5m
* visual contrast sensitivity within normal range at 2.5m as tested on Visteck 3000
* stereo acuity better than 80 seconds of arc on Frisby stereoacuity test
* no ocular history other than refractive glasses
* no family history of eye disease

Exclusion Criteria:

* family history of retinal degeneration, glaucoma, diabetes, hypertension, cataract, or amblyopia (dimness in vision).
* evidence in subject (upon examination) of amblyopia (dimness in vision), manifest strabismus (unable to focus both eyes on one spot), or anisotropia (non-uniform responsiveness between both eyes).
* intraocular pressure above 21mmHG from an average of three measures using Mentor tonopen-XL
Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure

To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive heart failure (CHF) NYHA Class III or greater, who are referred for a coronary catheterization procedure with or without PCI.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 65 years of age with cardiovascular disease who are referred for a coronary catheterization procedure with or without PCI.
* The subject has at least one of the following comorbidities:
* 1) Chronic renal insufficiency, (eGFR \<60 but 15 mL/min/1.73 m2 according to the MDRD equation) as measured within 2 weeks or at the screening visit;
* 2) DM diagnosed greater than 6 months prior to study entry and which requires either insulin or anti-hyperglycemic drug therapy;
* 3) CHF (NYHA) class III or greater measured within 2 weeks of enrollment or at the screening visit.

Exclusion Criteria:

* The subject has known allergies to either iodine or any ICM.
* The subject has severe renal insufficiency (eGFR \<15 mL/min/1.73 m2 according to the MDRD equation) or is on dialysis.
* The subject has acute coronary syndrome requiring emergency coronary angiography and/or intervention.
* The subject is not willing or unable to discontinue metformin (e.g., Glucophage) at the time of the study procedure.
Combination of AB-LIFE Probiotic Plus Monacolin K to Reduce Blood Cholesterol

This randomized study evaluates the effectiveness of a nutraceutical combining billion colony forming units (cfu) of three L. plantarum strains (CECT7527, CECT7528 and CECT7529) and 10 mg of monacolin K in reducing blood cholesterol.

Cardiovascular diseases (CVDs) are the number 1 cause of death globally, and retention of low-density lipoprotein cholesterol (LDL-C) and similar cholesterol-rich lipoproteins containing apolipoprotein B (ApoB) within the arterial wall is a key initiating event in CVDs. Statins are the mainstay of pharmacological cholesterol-reduction therapy. However, a significant proportion of patients report some degree of statin intolerance, which typically fade away when the statin is switched, discontinued or the dosage reduced. A growing attention has been devoted to the correction of increased LDL-C levels through the use of dietary supplements, either because some patients have milder forms of hypercholesterolemia or as an alternative to statins in patients who may have experienced or are worried of side effects. Nutraceutical combinations are increasingly used in clinical practice. In this pilot randomized study, we sought to evaluate of the effect on LDL-C and other blood lipid parameters of a nutraceutical combining Red Yeast Rice extract (also known by its scientific name Monascus purpureus) containing 10 mg of monacolin K, plus 1 billion colony forming units (cfu) of the AB-LIFE probiotic formula. The later is composed of three L. plantarum strains, namely CECT7527 (also known as KABP011™), CECT7528 (also known as KABP012™) and CECT7529 (also known as KABP013™).

Eligibility Criteria:
Inclusion Criteria:

* Total cholesterol (TC) ≥200 mg/dL and statin-naïve or having recently stopped statin treatment because of statin intolerance.

Exclusion Criteria:

* History of cardiovascular events or alcohol abuse, presence of diabetes, chronic advanced kidney disease, thyroid disorders, hepatic disorders, familial hypercholesterolemia or immunosuppression
* Body mass index (BMI) ≤ 18.5 or ≥40 Kg/m2
* Use of antibiotics within 4 weeks of study initiation, current use of other probiotics, lipid-lowering medications, corticoids, beta-blockers or calcium channel blockers, thiazide diuretics, estrogen replacement therapy
* Pregnant or lactating women
* Patients with other severe disease that could interfere with the results of the study.
* Patients not agreeing to maintain their usual physical activity throughout the study.
Multidisciplinary Program "Optimization of Drug Prescription" : Impact on the Quality of Drug Prescription in Hospitalized Elderly Patients

Drug prescription is a fundamental component of care for the elderly. Even if drugs are a chance for the older patient, because of changes in pharmacological, pharmacokinetic and pharmacodynamic parameters related with age and acute/or chronic pathologies, the risks associated with drug prescription, particularly those associated with potentially inappropriate medication (PIM), are increased in the elderly.

We suppose that many of hospitalized elderly have at least one prescribed medication without valid indication. Conversely, many diseases are currently undertreated in elderly patients: e.g. medicines used to treat heart failure and osteoporosis are underused in 20 to 70% of patients. Moreover, PMI prescription is associated with an increased of morbidity, mortality, risk of drug-related adverse events, utilization of health care system, care costs and impairment of quality of life. Thus, optimization of drug prescription is a major concern for improvement of the quality and safety of care in elderly.

The investigators' hypothesis is that a multidisciplinary program entitled "Optimisation de la Prescription MEDicamenteuse" ("Optimization of drug prescribing") focused on drug prescription optimization including a physician training to the specificity of the drug prescription in the elderly and a checklist allowing an adapted and standardized pharmaceutical analysis is effective in reducing PIM in elderly patients hospitalized in short-term medical and geriatric care departments.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject aged over 75 years hospitalized in one of the participating department
* Patient agreed to participate

Exclusion Criteria:

* Patient with a predictive length of stay equal or less than 48 hours
* Patients admitted in terminal illness
Sunitinib Drug Levels and Outcomes in Kidney Cancer

Sunitinib is an oral drug used for treatment of advanced kidney cancer. The standard dose is 50mg, but many patients require a dose decrease due to side-effects. Drug levels of sunitinib vary approximately 10-fold between patients.

This study will measure blood levels of sunitinib and its metabolite, and correlate these with side-effects and the response to the treatment. The study aims to establish whether blood levels change with time, and see how useful blood levels are for monitoring patients treated with sunitinib.

Rationale: Sunitinib is an oral multi-targeted tyrosine kinase inhibitor used for first-line systemic therapy in metastatic renal cell carcinoma. It is metabolised to a pharmacologically active metabolite, SU012662, which is of equal potency to the parent compound. At a standard 50mg daily dose, variability in plasma levels between patients is approximately ten-fold. In clinical trials, over 30% of patients require a dose reduction due to toxicity. However, some patients can tolerate up to 100mg without excessive toxicity. It is unknown if sunitinib clearance changes with time. Pre-clinical experiments observed tyrosine kinase inhibition at a plasma concentration of 50-100ng/ml.

Design: This is a prospective non-randomized, Phase II clinical study. Decision to treat patients with single-agent sunitinib is pre-determined by treating specialists before entering this study. Toxicity and trough sunitinib/metabolite levels will be measured every six weeks during treatment.

Aim: This study will prospectively examine the relationship between steady-state trough levels of sunitinib/metabolites and the time on treatment, in addition to changes in trough levels over time. Trough levels will also be correlated with other measures of efficacy and treatment-related toxicity. Furthermore, we aim to confirm that the putative target of 50ng/ml correlates with toxicity and time on sunitinib.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic renal cell cancer treated with single agent sunitinib
* No known primary liver disease and no other severe or uncontrolled concurrent medical conditions
* Signed informed consent

Exclusion Criteria:

* Patients who are unable to sign informed consent
* Patients unable to give blood
* Patients who are pregnant, nursing or not using an effective contraception method
* Patients who had bone-marrow-transplantation prior to sunitinib treatment
A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.

The purpose of this study is to assess the pharmacokinetics and safety of a single subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with varying degrees of renal function, including subjects requiring hemodialysis.

This adaptive design, non-randomized, open-label, staggered parallel group study evaluates the pharmacokinetics and safety of a single subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with varying degrees of renal function. During Stage 1, a single dose of albiglutide will be administered to subjects with normal renal function and subjects with moderate-to-severe renal impairment not requiring hemodialysis. In addition to subjects with normal renal function and moderate renal impairment, Stage 2 of the study will also include cohorts of subjects requiring hemodialysis, subjects with severe renal impairment not requiring hemodialysis, and potentially subjects with mild renal impairment.

Eligibility Criteria:
Inclusion Criteria:

* normal renal function or renal impairment
* stable hemodialysis treatment for at least 3 months before screening and able to tolerate a hemodialysis treatment lasting 3-4 hours with blood flow rates of \>200mL/min (cohort 3 only)
* neither pregnant nor lactating
* HbA1c 6-10.5% inclusive
* females of childbearing potential must be practicing adequate contraception.

Exclusion Criteria:

* inability to meet the PK objectives of the study
* history of hypoglycemia unawareness or severe hypoglycemia
* liver function tests greater than or equal to 2 times the ULN
* clinically significant cardiovascular and/or cerebrovascular disease
* positive test results for hepatitis B, hepatitis C, or HIV
* documented hypertension or hypotension at screening
* known hepatic or biliary abnormalities
* current use of sulfonylureas
* active history of tobacco use within 6 months before screening
* donation of blood in excess of 500mL within 56 days before albiglutide dosing
* receipt of any investigational drug within the 30days or 5 half lives, whichever is longer, before dosing
* previous or current receipt of exenatide or any other GLP-1 agonist
Immunosuppressants to Postoperative Infection and Death

The goal of this observational study is to explore the different immunosuppressive agents and related outcomes in organ transplantation patients in Taiwan. The main question it aims to answer is the risk of different immunosuppressive agents for infection and survival after transplant.

The study enrolled patients who underwent solid organ transplant (SOT), kidney (ICD-9-CM code V42.0), liver (ICD-9-CM code V42.7), or lung (ICD-9-CM code V42.6) transplants. We employed propensity score matching (PSM) to establish a matched cohort. The study will compare SOT patients and general patients to explore the risk of different immunosuppressive agents for infection and survival.

This study used secondary data from the Longitudinal Health Insurance Database (LHID), a subset of the NHIRD provided by the Health and Welfare Data Science Center (HWDC) of the Ministry of Health and Welfare in Taiwan.

The HWDC encrypts personally identifying data to protect the privacy of beneficiaries. The database includes detailed clinical records from both the inpatient and outpatient claims of the beneficiaries of Taiwan's National Health Insurance program. This program has provided coverage for up to 99% of the country's population since 1995. The NHIRD can serve as a foundation for the procurement of real-world evidence to support clinical decisions and health-care policy-making.

Diagnostic data within the NHIRD from before 2016 and from 2016 or later are respectively coded using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes.

The database was provided by the HWDC under license and so cannot be made freely available. Requests for access to these data should be made to HWDC (https://dep.mohw.gov.tw/dos/cp-5119-59201-113.html).

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent solid organ transplant (SOT)

Exclusion Criteria:

* Patients who received more than one SOT, had an infectious disease diagnosis before their SOT or had incomplete medical information in the database.
Medication Therapy Management With Pharmacogenetic Testing

This study aims to investigate the benefit and feasibility of providing pharmacogenetic (PGx) testing as part of a standard medication therapy management (MTM) session for patients taking multiple medications, a high-risk population for adverse drug reactions and non-response. Research participants will attend two MTM sessions and undergo PGx testing to inform the MTM plan. Participants will also complete 2 surveys pre and post-MTM/PGx testing. Data analysis will assess the impact of MTM/PGx testing on recommendations for drug dosing, clinical outcomes, patient satisfaction, and feasibility of service delivery. Safety issues are minimal with the primary risks being associated with loss of confidentiality, typical discomfort associated with acquiring blood samples, and genetic discrimination.


Eligibility Criteria:
Inclusion Criteria:

* currently prescribed 3 medications, one of which must be simvastatin or clopidogrel
* 18 years of age or older
* English speaking
* patients of Mahesh Patel or William Kraus at Duke Southpoint Clinic

Exclusion Criteria:

* if patient has ever had MTM or PGx
Aspirin Versus Aspirin+Clopidogrel as Antithrombotic Treatment Following TAVI

The purpose of this study is to compare aspirin/acetylsalicylic acid+ clopidogrel with aspirin/acetylsalicylic acid alone as antithrombotic treatment following TAVI for the prevention of major ischemic events (MI, ischemic stroke) or death without increasing the risk of major bleeding events.

Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to standard aortic valve replacement for the treatment of patients considered to be at very high or prohibitive surgical risk. Nowadays the procedure is associated with a very high success rate (\>95%) but major peri-procedural ischemic complications such as myocardial infarction (MI) or ischemic stroke occur in about 2% (0% to 17%) and 3% (2% to 7%) of the cases, respectively. The recently published PARTNER trial showed a stroke rate as high as 6.5% within the 30 days following TAVI, with most (77%) of these events diagnosed as major strokes. In order to avoid such ischemic complications full dose anticoagulation (usually intravenous heparin) is administered during the TAVI procedure, whereas aspirin (long-term) + clopidogrel (1 to 6 months) have been the recommended antithrombotic treatment following the procedure. However, this antithrombotic regime has been recommended on an empirical basis, and no studies have as yet shown the efficacy of aspirin + clopidogrel vs. aspirin alone or no antithrombotic treatment in preventing ischemic events following TAVI procedures. Also, patients undergoing TAVI nowadays are usually octogenarians and very frequently exhibit comorbidities such as hypertension, abnormal renal function or prior cerebrovascular disease, which significantly increase the risk of major bleeding. Indeed, TAVI procedures can also be associated with major vascular complications which in turn can complicate with life-threatening or major bleeding. It is well know that clopidogrel on top of aspirin is associated with a higher rate of major bleeding complications, especially in elderly patients. It would therefore be of major clinical relevance to determine the risk/benefit ratio of using a dual antithrombotic therapy following TAVI procedures in order to recommend the most appropriate antithrombotic treatment in this high-risk population. The ARTE trial is a multicenter randomized study to evaluate the efficacy and safety of aspirin/acetylsalicylic acid versus aspirin/acetylsalicylic acid+ clopidogrel as antithrombotic treatment after TAVI.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a TAVI procedure with the Edwards valve.

Exclusion Criteria:

* Need for chronic anticoagulation treatment
* Major bleeding within the 3 months prior to the TAVI procedure
* Prior intracranial bleeding
* Drug-eluting stent implantation within the year prior to the TAVI procedure
* Allergy to clopidogrel and/or aspirin/acetylsalicylic acid
Superior Silybin Bioavailability in Healthy Volunteers

Twenty-four healthy volunteers of both genders, aged 18 to 44 years old and body mass indexes between 18 to 27 kg/m2,were selected to participate in a two-way, balanced, prospective, blind, single-dose crossover study with a one-week wash-out period. It was assessed that volunteers were free from significant cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and hematological diseases. The volunteers clinical evaluation were determined by clinical examination, ECG, and the following laboratory tests: blood glucose, urea, creatinine, AST, ALT, GGT, alkaline phosphatase, total bilirubin and fractions, uric acid, total cholesterol, triglycerides, albumin and total protein, and routine urinalysis. All subjects were negative for HIV, HBV, and HCV.

In healthy volunteers single-dose crossover study with a one week, It was assessed that volunteers were free from significant cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and hematological diseases. The volunteers clinical evaluation were determined by clinical examination

Eligibility Criteria:
Inclusion Criteria:

* volunteers were free from significant cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and hematological diseases.

The volunteers clinical evaluation were determined by clinical examination, ECG, and the following laboratory tests: blood glucose, urea, creatinine, AST, ALT, GGT, alkaline phosphatase, total bilirubin and fractions, uric acid, total cholesterol, triglycerides, albumin and total protein, and routine urinalysis

Exclusion Criteria:

* Subject with HIV, HBV, HCV
* Subject with comorbidities
* Subject less 18 years old Subject higher 50 years old