cyrilzakka/clinical-trials huggingface dataset:
The Effect of Remote Ischemic Preconditioning on Elective Percutaneous Coronary Intervention in Diabetic Nephropathy

Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. When remote ischemic preconditioning is applied before percutaneous coronary intervention (PCI), the kidneys can be protected against ischemia-reperfusion injury and subsequently CI-AKI. In this randomised controlled trial, diabetic nephropathy patients undergoing PCI as part of their assessment and treatment of cardiovascular disease are randomized to receive RIPC or control sham preconditioning.

Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. Diabetes with pre-existing renal disease can increase the risk of CI-AKI. Remote ischemic preconditioning (RIPC) is a non-pharmacological strategy inducing transient episodes of ischemia by the occlusion of blood flow in non-target tissue such as a limb, before a subsequent prolonged ischemia-reperfusion injury occurs in a more distant organ. These brief, repeated ischemic episodes in the limb can confer a protection at more remote sites such as the heart, brain, lung, kidney, intestine or skeletal muscle. In a recent pilot study, using RIPC prior to coronary angiography in high risk patients with moderate chronic kidney disease, the authors found that RIPC significantly reduced the incidence of CI-AKI (Er et al Circulation. 2012;126(3),296). We hypothesized that RIPC would be protective as an adjunctive therapy in reducing the incidence of CI-AKI in diabetics with pre-existing CKD. This prospective study was performed to evaluate the efficacy of RIPC for the prevention of CI-AKI among diabetic nephropathy patients undergoing percutaneous coronary intervention.

Eligibility Criteria:
Inclusion Criteria:

* Informed written consent
* All of the following:
* Known diagnosis of Type 2 diabetes
* NSTEMI, unstable or stable angina
* Patients undergoing elective coronary angiography and/or percutaneous coronary intervention
* eGFR \< 60 mls/min or ACR \> 300 mg/dl

Exclusion Criteria:

* STEMI
* decompensated heart failure in the preceding 6 months
* patients with underlying end stage renal disease on maintenance dialysis
* recent (in the last 3 months) cerebrovascular disease
* chronic liver disease
* chronic obstructive pulmonary disease
* gastrointestinal bleeding
* acute or chronic infection or malignancy
Chemoradiotherapy With Gemcitabine/S-1 vs Gemcitabine/S-1 for Locally Advanced Pancreatic Cancer

The purpose of this study is to evaluate the clinical effectiveness of Gemcitabine/S-1 combination chemoradiotherapy with Gemcitabine /S-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.

When cancer develops outside of the pancreas from within the anatomical placement of the pancreas itself, it becomes difficult to excise in most cases. Generally, most pancreatic cancers are already unresectable at the time of diagnosis when we have recognized infiltration of over 1/2 the circumference of major arteries such as the celiac artery and super mesenteric artery in particular.

In comparison with advanced pancreatic cancer with distant metastases, it is not easy to treat unresectable locally advanced pancreatic cancer, even when performing standard gemcitabine monotherapy. In the case of unresectable locally advanced pancreatic cancers without distant metastases, we are left with the choice of whether or not to perform radiation therapy. This decision remains unsolved worldwide, despite the continuing efforts of researchers to bring an end to the clinical doubt.

We will report our results as well as the problems of combining treatments with chemoradiotherapy, using the novel anticancer agent gemcitabine as well as/or S-1, not 5FU, predominantly from our own clinical trials on this occasion.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer.
2. Patients who confirmed unresectable locally advanced pancreatic cancer with the criteria below.

   * Involving over 1/2 circumference of major artery (SMA/CA). (Under 1/2 that was borderline lesion.)
   * Involving over the merging section of portal-SMV.
   * No distal metastasis with diagnostic imaging.
   * Confirmed by CT image performed with in four weeks before registration.
3. Performance Status:0-1(ECOG)
4. Patients of age =\>20 and 80\>
5. sufficient organ functions

   * neutrophils\>=1,500/mm3
   * platelets\>=100,000/mm3
   * hemoglobin\>=9.0g/dl
   * AST(GOT)/ALT(GPT) \<=150IU
   * total bilirubin \<=2.0mg/dl, (or \<=3.0mg/dl if biliary drainage were present)
   * serum creatinine \<= 1.2mg/dl
   * creatinine clearance\>=60ml/min
6. Life expectancy more than 3 months.
7. Written informed consent.

Exclusion Criteria:

1. Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings.
2. Watery diarrhea
3. Severe infection
4. Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc)
5. Massive pleural or abdominal effusion.
6. Metastasis to central nervous system.
7. Active synchronous or metachronous malignancy other than carcinoma in situ.
8. Regular use of flucytosine, fenitoin or warfarin
9. Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
10. Severe mental illness
11. Patients who are judged inappropriate for the entry into the study by the investigator.
Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease

This study will evaluate the safety and Efficacy of donepezil in treatment of AD patients in China.

This study is a multi-center, single-arm, open labeling clinical trial, which the objective is to evaluate the safety and Efficacy of donepezil in Alzheimer's disease( AD) patients in China, and investigate the relationship between Apo-E gene type with adverse events of donepezil.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between 50 and 85 years of age.
2. Patients newly diagnosed as probable AD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria and National Institute of Neurologic and Communicative Disorders and Stroke-AD and Related Disorders Association (NINCDS-ADRDA) criteria; Mild to moderate AD with Mini-Mental State Examination (MMSE) 10-24, modified Hachinski ischaemic scale (MHIS)≤4, Activity of daily life scale (ADL)≥23, and Hamilton Depression Scale (HAMD) \<7.
3. MRI image supports the diagnosis of AD (medial temporal lobe atrophy, Fazekas scale of white matter lesions≤2 within 6 months prior to the screening).
4. 5mg daily of Donepezil for at least four weeks before the screening.
5. Patient with exclusive caregiver.
6. Patient should be ambulatory or ambulatory aided by a walker or cane.
7. With good eyesight and hearing, can cooperate with the examination and treatment.

Exclusion Criteria:

1. Patients with vascular dementia, other types of dementia or with other psychiatric or neurological disorders (e.g. delirium, depression, Parkinson's disease, etc.).
2. Patients with type I diabetes, obstructive lung disease or asthma, vitamin B12 or folic acid deficiency, thyroid dysfunction, severe liver or kidney dysfunction, severe cardiac insufficiency (congestive heart failure, myocardial infarction, sick sinus syndrome, II-III degree atrioventricular block or heart rate\<50 beats/minute \[bpm\]).
3. Epilepsy or head trauma resulting in unconsciousness that occurred in the two years prior to the screening.
4. Patients with hematologic diseases (such as anemia, granulocytes, leukemia, etc.), tumor, neoplasms within 2 years prior to the screening.
5. Patients with a history of alcohol dependence and drug abuse.
6. Patients with known hypersensitivity to medicines or foods;
7. Patients taking anticholinergic agents or antihistaminic agents;
8. Patients who had been hospitalized continuously for more than 3 months before the screening.
Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms

The purpose of this study is to analyse the effect of a probiotic supplement on functional intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).

The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on functional intestinal symptoms among subjects diagnosed with IBS according to Rome III criteria. Subjective assessment of bowel symptoms, quality of life, anxiety and depression and adequate relief will be assessed as with questionnaires as outcome measures. The intestinal microbiota will be analysed from faecal samples.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 to 65 fulfilling Rome III criteria for IBS will be recruited. Sufficient general health and orientation for participating in the study is required and will be evaluated by the MDs.

Exclusion Criteria:

* Diagnosed or suspected organic gastrointestinal diseases or severely impaired general health.
Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis

Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety, tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus extension) in patients with moderate to severe psoriasis.

Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis

Eligibility Criteria:
Inclusion Criteria:

* patients with a history of chronic, moderate to severe plaque psoriasis (PASI ≥12; BSA (body surface area) ≥10 and IGA mod 2011 (Investigator's Global Assessment) ≥3) for at least 6 months
* patient candidates for systemic therapy.
* informed consent.

Exclusion Criteria:

* previous treatment with agent targeting IL-17 (interleukine-17) or IL-17 receptor.
* recent treatment with topical treatment (2 weeks), systemic agents (4 weeks for methotrexate, Ciclosporine A; systemic retinoids and other systemic treatment), TNF (tumor necrosis factor) inhibitors (3 months) or IL-12/23 inhibitors (6 months).
Markers of Inflammation and Metabolism in the ER

Adult patients with suspected or confirmed infection and who will be sampled for blood culture will be recruited. Blood samples are collected for the analysis of matrix metalloproteinases (MMP) and their inhibitors. We also aim to analyse metabolic changes and use the samples for analysis of blood lactate, metabolomics, and fibroblast growth factor 21 (FGF-21) as well. The primary aim of the study is to test the performance of MMP-8 in finding severely ill patients who will need treatment in high dependency unit or intensive care. The secondary aim is to study the metabolic changes in acutely ill patients with infection.

Adult patients with suspected or confirmed infection and who will be sampled for blood culture (a surrogate for suspected severe infection) will be recruited from three large emergency departments in a University hospital. Two blood samples will be collected: one for the analysis of matrix metalloproteinases, their inhibitor tissue inhibitor of metalloproteinase-1 (TIMP-1), FGF-21 and metabolomic analyses. Another blood sample is for the analysis of blood lactate. Clinical data will be collected to calculate quick SOFA (qSOFA), in order to test whether lactate and/or MMP-8 will improve the prognostic model if they are added to qSOFA. The primary outcome measure is the number of days alive without the need for ICU or high dependency unit treatment. The ability of MMP-8 to discriminate severe infection from uneventful course of the disease will be studied. The secondary aim is to study the metabolic changes in acutely ill patients with infection and compare these variables between survivors and non-survivors. The planned number of patients recruited is 924. During this study the feasibility of a bedside rapid analysis of MMP-8 will be tested in 30 patients and the results obtained using the rapid analyser compared with laboratory results obtained using ELISA.

Eligibility Criteria:
Inclusion Criteria:

Age 18 or more Suspected or confirmed infection Admitted to any of the three emergency departments of university hospital Decision of blood culture

Exclusion Criteria:

Age \<18 Cancer with metastases Decision of treatment limitation probable or made Consent not obtainable
Systematic Review of Antiretroviral Treatments for Chronic Hepatitis B (CHB)

The purpose of this study is to support the clinical value of entecavir by assessing the relationship between viral load and histological improvement.

Systematic review of prospective clinical trials

Eligibility Criteria:
Inclusion Criteria:

* Patients with CHB diagnosis and no co-infection with Hep A, Hep C, Hep D, or HIV
* Age 16 years or older
* No post-transplant patients
* RCT, non-randomized trials, prospective cohort studies, prospectively analyses case series published since 2003
* At least one arm of trial must include monotherapy with entecavir, lamivudine, tenofovir, adefovir, or telbivudine
* Study arms must include at least 10 patients
* Follow-up of at least 48 weeks
* Published results available in English language

Exclusion Criteria:

* N/A
Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis

A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe atopic dermatitis


Eligibility Criteria:
Inclusion Criteria:

1. Males or females, aged ≥ 18 years (≥ 20 for Japanese subjects) at the time of consent.
2. Have a diagnosis of atopic dermatitis for ≥ 12 months.
3. Have moderate to severe atopic dermatitis which is considered inappropriate for topical therapy or which cannot be adequately controlled by topical therapy.
4. Meet the laboratory criteria as defined per protocol
5. Females of Childbearing Potential (FCBP) must have a negative pregnancy test at Screening and Baseline. Sexually active FCBP must use one of the approved contraceptive options required per protocol while on and for at least 28 days after the last dose of study medication
6. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception while on and for at least 28 days after the last dose of study medication.

Exclusion Criteria:

1. Active tuberculosis (TB) or a history of inadequately treated tuberculosis.
2. Positive for hepatitis B surface antigen or hepatitis C antibody
3. Pregnant or breast feeding
4. History of allergy to any component of the study medication.
5. Active skin infection requiring systemic antimicrobials at Baseline.
Outcome Study of Complex Distal Radius Fractures

The purpose of this study is to collect information about how people do after different treatments of a broken wrist to see if one treatment has better results.

Complex distal radius fractures are a common problem treated by orthopaedic surgeons. The purpose of this study is to compare the outcome between complex distal radius fractures treated with open reduction and internal fixation using a volar fixed angled plate versus and external fixator versus DRV. The hypothesis is that the volar fixed angled plate will have a superior outcome both radiographically and clinically.

Eligibility Criteria:
Inclusion Criteria:

* distal radius fracture

Exclusion Criteria:

* none
Augmented Reality Feasibility for Non-invasive Preoperative Tracking in Breast Cancer Surgery

Breast cancer is diagnosed by imaging at a non-palpable stage in more than half of all cases. Surgical removal requires preoperative guidance. Generally, preoperative guidance is performed using a metal guide under local anaesthetic and radiological control. This type of guidance has several limitations. For the patient, it can be painful and traumatic. The procedure involves two departments: radiology and the operating theatre, which poses logistical constraints. What's more, between 10% and 40% of patients require repeat surgery for unhealthy margins, raising the question of the effectiveness of the tracking procedure. The investigators propose to develop a non-invasive intraoperative guidance system: Augmented Reality, which will provide a 3D vision with virtual transparency of the breast during surgery, thanks to real-time fusion of preoperative imaging with video from a camera located in the operating room. The process is illustrated below.

Illustration of the general principle of the augmented reality system for locating non-palpable breast lesions. The images above represent a preliminary test carried out on the computer outside the operating room. This is an initial research prototype which has not yet been validated and is not suitable for routine use.


Eligibility Criteria:
Inclusion Criteria:

* Major women
* Requiring conservative surgical management of a subclinical cancerous breast lesion (not palpable), the histology of which has been previously proven by anatomopathology;
* Having a breast MRI indication at the time of the breast assessment performed at the Centre Jean Perrin
* Ability to give informed consent to participate in the study,
* Membership of a social security scheme

Exclusion Criteria:

* Patients with breast neoplasia during pregnancy;
* Persons deprived of their liberty or under guardianship or incapable of giving consent;
* Refusal to participate.
Effect of Clemastine Fumarate on Color Vision in Healthy Controls

In a1972 study in the French Annals of Pharmaceuticals, Laroche and Laroche reported that the drug clemastine has a negative effect on patients' color discrimination, which is the ability to distinguish different hues and arrange them in the correct order. In an upcoming clinical trial studying the effect of clemastine on vision outcomes, our lab aims to assess color visual performance adding assessment of color defectiveness as a clinical endpoint. Color defectiveness is the ability to see certain colors, and is commonly referred to as color-blindness. Color discrimination and defectiveness can be related, but do not always correlate. This study aims to detect the effect, if any, that clemastine has on color defectiveness in healthy controls, which could confound its use as an outcome endpoint in future clinical trials relating to clemastine.

Additional evaluation of pharmacokinetic data will be performed to confirm pharmacokinetic measures and correlate blood levels of drug to color performance if seen.

Eligibility Criteria:
Inclusion Criteria:

* Healthy control

Exclusion Criteria:

* Preexisting ophthalmologic conditions such as optic neuritis, macular star, glaucoma
Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure

The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender and height).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, ages 6-17, with a documented history of hypertension
* Must be able to swallow a pill
* Must be ≥ 18 kg or ≤160 kg
* MSSBP (mean of 3 measurements) must be ≥ 95th percentile, for age, gender and height, at Visit 2 (randomization), by office blood pressure measurement
* Patients who are eligible and able to participate in the study and whose parent(s)/guardian(s) consent in writing (written informed consent) to their doing so after the purpose and nature of the investigation has been clearly explained to them. (An assent will be required for some patients depending upon their age and local requirements regarding assents)

Exclusion Criteria:

* Renal artery stenosis
* Current diagnosis of heart failure (NYHA Class II-IV).
* MSSBP ≥ 25% above the 95th percentile
* Second or third degree heart block without a pacemaker.
* Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
* Clinically significant valvular heart disease.
* Patient that demonstrates clinically significant ECG abnormalities other than those associated with left ventricular hypertrophy.
* Previous solid organ transplantation except renal, liver or heart transplantation. Renal, liver or heart transplant must have occurred at least 6 months prior to enrollment. Patient must be on stable doses of immunosuppressive therapy for 3 months and deemed clinically stable by the investigator.

Other protocol-defined inclusion/exclusion criteria may apply
A Study of LY2157299 Monohydrate in Healthy Volunteers

This study involves a single dose of 150 milligram (mg) of radiolabeled LY2157299 monohydrate in healthy participants. The study will determine how the body eliminates the radioactivity and LY2157299 monohydrate. Participants must be healthy surgically sterile or postmenopausal females, or sterile males. This study is approximately 8 to 15 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy surgically sterile females, postmenopausal females, or sterile males
* Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\^2)
* Have venous access sufficient to allow for blood sampling

Exclusion Criteria:

* Have known allergies to LY2157299, related compounds or any components of the formulation
* Have an abnormal blood pressure as determined by the investigator
* Have participated in a \[\^14C\]-study within the last 6 months prior to admission for this study
Predictive Factors for Hypotensive Bradycardic Events During Arthroscopic Shoulder Surgery

Patients's demographics and perioperative factors affect the occurrence of hypotensive bradycardic events in the patients undergoing arthroscopic shoulder surgery in the sitting position under interscalene block.

Patients' age, Side of the block,Horner's syndrome, the degree of blockade, preoperative fasting time and fluid administration volume, waiting time for sitting position after the block, intraoperative use of opioids and antihypertensives, and change of heart rate variability before the block and after sitting position affect the occurrence of hypotensive bradycardic events in the patients undergoing arthroscopic shoulder surgery in the sitting position under interscalene block.

Eligibility Criteria:
Inclusion Criteria:

* Age between 15 and 80 years
* American Society of Anesthesiologists physical status I-II
* Body mass index \< 35 kg/m2

Exclusion Criteria:

* Coagulation deficiencies
* Known allergies to local anesthetics
* Neurologic deficit on the side to be operated
* Inflammation at the puncture site for interscalene brachial plexus block
* Coronary artery disease
* Cardiac conduction disorders and arrhythmias
* Congestive heart disease
* Diabetes mellitus
* Serum electrolyte abnormalities
* Autonomic dysfunction
* Psychiatric disorders
* Patients refusal
* Communications difficulties
* Failure of interscalene brachial plexus block