cyrilzakka/clinical-trials huggingface dataset:
Comparison of Everolimus-Eluting Stent vs Sirolimus-Eluting Stent in Patients With DIABETES Mellitus

The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Everolimus- Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.

Diabetic patients often present unfavorable coronary anatomy with small and diffusely diseased vessels (1) and exhibit exaggerated neointimal hyperplasia after bare-metal stent (BMS) implantation as compared with nondiabetics (2). Although drug-eluting stent (DES) implantation significantly reduced the neointimal hyperplasia and angiographic restenosis compared to BMS in diabetic patients (3), presence of diabetes mellitus (DM) have been still associated with an increased risk of restenosis and unfavorable clinical outcomes in the era of DES (4,5). Recently, the relative efficacies of sirolimua-eluting stent (SES) and paclitaxel-eluting stent (PES) in patients with DM have been evaluated in randomized and registry studies (6-10). The present study, ESSENCE-DIABETES Study, compare 8-month angiographic and 1-year clinical outcomes in patients with diabetes mellitus treated with sirolimus-eluting stent (CYPHER) or everolimus-eluting stent (XIENCE V)

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with angina and documented ischemia or patients with documented silent ischemia
* Patients who are eligible for intracoronary stenting
* Age \>18 years, \<75 ages
* De novo lesion
* Percent diameter stenosis ≥50%
* Reference vessel size ≥ 2.5 mm by visual estimation

Exclusion Criteria:

* History of bleeding diathesis or coagulopathy
* Pregnant state
* Known hypersensitivity or contra-indication to contrast agent and heparin
* Limited life-expectancy (less than 1 year)
* Acute ST elevation myocardial infarction on admission
* Characteristics of lesion

  1. Left main disease
  2. In-stent restenosis
  3. Graft vessels
* Hematological disease (Neutropenia \<3000/mm3, Thrombocytopenia \<100,000/mm3)
* Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3 times normal
* Renal dysfunction, creatinine ≥ 2.0mg/dL
* Contraindication to aspirin, clopidogrel or cilostazol
* Left ventricular ejection fraction \<30%
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma

The purpose of this trial is to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine improves outcomes for people with Malignant Melanoma which has been removed, but is at high risk of relapse.

NY-ESO-1 protein is an immune target found in many cancers including melanoma. ISCOMATRIX® adjuvant enhances immune responses. This trial compares NY-ESO-1 ISCOMATRIX® vaccine with ISCOMATRIX® adjuvant alone to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine improves outcomes for participants with Malignant Melanoma which has been removed, but is at high risk of recurrence.

Eligible participants are randomly allocated to a treatment arm. Treatment involves four intramuscular (into a muscle) injections (1 injection every 4 weeks x 3, plus 1 injection at 6 months).

Participants are assessed for recurrence of melanoma, safety and immune responses (by blood test) over the 18 month study period. Off study, their own doctor will follow them for melanoma recurrence and survival.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven malignant melanoma.
* Tumor expression of NY-ESO-1 antigen by immunohistochemistry.
* Fully resected AJCC stage IIc, IIIb, IIIc or IV melanoma.
* Within six months of surgery for melanoma.
* Full recovery from surgery.
* No immunotherapy or systemic adjuvant therapy for melanoma since most recent relapse and/or resection. (Previous adjuvant therapy accepted providing patient relapsed and resected after this.)
* Age 18 years or older.
* Able to give written informed consent.
* Vital laboratory parameters within normal range, or protocol specified ranges.

Exclusion Criteria:

* Other serious or significant illnesses.
* Resected cerebral metastases.
* Ocular melanoma.
* Other malignancy within last 3 years, except for treated non-melanoma skin cancer and cervical cancer in situ.
* Using immunosuppressive drugs.
* Anticoagulation.
* Known HIV positivity.
* Chemotherapy or radiation therapy in last four weeks (6 weeks for nitrosourea drugs).
* Not available for immunological and clinical follow-up assessments.
* Participation in prior clinical trial involving an investigational agent within last 4 weeks.
* Previous isolated limb perfusion (ILP).
* Pregnancy or breastfeeding.
* Refusal or inability to use effective means of contraception for women of childbearing potential.
* Mental impairment that may compromise ability to give informed consent and to comply with study requirements.
High Quality Fluorescent Cholangiography

The goal of this randomized controlled trial is to compare the quality of extrahepatic biliary fluorescent visualization under two injection protocols to optimize extrahepatic biliary cholangiography.

Biliary fluorescence imaging is widely used to identify the extrahepatic biliary tract during laparoscopic cholecystectomy. However, fluorescent developer Indocyanine Green（ICG） still lacks standardization, and not every visualization of the extrahepatic biliary tract is satisfactory. Some research groups have shown that injection of ICG 1 day before surgery can achieve the best fluorescence imaging of the biliary tract, but some research groups have suggested that injection of a very low dose of ICG 45 minutes before surgery can improve the satisfaction of fluorescence imaging. However, no study compares the quality of biliary fluorescence imaging between the two injection protocols. This study will compare the fluorescence imaging effects of the two schemes to obtain the best injection scheme at present and standardize the use of icg.

Eligibility Criteria:
Inclusion Criteria:

1. The patient has indications for cholecystectomy and requires laparoscopic treatment；
2. No biliary obstruction or cholestasis was found during preoperative examination；3.Volunteer to participate in this clinical trial and sign written informed consent.

Exclusion Criteria:

1. Patients who require emergency surgical treatment；
2. Patients with malignant tumors of the biliary tract；
3. Patients with a history of abdominal surgery；
4. Patients who are allergic to indocyanine green or iodine contrast agents；5.Patients participating in one or more other clinical trials simultaneously；

6.Patients who have received medication that affects bile excretion within 2 weeks before surgery； 7.Other situations that have been judged unsuitable for inclusion by researchers.
Use of Zolpidem in Parkinson's Disease

Levodopa treatment is associated with long-term complications. Dopamine deficiency is associated with abnormal activity in certain parts of the brain. Zolpidem may change this abnormal activity and, by doing so, may work in a different way than levodopa to help parkinsonism.

The working hypothesis for this aim is that ZLP is superior to placebo in acutely improving motor symptoms of PD. The investigators will conduct a randomized,controlled, double-blind, cross-over study in 40 patients with PD. Each patient will receive placebo, levodopa and 2 doses of ZLP in a randomized order on 4 different occasions, about one week apart.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will have Idiopathic Parkinson's disease according to diagnostic criteria of the United Kingdom Parkinson's Disease Society Brain Bank.
* Subjects will be capable and willing to provide written informed consent prior to participation.
* Subjects will be ambulatory (in ON- and OFF-states) men and women, between the ages of 30 and 75 years.
* Subjects will be on levodopa therapy, with a good response and indisputable motor fluctuations.
* All other PD medications are allowed.
* Subjects will be on a stable regimen of PD medications for 2 weeks prior to screening.
* Subjects will be required to come with a caregiver who can accompany the subject to/from each study visit. Note: Subjects will not be allowed to drive home.
* Female subjects will be advised to use adequate birth control throughout the study as the effects of ZLP on the fetus are unknown. Adequate birth control methods include surgical sterilization, a partner who has had a vasectomy, oral contraceptives, condom plus spermicidal cream/jelly, cervical cap plus spermicidal cream/jelly, diaphragm plus spermicidal cream/jelly, or intrauterine device (in place for at least 3 months) plus spermicidal cream/jelly. Abstinence is considered an acceptable contraceptive regimen. If a subject becomes pregnant during the study, it is important that they contact the study physician immediately.

Exclusion Criteria:

* Neurodegenerative diseases.
* Tremor predominant PD, with a score of \> 2 in more than one body part.
* Inability to tolerate being off levodopa for 12 hours.
* A score on the Montreal Cognitive Assessment (MoCA) of less than 26.
* Pregnancy or lactation.
* History of drug or alcohol abuse.
* Known or suspected sensitivity to the investigational study drugs.
* Other known medical or psychiatric condition that may compromise participation in the study or that judged by the site investigator could disqualify a subject from entering the study.
* Participation in another investigational drug study whereby they received experimental drug \< 30 days prior to start of this study.
* Subjects who have undergone surgical procedures for PD but otherwise meet inclusion criteria will not be excluded a priori but evaluated on an individual basis.
Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens

The purpose of this study was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.

This was a non-dispensing, randomized, double-masked, crossover study. Participants wore 2 different contact lenses bilaterally over 4 study visits, all conducted on the same day. Estimated duration of involvement for each participant was 4 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Were 17 to 40 years of age and have full legal capacity to volunteer;
2. Had read and signed an information consent letter;
3. Were willing and able to follow instructions and maintain the appointment schedule;
4. Were habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye
5. Were correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction;
6. Had an astigmatism of ≤ 0.75DC in subjective refraction;
7. Could be fit with the study contact lenses with a power between -1.00 and -6.00DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -1.00 and -6.00 (inclusive) at screening visit.
8. Demonstrated an acceptable fit with the study lenses.

Exclusion Criteria:

1. Had taken part in another clinical research study within the last 14 days;
2. Were currently habitual wearers of toric, multifocal or monovision lenses.
3. Had worn any rigid contact lenses in the past 6 months
4. Were an extended lens wearer (i.e., sleeping with their lenses)
5. Had a difference of ≥1.5 D in best vision sphere subjective refraction between eyes;
6. Had amblyopia and/or distance strabismus/binocular vision problem;
7. Had any known active ocular disease, allergies and/or infection;
8. Had a systemic condition that in the opinion of the investigator may affect a study outcome variable;
9. Were using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
10. Had a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
11. Had undergone refractive error surgery or intraocular surgery;
12. Were a member of CORE directly involved in the study.
Relationship Between Circulating Sclerostin and Bone Lesions in Patients With Mastocytosis

Mastocytosis is very rare and highly heterogeneous group of disorders, characterized by the accumulation of clonal mast cells which can infiltrate several organs and tissues.

Bones are the most frequent localization of systemic mastocytosis. The aim of our research was to explain the potential role of sclerostin in the pathogenesis of bone disease in mastocytosis.

Mastocytosis is a heterogeneous group of disorders, characterized by the accumulation of clonal mast cells which can infiltrate several organs, such as the skin, bone marrow or liver. The skeleton is the most frequent localization of systemic mastocytosis (SM). Bone involvement occurs in approximately 70% of SM patients. Pathogenesis of mastocytosis bone disease is poorly understood.

The aim of our research is to explain the potential role of sclerostin, a recently discovered bone tissue protein, in the pathogenesis of bone changes in patients with mastocytosis.

The study group consists of adult patients with mastocytosis divided according to their clinical variants of disease (aggressive systemic mastocytosis - ASM, systemic mastocytosis with an associated hematological neoplasms SM-AHN, smouldering systemic mastocytosis - SSM, indolent systemic mastocytosis - ISM and cutaneous mastocytosis - CM; and group of healthy volunteers.

The concentration of sclerostin, bioactive sclerostin and expression of the SOST gene in human plasma and HMC-1.2 human mast cell culture supernatants is assessed. The Real-Time PCR method is used to evaluate the expression of sclerostin at the mRNA level, while the concentration of the sclerostin protein and its bioactive form is assessed using the enzyme immunoassay ELISA method. The obtained results are correlated with selected demographic, clinical, laboratory and radiological findings. Low-dose CT scan is used to assess bone changes.

These preliminary results could serve that sclerostin may be a new therapeutic target in patients with mastocytosis.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Mastocytosis defined according to WHO criteria
* Known KIT mutation status

Exclusion Criteria:

* History of organ transplant
* Inability to give informed consent
* Pregnancy, Breastfeeding
* Vulnerable Patient, defined as: patient with another uncontrolled severe disease; patient under juridical protection
The Effect of Liquorice on Plasma Potassium

The hypothesis is that liquorice lowers plasma potassium. This study aims to elucidate the dose-response of this effect with two doses of liquorice (66 grams or 102 grams) per day for two weeks.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* age 18-40

Exclusion Criteria:

* any continuous medication
* hypertension or hypotension
* allergy to liquorice
* pregnancy or lactation
* difficult venipuncture
* drug or alcohol abuse
* participation in pharmaceutical trial
Self-control Trial to Evaluate the Remission Rate in Newly Diagnosed Type 2 Diabetes Patients After Treatment With Insulin Aspart

This trial is conducted in Asia. The aim of this trial is evaluate the remission rate in newly diagnosed subjects with type 2 diabetes after short-term intensive treatment with insulin aspart and insulin NPH.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes newly diagnosed within 6-12 months
* FBG: 11.1-17.0 mmol/L
* Body mass index (BMI) larger than 25.0 kg/m2

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Recurrent major hypoglycaemia as judged by the Investigator
Treating Stress Urinary Incontinence: Laparoscopic Obturator Urethropexy vs Burch Urethropexy

Stress urinary incontinence (SUI) is a highly prevalent concern within the female population. Although mid urethral slings (MUS) have been the first line treatment for SUI for almost twenty years, due to recent FDA warnings and many countries banning the use of vaginal mesh, a significant portion of patients now request non-mesh anti-incontinence procedures. In such cases, Burch colposuspension would be the next option discussed with patients.

In the short term, the efficacy of Burch colposuspension is comparable to MUS. However, the noteworthy disadvantages of Burch colposuspension include a high rate of urinary retention. This increased risk of urinary retention is due to the acute angle of the stitches, and is a problem that Burch colposuspension shares with the retropubic sling, a type of acutely-angled MUS. A variant of the retropubic sling, the transobturator tape (TOT), has shown that a rounder angle of elevation significantly reduces the risk of urinary retention. As such, this study proposes a novel technique of laparoscopic obturator urethropexy (LOU) as an alternative to the traditional Burch colposuspension.

In this new proposed technique, stitches are placed into the obturator internus fascia rather than Cooper's ligament, reducing the angle of elevation of the bladder neck, aiming to lower the risk of post-operative urinary retention. The aim of our randomized control trial is to assess the effectiveness of LOU compared to Burch colposuspension in terms of urinary continence. Our secondary aim is to report on perioperative and postoperative complications, functional outcomes including urinary retention, recurrent urinary tract infection, recurrent/persistent urgency, de novo urgency, recurrent SUI, and sexual function, as well as overall quality of life.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age and be able to read and write English
* Women with symptomatic SUI, stress predominant mixed urinary incontinence symptoms confirmed on urodynamic study (UDS), or occult SUI (i.e. demonstrable urinary leakage on preoperative urodynamics with prolapse reduction in a patient without overt urinary incontinence symptoms), including women undergoing concomitant pelvic organ prolapse (POP) surgery or MUS sling removal

Exclusion Criteria:

* Known or suspected disease that affects bladder function (e.g. multiple sclerosis, Parkinson disease), including a known diagnosis of voiding dysfunction
* Pregnancy
* Desired fertility
* Urethral diverticulum
* History of radical pelvic surgery or pelvic radiation therapy
* Current chemotherapy or radiation therapy for malignancy
Can Transcutaneous Electrical Acupoint Stimulation Improve the Quality of Recovery After Thyroidectomy?

The effect of transcutaneous electric acupoint stimulation (TEAS) on the quality of recovery in patients undergoing thyroidectomy surgery remains unclear. Therefore, the investigators conducted this prospective, randomized, double-blind study to verify the hypothesis that pre-operative TEAS could improve the quality of recovery (QoR) after thyroidectomy surgery.

Transcutaneous electric acupoint stimulation (TEAS) is a form of non-invasive electrical stimulation that produces a perceptible sensation via electrodes attached to the skin. It has no risk of infections and can potentially be applied by medical personnel with minimal training. Clinical trials have demonstrated that TEAS reduces the consumption of intra-operative anesthetics and general anesthesia related side-effects.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive female patients aged 18 to 60 with American Society of Anesthesiologists physical status (ASA) physical status I or II, who underwent general anesthesia for elective thyroidectomy surgery

Exclusion Criteria:

* potentially difficult airway,
* a history of chronic pain,
* drug or alcohol abuse,
* mental disorder,
* intake of any analgesic drug within 48 h before surgery, and
* previous experience with acupuncture treatment
Risk Factors of Cat Scratch Colon Developing.

This study was designed to: estimate the incidence of cat scratch colon in the investigators environment; explore the diseases associated to its development; identify the factors related to its development; and assess its clinical repercussions.

All of the ambulatory colonoscopies performed at the investigators University Hospital from September 2007 were prospectively included in the study. Data recorded for each patient included: age, sex, disease background, reason for the examination, hematological data and the endoscopic diagnosis.

Every patient presenting CSC lesions had colon biopsies taken. These were studied by a single anatomic pathologist specializing in gastrointestinal pathologies.

The characteristics (age, sex, disease background, indication for surgery, age at the time of surgery, time elapsed since surgery, hematological data and pathoanatomical study of the colon biopsies) of diversion colitis patients with and without CSC lesions will bi compared.

Eligibility Criteria:
Inclusion Criteria:

* All of the ambulatory colonoscopies performed at our University Hospita

Exclusion Criteria:

* Patients thats refused.