cyrilzakka/clinical-trials huggingface dataset:
Epicardial Adipose Tissue and Arterial Stiffness in People Living With Diabetes (METAB-CV-PWV)

The present study is a retrospective and prospective current care cohort that will allow us to evaluate the relationship between epicardial fat volume and increased arterial stiffness in a person living with diabetes.

Epicardial adipose tissue is considered as the cardiac visceral fat and is associated with increased cardiovascular risk, for example in diabetes. Thus, the mechanisms involved seem to be related to myocardial lipotoxicity; atherosclerosis in connection with inflammation and secretion of proinflammatory factors such as cytokines but also insulin resistance.

In this context, the investigators hypothesize that epicardiac adipose tissue volume will be higher in patients with increased arterial stiffness than in those without. In this study, the investigators will then try to verify the existence of a relationship between pericardial adipose tissue volume and increased arterial stiffness in people living with diabetes.

To do this, the investigators will analyze the results of measurements of pericardial fat volume, coronary calcium score, and pulse wave velocity in diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible for participation in the study if:

* They are informed and have not objected to participating in the research.
* They have type 1 or 2 diabetes.
* They perform a coronary calcium score measurement by CT scan and a pulse wave velocity assessment during their routine care practice.
Recurrence of Odontogenic Keratocyst

The aim of current cross over clinical trial is to evaluate the effect of topical 5-FU as adjunct therapy in reducing risk of the recurrence of OKCs

The main inclusion criteria in this study will be 48 patients with biopsy proved odontogenic keratocyst with no relevant systemic diseases which might affect healing process. patients will be treated with 5-FU cream (Efudex; Valeant Inc, Laval, Quebec, Canada) after enucleation and peripheral ostectomy of the odontogenic keratocyst.

* A detailed preoperative assessment for all patients will be carried out including history taking, clinical and radiographical examination.
* All surgical procedures will be carried out under general anesthesia with nasal endotracheal intubation.
* Through an intraoral incision, the full thickness mucoperiosteal flap will be raised. The entire cyst lining radically enucleated in conjunction with any overlying mucosa, followed by extensive cavity thorough curettage with meticulous evaluation of any residual daughter cyst lining with reduction of the lingual and buccal undercut bony walls to remove residual macroscopic cystic epithelium.
* After enucleation and peripheral ostectomy of the OKC lesion, a sterile radiopaque quarter-inch ribbon gauze is coated with 5-FU cream and packed into the surgical wound. The wound is closed in the usual manner using 3/0 vicryl leaving a small distal end (approximately1 cm) of gauze exposed to allow for gauze removal at 24 hours postoperatively.

All patients will be regularly followed up for 12 months postoperatively clinically and radiographically

Eligibility Criteria:
Inclusion Criteria:

* patients with biopsy proved odontogenic keratocyst

Exclusion Criteria:

* relevant systemic diseases which might affect healing process.
The Prevalence of Metabolic Syndrome and Its Associated Factors in an Urban City

The secondary objective is to evaluate the agreement between these criteria and the prevalence of concordant and discordant according to different criteria.

Up to now, there has been to uniform case definition for the metabolic syndrome. The World Health Organization and the Third Report of the National Cholesterol Education Program's Adult Treatment Panel (ATP III), and Bureau of Health Promotion, Taiwan proposed different criteria for the metabolic syndrome. Therefore, the secondary objective is to evaluate the agreement between these criteria and the prevalence of concordant and discordant according to different criteria. Three thousand persons will be randomly selected from resident of Taichung City. All the participants will fulfill a structured questionnaire. Blood pressure, anthropometric variables are measured. Biochemical markers are analyzed by a biochemical autoanalyzer. Kappa will be used to estimate the agreement between different criteria.

Eligibility Criteria:
Inclusion Criteria:

Residents aged 40 and over of Taichung City, Taiwan in October, 2004.

Exclusion Criteria:

-
Restoration of Microbiota in Neonates

The aim of the study is to examine the effect of exposure of cesarean section (CS) delivered neonates to a natural condition of birth, i.e. to the microbiota of the birth canal, on the acquisition of microbial genes during development of the microbiome at multiple body sites, immune system maturation and allergy risk in childhood

The primary outcome is to examine if exposure to the maternal vaginal and fecal microbiota directly after birth will halfen the cumulative incidence of Immunoglubulin E (IgE)-associated allergic disease at 2 years of age in CS delivered infants, compared with non-treated CS-delivered infants.

The secondary outcomes are to compare the community structure of microbes from mothers and their infants and immunological programming of infants delivered via scheduled CS, with or without exposure to the maternal vaginal and fecal microbiota, from birth until two years of age. The primary and secondary outcomes will also be compared with a reference group of vaginally delivered infants. Sex differences in the incidence and prevalence of allergic diseases have been described. The anticipated benefit of the intervention can be implemented in clinical practice regardless of sex, so that improved conditions for good health are created.

Eligibility Criteria:
Inclusion Criteria:

* Infants of healthy mothers with uncomplicated pregnancies at term, mothers of any ethnic or social background that can speak, read, and understand Swedish to the extent that they can consent in Swedish. An additional inclusion criterion for mothers in the CS groups is vaginal pH ≤ 4 at the time of birth.

Exclusion Criteria:

* Infants of mothers with pre-eclampsia or complicated pregnancies, mothers \<18 years or \>40 years of age, genital herpes simplex, genital warts, HIV, Hepatitis B or complications during delivery, infants delivered prior to 37 weeks of gestation. Additional exclusion criteria for mothers in the CS group: Mothers positive to Group B Streptococcus, Group A Streptococcus, bacterial vaginosis, vaginal pH \> 4 at the time of birth. Mothers with fecal samples positive for Salmonella, Shigella, Campylobacter or Yersinia.
Reduced Dissemination of Tumor Cells With Primary Ligation of the Inferior Mesenteric Vein in Rectal Cancer Patients.

Effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumor cells and survival in laparoscopic rectal cancer surgery: a prospective, multicenter, randomized controlled study (ARVECTS)

Several studies have demonstrated that the presence of circulating tumor cells (CTCs) in the peripheral blood can be a surrogate biomarker to predict recurrence and prognosis of rectal cancer. CTCs are released from the primary tumor into the bloodstream and have the potential to spread to distant sites and develop into micro-metastatic deposits. Numerous studies have demonstrated that surgical manipulation could promote the dissemination of tumor cells into the circulation. Theoretically, the potential risk of tumor cell dissemination can theoretically be minimized if the effluent vein was ligated first. However, there is no regulation in the current guidelines on the sequence of ligation of the inferior mesenteric artery and vein during rectal cancer surgery owing to a lack of sufficient evidence. This multi-center randomized controlled trial is to investigate effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumor cells and survival in laparoscopic rectal cancer surgery

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-75 years;
2. Histopathologically confirmed as rectal adenocarcinoma(tumor located within 15 cm from the anal verge at colonoscopy);
3. Patients with a stage I-III rectal cancer eligible for surgery and R0 resection is expected, patients with pelvic lateral lymph nodes metastasis are ineligible;
4. ECOG score: 0-1;
5. ASA score: I/II/III;
6. Laparoscopic surgery;
7. Informed consent.

Exclusion Criteria:

1. Patients who have received preoperative treatment (such as preoperative radiotherapy and chemotherapy);
2. Receiving transanal total mesorectal excision (taTME), specimen extraction through natural lumen (NOSES) ;
3. Recurrent rectal cancer;
4. Simultaneous or metachronous colorectal cancer;
5. Malignant tumors of other organs in the past 5 years or at the same time;
6. The results of preoperative physical examination and imaging examination showed that: (1) the tumor involved the surrounding organs and required combined organ resection; (2) distant metastasis; (3) could not be resected at R0;
7. Pregnant or lactating women;
8. Patients with severe mental disorder;
9. It is not suitable for patients undergoing laparoscopic surgery (such as extensive adhesion caused by previous abdominal surgery or inability to tolerate artificial pneumoperitoneum);
10. History of unstable angina pectoris or myocardial infarction in the past 6 months;
11. Have a history of cerebrovascular accident in the past 6 months;
12. Systemic administration of corticosteroids within 1 month before enrollment;
13. Taking folic acid related drugs within half a year before operation.
14. Severe cardiac insufficiency (FEV1\<50% of predicted values);
15. Emergency surgery.
Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections

RATIONALE: White blood cells that have been treated in the laboratory may kill cells that are infected with cytomegalovirus.

PURPOSE: This phase I trial is studying how well cytotoxic T cells work in treating patients who have undergone donor stem cell transplant and have cytomegalovirus infections.

OBJECTIVES:

Primary

* To provide access to cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T lymphocytes (CTL) in patients with persistent CMV infections after allogeneic stem cell transplantation.

Secondary

* To characterize CMV pp65- and IE-1-specific immune responses in terms of cytotoxicity and cytokine production pre-infusion and then periodically thereafter.
* To characterize the levels of CMV DNA in recipients of CMV pp65- and IE-1-specific CTL and observe whether the CTL infusion has any impact on level of virus.
* To determine the feasibility of CMV CTL culture from CMV-seronegative donors who have received a CMV vaccine.

OUTLINE: This is a multicenter study.

Patients receive allogeneic cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T-cell lymphocytes infusion over 5 minutes on day 1. Patients may receive up to 2 more doses at least 2 weeks after previous dose.

Blood samples are collected and analyzed by quantitative CMV PCR, chromium-release assays for CMV pp65- and IE-1-specific cytotoxicity, and immunophenotype for CD3, CD4, CD8, CD56, CD19, and CD45RA/RO. Intracellular cytofluorometry is used to assess IL-2, IL-4, IL-10, and IFN-γ production by CD4 and CD8 CMV-specific effector cells.

After completion of study therapy, patients are followed periodically for up to 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Recipient of an allogeneic stem cell transplantation
* Cytomegalovirus (CMV)-seropositive and meeting 1 of the following criteria:

  * Patient has a history of CMV antigenemia for ≥ 2 weeks
  * CMV DNA levels ≥ 600 copies/mcg of DNA despite antiviral therapy targeting CMV (e.g., ganciclovir or foscarnet)
* No ongoing graft-vs-host disease
* Has donor available for peripheral blood mononuclear cell collection (for cytotoxic T lymphocytes production), meeting either of the following criteria:

  * CMV-seropositive donor (≥ 2 years of age)
  * CMV-seronegative related donor (≥ 18 years of age) who consents to receive the CMV vaccine

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-3 OR Lansky PS 50-100% (for patients \< 16 years of age)
* Bilirubin \< 2.0 mg/dL
* AST and ALT \< 2.5 times normal
* Creatinine clearance ≥ 30 mL/min
* Pulse oximetry ≥ 94% on no more than 40% oxygen by face mask
* Not moribund
* No patients expected to survive ≤ 1 month after the T-cell infusion due to cardiac, pulmonary, renal, hepatic, or neurologic dysfunction

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Must be on ≤ 1 mg/kg/day of prednisone or its equivalent at the time of study CTL infusion
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion

The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient cohort.

The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient cohort. The historical patient cohort has not been previously published and therefore, no reference to this group can be provided.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age or older at the time of surgery
* Require spinal fusion using posterior Transforaminal Lumbar Interbody Fusion (TLIF), Posterolateral Fusion (PLF) or Posterior Lumber Interbody Fusion (PLIF) in 1 to 3 levels between L3-S1
* Follow-up radiographic imaging post surgery

Exclusion Criteria:

* Long term users of medications known to inhibit fusion,bone metabolism or epidural steroid injections
* Immunosuppressive agents, Disease Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs, Growth Factors or Insulin
* Treated with radiotherapy since their surgery
* Medical conditions known to impact bone metabolism, such as Paget's disease, osteoporosis
* Pregnant or lactating women or women wishing to become pregnant
* Prisoner
* Participating in an investigational drug or another device study
Developing, Implementing and Evaluating Effective Community-facility Interactions to Improve Blood Availability and Transfusion in Three Distinct County Settings in Kenya

The strategy of the CoBAnK study is to establish and enable the function of Community-Facility Transfusion Committees (CFTCs) incorporating diverse representation involving hospital, community, and county leadership, to improve blood availability and transfusion at the point-of-care.

The strategy of the CoBAnK study is to establish and enable the function of Community-Facility Transfusion Committees (CFTCs) incorporating diverse representation involving hospital, community, and county leadership, to improve blood availability and transfusion at the point-of-care. The CFTC strategy will be evaluated across nine transfusing facilities across three counties in Kenya (two intervention and one control site in each county). While the intervention will be tested in "beta" facilities (i.e., facilities without a co-located blood bank) in each county, blood availability will also be measured in "alpha" facilities (i.e., facilities with co-located blood banks) in the three counties, which supply blood to the beta facilities.

Eligibility Criteria:
Eligibility criteria for study sites (beta hospitals):

* Transfusing hospital at level 3 or higher
* Has conducted at least 20 blood transfusions in the preceding year
* Does not have a KTTA-approved blood bank (regional or satellite) in the facility premises
* Receives blood from a blood bank at an Alpha Facility in the same county
A New Technique to Produce Anatomical Alignment Results With Less Midflexion Instability in Total Knee Arthroplasty

Beside the current standard of classical mechanical alignment of total knee replacements, increased interest is being shown in anatomical alignment. However, no surgical technique is capable of controlling the stability of the joint in midflexion. The purpose of the present study was to present and evaluate a new surgical technique, which aims to reduce the need for soft-tissue release and optimize stability in midflexion.


Eligibility Criteria:
Inclusion Criteria:

* The patients were to undergo surface replacement due to primary osteoarthritis of the knee

Exclusion Criteria:

* Joints that had undergone open surgery beforehand (e.g. high tibial osteotomy, fracture treatment) were excluded.
High Dose Therapy Followed by Autologous Transplantation for Myeloma Patients With Severe Renal Impairment

Multiple myeloma (MM) is a malignant plasma cell disorder, characterized by the presence of more than 10 % of clonal plasma cells in the bone marrow. Therapeutic intervention is recommended when at least one of the myeloma defining events occurs (CRAB features). Renal impairment (RI) is one of the most common complications of MM, accounting for 20-30 % of MM patients at diagnosis and 40-50% of patients during the course of their disease. To date, there is no defined consensus for the management of myeloma patients with renal failure. It is then of clinical importance to better considering available therapeutic options to improve responses and survival of these patients.

RI is associated with poor prognosis and short median survival (32 months vs 55 months for MM patients with normal renal function). Thus, RI remains a major challenge for hematologists, including decisions on optimal anti-myeloma therapy, potential dialysis, supportive care and quality of life. The combination of a proteasome inhibitor and an immunomodulator is the preferred induction treatment for newly diagnosed transplant-eligible MM patients. After induction, high-dose therapy with Autologous Stem Cell Transplant (ASCT) is the standard of care for these patients. However, concerns related to management of comorbidities and treatment side effects question about therapeutic options for patients with severe renal damage. Of interest, recent studies argued that high-dose therapy followed by ASCT could be a feasible and safe method for renal failure MM patients. Yet, these observations on small sample size patients groups need to be confirmed with standardized conditions. This study proposes to evaluate the efficacy and the safety of this therapeutic strategy in MM patients with severe renal impairment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 66 years-old
* Patients with symptomatic, measurable and newly diagnosed multiple myeloma associated:
* Severe renal failure at the time of transplantation (creatinine clearance \< 40 ml/min/1.73m², CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration)
* Partial response after induction treatment
* For patients who undergo autologous transplantation, absence of known contraindication for transplantation
* Absence of amylose
* Patient affiliated to a social security regimen or beneficiary of the same
* Signed written informed consent form

Exclusion Criteria:

* Patient without at least a partial hematological response following the induction stage
* Medical history of previous malignancy
* Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent (art. L.1121-6, L.112-7, L.1211-8, L.1211-9)
* Pregnant or breastfeeding woman
* Declining participation
Randomized Evaluation of Anagliptin Versus Sitagliptin On Low-density lipoproteiN Cholesterol in Diabetes Trial

The purpose of this study is to determine whether Anagliptin or Sitagliptin are effective in reducing the low-density lipoprotein cholesterol in patients with type 2 diabetes and cardiovascular risk factors on statin.

Diabetes is a significant cause of cardiovascular and cerebrovascular events. Especially, diabetic patients with cardiovascular risk factors were significantly higher risk for cardiovascular and cerebrovasculara event. Therefore, several medical management strategies including anti-diabetic medications and statins were considered for those patients. However, in spite of such treatment, still many patients have cardiovascular and cerebrovascular events. One of the hypothesis is the residual risk such as elevated low-density lipoprotein cholesterol (LDLC) even with statin therapy. Anagliptin, one of the dipeptidyl peptidase-4 (DPP4) inhibiors, was reported to reduce LDLC and may have pontential to decrease the cardiovascular and cerebrovascular risk for such patients on statins. We, thus, conduct a randomized controlled trial to compare Anagliptin or Sitagliptin in terms of change of LDLC for 52 weeks as well as glycemic control.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes with cardiovascular risk factors (\*) who treated with diet, exercise or antidiabetic medications
* Patients who were treated with statins for 8 weeks or longer
* Patients with low-density lipoprotein cholesterol equal to or greater than 100 mg/dL in the at least one of three measurements after the administration of statins
* Patients with glycerated hemoglobin (HbA1c, NGSP) equal to or greater than 6.0 % (7.0 % if patients were not treated with dipeptidyl-peptidase 4 inhibitors) and lesser than 10.5 %

(\*) cardiovascular risk factors were any of following conditions

1. Presence of stenosis (\>=25%) or plaque on the previous coronary angiography or coronary CT
2. Presence of coronary calcification on the previous coronary CT
3. History of acute coronary syndrome
4. History of percutaneous coronary intervention or coronary artery bypass graft
5. History of stroke (ischemic stroke or hemorrhagic stroke)
6. History of transient ischemic attack
7. History of peripheral artery diseases or aortic disorders
8. Ankle-Brachial Index (AMI) equal to or less than 0.9 in the past measurement
9. Presence of carotid artery plaque (including Max IMT \>=1.1mm) on carotid ultrasonography in the past

Exclusion Criteria:

* Patients with type 1 diabetes
* Patients with triglyceride equal to or greater than 400 mg/dL in the previous fasting measurements
* Patients with pregnancy, possible pregnancy, or on breast-feeding
* Patients with severe infections, perioperative status, or severe trauma
* Patients with renal dysfunction (creatinine \>= 2.4 mg/dl for men, \>= 2.0 mg/dl for women)
* Patients who were received glucagon-like peptide-1receptor agonists
* Patients whom physician in charge considered inappropriate for the study