cyrilzakka/clinical-trials huggingface dataset:
Immunoregulatory Effects of Immunoglobulin Induction Therapy in Renal Transplant Recipients

The aim of this randomized prospective study in renal transplant recipients is to investigate immunological short and long-term effects of an IVIG induction therapy.

Furthermore clinical endpoints (patient and graft survival, incidence of acute and chronic rejection, infectious diseases and graft function) up to three years posttransplant will be analyzed.

Intravenous immunoglobulin (IVIG) preparations are known to be effective in the treatment of various autoimmune and inflammatory disorders due to their immunomodulatory and antiinflammatory properties. It has been demonstrated that IVIG is effective in the treatment of acute vascular rejection and steroid resistant cellular rejection. Furthermore, IVIG has been used to inhibit production of lymphocytotoxic antibodies in highly sensitized patients so that successful cadaveric or living renal transplantation could be performed.

The aim of this randomized prospective study in renal transplant recipients is to investigate immunological short and long-term effects of an IVIG induction therapy on Th1, Th2 and B-cell/monocyte responses, expression of adhesion molecules, costimulatory factors and cytokine receptors and on secretion of immunoregulatory autoantibodies (anti-F(ab)-, anti-F(ab')2G-, anti-hinge autoantibodies). These autoantibodies have been shown to significantly affect the risk of chronic rejection and graft loss.

Furthermore, clinical endpoints (patient and gaft survival, incidence of acute and chronic rejection, infectious diseases and graft function) up to 3 years will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* renal transplant recipients of the Giessen renal transplant unit
* cadaveric and living renal transplants
* first and retransplants

Exclusion Criteria:

* Contraindications against blood-taking (anaemia with hemoglobin \< 9,5 g/l, hypotension)
* intravenous immunoglobulin therapy in the last half year before study entry
* Hyperimmunoglobulin therapy for severe CMV infection
* Pregnancy
Effects of Antiviral Therapy on HBV Reactivation

Hepatitis B virus (HBV) reactivation happens after liver resection for HBV-related hepatocellular carcinoma (HCC) patients, particularly for those with positive serum HBV-DNA . The incidence rate and risk factors of HBV reactivation after hepatectomy for serum HBV-DNA negative HBV-related HCC are unclear.

Hepatitis B virus (HBV) reactivation happens after liver resection for HBV-related hepatocellular carcinoma (HCC) patients, particularly for those with positive serum HBV-DNA . The incidence rate and risk factors of HBV reactivation after hepatectomy for serum HBV-DNA negative HBV-related HCC are unclear.From July 2012 to December 2015, 174 consecutive patients with serum HBV-DNA negative HBV-related HCC underwent resection were prospectively enrolled in the studied. There are 66 patients received preoperative antiviral therapy (antiviral group) and 108 patients did not receive any antiviral therapy (non-antiviral group). The incidence of HBV reactivation, risk factors of liver function were analyzed in perioperative period. HBV reactivation developed in 30 patients (27.8%) in the non- antiviral group and 2 patients (3.0%) in the antiviral group, respectively (P \< 0.001). Multivariate analysis revealed that minor hepatectomy (HR, 4.695; 95% CI, 1.257-17.537, P = 0.021) and without antiviral therapy (HR, 8.164; 95% CI, 1.831-36.397, p =0.006) were risk factors attributed to HBV reactivation. Patients in antiviral group and non-antiviral group or reactivation group and without reactivation group have similar ALT, TBil, ALB, and PT in 7 days after resection. However, patients in antiviral group have significantly better ALT and ALB on day 30th after resection than those in control group. Moreover, similar phenomenon were observed when comparing those with or without HBV reactivation. Resection could lead to HBV reactivation during the perioperative period for serum HBV DNA negative HBV-related HCC, especially in patients who did not receive any antiviral therapy. Anti-HBV therapy can reduce the risk of reactivation, thus improving liver function after hepatectomy.

Eligibility Criteria:
Inclusion Criteria:

* underwent initial hepatectomy;
* preoperative serum HBsAg positive
* serum HBV DNA negative
* serum ALT in normal range
* Child-Pugh A liver function
* HCC was confirmed by histopathology
* patients in the treated group received Entecavir (ENT) while patients in the control group did not receive any antiviral therapy.

Exclusion Criteria:

* underwent preoperative TACE or other anti-tumor treatments
* underwent preoperative antiviral treatment for nearly a year
* with autoimmune disease, other organ malignant tumor, or other severe disease.
The Energy Flux Study

The focus of this randomized clinical trial study is an examination of the effects of maintaining energy balance at different energy fluxes. It will address the primary question: Are there increased health benefits related to body composition and metabolic function associated with maintaining energy balance at a high energy flux as compared to a low energy flux?

We will randomly assign 75 sedentary but healthy individuals to one of two exercise groups or a non-exercise group. We will follow the individuals for 6 months during the intervention period. Both groups will maintain weight by matching energy intake and expenditure (thus the exercise group will consume more calories).

Eligibility Criteria:
Inclusion Criteria:

* BMI \<35
* 21-45 years of age
* Fasting plasma glucose \<126 mg/dl
* Current medications must have been prescribed for 3 or more months and stable
* Internet access
* Able to participate in a somewhat strenuous physical exercise program
* Able to provide informed consent for participation in a research study

Exclusion Criteria:

* Currently participating in a weight loss or exercise intervention / program
* Planning to have weight loss surgery
* Weight change \>5 lb in last 12 months
* Currently taking any of the following: hormone replacement therapy, beta blockers, allergy shots or systematic corticosteroids (except inhalers)
* Significant cardiovascular disease or disorders including but not limited to: serious arrhythmias, cardiomyopathy, congestive heart failure, stroke or transient ischemic cerebral attacks, peripheral vascular disease with intermittent claudication, acute, chronic or recurrent thrombophlebitis, Stage II or Stage III hypertension, myocardial infarction or abnormal exercise stress test.
* Medical history with presence of significant conditions or disease that may interfere with study, recent surgery
* Pregnant or actively trying to become pregnant
* Gave birth in the last 12 months or \<6 months post-lactation
* \> 90th percentile on the Brief Symptom Inventory \[BSI\]
* Planning to move from the area in the next 8 months
* Other medical, psychiatric or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability ot follow the intervention protocol. Upon identification of individuals with suicidal ideation or other dangerous conditions, the individual will be contacted and told to immediately go to a medical emergency room.
Investigation of Genetic Disease Marker Associated With Korean Glaucoma Patients

A single-nucleotide polymorphism (SNP) analysis of DNA obtained from peripheral blood of the glaucoma patients and the normal control will be performed to find genetic marker for primary open angle glaucoma.

Unrelated Korean subjects who have primary open angle glaucoma were recruited in the current study. Genotyping for various SNP associated with POAG due to the linkage disequilibrium patterns is to be performed. Genotypes would be statistically compared between patients with primary open angle glaucoma and normal control subjects free of any eye diseases.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary open angle glaucoma

Exclusion Criteria:

* Primary open angle glaucoma combined with congenital ocular disease
* Primary open angel glaucoma combined with other ocular disease
* Significant systemic disease other than systemic hypertension and diabetes
Supplemental Perioperative Oxygen to Reduce the Incidence of Post-Cesarean Endometritis and Wound Infection

The purpose of this study is to determine whether supplemental perioperative oxygen significantly decreases the incidence of post-Cesarean endometritis and wound infection among women who undergo Cesarean section after the onset of labor.

Women undergoing cesarean section after rupture of membranes or onset of labor are randomized in a one to one ratio to either normal or supplemental perioperative oxygen during cesarean section and for two hours afterwards.

Eligibility Criteria:
Inclusion Criteria:

* Women who underwent a clinically indicated cesarean delivery after the onset of labor or rupture of membranes

Exclusion Criteria:

* Cesarean delivery prior to the onset of labor or rupture of membranes
* emergent cesarean delivery
* general endotracheal anesthesia
* clinical chorioamnionitis
* HIV infection
* less than 16 years of age
Clinical Nursing Practice Supported by Results of Research: Mixed-method Study

The purpose of the study is to assess the attitudes and the use of research by nurses at the IRCCS-CRO Aviano. Furthermore, it will make it possible to identify attitudes towards the use/non-use of research results, specific training needs and targeted interventions to ensure adequate care for cancer patients along the disease course, derived from a constant updating of nursing skills. The study will involve nurses working in different care settings of the Institute and some patients who will be able to express their care needs and research priorities, making a direct contribution towards development of care centred on the health needs, preferences and values of the cancer patients.


Eligibility Criteria:
Inclusion criteria for nurses:

* All nurses employed at IRCCS-CRO Aviano under fixed-term and permanent contract on 15 September 2023;
* Nursing activities in the departments of medical and surgical oncology and high technologies;
* Full-time and part-time employment contract;
* Signature of consent for participation in the study and processing of personal data (Privacy).

Patient inclusion criteria:

* Patients admitted to the institution as in-patients;
* Age ≥ 18 years;
* Signature of consent for participation in the study and processing of personal data (Privacy);
* Good understanding of the Italian language.

Exclusion criteria for nurses:

- Lack of willingness/interest in participating in the study and signing the consent.

Patient exclusion criteria:

* Day-Hospital patients;
* Age \< 18 years;
* Diagnosis of cognitive dysfunction or psychiatric disorders;
* Difficulties in understanding the Italian language.
Collection of Anonymized Data for Improvement of Domestic Patient Monitor System

Collection of anonymized data for improvement of domestic patient monitor system comparison of commercial patient monitor

the data from the patient will be collected as the baseline data for improvement of the domestic patient monitor system

Eligibility Criteria:
Inclusion Criteria:

* surgical patients

Exclusion Criteria:

* problem to monitor
Genetic Determinants of the Bronchodilatation Effect of Albuterol ex-Vivo

The role played by ß2AR polymorphisms in determining the bronchial response to ß2AR agonist drugs, has been confirmed by several studies.

The purpose of the present study is to examine possible causal relationships between genetically based alteration in the structure of ß2AR and drug responsiveness. An ex-vivo model (organ bath technique) will be used to investigate association between polymorphisms in the coding region of ß2AR and the response of bronchial rings derived from human lung tissue to the respective agonists (i.e. salbutamol).

In the second part of the study the same bronchial rings will be incubated for 24 hours in a solution containing fixed concentration of albuterol. A second dose response curve for rising concentrations of albuterol will be constructed and a relationship between β2 genetic polymorphisms and the extent of desensitization to albuterol will be investigated.

In addition, through specifically designed receptor binding assay the bronchial tissue will be used to define the affinity (Kd) and expression (Vmax) of the ß2 receptor. These data will enable to enhance our understanding regarding the mechanism responsible for the association noted between ß2AR polymorphism and altered drug effect.


Eligibility Criteria:
Inclusion Criteria:

* Macroscopically normal pulmonary tissue

Exclusion Criteria:

* The presence of pathological finding in the pulmonary tissue
Vitamin D Sulfates in Breastmilk

Infants The purpose of this study is to measure breastmilk's vitamin D sulfate nutritional value in infant's saliva and digesta (gut).

Breastfeeding Mothers The purpose of this study is to measure Vitamin D sulfates in freshly expressed breastmilk samples before and after 28 days of Vitamin D supplementation in lactating mothers.

Infants

Sign the consent form to confirm participation:

You will be asked to bring a soiled diaper from the morning of the study visit. You will meet with a study team member who will collect up to 6 swabs total:

Up to 3 cheek/mouth swabs to collect saliva Up to 3 stool/anus/diaper swabs

Lactating Mothers

Sign the consent form to confirm participation:

Visit 1 (Baseline) You will meet with a study team member complete some demographic information and gestational age of the baby and birthdate, next you will have a blood draw and express breast milk in a private location, the study team will collect up to 50 ml of freshly expressed breast milk for the research study, you will be asked to bring your personal breast pump and collection container to each research visit, or manually express milk, see options below. The study team member will schedule visit 2. The study will provide the vitamin D supplement that you will take daily for 28 days.

Visit 2 (post intervention) Approximately 28 days later you will meet with a study team member, have a blood draw and express breast milk in a private location, the study team will collect up to 50 ml of freshly expressed breast milk for the research study, you will be asked to bring your personal breast pump and collection container to each research visit, or manually express milk, see options below. The study team member will ask for the container the Vitamin D supplement was in.

You have 2 options:

Option 1:

Bring along your personal breast pump and collection container to each study visit.

The study team member will collect up to 50 ml of freshly expressed breast milk for the study.

Option 2:

You do not bring along your personal breast pump and containers to each study visit, instead you will be asked to:

Manually express your breast milk into a specimen collection cup at each study visit.

Eligibility Criteria:
Lactating Mothers

Inclusion Criteria:

* Lactating mothers
* ≥2 weeks after delivery
* No intentions of weaning during the study

Exclusion Criteria:

* History of sarcoidosis
* History of renal disease
* Premature birth- \<37 weeks
* Taking daily supplement with ≥600 IU vitamin D in the past 30 days

Breastfeeding Infants

Inclusion Criteria:

* Female and male infants
* Exclusively breastfed

Exclusion Criteria:

* No known gastrointestinal diseases that require medical treatment
* Currently prescribed antibiotics or have taken antibiotics \<2 weeks from collection
Metabolism and Disposition of [14C] Herombopag in Chinese Healthy Human Subjects

This study is a single-center, open-label, single-dose design. It is planning to enroll six Chinese healthy adult male subjects. The metabolism and disposition of Herombopag, will be studied in these subjects after a single oral administration of a solution dose of \[14C\] Herombopag (5 mg, 100 uCi).

The metabolism and disposition of Herombopag, will be studied in six healthy men after a single oral administration of a solution dose of \[14C\]eltrombopag (5 mg,100 uCi).

The sutdy will investigate total radioactivity pharmacokinetics in whole blood and plasma 、quantitatively analyze the the total radioactivity in the excreta、evaluate the predominant route of elimination and indentify the Metabolite profiles in plasma 、urine and faces.

Eligibility Criteria:
Inclusion Criteria:

* Health male subjects, age between 18-45 years.
* BMI between 19 and 26 kg/m2 .
* Signed informed consent.

Exclusion Criteria:

* Abnormal results in physical examination、laboratory tests、X-ray、abdominal ultrasound、echocardiography have clinical significance.
* Abnormal platelet counts or platelet aggregation has clinical significance.
* Abnormal troponin examination has clinical significance.
* Abnormal ophthalmic examination has clinical significance.
* Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody is positive.
* Those who have a history of allergies to test drugs or similar drugs.
* Those who have undergone surgery within 6 months prior to the trial .
* Those who took any drug within 14 days before the test (including Chinese herbal medicine).
* Any drug that inhibits or induces liver drug metabolism within 30 days before the test.
* Subjects who have participated in other clinical trial within the 3 months prior to study entry.
* One or more non-pharmacological contraceptive measures cannot be used during the trial or it is planned to have birth within one year.
Laser Treatment with Methylene Blue Vs. Nanoparticle-Assisted Photodynamic Therapy for Gingival Pigmentation: a Randomized Clinical Trial

This randomized controlled clinical trial aims to compare the effectiveness of methylene blue and methylene blue nanoparticles as adjuncts to photodynamic therapy in laser treatment of physiological gingival pigmentation. The study evaluates pigmentation reduction, recurrence rates, healing time, and patient satisfaction. Conducted at Kafrelsheikh University, it includes three patient groups: laser-only treatment, conventional methylene blue-assisted PDT with laser, and methylene blue nanoparticles-assisted PDT with laser. The findings will contribute to advancements in aesthetic dentistry and laser-assisted depigmentation techniques.


Eligibility Criteria:
Inclusion Criteria:

Patients with physiological gingival pigmentation confirmed by clinical examination.

Age range: 18-50 years.

Patients with no history of systemic diseases or conditions that could affect wound healing (e.g., diabetes, autoimmune diseases).

Patients willing to undergo laser treatment and provide informed consent.

Non-smokers or individuals who have stopped smoking for at least six months.

Exclusion Criteria:

Patients with pathological gingival pigmentation (e.g., associated with syndromes or systemic conditions).

Use of medications affecting pigmentation or healing (e.g., anticoagulants, immunosuppressants).

Pregnant or lactating women or those taking contraceptive drugs.

Individuals with known allergies to methylene blue or nanoparticles.
Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)

The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of intravesical instillation of EO9 in patients with non-muscle invasive bladder cancer (NMIBC).


Eligibility Criteria:
Inclusion Criteria:

* Patients who are clinically diagnosed as having stage Ta, T1, histological grade G1, G2 urothelial carcinoma of the bladder
* Patients who are confirmed to be urinary cytology negative (class I, class II) within 4 weeks prior to the present TURBT.
* P.S : 0-2 according to the ECOG.

Exclusion Criteria:

* Patients with a primary and solitary tumor.
* CIS lesions in the bladder or a history thereof.
* Grade 3 disease or a history thereof.
* Patients experiencing recurrence within 3 months following TURBT for prior NMIBC.
* Patients having stage T1 and high-grade disease.
* Invasive cancer of T2 or greater, with definite lymph node or other organ metastasis, or a history thereof.
* Patients who received intravesical chemotherapy/immunotherapy treatment within 6 months prior to the present TURBT.
* Patients who underwent systemic chemotherapy or radiotherapy whose field of exposure included the bladder.
* Patients with suspected bladder perforation at the time of the present TURBT.
* A complication of a malignant tumor of the upper urinary tract or urethra, or a history thereof.
* Malignancy within 5 years other than NMIBC (except thyroid cancer)
* A serious viral or bacterial infection within the last 4 weeks.
Cetrorelix and Ganirelix Flexible Protocol for (IVF)

Recombinant gonadotropins are currently used for ovarian stimulation in women undergoing to IVF for infertility. Recently new flexible protocols have been introduced: the "single dose" and "multiple dose" protocol. The single dose protocol is performed just using Cetrorelix by the administration of a single injection of Cetrorelix 3 mg subcutaneous when the lead follicle is ≥ 14 mm. The multiple dose protocol consider the daily administration of Cetrorelix 0.25 mg subcutaneous or Ganirelix 0.25 mg subcutaneous when the lead follicle is ≥ 14 mm and until the realization of hCG criteriaThere are few data from letterature about the comparison of the efficacy in pitituary suppression and pregnancy outcome of Ganirelix and Cetrorelix.

Objective: to compare the efficacy in pituitary gonadotropin suppression and IVF outcome of multiple dose flexible gonadotrophin-releasing hormone (GnRH) antagonist administration according to follicular size using daily injection of Cetrorelix or Ganirelix.

Interventions : patients are randomly assigned in to Cetrorelix acetate group or Ganirelix acetate group. Multiple dose of Cetrorelix acetate (0.25 mg) or multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met.Oocyte maturation trigger is performed by the administration of subcutaneous r-hCG (250 μg) or of intramuscular hCG (10,000 IU). After 36 hour transvaginal oocyte retrieval is performed followed by ICSI and embrio transfer (72 hours later).


Eligibility Criteria:
Inclusion criteria :

* 18-39 hyears old with regular menstrual cycles (25-35 days in length);
* Body Mass Index between 18-29 kg\\m2
* Basal follicle-stimulating hormone levels within normal range (\<30 mUI\\mL)
* Absence of clinically relevant anomalies at transvaginal ultrasound examinatio

Exclusion Criteria:

* Patients affected by grade III or IV endometriosis according to American Society for Reproductive Medicine (ASRM)
* History of Ovarian Hyperstimulation Stimulation (OHSS)
* History of poor response in previous IVF\\ICSI cycle: ≤ 3 oocytes retrieved
* ≥ 3 prior consecutive IVF\\ICSI cycle without a clinical pregnancy.