cyrilzakka/clinical-trials huggingface dataset:
Serum Copeptin as a Predictor of the Risk of Hyponatremia After Transurethral Prostatectomy

Hyponatremic hypovolemia is a frequent complication of transurethral resection of the prostate gland (TURP). Copeptin has been established as is a surrogate marker of vasopressin and is measured useful for thea clinical assessment of various sodium and water disturbances. The aim of our the study was to assess the utility of serum concentration of copeptin (CPP) and brain natriuretic peptide (NT-proBNP) for the prediction of postoperative alterations of serum sodium concentration. Study population comprised 43 patients with benign prostatic hyperplasia (BPH) undergoing transurethral resection of the prostate gland. In a forward stepwise multiple regression only serum copeptin before the surgery and the duration of TURP significantly explained the variation of sodium concentration for 12 hours from the start of the surgery. Serum NT-proBNP before the surgery did not predict hyponatremia 12 hours after TURP.Conclusion Serum copeptin before TURP surgery but not NT-proBNP may be a clinically useful marker of a decrease of serum sodium after TURP surgery.

Introduction.Hyponatremic hypovolemia is a frequent complication of transurethral resection of the prostate gland (TURP). Copeptin has been established as is a surrogate marker of vasopressin and is measured useful for thea clinical assessment of various sodium and water disturbances. The aim of our the study was to assess the utility of serum concentration of copeptin (CPP) and brain natriuretic peptide (NT-proBNP) for the prediction of postoperative alterations of serum sodium concentration.

Methods. Study population comprised 43 patients with benign prostatic hyperplasia (BPH) undergoing transurethral resection of the prostate gland (TURP) Serum sodium and copeptin (CPP) were measured before the procedure and 12 hours after its completion. and sSerum NT-proBNP was assessment at baseline. Total amount of fluids and sodium administered intravenously and to flush the bladder during TURP was calculated in each patient. Receiver operator characteristics (ROC) curve analysis was used to determine the value of of copeptin (CPP) and NT-proBNP for that could prediction of the decrease of serum sodium after TURP

Eligibility Criteria:
Inclusion Criteria:

- glomerular filtration rate estimated from serum creatinine with CKD-EPI formula (eGFR) \>45 ml/min.

Exclusion Criteria:

* acute infection
* heart failure (NYHA stage 3 or 4)
* diabetes insipidus
* nephrogenic diabetes insipidus
* other sodium homeostasis abnormalities
* impaired consciousness
* psychogenic polydipsia
* alcohol abuse.
The Risk for Clostridium Difficile Colitis During Hospitalization in Asymptomatic Carriers

The investigators hypothesize that development of symptoms characteristic of Clostridium difficile infection will be 2-3 times higher in asymptomatic carriers, compared to that of non carriers and expect to find risk factors for development of symptomatic clostridium difficile.


Eligibility Criteria:
Inclusion Criteria:

* History of hospitalization in recent year, residence of a nursing home or institutions
* Expected more than 48 hours hospitalization

Exclusion Criteria:

* Colitis/ diarrhea
* Rectal swab performed ≥48 hrs post arrival to hospital.
Clinical Outcomes After AcrySof® ReStor IOL Surgery in Faculty Practice at UTSW Medical Center at Dallas: A Retrospective Review

To evaluate the clinical outcomes of AcrySof® ReSTOR® IOL for the Faculty Practice at UTSW Medical Center at Dallas

The AcrySof® ReSTOR® intraocular lens (IOL) is the latest advance in vision surgery. This IOL has been uniquely designed to improve vision throughout the entire visual spectrum, up close, far away and everything in-between. Thus, giving cataract patients their best chance ever to function free of glasses.

The pre-operative and post-operative data from ReSTOR® IOL implant cataract surgeries will be analyzed to determine whether the desired outcome was achieved, i.e. excellent vision with no correction. Variables to be studied include patient age, gender, number of ReSTOR® IOL implants, ocular comorbidities, preoperative and postoperative corrected and uncorrected visual acuities, keratometry readings, and corneal topography readings. A patient survey will also be sent to patients having undergone the surgery to measure their level of satisfaction.

Project Goals: The ultimate outcome of this project is to learn more insight on the following:

1. Visual acuity with and without correction of distance and near at 3-6 months
2. Percent of patients requiring keratorefractive surgery
3. Ocular comorbidity subgroup analysis
4. Monocular implantation subanalysis (prior to LASIK)
5. Comparison of post-op spherical equivalent to target refraction
6. Posterior capsule opacity that may be treated with laser procedure known as a YAG laser capsulotomy?
7. Subjective patient satisfaction
8. Validated questionnaire assessing visual function and quality of life

Eligibility Criteria:
Inclusion Criteria:

All patients of any race and sex between the ages of 18-90 years of age who have undergone ReSTOR® IOL cataract surgery will be recruited in this retrospective project.

Exclusion Criteria:

Patients who underwent conventional IOL cataract extraction surgery
Prolonged Gadolinium Retention After MRI Imaging

The researchers propose to investigate the prevalence of gadolinium in the urine of patients with a prior gadolinium-enhanced MRI before and after a edetate calcium disodium challenge. Moreover, will investigate if there is any correlation of gadolinium urine levels with levels of endogenous (e.g zinc) and xenobiotic metals.

The investigators propose to enroll 20 volunteers in this pilot study, including males older than 20 years and postmenopausal women in two groups: Group 1: Individuals who had a gadolinium-enhanced MRI study within 1-4 weeks before participation and Group 2: Individuals who had gadolinium-enhanced MRI study within 3-6 months before enrollment. The results will inform future analyses of gadolinium retention, excretion, and potential symptoms associated with same.

Thus, the specific aims of this cross sectional study are to:

1. Evaluate levels of gadolinium in the urine of adults with normal kidney function and a prior MRI performed within 6 months at baseline, and after a single dose of edetate calcium disodium .
2. Evaluate levels of endogenous and xenobiotic metal levels and their relationship with gadolinium levels.
3. Evaluate for symptoms of gadolinium toxicity.

Eligibility Criteria:
Inclusion Criteria:

• Subjects who had a contrast enhanced MRI for any indication within 1-4 weeks or 3-6 months, and normal renal function assessed by normal glomerular filtration rate (GFR) \>60 mL/min/1.73 m2 at the time of the gadolinium-enhanced MRI study.

Exclusion Criteria:

* Allergy to edetate calcium disodium
* Prior chelation therapy with edetate disodium since the administration of gadolinium
* Blood pressure \>160/100
* No venous access
* Platelet count \<100,000/mm3
* Liver disease or alanine transaminase (ALT) or aspartate transaminase (AST) \>2.0 times the upper limit of normal
* Diseases of copper, iron, or calcium metabolism
* Women of child-bearing potential
* History of lead intoxication; lead encephalopathy; cerebral edema.
Women and Maternity: Development of a Nutritional Education Project

The "first 1000 days of life", from conception to 2 years of life, are crucial for promoting the health of both mother and baby. During this period, a woman's diet and lifestyle play a significant role in determining the future health of the child. The perinatal period is an ideal time for regular contact with healthcare providers who can institute an intervention to encourage pregnant women to make nutritional changes to improve their health and that of their babies.

Therefore, an educational program on an appropriate lifestyle during the "first 1000 days" can represent a crucial primary prevention strategy in reducing the risk of developing obesity and non-communicable diseases (NCDs) during childhood and later adulthood.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* first trimester;
* parents' ability to speak and understand the Italian language;
* parents' ability to sign the informed consent and to fill in the questionnaires

Exclusion criteria:

* age \< 18 years;
* diagnosis of chronic and/or eating disorders
Effect of Neck Extension on Intraocular Pressure in Patients Undergoing Palatoplasty

The purpose of this study is to investigate the change in intraocular pressure according to the neck extension during palatoplasty in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone a palatoplasty with cleft palate and who are 6 months or older and under 24 months
* Patients with ASA class 1-2
* Patients who agree to voluntarily participate in this study

Exclusion Criteria:

* Patients who refused to participate in clinical studies
* History of diagnosis of neurologic or ophthalmic disease
* History of neurosurgery or ophthalmic surgery
Perioperative Study of Iparomlimab and Tuvonralimab in Resectable NSCLC

This project intends to study the efficacy and safety of Iparomlimab and Tuvonralimab with or without chemotherapyin the perioperative treatment of NSCLC


Eligibility Criteria:
Inclusion Criteria:

* 1. Voluntary Participation，willing to participate in this study and has signed the Informed Consent Form (ICF).

  2. Age, ≥18 years old, both male and female. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

  4. Histologically or cytologically confirmed, treatment-naïve Stage II-IIIB (N2 only) non-small cell lung cancer (NSCLC) according to the 8th edition of the American Joint Committee on Cancer (AJCC). Only patients judged as T4 based on tumor size are allowed to be enrolled; other T4 conditions (e.g., invasion of the diaphragm, mediastinal involvement) are not permitted.

  5. The primary NSCLC is deemed resectable by multidisciplinary team (MDT) assessment, which must include a thoracic surgeon specializing in oncologic surgery.

  6. Ability to provide surgical or biopsy tumor tissue for biomarker analysis (e.g., genetic sequencing, PD-L1 testing). The following must be provided before enrollment: Formalin-fixed paraffin-embedded (FFPE) tissue block from within the past 3 months, or 5-10 unstained tissue slides, or 2 core biopsy specimens, along with the relevant pathology report. Fine-needle aspiration specimens are not acceptable.

  7. At least one measurable lesion according to RECIST v1.1 criteria, as determined by the investigator.

Exclusion Criteria:

* 1. Presence of confirmed EGFR or ALK positive mutations. 2. History of other malignancies within the past 5 years or concurrent malignancies, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery.

  3. Previous treatment with immune checkpoint inhibitors (e.g., PD-1/PD-L1 agents), other drugs targeting T-cell receptors (e.g., CTLA-4), immune checkpoint agonist antibodies (e.g., anti-ICOS, CD40, CD137, GITR, OX40 antibodies), or anti-tumor immune cell therapy.

  4. History of Allogeneic Hematopoietic Stem Cell Transplantation or Solid Organ Transplantation: (except for corneal transplantation).

  5. Presence of congenital or acquired immunodeficiency (e.g., HIV infection). 6. History of severe allergic reactions to other monoclonal antibodies. 7. As determined by the investigator, any other factors that may affect study outcomes or lead to premature termination of the study, such as alcohol or drug abuse, other serious diseases (including psychiatric conditions) requiring concomitant treatment, significant laboratory abnormalities, or social or family factors that may impact patient safety.
Helicobacter Pylori First-line Treatment Containing Tetracycline in Patients Allergic to Penicillin

The purpose of this study is to assess and compare the effectiveness of levofloxacin-tetracycline -containing and metronidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies.However,Helicobacter pylori eradication is a challenge in patients allergic to penicillin. Therefore, the investigators aim to assess and compare the effectiveness of levofloxacin-tetracycline -containing and metronidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 with H. pylori infection.
* Patients Allergic to Penicillin.

Exclusion Criteria:

* Patients with previous H. pylori eradication therapy.
* Patients treated with Histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks.
* Patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer.
* Patients with known or suspected allergy to study medications.
* Currently pregnant or lactating.
* Inability to provide informed consent
M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

The main purpose of this study was to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologically documented NSCLC who present with Stage III locally advanced, unresectable disease (International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology
* Participants with tumor harboring an Epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, Anaplastic lymphoma kinase (ALK) translocation, ROS-1 rearrangement are eligible.
* Participants must have adequate pulmonary function defined as a forced expiratory volume in 1 second (FEV1) greater than equals to (\>=) 1.2 liters or \>= 50% of predicted normal volume measured within 3 weeks prior to randomization.
* Adequate hematological, hepatic and renal function as defined in the protocol
* Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies

Exclusion Criteria:

* Participants with Mixed small cell with non-small cell lung cancer histology
* Recent major surgery within 4 weeks prior to entry into the study
* Significant acute or chronic infections including human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome, Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection and active tuberculosis
* Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization
* Active autoimmune disease that has required systemic treatment in past 1 year (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
* Any prior systemic cytotoxic chemotherapy for their NSCLC or any antibody or drug targeting T-cell coregulatory proteins
Polypodium Leucotomos Extract for the Treatment of Melasma

We will assess whether oral supplementation with Polypodium leucotomos, a commercially marketed fern extract, improves facial melasma in Hispanic women with moderate to severe melasma. Subjects will be randomized to either Group 1, which will receive oral Polypodium leucotomos extract plus topical sunscreen, or Group 2, which will receive oral placebo plus topical sunscreen. The study will last 12 weeks, and we hypothesize that the Polypodium leucotomos group will have more improvement in their melasma compared to the placebo group.


Eligibility Criteria:
Inclusion Criteria:

* Hispanic female with moderate to severe facial melasma

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Recent use of hydroquinone, topical retinoids, topical steroids, or mechanically abrading procedures (such as laser therapy or dermabrasion) to the face
* Frequent use of tanning parlors
Study of Acetyllevocarnitine Hydrochloride Tablets in Chinese Patients With Paresthesias Caused by DPN

The purpose of this study is to assess the efficacy of Acetyllevocarnitine Hydrochloride Tablets compared with placebo after 24 weeks, in chinese patients with paresthesia caused by Diabetic Peripheral Neuropathy (DPN).

This 24-week, multicentre, randomised, double-blind, placebo-controlled phase III study is to assess the efficacy and safety of Acetyllevocarnitine Hydrochloride Tablets in Chinese patients with paresthesia caused by DPN.The trial included a 2-week screening period, a 1-week placebo run-in period, a 24-week randomized treatment period, and a 2-week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 70 years, Male and female patients;
* Type 1 or 2 diabetes mellitus on hypoglycemic therapy for 3 months or more, and clinical diagnosis of DPN;
* HbA1c \< 9.0%;
* Toronto Clinical Neuropathy Score ≥ 6 at screening and baseline.

Exclusion Criteria:

* Peripheral neuropathy caused by other diseases;
* History of acute complications of diabetes within the past 6 months, such as diabetic ketoacidosis, diabetic hyperosmolar hyperglycemia syndrome or lactic acidosis, etc.;
* Severe peripheral arterial disease; severe cardiopulmonary disease; or have a history of myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months before enrollment; or uncontrolled asthma or shortness of breath 2 months before enrollment; World Health Organization (WHO) cardiac function class III-IV; systolic blood pressure \>160 mmHg or diastolic blood pressure \>90 mmHg at screening;
* Any infection at the screening visit that is not suitable for study participation;
* Aspartate Transaminase (AST) or Alanine Transaminase (ALT) or total bilirubin or creatinine \> 2 times Upper Limit of Normal (ULN);
* Known allergy to L-carnitine ingredients;
* Severe systemic or psychiatric illness, history of epilepsy;
* History of malignancy or antitumor therapy;
* Severe bleeding disorder;
* Clinically significant abnormalities in thyroid function tests;
* Triglyceride \>5.6 mmol/L;
* Change of 2 points or more in the same item in mTCNS;
* Nursing or pregnant women.
Cerebral Microembolism in Cardiology

During different interventional cardiology procedures we aim to identify cerebral microemboli load. Further we aim to differentiate the quality and the quantity of cerebral microemboli.We will measure cerebral microemboli in different interventional phases, e.g. during valve deployment, rapid pacing, post-implantation.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)

Exclusion Criteria:

* Allergy to ultrasound gel or materials contained in the TCD probe
* Missing temporal bone window
Evaluation of a Protocol of Pupil Dilation Before Laser-assisted Cataract Surgery

Laser-assisted cataract surgery is an innovative and growing procedure to improve the safety and results of modern cataract surgery. However, this technique faces to some obstacles: economics in the one hand due to the cost and time spent for the laser procedure before the conventional surgery, and technical in the other hand, especially due to some loss of pupil dilation during the surgery, which is highly important to ensure a perfect procedure. The present study aims at assessing a pharmacological protocol to maintain an accurate pupil dilation all along the surgery in order to improve the whole procedure.

Femtosecond laser-assisted cataract surgery (FLACS) is a major surgical development that would allow systematization of surgery and even improved safety of the procedure. The development of this new surgical technique must now face certain obstacles, in particular (i) financial considering the extra cost generated by the use of the laser and (ii) technique due to the need to re-learn certain gestures and certain variations related to the laser procedure and more specifically the instability of the pupillary mydriasis (dilatation) during the actual surgery. The use of a systematic preoperative pharmacological mydriasis protocol should allow maximum intraoperative mydriasis to be maintained, allowing satisfactory surgery throughout the procedure. Several drugs or medical devices are now indicated in cataract surgery, but their effectiveness has not been specifically evaluated for the laser technique. This study could thus make it possible to validate or not a protocol of mydriasis that could make consensus in the future for the practice of FLACS.

Eligibility Criteria:
inclusion criteria :

* Patient with unilateral or bilateral cataract requiring a cataract surgery
* Patient scheduled for laser-assisted cataract surgery

exclusion criteria :

* Limitation due to laser procedure (little orbits, corneal scares, lack of pharmacological mydriasis at the inclusion visit)
* Subject with general medication influencing iris state and/or pupil dilation (alpha-agonist, psychotropic drugs)
* Subject unable to give informed consent
* minors
A Study of CS1002 in Subjects with Advanced Solid Tumors

This is a multicenter, open-label, multiple dose, dose escalation phase I study to evaluate the clinical safety, tolerability, PK, and preliminary anti-tumor efficacy of CS1002.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
2. ECOG performance status of 0 or 1.
3. Life expectancy ≥12 weeks.
4. Subjects must have adequate organ function
5. Use of effective contraception

Exclusion Criteria:

1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
2. Subjects with active autoimmune diseases or history of autoimmune diseases.
3. Subjects with immunodeficiency or receiving systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of CS1002.
4. Has received prior therapy with an anti-CTLA-4 agent.
5. Subjects who had prior chemotherapy, targeted therapy, immunotherapy or any other anti cancer systemic treatment, within 14 days prior to the first dose of CS1002 or who has not recovered from adverse events due to prior therapy.
6. Receipt of major surgical procedure, wide field of radiation, local radiotherapy or radioactive agents within specified time frame prior to the first dose of CS1002.
7. Receipt of live vaccine within 28 days prior to the first dose of CS1002
8. Use of traditional medicinal herbal preparations within 7 days prior to the first dose of CS1002.
9. History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
10. Known history of HIV.
11. Subjects with active Hepatitis B or C infection
12. Subjects with active tuberculosis infection.
13. Subjects with an active infection requiring systemic therapy.
14. History of organ transplantation.
15. History of alcoholism or drugs abuse.
16. History of severe hypersensitivity reactions to other mAbs.
17. Subjects with major cardiovascular diseases.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com