cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer

The study is being done to determine the tolerance to single fraction intra-operative electron irradiation (IOERT) and external beam photon irradiation (EBRT) following lumpectomy for T1/T2N0M0 breast cancer. IOERT is used in lieu of the 5-8 days of electron beam boost irradiation that is usually given after EBRT. Data from two centers as well as preliminary data from a randomized trial in Europe suggest that IOERT boost is well tolerated and efficacious. In our study, patients will undergo standard lumpectomy and sentinel lymph node sampling or axillary dissection. After the lumpectomy, IOERT of 10 Gy will be delivered in a single fraction to the tumor bed by a mobile electron machine in the operating room. EBRT to the whole breast will be administered once the surgical wound has healed adequately. The primary objective is to determine the feasibility and acute patient tolerance to IOERT and EBRT after lumpectomy. Secondary objectives include assessment of local control and distant control of disease, as well as evaluation of long-term side effects and cosmetic outcome of the treatment.


Eligibility Criteria:
Eligibility:

1. Histologically proven primary invasive breast carcinoma.
2. Tumor pathologically determined \<= 5cm in diameter.
3. Single, discrete, well-defined primary tumor.
4. Any micro-calcifications must be focal. A specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications.
5. Pathologically negative surgical margins.
6. Axillary lymph node status can be determined by level I and II lymph node dissection or sentinel lymph node sampling.
7. ECOG performance status 0-2.

Contraindications:

1. Multicentric disease and/or diffuse malignant appearing microcalcifications.
2. Evidence of metastatic breast cancer.
3. Axillary lymph node involvement.
4. Pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy.
5. Prior irradiation to the ara of planned radiation field.
6. Pregnant or lactating women.
Subclinical Organ Damage in Overweight and Obese Patients: Does Presence of Metabolic Syndrome Matter?

Microalbuminuria and homocysteine levels are shown to be markers for endothelial dysfunction and subclinical organ damage and predictors of cardiovascular risk in several epidemiologic and randomized clinical trials. Carotis intima-media thickness is also found to be elevated in early stages of atherosclerosis. Recent studies have shown correlations between homocysteine, microalbumin levels and carotis intima-media thickness in type 2 diabetics but no data exists for obese or overweight patients who also have metabolic syndrome, in terms of markers of subclinical organ damage. Since obesity is a risk factor for cardiovascular disease and since it is known that patients with metabolic syndrome are at higher risk of cardiovascular events, the investigators wanted to examine whether there is an association between homocysteine, microalbumin levels and carotid intima-media thickness in patients with or without metabolic syndrome, who are either overweight or obese.


Eligibility Criteria:
Inclusion Criteria:

1. 18-80 years
2. BMI \>= 25
3. Ex or non-smokers (must have quit smoking at least 5 years ago)

Exclusion Criteria:

1. NIDDM or IDDDM
2. Nephropathy (GFR \< 60 ml/min), previous history of coronary artery disease or peripheral arterial disease
3. Current smokers
4. Active infection or other acute illness
Cerebral Blood Flow and PETCO2 on Neuromuscular Function During Environmental Stress

Environmental stress, such as low oxygen availability (hypoxia), has been associated with impaired neuromuscular performance; however, the mechanisms associated with these performance decrements remain unclear. While the majority of research suggests that the observed fatigue is related to the central nervous system, the influence of changes in cerebral blood flow (CBF) and associated changes in cerebral pH (partial pressure of carbon dioxide; PCO2) remains unexamined. In response to hypoxic stress, humans hyperventilate to maintain oxygen consumption, resulting in a hypocapnia mediated decrease in CBF and cerebral alkalosis (decreased PCO2). Previous research suggests that hyperventilation induces changes in neural excitability and synaptic transmission; however, it remains unclear if these changes are related to hypocapnia mediated decrease in CBF or cerebral alkalosis or both.

The purpose of the proposed research program is to examine the influence of changes in CBF and cerebral alkalosis on neuromuscular function during environmental stress. The research program will consist of 2 separate projects, summarized below in a table outlining the proposed protocols and resultant physiological manipulations. During each manipulation, neuromuscular function will be evaluated and compared to baseline (normoxic) conditions using a repeated measures design.

The research program will consist of 2 separate projects. Project 1 will examine the changes in CBF and alkalosis by using (a) indomethacin (decrease CBF; no change PCO2) and (b) hypocapnia (decrease CBF; decrease PCO2). Using a similar experimental design, Project 2 will examine the change in CBF and alkalosis during hypoxia by using (a) poikilocapnic hypoxia (decrease PO2; decrease CBF; decrease PCO2), (b) isocapnic hypoxia (decrease PO2; no change CBF; no change PCO2) and (c) isocapnic hypoxia + indomethacin (decrease PO2; decrease CBF; no change PCO2). During each manipulation, neuromuscular function will be evaluated and compared to baseline (normoxic) conditions using a repeated measures design.

Therefore, Project 1 will examine the separate and combined effect of changes in CBF and cerebral alkalosis on neuromuscular function independent of environmental manipulations. Subsequently, Project 2 will examine neuromuscular function during hypoxia while controlling CBF and cerebral alkalosis. It is hypothesized that changes in PCO2 and therefore, changes in cerebral alkalosis will contribute to neuromuscular fatigue independent of changes in CBF and oxygen availability.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 25 yrs old; healthy males

Exclusion Criteria:

* diagnosed medical condition; NSAID allergy; smoker; high altitude exposure; implants
The Expression of Matrix Metalloproteinase 13, Tissue Inhibitor of Metalloproteinases 3, and Calcium-sensing Receptor in Human Trabecular Meshwork

This study was to assess the distinct expression of matrix metalloproteinase 13,tissue inhibitor of metalloproteinases 3, and calcium-sensing receptor, in human trabecular meshwork between normal and glaucomatous eyes.The expressions of matrix metalloproteinase 13, tissue inhibitor of metalloproteinases 3 and calcium-sensing receptor in the trabecular meshwork tissues were examined by streptavidin-peroxidase immunohistochemical staining method and western blot, and histological changes of trabecular meshwork were studied by Hematoxylin and Eosin staining.


Eligibility Criteria:
Inclusion Criteria:

* intraocular pressure greater than 22 mmHg with two or more medications
* wide anterior chamber angle
* glaucomatous optic neuropathy (Glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect
* visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry

Exclusion Criteria:

* the presence of any secondary form of glaucoma including exfoliation syndrome or a history of ocular trauma, etc
Computer Vision Syndrome Visual Sequelae

the university students will respond to CVS-F3 survey form and then they will be subjected to complete ophthalmic examination and investigations

CVS-F3 is a survey form consisted of up to 30 questions regarding Computer Vision Syndrome (CVS) complains, thereafter a randomized sample of students will be subjected to complete ophthalmic examination including visual acuity and refractive measurements, intraocular pressure measurements, Slitlamp and fungus examinations, mfERG examinations. the sudents will be requested to decrease their screen time and the examinations will be repeated one month later.

Eligibility Criteria:
Inclusion Criteria:

- University students

Exclusion Criteria:

* Amblyopia
* Anisometropia
* strabismus
* Previous eye surgery
Use of Fosfomycin in the Treatment of Bacterial Infections

Fosfomycin is an antibiotic discovered since 1969. Disodium fosfomycin, for intravenous use (C3H5Na2O4P) is a bactericidal antibiotic, available in Italy since 2019 (AIFA approval). It works by blocking the enzyme UDP-N-acetylglucosamine enolpyruvil transferase, inhibiting the synthesis of peptidoglycan. It binds poorly to plasma proteins and is distributed very well in various tissues such as: eyes, bones, skin and subcutaneous tissue, muscles, lungs, prostate, bile and inflamed meninges. It also has a strong anti-biofilm activity.

Fosfomycin is active against Gram-positive bacteria (staphylococci, streptococci, enterococci, including MRSA and VRE) and Gram-negative bacteria (Enterobacterales, Haemophilus influenzae, Proteus mirabilis, Pseudomonas aeruginosa, including MDR strains) and against difficult-to-treat bacteria such as Serratia marcescens, Stenotrophomonas maltophilia, Bacteroides spp and intracellular bacteria such as Chlamydia and Mycoplasma. It has no activity against Acinetobacter spp, Peptococcus spp. and Peptostreptococcus spp, Burkholderia cepacia, and Mycobacterium tuberculosis.

IV fosfomycin is approved for the treatment of osteomyelitis, complicated urinary tract infections, pneumonia including hospital-acquired and ventilator-associated pneumonia, complicated skin and soft tissue infections, bacterial meningitis, and complicated bacteremia.

In this retrospective study, the investigators want to analyze the medical records of all patients admitted to the ASST of Lecco from 01/04/2020 to 31/12/2023 treated with fosfomycin IV in order to evaluate different clinical outcomes given the recent introduction at ASST Lecco


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Patients hospitalized at A. Manzoni Lecco between April 2020 and December 2023;
* Patients treated with IV fosfomycin as monotherapy or in combination with other antibiotics for at least 72 hours.

Exclusion Criteria:

* Patients who received fosfomycin IV for less than 72h for any cause (death, adverse events, clinical decision).
Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease

This protocol describes a prospective, randomized study examining the safety and efficacy of Itraconazole for preventing fungal infections in patients with Chronic Granulomatous Disease (CGD). CGD is a genetic disorder in which phagocytes are unable to produce oxygen radicals. As a result, affected patients are prone to recurrent, severe infections with bacterial and fungal organisms. Patients with CGD of 5 or more years of age without evidence of infection at the time of study entry will be eligible for enrollment. Patients will be randomized to receive itraconazole or placebo tablets daily, in a double blinded fashion. In addition to itraconazole, all patients will receive antimicrobial prophylaxis against bacterial infection, and may in addition receive gamma-interferon as prophylaxis against infection. Randomization of patients will be stratified among patients receiving or not receiving gamma interferon. The primary endpoint of the study will be the development of culture or histologically proved invasive fungal disease. Patients will be monitored every three months for evidence of drug toxicity. The anticipated accrual period will be approximately 36-48 months.

This protocol describes a prospective, randomized study examining the safety and efficacy of Itraconazole for preventing fungal infections in patients with Chronic Granulomatous Disease (CGD). CGD is a genetic disorder in which phagocytes are unable to produce oxygen radicals. As a result, affected patients are prone to recurrent, severe infections with bacterial and fungal organisms. Patients with CGD of 5 or more years of age without evidence of infection at the time of study entry will be eligible for enrollment. Patients will be randomized to receive itraconazole or placebo tablets daily, in a double blinded fashion. In addition to itraconazole, all patients will receive antimicrobial prophylaxis against bacterial infection, and may in addition receive gamma-interferon as prophylaxis against infection. Randomization of patients will be stratified among patients receiving or not receiving gamma interferon. The primary endpoint of the study will be the development of culture or histologically proved invasive fungal disease. Patients will be monitored every three months for evidence of drug toxicity, and surveillance cultures of nasopharynx and stool will be obtained. The anticipated accrual period will be approximately 36-48 months.

Eligibility Criteria:
Documented chronic granulomatous disease more than 5 years of age.

No fungal infection within the past year.

Not currently on other antifungals or have taken other antifungals during the past 3 months.

Not currently on phenytoin or rifampin.

Negative pregnancy test within 2 weeks of starting protocol.
Reproducibility of Glucose Fluctuations by Standardized Exercise for Patients With Type 1 Diabetes - a Method Study Based on Continuous Glucose Monitoring

The purpose of this project is to investigate whether the glucose response in type 1 diabetes patients measured using Continuous Glucose Monitoring measurement is reproducible in repeated standardized test sessions that include physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes with a diabetes duration of at least 2 years
* age 18-60 years (inclusive)
* given informed consent
* exercises (at least 30 minutes intentional exercise where participants feel exhausted) one or more times a week
* participants agree to use CGM correctly

Exclusion Criteria:

* pregnancy
* exercising at a high level (five or more times a week with high intensity)
* treatment with prednisolone or less than a month ago contestant has been treated with prednisolone
* treatment with beta blockers
* Abuse of alcohol / drugs
Vitamin D3 Supplementation in Participants Diagnosed With Early-Stage Prostate Cancer Who Decide to Undergo Active Surveillance Treatment Regimen.

This clinical trial is aimed at measuring the effect of vitamin D3 supplementation on serum prostate-specific antigen (PSA) levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer (Gleason score less than/equal to 6; PSA less than/equal to 10; clinical stage T1C or T2a), who elect to have their disease monitored through active surveillance for at least one year.


Eligibility Criteria:
Inclusion Criteria:

* lowgrade prostate cancer
* serum PSA less than/equal to 10 ng/ml
* Gleason score less than/equal to 6
* referred from their treating physician with treatment plan of active surveillance for one year
* serum creatinine less than/equal to 2.0 mg/dL
* serum phosphate (measured as phosphorus)greater than 2.3 and less than 4.8 mg/dL
* serum calcium greater than 8.5 and less than 10.5 mg/dL

Exclusion Criteria:

* concurrent malignancy, except non-melanoma skin cancer
* history of sarcoidosis
* history of high dose (greater than 1,000 IU daily) vitamin D3 supplementation
* history of hypercalcemia
* treatment with lithium medication
Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction Patients: a Real World Study in India

This was a non-interventional, retrospective EMR analysis of longitudinal prescriptions in India for a period of 1.5 years. Demographic profile of patients with heart failure with reduced ejection fraction on sacubitril/valsartan was recorded.

Index date was date of 1st prescription of sacubitril/valsartan. Dose titration of sacubitril/valsartan was assessed for a period of 6 months post index date.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years with a diagnosis of HFrEF as mentioned in database or heart failure with a recording of LVEF \<40% at or before the index date
* A prescription of sacubitril/valsartan

Exclusion Criteria:

* Diagnosis of HF specified as preserved/mid-range ejection fraction
Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers

The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 8 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo as a single oral dose after a fast of at least 10 hours.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male and female subjects between 18 and 45 years old (inclusive);
* BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;
* Willingness to remain in the clinic for the inpatient portion of the study and return for follow-up visit(s) as required by protocol and as deemed necessary by the Investigator;

Key Exclusion Criteria:

* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, GI, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;
* Clinically significant abnormal findings in vital sign assessments, including blood oxygen saturation (SAO2) \< 96% and \< 12 breaths per min; History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study
Traveling-wave Transcranial Electric Stimulation

This study will assess the impact of traveling wave transcranial alternating current stimulation (tACS) on working memory performance in adults.

Transcranial alternating current stimulation (tACS) can non-invasively alter neuroelectric activity in the brain by applying weak time-varying electric currents via the scalp. Complex patterns of electric brain activity can take the form of traveling waves - spatially coherent brain rhythms that gradually propagate through the neocortex. Traveling waves are crucial for the temporal coordination of informational flow in the brain. Using the novel traveling-wave transcranial alternating current stimulation (tACS) approach, the investigators will explore the effects of frontal-to-parietal and parietal-to-frontal traveling waves on working memory performance and brain electrophysiology in adults.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 45 years old.
2. Confident level of English language.

Exclusion Criteria:

1. History or evidence of chronic neurological or mental disorder.
2. Metal or electric implant in the head, neck, or chest area.
3. History of head injuries with loss of consciousness.
4. Any acute or chronic medical condition that requires ongoing pharmacological treatment.
5. Pregnancy or breast-feeding.
6. Alcohol or drug addiction.
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non Erosive Reflux Disease

The purpose of this study is to demonstrate the superiority of efficacy of DWP14012, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4.

This is a multi-center, double blind, randomized, placebo-controlled, parallel-group, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (DWP14012 A mg or DWP14012 B mg or placebo).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged between 20 and 75 years
2. Subjects who were not observed mucosal break according to the LA classification(LA grade) on the EGD
3. Subjects who had experienced major symptom within 3 months
4. Subjects who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week
5. Subjects who is able to understand and follow the instructions
6. Subjects who voluntarily signed written informed consent form

Exclusion Criteria:

1. Subjects who have Barrett's esophagus, gastroesophageal varices, esophageal stenosis, ulcer stenosis, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by endoscopy
2. Subjects who have erosive esophagitis, acute upper gastrointestinal bleeding, gastric ulcers or duodenal ulcers within 2 months before Visit 1
3. Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder, IBS, IBD in the last 3 months
4. Subjects who have a history of gastric acid suppression surgery or gastroesophageal surgery
5. Subjects with Zollinger-Ellison syndrome
6. Subjects with eosinophilic esophagitis
7. Subjects with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease .
Endoscopic Scissors Cutting Nasobiliary Duct VS Bilateral Plastic Stent

The purpose of this study is to explore the efficacy and safety of endoscopic scissors cutting nasobiliary ducts in the treatment of malignant hilar biliary tract stenosis

The early diagnosis of hilar bile duct stenosis is difficult, and when the patient is diagnosed, the opportunity for surgical radical resection is lost, resulting in a poor prognosis. Effective palliative treatment can significantly improve their quality of life and survival time. The method of cutting nasobiliary ducts with endoscopic scissors has many advantages. Firstly, there are multiple lateral foramen of the nasobiliary duct, which increases the drainage area. Secondly, the nasobiliary duct can be retained in the secondary bile duct, which is difficult to achieve with a conventional stent. The use of nasobiliary ducts can also reduce the difficulty of converting from external drainage to internal drainage.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years old and under 80 years old who were planned to carry out ERCP for malignant hilar biliary duct stenosis
2. Clinically and pathologically confirmed malignant hilar biliary duct stenosis
3. MRCP determines Bismuth classification: II-IV type
4. Comply with research procedures and sign the informed consent form

Exclusion Criteria:

1. The patient has multiple organ dysfunction and cannot tolerate endoscopic treatment
2. The patient has undergone biliary drainage (endoscopic, percutaneous, or surgical)
3. The patient is currently suffering from cholangitis
4. The patient is participating in other clinical trials
5. Inability to provide informed consent