cyrilzakka/clinical-trials huggingface dataset:
Acute-phase Response & Periodontal Treatment in Diabetes Affected Patients

Thirty-eight periodontitis- and diabetes-affected subjects will be randomly allocated to non surgical periodontal treatment with either Full-Mouth Approach (FM-SRP) or Quadrant approach (Q-SRP).

Patients will be seen one day and three months (study completion) after treatment. The 24 hours appointment will be occurring after the entire completion of the FM-SRP or the first quadrant of the Q-SRP. In the latter group other sessions of treatment will be performed within the following 3 weeks.

At baseline, 24 hours and three months, anthropometric, inflammatory and endothelial parameters will be collected. Periodontal parameters will be checked at baseline and at three months.

Main outcome of the study is the level of C-reactive protein 24 hours after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients affected by Periodontal disease
* 20% of periodontal pockets of the entire dentition
* 20% bleeding on probing of the entire dentition
* documented radiographic bone loss
* Diagnosis of Diabetes Type 2 as measured through international standards

Exclusion Criteria:

* age younger than 18 years and older than 80 years
* pregnant or lactating females
* females using contraceptive methods
* need of antibiotic coverage for periodontal treatment
* previous periodontal treatment in the last 6 months.
Skin Toxicity by Oncological Therapies

This is a multicenter, retrospective and prospective observational study. The project involves the collection of clinical data of patients treated with oncological therapies, to evaluate skin toxicities related to oncological treatment.

This is a multicenter, retrospective and prospective observational study. The research will include 300 patients treated with clinical practice oncological treatments (approved by Italian Competent Authority, AIFA) from January 2012 to February 2024.

Patients will follow the prescribed therapeutic indications according to regular clinical practice and data from their medical records will be collected in a study database.

Primary objective of the study is the evaluation of the type, frequency and severity of skin toxicities related to oncological treatment.

Secondary objectives are:

* Evaluation of the association between skin toxicities due to oncological treatment and drug activity and effectiveness parameters(ORR, PFS, OS);
* Evaluation of the association between clinical-pathological features of primary cancer and skin toxicities of oncological treatment;
* Evaluation of the optimal management of skin toxicities related to cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patient who have signed informed consent.
2. Consecutive retrospective patients and prospective patients treated with new clinical practice oncological treatments (approved by AIFA) from January 2012 to February 2024
3. Male or female, age ≥18 years.

Exclusion Criteria:

Participation in another clinical trial with any investigational drug.
Integrated Coronary Multicenter Imaging Registry

The coronary images of selective angiography and optical coherence tomography with FFR(Fractional Flow Reserve) values of the intermediate lesions (40-70% stenosis) will be prospectively registered.

The patients with intermediate lesions after CT angiography and invasive coronary angiography will be screened, and optical coherence tomography, FFR and selective CT angiography will be performed. The coronary images and FFR values will be registered, and the patients will be followed-up up to 2 years to investigate the adverse clinical events.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent coronary CT angiography because of chest pain
* Patients who need OCT or FFR evaluation because of intermediate lesions according to invasive angiography (diameter stenosis of 40-70%)
* Age: 20-80 yrs
* Patients who consent and fully understand the protocol
* Patients who consent the clinical follow-up
* Patients who can be followed-up

Exclusion Criteria:

* Patients who had contrast allergy
* Patients who had unstable blood pressure needing the vasopressors
* Patients who had severe left ventricular function (left ventricular ejection fraction\<30%)
* Chronic kidney disease who had Cr level of greater than 2.0 mg/dl
* Patients whose expected survival is less than 12 months
* Patients who had a severe valvular disease
Oxandrolone in Healthy Adults: A Relative Bioavailability Study

To assess the pharmacokinetics and relative bioavailability of a single dose of approximately 0.1 mg/kg of a medium chain triglyceride (MCT) oil oxandrolone solution vs. tablets in a small cohort of healthy adults.

The results of this study will provide data regarding the relative bioavailability of a novel preparation of oxandrolone in MCT oil, which will allow dosing in neonates and small infants. This pilot study will provide information to design a larger multicenter study of neonates undergoing surgery for complex congenital heart disease.

Eligibility Criteria:
Inclusion Criteria:

1. Male
2. Age 18 to 35 years (inclusive) at the time of screening
3. Body mass index \[BMI, body weight (kg)/height (m)2\] below 30 kg/m2
4. Medically healthy

Exclusion Criteria:

1. Known allergy to anabolic steroids
2. Use of any prescription medication currently or within 14 days prior to dosing
3. Use of tobacco or nicotine containing products (including smoking cessation products), within 6 months prior to dosing
4. Any chronic medical condition
5. Seated blood pressure \<90/40 mmHg or \>140/90 mmHg at screening
6. Heart rate \<40 or \>99 at screening
7. Subjects who have taken any investigational drug within 30 days prior to first dose in the current study
Frequency of Aerobic/Resistance Training in Older Women

The objective of this study is to provide insight into the effects combined training frequency has on improving fitness, ease of physical activity, and maintenance of a high total energy expenditure. Such information is critical to our understanding of ways to improve well-being, quality of life, and independence of an aging population. 105 participants will be enrolled in this study. The length of time for your involvement in the study will be 32 weeks. You will undergo the procedures listed in this consent form on 3 separate occasions-initially at your entry, at 16 weeks and again at 32 weeks.

Frequency of aerobic/resistance training in older women

Abstract Combined aerobic and resistance training have unique benefits for maintaining a physical activity (PA). However, the optimal training program for combining these two modes of training in older adults is unknown. This study builds on current and past studies showing that training induced gains in aerobic fitness, muscle strength, and ease of PA are important for maintaining an active lifestyle, a favorable body composition, and high bone density. Traditionally 3 d/wk combined training has been felt to be optimal while recent studies suggest 1 d/wk combined training may create similar adaptations as more frequent training. However, our previous and ongoing studies suggest that 1 d/wk combined aerobic and resistance training (C1) may be insufficient stimulus to induce optimal adaptations and that 3 d/wk combined training (C3) may be too frequent a stimulus for older adults. This study will enable us to compare the effects of C1, 2 d/wk combined training (C2), and C3 on fitness, body composition, ease of PA, PA, and total free-living energy expenditure (TEE). We hypothesize that C2 will result in a larger increase in muscle size, bone density, strength, aerobic capacity, power, ease of PA, PA, and TEE than either C1 or C3. Circulating cytokines and psychological mood states linked to chronic overstress will also be examined. Objectives: We will examine changes in circulating cytokines, mood states, muscle size, bone density, aerobic capacity, strength, power, ease of PA, PA, and TEE following 16 and 32 wks training. Design: We will to evaluate 78 (\>60 yrs) Black and White women matched for age, race, and BMI into C1, C2, or C3 groups prior to, after 16, and after 32 wks training. Women will undergo evaluation of metabolic parameters in a General Clinical Research Center. Significance: This study should provide insight into the effects combined training frequency has on improving fitness, ease of PA, and maintenance of a high TEE. Such information is critical to our understanding of ways to improve well being, quality of life, and independence of an aging population.

Eligibility Criteria:
Inclusion Criteria:,

* healthy women over 60 years of age,
* Caucasian or African-American.

Exclusion Criteria:

* smoking,
* diabetes,
* osteoporosis,
* inability to coperform weight bearing exercises, currently performing to much exercise.
Effect of Vitamin C Supplementation in Corneal Endothelial Damage in Phacoemulsification of Patients with Hard Cataracts

The goal of this clinical trial is to analyze the protective effects of oral ascorbic acid on the corneal endothelial layer undergoing oxidative stress due to phacoemulsification in patients with hard cataracts. The main questions it aims to answer are:

1. Will oral vitamin C administration provide better protection to the corneal endothelium in hard cataract phacoemulsification by comparing preoperative and postoperative administration, preoperative only, and no administration?
2. How does oxidative stress (MDA levels) in the aqueous humour increase after oral vitamin C administration compared to no administration?
3. Will there any changes in MDA levels in the aqueous humour and blood after oral vitamin C administration compared to no administration?
4. Does MDA levels in the aqueous humour correlate with MDA levels in the blood?

Researchers will compare vitamin C to a placebo to see if vitamin C as an antioxidant works in preventing corneal endothelial damage due to phacoemulsification.

Participants will:

* Take 500 mg of oral vitamin C or placebo three times a day for seven days prior to phacoemulsification
* Undergo phacoemulsification
* Take vitamin C or placebo three times a day for 28 days after phacoemulsification
* Visit the ophthalmology clinic 1, 7, 28, and 42 days post-operative for checkups
* Keep a logbook to record the drug they take and to write symptoms of possible side effect of the drug


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 60 years or older
* Patients with immature senile cataracts in one or both eyes, with LOC (lens opacities classification) III nuclear opacity grade 4-6 and nuclear color grade 4-6 criteria
* Patients willing to undergo phacoemulsification cataract surgery and consume the study medication as allocated, as well as participate in follow-up assessments for 7 weeks
* Patients with no history of previous intraocular surgery
* Patients with no history of allergy to vitamin C
* Patients not routinely consuming other vitamins
* Patients who agree to and sign the informed consent for the study

Exclusion Criteria:

-
Effects of Betaine Supplementation on Strength and Muscle Creatine Content

It has been suggested that betaine supplementation may improve muscle strength by increasing muscle creatine content. However, there is no data supporting this assumption. The investigators speculate that betaine supplementation could enhance intramuscular creatine content, which would result in strength improvements.


Eligibility Criteria:
Inclusion Criteria:

* physically inactive
* non-obese

Exclusion Criteria:

* skeletal muscle disturbance
* cardiovascular disturbance
* use of dietary supplements
A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented locally advanced or metastatic NSCLC
* Prior platinum-containing regimen or disease recurrence ≤ 6 months since prior platinum-based adjuvant/neoadjuvant regimen.
* Measurable disease as defined by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy ≥12 weeks
* Adequate hematologic and end-organ function

Additional Inclusion Criteria (Part 2 Only) • Availability of tissue and known epidermal growth factor receptor (EGFR) status

Exclusion Criteria:

* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Uncontrolled or symptomatic hypercalcemia
* Pregnancy or breastfeeding
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
* Severe infection ≤ 4 weeks
* Treatment with therapeutic oral or IV antibiotics ≤ 2 weeks prior to study treatment
* Significant cardiovascular disease
* Prior allogeneic stem cell or solid organ transplantation
* Treatment with a live, attenuated vaccine ≤ 4 weeks
* Treatment with systemic immunostimulatory agents ≤ 4 weeks or 5 half-lives of the drug
* Treatment with systemic immunosuppressive medication ≤ 2 weeks

Additional Exclusion Criteria (Part 2 Only)

• Tested tumor programmed death-ligand-1 (PD-L1) expression status with an intention to treat the patient if positive
A US Non-interventional, Effectiveness and Safety Study of Patients Treated With SKYTROFA

The goal of this study is to genrate evidence on long-term effectiveness and safety of SKYTROFA (lonapegsomatropin) in patients with growth hormone deficiency under routine clinical care

Patients will be treated according to routine clinical practice, and no additional visits, examinations or tests will be required beyond those performed as part of routine clinical practice except for COAs.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are on treatment with SKYTROFA (lonapegsomatropin)
* Patients being clinically managed in USA
* Patients with an appropriate written informed consent/assent as applicable for the age of the patient

Exclusion Criteria:

* Patients participating in any interventional clinical study
Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes

The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 6.6 and ≤ 9.5%
* Stable dose of metformin AND/OR a sulfonylurea, for at least 4 weeks prior to the enrollment visit
* Inadequate blood pressure (BP) control, defined as systolic BP (SBP) ≥ 130 and \< 165 mmHg, AND/OR diastolic BP (DBP) ≥ 80 and \< 105 mmHg
* C-peptide ≥ 0.8 ng/mL
* Estimated GFR by the Modification of Diet in Renal Disease (MDRD) formula \> 60 mL/min/1.73m² and \< 150 mL/min/1.73m²
* Urine albumin:creatinine ratio (UACR) \< 300 mg/g
* BMI ≤ 45.0 kg/m2

Exclusion Criteria:

* Administration of diuretics or other medication approved for the treatment of hypertension (with the exception of either ACEI or ARB), at any dose during the 12 weeks prior to the enrollment visit
* History of adverse reaction to radio-contrast dye
* Allergy or contraindication to use of thiazide diuretics
* Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN)
* Alanine aminotransferase (ALT) \> 3X ULN
* Serum Total Bilirubin \> 1.5X ULN
* Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncologic, endocrine, psychiatric, or rheumatic diseases
Prostate Localization During Radiotherapy Using a Ni-Ti Stent and Electronic Portal Imaging - Protocol II

A new method for localization of the prostate during external beam radiotherapy. The method is based on insertion of a new thermo-expandable Ni-Ti stent. The radiological properties of the stent are used for precise prostate localization during treatment using electronic portal images

Inclusion criteria's in the study were 1) Patients should present with histological verified local or locally advanced PC (stage T2b to T3b, N0, M0; UICC 1992 classification was used). 2) Patients should consequently be candidates for intended curative radiotherapy. Prostatic work up is done before inclusion in the study. A new prostatic Nickel - Titanium stent is placed in the prostatic urethra one week prior to the radiotherapy planning CT using a flexible cystoscope to insert the stent under urethral anaesthesia. The stent is then flushed with hot water (60 degrees Celsius). The hot water expands the stent collar, thereby locking the stent in place. Correct positioning of the stent is secured visually on retraction of the scope. Radiotherapy of prostate is given to a mean dose of 70 (department standard regime). Treatment are given with daily fractions of 2 Gy using a combination of 6 MV and 18 MV X-ray fields using isocentric 3D conformal treatment plan, consisting of three MLC conformal radiation fields (One anterior and two lateral wedged fields). This was assumed to be the optimal treatment plan. A pair of orthogonal 15 cm x 15 cm isocenter setup fields was added to the plan. The orthogonal fields are used to obtain pairs of electronic portal images. Electronic portal images are recorded using a Varian As500 electronic portal imaging device (EPID). The images are used to determine the 3D reference position of the stent. The image pairs of the stent were taken at eight treatment sessions in each patient (Session number 1,2,3,6,11,21,22 and 23). From each orthogonal set of images the 3D position of both the stent and the symphysis (pubic bone) are determined. Positions are calculated using orthogonal reconstruction. A control CT scan is made before treatment session number 21 to verify the intra prostatic position of the stent. The intra prostatic position of the stent is also verified during removal of the stent three months after radiation therapy. Before removal the stent was flushed with water at 10 degrees Celsius. When cooled with 10°C cold water, the stent became super soft, and can easily be removed as a twisted wire.

Eligibility Criteria:
Inclusion Criteria:

1. Patients should present with histological verified local or locally advanced PC (stage T2b to T3b, N0, M0; UICC 1992 classification was used).
2. Patients should consequently be candidates for intended curative radiotherapy -

Exclusion Criteria:

dislocation or removal of stent
The "Self Evaluation of Food Intake" (SEFI) as a Screening Test for Hospital Malnutrition in Children Over 10 Years

The goal is to find a simple tool that can be used by medical and paramedical staff and that is reliable to identify children at risk for malnutrition.

The Ingesta Easy Assessment Score (SEFI®) (formerly "food intake assessment tool or EPA®") is validated in hospitals in adults to detect the risk of malnutrition and guide nutritional management. SEFI® combines a visual analogue scale (VAS) with a visual assessment of the portions consumed (www.sefi-nutrition.com). It comes in the form of a ruler equipped with a cursor and allows a visual assessment, by the patient himself, of his food intake, using an analog scale, or a choice of portions. consumed (see appendix). A score \<7/10 is associated with malnutrition or the risk of malnutrition.

The investigators hypothesize that, in pediatric services for children 10 years of age or older, SEFI® would be a feasible and reliable tool for screening for the risk of malnutrition.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 10 to 17 and hospitalized in pediatric or pediatric surgery, regardless of the reason for hospitalization.
* Whose holders of parental authority have received information on the protocol and have not expressed their opposition to the child's participation in the study,
* Having received information on the protocol and not having expressed opposition to participating in the study.

Exclusion Criteria:

* Patients whose level of understanding does not allow the use of SEFI®
A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis

The goal of this observational study is to learn about risk of progressive pulmonary fibrosis (PPF). The main questions it aims to answer are:

* Risk factors of PPF
* Prevalence of PPF
* Mortality of PPF

Patients with interstitial lung disease (ILD) of known or unknown etiology other than IPF who has radiological evidence of pulmonary fibrosis will enroll in this study.

* All participants will have baseline investigations at the first visit having provided informed consent.
* At the first visit, baseline characteristics will be collected including demographics, medical history, smoking history, complications and medication use. 50 mL of blood will be obtained. High resolution computed tomography (HRCT), full lung function tests and a 6 min walk test will be performed.
* Further visits at 6 months and 12 months will include further 50 mL blood sampling. HRCT, full lung function tests and a 6 min walk test will be repeated.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Agree and sign the informed consent form
* Interstitial lung disease patients with imaging features of pulmonary fibrosis

Exclusion Criteria:

* Patients with idiopathic pulmonary fibrosis (IPF)
* Pregnant or lactating women
* mental illness or cognitive impairment
* participating in other clinical studies
* Unable to sign informed consent form
Voriconazole for IPA in Chinese Patients With COPD

voriconazole is recommended as first-line therapy for invasive pulmonary aspergillosis, however the efficacy and safety of voriconazole for treating invasive pulmonary aspergillosis secondary to COPD is not clear. This study aims to investigate the effectiveness and tolerability of intravenous voriconazole for treatment of invasive pulmonary aspergillosis in Chinese patients with COPD, by monitoring changes in clinical symptoms, eradication of aspergillus, improvement of chest imaging as well as record of possible adverse reactions following 2-week intravenous instillation of voriconazole.

This is a multiple-center open-label clinical trial to study the efficacy and safety of voriconazole for treating invasive pulmonary aspergillosis secondary to COPD in Chinese patients.The primary endpoint is treatment success rate as defined by improvement of symptoms related to invasive pulmonary asperillosis, secondary endpoints include the mortality, the eradication of sputum asperillus and profile of adverse reactions following intravenous instillation of voriconazole.

Eligibility Criteria:
Inclusion Criteria:

* Cases of invasive pulmonary aspergillosis secondary to COPD

Exclusion Criteria:

* Use of voriconazole or itraconazole or amphotericin B or caspofungin or micafungin within 4 weeks prior to enrollment
* Known allergy to voriconazole
* Severe impairment of live or kidney function
* Septic shock
* Unwilling to sign informed consent