cyrilzakka/clinical-trials huggingface dataset:
Sun Protection for Florida's Children

Purpose of the project is to develop a school-based intervention aimed at increasing hat use when children are outside at home and at school. The intervention is targeted to fourth grade children in Hillsborough County, Florida and is based on Theory of Reasoned Action and Planned Behavior. It is structured to accomplish the following goals: (a) increase sun protection knowledge of children in regards to hat use,(b) foster more positive attitudes in regard to wearing hats,(c) change the subjective norms of wearing hats (d) target persons that children perceive as controlling their behavior of wearing hats(parents,teachers) and increase the use of hats when children are outdoors at school(primary outcome) and when outdoors at times other than school(secondary outcome).

Intervention is aimed at encouraging students to use a wide brim hat when participating in outdoor activities. To accomplish this goal our approach will be multifaceted and will include:

1. individual sessions with school principals to facilitate a school policy that encourages hat use when children are outdoors.
2. sessions with fourth grade teachers that explains the importance of sun protection and hat use, and that addresses potential concerns by teachers.
3. classroom sessions with fourth grade children that improves sun protection knowledge, fosters more positive attitudes about hat use. and that changes the subjective norm of wearing hats when at school.
4. follow-up sessions in which children are provided free hats with a customized design that represents their school.
5. sun protection educational materials that are mailed to the parents of targeted children.

Eligibility Criteria:
Inclusion Criteria:

* One fourth/one fifth grade class.
* 20 students minimum.
* 25% of students are Caucasian.
* Principle/teachers agree to participate.
* Majority of parents agree to participate.
* Majority of 4th grade students provide written assent.
* One outdoor session lasting 20 minutes once per week where children are directly exposed to the sun.
* Outdoor session in an area observable by data monitors.
* School can accommodate intervention components of study.
* School environment stable over the intervention period.
* Randomized control school delay sun protection initiatives until project is completed.

Exclusion Criteria:

-
Discontinuation for Oral Anticoagulants in Patients With Atrial Fibrillation

The purpose of this study is to compare the discontinuation rates for vitamin K antagonists and for direct oral anticoagulants during their first year

The purpose of this study is to compare the discontinuation rates for vitamin K antagonists and for direct oral anticoagulants during their first year of use after their initiation during hospitalization in patients covered by our health insurance plan.

Eligibility Criteria:
Inclusion Criteria:

1. Patient older than 18 years of age covered by our Health Care Insurance Plan.
2. Indication for oral anticoagulation with an expected duration of use of no less than 1 year.

Exclusion Criteria:

1. Refusal to take part.
2. Use of oral anticoagulants within 6 months prior to admission.
3. Presence of mechanical prosthetic valve.
4. Chronic renal failure with creatinine clearance \<30 mL/min (estimated using the MDRD formula).
Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position

Goal of this study is to determine optimal PEEP levels for patients undergoing surgery in lateral decubitus position. Patients will be randomized into 3 groups - PEEP 0, 5 and 10 mbar. Endotracheal anesthesia will be conducted with propofol, fentanyl, rocuronium and sevoflurane/O2/air gas mixture.

Patients with preexisting lung disease, organ transplants and disseminated malignant disease will be excluded.

Demographic data - age, weight, height, ASA status, smoking history will be recorded. EIT measured parameters - tidal variation ratio of nondependent and dependent lung, regional end-tidal and end-expiratory lung impedances as well as horizontal and vertical centers of ventilation will be recorded and calculated at 3 time points - before anesthesia induction, 5 minutes after lateral positioning of the patient and 90 minutes after lateral positioning. ABGs will be sampled to calculate aA gradient and Horovitz quotient at those time points as well as measured hemodynamic parameters (HR, BP, CI, SVI).

Primary endpoints for the study are nondependent/dependent tidal variation ratios measured at predefined time points and changes in ABGs. Secondary endpoints are number of postoperative pulmonary complications (defined as new onset of pneumonia during 28 days of followup), length of hospital stay and changes in hemodynamic parameters.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for nephrectomy, adrenalectomy or urterotomy surgery which will be performed in lateral decubitus position
* signed informed consent form

Exclusion Criteria:

* preexisting moderate to severe obstructive (GOLD score \> 1) or restrictive lung disease (FVC \< 85%)
* history of organ transplant
* disseminated malignant disease
* pregnancy
The Prognostic Impact of Tumor Location in Non-Muscle-Invasive Bladder Cancer Patients

Based on large sample size studies at home and abroad, the prognosis of patients with non-muscular invasive bladder cancer in different sites undergoing transurethral bladder tumor resection was determined, providing important guidance for subsequent clinical treatment and surgical instrument development.

Background Most bladder cancers are non-muscle invasive bladder cancer (NMIBC), and transurethral resection of bladder tumors (TURBT) is the standard treatment. However, postoperative recurrence poses a challenge, and the influence of bladder tumor location on prognosis is unclear. This study aims to investigate how tumor location affects NMIBC patients' prognosis undergoing TURBT, and seeks optimal surgical approaches.

Methods Conducted a multicenter study, including Chinese NMIBC data from 15 hospitals (1996-2019) and SEER 17 registries (2000-2020). Analyzed patients initially diagnosed with NMIBC undergoing TURBT or partial cystectomy, excluding cases with lost follow-up or missing data. Studied overall survival (OS), disease-specific survival (DSS), and recurrence-free survival (RFS). Employed Kaplan-Meier, Cox regression, and propensity score matching to explore the association between tumor location and prognosis. Stratified populations were analyzed to minimize bias.

Findings This study, involving 118,477 NMIBC patients, highlighted tumor location as a crucial factor impacting post-TURBT prognosis. Anterior wall and dome tumors independently predicted adverse outcomes in both cohorts. For anterior wall tumors, Chinese cohort showed OS HR 4.35, p \< 0.0001; RFS HR 2.21, p \< 0.0001; SEER OS HR 1.10, p = 0.0001; DSS HR 1.13, p = 0.0183. Dome tumors displayed similar trends (Chinese NMIBC cohort OS HR 7.91, p \< 0.0001; RFS HR 2.12, p \< 0.0001; SEER OS HR 1.05, p = 0.0087; DSS HR 1.14, p = 0.0006). Partial cystectomy significantly improved dome tumor survival compared to standard TURBT (p \< 0.01).

Interpretation This study reveal that NMIBC tumor location significantly influences TURBT treatment outcomes. Specifically, tumors in the anterior wall and bladder dome have worse post-TURBT prognosis. Compared to TURBT, partial cystectomy improves prognosis for bladder dome tumors. This study guides personalized treatment and prognosis management for NMIBC patients.

Eligibility Criteria:
Inclusion Criteria:

1. Initially diagnosed with non-muscular invasive bladder cancer (NMIBC) who underwent TURBT or partial cystectomy.
2. The follow-up data of the patients were complete.
3. The tumor location information were complete.

Exclusion Criteria:

1. Patients with unknown survival time or missing tumor location information were excluded.
2. Exclude patients with missing pathological results.
3. Exclude patients who have had TURBT before.
Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients

The researchers tested the hypothesis that a protein pulse-feeding pattern was more efficient in improving muscle mass and immune functions than was a protein spread-feeding pattern, after 45 days, in elderly malnourished patients.

To estimate the amelioration of the accretion in protein and the immunizing deficit thanks to a nutrition "PULSEE" ( to hold on 80 % of the proteic by day in on meal) with a proteic distributed all along the day for old subjects having a denutrition

To also estimate that the diminution of the morbidity decrease (infections, bedsores) the average during the stay and the mortality according to 2 modalities of grip nutritional

Eligibility Criteria:
Inclusion Criteria:

* Must be malnourished
* Hospitalization into a geriatric rehabilitation care unit
* Age \> 70 years
* C-reactive protein (CRP) \< 50 mg/l

Exclusion Criteria:

* Enteral or parenteral nutrition
* Renal, cardiac or digestive insufficiency
* Diabetes
* Pacemaker
* Mini-Mental State (MMS) \< 15
Prospective, Post Market Surveillance Q3-registry (POLARIS)

This is a prospective, non-randomized post market surveillance registry designed to document the clinical Performance in Routine clinical practice of the POLARIS Peripheral Vascular Self Expanding Stent System


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Single target de novo superficial femoral artery lesion (angiographic evidence of \>50% Stenosis or occlusion) by visual estimate
* Rutherford category II-IV
* At least one patent outflow artery to the ankle.
* Patient signed the informed consent

Exclusion Criteria:

* Patient with acute or subacute Thrombus
* Patients with hyperkoagulopathy
* Patients with Stenosis or occlusion where lesion crossing with guide wire is not possible
* Pregnancy or positive pregnancy test
* Previous enrolment in this Trial or other industrial Trials
* Patient´s inability to fully cooperate with the registry protocol Patient with cancer Treatment (life expectancy less than 2 years) Patients with renal failure
Multisession Radiosurgery in Residual/Recurrent Grade II Meningiomas.

Fractionated radiosurgery will be delivered to atypical meningioma lesions in salvage setting for patients who present post-surgical residual lesion or develop recurrence.

Meningioma is the most common intracranial tumor (1). World Health Organization (WHO) grade II (atypical) meningioma recurs more frequently than WHO grade I (benign) meningioma, and patients with subtotally resected atypical meningioma should be treated with adjuvant radiation therapy (2). However, many atypical meningiomas can be gross totally resected, and whether to administer radiation to this population remains unclear. Apart from extent of resection, clinical characteristics such as age and gender and tumor-related characteristics such as tumor size and location have poor predictive capacity to determine which lesions will recur.

The lack of professional consensus on the role of adjuvant radiation therapy (RT) derived from the heterogeneity and retrospective nature of the published data: standard fractionation fails to demonstrate a benefit in term of local control and survival.

Recent advances in radiotherapy technology (staged radiosurgery) give the possibility to reach high dose levels only in tumor volume and in the same time to save the surrounding healthy tissues.

The purpose of this study is to verify the related toxicity of a new radiotherapy protocol and as second end point to evaluate the efficacy on disease local control at 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients had residual or recurrent atypical meningioma (grade II) after surgery (Simpson score)
* Age: ≥ 18 years old
* Karnofsky performance Status ( KPS) ≥ 70
* Written consent

Exclusion Criteria:

* Pregnancy
* Neurofibromatosis type 2 (NF2)
* Concomitant aggressive haematological or solid neoplasm
Causes of Visual Loss in Retinal Disease

This is a study of visual outcomes in retinal disease that seeks to identify the causes of visual loss. This data will be used to predict which patients are at risk of losing vision and how they can be better treated.

This is a study of visual outcomes in retinal disease. It is an observational study of patients who have been seen in the retinal clinic, and involves a retrospective casenotes analysis to identify patients who have suffered visual loss and the reason for that visual loss. These data will be analysed to enable the identification of factors that predict visual loss in patients who present earlier in the course of their disease.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of ocular inflammation
* patients with at least 6 months of follow-up

Exclusion Criteria:

* patients without a diagnosis of ocular inflammation
* patients with less than 6 months of follow-up
Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath

IgA nephropathy(IgAN) is the highest incidence of kidney pathology in the primary nephropathy. In terms of differences in prognosis, severe IgA nephropathy,one of the most main primary renal disease,could cause the uremia. It will be significant that early indicators of prognosis and early intervention can be normalized and the scientific criteria for judging the efficacy of great clinical can be established. The subject based on the past study,literature research and various treatment will take the method of multi-center, double-blind, randomized, control to investigate the standard treatment of severe IgA nephropathy. Otherwise the uniformity and objectivity of Traditional Chinese Medicine (TCM) will be improved by the standardization of TCM research based on the epidemiological investigation and statistical analysis. The subject will determine the efficacy of more sensitive biomarkers and establish more scientific criteria for judging the effect with the application of urine proteomics and metabolomics technologies in order to operate in the formation of the standardization program of the treatment of severe IgA nephropathy with the Integrative medicine of TCM.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed by renal biopsy and clinical examination as primary IgA nephropathy.
* Pathology:upon Lee's grade Ⅲ
* Age :18-60 years old.
* Gender and nationality are not limited
* Chronic Kidney Disease(CKD) Stage 3:（59 ml/min\>GFR\>30ml/min/1.73m2）
* 24-hour urine protein:≥1.0g.Informed consent

Exclusion Criteria:

* Patients within the past 3 months had received immunosuppressive agents or cytotoxic therapy is greater than 4 weeks
* Patients within the past 3 months who have received corticosteroids (prednisone or prednisolone) dose of more than 20mg / d up to 4 weeks
* Patients suffering from acute or rapidly progressive glomerulonephritis
* Patients continue with active hepatitis B and abnormal liver function tests transaminase
* Patients with a history of malignant tumor or malignancy, HIV infection, history of mental illness, acute central nervous system disorders, severe gastrointestinal disease, prohibiting the use of immunosuppressive agents
* Abnormal glucose metabolism, fasting blood glucose more than 6.2mmol/L
* Pregnancy or breast-feeding women
* Receiving other clinical trials
* Associated with other serious diseases and organ dysfunction
* Combined life-threatening complications such as severe infection
Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma

This observational study aims to gather comprehensive data on primary ovarian leiomyosarcoma (POLMS). This extremely rare malignancy accounts for less than 3% of primary ovarian malignancies and has an incidence of only 1% among ovarian cancers. This national, retrospective and prospective multicenter study will collect and analyze historical cases of POLMS with remote diagnoses accessed through clinical case reviews and newly identified cases. The study aims to expand a previously identified series of 113 cases described in the literature, uncovering patterns in diagnosis, treatment, and outcomes and ultimately establishing evidence-based guidelines for the optimal management of this rare and aggressive cancer.

This study adopts a national, multicenter, observational design, incorporating both retrospective and prospective methodologies to collect and analyze primary ovarian leiomyosarcoma (POLMS) cases. The retrospective component will include cases diagnosed since 1980, leveraging institutional archives and clinical case reviews.

Data collection will be standardized using an electronic Case Report Form (eCRF) implemented on REDCap. All data will be centralized for uniformity and undergo rigorous validation to ensure consistency across centers. Findings will be reported in aggregated form to preserve patient confidentiality.

The study will gather extensive data points, including:

* Patient demographics.
* Clinical presentation and tumor characteristics (symptoms, tumor markers such as CA-125, CEA, and Ki-67).
* Treatment modalities (surgical details, lymphadenectomy, chemotherapy, radiotherapy, or hormonal therapy).
* Recurrence patterns and outcomes (disease-free survival, overall survival).
* Immunohistochemical findings (positivity for desmin, SMA, and vimentin). The statistical analysis primarily involves descriptive and exploratory techniques to identify patterns and correlations within the dataset.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary leiomyosarcoma of the ovary;
* Patients diagnosed with POLMS for whom data relating to diagnosis and treatment are available.
* Aged between 18 and 99 years

Exclusion Criteria:

- All patients with other forms of ovarian sarcoma (rhabdomyosarcomas, fibrosarcomas, stromal cell sarcomas) and patients diagnosed with leiomyosarcoma of the uterus will be excluded.
A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC;
* adequate liver and kidney function;
* women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment.

Exclusion Criteria:

* prior chemotherapy or treatment with another systemic cancer therapy;
* surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment;
* brain metastasis or spinal cord compression;
* fertile men, and women of childbearing potential, not using adequate contraception;
* treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.
The Use of Fibrin Sealant to Reduce Bleeding After Total Knee Replacement

A randomized controlled study is performed to address the question of whether the topical application of a novel fibrin sealant, Evicel (Johnson \& Johnson Wound Management, Ethicon, Somerville, NJ) in patient undergoing total knee replacement (TKR) reduce the perioperative blood loss and the need for allogenic blood transfusion compared to a control group. We hypothesize that fibrin sealant decrease the drop in post-operative hemoglobin level after total knee replacement.

Total knee replacement is an invasive surgical procedure that can expose patients to massive perioperative bleeding. This hematic loss results in a high rate of blood transfusion after total knee replacement (TKR) with an incidence from 10% to 58%.Methods to prevent the need for allogenic blood transfusion after TKR include hemodilution, perioperative blood salvage and reinfusion, hypotensive anesthesia, preoperative autologous blood donation and intravenous administration of tranexamic acid.

In the last decade, the topical use of fibrin sealant has become a logical surgical stratagem for reducing blood loss in total knee arthroplasty.Fibrin sealants mimic the final step of the coagulation cascade reducing blood loss and transfusion requirements.

A novel hemostatic agent derived from banked allogenic human plasma (EVICEL, Johnson \& Johnson Wound Management, Ethicon, Somerville, NJ) is recently available on the market for a variety of surgical specialty.

A randomized controlled study is conducted to test if the post-operative reduction in hemoglobin level would be lower in the fibrin sealant group compared to a control group.

Eligibility Criteria:
Inclusion Criteria:

* patient scheduled for TKR
* written informed consent
* diagnosis of osteoarthritis

Exclusion Criteria:

* previous intervention on the same Knee (except for meniscectomy)
* Hb pre-operative level lower than 12g/dl for man and 11g/dl for woman
* Anticoagulation therapy or any anti-aggregate treatment not suspended at least 4 days before surgery
Renal Protective Effect of ACEI and ARB in Primary Hyperoxaluria

This study will test the effectiveness of two medications: ACEI (angiotensin converting enzyme inhibitor)and ARB (angiotensin receptor blocker) in reducing the renal injury induced by hyperoxaluria in patients with Primary Hyperoxaluria.

Hypothesis: Calcium oxalate crystal deposition in the kidney causes inflammation and resulting injury to kidney tissue. Angiotensin blockade will improve these changes, thus slowing the progression of renal insufficiency in patients with Primary Hyperoxaluria.

In patients with primary hyperoxaluria (PH), deficiency of hepatic enzymes important in disposition of glyoxylate results in marked hyperoxaluria. Calcium oxalate crystals and high oxalate concentrations in the renal filtrate result in inflammation and injury in the renal parenchyma. Loss of renal function over time is characteristic, with end stage renal failure occurring in half the patients by age 35 years, but as early as infancy in some patients. Experience in animal models of hyperoxaluria, and from other renal diseases, supports a role for ACEI and ARB medications in ameliorating inflammation and injury thus providing a renal protective effect.

We propose to study the short-term effect of combined angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocking (ARB) therapy in patients with PH, in a controlled, randomized, two-year study. Primary endpoints will be urinary markers of renal tubular injury (retinol binding protein (RBP), alpha 1 microglobulin (α1m), γ-glutamyl transferase (GGT)) and interstitial fibrosis (transforming growth factor beta 1 (TGFβ1). Secondary endpoints will be the rates of change in renal tubular injury and renal function as determined by serum creatinine and creatinine clearance.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of PH established by liver enzyme analysis in the patient or an affected sibling, DNA testing for mutations of the AGXT and GR/HPR gene, or meeting clinical criteria (Urine oxalate \> 70 mg/1.73 m2/day in the absence of malabsorption or dietary excess of oxalate. Elevated urine glycolate or glycerate provides supporting evidence of type I or type II PH, respectively).
2. Hyperoxaluria that persists during treatment with pyridoxine.
3. Ten years of age or older.
4. Glomerular filtration rate \> 50 ml/min/1.73 m2 at the start of the study.
5. Women of child bearing age will be required to use adequate contraception for 3 months before and throughout the study.
6. Patients will be on a stable program of pyridoxine, neutral phosphate, or citrate medications -

Exclusion Criteria:

a. Age \< 10 years. b. Glomerular filtration rate \< 50 at start of study c. Hypersensitivity to ACEI or ARB medications d. Chronic use of ACEI or ARB medications prior to enrollment e. Hyperkalemia f. Previous renal transplant g. Homozygosity for the G170R mutation of AGXT h. Unwillingness to use adequate contraception during the study. i. Pregnancy

-