cyrilzakka/clinical-trials huggingface dataset:
Environment and Lung Cancer

Cannabis is the most consumed drug in the world and the French are the main consumers in Europe. The most recognized effects of cannabis on human health are of a neuro-psychic nature. The medical literature on the effects of cannabis on the lung in general, and on lung carcinogenesis in particular, is most often reassuring (Tashkin, Chest 2018; Zhang, Int J Cancer 2015; Ghasemiesfe JAMA Netw. Open. 2019), despite the fact that the concentration of carcinogens in cannabis smoke is higher than that contained in tobacco smoke (Moir, Chem. Res. Toxicol. 2008), and that cannabis smoking has been implicated in the occurrence of ENT cancers. Rather, research focuses on the therapeutic effects of cannabis, especially analgesics, and even on its possible anti-tumor virtues (Abrams, Jama Oncol. 2020). These reassuring data should, however, be viewed with a great deal of caution. On the one hand, the illegal nature of cannabis in most countries and its frequent association with tobacco consumption make studies on the subject difficult and often biased. On the other hand, the daily practice of oncologists, who observe numerous cases of advanced and rapidly progressive lung cancer occurring in young patients who are heavy users of cannabis, raises suspicion of an unrecognized role of cannabis in lung carcinogenesis.

In a preliminary multicenter study on French patients under 50 years of age operated for primary lung cancer (Betser, ERJ 2021), we demonstrated that cannabis consumption was extremely frequent, concerning 43% of patients, but mentioned in patients' medical records only in 4 out of 10 cases, while the smoking status was always noted.

In addition, by comparing people who smoke cannabis (always here associated with tobacco) to patients who only smoke tobacco or to non-smokers, we identified a different profile of lung cancers, with more poorly differentiated tumors, presenting at a more advanced stage (more T3-T4 versus T1-T2) requiring more complex surgery, and mostly located in the upper lobes of the lung.

Similar research work is currently underway at Gustave Roussy (Dr Pradere-Dr Planchard, Villejuif, France) on patients with metastatic lung cancer, with a focus on overall survival and molecular profile.


Eligibility Criteria:
Inclusion Criteria:

* Any patient from 18 y.o to 59 y.o treated in one of the three above-mentioned hospitals for primary lung cancer, whatever its stage, and agreeing to participate in this research.

Exclusion Criteria:

* Patient denied participation.
Detection of Subclinical Atherosclerosis in Asymptomatic Individuals

This study will evaluate the use of cardiac CT in identifying atherosclerosis plaque in patients who have not been diagnosed with atherosclerosis and who have no symptoms of the disease but who are at risk of developing atherosclerosis based on traditional risk factors such as diabetes or a family history of coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Males between ages 35-90 or females between ages 40-90
* No known coronary artery disease

  * no prior coronary disease by cardiac catheterization (no more than 40% in any major epicardial vessel)
  * no prior myocardial infarction
  * no prior ST-elevation myocardial infarction (1 mm ST-elevation in 2 contiguous leads)
  * no prior non-ST-elevation myocardial infarction (CK-MB \> 2x ULN or elevated troponin that is indicative of myocardial necrosis based on local institutional cutpoints)
  * no prior coronary revascularization procedure
* Aymptomatic

  * no chest pain, shortness of breath, angina or angina-equivalent that is assumed to be related to myocardial ischemia
* Presence of a high-risk feature (at least one of the following four will quality)

  * High FRS ≥20% (http://hp2010.nhlbihin.net/atpiii/calculator.asp)
  * Diabetes Mellitus
  * Premature CAD in a first-degree relative
  * High Risk Lipid Profile (must meet one of the following laboratory criteria)

    1. LDL \> 250 mg/dL
    2. HDL \< 20 mg/dL
    3. Triglycerides \> 1000 mg/dL
    4. LP(a) \> 80 mg/dL
* Provide written informed consent and Authorization for Use/Disclosure of PHI

Exclusion Criteria:

* Known genetic form of hypercholesterolemia based on clinical criteria (e.g. familial hypercholesterolemia, etc.)
* Creatinine 1.5 mg/dL or greater
* Irregular rhythm precluding cardiac CT examination
* Uncontrolled hypertension (SBP\>210 mmHg or DBP\>140 mmHg on treatment)
* Known moderate or severe allergy to iodine-based contrast agents (mild prior reactions that could be treated as an outpatient or that could be prevented by pre-medication in the past do not constitute exclusion)
* Known Pregnancy
* Unwilling or unable to consent
* Presence of any co-morbidity that makes life expectancy less than 24 months
* Unwilling or unable to complete follow-up
* Unwilling or unable to provide written informed consent and Authorization for Use/Disclosure of PHI
Prospective Study of Using Novel Bipolar Scissors in Colorectal Endoscopic Submucosal Dissection

This study is an interventional, prospective, single-center study to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD in patients with superficial colorectal neoplasia.

This is a prospective study with the following study Objectives:

1. To evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD.
2. To assess the impact of the procedure on patient recovery time and postoperative adverse event.

This study is an interventional, prospective, single-center study to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD in patients with superficial colorectal neoplasia. Patients will undergo a ESD for superficial colorectal neoplasia. All ESD procedures will be performed by expert endoscopists with at least 50 prior experience of ESD.

Eligibility Criteria:
Inclusion criteria:

* Adult patient (age ≥18 and ≤80 years-old)
* Capability of understanding and complying with the study requirements, including signing the informed consent form.
* Patients with colorectal superficial mucosal neoplasia (clinically adenoma or early intramucosal cancer), scheduled to undergo endoscopic submucosal dissection (ESD).

Exclusion criteria:

* Patients unable or unwilling to provide consent.
* Patients with lesions unsuitable for ESD, including those suspicious of deep submucosal invasive cancer.
* Patients with lesions involving the appendiceal orifice or ileocaecal valve.
* Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake monitored anesthesia for the procedure.
* Poor performance status (Eastern Cooperation Oncology Group performance status ≥3).
* Pregnant women or those planning pregnancy or breastfeeding women.
* Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet count \< 50000/µl.
Intraocular Lens Implant Registry Study

The goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery.

A variety of intraocular lens implants are available for patients undergoing cataract surgery and new technologies are continuously being developed in this field.

In the planned monocentric retro- and prospective clinical study, a database to optimize outcomes with modern intraocular lens implants will be established to further improve anatomical and functional outcomes.

Patients treated with an intraocular lens implant will be included. The retrospective evaluation of data includes data routinely collected prior to study inclusion (preoperative, intraoperative, postoperative up to the 1st study visit). Prospectively, refraction, visual acuity, examination findings, intraocular pressure and complications are recorded 1-6 months postoperatively. Depending on the type of IOL, results of further non-invasive measurements are also recorded. Optional follow-up visits with the aforementioned examinations are possible up to 10 years postoperatively.

Eligibility Criteria:
Inclusion Criteria:

Treatment with an intraocular lens implant 18 years of age or older Patient consent Full legal capacity

Exclusion Criteria:

Dementia Pregnancy Breastfeeding
The Study to Evaluate Efficacy and Safety of Candesartan vs Losartan in Hypertension With Heart Failure (HONOR)

The purpose of this study is to compare efficacy and safety of candesartan and losartan in hypertension with heart failure.

This is a randomized, open-label, phase 4 study. wash out periods need at least 14 days if the patients take ARB or ACE inhibitor to control Blood pressure. Patients take Candemore or Cozzar once a day during 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients who aged above 19 and below 75
* Patients with 90\~109mmHg average sitting DBP on baseline
* NYHA class 2\~4
* Patients who agreement with written informed consent

Exclusion Criteria:

* above 110mmHg sitting DBP and/or 180mmHg sitting SBP
* Patients who have difference values that above 20mmHg sitting SBP or 10mmHg sitting DBP in both arms on screening
* Patients who have medical history that secondary hypertension or rule out secondary hypertension
* malignant hypertension
* symptomatic postural hypotension
* right heart failure due to pulmonary disease
* etc.
Effect of Conjugated Linoleic Acid Alone and in Conjunction With Vitamin E in Patients With Type 2 Diabetes Mellitus

Conjugated linoleic acids (CLAs) comprise a family of linoleic acid (18:2n-6; LA) isomers that are formed by biohydrogenation and oxidation processes in nature. The main form of CLA, cis-9, trans-11-18:2, can be produced directly by bacterial hydrogenation in the rumen or by delta-9 desaturation of the co-product vaccenic acid (trans-11-18:1) in most mammalian tissues including man. The second most abundant isomer of CLA is the trans-10, cis-12-18:2 form. Observations clearly emphasize that differences exist between mammalian species in their response to CLAs with mice being the most sensitive. The majority of studies on body compositional effects (i.e. fat loss, lean gain), on cancer and cardiovascular disease attenuation, on insulin sensitivity and diabetes and on immune function have been conducted with a variety of animal models. Recent studies indicate that some but not all of the effects observed in animals also pertain to human volunteers. Reports of detrimental effects of CLA intake appear to be largely in mice and due mainly to the trans-10, cis-12 isomer. Suggestions of possible deleterious effects in man due to an increase in oxidative lipid products (isoprostanes) with trans-10, cis-12 CLA ingestion require substantiation. Unresponsiveness to antioxidants of these non-enzymatic oxidation products casts some doubt on their physiological relevance. We hypothesized that supplementation with CLA + an antioxidant (vitamin E) in patients with diabetes mellitus may have beneficial effects on glycemic control and insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus \> 5 years
* HbA1c ≤ 9%
* Overweight or obese (BMI ≥ 25 kg/m2 and ≤ 30 kg/m2)
* Age ≥ 30 and ≤ 70 years (postmenopausal if female)
* Stable medical therapy for past 3 months
* Stable serum glucose for past 3 months (128-180 mg/Dl)
* Age between 30 to 50
* Use of metformin
* TG \< 240 mg/Dl
* No alcohol, no insulin, no smoke
* No pregnancy, no menopause

Exclusion Criteria:

* Personal history of coronary heart disease
* Cerebrovascular disease or vascular disease
* Renal or hepatic disease
* Inflammatory diseases and thyroid diseases within the last years
* Use of drugs known to affect glycemic control, beta blockers, any change in daily activity profile, and diet
Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure

This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure.

This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure. Data will be collected from preoperative urogynecological testing and medical histories. The urethral length will be measured intraoperatively using scaled catheters. Outcome data, including the development of postoperative complications, will be collected at several time intervals.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has objective, demonstrable signs of stress urinary incontinence (SUI), including patients with intrinsic sphincter deficiency (ISD). Objective testing includes: standing stress test, urodynamics evaluation or pad test.
2. Patient is age 18 or older.
3. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the Institutional Review Board/Ethics Committee-approved informed consent form.
4. Patient is able to fill in all questionnaires (based on judgment of investigator)

Exclusion Criteria:

1. Patient has an associated or suspected neurological disease.
2. Patient has an active lesion or present injury to perineum or urethra.
3. Patient has a urethral obstruction.
4. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
5. Patient has current urinary tract infection.
Influence of Imaging Angle in Measurement of Cisterna Magna

The aim of this study is to determine the effect of imaging angle on the measurement of fetal cisterna magna (CM) in the second trimester.

Fetal CM will be prospectively measured in women at 18-24.6 weeks' gestation. Measurements will be made on different angles between the transducer and fetal cerebellar axial plane with internal landmarks.

Design: Observative, cross sectional

Patients and methods: women with low risk single pregnancy will be studied. Fetuses with multiple pregnancies, maternal chronic disease and severe congenital anomalies except mega cisterna magna (MCM) will be excluded from the study. Measurements will be performed on the axial cerebellar plane.The anteroposterior measurement will be made between the posterior border of the cerebellar vermis and the internal face of the occipital bone.

The primary outcome variables will be cisterna magna length measured on different angles between the transducer and the axial cerebellar plane of the fetal head.

Cisterna magna length measurement related to fetal presentation and gender will be secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between the 18th and 24th weeks.
* Confirmed gestational age by regular menstrual cycle or determined from crown- rump length at first trimester ultrasonography for those with unknown menstruation date .

Exclusion Criteria:

* Uncertain gestational age
* Twin or multiple pregnancy.
* Increased risk for aneuploidy determined by first trimester screening.
* Absence of intracranial translucency in first trimester ultrasound examination.
* Fetal malformations identified EXCEPT megacisterna magna.
* Karyotype anomaly.
* Chronic maternal diseases such as arterial hypertension, diabetes mellitus, hypothyroidism and hyperthyroidism.
* Failure to obtain accurate measurement for technical reasons.
Outcome Predictors in Patients With Severe Sepsis and Optimized Central Venous Oxygen Saturation

The investigators perform a prospective observation study to search for the outcome predictors (ScvO2 and lactate) in patients with severe sepsis after admission to ICU.

Early goal-directed therapy in patients with severe sepsis or septic shock was found to provide survival benefit.It was thought that early optimization of ScvO2 within 6 hours in emergency department brought survival benefit to patients of septic shock or severe sepsis.On the other hand, early lactate clearance is associated with improved outcome in patients with severe sepsis or septic shock. In patients with severe sepsis and septic shock, those with low lactate clearance had poor prognosis, despite optimization of ScvO2. It is unknown if ScvO2 could still guide hemodynamic resuscitation after admission into ICU. The investigators perform a prospective observation study to see the correlation between ScvO2 and clinical outcome (including organ failure, disease severity, and survival) and the correlation between lactate and clinical outcome. Furthermore, if ScvO2 \>= 70% is still of prognostic significance in ICU, we will investigate the outcome in patients with high ScvO2 and high serum lactate levels, and to evaluate the clinical features of this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who are admitted to medical intensive care units with severe sepsis or septic shock

Exclusion Criteria:

* Patients would be excluded if they have any one of the exclusion criteria, \*including pregnancy

  * presence of acute cerebral vascular attack
  * acute cardiogenic lung edema
  * status asthmatics
  * cardiac dysrhythmia as the primary diagnosis
  * massive gastrointestinal bleeding
  * epileptics
  * drug overdose
  * requirement of immediate surgery
  * hematologic malignancies
  * febrile neutropenia
  * treatment with immunosuppressive agents before admission
  * advanced malignancy and poor pre-admission performance status
  * with inevitable short-term mortality or morbidity
  * HIV infection
  * refusal of consent
Galectin-3 in Septic and Non-septic Acute Kidney Injury

Acute kidney injury (AKI) is a common critical condition with high morbidity and mortality. The level of circulating Galectin-3 (Gal3) largely depends on renal function, so it is elevated in patients with AKI or CKD; elevated Gal3 also aggravates the progression of CKD after the onset of AKI. The proinflammatory and profibrotic properties of Gal3 may render it to be one of the key molecules mediating AKI, CKD, and cardiorenal syndrome. In this prospective observational study, the investigators will explore the differences of Gal3 levels among septic AKI, non-septic AKI, and non-AKI patients and its correlation with prognosis, inflammation, and disease severity in the ICU.

Acute kidney injury (AKI) is a common critical condition with high morbidity and mortality. Not only can AKI cause death in the acute phase, but also can it be associated with the development of chronic kidney disease (CKD) or the progression of CKD. Galectins are members of a lectin family widely expressed in vertebrates, among which galectin-3 (Gal3) is the most studied one. The level of circulating Gal3 largely depends on renal function, so it is elevated in patients with AKI or CKD; elevated Gal3 also aggravates the progression of CKD after the onset of AKI. The proinflammatory and profibrotic properties of Gal3 may render it to be one of the key molecules mediating AKI, CKD, and cardiorenal syndrome. However, the mechanisms of AKI differ from different etiologies, and the process and extent of levels of Gal3 may be also different, so its predictive value in prognosis may vary in different types of AKI. In critically ill patients, AKI is a common complication of sepsis, and sepsis is the most common trigger of AKI. In this prospective observational study, the investigators will explore the differences of Gal3 levels among septic AKI, non-septic AKI, and non-AKI patients and its correlation with prognosis, inflammation, and disease severity in the ICU.

Eligibility Criteria:
Inclusion Criteria:

* 1. 18 years old or more.
* 2. The patient himself or his agent is able to provide informed consent and provide adequate information for the endpoint assessment.
* 3. Renal function was stable before this onset, and there was no evidence of plasma creatinine rising by 0.3 mg/dL within 3 months of study entry and not receiving RRT.

Exclusion Criteria:

* 1. Age less 18 years old.
* 2. There were previous acute kidney injury, kidney transplantation, chronic kidney disease, or with a glomerular filtration rate of less than 30 mL/min, or hepatorenal syndrome, or pregnancy.
* 3. Patients with an expected survival time of less than 6 months.
Top Down Versus Step up in Pediatric Ulcerative Colitis

Pediatric Ulcerative Colitis (UC) patients with moderate to severe disease activity at high risk of colectomy. Early use of biologic agents will likely be more effective. But there were no studies identified that compared a strategy of upfront biologic-based therapy versus gradual step-up therapy. In our study, newly diagnosed moderate to severe pediatric UC patients (6-18 years old) will be randomly divided into infliximab (IFX) treatment group (Top down group, TD) and corticosteroids (CS) treatment group (Step-up group, SU). Mucosal healing rate at week 12 will be compared between the two groups. The relapse rates and sustained durations of remission within one year will also be evaluated.

Pediatric ulcerative colitis (UC) is typically more extensive and has a more active disease course than adult UC. Pediatric UC patients with moderate to severe disease activity at high risk of colectomy. Rapid disease control may improve the prognosis of the disease and reduce the rate of surgery. Early use of biologic agents will likely be more effective. But there were no studies identified that compared a strategy of upfront biologic-based therapy versus gradual step-up therapy. In our study, newly diagnosed moderate to severe pediatric UC patients (6-18 years old) will be randomly divided into infliximab (IFX) treatment group (Top down group, TD) and corticosteroids (CS) treatment group (Step-up group, SU). A decrease of pediatric ulcerative colitis activity index (PUCAI) at least 20 points were defined as Clinical response. Clinical response will be evaluated at week 2 in SU group and week 6 in TD group. For no-responder, treatment plan will be changed. Clinical remission rate at week 10 and mucosal healing rate at week 12 will be compared between the two groups. The relapse rates and sustained durations of remission within one year will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. newly diagnosed UC;
2. moderate to severe disease activity
3. Age: 6 to 18 years old

Exclusion Criteria:

1. with mild disease activity
2. Have been treated with Corticosteroid or biological agents for UC
Augmentation of Facial Wall in Defective Fresh Extraction Site for Immediate Implant Placement

The study is performed to clinically and radiographically assess the efficacy of using enriched bone graft combined with slowly resorbable membrane on bone quality in immediate implant placement in extraction socket in cases with localized facial bone defect.

The study is include twelve participants , and the patients are in rolled in two groups, group one receive implant, sticky bone and laminar bone membrane . group two receive implant, sticky bone and pericardium membrane using vestibular incision and 6 months post operative radiographically assessment is performed to measure labial bone quantity formed .

Eligibility Criteria:
Inclusion Criteria:

* patient with a single hopeless tooth in maxillary anterior region.
* sufficient bone apically and palatally
* presence of natural contralateral tooth for the tooth being replaced
* systemic healthy patients

Exclusion Criteria:

* extraction socket type III
* acute infection in hopeless tooth
* a heavy smoker patient
* pregnant
* had received chemotherapy or radiotherapy in previous year