cyrilzakka/clinical-trials huggingface dataset:
Liposomal Irinotecan and Apatinib in ES-SCLC

The purpose of this study is to observe the efficacy and safety of liposomal irinotecan combined with apatinib in the treatment of extensive stage small cell lung cancer progressed from first-line regimen.

Small cell lung cancer is a highly invasive neuroendocrine tumor characterized by high malignancy and rapid proliferation. Although most patients with extensive SCLC are sensitive to first-line treatments such as etoposide combined with platinum and immunotherapy, most patients experience disease progression again after first-line treatment. Therefore, extending the survival time of patients and improving their quality of life have become key issues in the second-line treatment of SCLC. The current guidelines for second-line treatment of SCLC recommend monotherapy, including topotecan, irinotecan, etc. However, the available options have poor efficacy and are prone to drug resistance. Irinotecan liposomes improve drug stability and prolong circulation time through liposome encapsulation, and target tumor tissues through high permeability and long retention effects, with the expected effect of reducing toxicity and increasing efficacy. Apatinib is a small molecule tyrosine kinase inhibitor that selectively inhibits vascular endothelial growth factor receptors to achieve anti angiogenic and anti-tumor effects. It has been proven to have positive therapeutic effects in multiple types of cancer, including SCLC. At present, the combination mode of chemotherapy and anti-angiogenic drugs has been explored in various tumors, and the results show that this mode has drug synergistic effects, which can significantly improve the efficacy of anti-tumor treatment. Therefore, exploring the efficacy, safety, and mechanism of liposomal irinotecan combined with apatinib is of great clinical and theoretical significance for the refractory tumor population of extensive stage small cell lung cancer with first-line treatment progress.

Eligibility Criteria:
Inclusion Criteria:

1. Age range of 18-75 years;
2. Expected survival period ≥ 12 weeks;
3. At least one measurable lesion (according to RECIST V 1.1);
4. For patients who have failed first-line or second-line treatment.

Exclusion Criteria:

1. Have received any systemic treatment targeting VEGF or VEGFR in the past, such as treatment with anti angiogenic drugs such as ranibizumab, fipronib, apatinib, anlotinib, lenvatinib, sunitinib, sorafenib.
2. Active or uncontrolled severe infection (CTCAE 5.0 ≥ 2) and/or antibiotic treatment within 2 weeks prior to enrollment;
3. There are multiple factors that affect the absorption of oral medication, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction;
4. Those deemed unsuitable for inclusion by doctors;
A Trial Comparing Bowel Preparation and Patient Tolerability of Miralax Versus Golytely

Prior to colonoscopies, the colon is cleansed using a laxative. Golytely is approved by the FDA for this purpose. Another laxative, called MiraLax, is approved by the FDA to relieve constipation, but it is not approved specifically for preparation for a colonoscopy. Nonetheless, it is commonly used in clinical practice for this purpose, just as is Golytely. The purpose of this study is to compare Golytely and MiraLax in two ways: to see whether one is better tolerated by patients than the other and to see whether one more effectively cleanses the bowel than the other. The investigators' hypothesis is that these 2 bowel preparation methods are equally effective in bowel cleansing, but that patients prefer Miralax to Golytely.


Eligibility Criteria:
Inclusion Criteria:

* average risk screening for colon cancer

Exclusion Criteria:

* subjects with a history of constipation
Dietary and Lifestyle Interventions in Obese Pregnant Women

Background: Maternal obesity is associated with higher risks of adverse maternal and fetal complications, but the effects of dietary and lifestyle interventions on gestational weight gain(GWG) and pregnancy outcomes in obese pregnant women are unclear.

Objective: This study examined whether intensive dietary and lifestyle interventions initiated in the early pregnancy could decrease GWG, and prevent relevant adverse pregnancy outcomes in Chinese obese pregnant women.

Design:A randomized controlled trial in obese pregnant women was performed at 6-12 weeks of gestation.The sample size was estimated using GWG reduction as the primary outcome variable. The investigators pilot study (data not published) showed the gestational weight gain was 12.73±5.97 for obese women. Assuming intervention may result in 25% (3.1825g) reduction in GWG, the estimated sample size with 90% power and type I error of 0.05 was 114 women in intervention group and 57 in control group. Adjusting for 15% refusal or loss to follow up during pregnancy, the total sample size required was 136 women in intervention group and 68 in control group(standard care group). Participants were randomly assigned to the control or the intervention group. The intervention focused on restricting energy intake combined with behavioral lifestyle modification through participation in group sessions and individual counseling. The primary outcomes were gestational weight gain (GWG) and secondary outcomes were the incidence of gestational diabetes mellitus (GDM), hypertensive disorders during pregnancy, large-for-gestational-age (LGA) infants, macrosomia and the rate of caesarian section.

Hypothesis:The intensive dietary and lifestyle intervention performed from the first trimester in obese women could decrease total GWG,and perhaps improve relevant pregnancy outcomes.


Eligibility Criteria:
Inclusion Criteria:

* gestational age between 6 and 12 weeks of gestation, pre-pregnancy≥28 (kg/m2)
* age ≥18 years, and a singleton pregnancy.

Exclusion Criteria:

* patients with prediabetes and diabetes, hypertension, chronic renal disease, thyroid disorder
* gestational weeks ≥ 13
* age \<18 years
* multiple pregnancy
* uterine malformation
* or physical restriction that prevents exercise.
Uveal Melanoma and Brachytheraphy: Long-term Outcomes.

This study investigated the visual and anatomical outcomes, tumor control, tumor recurrence, distant metastasis and cancer free survival in patients affected by uveal melanoma and undergoing Ru-106 plaque brachytherapy between February 2011 and March 2020


Eligibility Criteria:
Inclusion Criteria:

* age older than 40 years
* diagnosis of uveal melanoma

Exclusion Criteria:

* age older than 80 years
* No diagnosis of uveal melanoma
The Effect of Nuchal Ligament Calcification on Cervical Function in Patients With Neck Pain

Ossification of nuchal ligament often observed in patient with chronic neck pain, previous study showed ossification of nuchal ligament was associated with cervical spondylosis and radiculopathy. Patient with chronic neck pain was divided into two groups according to the presence of ossification of nuchal ligament on cervical radiographic images.

This study is to evaluate and compare the neck function including range of motion, neck strength and pressure pain threshold, radiography characteristics and functional disability between two groups.


Eligibility Criteria:
Inclusion Criteria:

* Patient with neck pain and stiffness last for more than 1 month

Exclusion Criteria:

* cervical trauma or fracture in 3 months
* evidence of cervical spine instability
* rheumatoid cervical spondylopathy
* previous cervical surgery
* head and neck cancer
* previous radiotherapy over neck and surrounding
* those complicated with myelopathy
* contraindication to radiography like pregnant woman
Comparison of Genomic and Transcriptomic Patterns Between CTC and Metastatic Tumormetastatic Tumor

This study aims to understand the metastasis in advanced NSCLC through comparing genomic and transcriptomic patterns between the circulating tumor cells and metastatic tumor cells by single cell sequencing analysis.


Eligibility Criteria:
Inclusion Criteria:

* All subjects need to sign the informed consent form
* All subjects have non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively
* Treatment naïve advanced lung cancer (including extensive stage IIIb and stage IV)
* Patients who were suitable to provide enough metastatic tumor tissue and blood (30ml) for the single cells sequencing

Exclusion Criteria:

* Patients with previous history of lung cancer
* Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer
* Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix within 5 years before enrollment
Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

The purpose of this study is to determine whether lozenges of interferon-alpha that are dissolved in the mouth can prevent relapse in patients with hepatitis C virus infection who had a complete virologic response after receiving a combination of injected interferon-alpha and oral ribavirin.


Eligibility Criteria:
Inclusion Criteria:

* HCV genotype 1b
* Will be completing pegylated IFN-alpha and ribavirin therapy within 4 weeks
* Serum HCV RNA negative within 4 weeks of study entry

Exclusion Criteria:

* Child-Pugh score of B or C
* Decompensated liver function
* History of malignancy within past 5 years
* Other causes of liver disease besides HCV infection
* Uncontrolled diabetes or hypertension
* Unwilling to use two forms of birth control during study treatment
Aortic Stiffness in Chronic Kidney Disease Stage 2 to 4

This study aimed to investigate in a cohort with chronic kidney disease the longitudinal relationship between aortic stiffness and renal function and mortality.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* CKD 2-4

Exclusion Criteria:

* pregnancy
* history of malignant disease with a prognostic life expectancy less than 24 months
* missing of written and informed consent
Measurement of Noradrenaline Concentrations Using Different Dilution Methods

Norepinephrine is the vasopressor of choice for the treatment of peri-anesthetic arterial hypotension. The use of this drug at significantly lower concentrations (dilution factor between 40 and 200) than the commercial preparation is increasingly common in the operating room ("baby-noradrenaline").

In addition, dilution errors are potentially serious for the patient (hypertensive peak) The preparation of precise dilutions is an important factor for the safe use of this medically In this study, the investigators wish to compare the dilution method of the protocol with another method of preparation (left to the free choice of the participant).


Eligibility Criteria:
Inclusion criteria:

* Adult person,
* Employee of Strasbourg University Hospitals,
* Likely to have to prepare anesthesia drugs in the operating room (intern, hospital student, IADE, IADE student)

Exclusion criteria:

- Subject's refusal to participate in the study
4SC-202 in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy

Phase Ib/II open-label, multi-center study with a priming cycle of 4SC-202 to evaluate the safety, tolerability and preliminary efficacy of combination treatment with 4SC-202 and Pembrolizumab. A dose expansion cohort at the Recommended Phase Two Dose (RPTD) will be added.

Adult patients with advanced (unresectable or metastatic) cutaneous melanoma primary refractory or non-responding to anti-PD-1 therapy as most current systemic anti-cancer therapy and for whom no standard therapy is available, will be enrolled. The last administration of anti-PD-1 therapy must have been performed within 6 months prior to screening.


Eligibility Criteria:
Main Inclusion Criteria:

* Patients with unresectable stage III or stage IV cutaneous melanoma, as per American Joint Committee on Cancer (AJCC) (Version 8) staging system (must have been histologically confirmed at least once during course of disease). Patients with metastatic tumor of unknown primary site and histology of melanoma are eligible.
* Patients must be primary refractory or non-responding to anti-PD-1 therapy (either as monotherapy or in combination with Ipilimumab)
* Measurable disease by computer tomography (CT) or Magnetic resonance imaging (MRI) per immune-related response evaluation criteria in solid tumors (irRECIST) 1.1 criteria, with longest diameter for non-nodal lesions ≥ 10 mm and ≥ 15 mm in short axis for nodal lesions
* At least one tumor site (either primary site or metastasis) must be accessible for sequential biopsies and patient must consent to the 2 mandatory biopsies. This requirement is not applicable for continuous dosing schedules and may be waived by the sponsor in other individual cases.

Main Exclusion Criteria:

* Patients who achieved a CR or PR, during or after prior anti-PD-1 mono- or anti-CTLA-4/anti-PD-1 combination therapy
* Patients with symptomatic brain metastases/central nervous system (CNS) involvement
* Patients with inadequate organ function
* Therapy with agents known to prolong the QT interval and increase the risk for Torsades de Pointes
Closed Loop Ventilation Strategy in Intensive Care Unit (ICU) Patients

Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both like PCV and PSV automatically. Some studies suggest that ASV can reduce the weaning time in ICU patients. The investigators hypothesized that using ASV from the beginning of intubation can reduce the total duration of MV and LOS in the ICU when compared to conventional modes such as PCV+PSV


Eligibility Criteria:
Inclusion Criteria:

* Intubated and mechanically ventilated ICU patients for more than 24 hours

Exclusion Criteria:

* Patient with a tracheostomy
* Patients under home mechanical ventilation
Voice Feminisation in Transgender Women

The voice is a reflection of our identity. In the case of transgender women, there may be a gap between perceived male voice and female appearance. Indeed, hormonal treatment in transgender women has no effect on the voice quality. This gap can have negative consequences on everyday life in banal situations such as telephonic contact leading to limited use of phone calls and social isolation.

Differences between female and male voices seem to be socially determined and do not depend directly on sexual dimorphism of the phonatory organs.

Speech therapy might thus be indicated as a vocal support for transgender women.

Only few studies have examined the impact of perceived voice on the quality of life of transgender women.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Follow-up in the Department of Endocrinology, Diabetology and Nutrition of the University Hospital of Nancy
* Gender dysphoria according to the ICD 11
* Voluntary, informed consent to participate in research
* Compulsory affiliation to the social security system

Exclusion Criteria:

-Refusal or incapacity to be involved in the study
Endothelial Dysfunction in Covid-19

SARS-CoV-2 targets endothelial cells via the angiotensin-converting enzyme 2 receptor. The specific impact of the resulting endothelial injury is currently unknown but may contribute to the pro-coagulant state classically described during Covid-19 disease and commonly associated with an exacerbated activation of the renin-angiotensin-aldosterone system.

We prospectively compared clinical and biological parameters in ICU- and non-ICU-admitted Covid-19 patients, ICU-admitted patients with septic shock unrelated to Covid-19 and matched control subjects.

Primary hemostasis and coagulation parameters and endothelial biomarkers are measured. Activation of the renin-angiotensin-aldosterone system is monitored through measurements of plasma renin, angiotensin II, aldosterone, and serum soluble angiotensin-converting enzyme 2. Vascular oxidative status is assessed by measuring plasma lipids peroxides. Neutrophilic polymorphonuclear activation is assessed by measuring plasma levels of Triggering receptor expressed on myeloid cells-1. Vascular nitric oxide bioavailability is measured by quantification of the concentration of heme-nitrosylated hemoglobin (HbNO) in venous erythrocytes using Electron Paramagnetic Resonance spectroscopy. Structural abnormalities of vascular endothelial cells were analyzed by Transmission Electron- and Scanning Electron Microscopy.

Eligibility Criteria:
Inclusion Criteria:

* positive result on a reverse-transcriptase-polymerase chain reaction testing performed on nasopharyngeal swab at hospital admission

Exclusion Criteria:

* ICU admission more than five days after admission on a general ward,
* concomitant bacterial infection
* older than 75 years
* cirrhosis
Efficacy Study With QIVc in Pediatric Subjects

This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of laboratory confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.


Eligibility Criteria:
Inclusion Criteria:

In order to participate in this study, all subjects must meet all of the inclusion criteria described.

* Individuals of 6 through 47 months of age on the day of informed consent.
* Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
* Individuals who can comply with study procedures including follow-up.
* Individuals in generally good health as per the Investigator's medical judgement.

If applicable, prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet the criteria of the original inclusion criteria listed above, they should not receive additional vaccinations.

Exclusion Criteria:

* Acute (severe) febrile illness. Enrollment could be considered if the fever is absent for 72 hours.
* History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study.
* Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. These may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination.
* A known history of Guillain-Barré Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
* Abnormal function of the immune system resulting from a clinical condition
* Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
* Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior infection caused by this organism.

Additional eligibility criteria are provided in the study protocol.
Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices

Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are restrained in daily life by possible electromagnetic interference (EMI). Case reports suggest EMI between PM or ICD systems and hand-held metal detectors that are intensively used as part of security screening processes in e.g. airport controls.

The objective was to determine the safety of screening procedures for ferrous materials with regard to possible in vivo EMI between hand-held metal detectors and PM and ICD systems.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for routine pacemaker or cardioverter defibrillator control
* appropriate PM/ICD function

Exclusion Criteria:

* atrial or ventricular sensing abnormalities that could not be avoided by reprogramming of device parameters
* low battery status of the device such as elective replacement indicator (ERI)
* intrinsic heart rate \> 120 beats per minute (bpm)
Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer

Current options to treat insulin resistance in diabetes are fairly limited. For this reason, novel treatments would represent a major progress. The generic drug hydroxychloroquine (HCQ) has poorly understood effects on blood sugar metabolism. In this study, the investigators will examine the mechanisms by which this drug affects glucose metabolism and which cells are affected. Findings emanating from this project will help establish whether HCQ may be a viable treatment for disorders of glucose metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-69 years-old;
* BMI 28-40;
* Presence of at least one of the following markers of insulin resistance: a) fasting hyperinsulinemia (\>7 uU/ml by ultrasensitive insulin assay); impaired fasting glucose (100-125 mg/dl); prior history of impaired glucose tolerance provided by the participant; history of previous gestational diabetes; history of PCOS; waist circumference \>40" (men) or \>35" (women) (cut-offs from ATP-III criteria for metabolic syndrome).

Exclusion Criteria:

* Pregnancy, or unable/unwilling to avoid pregnancy during the study;
* Unstable cardiopulmonary disease, hepatitis, liver dysfunction, renal insufficiency, or any other medical condition affecting glucose metabolism or safety during the study;
* Diabetes;
* Medications that affect glucose metabolism: (e.g. systemic glucocorticoids, antipsychotics);
* History of hypersensitivity to local lidocaine, similar anesthetics, or HCQ;
* History of G6PDH deficiency;
* History of retinopathy;
* Weight instability (\>3Kg of weight change in the past three months);
* Bariatric surgery in the last two years, intention to lose weight or engage in exercise regimen during study;
* Alcohol intake \>1 drink/day (averaged);
* Hemoglobin \<10g%
Success of Internal Jugular Vein Catheterization

Internal jugular vein cannulation can be performed with the blind technique under ultrasound (USG) guidance or using classical marker points. It has been shown that USG-guided interventions reduce the complication rate compared to the method performed with the blind technique (4%/13.5%). In addition, the initial entry success rate in the USG supported group is 65%. , this rate remained at 45% with the blind technique.

Although Pleth variability index monitoring is a noninvasive method, it is a technique that consistently predicts fluid sensitivity in patients under mechanical ventilation.

The aim of study is before applying USG guided catheterization; We think that by revealing the factors of the patient that are effective on the number of interventions, necessary measures can be taken for the success of catheterization as a result.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-75
* underwent coronary artery bypass surgery

Exclusion Criteria:

* \<18 years old
* Hemodynamic instability
* Use of inotropic agents