cyrilzakka/clinical-trials huggingface dataset:
Cardiac Dysfunction in Obstructive Sleep Apnea Patients: Prevalence of and Effect of nCPAP

The aim of this study is to clarify the influence of obstructive sleep apnea syndrome on left ventricular function using echocardiographic parameters including the myocardial performance index (Tei-index), and to determine the short-term effects of nCPAP on them.

Obstructive sleep apnea syndrome (OSAS) affects 2% and 4% of middle-aged women and men respectively, and is associated with an increased risk of cardiovascular complications. Therefore, cardiovascular consequences must be evaluated in the clinical management of OSAS and the study of cardiac functional parameters could be particularly useful. Reported findings are conflicting with respect to the influence of OSAS and nasal continuous positive airway pressure (nCPAP) on left ventricular function. In this study, we assess cardiac dysfunction with echocardiographic parameters, such as LVEF, left ventricular mass, ratio of E to A (E/A) and mitral deceleration time (DT) from the mitral inflow velocity, and Tei-index, or plasma brain natriuretic peptide (BNP) level at baseline, and 1 and 3 months after nCPAP treatment. The main endpoint is the comparison of echocardiographic parameters and BNP between OSAS patients and control subjects, and the changes of them after short-term of nCPAP treatment.

Eligibility Criteria:
Inclusion Criteria:

* OSAS patients: Moderate to severe OSAS patients with apnea-hypopnea index (AHI) ≥ 20 events/hour by overnight polysomnography and start nCPAP treatment.

Exclusion Criteria:

* Apparent lung diseases
* Daytime hypoxemia (PaO2 \<80 mmHg)
* Atrial fibrillation, bundle branch block, atrioventricular block and implantable pacemaker
* Left ventricular dysfunction (ejection fraction \<50%)
* Ischemic or valvular heart disease, and cardiomyopathy determined from medical history or a physical examination, electrocardiogram (ECG), chest radiography, and echocardiography
* Renal insufficiency (serum creatinine \>2.0 mg/dl).
Surveillance for Early Liver Injuries Caused by Runzao Zhiyang Capsule.

This is a prospective registry study to surveil early liver injuries caused by Runzao Zhiyang Capsule (RZZY Capsule) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to RZZY Capsule.

The primary objectives of this study include:

(i) The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of RZZY Capsule; (ii) The record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) The specimen collection of surveiled individuals. (iv) The attempt to establish a predictive model to screen susceptibilities to RZZY Capsule.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals in accordance with indications for RZZY Capsule, including skin pruritus, acne vulgaris and constipation;
2. The age range of 18 to 70 years；
3. Individuals taking RZZY Capsule over 2 weeks;
4. Abnormalities of serum biochemistry achieving one of the criteria as follows:

   (i) alanine aminotransaminase (ALT) or aspartate transaminase (AST) ≥2 folds of upper limit of normal (ULN); (ii) total bilirubin (TBiL) ≥ 2 ULN; (iii) alkaline phosphatase (ALP) ≥ 2 ULN;
5. Individuals can provide informed consent form.

Exclusion Criteria:

1. Individuals without indications for RZZY Capsule;
2. Unconformity with the RZZY Capsule drug label;
3. Individual taking RZZY Capsule less than 2 weeks;
4. Individuals taking other hepatotoxic drugs combined with RZZY Capsule, simultaneously;
5. Unconformity with the diagnostic standard for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003）.
Zinc Gel and Epidermal Regeneration in Healthy Human Volunteers

Zinc is an important metal for the maintenance of healthy skin and wound healing. Washing with detergents e.g. shower gels may deplete the zinc stores in the skin.

The purpose of our study is to see whether repeated washing with zinc containing shower gel of superficial wounds will result in increased healing.

Zinc is a trace element abundantly present in skin with a concentration gradient from the upper stratum corneum layer to the basal layer. This fact probably reflects the necessity for zinc as co-factor in numerous enzymes involved in skin homeostasis and wound healing. Theoretically, showering with surfactants increases the loss of zinc by the shedding of the zinc-rich corneocytes. Thus there is a concern that this forced exfoliation will result in suboptimal zinc levels for the maintenance of physiological processes involved in epidermal homeostasis and repair. A logical development would thus be to supplement shower gel with zinc to compensate for this loss.

In 30 healthy volunteers one epidermal wound (10 mm in diameter) is induced by suction and heat on each buttock. The wounds are washed with shower gel containing zinc, placebo shower gel or water (reference). The treatments are allocated by randomization ensuring that 20 wounds are washed with shower gel containing zinc, 20 wounds are washed with placebo shower gel and 20 wounds are washed with water.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers
* Age between18 and 65 years
* Written informed consent

Exclusion Criteria:

* Smoker
* Active skin disease in test areas
* Hypersensitivity to zinc or any of the shower gel ingredients
* Immunosuppressive treatment
* Pregnant or breastfeeding females
Evaluation of Wear Experience with a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers with Astigmatism

This open-label study is of adults with astigmatism who have never worn contact lenses. Subjects will be fit into a one week planned-replacement contact lenses and will wear lenses for approximately 3 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be new to contact lenses and have astigmatism of -0.75 or greater (within the parameters available for the P7fA lenses)
2. Subjects must have 20/20 or better best corrected visual acuity.
3. Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
4. Ability to give informed consent
5. Willing to spend time for the study. Subjects will be required to attend three study visits and wear contact lenses on days between study visits.
6. Willing and able to wear contact lenses for at least 8 hours per day for 5 days per week during the study as daily wear.
7. Currently not using eye lubricating drops and willing to not use during study.
8. Either gender and 18-40 years of age.
9. Any racial or ethnic origin

Exclusion Criteria:

1. Any active ocular inflammation or infection.
2. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
3. Are presbyopic and require or habitually uses reading glasses for near work
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
5. History of refractive surgery
6. Meets the diagnosis of dry eye disease with OSDI screening score ≥13.
7. Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein
8. Is pregnant or lactating or planning a pregnancy during enrollment in the study
9. Is participating in another clinical research study that includes invasive ocular tests
10. An inability to perform contact lens application and removal after instruction.
Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke

The purpose of this study is to determine the safety and feasibility of remote limb ischemic conditioning(RIC) in acute ischemic stroke patients who received r-tPA thrombolytic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age≥18;
* Acute ischemic stroke;
* modified Rankin Scale (mRS) score of 2-5;
* mRS score less than 1 before onset of stroke symptom;
* Onset of stroke symptoms within 4.5h before initiation of intravenous rt-PA thrombolytic therapy;
* Good compliance for Remote Ischemic Conditioning(RIC) therapy;
* Informed consent obtained.

Exclusion Criteria:

* Stroke or serious head trauma within the previous 3 months
* Major surgery or severe trauma with in the preceding 3 months
* Intracranial hemorrhage
* Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication) necessary to reduce blood pressure to these limits
* Symptoms rapidly improving
* Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
* Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days
* Arterial puncture at a noncompressible site within the previous 7 days
* Seizure at the onset of stroke
* Platelet count of less than 100,000 per cubic millimeter
* Received heparin within the 48 hours preceding the onset of stroke and had an elevated partial-thromboplastin time
* Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
* CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere)
* Use or plan to use intervention for diagnosis or treating
* Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation
* severe hepatic or renal dysfunction
* Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
* Life expectancy\<1 years
* Pregnant or breast-feeding women
* Unwilling to be followed up or poor compliance for treatment
* Patients being enrolled or having been enrolled
Retrospective and Prospective Cohort of Patients Entering the Multidisciplinary Management of Post-Covid Syndromes

SARS-CoV2 pneumonia has been a global public health emergency since 2020. The prevalence of the disease is particularly high with more than 500 million cases worldwide (7.5 million in France) since the emergence of the virus.

A substantial proportion of patients with SARS-Cov2 infection present persistent symptoms long after the acute infection. This is independent of the degree of severity of the SARS-Cov2 infection.

These symptoms can affect the quality of life and impede the return to work. While the majority of symptoms progress favourably with outpatient care, some persist and/or are particularly severe, justifying expert and multidisciplinary care.

This investigation aim to create a clinical database of patients with complex and/or severe post-CoviD and study blood markers what could predict the disease and orientate new ways of treatment.


Eligibility Criteria:
Inclusion Criteria:

All patients who have joined the Epsilon care pathway since its opening in February 2022, i.e.:

* Patients with post-Covid syndrome referred to the Epsilon sector from the city medicine:
* Patient with documented SARS-Cov2 pneumonia
* With persistent and severe symptoms beyond 4 weeks or complex or disabling symptoms beyond 3 months
* Patient over 18 years old.

Post-hospital sector:

* Patient with documented SARS-Cov2 pneumonia
* Hospitalized for oxygen therapy (at least 48h)
* Not having a referring pulmonologist
* Not institutionalized
* With a life expectancy of more than 6 months.

Exclusion Criteria:

* Patient refusing that this data to be used for research purposes (objection form).
* Patient with untreated comorbidities
Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients

Maturity level of dendritic cells (DC) plays a pivotal role in initiating and regulating autoimmunity. In Graves' disease (GD), DCs have more active immune responses than those in healthy subjects. Our previous study demonstrated immunoregulatory effects of in vitro 1,25-D3 on maturation of DC in GD patients. This study aims to evaluate the effect of oral 1α-D3 on DC maturation in GD patients.

Patients with Graves' disease were divided into two groups: groups receiving oral 1α-D3 in addition to propylthiouracil (PTU) and groups receiving placebos in addition to PTU. Comparison of DC maturation were performed before and after the oral 1α-D3. DC maturation was assessed based on the expression of DC markers (HLA-DR, CD80, CD40, CD83, CD14 and CD206) and the ratio of cytokines interleukin-12/IL-10.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Graves' disease and still have not gone into remission
* Willing to participate in the research

Exclusion Criteria:

* Pregnant patient
* Suffered from severe liver disease
* Suffered from severe kidney disease
* Taking vitamin D substitution therapy
* Suffered from another autoimmune disease
* Suffered from malignancy
Prospective Cohort Assessing the Role of the Genotoxin Colibactin From Escherichia Coli B2 in the Genesis of NASH

In a population of patients with Non Alcoholic Fatty Liver Disease (NAFLD), the investigators will compare the composition of the gut microbiota from patients with simple steatosis with that with steatohepatitis.

The purpose of this study is to determine if the pathogenic Escherichia Coli to the B2 group and producing the genotoxin colibactin is a factor for developing NASH.

Gut microbiota composition is now linked to the onset of obesity, metabolic disorders, and Non Alcoholic Fatty Liver Disease . While simple steatosis has benign prognosis, steatohepatitis (NASH) leads to cirrhosis and hepatocarcinoma and increases cardiovascular and cancer- related mortality. Some Escherichia coli (E. coli) belonging to the B2 phylogenetic group are involved in many diseases. Those producing the genotoxin colibactin are in addition known to induce a chronic alteration of intestinal permeability, one of the major factors leading to NASH.

Eligibility Criteria:
Inclusion Criteria:

* NAFLD
* indication of liver biopsy

Exclusion Criteria:

* presence of any other cause of liver or steatosis
* alcohol consumption exceeding 30 g / day for a men and 20 g / day for a woman
* a history of decompensated cirrhosis
* treatment with prebiotics, probiotics or antibiotics in the month prior to inclusion
* chronic gastrointestinal disease or history of gastrointestinal surgery
* pregnancy or breastfeeding
* patient under guardianship
Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome

The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.

A phase 2, randomized, double masked clinical, parallel-group clinical trial to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of mild-to-moderate drye eye syndrome.
* Male or female patients.
* Patients 18 years of age

Exclusion Criteria:

* Patients with one blind eye.
* Visual acuity of 20/40 in any eye
* Patients with history of active stage of any other concomitant ocular disease.
* Patients taking any medication, topically or by any other route, which could interfere with the study's results, in the 3 days prior to trial or until a time period in which residual effects could be present.
* Contraindications or sensitivity to any component of the study treatments.
* Ocular surgery within the past 3 months.
* Contact lens users.
* Females of childbearing potential )may not participate in the study if any of the following conditions exist:

  * They are pregnant,
  * They are breastfeeding,
  * They have a positive urine pregnancy test at screening,
  * They intend to become pregnant during the study, or
  * They do not agree to use adequate birth control methods for the duration of the study.
* Participation in any studies of investigational drugs within 90 days previous to the inclusion.

Discontinuation criteria:

* Patients could be discontinued before the completion of the study because of adverse events, pregnancy, protocol violations, lack of efficacy, or administrative reasons.
Neurocognitive Impairment in Pediatric Patients With Meningoencephalitis and Sepsis-associated Encephalopathy

Neurocognitive impairment is frequently observed in pediatric patients with meningoencephalitis (ME) and sepsis-associated encephalopathy (SAE) which represent two relevant central nervous system (CNS) diseases in pediatric patients. It is uncertain, if the the origin of the disease, located primarily in the CNS of patients with ME or secondarily in patients with SAE in the course of sepsis, is of importance for the severity of injury to the brain. Prospective clinical studies combining clinical and laboratory examinations including specific biomarkers of neuroaxonal injury were not performed in a comparative study. Biomarkers of neuroaxonal injury are therefore not only of great interest to detect and monitor neurocognitive impairment but also to quantify the severity of brain injury in patients with ME and SAE.

This is a prospective single-center observational study evaluating the incidence and severity of the neurocognitive impairment in pediatric patients with meningoencephalitis (ME) and sepsis-associated encephalopathy (SAE). All study participants will be assessed by clinical and neurological examination as well as comprehensive laboratory tests using biomarkers of neuroaxonal injury at study day 1 (day of study inclusion), day 3 and day 5. A panel of biomarkers derived from blood and cerebrospinal fluid (CSF) samples (among others NSE, S100B and neurofilament proteins) will be measured. Clinical assessment will be performed using validated scales of severity of disease (e.g. pSOFA score) and validated delirium tests (among others pGCS, pCAM-ICU) to assess the neurocognitive performance of study participants before and three months after study inclusion (among others POPC/PCPC).

A matched group of pediatric patients without evidence for ME or sepsis/SAE will serve as a control group and will undergo the same clinical and laboratory examinations except CSF analysis.

The investigators hypothesize, that:

1. Patients with ME (primary CNS infection) indicate a higher incidence and severity of neurocognitive impairment than patients with SAE (secondary CNS affection)
2. Specific biomarkers of neuroaxonal injury in blood and CSF correlate with the clinical severity of neurocognitive impairment in patients with ME and SAE
3. Specific biomarkers of neuroaxonal injury in blood and CSF correlate with the 3-months neurocognitive outcome of patients with ME and SAE

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients between 1 day and 17 years of age
* admission to hospital with suspected meningoencephalitis or sepsis \<24 hours after admission or time of diagnosis
* admission to hospital for minor surgery (herniotomy, osteosynthesis, adenoidectomy)

Exclusion Criteria:

* preexisting central nervous system diseases (stroke, hemorrhage, tumor, traumatic brain injury, brain surgery, epilepsy, hydrocephalus)
* preexisting immunosuppression
* participation in another interventional study
* no written informed consent from parents or legal representative
Efficacy of FreshKote and Systane for the Treatment of Dry Eye and Improvement of Osmolarity

The purpose of this study is to compare the efficacy of FreshKote and Systane for the reduction of dry eye signs and symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Dry eye patients with Level 2 disease or greater as defined by the Delpi Panel
* Tear osmolarity of at least 308 mosm
* At least 18 years of age, Male or Female
* Willing to provide written informed consent
* Likely to complete all study visits
* If currently using ocular lubricants, must complete a 10-14 day washout

Exclusion Criteria:

* Presence of any active ocular disease other than dry eye
* Use of topical ophthalmic medications
* Use of contact lenses during the trial
* Pregnant or nursing, or planning a pregnancy. Patients will be asked if they are pregnant or may be pregnant and excluded if they answer in the affirmative.
* Any known sensitivity to any ingredients of either study drop
* Oral anti-inflammatory medications, omega 3 supplements, or doxycycline
* Punctal plugs inserted within the last 6 months or less
* Uncontrolled systemic disease
* Subjects with known sensitivity or inappropriate responsiveness to any of the medications used.
* Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)
* Corneal abnormalities (e.g., ecstatic diseases, degenerations, or corneal dystrophies of the stroma or endothelium)
* Concurrent participation or participation in the last 30 days in any other clinical trial
A Phase Ⅱ Trial of Neoadjuvant Toripalimab Plus Platinum-doublet Chemotherapy in Locally Advanced NSCLC.

This is a Phase 2, prospective, single-arm, open-Label, single-center study that to find out (1)The effectiveness and safety of toripalimab combined with platinum-doublet chemotherapy as a preoperative neoadjuvant therapy for locally advanced (stage IIB, IIIA, and resectable stage IIIB) NSCLC, (2)The best treatment time for this combination of neoadjuvant therapy before surgery, (3)The effectiveness and safety of combination of neoadjuvant therapy as salvage neoadjuvant therapy after failure of neoadjuvant chemo-only for locally advanced non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent form before starting any trial related procedure.
* 18-80 years old, male or female.
* Non-small cell lung cancer confirmed by cytology or histology. Evaluation by the researchers to confirm resectable stage IIB, IIIA or resectable stage IIIB (CT3-4N2M0) NSCLC patients without any treatment before.
* If the pathological type is adenocarcinoma, genetic testing is required.
* Newly treated patients or patients with failure of traditional preoperative neoadjuvant chemotherapy can be enrolled;
* ECOG PS 0-1.
* Good cardiac function, left ventricular ejection fraction \>50%;
* Good respiratory function, able to tolerate radical resection of lung cancer;
* Bone marrow hematopoietic function is good, leukocyte\> 4×10\^9/l; Hemoglobin\> 10g/dl; Platelet \> 100×10\^9/l;
* Good renal function, glomerular filtration rate\>60 ml/min.
* Good liver function, Total bilirubin(TBIL)\<1.5ULN, AST\<2.5 ULN, ALT\<3ULN;
* There must be at least one evaluable focus judged according to recist1.1 standard.

Exclusion Criteria:

small cell lung cancer confirmed by cytology or histology. Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement.

Advanced lung cancer, or unresectable lung cancer A patient who had received preoperative neoadjuvant radiotherapy for NSCLC. Patients who have a history of active autoimmune disease or potentially recurrent autoimmune disease.

Patients with active hepatitis Allergic to study drug (Toripalimab ,cisplatin, carboplatin, paclitaxel, gemcitabine and pemetrexed) components excipients.

Patients were given antibiotics within 2 weeks. The investigator considered that the subject's comordities or other conditions may affect the compliance with the protocol or are not suitable for participating in this study