cyrilzakka/clinical-trials huggingface dataset:
Mucopolysaccharidosis Type II Observational

This is an observational study planned to document prospectively disease manifestation and neurocognitive course in pediatric patients with a clinical presentation consistent with neuronopathic ("severe") MPS II undergoing current standard of care and/or intrathecal Elaprase® for their condition. Some patients may be offered the opportunity to screen for a gene therapy study conducted by the same sponsor.

MPS II is a rare X-linked recessive genetic disease caused by mutations in the iduronate-2-sulfatase gene (IDS). Enzyme replacement therapy (ERT) with recombinant idursulfase (ELAPRASE®) is the only approved product for the treatment of Hunter syndrome; however, ERT as currently administered does not cross the blood brain barrier and is therefore unable to address the unmet need in MPS II patients with CNS (neurocognition and behavior) involvement. This is an observational study to document prospectively disease manifestation and neurocognitive course in pediatric patients with a clinical presentation consistent with neuronopathic ("severe") MPS II undergoing current standard of care for their condition. Approximately forty pediatric subjects who have severe MPS II will be enrolled. Changes in neurodevelopmental parameters of cognitive, behavioral, and adaptive function over time will be the primary focus for a duration of 104 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Meets any of the following criteria:

   1. Has a clinical diagnosis of severe MPS II and has a documented mutation in IDS, OR
   2. Has a relative clinically diagnosed with severe MPS II who has the same IDS mutation as the subject, OR
   3. Has documented mutation(s) in IDS that in the opinion of the investigator is known to result in a neuronopathic phenotype
2. Has sufficient communication capacity to complete the required protocol testing

Patient's legal guardian must be willing and able to provide written, signed informed consent.

Exclusion Criteria:

1. Has had prior treatment with an AAV-based gene therapy product
2. Is currently participating in a clinical trial of an investigational product for the treatment of MPS II with the exception of IT ELAPRASE trials; no investigational product may be taken starting 30 days or 5 half-lives of the investigational product prior to signing the ICF, whichever is longer
OTX-14-003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation


Eligibility Criteria:
Inclusion Criteria:

* Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber lens
* Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes

Exclusion Criteria:

* Any intraocular inflammation in the study eye present during the screening slit lamp examination
* Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening
* Any intraocular inflammation in the study eye present during the screening slit lamp examination
Assessment of Hemostasis Disorders in rtPA-treated Patients Requiring Endovascular Treatment for Ischemic Stroke

Stroke treatment includes thrombolysis, thrombectomy for patients with proximal artery occlusion and sometimes neurosurgery. It rises questions regarding hemostasis: thrombolysis induces fibrinolysis but its effects on coagulation, fibrinogen and platelets and duration of these effects are unknown. Thus management of antithrombotics and hemostasis during thrombectomy and surgery is an issue.

Objectives : to describe thrombolysis-induced hemostatic disorders (fibrinolysis, coagulation, fibrinogen, platelets) in patients requiring thrombectomy for stroke and to evaluate the time required for the normalization of these disorders.

Methods : Observational monocentric study including rtPA-treated patients requiring endovascular treatment for stroke. Blood sampling within the first 48 hours after rtPA administration to assess of fibrinolysis, coagulation and platelet functions with point of care devices and specific laboratory tests. Record of clinical and biological data.


Eligibility Criteria:
Inclusion Criteria:

* patient over 18
* treatment with rtPA for an acute stroke
* endovascular treatment required

Exclusion Criteria:

* opposition to participate in the study
* long term anticoagulant-treated patient
* pregnant patient
the Comparison of Voice Quality in Early Laryngeal Cancer Between Surgery and Radiotherapy

early laryngeal cancer is a well known field with great controversy in treatment. two options are available in treatment of patients the first one is partial laryngectomy and the second one is radiotherapy.one of major concern of patients have been the quality of voice ,so we design this trial to answer the priority of each options.

early laryngeal cancer is a well known field with great controversy in treatment. two options are available in treatment of patients the first one is partial laryngectomy and the second one is radiotherapy.one of major concern of patients have been the quality of voice as part of quality of life ,so we design this clinical randomised trial to answer the priority of each options.

Eligibility Criteria:
Inclusion Criteria:

* Early laryngeal cancer

Exclusion Criteria:

* No history of radiotherapy and collagen vascular disease
Study of the Effect of Beta-3 Adrenergic Receptor Agonists on Oxidative Stress and Signalling Pathways Implicated in Remodelling of the Uteroplacental Space: Experimental in Vitro Approach on Myometrial Tissue Explants

CHRONOLOGICAL DESCRIPTION OF THE STUDY

1. Information provided to study participants
2. Collection of written informed consent
3. Harvesting of myometrial biopsies
4. Creation of tissue explants using myometrial biopsies
5. Stimulation of the explants with LPS
6. Study of the effect of SAR150640 (beta3-adrenergic agonist) on LPS-induced oxidative stress Moreover, demonstrating the ability of beta3-adrenergic receptor agonists to prevent the appearance of oxidative stress and its consequences on tissues, as a complement to previous studies, is an additional argument for the clinical development of this class of pharmaceuticals in the management of threatened premature delivery and labour induction.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Patients with national health insurance cover
* Patients with a normal pregnancy requiring a caesarean section for obstetrical reasons
* No obvious infectious context

Exclusion Criteria:

* Obvious inflammatory or autoimmune diseases
* Suspected or confirmed infectious context, including HIV, HCV HBV
* Coagulation disorders
* Preexisting or gestational diabetes
Risk of Gastric Reflux During Tulip vs GMA(Glottis Mask Airway) Airway

Glottis mask airway (GMA) is supraglottic airway device and is frequently used in patients undergoing general anesthesia. However, gastroesophageal reflux remains a risk during ventilation through supraglottic airway devices. The classical shaped GMA and tulip shaped GMA differ in the shape of their tips. And theoretically the tulip shaped tip fits the larynx better. This study aims to compare the incidence of gastroesophageal reflux during ventilation through classical shaped vs tulip shaped glottis mask airway.


Eligibility Criteria:
Inclusion Criteria:

* age≥18 years old
* scheduled for surgery under general anesthesia with laryngeal mask airway

Exclusion Criteria:

* American society of anesthesiologists status score higher than 3
* morbid obesity (body mass index higher than 40 kg/m2)
* with high risk of gastroesophageal reflux
* with risk of difficult airway
* with airway disease
52-104 Week Off-therapy Second Extension to Study CSPP100A2365

52-104 week off-therapy second extension to study CSPP100A2365 to assess growth and development in pediatric hypertensive patients previously treated with aliskiren in studies SPP100A2365 and SPP100A2365E1


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of study CSPP100A2365E1
* Patients must meet inclusion criteria set forth for trials CSPP100A2365 and CSPP100A2365E1
* Informed consent/ patient assent

Exclusion Criteria:

•Patients who did not successfully complete studies CSPP100A2365 and CSPP100A2365E1
CT Scores Predict Mortality in 2019-nCoV Pneumonia

While 2019-nCoV nucleic acid swab tests has high false positives rate, How to diagnose 2019-nCoV pneumonia and predict prognosis by CT is very important.In this retrospective single-center study, we consecutively included suspected 2019-nCoV pneumonia critical cases in the intensive care unit of Wuhan third hospital from January 31, 2020 to February 16, 2020. The cases were confirmed by real-time RT-PCR, and all patients were evaluated with CT, cutoff values were obtained according to the Yoden index, and were divided into high CT score group and low CT score group. Epidemiological, demographic, clinical, and laboratory data were collected.


Eligibility Criteria:
Inclusion Criteria:

* all patients suspected of 2019 novel coronavirus infection.

Exclusion Criteria:

* patients' data are not available.
Menu Label Noticeability

To assess the relative noticeability of the following added-sugar menu label elements using a factorial experiment: label type (icon-only vs. icon-plus-text label vs. boxed icon), color (black vs. red), size (100% vs. 150% of the height of the menu item text), and placement (left vs. right side of item).

The objective of this aim is to assess the relative noticeability of legally-viable added-sugar menu label characteristics. The investigators will use a between-subject experiment with a factorial design. Participants will be randomized to label type (icon-only vs. icon-plus-text label vs. boxed icon), color (black vs. red), size (100% vs. 150% of the height of the menu item text), and placement (left vs. right side of item). This results in 24 arms of the experiment.

The primary outcomes are noticing a nutrition label and recognition of the label. Secondary outcomes are knowledge of items that are high in added sugar and perceived message effectiveness (PME) of labels.

For dichotomous outcomes (e.g., noticing the label, recalling label meaning), the investigators will directly estimate the probability ratio using Poisson regression with a robust error variance, regressing the outcome on an indicator for the level of the factor. For continuous outcomes (e.g., knowledge, PME scale), the investigators will use linear regression models regressing the outcome on an indicator for experimental condition.

A critical alpha 0.05 will be used, and statistical tests will be two-tailed. Exploratory outcomes include selection of ≥1 item high in added sugar and grams of sugar ordered from each menu, analyzed using the methods described above. The investigators will also explore proportions or means for the following process measures about reactions to the warning labels: Perception that the labels grabbed attention and support for an added sugars warning label policy. Additionally, the investigators will explore differences in the primary outcomes between each of the 24 unique conditions. If there is evidence of interactions between label elements, investigators will modify the modeling approach to account for those interactions (e.g., using interaction terms and stratified models).The investigators will use multiple testing corrections for families of outcomes (primary and secondary).

Eligibility Criteria:
Inclusion Criteria:

* Equal or greater than 18 years of age-
* Less than 100 years of age
* English-speaking
* U.S. residents
* Participants will reflect the U.S. Census Bureau's 2021 American Community Survey 5-year estimates for gender, race/ethnicity, educational attainment, and age

Exclusion Criteria:

* Failing the attention check question
* Completing the survey in less than 33% of the median completion time
Inflammation Regulation in Obese Patients

Insulin resistance is one of the main mechanisms involved in metabolic diseases. inflammation has been implicated in its pathogenesis, due to innate immunity activation by free fatty acids, lipopolysaccharides (LPS) and lactate. Free fatty acids, LPS and lactate activate innate immunity in squelettal muscle and adipose tissue via Toll-like receptor 2/4, NFkB, IRF3 (Interferon Responsive Factor 3) and cytokines secretion (TNFa, IFN g, IL1b, IL6), chemokines secretion (MCP1) and leukotrienes (LTB4). Feed back mechanisms involved in TLR signaling pathways as RLI (ribonuclease L inhibitor)/ABCE1, have never been studied in inflammation due to obesity. RLI inhibits an endoribonuclease, RNase L, which has been recently implicated in TLR signaling The purpose of this study is to analyse the role of RLI and RNase L in TLR regulation, and its potential implication in the link between obesity, inflammation and insulin resistance in adipose tissue and squeletal muscle in humans.

The investigators working hypothesis is that RNase L and RLI contribute to chronic inflammation regulation and to insulin response through TLR 4 pathway regulation in obesity. The investigators main purpose is to compare innate immunity activation pathway between insulin sensitive, insulin resistant obese patients and control patients. Insulin sensitive and insulin resistant obese patients will be distinguish thanks to the HOMA ir index. The investigators second objectives are to evaluate if the degree of inflammation in adipose tissue and squeletal muscle is correlated to insulin sensitivity measured by hyperinsulinemic euglycemic clamp and to characterise inflammatory pathway and regulation pathway. A special focus will be given to the leukotrienes and their potential role in insulin resistance pathogenesis. The investigators will have two approaches:- characterisation of subjects with normal weight, of obese insulin sensitive and obese insulin resistant through a metabolic evaluation, an inflammatory characterisation and a measure of insulin sensitivity at the systemic level, in adipose tissue and in squeletal muscle.- an in vitron approach with human myoblast and adipocytes culture, extracted from the investigators patients: characterisation of inflammation, innate immunity.

Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 65 years old
* Men/ menopausal women
* BMI \<25 kg/m2 for the control group, BMI \>30 kg/m2 for the obese group
* Non diabetic patients
* HOMAIR \<3 for the insulin sensitive obese group
* Non smoking
* Without any inflammatory disease
* Without any first degrees relative with diabetes
* Without any treatment that could interfere with insulin sensitivity
* without any infection
Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years

A multinational multi-centre, randomized, controlled non-blinded trial with participation of three fertility clinics in Denmark and one in Spain to assess the efficacy and safety of preimplantation genetic testing for aneuploidy (PGT-A) in 37-41-year-old women.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 37-41 years with a male partner, a female partner og undergoing fertility with no partner.
* Anti Müllerian Hormone (AMH) ≥6.28 pmol/L (AMH should be measured no more than one year prior to study inclusion). The optimal is to use the Elecsys® Assay. If other assays are used this should be reported to the investigator and the AMH cut-off level may appropriately be changed so that it corresponds to the cut-off used in the Elecsys® Assay.
* IVF/ICSI cycle number 1-5 (previous IVF/ICSI cycles will not count if the woman is recruited after an IVF/ICSI/FET-delivery).

Exclusion Criteria:

* PGT-SR or PGT-M.
* Testicular sperm aspiration (TESA), testicular sperm extraction (TESE), micro-TESE (or cryopreserved sperm from these procedures).
* Males with severely compromised semen quality (\<1 million progressively motile sperm cells following gradient centrifugation).
* Endometriosis stage three or four.
* Women with severe thyroid disease (women can be included if they have normal thyroid levels on relevant medication).
* Severe co-morbidity; diabetes mellitus type 1 (DM1), Mb Crohn or Colitis ulcerosa, systemic lupus erythematosus (SLE), HIV, Hepatitis B/C, or dysregulated thyroid disease.
* ≥2 previous ART treatment without blastocyst formation.
Effects of Intravenous Lidocaine on ED50, ED95 and NTI Values of Propofol Induced Unconsciousness

The effect of intravenous lidocaine on ED50 and ED95 of propofol, which causes unconsciousness, is unclear. In addition, it is not clear whether the depth of anesthesia induced by propofol changes when lidocaine is used in combination. Therefore, the purpose of this study was to study the effects of intravenous lidocaine on ED50, ED95 and NTI values of propofol induced unconsciousness .

Intravenous lidocaine has many advantages in perioperative period, in addition to reducing the amount of opioids and propofol, thus reducing the incidence of adverse reactions caused by them, it also has the effect on organ protection, can shorten the length of hospital stay, and promote postoperative recovery. The effect of intravenous lidocaine on ED50 and ED95 of propofol, which causes unconsciousness, is unclear. In addition, it is not clear whether the depth of anesthesia induced by propofol changes when lidocaine is used in combination. Therefore, the purpose of this study was to study the effects of intravenous lidocaine on ED50, ED95 and NTI values of propofol induced unconsciousness .

Eligibility Criteria:
Inclusion Criteria:

1. The informed consent is signed
2. Aged 18 to 65 years old
3. ASA is rated from I to II
4. Body mass index ranged from 18.5 to 24.9 kg/m2

Exclusion Criteria:

1. Unwilling to sign informed consent or refuse to participate in the study
2. Patients with serious arrhythmia and organic heart disease before surgery
3. Sedative and analgesic drugs were taken within 1 week before surgery
4. Lidocaine allergy
5. Patients with mental and neurological diseases
6. Patients with difficult airway
7. People with hearing impairment
a Case-control Study of the Association Between Heavy Mental and Children With Attention Deficit Hyperactivity Disorder in Korea

Heavy metal has been reported that it can cause attention deficit and behavioral disturbance. The investigators hypothesis is that heavy metal is associated with children with attention deficit/hyperactivity disorder(ADHD).


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K) interview

  * Subjects signed a written consent form voluntarily.
  * Patient 's assent to participate in the study and written informed consent form signed by one of the parents, parent surrogates, or legal guardian.
  * Subjects/parents, parent surrogates or legal guardian who can understand the participation of the study and voluntarily withdraw from the study at any time

Exclusion Criteria:

* Subjects who have any history of bipolar disorder, psychotic disorder, and substance use disorder, have been diagnosed with a pervasive developmental disorder, organic brain disease and seizure disorder.
* Subjects who have significant suicidal ideation or homicidal ideation
* Subjects with mental retardation
* Subjects with Tourette's syndrome requiring drug therapy.
* Subjects who currently have a significant medical conditions (e.g. diseases of cardiovascular, hepatic, renal, respiratory, glaucoma).
* Subjects who have abnormalities in the ECG or show clinically significant abnormalities of laboratory results, including serum chemistries and hematology.
* Subjects who have been administrated alpha-2 adrenergic receptor agonist,antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant within recent 2 months.
* Subjects who dyed their hair within 8 weeks
Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets

Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left main trunk disease, and small vessel diseases is still unknown.


Eligibility Criteria:
Inclusion Criteria:

1. A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome
2. Male or non-pregnant female
3. Key lesion inclusion criteria as follows

   1. Multi-vessel diseases
   2. Long lesion (lesion length \>30mm by visual estimation)
   3. Small vessel disease (reference diameter \<2.5mm by visual estimation)
   4. Bifurcation lesion
   5. Ostial lesion
   6. Calcified lesion
   7. Protected or non-protected left main trunk disease
   8. Chronic total occlusion
   9. In stent restenosis of bare metal stent or everolimus-eluting stent

Exclusion Criteria:

1. Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media.
2. Serum creatinine level \>3.0 mg/dL
3. Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.
The Effection Pain and Anxiety of a Breathing Exercise Applied Following Laparoscopic Cholecystectomy

One important part of individual nursing care is that that nurses teach and apply breathing exercises, which are vital and increase the patient's quality of life, in the light of their current knowledge and skills. The purpose of this study was therefore to determine the effect of postoperative breathing exercises on pain and anxiety in patients hospitalized in the general surgery clinic and who had undergone laparoscopic cholecystectomy.

Introduction: Several methods are employed for overcoming pain and anxiety that are frequently experienced in the postoperative period. This study was planned to determine the effect of a breathing exercise on patient pain and anxiety after laparoscopic cholecystectomy.

Methods: The sample determined using power analysis in this randomized, controlled, semi-experimental research performed in two hospitals in the west of Turkey between January and November 2019 consisted of 74 individuals (37 experimental and 37 controls). An information form involving descriptive characteristics, a visual analogue scale (VAS), and the State-Trait Anxiety Inventory (STAI I/II) were used for data collection. Descriptive statistical methods and parametric tests were employed in the data analysis.

Eligibility Criteria:
Inclusion Criteria

* Hospitalized in the general surgery clinics,
* with histories of laparoscopic cholecystectomy,
* consenting to take part.

Exclusion Criteria:

- Have a psychiatric disorders.