cyrilzakka/clinical-trials huggingface dataset:
Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery

This study is designed to investigate, whether Sugammadex improves muscle function after standard neuromuscular recovery (TOF 0.9) from relaxation with rocuronium.

Muscle relaxants are an integral part of today's anesthesia. They improve intubating conditions and reduce doses of other substances needed for general anesthesia. For ensuring patient safety, neuromuscular function is monitored during general anesthesia. The latter one is only terminated, when neuromuscular monitoring shows an objective normal value. Despite this accurate surveillance, a lot of patients complain about subjectively uncomfortable muscle weakness in the recovery room. A possible explanation for this ostensive contradiction can be the variable "margin of safety" of neuromuscluar transmission in different muscle groups. Waud et al describe this phenomenon, as the fact, that neuromuscular transmission is only clinically detectable, when a certain number of post-synaptic receptors is not blocked. The necessary fraction of free receptors differs a lot between the muscle groups (15-50%). As neuromuscular monitoring only measures one muscle group exemplarily, and a clinically non-detectable number of post-synaptic receptors can be blocked shortly after anesthesia, the subjective muscle weakness of patients could need treatment.

Sugammadex can encapsulate steroid-typ muscle relaxants within 2 to 5 minutes. After applying a sufficiently high dose, also those receptors will be free that elude neuromuscular monitoring. This constellation brings up the interesting problem to quantify the possible effect on patients' subjective muscle weakness.

This study is designed to investigate, if the application of sugammadex improves muscle function and consequently well-being of patients, that have been extubated according to clinical standard.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical stauts II - III
* Age: 18 - 65 years
* Patients scheduled for general anesthesia with intubation using rocuronium
* Patients have given informed consent to the study
* Patients receiving the investigational drug within 15 minutes after neuromuscular recovery to a TOF 0.9
* Sufficient knowledge of the German language

Exclusion Criteria:

* known or suspected neuromuscular disease
* significant hepatic or renal dysfunction
* known or suspected history or family history of disposition to malignant hyperthermia
* known or suspected allergy towards sugammadex, anesthetics, muscle relaxants, or other drugs used for general anesthesia
* Use o drugs that interfere with sugammadex
* Patients included in another trial within the last 30 days
* Patients with legal guidant
* Patients with contradiction towards the use of Sugammadex
* Pregnant women
* Breast-feeding women
3D Printed Guide in Ankle Arthrodesis

This study applies 3D-printed customized guide plate in assisting the accurate drilling of Kirschner wire in ankle arthrodesis. This technique can shorten the operation time, reduce the intra-operative radiation, and do not affect the surgical outcome.

Ankle arthrodesis is the standard procedure for treating end-stage joint diseases. In order to improve the surgical outcome and reduce the operation time, 3D-printed customized guide plates are fabricated using patients' ankle DICM data of ankle via CT examinations. Two 2mm Kirschner wires are drilled with the help of the guides; the C-arm fluoroscopy is used to confirm the position of the wires before applying the cannulated screws for effective fixation.

In the past when there were no customized guides, the surgeons would drill the Kirschner wire according to his/her previous experience and then use C-arm fluoroscopy to confirm whether the position of the wire is satisfactory; if not, repeated procedure will be performed. This would lead to an increase in the duration of surgery and intra-operative radiation, which is detrimental to both the surgeon and the patient. This problem is well solved by applying the 3D-printed customized guides.

The application procedure for the customized guide plates: the model of the ankle joint is established according to the patient's CT scan data to prepare the customized guide plate, then sterilize them for future use. Apply routine surgical treatment to the ankle joint surface, reset the fusion joint to the functional position, and drill two 2mm Kirschner wires with the guidance of the guide plate. If the locations of the fusion joint and the Kirschner wires are satisfactory under the C-arm fluoroscopy, drill the cannulated screws for final fixation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who receive ankle arthrodesis and consider internal fixation with screws

Exclusion Criteria:

* Patients who receive ankle arthrodesis but do not consider internal fixation with screws
MGCD0103 in Elderly Patients With Previously Untreated AML/High Risk MDS or Adults With Relapsed/Refractory Disease

In this study, MGCD0103, a new anticancer drug under investigation, is given three times per week to elderly patients with previously untreated acute myelogenous leukemia/high risk myelodysplastic syndrome or adults with relapsed/refractory disease.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic confirmation of AML or high risk MDS.
* Elderly cohort (70 years of age or more): no prior chemotherapy treatment for AML/high risk MDS and not currently candidates for intensive chemotherapy.
* Relapsed/refractory cohort (18 years of age or more): relapsed or refractory to prior treatment.
* ECOG performance status of 0 or 1.
* Total bilirubin \< 1.5 x upper limit of normal (ULN).
* AST/SGOT and ALT/SGPT \< 2.5 x ULN.
* Serum creatinine \< 1.5 x ULN.
* Patients must read, understand, and sign a written informed consent form (ICF).
* Women of childbearing potential and male patients' female partners must use an acceptable method of contraception while on study, and for 3 months after study drug treatment.

Exclusion Criteria:

* Pregnant or lactating women.
* Patients with uncontrolled, intercurrent illness, active or uncontrolled infections, or a fever \> 38.5C (not due to tumor fever) on the day of scheduled dosing.
* Patients with serious illnesses or medical conditions, including laboratory results, which, in the investigator's opinion, would interfere with a patient's participation, or with the interpretation of the results.
* Patients treated with an investigational drug within 30 days prior to study initiation.
* Known hypersensitivity to HDAC inhibitors or to any of the components of MG-0103.
* Known HIV or active hepatitis B or C.
* Any condition that may affect the patient's ability to sign the ICF and undergo study procedures.
* Any conditions that will put the patient at undue risk or discomfort as a result of adherence to study procedures.
Does Notch Regulate Glioma Proliferation ?

The investigators showed in 2015 (Guichet et al) that the Notch1 pathway has an anti-proliferative role on glial brain tumors. In this project, the investigators investigated which genes downstream of Notch1 pathway activation produce the anti-proliferative effect. The investigators hypothesized that the SNAI2 and TAL1 genes act downstream of Notch1

Main objectives:

To examine the expression of TAL1 and SNAI2 in protein extracts and glioma sections of different grades (glioblastomas and diffuse low-grade tumors).

To examine the effect of overexpression of Tal1 and Snai2 in high grade glioma cultures.

To show the expression of Tal1 and SNAI2 by tumor cells by FISH technique. Show that TAL1 and SNAI2 could be regulated by endothelial cells

Eligibility Criteria:
Inclusion criteria:

* Patient ≥18 years old
* Patient affected with brain glioma classified according to WHO 2016 classification

Exclusion Criteria:

* Patient who reject the study protocol
* Radiotheray or chemotherapy treatment
Pharmacokinetics of Chiglitazar in Subjects With Renal Impairment and Normal Renal Function

This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of Chiglitazar following administration of a single oral dose in subjects with renal impairment compared to subjects with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily sign informed consent, able to comply with the requirements of the study.
* Male or female, between 18 and 79 years of age.
* 18≤BMI≤30. Weight of male ≥50 kg and Weight of female ≥ 45 kg.
* No medication within 2 weeks, or stable medication for at least 4 weeks prior to screening.
* the absolute eGFR must meet standard in renal function classification.
* Physical examination, vital signs examination, 12-lead electrocardiogram (ECG) examination, and laboratory test have been determined by the investigator to be suitable for participating in this trial, and serum potassium ≥3.5 mmol/L and ≤5.5 mmol/L.

Exclusion Criteria:

* Allergic constitution, or allergic to PPAR agonist drugs or any component of Chiglitazar tablets.
* received PPAR agonist drugs within 2 weeks before screening.
* Those who have been vaccinated within 4 weeks before screening, or who plan to be vaccinated during the trial.
* positive test for COVID-19.
* suffer from uncontrolled serious diseases of heart failure/hypertension, respiratory, liver, gastrointestinal, endocrine, blood, mental/nervous systems within 1 year before screening.
* have previously undergone surgery that may affect the absorption, distribution, metabolism, and excretion of drugs; anticipate surgery or hospitalization during the trial.
* Drug abusers within 5 years before screening., or positive test for drugs of abuse.
* Smoking more than 5 cigarettes per day on average within 3 months before screening.
* The average daily alcohol intake in the 3 months prior to screening exceeds the following criteria: more than 14 g for women, or more than 28 g for men; ingested any products containing alcohol within 48 hours before administration; positive alcohol breath test.
* Ingestion of grapefruit juice/grapefruit juice, food or drink rich in methylxanthine within 48 hours before administration; strenuous exercise or other factors that affect drug absorption, distribution, metabolism, excretion.
* participated in clinical trials of any drug or medical device within 3 months before screening.
* donated blood (or blood loss) ≥400 mL within 3 months before screening, or have received blood products.
* Acute hepatitis, chronic liver disease, or any one of ALT, AST, and total bilirubin is greater than 2 times the upper limit of normal.
* HBsAg, HCV antibody, HIV antibody, or TP antibody antibody positive.
* Female subjects who are breastfeeding or positive test of serum pregnancy.
* Other circumstances assessed by the investigator are not suitable for participating in this trial.
Comparison Between Intranasal vs Intravenous Dexmedetomidine for EEG Sedation of Children With Behavior Disorders.

The aim of the project was to compare the efficacy and safety of intranasal (IN) and intravenous (IV) dexmedetomidine (DEX) in procedural sedation for electroencephalogram (EEG) in pediatric patients with behavioural disorders.

Single-centre comparative observational study in the tertiary care centre of Padua, regarding all consecutive pediatric patients affected by behavioural disorders, who needed sedation for EEG recording. A group of children received IV administration of DEX, the following year a second group of children received IN administration of the same drug. Target of sedation was level 2, according to the Paediatric Sedation State Scale (PSSS).

OBJECTIVE: The aim of the project was to compare the efficacy and safety of intranasal (IN) and intravenous (IV) dexmedetomidine (DEX) in procedural sedation for electroencephalogram (EEG) in pediatric patients with behavioural disorders.

METHODS: Single-centre comparative observational study in the tertiary care centre of Padua, regarding all consecutive patients \< 18 years old affected by behavioural disorders, who needed sedation for EEG recording. From 2018 to 2020 a group of children received IV administration of DEX (IV DEX), the following year a second group of children received IN administration of the same drug (IN DEX). In both groups, target of sedation was level 2, according to the Paediatric Sedation State Scale (PSSS). Heart rate (HR), pulse oxygen saturation and blood pressure (BP) were registered. EEG recording quality and caregivers' satisfaction were collected.

Eligibility Criteria:
Inclusion Criteria:

* children affected by behavioural disorders, who need sedation to perform EEG
* American Society of Anaesthesiologists (ASA) status \< 3
* Written informed consent by a parent or legal guardian.

Exclusion Criteria:

* previous hypersensitivity reaction or contraindications to administration of DEX (cardiac failure, cardiac arrhythmias, long QT syndrome, bradycardia, hypotension, use of beta-blockers or digoxin, uncontrolled arterial hypertension, recent stroke or intracranial bleeding, Moya-Moya syndrome)
* for IN administration, children with runny nose/mild respiratory infection
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.


Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening
* Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening
* Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.
* Have a body mass index of ≤35 kilogram/square meter (kg/m²)

Exclusion Criteria:

* Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes
* Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.
* Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months prior to screening.
Thought Field Therapy and Cognitive Therapy for Agoraphobia

The purpose for this study is to find out if Thought field therapy has the same effect as, or better effect than, Cognitive therapy for Agoraphobia.

Thought field therapy is an alternative treatment method that has shown, by casuistic reports, to give good results when applied for anxiety disorders. In this study 72 patients will be randomized to three groups. 24 patients will receive cognitive therapy as a control method, 24 patients will receive thought field therapy. The remaining 24 patients will wait three months, and then be randomized to either of the two therapies.

Before inclusion all patients will be diagnosed with M.I.N.I. and SCID II. They will fill out self evaluation forms for symptoms and quality of life, before and after treatment, and one year after treatment.

All patients will undergo an interview with ADIS on panic and agoraphobic diagnosis and symptoms before starting treatment, and on panic and agoraphobic symptoms immediately after and one year after treatment. These interviews will be done by psychologists who are blinded for which type of treatment the patients have got.

Eligibility Criteria:
Inclusion Criteria:

* Patients ages 18 years or older,
* Patients with agoraphobia,
* Patients with a score on Mobility Inventory "Alone" of 2.5 or more,
* Patients who give a written consent to participate.

Exclusion Criteria:

* Psychosis (past or present),
* Drug abuse or dependency,
* Moderate or high score on suicidal behaviour on the M.I.N.I.,
* Patients who have another illness (other than panic disorder or agoraphobia) and are in need of immediate treatment.
A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis

Coronary artery blockages can reduce blood flow to the heart muscle. Fractional flow reserve (iFR or FFR) assessment is an invasive tool used to determine how much blood flow is reduced. The investigators will perform iFR/FFR on all intermediate coronary stenoses using standard practice, immediately before (at the time of) transcatheter aortic valve replacement (TAVR) and after successful TAVR. The investigators will compare pre- and post-TAVR iFR/FFR values, and assess short-term outcomes. The investigators hypothesize that iFR/FFR values will be consistently and significantly higher pre-TAVR in comparison with post-TAVR for the same lesions.

The purpose of the study is to determine whether iFR assessment gives a valid assessment of coronary hemodynamics in patients with severe aortic stenosis.

Several factors confound the interpretation of fractional flow reserve (FFR) in patients with severe aortic stenosis (AS) and intermediate severity coronary stenoses, and the widely accepted cut-off value of 0.80 may not be applicable to this patient population. Coronary flow reserve is known to be attenuated under conditions of left ventricular hypertrophy and severe AS, with one study showing improvement in coronary flow reserve after aortic valve replacement. Left ventricular hypertrophy produces fixed resistance secondary to external compression of the coronary microcirculation. This potentially results in failure to achieve maximal hyperemia with adenosine and can lead to false negative FFR results. Neurohormonal influences in aortic stenosis can further attenuate vasodilator response and potentially result in false negative FFR values. Both of these conditions result in the potential deferral of lesions which may have been hemodynamically significant in the absence of severe AS. At present, there are no studies which have demonstrated validity of FFR measurement in patients with severe AS. Here, the investigators propose a prospective study of iFR/FFR in patients with AS and indeterminate coronary lesions undergoing TAVR to understand the hemodynamic consequences of AS on iFR/FFR. The investigators hypothesize that iFR/FFR values will be consistently and significantly higher pre-TAVR in comparison with post-TAVR for the same lesions.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have coronary stenoses between 40-70% severity and who have severe aortic stenosis undergoing TAVR work-up.

Exclusion Criteria:

* Patients with documented intraprocedural hemodynamic instability, shock, or major adverse event (myocardial infarction, aortic rupture/dissection, stroke, left ventricular perforation, cardiac arrest).
* Contraindication to adenosine, presence of cardiogenic shock, presence of acute coronary syndrome.
Metacognition in Semantic Dementia: Comparison With Alzheimer's Disease

This study aims at exploring patients' ability to monitor their own memory performance depending on their primary deficit and the type of memory involved in the criterion task. The goal is to evaluate if semantic dementia (SD) and Alzheimer's disease (AD) differently affect patients' awareness of their memory abilities.

Patients who will give their informed non-opposition will be included. Participants will undergo 6 metacognitive tasks in which they will be tested on newly learnt information (i.e., episodic memory) or prior knowledge (i.e., semantic memory) and asked to evaluate their performance either prior or after the test. Correlation between their evaluation and their actual performance will be measured. Performance and correlations will be compared across groups.

Eligibility Criteria:
Inclusion Criteria:

* native French-speakers
* normal or corrected-to-normal vision
* for patients ONLY : doctor-approved diagnosis of semantic dementia or Alzheimer's disease
* for healthy participants ONLY: score above 27 on the MMSE
* non-opposition in participation

Exclusion Criteria:

* other neurological/ psychiatric disorder, or cognitive disorder that might affect general cognition
* drug or alcohol abuse
Comparing the Efficacy of tDCS and tRNS to Improve Reading Skills in Children and Adolescents With Dyslexia

The present study grounds on the absence of evidence-based treatment in individuals with developmental dyslexia (DD). At this topic, the present study will explore the potential effect of transcranial random noise stimulation (tRNS) and transcranial direct current stimulation (tDCS) over bilateral temporo-parietal cortex (TPC), cerebral areas usually disrupted in individuals with DD.

The investigators hypothesized that active tRNS and tDCS over TPC will boost reading skills in children and adolescents with DD. On the contrary, sham (placebo) tRNS and tDCS over TPC will not have significant effect in improving reading skills. Further, both active and sham tRNS and tDCS will be safe and well tolerated.

The study design is within-subject, randomized stratified, double blind, placebo-controlled.

A group of children and adolescents with DD will be selected and exposed to three different conditions with an interval-session of at least 6 days: 1. tRNS over bilateral TPC; 2. anodal tDCS over left TPC (cathode over right TPC); 3. sham tRNS or tDCS. During stimulation (both real and sham), participants will undergo a concomitant reading task.

In this project, the investigators will work to understand whether a brain-based intervention, with the use of tRNS and tDCS, can improve the outcome of individuals with DD.

The protocol will allow the investigators to:

* comparing the efficacy of tDCS and tRNS over TPC in improving reading abilities,
* comparing the safety and tolerability of tDCS and tRNS in children and adolescents.

The investigator's overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in DD, based on the two most used brain stimulation techniques in pediatric population.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents with dyslexia (DSM-5, APA 2013)
* IQ ≥ 85

Exclusion Criteria:

* Having a comorbidity with an important medical conditions;
* Having neurological diseases;
* Having Epilepsy o family history of epilepsy;
* Receiving a treatment for dyslexia in the previous three months before the baseline screening.
Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery

The purpose of this research is to compare two outpatient pain management strategies in patients undergoing spinal surgeries such as microdiscectomies, foraminotomies, and spinal decompressions.


Eligibility Criteria:
Inclusion Criteria:

* Adults: males or non-pregnant females.
* Patients undergoing ambulatory microdiscectomies, foraminotomies, and spinal cord decompressions requiring pain control analgesics.

Exclusion Criteria:

* Pregnancy
* Active severe liver disease
* Chronic kidney disease 3a-5 (moderate to severe)
* Chronic obstructive pulmonary disease with impaired pulmonary function
* Chronic steroid use
* Chronic opioid use
* Current use of narcotics
* Allergy to sulfonamides
* Allergy to NSAIDs
* Allergy to Aspirin
* Allergy to Tylenol
* Allergy to Gabapentins
* Allergy to H2 blockers (cimetidine, famotidine)
* Allergy to steroid
* Current use of gabapentins for any medical condition
* Inability to be discharged home on the day of surgery
* Inability to swallow pills
* Myasthenia gravis
* History of gastrointestinal ulcers or stomach bleeding
* Have any condition that, in the investigator's opinion, will compromise the well-being of the patient or the study, or prevent the patient from meeting or performing study requirements.
Yoga in the Treatment of Eating Disorders: a Randomized Trial

Yoga facilitates the treatment of eating disorders by decreasing symptom severity over time.


Eligibility Criteria:
Inclusion Criteria:

* admitted to the Anna Westin House treatment facility of the Emily Program in MN during timeframe study is being run

Exclusion Criteria:

* declines participation in study