cyrilzakka/clinical-trials huggingface dataset:
Use of Multiple Doses of Convalescent Plasma in Mechanically Intubated Patients With COVID-19

This study will assess the feasibility and safety of administering multiple doses of convalescent plasma to Covid-19 positive patients admitted to the Intensive Care Unit (ICU) receiving mechanical ventilation. Donor plasma will be obtained from Covid-19 recovered patients. All plasma used in this protocol will be collected following the guidelines issued by the Food and Drug Administration (FDA) and the Ministry of Health in Panama.

Every patient recruited will receive one or two plasma units infused on days 0, 2, 4, 6, and 8. The primary objective of this study is feasibility. Feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of convalescent plasma more than once. The investigators will evaluate the safety and feasibility of this study by accounting for any related adverse event.

The secondary study endpoints are overall survival at days 14, 28, and 60 after the first dose of convalescent plasma. Respiratory status and overall clinical status will be reviewed during follow-up until day nine and on days 14, 28, and 60.

From historical and anecdotal data on convalescent plasma, it seems its administration is safe in cases of coronavirus infection. Now, the high mortality of COVID-19, particularly in elderly and vulnerable persons such as critically ill patients, suggests that the benefits of its use in those at high risk for death outweigh the risks. However, for all cases where convalescent plasma administration is considered, a risk-benefit assessment must be conducted to assess individual variables.

This study proposed the follow-up of 30 intubated patients due to COVID-19 who have been admitted to the ICU and have consented to receive five doses of one or two units of convalescent plasma.

Every patient will have a follow-up from the consent day to day 60. The study team will monitor and record: vital signs, daily ventilatory requirements, and assessment of clinical status, including new medical conditions and adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 Real Time-polymerase chain reaction(PCR) testing.
3. Subject or proxy (including by phone) is willing and able to provide written or digital informed consent and comply with all protocol requirements.
4. Intubated
5. Consent to storage of specimens for future testing.

Exclusion Criteria:

1. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
2. Severe multi-organ failure, and hemodynamic instability.
3. Other documented uncontrolled infections.
4. Severe disseminated intravascular coagulopathy (DIC) needing factor replacement, FreshFrozen Plasma, cryoprecipitate.
5. On dialysis.
6. Active intracranial bleeding.
7. Clinically significant myocardial ischemia.
Phase IV-Cervical Dystonia-INTEREST IN CD2

The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).


Eligibility Criteria:
Inclusion Criteria:

* Subject for whom there is an intention to treat with BoNT-A.
* BoNT treatment naïve or previously treated with BoNT.
* If previously treated with BoNT, at least a 12-week interval between the last injection (BoNT-A or BoNT-B) and inclusion.
* Subject able to comply with the protocol.
* Provision of written informed consent prior to collect the data.

Exclusion Criteria:

* Contraindications to any BoNT-A preparations.
* The subject has already been included in the study.
Comparison of Reverse Remodeling and PVI Versus CFAE and/or Linear Lesions and PVI for Persistent AF

The hypothesis of this study is that by facilitating reverse atrial remodeling with maintenance of sinus rhythm in the weeks preceding ablation makes it feasible to perform a simple pulmonary vein isolation (PVI) with results equivalent or superior to more complex atrial ablation for patients with persistent AF.

Atrial fibrillation (AF) is the most common cardiac disorder currently affecting 2.3 million U.S. adults with an expected increase in incidence to 5.6 million by the year 2050. Randomized clinical trials have shown that ablation was superior to antiarrhythmic drug (AAD) in maintaining sinus rhythm among patients with symptomatic predominantly paroxysmal AF. However the results for catheter ablation of persistent AF is much lower and more variable, ranging between 20-80%. Moreover there is no agreed-upon standard ablation approach. Prior studies suggest that pulmonary vein isolation (PVI) alone has an unacceptably low success rate so most laboratories supplement this approach with additional lesion sets. These include complex atrial fractionated electrograms ("CAFÉ"), autonomic denervation, and linear left atrial ablation at the roof and mitral isthmus, in an empirical manner or stepwise approach. However, these strategies are time consuming and prone to proarrhythmia, namely post-ablation atrial tachycardias which can occur with an incidence ranging from \< 5 to 50%.

The lower efficacy of PVI alone in persistent AF has been attributed to adverse electrical, molecular, and structural remodeling of the atria. Collectively, atrial remodeling decreases conduction velocity and the effective refractory period, and results in a shortened atrial wavelength, which increases the number and stability of reentrant wavelets. This can cause persistence of AF independent of a focal discharge. Standard PVI addresses the "focal discharge" or trigger from the PVs that initiates AF but not necessarily the underlying atrial substrate.

Based on these concepts, we hypothesized that successful atrial reverse remodeling by temporary AAD therapy would facilitate the performance of PVI alone in patients with persistent AF. The utilization of reverse remodeling to enhance the efficiency, efficacy and safety of ablation of AF has not been tested in a randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic persistent AF
* Failure of class I antiarrhythmic drug or amiodarone to control AF

Exclusion Criteria:

* Previous proarrhythmia to class III AAD including excessive QT prolongation or torsade-de-pointes
* Previous AF ablation procedure
* Congestive heart failure (NYHA III-IV functional class)
* Left ventricle ejection fraction less than 35%
* Left atrial diameter \>55 mm
* Unwillingness to participate
Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

To assess whether holding incretin-based therapy before endoscopy reduces the likelihood of clinically relevant Residual Gastric Volume (RGV).

Primary Outcomes:

* Residual gastric volume that precludes adequate endoscopic examination
* Residual gastric volume that necessitates premature termination of the endoscopy procedure
* Need for endotracheal intubation due to stomach contents.
* Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission

Secondary Outcomes:

* Presence of any solid food
* Presence of moderate liquid content
* Increased RGV(Residual Gastric Volume) defined as any amount of solid content or \> 0.8 mL/Kg of fluid content (measured from the aspiration/suction canister).
* Differences in primary and secondary outcomes between different medications


Eligibility Criteria:
Inclusion Criteria:

* Patients using incretin-based therapies at a stable dose for more than 1 month.
* Patients scheduled for outpatient esophagogastroduodenoscopy (EGD), endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP) under monitored anesthesia care.

Exclusion Criteria:

* Documented history of gastroparesis (based on a 4-hour solid-phase gastric emptying study)
* Known history of achalasia
* Surgical or genetically altered foregut anatomy
* Known gastric outlet obstruction or pre-procedure imaging suggestive of gastric outlet obstruction.
* Patients who did not follow the standard NPO (nil per oral) instructions.
Effect of Antiviral Therapy on Host Immune in Patients With Chronic Hepatitis B Virus(HBV) Infection

During hepatitis B virus(HBV) infection host immune plays important role.Recently there are many different antiviral therapy methods.Different antiviral therapy methods showed different effector.In order to investigate whether these antiviral therapy methods especially methods directly inhibit viral replication have some effect on host immune the investigators designed these study. The investigators want to observe the change of host immune during antiviral therapy in patients with chronic HBV infection, and analyze the relationship between these changes and the antiviral effector of these drugs.


Eligibility Criteria:
inclusion criteria:

* 18-65 years old
* chronic HBV infection
* HBeAg positive,HBV DNA more than 10E5 IU/mL
* ALT ≥2×UTL

exclusion criteria:

* with liver cancer
* with liver failure
* pregnant
Atrial Function and Supraventricular Arrhythmia of the Veteran Athlete.

Supraventricular arrhythmias (including atrial fibrillation) are the most common arrhythmias of the veteran athlete and have a major impact in terms of morbidity and mortality. Although moderate sports practice has been shown to decrease the occurrence of these arrhythmias, it has also been shown that very intense athletic activity is associated with an increased risk of developing atrial fibrillation. The pathophysiological mechanism is not clearly understood. However, it has already been shown that intensive sports practice leads to electrical and morphological atrial remodeling, which could be the cause of the occurrence of supraventricular arrhythmias for these athletes.

For sedentary patients, two major tools predict the risk of the onset of supraventricular arrhythmia: the electrocardiogram (ECG) and transthoracic echocardiography (ETT), particularly with the study of atrial function by the analysis of myocardial deformities.

No studies have tested these two tools for the evaluation of atrial remodeling of the veteran athlete to predict which ones are at risk of developing supraventricular arrhythmias.

However, the identification of predictive factors would make it possible to identify at-risk athletes and thus provide them with adapted sporting practice advice and personalized follow-up.

The aim of the study is to evaluate the relationship between atrial remodeling assessed by ECG and ETT with the occurrence of supraventricular arrhythmia by comparing an athlete group with supraventricular arrhythmia with a control group of healthy athletes.

Eligibility Criteria:
Inclusion Criteria:

* Supraventricular arrhythmia group : Veteran athletes with documented paroxysmal supraventricular arrhythmias.
* Control Group : Veteran athletes without documented supraventricular arrhythmia.

Exclusion Criteria:

* Any cardiopathy (valvulopathy, coronary heart disease, etc.).
* Minor patients,
* Major patients subject to legal protection (legal safeguards, guardianship)
* Persons deprived of their liberty
* Patients opposed to the use of their personal data.
Midazolam Effect in Children Undergoing Voiding Cystourethrogram (VCUG)

The purpose of this research is to validate the common administration of oral midazolam to children prior to voiding cystourethrogram (VCUG) to see if this will significantly decrease children's anxiety and make the experience less traumatic.


Eligibility Criteria:
Inclusion Criteria:

* Age 2-6 years
* Toilet trained
* English speaking
* Already scheduled for VCUG

Exclusion Criteria:

* Allergic to midazolam
* Active UTI
* Known urethral stricture
* Known urethral reconstruction
* Has history of abnormal sensation in pelvic area
* Has history of sexual abuse
* Has severe developmental delay
* Has diagnosis of anxiety disorders
Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.

This study will quantify the muscle function after breast reconstruction using a minimally invasive latissimus dorsi flap.

The proposed measures (clinical, isokinetic, electrophysiology, function and quality of life questionnaires) allow a precise, multidisciplinary, objective evaluation of the capacity of the latissimus dorsi muscle before surgery, 3 months, 6 months and 12 months after surgery. A function deficit is expected (decreased moment of adduction and internal rotation) 3 months after surgery and a return to the preoperative state 6 months and 12 months after surgery.


Eligibility Criteria:
* Inclusion Criteria:

  1. Patient managed for unilateral MR (immediate or secondary) by MSLD after therapeutic mastectomy.
  2. Breast assessment (Mammography + ultrasound +/- breast MRI) normal dating less than 6 months
  3. Age between 18 and 80 years old
  4. Signature of free and informed consent
* Exclusion Criteria:

  1. Patient with metastasis or disease progression
  2. Patient whose general condition does not allow her to answer a questionnaire or perform physical and functional measurements (neurocognitive disorders and/or neuro-orthopedic disorders)
  3. Patient with a poor understanding of the French language
  4. Patient having presented a failure of a first breast reconstruction (failure of DIEP, prosthesis removal)
  5. Patient not eligible for MR secondary to cancer (prophylactic mastectomy) or for which the flap was intended to cover loss of substance and not reconstruction
  6. Patient with a history of contralateral MR (all techniques combined)
  7. Patient with a history of contralateral breast cancer
  8. Patient does not have internet access to be able to connect to the "Exolis" software
Comparison Of Blue Light Filter Feature and Blue Blocking Lenses in Digital Device Users With Dry Eye Patients

Comparing Blue Light Filter feature and Blue Blocking Lenses for Dry Eye Patients Prolonged screen time can exacerbate dry eye symptoms.

Two solutions, blue light filter software and blue blocking lenses, aim to reduce eye strain. Blue light filter software adjusts screen color temperatures, reducing blue light emission. Blue blocking lenses provide a physical barrier, blocking blue light from reaching the eyes.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 12-34
* Spend at least 4 hours per day on digital devices.
* Experience dry eye symptoms.
* Willing to participate in the study and provide informed consent.

Exclusion Criteria:

* Pre-existing eye conditions (e.g., cataracts, glaucoma).
* Wear contact lenses.
* Have undergone eye surgery.
* Are pregnant or breastfeeding.
Vascular Effects of Sitagliptin in Diabetes Mellitus

Glucagon-like peptide 1 (GLP-1) is a 30-amino acid gut hormone secreted in a nutrient-dependent manner that stimulates insulin secretion and inhibits glucagon secretion and gastric emptying, thereby reducing postprandial glycemia.1,2 GLP-1 is derived from posttranslational proteolysis of preproglucagon, and its peptide sequence is identical in mouse, rat, and human.2,3 After secretion from enteroendocrine L cells, GLP-1(7-36) amide is rapidly degraded by dipeptidyl peptidase-4 (DPP-4) to its N-terminally truncated metabolite GLP-1(9-36), which does not interact with the known GLP-1 receptor.4,5 The diverse actions of GLP-1 include the proliferation, differentiation, and protection from apoptosis of pancreatic β cells and the induction of satiety. GLP-1 also improves memory and learning, stimulates afferent sensory nerves, and has neuroprotective functions.1,6 Furthermore, GLP-1 receptor agonists have been reported to have cardiac and vascular actions in rodents and humans that include effects on contractility, blood pressure, cardiac output,7-10 and cardioprotection.11-14

The aim of this study is to evaluate the effect of a therapy with the DPP-4-inhibitor sitagliptin on the prognostic relevant endothelial function and endothelial progenitor cells in patients with type 2 diabetes mellitus.

Primary endpoint: Endothelium-dependent vasodilation before and after treatment of patients with type 2 diabetes mellitus with the DPP-4-inhibitor Sitagliptin and placebo treatment respectively.

Secondary endpoint: effect of sitagliptin on mobilization, NO-production and in vivo regenerative capacity of human endothelial progenitor cells before and after treatment of patients with type 2 diabetes mellitus with the DPP-4-inhibitor sitagliptin and placebo treatment respectively

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes mellitus

Exclusion Criteria:

* Allergy to sitagliptin
* Treatment with PPAR-gamma agonist
Diagnostic Value of Fecal Calprotectin in Disorders of the Upper Gastrointestinal Tract

Fecal calprotectin is a very sensitive non-invasive inflammation marker in the detection of inflammatory bowel disease and, to a lesser degree, has also proven to be useful in adenomatous polyps, neoplasias, and infectious gastroenteritis. Elevated calprotectin levels can also be found in patients with lesion only in the upper gastrointestinal tract. However, the diagnostic value of calprotectin has never been tested in this setting. The aim of the study is therefore to determine the diagnostic value of fecal calprotectin in patients with diseases of the upper gastrointestinal tract.


Eligibility Criteria:
Inclusion Criteria:

* All patients referred for upper gastrointestinal endoscopy for any reason
* Older than 18 years

Exclusion Criteria:

* Patients who are not able to provide informed consent
* Patients who are not able to provide a stool sample
Left Ventricular Volume Index in the Adjustment of Initial Dose of Dobutamine in Heart Failure and Cardiogenic Shock

Recent studies have suggested that the use of left ventricular ejection volume index calculation may aid in the hemodynamic management of critically ill patients. However, a prospective and randomized comparison in patients with heart failure for inotropic dose adjustment has not been described. The objective of this study was to evaluate the efficacy and safety of ejection volume index versus liberal strategy in adjusting dobutamine dose in patients with heart failure and low cardiac output. Methodology: A unicentric, randomized and prospective study will be performed in a comparative manner. Hospital data (test results, medical outcomes, dobutamine dose, complications) of patients will be analyzed for safety and effectiveness. Expected results: The use of ejection volume index is not inferior to the liberal strategy in the initial adjustment of the dose of dobutamine in patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* LVEF ≤ 40% documented on echocardiography
* BNP\> 500 pg / mL
* Need for initiation of dobutamine and signs or symptoms of low cardiac output at admission defined by the presence of 2 or more of the following:

  * SBP ≤ 95 mmHg
  * FC\> 100 bpm
  * Peripheral vasoconstriction,
  * Cold extremities,
  * Reference of decrease of urine output,
  * Nausea, vomiting and food intolerance,
  * Presence of organic dysfunction

Exclusion Criteria:

* Pregnancy.
* COPD
* Hepatical cirrhosis
* Atrioventricular block of 2nd or 3rd degree. and. SBP \<80 mmHg or need for vasopressor.
* Use of definitive pacemaker.
* Body mass index greater than 40 kg / m2.
* Use of oral anticoagulant.
* Acute coronary syndrome.
* Indication of use of another inotropic other than dobutamine.
* Orotracheal intubation.
* Presence of significant pericardial effusion.
* Obstruction of left ventricular outflow tract.
* Serum creatinine\> 5.0 mg / dL or hemodialysis.
* Presence of 2 or more clinical / laboratory / radiological criteria of infection
Blood Glucose Levels in Children During Anesthesia

This cross-sectional study aims to investigate blood glucose levels in children during general anesthesia and explore the incidence of hypoglycemia after anesthesia induction in relation to preoperative fasting.

Blood glucose will be measured following anesthesia induction and prior to discontinuing the administration of the anesthetic agent.

This cross-sectional study aims to investigate blood glucose levels in children \< 18 years during general anesthesia, and explore the incidence of hypoglycemia after anesthesia induction in relation to preoperative fasting.

The purpose is to evaluate whether guidelines for shortening the preoperative fasting period of children at our hospital have resulted in a shorter fasting duration and prevalence of low blood glucose levels during anesthesia induction. Also to shed light on blood glucose levels during general anesthesia and its correlation with intravenous fluid management and administration of steroidal anti-emetics.

Blood glucose sampling will be obtained and measured following anesthesia induction and prior to discontinuing the anesthetic agent. If general anesthesia lasts longer than one hour, additional blood glucose analysis will be conducted one hour after the first measurement.

Eligibility Criteria:
Inclusion Criteria:

Children under 18 years of age who undergo intervention under general anesthesia. The parent or guardian understands and speaks Icelandic.

Exclusion Criteria:

Coexisting disease or treatment that may affect fasting blood glucose level; Preoperative intravenous fluid administration; Beta-blockers; Insulin and corticosteroids, endocrine disorders, acute pain, and emergency interventions.
Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis

Purpose and aims This as a pilot study that aims to investigate which inflammatory biomarkers can be found in saliva in children with Juvenile Idiopathic Arthritis (JIA).

The hypothesis is that children with JIA will show a different pattern of inflammatory biomarkers in saliva than healthy Children.

The null hypothesis is that there are no differences.

This is a comparison between 100 children with JIA and 100 healthy children. Saliva will be collected and analyzed with respect to biomarkers.

One-hundred consecutive patients with active JIA, as diagnosed by the Department of Pediatric Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included.

Inclusion criteria are:

* age between 7 and 14 years
* a diagnosis of JIA according to the International League of Associations for rheumatology

Exclusion criteria are:

* current malignancies
* TMJ surgery or trauma within two years
* recent intra-articular glucocorticoid injection in TMJ (within 1 month)
* other conditions or diseases than JIA that may cause orofacial pain. The parents of the patients and/or the patients will give their verbal and written informed consent to participate in the study according to the permission from the regional ethical committee 2011/2:1.

The control group of 100 age and sex matched healthy children will be included at Folktandvården Stockholms Län AB.

Inclusion criteria are:

• age between 7 and 14 years

Exclusion criteria are:

* current malignancies
* TMJ surgery or trauma within two years
* recent intra-articular glucocorticoid injection in TMJ (within 1 month)
* A diagnosis of JIA
* other conditions or diseases than JIA that may cause orofacial pain. The parents of the patients and/or the patients will give their verbal and written informed consent to participate in the study according to the permission from the regional ethical committee 2011/2:1.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of JIA according to the International League of Associations for rheumatology (ILAR) The parents of the patients and/or the patients will give their verbal and written informed consent to participate in the study according to the permission from the regional ethical committee 2011/2:1

Exclusion Criteria:

1. current malignancies
2. TMJ surgery or trauma within two years
3. Recent intra-articular glucocorticoid injection in TMJ (within 1 month)
4. Other conditions or diseases than JIA that may cause orofacial pain. Fore the controllgroup JIA are excluded