cyrilzakka/clinical-trials huggingface dataset:
Occurrence, Trends, Management and Outcomes of Patients Hospitalized With Myocarditis

The epidemiology of myocarditis is largely unknown and based mainly on small single-center studies. The study aim to evaluate the current incidence, clinical characteristics and outcomes of patients hospitalized due to myocarditis in a general population.

In this retrospective-prospective study, data from the National Health Fund (NHF), which is the only public healthcare insurer in Poland is used. The NHF reimburses drugs and healthcare services provided by healthcare providers (both public and private) with public funds collected from health insurance premiums. In Poland, public health insurance is obligatory for almost all Poles - in December 2019, 88.4% of approx. 38 million Poles had public health insurance and were entitled to obtain healthcare services and drugs reimbursed by the NHF.

Based on NHF claims data, the healthcare services reported over the years 2009-2021 with a diagnosis of myocarditis - hospitalizations reported with codes I40, I40.0, I40.1, I40.8, I40.9, I41, I41.0, I41.1, I41.2, I41.8, I51.4, B33.2 are derived according to the International Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). The dataset is narrowed to the first myocarditis hospitalization, i.e. patients for whom no information about the diagnosis of myocarditis is reported in the 400 days preceding the hospitalization. For such a group of patients, and to establish the baseline characteristics of the patients, data is analyzed 400 days back from the initial diagnosis of myocarditis. Also, in-hospital and long-term outcomes are analyzed, including all-cause mortality as well as the occurrence of selected diseases (defined as receiving a service where selected ICD-10 was reported), and selected procedures are obtained, defined with codes according to International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM). For the follow-up, at least a six-month period is required.

To show differences related to the age of patients hospitalized due to myocarditis, baseline characteristics and long-term outcomes are assessed with regard to age groups.

Data from the Central Statistical Office of Poland is also used to refer the obtained results to the population of Poland and to obtain life tables for survival analysis.

No specific exclusion criteria were applied. No ethics approval was required for this study, as it involved the analysis of administrative data.

Eligibility Criteria:
Inclusion Criteria:

* first myocarditis hospitalization

Exclusion Criteria:

* no specific exclusion criteria were applied
Cognitive Rehabilitation of Executive Dysfunction - Goal Management Training in Patients With Acquired Brain Injury

The main objective of this study is to examine the effect of Goal Management Training for patients with executive difficulties after acquired brain injury in a randomized controlled trial. The effect on cognitive functioning will be examined, as will the relationship between treatment effects and lesion location and size. The effect of Goal Management training on regulating emotions, quality of life and coping will be examined. The generalizability of treatment effects across etiologies will be explored by comparing effects in three patient groups; traumatic brain injury, cerebrovascular accidents and resected brain tumors. Structural Magnetic Resonance Imaging (MRI) scans and measures of white matter connectivity will be used to establish detailed lesion descriptions. Functional MRI data will provide information on the neural underpinnings of treatment related change. A secondary objective is to expand the Goal Management Training protocol with increased focus on emotional regulation and adherence to homework assignment.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic Brain Injury, stroke and resected brain tumor patients with no concomitant diseases
* Minimum 6 months post-injury/surgery
* Reporting executive problems by structured interview or baseline assessment (cognitive performance measures)

Exclusion Criteria:

* Major psychiatric disorder or reported ongoing alcohol or substance abuse
* Premorbid neurological disease or insult and/or comorbid neurological disease
* Aphasia or other specified language problems causing potential communication problems
* Impaired basic cognitive, linguistic, mnemonic, motor, or perceptual function that can interfere with the ability to engage with the training
Investigation of Community Reablement on Instrumental Activities of Daily Living in People With Schizophrenia

This is a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of Reablement-Instrumental Activities of Daily Living (RE-IADL) on schizophrenia patients at immediately and long-term.

Subjects will be randomized to intervention group and control group. The outcome measures include the Canadian Occupational Performance Measure, Instrumental Activities of Daily Living-3 Dimensions, Activities of Daily Living Rating Scale III, Frenchay Activities Index, Lawton Instrumental Activities of Daily Living, Mini Mental State Examination-2nd edition, Behavior Rating Inventory of Executive Function adult version, Allen Cognitive Level Screen-6th, Participation Measure-3 Domains, 4 Dimensions, Personal and Social Performance scale, Work Behavior Inventory, Schizophrenia-Quality of Life questionnaire, Beck Depression Inventory-II, and Functioning Scale of the Disability Evaluation System.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia by DSM-5
* age \> 20 years
* Stable mental symptoms
* Willing to sign the subject's consent

Exclusion Criteria:

* History of severe brain injury
* Substance abuse
* Diagnosis of intellectual developmental disorder
* Unable to follow instructions
Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma

Endoscopic submucosal dissection (ESD) is a minimally invasive alternative to esophagectomy for early esophageal squamous cell carcinoma (EESCC), The data of EESCC patients who received ESD or esophagectomy were retrospectively analyzed,The aim of this study was to compare the efficacy and safety of ESD and esophagectomy in EESCC,Risk factors affecting the prognosis of patients with early esophageal squamous cell carcinoma were analyzed.

Endoscopic submucosal dissection (ESD) is a minimally invasive alternative to esophagectomy for early esophageal squamous cell carcinoma (EESCC).The aim of this study was to compare the efficacy and safety of ESD and esophagectomy in EESCC，The data of EESCC patients who received ESD or esophagectomy were retrospectively analyzed. Overall survival (OS), disease specific survival (DSS), recurrence free survival (RFS), and procedure-related variables were compared between ESD and esophagectomy patients.Risk factors affecting the prognosis of patients with early esophageal squamous cell carcinoma were analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Mucosal or submucosal squamous cell carcinoma of the esophagus
2. no lymph node involvement or distant metastasis on computed tomography (CT) or pathology;

Exclusion Criteria:

1. Tis premalignant lesions (high-grade intraepithelial neoplasia;HGIN)
2. patients with neoadjuvant therapy
3. patients combined with severe diseases of other organs
Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice

Increased production of vasodilating substances such as NO plays an important role in the development of vasoplegic syndrome caused by obstructive jaundice.Methylene blue plays a role in raising blood pressure by inhibiting the vasodilator Nitric Oxide (NO)

The level of circulating hydrogen sulfide (H2S) in patients with obstructive jaundice is significantly increased. As a direct opener of KATP channels in vivo, H2S also has diastolic peripheral vasculature . H2S participates in the occurrence of vasoplegic syndrome in patients with obstructive jaundice by interacting with NO. However, it is unclear whether methylene blue can relieve vasoplegic syndrome in patients with obstructive jaundice by inhibiting the vasodilating effect of substances such as H2S and NO.

Therefore, this clinical study intends to include patients with obstructive jaundice, using randomized, controlled, prospective study to explore the effect of methylene blue on the occurrence of vasoplegic syndrome, organ function and prognosis in patients with obstructive jaundice.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18\~70 years old;
2. ASA grade I\~III;
3. Ability to comply with research protocols;
4. Patients with obstructive jaundice: patients with total bilirubin greater than 50umol/L;
5. Voluntarily participate in the study and sign the informed consent form. -

Exclusion Criteria:

1. ASA IV\~V grade;
2. women during lactation and pregnancy;
3. Patients with severe heart disease or lung disease before surgery;
4. Participating in other trials in the last 2 months;
5. Those whose mental state cannot cooperate, who suffer from mental illness, have no self-control, and cannot express clearly;
6. Those who refuse to sign the informed consent form. -
Collecting Information About Treatment Results for Patients With Cushing's Syndrome

The purpose of this study is to follow participants with Cushing's syndrome during the course of their routine care and to form a data registry to study long term participant outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age 14 or older
* Active or treated overt Cushing's (due to pituitary, ectopic, or adrenal tumor), mild adrenal Cushing's syndrome (MACS), or a silent corticotroph tumor
* The diagnosis of CS or MACS will be made by the PI, based on the below Endocrine Society guidelines, the patient's clinical presentation, and the PI's judgment.

  * Diagnostic criteria for ACTH-dependent Cushing's are according to the Endocrine Society and European Society of Endocrinology guidelines and include: Elevated 24-hour urinary free cortisol (UFC), normal or elevated plasma ACTH, elevated midnight salivary cortisol levels, or classic dexamethasone suppression testing for CD (morning cortisol \> 5 ug/dL after 1 mg overnight of classic 2-day low dose test) and a pituitary lesion on MRI. If patient does not have any of these results, pathology of ACTH tumor may confirm presence of disease.
  * Diagnostic criterion for MACS is according to the European Society of Endocrinology guidelines: Classic dexamethasone suppression testing for CD (morning cortisol \>1.8 µg/dL after 1 mg overnight).
* For pituitary Cushing's patients, if the patient demonstrates non-classic testing or no pituitary lesion is seen on MRI then petrosal sinus sampling or positive surgical pathology will be used to confirm pituitary source of Cushing's. Clinical or biochemical remission after surgery will also confirm pituitary source.
* Ectopic Cushing's will be confirmed by petrosal sinus sampling and appropriate imaging tests, or positive surgical pathology.
* Adrenal Cushing's will be confirmed by a suppressed plasma ACTH value and identification of an adrenal lesion on CT or MRI, or positive surgical pathology.
* Silent corticotroph tumors will be defined by surgical pathology demonstrating positivity for ACTH, in the absence of clinical and biochemical features of Cushing's syndrome.
* In lieu of MRI, surgical, or laboratory reports, physician's assessment note including mention of results will also be used as source for eligibility purposes.

Exclusion Criteria:

* Patients with a diagnosis of iatrogenic Cushing's.
Exercise Enhances Brain Function in Attention-deficit/Hyperactivity Disorder (ADHD)

The aim of the study was to investigate the different effects of exercise types on inhibitory control in children with attention-deficit/ hyperactivity disorder.

Study inclusion criteria were as follows: (1) age between 8 and 12 years; (2) diagnosed with ADHD by a pediatric psychiatrist; and (3) no history of brain injury or neurological conditions, such as exhibited epileptic seizures, serious head injuries, and periods of unconsciousness.

Eligibility Criteria:
Inclusion Criteria:

1. aged between 7 and 12 years
2. diagnosed by a pediatric psychiatrist
3. no history of brain injury
4. no neurological conditions

Exclusion Criteria:

1. less than 50% accuracy
2. failed to complete the task
3. cannot follow the instruction
Effect of White Potatoes on Glycemic Response and Satiety in Older Adults

The purpose of the present study is to explore the influence of cooking methods of potatoes on post-prandial glycaemia and satiety in healthy older adults.

Each of the 5 study sessions will be at least 7 days apart. Either meal skipping, or one of three treatments of white potatoes (a) baked (with skin), (b) mashed, (c) fried French fries, or white bread, prepared on the day of testing, will be served to healthy older adults (65+ years). Participants will consume the equivalent to 1 medium sized potato (\~280 kcal) or an equivalent amount of calories from white bread. Glycemic response, insulin, incretin hormones (glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP)), dipeptidyl peptidase 4 (DPP4), and cholecystokinin (CCK) will be measured for 2 h (0, 15, 30, 45, 60, 90 and 120 min) following meal consumption, as well as mood and subjective appetite. An ad libitum test meal will be provided at 120 min to assess food intake suppression.

Eligibility Criteria:
Inclusion Criteria:

* be 65 years or older
* be healthy
* not be taking medications that affect food intake regulation or blood glucose

Exclusion Criteria:

* anyone with food sensitivities or allergies to potatoes or potato-products,
* smokers
* diabetic or overweight/obese individuals.
A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD

The primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

* Out patient at least 40 years of age
* Both genders; females childbearing potencial must be willing to use birth control method
* A diagnosis of COPD at Screening
* Subjects with a current or prior history of at least 10 pack-years of cigarett smoking at Screening
* Post-bronchodilator FEV1/FVC ratio of less than 70%
* Post-bronchodilator FEV1 of less than 80%

Exclusion Criteria:

* Current diagnosis of sthma
* Respiratory disorders other than COPD
* Upper or lower respiratory infection, or exacerbation of COPD within 4 weeka prior to Screening
* Concurrent other disease that would confound study participation or affect subject safety
* Allergies to study drugs, study drugs' excipients, medications related to study drugs
* Taking another investigational medication or medication prohibited for use during this study
Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation

Hypothesis:

Blocking the angiotensin (AT) II type 1 receptor (Olmesartan) reduces the incidence of episodes of atrial fibrillation in patients with paroxysmal atrial fibrillation during 12 months by more than 25% compared to standard medication without angiotensin II type 1 receptor.

A total of 422 subjects will be included in the two study groups. The treatment arm will receive 40mg Olmesartan per day, the remaining patients will receive placebo. Follow-up is 12 months. Daily Tele-ECG recordings will determine the cardiac rhythm and asymptomatic episodes of atrial fibrillation (AF) every day. Concomitant therapy with AV-nodal blocking drugs are allowed during the study. In case of severe AF-induced symptoms, an antiarrhythmic "recovery medication" (amiodarone) is allowed during follow-up.

Double-blind, central randomization, two treatment groups, stratified by beta-blocker use. 211 patients in each treatment arm.

Eligibility Criteria:
Inclusion Criteria:

* Documented paroxysmal atrial fibrillation: ECG documentation of atrial fibrillation at least in one ECG recorded during the last 2 months prior to randomization plus additional ECG recording of sinus rhythm at least 12 hours after the above mentioned ECG documentation.
* Age ≥ 18
* Patient informed orally and in writing
* Written informed consent of the patient

Exclusion Criteria:

* Strong clinical evidence for therapy with AT II/ACE inhibitors
* AT II/ACE inhibitor therapy within the last month
* Therapy with antiarrhythmic agents of class I or class III within the last month, therapy with amiodarone within the last 3 months
* Direct current (DC) cardioversion within the last 3 months
* Symptomatic bradycardia
* Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in use
* Cardiac surgery or cardiac catheter ablation within the last 3 months
* Typical angina pectoris symptoms at rest or during exercise
* Known coronary artery disease with indication for intervention
* Valvular disease \> II degree
* Left ventricular ejection fraction \< 40%
* Diastolic blood pressure \> 110mm Hg at rest
* Symptomatic arterial hypotension
* Known renal artery stenosis
* Serum creatinine \> 1.8 mval/l
* Relevant hepatic or pulmonary disorders
* Hyperthyroidism manifested clinically and in laboratory
* Known drug intolerance for AT II inhibitors
* Females who are pregnant or breast feeding
* Females of childbearing potential who are not using a scientifically accepted method of contraception
* Participation in a clinical trial within the last 30 days
* Drug addiction or chronic alcohol abuse
* Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical study
* Evidence of an uncooperative attitude
Nasal Airway Stent (Nastent®) Study in OSA

This study intends to assess the effect of nasal airway stent (Nasten®) as a treatment modality in patients with sleep-disordered breathing (SDB) including snoring and/or obstructive sleep apnea (OSA). Nastent®, a distally perforated soft silicon nasal tube, is a mechanical splint against collapse of the upper airway at multiple levels. Nastent® might be able to prevent the vibrations caused by fluttering of various parts of the upper airway which leads to snoring. Furthermore, it also potentially secures a patent airway throughout the night securing airflow.

Patients with an established diagnosis of OSA with apnea/hypopnea-index (AHI)\< 20/ hour sleep from the ENT department are recruited and informed about the study. After obtaining informed consent and patient inclusion, a baseline portable sleep monitoring at home using WatchPAT™300 for one night is performed. During the next visit the objective size and position of the stent is determined under direct visualization using fiberoptic nasolaryngoscopy. Subsequently, the patients will receive a Nastent® Starter kit (containing 6 different stent sizes of Nastent®, 130, 135, 140, 145, 150 and 155mm) to gradually get accustomed to the stent and to find the right size for them. During the following consultation, a Nastent® classic kit (containing 7 stents of the same size, each can be used for two consecutive nights) is given to the patients to be used for 14 consecutive nights. During the last night of this 14-night period, a follow-up home portable sleep monitoring evaluation using WatchPAT™300 is performed with Nastent® in situ. Afterwards, during the final visit at the outpatient clinic, acceptance of the therapy with Nastent® by the patients is evaluated, and the decision of whether to continue the therapy and to proceed to the purchase of this product as a long-term treatment for the patient or not, is made.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* AHI ≤ 20 per hour of sleep
* Complaints of socially disturbing snoring by the partner of the patient
* Capable of giving informed consent

Exclusion Criteria:

* Craniofacial deformities
* Acute nasal trauma, fracture (during the past 3 months)
* Nasal valve collapse, synechiae and septal perforation, recurrent epistaxis, recent nasopharyngeal surgery, chronic rhinosinusitis with or without polyposis
* Cerebrospinal fluid leaks
* History of past or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient), intellectual disability, memory disorders, seizure disorders, neuromuscular disorders, cardiovascular diseases, coagulopathies (thrombocytopenia\< 100/µl), lower respiratory tract disorders.
* Pregnancy or willing to become pregnant
* Excessive alcohol or drug use (\> 20 alcohol units/week or any use of hard drugs)
* History of sleep medication use
Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers

Evaluate the immune response and reactogenicity of one dose of Meningococcal ACWY-cross reactive material (CRM) and Meningococcal ACWY-tetanus toxoid (TT) in 12-15 months old healthy toddlers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy children between 12 months and 15 months old inclusive who were born with an estimated gestational age ≥ 37 weeks.
2. Parent(s)/legal guardian(s) had given written informed consent after the nature of the study had been explained according to local regulatory requirements.
3. Parents/legal guardian available for all the visits and would comply with the requirements of the protocol (e.g., completion of the Diary Cards, availability for study visits / safety phone calls).
4. In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

1. Previous confirmed or suspected disease caused by N. meningitidis.
2. Previously exposed to clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization, i.e. possible meningococcal disease.
3. Previously immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
4. Received within 90 days prior to enrollment or were expected to receive during the study period any investigational or non-registered product (drug or vaccine).
5. Received or planning to receive any vaccines within 14 days before and 30 days after administration of the study vaccine (Exceptions: Injectable influenza vaccine could be administered up to 14 days prior to study vaccination and at least 14 days after study vaccination).
6. Major congenital defect or a serious chronic disease.
7. History of any anaphylaxis, severe vaccine reactions, or allergy to any vaccine components including diphtheria toxoid (CRM197) or tetanus toxoid (TT) and latex.
8. Required chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccination. (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids were allowed).
9. Receipt of immunoglobulins and/or any blood products within six months prior to study vaccination or who had administration planned during the study period.
10. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
11. Any bleeding disorder which was considered as a contraindication to intramuscular injection.
12. Moderate or severe acute infection and/or fever (defined as temperature ≥ 38°C) within 3 days prior to enrollment.
13. Systemic antibiotic treatment within 7 days prior to enrollment.