cyrilzakka/clinical-trials huggingface dataset:
Trustworthy Artificial Intelligence for Improvement of Stroke Outcomes

Stroke is a leading cause of death and disability worldwide. The clinical validation of explainable and interpretable Artificial Intelligence (AI) solutions to assist a timely, personalised management of the acute phase of stroke, would have a major impact since it can greatly reduce the disability levels of patients. Also, the prediction of long-term outcomes is a crucial factor as it may determine critical decisions such as the discharge destination for the patient. Moreover, compliance with guideline-based secondary stroke prevention has been demonstrated to reduce stroke recurrence, but currently, only 40% of patients are adherent to preventive treatments 3 months after stroke. Therefore, patients´ outcomes can improve with proper patient communication and engagement packages. AI may have a dramatic impact on stroke patient journey, improving predictions, resulting in a better choice of secondary stroke strategies, as well as using evidence-based information to promote better adherence to treatment and reduction of vascular risk factors.

The aim of this multicentre observational prospective study is to develop and validate AI-based tools to predict short and long-term outcomes in ischemic stroke patients. Specifically, this study aims to demonstrate the accuracy of AI models in predicting the functional outcome of ischaemic stroke patients as measured by the National Institutes of health Stroke Scale (NIHSS, 0-42) and the modified Rankin Scale (mRS, 0-6) scores at hospital discharge and at 3, 6 and 12 months after discharge. Prospective ischemic stroke patients from 3 Large European centres will be recruited. The training and testing of local AI models will be performed using hospitalization data, collected during the standard of care procedures for stroke patient pathways, and outpatient monitored data from a remote home-care system (NORA app) during the follow-up after discharge. These local models will then be integrated into a federated learning system, where only a global AI model, derived from combined insights of all local models, is shared across participating hospitals. The individual local models and the original data are not shared, ensuring data privacy and security. The accuracy and performance of prospectively optimized AI models in predicting clinical outcomes over a 12-month follow-up period will be evaluated and compared to the actual outcomes of the patients.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years of age or older
2. Diagnosis of acute ischemic stroke
3. Signature of the informed consent form by the patient or a next of kin

Exclusion Criteria:

* No exclusion criteria are contemplated for this study.
Prospective, International Monosyn® Quick - Non Interventional Study

The Monosyn® Quick non-interventional study (NIS) has been designed to implement an action within the framework of a proactive post-market surveillance system.

The aim of this NIS is to collect systematically and proactively different clinical parameters regarding safety, effectiveness and performance of Monosyn® Quick suture material under the daily clinical practice when used as intended.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric and adult patients undergoing mucosal wound or skin closure using Monosyn® Quick as suture material or women undergoing an episiotomy or pediatric patients undergoing an urological intervention such as a circumcision or phimosis or hypospadias etc.
* Written informed regarding the data collection for the Post Market Clinical Follow-Up (PMCF)

Exclusion Criteria:

- None
Intracranial Pressure in Monopolar and Bipolar Hysteroscopy

Two distinction fluids are used in operative hysteroscopy. One is monopolar and the second is bipolar. The monopolar fluid contains mannitol and the bipolar fluid contains serum physiologic. This study aims to compare intracranial pressure in patients undergoing monopolar and bipolar hysteroscopy.

Operative hysteroscopy is currently used in the treatment of several diseases including submucosal myomas, polyps, uterine septum, and abnormal intrauterine bleeding. Two different methods for distension of the uterus for hysteroscopy are available currently. One is monopolar and the second is bipolar. The monopolar fluid contains mannitol and the bipolar fluid contains serum physiologic. Passage of the distention fluid into the uterine veins during hysteroscopy might lead to volume overload, water intoxication, hyponatremia, pulmonary edema or brain edema. However, the effect of monopolar hysteroscopy or bipolar hysteroscopy on intracranial pressure in patients undergoing hysteroscopy is unknown. Optic nerve sheath diameter (ONSD) measurement is a surrogate marker of invasive intracranial pressure. This study aims to compare the impact of monopolar and bipolar hysteroscopy on intracranial pressure by using ONSD measurement in patients undergoing hysteroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Must be scheduled to hysteroscopy for treatment of uterine myoma, polyp, septum, or for endometrial ablation.

Exclusion Criteria:

* Postmenopause;
* Kidney disease;
* Cardiovascular disease;
* Glaucoma
Croatian Version of the Ocular Surface Disease Index Questionnaire (OSDI)

Ocular Surface Disease Index (OSDI) Questionnaire is an important tool for the diagnosis of dry eye disease. Croatian version is yet not available. With a permission of AbbVie company investigators want to make a Croatian version of the Ocular Surface Disease Index Questionnaire (Cro-OSDI).

Aim is to translate, adapt and validate the Croatian version of the Ocular Surface Disease Index (OSDI) Questionnaire. Validation process of the Croatian version of the OSDI questionnaire will be accomplished in two phases: the translation and assessment of psychometric properties.

The translation process will involve the following steps based on the previously established guidelines. First is forward translation, the second is backward translation and the third is pilot study. The final version (the Cro-OSDI) will be used to test psychometric properties of the Croatian version of the questionnaire.

Eligible participants will complete the Cro-OSDI and and the previously validated Croatian version of the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25). After completing the respective questionnaires, the participants will undergo a complete ophthalmic examination for both eyes and dry eye tests (corneal fluorescein staining, lissamine green staining, Schirmer test type I and II, tear break-up time (TBUT), noninvasive tear breakup time (NIBUT)).

Eligibility Criteria:
Inclusion Criteria:

* native Croatian-speaking participants with normal cognitive ability
* DED diagnosis complied with those defined by the DEWS II
* DED for at least 3 months
* BCVA logMAR\< 0.6 or better

Exclusion Criteria:

* symptoms of conjunctivitis
* a history of contact lens use
* previous intraocular or ocular surface surgeries within the previous 6 months
* allergies
* eyelid malpositions
* ptosis
* Parkinson disease
* hereditary corneal disease
* any other disease that could affect blinking
Movement Strategies During Balance Tasks in Children with and Without Developmental Coordination Disorder

The main objective of the study is to gain insights in how children learn a balance task and whether there is a difference between children with and without Developmental Coordination Disorder. Furthermore, the investigators are interested in the brain activity of these children while learning this new balance task.


Eligibility Criteria:
Inclusion Criteria:

For children with DCD

* Children with the clinical diagnosis of Developmental Coordination Disorder (DCD) based on criteria of the DSM-5 (APA, 2013), diagnosed by a pediatrician.
* Children who have no formal diagnosis are evaluated by the research team using the diagnostic criteria as outlined in the inclusion criteria, these children will be included as "suspected of having DCD"
* Balance problems need to be present and objectified with the Balance Evaluation Systems Test for Children, second edition (Kids-BESTest-2). (total score below 80%)

For children without DCD

* Total score at or below the 25th percentile on the Movement Assessment Battery for children, second edition
* Normal postural control, objectified by the Kids-BESTest-2 (score at or above 80%)
* Match with children with DCD based on their sex, age and potential comorbidities.

Exclusion Criteria:

Presence of:

* Intellectual problems
* Visual problems
* Vestibular problems
* Neurological conditions
* Not able to follow instructions due to behavioral problems
* Refuse to participate
Radiation Therapy Plus Hyperbaric Oxygen in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hyperbaric oxygen may increase the effectiveness of radiation therapy. Combining hyperbaric oxygen with radiation therapy may be an effective treatment for glioblastoma multiforme.

PURPOSE: Phase I/II trial to study the effectiveness of combining radiation therapy with hyperbaric oxygen in treating patients who have newly diagnosed glioblastoma multiforme.

OBJECTIVES: I. Determine the feasibility and toxicity of hyperbaric oxygen combined with conformal radiotherapy in patients with newly diagnosed glioblastoma multiforme. II. Determine the efficacy of this regimen in terms of radiographic tumor response, time to tumor progression, and survival in these patients.

OUTLINE: Within 2 weeks after surgery, patients receive hyperbaric oxygen over 90 minutes once daily, followed by conformal radiotherapy twice daily 5 days a week for 17 days in the absence of unacceptable toxicity. Patients are followed within 2 weeks and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 5-10 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven newly diagnosed glioblastoma multiforme Measurable residual tumor by MRI after biopsy or craniotomy

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: More than 8 weeks Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: No severe pulmonary disease (e.g., emphysema with carbon dioxide retention) No untreated pneumothorax Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except epithelial skin cancer No psychological, familial, sociological, or geographical conditions that would preclude study No intractable seizure disorder

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or concurrent bleomycin Endocrine therapy: Not specified Radiotherapy: No prior cranial radiotherapy Surgery: See Disease Characteristics Other: No other prior therapy, including adjuvant therapy, for glioblastoma multiforme
Convalescent Plasma for Patients With COVID-19

Pilot study of tolerability and efficacy of transfusion of 200mL of convalescent plasma in patients with COVID-19 respiratory disease.

Importance: Convalescent plasma has been shown to be safe in patients with COVID-19, but whether it is clinically effective in patients with severe COVID-19 pneumonia is still unclear.

Objective: To evaluate the safety, tolerability, efficacy, and adverse events related to transfusion of convalescent plasma in patients hospitalized with severe or critical COVID-19 pneumonia.

Design, Setting and Participants: Randomized, single center, open-label, controlled trial of patients hospitalized between May 1, 2020, and August 1, 2020, with severe COVID-19 pneumonia in 1 tertiary care health system in the United States. A total of 30 participants age ≥ 18 years with 1 or more of the following were enrolled: dyspnea; respiratory rate \> 30; O2 saturation ≤ 93%; PaO2/FiO2 or SaO2/FiO2 ratio \< 300 mm Hg; and bilateral airspace opacities on chest x-ray \> 50% within 24 to 48 hours.

Intervention: Transfusion with 1 unit of ABO compatible convalescent plasma in addition to standard care (n = 20) or standard care (n = 10). Standard care included steroids.

Main Outcomes and Measures: Primary outcome was improvement in oxygenation 72 hours after infusion measured by change in arterial blood gas or in PaO2/FiO2 or Sa/FiO2. Secondary outcomes were mortality at 28 days, days on mechanical ventilation, intensive care unit and hospital length of stay, and mSOFA score.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 with one or more of the following: Dyspnea Respiratory rate \>= 30 breaths/min Oxygen saturation \<=93% PaO2/FiO2 \<300 Bilateral airspace opacities on chest radiograph at 24 to 48 hours

Exclusion Criteria:

* Acute myocardial infarction in past 30 days Acute stroke in past 30 days VV ECMO VA ECMO
Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168)

Evaluate pleiotropic effects of simvastatin in hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* Females Or Males Over 18 Years Old
* Patients With Systemic Arterial Hypertension Grade I And II According With The European Society Of Cardiology
* Left Ventricular hypertrophy Demonstrated By Echocardiography
* Mild To Moderated hypercholesterolemia
* Willing To Participate And Sign The Informed Consent Form (ICF)

Exclusion Criteria:

* Type 1 Or 2 Diabetes Mellitus
* Familiar hypercholesterolemia
* Low Density Lipoprotein-Cholesterol (LDL-C) \> 190 mg/dl
* History Of Myocardial Infarction Or Stable Chronic Angina
* Triglycerides \>250 mg/dl
Using 18F-FPEB PET to Identify mGLUR5 Availability in Affective Disorders

Evidence suggests that mGLUR5 availability may play a key role in the biology of mood disorders. This study aimed to investigate the changes in metabotropic glutamate receptor 5 (mGLUR5) availability and clinical symptoms in patients with MDD and bipolar disorder(BD) after two months of vortioxetine treatment. The investigators hypothesized that patients with MDD and BP have abnormal mGluR5 availability in certain brain regions, and baseline mGLUR5 availability can predict prognosis the prognosis of MDD and BD. fMRI and NODDI are also used to evaluate the function or neurite condition at baseline and 8 week


Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-V criteria for a current depressive episode.
* Being first-episode patients who were medication-naïve;
* Score \>17 on 17-item Hamilton Depression Rating Scale (HDRS), score \>22 on Montgomery-Asberg Depression Rating Scale (MADRS), and score \<6 on Young Mania Rating Scale (YMRS).
* Age 18 to 35.
* Able to give written informed consent.

Exclusion Criteria:

* Have a current or past significant medical, neurological or metabolic disorder or head injury
* Have active, significant suicidal ideation or past suicide attempts
* Have implanted metallic devices or any MR contraindications
* Are women who are pregnant or breastfeeding
* Met DSM-5 criteria for substance use disorder
* Met DSM-5 criteria for any current Axis I diagnosis (except Generalized Anxiety Disorder)
* Are MDD patients present with delusions and/or hallucinations
Adherence Monitoring System in Managing Myelosuppression in Patients With Newly Diagnosed Malignant Gliomas Receiving Temozolomide and Radiation Therapy

This research trial studies an adherence monitoring system in managing myelosuppression in patients with newly diagnosed malignant gliomas who are receiving temozolomide and radiation therapy. The development of an adherence monitoring system may help doctors more effectively utilize electronic medical records to manage myelosuppression during standard treatment with temozolomide and radiation therapy in patients with malignant gliomas.

PRIMARY OBJECTIVES:

I. To develop an adherence monitoring system within Epic that is functionally equivalent to the previously designed and validated system in the Cancer Center Oncology Research Information System (ORIS) for patients with newly diagnosed malignant gliomas receiving concurrent temozolomide and radiation therapy.

II. To test the newly designed Epic system by comparing the frequency and timing of flags (laboratory date flags, visit date flags and in-patient status flags) and non-adherent days generated with the frequency and timing of those generated by ORIS for patients with newly diagnosed malignant gliomas receiving concurrent temozolomide and radiation therapy.

SECONDARY OBJECTIVES:

I. To develop both systems so that they may be easily adapted in the future to other therapies that require compliance monitoring.

OUTLINE:

Patient lab and visit dates are monitored by the Cancer Center ORIS and EPIC based systems during the 42 days of the concurrent temozolomide and radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* All patients who receive concurrent temozolomide and radiation therapy for newly diagnosed malignant gliomas during and after the construction of the system until the end of the study

Exclusion Criteria:

* Patients participating in clinical trials or other deviations from standard therapies that engender similar monitoring risk will be evaluated for this study on a case by case basis
Manualised Cognitive Behavioral Therapy of Anxiety Disorders in Children and Adolescents in Routine Care Setting

Manualised Cognitive Behavioral Therapy for children and adolescents with anxiety disorders is evaluated in a routine care setting to evaluate the efficacy of the intervention. Children and adolescents receive manualized Cognitive Behavioral Therapy for anxiety disorder.

It is expected, that the intervention will result in less anxiety / lower scores on the primary and secondary outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 4-18 years
* Primary diagnosis of an anxiety disorder:

  1. Generalized Anxiety Disorder
  2. Social Phobia
  3. Separation Anxiety Disorder
  4. Panic Disorder +/- Agoraphobia
  5. Specific Phobia

Exclusion Criteria:

* Other primary diagnoses
* Significant intellectual impairment
A Pilot Study of TMS Effects on Pain and Depression in Patients With Fibromyalgia

In this pilot study, the PI proposes to include 20 African American participants with Fibromyalgia to explore the effect of r TMS on pain and depressive symptoms.

In this pilot study, the PI proposes to include 20 African American participants with Fibromyalgia to explore the effect of r TMS on pain and depressive symptoms. The focus on African Americans is due to the mandate from the funding source (internal), as well as possible higher prevalence of FM in AA women. If recruitment is slow, the PI proposes to open up the study to other groups. Twenty subjects will be randomized to either sham or active TMS condition. Inclusion/exclusion criteria are well thought out and seem appropriate. mTreatments will be administered at IOP 5 times/wk with each session lasting 20 minutes. Pain intensity and unpleasantness will be measured pre and post each TMS session using three different pain evaluation paradigms. GCRC resource is mainly requested for two blood draws pre and post first TMS session. The blood samples will be used to measure inflammatory cytokines IL-1, IL-6, AND IL-8. The main aim is to ascertain feasibility of the study and secondary aim is to gather information on variability in response for power analysis for future larger study. The introduction and rationale (including pain evaluation, and methods relating to TMS) are clearly presented. Use of GCRC resources seem appropriate.

Eligibility Criteria:
Inclusion Criteria:

* age 18-80,
* meet ACR criteria for FM for more than 6 months,
* may or may not have a diagnosis of major depressive disorder (not bipolar) past or present,
* Current major depressive episode must be without psychotic features
* Not be on medication known to increase risk of TMS-induced seizures
* No prescription medication changes in the previous 4 weeks with agreement not to change during the treatment course (2 weeks) and 2 weeks thereafter
* No history of epilepsy or stroke or recent head trauma (LOC \> 5 minutes) within the past 6 months
* African Americans will be initially sought out for study, however the recruitment may extend to include Caucasian and Hispanic subjects to carry out the study.

Exclusion Criteria:

* Primary, current diagnosis of schizophrenia
* Other (non-mood disorder) psychosis
* Mental retardation
* Substance dependence or abuse within the past 6 months (except nicotine)
* Psychotic features in this episode, dementia, or delirium
* Contraindication to rTMS
* Increased intracranial pressure
* Brain surgery, or head trauma with loss of consciousness for \> 15 minutes
* Implanted electronic device
* Metal in the head, or pregnant
* Has an active autoimmune, endocrine, viral, or vascular disorder affecting the brain or unstable cardiac disease
* Uncontrolled hypertension, or severe renal or liver insufficiency
* Unstable and active suicidal intent or plan
* History of attempt requiring medical hospitalization within in the past 6 months
* -currently an involuntary inpatient on a psychiatric ward.
Insertion Angle and Needle Visualization During Ultrasound Guided Internal Jugular Vein Cannulation

Ultrasound guidance has been established as an effective and safe method during insertion of internal jugular vein catheter.. Needle visualization during advancement toward the vein has a great impact on both safety and success of the procedure. Clinicians have adopted variable techniques to increase needle visualization including changing needle- probe relation (in-plane vs. out-of-plane), or using specific ultrasound needles The angle between the inserting needle and the probe lying on patient skin affects both the distance to the vein and the length of the needle part travelling through the us beam


Eligibility Criteria:
Inclusion Criteria:

* all patients requiring central line insertion

Exclusion Criteria:

* refusal
* coagulopathy
* neck surgeries
Daily Protein Intake Distribution and MPS (ARCIII)

To determine whether a balanced total daily dietary protein distribution supplemented with whey protein during a weight-loss intervention will result in increased muscle protein synthesis


Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese (BMI 27-40 kg/m2)
* Non-smokers
* Non-diabetic
* No history of hyperlipidemia
* Not taking medications thought to interfere with study
* Considered generally healthy

Exclusion Criteria:

* Efforts to lose weight in previous 16 weeks
* Hyperlipidemia
* Blood pressure ≥ 140/90 mmHg
* Smoking
* Heart and other organ disease
* Type 2 diabetes
* Gastrointestinal disease
* Orthopedic injury interfering with exercise
* Use of certain medications (HRT, antihypertensives, diuretics, antiarythmia medications, antiresorptive agents, anabolic agents, hypoglycemic agents, and statins known to affect muscle i.e. Simvastatin and Zocor)