cyrilzakka/clinical-trials huggingface dataset:
Plasma Aldosterone Levels and Atrial Fibrillation Reduction (ALDO-AF Study)

Atrial fibrillation (AF) is the most common cardiac arrhythmias with a constantly growing prevalence. Two main techniques are used today to restore sinus rhythm: electrical cardioversion and radiofrequency ablation.

Radiofrequency ablation has become a recognized and effective treatment of AF. Despite a relatively high success rate (about 80%), a substantial number of patients require a second procedure to obtain sinus rhythm. Many publications have led to the study of predictors of failure of this ablation factors (BMI, uncontrolled hypertension, size of the OG...) but to date no parameter is reliable and usable in daily practice.

It is the same for electrical cardioversion. Despite a relatively high immediate success rate of approximately 80%, a significant number of patient relapse arrhythmia in short and long term. Many publications have led to the study of predictive factors of failure (seniority and type of AF, uncontrolled hypertension, size of the OG, mitral valve disease...) but so far the results are disappointing.

In AF patients with heart disease underlying, it has been well demonstrated that the renin-angiotensin system (RAAS) was strongly activated. In addition, it is now well established that elevated plasma aldosterone as in primary hyperaldosteronism is associated with a significantly increased risk of occurrence of cardiovascular events. The high plasma concentrations were also highlighted in the acute phase of myocardial infarction, or heart failure and are associated with an increase in major cardiovascular event rate, especially arrhythmias. In some experimental models of heart failure, it has been demonstrated a suppression of the occurrence of spontaneous FA by an anti-aldosterone treatment. The arrhythmogenic effect of aldosterone has also been shown in animal models. All these results indicate a potential role of aldosterone in the genesis of an arrhythmogenic substrate and the FA.

The hypothesis of this study is that aldosterone plasma levels in pre-reduced patients is predictive of recurrence risk of atrial fibrillation or other supraventricular tachycardias (flutter or atrial tachycardia) after FA reduction, either in using a radiofrequency ablation or via electrical cardioversion.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for atrial fibrillation cardioversion by radiofrequency ablation or electrical cardioversion
* scheduled hospitalisation or hospitalisation unrelated to cardiovascular events
* Age at least 18 years
* Clinically Stable (see criteria for non-inclusion)

Exclusion Criteria:

* Patient unstable defined as any cardiovascular event that occurred in the previous 30 days

These events are:

* hospitalisation for cardiovascular causes
* appearance or worsening of symptoms consistent with cardiac failure
* appearance or worsening symptoms of coronary

  * Patient refusing participation in the study
  * Patient unable to provide follow-up visits
Ion Therapy Patient Registry

The purpose of the study is the prospective and standardized data collection of patients treated with ion therapy at MedAustron.

During and up to 10 years after radiation therapy data regarding tumor control and treatment response as well as acute and late toxicities will be collected at regular time intervals. Additionally quality of life and sociodemographic status will be assessed in all study patients and neurocognitive assessment will be performed in patients undergoing ion radiation of the brain.

Eligibility Criteria:
Inclusion Criteria:

* Patients with tumor disease treated with ion beam therapy at MedAustron
* Signed informed consent form

Exclusion Criteria:

* Comorbidities endangering treatment delivery or study compliance
Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter

β thalassemia is an autosomal recessive hemoglobinopathy and considered as the most widespread genetic mutation. According to the World Health Organization (WHO) between 1.5-7% of the world population are carriers for this disease, and every year 60,000-400,000 birth of new patients are reported. In Israel, the incidence of carriers for β thalassemia is around 20% among the Jewish from Kurdish origin and around 5-10% among the Arab population.

β thalassemia is a severe disease which requires many resources, both medical and financial. The disease is expressed by chronic hemolytic anemia which requires regular blood transfusions every 3 weeks. As a result of the blood transfusions and the iron absorption by the digestive tract, those patients suffer from severe hemosiderosis which is the main mortality cause in the disease, mainly in the second decade for life. Daily treatment with iron chelator is required. Moreover, despite the actual treatment, the quality of life of those patients is still low.

Therefore the implementation of a prevention program which includes finding an effective and inexpensive way for identifying the β thalassemia carriers is a humanitary and publicly important goal.

In β thalassemia carriers, laboratory tests will show hypochromic microcytic anemia. Those findings are similar in iron deficiency anemia, but the RBC number and the RDW are normal in thalassemia carriers.

Few researchers tried in the past to determine cutoff point for diagnosis of β thalassemia carriers by different formulas.

We used the algorithm SVM (support vector machine) to find a reliable formula that can separate patients with Iron deficiency anemia/ healthy from patients with β thalassemia minor (carriers). This formula can be inserted to any automatic blood counter and search for suspected carriers without deliberately intention and without any further blood test.


Eligibility Criteria:
Inclusion Criteria:

* Blood count and Hgb electrophoresis analysis received from pregnant women send for screening for thalassemia.

Exclusion Criteria:

* Age below 17 yrs and older than 50 yrs.
* Sever anemia with hgb level below 8 gr/dl.
DepoCyt for Active Lymphomatous or Leukemic Meningitis

The purpose of this study is to determine the response rate of lymphomatous meningitis or leukemic meningitis to DepoCyt. The safety of DepoCyt, the number of people who respond well to the study drug, and the response of symptoms to the study drug will also be determined.

DepoCyt is a sustained-release formulation of the chemotherapy drug, cytarabine (Ara-C), which is used for the treatment of patients with lymphomatous or leukemic meningitis, a complication of lymphoma/leukemia that is characterized by the spread of cancer to the central nervous system.

DepoCyt is introduced into the spinal fluid, through a needle inserted into the spinal canal or through a reservoir placed under the scalp by a neurosurgeon. DepoCyt will be given every two weeks i.e. week 1 and week 3 initially. After the second dose, a lumbar puncture will be done to check the spinal fluid for cancer cells. If there has been a good response, DepoCyt will be given every 14 days for 6 doses i.e., weeks 5, 7, 9, 11, 13, 15 and then every 28 days for six doses i.e., weeks 19, 23, 27, 31, 35, and 39. Blood tests and lumbar punctures will be done throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Cytologically confirmed, or radiographic evidence for lymphomatous or leukemic meningitis. If the CSF cytology is negative, patients must have MRI/CT brain and clinical findings consistent with neoplastic meningitis.
* Karnofsky Performance Score of 60 or above.
* Age ≥ 18 years.
* Patients must have adequate hematologic, renal and liver function. Laboratory
* Absolute neutrophil count (ANC) ≥ 1,500/mm3 or white blood cell count \> 3,000/mm3
* Platelet count ≥ 100, 000/mm3
* BUN and serum creatinine must be ≤ 1.5 times upper limit of laboratory normal
* Total and direct serum bilirubin must be ≤ 1.5 times upper limit of laboratory normal
* SGOT and SGPT ≤ 3.0 times upper limit of laboratory normal
* Alkaline phosphatase derived from liver ≤ 2.0 times upper limit of laboratory normal
* No uncontrolled infection other than human immunodeficiency virus that is being treated with anti-retroviral therapy
* Patients who have had prior CNS radiation, prior intrathecal methotrexate, and prior CNS prophylaxis with intrathecal or intravenous cytarabine or methotrexate are eligible
* Written informed consent

Exclusion Criteria:

* Experimental/Investigational chemotherapy, immunotherapy, or biologic therapy within four weeks prior to study
* Concurrent systemic chemotherapy with high dose methotrexate, high dose cytarabine, or high dose thiotepa (they cross the blood brain barrier at high levels)
* Patients receiving whole brain radiotherapy or craniospinal irradiation
* Previous (less than 2 years from diagnosis) or concurrent malignancies at other sites with the exception of fully treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin, or prostate cancer not requiring ongoing chemotherapy
* Pregnant or lactating women
* Known active meningeal infection
* Evidence of obstructive hydrocephalus requiring neurosurgical intervention
Upper Limb Function in Mental Health Disorders

Background: Individuals with mental disorders (MD) often experience motor issues, yet upper limb functionality remains understudied.

Objective: To compare upper limb function in individuals with and without MD, focusing on motor capacity, dexterity, and performance.

Design: Cross-sectional, qualitative, multicenter study. Methods: Assessed strength, motor skills, sensitivity, and daily function. Used T-test, Mann-Whitney U, Spearman correlation, and Chi-square.

Background: Research suggests individuals with mental disorders (MD) often face motor difficulties, such as issues with gait and posture. However, there is limited research on upper limb functionality in the mental health context.

Objective: To compare upper limb functionality between individuals with and without MD, focusing on differences in motor capacity, manual dexterity, and functional performance.

Study Design: Cross-sectional, qualitative, multicenter study.

Methods: Strength, fine and gross motor skills, sensitivity, tactile discrimination, and were assessed, along with functional limitations in daily activities. Statistical methods used included independent samples T-test, Mann-Whitney U test, Spearman correlation, and Chi-square test.

Eligibility Criteria:
Inclusion Criteria:

Mental Disorder Group

* Participants with a mental disorder (MD) had to meet the following criteria:
* A formal diagnosis of a mental disorder according to the DSM-V.
* Aged between 18 and 65 years.
* Treatment stability, defined as being under stable pharmacological and psychiatric treatment for at least three months.
* Clinical stability, meaning no acute psychiatric episodes in the last three months that could interfere with participation in the study.
* Ability to follow instructions and communicate effectively, confirmed by scoring at least 23 points on the Mini-Mental State Examination (MMSE).

Control Group (Healthy Participants)

* Healthy individuals were required to meet the following inclusion criteria:
* Aged between 18 and 65 years.
* Ability to follow instructions and communicate effectively, also defined by a minimum MMSE score of 23.

Exclusion Criteria:

* Presence of neurological conditions, such as multiple sclerosis, stroke, or similar disorders.
* History of upper limb rehabilitation within the past six months.
* Any acute or chronic condition affecting the upper limb that could interfere with the results, including but not limited to arthritis, osteoarthritis, or carpal tunnel syndrome.
Rise Study for Depression

This study will examine the efficacy of digital CBT versus waitlist in improving symptoms for adults with Major Depressive Disorder.

This study aims to examine the effectiveness of app-based digital CBT in individuals with a diagnosis of Major Depressive Disorder. The primary outcomes are depression symptom reduction and engagement with fulfilling activities after 5 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥22 years old
* Score ≥10 and \<20 on the 8-item Patient Health Questionnaire (PHQ-8)
* Diagnosis of Major Depression
* Current resident of the USA
* Oral and written fluency in English
* Regular access to the internet via a mobile or tablet device using Android (5 or higher) or iOS (13 or higher)
* Participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form

Exclusion Criteria:

* Must not be currently receiving or be expecting to start therapy for depression, anxiety, or sleep during study participation, or have received cognitive behavioral therapy for depression, anxiety, or sleep in the past 12-months
* If on psychotropic medication, this must be stable for at least 60 days
* Past or present psychosis, schizophrenia, or bipolar disorder
* Moderate or greater suicide risk
* Treatment-resistant depression
* Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT or psychoeducation
* Intellectual disability or any Neurocognitive or Neurodevelopmental disorder that would prevent participants from following study procedures
* Any condition that the investigator believes would make participation in the study not in the best interest of the subject or would preclude successful completion of study activities
* Other exclusion criteria may apply
Problem Solving Skills Training For Parent Caregivers of Youth With Chronic Pain

The purpose of this study is to evaluate the feasibility and efficacy of problem-solving skills training (PSST) to reduce distress and increase coping abilities among parents of youth with chronic pain. We hypothesize that parents will complete the PSST intervention and will find it to be an acceptable and satisfactory treatment. We also hypothesize that parents who receive PSST will have less distress and better coping skills than parents who receive standard care, and that children of parents who receive PSST will have better physical and emotional functioning than children of parents who receive standard care.

Chronic pain affects 25-40% of children and adolescents, and results in significantly lower quality of life for these youth. Parents play an important role in how their children cope with chronic pain, and can also experience their own distress related to their child's illness. Parental psychological distress is widely recognized to be associated with poorer child adjustment. However, no interventions have been developed specifically to treat psychological distress in parents of children with chronic pain. Problem-solving skills training (PSST) has been shown to result in significant reductions in parental distress among caregivers of children with other types of chronic illness such as cancer. The purpose of this study is to test the feasibility and preliminary efficacy of PSST for parents of youth with chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* Child age 10-17 years
* Child's pain present for at least 3 months duration
* Pain occurs at least 1 time per week and interferes with daily functioning
* Pain is not related to a chronic disease
* Receiving evaluation or treatment in a pediatric pain clinic
* Literate in English

Exclusion Criteria:

* A serious comorbid chronic condition in the child (e.g., diabetes, arthritis, cancer)
* Non-English speaking
* Parent has lived with the child for less than one year
* Parent has active psychosis or suicidal ideation
Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis

This is a 3-week, non-interventional, observational study of patients undergoing chemotherapy (sutent) designed as a three-arm parallel study. In this study, the efficacy of Ectoin containing mouthwash given prophylactically for the prevention of mucositis in patients before radio- and/or chemotherapy; as well as during radio- and/or chemotherapy for patients with mucositis compared to standard treatment should be investigated. The study doesn't intervene with routine treatment strategy.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving radio- and/or chemotherapy (sutent) and suffering from mucositis
* Female or male individuals ≥ 18 years

Exclusion Criteria:

* Male or female under 18 years
* Any disease that can, in the opinion of the treating physician, affect the outcome of the study
* Patients with known intolerance to one of the substances used
* Pregnancy
Effects of Eccentric Potentiation Activation on Muscle Function

The purpose of this study is to examine the potentiation effects of 2 sets of multi-joint eccentric overload maximal contractions on muscle function.


Eligibility Criteria:
Exclusion Criteria:

* lower body surgery or injury in the last 12 months
* have any neuromuscular disease
* height \>76 inches tall
* height \<54 inches tall
* eccentric strength greater than 725 pounds
* pregnant or plan to be pregnant in the duration of the protocol
* don't do resistance exercise at least once per week
* perform intense cardio or strength training \>4 days per week
* Present with any other significant comorbid conditions that would impair the ability to participate in the exercise-based testing

Inclusion criteria:

* 18 - 30 years old
* strength train lower body 1-3 times per week
VIGAB-BIOSTAT: Neuronal Injury Panel Substudy

The purpose of this substudy is to collect and analyze control data to characterize the degree of neuronal injury in PASE patients who have not received vigabatrin to later compare with patients who received this therapy and expand data on the utility of the neuronal injury panel for neuroprognostication. Data from this cohort will be compared with the data generated by the treatment cohort in the main VIGAB-STAT study.

Post anoxic status epilepticus (PASE) is the development of intractable seizures in the post-cardiac arrest period once return of spontaneous circulation (ROSC) has been achieved. Historically, this condition has resulted in nearly 100% mortality, and the subset of patients diagnosed with PASE has been excluded from previous therapeutic trials in status epilepticus. The administration of vigabatrin, a GABA-ergic medication that blocks GABA catabolism, is being investigated as an adjunctive therapy to improve neurologic outcomes in this patient population through the VIGAB-STAT program at the University of Florida.

Neuroprognostication in cardiac arrest patients remains imprecise. Outcomes following cardiac arrest depend on a multitude of factors, from details of cardiac arrest (e.g., downtime and rhythm on arrest) to other factors that influence secondary brain injury-all of which are hard to ascertain from objective clinical and laboratory data. Neuronal and astroglial protein assays have been investigated in this patient population as a novel method of quantifying the degree of neuronal injury and may serve as an objective informant of ongoing secondary brain injury, thus being a helpful neuroprognostic tool. This assay can also demonstrate objectively if a neuroprotectant therapy mitigates secondary brain injury and decreases the overall hypoxic-brain injury burden. However, normative data on these assays on post-cardiac arrest patients suffering PASE are lacking.

Eligibility Criteria:
Inclusion Criteria:

* To be included in the study, subjects must be 18 - 80 years of age
* Non-traumatic cardiac arrest (regardless of non-perfusing rhythm, etiology, or location of arrest) in whom the decision to treat unequivocal electrographic SE (as defined by the American Clinical Neurophysiology Society: having generalized spike/sharp-wave discharges ≥ 3Hz or any evolving pattern reaching \> 4Hz, lasting ≥ 10 minutes, or comprising \> 50% of any hour of recording) has been made,
* Requiring anesthetic infusion for any reason,
* Have reliable arterial access for frequent blood sampling
* Be enrolled and have the first specimen drawn within 48 hours of PASE onset.

Exclusion Criteria:

* Subjects must not have a prior history of generalized epilepsy
* Be pregnant or
* Have PASE onset preceding initiation of EEG monitoring.
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)

Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).


Eligibility Criteria:
Inclusion Criteria:

1. The participant has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5™).
2. The participant has a CDRS-R total score ≥45 at the Screening Visit and the Baseline.
3. The participant has a CGI-S score ≥4 at the Screening Visit and the Baseline.
4. The participant is a boy or girl, aged ≥7 and \<12 years at Screening Visit
5. The participant has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.

Exclusion Criteria:

1. The participant has participated in a clinical study \<30 days prior to the Screening Visit.
2. The participant has previously participated in a study with vortioxetine.

Other protocol defined inclusion and exclusion criteria may apply
Transdermally Delivered Human Insulin Product

An Early Feasibility Study of a device formulation to deliver human insulin across intact skin

An attempt was made to formulate an insulin product that would complex human insulin in a stable anhydrous solution and when applied to the skin enable the uptake and release of insulin in a brittle T1D patient.

A series of formulations were produced at varing dose strengths and in conjunction with injected insulin products, applied and serum glucose measured to ascertain response and optimize a fomrula to be submitted for IND approval.

Eligibility Criteria:
Inclusion Criteria:

* Brittle T1D patient with poor insulin sensitivity requiring more than 3,000 IUs on insulin a day

Exclusion Criteria:

* High insulin sensitivity
* well managed serum glucose
A Study of Expiratory Pressure Modulation in Moderate to Severe COPD Patients - Phase 1b

Dynamic pulmonary hyperinflation (DH) and intrinsic positive end-expiratory pressure (PEEP) are well known problems in COPD patients with acute and chronic respiratory failure. Measurement of intrinsic PEEP level during both, invasive and non-invasive ventilation is of major importance since in some circumstances (e.g. during exercise or during exacerbations) it can significantly increase respiratory workload of COPD patients. Extrinsic PEEP applied during both, invasive and noninvasive ventilation is used to overcome intrinsic PEEP and therefore to avoid or reduce dynamic hyperinflation.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years who are contractually capable and mentally able to understand and follow the instructions of the study personnel
2. Signed informed consent
3. Moderate to severe COPD patients (FEV1/FVC ratio \<70% and FEV1 \< 50% pred) with chronic hypercapnic respiratory failure (PaCO2 \>45 mmHg)
4. Currently using NIV

Exclusion Criteria:

1. Acute exacerbation of COPD, acute respiratory failure (ph \< 7,35 and/or respiratory rate \>30/min)
2. Unstable heart failure
3. Cardiac failure with dehydration
4. Pregnancy/breastfeeding women
5. Pneumothorax/-mediastinum
6. Increased risk of pneumothorax, pneumomediastinum or venous air embolism
7. In the opinion of the investigator, the patient is unsuitable for the study