cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Levosimendan in Pediatric Intensive Care Units

To describe pharmacokinetics of levosimendan in neonates and children supported or not with extracorporeal circulation devices (ECMO, CRRT)

Levosimendan is a calcium sensitiver wih inotropic effects. It's use in the context of acute or chronic heart failure in children has yet to be defined. Due to physical proprieties of levosimendan and metabolites, we hypothesized that concomitant use of extracorporeal devices such as ECMO will cause major pharmacokinetic variations. Furthermore, pharmacokinetics of levosimendan in children with multiple organ failure has to be specify.

Eligibility Criteria:
Inclusion Criteria:

* All children admitted in pediatric intensive care units with planned infusion of 0.2 mcg/kg/min of levosimendan over 24h in context of routine care
* Arterial line or central venous catheter inserted for blood sampling procedures in context of routine care.

Exclusion Criteria:

* Absence of clear parental status or information
Mobilising Patients With Severe Brain Injury in Intensive Care

Introduction Patients with severe brain injury are often restricted to bed rest during the early period of brain injury which may lead to unwanted secondary complications. There is lack of evidence of when to initiate the first mobilisation. The Sara Combilizer® is an easy and efficient tool for mobilising patients with severe injuries, including brain injury.

Through a randomised cross-over trial the investigators will investigate the impact of early mobilisation on patients with severe acquired brain injury caused by traumatic brain injury, subarachnoid brain injury or intracranial haematoma.

The investigators hypothesise that mobilisation using the Sara Combilizer® does not affect partial oxygenation of brain tissue.

The primary purpose of this study is to quantify cerebral oxygenation, when mobilising patients with severe brain injury using a Sara Combilizer® to the seated position and during passive standing.

This study is conducted at the Department of Neurointensive care and Neuroanaesthesiology, Rigshospitalet, Copenhagen.

Based on the International Conference on harmonisation-Good Clinical Practice guidelines and the Danish "Good Clinical Practice" administrative order, a table regarding the responsibilities of sponsor/investigators before, during and after the clinical trial, will be filled and signed in order to avoid misunderstandings. This table can be found in the Trial Master File (TMF) located at the primary investigator's office and the sponsor's office.

This study is designed as a cross-over study with patients randomly assigned to (1) an initial intervention protocol on the first day and with a passive sedentary protocol on the second, or (2) an initial passive sedentary protocol on the first day followed by an intervention protocol on the second day.

Randomisation Included patients will, after stabilisation of ICP, be randomised to start with either the intervention or sedentary protocol, with the opposite protocol on the second day. A computer-generated randomisation algorithm will be created in REDCap, with age and Glasgow Coma Score (GCS) as dichotomised stratification variables. Age will be divided into young (18 to 60 years) and old (61+ years), and the GCS into severe brain injury (GCS 3-8) and moderate to mild injury (GCS 9-15). The following four composite groups of age and GCS will ensure an equal distribution of the patients within each stratum.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic brain injury, subarachnoid haemorrhage, intracranial haematoma
* Sedated for at least 48 hours after admission
* Equipment measuring partial brain tissue oxygenation and intracranial pressure
* Understands spoken and written Danish

Exclusion Criteria:

* Unstable spinal cord injury
* Unstable injury in the lower extremities prohibiting mobilisation
* No consent from nearest relative
The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity

This trial objective is to assess whether doubling the daily intake of vitamin D improves serum vitamin D levels and serves as primary prevention of respiratory infections and asthma in premature infants.

This is a prospective randomized (1:1) double-blinded trial.

The study population will be randomized into two groups (1:1):

* Intervention Group - 800 IU of Vitamin D once daily
* Control Group - 400 IU of Vitamin D once daily Patients will be followed up for one year after randomization for serum Vitamin D levels and respiratory morbidity.

The rational of this trial is that a daily supplementation of a double dose of Vitamin D (800 IU instead of 400 IU) to late premature infants during the first year of life will result in elevated Vitamin D serum levels and in an improvement in respiratory morbidity.

This randomized trial of vitamin D supplementation is planned to determine the optimal dose of daily vitamin D supplementation required to achieve sufficient vitamin D levels in preterm infants and to assess whether doubling the daily intake of vitamin D may serve as primary prevention of respiratory infections and asthma in premature infants.

Eligibility Criteria:
Inclusion Criteria:

1. Preterm infant born at 32+6 to 36+6 weeks of gestational age
2. Born at Soroka University Medical Center
3. Signed informed consent
4. Participants in the trial will be insured by "Clalit" HMO

Exclusion Criteria:

1. Chromosomal abnormality
2. Neurological or muscular congenital anomalies
3. Congenital cardiac defect
4. Congenital respiratory anomalies
5. Congenital GIT/ liver/ renal anomalies that effect the absorption and/or metabolism of Vitamin D and/or other substances.
6. Admission after birth to NICU persists more than 5 days
A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Administered Together

This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with capecitabine in patients with advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists
* Patient has good performance status (ECOG 0 or 1)

Exclusion Criteria:

* Prior treatment with either SU011248 or capecitabine.
* Hypertension that cannot be controlled by medications
The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress

Traditional offline interventions such as MBCT and MBSR have been implemented in treating patients with emotional disorders and obtained significantly improved clinical outcome. However, these offline interventions require the involvement of a therapist expertized in mindfulness and usually charge a high fee, which may not be accessible and cost-effective for lots of patients with psychological disorders. Fortunately, online self-help interventions can compensate for these disadvantages. Our research team has developed a self-help online mindfulness program targeting emotional distress (i.e., MIED), which has been demonstrated to be effective for individuals with emotional distress in a preliminary study. Since patients with emotional disorders usually suffered from emotional distress, the current study will apply this program to these patients, and investigate its auxiliary effects on patients' psychological and physical health.

The primary aim of the current study is to evaluate the effectiveness of MIED for patients with emotional disorders. To do so, we will use a design in which patients who receive online mindfulness training (MIED) except for treatment as usual (TAU) will be compared with patients who receive TAU alone. We expect the intervention to improve patients' psychopathological symptoms reported by the patients and the clinicians or the research team and increase their overall functioning, positive mental health, and physical health compared to TAU. In addition, previous studies have shown that mindfulness interventions improve psychological symptoms through improving cognitive flexibility, distress tolerance, intolerance of uncertainty, and experiential avoidance. Therefore, the secondary aim of the study is to examine the mediating effect of these factors on the relationships between mindfulness practice and improvements in outcome variables.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65;
* Diagnosis of emotional disorders, including anxiety disorders (e.g., panic disorder, social anxiety disorder, generalized anxiety disorder), and unipolar depression disorders;
* If taking medication, haven't changed for at least 4 weeks before intervention onset, and no change in medicine is expected;
* Voluntary participation in this study and sign an informed consent form.

Exclusion Criteria:

* No access to the internet;
* Inadequate proficiency in Chinese;
* Previous participation in mindfulness-based programs longer than 6 weeks, and/or current practice of meditation more than once per week;
* A history of schizophrenia or schizoaffective disorder, current organic mental disorders, substance abuse disorder, and pervasive developmental disorders;
* Manifesting with any self-injury or suicidal risks.
Artificial Intelligence-Based Disease Management in the Vulnerable Period of Heart Failure

The study aims to evaluate the effect of AI-based discharge training after acute decompensation of heart failure on the patient's quality of life and to examine the relationship between changes in voice and speech characteristics of patients and changes in hospitalization, discharge, and early post-discharge clinical status.

Heart failure (HF) is a progressive disease with a fluctuating course. From time to time, patients' symptoms and signs worsen enough to require hospitalization, and hospitalization occurs with acute decompensated HF. Acute HF decompensations are periods that worsen the prognosis of the patient. On the other hand, patients discharged after an acute decompensation have the highest risk during the first months after discharge. Patients get trained about lifestyle changes and medication management during the discharge period. Recent guidelines suggest that patients in the early post-discharge period be called for virtual/telephone or face-to-face control visits at short intervals(3rd, 7th, 14th, and 28th days ), then at 3-6 monthly intervals according to NYHA class.

In traditional cardiovascular practice, patients are called for outpatient control visit in the first month after discharge. However, the processes after the pandemic kept patients away from visiting the hospital at the frequency recommended in the American and European guidelines and caused them to stay at home not even following their routine visit schedules. Moreover, the risks and benefits of virtual visits in terms of patient prognosis are not well established.

This study aims to investigate relationships between routinely recorded findings, symptoms, and vocal biomarkers of heart failure patients in the hospitalization and in the post-discharge period and to investigate the effect of post-discharge education on patient-reported outcomes and re-hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalisation due to heart failure decompensation
* Having a smartphone with internet access
* Willingness to participate in the study
* NYHA 2-4 symptoms

Exclusion Criteria:

* Diagnosis of active malignancy
* Pregnancy
* Vision and hearing problems
* Moderate to severe cognitive impairment
* Dementia
Studies of Biological Changes Related to Weight Loss After Gastric Bypass Surgery

Weight loss achieved by dieting induces multiple changes. These changes include a decrease in metabolic rate (the rate in which the body burns its calories), an increase in appetite and other physiological and hormonal changes that may be the cause of failure in dieting. Many of these parameters that have never been evaluated when weight is lost after gastric bypass surgery will be tested in this study.

While gastric bypass surgery (GBS) is known to be highly effective in achieving significant weight loss, it is also associated with other biologic changes that occur in the body when weight is lost. In this study, subjects undergoing gastric bypass surgery will be followed throughout the weight loss period. They will undergo four detailed medical evaluations to assess changes in several biological systems that occur in the body when weight is lost.

The initial assessment will be performed before the surgery (testing period 1). After surgery is completed, subjects will attend clinic visits at the Rockefeller University outpatient clinic. During these visits, weight and leptin levels will be monitored. Two additional assessments will be performed during weight loss, when subjects lose 10% and 20% of their initial weight (testing periods 2 and 3 respectively). A final evaluation will be performed after weight is stabilized, about 18 months after the surgery is completed (testing period 4). Each testing period will be performed over a 2 week period in an inpatient setting at the Rockefeller University Hospital. During testing periods subjects will undergo a series of metabolic, behavioral, hormonal, immune and molecular tests to evaluate changes that occur in the body after weight loss. Subjects will receive monetary compensation for participating in the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 years old
* Subjects approved for gastric bypass surgery

Exclusion Criteria:

* Subjects not approved for gastric bypass surgery
Single Crown Supported by Short Implant Versus Standard Implant in Conjunction With Maxillary Sinus Floor Augmentation.

Implant placement in the posterior part of the maxilla is frequently compromised due to atrophy of the alveolar process. Therefore, alveolar ridge augmentation is frequently necessary before or in conjunction with implant placement. The most commonly used method to augment the maxillary premolar and molar region involves the maxillary sinus floor augmentation (MSFA) with autogenous bone graft or a bone substitute. However, the use of autogenous bone grafts is associated with risk at the donor site morbidity and unpredictable graft resorption. Consequently, short implants are used increasingly to eliminate the need for bone augmentation. However, long-term studies comparing short implants and standard implants in conjunction with MSFA supporting single crown restoration in the posterior maxilla are missing. The primary outcome measures include survival of implant and suprastructures, peri-implant marginal bone level (MBL), professional evaluation of the suprastructure and soft tissue using pink esthetic score (PES) and white esthetic score (WES), patient satisfaction using visual analogue scale (VAS), and oral health related quality of life using oral health impact profile (OHIP-14) questionnaire. Secondary outcome measure include evaluation of the complication rate related to the two treatment modalities.

The primary objective of the present study is to test the H0 hypothesis of:

1. No differences in survival of suprastructures and implants with the two treatment modalities.
2. No differences in peri-implant MBL, PES, WES, and patient satisfaction using VAS with the two treat modalities.
3. No differences in oral health related quality of life using OHIP-14 with the two treatment modalities.

The secondary objective will include:

1. Complications related to bone harvesting, implant installation, and MSFA.

The primary outcome measures included:

* Survival of suprastructures.
* Survival of implants.
* Radiographic peri-implant MBL.
* Professional evaluation of suprastructure and soft tissue using PES and WES.
* Patient satisfaction using VAS
* Oral health related quality of life using OHIP-14 questionnaire.

Secondary outcome measures:

• Pre- and postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* \>20 years
* Partial edentulism in the posterior maxilla.
* Height and weight of the maxillary alveolar process of at least 5.5 mm.
* Mandibular occluding teeth.

Exclusion Criteria:

* General contraindications to implant therapy.
* Poor oral hygiene.
* Progressive periodontitis.
* Acute infection in the area intended for implant placement.
* Parafunction, bruxism, or clenching.
* Psychiatric problems or unrealistic expectations.
* Heavy tobacco use, define as \>10 cigarettes per day.
* Pregnancy
Clinical Trials of Two Helichrysum Infusions in Adults

The study evaluates the effects of Helichrysum italicum and Helichrysum Arenarium on different components of the metabolic syndrome. The components of metabolic syndrome will be measured at baseline and four weeks after daily consumptions of either Helichrysum italicum or either Helichrysum Arenarium, and after two weeks of washout. In addition, stool samples will be also taken at baseline and after four weeks of daily consumtion of either Helichrysum italicum or either Helichrysum Arenarium.

Helichrysum arenarium (HA) has a long tradition in European ethno-medicine as a medicinal plant with many known activities; EU monograph supports its use for the digestive disorders, feeling of fullness and bloating, and, importantly, it re-ports no side effects. Assessment report of the European Medicines Agency Committee on Herbal Medicinal Products supports its stimulatory role in the bile flow and in the release of cholesterol to the bile. HA has also been used in chronic liver inflammatory disease and as a scavenger of free radicals. Similar to HA Helichrysum italicum (HI) is widely used in traditional medicine. Lately, much attention has been given to natural antioxidants and their ability to delay the progression of chronic diseases related to the formation and the activity of reactive oxygen species and other free radicals. Herbs are very often used to prepare recreational tea and are thereby important sources of antioxidants in different cultures. In traditional medicine, HI is also used in diet, mainly for the preparation of infusions in treating respiratory and digestive conditions.

Therefore,the ail of our study is to evaluate the effects of Helichrysum italicum and Helichrysum Arenarium on different components of the metabolic syndrome in adults presenting at least two components of metabolic syndrome and yet not receiving any medication. The components of metabolic syndrome (lipid profile, blood pressure, antrophometry, inflammation status, glucose levels) will be measured at baseline and four weeks after daily consumptions of either Helichrysum italicum or either Helichrysum Arenarium, and after two weeks of washout. In addition, stool samples will be also taken at baseline and after four weeks of daily consumtion of either Helichrysum italicum or either Helichrysum Arenarium.

Eligibility Criteria:
Inclusion Criteria:

* stable weight in the last 3 months
* BMI more than 25
* clinical diagnosis of at least two components of metabolic syndrome,

Exclusion Criteria:

* consumption of dietary supplements
* medications for any component of metabolic syndrome
A Study of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects

Liothyronine is indicated for the treatment of primary hypothyroidism. Between 6 and 10 Million in the United States and 80 Million patients world-wide are hypothyroid, usually the result of autoimmune thyroiditis called Hashimoto's Disease. Hypothyroid symptoms result from low levels of thyroid hormones (T4 and T3) in the blood due to inadequate thyroid hormone production by the thyroid gland. Every tissue in the body is a thyroid hormone target and hypothyroid symptoms can be debilitating.

BCT303 utilizes Liothyronine, Sodium as the active ingredient, the same Liothyronine salt utilized as the active ingredient in currently marketed products.

The current "gold standard" for treatment of hypothyroidism are products containing Levothyroxine (T4). T4 is known to be a pro-hormone, converted to the more active hormone T3 by deiodinases in various tissues. Patients on Levothyroxine therapy alone are occasionally not euthyroid as measured by clinical presentation, a condition hypothesized to result from low levels of T3 from inadequate T4 to T3 conversion. In addition, the efficiency of conversion of T4 to T3 is variable and dependent on the patho-physiologic state of the patient.

BCT303 contains Liothyronine, Sodium as the active ingredient. This product has a patented formulation and granulation procedure that solves multiple clinical and stability problems associated with T3-based products. Thus, BCT303 is designed to have:

1. Increased shelf stability to ensure the maintenance of claimed dosage.
2. A sustained-release profile to minimize side effects associated with spikes in serum T3 levels.
3. Uniformity of dose between production batches and between tablets.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Must be able to swallow tablets

Exclusion Criteria:

* Hypothyroid Disease
* Pregnant Females
User Satisfaction Using the ADI Insulin Pump

Approximately 250,000 people worldwide are currently being treated with an insulin pump. This number is growing dramatically as these devices become smaller and more user-friendly. Insulin pumps allow for tight metabolic control and lifestyle flexibility while minimizing the number of hypoglycemic events.

The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro- infusion pump, designed for continuous delivery of insulin. A custom reservoir is driven by the pressure of insulin within it to deliver preset basal profiles and patient programmed bolus of insulin through custom infusion sets, into subcutaneous tissue.

This type of device requires extensive user interaction and education in order to ensure its safety. This study was designed to test the independent home-use of the NiliMedix ADI Insulin Pump, and to evaluate user's satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Male/female age 18 years and up.
* Subject is diagnosed as Type 1 Diabetes.
* Pump Users for at least 6 months
* HbA1c: less than 8.5%
* Capable of reading pump screens in English.
* Subject understands the study procedure.
* Subject is willing to sign the informed consent form and comply with the study requirements.

Exclusion Criteria:

* Major physical, motor, mental, behavioral, or psychiatric limitations.
* Subject experienced a severe hypoglycemic episode that led to hospitalization during the last 6 months.
* Subject experienced an episode of Ketoacidosis during the last 6 months, while using an insulin pump.
* Concurrent additional major illness.
* Subject objects to the study protocol.
* Physician objection
* Concurrent participation in other study.