cyrilzakka/clinical-trials huggingface dataset:
rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP

The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known hospitals in China. In order to report the efficacy and safety of Recombinant Human thrombopoietin combining with Dexamethasone for the treatment of adults with primary immune thrombocytopenia (ITP), compared to High-dose Dexamethasone therapy.

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 200 primary ITP adult patients from 14 medical centers in China. One part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300Units/kg for7-14 consecutive days, following with a flexible dosage depending on platelet count until the 28th day), combining with dexamethasone (given intravenously at a dose of 40 mg per day for 4days, the others are selected to receive high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4 days). Platelet count was evaluated before and after treatment, in order to report the conversion ratio of primary ITP to chronic ITP.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. Untreated hospitalized patients, may be male or female, between the ages of 18 \~ 80 years.
3. To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
4. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.
5. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Received high-dose steroids or \[2\] intravenous immunoglobulin transfusion(IVIG)in the 3 weeks prior to the start of the study.
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
4. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
5. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
6. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
7. Patients who are deemed unsuitable for the study by the investigator.
Effects of Crystal Solution and Colloid Solution on Mother and Fetus

Comparison of the effects of crystal solution (lactic acid Ringer's solution) and colloid solution (hydroxyethyl starch) on mother and fetus after cesarean section

The Hydroxyethl group use 10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch. The control group 10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution. During the whole operation of elective cesarean section

Eligibility Criteria:
Inclusion Criteria:

* Healthy singleton pregnancy scheduled for elective cesarean section under CSEA; American Society of Anesthesiologists (ASA) physical status Ⅰ/Ⅱ; Age ranging from 20 to 40 years old.

Exclusion Criteria:

* History of mental disorder or epilepsy; History of central nervous system (CNS) disease; Preexisting or pregnancy-induced hypertension; History of lumber injury; Severe hypovolemia; Allergy or hypersensitivity to norepinephrine; Body mass index (BMI) above 40 kg/m2; Infection at the puncture site; Tricyclic or imipramine antidepressants.
Investigation of a Combination Treatment of Escitalopram and rTMS

We intend to test in a randomized, rater blinded, placebo controlled, prospective study the primary hypothesis that an escitalopram-rTMS-combination treatment is more efficacious in the treatment of refractory major depression assessed with the Hamilton Depression Rating Scale

We intend to test in a randomized, rater blinded, placebo controlled, prospective study the primary hypothesis that an escitalopram-rTMS-combination treatment is more efficacious in the treatment of refractory major depression assessed with the Hamilton Depression Rating Scale compared to placebo.

A second hypothesis is that the treatment of MDE with escitalopram (that means in the "Placebo group") alone lead to typical changes like

* An increase in neurotrophic factors concentration (measured by blood concentrations of nerve growth factor (NGF) and brain derived nerve growth factor (BDNF),
* An increase in hippocampal metabolites (measured with magnetic resonance spectroscopy (MRS
* An increase in motor cortical inhibitory activity (measured with motor evoked potentials (MEP
* An increase in serotonergic activity (measured with EEG parameters, Moreover, it is hypothesized that similar but pronounced changes occur in the group treated with the combination treatment.

Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Episode (according to DSM IV standards)
* HAMD \> 20
* Patient has an IQ \> 70 based on the investigator´s judgement
* Patient is male or nonpregnant female adequately protected from conception
* Patient is able to comply with all testing and follow-up visit requirements defined by the study protocol
* Patient has voluntarily signed an informed consent in accordance with institutional policies

Exclusion Criteria:

* Patient has a history of schizophrenia, schizoaffective disorder or delusional disorder
* Patient currently has a secondary diagnosis of, or signs of, delirium, dementia, amnestic or other cognitive disorder per DSM IV
* Patient is suicidal
* Patient has had an alcohol or substance dependence within the previous 12 month
* Patient is currently enrolled in another investigational study
* Patient has a history of, or evidence of, significant central nervous disease (especially seizures)
* Patient has previously been treated with escitalopram
* Contraindication against escitalopram or rTMS
What Are the Three Dimensional Soft Tissue Changes That Occur After Orthognathic Surgery for Skeletal Class II Patients? Pre-test Post-test Quasi Experimental Study

the aim of the study is to establish reference data that could be used for the creation of more accurate three dimensional prediction of soft tissue outcome.

in this study, 15 skeletal class 2 orthognathic patients will be selected. CBCT and proface will be done preoperatively. after the surgery and 6 months later the imaging investigations will be repeated to investigate the soft tissue changes that have resulted due to the bone movement.

Eligibility Criteria:
Inclusion Criteria:

* Patients with class II skeletal deformity
* Patients must be over 18 years of age to allow for growth cessation
* Patients must not have any systemic condition which contraindicates general anaesthesia

Exclusion Criteria:

* o patients with cleft palate

  * patients with syndromes affecting their craniofacial structure
  * patients with facial scars
  * patients with severe facial asymmetry
Sensory Processing Issues in Eosinophilic Esophagitis

Feeding dysfunction and/or dysphagia are the main symptoms of eosinophilic esophagitis (EoE). Also, these symptoms may be a part of sensory processing disorders. Therefore, the present study compared sensory processing abilities between children with EoE and typically developing (TD) controls.

Eosinophilic Esophagitis (EoE) is a chronic allergic/immune condition of the esophagus that affects all ages, from infancy through adulthood. The chronic inflammation can lead to symptoms that vary with age. It is critically important to know symptoms in the infancy/toddler period because in this period, they can't express symptoms directly. The frequent symptoms seen in this period are; vomiting, refusing sucking and eating, failure to thrive, and abdominal pain. School-aged children with EoE have decreased appetite, recurrent abdominal pain, vomiting, food impaction, and dysphagia. Feeding dysfunction (feeding refusal, slowly eating, picky eater, etc..) is one of the trouble issues in this period. Children who can't experience different texture (especially solid) and tastes of foods keep on eating with their same safe feeding habits. Whereas experiences gained in early childhood period form the basis of sensory and motor development. As currently known, humans have eight senses (visual, auditory, gustatory, olfactory, tactile, proprioception, vestibular, and interoception). Each sense is unique, a form of information and nourishment for the nervous system. In the meantime, it is crucial to receive, interpret, and integrate all this information from all these senses at a time. Sensory integration (SI) is the term used for the brain processing information that comes through the senses. The SI begins in the womb as the fetal brain senses the movements. Childhood activities and play lead to a lot of sensory integration as the child organizes the sensations of his body and gravity, along with sight and sound. If there is a problem in any sense, such as receiving or interpreting, the SI process can be interrupted, and this may result in sensory processing disorder (SPD). It is crucial to notice SPD in childhood because SPD can affect a child's development and education (learning, reading, math, visual and auditory perception, and skilled motor tasks).

Food intake is one of the most multi-sensory daily experiences (sight, smell, taste, sounds, texture of food) for both children and adults. In children with EoE, feeding dysfunction (vomiting, food impaction, regurgitation..) can affect the oral sensory system. Even considering that all the senses work in interaction, more senses can be affected.

To date, there is no study that has investigated sensory processing issues in children with EoE. Therefore, the present study aimed to compare sensory processing between children with EoE and healthy controls and also examine the correlations between sensory processing and disease characteristics among children with EoE.

Eligibility Criteria:
Inclusion Criteria:

* a confirmed diagnosis of EoE
* being between 3 and 10 years

Exclusion Criteria:

* having acute illnesses
* having any other chronic diseases
Interruptions in the Coagulationsystem in Relation With Cardiac Surgery - A Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery

The purpose of this study is to find the heparinization method, which

1. affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis
2. gives the smallest change in endogenous thrombin potential (ETP)postoperative compared to preoperative (deltaETP) as an indicator for haemostatic activation during cardiac surgery.

The hypothesis is that the deltaETP is larger in the Haemochron Signature Elite group than in the Hepcon-group because of the heparinization-method. Therefore there is a potential higher risk for use of bloodproducts postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Elective on-pump coronary artery bypass grafting (CABG) single procedure
* Elective aortavalve replacement (AVR) (single procedure)

Exclusion Criteria:

* Emergency procedures
* Children and youngsters less than 18 years
* Pregnancy
* Less than 2 days break with platelet inhibiting drugs (acetylsalicylic acid, NSAID, clopidogrel, serotonin reuptake inhibitors)
* Less than 2 days break with AC-treatment (warfarin, heparin, coumarin etc)
* Known coagulopathy
* Endocarditis
* Preoperative anaemia
* Dialysis patients
Otogenic CSVT Retrospective Case Series and Associated Thrombophilia

The aim of this study is to report the clinical presentation, Microbiological, laboratory and imaging evaluation, prothrombotic factors analysis, medical and surgical management and outcomes in children with Otogenic Cerebral Sinus Vein Thrombosis (CSVT).

Objective: Otogenic Cerebral Sinus Vein Thrombosis (CSVT) is a rare but serious intracranial complication of otitis media in children. The aim of this study is to report the clinical presentation, Microbiological, laboratory and imaging evaluation, prothrombotic factors analysis, medical and surgical management and outcomes in children with otogenic CSVT. Study design: Retrospective case series

Eligibility Criteria:
Inclusion Criteria:

* age of 18 years or younger
* both sexes are included
* a clinical or radiological finding of mastoiditis in the patient's file
* Documentation of CSVT in an imaging study, either CT or MRI.

Patient's exclusion criteria

* age above 18 years
* lack of a clinical or radiological finding of mastoiditis in the patient's file
* Lack of documentation of CSVT in an imaging study, either CT or MRI.
* previous unprovoked venous thromboembolism event.
A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis

The goal of this clinical trial is to test the safety and effectiveness of a single dose of RABI-767 given by endoscopic ultrasound (EUS) guided peripancreatic injection in participants with predicted severe acute pancreatitis.

The main question the study aims to answer is:

• Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection safe in patients with predicted severe acute pancreatitis.

The study also aims to answer:

• Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection effective in treating patients with predicted severe acute pancreatitis.

Study participants will be randomly assigned (like the flip of a coin) to receive a single dose of RABI-767 plus supportive care or supportive care only.

The study sponsor will compare safety and efficacy data collected from participants who receive RABI-767 to participants who receive supportive care only to test if RABI-767 is safe and effective.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of acute pancreatitis
* Predicted severe acute pancreatitis, based on protocol defined criteria
* Lack of clinically meaningful improvement from status at admission, at the discretion of Investigator, at the time of randomization
* Suitable for EUS-guided study drug administration procedure
* Contrast-enhanced computed tomography (CECT) or magnetic resonance imaging (MRI) of the abdomen/pancreas available for the evaluation of exclusion criteria

Key Exclusion Criteria:

* Confirmed severe acute pancreatitis as defined by the Revised Atlanta Classification of Acute Pancreatitis (ie, Persistent \[\> 48 hours\] organ failure, per Modified Marshall Score), prior to randomization
* Anticipated discharge from hospital within 48 hours of randomization
* More than 30% pancreatic necrosis on screening CECT or MRI
* History of previous pancreatic necrosis, including necrosectomy
* History of calcific chronic pancreatitis
* Evidence of cholangitis
Cerebral Oximetry and Neurocognitive Functions in Cardiosurgical Patients

It is previously reported that the cerebral oxygen desaturation during cardiac surgery is associated with an increased incidence of cognitive impairment. The aim of this study is to determine whether intraoperative monitoring and predetermined interventions protocol to improve cerebral oxygenation during coronary artery bypass surgery provides benefits in neurocognitive functions.

Neurologic complications are major cause of morbidity following coronary artery bypass graft surgery.

The neurologic injuries range in severity from subclinical cognitive changes to fatal brain injury and death. These complications represent a big impact on overall morbidity, and mortality in association with increased costs and length of hospital stay. The social impact is also very important with consequences on patients' quality of life. Several studies reported the incidence of cognitive decline after cardiac surgery that ranges from 30 to 80%. The most common etiologies are embolization and hypoperfusion of the brain.

The In Vivo Optical Spectroscopy (INVOS) system uses near-infrared spectroscopy (NIRS) and provides noninvasive and continuous information on changes in regional oxygen saturation of blood in the brain (rSO2). When rSO2 decline occurs it can be responded with simple interventions to prevent a brain injury. These interventions include: repositioning of the head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.

Recent studies reported that intraoperative cerebral oxygen desaturation is associated with early postoperative neuropsychological dysfunction in patients undergoing cardiac surgery.

Neurocognitive function can be assessed with battery of standardized neurocognitive tests. Mini Mental State Examination, Color Trail Test, Grooved Pegboard Test are easy to perform bedside tests that test orientation, registration, attention, calculation, recall, language and complex visual-motor coordination.

Eligibility Criteria:
Inclusion Criteria:

* All patients with coronary artery disease undergoing coronary artery bypass grafting (CABG) with cardiopulmonary bypass

Exclusion Criteria:

* Who refuse to participate
* Previous stroke
* Preexisting psychiatric disease
* Significant carotid stenosis
* Ejection fraction below 25%
* Reoperations
* Emergent surgery
* Dialysis
Provision of Small vs. Large Portion Sizes and Later Food Intake

In 3 laboratory experiments the effect that receiving a small vs. large portion size of food has on later intake of that food was examined

Historical increases in the size of commercially available food products have been linked to the emergence of a worldwide obesity crisis. Although the acute effect portion size has on food intake is well established, the effect that exposure to smaller portion sizes has on future portion size selection is yet to be examined.We tested whether reducing a food portion size may 'renormalize' perceptions of what constitutes a normal amount of food to eat and result in people selecting and consuming smaller portions of that food in future. Across three experiments participants were served a large or smaller portion of food. In experiments 1-2, twenty four hours later participants freely selected and consumed a portion of that food. In experiment 3, one week later participants reported on their preferred portion size of that food.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older

Exclusion Criteria:

* History of food allergy, eating disorder or currently dieting to lose weight
Clinical Validation of the RENISCHEM L-FABP POC Assay

This study will involve measurement of levels of a novel urinary biomarker of renal ischemia, L-FABP. The purpose of the study is to perform a clinical validation of the ability of L-FABP measurements in urine using the RENISCHEM L-FABP POC Test to predict the development of AKI within 2 days following cardiac and vascular catheterization procedures involving exposure to radiocontrast media.

This study will validate the ability of the RENISCHEM L-FABP POC test to predict AKI risk in patients undergoing cardiac catheterization and receiving iodinated contrast medium. Contrast medium is known to be both vasoconstrictive and chemotoxic, which can lead to renal ischemia and, ultimately, AKI. Infusion of radiographic contrast agents, with the associated increases in osmotic load and viscosity, increases hypoxia of the renal medulla and increases renal free radical production through post-ischemic oxidative stress. Earlier identification of contrast medium-induced acute kidney injury (CI-AKI) risk can facilitate improved management of patients to prevent AKI, for example, through selection of alternative imaging methods or contrast agents.

Subjects will be recruited prospectively based on pre-specified enrollment criteria. Blood and urine samples will be collected after enrollment and at several timepoints, and various tests will be performed, including point-of-care L-FABP measurements on urine samples.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 or older on the day of the procedure
* Undergoing cardiac or vascular interventional procedures for diagnostic angiography, coronary intervention, TAVR or TAVI, with planned use of radiocontrast media within the next 30 days
* Able to provide informed consent
* Available to participate in follow-up visits
* eGFR \< 45 within the last 90 days, or
* eGFR \< 60 within the last 90 days with at least one (1) of the following risk factors:
* Diabetes
* Heart failure (acute or chronic)
* Anemia (hemoglobin \< 12 g/dL for females and \< 13 g/dL for males) within the last 90 days
* Age \> 75 on the day of the procedure

Exclusion Criteria:

* Patient on dialysis or with eGFR \< 15 within the last 30 days
* History of renal transplant
* Current use of immunosuppressive drugs other than prednisone \< 10 mg/day
* Current clinically significant infection (including HIV, hepatitis)
* Presence of KDIGO Stage 1, 2, or 3 AKI within the last 7 days, according to KDIGO criteria
* Known or suspected nephritic or nephrotic syndrome.
* A current post-renal etiology of renal impairment
* Known allergy or hypersensitivity to radiographic contrast dye that cannot be pre-medicated
* Females that are known to be pregnant or nursing
* Participation within the last 30 days in another clinical trial involving use of any drug known to affect AKI and/or device known to affect AKI
Phase I, Double-Blind,Placebo, MAD Study to Evaluate the Safety, Tolerability, PK, and PD of AMG 333 in Healthy Subjects and Migraine Subjects

The primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of AMG 333 for 14 days in healthy subjects and migraine subjects. As part of the secondary objectives, the study will characterize the pharmacokinetic (PK) profile of AMG 333 after multiple oral doses in healthy subjects and migraine subjects, as well as characterize the effect of multiple doses of AMG 333 on increases in blood pressure (BP) induced by the cold pressor test (CPT) in healthy subjects.

This is a randomized, double-blind, placebo-controlled, ascending multiple-dose study evaluating AMG 333 in healthy subjects and subjects with migraines. Eight healthy subjects will be enrolled in each of cohorts 1 through 5. Study subjects will be randomized such that 6 subjects will receive AMG 333 and 2 subjects will receive placebo (3:1 ratio) per cohort. Likewise, 8 migraine subjects will be enrolled in cohort 6 and randomized to receive AMG 333 or placebo (3:1 ratio). All subjects will be housed for 15 days then allowed to return home. Migraine subjects will self-administer the headache diary at least once daily during the screening and out-patient portions of the study, and site personnel will administer the headache diary during the in-house period of the study. Healthy subjects will not keep the headache diary during screening and will have the headache diary administered by site personnel at least once daily starting on day 1 through day 14, and will then self administer throughout their participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects (cohorts 1 through 5) and male and female subjects with migraines (cohort 6), who are ≥ 18 and ≤ 55 years of age at the time of screening, and have no history or evidence of clinically-relevant medical disorders as determined by the investigator in consultation with the Amgen physician.

Exclusion Criteria:

* History or evidence of a clinically significant disorder, condition, or disease that in the opinion of the investigator and Amgen physician, would significantly impair pain perception (eg, history of stroke, history of neuropathy), would pose a risk to subject safety or interfere with evaluation, procedures, or study completion.