cyrilzakka/clinical-trials huggingface dataset:
Effect of APC and Epo on the Inflammatory Response During Sepsis

An observational study to determine the effect of APC and Epo in reducing the systemic inflammatory response during severe sepsis.

An observational study to determine the effect of APC and Epo in reducing the systemic inflammatory response during severe sepsis. Patients already prescribed either drug will be enrolled. The microcirculation of the sublingual vascular bed will be observed with a microscope to detect the alterations in the inflammatory response.

Eligibility Criteria:
Inclusion Criteria:

* patients in the ICU in severe septic shock undergoing APC and/or Epo treatment

Exclusion Criteria:

* any severe comorbid conditions
Right Ventricular and Pulmonary Artery Evaluation by CMR

Pulmonary hypertension results in right ventricle dysfunction. Cardiac magnetic resonance derived RV ejection fraction is a prognostic value in this condition.

Right ventricular geometry, function, morphology as well as pulmonary arterial stiffness and size may be evaluated by cardiac magnetic resonance imaging and could have great importance in evaluation of pulmonary hypertension prognosis and outcomes.

Pulmonary hypertension is defined as an increase in mean pulmonary artery pressure \> 25 mmHg evaluated by right heart catheterisation. Over time increased pulmonary artery pressure eventually causes vascular remodelling and right ventricular dysfunction. The right and left ventricles interact sharing a common pericardial sac and interventricular septum. Frequently right ventricle dysfunction reflects clinical PH worsening.

The aim of this study was to assess the geometry, function and morphology of right ventricle and also pulmonary artery diameter and stiffness in pulmonary hypertension patients by cardiovascular magnetic resonance.

Patients are recruited from the Hospital of Lithuanian University of Health Sciences Kaunas clinics Pulmonary hypertension center.

Study inclusion criteria:

1. Patient with diagnosed pulmonary hypertension
2. RHC, 6MWT, echocardiography, NT-pro BNP, CMR performed in one month period.
3. Patients who signed study informed consent form.

Study exclusion criteria:

1. Coronary and valvular heart disease
2. Atrial fibrillation
3. Expressed shortness of breath
4. Claustrophobia.

Suspected number of participants - 100.

Data Analysis Statistical analyses will be performed using SPSS 22.0 package (SPSS, Chicago, IL, USA). Continuous variables will be expressed as mean +/- standard deviation, skewed variables as median (interquartile range). Chi square test will be used for qualitative parameters. For continuous variables, differences between two groups will be compared using non-parametric Mann-Whitney U test. Relation between variables will be assessed using Spearman correlation coefficient. Univariate analysis of predictors for survival will be used. In order to assess minimally false negative and minimally false positive results with greatest accuracy, the method of ROC (Receiver Operating Characteristics) curve will be used. The optimal values will be separated out the different groups (survival/non-survival) with the highest accuracy (minimal false negative and false positive). Survival curves will be established by the Kaplan-Meier estimation method. Cox regression analysis will be used to identify independent predictor of outcomes. Two-tailed probability values at p\<0,05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with diagnosed pulmonary hypertension
2. RHC, 6MWT, echocardiography, NT-pro BNP, CMR performed in one month period.
3. Patients who signed study informed consent form.

Exclusion Criteria:

1. Coronary and valvular heart disease
2. Atrial fibrillation
3. Expressed shortness of breath
4. Claustrophobia.
Early Adiposity Rebound Amongst 4-y.o. Children and Overweight Risk Amongst 11-y.o Children : Third Phase of a Cohort Study in Franche-Comté

This study aims to assess different methods for early adiposity rebound determination at the age of 4/5 years old according to current medical screening criteria in schools, and to assess their prognostic value for obesity amongst 11 years old pre-adolescents according to the known risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls born between 1st July 2003 and 30th June 2004
* Attending school in Haute-Saône
* Enrolled in the 2008 cohort survey

Exclusion Criteria:

* Children whose parents refused to take part in this cohort study.
A Retrospective Study to Investigate the Additive Effectiveness of Chinese Herbal Medicine in Alzheimer's Disease

In China, herbal therapy as a complementary therapy is very popular. Should conventional therapy (such as donepezil and memantine) combined with herbal therapy make add-on benefit? Cognition, activities of daily living and behavioral symptoms will be assessed. Data will be collected from the medical records of patients with Alzheimer's disease (AD) in memory clinics.

Conventional therapy (CT), such as donepezil and memantine are well- known short-term treatments for the symptoms of Alzheimer's disease (AD). The efficacy of them, however, drops below baseline level after 9 months. Should Chinese herbal medicine make add-on benefit? The GRAPE formula was designed by Prof. J Tian, a prepared granules of Chinese herbs, according to Qifuyin in Jing Yue Quan Shu (published in A.D. 1624). Patients treated with CT+herbal therapy or CT alone for up to and over 12 months are collected. Cognition, activities of daily living and behavioral symptoms are selected as outcomes for assessing the effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Gradual and progressive change in cognitive functions for a period greater than 6 months;
* Objective evidence of significantly impaired episodic memory together with at least one of other cognitive domains on testing;
* Global cognitive decline measured by mini-mental state examination (MMSE) adjusted for education: ≤22 for illiteracy, ≤23 for primary school, ≤24 for middle school,≤26 for high education;
* Impaired abilities of daily living, ADLs score ≥16;
* Clinical Dementia Rating (CDR) total score 0.5\~3.0;
* ≤4 point on Hachinski Ischaemic Score (HIS);
* Age-adjusted medial temporal lobe atrophy scale (MTA-scale) based on coronary magnetic resonance imaging (MRI) scan of the brain (1.0 or more for ≤65 years; 1.5 or more for ≤75 years and 2.0 or more for ≥75 years);
* Other causes of dementia excluded.

Exclusion Criteria:

* Sudden onset of cognitive disorder with focal nervous system signs in the early stages of disease, (e.g., incomplete paralysis, anesthesia, dysfunctional visual field, and dystaxia);
* Early occurrence of the following symptoms: gait disturbances, seizures, extrapyramidal signs, hallucinations and cognitive fluctuations;
* Any major psychiatric disorders (e.g., DSM-IV(Diagnostic and Statistical Manual of Mental Disorders) defined psychosis, major depression, bipolar disorder, or alcohol or substance abuse);
* Other conditions that may explain cognitive impairment (e.g., hypothyroidism, electrolyte imbalance, toxic, inflammatory, and metabolic disorders).
Internet-delivered CBT for Patients With NCCP

Non-cardiac chest pain (NCCP) is common and has substantial impact on patients' psychological wellbeing, quality of life and healthcare use. Although cardiac diagnosis is 'ruled out', many patients think they have an undetected cardiac disease (i.e. they suffer cardiac anxiety) as no other explanation is offered. They therefore avoid activities that they believe might be harmful to their heart, leading to greater ill-health, and increased healthcare use and societal costs. Targeting cardiac anxiety with psychological interventions might break this vicious circle and improve patient outcomes. Patients need to evaluate the way they perceive and handle their chest pain, which can be done with cognitive behavioral therapy (CBT).

The aim of this study is therefore to evaluate the short- and long-term effects of an Internet-delivered CBT (I-CBT) program on psychological distress and other patient-reported outcomes in patients with NCCP. A second aim is to explore factors related to implementation of I-CBT in clinical care. The study has a randomized controlled design comparing I-CBT with Internet-delivered information program. Quantitative methods will be used to evaluate the effectiveness of the I-CBT program. Implementation issues will be evaluated from the perspectives of patients, healthcare professionals and policymakers using qualitative methods.


Eligibility Criteria:
Inclusion Criteria:

* at least 2 healthcare visits due to NCCP during the last 6 months
* patients suffering from cardiac anxiety (score ≥ 24 on the Cardiac Anxiety Questionnaire-CAQ)

Exclusion Criteria:

* language difficulties
* not able to perform physical activity/exercise due to physical constraints
* patients with severe depressive symptoms
* patients with acute ischemic heart disease
* patients with no access to computer/tablet and/or Internet
Trans-cerebellar Diameter and Placental Thickness in Third Trimesteric Pregnant Women for Calculation of Gestational Age

Pregnant women at 32-36 weeks gestational age with sure gestational dating (based in both last menstrual period and dating ultrasound) and otherwise normal singleton pregnancy will be recruited. Ultrasonographic estimation of gestational age using combined transcerebellar diameter and placental thickness will be compared to the actual estimated gestational age.


Eligibility Criteria:
Inclusion Criteria:

* Sure of dates
* Have dating ultrasound with crown rump length between (9 to 12 )weeks
* No hormonal contraception 3 months before conception.
* Regular menstrual cycles.
* Medically free.
* Single pregnancy
* Gestational age 32-36 weeks

Exclusion Criteria:

* Irregular menstrual cycles and not sure of dates
* Multiple pregnancy.
* Fetal anomalies.
* Placenta previa, placental anomalies and poor visualization of the placenta
* Fetal growth restriction
* Pregnant women with medical disorder e.g. diabetes mellitus, Pre-eclampsia, Systemic lupus erythromatosis, hypertension.
Impact of Intensive Outpatient Rehabilitation on Non-Motor Patient-Reported Outcomes in Parkinson's Disease (INTENSO)

This historical cohort study aims to evaluate the impact of different intensity rehabilitation protocols on the short and medium-term severity of non-motor symptoms in patients with Parkinson's Disease. One of the principal strengths of this study is that it is a real-life study, so it has a high external validity necessary to test the clinical effectiveness of these two types of training, which could have significant practical implications for rehabilitation in Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* adults diagnosed with Idiopathic PD, Hoehn \& Yahr stage ≥ 1 \< 5, consecutive referral to the rehabilitation facility between 1 January 2014 and 31 December 2019 to receive outpatient physiotherapy treatment for the management of motor disability, specifically targeting gait, balance, or posture disorders;
* completion of the course of rehabilitation treatment;
* availability of Non-Motor Symptom Scale and Unified Parkinson's Disease Rating Scale, recorded before and after treatment and 6 plus or minus 1 months later

Exclusion Criteria:

* diagnosis of any primary or secondary parkinsonism rather than PD
* symptom onset since less than three years
* any concomitant neurological disease (e.g. polyneuropathy, stroke, etc)
* any other chronically disabling disease (e.g. severe heart, liver or kidney failure, cancer, psychiatric disorders, limb amputation, severe musculoskeletal or neuropathic pain)
* changes in antiparkinsonian drug therapy during the whole study period
* exposure to a course of physiotherapy during the 6 months preceding the study
Opioid-Sparing Protocol Comparing With Opioid-based Protocol After Bilateral Total Knee Arthroplasty

The concern for the opioid use in the total knee arthroplasty continues to rise in recent decades. Historically, the total knee arthroplasty consumed high doses opioids in the postoperative periods. Compared to the Opioid-Based patient controlled analgesia(PCA), the opioid-sparing protocol may have benefits to decrease the concerns of the opioid use and opioid-related complication and provides the equivalent efficacy for pain control. The purpose of this trial in to provide a novel opioid-sparing protocol (OSP) to evaluate the efficacy for pain control and reducing the immediate postoperative opioid consumption.


Eligibility Criteria:
Inclusion Criteria:

* patient with bilateral advanced knee osteoarthritis undergoing simultaneous bilateral total knee arthroplasty surgery
* willing to participate in this study and randomly allocated to either opioid-sparing protocol or PCA protocol.

Exclusion Criteria:

* patient who refused to participate or with contraindication or hypersensitivity to any of the study drugs
* chronic pain disorder (exceeding 50 mg oral morphine equivalence per day at time of recruitment)
* substance abuse (e.g. alcoholism)
* severe renal impairment.
Transcranial Magnetic Stimulation for BECTS

Benign epilepsy with centrotemporal spikes (BECTS) is the most common pediatric epilepsy syndrome. Affected children typically have a mild seizure disorder, but yet have moderate difficulties with language, learning and attention that impact quality of life more than the seizures. Separate from the seizures, these children have very frequent abnormal activity in their brain known as interictal epileptiform discharges (IEDs, or spikes), which physicians currently do not treat. These IEDs arise near the motor cortex, a region in the brain that controls movement.

In this study, the investigators will use a form of non-invasive brain stimulation called transcranial magnetic stimulation (TMS) to determine the impact of IEDs on brain regions important for language to investigate: (1) if treatment of IEDs could improve language; and (2) if brain stimulation may be a treatment option for children with epilepsy.

Participating children will wear electroencephalogram (EEG) caps to measure brain activity. The investigators will use TMS to stimulate the brain region where the IEDs originate to measure how this region is connected to other brain regions. Children will then receive a special form of TMS called repetitive TMS (rTMS) that briefly reduces brain excitability. The study will measure if IEDs decrease and if brain connectivity changes after rTMS is applied.

The investigators hypothesize that the IEDs cause language problems by increasing connectivity between the motor cortex and language regions. The investigators further hypothesize that rTMS will reduce the frequency of IEDs and also reduce connectivity between the motor and language region


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Benign Epilepsy with Centrotemporal Spikes (BECTS), sometimes called Rolandic Epilepsy. Diagnosis will be based on a history of a focal motor seizure (affecting the face or causing hypersalivation) or a history of a seizure out of sleep AND an EEG with unilateral or bilateral centrotemporal spike waves.
* English-speaking

Exclusion Criteria:

* History of prematurity \< 35 weeks gestational age;
* History of serious neurologic problems (i.e. history of other seizure disorder other than simple febrile seizure, head trauma with prolonged loss of consciousness, cerebrovascular accident or neuro-inflammatory disease)
* Focal deficits on neurologic exam
* History of abnormal MRI (with clear gray or white matter abnormality)
Effects of Acutely Elevated Afterload on Left Ventricular Contractility and Relaxation

Aim of the study is to assess the effects of abruptly increased afterload on left ventricular contractility and relaxation in patients with heart failure with preserved ejection fraction (HFPEF), patients with heart failure with reduced ejection fraction (HFREF), and patients without HFPEF or HFREF.


Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for left and right heart catheterization
* HFPEF (Group 1) OR HFREF (Group 2) OR absent echocardiographic evidence of HFREF OR HFPEF(Group 3)

AND

* Sinus rhythm during invasive measurements
* Age ≥18 years
* Negative pregnancy test in women with childbearing potential
* Written informed consent

Exclusion Criteria:

* Acute coronary syndrome
* Acute myocardial infarction \<6 months
* Planned cardiac surgery or cardiovascular intervention within 6 months following inclusion
* Valvular heart disease \>2°
* Severe comorbidities with limited life expectancy \<12 months
* Precapillary pulmonary hypertension
* Participation in another trial
Parents Workgroup About Emotion Regulation

The purpose of this study is examine emotional regulation and reflective functioning in parents of children with Autism Spectrum Disorders (ASD) before and after an educational training (four sessions of group workshops). Our experimental aims are the following: 1) examine parental emotion regulation and reflective functioning in daily life, 2) examine child emotion regulation in their daily life 3)Learn about the training efficacy for ASD parents. This research study will help to formulate innovative treatment methods to reinforce positive emotion regulation and reflective functioning in both ASD children and their parents.

The parents will answer questionnaires and Parent Development Interview (PDI) and the Five Minute Free Speech Sample (FMSS) as well as a number of other questionnaires.

Parents will be randomized between intervention group and control group. First session

* Introduction
* Setting expectations and goals
* General explanation of emotions and their development.
* How to recognize emotions? Why is it important to recognize them?
* Minding parents and child emotions. Second session
* Emotion Regulation (general explanation).
* Strategic for emotion regulation (Adults)
* Strategic for emotion regulation (children)
* Parental emotion regulation and the influence on the child emotion regulation
* Difficulties in ER among children with ASD Third session
* Three steps method: Feel, Think-Rethink, Regulate.
* Theory, explanation and implementation.
* Discussion: Role play of challenging highly affective parent-child interaction

Fourth session:

* Three steps method: Feel, Think-Rethink, Regulate.
* Theory, explanation and implementation.
* Discussion: Role play of challenging highly affective parent-child interaction The parents will do another PDI and will fill up the questionnaires

Eligibility Criteria:
Inclusion Criteria:

* Parents of children with autism ages 3-18

Exclusion Criteria:

* If they cant understand English they can not be part of the study.
Study of Descartes-30 in Acute Respiratory Distress Syndrome

Emergency study to test the safety of Descartes-30 cells in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) AND COVID-19


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or older at the time of enrollment
* Patient maintains a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS

Exclusion Criteria:

* Patient is currently enrolled into another therapeutic clinical trial with an experimental therapy that has not received marketing approval by U.S. FDA.
* Patient is in moribund state with expected survival \<24 hours.
Effect of High-Intensity Interval Training Exercise on Cognitive Function of Young Adults

To explore the sustainability of the acute effect of High Intensity Interval Training (HIIT) on executive function in young adults.


Eligibility Criteria:
Inclusion Criteria:

* Young adult aged 18-40 years old
* No visionary defect or other sensory condition including uncorrected refractive defect and color blindness refraining the individual to be assessed by the tasks

Exclusion Criteria:

* With known neurological, cardiovascular, or other physical and mental conditions that limit the ability to safely participate in high-intensity interval training
* With known specific learning disabilities
* Known drug or alcohol abuse problems
Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization

The role of progesterone (P) supplementation in the luteal phase of in vitro fertilization (IVF) cycles is well established world-wide , but the influence of the luteal phase estradiol level on implantation is not clearly defined . There is a significant difference in estradiol levels between fertile and infertile cycles of fertile women who underwent donor insemination.


Eligibility Criteria:
Inclusion Criteria:

* Participants included in this study will have the following criteria : ( 2 of 3 criteria )

  1. advanced maternal age or any other risk factor for POR :

     1. Age ≥35 years
     2. other risk factor of poor responder : ovarian surgery especially in case of endometrioma , chemotherapy, radiotherapy, autoimmune disorders, single ovary, chronic smoking, and unexplained Infertility.
  2. previous poor ovarian response : Number of oocytes at the pickup time 3 or less .
  3. Abnormal ovarian reserve tests :

     1. FSH ≥12 mIu/ml in the early follicular phase .
     2. Estradiol level more than 70 pg/dl in the early follicular phase
     3. Anti-Mullerian hormone (AMH) below 0.5-1.1 ng/ml.
     4. Antral follicle count (AFC) \< 5-7 follicles .

Exclusion Criteria:

1. Age \>35 with good ovarian response .
2. any intra-uterine pathology can affect receptivity , ( for example ; Sub-mucosal fibroid , intra-uterine adhesions ).
3. Severe male factor infertility.
4. Extended endometriosis (stage 3 or more) .
5. All contraindications for estradiol : venous thrombo-embolism , stroke and breast cancer
Cytomegalovirus (CMV) Transmission by Frozen Breast Milk in Preterms

Cytomegalovirus infection threatens preterm infant. We investigated, whether thawed breast milk is a mode of transmission

Preterm infants are at risk of symptomatic human cytomegalovirus infections transmitted by breast milk. This study evaluates incidence, timing, and clinical rlevance of acquired human CMV infections in preterm infants younger than 32 weeks of gestational age receiving maternal thawed frozen breast milk until 33 completed weeks of gestational age.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants of less than 32 weeks of gestation

Exclusion Criteria:

* preterm infant of 32 weeks of gestational age or older, feeding with solely formula milk
* ourborn infants
* retroviral infection
* CMV status of mother unclear
* informed consent missing
Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia

This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 in multiple ascending doses in subjects with stable schizophrenia.

This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 compared to placebo over 14 days twice a day dosing in multiple ascending doses in subjects with stable schizophrenia.

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* Psychiatrically stable (≥3 months) male and female subjects with schizophrenia of non-childbearing potential between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>55 kg (121 lbs).
* DSM-IV Diagnosis of Schizophrenia; on stable medication treatment regimen ≥2 months.

Key Exclusion Criteria:

* Suicide attempt within 3 months prior to screening.
* History of or risk of seizures; head injury with long term abnormal resulting condition, abnormal EEG, clinically significant additional diseases or conditions, current medication with a significant risk of seizures, currently receiving antipsychotic medications.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply