cyrilzakka/clinical-trials huggingface dataset:
Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure

Evaluation of awake prone position on ventilation inhomogeneity in COVID-19 associated respiratory failure.

Awake prone position has been proposed as an additional treatment to alleviate hypoxemia during COVID-19 acute respiratory failure and potentially to avoid in some case tracheal intubation and invasive ventilation. Potential mechanism is improvement of ventilation: perfusion mismatch through redistribution of ventilation to the dorsal part of the lungs where perfusion is prominent. Electrical impedance tomography (EIT) is a non-invasive functional lung imaging of distribution of ventilation. Therefore, we aim to assess EIT on lung ventilation inhomogeneity during supine and prone position in COVID-19 patients.

Eligibility Criteria:
Inclusion Criteria:

* more than 18 Years (Adult, Older Adult)
* Confirmed COVID-19 (positive SARS-CoV-2 RT-PCR at nasopharyngeal swab)
* Acute respiratory failure with 100 \< PaO2:FiO2\< 300 mmhg
* Spontaneous ventilation with standard oxygen supply or high flow humidified oxygen
* Written informed consent of the patient

Exclusion Criteria:

* Contra-indication to prone position including pregnancy
* Presence of pacemaker
* Severe hypoxemia with PaO2/FiO2 \< 100 mmHg
* Evidence of clinical signs of respiratory distress with high probability of intubation in the next two hours
The Lyon Real World Evidence in Metastatic NeuroEndocrine Tumours

Neuroendocrine tumours (NETs) are rare and include a heterogeneous group of neoplasms derived from the endocrine system found in the gastrointestinal tract, pancreas and lung. Gastroenteropancreatic (GEP) NETs represent the majority of neuroendocrine neoplasms (NEN) and the annual incidence of all GEP-NETs has been estimated to 6.98 per 100,000 person-years in 2012 and is steadily rising. While data on the incidence of metastatic GEP-NET is limited, more than 50% of patients with GEP-NET have metastatic disease at the time of diagnosis. Incorrect and delayed diagnoses are still common. Treatment options include surgery, locoregional interventions, and systemic treatment.

The Lyon Real world Evidence in Metastatic NeuroEndocrine Tumours study (LyREMeNET) is a descriptive observational cohort study. The main objective is to assess the healthcare resources use and the corresponding costs for management of patients with metastatic GEP and lung NETs. The secondary objective is to describe the clinical characteristics, prognostic factors, treatment patterns, and the overall survival among patients with metastatic GEP and lung NETs.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of well-differentiated metastatic neuroendocrine tumour (either synchronous or metachronous)
* Diagnosis performed between 1 January 1990 and 31 December of 2017
* Patients seen at least once at the oncologic department of Hospices Civils de Lyon.

Exclusion Criteria:

* Poorly differentiated neuroendocrine carcinoma
* Histologic mixed neuroendocrine tumour
Safety and Efficacy Evaluation of γ-globin Reactivated Autologous Hematopoietic Stem Cells

This is a non-randomized, open label, single-dose, phase 1/2 study in up to 12 participants with β-thalassemia major.This study aims to evaluate the safety and efficacy of the treatment with γ-globin reactivated autologous hematopoietic stem cells in subjects with β-thalassemia major.

γ-globin reactivated autologous hematopoietic stem cells will be manufactured using Crispr/Cas9 gene editing system. Subject participation for this study will be 1 year. Subjects who enroll in this study will be asked to participate in a subsequent long-term follow up study that will monitor the safety and efficacy of the treatment they receive for up to 15 years post-transplant.

Eligibility Criteria:
Inclusion Criteria:

* Fully understand and voluntarily sign informed consent. 5-15years old. At least one legal guardian and/or Subjects to sign informed consent.
* Clinically diagnosed as β-thalassemia major, phenotypes including β0β0, β+β0,βEβ0 genotype.
* Subjects with no affection with EBV, HIV, CMV, TP, HAV, HBV and HCV.
* Subjects body condition eligible for autologous stem cell transplant.

Exclusion Criteria:

* Subjects acceptable for allogeneic hematopoietic stem cell transplantation and have an available fully matched related donor.
* Active bacterial, viral, or fungal infection.
* Treated with erythropoietin prior 3 months.
* Immediate family member with any known hematological tumor.
* Subjects with severe psychiatric disorders to be unable to cooperate.
* Recently diagnosed as malaria.
* History of complex autoimmune disease.
* Persistent aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin value \>3 X the upper limit of normal (ULN).
* Subjects with severe heart, lung and kidney diseases.
* With serious iron overload, serum ferritin\>5000mg/ml.
* Any other condition that would render the subject ineligible for HSCT, as determined by the attending transplant physician or Investigator.
* Subjects who are receiving treatment from another clinical study, or have received another gene therapy.
* Subjects or guardians had resisted the guidance of the attending doctor.
* Subjects whom the investigators do not consider appropriate for participating in this clinical study.
Lifestyle, Exercise, and Nutrition Study Early After Diagnosis

The proposed study is a randomized trial evaluating the impact of a dietary and physical activity guidelines intervention vs. usual care on adherence to breast cancer treatments, body composition, and changes in biomarkers in 172 women newly diagnosed with breast cancer scheduled to receive neoadjuvant or adjuvant chemotherapy.

Currently the Department of Health and Human Services, the American Cancer Society and others provide diet and exercise guidelines for cancer survivors. Many women with breast cancer do not follow these guidelines, and also elect to delay concerted efforts toward following them until active treatment is complete. However, adoption of these recommended lifestyle behaviors soon after diagnosis may prevent adverse changes in body composition and breast cancer biomarkers and may even improve the efficacy of treatment resulting in improved breast cancer prognosis. Further, by increasing our understanding of the mechanisms mediating the association between lifestyle behaviors and breast cancer survival, this study will improve our knowledge of how changes in diet and physical activity influence breast cancer outcomes. Lastly, guidelines for breast cancer survivors also overlap with those for diabetes and cardiovascular disease (CVD) prevention, the latter being a common cause of breast cancer mortality.

The proposed study will examine, in 172 women newly diagnosed with Stage I-III breast cancer who are not practicing the dietary and lifestyle guidelines, and who are scheduled to receive neoadjuvant or adjuvant chemotherapy, the effect of a 1-year dietary and physical activity guidelines intervention vs. usual care on the following breast cancer outcomes measured before beginning chemotherapy (Time 0), post chemotherapy (Time 1), at one-year post-diagnosis (Time 2), at two years post-diagnosis (Time 3), and at five-years post-diagnosis (Time 4): adherence to treatment, and changes in biomarkers, body composition, diet, physical activity and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Stage I-III breast cancer
* Scheduled to receive neoadjuvant or adjuvant chemotherapy
* Physically able to walk
* Able to complete forms, understand instructions and read intervention book in English
* Agrees to be randomly assigned to either intervention or usual care group

Exclusion Criteria:

* Women who have completed their 2nd chemotherapy
* Women already practicing dietary or physical activity guidelines
* Are pregnant or intending to become pregnant in the next year
* Recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction \< 40%
* Presence of dementia or major psychiatric disease
* Non-English speaking
The Serotonin Transporter in Attention Deficit Hyperactivity Disorder

The aim of the present proposal is to prove that adult attention deficit hyperactivity disorder (ADHD) patients show lower serotonin transporter (5-HTT) binding using positron emission tomography (PET) and the selective radioligand \[11C\]DASB. Specifically, the 5-HTT binding will be quantified in 20 adult medication-free ADHD patients (50% females) and in 20 age- and sexmatched healthy controls. Investigating untreated adult ADHD patients without any psychiatric comorbidities will provide the opportunity to estimate the change of serotonin transporter binding in adult ADHD patients compared to a group of healthy controls. Several lines of evidence support the hypothesis that serotonergic neurotransmission may, in addition to dopamine, play an important role in the aetiology of ADHD. So far, no PET study investigating serotonergic neurotransmission in adult ADHD patients has been conducted, although alterations in the serotonin system may be substantially involved in the susceptibility and subtype characterization of ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be male or female outpatients who are at least 18 years of age and no more than 65 years of age when informed consent is obtained.
* Patients must meet DSM-IV-TR criteria for current ADHD as well as for historical diagnosis of ADHD during childhood as assessed by the Conner´s Adult ADHD Diagnostic Interview for DSM-IV (CAADID, Conners 1999).
* Patients must have a score of \>2 on at least 6 items of either the inattentive or hyperactive score subscales at screening on the rated CAARS-Inv:SV (Conners 1999). In addition, their CAARS-Inv:SV 18-item total ADHD symptom score (the sum of the inattention and hyperactivity/impulsivity subscales) must be \>20.
* Patients must have a CGI-ADHD-S score of \>4 (moderate symptoms) at screening.
* Patients must be physically healthy.
* Patients must be able to understand and willing to sign the written informed consent document.

Exclusion Criteria:

* Patients suffering from severe somatic diseases will be excluded from the study.
* Any treatment with stimulants, selective norepinephrine reuptake inhibitors or any other psychotropic treatments, such as SSRIs, etc. within six months prior to screening.
* Patients suffering from any current comorbid psychiatric disorder (Axis I or Axis II diagnosis according to DSM-IV-TR) will be excluded.
* Patients who are currently using alcohol, drugs of abuse, or any medication in a manner which is indicative of chronic abuse or who meet DSM-IV-TR criteria for alcohol or other substance dependence.
* Any implant or stainless steel graft.
* Positive urine pregnancy test.
* Participation in studies with PET or SPECT within the last 10 years.
Instrument Assisted Soft Tissue Mobilization Versus Myofascial Release in Patients With Chronic Non¬Specific Low Back Pain

This study was done to compare the effect of instrumental-assisted soft tissue mobilization versus the effect of myofascial release on pain intensity, pressure pain threshold, back function, and back range of motion in patients with chronic nonspecific low back pain.

Low back pain affects 20% of the workforce annually, leading to increased work absenteeism. Chronic non specific low back pain restricts functional and occupational activities, impacting society and the economy. Treatment is often unsatisfactory, and there is no consensus on the optimal approach. Further scientific research is needed to understand the effects of facial tissue manipulation on Chronic non specific low back pain patients. The literature has not addressed the distinctions between myofascial force transmission instrumental assisted soft tissue mobilization and myofascial release on Chronic non specific low back pain patients, which could help physical therapists find effective treatments. This study is the first to include pain, Pressure pain threshold, back function, and range of motion as outcome measures and compare instrumental assisted soft tissue mobilization and myofascial release in Chronic non specific low back pain patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic non-specific low back pain for more than 3 months.
2. Age between 25-45 years.

Exclusion Criteria:

1. Patients who have serious spinal pathologies, such as fractures, tumors or inflammatory diseases (such as ankylosing spondylitis)
2. Patients who have nerve root compromise, disk herniation, spondylolisthesis with neurological involvement, or narrowing of spinal canal
3. Pregnant women
4. Cancer patients .
5. Lower limb injuries.
6. Body mass index (BMI) greater than 25.
Glucose Control by eMPC Algorithm in Peri- and Postoperative Period in Cardiac Surgery Patients

Randomized controlled trial to compare blood glucose control by the model predictive control algorithm with variable sampling rate (eMPC) with routine glucose management protocol (RMP) in peri- and postoperative period in cardiac surgery patients.

Context. Increased blood glucose levels frequently occur in critically ill patients and its normalization by intensive insulin treatment markedly improves clinical outcome.

Objective and Design: Randomized controlled trial to compare blood glucose control by the model predictive control algorithm with variable sampling rate (eMPC) with routine glucose management protocol (RMP) in peri- and postoperative period in cardiac surgery patients.

Setting: Department of Cardiac Surgery, University Hospital. Patients. 60 cardiac surgery patients. Interventions. Elective cardiac surgery and treatment with continuous insulin infusion to maintain euglycemia (target range 4.4 - 6.1 mmol/l). 30 patients were randomized for eMPC and 30 for RMP treatment. Blood glucose was measured in 1-4 hour intervals depending on request of each algorithm during surgery and post-operation period for 24 hours.

Main Outcome Measures. Mean blood glucose, percentage of time in target range. Results. Mean blood glucose was 6.15 ± 1.11 mmol/l in eMPC vs. 7.21 ± 1.08 mmol/l in RMP group (p\<0.05); percentage of time in target range was 60.4 ± 22.8% for eMPC vs. 27.5 ± 16.2% for RMP group (p\<0.05). No severe hypoglycemia (blood glucose bellow 2.9 mmol/l) was observed during the study. Average insulin infusion rate was 4.67 ± 3.34 in eMPC vs. 2.57 ± 1.66 IU/h in RMP (p\<0.05), average sampling interval was 1.46 ± 0.31 vs. 2.10 ± 0.22 hours (p\<0.05).

Conclusions. eMPC algorithm was more effective and comparably safe as compared to RMP in maintaining euglycemia in cardiac surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgery

Exclusion Criteria:

* Allergy against insulin
* Mental incapacity
* Language barrier
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures

The purpose of the study is to evaluate the efficacy of lacosamide (LCM) versus an Active Comparator chosen based on standard of care (StOC) in severe and nonsevere seizure burden (defined as total minutes of electroencephalographic neonatal seizures (ENS) per hour) in neonates with seizures that are not adequately controlled with previous anti-epileptic drug (AED) treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be ≥34 weeks of corrected gestational age (CGA), \<46 weeks of CGA, and \<28 days of postnatal age (PNA)
* Participants who have confirmation on video-electroencephalogram (EEG) of ≥2 minutes of cumulative electroencephalographic neonatal seizures (ENS) or ≥3 identifiable ENS prior to entering the Treatment Period
* Participants must have received either phenobarbital (PB), levetiracetam (LEV), or midazolam (MDZ) (in any combination) before entering the study
* Participant weighs at least 2.3 kg at the time of enrollment Informed consent
* An Independent Ethics Committee (IEC)-approved written informed consent form (ICF) is signed and dated by the participant's parent(s) or legal representative(s)

Exclusion Criteria:

* Participant with seizures responding to correction of metabolic disturbances (hypoglycemia, hypomagnesemia, or hypocalcemia) or with seizures for which a targeted, known treatment is available
* Participant has seizures related to prenatal maternal drug use or drug withdrawal
* Participant has a clinically relevant electrocardiogram (ECG) abnormality, in the opinion of the investigator
* Participant receiving treatment with phenytoin (PHT), lidocaine (LDC), or other sodium channel blockers at any time
Multi Center Case Control Study on Multiple Risk Factors of Aplastic Anemia

To ascertain the risk factors of AA in ZheJiang Province of China at the moment, especially the comprehensive multiple factors risks. The author conducted a case-control research included 338 AA cases and 1464 controls. Subjects were surveyed using same standard questionnaire including personal data, past histories of diseases, family history and histories of occupational and daily exposure to harmful substances. Single and multiple Logistic regression analyses were made using SPSS17.0 on the dates to study potential factors in the development of AA.


Eligibility Criteria:
Inclusion Criteria:

* All the patients of AA group met a AA diagnostic criteria；The control group were chosen from other departments who were under acute infection (such as pneumonia), acute abdominal emergency (such as appendicitis), cataract surgery;
* 1-65 years old, male or female;
* Sign the informed consent.

Exclusion Criteria:

* With myelodysplastic syndrome, leukaemia, multiple myeloma,megaloblastic anaemia, paroxysmal sleep hemoglobinuria disease blood disease, etc.
* History of tumor, radiation or chemotherapy, once accept the immunological therapy, autoimmune diseases or allergic disease patients;
* Patients with neurological diseases.
Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms

The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952) in a single dose application scheme.

Subjects will undergo a 2 - 28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. Safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. Efficacy will be assessed by application of motor examination scores.

The first subject is planned to be enrolled in February 2006. The last subject is planned to be enrolled in May 2006. Last subject out is expected for August 2006.

The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952)in a single dose application scheme. Subjects will undergo a 2-28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. Safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. Efficacy will be assessed by application of motor examination scores.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with idiopathic Parkinson's disease for at least 3 years in duration
* At least 30 years of age

Exclusion Criteria:

* Patients with atypical Parkinson's or clinically relevant concomitant diseases or medical conditions
Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency

To Evaluate the safety and efficacy of PEG Somatropin in the treatment of children with growth hormone deficiency, as well as to study the dosage of PEG Somatropin.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as GHD before starting treatment, according to medical history, clinical symptoms and signs, GH provocation tests and imaging and other examinations:

  1. According to statistical height data of physical development of Chinese children in nine cities in 2005, the height is lower than 3rd percentile growth curve of the same age, same sex normal children;
  2. Height velocity (HV) ≤5.0 cm / yr;
  3. GH provocative tests (with two drugs of different mechanism of action) confirmed plasma GH peak \<10.0 ng / ml;
  4. bone age for girl≤9 years old, for Boy≤10 years old, bone age is one year or more later than the actual age, that is the actual age - bone age ≥ 1 year;
* Before puberty (Tanner I stage), age≥3 years old, male or female;
* Have not received hormone therapy within 6 months;
* Subjects is willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.

Exclusion Criteria:

* Dysfunction of liver and kidney (ALT\> 2 times the upper limit of normal, Cr\> upper limit of normal);
* Patients positive for hepatitis B c-antibody (HBcAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg);
* Patients with known hypersensitivity to PEG Somatropin or Somatropin or any other components of the study product;
* Patients with severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases;
* Potential cancer patients (family history);
* Patients with diabetics;
* Patients with other growth disorders, such as Turner's syndrome, sexual physical delayed puberty, Laron syndrome, growth hormone receptor deficiency, girls with slowly growing who did not rule out chromosomal abnormalities;
* Patients with congenital bone dysplasia or scoliosis;
* Subjects took part in other clinical trial study during 3 months;
* Other conditions in which the investigator preclude enrollment into the study.