cyrilzakka/clinical-trials huggingface dataset:
PRT for Adolescents With High Functioning Autism

The purpose of this study is to identify improvement in behavioral and social function and changes in the brain following Pivotal Response Treatment (PRT) for Adolescents in highly verbal adolescents with autism spectrum disorder (ASD).


Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Autism Spectrum Disorder, higher functioning/low support needs
* Intelligence Quotient (IQ): Participants with a Full Scale IQ \> 80 on the Wechsler Abbreviated Scale of Intelligence (WASI-II)
* Right-handed
* No metal in their body/unremovable metal on their body (i.e., braces)
* First language is English
* Must live in the San Francisco Bay Area
* Able and willing to receive intervention weekly for 9 weeks
* Adolescent is interested in improving their social skills
* MRI Compatibility: No major contraindication for MRI.
* Diagnosis of ASD using ADOS-2 and ADI-R.
* No evidence of a genetic, metabolic, or infectious etiology for their autism.
* Primary diagnosis of ASD
* No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period.
* Stable treatment (e.g., ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation.
* Score of at least 50% or below on at least 4 out of the 9 social target areas in the SLO (administered during pre-measures)
* No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period.

Exclusion Criteria:

* History of claustrophobia, previous head injury, serious neurological or medical illness, birth weight less than 4 lb. and/or gestational age \< 34 weeks
* Left-handed
* Braces or any metal in their body
A Controlled Trial of High Dietary Fiber Intake on Serum Lipids

The study evaluates high fiber diet intake in patients with hyperlipidemia.

Dietary fiber intake has been shown to have modest effect in lowering cholesterol. However, most of these studies were done with 20g/daily fiber intake. Not much is known about high dietary fiber intake (30-40 g/day) and serum cholesterol. Also, there have been small studies that have shown modest decrease in oxidative stress by increasing dietary fiber intake. The goal of our study is to determine the efficacy /safety of high dietary fiber intake in raising HDL, lowering LDL, and lowering oxidative stress in patients with hyperlipidemia.

Eligibility Criteria:
Inclusion Criteria:

* All primary and secondary prevention patients aged 18 to 80 years with known or newly diagnosed isolated hypercholesteremia or combined hyperlipidemia.
* Inclusion criteria include patients with HDL \< 35 mg/dL for a man or \< 45mg/dL for women irrespective of LDL level.

Exclusion Criteria:

* Any patients with unstable angina, untreated hypothyroidism, uncontrolled diabetes, other endocrine or metabolic diseases not actively treated, acute inflammatory diseases, severe gastrointestinal diseases, chronic renal insufficiency (GFR\<30), end stage renal disease, liver disease or other severe diseases such as cancer, triglyceride level greater than 600 mg/dL, pregnant females, chronic use of systemic corticosteroid, or anticoagulants.
* Patients who were recently started or recently had their lipid lowering medications changed within the last 4 weeks will be excluded.
Simplified Rapid Hydration in Preventing CA-AKI Among Patients With Chronic Kidney Disease

No well-defined protocols exist to guide fluid administration for prevention of contrast-associated acute kidney injury in high risk patients. The investigators will compare long term hydration at routine speed(12h before and after procedure at 1ml/kg/h) with short term hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) to verify our hypothesis that the short term hydration may not be inferior to the long one.

No well-defined protocols exist to guide fluid administration for prevention of contrast-associated acute kidney injury in high risk patients undergoing coronary angiography. Long term hydration at routine speed(12h before and after procedure at 1ml/kg/h), as the most recommended adequate hydration, has been carried out to prevent contrast-associated acute kidney injury in lots of clinical trials. Base on the data in the POSEIDON randomized controlled trial with hemodynamic-guided fluid administration, short term hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) may not be inferior to the classic long term hydration, the speed should be reduced half of the intended speed in all the patients. We hypothesized short term hydration may not be inferior to the long one to reduced significantly the hospital stay and healthy cost.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age;
* Written informed consent;
* Candidates scheduled for coronary intervention (angiography and/or coronary intervention);
* Patients with chronic renal insufficiency, the baseline estimated glomerular filtration rate (eGFR) was 15-60 mL/min / 1.73 m²
* At least one risk factor (age\>75 years, medical history of diabetes mellitus or hypertension, congestive heart failure \[NYHA class \>II or history of acute pulmonary edema\]);

Exclusion Criteria:

* End-stage renal failure or heart/renal transplantation;
* History of exposure to contrast medium or acute infectious diseases within 48 hours prior to the procedure;
* Acute decompensated heart failure;
* Left ventricular thrombus;
* Allergy to contrast agent;
* Pregnancy or lactation;
* Malignant tumour or life expectancy \<1 year;
* Pre-procedural receipt of NSAIDs (except Asprin), aminoglycosides, cyclosporine or cisplatin in the past 48 h;
* Severe valve disease or elective undergoing surgery.
The Hordaland Health Study

The Hordaland Health Studies (HHS) were conducted in 1992-93 (The Homocysteine study) and in 1997-99 (HUSK). Both surveys were conducted as a joint project between the University of Bergen, the Norwegian Health Screening Service (SHUS) (now part of the National Institute of Public Health) and the Municipal Health Service in Hordaland.

The main focus of the studies is on chronic diseases including cardiovascular disease, cancer, osteoporosis, anxiety and depression. Some projects focus on psychosocial factors, occupational research, musculoskeletal diseases, urinary incontinence and mapping of drug use. The main purpose of the surveys is to gather information so that disease ultimately can be prevented.

Approximately 36,000 residents of Hordaland county participated in the studies, ca. 18,000 in 1992-93 and ca. 26,000 in 1997-99. About 7,000 of those who participated in the 1992-93 survey also participated in 1997-99.


Eligibility Criteria:
Inclusion Criteria:

* Born in a specific time-period
* From Hordaland County
* Community-dwelling people who were able to come to the study site on their own, and able to fill out questionnaires.

Exclusion Criteria:

* Not born within the specific time-period
* Not from Hordaland County
* Institutionalized People
* People who were not able to fill out questionnaires
Enhancing Fitness With Preoperative Exercise in Colorectal Cancer Surgery

This study examines whether a home-based telephone-guided preoperative exercise programme is feasible and effective in improving cardiorespiratory fitness in patients with colorectal cancer who are high risk due to their existing co-morbidity.

Preoperative exercise, also know as prehabilitation, has been shown to improve physical fitness and potentially reduce postoperative complications in patients undergoing surgery. Patients are often labelled high risk for surgery due to their existing ill-health e.g. heart and lung disease. High risk patients comprise approximately 12% of all elective cancer cases, but account for 80% of all post-operative mortality. Complications significantly affect the quality of life of each CRC patient, both in the short and long-term, and can also impact on survival. It is critical that patients who are deemed at high risk of complications are optimised in the preoperative period. Exercise in the period before surgery is therefore one potential method of improving high risk patients' physical fitness levels while potentially reducing their risk of postoperative complications and subsequent mortality.

Eligibility Criteria:
Inclusion Criteria:

* Primary operable colorectal cancer;
* Awaiting surgery with curative intent;
* Deemed high risk by the responsible clinical team;
* Ability to mobilise independently

Exclusion Criteria:

* Patients with primary or recurrent inoperable colorectal cancer.
* Patients undergoing preoperative chemo- and/or radiotherapy.
* Patients who decline or are deemed unfit for operative management.
* Patients who lack capacity to consent.
The Northern-European Initiative on Colorectal Cancer

Colorectal cancer (CRC) is a major burden in western countries. The disease develops from precursor lesions during a long time-interval. Colonoscopy can detect and remove CRC precursor lesions and may thus be effective for CRC prevention. Many national and international health organisations demand evidence from randomised trials to reduce incidence or mortality of the target disease before advocating population-wide cancer screening. However, while colonoscopy screening for the prevention of colorectal cancer is established in the United States and several European countries, no randomised trials exist to quantify the possible benefit of colonoscopy screening. NordICC is a randomised trial investigating the effect of colonoscopy on CRC incidence and mortality.

NordICC is a multicentre, randomised trial in Nordic countries, the Netherlands and Poland. A minimum of 66 000 individuals, age 55-64 years, are drawn randomly from the population registries in the participating countries. 22 000 are invited for once-only colonoscopy (2:1 randomisation). Expected work-load with 50% compliance will be 11,000 colonoscopies. At the screening examination, all detected lesions are biopsied and removed whenever possible. The remaining 44 000 individuals (control group) are not offered any screening examination (care as usual).The primary study aims are CRC incidence and CRC mortality after 15 years of follow-up, with an interim analysis after 10 years of follow-up. In an intention-to-treat approach, a risk reduction of CRC mortality of 25% in the colonoscopy screening group compared to the control group is expected after 10 years follow-up, estimating 50% compliance in the screening group.


Eligibility Criteria:
Inclusion Criteria:

* This study is a population-based randomised controlled trial, with randomisation of individuals age 55-64 years living in the screening areas directly from the Population Registries to either screening group or control group. Eligible persons with the same home address will be randomised to the same group (household randomisation).

Exclusion Criteria:

* Individuals with previous colorectal surgery (resections, enterostomies)
* Individuals in need of long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
* On-going cytotoxic treatment or radiotherapy for malignant disease
* Severe chronic (longer than trial duration) cardiac (NYHA III-IV)or lung disease
* Lifelong anticoagulant therapy with Warfarin
* A coronary event requiring hospitalization during the last 3 months
* A cerebrovascular event during the last 3 months
* Resident abroad
* Return of unopened letter of invitation and/or reminder (address unknown)
* Message from neighbour/family/post office on death of screenee (not updated in Population Registry)
MS Versus NICE for Colorectal Lesions

OBJECTIVE: Our study aimed to compare a recently-developed endoscopic classification with an established one for colorectal lesions in a randomised trial between 2013 and 2015.

OBJECTIVE: Current practice requires histopathological assessment to confirm diagnosis for colorectal lesions detected at colonoscopy. Advances in endoscopic imaging contribute for real-time diagnosis which, apart from being cost and time-saving, also guides decision-making and reduces risks. Our study aimed to compare a recently-developed endoscopic classification with an established one.

DESIGN: The modified Sano's classification (MS) was compared to the Narrow Band Imaging (NBI) International Colorectal Endoscopic classification (NICE) in a randomised trial between 2013 and 2015. An experimented endoscopist classified each polyp, what was compared to histopathology.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in the Endoscopy Unit for a colonoscopy
* Patients over 18 years-old
* Patients or their caregivers that have understanding of the procedure and that have signed the consent form for the study

Exclusion Criteria:

* Patients without colorectal polyps
* Patients with poor bowel preparation
* Patients that do not agree with or withdraw the consent form
Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study will assess the bronchodilator effects of multiple doses of QAX028 at two different dose levels when compared to tiotropium and placebo in a COPD population.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD according to GOLD guidelines
* Post-bronchodilator 30%≤FEV1\<80% of predicted normal and ost-bronchodilator FEV1/FVC \<0.7
* Smoking history of at least 10 pack years

Exclusion Criteria:

* Requiring oxygen therapy on a daily basis
* Exacerbation of airway disease in the 6 weeks prior to screening or between screening and dosing
* Lung reduction surgery
* Respiratory tract infection in the 6 weeks prior to screening
* Significant cardiac history
* History of asthma with onset of symptoms prior to age 40 years
* Active use of certain COPD medications, beta blockers

Other protocol-defined inclusion/exclusion criteria may apply
Prognostic Value of IgM in Covid-19 Infection

The primary objective of the research is to study the relation between the presence and /or the anti SARS-Co-V-2 IgM level in an early stage of COVID-19 infection, and the evolution of the illness.

The secondary objective is to determinate in what manner response of IgM anti-SARS-Co-V-2 relates to patient's immunity statute, in regards to the other so-called humain "seasonal coronavirus".

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years;
* Have been diagnosed positive of SARS-CoV-2 in the Virological Laboratory of Ambroise Paré hospital;
* Have been blood sampled between 1 day and 14 days from the first clinical syndromes, and their collections of serum or plasma are conserved and accessible;
* Affiliated to the social security scheme or entitled;
* Informed and non-opposed to participating to the study.

Exclusion Criteria:

* Opposition of patient to participation to the study;
* Foreign patients under french AME scheme.
Pupillometry and Locus Coeruleus Activation (PuLCA)

This project will apply non-invasive, trans-cutaneous vagal nerve stimulation using various stimulation parameters to young, healthy adults to find the optimal set of parameters to elicit pupil response.


Eligibility Criteria:
Inclusion Criteria:

* Fluent English speaker with reading and writing proficiency.

Exclusion Criteria:

* Participants with significant visual impairment or ocular illness may be excluded at the discretion of the principal investigator.
* Major medical illnesses including severe neurological illness (e.g. stroke, seizure history), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia)
* Any history of brain surgery, tumor, intracranial metal implantation, pacemakers, or other implanted devices.
* Current (i.e. within 48 hours of the session) prescription medication or over-the-counter medication use.
* Illicit alcohol or drug use. Caffeine (e.g, coffee, energy drinks) consumption prior to the visit.
Clinical Use of a New Neonatal MRI System

The purpose of the present study is to make medically indicated state of the art/high end magnetic resonance imaging (MRI) exams available to all infants in the Cincinnati Children's Hospital Medical Center (CCHMC) Neonatal Intensive Care Unit (NICU).

The current practice of transferring infants from the Neonatal Intensive Care Unit (NICU) to radiology departments and imaging in adult-sized magnetic resonance imaging (MRI) scanners is associated with significant safety and image quality issues. For these reasons, the smallest and/or sickest neonates are typically precluded from receiving an MRI exam. The overreaching goal of our research effort is to bring high-performance MRI into the NICU so that all neonates can benefit from the same quality of diagnostic imaging as adults. To accomplish this, we have converted a commercial small-bore 1.5 Tesla (T) MRI scanner designed for orthopedic use into a neonatal MRI system optimized for whole body imaging of neonates. To expand the imaging capabilities of the NICU MRI system, the measurement control electronics and operating system software of the FDA cleared imaging OPTIMA platform have been augmented with state of the art HDX electronics and software currently used on a conventional commercially available adult sized whole body MRI scanner. The clinical safety of the integrated HDX/OPTIMA NICU MRI system and its ability to produce diagnostic image quality has been shown in 15 pilot patients (CCHMC Protocol 2011-2045). The present protocol builds and expands upon the previous to use the integrated NICU MRI system to perform MRI exams in the neonatal population.

Eligibility Criteria:
Inclusion Criteria:

* Any infant admitted to the NICU at CCHMC
* Have a medical condition for which an MRI exam is indicated, as determined by the attending neonatologist
* Able to maintain body temperature for at least 90 minutes without the aid of an incubator or radiant warmer int he opinion of the attending neonatologist
* Parental/LAR permission obtained

Exclusion Criteria:

* Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants heavier than 6 kg)
* Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus

Compare the efficiency of the association, first line, the intravenous levetiracetam and the intravenous clonazepam, in that of a monotherapy of clonazepam intravenous in the pre-hospital treatment of tonicoclonic generalised status epilepticus.

At this time, the prehospital treatment of the status epilepticus use some molecule ("FOSPHENYLOINE") with large contra-indications. In this case the physician is not able to know the past medical history of the patient, the biological examinations and so he can not decide which molecules he can use.

The levetiracetam is a knowledge medication in the epilepsy since more than twenty years. One of specificity of the levetiracetam is to be able to be used in all situations (no clinical or biological contre-indication). This molecule seems like to be very interesting to be used in prehospital system.

The goal of this study is to evaluate the association levetiracetam / clonazepam in first line in the prehospital treatment of the status epilepticus

Eligibility Criteria:
Inclusion criteria :

* Age ≥ 18 years
* Patient taken care by a prehospital medical team participating in the study
* Diagnosis of tonicoclonic generalized status epilepticus confirmed on the spot by a physician of the team.

Exclusion criteria :

* Parent or the reliable person indicated by the patient present not giving its agreement for the inclusion
* Pregnancy clinically detectable or known for close relations at the time of the status epilepticus
* tonicoclonic generalized status epilepticus after anoxia post cardiac arrest
* Patient having already received another treatment for the same episode of status epilepticus
* Patient having already participated in the study during a previous episode of status epilepticus
* Patient in "latent" status epilepticus. Definition : patient in the coma having epileptic demonstrations (CLONISMS MYOCLONISMS) small or invalid, contrasting with permanent generalized electric seizures on the EEG
* Patient presenting certain diagnosis of pseudo name psychogenic seizure
* Patient whose neurological status requires an immediate surgery (traumatism)
* Patient having a hyper-responsiveness about the levetiracetam or about the other by-products of pyrrolidone or an one of the excipients
* Patient having a hyper-responsiveness about the clonazepam, about the benzodiazepins or about one of the other constituents of the product
* Patient under medical guardianship
* Not membership in a schema of medical assurance.
Role of Diaphragm Fatigue in Weaning From Mechanical Ventilation

The purpose of this study is to determine whether the diaphragm develops contractile fatigue during a weaning trial and if this is associated with weaning failure.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 year
* mechanical ventilation for at least 3 days
* the treating physician judges the patient to be ready to be weaned from the ventilator
* informed consent

Exclusion Criteria:

* pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases.
* upper airway / esophageal pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
* recent (\< 1 month) nasal bleeding
* phrenic nerve lesions
A Study of the Efficacy and Safety of ABH001 in the Treatment of Patients With Epidermolysis Bullosa Who Have Wounds That Are Not Healing

The purpose of this study is to evaluate the efficacy and safety of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing.

It is hypothesized that ABH001 may initiate and continue wound healing in patients with epidermolysis bullosa.


Eligibility Criteria:
Inclusion Criteria:

1. The subject or legal guardian must have read, understood and signed an Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent or Assent Form and must be able to and willing to follow study procedures and instructions
2. Male and female subjects.
3. Stable nutritional status.
4. Subjects with a confirmed diagnosis of generalized Epidermolysis Bullosa (EB)
5. Cutaneous wounds meeting the following criteria:

   1. Anatomical location: arms, legs, thorax, or back above the waistline and below the neck.
   2. Documented age (duration) of the wound(s).
   3. One or more wounds capable of potentially meeting the following wound selection criteria at the end of the observation period:

   i. Two clinically non-infected cutaneous wounds with no clinically meaningful change in wound size during the observation period.

   ii. Two matched wounds.
6. Negative urine pregnancy test for women of child-bearing potential.
7. Female subjects of childbearing potential and male subjects of procreative capacity must agree to use an effective method of contraception.

Exclusion Criteria:

1. Pregnant or nursing women.
2. Diagnosis of non-genetic generalized EB.
3. Localized, active clinical infection of study wounds.
4. Diseases or conditions that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the subject with study visits/procedures.
5. Known allergy to bovine products.
6. Known allergy to silver products.
7. Systemic infection at the time of enrolment in the study.
8. Currently receiving or have received oral steroid therapy within the previous 4 weeks.
9. Taking, or have participated in other clinical studies involving gene therapy, stem cell therapy, recombinant DNA/protein therapy.
10. Received ABH001, or other biologic or cell therapy for the treatment of EB in the study wound sites within the previous 3 months.
11. Hypersensitivity to any of the therapeutic agents.
12. History of malignant skin disease.