cyrilzakka/clinical-trials huggingface dataset:
Collaborative Study Of Neurofeedback Training Of 6-18 Year Olds With Autism

Neurofeedback, a neuro-cognitive training method based on operant conditioning, will be employed with 90 children with the Autistic Spectrum Disorders (ASD) over a 60 session training period to improve the limiting behavioral and sensory symptoms Autism presents (with each collaborative site working with 45 of the 90 participants). This study seeks to demonstrate that Neurofeedback training, a non-invasive approach based on Learning Theory, will mitigate presenting symptoms of Autism, and ultimately render the person with Autism significantly more able to interact with his/her environment successfully, independently function on a day-to-day basis, and improve overall mental health.

The specific objective is to demonstrate quantitative and qualitative improvements in functional and behavioral parameters in individuals affected by Autism Spectrum Disorders when 60 Neurofeedback training sessions are applied. The long term objectives for these individuals include improvement of quality of daily functioning, better ability to integrate and navigate within society, and overall to decrease the limitations caused by the disability. Additionally, increasing awareness by the public, as well as healthcare providers and legislation, that Neurofeedback is a viable intervention which may contribute not only to a significant reduction of the level of disability for affected individuals, but also in reducing required lifetime costs of healthcare. Hopefully in the future Neurofeedback training would be incorporated as a standard of care for ASD. As of today, there are around 1000 trained Neurofeedback practitioners in the US who are offering this intervention to a very limited number of individuals due to lack of recognition of NFB benefits.

Eligibility Criteria:
Inclusion Criteria:

* 6 to 18 year olds who have been diagnosed by their physician with mild to moderate autism, in accordance with DSM-IV diagnostic criteria

Exclusion Criteria:

* Any child with a diagnosis of Bipolar Disorder, Tourette's Syndrome, an uncontrolled seizure disorder, or a history of any major psychiatric disorder will be excluded from eligibility for the study.
Accuracy of Continuous Glucose Monitoring in Patients with Diabetes. a Prospective Observational Study

The goal of this observational study is to investigate the accuracy of the continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment.

The main questions it aims to answer are:

• Do CGM measurements have a decreased accuracy compared to standard blood glucose measurements in periods with circulatory impairment?

Participants will be asked to wear a blinded CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital but will receive standard care of their diabetes. The CGM device will be worn for up to 10 days.

This is a prospective observational study on patients living with diabetes who a) undergo surgery at the Department of Vascular Surgery, Rigshospitalet, Denmark and the Surgical Department and Department of Orthopedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital, Denmark, or b) are admitted to the intensive care unit (ICU) at Bispebjerg and Frederiksberg Hospital with circulatory impairment.

The study aim is to investigate the accuracy of the Dexcom G7 CGM in patients with diabetes undergoing surgery and in patients at the ICU with circulatory impairment. The glucose readings will be compared to standard practice with POC blood glucose measurements.

Included patients will be asked to wear the CGM device Dexcom G7 for up 10 days.

The study will include 60 patients

This study is part of an overall project that aims to investigate the use of CGM and continuous wireless monitoring of vital signs in patients with diabetes undergoing major surgery. Using this technology, postoperative complications including dysglycaemia can potentially be detected and treated earlier thus improving the perioperative care.

Eligibility Criteria:
Inclusion Criteria:

* Medical history with diabetes mellitus requiring antidiabetic drugs
* Age ≥18 years
* Surgery with estimated surgery time ≥45 minutes with expected stay for at least one night in hospital postoperatively OR
* Admission to the ICU with Circulatory impairment defined as need of vasopressors to maintain a mean arterial pressure (MAP) ≥65 mmHg and peripheral perfusion index \<1.5

Exclusion Criteria:

* Local skin symptoms including infection at the posterior aspect of the upper arm that does not allow the sensor to be placed on an unaffected skin area
* Contraindications to skin puncture (arteriovenous fistula for dialysis, post-mastectomy lymphoedema etc)
* Known allergy to plaster used in the CGM device
Plasma Oxalate in Patient With Short Bowel

Hyperoxaluria due to fat malabsorption is seen in patients suffering from short bowel and can lead to stones and nephrocalcinosis. Not all patients are prone to these renal complications. only urinary oxaluria is measured in practice. Plasma oxalate shouldn't increase theoretically in these patients. However recent report showed an increase of plasma oxalate in patient with enteric hyperoxaluria. The aim of this study is to assess the plasma oxalate distribution in this specific population to have a new tool to predict renal complication of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Type II short bowel for more than 6 months
* Affiliated to a social health care

Exclusion Criteria:

* Primary hyperoxaluria
* Other type of short bowel than type II
* Minor patient or major patient protected by the law
Hybrid Training and Middle Age

Modern living and physical inactivity results in many ailments, including obesity, non-alcoholic fatty liver disease (NAFLD), and inflammatory issues.

Though there are a lot of studies on physical training, there is little detail on hybrid training or electrical and voluntary contractions of the musculature. This study investigated the efficiency of hybrid training in biochemistry, ultrasound, and proinflammatory outcomes in middle-aged sedentary and obese women with NAFLD.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary women with one to two exercise sessions or less per month
* BMI equal to or above 30 kg/m-2
* WHR equal or above 0.85 m
* Confirmed NAFLD, with grade 2 and 3
* Systolic blood pressure not less than 130 mm Hg and diastolic blood pressure not less than 85 mm Hg
* Increased AST and ALT
* Mean age 45-65 years

Exclusion Criteria:

* Use of 140 grams or more of ethanol per week
* History of depression in the last 6 months
* History of chronic or acute viral hepatitis
* Drug-related liver disease and chronic liver disease
* History of diabetes
* Uncontrolled hypertension
* Myocardial infarction
* Chronic kidney disease
* Hyperthyroidism or heart failure
* Those who have weight loss programs or medical contraindications for physical training
* Serious arterial hemorrhagic disorders
* Serious neurological diseases
* Advanced atherosclerosis
* Elevated fever
Safety and Efficacy of Non-ablative Er:YAG Laser Therapy for the Treatment of Pelvic Organ Prolapse and Coexisting Stress Urinary Incontinence: A Retrospective Case Series.

The objective of the study is to retrospectively collect the data on patients who underwent pelvic organ prolapse treatment using a non-ablative Er:YAG laser with SMOOTH mode and to conduct an objective evaluation of safety and efficacy of Er:YAG laser treatment. In a group of patients that have concomitant stress urinary incontinence symptoms, the effectiveness of the treatments on these symptoms will be evaluated as well.

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) affect many women and can dramatically decrease their quality of life. Most of the patients diagnosed with stress urinary incontinence also have a degree of pelvic organ prolapse and vice-versa.

One of the more promising new approaches in treating disorders connected to pelvic floor dysfunction has been the introduction of vaginal erbium laser treatment for pelvic organ prolapse.

The primary aim of the present retrospective study was toassess the effectiveness of vaginal erbium laser with SMOOTH mode for the treatment of patients with pelvic organ prolapse and co-existing stress urinary incontinence, if present.

Eligibility Criteria:
Inclusion Criteria:

All patients that had pelvic organ prolapse with or without concomitant stress urinary incontinence and that were treated using non-ablative Fotona Er:YAG laser (ProlapLase treatment) in the time period from 2015 to 2016 will be included in this retrospective study.

Exclusion Criteria:

Patients who failed to attend a follow-up appointment will be excluded from this retrospective case series study.
Effect of iTBS on Children With ADHD

Attention Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder characterized by persistent symptoms of attention deficit and/or hyperactivity/impulsivity . Currently, the first line drugs for treating ADHD are central stimulants such as Tomoxetine and Guanfaxine. However, there is a risk of drug abuse and misuse, which often affects sleep and appetite, only 50% of patients can fully tolerate. This project uses the iTBS stimulation on weekends, children with ADHD finish scale evaluation, magnetic resonance imaging analysis, and cognitive function before and after stimulation, This study explores its therapeutic effect on attention deficit in children and adolescents with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ADHD in accordance with DSM-V;
* Age 6-12 years old, regardless of gender
* Right-handed
* Han nationality or born in the Han nationality Ghetto
* The course of the disease is greater than 6 months
* Webster children's intelligence ≥ 70
* The patient's guardian agrees and signs an informed consent form.

Exclusion Criteria:

* Concomitant mental disorders such as anxiety and depression;
* Widespread developmental disorders and other neurological developmental related disorders;
* Complication with other important organ diseases such as heart and lungs;
* Suffering from diseases such as epilepsy and tic disorder;
* Individuals who cannot tolerate rTMS treatment or cannot cooperate with treatment.
* Patients taking psychoactive drugs, antipsychotics, antidepressants, or mood stabilizers 3 months prior to enrollment or during rTMS treatment; In addition to the minimum effective therapeutic dose of Tomoxetine (1.2-1.4 mg • kg/day), there has been systematic use of first-line ADHD drugs in clinical practice Webster's intelligence\<70
* Implantation of metal and electronic components in the body (excluding the oral cavity), such as pacemakers;
Treatment for Post-Stroke Depression

The purpose of this study is to evaluate a program of education, medicine, and monitoring for the treatment of depression after a stroke.

This trial will compare outcomes in depressed patients receiving the Activate-Initiate-Monitor (AIM) intervention vs. those receiving usual care, and will also compare outcomes in depressed and non-depressed stroke survivors. Patients are screened for depression 1 to 2 months post-stroke. Patients with depression are then randomized to the AIM intervention or control group. Patients without depression are also enrolled at the same time and are matched by hospital site to the depressed patients.

The AIM intervention is a 3-part program consisting of activating or educating the patient and his/her family about post-stroke depression, instituting treatment for depression, and monitoring antidepressant treatments for side effects, efficacy, and compliance. Control patients are evaluated and treated with usual care by their physicians. Patients without depression do not receive the intervention but complete the same assessments on the same schedule as the patients with depression.

Eligibility Criteria:
* No severe language or cognitive deficits,
* life expectancy of at least 9 months, and
* willingness to participate.
Occurrence of Ventilator Associated Pneumonia in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage

Ventilator-associated pneumonia (VAP) is a serious complication and carries increased risks of morbidity and mortality for patients who require mechanical ventilation.

VAP is associated with the contamination and colonization of bacteria in the lower airway. These bacteria may be present in the lower airway by the aspiration of oropharyngeal secretions. Therefore limiting the amount of secretions that pass the glottis and enter the airway is paramount.

Patients who require prolonged mechanical ventilation may have a tracheostomy tube placed to manage breathing. These tubes may have a distal cuff which sits within the trachea. When the cuff is inflated, oropharyngeal secretions will pool above the cuff of the tracheostomy tube thereby limiting the amount of secretions entering the lower airway. These secretions may leak around the cuff and cause tracheobronchial colonization. It has been shown that removal of secretions that pool above the cuff via dorsal lumen suction leads to a decreased incidence of VAP.

The purpose of this study is to measure the effect of suction above the cuff tracheostomy tubes related to VAP incidence


Eligibility Criteria:
Inclusion Criteria:

* Patients on mechanical ventilation for respiratory failure for at least 72 hours.
* A score of 35 to 65 on the Simplified Acute Physiology Score II (SAPS II).
* Does not have a pulmonary infection estimated by a Clinical Pulmonary Infection Score (CPIS).
* Age \>= 18 years.
* have no exclusion criteria

Exclusion Criteria:

* A history of esophageal, tracheal or pulmonary cancer or an existing malignancy within the trachea at the tracheostomy site.
* Previous surgery at the tracheostomy site (e.g. thyroidectomy).
* Bleeding diathesis (e.g. due to anticoagulation therapy).
* Emergency surgical airway management.
* Morbid obesity and/or neck edema (skin to trachea distance may render tracheostomy tube too short).
* Pre-existing infection at the tracheostomy site.
* Uncertainty in identifying the anatomical landmarks.
* Patients with a do not resuscitate order.
* Immunosuppressed and/or immunodepressed patients (Immunodepression being defined by the following conditions: 1-Leukocytes \< 1000/µl, 2-Neutrophils \< 500/µl. 3-AIDS Long-term steroid treatment (daily dose \> 0.5 mg/kg) for more than 30 days)
* Patients already enrolled in other trials
Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival

An investigator-driven, retrospective study to compare long-term survival-data (10-year follow-up) of patients with coronary artery disease (CAD), previously enrolled in the SYNTAX trial, who were randomized to percutaneous coronary intervention (PCI) using a paclitaxel (TAXUS) drug-eluting-stent (DES) or coronary artery bypass grafting (CABG).


Eligibility Criteria:
Patients which have previously been enrolled in the SYNTAX trial (randomized and registry patients)
A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers

This randomized, double-blind, parallel-arm study will assess the safety and tolerability of RO4995819 in combination with citalopram in healthy volunteers. Subjects will receive citalopram orally on Days 1-9 and be randomized to receive either RO4995819 orally or placebo in combination with citalopram on Days 10-16. Safety follow-up will be up to Day 58.


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy male or female subjects, 18 to 65 years of age inclusive (healthy status defined as absence of evidence of any active or chronic disease)
* Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive
* Female subjects who are not either surgically sterile or post-menopausal must commit to using a barrier form of contraception in addition to either an intrauterine device or hormonal contraception until at least 5 months after the last dose of study drug
* Male subjects must use a barrier method of contraception throughout the study and for up to 5 months after the last dose of study drug (applies also to surgically sterilized males)
* Willing not to participate in any other clinical trial with an investigational drug for at least 5 months following the last dose of study drug

Exclusion Criteria:

* Pregnant or lactating females
* Suspicion of regular consumption of drug of abuse or positive test for alcohol on Day -2
* Hepatitis B, hepatitis C or HIV infection
* Smokers of \>5 cigarettes or equivalent tobacco intake per day
* Any confirmed allergic reaction against any drug, or multiple allergies (non-active hay fever is acceptable)
* Participation in an investigational drug or device study within 3 months prior to dosing
Study of Muscle Abnormalities in Patients With Specific Genetic Mutations

Hypertrophic cardiomyopathy (HCM) is a genetically inherited disease affecting the heart. It causes thickening of heart muscle, especially the chamber responsible for pumping blood out of the heart, the left ventricle. This condition can cause patients to experience symptoms of chest pain, shortness of breath, fatigue, and heart beat palpitations. Researchers believe the disease may be caused by abnormalities in the genes responsible for producing proteins of the heart muscle.

Oculopharyngeal muscular dystrophy (OPMD) is another genetically inherited disease. This condition affects the muscles of the eyes and throat causing symptoms of weak eye movements, difficulty swallowing and speaking, and weakness of the arms and legs.

In previous studies researchers have found that several patients with hypertrophic cardiomyopathy (HCM) also had oculopharyngeal muscular dystrophy (OPMD). Researchers are interested in learning more about how these two diseases are associated with each other.

In this study, researcher plan to collect samples of muscles (skeletal muscle biopsies) from patients belonging to families in which several members have inherited one or both of these diseases. The muscle samples will be used to link the muscle abnormalities with the specific genetic mutations.

Patients participating in this study may not be directly benefited by it. However, information gathered because of this study may be used to develop better techniques for diagnosing and treating these conditions.

Mutations of the fast alpha-tropomyosin gene cause hypertrophic cardiomyopathy (HCM), and are also expressed in skeletal muscle. However, the skeletal phenotype is undetermined. We have identified three families in which HCM is caused by an alpha-tropomyosin mutation. Several family members of one of these kindreds have also inherited a distinct skeletal myopathy called oculopharyngeal muscular dystrophy (OPMD) which is caused by mutations of the poly(A) binding protein-2 gene (PABP2). The pathologic hallmark of this disease is unique nuclear filament inclusions in skeletal muscle fibers. It is possible that the skeletal muscle phenotype is more severe when the two diseases occur in the same patient. We wish to perform skeletal muscle biopsies to determine the skeletal myopathy in patients with alpha-tropomyosin, in patients with PABP2 gene mutation, and in patients who have inherited both diseases.

Eligibility Criteria:
Patients will be of either gender, aged 10-80 years old, in whom alpha-tropomyosin and PABP2 genotypes have been determined under protocols 87-H-0057 and 98-H-0100.

No bleeding diathesis.

Negative urine test for pregnancy.

No skin infection at site of biopsy.
Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid Tumors

During this study, dose escalation will be conducted in subjects with advanced solid tumors who have experienced treatment failure after clinical standard of care treatments or who currently have no effective treatment available to evaluate the safety, tolerability, and PK of ICP-723


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histopathologically confirmed locally advanced malignant solid tumors that are unresectable or metastatic and that are unresponsive to standard treatments or have relapsed; patients who have progressed under standard treatment including prior treatment with TRK or ROS1 inhibitors.
2. Male or female patients with age ≥18 years old and ≤80 years old.
3. Measurable lesion according to RECIST 1.1.
4. Adequate organ functions that meet protocol requirement criteria.
5. Patients with asymptomatic, stable primary central nervous system (CNS) tumors or CNS metastases (treated or untreated)
6. Participates voluntarily, signs informed consent, and follows the study treatment plan and scheduled visits.

Exclusion Criteria:

1. Other than the advanced malignant solid tumor under study, patients with another one or more active malignancies within the previous 5 years except for locally curable cancers that have been apparently cured
2. Received systemic anti-cancer therapy including chemotherapy (except for oral fluorouracil chemotherapy), radiation therapy, hormones, targeted drugs, or biological immunotherapy within 4 weeks or 5 half-lives
3. Major surgery (thoracotomy, laparotomy, etc.) within 4 weeks or minor surgery (superficial skin surgery, lymphadenectomy, hernia repair, etc.) within 2 weeks before the first dose of the study drug
4. Clinically significant gastrointestinal/neurological dysfunction that may affect drug intake, transport, or absorption.
5. Has evidence of uncontrolled heart disease
6. At the investigator's discretion, evidence of severe or uncontrolled systemic disease.
7. Other conditions considered by the investigator to be inappropriate for participation in this study.
Enhancing Health Care Access With Cellular Technology

Despite the impressive economic progress in developing countries, significant proportion of young children and pregnant women living in low-resource settings remain inadequately immunized. Progressive decline in immunizations are in large part attributable to poor follow-up and compliance. National and international pediatric bodies, recommend a time sensitive schedule for childhood immunizations, boosting immunity with each subsequent cycle, leading to adequate levels of immune protection. Due to inadequate protective immunity, resulting from poor vaccination compliance, outbreaks of vaccine-preventable diseases are rampant, making childhood mortality in this group among the highest in the world. Major challenges of vaccination programs include maintaining / tracking records, linked to positive identification of individual children, and strategies to improve follow-up and compliance. Novel cellular technology based approaches targeting behavior modifications can therefore significantly impact health outcomes in these communities. In this proposal, the investigators will evaluate a novel software platform, utilizing biometric identification of subjects, paired with cell-phone reminders and compliance-linked incentives to improve uptake and coverage of primary vaccinations in young children and pregnant women.

A web-based, biometric-linked vaccination record, cell-phone reminder and compliance-linked incentive software platform to provide robust and universal access of vaccinations. The investigators will implement this platform in a low-resource settings with the following features: a) Web-based for robust and universal access. b) Biometric-linked for positive identification. c) Digital storage and reporting for transparent view of program operations. d) Global Positioning System (GPS)-linked, allowing rapid assessment of vaccination status of communities. e) Increasing vaccination uptake and coverage by automated text message reminders and compliance-linked incentives.

Eligibility Criteria:
Inclusion Criteria:

Mother-child (or caregiver-child) units with child \<2 years of age OR Pregnant women

Exclusion Criteria:

Family does not have cell-phone OR cannot provide informed consent