cyrilzakka/clinical-trials huggingface dataset:
Cultures in PICU Patients Compared to Healthy Children

This study is being done to determine if the bacteria found in your mouth (oral flora bacteria) in children admitted to the intensive care unit who need to be on a breathing machine is different from the oral flora in healthy children undergoing anesthesia for their dental caries. Children in the intensive care unit with a breathing tube are at a higher risk for getting a lung infection due to the bacteria in the mouth slipping into their lungs past the breathing tube over several days. This means that bacteria are found in the child's lung when this is normally not the case. If the bacteria in the mouth have changed from normal then they may get a pneumonia.

The oral cavity has natural flora of microbiology that may be associated with the development of dental decay. Another possible problem arising from this flora is the migration of the bacteria into the trachea causing pulmonary infections such as trachietis or pneumonia. The risk of developing a pulmonary infection appears to be increased in patients who have been intubated for a period of time (days) such as those patients ventilated in the intensive care unit (ICU). It has also been shown that in patients in the ICU the nature of the oral flora changes over time to include bacteria that are more commonly associated with the nosocomial pneumonia, ventilator associated pneumonia. We have previous demonstrated in a small pilot study (CYIRB2779) that the changes in the oral flora in children intubated in the ICU was similar to those bacteria grown from tracheal cultures ordered by the intensivist. Patients intubated in the ICU maybe at risk of decreased salivary flow, sedated and unable to clear secretions and are reliant on the bedside nurse to maintain adequate oral hygiene. Most ICU's have guidelines and policies to ensure that oral hygiene is appropriately cared for. They are also at risk for changes in the oral flora due to concomitant broad-spectrum antibiotic use that is common in the initial 48 hours after admission with respiratory failure.

The second are of interest is to determine whether children who are very sick and require intubation and ventilation support have different bugs growing in their mouth that may predispose them to future infection whilst in the ICU.

Eligibility Criteria:
Inclusion Criteria:

ICU Group:

* Intubated within 12 hours
* ASA 1 or 2 (ASA - AMERICAN SOCIETY ANESTEHESIOLOGY PREOPOERATIVE STATUS)
* Age 2 to 8

OR Group:

* ASA 1 or 2
* Elective dental surgery requiring intubation
* Age 2 to 8

Exclusion Criteria:

ICU Group:

* Trauma patients
* Postoperative patients
* Children under 2 or over 8

OR Group:

* Received antibiotics within the last week
* Received prednisone within the last 2 weeks
* Viral respiratory infective process within the last 2 weeks
Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy

Refeeding is an extracorporeal stool transport from the proximal stoma end to the distal end of stoma. Refeeding may be beneficial in preventing malabsorption, electrolyte imbalance, cholestasis and atrophy of the distal intestine. Investigators are focused on evaluating the efficacy and safety of the practice of refeeding in preterm infants with enterostomy. Clinical data including weight gain, total parenteral nutrition (TPN) usage, and other laboratory findings will be collected. Serial citrulline levels during refeeding procedure and pathologic specimens of bowel (at the time of stoma closure) will be collected for evaluating bowel adaptation.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants who are less than 35 weeks gestational age at birth and get stomas after laparotomy

Exclusion Criteria:

* Congenital gastrointestinal malformation
* Blind pouch (after laparotomy)
* Refeeding procedure related infection
* Hemodynamic instability requiring inotropic or vasopressor agents (if the condition improves, the refeeding procedure can be restarted again)
A P300 Brain Computer Interface Keyboard to Control Assistive Technology For Use by People With Amyotrophic Lateral Sclerosis

People with Amyotrophic Lateral Sclerosis (ALS) will use a P300 based brain computer interface (BCI) keyboard to type in assistive technology devices. The results of this study will be compared with a previous study of a P300 BCI keyboard used by healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Diagnosed with cerebral palsy, spinal cord injury, neuromuscular disease, or ALS that results in impaired hand and arm function making it difficult to manipulate objects (if at all) and requires help to prepare or modify activities
* Able to see the BCI display
* Able to give informed consent
* Able to understand and remember instructions concerning participation
* Able to communicate effectively at least with familiar conversation partners

Exclusion Criteria:

* Are unable to give informed consent.
* Are currently experiencing open head sores
* Have a history of photo-sensitive epilepsy
* Have a history of cognitive deficits requiring accommodation or special education services
* Are unable to sit without moving the head and neck for at least 15 minutes
AI-based Upper Limb Rehabilitation Therapy With MOTORE

Stroke is a common disease with a high disabling impact; it is the world's second leading cause of death and the third leading cause of disability. Robotic therapy has been proposed as a viable approach for the rehabilitation of the upper limb, as a way to increase the amount and the intensity of the therapy, and to standardize the treatment. However, robotic technologies have not yet been used to their full potential in terms of tailoring rehabilitation paths and monitoring the response to treatments. The main goal of the study is to use AI algorithms to (a) predict the recovery of the patients and (b) suggest exercises and parameters to improve the outcomes of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* first ischemic or hemorrhagic stroke (verified by MRI or CT);
* time since stroke onset between 1 and 6 months (subacute phase)
* cognitive abilities adequate to understand the experiments and the follow instructions
* upper limb impairment (Fugl-Meyer Assessment - Upper Extremity score ≤58);

Exclusion Criteria:

* fixed contractions in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);
* inability to understand the instructions required for the study;
* behavioral disorders that may influence therapeutic activity;
* other orthopedic or neurological diseases
* inability or unwillingness to provide informed consent.
Flecainide in Treating Patients With Chronic Neuropathic Pain

RATIONALE: Flecainide therapy may help patients with neuropathic pain live more comfortably.

PURPOSE: Phase II trial to study the effectiveness of flecainide in treating patients with chronic neuropathic pain from cancer or AIDS.

OBJECTIVES:

* Investigate the effectiveness of flecainide in the management of neuropathic pain.

OUTLINE: Patients are given a brief pain inventory (BPI) form to assess their pain upon enrollment in the study. Following a 7 day stabilization period, flecainide is administered. One capsule of flecainide is given twice a day on days 8-10, two capsules are given twice a day on days 11-14 and three capsules are given twice a day on days 15-21. BPI forms are completed on days 8, 15 and 22 to assess neuropathic pain.

PROJECTED ACCRUAL: A total of 7-20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Chronic neuropathic pain with diagnosis of cancer or AIDS

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* SGOT no greater than 2 times upper limit of normal (ULN)

Renal:

* Creatinine no greater than 2 times ULN

Cardiovascular:

* No clinical history of infarction or angina
* No advanced heart failure
* No sick sinus syndrome, intraventricular conduction disease, second or third degree AV block or arrhythmias requiring treatment (exception may be granted by cardiac consult)
* No focal wall motion abnormalities
* Ejection fraction at least 40%
* Systolic blood pressure at least 90 mm Hg

Other:

* Must be able to take oral medication
* No known allergy or adverse reaction to flecainide, mexilitene or any other type I antiarrhythmic drug
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 2 weeks since prior chemotherapy that may cause neuropathy

Endocrine therapy:

* At least 2 weeks since prior corticosteroids

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* No tricyclic antidepressant treatment within past 2 weeks
* No concurrent use of flecainide, mexiletene or any other type I antiarrhythmic drug
Role of Endoplasmic Reticulum Stress in the Pathophysiology of Type 2 Diabetes

The purpose of this study is to investigate whether Endoplasmic Reticulum (ER) stress pathway is activated in peripheral tissues (adipose tissue) in insulin resistant diabetic patients compared to healthy subjects normoglycemic matched for age and sex an to investigate whether ER stress pathway can be activated in response to insulin. Indeed, some preliminar on rates studies shows that ER stress pathway is activated by insulin in liver and adipose tissue showing that hyperinsulinemia might help trigger stress path ER.

For this, we propose a case control study of type 2 diabetic patients vs control subjects in which markers of ER stress will be evaluated from abdominal subcutaneous adipose tissue obtained before and after euglycemic hyperinsulinemic. We chose to consider adipose tissue subcutaneous rather than visceral adipose tissue for obvious reasons of lesser invasiveness.


Eligibility Criteria:
Inclusion Criteria:

* Specific criteria for diabetic patients:
* Having type 2 diabetes for at least 6 months
* HbA1c ≤ 8%
* Treated by lifestyle and dietary rules associated or not to a hypoglycemic therapy (metformin and / or sulfamid) and / or insulin secretors dependent glucose as inhibitors of DPP4 (dipeptidyl peptidase-4): Vildagliptin, Sitagliptin, Saxagliptin
* No modification of hypoglycemic therapy and / or insulin secretors for at least 3 months

Specific criteria for control subjects:

* Nondiabetic subjects (fasting blood glucose \<7.0 mmol / l without hypoglycemic treatment).
* The control subjects should be matched to patients for age (± 5 years), sex, and BMI (± 2 kg/m2).

Common criteria for patients and control subjects:

* Aged 18 to 60 years
* Body Mass Index between 25 and 35 kg/m2
* Accepting the constraints of the protocol and who signed the informed consent
* Systolic blood pressure \< 160 mmHg, diastolic blood pressure \< 90 mm Hg (with or without antihypertensive treatment)
* Resting heart rate between 55 and 100 beats/min.
* Normal laboratory tests or not clinically significant abnormality for NFS platelets, PT, aPTT, fibrinogen ALT, AST, GGT, Serum electrolytes, urea, creatinine, Uric acid Triglycerides, total cholesterol, HDL cholesterol
* HCG negative blood (for female subjects)
* Affiliated to the Social Security.

Exclusion Criteria:

* Current infections or recent infections (\<10 days)
* Neoplastic disorders (with the exception of carcinoma in situ of the cervix or cutaneous epithelioma), haematological, cardiovascular, psychiatric, neurological
* Poisoning smoking (\>10 cigarettes per day, what ever the duration of intoxication)
* Treatment with insulin or glitazones Pregnancy, Breastfeeding
* Body Mass Index \> 35 kg/m2
* Any drug taken for less than 8 days without the inclusion of minor analgesics (aspirin, paracetamol), anti-hypertensive medications, oral hypoglycemic (metformin and sulphonylureas) and insulin secretors dependent glucose as inhibitors of DPP4 (dipeptidyl peptidase-4) and oral contraceptives.
Hepatic Steatosis and Pituitary Gland Failure, Evaluation by Nuclear Magnetic Resonance (NMR) Imaging

The investigator put forward the hypothesis that liver fat mass in patients with pituitary gland failure is greater than that in a control population. Failure of the anterior pituitary and more particularly impaired production of growth hormone (GH) could be the principal mechanism responsible for increased liver fat mass in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided consent
* Patients over 18 years
* Patients with pituitary disease (Pituitary adenoma, anterior pituitary failure, craniopharyngioma, empty sella syndrome, hypophysitis, infiltration of the stalk) requiring Magnetic Resonance Imaging (MRI) of the pituitary.

Exclusion Criteria:

* Persons without national health insurance
* Pacemaker (Contra-Indication for MRI)
* Alcohol consumption greater than 4 glasses a day
* Any treatment able to increase liver fat content (glitazones, systemic corticoids, immunosuppressants) are forbidden
* Presence of metallic implants (Contra-Indication for MRI)
* Claustrophobia
* Adult under guardianship
* Pregnant or breast-feeding women
* Patients with a liver disease other than non-alcoholic steatosis
Self-hypnosis in Patients Awaiting Lung Transplantation

The proposed study is designed to utilize a self-hypnosis training program for patients awaiting lung transplantation. This technique can increase their well being, particularly by decreasing postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 15 years or more requiring lung transplantation

Exclusion Criteria:

* patients who cannot participate in learning sessions of self-hypnosis for cultural , cognitive or environmental reasons
* patients who have participated in only one learning self-hypnosis session before transplantation
A Cardiac Disease Quality of Life Study

A prospective, longitudinal, non-comparator, non-randomized observational cohort study to assess the quality of life in adult patients affected by hypertrophic cardiomyopathy and thoracic aortic dilatations who are not amenable to surgery, as well as those affected radiation-induced cardiac disease caused by radiation therapy.

While physicians and patients may be aware of the physical limitations that result from a diagnosis of hypertrophic cardiomyopathy (HCM), thoracic aortic dilatation (TAD) or radiation-induced heart disease (RIHD), there is little research on the impact on quality of life from the limitations imposed with these diagnosis. This study aims to address these unknowns in patients with HCM or TAD as well as radiation-induced heart disease in first-time patients at the Cleveland Clinic. Knowledge gained from this study will provide us the ability for better management of the chronic impacts of the disease by identifying potential risk factors of low quality of life or changes in quality of life over time.

This is a prospective, longitudinal, non-comparator, non-randomized survey study describing QOL outcomes for patients with HCM, TAD, or RIHD. Patients being seen for the first time at the Cleveland Clinic for cardiac disease with no previous or scheduled surgery for HCM or TAD will electronically complete a Cardiac Quality of Life Survey at 3 time points (baseline, 3 month \& 9 month). The Cardiac Quality of Life Survey measures the participant's health status in five domains - global, physical, emotional, social, and spiritual - as well as self-efficacy and resilience.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 at time of consent with a confirmed diagnosis of HCM, TAD, and/or RIHD being seen at CC Main Campus for a comprehensive clinical cardiac evaluation (i.e. physician, surgeon, nurse practitioner, geneticist, testing, imaging, etc) to define treatment plan for either diagnosis as per Cleveland Clinic provider.
* Patient or an individual in their social support network has the equipment (phone, computer, tablet) and internet connection to complete the emailed follow-up questionnaires.

Exclusion Criteria:

* Previously had surgery or plans to have surgery (full/mini sternotomy or endovascular) in the next nine months for HCM or TAD.
* Inability or unwillingness to comply with study requirements in the opinion of the investigator.
* Inability to provide informed consent.
Predictors of Malnutrition in Patients With Haematological Cancer

The primary purpose of this study is to conduct an exploratory study of which predictors are most significant for LBM loss in patients with lymphoma. Patients are measured by weight and bio impedance and furthermore, their physical activity, nutritional status, diet and quality of life during the course are estimated. This is done in order to determine any changes in the aforementioned factors during the course of the cancer treatment that may have a bearing on the loss of LBM.

It was assessed by the National Ethics Committee that the experiment was not subject to notification, cf. section 14 (1) of the Committee Act. 2. The project has been approved by the Ethical Research Committee for SUND and SCIENCE, University of Copenhagen.. The project was also approved by the Danish Data Protection Agency at Region Zealand with case no .: REG-166-2020. A data processor agreement was established between Region Zealand and thesis students.

Data is presented as mean +/- SD. Continuous data are analyzed using Pearson correlation analysis presented by correlation coefficient r and a p-value. Pearson correlation analysis is used to measure the strength of the linear relationship between normally distributed variables. A significance level of 5% is used.

Binary values are assigned for data assessing secondary endpoints. Subsequently, a multiple linear regression analysis is performed to examine the influence of discrete variables on the primary endpoint.

For statistical analysis and design of plots, the programs, R Studio (version 1.4.1106) and Excel (version 16.43) is used.

Eligibility Criteria:
Inclusion Criteria:

* Patients with haematological cancer
* Patients receiving myelosuppressive chemotherapy for haematological disease
* Adult patients

Exclusion Criteria:

* Patients who cannot understand and speak Danish or English
* Pregnant and breastfeeding
* Patients who suffer from dementia
Study to Investigate Adherence of Patients to Clodronate (Bonefos) Treatment

Adherence (or compliance with) a medication regimen is generally defined as the extent to which patients take medication as prescribed by their health care providers. The adherence to medications has close relation to effectiveness of the therapy. The primary objective of this study is to observe the adherence to treatment with oral clodronate (PDC, proportion of days covered, number of days in which clodronate is taken according to treating physician recommendation) in patients with malignancy. The secondary "hypothesis generating" objective is to describe the relation between adherence to treatment with oral clodronate and efficacy of the therapy (skeletal events, pain).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer, prostate cancer, multiple myeloma and other skeletal events causing tumors
* Bone metastases
* Therapy with clodronate (1600 mg per day, 800 mg tablets) according to SmPC (Summary of Product Characteristics) Bonefos.
* By agreeing to usage of patients diaries and goodwill with accounting of tablets

Exclusion Criteria:

* According to SmPC (Summary of Product Characteristics) Bonefos.
Femoroacetabular Impingement (FAI): The Effectiveness of Physical Therapy

The treatment of femoroacetabular impingement has evolved over the last several years. As the number of arthroscopic hip operations has risen over the last few years, so has the level controversy in regards to the appropriate initial management. There have been many recent advances in clinical diagnosis, advanced imaging techniques, improved indications for surgery and improved arthroscopic techniques which have led to improved clinical outcomes, but the effectiveness of physical therapy remains unknown.

The treatment of femoroacetabular impingement has evolved over the last several years. As the number of arthroscopic hip operations has risen over the last few years, so has the level controversy in regards to the appropriate initial management. There have been many recent advances in clinical diagnosis, advanced imaging techniques, improved indications for surgery and improved arthroscopic techniques which have led to improved clinical outcomes, but the effectiveness of physical therapy remains unknown.

A paucity of evidence exists in regards to the non-operative treatment of FAI.

Several insurance companies are now requiring three to six months of physical therapy prior to approval for surgery. There is not a single study that has objectively evaluated the effectiveness of physical therapy in the avoidance of surgical intervention. The investigators plan to evaluate this using an electronic outcomes data collection system. The hypothesis is that the majority of patients will not see a significant enough improvement with physical therapy to avoid surgery, especially in a subset of patients such as those with sub spine impingement. The investigators plan to prospectively collect data for three years and monitor the outcome of each hip patient, especially those treated with physical therapy as an initial treatment and there potential avoidance of surgery.

Eligibility Criteria:
Inclusion Criteria:

1. symptoms consistent with femoroacetabular impingement (FAI)
2. a physical exam consistent with FAI
3. radiographic measurements consistent with the diagnosis including an anterior pincer lesion and/or a alpha angle greater than 55 degrees

Exclusion Criteria:

1. subjects do not have FAI by physical exam and radiographic parameters
2. joint space \<2mm
3. have had prior physical therapy for FAI
4. have had prior hip surgery.
Fiberoptic Intubation and Transillumination-guided Fiberoptic Intubation：Success Rate and Time in Untrained Medical Personnel

Fiberoptic Intubation is the preferred technique to difficult airway. However, when performed by untrained anesthesiologists, bronchoscopic intubation has a high rate of failure. We want to know if the Transillumination-guided Fiberoptic Intubation technique can improves the success rate and time for tracheal intubation performed by inexperienced anesthesiologists; whether this technique improves the success rate and for normal intubations when performed by inexperienced anesthesiologists as well is unknown. Therefore, the authors compared the success rate and time of Fiberoptic Intubation versus the Transillumination-guided Fiberoptic Intubation performed by anesthesiologists inexperienced in Fiberoptic Intubation.


Eligibility Criteria:
Inclusion Criteria:

* general anesthesia
* ASA I\~II
* Mallampati Score grade I\~II
* thyromental distance ≥6cm
* mouth-open ≥3cm
* body mass index (BMI) ≤30kg/m2

Exclusion Criteria:

* neck and maxillofacial surgeries
* potential risks for regurgitation and pulmonary aspiration
* in pregnancy