cyrilzakka/clinical-trials huggingface dataset:
Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine

The investigators will implement a study to evaluate the hypothesis that applying General Movements Assessments (GMA) in a telemedicine setting with real-time scoring is feasible and comparable to scoring video recordings.

The investigators hypothesize that using telemedicine to conduct the GMA will improve early identification of risk for cerebral palsy and facilitate earlier referral and access to neurodevelopmental intervention. Preterm birth results from complex interactions of biological and socioeconomic risk factors, all of which continue to influence neurodevelopmental trajectories beyond the prenatal and neonatal period. Unfortunately many of the socioeconomic factors that contribute to increased risk of prematurity are also associated with decreased likelihood to attend appointments at high risk infant follow-up (HRIF) clinics. Early intervention has been shown to be most beneficial to infants with highest social risk. Additionally, mothers living in more rural communities tend to have higher social risk. They are often younger, more likely to be a single parent, and have lower income. Helping make follow-up more accessible and convenient for families through telemedicine and at an earlier age using the GMA has the potential to improve early identification, minimize loss to follow-up and ensure prompt referral to optimize outcomes for the most vulnerable babies in this already high-risk population.

Eligibility Criteria:
Inclusion Criteria:

* All preterm infants who meet the High-Risk Infant Follow Up (HRIF) Criteria (less than 32 weeks gestational age or birth weight less than 1500 grams) who are cared for at UC Davis Medical Center

Exclusion Criteria:

* Families who are non-English speakers requiring a translator
* Families who are unable to access data-capable wireless service to participate in telemedicine visits through Zoom.
Suggesting Score Scale for Risk of Bleeding in Bariatric Surgery

As bleeding is a major risk in bariatric surgeries, we aimed our study to find any predictors to such bleeding within the surgery or 30 days after surgery. The study is a retrospective study collecting patients data, surgeons data, and hospitals data in order to find if any of the factors influencing patients, surgeons or hospitals, has to do with bleeding in these surgeries and if it does impact bleeding in what way. The goal is finding a predictor that it's neutralizing may prevent bleeding in bariatric surgeries.

Were collected retrospectively the data of all patients (age 18 and older) that underwent bariatric surgery in Assuta Hospitals (Assuta is a nationwide privet hospitals network), during the years 2013-2016.

Patients underwent one of three procedures:

* laparoscopic sleeve gastrectomy (LSG),
* laparoscopic gastrectomy by-pass (LGBP)
* laparoscopic adjustable gastric band (LAGB) Demographic data of patients was collected (age, gender. BMI, habits, smoking, alcohol consumption etc.), as well as medical history, background diseases, family medical history, previous surgeries and procedures, chronic treatments, use of medications etc., We have also collected surgeons and hospital data - in which hospital was the surgery done? Surgery technique, surgeon's experience, capacity of surgeon - how many bariatric surgeries are done by the surgeon per months? Statistical analyses was done using chi square and Fisher's exact test for analyzing specific single variables. When analyzing the possible connection between BMI and bleeding, BMI values were split into three categories 30\<BMI\<35, 35\<BMI\<40 and BMI\>40. The use of single variable analyses enabled us to focus on a relatively small number of variables in the multivariable analyses. Variables that were statistically significant (p\<0.05) were used as independent variables in logistic regression tests.

Eligibility Criteria:
Inclusion Criteria:all patients that underwent bariatric surgery -

Exclusion Criteria: Under 18 years old

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Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis

This study aims to evaluate ocular changes in patients with carotid artery stenosis by optical coherence tomography angiography before and after carotid artery revascularization procedure.

A growing body of research indicates that abnormal ocular microvascular features may serve as a novel biomarker reflecting the severity of underlying cardiovascular, neurodegenerative, and microvascular disease. Since blood flow to the retina is predominantly supplied by the internal carotid artery (ICA), we hypothesized that ocular microvasculature and structure changes may reflect the disease status or therapeutic effects in patients with carotid artery stenosis.

Optical coherence tomography angiography (OCTA) is a novel, non-invasive imaging modality that can be a reliable tool for the qualitative and quantitative assessments of ocular vessels during various ocular pathological or physiological changes. Recent studies have also demonstrated the ability of OCTA to quantify retinal microvascular changes in monitoring cardiovascular risk.

This study aims to evaluate ocular changes in patients with carotid artery stenosis by optical coherence tomography angiography before and after carotid artery revascularization procedure.In this study, the patients with carotid artery stenosis and control group will receive a series of cerebral and ocular examinations including the most important cerebral CT perfusion (CTP) and OCTA. After that, the cerebral and ocular data between the two groups will be compared. Also, the preoperative and postoperative data acquired will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of carotid artery stenosis
* Age-gender-race-matched controls

Exclusion Criteria:

* age \<18 years
* intraocular pressure (IOP) \>21 mmHg
* VA \>logMAR 1.0
* spherical equivalent (SE) between \>1.00 or \< -6.00 D
* other serious eye diseases which may affect OCTA results including diabetic retinopathy, hypertensive retinopathy, retinal vascular occlusion, age-related macular degeneration, and uveitis
* major intraocular surgery performed in the past 6 months or a history of laser photocoagulation or intravitreal injection
* glaucoma or first-degree relatives with a history of glaucoma; and
* any disease that might cause poor scan quality (image quality \<6).
Comparable Investigation of One Fraction Radiotherapy and Multifraction Radiotherapy in Patients With Multiple Myeloma.

Radiotherapy is required to overcome pain and to evoke recalcification in multiple myeloma (MM) patients. Approximately 70% of all MM patients receive one or more radiotherapies in the course of their illness. The relief of pain is obtained in 75 - 100%. Recalcification is achieved in 40 - 50% of the irradiated bone destructions.There were a lot of randomized trials showed the same effect of single (SF) and multiple fractions (MF) in pain relief and recalcification for patients with painful bone metastases from solid tumors. The role of different palliative radiotherapeutic regimens for MM is not well established due to lack of clinical trials. Our prospective study analyzed the effect of two different radiotherapeutic regimens in the treatment of MM on pain relief, analgesics consumption and recalcification.

The primary aim of our prospective study is to analyzed the effect of two different radiotherapeutic regimens in the treatment of MM on pain relief, the secondary aim is to analyzed the effect of two different radiotherapeutic regimens in the analgesics consumption and recalcification.

Eligibility criteria are age more than 18 years, Karnofsky index more than 40%, patients with painful bone destructions, patients with impending fracture in the region of destructions.

Exclusion Criteria are: patients with bone metastases from solid tumors, patients with solitary plasmacytoma, patients who had received previous irradiation to the present painful destruction site, patients who were incapable to complete the quality of life questionnaires, patients with poor health status.

Eligibility Criteria:
Inclusion Criteria:

* Karnofsky index more than 40%
* Patients with painful bone destructions.
* Patients with impending fracture in the region of destructions

Exclusion Criteria:

* Patients with bone metastases from solid tumors
* Patients with solitary plasmacytoma
* Patients who had received previous irradiation to the present painful destruction site,
* Patients who were incapable to complete the quality of life questionnaires
* Patients with poor health status .
NOACs for Stroke Prevention in Patients With Atrial Fibrillation and Previous ICH

To determine the feasibility of a controlled trial examining the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) compared with ASA for stroke prevention in patients with a high-risk of atrial fibrillation and previous intracerebral hemorrhage.

The NASPAF-ICH study is an open-label, randomized, controlled, phase II study that will assess the feasibility of a controlled trial examining the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) compared with acetylsalicylic acid (ASA) for stroke prevention in patients with high-risk atrial fibrillation and previous intracerebral hemorrhage, as well as provide evidence of efficacy and safety for planning of a phase III trial. Recruitment will occur at 10 high-volume stroke research centres across Canada over 2 years, at which 100 adult patients with high-risk atrial fibrillation (CHADS2 ≥2) and previous spontaneous or traumatic ICH (intraparenchymal or intraventricular hemorrhage while on or off anticoagulation) will be randomly assigned to receive a NOAC (particular agent at the discretion of the local investigator) or ASA 81 mg per day. Patients will be followed for a mean of 1 year to a common end-study date. The feasibility of recruitment will also be tested. The investigators estimate that five patients per year per centre can be recruited.

Eligibility Criteria:
Inclusion Criteria:

* Previous primary intracerebral hemorrhage
* Atrial fibrillation (CHADS2 ≥ 2)

Exclusion Criteria:

* Non-stroke indication for antiplatelet or anticoagulant therapy
* Recent intracerebral hemorrhage within 14 days
* Platelet count less than 100,000/mm3 at enrollment or other bleeding diathesis
* Prior symptomatic lobar intracerebral hemorrhage other than the qualifying event
* Uncontrollable hypertension consistently above SBP/DBP of 160/100 mmHg
* Known hypersensitivity to either ASA or NOACs
* Inability to adhere to study procedures
Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

This trial is conducted in Asia, Europe and Oceania. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects)

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Treated with OAD(s) for more than or equal to 2 months
* Body mass index (BMI) less than or equal to 40.0 kg/m2
* HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy
* HbA1c greater than or equal to 7.5 % and less than or equal to 10.0 % for subjects on OAD combination therapy

Exclusion Criteria:

* Recurrent major hypoglycaemia
* Current smoking or smoking within the last 6 months
* Impaired hepatic or renal function
* Cardiac problems
* Uncontrolled hypertension
* Proliferative retinopathy or maculopathy
Is Fructose Linked to Adiposity in Babies?

The obesity epidemic has reached down into the infant and toddler age group. Dietary indiscretion during pregnancy, particularly in our current food environment, is a major risk factor for both gestational diabetes and neonatal macrosomia (\>4kg newborns), which is itself a risk factor for obesity and metabolic syndrome in the offspring, possibly even during childhood. Temporal increases in fructose consumption in the last two decades coincide with temporal increases weight gain during pregnancy and with increased birth weight, including a higher prevalence of macrosomic newborns. Our central hypothesis is that higher fructose consumption during pregnancy is a risk factor for infant obesity and metabolic syndrome.

The "fetal origins hypothesis" suggests that an individual's risk for obesity and metabolic disorders begins in utero; that fetal or early postnatal exposure to environmental factors, such as maternal nutrition or endocrine disrupting chemicals, adversely influences early development and results in permanent changes affecting energy storage and expenditure.

Most studies on "fetal origins" of obesity in the offspring have focused on maternal high-fat diets; yet dietary fat consumption has not changed appreciably in the last two decades. One chemical exposure in both pregnant mothers and newborns that has been steadily increasing worldwide is fructose. Although ostensibly a carbohydrate, fructose is a potent lipogenic substrate, and in the hypercaloric state, as much as 30% of an ingested fructose load undergoes de novo lipogenesis to form triglyceride thus the effects of high-fat and high-fructose diets in terms of physiology and outcome are comparable. Substituting sucrose (fructose + glucose) for glucose alone increases visceral adiposity, insulin resistance, and dyslipidemia in adult animals and humans. For humans, fructose is ubiquitous in the food environment, especially for pregnant mothers, who are often counseled to drink juice during pregnancy, as it is deemed to be healthier than soda. The effects of fructose consumption during pregnancy on infant birth weight and adiposity has not yet been studied.

Eligibility Criteria:
Inclusion Criteria:

* Agreement to participate in all measurements
* Plans to remain in the area through delivery
* Ability to understand and give informed consent in either English or Spanish.

Exclusion Criteria:

* Presence of diabetes prior to the index pregnancy
* Presence of gestational diabetes during a previous pregnancy
* Presence of diabetes or of other chronic metabolic disease such as cardiovascular disease, active thyroid disease, liver disease, pulmonary or psychiatric disorders, HIV
* Any disorder requiring diet therapy (i.e., renal insufficiency)
* Multiple gestation
* Prior history of intrauterine growth retardation
* Use of substances known to cause intrauterine growth retardation (e.g., smoking or drug use). -
* Once recruited, any ultrasonographic evidence of intrauterine growth retardation during the course of the pregnancy would also lead to exclusion.
Evaluation of Handheld Colonoscopy Force Monitor by Expert Endoscopists in the Performance of Colonoscopy

The purpose of this study is to evaluate a handheld Colonoscopy Force Monitor(CFM™), a push-pull force and torque measuring device, that grips the shaft of the colonoscope and wirelessly transmits and records all the forces applied by the endoscopist during colonoscopy.

Colonoscopy requires a skilled endoscopist to use visual and tactile information to advance and withdraw the instrument through a series of fixed and stationary loops. To develop and maintain the skills necessary to perform colonoscopy safely and effectively requires extensive training and ongoing education. Quantification of tactile information provides the opportunity to understand the "feel" used by the endoscopist to perform colonoscopy. The identification of force application patterns has the potential to enhance training and improve performance. CFM™ is a handheld device that uses load cells to transform applied force to electric signals and to transmit wirelessly the signal to a computer for storage and visual display. The device is designed so that the endoscopist maintains a conventional hand position and uses an electronically controlled grip and release mechanism to fix the position on the instrument. Several expert endoscopists from multiple institutions will use the CFM™ to perform colonoscopy. The data will be recorded and analyzed for differences by patient characteristics(e.g. gender, age, pain sensation, surgical history) and by endoscopist.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age: 30-75 years
* ASA Class I or II
* All ethnic and racial groups will be included

Exclusion Criteria:

* Colonic pathology that in the opinion of the endoscopist could interfere with the colonoscopy. Examples include: colonic stricture, poor preparation, obstructing tumor.
* Specific pathology that would limit the extent of examination
* ASA class 3 or greater
* Pregnancy
* Monitored anesthesia using propofol for sedation.
* Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity
MRI in Pre-operative Radiotherapy for Soft Tissue Sarcoma: MISTS Study

This study will use diffusion weighted MRI (DWI MRI) and dynamic-contrast enhanced MRI (DCE MRI) techniques to detect changes in sarcoma tumour vasculature. The main aims of this study are to correlate histological response of soft tissue sarcoma after pre-operative radiotherapy with several pre-treatment DCE and DWI MRI parameters and to assess the impact of these on early response prediction. Detected changes may reflect the sensitivity of the tumour to radiotherapy and may be associated with long term outcomes after treatment.

15 patients normally having pre-operative radiotherapy as part of their sarcoma treatment will be recruited to this study.

Patients will have an additional three specialised MRI scans: one prior to the start of radiotherapy, one during the second week of radiotherapy while on treatment and one scan a week before surgery but after the completion of radiotherapy.

Post-operatively, results of the histological examination of the sarcoma will be correlated to both the MRI scan data and outcomes after treatment


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed diagnosis of intermediate/high grade soft tissue sarcoma (STS)
* Patients must be suitable for treatment with preoperative radiotherapy and radical surgery
* Standard radiological assessments (CT or MRI) may have already been performed but must be done within 4 weeks of starting radiotherapy
* Patient must have measurable disease on CT/MRI imaging
* ECOG performance status 0-2
* Adequate pre-treatment haematological and biochemical parameters
* Age greater than or equal to 18 years
* No significant co-morbidity thereby excluding patient from having radical treatment.
* No previous treatment for diagnosis of STS including neo-adjuvant chemotherapy
* Women of child bearing age MUST have a negative pregnancy test prior to study entry and be using an adequate contraception method unless child bearing potential has been terminated by surgery/radical radiotherapy
* Patients must have given written informed consent

Exclusion Criteria:

* Patients with cardiac pacemakers, cochlear implants, intraocular foreign bodies or any other MRI incompatibility factors (e.g. recent surgery).
* Patients with a known history of anaphylactic reaction to contrast material for MRI
* Previous administration of gadoxetic acid or other contrast material 24hr prior to or after the MRI
* Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial
* Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial
* Any other serious uncontrolled medical conditions
* Clinical evidence of metastatic disease
* Any pregnant or lactating woman
* Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
* Evidence of impaired renal function, serum creatinine \>1.5x upper limit of normal
Synergistic Activity of Human Milk Nutrients and Infant Cognition

Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. There will be 84 breastfeeding dyads, 3 months postnatal.

Mothers will be randomized to a whole egg or egg white (due to lack of an appropriate control food). Initial diet intake will be screened using the NDSR. Participants will come to the lab 3 times across 3 months (age 3 months, 4.5 months, and 6 months). Milk, saliva, and plasma will be collected from the mother, while saliva and plasma (heel stick) are collected from the infant. Diet data will be collected at each visit. The infant will complete a recognition memory test using electrophysiology at 6 months as well as the Bayley Scales of Infant Development at 4.5 months. The mother will complete a temperament questionnaire at 3 months and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* infant is 12-15 weeks of age at enrollment
* healthy, lactating mother age 18-35
* gave birth at \>38 weeks gestation without remarkable incident
* consuming \<=50% of the recommended amounts of 2 of the 3, DHA, choline, and lutein

Exclusion Criteria:

* infant with diagnosis or documented suspicion of developmental delay
* egg allergy or family history of egg allergy
* gestational diabetes
* any documented seizure activity
Individual Patient Compassionate Use of GX-I7

Compassionate use of GX-I7 for patients with serious life-threatening illness that have exhausted all available therapies, with no other therapy options.

This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Coronary Vasomotor Response After Riociguat Exposure

The aim of the study is to assess the effects of intracoronary Riociguat on coronary blood flow in subjects with coronary artery disease and to compare this effect with the intracoronary nitroglycerin, a coronary vasodilator widly used to treat patients with coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with coronary artery disease

Exclusion Criteria:

* Patents with coronary artery disease with \>/= 70% luminal stenosis by coronary angiography in one of the 3 major epicardial coronary arteries (left anterior descending artery \[LAD\], left circumflex coronary artery \[LCX\] or right coronary artery \[RCA\]) undergoing cardiac catheterization