cyrilzakka/clinical-trials huggingface dataset:
Impact of Body Weight on the Immediate Health of the Pediatric Population

Objective: Obesity amongst children is a public health issue in the United States and is rising at an alarming rate. The purpose of this study is to determine if there is any correlation between At Risk body weight (overweight and obese) and immediate health of the pediatric population.

Methodology: As part of routine patient care, we measured length in addition to weight of patients 2 years to 18 years of age presenting to the pediatric emergency department. A report was run monthly to calculate the BMI of all patients for whom data is available. The data were plotted on the year 2000 gender based BMI for age percentile growth charts from CDC. A retrospective electronic chart review was conducted for patients At Risk body weight (BMI ≥ 85%), and were compared to "control" or healthy (BMI of 25 - 75 %) group for six groups of final ED diagnoses of infectious diseases.

A. Background and Significance:

Obesity is a public health issue in the United States. Obesity amongst children is rising at an alarming rate. Thirty percent of US children aged 6 to 19 are over weight and 15 % are obese1. It is estimated that over 18 million US children are over weight. The long-term impact of childhood obesity on such diseases as Diabetes, Asthmaand Hypertension, is well studied. The effects of childhood obesity on the current health status of the pediatric population have not been studied.

B. Methodology:

As part of routine patient care, we measured length in addition to weight of patients 2 years to 18 years of age presenting to the pediatric emergency department. A report was run monthly to calculate the BMI of all patients for whom data is available. The data were plotted on the year 2000 gender based BMI for age percentile growth charts from CDC. A retrospective electronic chart review was conducted for patients At Risk body weight (BMI ≥ 85%), and were compared to "control" or healthy (BMI of 25 - 75 %) group for six groups of final ED diagnoses of infectious disease (ID). Data were entered and analyzed via SPSS 14.0 for Windows 2000 software systems.

Eligibility Criteria:
Inclusion Criteria:Age 2-18 yrs for whom a length and weight is possible -

Exclusion Criteria:Under 2 yrs or over 18 yrs of age or inability to weigh and measure pt

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Prospective Clinicogenomic Program

The main purpose of this study is to evaluate the feasibility of a scalable, prospective research program for participants with metastatic non-small cell lung cancer (mNSCLC) or extensive-stage small-cell lung cancer (ES-SCLC) planning to start standard-of-care (SOC) systemic anti-cancer treatment. The study will also examine ctDNA status over the course of treatment as a predictor of response to therapy.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of mNSCLC or ES-SCLC
* Planned initiation of SOC systemic anti-cancer treatment
* Front-Line Immunotherapy Cohort: Received front-line treatment of an immune blockade therapy including anti-CTLA-4, anti-PD-1, or anti-PD-L1 therapeutic antibody on Protocol GX41563

Exclusion Criteria:

- Participant actively receiving investigational medicinal product(s) as part of an interventional trial at the time of signing informed consent
ProMRI 3T ENHANCED Master Study

The investigation is designed to provide supporting evidence for the clinical safety of the Biotronik's new Implantable Cardioverter Defibrillator systems when used under specific 3 Tesla MR conditions .


Eligibility Criteria:
Inclusion Criteria:

* Implanted with Implantable Cardioverter Defibrillator (ICD) system according to Clinical Investigational Plan (CIP)
* ICD system was implanted in the pectoral region
* Implantation at least 5 weeks prior to enrollment date
* Patient body height ≥ 140 cm
* Age ≥ 18 years
* Right Ventricular pacing threshold (at 0.4 ms) measurable and ≤ 2.0 V
* Written informed consent
* Able and willing to complete MRI testing
* Able and willing to complete all testing required by the clinical protocol
* Available for all follow-up visits at the investigational site

Exclusion Criteria:

* Standard contraindication for MRI scans
* Patient shows signs of a twiddler's syndrome, i.e. fiddles with implant
* Explantation, exchange or reposition of ICD or lead within 5 weeks prior to enrollment date
* Charging status of the battery is Elective Replacement Indicator (ERI) or End of Service (EOS)
* MRI scan within 5 weeks prior to enrollment date
* R-wave sensing amplitude \< 6.5 millivolt
* Lead impedance less than 200 or greater than 1500 Ohm
* Life expectancy of less than six months
* Cardiac surgery in the next six months
* Pregnant or breastfeeding
* Participation in another interventional clinical investigation
Global Registry for Endovascular Aortic Treatment (GREAT)

Prospective, observational Registry to obtain data on device performance and clinical outcomes.

This is a prospective observational cohort Registry designed to obtain data on device performance and clinical outcomes of patients treated with Gore Endovascular Aortic products.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age required by state regulations
* Indication for aortic endovascular stent graft repair
* Signed informed consent

Exclusion Criteria:

* N/A
Motor Imagery and Motor Execution Based BCI in Stroke

About 50% of stroke patients are unable to live independently because of residual disability. Brain-computer interface (BCI) is based on closed-loop theory, which facilitates neurological remodeling by establishing a bridge between central and peripheral connections. Studies have confirmed that BCI real-time neurofeedback training system based on motor imagery alone can effectively improve patients' motor function. So, is the benefit greater if motor imagery is combined with motor execution? Current conclusions are mixed. In addition, previous studies and our preliminary study found that prefrontal Fp1 and Fp2 areas play an important role in motor recovery after stroke, and they are involved in motor imagery, motor execution, attention and other behavioral processes. Therefore, we designed a BCI training system based on motor imagery and motor execution with prefrontal electroencephalogram (EEG) signals as the modulatory target. This was a randomized placebo-controlled double-blinded clinical trial. Patients in the test group performed BCI-controlled upper extremity motor imagery + upper extremity pedaling training. The control group had the same equipment and training scenario, and patients were also asked to imagine the upper extremity pedaling movement with effort, and patients also wore EEG caps, but the EEG signals were only recorded without controlling the pedaling equipment. After 3 weeks of treatment, we observed the changes of motor and cognitive functions as well as fNIRS-related brain network characteristics in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Aged 35-79 years old;
* Patients with first ischemic stroke onset from 2 week to 3 months;
* Hemiplegia with upper limb strength grades 1-3;
* Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment;
* The patient or its authorized agent signs the informed consent form.

Exclusion Criteria:

* Severely impaired cognition (MMSE\<20), unable to pay attention to and understand screen information;
* Severe pain, spasticity and limited mobility of upper extremity.
Improving Quality of Life in Men and Women With Overweight or Obesity

The purpose of this study is to evaluate the effect of the Noom Healthy Weight Program, a digital behavior change weight loss intervention, on quality of life as measured both by self-report and objective measures, compared to a waitlist control condition.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and provide informed consent
* 18-65 years old
* Self-report of good health (physical and mental)
* Not diagnosed with diabetes
* Overweight or obesity (BMI ≥ 25)
* Able to meet our criteria of adherence to the program (at least 1 engagement per week on one of the following: logged exercise, logged meals, steps, weigh-ins, coach messages, read articles, and days with at least one weigh-in.)
* For females
* Not within the 6 months postpartum time frame
* Not planning to become pregnant in the next 5 months.

Exclusion Criteria:

* Inability or unwillingness of a participant to give written informed consent
* Currently taking medication which affects sleep or heart rate (e.g., (i) central nervous system stimulants, (ii) respiratory medications, (iii) antihistamines, (iv) central acting hormones (e.g. corticosteroids, thyroid), (v) high-dose anticholinergics, (vi) and cannot be using the maximum recommended dose for antihypertensive medications or use of multiple antihypertensive medications)
* Current diagnosed mental health condition (except mild anxious or depressive symptoms)
* Current diagnosed sleep disorder or condition not related to obesity (e.g., narcolepsy)
* Currently pregnant or ≤ 6 months postpartum
* Currently participating in shift work and/or have travelled between time zones in the last month
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the quality of the data; E.g., evidence of an eating disorder, major chronic condition
Comparison of Human Insulin to Insulin Inhalation Solution in Children With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the pharmacokinetic profile of two different methods of insulin administration in children with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Treatment for at least 12 months
* HbA1c lesser or equal to 11.0%
* Body weight between 25 and 80 Kg
* Capable to use the device

Exclusion Criteria:

* Any diseases other than diabetes requiring prescriptive medication
* Known or suspected allergy to trial product or related products
* Active proliferative retinopathy as judged by the Investigator
* Recurrent severe hypoglycaemia as judged by the Investigator
* The receipt of any investigational drug within 4 weeks prior to this trial
Forearm Shaft Fractures: Plating of Radius and Ulna Versus Plating of Radius and Nailing of Ulna

The hypothesis is that intramedullary nailing of the ulna and plating of the radius will result in a superior outcome as evidenced by two primary end points:

1. a lower rate of implant pain
2. a lower re-operation rate to remove painful hardware.

This is a prospective, randomized study to determine if intramedullary nailing of the ulna and plating of the radius is equal to, or superior to plating of both the radius and ulna for the treatment of both bone forearm fractures.

Eligibility Criteria:
Inclusion Criteria:

* Diaphyseal fractures of both radius and ulna
* Ulna fractures that are oblique or transverse
* Fractures may be closed or Grade I-IIIA open
* Patients must be over 18 and skeletally mature

Exclusion Criteria:

* Children under the age of 18
* Pregnancy
* Comminuted ulna fractures
* Those with associated bony elbow or wrist trauma
* Elbow dislocation
* Subjects with bone pathology (osteoporosis, OI, Paget's disease, bone cancer)
Effect of Nephral 400 ST Dialysis Membrane on Coagulation in Hemodialysis

The purpose of this study is to investigate whether the dialysis filter AN69ST (Nephral 400 ST Dialysis Membrane) induces less clotting during hemodialysis than a conventional polysulphone filter. Our hypothesis is that the two filters induce the same degree of clotting.

Six consecutive hemodialysis (HD) sessions are evaluated per patient, altogether 10 - 12 stable HD patients (or at least 48 HD sessions altogether). During these six sessions, AN69ST and Fx8 are used on alternate days. Dalteparin is given intravenously as a single bolus dose at start of HD (50% of the conventional dose). Clinical clotting is evaluated visually each hour of HD after blood draining of the venous air trap: 1=no clot, 2=a fibrinous ring, 3=a clot \<1 cm, 4=a clot \>1 cm and 5=coagulated system (stop in HD).

Blood specimens are taken at start and after each hour of HD. Markers of coagulation (prothrombin 1+2) and of platelets (beta-thromboglobulin) are evaluated as well as anti FXa-activity.

The two filters are going to be compared statistically with respect to the degree of clinical clotting and of intravascular coagulation and platelets activation.

Eligibility Criteria:
Inclusion Criteria:

* patient aged 18 years or more having been in chronic HD for at least 1 month
* dialysis time at least 4 hours 3 times per week
* blood flow at least 200 ml/min
* Fragmin dose unchanged the last week before study start
* Fragmin given intravenously as one single dose at HD start
* Haemoglobin \>= 11.0 g/dL and stable +/- 20% the last week before study start
* erythropoietin and iron dose unchanged the last week before study start
* written and orally informed consent given by the patient

Exclusion Criteria:

* treatment with acetylsalicylic acid (ASA)
* use of Warfarin or another oral anticoagulant
* clinical signs of infection
* disseminated malignant disease
Application of Time Restriction Feeding in Patients With Type 2 Diabetes Mellitus

In this 3-week interventional study, the investigators hypothesize that therapeutic Time-Restricted Feeding in patients with poorly controlled Type 2 diabetes mellitus (T2DM) can improve their mean glucose or estimated glycated hemoglobin levels with the same dose, or even reduced dose, of antidiabetics.

Time-restricted feeding (TRF) has recently gained popularity as a means of reducing body weight and improving glycemia. A recent clinical trial in men who had prediabetes showed that TRF for five weeks significantly reduced fasting insulin concentration and improved the derived oral glucose tolerance test ( OGTT) indexes of beta-cell responsiveness and insulin resistance. However, the effects of TRF have not been studied in patients with poorly controlled Type 2 diabetes mellitus (T2DM). In this 3-week interventional self-controlled clinical trial, the investigators hypothesize that TRF in patients with poorly-controlled T2DM can improve their mean glucose with the same dose/reduced dose of antidiabetics. Potential study subjects will be identified from Endocrinology clinic patients with a diagnosis of poorly controlled type 2 DM (A1c \>= 8.0 in the 3 months before enrollment) based on inclusion and exclusion criteria. All study subjects will be in the ad libitum feeding phase for one week, and then will be placed on time-restricted fasting (feeding between 4 AM - 4 PM, fasting in the rest of the day) for the second week. For the third and final week, patients will be returned to the ad libitum feeding phase. The first and third weeks will serve as the control phases, and the second week will be the experimental phase. The mean glucose, serum triglyceride levels, insulin resistance, and body weights will be compared between the two phases. Results of this clinical study may demonstrate a low-cost and practical way of diabetic control.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and \< 65 years
* With the diagnosis of type 2 diabetes
* A1c \>= 8.0 on the most recent test in the 3 months before enrollment
* Have been on stable antidiabetics in the 3 months before enrollment
* OhioHealth Patient

Exclusion Criteria:

* Pregnant or breastfeeding patients
* Severe hypoglycemic episodes (defined as having low blood glucose levels that requires assistance from another person to treat) in the past 12 months
* Unable to give informed consent
* Currently enrolled in another therapeutic study
* Thyroid dysfunction, as defined by abnormal thyroid function test results within the past 6 months
* Advanced stage of renal (stage 4 or above) or hepatic (cirrhosis) or respiratory (needs oxygen) or heart failure (NYHA class 3 or above)
* Active infection or malignancy
* Dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
* Clinician-reported history of patient non-adherence
Cardiovascular Disease and the Effects of a Cross-curricular Physical Activity Intervention

The purpose of this study is to investigate the effects of a cross-curricular physical activity intervention on cardiovascular disease risk factors in 11-14 year olds. The null hypothesis states that the intervention will have no effect on cardiovascular disease risk factors.

Cardiovascular disease is the leading cause of mortality worldwide. Risk factors associated with cardiovascular disease including obesity, blood pressure and blood lipids have been shown to track from childhood through to adulthood. The prevalence of overweight and obesity for children (4-18 years) in the UK is reported to be 15 % and 4 % respectively. Furthermore, in comparison to England (2.9 %) obesity is more prevalent for those living in Scotland (7.6 %) and Wales (6.5 %). Previous research from two Welsh secondary schools indicate overweight and obesity rates for boys and girls aged 12-13 to be even greater at 26 % and 38 % respectively. Further to this, 19 % were identified as having elevated total cholesterol (≥5.2 mmol/L).

For many, overweight and obesity is the result of the combined effect of excess energy consumption and inadequate physical activity. Previous school-based physical activity interventions have demonstrated modest improvements to cardiovascular disease risk factors by implementing extra-curricular activities or improving current physical education curriculum. Few have attempted to increase physical activity using normally, class-room taught curriculum subjects. This study examines the impact of activity knowledge circuits to combat cardiovascular disease risk factors in 11-14 year old children.

Eligibility Criteria:
Inclusion Criteria:

* Any pupil attending years 7, 8, and 9 of a secondary comprehensive school in South Wales

Exclusion Criteria:

* Any pupil with an injury or illness that prevented them from taking part in any form of physical activity.
Perception of Stressful Social Stimuli After Trauma Exposure.

Post-traumatic stress disorder is associated with altered processing of sensory stimuli. The clinical phenotype PTSD has predominantly been described for the visual and auditory sensory modalities. However, PTSD symptoms such as intrusive memories are often evoked by olfactory and tactile cues in the environment. Moreover, little is known about whether aberrant responses to social olfactory and tactile stimuli are also present in a subclinical population.The purpose of this study is to compare trauma-exposed subjects (e.g. childhood maltreatment) with non-exposed controls in the processing of olfactory and tactile stimuli. This sensory characterizations hold potential to identify potential biomarkers for the course of trauma-related disorders and to inform trauma therapies focusing on sensory integration.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Subjects that have experienced a traumatic event that meets the DSM-5 criteria

Exclusion Criteria:

* Schizophrenia, schizoaffective or other psychotic disorder
* Neurological disorders
* Psychotropic medication
* Subjects suffering from a respiratory tract infection or other respiratory disorder known to affect olfactory functioning at investigator's discretion
* Subjects with anosmia or other previous primary olfactory dysfunction (olfactory threshold score using the "Sniffin' Sticks" ≤ 5)
* Dermatitis of the extremities or other skin disorders that affect the skin sensitivity of the extremities
Aviation Portable Oxygen Delivery System

This study aims to investigate dose based oxygen delivery vs. continuous flow of oxygen during simulated altitude conditions as would be experienced after a loss of pressure during commercial aircraft flight. Testing will be performed at rest and during light exercise at a simulated altitude of 15,000 feet in a hypobaric chamber. Performance of the two oxygen delivery systems will be compared using oxygen saturation determined by pulse oximetry.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* smoking
* pregnancy
* sickle cell trait
* cardiovascular or pulmonary disease
* significant ear or sinus problems that would prevent equalization during pressure change
* estimated VO2peak \<35 mL/kg per minute (males) or \<30 mL/kg per minute (females)
Single-dose Study of ANX007 in Participants With Primary Open-angle Glaucoma

This is a multi center, open-label, single dose, safety study. Approximately 9 to 15 participants with open-angle glaucoma are assigned into 3 sequential dose-levels and will receive ANX007 administered as single, IVT injections.

This is a phase 1, open-label, dose-escalation, safety study evaluating up to 3 dose levels of ANX007 administered as single IVT injections. Approximately 9 to 15 eligible participants are enrolled into one cohort each. All participants receive ANX007 in an open-label manner. The primary objective is to evaluate the safety and tolerability of a single intravitreal (IVT) injection of ANX007 in participants with primary open-angle glaucoma. Secondary objectives are to evaluate the serum pharmacokinetics (PK) and immunogenicity. An exploratory objective will evaluate the pharmacodynamic (PD) effect of ANX007 on serum C1q activity.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 years and older
* Diagnosis of primary open-angle glaucoma
* Intraocular pressure \<21 mm Hg on a stable IOP treatment regimen
* Reliable visual field testing

Exclusion Criteria:

* BCVA worse than 20/80 in either eye
* Extensive glaucomatous visual-field damage
* History of intraocular inflammatory or infectious eye disease in study eye
* Ocular trauma in study eye within the preceding 6 months
* History of uncomplicated cataract surgery less than 6 mos prior
* Any abnormality preventing reliable Tonopen tonometry in study eye
* Active malignancy within past 5 yrs
* Previous tx with another humanized monoclonal antibody
* History of any autoimmune or neurologic disease
* Concurrent use of glucocorticoid medications
* Receiving monoamine oxidase inhibitor therapy