cyrilzakka/clinical-trials huggingface dataset:
Prompting And encouRaging Community Hydration Through EDucation

PARCHED (Prompting And encouRaging Community Hydration through EDucation) is studying how to improve the hydration (fluid intake) of people living at home who use catheters. The investigator would like to see if improved hydration (fluid intake) reduces the risk of frailty.

PARCHED will randomise four areas in Cwm Taf University Health Board to receive one of four different interventions. Individuals will receive an intervention based on which area they live in, each participant will take part in the study for 12 weeks.

PARCHED is a cluster feasibility randomized control trial (RCT) exploring the potential of an innovative prompting cup and education as person-centred and holistic tools to empower nursing leadership to reduce frailty in a catheterised community-dwelling population. This project will investigate interventions to improve hydration as potentially economically viable solutions to reducing frailty in a vulnerable population. Interventions have been developed using behaviour change theory and techniques. 80 participants will be recruited and will receive one of three interventions or usual care for a period of 12 weeks, data will be collected at baseline, 4 weeks and 12 weeks. Questionnaires, semi-structured interviews, and routine hospital records will be collected or accessed as part of the study.

Eligibility Criteria:
Inclusion Criteria:

* PARCHED will recruit district nurse patients at medium or high risk of dehydration (using the G, U and L of the GULP tool1),
* with a urinary catheter,
* living at home in community or residential care,
* aged 18 years or above

Exclusion Criteria:

* Inability to provide informed consent,
* medical conditions or dietary restrictions that would substantially limit ability to complete study requirements (i.e. intravenous fluid intake, inability to lift cup),
* living in nursing care setting,
* end of life pathway,
* diagnosed swallowing difficulty,
* inability to communicate in English or Welsh.
Evaluation of Gastrointestinal Motility With SmartPill

The purpose of this study is to evaluate the clinical usefulness of a capsule (SmartPill\~) measuring pH, pressure and temperature from within the entire GI tract to determine gastric emptying time, combined small and large bowel transit time and total transit time. In addition, the Capsule will characterize pressure patterns and provide motility indices for the antrum and duodenum. It is believed that the condition of your digestive system can have a large impact on your overall physical health. Therefore,the investigators would like to assess whether using the pill device helps to determine any functional problems in patients in the ICU. The investigators are studying ICU patients because any change in their condition can have a large impact on their recovery.


Eligibility Criteria:
Inclusion Criteria:

* suffered from traumatic or non-traumatic intracranial hemorrhage and were admitted to an intensive care unit (ICU) at University of Louisville Hospital
* sedated and had tracheal intubation and mechanical ventilation
* older than 18 years

Exclusion Criteria:

* younger than 18 years
* multiple injuries, especially abdominal trauma or inflammatory bowel disease
* history of complicated abdominal surgery or unknown type of abdominal surgery
* clinical evidence of ileus or suspected bowel obstruction
* a pacemaker
A Study to Determine the Safety and Efficacy of Atralin (Tretinoin 0.05%) Gel for the Treatment of Rosacea

To compare the efficacy and safety of tretinoin gel 0.05% to its vehicle when dosed once or twice daily in female subjects with rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18-65
* Diagnosed with classical, centrofacial, erythemato-telangiectatic rosacea

Exclusion Criteria:

* Male, females less than 18 years
* Females over 65 years
* No diagnosed rosacea
Fighting Climate Change: Urban Greennes, Active Mobility and Health Co-benefits.

This is a prospective, non-randomized, controlled, interventional study aiming to assess, in a primary school in the city of Palermo, the health effects of a maintenance and care intervention of the school's green areas.

All children of the third, fourth and fifth classes of two school complexes of the same primary school will be selected. One complex will undergo maintenance and care of the green areas and gardens inside the school. The other complex will serve as a control group and will not undergo any intervention.

The study will involve three phases.

1. During the first phase (prior to the intervention) respiratory and allergic symptoms will be assessed through a standardized questionnaire to be administered to students, parents and teachers in both the school complexes.
2. During the second phase, the maintenance and care intervention plan will be implemented in the experimental complex.
3. During the third phase, 1 week after the maintenance intervention, respiratory and allergic symptoms will be re-assessed through a standardized questionnaire to be administered to the same students, parents and teachers in both the school complexes.


Eligibility Criteria:
Inclusion Criteria:

* male or female gender
* age between 7 and 11 years

Exclusion Criteria:

* no exclusion criteria
Reliability of a New Balance Assessment System in Patients With Adolescent Idiopathic Scoliosis

Postural stability is one of the most important factors that determine a person's ability to make and maintain movements. It has been reported that in the presence of scoliosis, the postural stability of people is negatively affected due to somatosensory disorders. There are many studies in the literature that evaluate the postural stability of cases diagnosed with scoliosis with objective methods. Evaluation of postural oscillations with objective devices is used to determine whether postural stability changes in AIS and whether the type and location of scoliosis affect the progression. The most commonly used objective devices for this purpose are balanced assessment systems in which changes in postural sway are recorded on the force platform. Our study aims to investigate the reliability of the "Postural Stability", "Limits of Stability", "Sensory Integration" and "Bilateral Comparison" tests of the Al Balance Balance Exercise and Analysis System in cases with Adolescent Idiopathic Scoliosis. After the demographic information of the cases that meet the inclusion criteria within the scope of the study is recorded, postural stability and balance evaluations within the Al Balance System will be performed on the cases. Evaluations will be carried out with bare feet and feet positioned at the same coordinates.

The tests will last 30 seconds and the test will be repeated a total of 3 times with a 1-minute rest between tests. These measurements will be repeated after 7 days to evaluate reliability.

With this study, the reliability of a new and local balance assessment system will be tested in cases with AIS.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 12 and 18
* Having been diagnosed with Adolescent Idiopathic Scoliosis by an orthopedic specialist
* Cobb angle measured on anteroposterior radiograph is below 40 degrees
* Ability to understand and follow instructions
* Volunteering to participate in the study

Exclusion Criteria:

* Presence of neuromuscular, rheumatic disease, or vestibular problems that may affect balance, vision-related diseases
* Having a recent history of orthopedic injury or surgery in the lower extremity
* Having had spine surgery
* Not having experienced any acute situation that could affect postural stability and balance between the two tests (within 7 days)
* Corset use has not changed between two tests (within 7 days)
OFA - Opioid Free Anesthesia

Opioids have been used for analgesia since many years, but despite potent analgesia they are also associated to side effects, including opioid induced Hyperalgesia (OIH).

OIH in the surgical setting is debated, and may predispose patients to higher analgesic consumption in the preoperative period, and peripheral and central sensitization. The aim of the study is to compare remifentanil-based vs non opioid analgesia (clonidine, lidocaine, ketamine) for intraoperative management of patients undergoing laparoscopic left hemicolectomy, with the hypothesis that non- opiod treated patients will have lower morphine consumption in the first 24 hours after surgery. Peripheral and central hyperalgesia will be tested with Von Frey hairs and pin-prick to evaluate acute CNS (Central Nervous System) sensitization after surgery. Acute and persistent (1 and 3 months) pain will be registered, together with any side effect and parameters of surgical rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* left hemicolectomy
* signed informed consent
* \>18 ys

Exclusion Criteria:

* \>90 ys \<18 ys
* no consent
* pregnancy
* psychiatric disease
* cardiac failure, aortic or mitral valve severe stenosis
* kidney or hepatic failure
* atrio-ventricular type II block
* immunodepression
* emergency surgery
* ICU admittance
* drug or alcohol abuse
* chronic pain
Eatable Alphabet as a Nutrition Education Tool

This pilot randomized controlled trial will test the effectiveness of Eatable Alphabet cards, a child friendly nutrition education tool, on child weight and related behaviors in a clinical sample of 2 to 10-year-old children with overweight/obesity, referred to a pediatric weight management program.

The goal of this research study is to determine whether the use of Eatable Alphabet cards in addition to standard weight management in a primary care setting will increase vegetable consumption. Additional outcomes that will be examined include fruit consumption, child engagement in meal selection and preparation, and clinic follow-up. If the intervention shows a significant effect in the above outcome measures, Eatable Alphabet cards can be implemented as a standard component of obesity management in primary care settings. It is hypothesized that the intervention will increase vegetable consumption, increase child engagement in meal selection and preparation, and increase clinic follow-up.

The study design is randomized control trial, in which the control group includes parent-child dyads receiving care as usual in the weight management program, including nutrition education, and the intervention group includes parent-child dyads receiving care as usual in the weight management program plus Eatable Alphabet cards in addition to typical nutrition education. All study participants will be families receiving care at the POWER Kids Weight Management Program at 410 Lakeville Road, with the child between the ages of 2 and 10 who have overweight or obesity. The primary outcome is parent reported frequency of child vegetable consumption. Secondary outcomes include: parent reported frequency of child fruit consumption, parent reported child engagement in meal selection/preparation, follow-up weight management visit attendance, and child anthropometric outcomes.

Eligibility Criteria:
Inclusion Criteria:

* New patient at Cohen Children's Medical Center POWER Kids weight management program (defined as not having been seen by the program within the past 2 years)
* Child between the ages of 2-10
* English-speaking

Exclusion Criteria:

- No appropriate caregiver available for consent.
Medtronic Enterra II Neurostimulator

Humanitarian Device: Authorized by Federal (U.S.A.) Law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

Description The Medtronic Enterra II Model 37800 Neurostimulator is a programmable device designed to deliver therapy through gastric electrical stimulation when connected to a lead system.

These components comprise the implantable portion of the Medtronic Enterra II system.

The operation of the neurostimulator is supported by a clinician programmer. The neurostimulator (Figure 1) operates on a sealed battery and electronic circuitry to provide controlled electrical pulse stimulation, through the implanted lead system.

A wide range of noninvasively programmable parameters and stimulation modes are available. The neurostimulator provides current parameter information, via telemetry, when used with the clinician programmer.

System Components

* Neurostimulator: Medtronic Enterra II Model 37800
* Controlling Devices: Medtronic Model 8840 Clinician Programmer with Model 8870 Application Card. Model 8527 Printer optional.
* Lead: Medtronic Enterra Model 4351 Unipolar Lead

Eligibility Criteria:
Inclusion Criteria:

* chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.

Exclusion Criteria:

* Organ transplant
* Organic obstruction
* Pseudo-obstruction
* Prior gastric surgery
* Scleroderma
* Amyloidosis
* History of seizures
* Peritoneal or unstable dialysis
* Chemical dependency
* Pregnancy
* Primary eating or swallowing disorders
* Psychogenic vomiting
* Implanted electronic medical devices
* Age \< 18 or \> 70 years
Comparison of Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the single dose and steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Currently on basal bolus treatment with soluble human insulin, Lispro and NPH insulin or Lantus. NPH insulin may be administered once or twice daily
* BMI (Body Mass Index) maximum 35 kg/m\^2
* Able and willing to perform self-blood glucose monitoring

Exclusion Criteria:

* The receipt of any investigational drug within the last 30 days prior to this trial
* Total daily insulin dose at least 1.8 U/kg/day
* Currently being treated with insulin aspart products
* A history of drug abuse or alcohol dependence within the last 5 years
* Impaired hepatic function
* Impaired renal function
* Blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
* Cardiac problems
* Severe, uncontrolled hypertension
Muscle Training of Patients With Amyotrophic Lateral Sclerosis (ALS)

Patients with neuropathic diseases are experiencing increasing muscle weakness, loss of muscle strength and functional abilities during their illness. In healthy people, regular exercise is the best way to maintain or improve muscle strength, endurance and general health status and thereby maintain functioning abilities. Previously, patients with neuromuscular diseases were advised to avoid any kind of physical exercise. However, lately a number of studies have evaluated the effect of training in patients with neuromuscular diseases, and positive effects on the functional abilities have been found. Based on these findings we want to investigate the mechanisms leading to development of muscle atrophy and loss of functional abilities, and to explore the opportunities of reducing muscle wasting and thereby improve the course of the disease development through strength training.

The main objective is to investigate the effects of strength training on slowing disease progression and reduce the decline in muscle strength and function in patients with amyotrophic lateral sclerosis (ALS). In addition, the aim is to carry out detailed studies of biological processes in muscle tissue in order to unveil mechanisms leading to muscle atrophy, and to examine effects of a strength training program. The goal is to be able to incorporate strength training in the treatment program of these patients in order to maintain muscle strength and function in the individual for as long as possible.

Minimum 10 patients with the disease are included in the study. Through a 12 week period the patients will participate in strength training 2-3 times per week. Muscles biopsies will be taken (i) 12 weeks before commencement of strength training program, (ii) at the beginning of training and (iii) after 12 weeks of strength training. Patients will function as their own controls. Blood samples will be collected simultaneously in order to follow the development of the strength training. Furthermore, participants will be assessed through at number of functional tests and questionnaires evaluating their strength, balance and social/ psychological status.

Subjects are recruited through their association with Odense University Hospital. In the present study, the participants become part of a social network, while participating in organized training sessions, and thus have a possibility to make contact with other ALS patients in the same situation as themselves.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Amyotrophic lateral sclerosis (ALS)

Exclusion Criteria:

* Late stage ALS
Evaluation of Gastric Insufflation Measured by Ultrasound of the Antral Surface During Optiflow Preoxygenation

Check in gastric ultrasound for lack of stomach insufflation during preoxygenation with high-flow nasal cannulas


Eligibility Criteria:
Inclusion Criteria:

* Adults Volunteers

Exclusion Criteria:

* History of gastric surgery
* Facial or oropharyngeal abnormality
Effect of an Aquatic Exercise Program in Patients With Chronic Low Back Pain

The goal of this pilot randomized controlled trial is to compare the effects of aquatic therapy versus standard care on paraspinal and gluteal morphology and function in individuals with chronic low back pain.The main questions it aims to answer are:

1. What are the effects of aquatic therapy versus standard care on a) paraspinal and gluteal muscle size, composition (e.g., fatty infiltration) and b) lumbar and gluteal muscle strength in individuals with chronic LBP?
2. Is aquatic therapy more effective than standard care to improve pain, function and psychological factors (e.g., kinesiophobia, catastrophizing, anxiety, and depression)?
3. Is using a digital application "play the pain" feasible to monitor pain levels and the activities that participants used to cope with pain?

Participants will be assigned to either the aquatic therapy group or standard care group where they will undergo a 10-week intervention including two 60-minute session per week.


Eligibility Criteria:
Inclusion Criteria:

1. chronic nonspecific LBP (\>3 months), defined as pain in the region between the lower ribs and gluteal folds, with or without leg pain
2. currently seeking care for LBP
3. aged between 18 and 65 years old
4. English or French speakers
5. have a score of "moderate" or "severe" disability on the modified Oswestry Low Back Questionnaire
6. do not currently engaged in sports or fitness training specifically for the lower back muscles (3 months prior the beginning of the trial).

Exclusion Criteria:

1. evidence of nerve root compression or reflex motor signs deficits
2. previous spinal surgery or vertebral fractures
3. other major lumbar spine structural abnormalities
4. comorbid health conditions that would prevent active participation in exercise programs
Diabetes Group Visits

This pilot study aims to increase access to diabetes education by delivering it in a culturally-appropriate community setting and by involving different members of the diabetes care team including physicians, diabetes educators, and health promoters/community health workers.

Diabetes medical group visits will be held at the Grady North DeKalb satellite clinic the third Thursday of the month starting in October 2009. There will be two cohorts of patients- English speaking patients and Spanish speaking patients. Each group will be scheduled for 4 2-hour group visits throughout a period of 9 months. These visits will be every 8 weeks for each group. During the visit, the patient will be seen by a physician, attend a diabetes education session, re-fill their diabetes medications and receive lab orders.

Patients who participate in the diabetes group visits should achieve improvement in Clinical outcomes - better A1C levels, reduced blood pressure, reduced cholesterol levels ; adherence to evidence-based medicine - keeping appointments and scheduling eye exams, foot-checks, and/or taking medication as prescribed; behavioral outcomes- goal setting, achievement of goals, problem solving; access - attendance at educational sessions; ability to obtain affordable medications and devices; and satisfaction among patients and health professionals.

Eligibility Criteria:
Inclusion Criteria:

* Primary care at the Grady North DeKalb Health center
* Valid Grady card
* Age 18-80
* HbA1c\>=8.0% - 11.0%
* Must speak English or Spanish

Exclusion Criteria:

* -Primary care provider excludes patient from study
* Patient is reluctant to participate in a group visit
* Reduced life expectancy as determined by any of the following:
* End-stage renal disease on dialysis
* Active congestive heart failure II and IV
* Lung disease requiring supplemental oxygen
* Current malignancy with any evidence of disease or currently undergoing chemotherapy or radiation therapy
* Cirrhosis of the liver
* AIDS
* Mayor mental health disorders
Use of Ranibizumab to Treat Rubeosis in Diabetics Prior to Cataract Surgery

The purpose of this study was to determine the safety of ranibizumab: a) as a surgical adjunct during cataract surgery in subjects with proliferative diabetic retinopathy (PDR) induced rubeosis and, b) in treatment of proliferative diabetic retinopathy (PDR).

This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in diabetic subjects presenting initially with dense cataract and proliferative diabetic retinopathy induced rubeosis. Ten subjects will be enrolled at a single center over a 10 month period. Patients will be followed for a total of 12 months in the treatment phase and will have safety follow-ups at Months 18 and 24. Eligibility for study entry will be determined by the principal investigator.

Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every month for 3 doses (loading dose on Day 0 and at Months 1 and 2) followed by as needed re-treatment based on specified criteria for the remainder of the study period. Subjects can receive a maximum of eight injections of ranibizumab during the study. All subjects will undergo cataract surgery after the first ranibizumab injection. Only one eye will be designated as the study eye for the duration of the study to receive the ranibizumab injections.

All subjects will be evaluated with best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, intraocular pressure measurement, ophthalmological examination, slit lamp photography, gonioscopy, fundus photography, fundus fluorescein angiography and Optical Coherence Tomography (OCT). An ultrasound will be done as needed. Best corrected ETDRS visual acuity and intraocular pressure measurements will be performed on both eyes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or over
* Subjects with diabetes mellitus
* Subjects with proliferative diabetic retinopathy induced rubeosis
* Be willing to undergo cataract surgery
* HgbA1c level \< 12%

Exclusion Criteria:

* History of glaucoma surgery
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
* Intraocular surgery in the study eye within 60 days preceding Day 0
* History of prior pars plana vitrectomy in the study eye
* Positive pregnancy test
* HbA1c \>12