cyrilzakka/clinical-trials huggingface dataset:
"Stepping On" to Pisando Fuerte: Adapting an Evidence-Based Falls Prevention Program for Latino Seniors

There are no evidence-based fall prevention programs for Hispanic/Latinos even though their age-adjusted death rate from unintentional falls is climbing in the US. "Pisando Fuerte", a linguistically and culturally appropriate version of an evidence-based fall prevention program for Spanish speakers ("Stepping On" \[SO\]) is evaluated. "Pisando Fuerte" consists of 2-hour group sessions over the course of 8 weeks delivered in Spanish by trained Hispanic/Latino personnel in two communities in Wisconsin. Implementation and intervention fidelity were evaluated by an independent assessor on three sessions using a-priori criteria based on key elements of SO. Uptake, proximal and distal outcomes were assessed through interviews 6 months after the program.

Stepping On is an evidence-based falls prevention program for community-dwelling persons 65+. It uses principles of self-efficacy in 2-hour sessions held once a week for 7 weeks + one home visit to review principles learned in class and one booster class after 3 months.

The program, developed and researched in Australia, was found to reduce falls by 30%. It was brought to the U.S. in 2006 by the Kenosha County Aging Division in collaboration with Dr. Jane Mahoney, U.W. Madison and other Wisconsin partners using foundation and state funding. Funding from the CDC provided the opportunity to adapt the program for widespread dissemination in the United States. In addition preliminary work was done on translating and culturally adapting Stepping On for the Latino community. The adapted program, known as Pisando, was offered as a pilot class at the United Community Center in Milwaukee in 2012. Further revisions were made to the program based on the experience at the pilot classes and advice from the advisory board, but questions remained about some key areas of workshop format.

Eligibility Criteria:
Inclusion Criteria:

- Have fallen in the past year

Exclusion Criteria:

* Living arrangement does not include a kitchen of their own (i.e., independent living)
* Unable to walk without help from another person, ambulate independently
* Reliant on a walker to get around inside of home
Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke

The thermal stimulation have been proven effective in upper extremity of stroke patients. Therefore, this study explored the efficacy of thermal stimulation in lower extremity of stroke patients.

There are two groups of stroke patients (onset \> 3 months) in this study. The independent factor is temperature of the alternated heat and cold applying.

Eligibility Criteria:
The inclusive criteria:

* first-ever stroke
* stroke onset \> 3 months and \< 3 years before the study enrollment
* unilateral hemiplegia
* ability to sit on a chair \> 30 minutes independently
* able to follow verbal instructions
* age between 18 y/o and 80 y/o
* be willing to participate in this study and gave their informed consent

The exclusive criteria:

* skin disease, skin injuries, burns, or fresh scars over the TS application area
* contraindication of ice or heat application
* speech disorder or global aphasia
* musculoskeletal or cardiac disorders that could potentially interfere
* diabetic history or sensory impairment attributable to neuropathy.
Investigating the Effects of Neuromobilization in Lateral Epicondylitis

This study aimed to determine the effects of neuromobilization techniques and conservative rehabilitation therapy on pain, grip strength, and functional status in patients with lateral epicondylitis (LE). A total of 40 patients (26 females and 14 males; age: 42.80 ± 8.91 years) with a history of LE participated in the study. The patients were randomly assigned to two groups: the neuromobilization group and the control group. The neuromobilization group completed a 6-week conservative rehabilitation and radial nerve mobilization program, whereas the control group received conservative rehabilitation therapy only. Both groups underwent a 7-day weekly conservative home rehabilitation program. Pain severity, grip strength, pinch strength, joint mobility, and upper extremity functional level were assessed before treatment, at the third week, after treatment, and at the sixth week after treatment.

Lateral epicondylitis (LE) is a painful situation, which usually occurs due to the overuse of the wrist extensor muscles. The prevalence of LE is 1%-3% in both men and women, and it is highest in individuals aged \>40 years. Pain and tenderness over the lateral epicondyle of the humerus at the origin of the common extensor tendon are the main characteristics. Different conservative treatment methods have been used for treating LE; however, no standard protocol has been documented in the literature. Physiotherapy programs have focused on relieving pain, controlling inflammation, and increasing muscle strength and endurance. The use of eccentric strengthening programs has been supported by current research. Eccentric exercises have been demonstrated to reduce pain and increase function in patients with LE. Recently, neuromobilization techniques have been employed in treating musculoskeletal problems and various compression syndromes. These techniques aimed to provide nerve gliding via joint movements wherein a therapist extends the nerve length in one joint while shortening the same in the adjacent joint. This tensioning technique increases the distance between each end of the nerve, and this neural elongation ability significantly decreases in patients with LE. Neuromobilization techniques have been also proposed to modulate central sensitization and peripheral pain mechanisms in musculoskeletal disorders. Given that central sensitization plays an important role in the increased nociceptive reflex and hyperalgesia in LE, inducing hypoalgesia via neuromobilization techniques may provide pain relief in the long term.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years
* A symptom duration of \>3 months

Exclusion Criteria:

* Bilateral symptoms
* Rheumatologic diseases affecting the elbow and the wrist
* Musculoskeletal disorders due to connective tissue diseases
* Diffuse pain syndrome
* Cervical radiculopathy
* Nerve compression syndromes involving upper extremity
* Undergone surgery at the affected arm
* Received an LE treatment in the last 6 months
* An inability to perform the exercises
Surveillance Study for HCC by Combining Biomarkers With Imaging (ALDUS)

This study is intended to be a prospective observational study at multiple sites, not a randomized controlled trial (RCT). The uses of the biomarkers has been approved by government regulations and adopted for surveillance programs in some countries, thus an RCT which compares patients followed by US alone with patients followed by both US and the biomarkers would raise an ethical conflict, especially in countries where the biomarkers have been routinely used.

For this study, enrolled patients will be followed by US and the biomarkers at regular intervals and classified after completing the study to evaluate the clinical effectiveness of the biomarkers. The comparisons of sensitivity, specificity, and other parameters with respect to tumor characteristics will be made among US alone, the biomarkers, and combined use of US and the biomarkers. Also economical effectiveness of using the biomarkers will be investigated in this study.

Requirement status is monitored every month.

Data are being stored in the electric data capture (EDC) server.

Eligibility Criteria:
Inclusion Criteria:

* Patients with compensated cirrhosis. No discrimination by underlying causes will done.
* Patients aged 18 years and older
* Patients agree to the informed consent

Exclusion Criteria:

* Patients with liver cancer at the time of enrollment
* Patients who have experienced HCC or other malignant tumor with in five (5) years
* Women with pregnancies
* Patients who are likely to be transplanted within one (1) year
* Patients with ≥ 3 mg/dL of total bilirubin
* Patients with uncontrollable ascites
* Patients with ≥ Grade II of hepatic encephalopathy
COVID-19 Associated Mucormycosis: A Multidisciplinary Dilemma in Assiut University Hospital

We aimed to describe the frequency; presentations, predictors, in-hospital outcome of mucormycosis patients in the scope of COVID-19.

All patients with COVID-19 associated Mucormycosis (CAM) admitted to Assuit University Hospital between March 1, 2021, and July 30, 2021, were included in this study. The patient characteristics, the site of mucormycosis, the comorbidities, the steroids usage, and the outcome were analyzed in people with COVID-19.


Eligibility Criteria:
Inclusion Criteria:We recruited all cases admitted to Assuit University Hospital for the management of COVID-19 and/or associated complications between March 1, 2021, and July 30, 2021, specifically those with probable mucormycosis based on clinical condition. At various times, internists, intensivists, neurologists, and otolaryngologists were among the specialists who assessed and treated them. Clinical; radiological and histopathological confirmed cases of mucormycosis with coexisting or previous history of COVID-19 were included in this study.

-

Exclusion Criteria:Participants with fungal infections other than mucormycosis or without a confirmed diagnosis of COVID-19 (or serological evidence of preceding COVID-19) were excluded.

-
Examination of the Safety and Tolerability of NNC 0070-0002-0349 in Overweight/Obese Volunteers

This trial will be conducted in the United States of America (USA). The aim of this clinical trial is to investigate whether NNC 0070-0002-0349 is safe and well tolerated.

Groups of eight subjects will be administered subcutaneous injections of NNC 0070-0002-0349 or placebo on Day 1 beginning with a low dose; after which laboratory and vital sign data as well as subject reported adverse events will be evaluated. If safe to proceed, the next group of subjects will be given a higher dose and the safety evaluation performed again before proceeding. In total, 5 dose levels will be evaluated.

Subjects will be administered a dose and remain in the clinic until the morning of Day 8 after dosing and vital signs and safety labs as well as blood drawn for pharmacokinetic samples taken. Subjects will return to the clinic on Days 10, 12, 14, 16, 18 and 22 for repeat blood draws and safety labs. Day 22 is the final study visit.


Eligibility Criteria:
Inclusion Criteria:

* BMI greater than 27.0 and less than 35.0 kg/m2

Exclusion Criteria:

* Systolic blood pressure greater than 140 mm Hg or diastolic greater than 90 mm Hg
* Depression or suicidal thoughts (Scoring on Patient Health Questionnaire-9-item)
* Eating disorders
* Unusual diets or eating habits
* Dieting, use of diet drugs or obesity surgery
* Diabetes history or abnormal fasting glucose
Urinary Biomarkers in Overactive Bladder in Children

It is a single-center, prospective, interventional, single-arm study. Aim is to investigate which variables are significantly correlated with prolonged anticholinergic treatment (\>6 months) in children with overactive bladder (OAB). Investigated variables will include urinary neurotrophins and inflammatory cytokines, sonographic biomarkers, symptom score scale, demographics, and urodynamic findings. Secondary aim is to analyze sensitivity and specificity of urinary biomarkers in diagnosis and management of OAB compared to urodynamics and treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* urgency with or without frequency, incontinence, enuresis, or nocturia
* an unremarkable clinical examination
* a minimum of 3 micturitions per day
* informed oral and written consent from the child and both parents/legal guardian

Exclusion Criteria:

* acute urinary tract infection
* diseases of central or peripheral nerve system
* anomalies of lumbosacral region
* bladder outlet obstruction
* operative procedures or anomalies of urinary or genital tract
* hypercalcuria, diabetes mellitus, diabetes insipidus
* neurogenic bladder
* constipation or fecal incontinence
* urolithiasis, depression, eating disorders or cardio-metabolic diseases
* prior use of anticholinergic treatment during the last year
The Effectiveness of Photographic Educational Material on Carbohydrate Counting for Adolescents With Diabetes

The hypothesis of this study focuses on obtaining accurate information on the effectiveness of photographic educational material on orientation of carbohydrate counting for adolescents with diabetes.

The adolescents with diabetes at the Pediatric Endocrinology and Diabetes outpatient clinic, will be randomly distributed between two groups: those who will receive orientation on carbohydrate counting through photographic educational material and those through a list of foods equivalent.

Research will follow 3 steps:

First, data will be collected on age, gender, BMI, HbA1C, schooling, type of educational material and parents grade level; answer sheets will be applied to evaluate previous knowledge on carbohydrate counting; orientation will be provided on counting with photo material or list.

Second, after a month of using the educational material, a quiz by phone will be conducted with the sole intent to reinforce orientation.

Third, two days later, adolescents will be directed to the experimental kitchen to see portions of real food and provide answers on amount or choice of carbohydrate.

Statistical tools will be applied to evaluate results.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents with diabetes aged 11 years to 19 years who count carbohydrates in their diet.
* Adolescents with more than 6 years of study .
* There is no restriction ethnic, social, gender, nutrition status, type of diabetes.

Exclusion Criteria:

* Adolescents with diabetes aged 11 years to 19 years who not count carbohydrate counting in your diet.
* Adolescents with less than 6 years of study.
* Adolescents who don't want to participated in this research.
Delayed Visual Maturation: Outcome and Predictive Factors

The objectives of the study are to describe the developmental outcome in a population of children with delayed visual maturation.

description of the developmental outcome of children with delayed visual maturation.

Eligibility Criteria:
Inclusion Criteria:

* Infants (male or female) with suboptimal/absent visual contact at the age of ≥3 months, without other known general developmental delay at the time diagnosis of delayed visual contact and without anatomic ocular abnormalities at the initial ophthalmological examination.

Exclusion Criteria:

* Children with known underlying psychomotor developmental delay or epilepsy at first ophthalmic consultation.
* Children with ophthalmic (anatomical) abnormalities that explain delayed visual maturation.
Moderna COVID-19 Vaccine mRNA-1273 Observational Pregnancy Outcome Study

The main goal of this study is to evaluate the outcomes of pregnancy in females exposed to the Moderna COVID-19 vaccine (mRNA-1273) during pregnancy.

The Moderna COVID-19 Vaccine Pregnancy Registry will collect and analyze information on the potential impact of exposure to the Moderna COVID-19 vaccine on pregnancy and birth outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant
* The outcome of pregnancy (that is, pregnancy loss or live birth) must not be known at entry.
* Agrees to electronically sign the release of medical information form permitting the study to contact her HCPs (for example, primary care provider \[PCP\], obstetrician, nurse midwife) and the infant's HCP (for example, pediatrician) for medical information.
* Received the Moderna COVID-19 vaccine at any point from 28 days prior to last menstrual period (LMP) throughout pregnancy.

Exclusion Criteria:

* Participant has received any other COVID-19 vaccines at any point from 28 days prior to LMP throughout pregnancy.
* Women currently participating in another investigational device or drug study, currently taking an investigational medicinal product, or having taken an investigational product within 28 days prior to LMP or during pregnancy.
Sonographic Examination Cubital Tunnel Release

The investigators want to compare changes in cross-sectional area (CSA) of the ulnar nerve at the elbow after open release or endoscopic release.

The investigators want to compare changes in CSA of the ulnar nerve at the elbow hypothesizing that US examination is a useful tool to detect unsuccessful release and defining which technique shows the best outcome in the first year postoperatively.

The measurement of cross-sectional area (CSA) as a diagnostic tool to detect entrapments syndrome in upper limbs has already been described. US typically demonstrates an abrupt narrowing and displacement of the nerve within the tunnel, possibly in association with a thickened retinaculum or a space-occupying lesions. Previous studies prospectively compared sonographic outcomes after decompression of the median nerve at the wrist.

Eligibility Criteria:
Inclusion Criteria:

* history of paresthesia or numbness in the ulnar nerve distribution;
* weakness or wasting of the small muscles of the hand;
* a positive elbow flexion provocation test;
* slowed motor conduction velocity in the ulnar nerve below 50 m/sec.

Exclusion Criteria:

* Patients with normal nerve conduction studies;
* prior surgery for Cubital Tunnel Syndrome;
* prior traumatic lesions of the elbow;
* coexistent neurological diseases;
* bone anormalities (cubitus valgus, deformities from previous elbow fractures, osteoarthritis with medial osteophytes ands loose bodies, heterotopic ossifications);
* subluxating ulnar nerve;
* space-occupying soft-tissue lesions.
V260 Registration Study (V260-013)(COMPLETED)

Immunogenicity and Safety of V260 in Healthy Infants in Korea


Eligibility Criteria:
Inclusion Criteria:

* At first study vaccination, age 6 weeks through exactly 12 weeks

Exclusion Criteria:

* History of congenital abdominal disorders, intussusception, or abdominal surgery
* History of known prior rotavirus disease
* Ongoing chronic diarrhea or failure to thrive
* Clinical evidence of active gastrointestinal illness
Sensory Motor Interventions on Preterm Infants

Preterm infants experiencing bottle feeding difficulties will be included in this study. Two distinct interventions, oral stimulation (OS) and infant massage (IM), will be administered in this study. The objective of this clinical trial is to compare the effectiveness of these two approaches, either individually or in combination, in improving the feeding performance and development of participants.

Currently, two rehabilitation approaches, Prefeeding oral stimulation (OS) and infant massage (IM), are often used by health professionals to facilitate preterm infants' oral feeding abilities. The purpose of this study is to compare the effectiveness of prefeeding OS and the combined approach of prefeeding OS and IM in improving feeding performance and development of preterm infants. Participants will randomly allocated to two groups and receive either OS or combined OS plus IM. Prefeeding OS is a 5-minute oral sensorimotor intervention, containing peri- and intra-oral stimulation for 3 minutes and pacifier sucking for 2 minutes. IM is a 15-minute intervention, including 5-min manual massage on the infant's head, neck, back, upper limbs, and lower limbs twice and 5-min passive exercise of moving the infant's arms and legs once. The OS group will receive OS twice a day for 10 days. The combined group will receive OS once and IM once a day for 10 days.

Both groups will undergo a bottle feeding assessment before, mid-term, and after the intervention period. Neurodevelopmental assessments will be conducted before and after the intervention period. Additionally, the investigator will conduct chart review to collect participants' birth and medical data. The primary outcomes are feeding performance parameters (e.g., the rate of milk transfer in the first 5 minutes of feeding, total oral intake volume, and milk leakage during bottle feeding) and neurodevelopment outcomes. Secondary outcomes include weight gain and hospital stay. Furthermore, a follow-up evaluation on feeding questionnaire at home and sensory processing function will be conducted when the infants reach three months of corrected age.

Eligibility Criteria:
Inclusion Criteria:

1. \< 34 weeks' gestational age
2. 34\~40 weeks' postmenstrual age at enrollment
3. being fed by oral for at least 2 days but with poor feeding performance defined as consuming less than 80% of the prescribed volume for the half or more feedings
4. weaning the ventilator and maintaining stable physiological status

Exclusion Criteria:

1. Congenital anomalies
2. Confirmed or suspected chromosomal or genetic abnormalities
3. Unsolved seizure, sepsis, necrotizing enterocolitis(NEC)
An Interactive Video Educational Tool Improves the Quality of Bowel Preparation for Colonoscopy

The investigators aimed to determine whether an interactive, online educational platform could improve procedure show rates and bowel preparation scores in an outpatient population presenting for routine colonoscopy.

The investigators performed a prospective, endoscopist-blinded, randomized controlled trial at a hospital-based outpatient endoscopy center. Eligible patients were randomized to two groups. Both groups received verbal and written instructions per standard care, while the intervention group received access to an interactive, on-line video. Primary outcomes were bowel preparation scores graded using the Boston Bowel Prep Score (BBPS), procedure show rates, patient satisfaction, and pre-procedure anxiety. Secondary outcomes included adenoma detection rate, mean bowel prep score per colonic segment, total number of polyps detected, and complication rates.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Access to text messaging and the internet (mobile phone access alone was considered sufficient)
* Prescribed standard split-dose bowel preparation
* Able to provide informed consent via telephone.

Exclusion Criteria:

* Pregnant
* Mentally impaired
* Undergoing screening or surveillance for inflammatory bowel disease .
Intracranial Pressure in Experimental Models of Headache

The purpose of this study is to determine whether increased pressure in the head is elevated in people who suffer from High Altitude Headache. We hypothesise that head pressure will be elevated in people with High Altitude Headache.

High Altitude Headache is the primary symptom of Acute Mountain Sickness. However, at present the reason why some individuals suffer from High Altitude Headache and others do not remains unknown. It is widely believed that elevated pressure within the brain leads to stretching of pain sensitive fibres and thus headache. However, evidence of raised intracranial pressure during High Altitude Headache is currently unavailable. Therefore, this study aims to examine a proxy measure of intracranial pressure (Optic Nerve Sheath Diameter) in persons visiting High Altitude, half of whom have been given the drug acetazolamide that is known to reduce headache symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Member of the Italian High Altitude Research Expeditions

Exclusion Criteria:

* Are under the age of 18years;
* sulfonamide allergy
* Liver or kidney disfunction
* Have any other uncontrolled medical condition
* Or are unable to give consent.