Kornimate/medical-research-clean huggingface dataset:
the efficacy of 1,064-nm picosecond laser with microlens array for the treatment of abdominal striae distensae

Conditions: Striae Alba

Summary: the objective of this study is to evaluate the efficacy and safety of a fractional 1,064 nm picosecond laser for the treatment of striae alba.

striae distensae are atrophic dermal scars that can cause psychosocial distress on affected patients. despite numerous available therapeutic modalities, no gold standard therapy has been established. picosecond lasers are a newer advancement in lasers that have primarily used in the treatment of tattoos. a fractional 1064-nm picosecond laser has recently become available for the treatment of pigmentation and skin rejuvenation. the main mechanism of action is tissue ablation via laser induced optical breakdown (liob) which occur when pulse intensity is high enough to strip electrons and generating plasma, the plasma absorbs the remaining laser energy forming a cavitation bubble within the dermis which has been demonstrated to improve fine wrinkles and acne scar through the stimulation of collagen formation.

Eligibility criteria:
inclusion criteria: * striae alba on abdomen for more than 3 months * fitzpatrick skin type iii-v exclusion criteria: * pregnancy and breastfeeding * previous topical treatment, filler injection, chemical peel or laser treatment within 6 months before starting the study * history of using isotretinoin * photosensitive dermatoses, infection, eczema * past history or family history of malignancy * history of herpes infection * history of hypertrophic scar or keloid, connective tissue disease * history of collagen or elastin disease * history of smoking * significant fluctuations in weight in the past 6 months

Keywords: striae alba, fractional picosecond laser, stretch marks
the influence of the body posture correcting therapy on pelvic floor muscles function

Conditions: Urinary Incontinence,Stress

Summary: the purpose of this study is to assess the influence of the body posture correcting therapy on pelvic floor muscles function and urinary incontinence problem.

this randomized, controlled study was aimed to asses influence of a six week global posture correction therapy on pelvic floor muscles function and urinary incontinence problem. participants were randomly divided into two groups. all subjects overcame assessment of pelvic floor muscles (semg, manometry and digital) and completed questionnaire about urinary incontinence problem and general health condition connected with lower tract symptoms. both groups had a pelvic floor education (what is it, where are the pelvic floor muscle, how to correct contract them etc.) additionally, the study group had a six week therapy focused on body posture correction. therapy consisted of manual therapy (once per week) and correction exercises.

Eligibility criteria:
inclusion criteria: * stress urinary incontinence (confirmed by a medical examination) * female * age between 25 and 45 years old exclusion criteria: * gynecological, spinal, and abdominal surgery (excluding cesarean delivery) * menopause * spinal and pelvis injuries * chronic diseases of the circulatory and respiratory system * neurlogical accidance
development of a web-based course to maintain skills in nurses trained to screen for dysphagia

Conditions: Deglutition Disorders; Dysphagia; Stroke

Summary: this research aims to facilitate the successful implementation of the new heart and stroke foundation of ontario dysphagia screening model for acute stroke patients. the objectives will be 1) to determine the natural history of dysphagia screening skill decay, and 2) to assess the benefit of independent web-based practice and periodic feedback on screening skill maintenance. we will enrol a convenience sample of nurses who currently work with stroke patients but who have had no prior formal training with dysphagia screening. the study will consist of 2 phases: a) an initial pilot phase followed by b) a prospective randomized controlled study. during phase a, three new web-based, self-instructed skill refresher courses will be developed to help nurses maintain the skills they will learn in an 8-hour workshop on dysphagia screening. during phase b, nurses will receive the 8-hour workshop and one-on-one evaluation by a speech-language pathologist (slp). following training, competent screeners will be randomized into one of two groups: group a - control group with no refresher course or periodic feedback from slp; group b - web-based skill refresher courses only. nurses will be evaluated at several timepoints throughout phase b to assess theoretical dysphagia screening knowledge and skills.


Eligibility criteria:
inclusion criteria: * nurses who care for acute stroke patients

Keywords: skill maintenance skill decay screening
risk factors for incontinence-associated dermatitis (iad) in icu patients suffering from fecal incontinence

Conditions: Irritant Contact Dermatitis; Diaper Rash; Incontinence-associated Dermatitis

Summary: this study aims to identify patient characteristics associated with the development of incontinence-associated dermatitis (iad) category 2 (skin erosion due to incontinence). 380 icu patients suffering of fecal incontinence will be included in the study. data on 19 possible risk factors will be collected at one point in time by the research team. different sources and methods will be used to collect patient data: skin assessment, patient record, direct patient observation, routine blood samples.

incontinence is a widespread problem in all health care settings. prevalence figures of incontinence vary around 20.0% of all hospitalized patients. in acute and critical care units the proportion of patients with fecal incontinence may rise up to 33.0%. one of the main complications of incontinence is inflammation of the skin in the genital and anal region, also known as incontinence-associated dermatitis (iad). iad is defined as skin inflammation manifested as redness with or without blistering, erosion, or loss of skin barrier function that occurs as a consequence of chronically or repeated exposure of the skin to urine or faeces. a range of skin care products and procedures for the prevention of iad exists. in order to provide cost-effective iad prevention, it's important to target preventive skin care interventions to patients at risk of iad. the aims of this study are: 1. to identify specific factors associated with the development of incontinence- associated dermatitis (iad) in a recognized high risk patient population (icu patients suffering from fecal incontinence) 2. to develop and statistically validate patient profiles being associated with high risk for iad development this study is a matched case control study. the cases are defined as patients with iad cat. 2 (red skin with skin breakdown). the controls are defined as patients with iad cat. 0 (at risk, no redness and skin intact). the patient will be matched for fecal incontinence. in total, 380 icu patients suffering from fecal incontinence will be included. 19 possible risk factors will be studied. all data will be collected at one point in time by the research team. different sources and methods will be used to collect patient data: skin assessment, patient record, direct patient observation, routine blood samples. specific iad risk factors will be determined by applying univariate and multivariate binary logistic regression modeling.

Eligibility criteria:
inclusion criteria: * being admitted to the intensive care unit * being fecal incontinent (=unintentional loss of stool) exclusion criteria: * being \< 18 years * no contact possible between skin en stool at the perianal region (e.g. due to enteral stoma)

Keywords: incontinence-associated dermatitis risk factor intensive care unit prevention
effects of sudoku mind activation & revitalizing training on cognitive function in people with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: this study aims to implement a sudoku mind activation and revitalization training (smart) program to promote cognitive health among patients with mild cognitive impairment (mci), and the use of active mind strategy in preventing dementia among the older adults. the smart program consists of two components including, a community empowerment-educational campaign on active mind strategies for older adults, and a 24-week sudoku training programme for people with mci.

this study aims to implement a smart program to promote cognitive health among patients with mci, and the use of active mind strategy in preventing dementia among the older adults. the smart program consists of two components including, a community empowerment-educational campaign on active mind strategies for older adults, and a 24-week sudoku training programme for people with mci. the community empowerment-educational campaign will be conducted in the elderly care centres of the two collaborating non-governmental organizations, with the purpose of increasing the awareness of people aged 55 or above on the importance of maintaining an active mind and preventing age-related cognitive decline and dementia. the campaign will include cognitive screening, poster exhibition, booth exhibition and individual counselling. the sudoku training program include a 12-week face-to-face training session and a 12-week facilitated self-practice. the face-to-face sessions aim at developing the skills of the participants in solving the sudoku using the t-code. the 12-week training program will be evenly divided into three modules of increasing difficulty, with consideration given to the suboptimal cognitive function of the participants with mci. these modules are developed by the co-investigator who has rich prior experience in teaching older adults on sudoku puzzle.

Eligibility criteria:
inclusion criteria: * people with mci as defined by a score of 19-26 out of the 30 on the montreal cognitive assessment in the general public and aged 55 or above. exclusion criteria: * persons with dementia and communication problems will be excluded.

Keywords: mild cognitive impairment
liquid biopsies for lung allograft damage classification - leonardo

Conditions: Lung Transplant Failure and Rejection; Lung Transplant Infection

Summary: ltx has the shortest survival of all solid organ transplants. the complex and time-demanding diagnostics of allograft dysfunction are a significant reason for this. the current study aims overarchingly to improve survival after lung transplantation (ltx) through precise and fast diagnostics. the specific aim is to develop direct-to-clinical implementation biomarkers for the most important aspects of long-term survival after ltx. an in-house-developed pcr-based cell-free-dna methodology (cf-dna) will be used for allograft damage and combined with specific other biomarkers to identify damage type. the current clinical golden standard for damage identification will be performed at every sampling instance. the research will be a single-centre prospective observational cohort study. the control samples at all time points will consist of the samples without allograft damage. blood will be drawn at fixed time points and clinical events. all analyses will be performed at a separate lab, blinded to the patient's status. .


Eligibility criteria:
inclusion criteria: * luing transplanted and followed up within the reach of the study paricipating centres. a good understanding to read and write within the languages in which the consent is provided. exclusion criteria: * not lung transplanted or not followed up within the reach of the study paricipating centres. no good understanding to read and write within the languages in which the consent is provided.
multimedia toolkits to implement 12-step recovery concepts in group counseling

Conditions: Alcohol Abuse; Drug Abuse

Summary: this study is developing and testing a 12-step toolkit with five modules, training counselors to use them, and studying their frequency of use, desirability, effectiveness and patient outcomes. the toolkit includes counselor written guides, posters, client worksheets, engagement activities, and videos designed to be shown during substance abuse treatment group sessions to explain and encourage 12-step participation.

the study has three aims. aim 1 involves the development of an evidence-based 12-step facilitation toolkit curriculum. toolkit structure and content is grounded in theory and empirical findings, and incorporates feedback from 12-step facilitation experts and individuals with a history of substance abuse. aim 2 consists of implementing the resulting five-module toolkit in a multi-site randomized controlled trial using a pre-/post-toolkit training design that includes 1- and 6-month post-training assessments. group counselors employed at community-based outpatient and inpatient substance abuse treatment programs will be randomly assigned to a toolkit or treatment-as-usual condition. data obtained from audiotaped sessions will identify between group differences in counselor adherence to 12-step content and skillfulness. additional data will be collected on counselor satisfaction, 12-step attitudes and beliefs, and 12-step knowledge, as well as on toolkit acceptability, feasibility, and short-term sustainability. aim 3 will determine whether exposure to the toolkit curriculum results in stable 12-step involvement and decreased self-reported substance use among clients.

Eligibility criteria:
inclusion criteria for counselors: * over 18 years of age * employed at a participating substance abuse treatment facility * provide treatment in a group format exclusion criteria for counselors: * at the time of the project they do not have primary responsibility for conducting at least three substance abuse group sessions per week * their therapy group is normally scheduled to run less than 50 minutes, or more than 150 minutes * unable to provide valid informed consent inclusion criteria for clients: * over 18 years of age * attending an observed group of a participating counselor * (for participation in the follow-up study/aim 3 only) patients must endorse heavy drinking, alcohol-related difficulties, or poor prior 12-step participation exclusion criteria for clients: - unable to provide valid informed consent
segmental mechanisms of transcutaneous spinal cord stimulation for spasticity control

Conditions: Spinal Cord Injuries

Summary: the aim of the pilot study is to gain first insights into the interaction of transcutaneous spinal cord stimulation with the altered activity of intraspinal circuits associated with spinal spasticity. the main goal is to evaluate the validity of the chosen measures and to generate a data base for statistical planning of a subsequent clinical study.


Eligibility criteria:
inclusion criteria: written informed consent prior to participation for participants with intact cns: • no previous neurological or musculoskeletal disorders for participants with spinal cord injury: * spinal cord injury due to trauma * ≥ 12 months post-spinal cord injury * complete or incomplete spinal cord injury classified as grade c or d on the american spinal injury association impairment scale (ais) * neurological level of spinal cord injury: c3-t10 * preserved tendon and cutaneo-muscular reflexes in the lower limbs exclusion criteria: * other neuromuscular diseases, e.g., amyotrophic lateral sclerosis (als), parkinson's disease, guillain-barré syndrome, muscular dystrophy * active implants (e.g., cardiac pacemaker, drug pump) * passive implants at vertebral level t10 or caudal (e.g., metal screws/plates for surgical stabilization of spinal fractures) * active infections or diseases, pressure sores * dermatological issues at the stimulation site * malignant diseases * heart insufficiency (nyha iii-iv) * potential pregnancy (pregnancy test to be conducted in women of child bearing age before application of transcutaneous spinal cord stimulation)
postoperative analgesia of tap block for laparoscopic sleeve gastrectomy

Conditions: Postoperative Pain

Summary: many methods were considered to control postoperative pain in laparoscopic bariatic surgery including non steroidal anti-inflammatory drugs, opioids and neuraxial block but subcostal (tap) block has provided good analgesic effect when used as a part of multimodal analgesia in bariatric surgery due to lack of visceral block

since long time opioid have been used to control postoperative pain in bariatric surgery however, an increasing awareness of opioid-related adverse events, including respiratory depression, paralytic ileums, and sedation, constipation has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia as neuroaxial block and ultrasound guided nerve blocks as the transverse abdominis plane (tap) block which is of increasing interest nowadays (basaran b, et al 2015) the ultrasound-guided oblique sctap block, first described by hebbard et al., has the potential to provide analgesia for both upper and lower abdominal surgery. there is a growing consensus that the sctap block provides better analgesia for upper abdominal incisions the tap block via various approaches provides some advantages over neuraxial anesthesia (ganapathy set al 2015). for example, tap blocks are associated with a lower use of intraoperative phenylephrine and a lesser degree of intraoperative blood pressure changes. the sctap block may be utilized in cases in which neuraxial anesthesia is contraindicated, such as patients with coagulation issues or infection at the epidural puncture site. although the sctap block provides sensory blockade of the abdominal wall, it is lacking in coverage of visceral pain (lissauer j,et al 2014). the lack of visceral pain analgesia may require the use of additional methods of postoperative pain control such as intravenous opioids or non-narcotic analgesics.

Eligibility criteria:
inclusion criteria: * age 20-60 years * asa ι-ιι * bmi \>35 exclusion criteria: * patient refusal. * allergy to study drugs. * infection at site of injection.

Keywords: subcostal tap laparoscopic sleeve gastrectomy
effects of alcohol after bariatric surgery

Conditions: Obesity

Summary: the investigators wish to study the effects of three forms of bariatric surgery: gastric bypass, sleeve gastrectomy, and lap banding. the surgery is not part of the clinical trial. if insurance does not cover the procedure, then the patient is responsible for payment of the surgical process. the investigators are doing pre- and post-surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on 1) alcohol absorption, distribution and elimination from the body; 2) the effects of alcohol on blood sugar; and 3) the effects of alcohol on mood.

the study includes seven groups of women: one group will be undergoing gastric bypass, another group will be undergoing lap banding, a third group will be undergoing sleeve gastrectomy, the fourth group will be women who underwent gastric bypass 1-5 years ago, the fifth group will be women who underwent lap banding 1-5 years ago, the sixth group will be women who underwent sleeve gastrectomy 1-5 years ago, and the seventh group will be a control group who have not undergone bariatric surgery.

Eligibility criteria:
inclusion criteria: * women * drink alcohol at least once per month exclusion criteria: * men * drinks more than 7 standard drinks per week or more than 4 standard drinks in a period of 2 hours for the month before enrolling in the study. * regular use of drugs of abuse or use of any medication interacting with alcohol pharmacokinetics or pharmacologic effects. * alcohol dependence * pregnancy, lactation or not using effective methods of birth control * smoking * anemia * liver disease

Keywords: alcohol intake after bariatric surgery alcohol and bariatric surgery
safety and efficacy of aliskiren in pediatric hypertensive patients 6-17 years of age

Conditions: Hypertension

Summary: this double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. the low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. this study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.


Eligibility criteria:
inclusion criteria: * documented diagnosis of hypertension as defined in the nhlbi 4th report, 2004 * mssbp (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at visit 2 (randomization) measurement as defined by the nhlbi 4th report, 2004 exclusion criteria: * patient receiving immunosuppressant medication (e.g. cyclosporine, mmf, etc) other than oral/topical steroids, for any medical condition * current diagnosis of heart failure (nyha class ii-iv) or history of cardiomyopathy or obstructive valvular disease * mssbp ≥ 25% above the 95th percentile * second or third degree heart block without a pacemaker * ast/sgot or alt/sgpt \>3 times the upper limit of the reference range * total bilirubin \> 2 times the upper limit of the reference range * creatinine clearance \< 30 ml/min/1.73m² (calculated using modified schwartz formula to estimate glomerular filtration rate \[gfr\]), based on the serum creatinine concentration obtained at the screening visit) * wbc count \< 3000/mm³ other protocol-defined inclusion/exclusion criteria may apply

Keywords: pediatric hypertension primary hypertension secondary hypertension
pilot study to determine safety and efficacy of orbital injections of lipo-102 in patients with symptomatic exophthalmos associated with thyroid-related eye disease (ted)

Conditions: Thyroid-Related Eye Disease

Summary: this is a pilot study to determine the safety and efficacy of orbital injections of lipo-102.


Eligibility criteria:
inclusion criteria: * male or non pregnant female * symptomatic exophthalmos * inactive thyroid eye disease * signed informed consent exclusion criteria: * known hypersensitivity to study drugs * treatment with an investigational agent within 30 days of first dose * history of thyroid eye disease less than 6 months * previous decompression surgery * glaucoma

Keywords: ted
ambispective clinical evaluation of sophono™

Conditions: Conductive Hearing Loss; Single-Sided Deafness; Mixed Hearing Loss

Summary: study to accumulate post-market clinical evidence for the safety and effectiveness of the sophono alpha 2 and alpha 2 maximum power output (mpo) systems in subjects diagnosed with conductive hearing loss, single-sided deafness and mixed hearing loss who currently have or have had the sophono implant.


Eligibility criteria:
inclusion criteria: * any subject who currently has or who has had the sophono implant (including those who have been explanted) * has or has had sophono implant for 3 months or longer exclusion criteria: * subject has implant but is unable or unwilling to perform audiologic testing * subject is currently participating in another clinical study and has not been approved for concurrent enrollment by the study sponsor