Kornimate/medical-research-clean huggingface dataset:
effect of btl-899 device for non-invasive lipolysis on human flanks

Conditions: Fat Burn

Summary: this study will evaluate the clinical safety and the performance of the btl-899 device (with its 899-ap-c-4 and 899-ap-c-5 applicators) during treatment of the flanks (also known as "love handles"). the study has a single-arm, open-label, interventional design. the subjects will be enrolled and assigned into one study arm and will be required to complete four (4) treatment visits. both flanks will be treated simultaneously for 30 minutes per session. the flanks' fat thickness reduction will be documented by ultrasound. at the baseline visits health status will be assessed and, if needed, additional tests will be performed. inclusion and exclusion criteria will be verified and informed consent will be signed. the treatment administration phase consists of four (4) treatment visits, delivered 5 - 10 days apart. at every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the btl-899 device. safety measures will include documentation of adverse events (ae) during and after the procedures. follow-ups visits at 1 month and 3 months after the final treatment will be held.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 20 to 35 kg/m2. * visible excess of adipose tissue confirmed with pinch test at the flanks ("love handles") area. * subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation. * successful initial determination of the flanks' fat thickness by means of ultrasound. * no procedure for fat reduction at the treated area in the last six months. * subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting a significant change of weight in either direction during study participation. * age between 18 and 70 years. exclusion criteria: * electronic implants (such as intrauterine device, cardiac pacemakers, defibrillators, and neurostimulators) * metal implants * drug pumps * malignant tumor * pulmonary insufficiency * injured or otherwise impaired muscles in the treatment area * cardiovascular diseases * disturbance of temperature or pain perception * hemorrhagic conditions * septic conditions and empyema * acute inflammations * systemic or local infection such as osteomyelitis and tuberculosis * contagious skin disease * elevated body temperature * pregnancy, postpartum period, nursing * graves' disease * scars, open lesions, and wounds at the treatment area * abdominal hernia * gynecological disease incl. inflammation in the pelvis * hip and rib cage trauma or recent surgery of those * previous liposuction in the treatment area in the last six months * unstable weight within the last 6 months (change in weight ± 3%) * previous body contouring or cellulite treatments in the flanks area in the last six months * any other disease or condition at the investigator's discretion
effects of virtual reality based rehabilitation in acute stroke patients in an inpatient rehab setting

Conditions: Stroke Syndrome; Hemiplegia

Summary: to evaluate the effects of virtual reality-based rehabilitation (neofect glove) for newly diagnosed cognitively intact adult dominant hemisphere stroke patients with paresis of their hand in supplementation with conventional occupational therapy to assess whether it improves motor function and speed recovery during inpatient rehabilitation versus conventional occupational therapy alone. also, what impact does this have on quality of life.

the american stroke association states that stroke is 5th leading cause of death in the united states and one of the leading causes of disability and loss of motor function. approximately 80% of stroke survivors have upper extremity limitations where the distal upper extremity motor function is severely affected and is the last body part to recover. restoration of arm function is essential to regaining activities of daily living (adl) such as holding objects like utensils, turning a doorknob, writing or telephone use. literature search shows that intensive and repetitive training may be necessary to modify neural organization and recover functional motor skills. along with traditional rehabilitation methods, virtual reality (vr) based rehabilitation has emerged in recent years. vr-based rehabilitation is more intensive, of longer duration and more repetitive. using vr rehabilitation, repetitive dull exercises can turn into a more challenging and motivating tasks such as games. moreover, vr-based rehabilitation can provide a quantitative measure of the rehabilitation progress. the investigators propose a study comparing conventional occupational services versus virtual reality-based rehabilitation intervention for participants during acute phase of stroke in the inpatient rehabilitation setting. the investigators hypothesize that by using vra, will see a significant increase in the overall motor function, shorter hospital course and improved quality of life for the participants.

Eligibility criteria:
inclusion criteria * minimum age of 18 years' old * unilateral upper extremity functional deficits after stroke * first ever clinical diagnosis of stroke in the dominant hemisphere * diagnosis of ischemic or hemorrhagic stroke with unilateral paresis of dominant hand exclusion criteria: * age less than 18 years' old * cognitive impairment resulting in inability to participate * severe aphasia resulting in inability to communicate to give consent or participate.
a recurrence nomogram for hepatoid adenocarcinoma of the stomach

Conditions: Gastric Cancer

Summary: this study aims to develop a nomogram to predict postoperative recurrence of has and guide individually tailored surveillance strategies.

patients were included from the china hepatoid adenocarcinoma of the stomach study group (china-hassg) database, which comprises 14 tertiary referral centers. all the patients who had undergone complete resection of a primary has between april 2004 and december 2019 were included. first, univariate analysis was performed in cox regression to identify the risk factors associated with rfs. next, variables with p\< 0.05 in univariable analysis were included in the multivariable model, and the forward likelihood ratio method was used for analysis to confirm the independent prognostic factors associated with rfs. finally, based on the results of multivariable analysis, variables that achieved significance at p\< 0.05 were selected to formulate a nomogram.

Eligibility criteria:
inclusion criteria: * patients who had undergone complete resection of a primary has between april 2004 and december 2019 exclusion criteria: * patients with metastatic disease, patients who had undergone palliative surgery, patients who had died within 30 days, and patients who were lost to follow-up

Keywords: reurrence-free survival nomogram
docetaxel plus carboplatin in treating patients with advanced cancer of the esophagus

Conditions: Esophageal Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. combining more than one drug may kill more cancer cells. purpose: phase ii trial to study the effectiveness of docetaxel plus carboplatin in treating patients who have advanced cancer of the esophagus.

objectives: i. evaluate the objective response rate in patients with advanced squamous cell carcinoma of the esophagus treated with carboplatin and docetaxel. ii. assess the toxicity of this regimen in these patients. iii. assess the time to progression and overall survival of this patient population. outline: patients receive docetaxel iv over 1 hour on day 1, followed by carboplatin iv over 15-30 minutes on day 1. treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months until year 2, every 6 months during years 2-5, and then annually thereafter until death. projected accrual: a total of 18-35 patients will be accrued for this study at a rate of 30 patients per year.

Eligibility criteria:
disease characteristics: histologically confirmed metastatic or incurable, locally advanced squamous cell carcinoma of the esophagus measurable disease outside of a previously radiated field required patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: not specified hematopoietic: absolute granulocyte count at least 1500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin normal sgot no greater than 2 times upper limit of normal renal: creatinine normal cardiovascular: no congestive heart failure or angina pectoris, even if medically controlled no prior myocardial infarction within the past year no clinically significant conduction system abnormalities, such as 2nd or 3rd degree heart block or bundle branch block pulmonary: not specified other: not pregnant or nursing fertile patients must use effective contraception no active infections or medical illnesses that are uncontrolled no second malignancy other than previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix or a prior malignancy from which patient has been disease free for past 3 years caloric intake greater than 1500 calories/day fluid intake greater than 1500 ml/day prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: at least 4 weeks since prior radiotherapy surgery: not specified

Keywords: stage iii esophageal cancer stage iv esophageal cancer squamous cell carcinoma of the esophagus
reaching out to adolescents with depression

Conditions: Depression

Summary: major depression is one of the most common mental health disorders in adolescence and is associated with significant impairments in development and functioning. this project will rigorously test the adolescent collaborative care treatment intervention, a health services intervention designed to improve management for depressive disorders among adolescents, via a randomized controlled trial comparing the intervention to usual care. key components of the trial include enhanced education for youth and parents, youth involvement in choice of evidence-based treatments, care management by an allied health professional with regular supervision by a mental health specialist and pediatrician, and stepped care to advance treatment when youth are not improving. additional features have been added to engage adolescents and parents including a moderated message board for youth to share with and learn from one another, formalized involvement of the parent, and availability of the care manager during after school hours. our findings will provide key information on the effectiveness of a developmentally-sensitive adapted collaborative care intervention for the treatment of adolescent depression.


Eligibility criteria:
inclusion criteria: * depression * age 13-17 years * enrollment in study primary care clinics exclusion criteria: * suicidality * already enrolled specialty mental health care * mental health hospitalization in the prior year * substance abuse * bipolar disorder * non-english speaker

Keywords: adolescents
star and deferred stenting study

Conditions: Coronary Occlusion; Coronary Stenosis; Coronary Restenosis

Summary: star is a minimal-risk pragmatic clinical trial of patients admitted for a cto-pci procedure. the overall objective of the star study is to address the current gaps in knowledge regarding use of star during cto-pci, as a prospective, multi-center study of 150 participants with randomization of timing of staged pci. five sites will be selected to participate in star from a national network of highly experienced cto-pci centers across the united states.

to date, there have been no studies that prospectively and systemically evaluated the efficacy and safety of star with deferred stenting and described the frequency of its use in the hybrid approach. the aim of this study is to address these current gaps in knowledge, including the frequency of use of star by experienced operators, the safety of its use, optimal timing of staged stenting and health status change associated with this procedure. this prospective study will enroll 150 patients undergoing elective pci of native cto utilizing the star technique and will subsequently randomize patients in a 1:1 fashion to early (5-7 weeks) and later (12-14 weeks) timing of subsequent stenting.

Eligibility criteria:
inclusion criteria: 1. subject is scheduled for a pci procedure for at least one chronic total occlusion with timi antegrade flow of zero. 2. subject is ≥ 18 years of age at the time of consent 3. the operator attempted star technique defined as knuckle guidewire across or into the cto segment during the cto pci and is planned for a staged procedure. 4. english speaking due to follow up. exclusion criteria: 1. the cto segment is in a graft. 2. female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy. 3. unable to participate in telephone follow-up 1. too hard of hearing to do follow-up by telephone or deaf. 2. incarcerated prisoner. 3. history of dementia. 4. subjects without a way for contact by telephone for follow-up. 4. previously enrolled in star. 5. patient not a candidate for baseline and final angiography (ckd with egfr\<30). 6. the knuckled guidewire did not cross into the cto segment during star attempt. 7. a stent was placed into the star segment during the index procedure. 8. refused participation in the study. 9. patient enrolled in another study.

Keywords: chronic total occlusion sub-intimal plaque modification
why are fertility preservation patients not coming back?

Conditions: Fertility Issues; Cancer

Summary: this is a single-center retrospective study carried out with a phone call follow-up to investigate women's decision not to return for criopreserved ovocytes use after cancer treatment. the study database includes all women who underwent fertility preservation cycles at a third-level university-affiliated center from january 2001 to december 2017. patients were asked a set of standardized questions whose purpose was to investigate their present health conditions, cancer treatment and any potential relapses, their family projects and sentimental status, any spontaneous conception, and why they had not yet returned for embryo transfer. all data were recorded anonymously in our dataset.

all women who underwent oocyte cryopreservation cycles for oncological purposes from january 2001 to december 2017 at fertility center of humanitas research hospital, rozzano (milano), italy, were contacted. the survey's purpose was to investigate their present health conditions, cancer treatment and any potential relapses, their family projects and sentimental status, any spontaneous conception, and why they had not yet returned for oocytes use.

Eligibility criteria:
inclusion criteria: the study database includes all women who underwent fertility preservation cycles at a third-level university-affiliated center
pressure ulcer monitoring platform (pump)

Conditions: Pressure Ulcer

Summary: this study will employ two monitoring device prototypes. the devices are sensors containing accelerometers and gyroscope. the raw output data will be analyzed to determine when patients are moved or are repositioned in their beds. the data is captured within a modem which will correlate these movements with video recordings for interpretation by the research team. one sensor is wearable on the patient gown or sleepwear, and the other is placed underneath the frame of the hospital bed. the investigators propose a non-blinded trial with n=10 where all subjects will undergo the two devices. a video camera will be placed in each subject room for recording the repositioning events to correlate the monitor signals with the actual subject repositioning captured by the video. the goal of the trial is to validate the ability of each of the sensor prototypes to accurately detect when subjects are turned, in order to reduce stationary positioning which contributes to the incidence of pressure ulcers and to improve compliance with patient repositioning trials.

the investigators propose a non-blinded trial with n=10 where all subjects will undergo the two devices. a video camera will be placed in each subject room for recording the repositioning events to correlate the monitor signals with the actual subject repositioning captured by the video. the goal of the trial is to validate the ability of each of the sensor prototypes to accurately detect when subjects are turned, in order to reduce stationary positioning which contributes to the incidence of pressure ulcers and to improve compliance with patient repositioning trials. the repositioning events recorded by the sensor devices will be automatically uploaded and abstracted by the research team, along with the events captured by the simultaneous video recording of patient repositioning.

Eligibility criteria:
inclusion criteria: * subject is over 18 years of age * subject is immobile and/or unable to independently re-position self exclusion criteria: * subject is under the age of 18 years * subject is able to independently re-position self
exercise induced asthma and airway reactivity in athletes

Conditions: Respiratory Function Tests

Summary: the overall aim is to explore pathophysiological factors related to airway hyperresponsiveness to direct and indirect provocation stimuli in athletes with different sport activities, with special focus on epithelial reaction linked to cc16 and to eicosanoid related inflammatory response. the investigators also wish to compare indirect testing done as hyper osmotic challenge with mannitol compared to a defined sport specific exercise challenge.

by non-invasive tools the investigators wish to characterize type of airway reaction to various provocative stimuli in athletes doing two different sort activities, tennis or swimming. as controls are being used sedentary age-matched controls from the same region, exposed to the same school environment. thus we wish to: * explore the prevalence of positive mannitol reactivity among swimmers and tennis player and how this relates to symptoms, disease history and to a sport specific exercise provocation test. * compare the results from sport specific testing with a standardized eucapnic hyperventilation test (ehv) * compare the overall reactivity to mannitol or ehv among swimmers and tennis players compared to aged matched controls. * explore the role by cc16 in airway reactivity to different provocative stimuli and to see whether there is a difference between different sport activities, different test protocols and between athletes and controls. * explore evidence of eicosanoid related inflammatory reaction in athletes and controls in relation to different provocative stimuli the study population consists of 100 elite swimmers, 100 elite tennis players and 100 non-elite, eged matched controls. in the latter group, 30 are aged matched non-atopic non-asthmatic controls.

Eligibility criteria:
inclusion criteria: * subjects aged 16-19 from skåne. * all should approve attendance in the study by signing an informed consent. igf they are aged under 18, parents should also sign. * three groups are included * elite aspiring swimmers with an average training intensity of at least hours per week the last year. exclusion criteria:

Keywords: exercise mannitol
growth and safety of a two-stage feeding system in preterm infants

Conditions: Preterm Infant

Summary: this study evaluates the safety and suitability of the two-stage feeding system in preterm infants.

this open-label trial will be conducted in up to 74 preterm infants to evaluate the formula as it would typically be used in the neonatal care unit and to document the safety and suitability of the two-stage feeding system in terms of growth in comparison to recommended growth goals, feeding tolerance, biochemical parameters, and adverse event reporting.

Eligibility criteria:
inclusion criteria: 1. written informed consent has been obtained from the parents/legally acceptable representative (lar). 2. infant's birth weight ≤1500 g and appropriate for gestational age (aga) as defined by weight ≥10 percentile and ≤90 percentile on the fenton growth chart. 3. infant's gestational age ≥ 27 weeks and ≤ 32 weeks. 4. infant is clinically stable. 5. infants are eligible to start experimental formula within the first 5 days (≤120 hours) of life. exclusion criteria: 1. parents not willing / not able to comply with the requirements of study protocol. 2. infants experiencing early onset sepsis. 3. major congenital or chromosomal abnormality known to affect growth. 4. preterm infants experiencing liver failure. 5. peri-/intra-ventricular haemorrhage. 6. infant requiring prolonged (more than 3 doses) of steroid treatment. 7. infants' participation in another interventional clinical trial.
effect of midazolam premedication on the satisfaction levels of patients after endoscopic submucosal dissection

Conditions: Early Gastric Cancer; Gastric Adenoma

Summary: endoscopic submucosal dissection is commonly performed under light to moderate sedation, and minimizing patient movement is of key importance for successful outcome. propofol has widely replaced benzodiazepines as sedative drug of choice, and has been reported to enhance the quality of procedure in our past study. however, despite higher satisfaction scores of the endoscopists and faster post-procedural recovery, patient satisfaction scores were found to be higher in patients that received midazolam and meperidine instead of propofol and remifentanil. this seems to be due to the anterograde amnestic effects of midazolam rather than the quality of sedation itself. investigator hypothesized that by premedicating the patient with low lose midazolam before receiving sedation for esd with propofol and fentanyl, patient satisfaction would be enhanced without affecting endoscopic performance.


Eligibility criteria:
inclusion criteria: 1. adult patients over the age of 19 diagnosed with early gastric cancer or gastric adenoma that are scheduled for endoscopic submucosal dissection 2. american society of anesthesiologist physical status 1\~3 exclusion criteria: 1. patient refusal 2. patients that received sedatives within 24 hours prior to endoscopic submucosal dissection 3. history of gastrectomy or previous endoscopic submucosal dissection at same site 4. allergies to propofol or its ingredients, soybeans or peanuts 5. pregnant or breastfeeding patients 6. patients with severe debilitating underlying medical conditions 7. patients with altered mental status 8. illiterate patients or foreigners

Keywords: midazolam satisfaction endoscopic submucosal dissection