Kornimate/medical-research-clean huggingface dataset:
evaluating the therapeutic effect of scalp acupuncture treatment for motor dysfunction in ischemic stroke patients

Conditions: Ischemic Stroke; Hemiplegia

Summary: the investigators design a randomized, control study to evaluate the therapeutic effect of scalp acupuncture using jiao's motor area for motor dysfunction in ischemic stroke patients using the following outcomes: motor function, activity of daily living,quality of life.

functional disorder is a common and serious consequence of stroke. a large proportion of stroke patients develop motor dysfunction in the early stage after stroke. acupuncture is often used as an adjunct to mainstream rehabilitation after stroke. jiao's scalp acupuncture is a contemporary acupuncture technique integrating traditional chinese needling methods with western medical knowledge of representative areas of the cerebral cortex. it has been widely applied to be a kind of effective treatment for stroke in china. but, there is meta-analysis suggests that with stroke rehabilitation, acupuncture has no additional effect on motor recovery but has a small positive effect on disability, which may be due to a true placebo effect and varied study quality. the efficacy of acupuncture without stroke rehabilitation remains uncertain, mainly because of the poor quality of such studies. the objective of this proposed study is to determine whether scalp acupuncture treatment could improve significantly motor function in ischemic stroke patients. in this 8-week, assessor-blind, randomized, controlled study of scalp acupuncture as additional treatment with the rehabilitation treatment, a total of 116 patients with ischemic stroke patients will be recruited. the patients will be randomly assigned to scalp acupuncture combined with rehabilitation treatment (n =58) or rehabilitation treatment (n =58). (40 sessions, 5 sessions a week). changes in the motor function over time are measured using fugl-meyer scale, modified barthel index and ss-qol scale. the study will be conducted at shanghai university of traditional chinese medicine, long hua hospital, fudan university, hua shan hospital.

Eligibility criteria:
inclusion criteria: 1. the ages of stroke patients from 40 years old to 70 years old 2. stroke diagnosed according to the criteria of cerebral arterial thrombosis in western medicine and apoplexy in chinese medicine 3. ischemic stroke confirmed by ct brain or mri brain, with stable medical condition and awareness clear 4. recent stroke from 1 month to 6 months after onset 5. stroke with limb motor dysfunction 6. sufficient cognition to follow commands and mini-mental state examination (mmse) score \> 24 7. voluntary participation and informed consent signed. exclusion criteria: 1. stroke with conscious disturbance or serious cognitive impairment 2. presence of another chronic disorder, including severe parkinson's disease, cardiac disease, cancers, epilepsy, or chronic alcoholism 3. impaired hepatic or renal function 4. bleeding tendency 5. being oversensitive to acupuncture 6. participation in another clinical trial.

Keywords: ischemic stroke motor dysfunction scalp acupuncture
spot-check noninvasive hemoglobin (sphb) repeatability and reproducibility

Conditions: Anemia; Healthy

Summary: single-arm study to investigate the repeatability and reproducibility of sphb measurements from the rad-67 and dci mini sensor.

this study aims to evaluate the repeatability and reproducibility of masimo's pulse co-oximeter and sensor to determine the device and sensor's precision in sphb measurements.

Eligibility criteria:
inclusion criteria: * age one month and older * weight greater than or equal to 3 kg * the subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study exclusion criteria: * decision-impaired adult and pediatric patients who are unable to give informed consent/assent * decision-impaired adult on behalf of a pediatric patient who is unable to assent * subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (dfu) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc. * subjects deemed not suitable for the study at the discretion of the investigator * subjects unlikely to be able to refrain from excessive motion during data collection. excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
clinical outcomes of preoperative and postoperative rehabilitation in the patients with hbp malignancy

Conditions: Hepatic Neoplasms; Biliary Tract Neoplasms; Pancreatic Neoplasms

Summary: clinical outcomes of preoperative and postoperative rehabilitation in the patients with hbp malignancy.

the most important outcome in the management of hbp malignancies is survival. since the application of eras (enhanced recovery after surgery), the improvement of qol(quality of life) has been known as one of important factor for the management of hbp malignancies as well as survival, and the improvement of qol, itself, affect the survival. there are several reports that perioperative rehabilitation affect positively for the outcome of surgery and qol in surgical patients. however, in the hbp field, there are rarely studied for this concept. this study aim to investigate that the application of rehabilitation program for the surgery of hbp malignancies affect on short-term outcome and lead the improvement of qol.

Eligibility criteria:
inclusion criteria: * \>18 years old or \<80 years old * ecog 0-2 * resectable hbp malignancies or premalignant lesions which should be required gi resection and anastomosis * open surgery * no distant metastasis * no functional disturbance in bone marrow; wbc at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, platelet count at least 125,000/mm3 * no functional disturbance in liver; ast less than 5 times upper limit of normal * no function disturbance in kidney; creatinine no greater than 1.5 times upper limit of normal * informed consent exclusion criteria: * distant metastasis (+) or recurred hbp tumor * active or uncontrolled infection * alcohol or other drug addiction * already enrolled patient in other study which affect this study * pregnant or the possibility of pregnancy (+) * uncontrolled cardiopulmonary disease * moderate to severe comorbidity which affect on the quality of life and nutritional status (liver cirrhosis, end stage renal disease, heart failure, etc.) * previous history of major gastrointestinal surgery (gastrectomy, colectomy, etc.) * previous history of neurological or musculoskeletal diseases which is impossible to allow investigator's order

Keywords: rehabilitation quality of life surgery hepatic neoplasms biliary tract neoplasms pancreatic neoplasms
epi-on corneal crosslinking for keratoconus

Conditions: Keratoconus; Keratoconus, Unstable

Summary: epithelium-on corneal crosslinking for keratoconus.

subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a candidate for corneal crosslinking (cxl). subjects that as candidates for cxl will be asked to participate in this study and will undergo the required screening procedures to determine study eligibility. informed consent will be obtained from each subject before performance of any required any required study procedures that are not part of the investigator's routine examination. all subjects will be evaluated at screening/baseline, day 0 (treatment day), then 1 day, 1 week, and 1, 3, 6, 12 months after treatment. pentacam measurements and measurements of best spectacle-corrected visual acuity will be obtained and baseline and at appropriate times after the epithelium-on cxl procedure. safety monitoring throughout the study will include observations at appropriate times for adverse events, clinically significant findings on ophthalmic examination, and slit-lamp examination. the primary efficacy parameter is the change from baseline over time in maximum keratometry (k-max). addition analyses for efficacy will include uncorrected visual acuity (ucva) and best corrected visual acuity (bcva).

Eligibility criteria:
inclusion criteria: * 12 to 40 years of age, having a diagnosis of keratoconus, signed written informed consent, willingness and ability to comply with schedule for follow-up visits exclusion criteria: * previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications (herpes simplex/zoster, recurrent corneal erosion syndrome, corneal melt, corneal dystrophy, etc.) pregnancy, intent to become pregnant, or lactation during study. corneal pachymetry \<350 microns at the thinnest point measured by pentacam in the eye(s) to be treated. nystagmus or any other condition that would prevent steady gaze. other systemic condition that in the investigator's opinion would not allow the patient to be a good candidate for the study.

Keywords: keratoconus corneal crosslinking cxl
resistance training in patients with morbid obesity

Conditions: Morbid Obesity; Obesity; Physical Activity; Metabolic Syndrome; Risk Factor, Cardiovascular

Summary: the researchers will conduct a study for avoiding the metabolic syndrome in morbid obese patients. thus, the aim of the present will be determine the effects of a resistance training programme (rt) in preventing or attenuating metabolic syndrome (mets) in patients with morbid obesity. a second aim will be report the prevalence of non-responders in terms of improvements in mets markers and other co-variables considered.

the prevalence of metabolic syndrome (mets) and cardiovascular disease is expected to rise along with the global obesity epidemic. mets is a cluster of clinical risk factors, including abdominal (visceral) obesity, hypertension, elevated serum triglycerides, low serum high-density lipoprotein (hdl) and hyperglycaemia.the mets for example, significantly decreases the life expectancy of individuals with morbid obesity and increases the disease burden and economic costs associated with healthcare. in this sense, more recently, there was reported that body mass index (bmi) and fat distribution showed higher associations with inflammation, fat indices, and more prevalence of mets in morbidly obese subjects, claiming for an early prevention of the mets in the morbid obese state. exercise training has proven to be effective in inducing a clinically significant weight loss and reducing cardiovascular risk. exercise have reported to be associated with increased muscle mass, decreased body fat, and improved metabolic profile (i.e., improved glucose control and lipid levels). in addition, supervised rt improved muscle strength and functional capacity in patients with obesity undergoing bariatric surgery. however, although rt has been widely studied in obesity, there is little information in the morbid obesity. on the other hand, there is poor knowledge similarly, about the interindividual variability to exercise training in terms of responders and non-responders (nr). thus, considering the poor knowledge about the mets prevention in morbid obese patients, as well as the little information about responders and non-responders for improving mets outcomes, the aim of this study will be determine the effects of a rt program on cardio-metabolic outcomes of mets in patients with morbid obesity. a second aim will be report the prevalence of non-responders in terms of the effects of resistance training on mets markers and other health-related variables.

Eligibility criteria:
inclusion criteria: inclusion criteria: * older than 18 and younger and ≤65 years of age. * with risk factors to metabolic syndrome * with obesity and morbid obesity condition * medical authorization by a physician. exclusion criteria: * physical limitations (e.g., restricting injuries of the musculoskeletal system, or dependent of a third person). * exercise-related dyspnoea or respiratory alterations. * chronic heart disease with any worsening in the last month. * adherence rate of less than 80% of the total interventions.
stress & social cognition in bpd (part 2)

Conditions: Borderline Personality Disorder

Summary: the investigators will examine how a combination of pharmacological mineralocorticoid receptor (mr) stimulation and psychosocial stress will influence prosocial behavior in patients with borderline personality disorder (bpd) compared to healthy controls (hc).

the investigators will examine whether mr stimulation enhances prosocial behavior in bpd patients under additional psychosocial stress. participants will be randomly assigned to receive either fludrocortisone as an mr stimulant or placebo. afterwards, participants will either undergo the stress or placebo condition of the trier social stress test ((p-)tsst). subsequently, cognitive and emotional empathy, as well as sharing and punishment behavior will be measured.

Eligibility criteria:
inclusion criteria "bpd group": * clinical diagnosis of borderline personality disorder * female * bmi between 17.5-30 inclusion criteria "control group": * female * bmi between 17.5-30 * no clinical diagnosis of any mental disorder exclusion criteria: * acute depressive episode, * acute or lifetime psychotic symptoms * acute substance abuse * physical illness
study of feasibility and efficacy of telecommunication platforms as an adjunctive clinical tool for a parkinson's disease clinic

Conditions: Parkinson Disease

Summary: telecommunication platforms are new technology founded to build better short messages service alternative. their use have increasingly drawn a wider range of interest as a text communication and video chat system between health care professionals and patients and health care professionals themselves. however, high-quality and adequately evaluated research, especially in the field of neurodegenerative diseases such as parkinson´s disease, is needed to establish whether patients with these specific neurological problems can be effectively managed with these technological tools in low, middle, and high-income countries

telecommunication platforms are new technology founded to build a better short message service alternative. their use have increasingly drawn a wider range of interest as a text communication and video chat system between health care professionals and patients and health care professionals themselves. however, high-quality and adequately evaluated research, especially in the field of neurodegenerative diseases such as parkinson´s disease, is needed to establish whether patients with these specific neurological problems can be effectively managed with these technological tools. in this study, patients with parkinson´s disease from high, middle, and low-income countries covering urban and rural populations, with at least one neurologist with movement disorders practice (spain, uruguay, saudi arabia, nigeria, tanzania, south korea, united states, egypt), will be included. feasibility, clinical management, providers and patient´s satisfaction will be compared between in-office vs. telemedicine (virtual) visits. this study will show the effectiveness of telemedicine, when the access to specialized neurological care is limited, especially now with the covid-19 pandemic.

Eligibility criteria:
inclusion criteria: * patients diagnosed with idiopathic parkinson´s disease, able to use a smart phone and running videoconferences, with easy access to wifi. exclusion criteria: patients with severe ambulatory problems that will interfere with in-office visits, without access to internet, with limited technical knowledge unable to use telecommunication platforms, or patients diagnosed with other types of parkinsonism.

Keywords: telemedicine cost-effectiveness
pmcf study to examine the debridement pad cutimed debriclean

Conditions: Wound

Summary: documentation of the performance and safety of the debridement pad cutimed debriclean in daily clinical practice

60 subjects with superficial wounds in need of debridement will undergo mechanical debridement with the study product. per subject, one application of the study product will be documented including photo documentation of the wound and evaluation of the wound bed condition and wound size before and after the debridement.

Eligibility criteria:
inclusion criteria: * male or female subjects aged 18 years or older with full legal competence * signed informed consent * subjects with wounds in need of debridement, especially diabetic ulcers, venous and arterial ulcers, pressure sores, postoperative wounds and wounds healing by secondary intention, superficial burns * superficial wound * minimum 30 % of the wound is covered by debris, necrosis or slough * wound size \> 4 cm² exclusion criteria: * subjects not willing to participate or to attend the scheduled study visit * known sensitivity or allergy to the product components * severe pain or hyperaesthesia in the wound area * patients who are pregnant or lactating * drug abuse or alcohol abuse * patients who participate in any other clinical study investigating drugs or medical devices

Keywords: debridement
zona pellucida thinning versus drilling during laser-assisted hatching

Conditions: Infertility

Summary: two hundred cycles will be enrolled (100 laser-assisted thinning and 100 laser-assisted drillings). they will be compared regarding the implantation and clinical pregnancy rates

two hundred cycles will be enrolled (100 laser-assisted thinning and 100 laser-assisted drillings). all study participants will undergo controlled ovarian stimulation by gnrh agonist long protocol starting from mid-luteal phase. the complete pituitary suppression will be confirmed by serume2 level less than 30 pg/ml and serum lh level less than 2 miu/ml, then gonadotropin therapy will be started from day 2 to the day of maturation confirmed by the presence of 3 mature follicles or more, one of them 18 mm; at this time 10000 iu of hcg will be administered then ovum pick up done 36 hours after hcg administration under transvaginal ultrasound guidance cumulus cell masses around the oocytes will be removed using pull-and-cut denudation pipettes in a 5-well culture dish (mtg, bruckberg, germany) containing 27 iu/ml of hyaluronidase. all oocytes that will be mature at 4-6 h after oocyte collection will be inseminated according to the quality of the spermatozoa and oocytes and the patient's previous ivf history. fertilization will be confirmed 17-18 h after insemination by the presence of two distinct pronuclei. zygotes will be cultured in 30-μl micro-drops with a 1-step medium and overlaid with paraffin oil in an atmosphere of 6% co2, 5%o2, and 95% humidity at 37 °c. the available embryos will be assessed in all patients according to the criteria of equal and regular blastomeres, a viable blastomere number, and fragmentation ratio. lah will be conducted using a laser system with a 1.48-μm diode-laser at 300 m w through thinning or drilling. the embryos will undergo either lat or lad in 10- to 20-μl micro-drops consisting of g-mops plus medium. the embryos will be fixed in the micro-drops on the inverted microscope. the size of one laser shot will be 5μm in the zp using the same total number of 3000-μs pulses. in lat, the goal of the thinning method is to make the outer portion of the outer protective glycoprotein layer thinner. the laser thinning will be performed by making 2-3 holes without reaching the inner membrane at a depth of60-80% of the zp thickness. in lad, the laser opening will be made from the outside to the inside of the zp. the laser beam shot towards the zp above the perivitelline space between two blastomeres to minimize the risk of harming the embryo, under careful control. the embryos in the micro-drop will be washed several times after lah and then transferred to a 1-well dish (falcon 353,653, usa) containing g-2 culture medium. lah was performed 2 to 3 h before embryo transfer. the embryos will be cultured in an atmosphere of 6% co2, 5% o2, and 95% humidity at 37 °c.

Eligibility criteria:
inclusion criteria: * patients who have a previous icsi failure, unexplained infertility or male infertility exclusion criteria: * patients with hydrosalpinx, pyosalpinx, endometriosis, or uterine fibroids
synergistic bilateral upper-limb stroke rehabilitation based on robotic priming technique

Conditions: Stroke Rehabilitation

Summary: this comparative efficacy study will be based on a 3-armed controlled trial: bilateral robotic priming combined with bilateral arm training (bilateral rt+bat), bilateral robotic priming combined with mirror therapy (bilateral rt+mt), and the control intervention (bilateral rt+iot). the goal of this 4-year project is to provide scientific evidence of the comparative efficacy research of hybrid interventions based on unilateral vs. bilateral approach to upper limb rehabilitation in subacute and chronic stroke.

this proposed research fits in the nhri research priority 4-1 by addressing innovative treatment strategies for stroke that is in desperate need of scientific scrutiny. stroke is one of the major medical conditions that lead to long-term disability and causes heavy health care and financial burden. advances in clinical and translational neurosciences have led to the new development of stroke rehabilitation. current stroke rehabilitation programs such as robotic therapy, mirror therapy, and bilateral arm training are bilateral approaches to intensive practice based on the tenet of practice-dependent neuroplasticity. bilateral robotic therapy can potentially be a movement-based priming technique to promote rebalancing of cortical excitability and create an enriched neuroplastic environment by priming the brain to facilitate motor and functional recovery. this proposed research project will: (1) examine the effects of bilateral robotic priming combined with bilateral arm training approach versus bilateral robotic priming combined with mirror therapy, relative to the control intervention approach (bilateral robotic priming combined with impairment-oriented training) on sensorimotor function, daily function, self-efficacy, quality of life, and motor control strategy in patients with stroke, (2) investigate the 3-month retention effects of robotic priming combined with contemporary rehabilitation approaches (i.e., bilateral arm training and mirror therapy) and the control intervention, and (3) identify the potential predictors of functionally relevant changes after therapy.

Eligibility criteria:
inclusion criteria: (1) ⩾3 months onset from a first-ever unilateral stroke; (2) age range from 18 to 80 years; (3) baseline upper extremity motor score on the fugl-meyer assessment \>10 (fugl-meyer et al., 1975); (4) no severe spasticity in any joints of the affected arm (modified ashworth scale ⩽ 3) (charalambous, 2014); (5) able to follow study instructions (mini mental state examination score ⩾24) (skidmore et al., 2010); (6) no serious vision deficits and no other neurologic or major orthopedic diseases; (7) able to participate in a rehabilitation intervention program for 6 weeks; and (8) no participation in other studies during the study period and willing to provide written informed consent. exclusion criteria: (1) acute inflammation and (2) major medical problems or poor physical conditions that might interfere with participation.

Keywords: stroke, robot-assisted therapy, mirror therapy