Kornimate/medical-research-clean huggingface dataset:
the efficacy and safety of tacrolimus in treated refractory focal segmental glomerulosclerosis

Conditions: FSGS

Summary: this is a prospective,multicentre study to compare the efficacy, safety, tolerability and relapse of fk506 versus ctx in the treatment of severe focal segmental glomerulosclerosis (fsgs).

1. using the response rate and completely response time to compare the efficacy of fk506 versus ctx therapy for the severe fsgs patients. 2. to compare the safety and tolerability of fk506 versus ctx for the severe fsgs patients.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of fsgs. * patients with a proteinuria ≥ 3.5g/24h,and blood albumin \ 30ml/min per 1.73m2. * patients who signed written informed consent form (patients less than 18 years old with their parents/legal representative's signatures), and have given their consent to follow all study procedures and follow-up. exclusion criteria: * patients who have received treatment of fk506 in latest 2 month or the cumulative dose ctx≥6 g. * patients who are known to be allergic to a macrolide. * patients who have active hepatitis. * patients who have impaired liver function, with alt/gpt or ast/got twice more than the normal upper limit . * patients with blood leukocyte \< 3000/ul. * patients with kidney disease family history * patients with 2 type diabetes. * patients with obesity whose bmi\>28kg/m2.

Keywords: fsgs fk506 ctx
possible effects of energy drink ingestion on perceived alcohol intoxication

Conditions: Perceived Alcohol Intoxication

Summary: the purpose of this study is to determine whether the ingestion of caffeine, energy drinks has an effect on perceived alcohol intoxication.

in each of the four study periods, subjects will receive one of the four study treatments in a double blind, randomised, manner. the effects of study treatment on alcohol intoxication will be determined by measurement of breath alcohol concentration and subjective effects of intoxication. safety and tolerability will be monitored by measurement of vital signs, in particular pulse, and review of adverse events.

Eligibility criteria:
inclusion criteria: * healthy male volunteers * able and willing to comply with the requirements of the study, confirmed by written informed consent * aged 20 to 26 years * within acceptable range for weight and body mass index (70-85 kg and 21 to 25 kg/m2) * at least 12-14 years of formal education * in good general health as determined by medical history and screening investigations (see below) * taking no regular medication * no history of psychiatric disorders * moderate alcohol consumption (less than 190.4 g/week) according to the daily drink questionnaire (collins et a., 1985) * "sporadic" users of energy drinks (fewer than 10 cans of 250 ml in the last 6 months) * confirmation that the general practitioner/primary care physician knows no reason that would prevent their participation * similar in social and demographic data, similar quality of life * similar patterns of use of alcoholic beverages and energy drinks as well as quality of life (martinez et al., 2000) * similar level of physical activity (physical activity questionnaire) (baecke et al., 1982) exclusion criteria: * any condition that the investigator and/or sponsor consider might increase the risk to the volunteer or decrease the chance of obtaining satisfactory data * consumed 2\>x\>4 caffeine-containing drinks/day within 3 months of screening * smoked \>10 cigarettes/day or equivalent within 3 months of screening * consumed more than 190.4 g alcohol per week, or have a history of alcohol or drug abuse or * consumed less than one alcoholic drink per week

Keywords: energy drinks alcohol intoxication
the effect of telerehabilitation-based structured exercise program in video game-addicted adults

Conditions: Video Game Addiction

Summary: the increasing use of computers and mobile devices due to advancing technology has brought with it some negative consequences such as video game addiction. research has shown that playing video games for too long can lead to a number of acute and chronic serious musculoskeletal problems that can negatively affect health. the aim of the present study is to investigate the effect of telerehabilitation-based structured exercise program in video game-addicted adults and compare these effects with the effect of brochure-based exercise. postural assessments, pain assessments, fine motor skill assessments, grip strength measurements, and reaction time assessments were performed. all assessments were repeated before and after the 8-week program for both groups. participants in the eg were given a telerehabilitation-based structured exercise program for an average of 40 minutes three days a week for 8 weeks. participants in the cg were given brochure-based exercises three days a week for 8 weeks.


Eligibility criteria:
inclusion criteria: * being between 18-40 years old * having a score of ≥30 on the game addiction inventory for adults (gaia) * volunteering to participate in the study * having high-speed internet, a camera, and a microphone exclusion criteria: * having a neurological/orthopedic condition that would prevent exercise * having a cognitive impairment * having a vision or hearing loss
sp16 serpin-like peptide administration in healthy individuals

Conditions: Healthy Participants

Summary: this study is a randomized, double-blind, placebo-controlled phase 1 clinical trial of 24 healthy individuals to test the safety, tolerability and pharmacokinetics of a single subcutaneous administration of serpin peptide 16 (sp16), a serine protease inhibitor (serpin)-like, small peptide agonist of the low density lipoprotein receptor-like protein 1 (lrpp1) hypothesized to have anti-inflammatory activity.

one of the major determinants for outcome in patients with acute myocardial infarction (ami) is the degree of inflammatory response. sp16 is a synthetic anti-inflammatory peptide developed to reproduce the anti-inflammatory activities of naturally occurring serpins and has been tested as a treatment for ami in mice. this phase i trial will be the first to test the hypothesis that a single subcutaneous administration of sp16 is safe and well tolerated in healthy individuals, while also assessing the pharmacokinetic parameters of three different dosages. participants will undergo direct clinical monitoring for up to 12 hours after drug administration. additionally, participants will follow up with the same assessments at 24 hours, 48-72 hours and 7 days post drug administration.

Eligibility criteria:
inclusion criteria: * written informed consent * age 18 to 59 years * stated willingness to comply with all study procedures and availability for the duration of the study * ability to take oral medication and be willing to adhere to the medication regimen * for females of reproductive potential: use of highly effective contraception * for males of reproductive potential: use of condoms exclusion criteria: * acute or chronic illness affecting organ function or requiring medications (including, but not limited to, cardiovascular, hepatic, renal hematologic, neurologic, dermatologic, psychiatric, or rheumatologic disease); * febrile illness within the previous 14 days; * known allergic reactions to components of the study agent; * treatment with another investigational drug or other intervention within 30 days; * current tobacco use or tobacco use within 60 days; * household contacts who are immunocompromised; * chronic infection(s) (of any kind); * malignancy (of any kind); * substance abuse disorder(s); * pregnancy or breastfeeding; * any other conditions that would place the subject at increased risk of adverse events or interfere with the conduct or interpretation of the study, in the opinion of the investigators.

Keywords: acute myocardial infarction inflammation
efficacy study of panax ginseng to boost antipsychotics effects in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder; Tardive Dyskinesia; Insulin Resistance; Obesity

Summary: the objective of the study is to determine whether panax ginseng with multiple interactions with key components of brain signaling pathway, can augment the effects of antipsychotics in schizophrenia. we are primarily interested to examine the actions of ginseng combined with antipsychotics in improving the ways patients diagnosed with schizophrenia behave in social environment, store, process and retrieve information.

schizophrenia is a serious mental disorder affecting individuals in multiple ways: behavior control, emotional and information processing and the functional levels conforming to societal norms. despite recent advances in medication therapy in treating the target symptoms of schizophrenia , subsets of patients diagnosed with schizophrenia continue to exhibit negative symptoms ( social withdrawal,apathy, lack of drive )and cognitive impairment (memory, attention, judgment and reasoning). recently, there has been interest to explore the efficacy of avenue of dietary and herbal supplements with known pharmacological actions in treatment and prevention of neuropsychiatric disorders, especially bipolar and schizophrenia. we hypothesize that panax ginseng , with multiple interactions with chemical pathways in the brain described as neurotransmitter systems (dopamine, gaba and nmda ) can improve the residual symptoms of schizophrenia when added to the antipsychotics currently used in the treatment of schizophrenia. furthermore, in view of previous studies of ginseng in enhancing memory , we hypothesize that the standardized formulation of ginseng (ginsana-115 from boehringer ingelheim-pharmaton,switzerland ) will optimize the antipsychotics in cognition impairment and negative symptoms. in the 18-week rct cross-over study, schizophrenic subjects will be treated with either ginsana-115 ( 100 mg or 200 mg by oral route) or placebo in a cross-over design. we plan to recruit 60 subjects diagnosed as schizophrenia from the four sites : london-st. thomas, ontario, canada; kingston ontario canada; thunderbay, ontario canada and middlesex, united kingdom.

Eligibility criteria:
inclusion criteria: * male or female * age 18-65 years * dsm-iv diagnosis of schizophrenia * sans score greater than 30 exclusion criteria: * current (past 12 months) substance use disorder * except nicotine dependence * major medical disorders : hematological disorder * chronic active hepatitis, acute hepatitis, cirrhosis of liver, aids * pregnancy and breast-feeding * neurological disorders including epilepsy * traumatic brain injury * ham-d score greater than 24

Keywords: negative symptoms schizophrenia atypical antipsychotics neurocognition impairment obesity risk factor diabetes insulin resistance schizophrenia
double-blind, multicenter study to assess the efficacy of bilateral pallidal stimulation in patients with medically refractory primary cervical dystonia

Conditions: Cervical Dystonia

Summary: the purpose of this study is to investigate the efficacy and safety of bilateral pallidal stimulation in patients with medically refractory primary cervical dystonia.

primary cervical dystonia (cd) affects about 20-40/100.000 population. the disease is chronic and life-long. the therapy of choice are local intramuscular botulinum toxin injections given every three months. oral medication such as anticholinergics or dopamine depleting drugs are usually of limited efficacy or their use is limited by intolerable side-effects. about 5-10% of cd patients develop neutralizing antibodies against botulinum toxin. two previous controlled multicenter trials have shown the efficacy and safety of bilateral pallidal stimulation in patients with primary segmental and generalized dystonia (one study was performed by our group). following surgery, patients will be randomized 1:1 to verum or placebo stimulation for a period of three months. primary outcome measure is the twstrs (toronto western spasmodic torticollis rating scale) - a validated and widely accepted physician-based outcome measure for cervical dystonia. the independent twstrs raters are movement disorders specialists unaware of the stimulation status (verum/placebo) and they compare the twstrs-score at baseline and 3-months follow-up. our hypothesis is that stimulated patients will have a significantly better improvement of dystonia as compared to those without stimulation (placebo group). after the 3-months period, all patients are unblinded and receive continuous effective stimulation by the implanted system. regular follow-up visits are scheduled every 12 months for 5 years postoperatively to assess the long-term efficacy of pallidal stimulation. side-effects are assessed in a standardized way and include the assessment of surgery-induced as well as stimulation-induced side-effects.

Eligibility criteria:
inclusion criteria: * primary cervical dystonia * disease duration 3 years or longer * adult patient (18 years or older) * twstrs severity score 15 or more * non-response to botulinum toxin * non-response to oral antidystonic medication * informed consent exclusion criteria: * dementia (mattis dementia rating scale below 120) * severe depression (beck depression inventory \>25) * previous functional stereotactic surgery * hemidystonia or generalized dystonia * severe brain atrophy * contraindication against surgery

Keywords: cervical dystonia torticollis deep brain stimulation pallidal stimulation globus pallidus internus
effects of tupler's technique on the management of diastasis rectus abdominis.

Conditions: Diastasis Rectus Abdominis

Summary: diastasis rectus abdominis is the condition in which two abdominal muscles rectus abdominis separated and cause widening and thinning of linea alba. the tupler's technique is evidence based intervention for the management of diastasis rectus abdominis. the purpose of this study is to see the effectiveness of tupler's technique on the management of diastasis rectus abdomins in post-partum females.

literature suggest that during pregnancy due to hormonal changes such as increased in relaxin, estrogen and progesterone level and also increased in the size of uterus affect the aponeurosis connection of abdominal muscles and due to these changes diastasis rectus abdominis is common during pregnancy especially in third trimester and in the post-partum period. we can measure diastasis rectus abdominis by different methods such as palpatory, caliper and ultrasound. the condition can be mild (two fingers gap), moderate (two to three fingers gap) and severe (more than three fingers gap). the separation of greater than 2cm is considered as diastasis rectus abdominis. in this study effectiveness of tupler's technique will be assessed in post-partum diastasis rectus abdominis patients. patients will have to wear diastasis rehab splints and then perform tupler's technique exercises. the mechanism behind this is when patients wear splint the splint will keep the connective tissues in narrow position for better healing and strengthening of muscles will be done by tuper's technique exercises and diastasis of rectus abdominis willl be treated.

Eligibility criteria:
inclusion criteria: * primiparous and multiparous females (vaginal delivery). * greater than and equal to 12 weeks post-partum * age limit will be18-30 years * bmi under or equa to 29kg/m2 * visiting with the complain of low back pain * diastasis of rectus abdominis at the level of umbilicus with mild, moderate and severe condition. exclusion criteria: * other musculoskeletal disease (disc prolapse and disc bulge) * trauma of bowel and bladder * heart and respiratory conditions including sneezing and excessive coughing * any pelvic floor, abdominal and spinal surgery

Keywords: diastasis rectus abdominis post-partum period tupler's technique abdominal strength
a new classification and interventional therapy for coronary artery ectasia

Conditions: Coronary Artery Ectasia

Summary: this study is aim to present a new classification for coronary artery ectasia and find the best interventional therapy for different types of patients were treated and studied.

coronary artery ectasia refers to a variety of reasons cause coronary artery expansion, its diameter is more than 1.5 times that of the adjacent normal coronary artery. clinical symptoms include angina, myocardial infarction and sudden death.at present, there is no consensus on the mechanism and treatment of the disease, which may be related to the structural failure of the vessel wall and abnormal hemodynamics in the dilated segment.most of the existing studies are case reports or single-center retrospective analysis of small samples, with low level of evidence.as a common fluid analysis method in the field of engineering, computational fluid dynamics can effectively simulate the movement and stress state of blood under reasonable model assumptions.by comparing the preoperative and postoperative data of real cases, the validity of simulation analysis results can be tested.the purpose of this study is to carry out a multi-center study combining morphological and hemodynamic factors, to propose a new classification and interventional treatment strategy for atherosclerotic coronary artery ectasia, and to provide evidence-based medical evidence for the development of treatment guidelines.

Eligibility criteria:
inclusion criteria: * male or non-pregnant female aged ≥18 years; * coronary artery ectasia was confirmed by coronary ct or coronary angiography; * the patient (or guardian) is fully aware of the study process and signs the informed consent; * patients were able to undergo subsequent follow-up. exclusion criteria: * congenital coronary artery fistula; * kawasaki disease; * treponema pallidum or lyme treponema; * marfan; * primary lymphoma; * coronary artery pseudoaneurysm; * acute infectious disease or autoimmune disease; * hematological disease; * severe liver and kidney dysfunction (ami one week later, alanine transaminase ≥3 times the upper limit of normal value; creatinine clearance rate ≤30ml/min or blood creatinine ≥2.5mg/dl); * unstable craniocerebral disease; * cancer; * severe cognitive impairment (dementia or severe mental illness); * patients with severe physical disabilities who cannot be followed up regularly; * other serious uncontrolled systemic diseases; * female patient who is ready to become pregnant, already pregnant or nursing; * contraindications to percutaneous coronary intervention (pci) : for patients at high risk of massive bleeding in the digestive tract, intracranial and other areas, or allergic to contrast agents; * cannot tolerate dual antiplatelet therapy for at least 1 year; * age \< 18 years old; * patients who are unable or unwilling to sign informed consent

Keywords: coronary artery ectasia new classification interventional therapy coronary artery aneurysm
peri-operative application of eyeprotx general anesthesia goggles as prevention against corneal injury post intubation.

Conditions: Corneal Injuries

Summary: this is a randomized controlled trial that seeks to examine the effectiveness of eyeprotx™ protective goggles in comparison to traditional methods against ocular injury that can occur perioperatively under general anesthesia.

ocular injury is but a devastating condition that can occur perioperatively under general anesthesia. corneal abrasion is the most common ocular injury during general anesthesia, surpassing case incidence of damage caused by patient movement in ophthalmologic surgery. causes of ocular injury include corneal drying due to the suppression of tear ducts from anesthetic agents, direct physical trauma, or agitation from the volatile anesthetic used. ocular injury may also occur due to bacterial infection with mrsa, preventative methods, or rubbing of the eyes postoperatively due to agitation. agitation may be caused by corneal drying or by shift or disruption in rapid eye movement sleep cycle from light penetration through the eyelids. attempts at prevention of corneal abrasion have been used, including taping the eyelids shut, manual eye closure, paraffin-based ointment application into the conjunctival sac, and the use of hydrophilic contact lenses, although only a few studies have validated the comparison of these methods' effectiveness. eyeprotx™ protective goggles have been designed specifically for use in the operating room or in any scenario where general anesthesia must be used, such as intubation in an emergency. current ocular protective measures such as tapes during anesthesia have been associated with injury and infection. with this study, we hope to find a safer preventative technique against ocular injury during the perioperative period.

Eligibility criteria:
inclusion criteria: * patients undergoing general anesthesia * patients admitted to jackson memorial hospital exclusion criteria: * patients unable to communicate, for whatever reason * patients predisposed to eye conditions * patients with history of increased intraocular pressure * patients with a medical history of sicca syndrome * patients with claustrophobia * patients with pseudoexfoliation syndromes * patients with a current exopthalmic condition
minimally invasive pancreatoduodenectomy for distal cholangiocarcinoma

Conditions: Distal Cholangiocarcinoma

Summary: outcomes for minimally invasive and open pancreatoduodenectomy for distal cholangiocarcinoma have not been compared. this is an international multicenter propensity score matched cohort study including patients after mipd or opd for dcca. primary outcomes included overall survival (os) and disease-free interval (dfi).

this study is an international multicenter propensity score matched cohort study using the database of the international study group on non-pancreatic periampullary cancer, the isgaca consortium (www.isgaca.com), including all patients who underwent a pancreatoduodenectomy for non-pancreatic periampullary cancer. data will be retrospectively collected. to minimize differences between groups, all the participating centers perform both opd and mipd and all centers meet the miami guideline minimum volume of at least 20 mipd per year. this study is approved by all the locals ethical committees (approval number from the promoting center, comitato etico di brescia, np 5318 - 01.06.2022) and it will be performed according to the strengthening the reporting of observational studies in epidemiology (strobe guideline and checklist), and the declaration of helsinki.

Eligibility criteria:
inclusion criteria: * adult patients * elective upfront curative mipd or opd between january 1, 2010 and december 31, 2021 * pathological confirmed dcca exclusion criteria: * neoadjuvant chemotherapy * palliative surgical procedures * intraoperative detection of unresectable disease (i.e., metastasis or locally advanced disease) * post-operative pathological diagnosis was other than dcca (e.g., neuroendocrine tumor, polyposis adenoma) * r2 positive resection margin * pregnancy * missing primary endpoints

Keywords: minimally invasive pancreatoduodenectomy whipple distal cholangiocarcinoma survival