Kornimate/medical-research-clean huggingface dataset:
clinical trial to analyze lateralized models and medializations of inverted arthroplasty.

Conditions: Rotator Cuff Arthropathy; Glenohumeral Osteoarthritis

Summary: to determine the functional outcomes, complications and muscle performance by isokinetic study of two reverse arthroplasty systems (one with medialized center of rotation and the other with lateralized center of rotation) in the treatment of rotator cuff arthropathies or irreparable cuff tears.

this is an experimental, prospective, unblinded, randomized, comparative clinical trial between patients with two types of prosthetic implants (inverted arthroplasty with medialized center of rotation vs inverted arthroplasty with lateralized center of rotation). those male or female patients who meet the inclusion criteria will be selected to form part of one of the two randomly distributed study groups. sample size based on studies with similar characteristics but where lateralization is not performed with the implant but with a bone graft would require a sample size of 34 patients (17 in each group) assuming 20% losses with a type i error of 0. 05 and a statistical power of 80% to show a difference of 10 points on the constant scale (the minimal clinically important difference on the constant scale for reverse arthroplasty is described as 8 points in previous comparative studies so we consider the detection of a difference of 10 to be sufficient. the minimal clinically important difference for function and strength in patients undergoing reverse shoulder arthroplasty. the final n needed would be 42 patients (21 per group). a randomization of patients will be performed to assign them to one or the other study group, which will be carried out by an independent assistant, who will generate a random sequence that will be unknown to the investigators. each patient will be given a sealed and numbered envelope to choose from, in which the randomized group in which he/she has been included will be determined. the study will be blinded for the patient and rehabilitator but not for the surgeon.

Eligibility criteria:
inclusion criteria: 1. male or female patients over 65 years of age with rotator cuff arthropathy refractory to conservative treatment after six months. 2. ability to understand the information sheet, informed consent and evaluation scales. exclusion criteria: patients with sequelae of fractures, rheumatoid arthritis, avascular necrosis, primary glenohumeral arthrosis, revision surgeries that have required conversion to a athi 3. patients in whom another surgical procedure has been associated with athi such as a tendon transfer 4. glenoid bone defects in the horizontal plane (type b2 and c of the walch classification) or in the vertical plane (e3 sirveaux).
quick skin sealant in closure of surgical wound after laparoscopic surgery

Conditions: Complications of Surgical Procedures; Surgical Site Infection; Gastric Cancer; Colorectal Cancer; Gastrointestinal Stromal Tumor; Inflammatory Bowel Disease; Diverticula

Summary: the purpose of this study is to evaluate the short-term effect of sealant-assisted skin closure in prevention of surgical site infection after laparoscopic surgery.

* study design: a prospective cohort study * populations: patients who have confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor (gist), inflammatory bowel disease and diverticula decide to receive laparoscopic surgery. * surgical techniques: laparoscopic operations should be successfully performed with a 3-4 cm minimal incision left for sample retrieval. in all, about five trocar-associated mini incisions and a sample-retrieval incision would be left prior to skin closure. * skin closure: a quick skin sealant would be applied to achieve a seal, without any suture made under the skin. * postoperative treatment: an enhanced recovery after surgery (eras) bundles would be applied for enrolled subjects. as for wound management, additional wound cares are not required. patients can take shower at postoperative day 3 (pod3). * primary endpoint: the primary study endpoint is freedom from surgical site infection (ssi) within 30 days. the incidence of surgical site infection with the first 30 days after surgery would be explored.

Eligibility criteria:
inclusion criteria: * the informed consent has been obtained from the patient. * with confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor, inflammatory bowel disease and diverticula. * endurable laparoscopic surgery without conversion. * with moderate/good ecog health rating (ps): 0-1 score. exclusion criteria: * pregnant woman or lactating woman. * with confirmed distant metastasis in liver, lung, bones, or other organs. * intolerable laparoscopic operation or converted to open surgery. * with severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction. * with bad compliance or contraindication to enrollment.

Keywords: skin sealant laparoscopic surgery surgical site infection wound healing
mobility training using a bionic knee orthosis in patients chronic post-stroke: a case series

Conditions: Stroke

Summary: this pilot study examined the effect of task-oriented mobility training in three persons chronic post-stroke using a novel, wearable, mobile intention-based robotic orthosis (tibion bionic leg).


Eligibility criteria:
inclusion criteria: * male or female * aged 40 to 60 years * one year status post-stroke * able to walk at least 10 meters * independence in self-care exclusion criteria: * medically unstable * major cardiopulmonary deficiency * major depression * significant cognitive deficit * currently receiving gait training * younger than 40 years of age * older than 60 years of age * unable to walk at least 10 meters

Keywords: stroke tibion bionics rehab therapy robotics intention
nmes for rehab after surgery

Conditions: Surgery; Vascular Diseases

Summary: a randomised pilot study assessing the acceptability and feasibility of utilising neuromuscular stimulation devices to enhance post-operative rehabilitation and recovery after general, vascular and urological surgery procedures.

patients undergoing inpatient rehabilitation after general, vascular or urological surgery will be invited to take part in a randomised study utilising either sham or active neuromuscular stimulation devices to enhance post-operative rehabilitation and physiotherapy.

Eligibility criteria:
inclusion criteria * medically stable after index surgery * willing and able to participate in study protocol * all ethnic groups, male or female above the age of 18 years * baseline rockwood frailty score of 3 or greater exclusion criteria * inability or unwillingness to participate in trial * implanted electrical device such as pacemaker or defibrillator. * pregnant * acute deep vein thrombosis * previous use of nmes device

Keywords: rehabilitation
gene therapy for wiskott-aldrich syndrome

Conditions: Wiskott-Aldrich Syndrome (WAS)

Summary: this is phase i/ii protocol to evaluate the safety and efficacy of was gene transfer into hematopoietic stem/progenitor cells for the treatment of wiskott aldrich syndrome.

wiskott-aldrich syndrome (was) is an x-linked primary immunodeficiency caused by mutations in the was gene which encodes the was protein (wasp), a cytoskeletal regulator which is expressed exclusively in hematopoietic cells.

Eligibility criteria:
inclusion criteria: 1. diagnosis of was defined by genetic mutation and at least one of the following criteria: * severe was mutation * absence of wasp expression * severe clinical score (zhu clinical score ≥ 3 2. no hla-identical sibling donor 3. negative search for a matched unrelated donor (10/10) or an adequate unrelated cord blood donor (5-6/6) within 4-6 months * patients of \> 5 years of age who are not candidate to unrelated allogeneic transplant based on clinical conditions. 4. parental/guardian/patient signed informed consent. exclusion criteria: 1. patients positive for hiv-infection. 2. patients affected by neoplasia. 3. patients with cytogenetic alterations typical of mds/aml. 4. patients with end-organ functions or any other severe disease which, in the judgement of the investigator, would make the patient inappropriate for entry into this study. 5. patients who underwent an allogeneic haematopoietic stem cell transplantation in the previous 6 months. 6. patients who underwent an allogeneic haematopoietic stem cell transplantation with evidence of residual cells of donor origin.

Keywords: lentiviral vector gene therapy wiskott-aldrich syndrome tlt003 previously gsk2696275 previously otl-103
fructose extra-splanchnic metabolism and its effects on systemic flux of substrates (frupp)

Conditions: Test Meal

Summary: in parallel to the dramatic rise in metabolic diseases and diabetes observed over the past fifty years, the generalization of added sugar in processed food led to a marked increase in fructose consumption in almost all countries, and epidemiological studies demonstrated that the consumption of sugar-sweetened beverage (containing at least 50% of fructose) is associated with the development of diabetes, hepatic steatosis, dyslipidemia and obesity. the objective of the study is to measure the amount of fructose that escape first-pass hepatic extraction after oral ingestion (fructose+glucose), and gain insights into its metabolic fates with the use of tracers.


Eligibility criteria:
inclusion criteria: * aged from 18 to 40 years * body mass index of 18.5 to 25 kg/m² * sex male of female exclusion criteria: * fructose intolerance * antidiabetic and hypolipemic drugs * alcohol consumption \>10g/day * severe eating disorders * severe psychological problems * vegetarian diet or other specific diet * consumption of illicit substances * pregnancy * weight gain or weight loss \> 3 kg in the last 3 months

Keywords: fructose obesity metabolism post-prandial kinetics
vimpat® added as adjunctive therapy to one baseline antiepileptic drug

Conditions: Epilepsies, Partial

Summary: the purpose of this study is to systematically and prospectively collect data from patients with partial-onset seizures in routine clinical practice setting receiving adjunctive vimpat®. the observed population will be only patients with one baseline antiepileptic drug. seizure control and tolerability data will be evaluated.


Eligibility criteria:
inclusion criteria: * the patient's treatment must be in accordance with the local marketing authorization (ma) for vimpat® * the decision to prescribe vimpat® has to be made by the physician before and independently of his/her decision to include the patient in the study * the vimpat® treatment should have been started not longer than 2 weeks before study inclusion of the patient * the patient must have a diagnosis of epilepsy with partial-onset seizures * based on the physician's clinical judgment, the patient's seizure activity is not controlled sufficiently on a current monotherapy and it is in the patient's best interest to be prescribed adjunctive vimpat® exclusion criteria: in accordance with the summary of product characteristics (smpc)

Keywords: lacosamide vimpat® epilepsy partial-onset seizures adjunctive therapy
metaplasticity experimental design and comparison of motor outcome measure sensitivity to change

Conditions: Healthy

Summary: the overall objective is to validate the methodology of a metaplasticity experimental design by assessing change in motor excitability after administration of priming transcranial direct current stimulation (tdcs) followed by repetitive transcranial magnetic stimulation (rtms) in healthy human participants.

the overall objective is to validate the methodology of a metaplasticity experimental design by assessing change in motor excitability after administration of priming transcranial direct current stimulation (tdcs) followed by repetitive transcranial magnetic stimulation (rtms) in healthy human participants. our primary objective is to compare pre- and post-measures of cortical excitability before priming tdcs (anodal, cathodal or sham) \[m1\], directly after priming tdcs \[m2\], directly after inhibitory rtms \[m3\], and 10 minutes after inhibitory rtms \[m4\]. our secondary objective is to evaluate the sensitivity of motor excitability outcome measures response to the noninvasive neurostimulation (e.g. rtms and tdcs). we also aim to compare pre- and post- measures of cortical excitability after inhibitory and excitatory priming of the motor cortex, and to evaluate the sensitivity of motor outcome measures to changes in cortical plasticity.

Eligibility criteria:
inclusion criteria: * must be at least 18 years of age (all genders, races, ethnicity) * must have no current psychiatric or neurologic issues * must not have any conditions listed in exclusion criteria * must be fluent in english exclusion criteria: * history of major psychiatric illness * actively using neuropsychoactive medication * legal or mental incompetency * substance use disorder, abuse or dependence, with active use within the last three months * significant medical or neurological illness * prior neurosurgical illness * prior neurosurgical procedure * history of seizure * history of ect or tms treatment within the past there months * presence of a pacemaker, implanted medical pump or device, metal plate, or metal object in skull or eye (including shunts, dental implants, facial tattoos with metallic ink) * pregnant women

Keywords: metaplasticity motor excitability rtms tdcs
safety study of polylactide-caprolactone-trimethylenecarbonate copolymer for post-operative adhesion prophylaxis

Conditions: Adhesions

Summary: the purpose of this study is to compare adhesion prophylaxis with polylactide-caprolactone-trimethylenecarbonate copolymer to icodextrin 4% in terms of safety, side effects and usability in addition to gaining early evidence of the effectiveness of polylactide-caprolactone-trimethylenecarbonate copolymer.


Eligibility criteria:
inclusion criteria: * age 18-60 years * sex female * laparoscopic myomectomy indicated * ability and intention to conform to the study protocol * written informed consent exclusion criteria: * pregnancy * indication for laparotomy * inflammatory bowel disease * additional surgical interventions * known or suspected intollerance or hypersensibility to the interventions * chronic pain * systemic corticoids or irradiation * alcohol abuse or other substance abuse * clinical signs of malignancy * psychiatric or neurological disease * participation in another clinical trial within 30 days * inability to understand the purpose of the trial or to conform to the study protocol * absence of written informed consent * inflammation of pelvic organs * presence of adhesions which lead to a conversion from laparoscopy to laparotomy * concurrent therapy with corticoids, anti-neoplastic agents or irradiation * maintenance therapy with non-steroidal anti-inflammatory drugs or analgesics
efficacy and safety of dlbs1425 as neoadjuvant in stage ii or iii breast cancer patients

Conditions: Breast Cancer

Summary: this is a 2-arm, randomized, double-blind, placebo-controlled study aiming to determine the efficacy and safety of dlbs1425 in combination with anthracyclin-based regimen as a neoadjuvant therapy in subjects with previously untreated stage ii or iii (operable) breast cancer. the anthracyclin-based regimen in the study will be either caf/iv and cef/iv only. the neoadjuvant anthracyclin-based chemotherapy will be given for 3 cycles. the length of each cycle will be 21-28 days.

the duration of treatment for each subject will be 63 - 84 days (or 3 cycles). the cycle will be initiated at day-1 (d1 of the 1st cycle). the subsequent cycles will start on day-22 (d1 of the 2nd cycle) and day-43 (d1 of the 3rd cycle). dlbs1425 capsules will be administered orally every day (starting from d1 of each cycle) during the study period. all subjects will be under direct supervision of a medical doctor during the study period. clinical and laboratory examinations to evaluate investigational drug's efficacy and safety will be performed at baseline and at the end of every cycle over the study course; whilst breast-ct scan will be performed at baseline and at the end of study course. in addition, at the end of study, at the discretion of investigator and subjects' own willingness, subjects with good response to treatment (i.e. recist and pathological evaluation are regarded as complete or partial response) may continue their breast-cancer therapy with dlbs1425.

Eligibility criteria:
inclusion criteria: * confirmed stage ii or iii (operable) primary breast cancer * having radiologically evaluable and measurable lesion(s) of the primary tumor * karnofsky performance status 80 % * normal cardiac function: lvef \> 50 % * adequate hematological function: hb ≥ 10.0 g/dl, wbc ≥ 3,000/mm3, anc ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3 * adequate liver function: alt ≤ 2.5 times upper limit of normal, total bilirubin level ≤ 1.5 times upper limit of normal * adequate renal function: serum creatinine ≤ 1.5 times upper limit of normal * able to take oral medication exclusion criteria: * pregnancy or breast feeding subjects * history of previous breast cancer (recurrent breast cancer) * history of other cancer within the past 5 years * prior systemic treatment for the current breast cancer * prior preoperative topical treatments for the current breast cancer * uncontrolled or serious cvd * known or suspected hypersensitivity to any of the chemotherapeutic agents used in the study * any other serious disease state or medical condition which judged by investigator could interfere with trial participation or trial evaluation * concurrent herbal (alternative) medicines or food supplements suspected to have effect on breast cancer disease within 14 days prior to screening * severe psychological or neurological disorder or dementia that would preclude understanding of the informed consent * participation in any other clinical studies within 30 days prior to screening

Keywords: breast cancer neoadjuvant therapy stage ii/iii
comparison of postoperative analgesic efficacy of suprainguinal fascia iliaca block and pericapsular nerve group block with lateral femoral cutaneous nerve block in patients undergoing total hip arthroplasty

Conditions: Coxarthrosis; Primary

Summary: the goal of this observational study is to compare the analgesic efficacy of sfib and peng with lfcn block, and study their effects on opioid consumption, motor strength and ability to perform physiotherapy in the postoperative period in patients who underwent primary total hip arthroplasty under general anesthesia.

48 patients undergoing tha under general anesthesia who received either sfib or peng block with lfcn block using will be included in the study. postoperative static and dynamic vas scores, opioid consumption, quadriceps motor strength, ability to perform physiotherapy and presence of opioid or nerve block related complications will be recorded.

Eligibility criteria:
inclusion criteria: * patients who are scheduled to undergo primary total hip arthroplasty with a diagnosis of coxarthosis exclusion criteria: * patients who have a history of neuropathy, patients with renal and hepatic insufficiency, patients with known coagulopathy, patients with a history of allergy to local anesthetics, patients with a history of inguinal surgery on the same side and patients with impaired mental status

Keywords: suprainguinal fascia iliaca block peng block lateral femoral cutaneous nerve block postoperative analgesia
understanding poor vaccine responses to hepatitis b vaccination

Conditions: Vaccine Reaction

Summary: vaccines have prevented countless infections but poor vaccine responses remain a major challenge in many scenarios. hepatitis b vaccine nonresponses are common but immunologically not well-understood. this study aims to study the immunology of hepatitis b vaccine responses by comparing traditional hbv vaccine, which is associated with nonresponses in some patients, to cpg-adjuvanted hbv vaccine, which is associated with far fewer rates of nonresponses. this research will build upon prior studies of the human immune response to infection to gain a deeper understanding of the complexity of these responses. this information will be broadly useful as many vaccine candidates fail due to lack of immunogenicity, potentially enabling improved vaccine design and better protection.


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age 2. must be able to understand and sign the informed consent form (icf) exclusion criteria: 1. known chronic hbv infection 2. pregnancy 3. known clinically significant anemia or contraindication to phlebotomy; i.e., anti-coagulation therapy or clinically significant thrombocytopenia 4. any condition that, in the opinion of the investigator, would make study participation unsafe or would interfere with the objectives of the study 5. use of immune-suppressing medications in the 30 days prior to enrollment hiv/aids patients will be included in the study as these patients often have poor responses to hbv vaccine.
a pilot peer mentor intervention that trains black men who have sex with men (bmsm) to use and promote uptake of hiv/sti self-testing to peers and sex partners: star study (self-testing at your residence)

Conditions: HIV/AIDS; Sexually Transmitted Diseases

Summary: the objectives of the study are to assess the feasibility, reach and preliminary efficacy of a brief intervention that trains black men who have sex with men \[referred to as index\] (a) to use home-based testing for hiv and sexually transmitted infections and (b) promote home-based testing to their peers and sexual partners.

sexually transmitted infections (stis) increase one's risk of hiv infection, are serious co-infections that affect hiv clinical outcomes, and remain a risk for individuals using prep. self-testing methods address barriers to clinic-based testing by offering convenience and privacy and have been shown to be well accepted by msm. therefore, use of self-testing is a potential approach through which to improve hiv and sti testing rates in msm. internet-based distribution (herein: web-based) of sti self-test kits enables an individual to request sampling kits via a website, mail biological specimens (e.g. urethral swabs) to a laboratory for testing, and view test results through a web-based account. web-based self-hiv oral testing enables an individual to request a test kit, collect an oral specimen, and receive results within 20 minutes. despite these potential benefits and reports of willingness to use free self-testing, uptake has been low due to barriers such as concerns about accuracy of the tests, apprehension to collect specimens, low risk perception, and the desire for counseling. in the proposed study, investigators will pilot test an intervention that address these barriers by training bmsm with information about the accuracy of the hiv rapid oral test kit, demonstrating how to properly collect specimens for hiv and stis (gonorrhea, chlamydia and syphilis) self-testing, and providing resources for linkage to hiv and sti treatment and prep services. study participants will utilize a secure website to request test kits.

Eligibility criteria:
inclusion criteria: * self-report male sex * condomless anal sex with \>1 male in the prior 6 months * self-report black race * aged 18 or older * internet use at least once a week. exclusion criteria: * younger than 17

Keywords: black msm social network