Kornimate/medical-research-clean huggingface dataset:
intensive neurorehabilitation and stimulation in chronic stroke patients

Conditions: Chronic Stroke

Summary: chronic stroke patients (\> 6 months) with severe motor impairment of the upper extremity will be enrolled in this single-centre, randomized controlled clinical trial (rct). all patients will take part in two blocks of high-intense motor training with concurrent neuromuscular stimulation of the paretic upper extremity. in a randomized, cross-over block design, patients will receive transcranial stimulation of either the ipsi- or contralesional hemisphere.

chronic stroke patients (\> 6 months) with severe motor impairment of the upper extremity and non-proportional recovery will be enrolled in this single-centre, randomized controlled clinical trial (rct). all patients will take part in two blocks of high-intense motor training with concurrent neuromuscular stimulation of the paretic upper extremity. in a randomized, cross-over block design, patients will receive transcranial stimulation of either the ipsi- or contralesional hemisphere. the primary outcome measure is the fugl-meyer assessment for upper extremity (fm-ue), acquired at baseline, after the intervention period, and at 3 months follow-up. secondary outcome measures consist of further clinical parameters and biomarkers of corticospinal connectivity.

Eligibility criteria:
inclusion criteria: * written informed consent * chronic stage of stroke (\> 6 months) * no active finger extension/hand opening of the paretic side exclusion criteria: * pregnancy * epilepsy * metal implants * pacemaker
post-operative exparel study following rotator cuff repair

Conditions: Rotator Cuff Tears

Summary: the primary purpose of this study is to determine if the postoperative oral narcotics consumption in patients receiving liposomal bupivacaine (lb) interscalene brachial plexus nerve block (isbpb) is different than the narcotics consumption receiving traditional bupivacaine isbpb for arthroscopic rotator cuff repair analgesia.


Eligibility criteria:
inclusion criteria: * males and females aged 18 years or older with a full-thickness rotator cuff tear (confirmed on mri) undergoing arthroscopic rotator cuff repair surgery. * anesthesiologists physical status 1, 2, or 3 and normal preoperative motor (lovett scale: biceps, wrist, thumb) and sensory function. exclusion criteria: * revision shoulder surgery * history of more than 1 prior surgery performed on the operative shoulder * concomitant severe glenohumeral arthritis * concomitant adhesive capsulitis * worker's compensation claim * pregnancy * history of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics * history of renal or hepatic failure * chronic neuromuscular deficit affecting the surgical limb. * uncontrolled psychiatric or neurologic disorder
clinical significance of antiphospholipid antibodies in healthy subjects

Conditions: Antiphospholipid Antibodies

Summary: antiphospholipid (apl) antibodies are a heterogeneous family of auto-antibodies, predominantly represented by anticardiolipin (acl) antibodies and lupus anticoagulant (la). antiphospholipid syndrome (aps) is defined as the presence of apl associated with venous and/or arterial thrombosis or repeated foetal loss. aps may be either primary or secondary to an autoimmune disease, mainly systemic lupus erythematosus (sle). however, other than in the context of aps, apl can also be observed in various clinical situations and in healthy subjects. published studies have reported a variable prevalence of apl in healthy subjects, essentially acl and/or la, and their clinical significance currently remains unclear. several studies have highlighted the link between apl and atherosclerosis. it therefore appears interesting to more specifically study the association between the presence of apl and the presence of cardiovascular risk factors in a population of healthy subjects. atherosclerosis is currently considered to be a chronic inflammatory disease arising from a complex interaction between atherogenic plasma factors and cells of the arterial wall. several inflammatory markers are now known to be associated with cardiovascular risk. lipid peroxidation also plays a major role during the atherogenesis process. it will therefore also be important to correlate apl with markers of vascular inflammation and markers of oxidative stress. a prospective case-control study will therefore be conducted on 1,500 healthy blood donors. subjects screened apl-positive will be compared to apl-negative subjects in terms of cardiovascular risk factors (cardiovascular risk per se, the presence of cardiovascular disease will not be studied). in the context of a blood donation, all subjects wishing to participate in this study will attend a medical interview and a clinical examination during which various data will be collected, mainly the presence of cardiovascular risk factors. a blood sample will also be taken to assay the various laboratory markers studied. this study should provide a better understanding of the role of apl in healthy subjects and more clearly specify their possible link with atherosclerosis in this population.


Eligibility criteria:
inclusion criteria: * healthy blood donors exclusion criteria: * contraindication to blood donation

Keywords: healthy subjects cardiovascular risk factors markers of arterial inflammation markers of oxidative stress
the double factor technique: a computer-guided implant surgery technique for fully edentulous patients

Conditions: Surgery, Computer-Assisted; Dental Implants

Summary: to overcome the limitations of the current dynamic and static computer assisted surgery protocols in fully edentulous patients, and combine the advantages of both approaches, a new technique has been developed, referred to as the "double factor" technique. this study consists in a single arm observational prospective clinical study and the aim was to assess the accuracy and patient's perception and quality of life of the "double factor" technique in treating fully edentulous patients.

this is a prospective observational clinical study. each patient enrolled in this study will be treated using the "all on four concept" using the double factor technique. preoperative virtual planification of dental implants on a pre-acquired cone beam computed tomography (cbct) will be performed for each patient using the same system. during the surgical phase, four dental implant will be placed in a fully guided approach using "the double factor technique. this technique merges the static and dynamic computer-guided surgical approach in the same surgery. then after the surgical procedure a proms questionnaire will be asked to the patients. finally, a postoperative cbct will be performed and overlapped with the preoperative cbct (with the implants planification) and implant position deviations between the planned and final position will be measured. the study devices are ce- (conformité européenne, meaning european conformity) marked products and used within their intended use.

Eligibility criteria:
inclusion criteria: * fully edentulous patients or with terminal dentition that requires an implant supported rehabilitation * healthy patients asa i and ii (american society of anesthesiologists classification) * over 18 years old patients exclusion criteria: * partially edentulous patients * systemic or local conditions that contraindicates dental implant surgery

Keywords: dental implants surgery, computer-assisted fully edentulous
occlusal bite force changes after surgical correction of the increased vertical dimension

Conditions: Orthodontic Appliance

Summary: the aim of this study was to record the obf changes after surgical correction of mandibular prognathism in patients with or without increased vertical skeletal dimensions at different time intervals (t0: before surgery; t1: at debond; t2: 3 months post-retention).

forty-two patients who presented to orthodontic clinics with severe class iii skeletal malocclusion and were already into orthodontic preparation for orthognathic surgery were selected to participate in thestudy. patients were allocated into one of 2 groups as follows: - group 1: - class iii patients with increased vertical relationship included 22 patients (8 males, 14 females).these patients were scheduled for bimaxillary surgical procedures (maxillary advancement and mandibular setback with posterior maxillary impaction) to correct the antero-posterior and vertical skeletal discrepancies. group 2: - class iii subjects with normal vertical relationship included 20 patients (8 males, 12 females).these patients were scheduled for mandibular setback surgical procedure (with no posterior maxillary impaction) to correct the antero-posterior skeletal discrepancy. diagnostic records (orthopantomogram, lateral cephalogram, study casts, clinical photographs) were taken for all subjects before surgery. the same records were taken post surgery just before fixed orthodontic appliance debond. the included patients were treated by orthodontic teaching staff and postgraduate residents at orthodontic clinics/just using pre-adjusted edgewise fixed appliance (3m gemini uniteks, 0.022" mbt prescription brackets). bite force was measured bilaterally in the first molar region using a portable occlusal force gauge (gm10, nagano keiki, tokyo, japan), that consisted of a hydraulic pressure gauge and a biting element made of a vinyl material encased in a polyethylene tube. 3 obf measurements were recorded on each side and incisally with a 15 second rest between each bite, the average of the three readings was used. three obf measurements were considered in the analysis: the maximum obf (mobf) achieved by the subject, the averaged obf on molars (aobf), and the obf at the incisal region (iobf). number of teeth in contact was measured using double-sided articulation paper strips that was smeared with a thin layer of petroleum jelly prior to its' use so as to improve the visualization of the markings of the contact points that existed in a subject's intercuspal position.

Eligibility criteria:
inclusion criteria: * adults ≥18 years * severe skeletal class iii malocclusion * patients willing to undergo surgery * no systematic medical conditions exclusion criteria: * poor oral hygiene * heavily restored or endodontically treated first molars

Keywords: bite force mandibular prognathism increased vertical dimension surgical correction
study to evaluate the pharmacokinetics (pk), safety, and efficacy of b/f/taf in human immunodeficiency virus (hiv)-1 infected, virologically suppressed, pregnant women in their second and third trimesters

Conditions: HIV-1-infection

Summary: the primary objective of this study is to evaluate the steady state pk of bictegravir (bic) and confirm the dose of bic/emtricitabine/tenofovir alafenamide (b/f/taf) 50/200/25 mg fixed dose combination (fdc) in hiv-1 infected, virologically suppressed pregnant women in their second and third trimesters.


Eligibility criteria:
key inclusion criteria: * the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * with singleton pregnancy, at least 12 weeks but not more than 31 weeks pregnant at the time of screening * agree not to breastfeed for the duration of the study * currently on a stable antiretroviral regimen for ≥ 6 months preceding the screening visit * documented plasma hiv-1 ribonucleic acid (rna) levels of \< 50 copies/ml for ≥ 6 months preceding the screening visit and have hiv-1 rna \< 50 copies/ml at the screening visit * have no documented or suspected resistance to ftc, tenofovir (tfv), or integrase strand-transfer inhibitors (instis) including, but not limited to, the reverse transcriptase resistance mutations k65r or m184v/i * have a normal ultrasound, completed locally prior to the day 1 visit, with no evidence of any fetal malformation or structural abnormality affecting either fetus or placenta * normal maternal alfa-fetoprotein level at the screening visit key exclusion criteria: * have chronic hepatitis b virus (hbv) * have active hepatitis c virus (hcv) infection * an opportunistic illness indicative of stage 3 hiv diagnosed within the 30 days prior to screening note: other protocol defined inclusion/exclusion criteria may apply.
dermatological assessment of primary dermal irritability accumulated, sensitization, photoallergy and phototoxicity.

Conditions: Sensitivity, Contact

Summary: this is a clinical study for health care product safety assessment. the research is going to conducted with 55 subjects, aged 18 to 70 years. the product is applied on the right and/or left participant back. after a wash out, the product is reapplied. medical evaluation will be available throughout the study to assess possible adverse events. the main of the study is to observe the effects of the application of the product on the skin and prove the absence of irritability and/or allergy, photoallergy and phototoxicity.

subjects phototypes i to iv (according to fitzpatrick classification). the products is applied over semi-occlusive dressings, remaing in contact with the skin.

Eligibility criteria:
inclusion criteria: * healthy participants; * non-injured skin in the test region; * agreement to adhere to the test procedures and requirements and to attend the institute on the day(s) and at the time(s) determined for the evaluations; * ability to consent to participation in the study; * phototype (fitzpatrick): ii and iii; exclusion criteria: * pregnant or breastfeeding women; * use of the following systemic drugs: antihistamines, non-hormonal anti-inflammatory drugs and corticoids; * history of allergy to cosmetics, topical products or research product; * localized or widespread dermatological diseases or inflammatory dermatoses active and nerve damage in the test region; * personal or family pathological history of skin cancer; * use of topical or systemic photosensitizing medication; * history of phototoxic, photoallergic reactions, dermatoses caused by light, atopy, pathologies aggravated or triggered by ultraviolet radiation; * photo-induced pathologies; * frequent exposure to the sun or tanning chambers; * participated in an allergenicity study in a period of less than 4 weeks from the start of the study; * skin marks in the experimental area that interfere with the evaluation of possible reactions; * active dermatoses; * forecast to take a bath in the sea, pool or sauna during the study; * participants who play water sports; * dermography; * use of the following topical or systemic drugs: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs and corticoids up to 2 weeks prior to selection or, considering deposit corticoids, the interval shall be 1 month prior to selection; * treatment with acid vitamin a and/or its derivatives via oral or topical until 1 month before the beginning of the study; * aesthetic and/or body dermatological treatment until 3 weeks before selection; * vaccination during the study or until 3 weeks before the study; * being participated in another clinical trial.
antibiotics treatment of cholangitis post-kasai portoenterostomy

Conditions: Cholangitis, Secondary Biliary; Treatment Compliance; Antibodies Drug Specific

Summary: application of multi-center, prospective study on the severity of postoperative cholangitis biliary atresia classification, according to the degree of cholangitis targeted therapy, to improve the therapeutic effect of postoperative cholangitis biliary atresia, decrease the overuse of antibiotics related complications.

cholangitis patients post-kasai portoenterostomy were grouped by cholangitis severity score, according to the severity was divided into mild, moderate, severe cholangitis, all levels of cholangitis patients were divided into subgroups by age and post-kasai portoenterostomy jaundice matching design of experiment, then they were randomly divided into control group and experimental group, and all the control group unified antibiotic treatment, the experimental group was graded antibiotic treatment according to the severity cholangitis, after three days treatment，evaluate each treatment effect, average hospitalization days, the average hospitalization expenses, antimicrobial drug use strength to evaluate the therapeutic effect of postoperative cholangitis biliary atresia.

Eligibility criteria:
inclusion criteria: 1. age 3 months to 2 years old, gender is not limited. 2. patients with cholangitis post-kasai portoenterostomy. 3. no other treatment before entering the group. 4. the patient must sign an informed consent form and can actively cooperate with the treatment and follow-up. exclusion criteria: 1. patients with other infectious lesions. 2. patients with other severe deformity. 3. patients with end-stage liver failure. 4. patientsn with liver transplantation. 5. patients with mental symptoms or other disease.

Keywords: cholangitis biliary atresia kasai portoenterostomy antibiotics treatment
the role of maintenance oral clofarabine in older adults with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to determine the side effects of the study drug, clofarabine, when given by mouth to patients with acute myeloid leukemia (aml), in remission.

standard induction chemotherapy (chemotherapy given with the intent of inducing a remission/disappearance of the cancer) can lead to a complete remission (cr) in a large percentage (60% to 80%) of younger patients with newly diagnosed aml. however, the majority of patients relapse (their disease returns) despite intensive consolidation chemotherapy. in most chemotherapy studies, only a small percentage (30% to 40%) of patients who achieve a cr still are disease-free 5 years later. the outcome for older adults is even less favorable. approximately 75% of elderly patients who achieve cr will relapse after 2 years or less and the toxicities seen with treatment are significant. a number of studies have shown that chemotherapy given to older adults after a remission has not improved this outcome; therefore new treatments need to be investigated. clofarabine is a drug that has been studied in older adults who have achieved a cr. the treatment was found to have fewer side effects then other consolidation therapies. this study will give participants the drug for a longer period of time to see if doing this will extend the cancer remission. clofarabine has been approved by the fda for the treatment of acute lymphoblastic leukemia (all), another form of acute leukemia. the study drug is considered experimental for aml because it has not been approved by the food and drug administration (fda) for the treatment of aml.

Eligibility criteria:
inclusion criteria: * diagnosis of acute myeloid leukemia, in first or second remission. * age 55 or older * patients must have given signed, informed consent prior to registration on study. * participants must have attained a complete remission (cr) to induction chemotherapy and are not good candidates for further intensive chemotherapy or a transplant. * female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. * male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. exclusion criteria: * patients with a diagnosis of acute promyelocytic leukemia are not eligible. * participants cannot be currently receiving chemotherapy, radiation therapy, or immunotherapy. * patients must not be receiving any other investigational agents. * participants cannot have hepatitis b or c or hiv. * patients must not have an uncontrolled infection

Keywords: leukemia
fibrinogen as an alternative to ffp in aortic surgery.

Conditions: Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair

Summary: thoracoabdominal aneurysm (taaa) repair is a major elective vascular operation associated with a large blood loss and potentially life-threatening clotting abnormalities. theses clotting abnormalities are principally treated using fresh frozen plasma (ffp) (derived from human blood donations), the administration of which carries a number of risks including virus transmission (human immunodeficiency virus (hiv), hepatitis b, hepatitis c) and infection with variant creutzfeld-jacob disease (vcjd). ffp is no longer administered to children or high-usage adults in the uk because of the infection risk, and recently it was decided by a uk advisory body that the use of uk-derived ffp should cease. fibrinogen concentrate is an alternative treatment option to ffp which is thought have less infection risk (purified, heat treated) and has been in licensed use for many years in other european countries. the investigators have been using fibrinogen concentrate recently in their department as an alternative to ffp with encouraging results. 20 patients undergoing elective taaa repair at the royal infirmary of edinburgh will be randomly allocated to receive standard treatment (ffp) or fibrinogen concentrate as treatment for clotting abnormalities during their surgery. the investigators will take a number of additional blood samples which will provide valuable information about the pattern of clotting abnormalities during this type of operation. the investigators will also record blood loss and the number of allogeneic (derived from human donors) blood components transfused to the patient (red cells, ffp and platelets). our primary objective is to assess the pattern of coagulation abnormalities in both groups. we will also examine whether the use of fibrinogen concentrate during taaa repair avoids the need to administer ffp.


Eligibility criteria:
inclusion criteria: * undergoing elective thoracoabdominal aneurysm repair. * over 18 years of age. * able to give written informed consent. exclusion criteria: * previous aortic surgery (re-do surgery). * emergency surgery. * pregnancy. * females of child-bearing age (less than 45 years) not using medically approved method of contraception. * congenital or acquired coagulopathy. * known allergy to study drug.

Keywords: thoraco-abdominal aneurysm (taaa) coagulopathy fresh frozen plasma fibrinogen concentrate