Kornimate/medical-research-clean huggingface dataset:
subcutaneous nitroglycerin to prevent radial artery occlusion in children

Conditions: Arterial Line; Ischemia

Summary: the primary objective of the study is to evaluate the vasodilative effect of subcutaneous nitroglycerin to prevent radial arterial occlusion(rao) after removal of the radial arterial catheter in pediatric patients. the hypothesis of this study is that subcutaneous nitroglycerin will decrease the incidence of radial arterial occlusion after radial arterial catheter removal in pediatric patients by increasing the radial artery size. this is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of subcutaneous nitroglycerin and saline on radial artery cannulation and catheter removal in pediatric patients. prior to the procedure, each patient will be randomized into either the control arm, saline, or the study arm, nitroglycerin.


Eligibility criteria:
inclusion criteria: * patients undergoing general anesthesia * patients in the intensive care unit * arterial cannulation for hemodynamic monitoring, or multiple blood sample exclusion criteria: * unstable vital signs, significant arrhythmia or hypotension, shock * high risk of peripheral ischemia * skin disease, infection, hematoma, recent cannulation at the radial artery * history of anaphylaxis to nitroglycerin

Keywords: radial artery vascular catheters
single incision versus standard laparoscopic splenectomy

Conditions: Hereditary Spherocytosis; Idiopathic Thrombocytopenic Purpura

Summary: this is a prospective trial of single incision versus standard 4-port laparoscopic splenectomy. the hypothesis is that there may be a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars. however, the technical difficulty is considerable and the primary outcome is operative time which will be expressed in minutes.

this will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for splenectomy. we will offer enrollment to several institutions provided they reach institutional approval. this will be a definitive trial design. based on our operative times with sils compared with our recent experience in standard laparoscopy, a sample size of 30 patients will give us a power of 0.8 with an α of 0.05. thus operative time is the primary outcome variable by definition. this is recorded and reported in minutes. after the procedure, both groups will be managed in the same manner per routine care. they will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication. secondary outcome measures include days in the hospital (measured in days), doses of analgesics (measured in doses) and perception of cosmesis as recorded by a scar assessment form which will be filled out by the patient and/or parents at 6 weeks and 6 months. this is a validated quality of life survey with 39 questions and each has 4 categories from best to worst.

Eligibility criteria:
inclusion criteria: * need for splenectomy exclusion criteria: * splenomegaly

Keywords: laparoscopy splenectomy single site trial
laparoscopic recurrent inguinal hernia repair

Conditions: Congenital Hernia

Summary: laparoscopic management of recurrent inguinal hernia in children has been recently introduced in surgical practice. one of the most important advantages of using the laparoscopic approach in cases with recurrent inguinal hernia (rih) is that it avoids the previous operation site thus avoiding injuries to the vas and vessels \[19\]. some authors designed a study to compare laparoscopic hernia repairs with classical open repairs for pediatric rih following the ﬁrst open repair. they stated that avoiding the scarred tissue the former operation area with the laparoscopic approach facilitates the procedure and decreases both the operative time and complication rate. \[5\]. further, it is as simple as a fresh hernia repair because the time taken for the repair of recurrent hernia laparoscopically was the same as the fresh laparoscopic repair with no added complication \[5,20\]. in laparoscopic surgery, approaching the hernia defect from within the abdomen, makes the area of interest bloodless, and the magnification renders anatomy very clear, making surgery precise \[6,7\].

abstract: background: open repair of recurrent inguinal hernias \[rih\] in infancy and childhood is difficult and there is definite risk of damaging the vas deferens and testicular vessels. laparoscopic repair of rih has the benefit of avoiding the previous operative site. the aim of this study is to present the investigator's experience with laparoscopic repair of rih either after open or laparoscopic hernia repair with stress on technical refinements to prevent recurrence. patients and methods: this is a retrospective study of laparoscopic repair of recurrent inguinal hernia. records of patients that have been subjected to laparoscopic inguinal hernia repair for rih were reviewed and evaluated. all patients were subjected to laparoscopic repair of 42 recurrent hernial defects. the primary outcome measurements of this study include; operative time. the secondary outcomes include; hydrocele formation, iatrogenic ascent of the testis and testicular atrophy.

Eligibility criteria:
inclusion criteria: * recurrent inguinal hernia exclusion criteria: * complicated inguinal hernia

Keywords: laparoscopy recurrent inguinal hernia children
safety study of plx108-01 in patients with solid tumors

Conditions: Solid Tumor

Summary: plx3397 is a selective inhibitor of fms, kit, and oncogenic flt3 activity. the primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered plx3397 in patients with advanced, incurable, solid tumors in which these target kinases are linked to disease pathophysiology. the secondary objective is to measure the pharmacodynamic activity of plx3397 via blood, plasma and urine biomarkers of fms activity.


Eligibility criteria:
inclusion criteria: * age 18 and older * solid tumors refractory to standard therapy * for the extension cohorts, patients must have measurable disease by recist criteria and meet the following disease-specific criteria: * for advanced or recurrent mucoepidermal carcinoma (mec) of the salivary gland, patients must not be candidates for curative surgery or radiotherapy. * for pigmented villo-nodular synovitis (pvns), patients must have a histologically confirmed diagnosis of inoperable progressive or relapsing pvns, or resectable tumor requesting mutilating surgery, as well as demonstrated progressive disease in the last 12 months. * for gastrointestinal stromal tumors (gist), patients must have failed previous therapy with imatinib and sunitinib. patients with known pdgfr mutations are excluded, but mutation testing is not required for study entry. * for anaplastic thyroid cancer (atc), patients must have histologically or cytologically diagnosed advanced atc. * for metastatic solid tumors with documented malignant pleural and/or peritoneal effusions, patients must not be receiving specific therapy for the effusion or have an indwelling drain. * eastern cooperative oncology group performance status 0 or 1 * life expectancy \>= 3 months * adequate hepatic, renal, and bone marrow function exclusion criteria: * specific anti-cancer therapy within 3 weeks of study start * uncontrolled intercurrent illness * refractory nausea or vomiting, or malabsorption * mean corrected qt interval (qtc) \>= 450 msec (for males) or qtc \>= 470 msec (for females)

Keywords: pvns
the influence of systematic psychological intervention on patients about vsd drainage surgery

Conditions: Chronic Wounds

Summary: this study focuses on providing clinical care to patients undergoing vsd drainage surgery for chronic wounds, while also paying attention to the impact of negative emotions such as depression and anxiety, as well as quality of life and social support, on the patients' physical and mental well-being. it observes the influence of psychology on patients.

the chronic, difficult-to-heal wounds not recovering within the expected timeframe not only impact the quality of life for patients and hinder the recovery of the primary condition but also exacerbate their financial and psychological burdens, further affecting the quality of wound healing. the objective of this study is to employ psychological nursing interventions effectively combined with nursing techniques and communication strategies. by listening to patients' fears, anxieties, and tensions, it significantly alleviates their negative emotions, enhances compliance with medical advice, and predicts postoperative complications to mitigate them. tailored and empathetic care, along with psychological counseling, is provided to expedite wound healing.

Eligibility criteria:
inclusion criteria: - a mentally healthy, communicative adult. patients and their families are cooperative, understanding, and supportive of this study. adult patients undergoing vsd surgery for chronic wounds. exclusion criteria: - patients who are unable to effectively cooperate with nursing questionnaires due to auditory or visual impairments, cognitive impairments, or low levels of cultural literacy. patients with poor compliance or those who harbor skepticism and hostility towards this research.

Keywords: vsd drainage surgery systematic psychological intervention chronic wounds
chidamide+decitabine plus anti-pd-1 antibody for patients with r/r chl who are transplant-ineligible or refused transplant.

Conditions: Ineligible Or Refused Transplant Patients With Classical Hodgkin Lymphoma

Summary: the prognosis for patients with relapsed/refractory classical hodgkin lymphoma (chl) who refuse or are ineligible for transplant is poor. this open label, randomized, phase 2 study aims to evaluate the efficacy of chidamide+decitabine plus anti-pd-1 antibody and brentuximab vedotin plus anti-pd-1 antibody in transplant-ineligible or refused transplant diagnosedr/r chl. the primary objective of the study is to evaluate progression-free survival.

the prognosis of refractory or early-relapsed lymphoma is poor, and it is even worse for those who are not eligible or refuse transplantation. although many salvage regimens have been developed, there is no standard of care. preliminary clinical observations have shown that chidamide +decitabine plus anti-pd-1 antibody might be beneficial for these patients. brentuximab vedotin plus anti-pd-1 antibody is a standard regimen . this open-label, randomized, phase 2 study aims to evaluate the efficacy of chidamide+decitabine plus anti-pd-1 antibody and brentuximab vedotin plus anti-pd-1 antibody, in patients with classical hodgkin lymphoma who are transplant-ineligible or refused transplant . the primary objective of the study is to evaluate the progression free survival.the key secondary end points are complete response rate, objective response rate and the safety.

Eligibility criteria:
inclusion criteria: 1.18 to 75 years of age. 2.ecog performance of less than 2. 3.subjects must have histological confirmation classical hodgkin lymphoma (chl). 4. patients must have at least two lines of antitumor therapy, those who were transplant-ineligible or refused transplant. 5.life expectancy of at least 3 months. 6.subjects with lymphoma must have at least one measureable lesion \>1cm as defined by lymphoma response criteria. 7. previous treatment must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to ≤ grade 1 toxicity. 8.subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. 9.subjects must have adequate marrow, live, renal and heart functions. exclusion criteria: 1. subjects have received the combination therapy of chidamide+decitabine and anti-pd-1 antibody or bv+ anti-pd-1 antibody.2.subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 3. serious uncontrolled medical disorders or active infections, pulmonary infection especially. 4. active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month. 5. prior organ allograft. 6. women who are pregnant or breastfeeding. 7. women with a positive pregnancy test on enrollment or prior to investigational product administration. 8. subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
effect of intravenous methylprednisolone and intravenous erythropoietin in toxic optic neuropathies: randomized clinical trial.

Conditions: Toxic Optic Neuropathy; Treatment; Methylprednisolone; Erythropoietin

Summary: the goal of this double-blind prospective randomized clinical trial is to determine if the effect of intravenous erythropoietin is superior to the effect of intravenous methylprednisolone in cases of toxic optic neuropathy 4 weeks after therapeutic intervention. the main question it aims to answer: • is there a difference in the visual recovery of toxic optic neuropathies treated with intravenous methylprednisolone in comparison with those treated with intravenous erythropoietin?

a double-blind prospective randomized clinical trial of treatment for toxic optic neuropathies comparing visual outcome of patients treated by standard treatment (intravenous methylprednisolone) vs intravenous erythropoietin. enrollment: 18. randomized groups (2) 1. standard treatment (intravenous methylprednisolone) 2. intravenous erythropoietin masking: double (participant and outcomes assessor) participants won't be aware to which group they were assigned. investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned

Eligibility criteria:
inclusion criteria: * both genres. * age between 18 and 75 years. * clinical diagnosis of toxic optic neuropathy (afferent pupillary defect, acquired dyschromatopsia, visual loss and bilateral prechiasmatic field defect). * exposure with a temporal relationship of less than two weeks to a known toxicant for the function of the optic nerve. * up to 21 days from symptom onset. * informed consent signature. exclusion criteria: * history of previous optic neuropathy. * history of additional ophthalmological or neurological pathology that has caused permanent visual loss. * history of previous treatment with intravenous methylprednisolone or some other experimental treatment since the onset of symptoms. * poorly controlled diabetes mellitus. * poorly controlled systemic arterial hypertension. * hemoglobin \>16 mg/dl * patients with a history of thromboembolic event. * patients with a history of coronary heart disease, myocardial infarction or cerebral vascular event. * pregnancy or lactation.

Keywords: toxic optic neuropathy methylprednisolone erythropoietin
study of pembrolizumab (mk-3475) in participants with advanced melanoma (mk-3475-041/keynote-041)

Conditions: Melanoma

Summary: this study will assess the safety, tolerability, and efficacy of every-3-week dosing (q3w) of pembrolizumab (mk-3475) in participants with advanced melanoma; participants may receive pembrolizumab for up to 2 years if deriving clinical benefit. the primary study hypothesis is that treatment with single agent pembrolizumab will result in a clinically meaningful overall response rate.

participants who discontinue pembrolizumab after achieving a complete response (cr) and subsequently develop progressive disease (pd) may be eligible to enter a second course phase and receive pembrolizumab again. the end of the study for each participant will occur with: 1) the marketing approval of pembrolizumab for melanoma, 2) the completion of safety follow up or 3) the time when a possibility of entry to second course of treatment is lost, whichever occurs last.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of locally advanced (unresectable stage iii) or metastatic (stage iv) melanoma not amenable to local therapy * eastern cooperative oncology group (ecog) performance status of 0 or 1 * at least one measurable lesion * adequate organ function exclusion criteria: * prior therapy with an anti-programmed cell death-1 (anti-pd-1), anti-pd ligand-1 (pd-l1), anti-pd-l2, anti-cd137 antibody, or anti-cytotoxic t-lymphocyte-associated antigen-4 (ctla-4) agent * is currently participating or has participated in a study with an investigational compound or device within 30 days, or 5x half-life of the investigational compound, whichever is longer, of initial dosing on this study * chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer therapy (including monoclonal antibodies) within 4 weeks prior to the first dose of trial treatment, or not recovered (\<= grade 1 or baseline) from adverse events due to a previously administered agent * expected to require any other form of systemic or localized antineoplastic therapy while in study * known active central nervous system (cns) metastases and/or carcinomatous meningitis * documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents * receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week prior to the first dose of study treatment * received a live vaccine within 4 weeks prior to the first dose of trial treatment * has a known hypersensitivity to the components of the study drug or another monoclonal antibody * history or evidence of active pneumonitis * human immunodeficiency virus (hiv)-positive * has known history of active hepatitis b or c * pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial treatment through 120 days after the last dose of study medication

Keywords: pd1 pd-1 pdl1 pd-l1
fat grafts with adipose-derived regenerative cells for soft tissue reconstruction in children

Conditions: Craniofacial Microsomia

Summary: although first reports of the clinical use of adipose-derived regenerative cells (adrc) suggest that this approach may be feasible and effective for soft tissue augmentation, there is a lack of randomized, controlled clinical trials in the literature. hence, this study aimed to investigate whether a novel protocol for isolation of adrc and their use in combination with fat tissue improve the long-term retention of the grafts in paediatric patients with craniofacial microsomia.

to overcome problems associated with fat grafting, such as unpredictable clinical results and a low rate of graft survival, many innovative efforts and refinements of surgical techniques have been reported. for example, condensation of living tissue and removal of unnecessary components have been performed by centrifugation, filtration or gravity sedimentation; external mechanical force has been used to expand the recipient tissue as well as the overlying skin envelope; and a recent experimental study has suggested that repeated local injections of erythropoietin might enhance retention of grafted fat. based on the finding that aspirated fat tissue contains a much smaller number of adipose-derived regenerative cells (adrc) compared with intact tissue and that these cells play pivotal roles in the adipose tissue remodeling after lipoinjection, the supplementation of fat grafts with stromal vascular fraction isolated from adipose portion of liposuction aspirates has been proposed as a method to compensate its relative deficiency of adrc. in the literature, there are at least three experimental studies demonstrating that supplementation of adipose progenitor cells enhances the volume or weight of surviving adipose tissue, and first reports of the clinical use of adrc suggest that this approach may be feasible and effective for soft tissue augmentation. however, since these studies represent level of evidence iv, which correspond to the publication of case series, there is a lack of randomized, controlled clinical trials comparing this method to current standard techniques. hence, this study aimed to fill this gap by investigating whether a novel protocol for isolation of adrc and their use in combination with fat tissue improve the long-term retention of the grafts in paediatric patients with craniofacial microsomia.

Eligibility criteria:
inclusion criteria: * unilateral craniofacial microsomia * 10 to 18 years old * phenotype: (m0, m1 or m2) and (s1 or s2) according to the omens-plus classification exclusion criteria: * previous facial soft tissue surgery * absence of fat donor site
study of total body irradiation and fludarabine followed by allogeneic peripheral blood stem cell or bone marrow transplantation in combination with cyclosporine and mycophenolate mofetil in patients with inherited disorders

Conditions: Metabolism, Inborn Errors; Granulomatous Disease, Chronic

Summary: objectives: i. determine the safety of total body irradiation and fludarabine followed by allogeneic peripheral blood stem cell or bone marrow transplantation in combination with cyclosporine and mycophenolate mofetil for establishing mixed chimerism in patients with inherited disorders. ii. determine whether this regimen can establish mixed chimerism in these patients. iii. determine whether mixed chimerism is sufficient to reverse disease symptoms in these patients. iv. determine the safety of donor lymphocyte infusions to eliminate persistent disease in these patients with mixed chimerism.

protocol outline: patients receive fludarabine iv over 2 hours on days -4 to -2 followed by total body irradiation and peripheral blood stem cell or bone marrow transplantation on day 0. patients also receive oral or iv cyclosporine 2-3 times daily on days -3 to 50 (related donor) or 100 (unrelated donor) and oral mycophenolate mofetil twice daily on days 0 to 28 (related donor) or 40 (unrelated donor). patients may also receive donor lymphocyte infusion for continued treatment of symptoms in the event of mixed chimerism and in the absence of graft-versus-host disease. patients are followed weekly for 1 month, monthly for 2 years, and then annually thereafter.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * inherited disorders treatable with allogeneic peripheral blood or bone marrow transplantation at high risk for regimen related toxicity with a conventional transplant * no severe cns involvement of disease, defined by iq score less than 70 * hla matched donor sibling donors must be a confirmed match at hla-a, b, and drb1 other related and non-related donors must be matched at hla-a, b, c, drb1, and dqb1 a donor homozygous for one allele only at hla-a, b, c, drb1, or dqb1 allowed (1 antigen mismatch for graft-versus-host disease, 0 antigen mismatch for graft-rejection) --prior/concurrent therapy-- * no concurrent growth factors with mycophenolate mofetil --patient characteristics-- * age: under 55 * performance status: not specified * life expectancy: at least 100 days * hematopoietic: not specified * hepatic: no evidence of synthetic dysfunction no severe cirrhosis * renal: not specified * cardiovascular: lvef at least 30% no poorly controlled hypertension on multiple antihypertensives * other: no organ dysfunction that would preclude survival not pregnant or nursing fertile patients must use effective contraception during and for 12 months following study
ump lifestyle medicine program

Conditions: Obesity

Summary: to systematically follow patients seen at the university of minnesota's lifestyle medicine program for weight management.


Eligibility criteria:
inclusion criteria: * all patients seen who sign medical release form exclusion criteria: none

Keywords: obesity