Kornimate/medical-research-clean huggingface dataset:
alxn1830 in patients with warm autoimmune hemolytic anemia

Conditions: Warm Autoimmune Hemolytic Anemia

Summary: the main objective of the study is to evaluate the safety and efficacy of alxn1830 compared to placebo in adult participants with warm autoimmune hemolytic anemia (waiha).

this study will consist of a 4-week screening period, 13-week primary treatment period, and optional extended treatment period (up to 2 years).

Eligibility criteria:
key inclusion criteria: * primary or secondary waiha, diagnosed at least 6 weeks prior to screening * failed or not tolerated at least 1 prior waiha treatment regimen, for example, corticosteroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, danazol, or vincristine * hemoglobin \< 10 g/dl and ≥ 6 g/dl * positive direct antiglobulin test (coombs) (igg positive, complement c3 \[c3\] positive or negative) * evidence of active hemolysis including any of the following: a) lactate dehydrogenase (ldh) \> upper limit of normal (uln), b) haptoglobin \ uln * total igg \> 500 mg/dl key exclusion criteria: * human immunodeficiency virus (hiv) infection (positive hiv-1 or hiv-2 antibody test) * positive hepatitis b surface antigen (hbsag) or hepatitis c antibody test

Keywords: warm autoimmune hemolytic anemia waiha immunoglobulin g (igg)-mediated autoimmune disorder pathogenesis
yag laser vitreolysis for floaters

Conditions: Vitreous Detachment

Summary: vitreous fluid, containing 95% water, fills the space behind the lens. its gelatinous consistency is due to the presence of hyaluronic acid, mucopolysaccharide and collagen fibers. with age, the collagen aggregates into parallel bundles, bound by cross links, leaving the pockets of liquid in the glass body. this redistribution is referred to as syneresis, which is found in 90% older than 40 years. after liquefaction, the vitreous enters the retroviral space and separates the posterior hyaloid membrane from the retina. when separating from the optical disk it forms an annular formation (weiss ring) in front of the optical disc. these agglomerated collagen bundles (opacities) disperse the photons of light and are perceived by the patients as a "gray silhouette-like artifact". two major interventions for these symptoms include nd: yag laser vitreolysis and vitrectomy. the less invasive method nd: yag laser increases the temperature of the opacity thus vaporizing them to smaller fragments that are easier to sediment onto the bottom of the vitreous cavity thereby relieving the symptoms.


Eligibility criteria:
inclusion criteria: * age 18 years or older * is able to give written informed consent to the procedure * patients with clinical symptoms of floaters and clinically confirmed diagnosis of opacity in the vitreous body. exclusion criteria: * inability to tolerate the procedure * blurred anterior eye segment * cataract or intraocular lens opacity * blurred posterior eye segment * active eye inflammation * iris synechiae * uncontrolled intraocular pressure elevation * peripheral retinal degeneration
the incidence and incubation period of false positive cultures in shoulder surgery

Conditions: Infection

Summary: this study will describe the time point at which a positive culture from a patient who has undergone shoulder surgery should be treated as an infection versus a false positive result that should be disregarded. intraoperative biopsies will be taken and cultured from 50 subjects who have undergone an "open" surgical procedure and 50 from subjects undergoing an arthroscopic procedure.

postoperative infection is a significant complication that requires timely identification and treatment. indolent infections, such as those involving propionibacterium acnes (p. acnes), pose a diagnostic dilemma as they present differently than the acute symptoms typically associated with most postoperative bone and joint infections. the workup of these suspected infections is also somewhat difficult, as these colonies are slow growing, necessitating that cultures be kept for an extended period of time. previous studies have shown that positive cultures are typically identified between 7 and 13 days. in a recent study of patients undergoing primary shoulder arthroplasty, 41.8% of patients were found to have p. acnes growth from their joint fluid at a mean of 7 days (range 5-9 days). all of these patients were then treated immediately with 4 weeks of dual oral antibiotic therapy1. as the incubation of laboratory cultures increases, there is the potential concern of false positive growth. timely identification is critical in order to avoid performing unnecessary treatments on patients in whom no infection is actually present. the investigators will enroll patients undergoing primary shoulder surgery for a clearly identified mechanical dysfunction, in which there is no clinical suspicion for infection. infection should not exist in this population, making it an appropriate clinical sample in which to study results that the investigators would consider to be false positives.

Eligibility criteria:
inclusion criteria: * patients undergoing primary open and arthroscopic shoulder surgery in which there is a clear diagnosis of a mechanical problem that is felt to be amenable to surgical intervention and there is no suspicion of infection. examples include, but are not limited to: rotator cuff tear, labral tear, instability, impingement, and osteoarthritis. exclusion criteria: * prior shoulder surgery * prior glenohumeral injection within the last 6 months * systemic or shoulder inflammatory disorder * any clinical, imaging, or laboratory findings that raise suspicion of infection * minors * erythrocyte sedimentation rate (esr) \>15 mm/hr for males less than 50 years old, \>20 mm/hr for males greater than 50 years old and females less than 50 years old, and \>30 mm/hr for females greater than 50 years old * c reactive protein (crp) \>1 mg/d, * procalcitonin (pct) \>0.05 ng/ml.

Keywords: propionibacterium acnes shoulder surgery infection
program to increase fathers' involvement in infant care

Conditions: Randomised Controlled Trial; Public Health Nursing; Child Health

Summary: fathers participating in the study will be given an 8-week formality intervention. participants will be shown 4-week infant care training records and then 4-week videos prepared on educational topics. the effect of the intervention will be determined annually by the mean scores of the fathers' participation in infant care questionnaire, father infant attachment scale, and edinburgh postpartum depression scale.

the study will be conducted in a family health center in turkey, selected by random lottery. fathers who are registered in a family health center and have babies aged 4-12 months and fathers who have children for the first time will be included in the study. the type of the study is planned as randomized controlled pre-test post-test, parallel group experimental type. a total of 80 fathers will be included in the study, 40 in each group, according to the calculation made with gpower analysis. participants will be randomly assigned to groups. nursing interventions will last for 8 weeks and participants will be given training and watched videos during this process.

Eligibility criteria:
inclusion criteria * having a healthy baby between 4-12 months old, * being a first-time father, * volunteering to participate in the study, * having a smartphone exclusion criteria: * being under 18 years old, * having a psychiatric diagnosis.

Keywords: fathers&#39; involvement in infant care edinburgh postpartum depression scale. father-infant attachment child health
a study to assess how vaborem® is taking up in the body and tolerated in paediatric patients with complicated urinary tract infection

Conditions: Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis

Summary: the goal of this clinical trial is to assess the pharmacokinetic (pk) and safety and tolerability of vaborem ( fixed combination of meropenem and vaborbactam) in the paediatric population aged from 3 months to \< 18 years with complicated urinary tract infection (cuti) including acute pyelonephritis (ap) in need of hospitalisation and intravenous (iv) antibiotic administration. all participants will receive vaborem iv every 8 hours to treat cuti and/or ap for 10 up to 14 days; switch to stepdown oral antibiotic is allowed after a minimum of 3 days of vaborem. pk sample collection will occur after at least 6 doses administration. participant's clinical conditions will be monitored during the entire duration of their hospitalization and during scheduled visit/s after the completion of the treatment.


Eligibility criteria:
main inclusion criteria: * written informed consent before initiation of any study-related procedures. * male or female, 3 months and \< 18 years of age, inclusive. * require hospitalization for cuti/ap and a minimum of 3 days of iv antibiotic treatment for cuti/api as per investigator's judgement.current or suspected cuti or ap as indicated by the presence of clinical signs and symptoms, and complicating factors. main exclusion criteria: * history of any moderate or significant hypersensitivity or allergic reaction to beta-lactam antibiotics or to any component of the investigational medical product. * cuti/ap that in the opinion of the investigator is unlikely to respond to the study treatment. * creatinine clearance \<50 ml/min. * in treatment with immunosuppressive agents, valproic acid, or probenecid.

Keywords: complicated urinary tract infection cuti acute pyelonephritis pediatric meropenem vaborbactam vaborem
a study to assess the long-term safety outcomes in patients previously treated with rp1, rp2, or rp3

Conditions: Melanoma; Metastatic Melanoma; Advanced Solid Tumor; Hepatocellular Carcinoma

Summary: this is a noninterventional, observational, long-term follow-up (ltfu) study. patients in this study will be followed for 5 years from enrollment on this study to assess potential delayed risks of rpx products. eligible participants for this ltfu study include patients who received at least 1 dose of an rpx product under the interventional parent study. patients will be rolled over into this ltfu study after completion of the replimune-sponsored parent study (ie, either completion of the ltfu in the parent study or withdrawal from the parent study). all patients in ongoing rpx studies will be asked to participate in this ltfu study so that the sponsor can evaluate potential delayed risks.

long-term outcomes include detection of delayed adverse event(s) for any new malignancy(ies), new incidence or exacerbation of a pre-existing neurologic disorder, rheumatologic or other autoimmune disorder, hematologic disorder, new incidence of infection related to rpx product and new incidence of herpetic-like infection. patients with a suspected herpetic infection will be asked to provide a sample of the area of the suspected infection (using a swab), and also may be asked to provide additional biological samples (eg, a blood or urine sample to determine presence of rpx.) no study interventions will be administered in this observational study. patients will be contacted by telephone every 3 months (q3m) for 5 years from enrollment on this study. participant visits may occur in person, over the phone, by video conference, or other technology.

Eligibility criteria:
inclusion criteria: patients are eligible for inclusion in the study only if they meet all of the following criteria: 1. patient has received at least 1 dose of an rpx product and has completed or discontinued participation in the parent study. 2. patient or patient's legal guardian has provided signed informed consent (or assent) as , which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria: patients are excluded from the study if the following criterion applies: 1. cannot comply with the requirements of the study.

Keywords: advanced solid tumors immunotherapy immuno-oncology oncolytic virus oncolytic immuno-gene therapy hepatocellular carcinoma cutaneous melanoma anti-pd1 failed non-melanoma skin cancer melanoma (skin)
detection and cytotoxic t lymphocyte therapy of post-transplant lymphoproliferative disorder after liver transplant

Conditions: Liver Disease; Lymphoproliferative Disorders

Summary: despite advances in medical and gene therapy, orthotopic liver transplantation remains the only definitive therapeutic option for children with end-stage liver disease. recent advances in pre-, intra-, and early post-transplant care have resulted in a dramatic improvement in survival of the pediatric liver transplant patient. the broad long-range goal of our research program is directed at enhancing the patient's long-term survival. our primary focus relates to obligate life-long immunosuppression, with its inherent complications including severe infection and development of cancer. these two complications come together in a single disease, epstein-barr virus (ebv)- associated post-transplant lymphoproliferative disorder (ptld). ebv, a latent human lymphotrophic herpes virus infects and immortalizes b cells. primary infection usually occurs via salivary exchange and results in a mild, self-limited illness followed by life-long ebv-specific t cell controlled ebv latency. t cell-based immunosuppression prevents allograft rejection, however, it also suppresses cytotoxic t lymphocyte (ctl) function, generating an environment in which ebv-infected cells can proliferate. patients receiving life-long t cell-based immunosuppression have an increased risk of developing ptld due to their inability to produce normal immunoregulatory responses. this disease is particularly devastating to the pediatric patient as its incidence is at least 4-fold greater than in the adult liver transplant patient population. in fact, ptld is the number one cause of death following pediatric liver transplantation. at this time, there is no definitive method of prospectively detecting, diagnosing, or treating ptld, and current treatment protocols place the liver allograft and patient at risk. therefore, a diagnostic tool that is both sensitive and specific, and a treatment strategy with low toxicity are greatly needed to decrease the morbidity and mortality suffered by the pediatric liver transplant patient with ptld. our proposed studies will support our hypothesis that the combination of a persistently elevated ebv load in the setting of a diminished immune response to ebv will be an early risk indicator associated with ptld development, and that pre-emptive treatment utilizing autologous adoptive ebv-specific ctl immunotherapy will provide a low toxicity treatment option.


Eligibility criteria:
pediatric patients s/p orthotopic liver transplantation

Keywords: ptld ctl therapy post-transplant lymphoproliferative disorder
study evaluating the long-term safety and efficacy of abx464 in patients with moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: a phase 2a open-label study to evaluate the long-term safety and efficacy of abx464 50mg as maintenance therapy in patients with moderate to severe rheumatoid arthritis.

this phase 2a open-label study aims at investigating the long-term safety and efficacy of an oral dose of abx464 in patients who have been previously enrolled in the abx464-301 clinical study and who are willing to continue their treatment. all patients will receive abx464 given at 50mg o.d. irrespectively of their previous treatment received in the abx464-301 study (i.e. abx464 or placebo). the enrolment in this follow-up study will be based on the willingness of the subject to carry on his/her participation and also based on investigator's judgement. patients will be treated with abx464 for a period of 52 weeks. if they achieve a clinical response on week 52 (defined as das28-crp ≤ 2,6 for anti-tnfα naïve patients or das-28-crp ≤ 3,2 for patients previously treated by anti-tnfα), they will be eligible to continue treatment for up to 104 weeks.patients will be followed up at week , week 2 and then, on a monthly basis the first year (up to w52), and quaterly the second year (up to w104).

Eligibility criteria:
inclusion criteria: * patients previously enrolled in the abx464-301 clinical study who have completed the initial 12 weeks of treatment period; criteria that should be met by patients at week 52 to be eligible for 52 additional weeks of study treatment: ▪ patients should be in clinical response. clinical response is defined as: das28-crp ≤ 2,6 for anti-tnfα naïve patients or das-28-crp ≤ 3,2 for patients previously treated by anti-tnfα. exclusion criteria: * any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol

Keywords: moderate to severe rheumatoid arthritis
evaluation of interventions to prevent suicide of medical students through the school-based social support system

Conditions: Healthy

Summary: the purpose of this study is to determine whether school-based social support systems are effective in preventing suicide in medical students.


Eligibility criteria:
inclusion criteria: * medical university students grades 1 through 2 exclusion criteria: * psychopath
a study on the efficacy and safety of gabapentin in the treatment of patients with painful diabetic neuropathy

Conditions: Diabetic Neuropathies

Summary: the purpose of this study was to evaluate the efficacy, safety, and tolerability of gabapentin for the treatment of patients with painful diabetic neuropathy. the quality of life of all treated patients was also assessed.


Eligibility criteria:
inclusion criteria: * patients with stable diabetes mellitus 1 or 2 * clinical diagnosis of distal symmetric polyneuropathy with a minimum duration of 8 weeks * no clinically significant motor deficits * pain described according to at least one of the following clinical manifestations: burning, cramps or twinges, thermal or mechanical alodinea exclusion criteria: * treatment with any medication that may interfere with the assessment of gabapentin during the study or within 7 days of the adminstration of gabapentin * specific systemic diseases or other medical conditions that would interfere with the assessment of gabapentin therapeutic response or safety
iron supplementation among adolescent girls in india

Conditions: Iron Deficiency Anemia

Summary: this study will implement and evaluate a community-based intervention to distribute and promote consumption of weekly iron-folic acid supplements and to provide nutrition education to reduce the prevalence of iron deficiency anemia among adolescent girls in west bengal, india.


Eligibility criteria:
inclusion criteria: * girl 12-19 years of age * resides in study area exclusion criteria: * does not reside in study area

Keywords: iron deficiency anemia adolescent girls india
safety and efficacy of injection of human placenta mesenchymal stem cells derived exosomes for treatment of complex anal fistula

Conditions: Fistula Perianal

Summary: study aim: safety of human placenta mesenchymal stem cells derived exosomes for treatment of complex anal fistula 2.efficacy of human placenta mesenchymal stem cells derived exosomes for treatment of refractory anal fistula 3.fistula changes in mri studies, 12 weeks after treatment 4.evaluation of quality of life in perianal fistula patient's questionnaire score before and 12 weeks after treatment participants/inclusion and exclusion criteria: inclusion criteria : 1.age between 18-70 years old 2.occurrence of complex perianal fistula 3.informed consent exclusion criteria: 1.active inflammatory bowel disease 2.synchronous perianal abscess 3.alcohol,narcotic and stimulant consumption 4.having active hepatitis b,c,hiv or tb 5.peregnancy and lactation 6.uncontrolled diabetes mellitus 7.evidence of surgical contraindication 8.psychological disorders and noncooperative patient intervention groups: human placenta mesenchymal stem cells derived exosomes injected in fistula tract of patients with complex perianal fistula in 3 weekly episodes and it's safety and efficacy was evaluated. design: this study includes two separate groups of cases and controls each consisting of 40 participants randomly allocated for the phase 2 of clinical trial. settings and conduct: patients with complex perianal fistula referred to imam khomeini hospital, will be included in the study if they contain inclusion criteria. the fistula was evaluated by clinical examination and mri and patients fill the quality of life questionnaire. exosome injections are performed weekly for consecutive three weeks. patients will reexamined and fill the questionnaire and mri will done 12 weeks later. recent findings will compare with the initial data. during this period, patients are examine for complications. main outcome variables: discharge amount; external orifice re-epithelialization ; inflammation, discharge and abscess larger than 2 cm in mr imaging; quality of life questionnaire score, inflammatory markers such as crp, il-6, tnf-a, calprotectin


Eligibility criteria:
inclusion criteria: 1. age between 18-70 years old 2. occurrence of complex perianal fistula 3. informed consent exclusion criteria: 1. active inflammatory bowel disease 2. synchronous perianal abscess 3. alcohol,narcotic and stimulant consumption 4. having active hepatitis b,c,hiv or tb 5. peregnancy and lactation 6. uncontrolled diabetes mellitus 7. evidence of surgical contraindication 8. psychological disorders and noncooperative patient