Kornimate/medical-research-clean huggingface dataset:
pmcf study on the safety, performance and clinical benefits data of the xtrafix® small external fixation system

Conditions: Wrist Fracture; Proximal Humerus Fracture

Summary: the study is a monocentric, retrospective, non-randomized, non-controlled and consecutive series post-market study. the purpose of this study is to confirm safety, performance and clinical benefits of the xtrafix® small external fixation system (implants and instrumentation) when used to treat long bone fractures. the primary objective is the assessment of performance by analyzing fracture healing. the secondary objectives are the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. relation of the events to implant, instrumentation and/or procedure should be specified. subjects' outcomes will also be assessed.

the xtrafix® small external fixation system is intended to be used for the treatment of appropriately sized long bone fractures (in foot, arm, wrist and hand), which account for 20% of all fractures in emergency departments and are the most common fractures in all patients under the age of 75. in this study we will only collect data on wrist and proximal humerus fractures. one site will be involved in this study. the aim is to include a maximum of 91 consecutive series cases who received the xtrafix® small external fixation system at the azienda ospedaliera di rilievo nazionale "antonio cardarelli" (naples, italy) starting from 2019 until 2021. all potential study subjects will be required to participate in the informed consent process. baseline data from the preoperative, intraoperative, immediate post-operative and device removal visit will be available in medical notes and collected retrospectively. during a follow up phone call at least 1 year post-operative the subject will be asked to complete a patient questionnaire and a clinical assessment of the fracture healing will be done. in addition, any complications since the last consultation visit at the clinic and information about the treatment of the complications will also be collected over the phone.

Eligibility criteria:
inclusion criteria: * 18-year-old or older patients having received the xtrafix® small external fixation system for the treatment of long bone fractures. * specifically, the system is intended for temporary stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated. * revision surgeries will also be included in the study. * in this study we will only collect data on wrist and proximal humerus fractures. exclusion criteria: * off-label use * active or suspected infection * conditions that limit the patient's ability and/or willingness to follow instructions during the healing process * inadequate skin, bone, or neurovascular status

Keywords: post-market clinical follow-up study medical device performance clinical benefits safety wrist fracture humerus fracture
a study of minimally invasive surgical strategies for robot-assisted supratentorial large hematoma

Conditions: Hematoma Brain

Summary: the ai robot is used to design precise coordinates and access routes for hypertensive cerebral hemorrhage patients with large supratentorial hematomas in conjunction with imaging data, to clarify the therapeutic efficacy of robotic-assisted endoscopic debridement of precise minimally invasive surgical system for perioperative and long-term functional recovery of supratentorial hematomas, and to ultimately achieve the improvement of prognosis for this group of patients, and to alleviate the economic burdens on the society and the families

in this randomized controlled study, we investigated the efficacy of robotic assistance for supratentorial large hematomas by comparing robotic-assisted minimally invasive removal of supratentorial large hematomas with conventional surgical hematoma removal. our main comparisons were the 6-month mortality rate and good prognosis rate, and the main evaluation indexes included mrs score and gos score.

Eligibility criteria:
inclusion criteria: 1. patients who were diagnosed by imaging (ct, cta, etc.), measured by the abc/2 method, and clearly recognized as having a supratentorial hypertensive cerebral hemorrhage. patients with hematoma volume \>30ml and gcs score ≥5; 2. the patient's age is 18-70 years old; patients aged 18-70 years; 3. time from onset to surgery ≤72h; 4. repeat ct scan at least 6 hours after the diagnostic ct scan showed that the hematoma was stable; 5. sbp \<180 mmhg was recorded near the time of random assignment; 6. mrs score ≤1 in the past medical history; 7. patient/family informed and signed informed consent. exclusion criteria: 1. the hematoma is not located on the curtain or the volume of the hematoma is less than 30 ml; 2. the onset of the disease is more than 3 days at the time of admission; secondary cerebral hemorrhage (secondary causes such as aneurysm, vascular malformation, hemorrhagic transformation of cerebral infarction, tumor, trauma, drug-related or abnormal coagulation mechanism). 3. secondary causes such as aneurysm, vascular malformation, hemorrhagic transformation of cerebral infarction, tumor, trauma, drug-related or abnormal coagulation mechanism); 4. presence of serious immune diseases (e.g., cirrhosis, malignant tumors, rheumatic immune diseases, etc.); 5. poor compliance or inappropriate for enrollment as judged by the investigator.
immunotherapy and irreversible electroporation in the treatment of advanced pancreatic adenocarcinoma

Conditions: Pancreatic Adenocarcinoma

Summary: compare the efficacy and tolerability of irreversible electroporation in combination with nivolumab in patients with locally advanced pancreatic cancer.

immunotherapy and irreversible electroporation in the treatment of advanced pancreatic adenocarcinoma. this is a phase ii study in which all patients undergoing irreversible electroporation of locally advanced pancreatic adenocarcinoma will be treated with nivolumab post-operatively.

Eligibility criteria:
inclusion criteria: * ≥ 18 years if age * diagnosed with stage iii pancreatic cancer * tumor is measurable * glomerular filtration rate \> 60 m/l/min/1.73 m(2) * willing and able to comply with the protocol requirements * able to comprehend and have signed the informed consent to participate exclusion criteria: * participating in another clinical trial for the treatment of cancer at time of screening * are pregnant or currently breast feeding * have a cardiac pacemaker or implantable cardioverter defibrillator implanted that cannot be deactivated during the procedure * have non-removable implants with metal parts within 1 cm of the target lesion * had a myocardial infarction within 3 months prior to enrollment

Keywords: irreversible electroporation nivolumab
safety and efficacy of gmx1777 in the treatment of refractory solid tumors or lymphomas

Conditions: Solid Tumors and Lymphomas

Summary: gmx1777 is a water-soluble, intravenously-administered prodrug of gmx1778. gmx1777 is rapidly converted to gmx1778 in vivo. gmx1778 has potent anti-tumor activity against a variety of cell lines and models from different tumor origins.

this is a single-center, open-label, phase i study of single-agent gmx1777 administered every 3 weeks to patients with cll, mm, refractory solid tumors or lymphomas. no investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.

Eligibility criteria:
inclusion criteria: * patients must have a histologically or cytologically confirmed solid tumor or lymphoma * no limitations on allowable type and amount of prior therapy. * patients must have a life expectancy of greater than 8 weeks * patients must have normal organ and marrow function * patients must be willing to submit blood sampling for planned pk analysis * patients must have the ability to understand and willingness to sign a written informed consent form exclusion criteria: * no other agents or therapies administered with the intent to treat malignancy * patients with prior exposure to gmx1777 or gmx1778 * uncontrolled, intercurrent illness * pregnant women and women who are breast feeding
septic shock-induced immunosuppression

Conditions: Septic Shock

Summary: septic syndromes are a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units (icu). while it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immune response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. as a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. this is illustrated in those patients by reactivation of dormant viruses (cytomegalovirus (cmv) or herpes simplex virus (hsv)) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. these alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. new promising therapeutic strategies are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients. the prerequisite for immunostimulation administration (interferon gama (ifng), granulocyte macrophage colony stimulating factor (gm-csf), interleukin 7 (il-7)) however relies on clinicians' capacity to identify patients who could benefit the most from these immunoadjuvant therapies, as there is no clinical sign of immune dysfunctions. in this context, the main objectives of immunosepsis 4 study are: 1. to identify the best biomarkers for sepsis-induced immunosuppression 2. to evaluate ex vivo candidate treatments which could rejuvenate immune functions after septic shock


Eligibility criteria:
inclusion criteria: * age over 18 years * patient admitted to icu * diagnosis of septic shock within less than 48h at time of screening defined by : * presence of a microbiologically diagnosed or suspected infection * initiation of a vasopressive treatment to maintain mean arterial blood pressure ≥ 65 mm hg initiated during the first 48h after icu admission * presence of an hyperlactatemia \> 2 mmol/l (18 mg/dl) during the 24h before or after initiation of vasopressive treatment despite adequate volemic reanimation (30 ml/kg) * blood sample at d3/d4 available (lab working days) * non opposition to study participation obtained from patient or next of kin exclusion criteria: * pregnant or breastfeeding woman * patient with no social security insurance, with restricted liberty or under legal protection * language barrier * patient taking part in interventional study about medicin that could interfere with biologic results
tiotropium+olodaterol fixed dose combination (fdc) versus tiotropium and olodaterol in chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol fdc (delivered by the respimat inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the respimat inhaler) in patients with chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: 1. diagnosis of chronic obstructive pulmonary disease. 2. relatively stable airway obstruction with post fev1\< 80% predicted normal and post fev1/fvc \<70%. 3. male or female patients, 40 years of age or older. 4. smoking history of more than 10 pack years. exclusion criteria: 1. significant disease other than copd 2. clinically relevant abnormal lab values. 3. history of asthma. 4. diagnosis of thyrotoxicosis 5. diagnosis of paroxysmal tachycardia 6. history of myocardial infarction within 1 year of screening visit 7. unstable or life-threatening cardiac arrhythmia. 8. hospitalization for heart failure within the past year. 9. known active tuberculosis. 10. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years 11. history of life-threatening pulmonary obstruction. 12. history of cystic fibrosis. 13. clinically evident bronchiectasis. 14. history of significant alcohol or drug abuse. 15. thoracotomy with pulmonary resection 16. oral ß-adrenergics. 17. oral corticosteroid medication at unstable doses 18. regular use of daytime oxygen therapy for more than one hour per day 19. pulmonary rehabilitation program in the six weeks prior to the screening visit 20. investigational drug within one month or six half lives (whichever is greater) prior to screening visit 21. known hypersensitivity to ß-adrenergic drugs, anticholinergics, bac, edta 22. pregnant or nursing women. 23. women of childbearing potential not using a highly effective method of birth control 24. patients who are unable to comply with pulmonary medication restrictions
a phase 1 study of medi7734 in type i interferon-mediated autoimmune diseases

Conditions: Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc

Summary: to evaluate the safety and tolerability of escalating, single subcutaneous doses of medi7734 in adult subjects with type i interferon-mediated autoimmune diseases.

medi7734 is a human monoclonal antibody that binds to and causes temporary depletion of plasmacytoid dendritic cells (pdcs), a type of white blood cell. the objectives of this study are to evaluate the safety, drug levels, and pdc levels in subjects who are given a single injection of medi7734 or a placebo. the study will be conducted in subjects with at least one of the five following autoimmune diseases: dermatomyositis, polymyositis, sjogren's syndrome, systemic lupus erythematosus, or systemic sclerosis. after a screening period, subjects will be randomized in a 3:1 ratio to receive a single dose of medi7734 or matching placebo, administered as a subcutaneous (under the skin) injection. after that, subjects will be evaluated periodically at the study site over at least the next 85 days. study acquired from horizon in 2024. originally viela bio was the sponsor.

Eligibility criteria:
key inclusion criteria: 1. age 18-65 years old 2. diagnoses of dematomyositis, polymyositis, sjogren's syndrome, systemic lupus erythematosus and/or systemic sclerosis based on standard criteria. 3. weight 40-120kg 4. stable disease such that in the opinion of the investigator it is unlikely that a change in subject's therapeutic regimen would be required during the subsequent 3 months. key exclusion criteria: 1. history of a hypersensitivity reaction or anaphylaxis to a previous mab or human immunoglobulin therapy. 2. chronic hepatitis b, chronic hepatitis c, or hiv infection. 3. history of latent or active tuberculosis (tb), or a positive quantiferon®-tb gold test at screening. 4. herpes zoster infection within 3 months before randomization 5. any of the following medications within 6 months of day 1: cyclophosphamide, leflunomide \> 20 mg/day, abatacept. 6. receipt of a mab within 5 published half-lives prior to day 1. 7. receipt of rituximab or an experimental b-cell depleting mab within 6 months of day 1. 8. receipt of rituximab or an experimental b-cell depleting mab without return of cd19 or cd20 count to above the lower limit of normal. 9. receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, or t-cell vaccination therapy -

Keywords: polymyositis, dermatomyositis, sjogren's syndrome, sle, ssc
the effect of structured pain education on pain and performance parameters in patients with chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the effect of structured pain education on pain and performance parameters in patients with chronic low back pain the aim of this study is to compare the effects of only low load motor control exercises and pain education in addition to these exercises on pain, performance, disability and psychological factors, and to present a generalizable pain education in patients with chronic low back pain. we think that dymk exercises applied together with a general pain education given to the patients will provide more improvement on these factors. the patients will be divided into 2 groups, as a pain training group and an exercise group, with 20 people in each group, in a randomized controlled manner. only dymk exercise training will be applied to the exercise group. in the pain training group, pain training will be applied in addition to the dymk exercise training. as an evaluation parameter to the participants; numerical rating scale, short-form mcgill pain questionnaire, pain catastrophizing scale, tampa kinesiophobia scale, roland-morris disability questionnaire, pain self-efficacy questionnaire, passive lumbar extension test, finger-place test and physical performance test battery will be applied. patients will be evaluated before the start of the study (t0) and at the end of the study (t1). low load motor control exercises will be applied to people in both groups for 4 weeks, 3 days a week, during 20-30 minute sessions. in addition to the dymk exercise training, a session of 30 to 50 minutes of pain training in groups of 4 to 5 people will be given to the patients included in the pain training group at the beginning of the exercise training and the exercise training will begin.


Eligibility criteria:
inclusion criteria: * 18 to 65 years old * chronic low back pain 3 days a week and ≥ 3 months * absence of spinal fracture or acute disc herniation * absence of existing psychiatric problems and mental deficiencies * absence of exercise contraindications \[28\] \[29\] \[30\] exclusion criteria: * being diagnosed with lumbar radiculopathy * pain due to tumors or infections, metastases, osteoporosis, inflammatory arthritis or fractures * specific medical conditions (neck or back surgery in the previous 3 years, osteoporotic vertebral fractures or rheumatological diseases) * chronic widespread pain syndromes (fibromyalgia or chronic fatigue syndrome) * receiving any other treatment for chronic low back pain during the study \[28\] \[29\] \[30\]
a telerehabilitation intervention for people with heart failure and chronic fatigue

Conditions: Heart Failure

Summary: this study compares the effectiveness of a 6-week energy conservation + problem solving therapy intervention to health education intervention for reducing the fatigue impact and fatigue level and improving the level of participation in instrumental, leisure, and social activities in people with heart failure associated fatigue. half of the participants received energy conservation + problem solving therapy intervention, and the other half received health education intervention.

energy conservation+problem solving therapy (ec+pst) intervention: in this study, the ec+pst intervention will ideally occur twice a week for 6 weeks with each session lasting approximately 30 minutes. the intervention will be individually delivered via telehealth; therefore, participants will receive the intervention in their home to minimize fatigue from the intervention. health education intervention: the health education intervention will occur once a week for 6 weeks with each session lasting approximately 30 minutes. the health education intervention will be delivered via telehealth; therefore, participants will receive the intervention at their convenient quiet place to minimize fatigue from the intervention.

Eligibility criteria:
inclusion criteria: (a) a minimum 6 months since diagnosed with hf and 3 months post-hospitalization, (b) reporting of moderate to severe fatigue by scoring ≥4 according to fatigue severity scale, (c) living in the community, (d) having access to the internet or telephone in the place of residence, (e) having functional english fluency, and (f) having functional vision to operate the tablet computer. exclusion criteria: 1. had a score of ≥9 in short blessed test indicating cognitive impairment 2. were classified as having new york heart association (nyha) functional classification level iv on their medical record

Keywords: heart failure fatigue rehabilitation occupational therapy
a study of incb050465 in subjects with relapsed or refractory marginal zone lymphoma (citadel-204)

Conditions: Lymphoma

Summary: the purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (mzl) who are naive to or were previously treated with a bruton's tyrosine kinase (btk) inhibitor.


Eligibility criteria:
inclusion criteria: * men and women, aged 18 or older (except in south korea, aged 19 or older). * histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes. * radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures \> 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter. * participants with splenic mzl who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of mzl is histologically confirmed. * participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue. * eastern cooperative oncology group performance status 0 to 2. exclusion criteria: * evidence of diffuse large b-cell transformation. * history of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease. * prior treatment with idelalisib, other selective pi3kδ inhibitors, or a pan-pi3k inhibitor. * allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment. * active graft versus host disease. * subjects positive for hepatitis b surface antigen or hepatitis b core antibody will be eligible if they are negative for hbv-dna. subjects positive for anti-hcv antibody will be eligible if they are negative for hcv-rna.

Keywords: marginal zone lymphoma phosphatidylinositol 3-kinase (pi3k)δ inhibitor indolent (slow-growing) non-hodgkin lymphoma b-cell lymphoma