Kornimate/medical-research-clean huggingface dataset:
micafungin versus fluconazole for prevention of invasive fungal disease in living donor liver transplant recipients

Conditions: Liver Transplant Recipient

Summary: the purpose of this study is to demonstrate non-inferiority of micafungin at a dose of 100 mg/day versus fluconzeole for the prevention of invasive fungal disease, defined according to the revised eortc/msg criteria, undergoing living-donor liver transplantation.

this is randomized, open label, non-inferiority study of micafungin versus fluconazole for the korean prevention of invasive fungal disease in living donor liver transplant recipients after transplant subjects will be randomized to one of the following treatment arms: * micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing \<40 kg) * fluconazole 100\~200mg/day, iv care until oral medication becomes possible stratification according to centers. antifungal prophylaxis will be administered once daily for a period of 21 days, or until hospital discharge, whichever occurs first. this is an open label study; study center personnel will not be blinded to treatment.

Eligibility criteria:
inclusion criteria: * age \> 20 years. * undergoing living donor liver transplantation(ldlt) exclusion criteria: * any systemic antifungal therapy (excluding fluconazole or sdd for a maximum of 7 days) within 14 days prior to randomization. * evidence of documented ('proven' or 'probable') or suspected ('possible') ifd (according to the eortc/msg criteria). * allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal, or any of the study drugs or their excipients. * reimplantation or orthotopic transplantation patient.

Keywords: living donor liver transplant antifungal prevention
comparison of muscle atrophy after direct anterior & posterior total hip arthroplasty

Conditions: Osteoarthritis, Hip

Summary: this project is designed to use mri to evaluate pre- and post-arthroplasty hips; the specific aims of this project are three-fold. first, the investigators intend to compare the amount of muscle atrophy and tendon damage that occurs around the hip between two commonly-used operative approaches: the direct-anterior approach and the posterior approach. second, the investigators aim to provide baseline data on the amount of muscle atrophy and tendon damage that should reasonably be expected to occur with both of these approaches. third, the investigators will document the degree of recovery of the periprosthetic soft tissues post-surgery in both patient groups. the investigators first hypothesis is that the posterior approach will demonstrate significantly more damage to the abductors, piriformis, and short external rotators than the direct anterior approach, which will demonstrate minimal soft tissue damage. the investigators second hypothesis is that both surgical approaches will cause some degree of baseline muscle damage and atrophy, in a predictable pattern. the investigators third hypothesis is that each of the surgical approaches inherently cause some degree of soft tissue damage, and that the periprosthetic soft tissues that are incised during the surgical exposure will recover in a predictable pattern which is consistent but unique within each group


Eligibility criteria:
inclusion criteria: 1. patients undergoing elective, primary total hip arthroplasty 2. use of cementless total hip components 3. preoperative diagnosis of degenerative joint disease secondary to osteoarthritis exclusion criteria: 1. prior surgery on the affected hip 2. no implanted medical devices or metallic debris in the patient which will preclude use of mri 3. patients must be able to participate in standard post-arthroplasty rehabilitation protocols.
a study of combined c- met inhibitor and pan-her inhibitor (pf-02341066 and pf-00299804) in patients with non- small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: lung cancer tumors become resistant to the first generation epidermal growth factor receptor (egfr) inhibitors erlotinib or gefitinib by changing and increasing the activity of two cell signaling pathways: the cmet pathway and the egfr pathway. both resistance mechanisms can occur at the same time, in the same patient and even in the same tumor. this study combines a second generation egfr inhibitor and a cmet inhibitor to block both these pathways in order to overcome resistance and treat this disease.


Eligibility criteria:
inclusion criteria: * advanced non small cell lung cancer (dose escalation phase) * acquired resistance to erlotinib or gefitinib (expansion phase) * mandatory entrance biopsy (expansion phase) exclusion criteria: * interstitial lung disease * unstable brain metastases * leptomeningeal disease

Keywords: phase 1 acquired resistance to erlotinib or gefitinib cmet inhibitor egfr inhibitor panher inhibitor combination trial crizotinib
implementation of a clinical tool to improve waitlist mortality in patients with cystic fibrosis

Conditions: Cystic Fibrosis; Lung Transplant; Complications

Summary: implementation of a clinical tool to improve waitlist mortality in patients with cystic fibrosis

the aim of this project is to implement a clinical tool utilizing predictors of mortality for patients with cystic fibrosis (cf) on the waiting list to identify candidates that should present for urgent medical care and, if appropriate, will prompt clinicians to update a candidate's lung allocation score (las), the score used to prioritize lung transplant candidates for transplant by medical urgency, and avoid undetected decline. the clinical tool consists of home spirometry measures and patient reported outcomes that is completed weekly on a mobile application device used clinically to track spirometry.

Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis * to be listed for lung transplant * has purchased home spirometer exclusion criteria: * diagnosis other than cystic fibrosis * unable to read * unable to use computer or smartphone device to access mobile application
posterior corpectomy in thoracolumbar spinal metastatsis

Conditions: Spine Metastases

Summary: to analyze the short-term outcomes of posterior corpectomy of patients with thoracolumbar spinal metastasis in spine unit in assiut university hospital regarding the pain control , neurological status , complication and ambulatory status as well as mortality rate.

the metastasis is the spread of cancer from one part of the body to another. two-thirds of patients with cancer will develop bone metastases. breast, prostate and lung cancer are responsible for more than 80% of cases of metastatic bone disease. a spinal metastasis may cause pain, instability and neurological injuries. * the spine is the most common site of bone metastasis . it is estimated that over the 10% of patients with cancer will develop a symptomatic spinal metastasis . algra et al. suggest that the initial anatomic location of metastases within vertebrae is in the posterior portion of the body. * spinal metastases are the most common tumors of the spine, comprising approximately 90% of masses encountered with spinal imaging. within the spinal column, metastasis is more commonly found in the thoracic region, followed by the lumbar region, while the cervical region is the least likely place professionals find metastasis . * spinal metastases most commonly affect the vertebral bodies of the spinal column, and spinal cord compression is an indication for surgery. commonly, an open posterior approach is employed to perform a transpedicular, costotransversectomy or lateral extracavitary corpectomy. because of the short life expectancies in patients with metastatic spinal disease, decreasing the morbidity of surgical treatment and recovery time is critical. * at present, both surgical and nonsurgical treatments are used for the treatment of spinal tumors, however, treatment outcome is dependent on various factors, such as patient age, overall health of the patient . * when treating patients with vertebral metastases, surgical strategy is mainly based on life expectancy, primary site of tumor, and staging. this helps determine which patients will benefit from surgery and the type of procedure. tokuhashi developed a score to determine life expectancy in order to facilitate the treatment modality decision . * vertebral corpectomy refers to the removal of one or more vertebral bodies from the spine, as well as the intervertebral discs above and below the surgical level. corpectomies may be accomplished through a multitude of approaches. posterior approaches have been associated with less intraop- erative blood loss, complications, shorter operative time, and better pul- monary function post-operation compared to anterior approaches .

Eligibility criteria:
inclusion criteria: patients \> 18 years old patient diagnosed as cancer intractable pain progressive neurologic comprise radioresistant tumors * failure of radiotherapy * failure of chemotherapy * fit for surgery exclusion criteria: patient younger 18 years old spinal 1ry tumor
to evaluate long-term safety and efficacy of pregabalin in the treatment of neuropathic pain after spinal cord injury.

Conditions: Neuropathic Pain

Summary: to evaluate long-term safety and efficacy of pregabalin in the treatment of neuropathic pain after spinal cord injury.


Eligibility criteria:
inclusion criteria: * must have met the inclusion criteria of the preceding double-blind bid study in central pain following spinal cord injury. * must have received study medication under double-blind conditions. exclusion criteria: * patients cannot participate if they experienced a serious adverse event during the previous double-blind bid study which was determined to be related to the study medication.
reducing depression self-stigma and increasing treatment seeking intentions among youth

Conditions: Stigma, Social; Mental Health Disorder; Depression

Summary: young people with depression, especially those of underserved minority groups, avoid treatment due to stigma and discrimination. social contact is a form of interpersonal contact with members of the stigmatized group and the most effective type of intervention for improvement in stigma-related knowledge and attitudes. in a prior study, the investigators developed short video interventions to reduce stigma and increase treatment seeking among people with depression. the videos vary by protagonist race/ethnicity (latinx, non-latinx black, non-latinx white) who share their experiences with depression, challenges, and recovery process. the investigators would like to test the efficacy of these videos using prolific (a crowdsourcing platform). specifically, the investigators are interested in conducting a randomized controlled trial (rct) to test the efficacy of these videos as compared to a vignette control condition on reducing self-stigma and increasing help-seeking intentions and behavior at baseline, post, and 30 day follow-up among youth with depressive symptom scores on the phq-9≥ 5.

in a randomized control trial (rct) with pre-, post-intervention, and 30-day follow-up assessments, we aim to 1) test the efficacy of brief social video interventions, varying protagonist race/ethnicity, as compared to vignette control in reducing self-stigma and increasing treatment-seeking intentions and behavior among 1600 prolific users ages 18-25 with depressive symptoms (phq-9≥ 5), and 2) explore whether matching to protagonist race/ethnicity increases intervention efficacy. we hypothesize that 1) brief social contact-based video interventions will reduce self-stigma towards depression and increase treatment-seeking intentions and behavior compared to vignette control, and 2) the participants whose race/ethnicity match the protagonist will have greater changes in self-stigma and treatment-seeking than participants with unmatched protagonists, i.e., matching moderates the intervention's effects.

Eligibility criteria:
inclusion criteria: * endorsing mild to severe depressive symptoms (patient health questionnaire (phq-9) score of 5 or greater) * ages 18-25 * us residents * english speaking exclusion criteria: * not endorsing mild to severe depressive symptoms * age less than 18 or greater than 25
study of latiglutenase in t1d/cd patients

Conditions: Celiac Disease

Summary: this is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in type 1 diabetes and celiac disease subjects attempting a gfd for at least one year prior to screening.

this is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in type 1 diabetes and celiac disease subjects attempting a gfd for at least one year prior to screening. seropositive subjects (blood test confirmed at visit 0) will be scheduled for a screening visit (visit 1) whereas seronegative subjects will be discontinued from study participation (screen failures). subjects who meet visit 1 protocol enrollment criteria will be enrolled.

Eligibility criteria:
inclusion criteria (select): * confirmed cd diagnosis * confirmed t1d diagnosis * seropositive * gluten free diet (12 months minimum) * experienced at least one self-reported moderate or greater severity symptom during the last 28 day period * willing to take study treatment daily * must sign informed consent exclusion criteria (select): * wheat allergy * history of peptic ulcer disease, esophagitis, ibs, ibd * active colitis * subjects with known rapid gastric emptying (post-bariatric surgery, billroth i or ii surgery) * chronic infectious gastrointestinal illness or acute infectious gastrointestinal illness within the 4 week period prior to screening * known refractory celiac disease (rcd1 or rcd2) * inability to give informed consent

Keywords: celiac
pmdt in thoracic surgery--------for the baseline investigation and technical preparation stage

Conditions: Pain, Postoperative

Summary: the risk of acute and chronic pain after thoracic surgery is high. the multi-disciplinary postoperative pain management strategy is the best way to control postoperative pain in thoracic surgery. through nearly one year of experience in implementation of the pmdt in the thoracic surgery department of peking university people's hospital, the investigators have summarized the experience in multidisciplinary pain management and promoted this study in multi-centers across the country, hoping that this study can improve the current situation of acute pain management in patients after thoracic surgery, and at the same time, the deficiencies of this clinical protocol can be found out and improved.

the postoperative acute pain refers to the acute pain (usually lasting less than 7 days) that occurs immediately after surgery, and its nature is traumatic pain. it may develop into a chronic pain, such as a neuropathic pain or a mixed pain, if it is not fully controlled at the initial state. it will seriously impact the physiology and psychology of a patient. according to the study, the postoperative acute pain is one of the risks for postoperative complications, and it may result in the death of a patient. however, the alleviation of a postoperative acute pain can shorten the duration of stay in hospital, and reduce the overall cost for treatment of a patient. the risk of acute and chronic pain after thoracic surgery is high. the multi-disciplinary postoperative pain management strategy is the best way to control postoperative pain in thoracic surgery. through nearly one year of experience in implementation of the pmdt in the thoracic surgery department of peking university people's hospital, the investigators have summarized the experience in multidisciplinary pain management and promoted this study in multi-centers across the country, hoping that this study can improve the current situation of acute pain management in patients after thoracic surgery, and at the same time, the deficiencies of this clinical protocol can be found out and improved.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 75, asa i-ii; * patients undergoing thoracoscopic surgery; * patients who can understand and fill in the self-evaluation; * patients who signed the informed consent form. exclusion criteria: * pregnant women; * patients with preoperative chronic pain and long-term opioid use; * patients with advanced tumors who have received preoperative chemotherapy or who are expected to receive postoperative chemotherapy.

Keywords: pmdt pain thoracic surgery
endovascular aaa intervention using the gore® excluder® conformable aaa endoprosthesis or iliac branch endoprosthesis

Conditions: AAA - Abdominal Aortic Aneurysm

Summary: a prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the gore® excluder® conformable aaa endoprosthesis (excc device) or the gore® excluder® iliac branch endoprosthesis (ibe device) as a part of routine clinical practice.

the purpose of the gore together aortic registry is to collect real-world data (rwd) for gore aortic endovascular devices. due to the nature of the program, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice. therefore, the sponsor will not be outlining requirements that would influence healthcare decisions. participants will be asked to return for regular scheduled visits as requested by their surgeon. patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.

Eligibility criteria:
inclusion criteria: 1. patient or legally authorized representative (lar) provides written authorization and/or consent per institution and geographical requirements 2. patient has been or is intended to be treated with an eligible registry device 3. patient is age ≥ 18 years at time of informed consent signature. exclusion criteria: 1. patient who is, at the time of consent, unlikely to be available for standard of care (soc) follow-up visits as defined by the site's guidelines and procedures. 2. patient with exclusion criteria required by local law. 3. patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of together registry enrollment. subjects cannot be enrolled in another together registry module protocol.

Keywords: aneurysm aneurysm repair endovascular evar endoprosthesis aortic aortic repair
immunotherapy with cd22 car t-cells for b-cell lymphoma, all and cll

Conditions: Leukemia; Lymphoma

Summary: this study aims to evaluate the safety, efficacy and duration of response of cd22 chimeric antigen receptor (car) redirected autologous t-cells in patients with high risk, relapsed cd22+ haematological malignancies.

this is a multi-centre, non-randomised, open label phase i clinical trial of an advanced therapy investigational medicinal product named cd22 chimeric antigen receptor (car) t-cells (cd22 car t-cells) in patients with high risk, relapsed cd22+ haematological malignancies (leukemia and lymphoma). following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the cd22 car tcells. patients will receive the cd22car t-cells following lymphodepleting chemotherapy. the study will evaluate the safety, efficacy and duration of response of the cd22 car t-cells in patients with high risk relapsed cd22+ malignancies

Eligibility criteria:
inclusion criteria: 1. relapsed or refractory b cell derived acute lymphoblastic leukemia(all), chronic lymphoblastic leukemia(cll) and non-hodgkin lymphoma. 2. kps\>60. 3. life expectancy\>3 months. 4. gender unlimited, age from 2 years to 70 years. 5. cd22 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry. 6. patients who have failed at least one line of a standard treatment. 7. no serious mental disorder. 8. patients must have adequate cardiac function(no cardiac disease, lvef≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(cr≤133umol/l). 9. no other serious diseases(autoimmune disease, immunodeficiency etc.). 10. no other tumors. 11. patients volunteer to participate in the research. 12. patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active gvhd and no longer taking immunosuppressive agents for at least 30 days prior to exclusion criteria: 1. kps\<50. 2. patients are allergic to cytokines. 3. central nervous system leukemia within 28 days. 4. uncontrolled active infection. 5. acute or chronic gvhd. 6. treated with t cell inhibitor. 7. pregnancy and nursing females. 8. hiv/hbv/hcv infection. 9. other situations we think improper for the research.

Keywords: car-t leukemia lymphoma
evaluation of the pharynx in patients undergoing lateral pharyngoplasty

Conditions: Sleep Apnea, Obstructive

Summary: this study will evaluate the pharynx in patients undergoing lateral pharyngoplasty for treatment of obstructive sleep apnea through mri, before and 6 months after surgery.


Eligibility criteria:
inclusion criteria: * diagnosis of obstructive sleep apnea syndrome exclusion criteria: * mri contraindications

Keywords: magnetic resonance imaging sleep apnea, obstructive pharyngeal muscles