Kornimate/medical-research-clean huggingface dataset:
human composite facial allotransplantation

Conditions: Transplantation: Facial Transplantation

Summary: allotransplantation of maxillofacial of subject with severe facial deformities due to traumatic events.

a facial transplantation is a highly dynamic, prolonged operation requiring teams communicating seamlessly through its duration. this is similar to complex solid organ transplant teams at methodist transplant institute. the institute's clinical experience in management of complex facial defects and deformities along with the personnel and infrastructure at methodist dallas transplant institute would help develop a center for facial allotransplantation. the team experience, true collaboration, creativity and a unique approach to each patient would help provide the optimal care and reconstruction for the face allotransplant patient both before and after surgery. the purpose of this study is centered on the advancement of a safe and effective procedure for facial allotransplantation at methodist hospital medical center at dallas. composite tissue allotransplantation for facial reconstruction is in its infancy as liver transplantation was 30 years ago when the first liver transplant was completed in texas. this study will establish methodist hospital system as a center for facial allotransplantation for reconstruction of extensive facial defects resulting in functional loss and poor quality of life. patient participation post transplantation will either be for life, or failure of the composite tissue allograft. patient enrollment will be initiated immediately after the irb approval. the enrollment period will be completed after the patient receives the final transplant, and the study will be completed at 24 months after the final transplant. however, all patients enrolled into the study will have lifelong follow up with immunosuppressive management, psychological support, and evaluation of functional recovery per protocol.

Eligibility criteria:
inclusion criteria: * between ages 18-70 years * must be willing to undergo major facial reconstruction * be able to understand the pre and post-transplantation evaluation, physical therapy, and follow up procedures * conventional reconstruction deemed unsatisfactory exclusion criteria: * medically unable to provide consent * active infections such as human immunodeficiency virus, mycobacteria, hepatitis b, and hepatitis c * recent history of alcohol or iv drug or chemical dependency * psychiatric evaluation that indicate mental instability or non-compliance * cognitively impaired and terminally ill * women of child bearing age with intent to conceive, pregnant or lactating * unable to receive immunosuppression after transplantation because of either geographic or financial limitations * end stage organ disease (renal failure, congestive heart failure (chf), chronic obstructive pulmonary disease (copd), etc.) * chronic infections such as osteomyelitis

Keywords: facial transplantation
development of the palate in bilateral orofacial cleft newborns one year after early neonatal cheiloplasty

Conditions: Cleft Palate; Cleft Lip; Cleft Lip and Palate; Cleft Lip, Bilateral

Summary: early neonatal cheiloplasty is modified surgery protocol applied in the first week of newborn's life used for treating orofacial cleft patients. this prospective study analyzes the effects of early neonatal cheiloplasty on the growth and development of maxilla and palate during the observed period of one year.

multidisciplinary treatment of patients with orofacial clefts begins immediately after birth. the first surgical procedure is early neonatal cheiloplasty applied in the first week of the newborn's life, which has been practiced in the czech republic for many years. it is a popular parental choice and has a lot of benefits compared to classic cheiloplasty performed between 3-6 months. unrestricted growth of jaws is essential for the successful therapy of aesthetics and functions. although there are known a lot of benefits to this surgery, its influence on facial growth is still being studied. the methodology of this study is based on modern three-dimensional imaging methods and will be evaluated by classic and geometric morphometric analysis of virtual dental models. the existing database includes 137 virtual dental casts (complete and incomplete bilateral or unilateral cleft lip and palate). the main aim is to verify that the effects of early neonatal cheiloplasty on the facial or palatal growth are minimal in affected individuals and therefore the subsequent development of these structures can be predicted at a later age. other goals are to evaluate palatal morphology before and one year after early neonatal cheiloplasty, to assess growth of maxilla and palate using classic and geometric morphometry, to assess morphological differences between cleft types and to compare the results with previously published data of neonates operated by later operation protocol and noncleft control groups.

Eligibility criteria:
inclusion criteria: * nonsyndromic orofacial cleft * czech origin * operated by the same surgeon * following same surgery protocol (modified veau surgery protocol) * excellent body temperature, blood pressure, oxygen saturation, heart function * performing of early neonatal cheiloplasty exclusion criteria: * poor health * syndromic orofacial cleft * operated by later operation protocol (3-6 months) * non-czech origin

Keywords: bilateral cleft lip and palate unilateral cleft lip and palate 3d geometric morphometrics upper dental arch classical morphometrics early neonatal cheiloplasty
alvimopan and ileus in psf

Conditions: Ileus; Spinal Fusion

Summary: the purpose of the study is to determine with alvimopan reduces the incidence of post operative ileus in patients who undergo posterior spinal fusion.

posterior spinal fusion (psf) is a common orthopaedic procedure associated with a high incidence of post-operative ileus (poi) and concomitant increased length of hospital stay (lohs). poi is exacerbated by high dose opiate consumption often required by these patients post-operatively. we propose a randomized, double-blinded, placebo-controlled pilot trial studying the use of alvimopan, a peripherally-acting mu-opioid receptor antagonist known to reduce poi in bowel resection. we hypothesize that alvimopan will shorten poi in spine fusion patients without negatively affecting post-operative pain control. treatment efficacy will be assessed by recording time to first bowel movement, time to hospital discharge, and post-operative pain control. we hypothesize that acute administration of alvimopan, a peripherally-acting mu-opioid antagonist, shortens the duration of post-operative ileus (poi) in patients undergoing long-segment (5 or greater thoracolumbar levels) posterior spinal fusion (psf). the study will be a randomized, double-blinded, placebo-controlled pilot trial. reducing the morbidity of poi in patients undergoing psf will decrease hospital stay and costs, and also improve patient satisfaction and post-operative care after major orthopaedic surgery.

Eligibility criteria:
inclusion criteria: * adult patients undergoing elective psf of at least 5 levels and/or fixation to pelvis exclusion criteria: * pregnant women * ischemic heart disease * chronic liver or renal disease * prior bowel resection * presence of colostomy or ileostomy * gastroparesis * complete bowel obstruction * inflammatory bowel disease (ulcerative colitis or crohn's disease).

Keywords: alvimopan ileus posterior spinal fusion
probiotics for inflammation in pediatric chronic pain

Conditions: Chronic Pain; Body Mass Index >=85th Percentile

Summary: to examine benefits of a probiotic for youth with chronic pain and a body mass index \>=85th percentile.

the purpose of the current study: (1) examine whether a 7-11 week supplement of a single-strain probiotic (lactobascillus plantarum, lp299v) reduces systemic inflammation; (2) determine whether reductions in systemic inflammation will correlate with reductions in pain, disability, mood impairment and changes in mechanical pain threshold and mechanical pain sensitization; (3) explore whether reductions in systemic inflammation will correlate with reductions in other outcomes.

Eligibility criteria:
inclusion criteria: 1. male or female biological sex 2. 13-17 years of age 3. body mass index ≥85th percentile for sex and age exclusion criteria: 1. probiotic (or prebiotic) supplement use or antibiotic use within the past month 2. chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids 3. patients who have had a poor response to blood draw or immunizations in the past 4. chronic use of medications known to alter gastrointestinal function or inflammation (e.g. metformin, non-steroidal anti-inflammatory medications) 5. any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results 6. use of illicit drugs 7. females who are pregnant or lactating
visual study of molecular genotype in glioma evolution

Conditions: Glioma of Brain

Summary: the key molecular changes in the progression of glioma are closely related to tumor heterogeneity, pathological grade, precision treatment and prognosis of glioma. at present, a visually quantitative assessment criteria about the key molecular typing of glioma is still absent. based on the previous research, this project intends to establish a multi-dimensional database of glioma from clinical, radiomics and microomics levels. the investigators aim to filter out the specific molecular markers in the progression of glioma and explore the intrinsic connection of radiomics features and microomics molecular markers by using bioinformatics integration analysis and artificial intelligence multiple kernel learning. thus, the investigators could determine the specific molecular mechanism in the progression of glioma, and establish a visually quantitative assessment system of pre-operative precisive grading, molecular typing discrimination and prognosis prediction. the completion of this project is of great significance for improving molecular diagnostic level of glioma, guiding individualized diagnosis and treatment decisions, and improving the survival rate of patients.


Eligibility criteria:
inclusion criteria: 1. postoperative pathological and genetic test confirmed brain glioma; 2. the preoperative clear and complete multimodal imaging data were collected within 10 days. exclusion criteria: 1. patients who underwent surgery more than 4 weeks after mri; 2. patients with motion artifacts.
reliability, validity of the turkish version of the back performance scale

Conditions: Low Back Pain

Summary: in this study, we performed the validity and reliability of the turkish version of back performance scale.

low back pain (lbp) is defined as the pain that occurs in the area between the lower border of the scapula and the buttocks and sometimes radiates to the lower extremities. in the community, lower back pain is the second most common health problem after cold. 15% of lbp cases are chronic. appropriate use of assessment questionnaires is one of the most important steps in the evaluation of the functional level of the patient and in deciding on an effective treatment protocol. the purpose of study is to determine the turkish version, validity and reliability of back performance scale. 180 patients with chronic low back pain were included in the study. test-retest and internal consistency analysis were conducted to determine the reliability of the questionnaire. test-retest results evaluated using the intraclass correlation coefficient method.

Eligibility criteria:
inclusion criteria: * having a low back pain * literate persons exclusion criteria: * cancer disease * trauma * pregnant

Keywords: validity reliability low back pain
dexamethasone on fetal and uteroplacental doppler

Conditions: Preterm Birth

Summary: the current study aims to investigate the effects of dexamethasone exerted on fetal and uteroplacental circulation as measured by doppler ultrasonography in pregnancies at risk for preterm birth after 24 hours of its administration.


Eligibility criteria:
inclusion criteria: * patients at risk of preterm labor to be included were those with preterm uterine contractions, placenta previa, and mild preeclampsia exclusion criteria: * patients who were actively in labor, presented with premature rupture of membranes, intrauterine growth restriction (iugr), those who had received corticosteroids in their pregnancies and/or fetuses with suspected structural abnormalities
abc-scores for reduction of stroke and mortality in atrial fibrillation - the abc-af study

Conditions: Atrial Fibrillation

Summary: the primary study objective is to evaluate if personalized treatment by decision support, based on the biomarker-based risk prediction (abc-scores) guided strategy, reduces the occurrence of the composite outcome of stroke or death in patients with atrial fibrillation. approximately 6500 patients will be randomized 1:1 to abc risk score guided therapy or standard care.


Eligibility criteria:
inclusion criteria: 1. patients with diagnosis of atrial fibrillation, including newly diagnosed, with or without current oral anticoagulant treatment 2. signed informed consent exclusion criteria: 1. contraindication for any oral anticoagulant, according to the smpc (in sweden fass) 2. indication for oral anticoagulant treatment beyond atrial fibrillation, e.g. venous thromboembolism and/or mechanical heart valve prosthesis 3. currently on treatment with a non-vitamin k antagonist oral anticoagulant (noac) and not eligible for change of noac drug e.g. drug-drug interactions 4. concomitant dual antiplatelet treatment 5. acute coronary syndrome (myocardial infarction or unstable angina) within the last 30 days 6. participation in anti-thrombotic pharmaceutical trial 7. planned for af ablation or af surgery 8. haemoglobin \<90 g/l 9. patients who, in the opinion of the investigator, cannot or will not comply with the requirements of the protocol
safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus receiving background treatment with glimepiride alone or in combination with metformin or with pioglitazone alone

Conditions: Diabetes Mellitus, Type 2

Summary: this study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (t2dm).


Eligibility criteria:
inclusion criteria: * have successfully completed all required visits of a qualifying phase 3 core protocol * be currently receiving treatment for t2dm as set forth in the qualifying phase 3 core protocol exclusion criteria: * any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment
active surveillance for low-risk papillary thyroid carcinoma

Conditions: Thyroid Cancer; Papillary Thyroid Carcinoma

Summary: this is a multi-center, non-randomized, prospective observational cohort study aimed at establishing a cohort of low-risk papillary thyroid cancer patients with a maximum tumor diameter of 1.5 cm or less, consisting of an active surveillance group and an immediate surgery group.

the primary objective of this study is to evaluate the natural course of low-risk papillary thyroid cancer, specifically the progression rates of tumor size increase and the occurrence of local or distant metastasis. ultimately, it is expected that establishing new criteria for active surveillance of low-risk papillary thyroid cancer in korean patients will lead to a reduction in unnecessary surgical treatments, improving quality of life and decreasing national healthcare costs.

Eligibility criteria:
inclusion criteria: * subjects over 18 years old with a thyroid nodule of ≤ 1.5 cm in maximum diameter and a bethesda category v or vi diagnosis on cytopathology * subjects without high-risk features, including lymph node (ln) metastasis, distant metastasis, signs or symptoms of invasion to the recurrent laryngeal nerve or trachea, poorly differentiated cancer or variant with a poor prognosis, such as the tall cell, diffuse sclerosing, columnar cell, or solid variants. exclusion criteria: * subjects who are unable or unwilling to attend regular follow-ups.. * subjects with a diagnosis of benign, atypia of undetermined significance, suspicious for follicular neoplasm, or follicular neoplasm (bethesda category ii, iii, or iv) based on fine needle aspiration or, or benign, indeterminate by core needle biopsy.

Keywords: active surveillance immediate surgery
duloxetine vs. placebo in the treatment of osteoarthritis knee pain

Conditions: Osteoarthritis Knee Pain

Summary: the primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.


Eligibility criteria:
inclusion criteria: * male or female outpatients with osteoarthritis knee pain. exclusion criteria: * serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study. * previous exposure to duloxetine.
haic plus toripalimab vs. haic plus sorafenib for hcc with pvtt: a non-comparative, prospective, randomized trial

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus toripalimab versus hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib in patients with hepatocellular carcinoma (hcc) with portal vein tumor thrombus.

our previous study showed that hepatic arterial infusion chemotherapy (haic) of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib was more effective and safe than sorafenib for hepatocellular carcinoma with portal vein tumor thrombus. programmed cell death protein-1 (pd-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. no study has compared haic plus toripalimab with haic plus sorafenib. thus, the investigators carried out this prospective, randomized, non-comparative study to find out it.

Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * patients with portal vein tumor thrombus * eastern cooperative oncology group performance status of 0 to 2 * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * the following laboratory parameters: platelet ≥75,000/μl hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/l serum albumin ≥ 32 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 • ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma hepatic arterial infusion chemotherapy oxaliplatin, 5-fluorouracil and leucovorin toripalimab sorafenib
a behavioral intervention for ameliorating sleep problems in children with asd

Conditions: Autism; Autism Spectrum Disorder; Sleep

Summary: the present study will test the effectiveness of a behavioral intervention program that targets sleep problems in 1.5-5-year-old children with asd. sleep patterns will be measured using questionnaires and sleep diaries that will be completed by the parents as well as by fitbit sensors that will be placed on the child's wrist or back of the arm. the study will also explore whether specific child (e.g., severity of cognitive abilities) or parent characteristics (e.g., parent stress levels) impact the effectiveness of the intervention. in addition, we will examine whether changes in sleep disturbances are associated with changes in the family's quality of life.


Eligibility criteria:
inclusion criteria: parents of 1.5-5-year-old children with autism will be asked to fill the child sleep habits questionnaire (cshq). those who report high scores on the following 3 cshq subscales will be invited to participate: bedtime resistance, sleep onset delay, and night-wakings. exclusion criteria: none
help pain training program

Conditions: Pain

Summary: the aim of this project is to develop and test the helping educators learn pediatric pain assessment \& intervention needs (help pain) program. help pain provides training for school providers (e.g., school nurses, mental health professionals) on strategies to assess and manage pain-related concerns in school children. participants will learn cognitive behavioral therapy techniques to help school children manage pain, and report on their use of strategies, and child's progress throughout the school year. follow-up data will be collected in year 2.

chronic pain is common among school children, and impacts social, emotional and academic functioning. school providers are often tasked with addressing student pain, but may have limited training in evidence-based pain management strategies. thus, the pi developed a training program, help pain, to train school providers, such as school nurses and mental health professionals, in cognitive behavioral therapy strategies for addressing student pain. in this study, the feasibility and acceptability of the training program will be evaluated. provider knowledge will be evaluated before and after receiving the help pain training. further, the use of help pain strategies with students and their associated disability and pain outcomes will be evaluated. results will help to tailor the help pain training program for future use.

Eligibility criteria:
inclusion criteria: * engaged as a school provider in michigan

Keywords: pain cognitive behavioral therapy school providers