Kornimate/medical-research-clean huggingface dataset:
comparison of infix and plating for pelvic ring injuries with symphysis disruptions

Conditions: Anterior Pelvic Ring Injury With Symphysis Disruption

Summary: the purpose of this study is to compare subcutaneous internal fixation and open plating of the symphysis in patients with a disruption of the symphysis requiring stabilization.

the aim of this study is to determine whether either one of the two procedures has significant advantages over the other. the null hypothesis of this study is that there is no difference between plating and subcutaneous internal fixation of symphysis disruptions with respect to primary and secondary outcomes. the study is a randomized trial with patients who sustained a symphysis disruption who will randomize to either closed reduction and subcutaneous internal fixation, or open reduction and plating of the symphysis. there will also be two observational arms of the study, patients who do not agree to randomization and will receive internal fixation according to the treating surgeon's discretion and patients with a symphysis disruption that do not require any form of anterior pelvic internal fixation based on the treating surgeon's opinion. clinical assessments will occur at the time of hospital admission and at all post-operative follow-up intervals (2 weeks, 6 weeks, 3 months, 6months, 12 months, and 24 months).

Eligibility criteria:
inclusion criteria: * a symphysis disruption either in the coronal and/or sagittal plane on anterior-posterior , inlet and/or outlet pelvic radiographs * need for anterior pelvic ring stabilization * injury amenable to plating as well as subcutaneous internal fixation per the treating surgeon's opinion * patient was ambulatory prior to sustaining the injury * provision of informed consent by patient or proxy exclusion criteria: * patients with a slim build with little subcutaneous fat who cannot be treated with a subcutaneous internal fixator based on the treating surgeon's opinion * patients who are deemed not likely to follow-up (e.g. patients who live more than 50 miles away and patients with no fixed address) * moderately or severely cognitively impaired patients * pregnant women * prisoners

Keywords: anterior pelvic ring symphysis disruption
study of behavioral weight loss therapy for obesity and binge eating in monolingual hispanic persons

Conditions: Obesity; Binge Eating

Summary: this is a research study designed to examine the effectiveness of an obesity medication (orlistat) given in addition to behavioral weight loss therapy. participants will be obese monolingual (spanish-speaking only) men and women.


Eligibility criteria:
inclusion criteria: * monolingual spanish speaking * obese (bmi \>= 30) exclusion criteria: * pregnancy * current cardiac disease * serious neurologic illnesses

Keywords: obesity binge eating monolingual hispanic persons orlistat behavioral weight loss treatment
lung cancer biomarkers and screening

Conditions: Lung Cancer

Summary: rationale: screening tests that use biomarkers may help doctors find tumor cells early and plan effective treatment for lung cancer. purpose: this clinical trial is studying biomarkers in screening participants for lung cancer.

objectives: * identify and validate biomarkers for the early detection of lung cancer in individuals at low- or high-risk for smoking-related cancers. * identify preneoplastic cellular changes and lesions in these patients. outline: participants are stratified according to lung cancer risk status (with or without increased risk). group 1 (screening cohort): participants complete a questionnaire and undergo pulmonary function testing, multidetector chest ct scan, sputum induction, and phlebotomy. group 2 (rule-out lung cancer): participants complete the same questionnaire and undergo the same tests and scans as in group 1. some participants may undergo fiberoptic bronchoscopy based upon ct scan results with transbronchial or endobronchial biopsies. some participants may undergo lung resection. tissue samples are collected from surgery or biopsy. projected accrual: a total of participants will be accrued for this study.

Eligibility criteria:
disease characteristics: * screening cohort * at high- or low-risk for lung cancer * smoking history ≥ 20 pack years\* * with or without workplace exposure to asbestos * note: \* participants with \< 20 pack years of smoking are eligible if 50 years of age or older * rule-out lung cancer group * referred for evaluation of suspicious nodules with 1 of the following diagnoses: * lung cancer * nonmalignant nodules (control group) patient characteristics: * not pregnant * no prior malignancy except nonmelanoma skin cancer prior concurrent therapy: * not specified

Keywords: small cell lung cancer non-small cell lung cancer smoker lung cancer screening low dose spiral ct screening
a trial of imatinib for patients with aggressive desmoid tumor (aggressive fibromatosis)

Conditions: Fibromatosis

Summary: aggressive fibromatosis (af, also known as desmoid tumor) is a fibroproliferative neoplasm that typically arises in the abdomen but can develop at other anatomic sites, most commonly in the extremities. these tumors have a relatively high local failure rate after primary treatment using surgery and/or radiotherapy, and although rarely giving rise to distant metastases, can be multifocal and, therefore, not surgically resectable. moreover, tumor may recur adjacent to the site of surgical resection, underscoring the limitations of surgery in the palliative setting. therefore, effective medical therapies for af are needed to maintain quality of life and prolong survival.the goal of the current study was to better define the activity of imatinib in the treatment of af and to determine the molecular basis for response/nonresponse


Eligibility criteria:
inclusion criteria: 1. written consent; 2. age ≥ 10 years; 3. eastern cooperative oncology group performance status ≤ 2; 4. histologically confirmed desmoid tumor; 5. disease progression after local treatment 6. measurable target lesion (recist criteria) ; 7. adequate hematological, renal and liver functions : exclusion criteria: 1. other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. 2. pregnant or lactating female 3. evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
regimen for the treatment of cachexia in subjects with nsclc

Conditions: Cachexia

Summary: cachexia is a presentation of a chronic manifestation of acute metabolic stress, a hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are not functioning and increased nutrition is not utilized. to switch the nutritional system from a hypercatabolic to a normal nutritional state, therapy must block multi-factorial stress signaling a threshold of activation. consistent with the synergistic hypothesis, propranolol and etodolac have been evaluated in subjects with advanced cancer demonstrating cachexia. this trial will evaluate the safety and efficacy of vt-122 in subjects with nsclc who have hypercatabolic cachexia.

the objective of this trial is to evaluate the safety and dose tolerability of vt-122 regimen and to evaluate the efficacy of vt-122 regimen this trial is to be conducted on patients who have a diagnosis of stage iv nsclc, are not on chemotherapy, have lost 5% of their body weight in the previous 2 months and are deemed to be hypercatabolic.

Eligibility criteria:
inclusion criteria: * subjects with nsclc * demonstrating average weight loss of 5% within 2 months prior to enrollment * heart rate of 72 bpm or greater * negative pregnancy test (female patients of child bearing age) * able to give informed consent * able to be administered medication * able to take food and defined nutritional support * have not been on beta-blockers for a minimum of 1 week prior to administration of the medication screening dose * have not undergone surgery for at least 2 weeks prior to entry into trial * have not been on chemotherapy, immunotherapy, biologic therapy, radio therapy, and experimental therapy for a minimum of two weeks prior to medication screening dose and during their participation in this trial * an expected survival for a minimum of 12 weeks exclusion criteria: * contraindication to nonsteroidal antiinflammatory drugs (nsaids) and beta blockers * blood pressure less than 100/65 * weight loss of 15% within 2 months prior to recruitment * hypersensitivity reaction to the active components in vt-122 * history of myocardial infraction within the past 3 months * congestive heart failure (as determined by symptoms and ecg) * a-v block of second or third degree * unstable angina * uncontrolled diabetes * unable to be assessed for grip strength * a positive pregnancy test * chronic infection or sepsis * history of bleeding disorders * patients with peripheral edema * patients on digoxin or other chronotropic drugs * patients with evidence of severe dehydration * patients with evidence of ascites

Keywords: nsclc anorexia cachexia grip strength lean body mass
immediate effects of high-intensity laser therapy on knee joint position sense and knee muscle strength in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the goal of this clinical trial is to compare whether hilt versus sham-hilt is effective to reduce pain, improve knee joint position sense, and knee muscle strength. participants will undergo a single-session of hilt or sham-hilt, the measurements of pain, knee joint position sense error, and knee muscle strength will be done at before, immediately after, and 24-hour after the single-session intervention.

the investigators would like to investigate whether single session of high-intensity laser therapy (hilt) is promising to see the changes in individuals with knee osteoarthritis (koa)-related knee pain regarding pain intensity, knee joint position sense, and knee muscle strength. the objectives of this study is to compare pre and post, and between the two groups (hilt versus sham-hilt) at after interventions regarding pain, knee joint position sense, and knee muscle strength. participants will undergo a single-session of hilt or sham-hilt by an experienced musculoskeletal physical therapist, the measurements of pain, knee joint position sense error, and knee muscle strength will be done at before, immediately after, and 24-hour after the single-session intervention.

Eligibility criteria:
inclusion criteria: * knee pain greater than 3 on the visual analog scale (vas) for more than 3 months * diagnosed with unilateral knee osteoarthritis by a physician or meeting the american college of rheumatology classification criteria for clinical knee osteoarthritis * the severity of knee osteoarthritis is classified as grades 0-3 according to the kellgren-lawrence (kl) classification * should not have undergone any specific treatments in the 3 months preceding the recruitment for the study, such as steroid injections. exclusion criteria: * any other musculoskeletal problems associated with knee pain * musculoskeletal problems associated with the hip and ankle joints * a history of lower limb fracture * neurological conditions * contraindications for laser therapy

Keywords: hilt laser therapy joint sense muscle strength pain
efficacy and safety of pentoxyphilline and tocopherol on the fibrosis in patients with chronic hepatitis c

Conditions: Hepatitis C, Chronic; Liver Fibrosis

Summary: the fibrosis of liver is a complication of chronic hepatitis c. there is actually no established treatment for fibrosis of the liver. pentoxyphilline and tocopherol may have an activity on fibrosis. the aim of the study is to analyse the efficacy and the safety of the combination with pentoxyphilline and tocopherol (12 months) on liver fibrosis, in patients with chronic hepatitis c, who are non-long-term responders, or with intolerance or contra-indication to interferon-alfa and ribavirin.

the aim of this study is to analyse the efficacy and the safety of the combination of pentoxyphilline (400 mg, twice a day) and tocopherol (500 mg, twice a day), given during 12 months on the fibrosis related to hcv chronic hepatitis in 100 patients who are non-long-term responders, or with contra-indication or intolerance to the current treatment of reference (combination with interferon-alfa and ribavirin). it is a therapeutic, national, multicentric, double-blind, placebo-controlled phase iii trial. the patients included had histological liver injuries with a metavir score of a 0 to 2, f 2 or 3 and no other etiology of liver disease. the primary objective is to analyse the variation of the liver fibrosis evaluated by morphometric analysis between the 2 liver biopsies performed at the end of the trial and within 3 years before the treatment. the secondary objectives are the variation of the metavir fibrosis and activity scores, of serum markers of fibrosis (hyaluronate, piiip, tnf-alfa, fibrotest) and alt between the end and the beginning of the treatment.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * chronic hepatitis c defined by positive hcv ab and hcv rna and histological proven injuries * liver biopsy with a size over or equal to 15mm, performed within 3 years of enrolment, with a metavir score of activity from 0 to 2 and fibrosis score of 2 or 3. * non long term responders or patients with contra-indication or intolerance to interferon alfa or ribavirin * no anti-viral treatment during the trial * signed written informed consent exclusion criteria: * alcohol consumption over or equal to 40 g/d * allergy to tocopherol or pentoxyphilline * treatment with platelet anti-aggregates, anti-vitamin k, theophylline, armophylline * treatment with tocopherol or pentoxyphilline since the last liver biopsy * pregnancy, breast feeding, lack of contraception * decompensated cirrhosis, organ graft, chronic renal insufficiency * bmi over 27 * diabetes type i or ii * other etiology of liver disease (hbv, hiv, hemochromatosis, alfa-1 antitrypsin deficiency, wilson's disease, auto-immune hepatitis, drug-related hepatitis)

Keywords: hepatitis c liver cirrhosis tocopherols
an open-label study to assess the pharmacokinetics, safety and toleration of vfend®; following multiple dosing with vfend

Conditions: Kidney Failure

Summary: this is a study to investigate the pharmacokinetics, safety and tolerability of intravenous voriconazole and sbecd in patients with moderate renal insufficiency

the study was put on hold after the first subject was enrolled and experienced a serious adverse event (sae) of renal failure chronic after receiving his i.v. dose on day 1. the study was taken off hold after the subject recovered and an independent consultant had deemed the sae as not treatment related; however, the site was unwilling to enroll additional subjects. another site, based in new orleans, was damaged by hurricane katrina and was unable to enroll any subjects. a decision was made by the sponsor to terminate the study on 11 apr 2006 due to poor study enrollment. there were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Eligibility criteria:
inclusion criteria: * patients with moderate renal insufficiency exclusion criteria: * active infection
a study of bermekimab (jnj-77474462) in the treatment of participants with moderate to severe atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: the purpose of this study is to evaluate the efficacy and safety of bermekimab in participants with moderate to severe atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiograms (ecgs) performed at screening. any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator * have atopic dermatitis (ad) for at least 1 year (365 days) prior to the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history * have a history of inadequate response to treatment for ad with topical medications or for whom topical treatments are otherwise medically inadvisable (example \[eg\], due to important side effects or safety risks) * be considered, in the opinion of the investigator, a suitable candidate for dupilumab (dupixent) therapy according to their country's approved dupixent product labeling * have an eczema area and severity index (easi) score greater than or equal (\>=) to 16 at screening and at baseline * have an investigator global assessment (iga) score \>=3 and involved body surface area (bsa) \>=10 percent (%) at screening and baseline exclusion criteria: * has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months * has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis), or has been hospitalized or received intravenous (iv) antibiotics for an infection during the 2 months before screening * has or has had herpes zoster within the 2 months before screening * has a history of being human immunodeficiency virus (hiv) antibody-positive, or tests positive for hiv at screening
withholding feeds during red blood cell transfusion and tragi

Conditions: Transfusion; Feeding During Transfusion; Transfusion Related Acute Gut Injury; Necrotising Enterocolitis

Summary: necrotising enterocolitis (nec) is a devastating picture that all the neonatologists are afraid of facing during the follow up of newborns. during the last years, investigators ran retrospective observational studies abut nec developing within the 48 hours after red blood cell transfusion. in the previous studies, the incidence of transfusion associated nec (tanec) was found to be 20-35%.multiple transfusions potentially cause an increased risk for retinopathy of prematurity (rop) and nec. investigators have also proposed a hypothesis about transfusion related acute gut injury (tragi), an adverse reaction of transfusion, similar to transfusion related acute lung injury (trali) seen in adults.in most of the neonatology clinics, withholding feeds during transfusion is not preferred. but several recent studies show an increase in the incidence of tanec if the newborn goes on feeding before, during and after the transfusion process, especially if it is fed with a formula. the main aim of this study is to investigate the effect of withholding feeds during transfusion, on the development of tragi.


Eligibility criteria:
inclusion criteria: * \ 7 days old premature babies. * babies which are fed enterally well at the time of tha planning of transfusion. exclusion criteria: * babies with severe sepsis signs. * babies with severe hypoxia and asphyxia. * babies with congenital anomaly or complex cardiac anomaly.

Keywords: transfusion feeding tragi nec
implementing a pilot patient navigator program to improve access to infertility care for underserved patients

Conditions: Infertility

Summary: this investigators will conduct a pilot study investigating the implementation of an infertility patient navigator (pn) program to mitigate challenges for underserved individuals at boston medical center (bmc) seeking infertility care. the primary objective is to assess whether the pn program can significantly reduce time to completion of infertility evaluation and to initiation of fertility treatment (if recommended) for infertile patients from an underserved patient population. the study aims are to: 1. evaluate the impact of the pn program on timelines including obtaining commercial insurance coverage for infertility, expediting labwork/imaging, weight management, and partner urology appointments, and initiating fertility treatment; and 2. ascertain the medical literacy of participants with a validated tool to assess the impact of low medical literacy on pn facilitation. participants will be contacted by the pn and provided with a survey instrument that will test their medical literacy. then the pn will assist with scheduling cycle-based testing including labwork and uterine cavity evaluation, the partner's urology appointment, the patient's appointments such weight management/nutrition referral, mammograms (if indicated by age), and insurance counseling if the participant's current insurance does not cover infertility diagnostic testing and treatment. these tasks are part of pursuing fertility care at bmc. duration of evaluation and time to treatment in age-matched control patients from the year prior that did not have pn services will be utilized as a comparison group. regression analyses will be conducted to explore the association between utilization of a pn and pregnancy rates, considering potential confounding factors. establishment of the pilot program will enable the investigators to apply for a larger institutional patient care grant going forward. strategies developed through this research can may enhance fertility care access for underserved communities across various healthcare settings. by tailoring interventions to populations not usually able to access specialized healthcare services, this study pioneers a paradigm shift towards inclusivity and equity in reproductive medicine.


Eligibility criteria:
inclusion criteria: intervention cases * a new patient at bmc reproductive endocrinology for the diagnosis of infertility from july 1, 2024 to january 31, 2025 controls * a new patient at bmc reproductive endocrinology for the diagnosis of infertility from july 1, 2023 to january 31, 2024. exclusion criteria: * patients in whom fertility treatment with their own eggs is not recommended, egg freezing or oncofertility cycles. * non-english speaking

Keywords: infertility patient navigator (pn) under-resourced patients cycle based testing urology appointments health literacy boston medical center
multi-center research project for glioma molecular pathology intraoperative rapid detection

Conditions: Glioma, Malignant

Summary: we explores the accuracy and sensitivity of rapid intraoperative detection of idh, tert, braf indicators through a prospective clinical multi-center study. this part includes a total of 300 fresh tissue samples, paired blood samples, relevant clinical information and follow-up information from 300 patients with different grades of adult glioma. by comparing with the postoperative sequencing results, the specificity and sensitivity of intraoperative idh and tert rapid detection results are clear.


Eligibility criteria:
inclusion criteria: * 1. glioma patients with informed consent form 2. glioma patients with intact clinical information exclusion criteria: * 1. glioma patients without informed consent form 2. glioma patients without intact clinical information