Kornimate/medical-research-clean huggingface dataset:
an alternative radiation fractionation strategy for locally advanced non-small cell lung cancer (nsclc)

Conditions: Stage IIA Non-small Cell Lung Cancer; Stage IIB Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer

Summary: this phase i trial studies the best dose of radiation therapy in treating patients with locally advanced non-small cell lung cancer that cannot be removed by surgery. radiation therapy uses high energy x rays to kill tumor cells. specialized radiation therapy, such as stereotactic body radiation therapy (sbrt), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. sbrt has been shown to provide excellent results when used in early stage lung cancer, but has not yet been applied to patients with more advanced disease.

primary objective: to test the safety and tolerability of an alternative fractionation regimen in locally advanced non-small cell lung cancer (nsclc), consisting of 44 gy with concurrent chemotherapy followed by a stereotactic body radiation therapy (sbrt) boost to remaining parenchymal and nodal disease. the maximum tolerated dose of the sbrt boost will be determined. secondary objectives: 1. to assess local control. 2. to assess distant metastasis and patterns of failure. 3. to assess overall survival at 1 and 2 years. outline: this is a dose-escalation study of radiation therapy and sbrt. patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for 4.5 weeks. patients then undergo 2 boost sbrt treatments 2-3 days apart. after completion of study treatment, patients are followed up for 5 years.

Eligibility criteria:
inclusion criteria: * biopsy proven nsclc, within 8 weeks prior to patient registration * unresectable disease * clinical stage tx, t1-t4, n1-3, m0 * karnofsky performance status (kps) ≥ 70 * pretreatment positron emission tomography (pet) ct scan to rule out metastatic disease * the primary tumor may not be larger than 8 cm in maximum dimension * if the primary tumor is central in location, defined as within 2 cm from the tracheobronchial tree, it must be no larger than 5 cm * mediastinal and hilar lymphadenopathy can be no larger than 5 cm at any nodal station * pretreatment brain ct with contrast or brain mri to rule out metastases * pathologic assessment of the mediastinum to document involved nodal stations * all of the above inclusion criteria must occur within 8 weeks prior to patient registration, with the exception of pathologic assessment of the mediastinum and biopsy to confirm nsclc, which can be done within 12 weeks of patient registration exclusion criteria: * prior history of lung cancer * pregnancy * prior history of radiation to the chest
pilot study of bone biopsy and aspirate in women with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: this is a feasibility study to demonstrate the team's ability to collect bone marrow aspirates and biopsies for research purposes from women with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * patients with metastatic breast cancer (any site) age 21 or older * patients willing and able to provide informed consent \& perform study procedures * patients may enroll with recently (with 2 months) progressive tumor burden * performance status of 0,1 or 2 exclusion criteria: * patients unable or unwilling to provide informed consent and or perform study procedures * patients with active, uncontrolled coagulopathy * patients on treatment dose anticoagulation or an international normalised ratio of 2 or greater if on warfarin * patients who are known to be pregnant are not eligible to participate in this study during the time of the pregnancy
auricular point acupressure to manage chemotherapy induced neuropathy

Conditions: Chemotherapy-induced Neuropathy

Summary: the proposed randomized control trial will evaluate auricular point acupressure (apa) on chemotherapy-induced neuropathy (cin), rigorously considering point specificity and placebo effects by integrating self-report measures, psychophysical measures (qst), endogenous biomarkers (cytokines), and neuro-imaging to investigate apa's efficacy and underlying mechanism(s).

chemotherapy-induced neuropathy (cin)-pain, numbness, or tingling distributed in the hands and feet-produces persistent symptoms affecting sensation and balance in cancer survivors. up to 50% of cancer survivors still suffer cin 6 years after treatment. duloxetine, the only recommended drug by the american society of clinical oncology, was found to be superior to placebo but improved cin by only 0.73 points (0-10 scale). no effective treatment for cin has been established except exercise, with an effect size of \<0.508. opioids relieve cin pain, but long-term use is strongly discouraged due to opioid overuse. the investigators propose to test auricular point acupressure (apa), an innovative and scalable solution developed from auricular acupuncture. apa is a non-invasive (needleless) and active treatment for patients with pain, whereas acupuncture is an invasive (using needles) and passive treatment (administered by a licensed practitioner). in apa, small seeds are taped on specific ear points by a skilled provider and patients press on the seeds to stimulate ear points three times daily, three minutes per time, for a total of nine minutes per day. apa provides pain relief within 1-2 minutes after ear stimulation and sustains pain relief for one month after a 4-week apa intervention. apa is popular in taiwan, china, and europe. though its use is sparse in the u.s., a limited number of clinical trials have supported apa in pain management.

Eligibility criteria:
inclusion criteria: * cancer patients ages ≥18 years * have received a medication in one of the following categories: platinum-based, vinca alkaloids, bortezomib, eribulin, and/or taxanes * have cin due to receiving neurotoxic chemotherapy for cancer or have pre-existing peripheral neuropathy of another etiology that worsened after chemotherapy * have one of the average intensity of pain, or numbness, or tingling on their extremities the previous week due to cin ≥ 4 on a 11-point numerical scale. exclusion criteria: * use of an investigational agent for pain control concurrently or within the past 30 days * use of an implantable drug delivery system, e.g. medtronic synchromed® * prior celiac plexus block or other neurolytic pain control treatment * other identified causes of painful paresthesia existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy,) * allergy to latex (the tapes for the apa include latex) and/or having a history of allergic reactions to the adhesive tape * pregnant women (based on the self-reported data) * individuals diagnosed with diabetic neuropathy

Keywords: acupressure chemotherapy induced neuropathy auricular acupressure
a dose ranging study of modafinil for methamphetamine dependence

Conditions: Substance Dependence; Amphetamine Dependence

Summary: patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. modafinil (d, l-2-\[(diphenylmethyl)sulfinyl\]acetamide) is a novel wake- and vigilance-promoting agent that is chemically and pharmacologically dissimilar to cns stimulants. it is well tolerated and has low abuse liability compared to cns stimulants. modafinil is fda approved for a variety of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to reduce cocaine use in dependent users, and is safe when coadministered with intravenous methamphetamine. we will conduct a randomized dose ranging clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 50 years 2. patient is agreeable to conditions of study and signs consent form

Keywords: methamphetamine addiction, meth dependence
anti-cmv cellular immunity quantification using an igra test in kidney transplant récipients and hemodialysis patients, comparison to control patients

Conditions: Quantiferon-CMV; Cytomegalovirus Infections; Kidney Transplant Infection; Hemodialysis

Summary: evaluation of anti-cmv t cellular immunity using an igra test (quantiferon-cmv test) in kidney transplant recipients and hemodialysis patients, comparison to control patients.

cytomegalovirus (cmv) infection is a common opportunistic complication after kidney transplantation (kt). it has been associated with high morbidity and mortality in kidney transplant recipients (ktr). its actual management is only based on the humoral immunity : the main risk factor for cmv infection after kt is the association of a seropositive donor and a seronegative recipient (so-called "d+/r- mismatch"). however several studies have highlighted the essential role of cellular immunity to control cmv infection. the quantiferon-cmv (qf-cmv) is an igra test (interferon gamma releasing assay) which evaluates t cd8 lymphocytes production of interferon gamma (ifny) exposed to cmv antigens. some studies have shown the possible interest of the qf-cmv in predicting cmv infection after antiviral prophylaxis discontinuation or when cmv viremia is detected. however some limits have been underlined. first its positivity threshold hasn't been approved in ktr. hemodialysis patients (hp) called to receive a renal allograft also suffered from altered immunity. no study has directly compared the qf-cmv value in ktr, hp and control patients. that's why we propose evaluating the expression of basal cellular immunity against cmv (far from any active infection) in ktr and hp using the qf-cmv and comparing it to control patients population (not suffering from kidney dysfunction or immunosuppression).

Eligibility criteria:
inclusion criteria : * for all patients : * to be seropositive for cmv * to not be opposed to the study * for kidney transplant recipients : * to have received a kidney graft for over 1 year * to have received an induction therapy at transplantation time by anti-lymphocytes antibodies and steroids * to be currently receiving immunosuppressive therapy by calcineurins inhibitors (tacrolimus or cyclosporine), mycophenolic acid with or without steroids * to not suffer from another cause of immunosuppression * for hemodialysis patients : * to be treated by hemodialysis for end stage renal disease * without prior solid organ transplant history * to not suffer from another cause of immunosuppression * for control patients : * with normal kidney function (estimated gfr \> 90 ml/min) * to not suffer from another cause of immunosuppression exclusion criteria : * patient under guardianship or deprived of his liberty
morbidity after surgical treatment of perforated ulcer

Conditions: Peptic Ulcer Perforation

Summary: the main objective of our study is to identify the risk factors for postoperative morbidity after surgical treatment of perforated peptic ulcer

the investigators conducted a retrospective study of 116 patients, operated on for a perforated peptic ulcer, carried out in the general surgery department of taher sfar university hospital in mahdia over a period of 11 years 6 months.

Eligibility criteria:
inclusion criteria: * patients who underwent surgery for a perforated peptic ulcer in the general surgery department of taher sfar university hospital in mahdia, between january 1, 2010, and june 1, 2021, were included in this study. exclusion criteria: * patients who have medical treatment

Keywords: postoperative complication risk factor
remote weight management program for obese women

Conditions: Weight Loss

Summary: the purpose of the research project is to see if counseling on the mediterranean diet combined with motivational interviewing via a telemedicine platform (zoom) while using smart technology ("smart" scales and tape) improves participants' weight loss, reduces waist circumference, and improves satisfaction with their care.

the investigators will evaluate a formal remote weight management and follow-up program, utilizing a technology-based intervention using the renpho application paired with a smart scale and smart tape measure. the primary communication technologies will be the redcap and zoom platforms. renpho's smart body fat scale and tape measure are health applications that sync with fitness applications such as apple health, myfitnesspal, fitbit, and samsung health. the renpho bluetooth-enabled smart scale and smart tape devices will allow participants to sync with the renpho application on their smartphone to automatically upload data such as weight, bmi, and wc to their phone. the project leader will review participants' self-reported weights and wc fortnightly. the participants will be asked to complete a post-participation satisfaction survey that includes a 5-point scale ("strongly agree", "agree", "neutral", "disagree:", to "strongly disagree") likert-style questions. expected outcomes. the primary outcomes for this eight-week intervention are to achieve a clinically significant reduction in weight of at least 5-10 % and at least 2.5 inches reduction in wc per participant from baseline.

Eligibility criteria:
inclusion criteria: 1. women with a clinical diagnosis of obesity (bmi ≥30 kg/m2), 2. age of 18 years or older, 3. english-speaking participants with access to a smartphone device 4. at least one cardiovascular risk factor (at least one clinical diagnosis of the following conditions: hypertension, dyslipidemia, type 2 diabetes, pre-diabetes, sleep apnea, family history of heart disease, cigarette smoking, inactivity, preeclampsia, gestational diabetes, gestational hypertension, preterm birth, rheumatological diseases, or premature menopause). exclusion criteria: 1. must not be taking medications specifically for weight loss or currently participating in a weight loss program, 2. must not be pregnant or breast-feeding, 3. women without a clinical diagnosis of obesity (bmi \< 30 kg/m2) 4. must not have lost \>3 kg body weight or dramatically changed physical activity patterns within the past six months, 5. clinical diagnosis of eating disorders 6. clinical diagnosis of uncontrolled hypertension or neurological or psychological disorders 7. must not have any obesity-related surgery within the past six months (i.e., gastric bypass).
tyg index levels in klinefelter syndrome

Conditions: Cardiac Event; Klinefelter Syndrome; Endothelial Dysfunction

Summary: it is well known that the frequency of cardiometabolic diseases are increased in patients with klinefelter syndrome. the triglyceride-glucose index (tyg index) is a simple surrogate marker of insulin resistance and is also associated with various cardiometabolic diseases. the aim of this study to investigate the tyg index levels and its relationship with insulin resistance and endothelial dysfunction in patients with ks.

from the patient database of our endocrinology department we randomly included a total of 30 patients with ks and 32 healthy controls in the study. all the recorded data in the database were registered under the approval of local ethical committee of gulhane school of medicine. the clinical and laboratory parameters, tyg index, asymmetric dimethylarginine (adma), homeostatic model assessment of insulin resistance (homa-ir) and high-sensitivity c-reactive protein (hs-crp) levels were gathered from the database and the triglyceride-glucose index was calculated by the help of pre-measured laboratory parameters.

Eligibility criteria:
inclusion criteria: * patients with a verified klifelter syndrome karyotype (all subjects included were 47, xxy) and who were not previously given testosterone replacement. exclusion criteria: * age \<18 years, * acute infection, malignancy, any visceral organ dysfunction, nutritional derangements, clinical history of cardiovascular disease, cerebrovascular disease, drug use such as antidiabetic or lipid-lowering medications, or those lacking complete clinical data.

Keywords: klinefelter syndrome, tyg index, cardiometabolic risk
post-market clinical-follow-up study of suprasorb® c collagen wound dressing

Conditions: Venous or Mixed Leg Ulcers

Summary: post-market clinical-follow-up study of suprasorb® c collagen wound dressing

prospective, uncontrolled multi-center, observational cohort study. the objectives of the pmcf study are confirmation of the performance, and to collect additional safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of suprasorb®c under the conditions of routine use. suprasorb® c collagen wound dressing is a certified medical device (manufacturer: lohmann \& rauscher international gmbh \& co. kg). the product has been marketed in the eu since 1983 as opragen® (medicinal product), since 1995 as the medical device opraskin® and since 2001 under the name suprasorb c (medical device). suprasorb® c is intended to be used as a wound dressing for the support of wound healing or wound area reduction. participating centers: 40 study nurses will participate to the pmcf study duration: 24 months cohort size: 110 patients follow-up: 8 weeks

Eligibility criteria:
inclusion criteria: * patient over 18 years of age and under 85 years of age * patient suffering from confirmed venous or mixed vascular leg ulcers * stagnating wound conditions, i.e. exudation phase \> 2 months, not responding to traditional dressing and standard treatment (standard treatment is a clear definition and for venous ulcers compression should be included) * target ulcers between 2 cm and 10 cm in the largest diameter * written confirmation from the study nurse that the patient was informed, orally agreed to participate and to comply with study treatment and planned visits exclusion criteria: use of suprasorb® c collagen wound dressing is contraindicated according to the current ifu: * clinically infected areas * presence of known allergies to one or several of its components. in addition following patients shall not be included into this study: * patient not covered by health insurance/social security * patient suffering serious life threatening disease * pregnant or breastfeeding women * minor patient, protected adult, person without liberty
a phase 2 study to compare the efficacy and tolerability of tarafenacin 0.2 mg and tarafenacin 0.4 mg to placebo in patients suffering from overactive bladder.

Conditions: Overactive Bladder

Summary: 1. primary objective: to evaluate the dose-response relationship of tarafenacin on efficacy. 2. secondary objectives: * to compare 12 weeks' efficacy of different doses of tarafenacin to that of placebo in patients suffering from overactive bladder. . * to compare the tolerability of different doses of tarafenacin to that of placebo in patients suffering from overactive bladder. .


Eligibility criteria:
\ 1. patient of either sex aged 20 to 80 years (both inclusive); 2. patients suffering from overactive bladder. based on cardinal symptoms (urgency, nocturia, frequency with or without urge incontinence) for at least 6 months prior to inclusion; 3. patients who document the following symptoms in a 3-day diary card during the 14 day placebo run-in period * an average of ≥8 micturitions/24 hours; * greater than or equal to three incontinence episodes * a total of ≥3 urgency episodes. \ 1. patients with clinically significant bladder outlet obstruction 2. patients with predominant stress incontinence (\>2 episode/week) 3. patients with significant urogenital disease such as recurrent urinary tract infection (more than 2/6 months), bladder calculi, interstitial cystitis, urothelial tumours, hysterectomy or prostatectomy in the previous six months; 4. females diagnosed with bladder cancer 5. males diagnosed with bladder cancer 6. patients with obstructive disease of the gastrointestinal tract, intestinal inflammatory disease, severe ulcerative colitis, inflammatory bowel disease, toxic megacolon, intestinal atony or paralytic ileum 7. patients with acute noehyeolgwangye disease, significant cardiovascular disease (arrhythmias, unstable angina pectoris, myocardial infarct, or are using a pacemaker), significant orthostatic hypotension in the previous six months 8. patients diagnosed with closed angle glaucoma or shallowness of the anterior chamber 9. patients with any contraindication to antimuscarinic drugs

Keywords: overactive bladder tarafenacin
pertrochanter arthroplasty versus osteosynthesis

Conditions: Pertrochanter Fracture

Summary: this is a single-centre, comparative, prospective randomised trial. it will include 70 patients over a period of 2 years randomized into two groups of 35 patients: one group of patients treated with osteosynthesis (plate, nail or screw) and the second group treated with total hip replacement. the harris and pma functional scores will be assessed at 6 weeks, 3 months, 6 months and 1 year. the time to recovery of weight-bearing, the subjective satisfaction score, the eq5d quality of life questionnaire, the vas score for pain at rest and when walking, the parker score, the rate of complications and deaths will also be measured. operating time, blood loss and scar size will also be evaluated.


Eligibility criteria:
inclusion criteria: * patients who have provided written informed consent * patients over 18 years old * patients less than 70 years old * patient presenting with a fracture of the trochanter (type 1 to 6 according to the ender classification, and a1 and a2 according tyo the ao classification (association suisse pour l'étude de l'ostéosynthèse : classification internationale) exclusion criteria: * adult under guardianship * patients not covered by national health insurance * pregnant or breast-feeding women * unable to walk independently before the trauma * patients with dementia