Kornimate/medical-research-clean huggingface dataset:
the national lipedema study

Conditions: Lipedema

Summary: lipedema is a chronic condition with a symmetrical accumulation of painful fatty tissue primarily affecting the limbs, sparing hands, feet and trunk. the subcutaneous fatty tissue is disproportionately voluminous and may have a different microstructure and metabolism than the patient's regular fatty tissue. the condition affects almost exclusively women and usually debuts around puberty. lipedema seems to have a hereditary component, may be affected by hormonal variations and worsens with obesity. guidelines advocate conservative treatment with compression therapy, weight management, physical activity, life style changes and psychological support;and in some cases surgical treatment such as bariatric surgery and liposuction. treatment of lipedema is indicated when the condition causes significant pain and inhibits the patient's everyday activities. well-designed randomized controlled studies on lipedema are lacking. the ministry of health and care services in norway has found the scientific documentation for the effects of liposuction to be insufficient and has recommended that surgical treatment of lipedema should be evaluated through a 5-year clinical trial. a national task force, consisting of representatives from all four regional health authorities in norway has been set up. this task force has now initiated this study. a national multi-center study with homogenous treatment protocols can provide globally sought insight on lipedema and the effect of its treatment regimes, and the findings will be important to adjust future treatment strategies regarding both effect and cost/effectiveness.


Eligibility criteria:
inclusion criteria: * female * age 20-65 years * significant pain from lipedema * lipedema stage 1-2 or localized stage 3 exclusion criteria: * non-fluency in the norwegian language * pregnancy * current malignancy * previous surgical treatment for lipedema * smoking * bmi \> 28 * serious comorbidities such as cardiac-, pulmonary-, renal disease * unwillingness to wear compression garments

Keywords: liposuction conservative treatment intermittent pneumatic compression lipoedema compression therapy self management dietary management
predictive factor study of the occurrence of endometrial cancer in patients with lynch syndrome

Conditions: Lynch Syndrome

Summary: lynch syndrome increases endometrial cancer occurrence in women due to failure in mismatch repair system. lifetime cumulative risk of developing endometrial cancer is approximatively 40% in women with lynch syndrome. endometrial cancer is the third women cancer in france. many risk factors are known in general population. lots of factors are related to over exposure to estrogen. data about influence of general risk factors in women with lynch syndrome are poor. recently, a cohort study appears to have shown a significant decrease in the risk of endometrial cancer with multiparity, the use of hormonal contraception and late menopause in lynch women. the impact of weight and certain metabolic parameters on the occurrence of endometrial cancers remains poorly known to this day.


Eligibility criteria:
inclusion criteria: * lynch syndrome diagnosis at university hospital * alive at study time * age over 30 at endometrial cancer or lynch syndrome diagnosis case group : - no cancer before endometrial cancer diagnosis control group : * no endometrial cancer developped * free cancer women at lynch syndrome diagnosis exclusion criteria: * refusing to participate * poor understanding of the french language * other cancer diagnosed before endometrial cancer * hysterectomy before lynch diagnosis for free cancer women

Keywords: lynch syndrome endometrial cancer
assessment of video assisted thoracoscopic surgery (vats) versus open surgery for patients undergoing lobectomy

Conditions: Non Small Cell Lung Cancer

Summary: assessment of vats versus standard open surgery for treatment of non small cell lung cancer.


Eligibility criteria:
inclusion criteria: * subject must be 18 years of age or older. * subject must have been clinically diagnosed with stage i to stage iia non small cell lung cancer measuring and judged to be resectable. * subject must be able to tolerate general anesthesia, and have cardiopulmonary reserve to tolerate a lobectomy exclusion criteria: * subject is pregnant (documented by pregnancy test) or breastfeeding. * subject has other severe illnesses that would preclude surgery such as * unstable angina * myocardial infarction within 3 months * coronary artery bypass graft surgery * subject has other active cancers * subject is unable to comply with any of the following: * study requirements * give valid informed consent * follow-up schedule

Keywords: vats lung cancer nsclc
participant preference of subcutaneous (sc) versus intravenous (iv) herceptin (trastuzumab) in human epidermal growth factor receptor (her) 2-positive early breast cancer

Conditions: Breast Neoplasms

Summary: this randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (hcp) satisfaction with sc versus iv herceptin administration in her2-positive early breast cancer. participants will be randomized to receive either sc herceptin or iv herceptin every 3 weeks for cycles 1 to 4, followed by crossover to the other treatment administration for cycles 5 to 8. for up to 10 additional cycles (for a total of 18 cycles), participants will receive iv or sc herceptin every 3 weeks.


Eligibility criteria:
inclusion criteria: * histologically confirmed her2-positive primary breast cancer * no evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neo-adjuvant or adjuvant) * completed neo-adjuvant chemotherapy prior to entry, if received * at least 8 remaining cycles out of the total 18 planned 3-week cycles, if received iv herceptin * eastern cooperative oncology group (ecog) performance status 0 or 1 exclusion criteria: * history of other malignancy, except for ductal carcinoma in situ of the breast, curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or other curatively treated malignancies of which the participant has been disease-free for at least 5 years * inadequate bone marrow function * impaired liver function * inadequate renal function * serious cardiovascular disease * human immunodeficiency virus or hepatitis b or c infection * prior maximum cumulative dose of doxorubicin greater than (\>) 360 milligrams per meter-squared (mg/m\^2) or epirubicin \>720 mg/m\^2 or equivalent
the safety and effectiveness of ritonavir in the treatment of hiv-related kaposi's sarcoma

Conditions: Sarcoma, Kaposi; HIV Infections

Summary: to evaluate the safety and anti-kaposi's sarcoma activity of ritonavir.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * patients may receive oral acyclovir and may continue prophylactic treatment for pcp, fungal infection, mac and toxoplasmosis. * topical treatment and intralesional chemotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions. concurrent treatment: allowed: localized radiotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions. patients must have: * documentation of a positive elisa test for hiv with a confirmatory test. * biopsy proven, cutaneous or oropharyngeal kaposi's sarcoma. * vital signs, physical examination and laboratory assessments that exhibit no evidence of an acute illness. * patients must agree to report all current medications to the primary investigator and obtain prior permission to use them when feasible. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * evidence of pulmonary kaposi's sarcoma. * positive urine screen for recreational drugs. * current participation in another antiviral research study. * investigator anticipates poor patient compliance with the protocol. * patient has any condition that, in the investigator's opinion, may obscure the proper observation of the safety or activity of ritonavir. concurrent medication: excluded: * antiretroviral therapy. * protease inhibitor therapy. * antiviral agent (e.g., oral ganciclovir or foscarnet) or prophylactic medication for an aids defining illness which the patient cannot be removed from. * chemotherapy for kaposi's sarcoma. * treatment with any medications that may interact with ritonavir. concurrent treatment: excluded: radiotherapy for kaposi's sarcoma. patients with any of the following prior conditions are excluded: * history of psychiatric illness which is currently medically significant. * history of pancreatitis. prior medication: excluded: * all antiretroviral therapy within 2 weeks prior to the start of the treatment phase of the study. * systemic chemotherapy of interferon within 30 days prior to study entry. * previous treatment with a protease inhibitor. risk behavior: excluded: active substance abuse.

Keywords: skin neoplasms sarcoma, kaposi acquired immunodeficiency syndrome hiv protease inhibitors ritonavir
evaluation of the effect of gabexate mesilate in the hepatocyte protection after liver resection

Conditions: Liver Disease

Summary: liver resection have been a primary treatment option for lesions found in the liver. with improvements in surgical technique and perioperative patient management, morbidity and mortality related to liver resection have been greatly reduced. however, many patients with hepatocellular carcinoma have underlying liver disease. severity of underlying liver disease plays an important role in decision making of resection extent. therefore, liver failure and decreased liver function following liver resection still remains to be an critical issue. postresection liver failure is generally defined by serum total bilirubin greater than 3mg/dl and prothrombin time of less than 50% of normal (inr \>1.7). pathophysiology of postresection liver failure is not yet well known. however, sepsis after liver resection, small-for-size syndrome (sfss), and ischemia/reperfusion injury are known to have important roles in persistant liver injury after resection. after a liver resection, kupffer cells are drastically decreased and innate immunity of the patient is also damaged. this process causes the patient to be vulnerable to infection. in addition, with continuous endotoxin secretion, dysfunction in kupffer cells are triggered and liver regeneration is affected. complex mechanisms leading to dysfunctional kupffer cells and apoptosis and necrosis of hepatocytes are mediated by neutrophils, complement, reactive oxygen species, and acute inflammatory cytokines. recent studies have reported on many promising effects of the synthetic protease inhibitor, such as gabexate mesilate. these include antioxidant effect, inhibition of acute inflammatory cytokine reaction, and anticoagulatory property. based on these effects, synthetic protease inhibitor have gained attention in the role of hepatocyte protection after liver resection. currently, there is a report on the hepatocyte protective effects of gabexate mesilate on ischemia/reperfusion injury caused by the pringle maneuver. however, with the advances in surgical technique and equipment, many surgeons now perform liver resection without pringle maneuver. therefore, this study was designed to determine effects of gabexate mesilate in the liver resection performed without pringle maneuver.


Eligibility criteria:
inclusion criteria: * all liver tumors that require resection of more than two segments of the liver. * age ≥20 and ≤80 * general performance status: the karnofsky score\> 70% or ecog 0-1 exclusion criteria: * hepatic duct reconstruction was performed * asa (american society of anesthesiologists' physical status classification) score: ≥3 * patients with drug or alcohol addiction * patients showing low compliance * patients who not want to involve the clinical trial * patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.)

Keywords: synthetic protease inhibitor hepatectomy postoperative complications
association between laser interferometric measurement of fundus pulsation and pneumotonometric measurement of pulsatile ocular blood flow in patients with age-related macular degeneration

Conditions: Age-related Macular Degeneration

Summary: several methods have been proposed for the measurement of pulsatile ocular blood flow (pobf). the pneumatic tonometer, which is commercially available, assesses pobf by measurement of intraocular pressure (iop) changes during the cardiac cycle. the investigators have recently developed a method for the measurement of ocular fundus pulsation, which is based on laser interferometry. in contrast to the langham system the method is non-contractile and yields a high topographic resolution. moreover, the pneumatic tonometer assesses the ocular pressure pulse, whereas ocular fundus pulsation is a point measure of the ocular volume pulse. these two parameters are related by the ocular rigidity, which refers to the mechanical properties of the eye coats. age-related macular degeneration (amd) is the most common cause of blindness in the industrialized nations. the mechanisms behind this severe eye disease are, however, still obscure. it has been hypothesized that alterations in choroidal blood flow and ocular rigidity may contribute to the development and progression of amd. however, there is currently little data to confirm this hypothesis. the present study is an attempt to investigate choroidal blood flow and ocular rigidity by employing laser interferometric measurement of fundus pulsation and pneumotonometric measurement of fundus pulsation.


Eligibility criteria:
inclusion criteria: * patients with amd (defined as soft drusen \> 63 µm, hyperpigmentation and/or hypopigmentation of the retinal pigment epithelium (rpe), rpe and associated neurosensory detachment, (peri)retinal hemorrhages, geographic atrophy of the rpe, or (peri)retinal fibrous scarring) * age between 50 and 90 years exclusion criteria: * evidence of any other retinal or choroidal vascular disease * regular use of pentoxifylline in the last month before the trial period * evidence of a choroidal neovascular membrane * diabetes mellitus

Keywords: amd rigidity pulsatile ocular blood flow physiology of the eye
a randomised trial of chemotherapy plus surgery for recurrent non-small cell lung cancer

Conditions: Recurrent Non-small Cell Lung Cancer

Summary: the purpose of this study is to determine if the commonly administered chemotherapeutic agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid tumors in clinical oncology, either a single format or given as combinations followed by surgery are effective in the treatment of relapsed and refractory non-small cell lung cancer patients.

lung carcinoma is a malignant disease characterized by uncontrolled alveolar type ii epithelial cell growth in lung tissues. worldwide in 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths, making it the most common cause of cancer-related death in men and second most common in women after breast cancer. the most common age at diagnosis is 70 years, and less than 20% of people diagnosed with lung cancer can survive five years post diagnosis. the two main types of lung carcinomas are small cell lung carcinoma (sclc) and non-small cell lung carcinoma (nsclc). nsclc represents the most common type of lung cancers, and approximately 85% of lung cancers are nsclc. squamous cell carcinoma, adenocarcinoma, and large cell carcinoma are all subtypes of nsclc, the latter associated with high mortality in overall cancer populations with limited treatment options. in this study, the investigators performed a phase i, open label, agent-combination exploration, multicenter clinical trial to establish the treatment efficacy of several chemotherapeutic agents in patients with recurrent nsclc who have undergone prior surgery for the primary disease. up to four cohorts have been enrolled to determine the effectiveness and safety of single or combinational therapeutic strategy. besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also take into account the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to support the treatment efficacy and assess the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.

Eligibility criteria:
inclusion criteria: * age ≤ 75 years with histologically proven nsclc * no severe major organ dysfunction * who performance status of 0 or 1 * no prior cancer chemotherapy * a clinical stage ≥ ia (t1a, n0, m0) of lung disease but without diagnosed distant metastasis (according to the 1997 revision of the international union against cancer tnm staging system) as determined by a preoperative evaluation that included a pleural computed tomography (ct) scan. exclusion criteria: * age ≥ 76 * severe major organ dysfunction * who performance status of \>1 * prior cancer chemotherapy * stage iv

Keywords: relapsed non-small cell lung cancer cisplatin carboplatin oxaliplatin docetaxel gemcitabine
effects of bloodletting acupuncture for subacute and chronic non-specific low back pain

Conditions: Back Pain, Low

Summary: evaluation of a bloodletting acupuncture at the fossa poplitea in comparison to bloodletting acupuncture at the regio glutaea and a waiting list control group in patients with subacute and chronic non-specific pain low back pain.


Eligibility criteria:
inclusion criteria: * specialist confirmed diagnosis of subacute or chronic non-specific low back pain for at least 6 weeks prior to inclusion * average pain intensity with at least 50 mm on the vas from 0 to 100 mm exclusion criteria: * serious illnesses * poor general condition * coagulation disorder, therapy with anticoagulants * thrombophlebitis, skin inflammation in the area of the lower extremities * alcohol, drug or medication addiction * pregnancy * lack of willingness to cooperate, linguistically or mentally unable to understand the contents of the study * participation in another clinical trial during the study period * starting a new therapy for the treatment of low back pain in the last 2 weeks
assessment of shuntcheck performance characteristics in asymptomatic patients with normal pressure hydrocephalus

Conditions: Hydrocephalus, Normal Pressure

Summary: the purpose of the study is to determine if the shuntcheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with asymptomatic normal pressure hydrocephalus.


Eligibility criteria:
inclusion criteria: * asymptomatic men or women 40 years old or older and have a ventriculoperitoneal shunt placed for normal pressure hydrocephalus and are visiting for routine care. * capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker capable of providing valid, signed informed consent. exclusion criteria: * presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction; * shuntcheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated; * presence of an interfering open wound or edema over any portion of the ventriculoperitoneal shunt.

Keywords: asymptomatic normal pressure hydrocephalus ventriculoperitoneal shunt
danish quality assurance project on diagnosis and treatment of chronic obstructive pulmonary disease (copd) in outpatient lung clinics

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: danish quality assurance project on diagnosis and treatment of copd in outpatient lung clinics

study hypothesis: comparison(s): none

Eligibility criteria:
inclusion criteria: * outpatient with the diagnosis or referral diagnosis of copd. * copd must be the primary reason for this outpatient contact (for both new patients and controls). exclusion criteria: * any co-morbidity that hampers the diagnosis and treatment of copd in accordance with the copd guidelines used locally (e.g. malignant disease, dementia or sequelae of apoplexy). * asthma without the presence of copd
observation only study involving participants enrolled in the chat trial

Conditions: Breast Cancer

Summary: the aim of the chat study ("an open-label, randomized phase ii study of herceptin (trastuzumab), taxotere® (docetaxel) and xeloda (capecitabine) in combination, versus herceptin (trastuzumab) plus taxotere® (docetaxel), in patients with advanced and/or metastatic breast cancers that overexpress her2") was to test the combination of trastuzumab and docetaxel with or without capecitabine as first-line therapy for her2 positive locally advanced or metastatic breast cancer. overall response rate was the primary endpoint of the chat study. this study failed to meet its primary objective of showing a difference between the treatment groups, with equivalent high response rates for the trastuzumab plus docetaxel and trastuzumab, docetaxel plus capecitabine arms. secondary endpoints in the chat study were progression-free-survival, time-to-progression, overall survival, duration of response and safety profile. whilst analysis of the existing data is consistent with improvement with the triplet therapy, interpretation is compromised by the relatively short median follow-up of 24 months. in hindsight the statistical design was flawed by selection of a sub optimal primary endpoint and consequently data was collected and analysed early in relation to time-dependent endpoints. beyond chat will permit capture of mature data for time-related endpoints. time-to-progression and overall survival are the co-primary endpoints for the beyond chat protocol. the impact of treatment following the first progression, on survival, will be explored. time-to-progression will be defined from the time interval between the date of randomisation and the occurrence of progressive disease under therapy according to recist criteria. overall survival will be defined as the time from date of randomisation to date of death

the objective of this study is to gain mature data on the long-term efficacy of the combination of trastuzumab and docetaxel with or without capecitabine as first-line therapy for her2 positive locally advanced or metastatic breast cancer. the study also aims to gain information on the additional treatments and sequencing used in patients that have progressed following the combination of trastuzumab and docetaxel with or without capecitabine as first-line therapy for her2 positive locally advanced or metastatic breast cancer. overall survival data on patients who have progressed following the combination of trastuzumab and docetaxel with or without capecitabine as first-line therapy for her2 positive locally advanced or metastatic breast cancer will also be analysed and reported.

Eligibility criteria:
inclusion criteria: * chat trial participants whose data was used in the final data analysis for the chat study exclusion criteria: * any patients who have withdrawn consent to the chat study

Keywords: chat breast cancer non interventional observational study