Kornimate/medical-research-clean huggingface dataset:
combination chemotherapy compared with no treatment following surgery in treating patients with non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. it is not yet known if combination chemotherapy given after surgery is more effective than surgery alone for non-small cell lung cancer. purpose: randomized phase iii trial to compare the effectiveness of combination chemotherapy following surgery with that of surgery alone in treating patients who have stage i, stage ii, or stage iiia non-small cell lung cancer.

objectives: i. compare the impact on overall survival of adjuvant cisplatin and either a vinca alkaloid or etoposide (with or without radiotherapy) vs. no adjuvant chemotherapy in patients with completely resected stage i/ii/iii non-small cell lung cancer. ii. assess the frequency of treatment-related deaths and severe toxic effects. iii. describe the patterns of failure, second malignancies, and toxic effects associated with each treatment regimen. outline: this is a randomized, multicenter study. patients are stratified by participating institution, type of prior surgery, and pathologic stage. each participating center will determine which combination chemotherapy regimen and which of three cisplatin doses will be given to all patients treated at that center. the treatment group receives cisplatin combined with either vindesine, vinblastine, vinorelbine, or etoposide every 3-4 weeks for 3-4 courses, depending on the dose of cisplatin. the second group receives no adjuvant chemotherapy. treating institutions determine prior to entering the trial which patients receive adjuvant radiotherapy: none; those with node-positive disease; those with n1 disease only; those with n2 disease only; or those eligible for a randomized radiotherapy trial. for patients in the treatment group, radiotherapy begins 3-4 weeks after the last course. patients are followed at 6 months, then annually. projected accrual: a maximum of 3,300 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically documented non-small cell lung cancer any non-small cell histology eligible pathologic stage i/ii/iii disease that is completely resected with microscopically clear margins within 60 days of entry (30 days preferred) patient characteristics: age: 18 to 75 performance status: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: no clear contraindication to chemotherapy no second malignancy except: nonmelanomatous skin cancer carcinoma in situ of the cervix prior concurrent therapy: biologic therapy: no prior immunotherapy chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: no prior thoracic radiotherapy surgery: complete resection required prior to entry

Keywords: stage i non-small cell lung cancer stage ii non-small cell lung cancer stage iii non-small cell lung cancer squamous cell lung cancer large cell lung cancer adenocarcinoma of the lung adenosquamous cell lung cancer
monocyte profiles in critically ill patients with pseudomonas aeruginosa sepsis

Conditions: Pseudomonas Infections; Pseudomonas Septicemia; Pseudomonas; Pneumonia; Pseudomonal Bacteraemia; Pseudomonas Urinary Tract Infection; Pseudomonas Gastrointestinal Tract Infection; Sepsis; Sepsis, Severe; Critically Ill

Summary: the present study focuses on patients with pseudomonas aeruginosa (psa) sepsis. the aim of the present study is to find out whether the m1 (pro-inflammatory) or m2 (anti-inflammatory) phenotype predominates in blood monocytes in critically ill patients with psa-sepsis, and whether the severity of sepsis and outcome is associated with distinct monocyte phenotype and function.

during bacterial related sepsis, one of the key playing cells are macrophages, monocytes and t-lymphocytes (hotchkiss et al., 2003). macrophages and monocytes are supposed to be essential for the septic reaction to gram-negative bacteria (hotchkiss et al. 2003). generally, there are two dominant types of macrophages: the pro-inflammatory m1 macrophage and the anti-inflammatory m2 macrophage (mantovani et al., 2006). similar to this macrophage characteristics, monocytes can also be categorized into pro-or anti-inflammatory. these macrophage/monocyte phenotypes can be differentiated in vitro from freshly isolated human blood monocytes using either gm-csf giving raise to m1 macrophage/monocyte or m-csf resulting in m2 macrophage/monocyte (mantovani et al., 2006; neu et al., 2013). brunialti et al. (2012) have already demonstrated that the population of antiinflammatory m2 monocytes in septic patients is bigger than the pro-inflammatory m1 population. however, the authors did not further analyze the underlying mechanisms of m2 polarization nor did they identify the sepsis-causing pathogens. in the present study, monocytes and macrophages of patients with pseudomonas aeruginosa (psa) sepsis are characterized by their surface marker expression profile via flow cytometry and cytokine pattern by elisa in vivo and after ex-vivo lps stimulation. in addition, an ex-vivo model system for psa induced sepsis is validated. blood of critically ill patients in the icu infected with psa is sampled to isolate peripheral blood mononuclear cells (pbmcs). blood monocytes are analyzed for surface marker expression to determine the relative proportions of m1 and m2 monocytes in these patients and in healthy controls by flow cytometry

Eligibility criteria:
inclusion criteria: * age \> 18 years * critically ill patients with sepsis * microbiologically proven infection with pseudomonas aeruginosa exclusion criteria: * life expectancy \< 24 hours * participation in other studies

Keywords: pseudomonas aeruginosa critically ill patient sepsis monocyte macrophage cytokine severity of disease
high-activity natural killer immunotherapy for small metastases of melanoma

Conditions: Melanoma

Summary: the aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of melanoma.

by enrolling patients with small metastases of melanoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 2 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: metastatic melanoma high-activity natural killer
influence of natural images on patients' anxiety in the waiting rooms of imaging ward

Conditions: All Conditions for Which a CT or MRI Exam Can be Required

Summary: vertim study aims to evaluate the influence of different environments of imaging waiting rooms on the anxiety felt by patients before mri or ct scans. for this, four environments (neutral/standard; and nature "green", "sea", and "zen") will be set up in mri and ct waiting rooms.

each year, the medical imaging unit of the university hospital of bordeaux (chu bordeaux) receives 80,500 patients for ct or mri scans in usual care. the length of waiting, the environment of the waiting room, the reasons for the examination are factors that increase the levels of anxiety during waiting and but also during early examination. previous studies have shown that the integration of nature (real as well as artificial) is likely to decrease the level of anxiety. before implementing a multicentre and randomised trial, a pilot study is necessary to assess the feasibility of the procedure, to test the relevance of the tools, to identify the influence of socio-cultural and socio-demographic characteristics on anxiety's level. for this, the present study will be conducted over the same period of the year in order to avoid seasonality biases. the study will take place over 8 weeks, during which mri or scanner patients will be exposed either to the neutral environment (standard environment of the waiting room) or to one of the 3 environments (wall posters representing the nature ("green", "sea", "zen")). there is no specific intervention assigned to the study participants, i.e. the patients will receive one of the four environments as part of routine medical care, and a researcher studies the effect of this environment on anxiety's level. every week, one environment will be set up in the mri or scanner waiting room and the study will be proposed to all eligible patients present in this room. fifty patients are expected each week so that 100 patients per environment and equally distributed between the mri and scanner waiting rooms are expected.

Eligibility criteria:
inclusion criteria: * patient 18 yrs and older; * patients in mri or scanner's waiting room awaiting one of these 2 exams; * patients not objecting to answer questionnaires; * patient covered under social security exclusion criteria: * patient \<18yrs old; * patients with hearing and visual impairments; * patients unable to answer questionnaires; * patients awaiting for other exams than mri or scanner; * legally protected patient

Keywords: ct mri anxiety-state anxiety state-trait
using repetitive transcranial magnetic stimulation (rtms) for the treatment of bipolar depression

Conditions: Bipolar Disorder

Summary: the purpose of this study is to evaluate whether repetitive transcranial magnetic stimulation (rtms) treatment is an effective adjunct treatment to mood stabilizers and bupropion.


Eligibility criteria:
inclusion criteria: bd type i or ii subjects diagnosed according to the diagnostic and statistical manual of mental disorders (dsm-iv) in depressed phase. age 18 to 70. rating on the montgomery-asberg depression rating scale (madrs) score \> 20. rating on the beck depression inventory (bdi-ii) \> 20. rating on the young mania rating scale (ymrs) \< 8. non-treated new depressive episode, at least 2 weeks in duration. if recently started on an antidepressant other than wellbutrin, subject must spend at least 4 weeks at a therapeutic dose before entering the study. lithium and epival (sodium valproate) in monotherapy or in combination. novel antipsychotics can be combined with mood stabilizers for at least 4 weeks at a steady dosage prior to the study. exclusion criteria: history of any dsm-iv axis i diagnosis other than bd type i or ii presence of any psychotic symptoms, characterized by a score of 3 or more on item 10 of the madrs, a score of 6 on item 9 of the madrs, or a score of 6 or more on item 8 of the ymrs comorbid active dependence or substance abuse (except nicotine) prior electroconvulsive therapy failure pacemaker, automatic implantable defibrillator or implantable pump aneurysm clip heart/vascular clip prosthetic valve metal prosthesis pregnancy (must do a blood β-hcg test to exclude) metal or metal fragments in the head personal or family history of seizure disorder increased intracranial pressure history of stroke, meningitis/encephalitis, moderate to severe traumatic brain injury, neurosurgical procedure pharmacotherapy using any substances not mentioned in the inclusion criteria, except benzodiazepines at an equivalent dose of less than or equal to 1mg/day of lorazepam. failure of previous wellbutrin treatment. mood disorder secondary to a medical condition. subject currently enrolled in any detoxification program

Keywords: bipolar disorder repetitive transcranial magnetic stimulation (rtms) bupropion lithium a/o epival
virtual reality assisted conscious sedation during tavi

Conditions: Severe Aortic Valve Stenosis; Anxiety; Pain

Summary: transcatheter aortic valve implantation (tavi) is an established therapy for patients with severe aortic valve stenosis. pain and anxiety are major contributors to procedural complications. virtual reality (vr) glasses have already been used successfully in different clinical settings to treat anxiety and delirium. the aim of this prospective, randomized investigation is to prove the feasibility and safety of vr interventions in patients undergoing conscious sedation during tavi with local anesthesia only.


Eligibility criteria:
inclusion criteria: * interventional transfemoral tavi * informed consent * normal or corrected vision (through glasses) exclusion criteria: * patients whose communication is limited due to a language barrier * patients who could not watch the 3d video due to uncorrectable vision * all patients with transapical tavi were also excluded.

Keywords: tavi vr 3d glasses
low concentrate detergents versus hypertonic glucose for the treatment of telangiectasia

Conditions: Sclerotherapy

Summary: using of low concentrate sodium tetradecyl sulfate for sclerotherapy of telangiectasias should be no less effective than hypertonic glucose, and have a comparable frequency of adverse events.

for sclerotherapy of telangiectasias are used detergents. these are aggressive substances, which have a high frequency of adverse events. according to histological studies the safest concentration for the treatment of telangiectasias is less than that specified in the official instructions. the concentration of sodium tetradecyl sulfate 0.15% was effective and did not cause any adverse reactions in the treatment of telangiectasias from 0.8 to 1 mm in diameter. small telangiectases (0.5 mm or less) require the treatment with the less aggressive sclerosing agent. perhaps, the sodium tetradecyl sulfate 0.15%, 0.1% or even 0.05% and hypertonic glucose may be more effective and safe in this situation.

Eligibility criteria:
inclusion criteria: * women over 18 * single primary or secondary telangiectasias unrelated to the reticular veins * signed informed consent to participate in the study exclusion criteria: * telangiectasias associated with reticular veins * diabetes mellitus * pregnancy or lactation * malignant neoplasms * inability or unwillingness of the patient to wear compression stockings * hypersensitivity to one of the drugs * concomitant diseases: bronchial asthma, severe liver and kidney disease, acute thrombosis and thrombophlebitis, infection of the skin and/or soft tissues, infectious diseases, arteriosclerosis, diabetic angiopathy, heart defects requiring surgery, fever, toxic hyperthyroidism, obesity, tuberculosis, sepsis, violation of the cellular composition of the blood, all diseases requiring bed rest, heart disease with decompensation phenomena, known hereditary thrombophilia. * period after treatment of alcoholism * reception of oral contraceptives * sedentary lifestyle

Keywords: sclerotherapy, hypertonic glucose, sodium tetradecyl sulfate
comparison of mackenzie exercise program versus routine physical therapy management in chronic mechanical neck pain

Conditions: Neck Pain

Summary: study will be a randomized clinical trial to check comparison of mckenzie exercise program versus routine physical therapy management on pain, range of motion and function in patients with chronic neck pain so that we can devise a treatment protocol.total fifty subjects will be included in this study .out of total 25 will be randomly allocated via lottery method in group 1 and 25 will be allocated in group 2. group 1 will receive mckenzie exercise program and routine physical therapy(joint mobilization, hot pack for 15 minutes and home exercise program) while group 2 will receive only routine physical therapy (joint mobilization , hot pack for 15 min and home exercise program). all patients will be treated for 12 sessions, two sessions per week for 6 weeks. neck pain and disability index consist of two parts, part one which assesses pain severity and part two which assesses functional disability. study setting will be services hospital. assesment will be done at 0 week, 4week, 8week and 12weeks. data was analysed by using spss version 26.

neck pain is a key public health issue that affects the human beings with reduction productivity and quality of life and produced significant socioeconomic burden on society.the purpose of this study to determine the effectiveness of mckenzie exercise program and routine physical therapy management on pain range of motion and function in patient with chronic mechanical neck pain. patients of both gender, neck pain for at least 3 months and age 25-55 years will be included. patients having history of trauma, vertebral fracture, congenital disorder, ankylosing spondylitis, tumour, pott's disease and any bony or soft tissue systematic disease will be excluded. the main objective of this study is to evaluate pain level and effect of mackenzie protocol for individuals suffering from chronic neck pain. the tools used will be neck disability index score (ndi), numeric pain rating scale (nprs) and goniometer for outcome measure pain, range of motion and function. study will be conducted into 2 groups, each group will have 12 patients and comparisons of two groups will be evaluated. one group will receive mckenzie exercise program and routine physical therapy (joint mobilization, hot pack and home exercise program) for 12 weeks and 2 days a week for 40 min each session and other group will receive routine physical therapy (joint mobilization, hot pack and home exercise plan) for 12 weeks and 2 days a week for 30 min each session. assessment will be done at 0 weeks, 4 week, 8 week and 12 week.both groups received hot packs for 15 minutes for warming up.

Eligibility criteria:
inclusion criteria: * both gender * neck pain for at least 3 months * age 25-55 years old exclusion criteria: * • history of trauma * vertebral fracture * congenital disorder * ankylosing spondylitis * tumour * pott's spine * any bony or soft tissue systemic disease
efficacy of immunosuppressive therapy for iga nephropathy with stage 3 or 4 ckd

Conditions: Glomerulonephritis, IGA

Summary: the purpose of this clinical trial is to evaluate the long-term efficacy and safety of low-dose oral corticosteroids combined with cyclophosphamide therapy and low-dose corticosteroids monotherapy, on a background of maximal ras inhibitor therapy, for iga nephropathy with stage 3 or 4 chronic kidney disease.


Eligibility criteria:
inclusion criteria: * biopsy-proven iga nephropathy; * proteinuria ≥1.0g/day while receiving maximum tolerated dose of ras blockade; * estimated glomerular filtration rate 15-60 ml/min/1.73/m2. exclusion criteria: * indication or contraindication for immunosuppressive therapy with corticosteroids * use of corticosteroids and other immunosuppressive drugs within the last 1 year * current unstable kidney function for other reasons * under 18 years old * patients with secondary igan * patients who are unlikely to comply with the study protocol in the view of the treating physician
ripc during free flap with preoperative radiotherapy

Conditions: Ischemic Reperfusion Injury; Other Reconstructive Surgery; Radiotherapy

Summary: remote ischemic preconditioning (ripc) has shown organ-protective effects in many clinical settings including patients with ischemic heart disease. however its protective role in head and neck cancer patients with preoperative radiotherapy undergoing free flap reconstructive surgery has not yet been evaluated. the purpose of the current study is to evaluate the effect of ripc on tissue oxygen saturation and skin temperature of the flap.

patients undergoing free flap reconstructive surgery for head and neck cancer with preoperative radiotherapy will be randomized to either remote ischemic preconditioning (ripc) group or control group. on the day of surgery, after induction of anesthesia, ripc, consisting of 4 cycles of 5-min ischemia (using pneumatic cuff pressure of 200 mmhg) followed by 5-min reperfusion at the upper arm, or sham-ripc (pressure \< 10 mmhg) will be induced in the ripc or control group, respectively. before completion of surgery, ripc or sham-ripc will be repeated. tissue oxygen saturation and skin temperature of the flap will be recorded until postoperative day 1.

Eligibility criteria:
inclusion criteria: * adult head and neck cancer patients undergoing free flap reconstructive surgery with preoperative radiotherapy exclusion criteria: * radiotherapy within 4 weeks * body mass index \ 35 kg/m\^2 * presence of av fistula at the arm, any reason to protect arms * presence of vascular abnormality or discomfort at arms * peripheral vascular disease, peripheral neuropathy, or coagulopathy * uncontrolled diabetes mellitus * preoperative use of beta-blockers * refuse to enrol

Keywords: remote ischemic preconditioning free flap reconstruction preoperative radiotherapy
cabozantinib and pembrolizumab in metastatic pancreas

Conditions: Pancreatic Cancer

Summary: this study aims to evaluate cabozantinib and pembrolizumab for the treatment of metastatic pancreatic adenocarcinoma.


Eligibility criteria:
inclusion criteria: * diagnosis of pancreatic ductal adenocarcinoma * evidence of progression or intolerance to previous standard of care pancreatic cancer systemic or locoregional therapies * patients must have adequate organ function exclusion criteria: * chemotherapy or other locoregional anti-tumoral therapies performed within 28 days of study treatment initiation * received palliative radiation therapy within 2 weeks or any other radiation therapy within 4 weeks of start of study intervention * has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation * has a diagnosis of immunodeficiency (autoimmune disease) or is receiving chronic systemic steroid therapy * clinically significant cardiovascular disease * uncontrolled hypertension * inability to swallow tablets

Keywords: adenocarcinoma metastatic
a dose ranging study to compare the safety and efficacy of aliskiren in patients with high blood pressure

Conditions: Hypertension

Summary: this is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. each patient is in the study for 8 weeks


Eligibility criteria:
inclusion criteria: * male and female outpatients 18 years of age and older * patients who are eligible and able to participate in the study exclusion criteria: * severe hypertension * history or evidence of a secondary form of hypertension * history of hypertensive encephalopathy or cerebrovascular accident. other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension aliskiren blood pressure