Kornimate/medical-research-clean huggingface dataset:
study of bortezomib +hsct in primary systemic amyloidosis (al)

Conditions: Amyloidosis

Summary: to evaluate the efficacy and safety of vel-dex therapy (bortezomib and dexamethasone) followed by autologous hematopoietic stem cell transplantation as an initial treatment in patients with newly diagnosed al.

patients will receive two 21-day cycles of induction therapy with vel / dex regimen. bortezomib 1.3mg/m2 on days 1, 4, 8 and 11 will be given by intravenous bolus injection while dexamethasone 40 mg/d will be taken orally on days 1-4. after two cycles of vel / dex therapy, the collection of peripheral blood stem cells (pbsc) should be completed within 4 weeks.patients will receive asct therapy in 8 weeks after collection of pbsc (recorded as day 0), while melphalan (day -2) with a dose of 100,140 or 200 mg/m2 (choosing a dose according to the degree of risk for patients ) and vel 1mg/m2 (days -6, -3, +1, +4) will be given. four additional 21-day cycles of vel treatment (with a dose of 1.6mg/m2 on day 1 and 8 of the cycle) will be conducted as consolidation therapy during the recommended 60-90 days after hsct, or after resumption of hematopoietic function ( neutrophil count \> 1.5x109/l and platelet count\> 50x109/l). later patients won't need maintenance therapy. the efficacy criteria are the international standards set with consensus of experts in the tenth international symposium on amyloid and amyloidosis.

Eligibility criteria:
inclusion criteria: 1. male or female; 2. aged 18-65 years; 3. patients with newly diagnosed al; 4. appropriate for autologous hematopoietic stem cell transplantation; 5. abnormal m protein or free light chain detected in serum and / or urine 6. ecog score 0-2 points; 7. subjects (or their legal representatives) must signed an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study. exclusion criteria: 1. subjects received systematic treatment with steroids 2. subjects received plasmapheresis to treat clinical significant hyperviscosity syndrome within 4 weeks before enrollment. 3. pregnant and breastfeeding women; 4. subjects suffering from multiple myeloma. 5. hypersensitivity to dexamethasone, bortezomib, mannitol, boron, or heparin (if use catheters); 6. subjects have severe cardiovascular disease, 7. subjects have serious physical disease and mental illnesses which may interfere the study

Keywords: hematopoietic stem cell transplantation amyloidosis bortezomib
dose ranging study evaluating the efficacy and safety of gsk2190915 administered once daily

Conditions: Asthma

Summary: to evaluate the efficacy, dose response and safety of four doses of gsk2190915 in tablet form (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in adolescent and adult subjects (12 years of age and older) with persistent asthma. these data will form the basis for the selection of the optimal daily dose of gsk2190915 to be carried forward in phase iii asthma studies. the study also includes fluticasone propionate inhalation powder (100 mcg, twice daily) and montelukast (10mg, once daily) to allow for an exploratory analysis of the efficacy of gsk2190915 versus a low dose inhaled corticosteroid and a leukotriene receptor antagonist.


Eligibility criteria:
inclusion criteria: * type of subject: outpatient * age: ≥12 years of age * gender: eligible female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control) * asthma diagnosis: as defined by nih * severity of disease: fev1 50-85% predicted and in current and former smokers a post salbutamol/albuterol ratio \>0.70 * reversibility: ≥12% and ≥200ml in fev1 within 30 ±15 minutes following salbutamol/albuterol * current anti-asthma therapy: using short-acting beta-agonist (saba) for ≥3 months * tobacco use: non-smoker /former smoker with ≤10 pack years or current smoker with ≤10 pack years * qtc: qtc(f)\<450msec or qtc(f)\<480 for subjects with bundle branch block * liver function: normal liver function * informed consent exclusion criteria: * history of life-threatening asthma: within previous 5 years * asthma exacerbation: requiring ocs within 3 months or hospitalisation within 6 months * respiratory infection: not resolved within the 4 weeks before v1 and led to a change in asthma management or treatment with antibiotics or is expected to affect the subject's asthma status or ability to participate * corticosteroid use: ics used within 6 weeks or ocs/depot corticosteroids within 12 weeks * oatp1b1 substrates: oatp1b1 substrates (e.g. statins, rifampicin, bromosulphophthalein, benzylpenicillin, methotrexate) within 4 weeks * immunosuppressive medications: either using or required during the study * liver disease: current or chronic history * concurrent disease/abnormalities: clinically significant uncontrolled disease * investigational medications: participation in a study or used investigational drug within 30 days * drug allergy: β-agonists, corticosteroids, constituents of inhalers * milk protein allergy: history of severe milk protein allergy * compliance: factors likely to impair compliance either with regards to study medication, procedures or attendance * unable or unwilling to follow instructions: procedures, dosing directions, e-diaries or pmdis * history of alcohol or drug abuse: likely to interfere with the study * affiliation with investigator's site: relative or employee

Keywords: efficacy asthma safety fluticasone propionate flap beta-agonists gsk2190915 montelukast placebo flair
evaluation of safety & tolerability of multiple dose regimens of chf 5074

Conditions: Alzheimer's Disease

Summary: to evaluate the safety and tolerability of ascending oral doses of chf 5074 administered once per day for up to 12 weeks to patients with mild cognitive impairment.


Eligibility criteria:
inclusion criteria: * diagnosis of amnestic or non-amnestic mild cognitive impairment. * mini-mental state examination score higher than 24 at screening. * mri scan of the brain at screening with fluid-attenuation inversion recovery (flair) and t2\*-weighted gradient-recalled-echo (gre) sequences. exclusion criteria: * diagnosis of alzheimer's disease according to the (dsm-iv-tr) or nincds-adrda criteria. * any medical condition that could explain the patients cognitive deficits. * ct or mri brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance * mri scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm). * geriatric depression scale (30-point scale) score \> 9 at screening. * history of stroke. * modified hachinski ischemic scale score \> 4 at screening. * women of childbearing potential. * vitamin b12 or folate deficiency. * diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening. * current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease. * concomitant use of donepezil at doses \> 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose. * concomitant use of memantine at dose \> 20 mg/day. * concomitant use of psychoactive drugs (sedatives, hypnotics, etc).
inflammation and the host response to injury (burns)

Conditions: Trauma; Burns; Multiple Organ Failure

Summary: the purpose of this study is to help improve our understanding of the biology involved in the body's response to serious trauma or burn injury. the host response to trauma and burns is a collection of physiological and pathophysiological processes that depend critically upon the regulation of the human innate immune system, with particular emphasis on the inflammatory component of that system. no single research center or small group of centers has the capacity to delineate the integrated response of this complex biological system, which involves multiple molecular and genetic interactions that vary in time. our proposal promotes the identification of important dynamic relationships that regulate the integration of this complex biological system, with the expectation that this understanding will ultimately impact the diagnosis, prognosis, and treatment of the hospitalized, severely injured patient.

this large-scale collaborative project provides the means to acquire the necessary new knowledge directly in humans. knowledge will be acquired using diverse state-of-the-art genomic and proteomic technologies, a highly complex clinical, proteomic, and genomic database, as well as newly-developed, novel analytical tools to probe this complex dataset. our analytical capabilities at the genomic and proteomic level are now rapidly evolving and our ability to link these genomic and proteomic data to pathways and functional modules will help us more closely link this cellular data to immunological processes and ultimately, to the phenotypic response (i.e., trajectory) in the injured host. as a result, potential interventions, whether through our program or other funding mechanisms, can be more effectively designed.

Eligibility criteria:
inclusion criteria: * burn patients of all ages with 20% or greater of total body surface area burns that require surgical treatment * burn patients admitted to the burn unit within 96 hours (4 days) of burn injury all patients meeting these criteria are entered into the epidemiologic database and assessed for specific exclusion criteria to establish whether serial blood draws are warranted. exclusion criteria: * injury caused by chemical agent * deep injury caused by conduction of electrical current or charge * decision not to treat due to severity of injury * anoxic brain injury that is not expected to result in complete recovery * associated multiple injuries exclusive of burns (iss \>=25) * pre-morbid condition: severe congestive heart failure (measured ejection fraction \<20%) * pre-morbid condition: malignancy currently under treatment * pre-morbid condition: medical condition requiring systemic glucocorticoid treatment * pre-morbid condition: current systemic immunosuppression for organ transplant or chronic inflammatory condition

Keywords: immunity, innate inflammation genomics proteomics
a study of selpercatinib (ly3527723) in participants with advanced or metastatic ret fusion-positive non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: the reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (ret) fusion-positive non-squamous non-small cell lung cancer (nsclc) that has spread to other parts of the body. participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed, stage iiib-iiic or stage iv non-squamous nsclc that is not suitable for radical surgery or radiation therapy. * a ret gene fusion in tumor and/or blood from a qualified laboratory. * eastern cooperative oncology group (ecog) performance status of 0-2. * adequate hematologic, hepatic and renal function. * willingness of men and women of reproductive potential to observe conventional and highly effective birth control for the duration of treatment and for 6 months after. * ability to swallow capsules. exclusion criteria: * additional validated oncogenic drivers in nsclc if known. * prior systemic therapy for metastatic disease. treatment (chemotherapy, immunotherapy, or biological therapy) in the adjuvant/neoadjuvant setting is permitted if it was completed at least 6 months prior to randomization. * major surgery within 3 weeks prior to planned start of selpercatinib. * radiotherapy for palliation within 1 week of the first dose of study treatment or any radiotherapy within 6 months prior to the first dose of study treatment if more than 30 gy to the lung. * symptomatic central nervous system (cns) metastases, carcinomatous meningitis, or untreated spinal cord compression. * clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the qt interval corrected for heart rate using fridericia's formula (qtcf) \> 470 milliseconds. * active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. * clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug. * pregnancy or lactation. * other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed ≥2 years previously and not currently active. * uncontrolled, disease related pericardial effusion or pleural effusion. * requiring chronic treatment with steroids. exclusion criteria for participants receiving pembrolizumab: * history of interstitial lung disease or interstitial pneumonitis. * active autoimmune disease or any illness or treatment that could compromise the immune system.

Keywords: targeted therapy
treatment of sars caused by covid-19 with ruxolitinib

Conditions: COVID-19; Severe Acute Respiratory Syndrome Coronavirus 2

Summary: in december 2019, a new virus emerged in wuhan, china rapidly becoming a pandemic with registered cases above 800,000 around the world. the virus is now known as sars-cov2 calling its disease coronavirus-19 or covid-19. the mortality of the virus has been reported around 2-10% and its causes because of the proinflammatory immune response generated on the host. the cytokines involved in the immune response to covid-19 are il-1, il-2, il4, il-6, il-10, il-12, il-13, il-17, gcsf, mcsf, ip-10, mcp-1, mip-1α, hgf, ifn-γ y tnf-α. ruxolitinib is an inhibitor of jak 1/2 which is responsable for multiple cellular signals including the proinflammatory il-6. ruxolitinib works as and immunomodulator decreasing the cytotoxic t lymphocytes and increasing the treg cells. this study is intended to stop the disregulated immune response caused by covid-19 that generates the pneumonia and subsequent severe acute respiratory syndrome.


Eligibility criteria:
inclusion criteria: * patients with diagnosed covid-19 with confirmatory test * increase in work of breathing or presence of dyspnea * presence of lung changes associated with covid pneumonia by chest imaging * informed consent exclusion criteria: * pregnancy or breastfeeding * thrombocytopenia below 20,000 cells/mm3 * neutropenia below 500 cels/mm3 * known and active infection of hiv, hepatitis c, hepatitis b, herpes zoster or mycobacterium tuberculosis
erector spinae plane block for carotid endarterectomy

Conditions: Pain

Summary: the purpose of this study is to test the hypothesis that erector spinae plane block will decrease intraoperative local anesthetic and postoperative analgesic consumption in patients undergoing carotid endarterectomy.

patients who decided to participate in the study will be randomized into 2 groups: erector spinae plane block group (group e) and control group (group c). intraoperative local anesthetic consumption, postoperative tramadol consumption, intraoperative and pain scores, hemodynamic parameters and patient satisfaction will be recorded.

Eligibility criteria:
inclusion criteria: * patients undergoing carotid endarterectomy * american society of anesthesiologists class 2 to 3 * ability to consent exclusion criteria: * inability to communicate * not understand the aim and objectives of the study * not provide informed written consent * contraindications for the block (local infection, coagulation disorders) * hypersensitivity to the local anesthetics * refusal of regional anesthesia
intraocular gas tamponade for treatment of large idiopathic macular holes

Conditions: Idiopathic Macular Hole; Macular Hole; Macular Holes; Full Thickness Macular Hole

Summary: the goal of this clinical trial is to evaluate the visual and anatomical outcomes of large (410-1000 μm) full-thickness macular holes repair surgery using perfluoropropane (15% c3f8), sulfur hexafluoride (20% sf6) gas tamponade.

the project is a randomized clinical trial with a follow up time of 6 months comparing the effects of surgical treatment of large (410-1000 μm) idiopathic macular holes. patients are randomized to vitrectomy surgery with internal limiting membrane peeling using perfluoropropane (15% c3f8), sulfur hexafluoride (20% sf6) gas tamponad. intra- and postoperative complications are registered.

Eligibility criteria:
inclusion criteria: * patient age 50 or above. * duration of symptoms ≤ 12 months. * macular holes having a diameter 410-1000 μm. * informed consent. exclusion criteria: * patients under 50 years of age. * a patient who has already undergone treatment (surgery, laser etc.) for any disease of the retina. * traumatic or pediatric macular holes, and associated retinal detachment. * history of any retinal disease such as high myopia, retinal dystrophies, central serous retinopathy, retinal vascular diseases, diabetic retinopathy, uveitis etc. * previous history of glaucoma or ocular hypertension. * failure to give informed consent.

Keywords: macular hole pars plana vitrectomy perfluoropropane (c3f8) sulfur hexafluoride (sf6) idiopathic macular hole full thickness macular hole large macular hole large macular holes
effect of aerobic exercise on premenstrual syndrome symptoms (pms).

Conditions: Premenstrual Syndrome; Quality of Life

Summary: to determine the effect of regular aerobic exercise training on severity of premenstrual syndrome symptoms and health-related quality of life on working women.exercise can be used as an alternative therapy in reducing premenstrual symptoms.but still there is lack of literature on pms in work place and effect of treatments to improve overall quality of life in working women.and this study aims to fill the gap by assessing the impact that premenstrual syndrome can have on working women's quality of life and can be used to establish a model of regular exercise program with the potential to decrease premenstrual symptoms and improve quality of life for a menstrual health-friendly workplace environment for female employees.

a review conducted to assess the effect of 8 weeks of aerobic exercise on the non-athletic females facing premenstrual syndrome symptoms. the results displayed positive effects of 8 weeks of exercise on symptoms of pms. the aerobic exercise helped to reduce both psychological and physical symptoms. regular swimming for 8 weeks also decreased the severity of pms symptoms in females. results deduced that the exercise improved the vascular activity of the heart, and reduced stress and anxiety. moreover, it also enhanced bone density. in one of rct the effect of 3 months of exercise through treadmill on pms and hormones was also evaluated. it was assumed that many symptoms of pms were reduced including the carbohydrate cravings, stress, and depression. the electrolyte change was also reduced. exercise also reduced the proportion of backache and menstrual cramps in females. another review on a balanced diet and regular exercise demonstrated that the diet rich in the essential nutrients and regular exercise improved the health of the females. the symptoms of pms were also reduced in these females along with the intensity of dysmenorrhea.

Eligibility criteria:
inclusion criteria: * regular menstrual cycles (cycles of 21-35days with a bleeding time of 3-10days). * pms (as per screening questionnaire psst criteria). * no history of psychiatric disorder (score below 40 from beck depression questionnaire). * women working in hospital settings (health care professionals). exclusion criteria: * no history of co-existing medical illness including dm, thyroid dysfunction, hypoglycemia, cardiac pathologies. * women undergone hysterectomy or other gynecological procedure. * women on medications i.e. contraceptive pills and hrt. * pregnant women. * history of drug abuse or alcohol intake. * participation in another sports program

Keywords: aerobic training
patients with chemotherapy-induced polyneuropathy are treated with an integrated program including massage, mobilization in posture and transport layers, physical exercises or with whole-body vibration platform training

Conditions: Polyneuropathy

Summary: in a phase-iii study patients with chemotherapy-induced polyneuropathy (nci ctc grade 2/3) are randomized for an integrated program (ip) including massage, mobilization in posture and transport layers, physical exercises (standard) or with whole-body vibration (wbv) platform training (experimental).

subjects with a haematological malignancy or solid and a diagnosis of a chemotherapy-induced polyneuropathy. in a phase-iii study patients with chemotherapy-induced polyneuropathy (nci ctc grade 2/3) are randomized for an integrated program (ip) including massage, mobilization in posture and transport layers, physical exercises (standard) or with whole-body vibration (wbv) platform training (experimental). 15 training sessions in a time period of 12 to 15 weeks were intended. evaluation included locomotor and neurological tests and self-assessment-tools. the primary objective of the study was the physical fitness and coordination assessed by the chair-rising test (crt).

Eligibility criteria:
inclusion criteria: patients 18 to 70 years of age with solid and hematological neoplasms suffering from chemotherapy-induced polyneuropathy grade ii-iii according to national cancer institute common toxicity criteria (nci ctc, version 3.0) and pathological chair-rising test (crt)28 ( ≥10 s) were eligible exclusion criteria: * psychiatric disorders * plasmatic coagulation disorders * thrombotic/thromboembolic events within 6 months before randomization * severe neurological disorders like seizures
the effect of 0.05% csa eye drops on diabetic patients with dry eye disease

Conditions: Dry Eye

Summary: the objective of this study is to observe the effects of 0.05% cyclosporine eye drops combined with artificial tears on patients with diabetes-associated dry eye, and to monitor changes in ocular surface characteristics and inflammatory cytokines in tears before and after treatment.


Eligibility criteria:
inclusion criteria: i. age: 50 to 70 years old; ii. gender: no restriction; iii. meets the diagnostic criteria for dry eye: refer to the 2020 chinese expert consensus on diagnostic criteria for dry eye. iv. meets the diagnostic criteria for diabetes: history of type 2 diabetes with a course of ≥5 years; diagnosis refers to the 1999 who diagnostic criteria for diabetes. v. provision of written informed consent. exclusion criteria: i. active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin. ii. uncontrolled systemic disease. iii.suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc. -

Keywords: dry eye 0.05% cyclosporine diabetes