Kornimate/medical-research-clean huggingface dataset:
study of autologous t-cells in patients with metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this is a study in which pancreatic cancer patients receive a immunotherapy with cart-meso cells administered at 3 days after one dose of cyclophosphamide. cart-meso cells are patients' own t cells lentivirally transduced to express anti-mesothelin scfv fused to tcrζ and 4-1bb costimulatory domains.the lymphodepletion with cyclophosphamide may prolong the persistence of cart cells.

this study is being conducted to assess the safety and efficacy of immunotherapy with cart-meso cells in dose escalation design. the trial will begin in cohort 1 and progress to cohorts 2, depending upon dose limiting toxicity (dlt) assessment . subjects will be enrolled serially, but infusions will be staggered to allow assessment of dlts for determination of cohort progression, expansion, or dose de-escalation. cohort 1 subjects will receive a single dose of 1-3x10\^7 /m\^2 lentiviral transduced cart-meso cells after conditioning chemotherapeutic regimen. cohort 2 subjects will receive a single dose of 1-3x10\^8 /m\^2 lentiviral transduced cart-meso cells cells after conditioning chemotherapeutic regimen. dose limiting toxicity is defined as any adverse reactions at level 3 or above that may be associated with cart-meso within 4 weeks after infusion.

Eligibility criteria:
inclusion criteria: * signed informed consent * unresectable or metastatic pancreatic cancer * persistent cancer after at least one prior standard of care chemotherapy for advanced stage disease * 18 - 70 years of age * ecog performance status of 0 or 1 * life expectancy greater than 3 months * satisfactory organ and bone marrow function * meets blood coagulation parameters * male and female subjects of reproductive potential agree to use approved contraceptive methods exclusion criteria: * participation in a therapeutic investigational study within 4 weeks prior to the screening visit * anticipated need for systemic chemotherapy within 2 weeks before apheresis and infusion * active invasive cancer other than pancreatic cancer * hiv, hcv, or hbv infections * active autoimmune disease requiring immunosuppressive therapy within 4 weeks prior to screening visit, with exception of thyroid replacement * ongoing or active infection * planned concurrent treatment with systemic high dose corticosteroids * patients requiring supplemental oxygen therapy * prior therapy with gene modified cells * previous experimental therapy with ss1 moiety, murine or chimeric antibodies * history of allergy to murine proteins * history of allergy or hypersensitivity to study product excipients (human serum albumin, dmso, and dextran 40) * clinically significant pericardial effusion, chf, or cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study * pregnant or breastfeeding women
is intralymphatic allergen immunotherapy effective and safe?

Conditions: Allergic Rhinitis Due to Grass Pollen

Summary: 15 patients with moderate to severe allergic rhinitis against grass were recruited and enrolled in the study. they received three open label intralympatic grass allergen injections with the dose 1000 sq-u each and with one month interval. the next year the patients were randomized double blind to an active or placebo booster injection of 1000 sq-u before the pollen season. grass specific igg4 levels were measured before and at various time ponts after treatment.

the purpose of the study is to evaluate whether intralymphatic administration of ait is a safe and effective treatment for patients with pollen-induced allergic rhinitis. the long term goal is to provide a base for a more efficient administration of asit, which will reduce both the dose necessary and the number of clinic visits associated with the conventional subcutaneous asit. the aim of the present substudy is to evaluate if a randomized preseasonal ilit booster, after three open label ilit injections, can increase the allergen specific igg4 antibodies, and if the igg4 increase can be correlated to clinical effect characterized with seasonal questionnaires. the first part of the study is completed and published (pmid: 23374268)

Eligibility criteria:
inclusion criteria: * age 18-50, * seasonal allergic symptoms for birch and/or grass verified by skin prick test, * accepted informed consent exclusion criteria: * pregnancy or nursing * autoimmune or collagen disease (known) * cardiovascular disease * perennial pulmonary disease * hepatic disease * renal disease * cancer * any medication with a possible side-effect of interfering with the immune response * previous immuno- or chemotherapy * chronic diseases * other upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease) * disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers) * major metabolic disease * known or suspected allergy to the study product * alcohol or drug abuse * mental incapability of coping with the study * withdrawal of informed consent
a study evaluating nexagon™ in the treatment of skin wounds.

Conditions: Wound Healing

Summary: nexagon™ is a novel compound that promotes wound healing by temporarily disrupting cellular communication at the wound site, thereby promoting accelerated healing, reducing inflammation and pain. this randomized double-blind study will assess the safety, tolerability and clinical effect of nexagon™ when applied to skin wounds created by punch biopsy in healthy volunteers. 43 healthy, fair-skinned males and females between ages 18-40 will be enrolled. subjects will be reviewed again at 3 months and 9 months for follow-up safety assessments and wound appearance evaluation.


Eligibility criteria:
inclusion criteria: 1. healthy male or female subjects. 2. fair skinned (fitzpatrick classification level i - iii). 3. aged between 18 and 40 years inclusive. 4. subjects who are able to comply with all study procedures, including follow-up assessment visits. 5. subjects who are willing and able to give written informed consent to take part in the study. exclusion criteria: 1. subjects who have pigmented skin due to an increased susceptibility to hypertrophic and keloid scarring (fitzpatrick classification level iv - vi). 2. subjects who are known hypertrophic or keloid scar formers. 3. subjects who smoke. 4. subjects with a body mass index of greater than 30 kg/m2. 5. subjects with bleeding disorders or taking anti-coagulants. 6. subjects with any other skin lesion sites or a chronic or currently active skin disorder, which would adversely affect the healing of the acute wounds or which involve the areas to be examined in this study. 7. subjects taking or who have taken prescribed drugs in the 30 days prior to day 0, in particular, topical or systemic steroids, anti-inflammatories, anti-coagulants, anti-proliferative drugs, or antibiotics. 8. subjects who regularly take aspirin, ginseng, gilboa, alka seltzer or any other over-the-counter medicine or complimentary health product that can affect the blood clotting process. 9. subjects with a history of clinically relevant allergies. 10. subjects with tattoos, scars or abrasions at the site to be studied. 11. subjects with any clinically significant abnormality following review of pre-study laboratory data and physical examination. 12. subjects showing evidence of drug abuse. 13. subjects with any clinically significant mental illness in the opinion of the investigator. 14. females who are currently pregnant or breast-feeding. females of child-bearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined the protocol. 15. subjects who have a past or present disease, which as judged by the investigator may affect the safety of the subject or the outcome of the study. 16. subjects who have participated in a clinical study within the 30 days prior to day 0.

Keywords: wound healing
pharmaceutical care program for type 2 diabetes mellitus

Conditions: DIABETES MELLITUS, TYPE 2

Summary: evaluation of pharmaceutical care program for type 2 diabetes mellitus in dhule objectives:- 1. to evaluate pharmaceutical care program in type2 diabetics. 2. to evaluate the impacts of pharmaceutical care on quality of life (qol) in patient with type-2 diabetes mellitus. 3. to study the prevalence of type2 diabetics cases in dhule. 4. to study the assessment of different type of adverse drug reactions (adrs). in type2 diabetics. 5. to evaluate the drug drug intereaction in type-2 diabetes mellitus. 6. to study the impacts of pharmaceutical care program on glycemic control in patients with type-2 diabetes mellitus. 7. to study the drug utilization pattern in type-2 diabetes mellitus in civil hospital dhule. 8. to compare the efficiency of pharmaceutical care program and drug in patients with type-2 diabetes mellitus. 9. to study the pharmaco-economic evaluation in type-2 diabetes mellitus patient's. 10. to increase the patient compliance and positive attitude of patients towards the diabetes disease by counseling.

to evaluate the impacts of pharmaceutical care on quality of life (qol) in patient with type-2 diabetes mellitus. to study the prevalence of type2 diabetics cases in dhule. to study the assessment of different type of adverse drug reactions (adrs). in type2 diabetics. to evaluate the drug drug intereaction in type-2 diabetes mellitus.

Eligibility criteria:
inclusion criteria:inclusion criteria: * patients with type 2 diabetes mellitus of either * patients with hba1c more than 7% and * patients with blood sugar level more than 140 mg / dl exclusion criteria: * patient with end stage kidney disease. * patient with heart failure. * patient with chronic diabetes problem and orthopedic problem

Keywords: pharmaceutical care
whole egg intake and the mediterranean diet

Conditions: Overweight; Obesity

Summary: this project will evaluate the daily intake of whole eggs in the mediterranean diet (med diet). cholesterol levels are normally related to cardiovascular disease (cvd) risk. dietary fat and the total diet makeup are well known modifiers of cvd risk. the med diet has been shown to decrease blood lipids (fats) and reduce inflammation. cholesterol intake from eggs may not be as bad as once thought and, in fact, may help to improve the blood lipid (fat) levels. this study is being done to test how the addition of eggs to a med diet affects blood lipids and other risk markers for cvd.

elevated serum cholesterol is a major contributor to cardiovascular disease (cvd), which is responsible for \~1/3 of all deaths in the us. however, about 50% of those who experience heart attacks have normal cholesterol levels. cholesterol is carried in lipoproteins (hdl, ldl, and vldl) and the amount in circulation is used to evaluate cvd risk. however, the particle size and density of lipoprotein subfractions may be more predictive for atherogenesis than their total levels. dietary fatty acids are well recognized modulators of lipoproteins, and ultimately cvd risk. saturated and trans fatty acids have a negative effect on cvd risk while poly- and monounsaturated fatty acids (pufa, mufa) appear to be protective. the mediterranean diet (med diet) decreases atherogenic lipoproteins and reduces systemic inflammation. it is unknown how high cholesterol intake within a med diet will affect these parameters, although recent evidence implies that the fatty acid content of the diet is more important than the cholesterol content. therefore, this project will evaluate the daily inclusion of whole eggs, a high cholesterol food, in the med diet on lipid profiles, lipoprotein particle size and density and biomarkers of systemic inflammation.

Eligibility criteria:
inclusion criteria: * willingness to comply with the demands of the experimental protocol * not performing vigorous exercise \>2 times per week * bmi 25-39.9 kg/m2 * non-nicotine-using exclusion criteria: * have an egg allergy * have diabetes * have high triglyceride levels * have uncontrolled high blood pressure * have used tobacco products or nicotine in any form including snuff, pills and patches, or e-cigarettes in the previous 6 months * use prescription medications or over-the-counter lipid lowering drugs (such as statins) or anti-inflammatory medications (such as aspirin, ibuprofen or aleve) on a regular basis * take omega 3 supplements, plant sterols or sterol esters * are pregnant or lactating * have been diagnosed with an eating disorder * inability to give consent * unwillingness or inability to consume the treatment diets
positron emission tomography (pet) study in patients with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: to investigate the brain receptor occupancy of idalopirdine in patients with alzheimer's disease (ad)


Eligibility criteria:
inclusion criteria: * the patient has probable ad diagnosed according to national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association (nincds-adrda) criteria. * the patient has had a positive amyloid pet scan, which in the opinion of the principal investigator is consistent with a diagnosis of ad. * the patient has a mini mental state examination (mmse) score at screening of at least 15 and no greater than 22. * the patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the study and answer questions about the patient. * the patient is a man or woman of at least 50 years of age and has a body mass index (bmi) ≥ 18.5 kg/m2. exclusion criteria: * the patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than ad including but not limited to lewy body dementia, fronto-temporal dementia, parkinson's disease, huntington's disease, major cortical stroke, major head trauma, primary or secondary cerebral neoplasia or systemic medical diseases that are, in the investigator's opinion, likely to affect central nervous system functioning and may influence the outcome or analysis of the scan results. * the patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Keywords: lu ae58054
what works to get the elderly vaccinated against covid-19? experimental evidence from india

Conditions: Aging; Covid19

Summary: covid-19 poses a substantial risk to elderly populations; understanding how to get elders vaccinated against the virus is therefore a policy priority. an experiment with elders in tamil nadu, india will be used to evaluate interventions policymakers might use to raise vaccination rates amongst the elderly. the particular interventions being tested are: calling elders to inform them about vaccination; encouragement of a "buddy system," whereby elders are accompanied to the vaccination site by another adult who could also get the vaccine; and seeding vaccination information with "gossips," individuals who elders identify as being good at spreading information in the elders' communities. the interventions are phone-based, and can be implemented quickly and at low cost. this makes them promising strategies the tamil nadu government and other governments could use to vaccinate elderly populations against covid-19.


Eligibility criteria:
inclusion criteria: * at least 55 years of age * has phone number exclusion criteria: - not part of the experiments registered under protocol ids 223749 or 172020
effect of personal versus video instruction in elastic resistance exercise on technical execution (irma05)

Conditions: Musculoskeletal Disorders

Summary: resistance training is widely used in training and rehabilitation. during recent years elastic resistance training has become increasingly popular for preventing or relieving neck/shoulder/arm pain among sedentary employees. while most research studies documenting positive effects of such interventions have used training instructors, most training in practice does not use an instructor but rather depends on information from other sources such as the internet. here the investigators examine - in a outcome assessor blinded randomized controlled trial - the effect of 2 weeks elastic resistance training for the neck/shoulder/arm with personal versus video instruction on technical execution.


Eligibility criteria:
inclusion criteria: * neck or shoulder pain exclusion criteria: * blood pressure above 160/100 mmhg * pregnancy * life-threatening disease

Keywords: neck pain shoulder pain resistance training
mechanisms of mindfulness-based cognitive therapy in the treatment of recurrent major depressive disorder

Conditions: Major Depressive Disorder, Recurrent

Summary: the primary purpose of this study is to investigate neural mechanisms and predictors of treatment outcome in mindfulness-based cognitive therapy (mbct) for recurrent major depressive disorder.

aim and hypotheses the primary aim is to investigate treatment mechanisms of mbct and markers of relapse risk. controlled design: first, we aim to first investigate the effect of treatment on clinical outcomes in the controlled design post treatment and at 3 months follow up. second, we will run mediation analyses of hypothesized mechanisms (increased mindfulness skills, decentering, interoceptive and decreased rumination, and change in neural connectivity in a priori networks), and finally check for moderating influences of vulnerability markers (childhood trauma, no. episodes of depression and residual symptoms). prospective design: we aim to investigate predictors of relapse risk at 12 month follow treatment using i) baseline markers and ii) mechanism outcomes that change significantly due to treatment, and iii) check for moderating influences of vulnerability markers

Eligibility criteria:
inclusion criteria: 1. age above 18 years 2. meeting dsm-iv criteria for a history of recurrent major depressive disorder (mdd) with or without a current episode of depression 3. recurrent mdd evaluated a being the primary disorder. 4. danish literacy exclusion criteria: 1. a history of schizophrenia, schizoaffective disorder, bipolar disorder, current severe substance abuse, organic mental disorder, current/past psychosis, pervasive developmental delay, persistent antisocial behaviour, persistent self-injury requiring clinical management/therapy 2. formal concurrent psychotherapy 3. previous mindfulness-based cognitive therapy/mindfulness-based stress reduction 4. anti-psychotic medication and benzodiazepines 5. standard exclusion criteria for undergoing magnetic resonance imaging (mri) procedures for research purposes, i.e., claustrophobia, pregnancy, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, non-mr-compatible implants or devices.

Keywords: mindfulness-based cognitive therapy neural, psychological and molecular mechanisms
a study in adults with moderate to severe dermatomyositis

Conditions: Dermatomyositis

Summary: a study looking at investigational drug and placebo administered to adult patients with moderate to severe dermatomyositis


Eligibility criteria:
inclusion criteria for patients with skin predominant activity: * must have cdasi activity score of greater than or equal to 14, and have failed at least 1 standard of care systemic treatment, (eg, corticosteroids). * confirmation of dm by the investigator and two of the following: 1. gottron's papules; 2. gottron's sign; 3. heliotrope eruption; 4. nailfold changes, (dilated capillary loops, capillary dropout, cuticular hypertrophy and/or rugged cuticles; 5. photodistributed violaceous erythema, (skin that is exposed to sunlight and appears purplish/reddish, and patchy in appearance; 6. positive dm serology - * post dm diagnosis; standard of care workup for dm must have been completed prior to entry into this research study. * willing to provide 8 biopsies during the course of the research study inclusion criteria for patients with muscle predominant activity: * mmt-8 ≤136/150 and phga, vas ≥3 cm (0-10 cm) by visual analog scale (vas) * sum of phga, vas, ptga, and extramuscular global assessment vas scores is ≥10 cm (0-10 cm) vas for each. * participant has failed at least two or more adequate courses of an immunosuppressive agent or immunomodulatory agent, including ivig, at a dose known to be effective for rheumatologic diseases. exclusion criteria for patients with skin predominant activity: * investigator site staff or members of their family. * acute and chronic present medical conditions * intake of greater than 15 mg of prednisone or equivalent per day * pregnant or breastfeeding females. fertile men and women who will not comply with the use of 2 effective birth control methods as per the research protocol * have required management of acute or chronic infections * have pre existing demyelinating disorder such as multiple sclerosis, or other severe neurological deficits. * clinically significant lab abnormalities * any health condition that may be worsened by immunosuppression exclusion criteria for patients with muscle predominant activity: similar to patients with skin predominant activity; intake of \>20 mg oral prednisone/day, or equivalent
rituximab combined with chemotherapy in burkitt's lymphoma

Conditions: Acute Lymphoblastic Leukemia; Burkitt's Lymphoma

Summary: the purpose of this clinical trial is to prove the efficacy of the following new regimen treatment: * administration of anti-cd20 (rituximab) combined with chemotherapy. * combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block c) * prophylactic administration of g-csf after all chemotherapy cycles * local irradiation after 6 cycle if cns was affected or if there are residual tumour

clinical trial with a pharmaceutical speciality in new conditions to use.

Eligibility criteria:
inclusion criteria: * patients diagnosed with mature lla-b cell (lla-l3) * patients diagnosed with burkitt´s and burkitt´s like lymphoma * patients 15 years old or up * written informed consent signed exclusion criteria: * serious complications related with lal3/lb or secondary illness: serious complications, uncontrollable, for example, sepsis, pneumonia with hypoxia, shock, haemorrhage at diagnosis. * renal failure unconditional for the lymphoma/leukemia * heart failure or serious liver. * pulmonary obstructive disease or serious restrictive that not allow to treat the patient with intensive chemotherapy. * secondary lymphoma after chemotherapy or previous radiotherapy or second malignant tumour. * known hypersensitivity to any foreign protein. * previous treatment with cytostatics of the lla-b or burkitt´s lymphoma (exception: administration on short time of glucocorticoids ≤ 7 days, one administration of vincristine or cyclophosphamide, one cycle of chop, urgent administration of the another cytostatics). * with another malignant tumour in the last 5 year. * women in fertile age must give positive in the pregnancy test or nursing mother. * mental disability or emotional or psychiatric significant disorder were the patient can't understand nor cooperate with treatment. * patients is enrolled in another clinical research study.

Keywords: all (l3) burkitt's lymphoma rituximab