Kornimate/medical-research-clean huggingface dataset:
treatment of cervical spinal cord injury with imatinib - a safety and feasibility study

Conditions: Cervical Spinal Cord Injury

Summary: this is a phase ii, single center, open-label, non randomized clinical study to assess the uptake, safety and tolerability of imatinib in acute cervical spinal cord injury patients. the aim is to determine if imatinib reaches sufficient blood levels when given to patients with cervical spinal cord injury, via a gastric feeding tube, and also evaluate the safety and tolerability of this drug treatment.


Eligibility criteria:
inclusion criteria: 1. men and women aged 18-80 years 2. clinical signs of cervical spinal cord injury due to trauma. 3. in otherwise good health condition as determined by past medical history, physical examination, laboratory tests and vital signs 4. patient that is conscious and oriented x 4 (regarding date/time, localisation, situation and personal details), with higher level of consciousness, i.e. glasgow coma scale \> 14, and is assessed to be competent to give informed consent. exclusion criteria: 1. diabetes (type i and ii) 2. ongoing cancer treatment 3. known allergy to study drug imatinib or its excipients 4. on current therapy with drugs which may interfere with imatinib, (e.g. paracetamol, ketoconazole, itraconazole, erythromycin, clarithromycin, dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidon, hypericum perforatum). 5. female subjects lactating or with positive pregnancy test 6. known liver or kidney disease 7. any relevant surgical or medical condition which in the opinion of the investigator may interfere with the conduct of the study or the scientific results. this includes hemorrhagic conditions.
the accuracy and acceptability of magnet assisted capsule endoscopy in the diagnosis of esophageal pathology: a pilot study

Conditions: Barrett's Oesophagus; Oesophageal Varices

Summary: a pilot study to assess the accuracy and acceptability of a magnet assisted capsule endoscopy in detecting esophageal pathology compared to standard endoscopy.

this will be a single centre feasibility study performed at nottingham university hospitals nhs trusts. we will assess the accuracy of mace compared to gastroscopy in diagnosing barretts oesophagus and esophageal varices. patients will have both tests on the same ay, with the endoscopic findings compared.

Eligibility criteria:
inclusion criteria: due to have a clinically indicated gastroscopy barrett's oesophagus/ oesophageal varices or controls able to give informed consent exclusion criteria: unable to give consent pregnant pacemaker swallowing difficulties
effectiveness of theta-burst stimulation (tbs) in patients with major depression

Conditions: Depression

Summary: repetitive transcranial magnetic stimulation (rtms) as well as theta- burst stimulation of the frontal cortex are used to modulate the neuronal excitability in patients with depression. in the proposed study we investigate whether high frequent rtms or theta-burst stimulation of the dlpfc is more effective in patients with a depressive episode.

depression is a common mental disorder that presents with depressed mood, loss of interest, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy, and poor concentration. these problems can become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities, at its worst, depression can lead to suicide.depression can be reliably diagnosed in primary care. antidepressant medications and brief, structured forms of psychotherapy are effective for 60-80 % of those affected and can be delivered in primary care. in patients with depression the cerebral metabolism is deranged in some specific areas such as hypoexcitability in frontal cortical areas. high-frequency rtms of the dorsolateral prefrontal cortex (dlpfc) has been investigated for the treatment of hypoexcitability disorders. pilot data indicate that the mild effects of the rtms could be increased by a special kind of tms, the theta-burst stimulation. in the proposed study we investigate whether high frequent rtms or theta-burst stimulation of the dlpfc is more effective in patients with a depressive episode.

Eligibility criteria:
inclusion criteria: * episode of depression (unipolar or bipolar)( icd-10) * female or male between 18 and 70 years * skills to participate in all study procedures * 18 or more points in the hamiliton rating scale or depression * stable antidepressant drugs * written informed consent exclusion criteria: * clinically relevant unstable internal or neurological comorbidity * evidence of significant brain malformations or neoplasm, head injury * cerebral vascular events * neurodegenerative disorders affecting the brain or prior brain surgery * metal objects in and around body that can not be removed * pregnancy * alcohol or drug abuse * epilepsy or a pathological eeg * heart pacemaker * high dose tranquillizers

Keywords: depression transcranial magnetic stimulation thetaburst stimulation alternative treatment methods
sirolimus as secondary therapy in chronic graft-versus-host disease not responding to prior treatment

Conditions: Graft Versus Host Disease

Summary: this phase ii trial studies the side effects and how well sirolimus works as secondary therapy in treating patients with chronic graft-versus-host disease (gvhd) that did not respond to prior treatment. sirolimus may be an effective treatment for chronic gvhd

primary objectives: i. to assess the safety of sirolimus administered at a dose which provides steady-state, whole blood trough levels of 5-10 ng/ml in patients with chronic gvhd. ii. to determine whether administration of sirolimus provides benefit for patients with chronic gvhd that has not responded adequately to previous systemic treatment. outline: patients receive sirolimus orally (po) once daily (qd). patients continue to receive prednisone and cyclosporine or tacrolimus at the discretion of the managing physician. after completion of study treatment, patients are followed up periodically.

Eligibility criteria:
inclusion criteria: * biopsy-confirmed diagnosis of clinical extensive chronic gvhd with inadequate response to previous treatment and where secondary systemic therapy is indicated because of * clinical progression of signs and symptoms of chronic gvhd in a previously involved organ, or * development of signs and symptoms of chronic gvhd in a previously uninvolved organ, or * absence of improvement after 3 months of primary treatment, or * continued need for treatment with prednisone at doses \>= 1.0 mg/kg/day for more than 2 months, without qualification for type of donor, graft or conditioning regimen * patient or guardian able and willing to provide informed consent * stated willingness to use contraception in women of child-bearing potential (food and drug administration \[fda\] requirement) * stated willingness of the patient to comply with study procedures and reporting requirements * stated willingness of the physician most involved in management of chronic gvhd (the "managing physician,") to comply with study procedures and reporting requirements exclusion criteria: * fungal or viral infection with no radiographic evidence of improvement during continued appropriate antimicrobial therapy * cytomegalovirus (cmv) antigenemia unresponsive to antiviral therapy * active disseminated varicella zoster virus (vzv) infection with persistent non-crusted lesions * inability to tolerate oral medications * absolute neutrophil count (anc) \< 1500/ul * platelet count \< 50,000/ul * persistent or recurrent malignancy, including histopathologic evidence of myeloma or lymphoma; patients with breakpoint cluster region-abelson (bcr/abl) detected by polymerase chain reaction (pcr) assay as the only evidence of persistent chronic myeloid leukemia may be enrolled * pregnancy * known history of hypersensitivity to sirolimus
assessing the efficacy and safety of selective metabolically adaptive radiation dose escalation in locally advanced non-small cell lung cancer receiving definitive chemoradiotherapy

Conditions: Non-Small Cell Lung Cancer

Summary: a randomized phase ii trial to assess the efficacy and safety of selective metabolically adaptive radiation dose escalation in locally advanced non-small cell lung cancer receiving definitive chemoradiotherapy. eligible and consenting patients will be randomized to receive conventional chemoradiotherapy or chemoradiotherapy with a radiation (rt) integrated boost. all patients will receive a fludeoxyglucose-positron emission tomography (fdg-pet) scan within two weeks prior to starting treatment. the primary outcome is to determine if dose escalation to metabolically active tumor subvolumes will reduce local-regional failure rate at 2 years.


Eligibility criteria:
inclusion criteria: * patients who are at least 18 years old and are able to consent * patients who will undergo chemo-rt as primarily modality of treatment * patients with a primary tumor or node measuring at least 10mm on ct scan * patients with a pet avid tumor having standardized uptake values (suv) \> 4 * patients with eastern cooperative oncology group (ecog) status 0-2 within 4 weeks of randomization exclusion criteria: * trimodality patients who have surgery as part of curative treatment * previous radiotherapy to intended treatment volumes * active invasive malignancy other than lung cancer * active pregnancy * poor respiratory function (forced expiratory volume \< 1.0 or diffusing capacity \< 50% age-adjusted normal) * ecog status \> 2 * pre-treatment complete blood count/differential showing inadequate bone marrow reserve (absolute neutrophil count \< 1800 cells/mm3 or platelets \< 100 000 cells/mm3 or hemoglobin \< 90g/l), measured within 4 weeks of registration * ast, alt or total bilirubin \> 2.5 times the upper limit of normal, measured within 4 weeks of registration * unintentional weight loss \>10% over 3 months within 4 weeks of registration * severe active co-morbidity defined by: * significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, myocardial infarction within the last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction * transmural myocardial infection requiring intravenous antibiotics at the time of registration * chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization * acquired immune deficiency syndrome (aids) based on the current centre for disease control definition; note, however, that hiv testing is not required for entry into this protocol
effect of delayed remote ischemic preconditioning on myocardial injury

Conditions: Myocardial Injury

Summary: the purpose of this study is to evaluate delayed myocardial protective effect of ripc in patients undergoing cardiac valve replacement surgery.

ischemic preconditioning is one of the strategies that can reduce perioperative myocardial injury. it is a concept that briefly induced ischemia and reperfusion before the myocardial injury can reduce the myocardial injury. but it is difficult to apply ischemic preconditioning in operative field, because cross-clamping of aorta or coronary artery is difficult and invasive. afterward concept of remote ischemic preconditioning(ripc) has introduced that ischemia of remote organs like kidneys, skeletal muscles can reduce distant myocardial injury. it is known that myocardial protective effect of ischemic preconditioning have biphasic pattern. early protective effect wanes after a few hours, then recurs after 24-48 hours, and can persist for up to 3-4 days. it is called second window of preconditioning or delayed ischemic preconditioning. delayed ischemic preconditioning is similar to early ischemic preconditioning in mechanism but it is different that it produces protein that can mediate myocardial protection effect. unlike ischemic preconditioning, it is little known about delayed effect of ripc. ripc can be done by applying compression cuff on upper or lower extremities and it is noninvasive and easy to deliver compared to ischemic preconditioning that is done by aorta or coronary artery clamping. delayed ischemic preconditioning is performed one day before the surgery, and it is safe and easy to apply ripc in a clinical setting. and in this study investigators are going to evaluate cardioprotective effect of delayed ripc. myocardial injury can be predicted by elevation of cardiac enzyme. investigators are going to perform ripc one day before the valve replacement surgery and compare troponin i with control group to assess cardioprotective effect of delayed ripc.

Eligibility criteria:
inclusion criteria: * 18 - 80 years of adult patient undergoing cardiac valve surgery exclusion criteria: * patient who did not agree to the study * emergency operation * using inotropics, mechanical assisting device * severe liver disease (\>child class ii ) * severe renal disease (renal replacement therapy) * left ventricular ejection fraction \< 30% * co-operation of major surgery (carotid endarterectomy ) * oral hypoglycemic agent (sulfonylurea, glibenclamide) * peripheral vascular disease affecting upper extremity

Keywords: delayed remote ischemic preconditioning troponin valve replacement surgery
improvement of erectile dysfunction by fluvastatin in patients with cardiovascular risk factors

Conditions: Impotence

Summary: the purpose of the study is to determine the effect of fluvastatin on penile arterial blood flow and erectile function in patients with arteriogenic ed and cardiovascular risk factors.

physiology of erection is mainly dependent on endothelial no-production with consecutive activation of guanylate-cyclase. pleiotropic effects of statins are well known regarding the increase of endothelial function. thus, activation of endothelial no-synthase could raise the activation of guanylate-cyclase with a consecutive relaxation of smooth muscle cells in the penile arteries and the corpus cavernosum leading to an improvement of erectile function. therefore, statins are supposed to be effective in the treatment of erectile dysfunction, especially in patients with cardiovascular risk-factors with underlying endothelial dysfunction. the effect of fluvastatin on penile blood-flow and erectile function in patients with arteriogenic erectile dysfunction and cardiovascular risk factors will be determined in a cross-over design. patients were either treated with fluvastatin-sodium 80mg or placebo for 8 weeks. after a wash-out of 4 weeks, treatment will be switched (placebo / fluvastatin-sodium). penile blood flow measurement and assessment of erectile function with the iief-5-score and the keed-score will be performed at baseline, after 8 weeks of treatment, after 4 weeks wash-out and after cross-over treatment (8 weeks).

Eligibility criteria:
inclusion criteria: * male * age \> 18 years * arteriogenic erectile dysfunction (penile blood flow - peak systolic velocity\<30cm/s, diastolic velocity\<5cm/s) * two or more cardiovascular risk factors (smoking, hypertension, hyperlipoproteinaemia, family history of atherosclerosis, oral treated diabetes mellitus with a hba1c\<7%) * stable course of disease without expected changes in medical treatment during the next 3 months * written informed consent * no statin-treatment so far exclusion criteria: * known hypersensitivity or anaphylaxis against a statin * active liver disease or unclear increase of transaminases, cholestasis or myopathy * acute cardiovascular event (myocardial infarction, stroke, ptca, vascular surgery) within 3 months before randomization * clinical signs of heart failure or reduced left ventricular function * current treatment with lipid lowering drugs * insulin dependent diabetes mellitus or orally treated diabetes mellitus with a hba1c-value \>6.9% * erectile dysfunction due to hormone disorders * known malignant tumor * known disposition to priapism * patients with morphological changes of the penis (i.e. deviation) or penis-prosthesis * current treatment with anticoagulants * current treatment with immunosuppressive drugs, phenytoin, erythromycin, gemfibrozil or nicotinic acid derivates * absence or inability of written informed consent

Keywords: impotence erectile dysfunction cardiovascular risk factor statin
safety study of 20,000 eu of clinical center reference endotoxin in allergic adults with and without mild asthma

Conditions: Mild Allergic Rhinitis; Mild Allergic Rhinitis With Mild Asthma

Summary: endotoxin is a component of outdoor air pollution, an air contaminant found in a number of different workplaces, and is even found in homes. the endotoxin used for this study is obtained from the national institutes of health, and is called "clinical center reference endotoxin", or ccre. the purpose of this phase 1 research study is to identify a dose of inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other problems), but causes changes in your sputum cell samples that the scientists can measure. phase 1 research studies like this one are not intended to be a treatment, but are a scientific investigation. eventually, with these types of studies we will be able to examine why some people are more sensitive to endotoxin. scientists at other universities have found that while most people do not have a considerable lung response to endotoxin at doses as high as 60,000 eu (endotoxin units), a few respond to as little as a total dose of 4500 eu. our study is designed to identify if using a dose of 20,000 eu causes changes in the lung cells but does not cause symptoms in our study subjects. in our previous studies in our lab, using an endotoxin from another source, we have used higher doses (15,000 eus) in subjects with asthma with no major problems, and we have used 10,000 eus of ccre in subjects with allergies and asthma without problems. we have used 20,000 eus of ccre in healthy individuals with no major problems.


Eligibility criteria:
inclusion criteria: * mild allergic rhinitis * mild allergic asthma * normal lung function * no other chronic illness exclusion criteria: * use of inhaled or oral steroids * emergency treatment of asthma in last year * inhaled tobacco use

Keywords: mild asthma, mild allergies
prevention of de novo allosensitization in islet transplant recipients following complete graft loss

Conditions: Type 1 Diabetes Mellitus

Summary: this is a single-center, prospective, open label study in islet transplant recipients after complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/ml.

after complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus and tacrolimus) will be discontinued and they will be placed on myfortic® monotherapy for 2 years thereafter. after completion of two years of myfortic® maintenance monotherapy, it will be weaned and subjects will be monitored over the subsequent twelve months, for the appearance of sensitization using panel reactive antibody (pra) levels.

Eligibility criteria:
inclusion criteria: 1. male and female patients age 18-70 years of age. 2. ability to provide written informed consent. 3. mentally stable and able to comply with the procedures of the study protocol. 4. any subject currently prescribed immunosuppressive medications or discontinuation of immunosuppressive medications indicated as per current protocol of islet transplantation. 5. history of at least one islet transplant. 6. stimulated c-peptide \<0.3 ng/ml. exclusion criteria: 1. known history of untreated severe hyperlipidemia, obesity, or refractory hypertension 2. for female participants: positive pregnancy test or presently breast-feeding. 3. history of active infection including hepatitis b, hepatitis c, hiv, or tb. 4. any history of malignancy except for completely resected squamous or basal skin cell carcinoma. 5. known active alcohol or substance abuse. 6. severe co-existing history of cardiac disease, characterized by a history of any one of these conditions: recent myocardial infarction (within past 6 months), evidence of ischemia on functional cardiac exam within the last year, or left ventricular ejection fraction \<30%. 7. history of persistent elevation of liver function tests. sgot (ast), sgpt (alt), alkaline phosphatase or total bilirubin, with values \>1.5 times normal upper limits will exclude a patient. 8. evidence of inter-current infection. 9. active peptic ulcer disease 10. history on non-adherence to prescribed regimens including immunosuppression. 11. pra ≥ 50% or evidence of significant sensitization to be determined at discretion of the investigator.
the role of transanal tube drainage as a mean of prevention of anastomotic leakage anastomotic leakage

Conditions: Rectal Cancer; Rectal Neoplasms; Anastomotic Leak

Summary: anastomotic leakage (al) is considered the commonest major complication after surgery for rectal cancer. transanal tube drainage role in the prevention of al is still debatable.

patients who underwent low or ultralow anterior resection for rectal cancer were enrolled between 01/2015 and 06/2017. a de-pezzer catheter was placed transanally after the creation of the anastomosis, secured to the buttocks, and connected to a urine bag to allow monitoring the amount and the color of the drainage. the catheter was removed on the 3rd day postoperative if the volume collected was insignificant. patients were followed-up on the ward and then in the outpatient's department at two weeks, and one month postoperative. patients who were suspected to have al underwent ct with rectal contrast to assess the integrity of the anastomosis. the primary outcome was the incidence of al. we adopted the definition published by the international study group of rectal cancer.

Eligibility criteria:
inclusion criteria: * low or ultralow anterior resection with primary anastomosis for biopsy-proven primary rectal cancer exclusion criteria: * no anastomosis
evaluation of double tract reconstruction after total gastrectomy in patients with gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the double tract reconstruction after total gastrectomy in patients with gastric cancer. a prospective randomized controlled trial was conducted to compare double tract method with roux-en-y method

patients with gastric cancer were intraoperatively randomized for r-y reconstruction or dt reconstruction after total gastrectomy.

Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma without esophageal invasion, tumor status t1-2 * age 80 years or younger * no distant metastasis exclusion criteria: * carcinoma in the remnant stomach * stage intravenous (iv) * history of laparotomy * history of serious heart disease * liver cirrhosis or chronic liver disease with indocyanine green excretion test at 15 min of 15% or more * absence of informed consent

Keywords: total gastrectomy double tract reconstruction gastric cancer total gastrectomy in patients with gastric cancer
tolerability and safety of an infant formula

Conditions: Milk Hypersensitivity

Summary: the purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.


Eligibility criteria:
inclusion criteria: * clinically diagnosed cma * \</= 12 weeks at time of study entry * full-term infant * must be willing to use provided formula as sole source of nutrition * other than cma, infant must be otherwise healthy exclusion criteria: * underlying or confounding gastrointestinal abnormalities * infants born from an addictive situation, hiv positive * if parent/guardian is considered likely to be non-compliant with the protocol requirements

Keywords: infant formula cow's milk allergy