Kornimate/medical-research-clean huggingface dataset:
msc for occlusive disease of the kidney

Conditions: Atherosclerotic Renal Artery Stenosis; Ischemic Nephropathy; Renovascular Hypertension

Summary: to determine the safety and toxicity of intra-arterial infused autologous adipose derived mesenchymal stromal (stem) cells in patients with vascular occlusive disease of the kidney.

individuals with unilateral arterial occlusive disease will be treated to injured kidney with autologous cells.

Eligibility criteria:
4.1 inclusion criteria 1. are between ages 40 and 80 years old. 2. advanced vascular occlusive disease (atherosclerosis) affecting one or both kidneys: defined as a) loss of parenchymal volume and renal blood flow (measured by mdct as previously described (17) and/or duplex ultrasound velocity above 300 cm/sec to the affected kidney to be infused with msc's. 3. have serum creatinine below 2.5 mg/dl 4. have no-contraindications to angiography: severe contrast allergy 5. have no contraindications to mr evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia 6. ability to comply with protocol 7. competent and able to provide written informed consent 4.2 exclusion criteria 1. advanced ckd: stage 5 (two kidney egfr \< 15 ml/min/1.73 m2) contralateral renal artery occlusion/stenosis above 75% or esrd requiring dialysis 2. clinically significant abnormalities on laboratory examination, including bilirubin (\> 2 x normal), platelets (\ 5.5 meq/l), and sodium (\ 1.4), hemoglobin \<10.0 g/dl. 3. clinically significant medical conditions within the six months before administration of mscs: e.g. myocardial infarction, active angina, congestive heart failure) that would, in the opinion of the investigators, compromise the safety of the patient. 4. specific exclusions: 1. clinical history of deep vein thrombosis within three months of msc administration 2. uncontrolled hypertension (systolic bp \>180 mmhg despite therapy) 3. active infection 4. reduced ejection fraction (below 30%) 5. evidence of hepatitis b,c, or hiv 6. diabetes treated with insulin and/or glucose lowering agents 7. anemia (hgb\<10 g/dl) 8. regular use of potentially renotoxic drugs, e.g. non-steroidal anti-inflammatory agents (nsaid's): (\>2 x weekly) 5. history of cancer including melanoma (with the exception of localized skin cancers) 6. investigational drug exposure within thirty (30) days of baseline 7. beck's depression score above 16 8. pregnant or breast feeding. 9. history of clinically significant auto-immunity or any previous example of fat-directed autoimmunity

Keywords: renal artery stenosis renovascular hypertension ischemic nephropathy chronic kidney disease
health status of women with breast cancer

Conditions: Women With Early Breast Cancer; Breast Conserving Surgery; Radiotherapy

Summary: the quality-adjusted life-year (qaly) is the outcome measure of choice in england and wales for national institute for health and care excellence (nice). to be able to conduct a cost utility analysis, qaly data is required. this can either be collected within trial or published data can be used. in the united kingdom (uk) there is no up to date qaly data for women with early breast cancer treated with surgery followed by radiotherapy. the ostara study aims to provide up to date qaly data for women in this cohort.


Eligibility criteria:
inclusion criteria: * female * over 18 year of age * has had breast cancer, treated with both breast conserving surgery and radiotherapy. * is willing to complete an eq5d and a demographic questionnaire. exclusion criteria: * does not speak sufficiently to complete a study questionnaires. * has not already been approached to complete an ostara questionnaire.
prostatic acid phosphatase (pap) vaccine in patients with prostate cancer

Conditions: Prostate Cancer

Summary: the investigators are trying to find new methods to treat prostate cancer. the approach they investigators are taking is to try to enhance patients own immune response against the cancer. in this study the investigators will be testing the safety of a vaccine that may be able to help the body fight prostate cancer.

the purpose of this research is to determine the safety of serial intradermal vaccinations of a dna vaccine encoding human pap, with gm-csf as a vaccine adjuvant, in subjects with stage d0 prostate cancer. in addition, to determine whether pap-specific ifnу-secreting cd8+ t cells can be augmented in subjects with stage d0 prostate cancer by means of immunization with a plasmid dna vaccine encoding pap. this is a phase i design where patients will receive the vaccine ptvg-hp with rhgm-csf administered i.d. biweekly for 6 total doses. there will be three escalating dose cohorts. the dosing cohort considered to be the maximum tolerated dose level will be expanded up to a total of 16 patients.

Eligibility criteria:
inclusion criteria: * must have histologic diagnosis of adenocarcinoma of the prostate * must have completed local therapy by surgery and/or ablative radiation therapy at least 2 months prior to entry. * must have clinical stage d0 disease defined by the following: in patients treated by surgery, serum psa values must be \> 2 ng/ml by two measurements at least two weeks apart. in patients treated with ablative radiation therapy, three consecutive increases in serum psa must be documented, with at least a one month interval between values with the finalpsa \> 2ng/ml. * prior history of a second malignancy is allowed if treated with curative intent disease free for \> 5 years. * karnofsky performance score of \> 70 exclusion criteria: * no evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy, chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), or radiation therapy to \>30% of the bone marrow, within 6 months of the first vaccination. * must not be on concurrent androgen ablative (hormonal) therapy, or must have completed this therapy at least one month prior to study entry. * must not have demonstrated psa progression during any prior hormonal therapy or chemotherapy. * must not have known evidence of bone metastases or non-regional lymph node involvement (stage d2 disease) as determined by bone scan or ct scan. -must not have been treated previously with another investigational anti- tumor vaccine.

Keywords: prostate cancer stage d0 non-metastatic rising psa
association between sagittal patellar offset and anterior knee pain in total knee arthroplasty

Conditions: Primary Gonarthrosis, Bilateral; Knee Osteoarthritis; Knee Arthritis

Summary: the aim of this study to evaluate whether the position of the sagittal patellar offset is a predictive factor for anterior knee pain in subjects having undergone bilateral multiradius total knee replacement.

a prospective, observational study. a total of to 80 subjects requiring bilateral multiradius knee arthroplasty will be enrolled. anterior femoral offset, femoral diameter and patellar offset will be measured by orthopaedic surgeons. in addition, visual analogue scale score, oxford knee score, womac, sf12 and sf36 will be evaluated postoperative in patients long-term follow up to see if there is a relationship between anterior femoral offset and anterior knee pain.in the direct lateral knee joint radiograph, the distance between the two parallel axis extending from both cortices of the femur is measured as "femoral diameter".the remaining length between the anterior axis and the maximum peak at the anterior of the prosthesis is considered as an "anterior femoral offset"\[1\]. sagittal patellar offset defined by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography.

Eligibility criteria:
inclusion criteria: * patients over 50 years of age with primary severe gonarthrosis who will undergo total knee replacement exclusion criteria: * patients with severe gonarthrosis, with a history of malignancy, with severe extraarticular deformity, with posttraumatic and septic arthritis sequel

Keywords: total knee arthroplasty anterior knee pain sagittal patellar offset
initiation of hydrocortisone for the treatment of septic shock

Conditions: Septic Shock

Summary: the purpose of this study : 1）to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administration in septic shock patients.


Eligibility criteria:
inclusion criteria: 1. age 18 years old or older; 2. onset of septic shock within 6 h exclusion criteria: 1. systemic corticosteroid therapy within the last 3 months before septic shock; 2. high-dose steroid therapy; 3. immunosuppression; 4. refusal of the attending staff or patient family.

Keywords: septic shock hydrocortisone mortality
improving the sleep and circadian rhythms of mechanically ventilated patients

Conditions: Critical Illness; Sleep Deprivation; Respiratory Failure; Sleep Disorders, Circadian Rhythm

Summary: the goal of this project is to determine whether the sleep and circadian rhythms of critically ill patients undergoing mechanical ventilation can be improved through practical strategies that can be employed at the bedside.

nearly 1 million patients develop respiratory failure annually in the united states; yet, the sleep of patients undergoing mechanical ventilation has received little attention. this project is designed to characterize sleep and circadian rhythmicity in critically ill patients and to explore the efficacy of a non-pharmacological intervention to improve sleep and normalize circadian phase. the study will examine the effect of a protocol employing noise reduction and enforcement of a robust light-dark cycle on sleep quality and circadian rhythmicity. a secondary analysis will examine the relationship between delirium and sleep disruption and loss of circadian rhythmicity. circadian rhythmicity will be characterized through the measurement of urinary 6-sulfatoxymelatonin levels at frequent intervals, while sleep will be assessed using continuous polysomnography.

Eligibility criteria:
inclusion criteria: * age 18 years or older * receiving mechanical ventilation and intravenous sedation exclusion criteria: * debilitating central nervous system disease or degenerative disorder * active seizures * persistent coma * renal failure requiring dialysis * expected to be extubated within 24 hours * currently receiving neuromuscular blocker

Keywords: critical illness sleep polysomnography respiratory failure circadian rhythm sedation
treatment of cutaneous leishmaniasis with liposomal amphotericin b in the elderly

Conditions: Cutaneous Leishmaniasis, American

Summary: a randomized controlled pilot trial with the aim of identifying the dose of liposomal amphotericin b associated with the highest cure rate in cutaneous leishmaniasis (cl). we selected 28 patients of both sexes, aged 60 years or older, diagnosed with cl and confirmed by detection of l. braziliensis dna. the groups were treated with different total doses of medication: g1: 12 mg/kg; g2: 18mg/kg; g3: 24 mg/kg. clinical and laboratory evaluations were carried out during the period of 180 days (d0, d15, d30, d60, d120, d150 and d180).

the study was carried out through a randomized and double-blind pilot clinical trial, with the inclusion of patients treated at the corte de pedra health center, endemic region for cutaneous leishmaniasis. twenty-eight patients participated in the study, after accepting and signing the free and informed consent form they were randomized through the list generated electronically by the website www.randomization.com and allocated into three groups. the groups were treated with liposomal amphotericin b (ambisome®) with three different total doses: group 1 (g1) total dose of 12 mg/kg (10 patients). group 2 (g2): 18 mg/kg (9 patients). group 3 (g3): 24 mg/kg (9 patients). the drug was used twice a week in a hospital outpatient setting. clinical evaluations were performed before starting therapy (d0), and at d15, d30, d60, d120 and d180. laboratory evaluations (hemogram, bun, creatinine, k, alt, ast) were determined on d0, d15 and d30 or d60.

Eligibility criteria:
inclusion criteria: * cl clinical diagnosis (presence of an ulcer) * cl confirmed by detection of amastigotes in pathology and/or positive pcr for l. braziliensis in tissue obtained from the ulcer border * presence of one to a maximum of three ulcers * ulcer size between 1 and 5 mm * ulcer evolution of 1 to 6 months exclusion criteria: * previous cl treatment * renal or hepatic disease * hiv co-infection.

Keywords: cutaneous leishmaniasis liposomal amphotericn b l. braziliensis elderly
electromyographic and acceleromyographic monitoring in restricted arm movement surgical setting

Conditions: Residual Neuromuscular Blockade

Summary: researchers are comparing the ease of use and repeatability of the force vs electrical activity produced by a muscle after it has undergone nerve stimulation during a surgical procedure in which the patients' arm movement is restricted (placed under surgical drapes) in laparoscopic or robotic procedures.


Eligibility criteria:
inclusion criteria: * age \> or = 18 years old * patients willing to participate and provide an informed consent * patients undergoing an elective laparoscopic or robotic surgical procedure that requires use of nmba agents administered intraoperatively. exclusion criteria: * patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, dupuytren contracture, or any similar wrist injury. * patients with systemic neuromuscular diseases such as myasthenia gravis * patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease. * patients having surgery that would involve prepping the arm or leg into the sterile field

Keywords: neuromuscular blockade tetragraph amg emg
quantifying brain injury on computed tomography in hospitalized children

Conditions: Trauma, Brain; Pediatric

Summary: lay summary: to evaluate a novel early diagnostic tool for hospitalized children with traumatic brain injury. the problem: children who present with decreased level of consciousness after injury require urgent medical attention determined by the type and the severity of injury. unfortunately, history and physical findings are often unreliable in the first hours after hospitalization, the period in which urgent management decisions must be made for their treatment. the solution: a promising tool developed for measuring detectable evidence of traumatic brain injury on routine brain scans. the tool combines features invisible to the human eye but detectable by computer software with expert knowledge.this study will evaluate how well the tool can perform in a real health care setting. it is believed that it will greatly improve the efficacy and quality of care provided to children after traumatic brain injury.

to evaluate a novel early neuroimaging diagnostic tool for hospitalized children with traumatic brain injury. this tool is used to detect evidence of traumatic brain injury on routine brain scans. the tool combines features invisible to the human eye but detectable by computer software with expert knowledge.this study will evaluate how well the tool can perform in a real health care setting. it is believed that it will greatly improve the efficacy and quality of care provided to children after traumatic brain injury.

Eligibility criteria:
inclusion criteria: * hospitalized with tbi * age: less than 18 years of age who undergoes routine head ct in the acute period with any severity of injury based on glasgow coma scale score (3 to15). exclusion criteria: * non hospitalized * non traumatic brain injury

Keywords: pediatric traumatic brain injury
effects of exercise and relaxation techniques on tension headache pain parameters of university students

Conditions: Tension-Type Headache

Summary: tension headache is a common disabling disease and a worldwide public health problem. this research tries to demonstrate the efficacy of physical therapy, based on cervical training and postural self-correction instructions, which aims to increase the positive results obtained from traditional relaxation techniques (schultz autogenic training). university students are selected, because headaches are very common in this sector of the population. the design is a non-pharmacological randomized controlled trial, with blinded evaluation of the response variables. the investigators compare two independent samples. one of them receives an only treatment (autogenic training) and the other group receives a combined program (autogenic training + specific cervical exercises and postural correction). pain parameters (frequency, intensity and duration) and drug consumption are measured before treatment, and then, at 4 weeks and 3 months, to value the results.


Eligibility criteria:
inclusion criteria: * college students of complutense university of madrid, diagnosed with frequent episodic or chronic tension-type headache (according to the criteria of international headache society (ihs)). exclusion criteria: * cases with other headaches * students with excessive state anxiety and / or trait anxiety (≥ 85 percentile, state-trait anxiety inventory ) * students that had received treatment for tension headache, based on physical exercise or relaxation techniques, in the last 6 months.

Keywords: tension-type headache relaxation techniques physiotherapy
a study on the long term survivals in an expand access program (eap) of iressa

Conditions: Non-small Cell Lung Cancer

Summary: the primary objective is to describe the quality of life of long-term survivors who are not terminated from the eap.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures. * participated in the iressa eap in china. * diagnosed as nsclc. * patients who started eap at least 3 years before this study initiated and have not yet terminated from the eap (active long-term survivors). * patients who consent to provide blood sample and available archival tumour tissue sample for egfr gene testing (provision of tumour tissue sample is optional). exclusion criteria: * patients who disagree to participate this study. * patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.

Keywords: eap long term survival (3 years) gefitinib efficacy
intravenous tramadol versus intravenous paracetamol in patients with dysmenorrhea

Conditions: Dysmenorrhea

Summary: patients presented with primary dysmenorrhea composed the study population. one gram paracetamol and 100 mg tramadol in 100 ml saline with a slow infusion were compared in ceasing dysmenorrhea in the emergency department

patients over 18 years old who presented with dysmenorrhea composed the study population. patients received painkiller within the last six hours, physical findings consistent with peritoneal irritation, allergy to the study drugs, renal or liver failure, drug addiction, pregnancy or woman with lactation and denied to give inform consent were the exclusion criteria. the pain of the study patients is measured with the visual analogue scale at baseline, 15th and 30th minutes and 1 hour after study drug administration. at the end of the 60 minutes, rescue drug need is also recorded.

Eligibility criteria:
inclusion criteria: * patients with moderate to severe primary dysmenorrhea and visual analog scale (vas) pain scores ≥40 * patients over 18 years old exclusion criteria: * denied to give inform consent, irregular menstrual cycles, known or suspected secondary dysmenorrhea * renal or liver failure * allergy to the study drugs * receiving pain killer within the last 6 hours. * physical examination findings consistent with peritoneal irritation * pregnancy or patients with lactation * drug or alcohol abuse
assessing reproductive outcomes in young female cancer survivors through a national fertility preservation registry

Conditions: Cancer; Infertilty

Summary: the first project is a national fertility preservation registry for young women facing cancer treatments. the investigators will examine how different cancers and treatments affect the reproductive health of young survivors. this prospective cohort study seeks to recruit young women close to time of cancer diagnosis and treatment. participants will answer a yearly questionnaire on their current health. a subset of participants will provide dried blood spots to measure reproductive hormones. the primary goal of the study is to determine the risk of infertility and time to pregnancy in young female cancer survivors.


Eligibility criteria:
inclusion criteria: * diagnosed with cancer or exposure to cancer treatment * english speaking * ability to consent to the study

Keywords: cancer fertility preservation infertility pregnancy
study to evaluate the immunogenicity and safety of a second vaccination with the adjuvanted influenza vaccine candidate

Conditions: Influenza

Summary: the purpose of this study is to evaluate the immunogenicity and the safety of a second vaccination with candidate vaccine compared to fluarix™ administered intramuscularly in elderly aged 60 years and above

the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

Eligibility criteria:
inclusion criteria: * a male or female age 60 years or older at the time of the revaccination, who previously participated in 107192 \& 107214 clinical trials. * subjects who the investigator believes can and will comply with the requirements of the protocol * written informed consent obtained from the subject. * free of an acute aggravation of the health status as established by clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. * acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination. * history of hypersensitivity to a previous dose of influenza vaccine. * history of confirmed influenza infection within the last 12 months. * history of allergy or reactions likely to be exacerbated by any component of the vaccine(s) * acute disease at the time of enrolment.

Keywords: influenza vaccine influenza