Kornimate/medical-research-clean huggingface dataset:
investigation of the use of hyperspectral imaging in foot surgery patients

Conditions: Foot Ulcers; Osteomyelitis; Amputation

Summary: to investigate novel advanced imaging techniques (hyperspectral imaging) that could enable clinicians to determine the degree and effectiveness of blood flow to tissues during surgery. there are a number of disorders where blood flow is inadequate to provide nutrients and oxygen to tissues. under some circumstances, surgery is required to either improve the blood flow or remove tissues that are poorly perfused. in other cases, occlusion of the blood supply to an organ is temporarily or permanently performed to minimize blood loss during a surgical procedure. additionally, there are disorders where the location of certain blood containing structures is important but not immediately obvious to surgeons during an operation. knowledge of where those structures are is very important and could greatly improve the safety of various surgical procedures. patients of the investigator who are scheduled for foot surgery will be provided the opportunity to participate in this research. after giving informed consent, hyperspectral images will be obtained at various points during the surgical procedure. as this technology is non-invasive, it is not expected to interfere with or change the procedure they are undergoing. once the surgical procedure is complete, imaging will be saved to a disk for later evaluation. 100 subjects will participate in this study.

the hyperspectral imager will be turned on at various time points during surgery, to measure the spectral wavelengths of tissues. the surgery being performed will in no way be altered by the imaging device and post surgical follow-up of patients will be standard of care appropriate to the surgical procedure. patients will have hsi performed only during their surgery. they will not receive additional medications and will have no additional follow up. participating in this study will not add extra appointments, procedures, or time requirements for the patient. the patient's medical record may be referenced for information after the surgery for up to one year. there are no costs to the patient for participation in this study.

Eligibility criteria:
inclusion criteria: * male and female patients * 18 years or older undergoing foot surgery * speak and read english or spanish. * able to provide written informed consent. exclusion criteria: * patients unable to give written informed consent * patients who cannot speak and read english or spanish will be excluded.

Keywords: foot ulcers foot surgery hyperspectral imaging
epidemiologic multicenter prospective study in advanced nsclc (non small cell lung cancer) patients with pdl1 (protein death ligand 1) expression.

Conditions: Lung Cancer

Summary: epidemiologic multicenter prospective study in advanced nsclc patients with pdl1 expression : evaluation of clinical and pathological characteristics of pdl1 high expression patients compared to patients with a weak or no expression of pdl1.

few data are published on the clinical and pathological characteristics of advanced nsclc with high pdl1 expression compare to weak and no expression populations. there is not for the moment a standard test to determine a relevant target population. preliminary data showed that around 25% of the nsclc population may have a high pdl1 expression and may have a greater benefit of anti pdl1 therapy. but in fact limited data have been published in european populations on the clinical and pathological characteristics (high pdl1 expression) compared to the weak expression and no expression populations. more over the prognosis rule of a high pdl1 expression in nsclc is not definitive, with some studies indicating it is a positive prognostic factor while other studies showing that it is a negative prognostic factor. to understand if there are differences in terms of prognostic between advanced nsclc with high and low/no expression of pdl1 is a major challenge for the future management strategy of these patients. the results of this study should helps to elaborate new guidelines for this population. therefore is also important to had data's on the natural course of the disease in these population for building cost effectiveness models of new immune therapies.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or more * with locally advanced stage (iiib) to stage iv nsclc - non small cell lung cancer - * histological diagnostic : * no known epidermal growth factor receptor (egfr) or anaplastic lymphoma kinase (alk) / reactive oxygen species (ros) translocation * at least 2 slides of tumoral sample available * no previous chemotherapy treatment. neo or adjuvant therapy is allowed if done at least one year before inclusion * performance status ( ps) 0/1 planned to receive a platin based standard treatment (cisplatin or carboplatin with bevacizumab (restricted to no squamous) pemetrexed(restricted to no squamous) , gemcitabine, vinorelbine, docetaxel or taxol, on first line setting, in standard dose • a recist - response evaluation criteria in solid tumor - target lesion exclusion criteria: * age fewer than 18 * pregnancy * known immune deficit * ps \> 1 * inclusion in a clinical therapeutic trial in first line * patient treated with protein d1/protein death ligang1 (pd1/pdl1) therapy on first line setting.

Keywords: pdl1 expression : protein death ligand 1 expression .
the impact of hormonal contraceptive use and lifestyle factors on fracture risk and bone quality in young female adults

Conditions: Osteoporosis; Osteopenia; Fracture Reduction; Body Composition; Nutrition; Hemoglobin; Muscle Strength; Bone Density; Contraception Behavior; Physical Activity; Menstrual Irregularities

Summary: the study on hand is based on a cross-sectional design and aims to acquire 1) descriptive data on the physical state and health condition of female soldiers in the german armed forces. 2) a possible influence of different contraceptive methods as well as physical activity, body composition, strength, nutrition, and hemoglobin levels on bone health should be investigated.


Eligibility criteria:
inclusion criteria: * 18 - 35 years * female * willing to participate under a pseudonym * occupational soldiers * free from chronic or acute musculoskeletal injury exclusion criteria: * for the bioelectrical impedance: electronic implants like defibrillator, pregnancy

Keywords: impact of lifestyle factors on bone quality impact of hormonal contraceptive use on bone quality impact of body composition on bone quality impact of nutrition and energy balance on bone quality impact of amenorrhea on bone quality impact of physical activity on bone quality impact of the occupation soldier on bone quality impact of muscle strength on bone quality
melatonin supplementation in postmenopausal women with h. pylori-associated dyspepsia

Conditions: Melatonin Deficiency

Summary: background: the aim of the study was to assess the role of melatonin in chronic dyspepsia in this group of women, with consideration of helicobacter infection. methods: the study comprised 152 subjects including 30 healthy women (group i), 60 women with asymptomatic h.pylori infection (group ii), and 64 women h. pylori infected with chronic dyspepsia(group iii). endoscopic examination, histological assessment of gastric end duodenal mucosa, urease breath test(ubt-13c), and serum levels of 17-β-estradiol, follicle stimulating hormone, melatonin and urinary concentration of 6-sulfatoxymelatonin were determined by immunoenzymatic method. in group iii - 14-day antibacterial treatment was introduced with pantoprazole, amoxicillin and levofloxacin. afterward, in 32 women was administered placebo(group iiia), and in 32 women (group iiib) melatonin at a dose 1 m/morning and 3 mg/at bedtime, for six months.

background:dyspeptic syndrome in the form of epigastric pain are particularly frequent in postmenopausal women. the aim of the study was to assess the role of melatonin in chronic dyspepsia in this group of women, with consideration of helicobacter infection. methods: the study comprised 152 subjects including 30 healthy women (group i), 60 women with asymptomatic h.pylori infection (group ii), and 64 women h. pylori infected with chronic dyspepsia(group iii). endoscopic examination, histological assessment of gastric end duodenal mucosa, urease breath test(ubt-13c), and serum levels of 17-β-estradiol, follicle stimulating hormone, melatonin and urinary concentration of 6-sulfatoxymelatonin were determined by immunoenzymatic method. in group iii - 14-day antibacterial treatment was introduced with pantoprazole, amoxicillin and levofloxacin. afterward, in 32 women was administered placebo(group iiia), and in 32 women (group iiib) melatonin at a dose 1 m/morning and 3 mg/at bedtime, for six months.

Eligibility criteria:
inclusion criteria: patients with * epigastric pain of a hunger nature * pain at night in the epigastric region * increased appetite exclusion criteria: patients with * functional or inflammatory diseases of the gastrointestinal tract liver and pancreas * metabolic, allergic and mental disease * hormone replacement therapy
prevalence of neglected side effects to radical prostatectomy

Conditions: Prostate Cancer

Summary: the purpose of this exploratory data collection is to strengthen our knowledge of some of the rarer distresses following surgical removal of the prostate. in general these are: * side effects related to sexuality, including: * altered perception of orgasm, * orgasm associated pain, * penile shortening and deformity. * side effects related to urinary incontinence. * urinary tract infection after operation. * influence of distress on sexual quality of life. * influence of distress on the patient´s sex drive. in addition information on a range of demographics and information on the patient´s erectile function will be collected.

approximately 1 out of 6 men will, at some point of their life become diagnosed with prostate cancer. treatment options included medication therapy, radiation therapy, and surgery. this data collection aims to gather information on some of the lesser known distresses experienced by patients following surgical removal of the prostate gland. erectile dysfunction and urinary incontinence remain common, but thoroughly investigated side effects. thus they will not be of primary interest here, but considered factors for correlation. during the last couple of years, a series of lesser known side effects have come to investigators attention. these include altered perception of orgasm, orgasm related pain, sexual-related urinary incontinence, and shortening -and impairing deviations of the penis. few studies have investigated these side effects, and clear knowledge of why, and how often these problems arise, remain scarce. this study will contribute to that knowledge. in addition, the questionnaire will include a series of exploratory questions, concerning lower urinary tract infections, treatment satisfaction, alcohol and urinary incontinence, reasons for abandoning treatment for erectile dysfunction, and an assessment of libido prior to and after radical prostatectomy. the data collection will include approximately 400 patients from the department of urology at the university hospital in herlev, copenhagen, denmark. a questionnaire will be sent to patients together with a stamped addressed envelope in order to optimize the response rate. results will be kept in a separate database from personal information.

Eligibility criteria:
inclusion criteria: * all patient who have undergone radical prostatectomy at the department of urology, copenhagen university hospital, herlev, between 3 months and 3 years before initiation of the study. exclusion criteria: * incontinence associated with sexual activity prior to surgery * peyronies disease prior to surgery * orgasm related pain prior to surgery * anorgasmia prior to surgery

Keywords: prostatectomy prostate cancer orgasm urinary incontinence climacturia(orgasm related urinary incontinence) penis dysorgasmia (pain in relation to orgasm) pain anorgasmia penile shortening erectile dysfunction
sirolimus as treatment of steroid-refractory or steroid-dependent chronic graft-versus-host disease

Conditions: Graft vs Host Disease

Summary: to study the effectiveness of an immunosuppressive drug sirolimus, in the treatment of chronic graft versus host disease in combination with prednisone.

the purpose of this trial is to study the effectiveness of an immunosuppressive drug, sirolimus, in the treatment of chronic graft versus host disease in combination with prednisone. graft versus host disease (gvhd) is a common complication in patients who have received blood or marrow transplantation from a related or unrelated donor. chronic gvhd occurs approximately 100 days after transplantation and is the result of the donor immune system recognizing the patient's tissues as foreign and creating harmful effects on the patient's organs. we hope the use of sirolimus will decrease the significant disabling effects and deaths caused by chronic gvhd.

Eligibility criteria:
inclusion criteria: * age ≥ 13 years * weight ≥ 40 kg. * biopsy or clinical presentation diagnostic of chronic gvhd \>100 days following allogeneic bone marrow/peripheral blood/umbilical cord blood transplantation that has failed prior corticosteroid therapy or corticosteroid taper. in the event that histological confirmation poses undue risk, clinical evaluation is sufficient. * women of child-bearing potential must have a negative pregnancy test before sirolimus administration and agree to use a medically acceptable contraceptive throughout the treatment period until 3 months after discontinuation of sirolimus. * any woman becoming pregnant during the treatment period must discontinue the use of sirolimus. * absolute neutrophil count (anc) \> 1000/mm³, unless receiving g-csf to maintain neutrophil count \> 500/mm³. * at the time of initiating sirolimus the cyclosporine trough level is recommended to be \< 100 mg/dl and fk506 level is recommended to be \< 5 mg/dl. fk506 or cyclosporine is to be discontinued soon after initiation of sirolimus. * karnofsky performance score ≥ 50 during pre-study screening. * written, signed, and dated informed consent exclusion criteria: * uncontrolled systemic infection * unstable disease states (i.e., hepatic failure, ventilatory-dependent respiratory failure, etc.) * serum creatinine ≥ 3.0 mg/dl * platelet count ≤ 50,000/mm³ * history of post-transplant microangiopathic hemolytic anemia * uncontrolled hyperlipidemia * use of any investigational drug within 4 weeks of entry into the study * use of methotrexate or antibody therapies within 24 hours of sirolimus administration * inability to tolerate oral therapy for any reason * evidence of infiltrate, cavitation, or consolidation on chest x-ray during pre-study screening * known hypersensitivity to macrolide antibiotics

Keywords: gvhd
digital colposcopy in finding cervical intraepithelial neoplasia in patients with an abnormal pap smear

Conditions: Cervical Cancer; Precancerous Condition

Summary: rationale: diagnostic procedures, such as digital colposcopy, may help doctors find and diagnose cervical intraepithelial neoplasia. purpose: this clinical trial is studying digital colposcopy to see how well it works in finding cervical intraepithelial neoplasia in patients with an abnormal pap smear.

objectives: * to identify potential improvements for a noninvasive method of diagnosing cervical dysplasia and neoplasia using the multispectral digital colposcope (mdc), a device that uses fluorescence and reflectance spectroscopy to compare images with histopathologic mapping of the cervical epithelium. * to measure mdc images in vivo of the cervix using a modified device that makes measurements in seconds rather than over 2 minutes before and after acetic acid. * to evaluate, preliminarily, the effect of the fading of acetic acid in the image contrast obtained over time to see if this fading can predict the grade of intraepithelial neoplasia. * to evaluate mapping of the cervix so that software can reconstruct the cervical epithelial map to compare the map with routine colposcopic images as well as with those from the mdc. * to compare, preliminarily, mdc performance with colposcopy and pathologic analysis of tissue removed after colposcopy in the form of the loop electrosurgical excision procedure (leep). outline: this is a multicenter study. patients undergo routine colposcopy as part of their regular colposcopic evaluation. the digital colposcope is used to take images of the vagina and cervix, pre- and post-acetic acid, using white, green, and blue light. colposcopically abnormal areas are biopsied; a normal area may also be biopsied. patients undergoing loop electrosurgical excision procedure (leep) may undergo one additional biopsy of a colposcopically normal site.

Eligibility criteria:
criteria inclusion criteria: * included subjects will be ≥18 years old. * included subjects will not be pregnant. * included subjects will have a negative urine pregnancy test. * included subjects will be scheduled for colposcopy and/or leep treatment at the vgh women's clinic. * included subjects will indicate understanding of the study. * included subjects will provide informed consent to participate. exclusion criteria: * individuals \<18 years old will be excluded. * pregnant individuals will be excluded. * individuals that have had an operation to remove their cervix will be excluded.

Keywords: cervical cancer cervical intraepithelial neoplasia grade 1 cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3
oral vinorelbine or capecitabine combined with trastuzumab as adjuvant treatment for patients with lymph node negative, her-2 positive and small tumor size breast cancer (orchid)

Conditions: Breast Cancer

Summary: this is a prospective, open-lable phase ii clinical trial (orchid study) evaluating the effectiveness and safety of oral vinorelbine or capecitabine combined with trastuzumab as adjuvant treatment for patients with lymph node negative, her-2 positive and small tumor size breast cancer


Eligibility criteria:
inclusion criteria: 1. women aged 18-70 years old; 2. t ≤1cm and negative lymph node confirmed by histopathology after early breast cancer surgery 3. her2 positive confirmed by histopathology after early breast cancer surgery（her2-positive breast cancer defined as a positive in situ hybridization test or an immunohistochemistry (ihc) status of 3+. if ihc is 2+, a negative in situ hybridization (fluorescence in situ hybridization (fish), chromogenic in situ hybridization (cish) , or silver in situ hybridization (sish)) test is required by local laboratory testing.) 4. has an eastern cooperative oncology group (ecog) performance status of 0 or 1; 5. has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/l (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /l; platelet count ≥ 100 \* 109 /l; (2)adequate liver and kidney function: alanine aminotransferase (alt) ≤ 3×upper limit of normal (uln), aspartate aminotransferase (ast) ≤ 3×uln, total bilirubin (tbil)≤ 1.5×uln, serum creatinine ≤ 1×uln，and with endogenous creatinine clearance rate of \>50 ml/min (cockcroft-gault formula). 6. participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up. exclusion criteria: 1. has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy）; 2. has bilateral breast cancer; 3. has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ. 4. has metastic (stage 4) breast cancer; 5. is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives; 6. patients participating in other clinical trials at the same time; 7. has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (lvef) \ 150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension; 8. has severe or uncontrolled infection; 9. has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders; 10. the researchers judged patients to be unsuitable for the study.

Keywords: oral vinorelbine capecitabine trastuzumab adjuvant treatment
ibuprofen and biomarkers of acute kidney injury after running in the heat

Conditions: Acute Kidney Injury

Summary: the goal of this study is to determine if ibuprofen prior to exercise in the heat worsens biomarkers of acute kidney injury. participants were given 600mg of ibuprofen or placebo (corn starch) 12- and 1-hour prior to running for 1-hour in a hot environment (35°c) at moderate intensity. urine, plasma, and serum samples were collected pre-, post-, and 1hour post-exercise to assess biomarkers of acute kidney injury. this was a double blind, randomized crossover design, so that participants completed the alternate trial (ibuprofen or placebo) at least seven days later.


Eligibility criteria:
inclusion criteria: participants will be physically active males and females between the ages of 18 and 45. participants will be able to run continuously for at least 60 minutes. all will be able to speak and read english. exclusion criteria: 1. non-english speakers, prisoners, pregnant women, or persons requiring a lar will not be included 2. previous history of heat stroke or heat illness 3. currently experiencing a sunburn or other burn injury 4. have repeated exposure to heat, such as hot baths, sauna, or travel to a hot environment 5. has resided in a hot climate within 2 months prior to the trial 6. answered "yes" to at least one question on the physical activity readiness questionnaire, 7. show signs or symptoms of or are known to have cardiovascular, renal, metabolic, or pulmonary disease as determined by a health questionnaire 8. are a current smoker, 9. history of regular gastrointestinal distress, 10. known history of stomach ulcers or taking blood thinning medication, 11. known allergy to caffeine 12. have a resting blood pressure greater than 140 systolic or 90 diastolic, and 13. do not engage in at least 150 minutes of moderate to vigorous intensity exercise per week.
lifestyle intervention in obesity, effect on diabetes

Conditions: Type 2 Diabetes

Summary: there are evidence from numerous studies on effect of lifestyle intervention in morbidly obese patients with type 2 diabetes. this study examines the effect of the "evje-model" on type 2 diabetes. the "evje-model" is a combined 12 months model, consisting of repeated stays in a specialist centre, telephone follow-up at home, home groups, self monitoring and close contact with the patients' local physician.

there will be done qol-measures, blood- and urine analysis, weight, waist- and hip measurement, blood pressure and vo2-max measurement at baseline, after 6 months and after 12 months.

Eligibility criteria:
inclusion criteria: * all patients with bmi \> 35 with diagnosed type 2 diabetes * referred to lifestyle intervention from a public hospital exclusion criteria: * pregnancy * active major psychiatric disease(s) * active and serious eating disorder * drug- and/or alcohol dependency

Keywords: obesity diabetes weight lifestyle follow up