Kornimate/medical-research-clean huggingface dataset:
lanugo hair loss as a marker for peri-ocular malignancy

Conditions: Skin Cancer Face

Summary: skin cancers around the eye are common, but so are other lid lumps. it is useful to be able to tell which lumps are likely to be cancer. this study looks at whether the loss of fine hairs (lanugo hairs) on the skin are a good indicator of whether a lump is a skin cancer or not. the investigators are recruiting patients who have lid lumps who haven't had a biopsy before, who would be having a biopsy as part of their treatment, and seeing whether those who have loss of the fine skin hairs are the same as those who have skin cancer confirmed on their biopsy. the study doesn't involve any extra examinations or treatments for participants. the investigators look at the patients before the biopsy as part of their usual care, and take a note of whether or not they have lost the fine hairs at this stage. the main benefit of participating is that the medical community has better evidence about which lid lumps are likely to represent skin cancer, helping future diagnosis. there are no additional risks to participating. the risks of biopsy are unchanged whether patients participate in the study or not. the study is run from the princess alexandra eye pavilion in edinburgh, in conjunction with moorfields eye hospital, london the investigators aim to start the study in spring 2018, and will most likely recruit for 6 months depending on the number of participants recruited. there is no additional funding from any source at present - the work will be undertaken by doctors in their research time.


Eligibility criteria:
inclusion criteria: * patients undergoing biopsy for peri-ocular lesion exclusion criteria: * age under 18; previous biopsy or excision on the same lid

Keywords: peri-ocular
abca2 girms analytical validation clinical performance study

Conditions: Gastroparesis

Summary: the purpose of this study is to collect human breath samples for use in a validation study intended to demonstrate equivalent clinical performance measures of new abca2 girms (automated breath carbon analyzer-2 gas isotope ratio mass spectrometer) instruments to the currently fda-approved abca girms (automated breath carbon analyzer gas isotope ratio mass spectrometer) system. abca girms systems are used to analyze the ratio of 13co2 to 12co2 in patient breath samples during the gebt (gastric emptying breath test) procedure.

in this study the participants will be administered the fda-approved gebt test, which involves collecting breath samples prior to and after consumption of a non-radioactive carbon stable isotope (13c) labeled test meal. breath samples will be collected at times consistent with fda approved labeling. participant's breath samples will be analyzed on the currently approved abca girms and on the new abca2 girms instruments. the values collected from both systems will be used to determine the clinical diagnostic agreement at each individual time points and percent agreement in diagnosis between the approved abca girms and the new abca2 girms.

Eligibility criteria:
inclusion criteria: * males and females, 18-85 old at time of signing the informed consent form fro healthy and intended use population participants (i.e. symptomology of gastroparesis). women of childbearing potential must not be pregnant at the time of gebt administration. * ability to eat test meal and provide breath samples exclusion criteria: * history or physical exam suggestive of pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease or malabsorption syndrome * history of abdominal surgery except appendectomy * use of any medications that may alter gastric motility within two days of the study * use of narcotics or anticholinergics within two days of the study * females on hormone replacement therapy other than birth control medications * receipt of an investigational drug within 4 weeks of the study * pregnancy * intolerance or allergy to any component of gastric emptying breath test meal * history of neurologic or psychiatric disorders

Keywords: gastroenterology gastric emptying breath test
a single-arm, open-label, multicenter clinical trial with nivolumab (bms-936558) for subjects with histologically confirmed stage iii (unresectable) or stage iv melanoma progressing post prior treatment containing an anti-ctla4 monoclonal antibody (checkmate 172)

Conditions: Melanoma

Summary: the purpose of this study is to determine the rate and frequency of high-grade (ctcae v4.0 grade 3 or higher), treatment-related, select adverse events in subjects with histologically confirmed stage iii (unresectable) or stage iv melanoma and progression post prior treatment containing an anti-cytotoxic t lymphocyte antigen (ctla-4) monoclonal antibody, treated with nivolumab (bms-936558) at a dose of 3 mg/kg every two weeks.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * subjects with histologically confirmed malignant melanoma * eastern cooperative oncology group (ecog) performance status (ps): * ps 0 to 1 * ps 2 * previously treated unresectable stage iii or stage iv melanoma as per the american joint committee on cancer 2010 guidelines regardless of braf mutation status * subjects must have experienced evaluable response evaluation criteria in solid tumors (recist 1.1)-defined disease progression * prior treatment with chemotherapy, interferon (adjuvant setting), interleukin (il-2), braf/mek inhibitors for subjects with known braf mutations, mitogen-activated or extracellular signal- regulated protein kinase (mek) inhibitors for neuroblastoma ras viral (v-ras) oncogene homolog (nras) mutations, and ckit inhibitor subjects with known ckit mutations are allowed * patients with cns metastases are eligible: * if cns metastases are treated, patients are asymptomatic or neurologically returned to baseline * if they have previously untreated cns metastases and are asymptomatic * if they have leptomeningeal metastases, are treated and asymptomatic or neurologically returned to baseline with life expectancy \> 3 months * patients with a known history of grades 3-4 immune-related adverse reactions during/after anti-ctla-4 therapy if all toxicities have resolved at least to grade 1 exclusion criteria: * subjects with untreated, active central nervous system (cns) metastases are excluded
randomized trial of a quality improvement intervention to decrease d2b time in primary pci for ami

Conditions: STEMI

Summary: the primary objective of this study is to assess whether an aggressive quality improvement intervention strategy will decrease time from hospital presentation to first balloon inflation in non-transfer patients with acute st segment elevation mi (stemi) treated with primary percutaneous coronary intervention (pci). twelve hospitals in michigan were randomized to either aggressive intervention or control. the intervention consisted of grand rounds at each hospital, sharing of best practices, and coordinating center staff working closely with staff at each intervention hospital to discuss solutions to barriers to rapid treatment for stemi patients.

the participating hospitals randomized to the aggressive intervention strategy actively worked to create teams to analyze processes of care for stemi patients, identify areas needing improvement, and implemented strategies to streamline treatment. hospitals randomized to control were instructed to conduct "business as usual".

Eligibility criteria:
inclusion criteria: * acute st segment myocardial infarction, non transfer patients, with symptom onset to balloon time less than or equal to 24 hours. exclusion criteria: * patients transferred from one facility to another, * non st segment myocardial infarction patients.

Keywords: myocardial infarction time to treatment door to balloon time
treatment of benign uterine disorders using high intensity focused ultrasound (mr-hifu)

Conditions: Uterine Fibroids; Adenomyosis

Summary: mri-guided high intensity focused ultrasound (mri-hifu) has been proven to be a safe and effective method in treating uterine fibroids and also adenomyosis. however, systematic studies on the effect of this treatment on factors affecting fertility are still lacking. also quite little is known about body's systemic response to mri-hifu. thus the aim of this study is to obtain more information on the systemic response of the body to the hifu-treatment when treating non-malignant disease as well as to study the effect of mri-hifu on factors affecting fertility. women with symptomatic uterine fibroids or adenomyosis suitable for mri-hifu treatment are recruited to this study. the severity of symptoms will be assessed with ufs-qol and the same questionnaire will also be used in follow-up 3, 6 and 12 months after treatment. blood, urine and endometrium samples will be collected pre- and postoperatively and during follow-up 3, 6 and 12 months after the treatment. from these samples detailed analysis of the immunological, inflammatory and hormonal response will be performed. as this is the first study in finland of treating uterine fibroids and adenomyosis using mri-hifu, also a report about the efficacy of the mri-hifu in treating the uterine disorders will be published, and a key tool in assessing the treatment outcome would be the ufs-qol questionnaire. also new methods for improving patient selection as well as treatment efficacy will be evaluated in this study.


Eligibility criteria:
inclusion criteria: * bmi \< 35 * premenopausal * uterine size \<20 gw * willingness to participate to the research * uterine fibroids with typical symptoms * maximum of 4 treated fibroids * dominant fibroid \>2.5cm * \>50% of the fibroid is treatable exclusion criteria * unspecified pelvic tumours or ovarian masses, pid * major corrective surgery to uterus (simple myomectomy excluded) * major uterine anomalies * unability to calculate the volume of uterine fibroids * marked uterine calcification * marked scarring of the lower abdomen * suspicion of malignancy * marked general health problem contraindicating mri * claustrophobia
analysis of faz in diabetic retinopathy using oct angiography

Conditions: Diabetic Retinopathy

Summary: study and assessment of characteristic changes in foveal avascular zone during different stages of diabetic retinopathy using octa.

octa is superior to other retinal imaging techniques like fluorescein angiography(fa) as it does not require dye injection, intravenous dye injection is time consuming and can have adverse side effects. furthermore, the edges of the capillaries can become blurred due to dye leakage and imaging of the retina can only be 2d when using fa. octa provides both structural and functional (i.e. blood flow) information in tandem. the "corresponding" oct b-scans can be co-registered with the simultaneous oct angiograms so the operator is able to scroll through the oct angiogram like a cube scan. as a result, the precise location of pathology can be viewed on the corresponding oct b-scans. this makes octa a better tool when detecting the exact location of a retinal pathology. in diabetic retinopathy octa can show choriocapillaris abnormalities and/or retinal microvascular abnormalities such as microaneurysms, vascular remodeling adjacent to the foveal avascular zone (faz), enlarged faz, and capillary tortuosity and dilation through different stages. octa can show smaller vascular changes not detectable by fa.

Eligibility criteria:
inclusion criteria: * diabetic patients suffering from different stages of diabetic retinopathy. exclusion criteria: * other ocular problems affecting vision including glaucoma, cataract, amblyopia, hypertensive retinopathy, vein occlusion and uveitis.
serum albumin ratios can improve sepsis mortality prediction

Conditions: Sepsis

Summary: sepsis remains a leading cause of mortality in hospitalized patients, despite advancements in critical care. existing clinical scores for predicting sepsis outcomes often lack generalizability and complexity, hindering accurate risk assessment and timely intervention. this study aimed to evaluate the prognostic performance of serum albumin ratios to c-reactive protein (crp), procalcitonin (pct), and lactate in predicting 28-day morbidities and mortality in sepsis patients admitted to surgical icus. by incorporating these albumin ratios into clinical decision-making, we hypothesized that clinicians could more accurately identify patients at high risk of adverse outcomes and tailor treatment strategies accordingly.


Eligibility criteria:
inclusion criteria: * patients newly admitted to icu with sepsis or septic shock; * patients were free of exclusion criteria. exclusion criteria: * patients with acute kidney injury; * patients with hemorrhagic shock; * patients with immunosuppressive or autoimmune disorders; * patients suspected to die in icu.
treatment and fate in fistulizing crohn's disease in a pediatric population

Conditions: Crohn Disease

Summary: crohn's disease is a inflammatory bowel disease evolving towards the destruction of the intestinal wall resulting in stenosing or perforating complications (fistulas, abscesses). the treatment of perforating crohn's disease is not codified.

the old dogmas leading to surgery after failure of medical treatment have recently been overturned, particularly since the advent of anti-tnfs. biotherapies now have a central place, including for complicated forms. previous studies have already looked at the usefulness of anti-tnfs in stenosing forms, or concerning ano-perineal lesions, but what about digestive fistulas. indeed, data are scarce, especially in paediatrics.

Eligibility criteria:
inclusion criteria: * minor patients (aged 3 to 18). * diagnosed with crohn's disease. * fistulizing crohn's disease exclusion criteria: - perianal crohn disease

Keywords: fistula abscess pediatrics medical treatment surgery drug
sbrt±stad for unfavorable intermediate risk/high risk prostate cancer

Conditions: Prostate Cancer

Summary: this is a prospective, open, randomized phase ii trial.

patients will be randomized between sbrt alone (38 gy in 4 fractions) or sbrt (same schedule) along with short course (6 months) androgen deprivation (stad). all patients will be treated by intensity modulated radiotherapy. regarding the combined modality approach, sbrt has to start within 3 months from the first injection of lhrh analogue.

Eligibility criteria:
inclusion criteria: * histologically proven prostate adenocarcinoma * ir or hr in the nccn definition * n0m0 at staging with choline or (preferably) psma pet-ct; * ecog performance status between 0 and 2; exclusion criteria: * previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy) * previous radiotherapy to the pelvis * previous chemotherapy for malignancy in past 5 years * impossibility to implant fiducials for tracking purposes * impossibility to undergo mri of the prostate * contraindication to short term ad * prostate volume \>90cc

Keywords: neoplasm, prostate cancer,
effects of creatine supplementation as compared to glucosamine/chondroitin sulfate supplementation in addition to exercise and physical therapy in the management of knee osteoarthritis.

Conditions: Knee Osteoarthritis

Summary: osteoarthritis (oa) is one of the most common joint disorders, affecting not only the joints but also the surrounding muscles, which become weak. resistance exercise reduces pain and improves function in patients with oa of the knee. nonsteroidal anti-inflammatory drugs (nsaids) are widely used by patients with oa to reduce pain and thereby maintain the ability to perform daily activities. however, there is accumulating evidence for a negative effect of nsaids, thus many patients with oa are treated with dietary supplementations such as glucosamine and chondroitin sulfate, and some studies show a beneficial effects on cartilage and pain. however, their effect on oa symptoms and cartilage remains controversial. on the other hand creatine supplementation has also been observed to show promising effects when combined with resistance training exercise in the elderly, but the evidence is limited in terms of knee osteoarthritis. for this reason the purpose of this study is to determine the effects of creatine supplementation as compared to glucosamine/chondroitin sulfate in the management of knee osteoarthritis when combined with resistance training exercise.


Eligibility criteria:
inclusion criteria: * age 40-70 years * knee oa with history not less than three months. * radiological evidences of grade iii or less on kellgren classification. * knee pain on vnrs no more than 8/10 exclusion criteria: * neuromuscular conditions that may lead to fatigue such as multiple sclerosis * signs of serious pathology (e.g., malignancy, inflammatory disorder, infection). * history of trauma or fractures in lower extremity. * signs of lumbar radiculopathy or myelopathy. * history of knee surgery or replacement. * patients on intra-articular steroid therapy within two months before the commencement of the study. * impaired skin sensation. * impaired renal function
combined spinal-epidural temperature and duration of action

Conditions: Pain

Summary: the hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have a shorter period of pain relief than that maintained at room temperature. the temperature of the dose of medication will be measure with an infrared thermometer immediately prior (within 5 minutes) to administration.

subjects will receive a combined spinal epidural medication as per standard of care to treat their labor pain; however, they will be randomized to receive either a dose maintained at room temperature (60-75 degrees f) or one maintained in a refrigerator (\~\<43 degrees f). duration of action will be done by assessments of pain, vital signs, nausea, itching, bromage and fetal heart rate every 15 minutes until the subject requests additional pain medication to treat their labor pain.

Eligibility criteria:
inclusion criteria: * \>/= 18 years of age not allergic to medications used to treat labor pain \ /=3 exclusion criteria: * \ 6 cm cervical dilation non-english speaking subjects

Keywords: combined spinal epidural duration labor pain
evaluation of hearing aids rehabilitation within age-related hearing loss population.

Conditions: Hearing Loss

Summary: hearing aids restore efficiently some auditory functions in age-related hearing loss (arhl or presbycusis) providing to the elderly an access to oral communication and a return to social life. however, a most of the assessments of their efficacy focus on speech recognition. spatial hearing and localization are anothers important auditory functions merely evaluated. the purpose of this study is to evaluate the hearing aids benefits for spatial hearing.

the main objective is to evaluate the hearing aids benefits for spatial hearing with a multidisciplinary approach combing psychophysics, and positron emission tomography (pet) brain imaging in a before/after experimental design. the novelty of the proposal is both theoretical and methodological: the team aim is to identify neural correlates of spatial hearing after hearing rehabilitation and evaluate the evolution of spatial hearing abilities once subjects with presbycusis are fitted with hearing aids. the assessment of spatial hearing processing will rely on both a virtual visuo-auditory 3d immersive platform and functional neuroimaging using pet scan. this project will provide crucial elements for understanding and improving the rehabilitation of age-related hearing loss.

Eligibility criteria:
inclusion criteria: for presbyacusics subjects: * subjects aged over 50 with a difference in symmetrical audiometric thresholds (\< 15 db) between the two ears and requiring hearing aids * affiliation to a social security scheme or equivalent * acceptance of the protocol and signature of the consent form for older people with normal hearing: * subjects matched in age (+/- 2 years) and gender with the presbycusis group * affiliation to a social security scheme or equivalent * acceptance of the protocol and signature of the consent form * subjects with normal hearing, with hearing thresholds of 20 db \< 2khz and 40 db \< 4khz for young people with normal hearing: * subjects aged between 18 and 40 years old, * symmetric normal hearing * affiliation to a social security scheme or equivalent * normally hearing subjects with audiometric thresholds \< 20 db * acceptance of the protocol and signature of the consent form exclusion criteria: * persons under a legal protection regime for adults (safeguard of justice, guardianship, curator ship, institutionalized, or under mandate for future protection) * history of associated neurological pathology * contraindications to pet * cognitive impairment confirmed by the montreal cognitive assessment (moca) test (for presbyacusic subjects and normal-hearing elderly subjects) * taking psychotropic drugs * history of epilepsy * pregnant or breastfeeding woman * participation in another intervention protocol

Keywords: presbycusis auditory cortex. auditory plasticity. localization speech-in-noise pet
motor cortex versus insula stimulation using transcranial current stimulation on chronic post-mastectomy pain

Conditions: Post-Mastectomy Chronic Pain Syndrome

Summary: this study is designed to evaluate the effect of two concentric electrode transcranial direct current stimulation over the primary motor cortex versus insular cortical targets in post mastectomy neuropathic pain.

eighty patients within age group 18-65 years old with post mastectomy neuropathic pain that are resistant to medical treatment in the form of tramadol hydrochloride 100 mg twice daily, pregabalin 75 mg twice daily and amitriptyline 25 mg once daily for at least two months or associated with significant adverse effect from medication will be involved in this study. twenty patients will be randomly allocated into one of the study designed groups using serially numbered opaque closed envelopes. each patient will be placed in the appropriate group after opening the corresponding sealed envelope. the patient will receive one of the following interventions either: * active tdcs (2 ma) targeting the primary motor cortex of the contralateral side of the pain for 20 minute duration for five sessions in five consecutive days (one session /day), * sham tdcs over the primary motor cortex in the same stimulation parameters will be used but the device will be turned off without patient knowledge after 30 seconds , * active tdcs (2ma) targeting the insula of the contralateral side of the pain for 20 minute duration for five sessions in five consecutive days (one session /day), * sham tdcs over the insula in the same stimulation parameters will be used but the device will be turned off without patient knowledge after 30 seconds.

Eligibility criteria:
inclusion criteria: * eighty patients within age group 18-65 years old with post mastectomy neuropathic pain that are resistant to medical treatment in the form of tramadol hydrochloride 100 mg twice daily, pregabalin 75 mg twice daily and amitriptyline 25 mg once daily for at least two months or associated with significant adverse effect from medication will be involved in this study. exclusion criteria: * we will exclude patients with intracranial metallic devices or with pacemakers or any other device. we also exclude those with extensive myocardial ischemia and those known to have epilepsy