Kornimate/medical-research-clean huggingface dataset:
intracavernous injection of autologous mesenchymal stem cells in the treatment of erectile dysfunction resistant to oral treatment in patients with type i diabetes

Conditions: Erectile Dysfunction; Stem Cells; Diabetes Mellitus, Type 1

Summary: diabetes is a major concern in public health because of its high frequency and its negative consequences. erectile dysfunction (ed) is present, regardless of age, in 50 to 75% of men with diabetes. it is related to endothelial dysfunction and a decrease in smooth muscle and nerve cells. in type 1 diabetic patients, ed is part of the chronic complications of microangiopathy. current therapies are exclusively symptomatic with moderate efficacy, estimated between 44 and 56%. the administration of culture-grown medullary mesenchymal stem cells (mscs) would be a curative treatment and have the advantage of being single injection. however, the data in the literature do not allow to define the optimal dose of msc in this indication. in addition, the feasibility of this procedure is not known at present. the aim of this study is to evaluate the tolerance and the efficacy of intracavernous injection of autologous msc (bone marrow-derived mscs) administered in a 4-dose-escalating design in patients from 18 to 50 years old with complicated type 1 diabetes mellitus and erectile dysfunction.


Eligibility criteria:
inclusion criteria: * type 1 diabetic man * aged from 18 to 50 years * having a diabetes evolving for at least 10 years * presenting at least one severe manifestation of microangiopathy, with or without dysautonomia: diabetic retinopathy, diabetic or vascular nephropathy, diabetic neuropathy, diabetic foot * presenting an erectile dysfunction refractory to oral treatment (sildenafil, tadalafil ...) * iief-5 score less than or equal to 10 exclusion criteria: * any intercurrent event that does not allow the injection of amsc * violation of the protocol by self erectile dysfunction medication * withdrawal of the protocol
safety study of a refrigerator-stable formulation of varivax®

Conditions: Varicella; Measles; Mumps; Rubella

Summary: primary objective: to describe the safety profile of a refrigerator-stable formulation of varivax® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination. secondary objectives: na


Eligibility criteria:
inclusion criteria: 1. healthy infants from 12 months of age to 15 months of age. 2. consent form signed by both parents or by the legal representative(s), properly informed about the study, 3. parent(s) able to understand the protocol requirements and to fill in the diary card. exclusion criteria: 1. prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine, 2. known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster, 3. any known recent (≤30 days) exposure to measles, mumps or rubella, 4. any known recent (≤30 days) exposure to varicella or zoster involving: 5. any recent (≤3 days) history of febrile illness (rectal temperature ≥38.0°c), 6. active untreated tuberculosis, 7. any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems, 8. any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity, 9. any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 3, 10. any recent receipt of an inactivated or a live vaccine (≤ 30 days) or scheduled vaccination through visit 3

Keywords: prevention of : varicella measles mumps rubella
topical phytoterpenes for plantar fasciitis

Conditions: Plantar Fasciitis

Summary: randomized controlled trial of mixture of essential oils containing tea tree oil, rosemary, clove, pepper, in a formulation with skin permeation enhancers including limonene for the treatment of plantar fasciitis in adult men and women. forty-two patients will be randomized to receive twice daily topical application of the treatment formulation or plain tea tree oil as a control. analog pain scores will be assessed at the start of treatment and at two weeks. analysis will be by student's t-test.

randomized controlled trial of mixture of essential oils containing tea tree oil, rosemary, clove, pepper, in a formulation with skin permeation enhancers including limonene for the treatment of plantar fasciitis in adult men and women. forty-two patients will be randomized to receive twice daily topical application of the treatment formulation or plain tea tree oil as a control. analog pain scores will be assessed at the start of treatment and at two weeks. analysis will be by student's t-test. primary outcome measure will be the difference in pain score between baseline score and pain score at 2 weeks.

Eligibility criteria:
inclusion criteria: * plantar fasciitis diagnosed by a medical practitioner and at least 3 months in duration exclusion criteria: * age under 18 years, any history of diabetes, history of foot surgery

Keywords: heel pain plantar fasciitis foot pain
evaluation of autonomic cardiac function in patients with crps

Conditions: CRPS (Complex Regional Pain Syndromes)

Summary: to evaluate the autonomic cardiac function in patients with complex regional pain syndrome

tilt table testing in patients with complex regional pain syndrome: effects on heart rate variability and baroreceptor sensitivity. primary outcome parameter: autonomic cardiac function

Eligibility criteria:
inclusion criteria: * age: 18 or older. * pain \> 3 months. * diagnosed with cprs acc. to diagnostic research criteria (harder et al., 2005). * inclusion of healthy subjects: age-, gender-, and bmi-matched. exclusion criteria: * other significant disease affecting the parameters measured, including cardiovascular disease. * treatment with anticholinergics, sympathomimetics and parasympathomimetics, and alpha- and beta-adrenergics.
acqmap® global registry of procedural and long-term clinical outcomes (acqmap registry)

Conditions: Ablation of Arrhythmia's

Summary: acqmap registry is an observational study

acqmap registry is an observational, prospective, multi-center, multi-national, open-label registry designed to provide clinical data regarding the commercial, real-life experience with the diagnostic acqmap system.

Eligibility criteria:
inclusion criteria: * male or female 18 years of age or older. * currently scheduled for an ablation of an arrhythmia utilizing the diagnostic acqmap system. * willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study. * willing and able to give written informed consent. exclusion criteria: * in the opinion of the investigator, any known contraindications to an ablation procedure. * current enrollment in any study protocol sponsored by acutus medical. * any other condition that, in the judgment of the investigator, makes the participant a poor candidate for this procedure, the study, or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, etc.).

Keywords: arrhythmia's
clinical study of pm1003 in phase i/iia treatment of advanced malignant solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a single-arm, open-lable, multicenter phase i/iia clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of pm1003 in the treatment of advanced solid tumors.

pm1003 is a bispecific antibody targeting pd-l1 and 4-1bb.

Eligibility criteria:
inclusion criteria: 1. voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures; 2. male or female aged 18 to 75 years; 3. subjects with malignant tumor confirmed by histology or cytology; 4. adequate organ function; 5. ecog score was 0-1. 6. pre-menopausal female subjects with negative blood pregnancy results within 7 days prior to the study treatment, and agree to abstain from sex or use medically approved effective contraceptive measures for 6 months from the date of signing the informed consent form to the end of the last medication; 7. male subjects are agree to abstain from sex or use medically approved effective contraceptive methods for 6 months from the date of signing the informed consent form to the end of the last medication, and do not donate sperm during this period. exclusion criteria: 1. history of severe allergic to macromolecular protein drugs, severe allergy to drugs or known allergy to any component of the drug in this study; 2. treatment with any 4-1bb monoclonal antibody or 4-1bb-containing dual antibody immune co-stimulatory molecule agonist; 3. current active infection requiring intravenous anti-infective therapy; 4. current presence of uncontrolled pleural, pericardial, and peritoneal effusions; 5. known history of alcohol abuse, psychotropic drug abuse or drug abuse; 6. history of neurological or psychiatric disorders, such as epilepsy, dementia, schizophrenia, etc.; 7. anticipated need for any other form of antineoplastic drug treatment during the trial; 8. women who are pregnant or breastfeeding; 9. other conditions lead to inappropriate to participate in this study as judged by the investigator.

Keywords: pd-l1, 4-1bb
pilot assessment of eyeart as an automated diabetic retinopathy screening tool

Conditions: Diabetic Retinopathy

Summary: more than 29 million people in the us are living with diabetes, many of whom will develop diabetic retinopathy (dr) or diabetic eye disease (ded), the leading cause of vision loss and blindness in working-age adults. annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-vegf injections if dr is diagnosed in its early stages. currently, the number of clinical personnel trained for dr screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. therefore, to meet this large unmet need for dr screening, a fully-automated computerized dr screening system is necessary. this study is designed to assess the performance of eyeart, an automated dr screening tool.


Eligibility criteria:
inclusion criteria: * 18 years of age or older; * a diagnosis of diabetes mellitus; and * understanding of study and provision of written informed consent. exclusion criteria: * persistent visual impairment or sudden vision loss in one or both eyes; * history of uncorrected media opacity in one or both eyes; * history of retinal vascular disease other than diabetic eye disease; * history of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract; * subject has contraindications for mydriatic medications or is unwilling or unable to dilate; * subject is currently enrolled in an interventional study of an investigational device/drug; or * subject has a condition or is in a situation which in the opinion of the investigator, might confound study results, may interfere significantly with the subject's participation in the study, or result in ungradable 4-wide field stereoscopic mydriatic fundus photographs.
efficacy, safety and tolerability of rotigotine nasal spray for the acute treatment of rls symptoms

Conditions: Restless Legs Syndrome

Summary: the main objective of this phase 2a proof-of-concept trial is to assess the efficacy of rotigotine nasal spray in ascending doses in subjects with idiopathic restless legs syndrome.

each patient of the placebo and rotigotine group performed an eligibility assessment, as well 4 treatment days at which subjects performed a repeated 'suggested immobilization test' (sit) during a 30min pre-dose and a 4 hours post-dose period. during these periods the severity of rls symptoms in the legs was assessed by the subject using a numeric symptom severity scale. in addition the leg movements were measured by actigraphy to assess the periodic leg movement index during wakefulness (plmwi, plm per hour). subjects applied a single dose of treatment on each treatment day (placebo nasal spray or rotigotine nasal spray in 3 ascending doses).

Eligibility criteria:
inclusion criteria: * subjects with idiopathic rls, who are responding to an ongoing l-dopa treatment exclusion criteria: * patients with secondary rls or clinically relevant concomitant diseases or medical conditions are excluded

Keywords: rotigotine rotigotine nasal spray efficacy, safety and tolerability restless legs syndrome
pulsed electromagnetic field stimulation and charcot foot ulcer

Conditions: Charcot Foot Ulcer

Summary: thirty-four patients with charcot foot ulcer will be included, their ages will be ranged from 50 to 70 years old and randomly distributed into two equal groups : study group includes 17 patients who will recieve pulsed electromagnetic field and electrical stimulation three days per week for three months . control group includes 17 patients who will recieve electrical stimulation , standard wound care and medical treatment


Eligibility criteria:
inclusion criteria: * age ranges between 50 and 70 years old male and female patients all patients with charcot foot ulcer exclusion criteria: * presence of malignancy hypotensive patients pregnancy immunological and rheumatological disorders
risk assessment of carotid plaques using 3d contrast-enhanced ultrasound

Conditions: Carotid Atherosclerosis

Summary: this is an open-label, non-randomized study conducted at thomas jefferson university comparing pressure-gradient estimates (obtained between a carotid plaque and the carotid artery) to imaging and histology markers of plaque vulnerability. there is an inverse relationship between the subharmonic signal magnitude from contrast-enhanced ultrasound microbubbles and ambient pressure. this pressure estimation technique (referred as shape) will be used to estimate the pressure gradient across the carotid plaque cap noninvasively in vivo.


Eligibility criteria:
inclusion criteria: * patients \>18 years old and willing and able to participate. patients with atherosclerosis scheduled for carotid endarterectomy exclusion criteria: * • pregnancy or breast-feeding at the time of the scan * patients with known hypersensitivity or allergy to any component (including perflutren) of definity (lantheus medical imaging, billerica, ma). * patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. for example: * patients on life support or in a critical care unit. * patients with unstable occlusive disease (e.g., crescendo angina). * patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia. * patients with uncontrolled congestive heart failure (nyha class iv). * patients with recent cerebral hemorrhage. * patients who have undergone surgery within 24 hours prior to the study sonographic examination. * patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) or respiratory distress syndrome. * patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli. * patients who have received any contrast medium (x-ray, mri, ct or ultrasound) in the 24 hours prior to the research ultrasound exam
poct detection for blood concentration of tirofiban in acute myocardial infarction based on azo-pop probe.

Conditions: Acute Myocardial Infarction (AMI)

Summary: the goal of this observational study is to monitor blood drug concentration during the use of tirofiban, predict the occurrence of intraoperative and postoperative complications related to interventional therapy, and evaluate the efficacy of multiple antiplatelet drugs.the main question it aims to answer is: 1. if the poct detection technology for blood concentration of tirofiban based on portable mass spectrometer can be used for on-site sampling, clinical testing, and immediate analysis next to patients undergoing coronary intervention therapy. 2. lc-ms/ms untargeted metabolomics analysis techniques combined with machine learning algorithms will be used to screen biomarkers for myocardial infarction.


Eligibility criteria:
inclusion criteria: * the patient meets the diagnostic criteria for stemi (refer to the "diagnosis and treatment guidelines for acute st segment elevation myocardial infarction (2019)") * the onset time is less than 12 hours * agree to perform direct pci * heart function (killip class) ≤ level iii * there are no direct pci contraindications. exclusion criteria: * patients allergic to tirofiban or/and aspirin * patients with a history of intracranial hemorrhage * patients with stroke/transient ischemic attack within six months * patients who have taken oral anticoagulants within 30 days before admission and cannot stop taking them * patients receiving clopidogrel or ticagrelor from other manufacturers or formulations due to directive events * patients who have received or plan to undergo fibrinolysis therapy within 24 hours * patients with a history of major surgery within 30 days, or those who plan to undergo major surgery during the study process * patients with a history of gastrointestinal bleeding within 6 months, or those with severe bleeding disorders or tendencies towards bleeding * patients with severe combined liver and kidney dysfunction * refuse to participate in this experiment.
genotyping and phenotyping of cyp2d6 breast cancer patients on tamoxifen

Conditions: Breast Cancer Female

Summary: this study is an observational study to determine phenotype and genotype of cyp2d6 as predictors of z-endoxifen concentrations in plasma of outgoing patients treated with tamoxifen for at least 4 months

tamoxifen is an antiestrogen drug with concentration dependent properties, with z-endoxifen known as active metabolite. until know therapeutic range for z-endoxifen to improve treatment response was not known. variation response on tamoxifen can be cause of genetic polymorphism cyp2d6 that can be different between interindividul and ethnic. the aim of this study is to determine phenotype and genotype of cyp2d6 as predictors of z-endoxifen concentrations in plasma of outgoing patients treated with tamoxifen for at least 4 months

Eligibility criteria:
inclusion criteria: * breast cancer patients on tamoxifen treatment for at least 4 months exclusion criteria: * abnormalities in liver markers (ast \>2.5 x uln)

Keywords: tamoxifen breast cancer z-endoxifen
rose-longitudinal assessment with neuroimaging

Conditions: Intracerebral Hemorrhage

Summary: the investigators will perform follow-up on 250 of 500 cases recruited into the rose study of cases with deep and lobar intracerebral hemorrhage to perform advanced neuroimaging at 12-24 months post stroke, and evaluations of motor and cognitive function at baseline, 6 months after baseline, and 12 months after baseline to determine predictors of recovery, progressive cognitive or functional impairment. the investigators propose to leverage the recruitment, dna, rna-seq and baseline advanced neuroimaging cohort of rose to obtain long-term neuroimaging and identical assessments longitudinally to address critical questions regarding the progressive decline of patients 12 to 24 months post intracerebral hemorrhage (ich) with long term cognitive follow-up to 36 months on average. this proposal would represent the largest, and longest advanced neuroimaging and rna-sequencing evaluation after ich to date.

the investigators propose to leverage the recruitment, dna, rna-seq and baseline advanced neuroimaging cohort of rose to obtain long-term neuroimaging and identical assessments longitudinally to address critical questions regarding the progressive decline of patients 12 to 24 months post ich with long term cognitive follow-up to 36 months on average. this proposal would represent the largest, and longest advanced neuroimaging and rna-sequencing evaluation after ich to date. specific aim #1: determine if progressive cognitive impairment correlates with an increase in established markers of cerebral small vessel disease(csvd) and cerebral amyloid angiopathy(caa) (white matter disease, siderosis and microbleeds). hypothesis #1: incidence of progressive cognitive impairment after ich will be associated with an increase in total burden of small vessel disease (including white matter disease (wmd), microbleeds or siderosis, perivascular spaces, lacunar infarcts and atrophy). specific aim #2: determine if inflammation as measured by rna-sequencing markers of inflammation correlates with progressive cognitive impairment. hypothesis #2: interleukin-8 related inflammation will be associated with incidence of cognitive impairment. specific aim #3: in this exploratory aim, we seek to identify novel neuroimaging markers associated with progressive cognitive decline. exploratory hypothesis #3: contralateral hemispheric diffusion tensor imaging (dti) measures and cortical to cortical tract integrity will decline in association with progressive cognitive impairment.

Eligibility criteria:
inclusion criteria: * age 18 years or greater, fulfillment of the criteria for deep, subcortical or lobar intracerebral hemorrhage * no evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of ich. * ability of the patient or legal representative to provide informed consent exclusion criteria: * brainstem or cerebellar ich * patients severely affected by the ich, early mortality, hospice, or withdraw of care not eligible for ros

Keywords: hemorrhagic stroke, intracerebral intracerebral hemorrhage outcomes after stroke intracerebral hematoma
endoscopically assisted colostomy with colopexy for critically ill patients without general anesthesia or laparotomy

Conditions: Colonic Neoplasms; Rectal Neoplasms; Fecal Incontinence

Summary: indications for colostomy are rectal or anal cancer, diverticular disease, radiation enteritis, complex perirectal fistulas, anorectal trauma, severe incontinence, motility and functional disorders. it is frequently required in critically ill patients who may not be able to tolerate a laparotomy. laparoscopic-assisted colostomy is an alternative method for colostomy without laparotomy, but require general anesthesia. additionally, percutaneous anterior colopexy under colonocopic control offers the possibility for improved and faster fixation of the anterior colonic wall to the anterior abdominal wall. the objective of this study is to evaluate the feasibility of performing fecal diversion with the help of a colonoscope and colopexy, without the additional morbidity of abdominal exploration.

the colonoscope will be passed transanally into the left colon. it will be identified the endoscopic transilluminating point to the abdominal wall. percutaneous anterior colopexy will be performed, using a gastropexy device that is included in the percutaneous endoscopic gastrostomy (peg) kit . this technique involves the placement of a threaded nylon fastener into the colon through a needle. the endoscope will be manipulated until the light approaches the premarked site. a small skin disc will then be removed at this location and a loop colostomy will be made. the colonoscope will also be used as a guide to identify the proximal and distal limbs of the loop colostomy.

Eligibility criteria:
inclusion criteria: * good health and without surgery exclusion criteria: -

Keywords: endoscopic, colostomy, colopexy