Kornimate/medical-research-clean huggingface dataset:
wide area transepithelial sample esophageal biopsy combined with computer assisted 3-dimensional tissue analysis (wats3d) for the detection of high grade esophageal dysplasia and adenocarcinoma

Conditions: Barrett Esophagus; Esophageal Dysplasia; Esophageal Adenocarcinoma

Summary: this is a multi-center, prospective, randomized study which will enroll patients undergoing endoscopic surveillance due to a history of histologically confirmed dysplasia. a member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. if this is of interest to the subject, the informed consent form is discussed and presented. the subject must sign the consent form prior to enrollment. this form will have prior approval of the study site's institutional review board (irb). failure to obtain informed consent renders the subject ineligible for the study.


Eligibility criteria:
inclusion criteria: 1. patients age: ≥ 18 years 2. patients should have a history of barrett's associated esophageal dysplasia (either low or high-grade) confirmed on histology 3. willingness to undergo both wats3d and random forceps biopsies while undergoing conventional egd with sedation 4. ability to provide written, informed consent (approved by irb) and understand the responsibilities of trial participation 5. only patients who no visible mucosal abnormalities at the time that they undergo both random forceps biopsies and wats3d testing of the esophagus will be included in this study exclusion criteria: 1. coagulopathy with inr \> 2.0, thrombocytopenia with platelet counts \< 50,000 2. the subject is pregnant or planning a pregnancy during the study period 3. history of esophageal or gastric surgery other than endoscopic mucosal resection (emr) 4. patients who have undergone endoscopic ablative therapies 5. subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines 6. study patients with inadequate wats3d specimens will not undergo a repeat brush biopsy test and will be excluded from the study 7. be length \ 10 cm 8. patients within six weeks of receiving targeted forceps biopsies and/or emr 9. patients with visible mucosal abnormality at the time of the wats3d and random biopsy testing 10. patients with visible lesions that are either submucosal or covered with a clinically intact epithelium
pilot study of exenatide pharmacokinetics and pharmacodynamics in gestational diabetes

Conditions: Gestational Diabetes

Summary: this study is being done to study how exenatide, an fda-approved drug that lowers blood sugar in non-pregnant patients with type ii diabetes, works in pregnant women. to do this, we will study the drug's pharmacokinetics (what the body does to the drug; specifically, how quickly your body breaks down and excretes exenatide) and pharmacodynamics (what the drug does to the body; specifically, how effectively exenatide helps your pancreas secrete insulin and how well it controls blood sugar after a meal). there are only two main drug therapies (insulin injections and glyburide pills) currently used for gestational diabetes and not all women achieve good enough blood sugar control without side effects. therefore, we hope to find out if exenatide might also be helpful in gestational diabetes.


Eligibility criteria:
inclusion criteria: * pregnant women (singleton) * gestational diabetes not requiring medical therapy * between 18 and 50 years of age * able to give written informed consent exclusion criteria: * women in the first trimester of pregnancy * hematocrit less than 30% * current or past treatment with any hypoglycemic agent * women with gastrointestinal disease or symptoms consistent with nausea, vomiting, abdominal pain or reflux requiring medical treatment. * women with high triglyceride levels, history of gallbladder or pancreatic disease. * clinical diagnosis or history of any renal insufficiency (or decreased creatinine clearance)

Keywords: exenatide tcf7l2 polymorphism pharmacodynamics pharmacokinetics
factors affecting response to extracorporeal shock wave therapy in plantar fasciitis: a cross-sectional clinical study

Conditions: Plantar Fasciitis; Plantar Heel Pain

Summary: heel pain is a problem that affects daily life activities and quality of life. extracorporeal shock wave therapy (eswt) is a treatment used for heel pain. however, some people do not benefit from eswt treatment. the aim of this study is to determine the factors that affect the response to eswt in the treatment of heel pain.

plantar heel pain is one of the reasons that affect daily life activities. there are many treatment methods for this. extracorporeal shock wave therapy (eswt) is one of them. however, some patients do not respond to eswt treatment. in this study, patients were divided into 2 groups as those who did not respond to eswt treatment in terms of pain (less than 50% decrease in pain level) or those with recurrence of pain and those who responded to treatment. patients who had passed 3-6 months after eswt constituted the study groups. these two groups will be compared in terms of age, gender, occupation, weight, height, body mass index (bmi), side: right / left / bilateral, calcaneal angle, meary angle, presence of spur on x-ray (size in mm if present), dorsiflexion angle degree, plantar fascia thickness with ultrasonography, tibial / plantar nerve conduction study evaluated with electroneuromyography, visual analog scale, heel sensitivity index and foot function index.

Eligibility criteria:
inclusion criteria: * \>18 years * unresponsive to conservative treatments (physical therapy, rest, exercises, anti-inflammatory medical treatment, insoles, etc.) * patients who have received eswt treatment and 3-6 months have passed since eswt exclusion criteria: * history of injection therapy including steroids after eswt treatment * those taking nsaids in the last 2 weeks * those with a history of trauma or surgery to the foot or ankle * presence of rheumatic disease affecting the foot or ankle (e.g. spondyloarthritis, etc.) * malignancy * pregnancy

Keywords: pain plantar fasciitis plantar heel pain eswt extracorporeal shock wave therapy
photobiomodulation therapy in the prevention and management of chemotherapy-induced peripheral neuropathy

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: this study aims to investigate the effectiveness of photobiomodulation therapy (pbm) in the management of chemotherapy-induced peripheral neuropathy (cipn). therefore, the hypothesis is that pbm can reduce the severity of cipn in cancer patients, increasing the patient's quality of life.

chemotherapy-induced peripheral neuropathy (cipn) is one of the common complications of cancer treatment and involves paresthesia, numbness and/or burning pain in distal limbs. this condition has a high health impact because it is associated with psychological distress, fall risk, and poor sleep quality. furthermore, it impairs patients' daily activities and thereby decreases their quality of life. the overall incidence of cipn is approximately 68% in the first month after chemotherapy. the available evidence for preventive and therapeutic options for cipn is limited. therefore, only symptom management based on pharmacological and/or physical therapy is applied with limited success. our research group showed that photobiomodulation (pbm) has the potential to reduce the development of cipn in breast cancer patients (unpublished data). pbm uses visible and/or (near)-infrared light at a low power produced by laser diodes or light-emitting diodes (led) to stimulate tissue repair and reduce inflammation and (neuropathic) pain. the aim of this project is to evaluate the effectiveness of pbm in the management of cipn in general.

Eligibility criteria:
inclusion criteria: * finished one of the following types of chemotherapy: paclitaxel, docetaxel, oxaliplatin, cisplatin, vincristine, thalidomide and/or bortezomib. * diagnosed with cipn * age 18 years or above * have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis) * dutch-speaking * signed informed consent exclusion criteria: * taking stable doses of medication on prescription for peripheral neuropathy. related medications are: gabapentin, pregabalin (lyrica), nortriptyline, amitriptyline, duloxetine (cymbalta), and venlafaxine. * severe or unstable cardio- respiratory or musculoskeletal disease * interruption of more than two consecutive laser treatments * dark brown or black skin pigmentation (described as skin type vi in the fitzpatrick scale)

Keywords: photobiomodulation therapy
phase 3 study of dexpramipexole in als

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of amyotrophic lateral sclerosis (als).

amyotrophic lateral sclerosis (als) is a rapidly progressive, degenerative disease of motor neurons in the brain and spinal cord that leads to muscle atrophy and spasticity in limb and bulbar muscles resulting in weakness and loss of ambulation, oropharyngeal dysfunction, weight loss, and ultimately respiratory failure. the purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of als.

Eligibility criteria:
inclusion criteria: * aged 18 to 80 years old, inclusive, on day 1. * diagnosis of sporadic or familial als. * onset of first als symptoms within 24 months prior to day 1. * world federation of neurology el escorial criteria are met for a possible, laboratory-supported probable, probable, or definite als diagnosis. * upright slow vital capacity (svc) of 65% or more at screening. * patients taking or not taking riluzole are eligible for this study: if a patient has never taken riluzole, he or she is eligible; if a patient is currently taking riluzole, he or she must have been on a stable dose for at least 60 days; if a patient has discontinued riluzole, he or she must have stopped taking it for at least 30 days. * must be able to swallow tablets at the time of study entry. exclusion criteria: * other medically significant illness. * clinically significant abnormal laboratory values. * pregnant women or women breastfeeding. * prior exposure to dexpramipexole. * currently taking pramipexole or other dopamine agonists. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: amyotrophic lateral sclerosis als motor neurone disease motor neuron disease lou gehrig's disease
study of cyclosporine in the treatment of dry eye syndrome (st-603-006)

Conditions: Dry Eye Syndromes

Summary: the purpose of this phase iii, open-label study is to determine the safety and tolerability of cyclosporine in the treatment of dry eye syndrome.


Eligibility criteria:
inclusion criteria: * diagnosis of dry eye syndrome exclusion criteria: * intraocular or refractive surgery in the study eye within 3 months prior to study start * unwilling to discontinue use of contact lenses during the study * pregnancy or lactation
6-year follow-up of a prevention program for bereaved families

Conditions: Mental Disorders Diagnosed in Childhood

Summary: six-years following participation in the family bereavement program (fbp) participants in the program as compared to a self-study control group will have lower levels of mental health problems, lower one-year prevalence of mental disorder that meets diagnostic criteria, lower use of substances, higher levels of competence at achieving developmentally appropriate tasks in academic achievement and social competence, and better self-esteem. the effects of the fbp will be moderated by baseline levels of mental health problems and gender. bereaved caregivers who participated in the program will also show lower levels of mental health problems as compared with controls. program effects will be mediated by theoretical mediators targeted by the program.


Eligibility criteria:
inclusion criteria: * experienced parental death in prior 30 months * youth age 8-16 years old exclusion criteria: * not currently in other treatment for mental health problems * caregiver not meet criteria for clinical depression * youth not meet criteria for externalizing problems * not currently suicidal
short-term outcomes of full bowel preparation (mbp+oa) for rectal resections for cancer versus mbp alone

Conditions: Rectal Cancer

Summary: the purpose of the study is to determine if short-term outcomes of rectal resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to rectal resections with only mechanical bowel preparation.

the design involves random allocation of eligible patients to full bowel preparation or only mechanical bowel preparation in 1:1 ratio. after that rectal resection is performed in both groups. short-term outcomes are assessed in 30 day period after surgery. this is a superiority trial evaluating statistical superiority. rate of surgical site infection is anticipated to decrease from 12% (data from local registry) to 6%. for power of 80% enrolment of 622 patients is required. the intent-to-treat principle is used for the data analysis.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the rectum or rectosigmoid junction * clinical stage t1-4an0-2m0-1 (distant metastases must be resectable) * indications for surgical rectal resection * ecog status 0-2 * at least 18 years of age * written informed consent exclusion criteria: * medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol * pregnancy or breast feeding * medical contraindications for surgical treatment * any use of antibiotics 30 days prior to inclusion * functioning stoma * contraindications for use of mbp or oa drugs or their components * indications for obstructive resection or abdominoperineal excision * acute bowel obstruction, bleeding or perforation * other malignancies not in remission

Keywords: rectal cancer bowel preparation mbp oral antibiotics
atropine 0.01% eyedrops for evolutive myopia treatment in children

Conditions: Myopia; Children

Summary: prevalence of myopia and its complications has been increasing over the past decades, especially among children and adolescents. it reaches record levels in asia: nearly 80% of the population in some regions in 2012 where the investigators speak in terms of epidemic. atropine 0.01% eyedrops one drop per day is today an evolutive myopia treatment, whose results are promising. the investigators use this eye drops in our clinical practice at hospital of saint-etienne since 2017. few clinical data have been published so far concerning the french population. the investigators would like to build a database so that the investigators can publish our results and share our experience.


Eligibility criteria:
inclusion criteria: * children with active myopia treated with atropine 0.01% eye drops * patient affiliated with a social security organization * agreement of both parents exclusion criteria: * non compliance with treatment

Keywords: atropine
treatment of mantle cell lymphoma at diagnosis for patients under 65 years

Conditions: Mantle Cell Lymphoma

Summary: phase ii study to test in first line the vad (vincristine adriablastine dexamethasone) + c (chlorambucil ) regimen associated to rituximab ( r-vad + c ) in a cohort of young patients under 66 years with a mantle cell lymphoma and also the test the role of an in vivo marrow purge with rituximab before an autologous stem cell transplantation for the consolidation of the patients which fulfilled a response to 4 cycles of (r vad + c) regimen.

all patients at diagnosis with a stage ii, iii or iv an arbor disease are treated with 4 cycles of (r vad +c) . the responders more than rp \> 50% received 2 other cycles before to be intensified with alkeran 140 mg/ m2 and a 8 grays tbi over 4 days before an autologous pbsct.the stem cell collection is realised after a mobilisation with hd cyclophosphamide (4 mg/m2) after the four r-(vad + c) cycles and purged by a rituximab injection 10 days before the collection. there is an clinical and molecular evaluation of the strategy

Eligibility criteria:
inclusion criteria: * mantel cell lymphoma * cd 20+ * at diagnosis or without anterior chemotherapy * age \>18 and \< 66 years * ann arbor ii, iii or iv * ecog \<3 * contraindication for rituximab treatment * informed consent signed * no cancer anteriory * renal and hepatic function compatible with the treatment * ventricular fraction \> 50 % with echographic method and \> 40% with isotopic method exclusion criteria: * other type of lymphoma * age\ 66 years * informed consent not signed * anterior cancer * contraindication to rituximab * cardiac insufficiency

Keywords: mantle cell lymphoma chemotherapy autologous pbsct molecular evaluation
preadmission metformin exposure and incidence of acute kidney injury

Conditions: AKI

Summary: more than 50% of icu patients suffer from acute kidney injury (aki). metformin shows protective properties in kidney disease. our study aimed to validate aki incidence among diabetes patients in the icu with or without preadmission metformin exposure. we included non-aki patients with type 2 diabetes in medical information mart for intensive care (mimic)-iii database. incidence of aki and mortality were compared between those with and without preadmission prescriptions.

emerged as a major public healthy problem, acute kidney injury (aki) is now influencing millions of people worldwide and leading to reduced survival, increased progression of latent chronic kidney disease (ckd), and even new onset of ckd. more than half of intensive care unit (icu) patients underwent aki in a recent multinational cross-sectional study, often resulting in the need for renal replacement therapy with a high socio-economic impact for the patients.the effective precaution and treatment strategy remains limited. as the most general and first-line biguanide antihyperglycemic drug, metformin has anti-inflammatory characteristics and is related with decreased all-cause mortality compared with other antihyperglycemics.. in some clinical trials and experimental studies conducted on divergent rodent models representing various types of kidney diseases going from aki to ckd, metformin has been shown beneficial effects on the kidney. moreover, preadmission metformin exposure is associated with a lower rate of 28-day mortality among aki patients showed in several clinical studies. however, in critical care patients with type 2 diabetes, the evidence of preadmission metformin usage decreasing a risk of aki incidence is still absented. therefore we performed a retrospective cohort study to validate the association of preadmission metformin exposure and aki incidence in patients with diabetes in the icu .

Eligibility criteria:
inclusion criteria: * type 2 diabetes * \>16 years old and \<90 years old * without aki exclusion criteria: * ckd * data error * type 1 diabetes * diabetes patients with pregnancy * no metformin record * with aki

Keywords: metformin;aki; type 2 diabetes; icu
efficacy and safety of injectable association of dexamethasone, dipyrone and hydrocobalamin in lumbar sciatic pain

Conditions: Lumbar Sciatic Pain

Summary: a phase iii, randomized, multicenter, open label clinical trial to evaluate efficacy and safety of the injectable association of dexamethasone, dipyrone, and hydroxocobalamin in lumbar sciatic pain. the study will enroll 140 patients in each arm (280 total).


Eligibility criteria:
inclusion criteria: * sign the study informed consent form; * to be diagnosed with moderate to severe lumbar sciatic pain (defined as limiting the work activities or the ordinary tasks performance or at the investigator's discretion) within the last 3 days; * aged 18 to 75 years old; * to be able to meet the study procedures exclusion criteria: o-diagnosed with chronic rheumatologic diseases, except recurrent lumbar sciatic pain; * patients with one of the following conditions, as per the investigator's criteria: * severe renal failure under hemodialysis, severe liver failure, uncontrolled severe heart failure; * severe injuries on gastrointestinal tract; * other severe comorbidities; * patients taking acetylsalicylic acid or any anti-clotting; * female patients who are pregnant, lactating, willing to get pregnant or not willing to use an appropriate contraceptive method during the study period.

Keywords: lumbar sciatic pain moderate to severe lumbar sciatic pain within the last three days
trial in arrhythmia radioablation for ventricular tachycardia: single fraction vs three fractions

Conditions: Ventricular Tachycardia

Summary: this is a research study that aims to understand if giving a lower dose of treatment all at once is as effective and safe as dividing it into three smaller doses for patients with a heart condition called refractory ventricular tachycardia (vt). these patients have not exhibited positive responses to conventional medications or procedures. this study aims to explore whether an alternative approach could yield more beneficial outcomes.

ventricular tachycardia (vt) is a life-threatening heart rhythm disorder that arises from areas of diseased tissue in the heart. treatment of vt can involve anti-arrhythmic drugs and catheter-based ablations. unfortunately, despite multiple antiarrhythmic drugs, as well as the catheter-based ablation procedures, vt continues to persist in your case. at this point in time, the investigators believe that stereotactic body radiotherapy (sbrt) remains the only possible option to potentially treat vt. the investigators hypothesize that by administering sbrt at different dose levels and fractionation may achieve a better therapeutic ratio, defined as comparable efficacy with less risk of toxicity due to lower dose exposure to the normal tissue, including the heart vasculature, in patients when compared to vt patients who receive a dose of 25gy in a single fraction which is the current treatment option. this is a randomized dose de-escalation trial where the patients will be randomized in in one of the two experimental arms, receiving 1 single fraction or 3 daily consecutive fractions of rt, and will be treated into a prespecified dose level group, based on the study development. the study includes three de-escalated consecutive dose level groups for each of two randomized treatment arms and there will be 3 patients per group and each group will receive a particular radiation treatment either as single treatments or three treatments. the purpose of this treatment is to safely reduce episodes of vt.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * structural heart disease: 1. ischemic cardiomyopathy 2. non-ischemic cardiomyopathy 3. hypertrophic cardiomyopathy * refractory vt severity: 1. vt leading to icd shock with minimum 3 episodes in any 3-month period without reversible cause; 2. failed or intolerant to antiarrhythmic drug therapy (either amiodarone or ≥ 2 aads) and failed ablation (ca) 3. or ablation (ca) contraindicated * ability to understand study protocol and to write informed consent * willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements * expected to remain available for at least 36 months after enrollment exclusion criteria: * age \< 18 years * pregnancy * prior chest radiation therapy