Kornimate/medical-research-clean huggingface dataset:
use of pentoxifylline in human t-lymphotropic virus type-1 (htlv-1) diseases

Conditions: HTLV-1; Tropical Spastic Paraparesis; Immune System Diseases; Physical Disability; Pentoxifylline

Summary: in this study the investigators are going to evaluate the efficacy pentoxifyline in htlv-1 patients with neurological diseases: ham/tsp or neurogenic bladder. in some laboratory experiments the investigators observed that this drug had the capacity to reduce the immune response in htlv-1 infected cells. since the exacerbated immune response is know to cause neurological disease in patients with htlv-1 the investigators hope that pentoxifyline can alleviate symptoms and delay the progress of ham/tsp in patients.

the human t-lymphotropic virus type 1 (htlv-1) infects 20 million individuals worldwide and is the causative agent of htlv associated myelopathy/ tropical spastic paraparesis (ham/tsp). although only 5% of htlv-infected individuals will develop ham/tsp, the investigatorts have observed that about 30% have neurological complaints and/or neurogenic bladder associated with htlv-1. the immunopathogenesis of those diseases is related to the exaggerated immune response with high production of cytokines and induced neurological injury. so far there is not any effective drug against htlv-1 and modulation of the immune response can help to alleviate the clinical manifestations of those patients and prevent the progression of symptoms. the preliminary data show that pentoxifylline has ability to decrease production of tnf-α and ifn-γ in patients with htlv-1 infection and patients with ham/tsp. the proposal entitled "evaluation of the efficacy of pentoxifylline in attenuating the neurological disease associated with htlv-1 and negatively modulate the immune pathological response" extends the previous studies in order to determine the ability of pentoxifylline in modulate the immune response and modify the course of the clinical manifestations in patients infected with htlv-1. the influence on the immune response in the expression of disease will be determined in a therapeutic trial with two groups of patients: 1) patients with neurogenic bladder associated with htlv-1, 2) patients with ham/tsp. primary end point is clinical and neurological exam and secondary end point are measure of proinflammatory cytokines (tnf-α, ifn-γ, il-1 and il-6) and chemokines that attract t cells to sites of inflammation (cxcl9 and cxcl10).

Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 80 years; * confirmed htlv-1 infection with western blot analysis; * ham/tsp diagnosed patients according to the who * patients with htlv-1 and neurogenic bladder diagnosed by clinical and urodynamic study * disease duration \< 5 years exclusion criteria: * neurological diseases with functional limitations. * co-infection with hepatitis b or c, syphilis, chagas disease or hiv * use of immunossupressive drugs * immune disease * pregnancy

Keywords: htlv-1 tropical spastic paraparesis immune system diseases physical disability pentoxifylline
study of oral atogepant when added to onabotulinumtoxina (botox) to assess adverse events and change in disease activity in adult participants with chronic migraine

Conditions: Chronic Migraine

Summary: migraine is characterized by attacks of throbbing, moderate or severe headache, often associated with nausea, vomiting, and/or sensitivity to light and/or sound. the study will assess safety and tolerability of atogepant when added to botox, as well as prospectively evaluate the efficacy of add-on atogepant for migraine prevention. adverse events and change in disease activity will be monitored. atogepant is an investigational drug being developed to prevent chronic migraine. approximately 75 adult participants will be enrolled at approximately 30 sites in the united states. all participants will receive atogepant oral tablet once a day (qd) during the 24-week treatment period, in addition to their standard of care botox. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * at least a 1-year history of chronic migraine (cm), with or without aura, consistent with a diagnosis according to international classification of headache disorders 3rd edition (ichd-3 2018) and with or without acute medication overuse as defined in the protocol. * must be currently treated with botox for cm: treated with \>= 2 treatment cycles in the 8 months prior to visit 2 (day 1) with documentation of payer authorization or written attestation of self-pay to support continued use of botox. * must have 8 to 23 (inclusive) migraine days in the electronic diary \[ediary\] screening/baseline period (ediary data must have been collected for at least 20 days). exclusion criteria: * use of opioid-containing products for more than 4 days per month for acute treatment of headache in the 3 months prior to screening or during the screening/baseline period. * treatment of study target muscles using acupuncture, transcutaneous electrical nerve stimulation (tens), cranial traction, dental splints for headache, or head and/or neck injections of anesthetics/steroids within 4 weeks prior to screening and throughout the study. * concurrent use of any migraine prevention treatment other than botox (required concomitant medication; or topiramate \<=100mg daily) including use of oral gepants in the 4 weeks prior to screening nor during the screening/baseline period. * current use or use within the 6 months (24 weeks) prior to screening, of mabs blocking the cgrp pathway. * concurrent use of oral gepants for acute migraine treatment in the 4 weeks prior to screening nor during the screening/baseline period.

Keywords: chronic migraine migraine atogepant onabotulinumtoxina botox qulipta
comparison of captivator tissue cassettes vs. no cassettes for endoscopic mucosal resection in esophageal carcinoma

Conditions: Esophageal Neoplasms

Summary: the main purpose of this study will be to two-fold; firstly to determine whether the use of a captivator tissue cassette has an effect on the preservation of tissue histology (minimizing artifactual curling) , and secondly to determine whether the use of a intraprocedural cassette is practical. the investigators believe that this will greatly aid in elucidating the best technique for optimizing performance of emr for esophageal lesions.

as a result of the advances in endoscopic procedures, the detection of early stage esophageal carcinoma has increased. endoscopic mucosal resection (emr) is an innovative technique for removal of high grade intraepithelial neoplasia/dysplasia to prevent the progression of invasive carcinoma which occurs in about a third of patients. emr involves the endoscopic therapeutic removal of the abnormal esophageal area(s) of tissue by snare or suction, aiming to include as much of the submucosal layer as possible, which is (are) then submitted for histopathological examination for pathological diagnosis and tumor staging. compared with esophageal biopsy, this methodology reveals more advanced tumor stages in terms of grading and vertical infiltration in 10-20% of patients. because of the importance of histopathologic diagnosis, the specimen should be pinned on a cork or styrofoam board to prevent curling and maintain the orientation, integrity of the size and shape, and fixed in an appropriate volume of 10% formalin. unfortunately, specimens are often not pinned as emr specimens can be difficult and time consuming to pin because of their thickness, hence the specimen integrity (size and shape) and orientation is compromised. therefore the main purpose of this study will be to two-fold; firstly to determine whether the use of a captivator tissue cassette has an effect on the preservation of tissue histology (minimizing artifactual curling) , and secondly to determine whether the use of a intraprocedural cassette is practical. the investigators believe that this will greatly aid in elucidating the best technique for optimizing performance of emr for esophageal lesions.

Eligibility criteria:
inclusion criteria: * all patients referred to florida hospital endoscopy unit for assessment of an esophageal lesion that require emr * age ≥ 19 years exclusion criteria: * age \<19 years * unable to safely undergo emr for any reason * coagulopathy (inr \>1.6, thrombocytopenia with platelet count \<80,000/ml) * unable to provide consent for any reason * pregnancy (confirmed with standard of care urine pregnancy test for all women with child-bearing potential)
serum citrate in diagnosis and follow-up for glaucoma

Conditions: Glaucoma

Summary: glaucoma might be a mitochondria associated disease. since citrate is a major component in mitochondrial metabolism its determination in blood might serve as a biomarker.


Eligibility criteria:
inclusion criteria: * age\> 18 years * glaucoma exclusion criteria: * active ocular inflammation * ocular hypertension * nephropathy * alcohol-, drug abuse * mitochondriopathy

Keywords: glaucoma citrate
effect of smokeless tobacco on anterior segment

Conditions: Eye Manifestations; Tobacco; Use, Harmful; Tobacco Chewing Toxicity

Summary: observational, comparative, cross-sectional study

to evaluate the acute and chronic effects of smokeless tobacco (st) on the anterior segment parameters using optical biometry. observational, comparative, cross-sectional study place and duration of study: department of ophthalmology, kahramanmaras sutcu imam university. the study included 53 right eyes of 53 subjects (study group), who used st and 54 right eyes of 54 healthy subjects without st (control group). following a full ophthalmological examination, baseline measurements were taken with optical biometry and these measurements were repeated at 5, 30 and 60 mins after using st.

Eligibility criteria:
inclusion criteria: * a subject who use st * a subject who was not using st exclusion criteria: * refractive disorder * systemic chronic disease (diabetes, hypertension, neurological, etc.) * ocular trauma * ocular surgery * glaucoma * optic disc abnormalities * congenital anomaly

Keywords: optical biometry pupillar diameter smokeless tobacco
the renew trial: a multi-center, randomized, double-masked, parallel-group, vehicle-controlled, adaptive phase 3 clinical trial to assess the safety and efficacy of subjects with dry eye disease

Conditions: Dry Eye

Summary: the renew trial is a multi-center, randomized, double-masked, parallel-group, vehicle-controlled, adaptive phase 3 clinical trial to assess the safety and efficacy of reproxalap 0.25% ophthalmic solution compared to vehicle in subjects with dry eye disease


Eligibility criteria:
inclusion criteria: * be at least 18 years of age of either gender and any race; * have a reported history of dry eye for at least 6 months prior to visit 1; * have a history of use or desire to use eye drops for dry eye symptoms within 6 months of visit 1 exclusion criteria: * have any clinically significant slit-lamp findings at visit 1, including active blepharitis; meibomian gland dysfunction (mgd); lid margin inflammation; or active ocular allergies that require therapeutic treatment, or, in the opinion of the investigator may interfere with the assessment of the safety or efficacy of reproxalap or vehicle; * have or be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at visit 1; * have worn contact lenses within 7 days of visit 1 or anticipate using contact lenses during the study; * have used any eye drops within 2 hours of visit 1; * have previously had laser-assisted in situ keratomileusis (lasik) surgery within the last 12 months; * have used ophthalmic cyclosporine or lifitegrast 5.0% ophthalmic solution within 90 days of visit 1; * have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of visit 1; * have used temporary or permanent punctal plugs within 30 days prior to visit 1 or anticipate their use during the study period
the effect of gender on the consumption of pain medication in infants undergoing craniosynostosis repair or untethering of cord in itu

Conditions: Craniosynostosis Repair; Untethering of Cord

Summary: postoperative pain is a major concern in routine management of children admitted to pediatric intensive care treatment. there are significant negative physiological and psychological ramifications of postoperative pain such as impairment of cardiac function due to tachycardia, restlessness in an intubated patient requiring increase dosage of sedative and paralytic drugs and reduced patient cooperation in the healing process. the main body of evidence dealing with gender differences in pain perception and treatment stems from studies in the adult and adolescent population as the gonadal hormones have a central role in the way one experiences pain the hypothesis of this study is that there is a difference in the perception of pain, the amount of analgesia used and the response to pain medication between male and female infants undergoing craniosynostosis repair or untethering of cord.


Eligibility criteria:
inclusion criteria: all infants 0-1 year old, admitted to picu after craniosynostosis repair or untethering of cord. exclusion criteria: 1. contraindication to analgesic medication 2. infants with neurologic deficits that may hinder the assessment of pain severity such as facial nerve palsy and limb paralysis. 3. ventilated infants.
a study of adherence to once monthly ibandronate (bonviva) in women with post-menopausal osteoporosis, supported by a patient relationship program (prp)

Conditions: Postmenopausal Osteoporosis

Summary: this 2 arm study will assess the impact of bone marker feedback (bmf), using serum carboxy-terminal collagen crosslinks (ctx) and communication of results at 3 months, on adherence to once monthly ibandronate (150 milligrams \[mg\] per oral \[po\]) in women with post-menopausal osteoporosis supported by patient-relationship program (prp). participants will be randomized either to receive bmf or no bmf; both groups will be supported by prp. the anticipated time on study treatment is 3-12 months.


Eligibility criteria:
inclusion criteria: * ambulatory, post-menopausal women with osteoporosis; * eligible for bisphosphonate treatment; * naïve to bisphosphonate therapy, or lapsed users (last bisphosphonate intake greater than or equal to \[\>=\] 6 months ago). exclusion criteria: * inability to stand or sit upright for at least 60 minutes; * inability to swallow a tablet whole; * hypersensitivity to bisphosphonates; * treatment with drugs, or presence of active disease, known to influence bone metabolism; * history of upper gastrointestinal disease.
evaluating the safety of exemestane following 2-3 years of adjuvant tamoxifen therapy in postmenopausal early breast cancer patients

Conditions: Early Breast Cancer

Summary: evaluating the safety, tolerability and efficacy of aromasin® when used in routine clinical practice, evaluating adherence to prescribed aromasin® treatment and to understand reasons for early discontinuation.

this study was terminated on 01-aug-2011 due to very low potential to enroll planned number of patients or any sufficient number of patients for complete statistical analyses. this study is not being terminated because of safety or efficacy concerns.

Eligibility criteria:
inclusion criteria: * postmenopausal females. * patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis. * patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment. * patients whose tumour was estrogen receptor positive (er+). * evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: * patients for whom aromasin® treatment is contraindicated (see spc). * presence of metastasis or a contra lateral tumour. * other adjuvant endocrine therapy. * another concomitant antineoplastic treatment. * participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.

Keywords: exemestane adjuvant treatment in postmenopausal women estrogen receptor positive early breast cancer tamoxifen
venue ultrasound evaluation - israel

Conditions: Ultrasound Exam in Emergency/Medical Care

Summary: the study purpose is to collect images and user feedback from the next generation venue ultrasound system, components, and accessories under clinical conditions, as required for device development and optimization.

adult patients (aged \>18 years) will be enrolled that present for emergency or immediate medical care, in facilities such as the intensive care unit (icu), us unit, and/or other departments. subjects may or may not have a clinical indication for ultrasound scanning as part of their regular medical care and will be required to meet the inclusion criteria and none of the exclusion criteria. if a subject has a clinical indication for ultrasound exam, the routine exam will be performed with the standard equipment, and an additional exam will be performed using the investigational ultrasound device.

Eligibility criteria:
inclusion criteria: 1. adults (aged 18 years of age or older) at the time of consent; 2. eligible to undergo ultrasound scanning per the site standard of care (with or without a clinical indication for scanning); 3. able and willing to provide written informed consent for participation exclusion criteria: 1. are pregnant subjects 2. require procedures that cannot be readily completed using available investigational devices; 3. require or are anticipated to require medical care where study participation could reasonably be expected to adversely impact patient care.
hemorrhoidal artery ligation and rectoanal repair versus stapled hemorrhoidopexy

Conditions: Hemorrhoids

Summary: background: hemorrhoids of grade 3 and 4 can be treated either by conventional, rather invasive procedures, like milligan-morgan or ferguson or by modern, less invasive procedures with less postoperative pain. doppler guided hemorrhoidal artery ligation and stapled hemorrhoidopexy are examples for such modern procedures. hemorrhoidal artery ligation causes less post operative pain than stapled hemorrhoidopexy, however the former has a higher recurrence rate. combining hemorrhoidal artery ligation with rectoanal repair should reduce the recurrence rate without increasing the post operative pain. hypothesis and aim: the study tries to prove the assumption that combined hemorrhoidal artery ligation and rectoanal repair cause less pain and have less post operative complications than stapled hemorrhoidopexy.


Eligibility criteria:
inclusion criteria: * hemorrhoids grade 3 * no active anti-coagulation treatment * no hemorrhoidal recurrence * no previous surgery on rectum or anus * no previous local radiotherapy * no mental incapacities, good study compliance can be expected * no severe incontinence (wexner score \> 12) * no severe comorbidities * no inflammatory anal diseases (abscesses, fistulas) * informed consent exclusion criteria: * patient wish * inoperability with the assigned intervention, switching to other treatment method

Keywords: hemorrhoids
anal dysplasia in patients with inflammatory bowel disease and healthy controls

Conditions: Anal Squamous Intraepithelial Lesion (ASIL); HPV DNA

Summary: this study is designed to establish the prevalence of anal squamous intraepithelial lesion (asil) in patients with inflammatory bowel disease (ibd) and healthy controls.

ibd patients attending the stanford inflammatory bowel disease (ibd) clinic and age-matched healthy controls are screened for eligibility. informed consent is obtained for eligible subjects. an anonymous self-administered questionnaire is administered to assess risk factors for hpv. for ibd patients, information regarding ibd diagnosis and treatment is obtained. an anal pap smear is performed at the time of a clinic visit or at the time of an already scheduled colonoscopy. samples are collected and processed at stanford pathology where a blinded pathologist reads all specimens. human papillomavirus (hpv) dna testing is performed on all specimens. all patients with anal squamous intraepithelial lesion (asil) are referred to a colorectal surgeon for further recommendations or treatment, which includes a high-resolution anoscopy.

Eligibility criteria:
inclusion criteria: * all ibd patients followed in the ibd clinic and healthy controls who are greater than 18 years old exclusion criteria: * history of hpv vaccination * pregnancy * other immunosuppressed states (i.e. systemic lupus erythematosus, rheumatoid arthritis, cancer, human immunodeficiency virus (hiv), transplant) * ibd patients who don't meet immunosuppression/non-immunosuppression criteria * inability to obtain informed consent from patient * previous diagnosis of asil or anal/rectal cancer

Keywords: asil anal dysplasia ibd hpv dna
efficacy and safety of resveratrol and lipoic acid transdermal patch for lipolysis in overweight volunteers

Conditions: Lipolysis

Summary: to evaluate the lipolysis effect of resveratrol and lipoic acid transdermal patch in overweight volunteers

66 participants with overweight received a resveratrol and lipoic acid transdermal patch treatment. the treatment areas have been treated including left and right arms. subjects were evaluated using standardized measurements of body weight and circumference of arms at baseline and 2 weeks follow-up visits. evaluation of physician were also measured.

Eligibility criteria:
inclusion criteria: * healthy volunteers with bmi \> 23 exclusion criteria: * resveratrol or lipoic acid allergies