Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of cnv2197944 versus placebo in patients with post-herpetic neuralgia

Conditions: Post-herpetic Neuralgia

Summary: to investigate the effect of repeat oral dosing of cnv2197944 75 mg tid on the pain experienced in post-herpetic neuralgia (phn) as measured by changes in pi-nrs after three weeks of treatment compared to the baseline period.

a 3 week randomised crossover study to investigate the effect of repeat oral dosing of cnv2197944 75 mg tid versus placebo for on the pain experienced in post-herpetic neuralgia (phn. each 3 week treatment period is seperated by a 2 week washout period. the primary outcome measure is the change from baseline in the pi-nrs after three weeks of treatment. secondary outcome measures include pain responder rates, clinical and patient global impressions of pain, and the neuropathic pain symptom inventory.

Eligibility criteria:
inclusion criteria: male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent. patients with post-herpetic neuralgia (phn) with pain at screening present for more than 3 months after healing of the herpes zoster skin rash. the maximum duration of phn will be no longer than 5 years. exclusion criteria: patients having other severe pain, which may impair the self-assessment of the pain due to phn. patients who have received nerve blocks for neuropathic pain within 4 weeks prior to the start of the single-blind placebo run-in certain medications used to relieve the pain of phn, specifically gabapentinoids (gabapentin and pregabalin), carbamazepine and topical agents (eg capsaicin, lidocaine) patients with a documented failure to respond to a maximally tolerated dose regimen of gabapentin or pregabalin. patients taking more than one medication to treat the phn pain
cervix hypoxia faza

Conditions: Cervix Cancer

Summary: the purpose of this study is to look for low levels of oxygen (hypoxia) in your cervix cancer using a special x-ray test called a positron emission tomography (pet)scan. hypoxia may have an effect on how cervix cancer grows and responds to treatments like radiotherapy and chemotherapy. doctors at princess margaret hospital have measured hypoxia in over 300 patients. the use of pet scans to measure hypoxia may be better and simpler than the methods used previously.


Eligibility criteria:
inclusion criteria: * age ≥18 years * histologic diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix * tnm (7th edition) ct1-4, n0-1, m0-1 * intention to treat using radiotherapy with or without concurrent cisplatin chemotherapy according to the current treatment policies of the pmh gynecology group * no cytotoxic anti-cancer therapy for cervix cancer prior to study entry * a negative urine or serum pregnancy test within the two week interval immediately prior to pet-ct imaging, in women of child-bearing age * ability to provide written informed consent to participate in the study exclusion criteria: * prior complete or partial hysterectomy * carcinoma of the cervical stump * inability to lie supine for more than 30 minutes * patients taking the drug disulfuram (antabuse)
cholecalciferol on hemodialysis patients

Conditions: Hemodialysis Complication; Vitamin D Deficiency; Vascular Calcification

Summary: * screening the prevalence of vitamin d deficiency among egyptian hemodialysis patients on a single center (ain shams university hospital). * assessing the effect of the native type of vitamin d (cholecalciferol) on replenishing its deficiency via extra-renal vitamin d receptors (vdr), among egyptian hemodialysis patients. * assessing the effect of cholecalciferol on vascular calcification among egyptian hemodialysis patients. * assessing the effect of cholecalciferol on blood pressure, parathyroid hormone.


Eligibility criteria:
inclusion criteria: 1. both sexes aged between 18-75 years 2. patients on hd greater than 3 months at least. 3. stable clinical condition (no hospitalization in the previous 3 months) 4. informed consent in accordance with the declaration of helsinki. 5. pth level between 150 - 800 pg/ml. exclusion criteria: 1. hypersensitivity to cholecalciferol. 2. participant in an another clinical trial within the past 4 weeks. 3. judged to be unsuitable as a subject by the attending physician. 4. pregnant or breastfeeding female
deplin® p.l.u.s. program (progress through learning understanding & support)

Conditions: Major Depressive Disorder

Summary: this study will be an observational study in which patients who have been prescribed deplin® are invited to participate in surveys regarding their experiences with deplin®. the purpose of this study is to increase the understanding of the role of l-methylfolate among patients who are candidates for deplin®, provide patients with personalized education and support, and contribute to the overall understanding of the needs and concerns of patients being treated for depression.

surveys used to conduct this study will be administered via telephone or online by infomedics, inc., a company with a system for developing such patient-physician feedback programs. participating physicians will ask their patients to participate in the program after deplin® has been prescribed and provide them with a brochure containing an introduction to the program and instructions on how to enroll. patients self-enroll, take a brief survey before starting their deplin® prescription, and then a follow-up survey after 90 days of treatment with deplin®. as patients complete surveys within the study, their physician will receive individualized feedback reports outlining their patient's treatment experience and progress. patients will also receive a copy of their own reports, to help encourage them to continue taking deplin® as directed. patients will also receive educational materials about managing their depression.

Eligibility criteria:
inclusion criteria: * new deplin® start * only for patients with depression who have been prescribed brand name deplin® to help metabolic management of depression. * clinically depressed patients who have been prescribed deplin® in combination with an antidepressant. * at the start of antidepressant therapy * as augmentation to antidepressant therapy exclusion criteria: * patients who do not meet dsm iv criteria for major depression * if participant indicates that he or she did not get a prescription for deplin®, he/she will not be able to complete the survey(s). * for follow-up surveys, if the participant indicates that he/she has not been taking deplin®, he/she will not be able to complete the survey(s).

Keywords: l-methylfolate deplin depression antidepressant combination therapy augmentation folate folic acid homocysteine methionine mthfr genotype c677t mutation vitamin b6 vitamin b12
evaluation of the periotest method in dental traumatology

Conditions: Dental Trauma

Summary: background/aims: the periotest® method represents a technique for objective tooth mobility assessment. the aims of this study were: 1. receiving information about normal periotest® values in vertical and horizontal dimension on periodontally healthy teeth for individuals aged 20-35, 2. investigating the reliability of the periotest® method in terms of intra-serial and inter-serial reproducibility before splinting and with an applied dental trauma splint, 3. evaluating the splint effect of two different wire-composite splints in vivo. materials and methods: on periodontally healthy dental students (n=33; mean age 24.7 years) periotest® values were measured on reproducible measuring points, in vertical and horizontal dimension and before splinting and after splint insertion. three readings were taken per serial to observe the intra-serial reproducibility, and for testing inter-serial reproducibility three serials were measured (friedman-test; p ≤ 0.001). two different wire-composite-splints (1 = dentaflex 0.45 mm, 2 = strengtheners 0.8x1.8) were inserted, the periotest® values were measured and the splint effects were calculated and compared (whitney-mann-u-test; p ≤ 0.001).


Eligibility criteria:
inclusion criteria: * age 19-36 * healthy upper front teeth exclusion criteria: * periodontal disease * orthodontic treatment during the investigation period * history of dental trauma * fillings or restorations on upper front teeth * endodontically treated teeth

Keywords: tooth mobility assessment splinting splint rigidity
adjuvant hepatic arterial infusion and combination chemotherapy in treating patients with resectable hepatic metastases from colorectal cancer

Conditions: Colorectal Cancer; Metastatic Cancer

Summary: the purpose of this study is to find the highest dose that can be given safely to people who have had liver disease resected. this is a phase i study. the goal of a phase i study is to find a safe dose range based on side effects. the drugs that will be given by vein are oxaliplatin ("oxali") plus 5-fluorouracil and leucovorin ("5fu" and "lv"). this is systemic chemotherapy, since it goes to the whole body. the drugs that will be placed in the pump are floxuridine (fudr) and dexamethasone. (the dexamethasone is not an anti-tumor drug; it helps protect healthy liver tissue from possible side effects of the fudr.) this is the regional chemotherapy, since it goes only to the liver. the researchers have studied these drugs and know the best doses of each when they are used in patients who have not had liver resections. we do not yet know how the drugs work with each other in patients with a liver resection. this study will tell us the best doses of each drug when they are given over the same period of time.


Eligibility criteria:
subject inclusion criteria: * history of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. confirmation of diagnosis must be performed at mskcc. * potentially completely resectable hepatic metastases without current evidence of other metastatic disease. * abdominal and pelvic ct scans and chest ct or x-ray within 6 weeks prior to registration. (mri of abdomen may be substituted for ct of abdomen.) * lab values within 14 days prior to registration: * wbc ≥ 3.0 k/ul * anc \>1.5 k/ul * platelets ≥ 100 k/ul * total bilirubin ≤ 1.5 mg/dl. * prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to registration to this study. * kps ≥ 60% * signed informed consent. subject exclusion criteria: * prior radiation to the liver. (prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration.) * active infection, ascites, hepatic encephalopathy * prior oxaliplatin or cisplatin or hai fudr * female patients who are pregnant or lactating

Keywords: liver metastases stage iv colon cancer stage iv rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum recurrent colon cancer recurrent rectal cancer
treatment chronic uti post kidney transplant

Conditions: Urinary Tract Infections; Transplant-Related Disorder

Summary: urinary tract infections (utis) with extended-spectrum -lactamase (esbl)-positive enterobacteriums (esbl-e) are a common infectious complication of renal transplant recipients, with 10% of patients suffering from utis with esbl-e within the first year posttransplant. moreover, recurrence rates of uti caused by esbl-e are almost three times higher than those by cephalosporin-susceptible enterobacteriums demonstrating the decreased efficacy of antibiotics in the treatment of these utis.

according to each patient's urine culture, resistant urinary tract infections will be treated with specific phages and patients will be followed up with their urine cultures for response to therapy.

Eligibility criteria:
inclusion criteria: * stable kidney transplant recipients * stable immunosupression dose * stable renal function * resistant urinary infection with positive uc exclusion criteria: * rejection periods * frail patients
clinical evaluation of daily disposable contact lenses

Conditions: Myopia

Summary: the objective of the study is to compare the overall subjective preference of filcon ii 3 daily disposable silicone hyrogel contact lenses compared to etafilcon a and nelfilcon a daily disposable conventional hydrogel contact lenses.

double-masked, randomised, controlled crossover trial. subjects were randomized to wear one or the other of the conventional hydriogel lenses; all subjects wore the filcon ii 3 lenses. the first randomly assigned lens type was worn for 3 days, with daily replacement, followed by 3 days of wear of the other lens type, with daily replacement.

Eligibility criteria:
inclusion criteria: * is between 18 and 40 years of age (inclusive) * has had a self-reported visual exam in the last two years * is an adapted soft cl wearer * must be able to wear their lenses at least 3 full days, 10 hours per day, assuming there are no contraindications for doing so * has a cl spherical prescription between - 1.00 and - 6.00 (inclusive) * has less than 1.25 d spectacle cylinder in each eye. * baseline vision of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. * is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye * has clear corneas and no active ocular disease * has read, understood and signed the information consent letter * is willing to comply with the wear schedule (at least 3 full days) * is willing to comply with the visit schedule exclusion criteria: * has never worn contact lenses before. * currently wears rigid gas permeable contact lenses. * has a history of not achieving comfortable cl wear (3 days per week; \> 8 hours/day) * has a cl prescription outside the range of - 1.00 to -6.00d * has a spectacle cylinder greater than -1.25d of cylinder in either eye. * has best corrected spectacle distance vision worse then 20/25 in either eye. * has any systemic disease affecting ocular health. * is using any systemic or topical medications, (includes rewetting drops, artificial tears and allergy drops), that will affect ocular health. occasional use is acceptable but not during the trial. * has any ocular pathology or severe insufficiency of lacrimal secretion * has persistent, clinically significant corneal or conjunctival staining * has active neovascularization or any central corneal scars. * is aphakic. * is presbyopic. * has undergone corneal refractive surgery. * is participating in any other type of eye related clinical or research study.
predicting response to neoadjuvant endocrine therapy (neo-predict)

Conditions: Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III; Carcinoma, Breast

Summary: the goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called "neoadjuvant" treatment) affects breast cancer. the main questions the trial aims is answer are: 1. how breast cancer responds to endocrine therapy given prior to surgery? 2. to predict tumor pre-operative endocrine prognostic index (pepi) score for subjects enrolled in cohort b or c participants with early-stage breast cancer (stage i-iii) who are eligible for neoadjuvant endocrine therapy (net) will be enrolled in the study. participants will: * receive endocrine therapy as part of regular care for breast cancer * consent to samples of blood and tissue evaluation to determine how endocrine therapy effects the tumor * participate in this research anywhere from 2 weeks to 1 year, depending on duration of endocrine therapy and when surgery will be performed


Eligibility criteria:
inclusion criteria: * be capable of understanding the investigational nature of the study and all pertinent aspects of the study * be capable of signing and providing written consent in accordance with institutional and federal guidelines * histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast * clinical stage 1 to 3 breast cancer * candidate for surgical resection * estrogen receptor \> 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record. * her2 negative or her2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory or medical record. her2 negative tumor is defined per american society of clinical oncology and the college of american pathologists guidelines, 2018. patients with her2 low tumors are eligible as long as patients are not candidates for any her2 directed therapy. * ability to take oral medication * be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff * age ≥ 21 years exclusion criteria: * inability to comply taking net * inability to comply to study procedures

Keywords: breast cancer her2 carcinoma
effect of oxytocin nasal sprays on social behavior in social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: the purpose of this study is to learn more about how the hormone, oxytocin, impacts social behavior in terms of cooperation with others, attention processing, and reward processing, among patients with social anxiety disorder. based on available research, the investigators predict that in patients with social anxiety disorder, oxytocin will improve social cooperation during an online ball-tossing game called cyberball, reduce attention toward socially threatening cues during a dot-probe task, and lead to greater willingness to work for monetary rewards for others rather than themselves during an effort expenditure task.


Eligibility criteria:
inclusion criteria: * males \> 18 years of age with a primary (or co-principal) psychiatric diagnosis of social anxiety disorder (sad), as defined by diagnostic and statistical manual-iv (dsm-iv) criteria; * current liebowitz social anxiety scale (lsas) score \> 60, which is a clinical threshold for sad symptoms; * comorbid present dsm-iv major depression, dysthymia, specific phobia, or any of the other anxiety disorders as diagnosed by dsm-iv criteria will be permitted as long as sad is primary (the disorder that is most distressing to the patient). inclusion of patients with comorbidity will permit accrual of a more clinically relevant patient population; * willingness to participate in and comply with the study procedures as indicated by signing the informed consent form. exclusion criteria: * subjects with a serious medical illness for which hospitalization may be likely within the next three months; * subjects with a current diagnosis of schizophrenia, psychotic disorders, bipolar disorder, mental disorder due to a medical condition or substance, substance abuse or dependence, as diagnosed by dsm-iv criteria; * concurrent use of other psychotropic medications is excluded, except for antidepressants that have been taken at a stable dose for at least 2 weeks; * active suicidal or homicidal ideation or suicide attempts within the past six months requiring hospitalization; * subjects with significant nasal pathology (atrophic rhinitis, recurrent nose bleeds, or history of hypophysectomy); * smokers who smoke more than 15 cigarettes per day; * those who smoke cigarettes or have caffeine or alcohol within 24 hours of the study visit.
study to evaluate effectiveness of aranesp®

Conditions: Kidney Disease

Summary: the purpose of this study was to evaluate subject preference for aranesp® administered once monthly (i.e., every 4 weeks (q4w)) or procrit® administered once weekly (qw).


Eligibility criteria:
inclusion criteria: - subjects must have signed written informed consent - be on procrit® qw or q2w for a minimum of 12 weeks - must currently be on a stable dose of procrit® (defined as less than 25% change in procrit® dose over the 4 week period immediately prior to enrollment, with no missed doses) - have hgb 10-12 g/dl for at least 4 weeks prior to study start - have 15 less than gfr less than 89 ml/min/1.73 m2 - have serum vitamin b12 and folate levels above the lower limits of normal - transferrin saturation greater than 20% exclusion criteria: - currently receiving investigational erythropoietic agents - expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - have less than 1 year life expectancy

Keywords: kidney disease, renal, ckd (chronic kidney disease) cri (chronic renal insufficiency), pre-dialysis, amgen aranesp®, darbepoetin alfa, qw dosing q2w dosing, q4w dosing patient preference, subject preference
transvaginal natural orifice endoscopic surgery for extremely obese patients with early-stage endometrial cancer

Conditions: Endometrial Cancer; Extreme Obesity

Summary: the aim of this study is to investigate the feasibility and efficacy of the v-notes approach for extremely obese patients with early-stage type 1 endometrial cancer.


Eligibility criteria:
inclusion criteria: * extreme obese patients * early stage type-1 endometrial cancer proved by endometrial sampling exclusion criteria: * any contraindication for pneumoperitoneum * any contraindication for the dorsal lithotomy position * any contraindication for general anesthesia, * any contraindication for v-notes * suspicion of pelvic adhesions * presence or suspicion of obliteration of the pouch of douglas

Keywords: early stage endometrial cancer extreme obesity transvaginal notes
diet, insulin resistance, and cardiovascular risk

Conditions: Cardiovascular Diseases; Heart Diseases; Insulin Resistance; Hyperinsulinism; Diabetes Mellitus, Non-insulin Dependent; Diabetes Mellitus

Summary: to elucidate dietary factors that elevate risk for cardiovascular disease (cvd) in conjunction with insulin resistance.

background: clinical studies indicate that high carbohydrate intake may exacerbate the dyslipidemia often seen with insulin resistance. consequently, there is much debate as to the optimal dietary pattern for individuals with niddm to minimize risk for microvascular disease. data on this topic from free-living populations are scarce. in addition, associations of dietary antioxidants with cvd risk have not been evaluated in large community samples of persons with diabetes. design narrative: potential dietary determinants of hyperinsulinemia or of insulin resistance were evaluated, including high intake of dietary fats and of simple sugars and low alcohol consumption. as a major focus, dietary factors that may contribute to elevated cvd risk among persons with existing insulin resistance, including impaired glucose tolerance (igt) and non-insulin-dependent diabetes mellitus (niddm) were examined. five datasets from epidemiologic studies were available to evaluate specific hypotheses for men and women of black, hispanic and non-hispanic white ethnicity. the unique contributions of each dataset were as follows. the san luis valley diabetes study and the san antonio heart study enabled prospective analyses for large numbers of subjects with igt or niddm; the mexico city study provided a sample with contrasting dietary patterns in a non-white population; the kaiser permanente women twins study allowed for the removal of genetic influences by evaluating associations within monozygotic twin pairs; and the insulin resistance atherosclerosis study (iras) provided direct measurement of insulin sensitivity and subclinical atherosclerosis across the spectrum of glucose tolerance in three ethnic groups. an understanding of the accuracy of the dietary assessment instruments used in the three ethnic groups was critical to the interpretation of the findings related to diet and cvd risk variables. therefore, a second component of research was also conducted, that being an evaluation of the comparative validity of the food frequency interview used in the multi- cultural iras population using a series of 24-hour dietary recalls as the standard.

Eligibility criteria:
no eligibility criteria