Kornimate/medical-research-clean huggingface dataset:
nonmyeloablative conditioning and transplantation for patients with refractory systemic lupus erythematosus (sle)

Conditions: Lupus Erythematosus; Graft-versus-host Disease

Summary: the main goal of the study is to determine if bone marrow transplant (bmt) from a less specific pool of donors in combination with high dose cyclophosphamide can induce remission of refractory systemic lupus erythematosus.

systemic lupus erythematosus (sle) is a devastating systemic autoimmune disease that predominantly affects young women, is more common in african-americans than in whites, and results in poor quality of life. lupus has no cure, and up to 90% of patients require corticosteroids for disease control. more than half of patients with lupus have permanent organ damage, much of which is either directly due to or increased by corticosteroids. to satisfactorily manage moderate-to-severe sle, the investigators need effective treatments that will allow corticosteroid-sparing. high-dose chemotherapy followed by autologous bmt or peripheral blood progenitor transplantation (pbsct) has been proposed as a novel approach to treat severe autoimmune diseases. allogeneic bmt is not currently utilized for the routine treatment of sle because of the significant morbidity (gvhd) and mortality associated with the procedure. the investigators have recently developed an approach to bmt using post-transplant cyclophosphamide that allows us to safely perform allogeneic bmt from matched, mismatched, unrelated or haploidentical donors. transplant-related mortality, graft-failure and risk of gvhd have been very low with this approach. furthermore, this approach allows us to greatly expand the donor pool since any patient shares exactly one hla haplotype with each biological parent or child and half of siblings, an eligible haploidentical donor can be identified rapidly in nearly all cases. this trial will employ a fludarabine + cyclophosphamide conditioning along with posttransplantation cyclophosphamide on for patients with refractory sle. the purpose of this trial is to improve the salvage rate for patients with refractory sle through a reformatting of the immune system.

Eligibility criteria:
inclusion criteria: * four or more american college of rheumatology (acr) criteria for the classification of sle or 4 or more of the slice criteria * involvement of one or more of the following organ systems: renal, neurologic, hematologic, cardiac, pulmonary, gastrointestinal * a lack of response to corticosteroids in moderate-to-high doses, and to either an equivalent degree of immunosuppression with azathioprine, methotrexate, cyclosporin, tacrolimus, belimumab, rituximab, mycophenolate mofetil, and/or appropriate other treatment * patients should be eligible for transplantation according to the bmt policy manual exclusion criteria: * age less than 18 years and over 75 years * any risk of pregnancy * patients who are preterminal or moribund
low molecular weight heparin on the adenomyosis patients'ivf-et outcome

Conditions: Adenomyosis; Assisted Reproductive Technology

Summary: in assisted reproductive technology, adenomyosis patients are characterized by lower clinical pregnancy rate, lower implantation rate and higher abortion rate. the purpose of this study is to explore whether low molecular weight heparin can reduce the abortion rate of adenomyosis patients in frozen thawed embryo transfer cycles.


Eligibility criteria:
inclusion criteria: 1. the basal serum level of fsh was less than 10 iu / l 2. diagnosed with adenomyosis by ultrasound 3. the first frozen thawed embryo transfer cycle, by hormone replacement protocol 4. transfer at least one high quality frozen embryo; 5. patients agreed to use low molecular weight heparin after fet, and they were able to sign informed consent in person. exclusion criteria: 1. with abnormal karyotype; 2. accompanied with other uterine diseases: intrauterine adhesion, intramural myoma, moderate to severe endometriosis, congenital uterine malformation, endometrial tuberculosis, thin endometrium \< 8mm on the day of transformation, etc; 3. pcos, rif patients; 4. there are indications of conventional anticoagulation or antiplatelet therapy, such as antiphospholipid syndrome, autoimmune diseases, coagulation dysfunction, etc; 5. there were contraindications to hormone replacement therapy and low molecular weight heparin; 6. participating in other clinical studies; 7. unable to follow-up
dose adjusting enoxaparin thromboprophylaxis dosage according to anti-factor xa plasma levels improve pregnancy outcome

Conditions: Fetal Demise; Fetal Growth Restriction; Preeclampsia; Abruptio Placentae; Thromboembolism

Summary: the risk of venous thromboembolism increases in pregnancy. thrombophilia whether genetic or acquired, is a hypercoagulable disorder that may increase the risk of venous thromboembolic events. clinically, these events are presented as maternal deep vein thrombosis and pulmonary emboli. thrombophilias are also associated with adverse fetal outcomes including intrauterine growth restriction, intrauterine fetal death, severe preeclampsia, placental abruption and recurrent abortions. pregnant women who experienced one or more of the above complications are advised to be examined for the presence of the genetic or the acquired form of thrombophilia. low molecular weight heparin prophylaxis, an anticoagulant, is advised for pregnant women with a history of thromboembolism, and many experts recommend prophylaxis for pregnant patients with a known thrombophilia and history of adverse pregnancy outcomes associated with these hypercoagulable states. physiologic changes in normal pregnancy, including weight gain, increased renal clearance and volume of distribution, may decrease the availability of low molecular weight heparin (enoxaparin or dalteparin), or produce a less predictable response in pregnant women compared with nonpregnant women. there are no clear recommendations for use of prophylactic low molecular weight heparin in pregnancy. clinicians tend to use doses suggested for nonpregnant patients. regarding pregnant patients taking enoxaparin or dalteparin, the american college of obstetricians and gynecologists states that "because of the lack of data regarding adequate dosing during pregnancy, anti-factor xa levels may be monitored". two recently published studies demonstrated that plasma anti-factor xa levels during pregnancy were lower than expected, indicating that many pregnant patients may receive a subprophylactic dosing. our objective is to check pregnancy outcome among thrombophilic women treated with an adjusted enoxaparin thromboprophylaxis dosage according to anti-factor xa plasma levels compared to women with fixed dosage.


Eligibility criteria:
inclusion criteria: women with * singleton gestation * a history of fetal demise, fetal growth restriction, placental abruption, preeclampsia, recurrent abortions or maternal thromboembolic event. * acquired or congenital thrombophilia treated with low molecular weight heparin exclusion criteria: * women treated empirically with low molecular weight heparin * women with a history of pregestational diabetes. * significant polyhydramnios or oligohydramnios, major fetal structural, generic or chromosomal malformations

Keywords: placental syndrome maternal thromboembolic event enoxaparin anti-factor xa
wavecrest post market clinical follow-up (pmcf) study

Conditions: Non-valvular Atrial Fibrillation

Summary: the wavecrest pmcf study is a prospective, non-randomized, multicenter study to confirm safety and performance of the coherex wavecrest left atrial appendage (laa) occlusion system in the current medical practice setting in patients with non-valvular atrial fibrillation who are at increased risk for stroke. up to 65 subjects may be enrolled at up to 15 study sites in europe. patients will be followed through 45 days post-procedure.

the coherex wavecrest® left atrial appendage occlusion system is designed to permanently occlude the left atrial appendage (laa).

Eligibility criteria:
the criteria for implant are in accordance to the current version of the instructions for use: inclusion criteria: 1. non-valvular paroxysmal, persistent, or permanent atrial fibrillation 2. 18 years of age or older 3. laa anatomy amenable to treatment by percutaneous techniques 4. risk factors for potential thrombus formation in the laa 5. willing to participate in the required follow-up visits and tests 6. subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee or institutional review board at the study site exclusion criteria: 1. known contraindication to percutaneous transseptal intervention 2. left atrial appendage anatomy or size that will not allow appropriate implantation of the wavecrest implant 3. intracardiac thrombus or other cardiac abnormality visualized prior to implant that would significantly impact procedural safety 4. mitral valve stenosis \< 1.5 cm2 or any stenosis consistent with rheumatic valvular disease or history of mitral valve replacement or repair 5. known contraindication and/or allergy to nickel 6. known active bacterial infection (i.e., sepsis, endocarditis) 7. any known medical condition or overall health of the subject that could adversely affect procedural safety or potentially prevent the patient from completing all study required visits and tests. 8. pregnant or breastfeeding women due to the risk of exposure to x-rays and medications associated with the implant procedure.

Keywords: non-valvular atrial fibrillation atrial fibrillation stroke left atrial appendage (laa) laa closure laa occlusion wavecrest
rna cloning and visualization in human atherosclerosis

Conditions: Atherosclerosis

Summary: the research objectives of this project are as follows: 1. obtain high-quality human atherosclerotic arterial samples from diseased donors. 2. perform biochemical analysis to determine the abundance, localization and activity of dicer and double-stranded rnas in these diseased tissues.

participants enrolled in to this pilot study will not be randomized and will not receive any investigation medication. in collaboration with dr. sibu saha, professor of surgery, university of kentucky, the investigator will obtain freshly isolated human atherosclerotic tissue from patients undergoing carotid endarterectomy. the surgical process by which the tissue is obtained is not part of this research project. these tissues are surgically removed from patients as a treatment for atherosclerosis of the carotid arteries and typically sent for pathological examination. after the the clinical pathology has been completed, the investigator will obtain and analyze a small amount of discarded (200mg) tissue. subsequent analyses will be performed on the basis of the pathological grading provided by uk pathology (e.g do readouts of the dicer pathway correlate with pathological plaque characteristics). tissue will be anonymized, with only information with respect to drug history, age, gender and pathological grade of the tissue. the will extract protein and rna. dicer abundance will be assessed by western blot, quantitative rt-pcr and northern blot. dicer related rnas will be measured by quantitative rt-pcr and northern blot. the invesigator will inspect the tissue for evidence of altered dicer activity by measuring the relative levels of abundant canonical dicer substrates/enzymatic products (i.e. the ratio of pre- to mature micro-rna) via northern blot. the investigator predicts that dicer levels and activity are reduced in human atherosclerotic tissue compared to healthy arteries. next, the investigator will assess whether downstream mediators of dicer dysregulation are activated in these tissue samples by comparing levels and activation of the inflammasome (caspase-1, nlrp3, asc), cytokines (il-1β, il-18) and signaling intermediates (myd88, irak1/4) between healthy and diseased tissues. the investigator predicts that atherosclerotic plaques will exhibit evidence of dicer dysregulation. next, the investigator will co-stain tissue sections with antibodies recognizing dicer as well as cell-specific markers (cd31 for endothelium, sma for smooth muscle, mac-1 for macrophages) to assess whether dicer dysregulation displays cell type-specific patterns.

Eligibility criteria:
inclusion criteria: * age of 18 and older * undergoing carotid endarterectomy exclusion criteria: * under 18 years of age * not undergoing carotid endarterectomy

Keywords: atherosclerosis carotid endartherectomy
evaluating the safety and efficacy of topical sirolimus 0.2% to treat acanthosis nigricans

Conditions: Acanthosis Nigricans

Summary: the purpose of this study is to demonstrate the safety and efficacy of sirolimus 0.2% topical gel for patients with acanthosis nigricans


Eligibility criteria:
inclusion criteria: * men and women ages 18+. * clinical diagnosis of acanthosis nigricans. * available and willing to comply with study instructions and attend all study visits. * able and willing to provide written and verbal informed consent. exclusion criteria: * subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy. * subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. * pregnant, lactating, or is planning to become pregnant during the study. * subject is currently enrolled in an investigational drug or device study. * subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (baseline). * subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function. * subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles. * subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial. * erosions, ulcers, or other skin lesions within or closely neighboring the an lesion application site. * hypersensitivity reactions such as anaphylaxis or angioedema to sirolimus or any component of sirolimus 0.2% topical gel (hyftor). * dyslipidemia (cholesterol level \>300mg/dl or \>7.75mmol/l, triglyceride level \>300 mg/dl or \>3.42 mmol/l). * subject cannot agree to take appropriate contraception for the duration of the study and 12 weeks after the final dose. * exclusions apply to those who have used the following topical treatments to treat an: retinoids, hydroquinones, corticosteroids, or other depigmenting agents within one month prior to the study, or oral retinoids within six months prior to the study, or medications with mammalian target of rapamycin(mtor) inhibitory action within 12 months prior to the first visit. * subjects with a malignant tumor

Keywords: acanthosis nigricans
clinical study on the re-irradiation of lateral pelvic recurrences of gynecological malignancies

Conditions: Tumor Recurrence; Malignant Epithelial Neoplasm of Vulva; Malignant Epithelial Tumor of Ovary; Malignant Epithelial Neoplasm

Summary: the study aims to obtain a local control rate in patients with lateral pelvic relapses of gynecologycal cancers previously irradiated. high let (linear energy transfer) particles as carbon ions can guarantee a biologic advantage compared to photons in radioresistant neoplasms, given to their higher biological efficacy (rbe).

primary aim: estimate the effect, in terms of clinical response, of carbon ion treatment (cirt) in patients with lateral pelvic recurrences of gynecological malignancies. secondary aims: 1. to describe the safety profile of carbon ion therapy. 2. to estimate the effect, in terms of survival, of carbon ion treatment

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age * karnofsky index ≥ 70 * histological or radiological diagnosis of pelvic and groin recurrence * contraindications for radical surgery * no other distant progression or stable disease (sd) of known secondarisms (≥6 months) * previous radiation therapy on pelvis * distance ≥ 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated * possibility to perform a surgery to space the intestinal loops, in case of distance \< 10mm * if needed, spacer in biocompatible material (silicon, goretex) or anatomical material (omentum, muscle patch), non-absorbable. * dicom (digital imaging and communications in medicine) images of the previous treatment plan availability * written informed consent * patient's ability to understand the characteristics and consequences of the clinical trial exclusion criteria: * hip prosthesis, metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan * intestinal infiltration * bladder infiltration * vessel infiltration * previous therapy with anti-angiogenesis drugs * psychic or other disorders that may prevent informed consent * previous invasive tumor, with the exception of skin cancer (excluding melanoma) unless disease-free for at least 3 years * spacer in absorbable material (i.e. vycril) * distance \< 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated * impossibility to assess mri

Keywords: gynecological cancer carbon ion radiation therapy recurrencies cirt
pharmacokinetic study of hydrocodone/apap in chronic pain patients

Conditions: Chronic Pain

Summary: objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3 months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.

hydrocodone combinations are the most commonly prescribed pain medications in the united states. all the current available hydrocodone formulations are short acting and have acetaminophen/ibuprofen in them. chronic pain patients who take pain medications for extended time are overloaded with acetaminophen and there is a very serious concern about liver failure from excessive concurrent alcohol use. also all the current hydrocodone combinations available in the u.s. are short acting and provide pain relief for 3-6 hrs. hydromorphone is a metabolite of hydrocodone and plays a significant role in providing pain relief in these patients. although there are no long acting or extended release hydrocodone formulations that are fda approve at this time, there is once a day extended release hydromorphone (er) approved by fda and is currently marketed under the name exalgo ®. pk study of chronic hydrocodone/acetaminophen usage is important to determine equivalent potency with hydromorphone er, so that clinicians can use a simple conversion formula to switch to hydromorphone er. although medical professionals use the opiate conversion formula on a regular basis for opioid rotation, there are no published studies showing the pharmacokinetic data in patients taking hydrocodone for chronic pain. our goal is to use this pk data to guide clinicians with this data in using extended release hydromorphone for chronic pain management to provide predictable pain relief and minimize the acetaminophen usage.

Eligibility criteria:
inclusion criteria: * man or woman aged 18-75 * documented clinical diagnosis of chronic pain. * have been taking hydrocodone/apap for their chronic non-cancer pain. * subjects currently on hydrocodone/apap must be taking minimal daily dose of 15mg of hydrocodone for at least 30 days. * subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. exclusion criteria: * subjects who are taking concomitant medications or nutraceuticals that interfere with hydrocodone metabolism as listed in appendix 11 and/or as deemed clinically significant by a pharmacovigilance team that is contracted to monitor and advise. * health concerns that the study physician feels may confound study results. * individuals who are cognitively impaired or who are not able to give informed consent. * previous participation in a clinical research trial within 30 days prior to randomization. * the subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.

Keywords: pharmacokinetics hydromorphone hydrocodone apap
endurance training in patients with post-tb lung disease

Conditions: Tuberculosis; Post-Tuberculous Pleural Fibrosis; Post-Tuberculous Bronchiectasis

Summary: to determine the effects of endurance training on functional capacity and qol(quality of life) in patients with post-tb (tuberculosis) lung disease. post-tuberculosis lung disease is a major health concern nowadays. there is limited evidence in the literature regarding the rehabilitation of patients with cured tuberculosis which leads to post-tb complications.

adults with post-tb respiratory symptoms experience skeletal muscle weakness due to inactivity, systemic inflammation, and poor nutrition, which is frequently made worse by poverty. such patients experience a vicious cycle that includes decreased body weight, increasing morbidity, and higher mortality. people with chronic respiratory diseases frequently avoid exercise, which causes them to lose motivation and decondition. this cycle of decline continues. in pakistan, there is no concept of pulmonary rehabilitation for tb patients. the current study will attempt to fill this literature gap and also promote the concept of pulmonary rehabilitation for post-tuberculosis patients in pakistan.

Eligibility criteria:
inclusion criteria: * tb (diagnosed) with completed tb course * dyspnea (with or without cough) * age (18-50yrs). * after 3 months of afb and gene expert (-) * decreased pft predicted values exclusion criteria: * smoker, diabetes, and cardiac patients * physical disabled, pregnant (lactating women) * sputum + testing for tb * gene expert * cvd (unstable) * not willing to participate

Keywords: endurance training functional capacity post-tb lung disease quality of life