Kornimate/medical-research-clean huggingface dataset:
use of cadiss medical device to facilitate dissection of epidural fibrosis in revision spine surgery

Conditions: Spine Surgery

Summary: the cadiss® system, chemically assisted mechanical dissection, is intended for the selective detachment of pathological tissue layers and/or fibrotic tissues in various surgical procedures without using cutting instruments. it is based on the property of the drug mesna (sodium 2-mercaptoethane sulfonate) to cleave the disulfide bonds responsible for the adherence of pathological tissues and for the strength of fibrosis. revision spine surgery is more difficult than primary surgery because of the development of fibrosis and scar tissues since the first operation. fibrosis may develop in the spinal canal and will adhere strongly to the dura mater and to the nerve roots. this study is a prospective, multi-sites, open label, single cohort clinical trial evaluating the use of cadiss medical devices to facilitate dissection of epidural fibrosis in patients who undergo a revision in spine surgery after at least one year.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old, weight \> 30 kg * eligible for spine revision surgery, at least one year after primary surgery * agree to participate and sign the informed consent the age and weight of patient are defined according to the instruction for use of the cadiss system currently on the eu market. exclusion criteria: * \< 18 years old * weight ≤ 30 kg * primary surgery * known hypersensibility to mesna * patient is pregnant, breastfeeding or has wish of pregnancy during the study. * unable to sign the informed consent * participation in any study involving an investigational drug or device within the past 3 months. * individuals under tutorship or trusteeship.

Keywords: spine lumbar surgery revision cadiss fibrosis chemically assisted dissection
ps-341 in treating women with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: ps-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. purpose: phase ii trial to study the effectiveness of ps-341 in treating women who have metastatic breast cancer.

objectives: * determine the objective tumor response in women with metastatic breast cancer treated with bortezomib. * determine the toxic effects of this drug in these patients. * determine the progression-free survival in patients treated with this drug. outline: patients receive bortezomib iv over 3-5 seconds twice weekly for 2 weeks. treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 12-35 patients will be accrued for this study within 6-24 months.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the breast * metastatic disease * at least 1 unidimensionally measurable lesion * at least 20 mm by conventional techniques or * at least 10 mm by spiral ct scan * previously treated with 1 prior chemotherapy regimen (with or without trastuzumab \[herceptin\]) for metastatic disease * relapse during or within 6 months after completion of adjuvant chemotherapy considered treatment failure * no known brain metastases * hormone receptor status: * not specified patient characteristics: age: * 18 and over sex: * female menopausal status: * not specified performance status: * ecog 0-2 life expectancy: * more than 3 months hematopoietic: * wbc at least 3,000/mm\^3 * absolute neutrophil count greater than 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin normal * sgot/sgpt no greater than 2.5 times upper limit of normal renal: * creatinine normal or * creatinine clearance at least 60 ml/min cardiovascular: * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia other: * no uncontrolled concurrent illness * no ongoing or active infection * no psychiatric illness or social situation that would preclude study * no prior allergic reaction attributed to compounds of similar chemical or biological composition to bortezomib * no other prior malignancy within the past 5 years unless curatively treated and disease free * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * see disease characteristics chemotherapy: * see disease characteristics * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered endocrine therapy: * prior hormonal therapy for metastatic disease allowed * at least 4 weeks since prior hormonal therapy and recovered radiotherapy: * at least 4 weeks since prior radiotherapy and recovered surgery: * not specified other: * prior adjuvant therapy allowed * at least 4 weeks since prior investigational drugs and recovered * no other concurrent investigational or commercial agents or therapies for breast cancer * no concurrent combination antiretroviral therapy for hiv

Keywords: stage iv breast cancer recurrent breast cancer
maternal and perinatal outcome in women with history of premature labor in previous pregnancy

Conditions: Pregnancy; Vulvovaginitis; Uterine Cervicitis; Pregnancy Outcome

Summary: introduction: preterm labor (ptl) is an important obstetric intercurrence that affects 5 to 10% of pregnancies. among the known factors of ptl etiology are ptl occurrence in previous pregnancies, multiple pregnancies, polyhydramnios, vaginal bleeding during pregnancy, premature membrane rupture (pmr) and bacterial vaginosis. despite the advancement achieved in neonatology, morbidity and mortality resulting from high rates of preterm births have remained constant in the last few decades. objective: this study aims at evaluating maternal and perinatal outcomes of pregnant women with a history of preterm labor in previous pregnancies and submitted to active search for vaginal infection. material and method: it is a prospective-cohort epidemiological study to be conducted in botucatu/sp. two study groups (g1 and g2) will be formed, and each of them will comprise 140 pregnant women with a history of preterm childbirth. g1 will be related to the active search and etiological diagnosis of lower genital tract infections, and g2 will be related to non-search for such infections, for which the routine care protocol of primary health units in the city of botucatu will be maintained. care propedeutics for the pregnant women (g1) will include the performance of direct examination of vaginal content stained by the gram method, culture in diamonds medium, polymerase chain reaction (pcr) of endocervical secretion collected in the primary health care services in the city at two moments: prior to the 20th gestational week (m1) and at the 36th week (m2). moment m3 will take place after childbirth for evaluation of the perinatal outcome.


Eligibility criteria:
inclusion criteria: * will be included in the study women with a history of preterm labor in previous pregnancy, without other risk factors identified in the initial prenatal current to initiate prenatal care until 20 weeks of gestation in any unit of primary care and botucatu they have agreed to participate. exclusion criteria: * will be excluded from the study women who have complications during pregnancy such as urinary tract infections, severe periodontal disease, hypertension, diabetes or multiple gestation, among others.

Keywords: pregnancy vulvovaginitis uterine cervicitis pregnancy outcome
exploratory p2 trial to evaluate efficacy and safety of clotinab® (abciximab) in acute mi patients

Conditions: Acute Myocardial Infarction

Summary: exploratory phase ii clinical trial to evaluate the efficacy and safety of clotinab® (abciximab) in acute myocardial infarction patients: multicenter, randomized, double-blind, placebo-controlled and parallel group trial

this study was an exploratory phase 2 of clinical trial to evaluate the efficacy and safety of clotinab® (abciximab) in the acute myocardial infarction patients and was designed as a multicenter, randomized, double-blinded, placebo-controlled and parallel group study. the objective of this phase 2 clinical trial is to evaluate correlation between infarct size and major adverse cardiac event (mace) of acute myocardial infarction patient, prearranged for percutaneous coronary intervention(pci), to measure possibility to use infarct size as a primary efficacy test variable in phase 3 for final confirmation of safety and efficacy. also to determine exploratively an average variance estimation of infarct size between study drug and placebo to confirm safety and efficacy of study drug, compared to placebo and to use the estimation for calculating sample size for phase iii clinical trial.

Eligibility criteria:
inclusion criteria 1. patients with acute myocardial infarction having st segment, 1 mm or above, from at least 2 consecutive segment. 2. patients have a plan of percutaneous coronary intervention (pci) exclusion criteria 1. history of myocardial infarction 2. history of hypersensitivity in aspirin, heparin, or protein drugs 3. bleeding disorders 4. thrombocytopenia (\<100,000unit/㎕) 5. cardiogenic shock, chronic atrial fibrillation, and cancer 6. patients with following criteria: implanted pacemakers, defibrillators, intracranial metallic implants, pregnant, etc 7. had a history of surgical operation within 4 weeks 8. participated in other clinical trials within 2 months
treatment of advanced gastrointestinal cancer in a phase i/ii trial with modified autologous msc_apceth_101

Conditions: Advanced Gastrointestinal Cancer

Summary: to evaluate the safety and tolerability of msc_apceth_101.


Eligibility criteria:
inclusion criteria: * patients with advanced or recurrent or metastatic gastrointestinal adenocarcinoma. * premature or scheduled termination of standard therapy * progressive disease as clinically assessed by the investigator * max. tumour lesion ≤ 5 cm * adequate organ function * ability of patient to understand character and individual consequences of clinical trial * age ≥ 18 years * written informed consent must be available before any study specific procedure is performed exclusion criteria: * patients with severe heart diseases * clinical significant ischemic disease during the last 4 weeks before visit 1 * severe lung disease * symptomatic peritoneal carcinomatosis * symptomatic pleural or pericardial effusion * serious uncontrolled acute infections less than 3 weeks before visit 1 * known dependency on alcohol or other drugs * patients requiring corticoids in doses above the cushing threshold * known liver fibrosis or liver cirrhosis * any concomitant severe disease which could compromise the objectives of this study in the judgment of the investigator * female patient who is pregnant or breast feeding * participation in another clinical trial or observation period, respectively, during the last 4 weeks prior to the first imp dose
rifaximin therapy in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to determine if rifaximin decreases serum and urine levels of bacterial byproducts and inflammatory markers in patients with chronic kidney disease and to evaluate changes in the bacterial content of the stool from these individuals.


Eligibility criteria:
inclusion criteria: * chronic kidney disease with egfr ≤ 39 ml/min/1.73m2 exclusion criteria: * patients with normal renal function or those with less advanced kidney disease * inability or unwillingness to provide consent * patients undergoing hemodialysis or peritoneal dialysis therapy or those who have undergone organ transplant * patients who may be pregnant * hemodynamically unstable patients * patients with liver failure, pancreatic insufficiency, or inflammatory bowel disease * patients with ongoing or recent infection and those with history of c-diff infection * patients with abnormal bowel structure secondary to surgical or anatomic variations * patients on certain medications including immunosuppressants, antidiarrheal agents, bile acid sequestrants and current or recent (within the last 3 months) use of antibiotics
observational study of meloxicam in any labeled indication

Conditions: Arthritis, Rheumatoid

Summary: evaluation on the amelioration of symptom intensity of the indication and to evaluate drug tolerability.


Eligibility criteria:
inclusion criteria: * patients according to the physicians medical criteria on the labeled indications for meloxicam exclusion criteria: * none
continuous glucose monitoring, contingency management, and motivational interviewing for patients with type 2 diabetes in kansas city

Conditions: Type 2 Diabetes

Summary: this study is evaluating a behavioral treatment program that uses diabetes coaching and financial rewards in addition to continuous glucose monitoring to improve diabetes management in adult patients with type 2 diabetes. this study will evaluate if this behavioral treatment program increases individual adherence to a diabetes treatment plan and improves blood sugar management.

a randomized parallel-group pilot study of a combination intervention using motivational interviewing (mi) and contingency management (cm) for patients with t2dm. individuals will be randomized in a 1:1 ratio to the intervention group or the control group. randomization will be blocked and stratified by long-acting insulin and glp1 medication use. all participants will be given a continuous glucose monitor (cgm) to assess real-time blood sugar levels and establish cm rewards for those assigned to the treatment group.

Eligibility criteria:
inclusion criteria: 1. diagnosed with type 2 diabetes 2. age 18 to 65 3. hemoglobin a1c (blood draw or point-of-care) test available within the last 3 months 4. most recent hemoglobin a1c result between 8.0 and 11.0 5. currently receiving treatment for diabetes by a licensed healthcare provider. 6. reliable access to a personal smart phone that is compatible with cgm 7. english speaking exclusion criteria: 1. type 1 diabetes 2. secondary type 2 diabetes (diagnosis secondary to other medical conditions such as pancreatitis, cystic fibrosis, or cushing disease) 3. prescribed short-acting (mealtime) insulin as part of diabetes treatment plan 4. known or acknowledged active substance use disorder or that would interfere or negatively impact participation in the study 5. diagnosis of a medical/psychiatric condition that would prevent participation in the study (e.g., intellectual disability, alzheimer's disease, traumatic brain injury, schizophrenia)

Keywords: type 2 diabetes glucose contingency management motivational interviewing
digital breast tomosynthesis guided tomographic optical breast imaging (tobi)

Conditions: Breast Cancer

Summary: screening for breast cancer improves early detection of aggressive cancers and has been shown to reduce breast cancer related mortality. currently, mammography is the most effective way of detecting early stage, non palpable breast cancers. however, mammography only reveals the breast structure, and cannot say much about the breast physiological state. we propose tomographic optical breast imaging (tobi) as an inexpensive, patient friendly technique that is non-invasive and does not use non-ionizing radiation. tobi uses near infrared light and by measuring how such light passes through the breast, images of blood volume and hemoglobin oxygenation can be obtained. in this study, tobi is combined with digital breast tomosynthesis (dbt, a form of 3d mammography) and our hypothesis is that the tobi-dbt combined images can be used to diagnose breast cancer with significantly improved sensitivity and specificity compared to dbt alone.


Eligibility criteria:
inclusion criteria: * any adult female volunteers of any race or ethnic background, between the ages of 30 to 80, either * scheduled for a clinically indicated diagnostic mammogram or percutaneous biopsy. * presenting for breast cancer treatment exclusion criteria: * under 30 years old or over 80 years old * is pregnant or thinks she may become pregnant. * open wounds on breast * breast implants * any condition that impairs the ability to give informed consent

Keywords: diffuse optical tomography digital breast tomosynthesis breast cancer solid benign lesions cysts malignant lesions
a study of a novel compound for excessive daytime sleepiness associated with narcolepsy

Conditions: Excessive Daytime Sleepiness; Narcolepsy

Summary: histaminergic agents are known to be involved with the sleep/wake cycle. this compound is a histaminergic agent which therefore may improve alertness and awakeness in patients with excessive daytime sleepiness (eds) associated with narcolepsy. significant improvement in eds when treated with this compound compared to placebo in patients with narcolepsy is hypothesized.


Eligibility criteria:
inclusion criteria: * isdc diagnosis of narcolepsy * excessive daytime sleepiness in association with a diagnosis of narcolepsy * an mwt (maintenance of wakefulness test) average sleep latency of under 15 minutes at baseline exclusion criteria: * no other diagnosed sleep disorders (e.g., sleep apnea) * major medical disorders * major psychiatric disorders

Keywords: randomized double-blind placebo-controlled crossover study of pf-03654746 in excessive daytime sleepiness associated with narcolepsy
contribution of new generation oxford nanopore-type high-throughput sequencing in the diagnostic strategy of neurogenetic diseases.

Conditions: Neuro-Degenerative Disease

Summary: since 2012, ngs sequencing of long fragments or long reads has developed in various fields of research and today presents itself as a very promising alternative solution in the analysis of repeat amplifications. the oxford nanopore ngs automaton offers the prospect of bringing together 1st and 2nd line analyzes of all loci potentially indicated in neurogenetics at the same time. the project aims to compare the use of this new technology with methods currently used in reference laboratories. the main objective is to evaluate the ability of next-generation high-throughput oxford nanopore-type sequencing (neurongs3) to diagnose 9 neurogenetic diseases compared to reference protocols via pcr (+/- southern blot). the secondary objective is to evaluate the repeatability of the ngs (intra-sample reproducibility) analysis in the diagnosis of 8 neurogenetic diseases.

since 2012, ngs sequencing of long fragments or long reads has developed in various fields of research and today presents itself as a very promising alternative solution in the analysis of repeat amplifications. the oxford nanopore ngs automaton offers the prospect of bringing together 1st and 2nd line analyzes of all loci potentially indicated in neurogenetics at the same time. the project aims to compare the use of this new technology with methods currently used in reference laboratories. multicenter cross-sectional early phase diagnostic study on already existing biological collections. analyzes with the new technique (ngs) will be carried out blinded to the results obtained with the current reference algorithm based on the sequential performance of pcrs the main objective is to evaluate the ability of next-generation high-throughput oxford nanopore-type sequencing (neurongs3) to diagnose 9 neurogenetic diseases compared to reference protocols via pcr (+/- southern blot). the secondary objective is to evaluate the repeatability of the ngs (intra-sample reproducibility) analysis in the diagnosis of 8 neurogenetic diseases.

Eligibility criteria:
inclusion criteria: * minors, adults and protected adults. * subject carrying an amplification of nucleotide repeats in one of the following 9 genes fmr1, dmpk, znf9, sca2, jph3, hd, fxn, c9orf72, rfc1 * dna available in sufficient quantity (5 to 10 µg) exclusion criteria: * dna degraded or of medium size \<30kb, * patient objection to research - this patient objection must be reached to the center's investigator within 1 maximum period of 1 month after sending the information note.
domperidone for gastroparesis in solid organ transplantation

Conditions: Gastroparesis; Gastroesophageal Reflux

Summary: the purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis.

after heart or lung transplantation, the stomach tends to empty much slower than normal. this slow emptying is called "gastroparesis." gastroparesis is uncomfortable and often leads to nausea and vomiting. in addition to drastically impacting quality of life, severe nausea and vomiting can also lead to malnutrition and an inability to take oral medications, contributing to complications of transplantation. treatments for gastroparesis include both medical and surgical therapies that work for some but not all patients. domperidone is a peripheral d2 antagonist that improves the emptying of the stomach in patients with gastroparesis. domperidone is not fda approved at this time. some patients have developed lifethreatening abnormal heart rhythms after receiving domperidone intravenously. this problem has not been seen with domperidone given by mouth. we propose to administer domperidone by mouth at standard doses to solid organ transplant patients who have gastroparesis that is not responsive to standard medical therapies or who experience adverse drug side effects. this study will not be blinded (open-label) and has a single treatment arm (no control or placebo group).

Eligibility criteria:
inclusion criteria: * gastroparesis or gastroesophageal reflux that is refractory to standard therapy. * signed informed consent exclusion criteria: * serious cardiac arrhythmias * clinically significant bradycardia, sinus node dysfunction, or heart block. * prolonged qtc * clinically significant electrolyte disorders. * gastrointestinal hemorrhage or obstruction. * prolactinoma * pregnant or breast feeding female * known allergy to domperidone.

Keywords: gastroparesis gastroesophageal reflux
a study to evaluate shr-1210 in subjects with advanced hcc

Conditions: Hepatocellular Carcinoma Non-Resectable

Summary: this a randomized controlled phase 2/3 study to evaluate the efficacy and safety of shr-1210 in subjects with advanced hcc who failed or intolerable to prior systemic treatment. the primary study hypothesis is that shr-1210 treatment improves objective response rate and overall survival when compare with soc.

in june 2017, this study was revised to expand the phase 2 part to enroll more subjects and remove the phase 3 part under the same protocol. a phase 3 study will be initiated separately.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed hcc in advanced stage; not suitable to surgery or local regional treatment; with at least one measurable lesion per recist 1.1 2. failed or intolerable to at least one prior systemic treatment for advanced hcc 3. ecog performance status of 0 or1 4. child-pugh class a or b with 7 points 5. life expectancy of at least 12 weeks 6. hbv dna\<500 iu/ml 7. adequate organ function 8. male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 60 days for female subjects and 120 days for male subjects after the last dose of study drug exclusion criteria: 1. known fibrolamellar hcc, sarcomatoid hcc, or mixed cholangiocarcinoma and hcc 2. known liver transplant or plan to transplant 3. gi hemorrhage with 6 months 4. history or current brain metastases 5. active known, or suspected autoimmune disease