Kornimate/medical-research-clean huggingface dataset:
micafungin versus amphotercine b in treatment of invasive fungal infection

Conditions: Neonatal Infection; Invasive Fungal Infections

Summary: the incidence of fungal infection has increased dramatically over the past few decades.this is due to increase in survival rates of preterm neonates, advances in medical technology and drug therapy, broad spectrum antibiotics and parenteral nutrition . the resistance to antifungal agents has increased. this study will assess the efficacy of micafungin versus amphotericin b in neonates with positive fungal culture.

neonatal candidiasis is associated with significant mortality and morbidity and high rates of neuro-developmental impairment on follow up prevalence of invasive fungal infection (ifi) has increased in neonates during the last two decades due to increased survival rate even in the extremely premature neonates. candida albicans and candida parapsilosis are responsible for the majority of candidiasis in the neonatal intensive care unit (nicu) according to the european society for clinical microbiology and infectious diseases (escmid)guidelines published in 2012, micafungin, amphotericin b deoxycholate, and fluconazole are recommended as first line treatment of invasive candidiasis in neonates currently, fluconazole and micafungin are among the most frequently used antifungal agents for the treatment of neonatal invasive candidiasis high dose of micafungin (8 to 15 mg/kg/day) can be used with neonates and infant with invasive candidiasis in this study we will explore the effectiveness and safety of micafungin for treatment of candidiasis after fluconazole for preterm neonates with invasive fungal infection and to compare it with amphotericin b.

Eligibility criteria:
inclusion criteria: * patient less than 36 weeks gestational age * started fluconazole either prophylactic or therapeutic dose * and blood culture is positive for fungal infection. exclusion criteria: * any neonate with hepatic dysfunction for any cause (hepatitis or hepatic failure), or with elevation in ast, alt, alkhaline phosphatase * any neonate hypertensive, neutropenic, thrombocytopenic * any neonate with elevated renal function * any neonate with arrythmia

Keywords: preterm neonate invasive fungal infection micafungin
a study comparing fusion rates of two lumbar fusion procedures

Conditions: Pseudoarthrosis; Spinal Stenosis; Spondylolisthesis; Degenerative Disc Disease (DDD)

Summary: the purpose of this study is to demonstrate the relative efficacy of two lumbar fusion procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or bilateral posterior pedicle screw fixation as an adjunct to fusion, in comparison to transforaminal lumbar interbody fusion (tlif) when used in conjunction with unilateral or bilateral supplemental screw fixation as an adjunct to fusion. subject candidates are those who had previously required and received fusion at l4-l5-s1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (ddd).

consecutive subjects who were treated with the transsacral lumbar interbody fusion or tlif procedures at least 2 years prior to the date the data is collected will be evaluated.

Eligibility criteria:
inclusion criteria: * adult 18 years of age or older * male or female subject that had previously received the transsacral two-level procedure when used in conjunction with pedicle screw or facet screw fixation or tlif two-level procedure with unilateral or bilateral supplemental screw fixation (e.g. pedicle screws, facet screws at l4-l5-s1 to treat pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (ddd) * subject that was treated no less than 2 years prior to this evaluation with an transsacral or tlif procedure by the participating surgeons * subject that had a diagnosis that required a transsacral or tlif procedure at the l4-l5-s1 levels and did not require treatment at any other lumbar levels at the time of surgery exclusion criteria: * subject who did not receive the transsacral or tlif procedure for fusion of l4-l5-s1 * subject who received lumbar fusion procedures at levels other than l4-l5-s1 at the time of surgery
effect of cervical epidural analgesia on the occurrence of pharyngocutaneous fistula

Conditions: Cutaneous Fistula; Laryngectomy

Summary: pharyngocutaneous fistula (pcf) is the most commonly reported postoperative complication in total laryngectomy patients. pcf significantly increases morbidity, length of hospitalization, and cost of care, in addition to delaying the beginning of adjuvant therapy. the reported incidence of pcf ranges from 3% to 65%.the increased use of radiation in the primary management of laryngeal carcinoma has resulted in an increase in the pcf formation after salvage laryngectomy (stl). previously reported risk factors for pcf development include preoperative radiotherapy, tumor stage, concomitant neck dissection, prior need for tracheotomy, hypoalbuminemia and anemia. among surgical options, the pectoralis major myofascial flap has been proposed to cover the pharyngeal closure, to interpose non-irradiated tissue between the neopharynx and the skin during stl. nonetheless, the efficacy of this approach is not fully established.epidural anesthesia improves the blood supply due to its vasodilating effect. the aim of the study is to evaluate the effect of perioperative cervical epidural analgesia on the occurrence of pharyngocutaneous fistula following salvage laryngectomy and reconstruction with pectoralis major myocutaneous flap.

patients will be divided into two equal groups, group (ep), will receive perioperative cervical epidural analgesia in addition to general anesthesia and group (ga) will receive general anesthesia and postoperative analgesia through patient controlled intravenous morphine analgesia (pca), that involve 1 mg continuous infusion and 2 mg boluses with lockout interval 10 min. cervical epidural technique: epidural needle will be inserted at c 6-c7 or c7-t1 under fluoroscopy in prone position, 6 ml of 0.125% bupivacaine and fentanyl 2 mic/ ml will be administered before skin incision followed by 4 ml of the same injectate, will be infused continously for 2 days

Eligibility criteria:
inclusion criteria: * patients who failed treatment with radiotherapy for laryngeal cancer exclusion criteria: 1. infection at the site of flap 2. primary laryngectomy without radiotheraapy

Keywords: cervical epidural, laryngectomy, pharyngocutaneous fistula
medi9447(oleclumab) pancreatic chemotherapy combination study.

Conditions: Carcinoma; Metastatic Pancreatic Adenocarcinoma

Summary: the objective of this study is to evaluate the safety, tolerability, and antitumor activity of oleclumab (medi9447) in combination with or without durvalumab plus chemotherapy in participants with metastatic pancreatic cancer.

this is a phase 1b/2, multicenter, open-label, dose-escalation, and dose-expansion study to assess the safety, preliminary antitumor activity, immunogenicity, and pharmacokinetics (pk) of oleclumab with or without durvalumab in combination with chemotherapy administered in participants with metastatic pancreatic ductal adenocarcinoma (pdac). participants with previously untreated metastatic pdac (first-line \[1l\] metastatic pdac) will be enrolled in cohort a. participants with metastatic pdac previously treated with gemcitabine-based chemotherapy (without exposure to 5-fluorouracil \[5-fu\], capecitabine, or oxaliplatin; second-line \[2l\] metastatic pdac) will be enrolled in cohort b. the study consists of 2 parts, dose escalation (part 1) and dose expansion (part 2).

Eligibility criteria:
inclusion criteria: 1. age \>= 18 2. written and signed informed consent must be obtained 3. eastern cooperative oncology group (ecog) performance status 0 or 1 4. weight \>= 35 kg 5. participants must have histologically or cytologically, confirmed pancreatic adenocarcinoma: cohort a: participants with previously untreated metastatic pancreatic adenocarcinoma (1l metastatic disease) not previously treated with systemic therapies cohort b: participants with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based chemotherapy (without exposure to 5-fu, capecitabine, oxaliplatin) 2l metastatic disease 6. participants must have at least 1 measurable lesion according to recist v1.1 7. all participants must consent to providing archival tumor specimens. exclusion criteria: 1. receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment. 2. prior receipt of any immune-related therapy 3. concurrent enrollment in another therapeutic clinical study. enrollment in observational studies will be allowed. 4. participants with a history of venous thrombosis within the past 3 months 5. participants with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 3 months prior to start of treatment 6. active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment 7. other invasive malignancy within 2 years 8. any history of leptomeningeal disease or cord compression 9. current or prior use of immunosuppressive medication within 14 days prior to the first dose.

Keywords: medi9447 oleclumab immunotherapy pancreatic cancer durvalumab
treatment of advanced periodontitis using an oscillating chitosan device versus regular curettes alone

Conditions: Periodontal Diseases

Summary: 40 patients diagnosed with localised periodontitis will be included at each center, 20 patients will be treated with the control treatment, 20 patients will be treated by test treatment.

2.3 this will be a prospective multicentre parallel arm randomized clinical trial of 6 months' duration. clinical parameters of periodontal disease will be recorded at baseline and at 6 months. radiographs will be taken at baseline and at 6 months.treatment will be performed at baseline and thereafter every three months. 2.5 study setting patient screening, inclusions and all clinical examinations will be performed by a board-certified specialist in periodontology at the test centres. treatment will be performed by a registered separate therapist, either dentist or dental hygienist. 2.7 treatment allocation patients will be allocated to one of the following treatments: control (curettes+ ultrasound scaler (uss) supra and subgingivally), test (curettes + uss supra and chitosan brush in oscillating handpiece subgingivally) by computer-generated block randomization to ensure equal sample sizes.

Eligibility criteria:
inclusion criteria: * 1. periodontitis as previously defined on at least three teeth but less than 8 teeth. 2. above 18 years of age. 3. eligible for treatment in an outpatient dental clinic (ie, american society of anesthesiologist index (asa) i and ii). 4. had full-mouth plaque scores ≤ 20% prior to final inclusion3 5. signed informed consent obtained prior to start. 6. psychological appropriateness 7. consent to complete all follow-up visits exclusion criteria: 1. prosthetic constructions with technical complications which according to the examiners judgement has contributed to the disease state and not possible to resolve prior to final inclusion. 2. receiving systemic antibiotics \< 3 months prior to study start. 3. pregnant or lactating. 4. any condition or current treatment for any condition, which in the opinion of the investigator and/or consulting physician, may constitute an unwarranted risk. 5. presence of psychological characteristics such as inappropriate attitude or motivation which, in the opinion of the investigator, are incompatible with the protocol. 6. unwillingness to undergo treatment. 7. ongoing or previous radiotherapy to the head-neck region. 8. ongoing chemotherapy.
prostate interstitial brachytherapy with i125 implant with target dose supplementation in the tumor volume guided by trinity® perine 3d system

Conditions: Prostate Cancer

Summary: the objective of the focus-boost project is to implant for the first time with a 3d ultrasound image fusion registration system (3d echo) implant of iodine 125 with precision in a target volume determined by positive biopsies.

the interstitial brachytherapy procedure for the prostate does not allow for a robust focal treatment to accurately deliver additional dose to the tumour volume. focus boost allows the precise implantation of 125 iodine implant with greater accuracy (using a 3d ultrasound image fusion registration system) in a target volume. for this purpose, positive biopsies, performed in this research protocol, will be used prior to surgery. prostate brachytherapy will be optimised thanks to the trinity® system and its guidance quality, by increasing the dose of the intra-prostate tumour volume (boost) without increasing the total dose delivered to the prostate. increasing the dose to the tumour target volume could improve disease control and decrease the risk of recurrence.

Eligibility criteria:
inclusion criteria: * at least 18 years * patient to be treated with brachytherapy * patient with low or favorable intermediate risk prostate adenocarcinoma isup 1 and 2, g6 (3+3) or g7 (3+4) * life expectancy of more than 10 years * psa (prostate-specific antigen) \< 15 ng/ml * ct1c or ct2a or ct2b * prostate volume ≤ 60 cc * ecog performance status 0-2 * patient is affiliated to a health insurance system * patient who has signed consent form exclusion criteria: * patient with urinary function disorders ipss\> 14 * prostate volume \> 60cc. * gleason 7(4+3) or gleason score ≥8 * psa ≥ 15 ng/ml * patient with metastases * hormone therapy with antiandrogen or lhrh analogue * history of abdominopelvic irradiation * inflammatory digestive disease (haemorrhagic rectocolitis, crohn's disease) * interventional study in progress that may interfere with the present study * protected persons (patient concerned by articles l1121-5, l1121-6, l1121-8 of the french public health code)

Keywords: interstitial brachytherapy iodine 125 implant 3d trinity® perine system
aflibercept plus micropulse laser versus aflibercept monotherapy for diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: purpose: to evaluate the role of adjuvent micropulse laser with aflibercept injections in the management of treatment naïve centre involving dme, looking at decreased treatment burden and increased efficacy as outcomes. methods: this was a prospective, single centre, randomized trial that included 40 eyes (40 patients) with previously untreated centre involved dme. patients were randomly assigned to receive either aflibercept plus micropulse laser (group a) or aflibercept monotherapy (group b).

patients were randomly distributed in a 1:1 ratio between the two studied groups. group a received 3 monthly injections of aflibercept 2 mg/0.05 ml (eylea; bayer, berlin, germany) as a loading dose, followed one month later by one 577 nm yellow micropulse laser session with monthly prn aflibercept injections. group b received 3 monthly injections of aflibercept 2 mg/0.05 ml as a loading dose, followed by monthly prn aflibercept injections. patients in both groups were assessed one month after the end of loading phase; at this point, group a received the micropulse laser session and started prn aflibercept injections, while group b started prn aflibercept injections without receiving the micropulse laser session. after that, both groups were followed for 12 months.

Eligibility criteria:
inclusion criteria: * patients were older than 18 with the clinical diagnosis of previously untreated centre involved dme documented by fluorescein angiography and central macular thickness (cmt) ≥ 300 µm on the spectral-domain oct best corrected visual acuity was better than 3/60 with hb a1c less than 10%. exclusion criteria: * any previous treatment for dme, proliferative diabetic retinopathy, macular ischemia on fluorescein angiography, epiretinal membrane or tractional maculopathy on oct, media opacity and any previous intraocular surgery with the exception of uneventful cataract surgery more than 6 months before the beginning of the study.
effectiveness of ttns in ms patients with lower urinary track symptoms

Conditions: Multiple Sclerosis; Lower Urinary Tract Symptoms

Summary: multiple sclerosis (ms) is the most common inflammatory disease of the central nervous system. it is characterized with demyelinated plaques affecting subcortical, brain stem, and spinal cord nerve fibers. during the course of the disease, with the affection myelinated nerve tracks, lower urinary track symptoms may occur. 50-90% of the ms patients experience lower urinary track symptoms (luts) such as urinary incontinence, urgency, nocturia and/or urinary frequency during the at one point of their life. aim of this study is to determine the effects of transcutaneous tibial nerve stimulation (ttns) on symptoms and quality of life in ms patients with luts.

this is a single-centered, prospective, single blind, randomized controlled study of patients with ms who suffer lower urinary track symptoms. all patients will be informed of the details of all the procedures and of the details of the study. after the written informed consent is obtained, patients will be distributed to two equal groups using randomized number table. at the beginning and end of the study, post-void residue (pvr) will be calculated with ultrasonography, international consultation on incontinence questionnaire short form (iciq-sf), incontinence quality of life( i-qol), 3 day bladder diary (number of urination, urge, incontinence, nocturia) forms will be administered. patients will be evaluated via pvr, urodynamic measurements, iciq-sf, i-qol and bladder diary.

Eligibility criteria:
inclusion criteria: * volunteer adults (age 18-50) * diagnosis of multiple sclerosis * expanded disability status scale (edss) 0-6,5 * lower urinary track symptoms (urinary incontinence, urgency, nocturia and/or urinary frequency) * diagnosis of bladder disfunction with urodynamic study within 1 months exclusion criteria: * age less then 18 * pacemaker or implantable defibrillator usage * diabetic polyuria * bleeding diathesis or severe bleeding tendency * pelvic floor disfunction or nerve damage effecting tibial nerve * currently pregnant or planning pregnancy * active urinary infection * active malignancy * severe mental disability * cognitive deficit * expanded disability status scale (edss) greater than or equal to 7 * unable to attend to tptns treatment 2 times a week * urodynamic findings of bladder outlet obstruction * surgical history because of urinary incontinence * urologic surgical history because of lower urinary track disfunction or symptoms * diagnosis of prostatic enlargement * diagnosis of pelvic organ prolapse

Keywords: multiple sclerosis lower urinary track symptoms luts posterior tibial nerve stimulation tptns ttns
study to evaluate the safety and efficacy of nktr-102 in patients with metastatic or locally advanced ovarian cancer

Conditions: Tumor; Ovarian Cancer

Summary: this is a multicenter, open-label, two-arm, 2-stage, phase 2 study of nktr-102 in patients with metastatic or locally advanced platinum-resistant ovarian cancer. approximately 70 patients will be randomized 1:1 into one of two treatment arms. nktr-102 will be administered at a dose level of 145 mg/m\^2 in both arms. in arm a, nktr-102 will be given on a q14d schedule. in arm b, nktr-102 will be given on a q21d schedule. after the initial 70 patients have been enrolled, arm b will enroll approximately 110 additional patients.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer 2. inoperable metastatic or locally advanced ovarian cancer 3. platinum-resistant ovarian cancer defined as progression by recist within 6 months of last dose of most recent platinum drug 4. platinum-resistant patients who have progressed after receiving pld (doxil/caelyx)therapy in a platinum-resistant setting or who otherwise unable to receive pld therapy. 5. diseases must be measurable as defined by recist in at least 1 lesion not previously irradiated. 6. ecog performance score of 0 or 1. 7. adequate organ and bone marrow functions at screening. exclusion criteria: 1. patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) and have not recovered to nci-ctcae grade 1 toxicity prior to day 1 of cycle 1 2. patients who have had any major surgery within 4 weeks prior to day 1 of cycle 1 or minor surgery within 2 weeks prior to day 1 of cycle 1 3. patients who have received cyp3a4 inducers or inhibitors. 4. patients who have received any treatment with a camptothecin derivative (eg. irinotecan, topotecan, sn38 investigational agents, etc.). 5. patients with cns metastases.
titration study of abx-1431

Conditions: Post Herpetic Neuralgia; Diabetic Peripheral Neuropathy; Small Fiber Neuropathy; Post-Traumatic Neuralgia

Summary: this study is designed to identify a titration regimen of abx-1431 in adults with neuropathic pain with satisfactory tolerability to central nervous system (cns) adverse events (aes). during the course of this study, each participant will take a daily dose of abx-1431 or a matching placebo for 28 days.

this is a double-blind, placebo-controlled, optimized titration study of abx-1431 hcl. the study will explore whether patients experiencing abx-1431-related cns ae accommodate or become tolerant to them with continued dosing. the efficacy of abx-1431 in treating neuropathic pain will be assessed by the change from baseline in pain intensity scores using numerical rating scale (nrs-11). all patients will undergo a screening visit for enrollment criteria. eligible patients will be treated with daily medication for 28 days which will include some treatment with placebo and some treatment with abx-1431 hcl. patients will record their daily average pain using a paper numerical rating scale (nrs-11). this study will enroll up to 32 patients with peripheral neuropathic pain due to one of the four following diagnostic groups: post-herpetic neuralgia, diabetic peripheral neuropathy, small fiber neuropathy or post-traumatic neuropathic pain.

Eligibility criteria:
key inclusion criteria: * patient is a male or female over the age of 18 years of age at the screening visit. * patient has a peripheral neuropathic pain in one of the following diagnostic groups that is persistent for \> 3 months * post-herpetic neuralgia * diabetic peripheral neuropathy * small fiber neuropathy * post-traumatic neuropathic pain * patient's median nrs-11 pain intensity score must be ≥ 4 during the baseline period * if a patient enters the trial on daily background neuropathic pain medications, then the patient must be on stable dose of medications for at least 30 days before enrollment and throughout the study. * patient is able to understand and comply with the protocol procedures for the entire trial and must give written informed consent. * men and women must agree to a medically approved contraceptive regimen. key exclusion criteria: * patient is taking potent cytochrome p450 3a4/5 inducers or inhibitors * patient has received injection therapies (e.g., botulinum toxin, anesthetic or nerve block) or transcutaneous electrical stimulation to control pain in the past 60 days * patient has evidence of alcohol, drug or chemical abuse in the year before the screening visit. * patient is a lactating or pregnant female or a female who intends to become pregnant within 90 days following the last dose of investigational product. * patient has specific laboratory abnormalities other protocol-defined inclusion/exclusion criteria may apply.