Kornimate/medical-research-clean huggingface dataset:
genotypic versus phenotypic susceptibility testing of positive blood cultures

Conditions: Bloodstream Infection

Summary: this study is designed as a prospective, randomized, open-label trial evaluating antimicrobial utilization, clinical outcomes, and healthcare costs among patients with positive blood cultures. patients will be randomized to one of the following fda-cleared devices that will be used to assess the workflow impact of fast identification (id) and antimicrobial susceptibility testing (ast) in the microbiology lab and in the quality of care in patients: 1) standard culture and ast of positive blood culture bottles plus the verigene® blood culture gram-positive/gram-negative kit (bc-gp/gn); or 2) fast id and ast of positive blood culture bottles using the accelerate phenotest™ bc kit with the accelerate pheno™ system.


Eligibility criteria:
inclusion criteria: * all positive blood cultures (including on-panel/off-panel/contaminants) identified during local laboratory business hours * all adult (≥18 years of age) exclusion criteria: * identification of blood culture positivity outside of local laboratory business hours (e.g. whenever laboratories are staffed to perform both rapid testing and routine testing) * positive blood culture in the prior week with same gram stain result * transferred from an outside hospital and had a history of a previously positive blood culture of the same gram stain result * previously enrolled in the study * only the first positive culture for each patient will be included during the study period; any subsequent episode of bloodstream infection (bsi) will be excluded * died or were transitioned to comfort care within 24 hours of enrollment * negative gram-stain * not admitted to hospital for ≥ 24 hours following blood culture positivity
lisa catheter with marked vs. unmarked tip in extremely low birth weight infants with rds

Conditions: Respiratory Distress Syndrome, Newborn

Summary: this is an unblinded, randomized, controlled, crossover (ab/ba) trial of surfactant treatment with lisa catheter with a marked tip vs. lisa catheter with an unmarked tip in a manikin simulating an extremely low birth weight infant. participants will be level iii nicu consultants and residents. randomization will be performed using a computer-generated random assignment list. the primary outcome measure will be the positioning of the device at the correct depth in the trachea. the secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.

although less invasive surfactant administration (lisa) offers some advantages in ventilation procedure and neonatal outcomes, achieving the correct depth in the trachea using a lisa catheter may be difficult. this may have some drawbacks such as impaired surfactant administration (reducing the efficacy of the procedure) or prolonged duration of the laryngoscopy (aggravating the invasiveness of the procedure). the aims of the present study should be: i) positioning of the device at the correct depth in the trachea, ii) time and number of attempts to achieve the correct depth, iii) participant satisfaction. this is an unblinded, randomized, controlled, crossover (ab/ba) trial of surfactant treatment with lisa catheter with a marked tip vs. lisa catheter with an unmarked tip in a manikin simulating an extremely low birth weight infant. participants will be level iii nicu consultants and residents. randomization will be performed using a computer-generated random assignment list. the primary outcome measure will be the positioning of the device at the correct depth in the trachea. the secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.

Eligibility criteria:
inclusion criteria: * level iii nicu consultants and residents will be eligible to participate in the study exclusion criteria: * refusal to participate in the study.
unroofing curettage for pilonidal disease

Conditions: Pilonidal Disease; Recurrence; Healing Wound

Summary: this study aimed to investigate the outcomes of patients who underwent uc as the primary intervention for simple or complex spd

sacrococcygeal pilonidal disease (spd) is a well-known chronic inflammatory condition that affects young adults; there are many treatment options available today, from simple non-surgical methods to extensive flap procedures. however, elaborate treatment strategies can turn this easily treatable disease into a long-term surgical ordeal, causing complications worse than the primary disease itself. while, uc is considered safe and effective for treating simple spd, its suitability for treating complex disease is poor and controversial. to date, no studies have investigated the efficacy of uc specifically when treating complex spd. this is the first study to identify and compare efficacy and outcomes after uc in patients classified into simple and complex spd groups. this study was conducted at the department of surgery of the diskapi training and research hospital in ankara, turkey. the local ethics committee of the institution approved the study protocol (number 27/02, dated march 22, 2016), and written informed consent was obtained from all participants.

Eligibility criteria:
inclusion criteria: * consecutive patients aged 18 years or older exclusion criteria: * acute pilonidal abscess * poorly controlled * diabetes mellitus, * immunosuppressive or coagulation disorders, * pregnancy and/or lactation, * other acute surgical diseases

Keywords: complex pilonidal disease unroofing curettage recurrence lay open technique
conservative surgery with modified widman flap vs papilla preservation technique for the treatment of residual pockets

Conditions: Periodontitis

Summary: the primary aim of the study is to evaluate the efficacy of conservative surgery with or without papilla preservation technique in the treatment of deep residual pockets ≥ 6 mm in stage iii-iv periodontitis patients after cause related therapy (step ii) in terms of endpoints of therapy and other secondary outcomes at different time intervals (1, 3 and 5 years). moreover, the study aims to evaluate the stability of the results obtained for the different surgical approaches over a 5 years follow-up period.


Eligibility criteria:
inclusion criteria: * diagnosis of stage iii/iv periodontitis. * completed steps i-ii periodontal therapy at least 6 weeks before. * full mouth plaque score of less than 15% at re-evaluation. * full mouth bleeding score of less than 15% at re-evaluation. * sextant with residual probing pocket depth (ppd) ≥ 6 mm at ≥ 2 natural teeth (third molars excluded). * signed informed consent. exclusion criteria: * compromised general health which contraindicates the study procedures (asa iii-vi patients). * systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives). * pregnant or nursing women. * presence of tooth mobility ≥ class 2.
psychosocial treatment for improving chances of survival in women with breast cancer

Conditions: Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer

Summary: this study will investigate the influence of psychosocial treatment on psychological outcomes and survival among women with metastatic or recurrent breast cancer.

the objective of this study is to investigate the influence of psychosocial treatment on psychological outcomes and survival among women with metastatic/recurrent breast cancer.

Eligibility criteria:
inclusion criteria: women were eligible for the study if they had documented metastatic or recurrent breast cancer, were proficient enough in english to be able to complete questionnaires and participate in a support group, were living in the greater san francisco bay area, and had a karnofsky score of at least 70%.19 exclusion criteria: women were excluded if they had any of the following risk factors: positive supraclavicular lymph nodes as the only metastatic lesion at the time of initial diagnosis; active non-breast cancers within the past 10 years; or other concurrent medical conditions likely to influence short-term survival. basal cell or squamous cell carcinomas of the skin, in situ cancer of the cervix, or melanoma with a breslow depth less than 0.76 mm were allowed.
safety & effectiveness study of aegea vapor system to treat excessive uterine bleeding

Conditions: Menorrhagia

Summary: the purpose of this study is to determine if the aegea vapor system for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia)

this is a single-arm, multi-center study with three years of follow-up.

Eligibility criteria:
inclusion criteria: * female subject from (and including) age 30 to 50 years * self-reported history of heavy menstrual bleeding in at least 3 of the last 6 months * predictable cyclic menstrual cycles over past 6 months * excessive uterine bleeding * premenopausal at enrollment * normal pap * normal endometrial biopsy * willing to use reliable contraception * not currently taking hormonal medication * agree to use sponsor provided catamenial product (sanitary pads/tampons) exclusion criteria: * pregnant * desires future childbearing * presence of an iud * previous endometrial ablation procedure * evidence of sti * evidence of pid * active infection of genitals, vagina, cervix, uterus or urinary tract * active endometritis * active bacteremia, sepsis or other active systemic infection * gynecologic malignancy * endometrial hyperplasia * known clotting defects or bleeding disorders * on anticoagulant therapy * hemoglobin \<8gm/dl * prior uterine surgery * currently on medication that could thin myometrial muscle * severe dysmenorrhea, secondary to adenomyosis * abnormal uterine cavity * hydrosalpinx * uterine length \ 12cm * currently in other clinical trial

Keywords: endometrial ablation with vapor
phase iib clinical trial with tgf-β2 antisense compound ap 12009 for recurrent or refractory high-grade glioma

Conditions: Glioblastoma; Anaplastic Astrocytoma

Summary: in this multinational dose finding phase iib study the efficacy and safety of two doses of ap 12009 compared to standard chemotherapy (temozolomide or pcv) is investigated in adult patients with confirmed recurrent high-grade glioma.

the purpose of this study is to compare the safety and efficacy of two doses of ap 12009 and standard chemotherapy in adult patients with recurrent high-grade glioma (anaplastic astrocytoma \[aa\], who grade iii; or glioblastoma \[gbm\], who grade iv). ap 12009 is a phosphorothioate antisense oligodeoxynucleotide specific for the mrna of human transforming growth factor-beta2 (tgf-beta2). the growth factor tgf-beta plays a key role in malignant progression of various tumors by inducing proliferation, invasion, metastasis, angiogenesis and escape from immunosurveillance. it has been shown that in a number of tumor types the degree of tgf-beta production strongly correlates with tumor grade and stage. in patients with high-grade glioma, the tgf-beta2 overexpression is associated with disease stage, clinical prognosis and the immunodeficient state of the patients.

Eligibility criteria:
inclusion criteria: * histopathologically confirmed diagnosis of recurrent or refractory high-grade glioma (anaplastic astrocytoma, who grade iii; or glioblastoma, who grade iv) * supratentorial localization * no more than two chemotherapy regimens including radiochemotherapy since primary diagnosis * eligible for either tmz or pcv treatment * recovery from acute toxicity caused by any previous therapy * adequate organ functions * kps at least 70% exclusion criteria: * tumor surgery within 2 weeks prior to study entry * radiation therapy within 8 weeks prior to study entry * chemotherapy within 4 weeks prior to study entry (nitrosureas: 6 weeks) * no more than 3 mg/day dexamethasone (or equivalent) at baseline * prior tgf-beta targeted therapy or tumor vaccination * baseline mri shows mass effect * known active infection with hiv, hbv, or hcv; acute viral, bacterial, or fungal infection * significant psychiatric disorders/legal incapacity or a limited legal capacity

Keywords: glioblastoma anaplastic astrocytoma antisense cancer transforming growth factor beta2 (tgf-beta2) targeted therapy immunotherapy brain tumor central nervous system (cns) convection-enhanced delivery (ced) / microperfusion locoregional application
identification of factors associated with a delayed diagnosis in crohn's disease

Conditions: Crohn Disease

Summary: the goal of this observational study is to determine the factors associated with a delayed diagnosis and/or an immediately complicated disease for cd patients. a questionnaire will be completed by the patients, each questionnaire has a patient section and a physician section.

number of patients expected : at least 600, coming from all types of practices (angh (expert hospitals), getaid (expert university hospitals) and cregg (expert private practice)). recruitment period : 1 year primary endpoint : the primary endpoint is the description of the factors linked to: * the ibd * the patient (see patient questionnaire in annex 1) * the health care system * the patient's self-care secondary endpoint : * validation of the "red flags" in a prospective cohort. * comparison with the epimad population, especially the location and severity.

Eligibility criteria:
inclusion criteria: * crohn's disease diagnosed less than a year prior to inclusion * written consent * age ≥ 18 years exclusion criteria: * diagnosis of crohn's disease more than one year before inclusion * patient protected by the law * patient without health cover

Keywords: ibd crohn cd
risdiplam in patients with spinal muscular atrophy previously treated with nusinersen

Conditions: Spinal Muscular Atrophy

Summary: risdiplam exchange (rise) is a study of spinal muscular atrophy (sma) patients who crossover to 36 months of open-label risdiplam monotherapy following a comparable period of nusinersen treatment. the schedule of assessments (soas) carry over seamlessly for the cohort from studies done while treated with nusinersen and continue to track the most informative outcomes from that trial (e.g. nine hole peg test and grip strength), while adding the box and block test (bbt) as an additional measure of upper limb endurance and function.

risdiplam is an orally bioavailable small molecule that distributes into the central nervous system (cns) and peripheral tissues where it modifies smn2 pre-mrna splicing and increases tissue smn protein levels. it was approved by the u.s. food and drug administration for all sma patients older than 2 months of age in august 2020. clinical trial data prompted us to consider risdiplam a reasonable alternative to nusinersen administered intrathecally or by subcutaneous intrathecal catheter (sic) for patients with more advanced sma. considered within this clinical context, risdiplam presents a significant advantage by eliminating the risks of mechanical failure, intrathecal bleeding, and cns infection associated with the sic device. the schedule of assessments (soas) used in this cohort during the previous three-year period as part of a nusinersen study provide us with an established framework for data collection. thus, the overall clinical experience with risdiplam as compared to nusinersen can be assessed using a prospective, crossover design in a real-world setting.

Eligibility criteria:
inclusion criteria: * biallelic smn1 deletions * 3 or 4 copies of smn2 * prior treatment with nusinersen for a minimum of 22 months exclusion criteria: * prior treatment with smn gene replacement therapy * prior exposure to another investigational agent. * confounding neuromuscular disorder other than sma

Keywords: nusinersen prospective risdiplam
d20054;litt for spine tumors

Conditions: Spinal Metastases

Summary: the objective of this clinical study is to evaluate the efficacy and safety of spinal laser interstitial therapy in the treatment of metastatic spinal tumors. the investigators hypothesize that rates of local tumor control are comparable between conventional open surgical techniques and spinal laser interstitial therapy.


Eligibility criteria:
inclusion criteria: 1. histology confirmed spinal tumor involving the t2-t12 spine segments. 2. indication for spine stereotactic radiosurgery or palliative intervention. 3. normal neurologic exam at the time of presentation (frankel grade e). exclusion criteria: 1. contraindication to mri 2. any neurologic deficit 3. tumor spanning more than 3 consecutive vertebral segments 4. contraindication to general anesthesia 5. pregnancy
hypofractionated radiotherapy and concurrent cisplatin for head and neck cancer

Conditions: Radiotherapy; Complications

Summary: the aim of this study is to evaluate the feasibility of hypofractionated radiation therapy and concomitant chemotherapy with cisplatin for locally advanced head and neck cancer in a high volume brazilian center.

to evaluate if concomitant cisplatin and hypofractionated radiation therapy wold be feasible in a brazilian population. patients eligibility criteria: older than 18 years old biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx. stage iii an iv, with no distant metastasis. ecog performance status 0-2. adequate renal and liver function. good status for radical treatment treatment considered feasible if: 1. patient receive at least 90% of radiation dose (18 of 20 fractions of 275cgy) 2. patients receive at least 3 of 4 weekly cycles of cisplatin (35mg/m2) 3. treatment length up to 35 days. 4. grade 4 toxicity lower than 25%

Eligibility criteria:
inclusion criteria: * biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx. * stage iii an iv, with no distant metastasis. * ecog performance status 0-2. * adequate renal and liver function. * good status for radical treatment exclusion criteria: * other oncologic treatment before * distant metastasis * history of previous malignancy

Keywords: chemotherapy complication
myocardial damage and music study

Conditions: Chronic Stable Angina; PTCA

Summary: myda-music study is a randomized, double blind (operator and analyst) study performed in san filippo neri hospital, roma, italy and in di venere hospital, bari, italy. the planned study duration is 12 months. the objectives are to assess the effects of heart-rate-variability based music on the incidence and magnitude of peri-procedural myocardial damage caused by coronary angioplasty in stable patients. 443 patients with chronic stable angina scheduled for a coronary angiography and possible ad hoc angioplasty will be randomized to receive music or dumb earphones.


Eligibility criteria:
inclusion criteria: * chronic stable angina scheduled to undergo a coronary angiography and ad-hoc angioplasty exclusion criteria: * abnormal c-tni level before angiography * participation in other clinical studies * patients with pacemakers or defibrillators * high rate atrial fibrillation (baseline heart rate \>99 bpm) at enrolment
platelet function monitoring in patients with acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: this study is being done to learn more about platelet reactivity (how well the small cells in the bloodstream work) in people who undergo percutaneous coronary intervention (pci) for stable and unstable (acute myocardial infarction) indications. stable means you have not demonstrated any acute injury to your heart prior to your pci; unstable means you have demonstrated some acute injury to your heart prior to your pci. the investigators intend to determine if there is a change in platelet reactivity from the time of pci to 30days post-pci and does this change differ depending upon the conduction in which you present for pci. this is going to be done with a variety of platelet reactivity assays.


Eligibility criteria:
inclusion criteria: * patient \>18 years old. * patient scheduled to undergo pci for either stable cad or ami: * stable cad defined as negative cardiac isoenzymes prior to the pci as well as no resting ecg changes indicative of acs. * ami defined as positive cardiac isoenzymes prior to the pci and/or resting ecg changes indicative of acs. 3. patients treated with a loading dose of clopidogrel at least 6 hours prior to the blood draw or on a maintenance dose of clopidogrel (of at least 75mg qd) for a minimum of 5 days. exclusion criteria: * known allergies to aspirin, clopidogrel, or prasugrel * use of a glycoprotein (gp) iib/iiia inhibitor within 8 hours of the blood draw; * patient known to be pregnant or lactating; * patient with known history of bleeding diathesis or currently active bleeding; * platelet count \<100,000/mm the day of the blood draw; * hematocrit \<25% the day of the blood draw; * on warfarin therapy at the time of the blood draw or the need for warfarin therapy in the subsequent month following the blood draw; * known blood transfusion within the preceding 10 days of the blood draw; * patient who has received nsaid (not including asa) within preceding 24 hours of the blood draw; * patients presenting with cardiogenic shock; * any significant medical condition, which in the investigator's opinion may interfere with the patient's optimal participation in the study.

Keywords: platelet reactivity