Kornimate/medical-research-clean huggingface dataset:
krn7000 in treating patients with solid tumors

Conditions: Lung Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: biological therapies such as krn7000 use different ways to stimulate the immune system and stop cancer cells from growing. purpose: phase i trial to study the effectiveness of krn7000 in treating patients who have solid tumors that have not responded to previous treatment.

objectives: i. determine the safety profile and maximum tolerated dose of krn7000 in patients with solid tumors. ii. assess the biological and immunological parameters that would suggest the optimal biologically active dose of krn7000 in these patients. iii. determine the pharmacokinetics of krn7000 at the different dose levels in these patients. iv. measure any antitumor activity in these patients treated with this regimen. outline: this is a dose escalation study. patients receive krn7000 by slow intravenous injection on days 1, 8, and 15. treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients each receive escalating doses of krn7000 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose at which at least 2 of 6 patients experience dose limiting toxicity. projected accrual: approximately 40 patients will be accrued for this study within 18 months.

Eligibility criteria:
disease characteristics: histologically or cytologically proven solid tumor that is refractory to conventional treatment or for which no curative or standard palliative treatment exists no brain involvement or leptomeningeal disease patient characteristics: age: 18 and over performance status: ecog/who 0-2 life expectancy: at least 3 months hematopoietic: wbc at least 4,000/mm3 platelet count at least 100,000/mm3 lymphocyte count at least 600/mm3 hepatic: bilirubin less than 1.5 mg/dl ast and alt no greater than 2.5 times upper limit of normal no liver cirrhosis hepatitis b surface antigen negative renal: creatinine no greater than 1.4 mg/dl or creatinine clearance at least 60 ml/min cardiovascular: no new york heart association class iii or iv heart disease immunologic: no immunodeficiency no autoimmune disease other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception no active infection no nonmalignant disease incompatible with study no prior alcoholism, drug addiction, or psychotic disorders unless suitable for adequate follow up no cerebroside metabolite abnormalities (e.g., gaucher's disease) hiv negative prior concurrent therapy: biologic therapy: at least 3 months since prior immunotherapy no concurrent cytokines chemotherapy: at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, and high dose chemotherapy) endocrine therapy: not specified radiotherapy: at least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy) no concurrent radiotherapy surgery: not specified other: no other concurrent investigational or antitumor drugs

Keywords: non-small cell lung cancer unspecified adult solid tumor, protocol specific
effect of electric impedance tomography-guided peep titration

Conditions: ARDS, Human

Summary: acute respiratory syndrome distress (ards) is a clinical common syndrome with high mortality. mechanical ventilation (mv) is the cornerstone of management of ards but can lead to ventilator-induced lung injury. positive end-expiratory pressure (peep), as one of main component of mv, has been widely used in the clinical practice. however, how to best set peep is still a difficult problem for moderate to severe ards patients. eit, an imaging tool evaluating the regional ventilation distribution at the bedside, can achieve the individual peep selection for all mechanically ventilated patients. this article compared the effect of peep titrated guided by eit with fraction of inspired oxygen (fio2)-peep table on the ventilation-perfusion mismatch.


Eligibility criteria:
inclusion criteria: 1. intubated patients with moderate and severe ards (berlin definition, pao2/fio2 ≤200 mmhg at peep 5 cmh2o) 2. undergoing deep sedation on controlled mechanical ventilation within72 hours after ards onset exclusion criteria: 1. age \<18 years old 2. patient undergoing legal protection 3. contra-indications to eit (e. g. severe chest trauma or wounds) 4. pneumothorax 5. patient undergoing ecmo 6. pregnancy
melatonin as an analgesic in preterm neonate

Conditions: Preterm Neonate Analgesia

Summary: melatonin (n-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland with several important functions, including regulation of the circadian rhythms, antioxidant and anti-inflammatory effects, accumulating evidence revealed that it also plays an important role in pain modulation through multiple mechanisms. the investigators aimed to evaluate the analgesic effect of enteral melatonin given 30 minutes before cannula insertion in preterm neonates by assessing premature infant pain profile score (pipp) before and 5 minutes after the procedure. additionally, the study aimed to explore the relationship between procedural pain and oxidative stress, along with the effectiveness of pain management of melatonin by measuring malondialdehyde (mda), a well-accepted marker of oxidative stress, 60 minutes after the procedure.

this is a randomized, double-blind, controlled trial

Eligibility criteria:
inclusion criteria: * preterm infant * less than 37 weeks gestational age * who started enteral feeding. exclusion criteria: * multiple congenital anomalies. * facial malformation. * receiving analgesia or sedation. * contraindication of enteral feeding. * clinical or laboratory signs of sepsis. * infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.

Keywords: preterm analgesia melatonin oxidative stress
back school for non-specific low back pain (lbp) in an urban setting

Conditions: Low Back Pain

Summary: this study will be a comparative design between 2 groups of subjects attending classes on back education in an urban setting. participants will be randomized to either an individual one-on-one back school session or to the 8 group sessions.


Eligibility criteria:
inclusion criteria: * participants 18 years of age or older who have been suffering from non-specific lbp for at least 3 months exclusion criteria: * additional impairments contraindicating their safe participation in the back school program, such as evidence of spinal cord pathology, cauda equina, progressive neurological damage, infection, inflammation, malignancy, fracture or a progressive, neurodegenerative disease as well as back surgery within the past year
evaluation of predictive proteic profile on mortality in the acute phase of septic shock in cancer patients

Conditions: Sepsis; Septic Shock; Cancer

Summary: the mortality induced by infections in onco-hematological patients is abnormally high at the acute phase of septic shock. consequently, it is important to detect the population with a high risk of short term mortality among patients with a septic shock. the aim of this study is the evaluation of predictive proteic profile on the short term mortality in the acute phase of septic shock in cancer patients.

method: monocentric prospective study with diagnostic and prognostic expectations. primary objective: identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock. secondary objective: research of clinical and biological prognostic factors.

Eligibility criteria:
inclusion criteria: * patient from oncology or hematology with a septic shock * patient aged 18 years and older * inclusion within the 24 hours of the septic shock in the intensive care unit * signed consent according to the emergency reglementation exclusion criteria: * pregnancy, breast feeding * patient with decision of care limitation * patient with legal protection

Keywords: sepsis septic shock
chest tube drainage of transudative pleural effusions hastens liberation from mechanical ventilation

Conditions: Liberation From Mechanical Ventilation

Summary: the purpose of this study is to determine whether chest tubes to drain transudative pleural effusions helps patients come off mechanical ventilation earlier.


Eligibility criteria:
inclusion criteria: * patients with transudative pleural effusion and requiring mechanical ventilation exclusion criteria: * patients with coagulopathy
randomized trial comparing terazosin 5 mg daily and doxazosin gits 4 mg daily for trial without catheter in acute urinary retention with long term follow up

Conditions: Prostatic Hyperplasia; Urinary Retention

Summary: the purpose of the study is to compare two alpha blockers, terazosin and doxazosin gits, in achieving a successful twoc after aur due to bph, among chinese males in hong kong, and in delaying or avoiding a turp.


Eligibility criteria:
inclusion criteria: * aged 50 or above * admitted for aur due to bph with pvr of 500 ml or more exclusion criteria: * previous history of turp * use of alpha blockers within recent 8 months * renal impairment (serum creatinine \>140 umol/l) * poor premorbid state

Keywords: benign prostatic hyperplasia (bph) acute retention of urine (aur)
a safety and efficacy study of brimonidine intravitreal implant in geographic atrophy secondary to age-related macular degeneration

Conditions: Geographic Atrophy; Macular Degeneration

Summary: this study will assess the safety and efficacy of the brimonidine intravitreal implant in participants with geographic atrophy due to age-related macular degeneration.


Eligibility criteria:
inclusion criteria: * geographic atrophy due to age-related macular degeneration in the study eye * visual acuity better than or equal to 20/125 snellen equivalent in the study eye and 20/200 snellen equivalent in the fellow eye. exclusion criteria: * cataract surgery or laser-assisted in situ keratomileusis (lasik) in the study eye in the last 3 months * infections in either eye in the last 3 months
a space-expanding shield in decompressive hemicraniectomy for stroke

Conditions: Stroke

Summary: instead of the standard decompressive hemicraniectomy with subsequent cranioplasty a single surgery with the implantation of an individually molded space-expanding shield is investigated in for patients with increased intracranial pressure due to a malignant stroke.

background: a malignant cerebral infarction causes edema resulting in a threatening increase of the intracranial pressure (icp). standard of care is a surgical removal of a part of the skull above the ischemic brain, the so-called decompressive hemicraniectomy (dce). dce allows the brain to swell, after detumescence of the brain parenchyma (usually several months later) the patients undergo a second surgery with implantation of either their own preserved bone flap or a bone flap substitute (a procedure referred to as cranioplasty (cp)). objective: despite its proven life-saving benefits, the strategy of dce followed by cp carries several risks, among others * exposure of the brain parenchyma * various neurological deficits subsumed under the syndrome of the trephined * bone resorption: as shown in a previous prospective cohort study the above-mentioned risks may be prevented using an intraoperatively molded space-expanding protective shield, which is implanted and fixed directly after having performed (a so far customary) dce. this shield allows the brain to swell while still providing protection. space shield investigates whether the single-stage strategy of implanting a space-expanding shield represents a viable alternative to the standard dce followed by cp." methods: the inclusion of patients is planned to take place from january 2025 to december 2029. the study duration for the individual patients is 6 months. while the intervention group will be treated with the above-described space-expanding shield the control group will be treated with the customary dce and following cp. the cp will be performed either with the original bone flap stored in customary manner or with a pmme bone flap. examinations of the patients are planned after 1 - 7 days, 6 weeks, 3 months and 6 months after the initial surgery.

Eligibility criteria:
inclusion criteria: * patients with malignant infarction of the middle cerebral artery identified by mri including diffusion-weighted imaging or ct including perfusion imaging - fulfilling the european guidelines for decompressive hemicraniectomy (dce) for stroke * ≥ 18 and \< 70 years of age * availability of consent from a next of kin and from the patient represented by an independent physician exclusion criteria: * hyperacute need for dce due to rapid neurological decline * contraindications to the use of polymethyl-methacrylate (pmma), e.g., known hypersensitivity, allergy * known gentamicin allergy * pregnancy and active breast-feeding * patients with a former history of dce and/or cp * active pulmonary or cranial infection * known coagulopathy independent of medication

Keywords: stroke bone flap cranioplasty
mcaf and emd with and without ctg wall technique for the treatment of class iii and iv gingival recessions-a randomized control trial

Conditions: Gingival Recession

Summary: research is to compare and evaluate the clinical outcomes of the connective tissue graft wall technique with modified coronally advanced flap to improve root coverage and clinical attachment levels in miller's class iii and iv gingival recession.

research is to compare and evaluate the clinical outcomes of the connective tissue graft wall technique with modified coronally advanced flap to improve root coverage and clinical attachment levels in miller's class iii and iv gingival recession. the objectives is to assess the probing pocket depth reduction, clinical attachment level gain, patient esthetic evaluation, complete root coverage and mean root coverage. the control group will be treated with modified coronally advanced flap with connective tissue graft and enamel matrix derivative and the study group will be treated with modified coronally advanced flap with connective tissue graft wall and enamel matrix derivative. the total number of participants included will be 24 (control-12; study-12) with a 6 month follow up.

Eligibility criteria:
inclusion criteria: * participants aged 18-60 years * systemically healthy individuals * participants with miller's class iii and iv or cairo's rt3 gingival recession in maxillary and mandibular anteriors. * participants with nordland and tarnow's papillary recession of either i, ii or iii. * presence of interdental ppd, cal and recession * radiographic evidence of interdental bone loss * no prior experience of root coverage procedures * able to achieve good oral hygiene and control gingivitis in the whole of the dentition (fmps \< 25% and fmbs \< 25%). exclusion criteria: * grade iii mobile teeth * pathologically migrated teeth * endodontically treated teeth * open contacts * pregnancy and lactating women * participants with systemic conditions * untreated periodontitis * persistence of uncorrected gingival trauma from tooth brushing * self-reported current smoking * presence of medical contraindications to elective surgery
effect of smart phone app-based human coaching program in gastrectomized patients

Conditions: Stage I Gastric Cancer

Summary: this study is a single center, prospective, randomized controlled study. the aim of this study is to evaluate the effect of smart phone app-based human coaching program on qol in patients who underwent gastrectomy for stage i gastric cancer. the hypothesis of this study is the patients who used smart phone app-based human coaching program for three months after surgery will have better qol than patients who did not use it. the qol will be assessed using eortc qlq c30 and sto22 at 3 months postoperatively. the secondary endpoints are qol at 6 months postoperatively, 12 months postoperative, food intake, body composition, and nutritional indicators from blood test.

\ * 90 patients in each group, a total of 180 patients * 1:1 randomization using permutated mixed block randomization * stratified by surgical extent (distal gastrectomy vs. total gastrectomy) * using nquery program and web-based management system * before discharge, patients are informed how to use the smart phone app and registered to the app. * patients use the app after discharge until 3 months postoperatively.

Eligibility criteria:
inclusion criteria: * patient aged 19 or more * patient diagnosed as stage i in preoperative examination * planned distal gastrectomy or total gastrectomy * patient who can use smart phone app or whose family can help the * patient to use the smart phone app exclusion criteria: * pregnant * disabled to communication * patient who cannot use smart phone app

Keywords: gastric cancer quality of life smart phone app human coaching program
study of nolasiban to increase pregnancy rates in women undergoing ivf

Conditions: Infertility

Summary: the primary objective of this study is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer (et) day.

the study is a prospective, randomised, parallel group, double-blind, placebo-controlled, phase 3 study to confirm the efficacy and the safety of nolasiban versus placebo to increase pregnancy and live birth rates in 820 women undergoing fresh single blastocyst transfer following in vitro fertilisation (ivf) or intra-cytoplasmic sperm injection (icsi).

Eligibility criteria:
inclusion criteria: * indicated for ivf/icsi in the context of assisted reproductive technology (art) * follow a gonadotropin releasing hormone (gnrh) antagonist protocol, single injection of human chorionic gonadotropin (hcg) for triggering final follicular maturation and luteal support with vaginal micronized progesterone. * single fresh d5 embryo transfer exclusion criteria: * frozen-thawed embryo transfer * donor egg in the current transfer * more than 20 oocytes in the current controlled ovarian hyperstimulation (coh) cycle * serum p4 greater than 1.5 ng/ml prior to hcg administration

Keywords: ivf icsi art et
effects of ulinastatin on myocardial protection and blood loss in patients undergoing aortic valve replacement

Conditions: Abnormal Aortic Valve

Summary: according to teg (thromboelastography), as maximum amplitude is increased the amount of bleeding and transfusion and cardiac enzyme is reduced by using ulinastatin.


Eligibility criteria:
inclusion criteria: * 40% below of output of left ventricle * tricuspid valve failure from moderate to severe * urgent surgery required * infectious endocarditis
clinical application of carbon nanoparticles in lymph node tracing and surgery guiding of colorectal cancer

Conditions: Colorectal Cancer

Summary: this trial aims to clarify the relationship between carbon nanoparticles labeled lymph nodes and lymph node metastasis in different lymph node regions of colorectal cancer, and to clarify the application value of carbon nanoparticles in lymph node dissection in colorectal cancer surgery.


Eligibility criteria:
inclusion criteria: 1. a diagnosis of colorectal cancer; 2. endoscopic injection of cnp suspension preoperatively 3. planned radical resection of colorectal cancer 4. older than 18 years of age exclusion criteria: (a) emergency surgery;

Keywords: carbon nanoparticle colorectal cancer lymph node
physical therapy intervention in pleural effusion

Conditions: Pleural Effusion

Summary: to know the effects of a physical therapy intervention in patients hospitalized with pleural effusion. the investigators will study the effects of the intervention in hospital stay, health status, psychologica distress and quality of life.


Eligibility criteria:
inclusion criteria: * inclusion criteria were pleural effusion patients hospitalized. exclusion criteria: * inability to provide informed consent. * presence of psychiatric or cognitive disorders. * progressive neurological disorders, organ failure, or inability to cooperate. * patients who had experienced another pleural effusion in the previous month.

Keywords: physical therapy pleural effusion
atomized inhalation icg for treatment of congenital lung malformations

Conditions: Pulmonary Sequestration; Congenital Pulmonary Airway Malformation; Indocyanine Green; Thoracoscopic Surgery; Children

Summary: to investigate the safety and effectiveness of preoperative aerosol inhalation icg solution for thoracoscopic accurate resection of congenital lung malformations in children.

preoperative preparation preoperative evaluation of pulmonary ventilation function and enhanced ct examination of the lungs were performed. respiratory symptoms should be improved first in case of complicated respiratory infection. icg solution dissolved in 5ml of normal saline (dose 0.5mg/kg) was inhaled 30 minutes before surgery. operation method intraoperative fluorescence thoracoscopic imaging was used, and focal resection was performed. all patients were placed in lateral decubitus position under general anesthesia, and single lung ventilation was selected. a low flow rate (1-2 l/min) and low co2 pressure (4-5 mmhg) were maintained in the thorax to establish an artificial pneumothorax. the observation hole is in the 7th or 8th intercostal space of the midaxillary line, and the two operating holes are in the 4th or 5th intercostal space of the anterior axillary line and the 8th or 9th intercostal space of the posterior axillary line, respectively. 30 degrees 10 mm fluorescence thoracoscope. after entering the chest cavity, the fluorescence endoscope was switched to the fluorescence display mode, and the fluorescence-stained normal lung tissue and non-stained lesion tissue could be clearly displayed through the display screen, and the external boundary of the lesion was marked with an electric hook. the mediastinal pleura and pulmonary pleura were opened along the boundary of the lesion, and the lung tissue was split along the gap between the lesion and the lung tissue with an electric coagulation hook and an ultrasonic knife, and the lesion arteries and bronchi were freed. smaller blood vessels could be cut by ligasure or ultrasonic knife directly, and thicker blood vessels and bronchi should be cut by hemolock until the lesion resection was completed. after the lesion was removed, the chest was rinsed with warm normal saline, and the lung tissue section was carefully examined to confirm that there was no active bleeding and air leakage, and the lung was well dilated. the intercostal nerve was blocked under thoracoscopic vision. finally, the thoracic closed drainage tube was placed in the midaxillary line puncture hole and the incision was closed. post-operation follow-up all patients undergo outpatient follow-up 3-6 months after surgery, including pulmonary ct and pulmonary ventilation function measurements, and comparison of vt (tidal volume), ti/te suction/exhalation time ratio, tptef/te (peak time ratio) and vpef/ve (peak volume ratio) before and after surgery.

Eligibility criteria:
inclusion criteria: * children with congenital lung malformations diagnosed by ct or mri scan exclusion criteria: * 1. ages \ 14 years 2. complicated other life-threatening disease; 3. complicated severely pulmonary infection