Kornimate/medical-research-clean huggingface dataset:
study of concurrent chemo-radiotherapy combined with recombinant human endostatin for local advanced non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer

Summary: it is a trials to evaluate the overall survival (os) of radiotherapy / ep combined with recombinant human endostatin in treatment of locally advanced (ⅲ a / unresectable ⅲ b) non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: 1. patients with pathologically or histologically confirmed and inoperable stage ⅲ (ⅲ a or unresectable ⅲ b) nsclc; 2. patients with ages of 18\~70 years, general condition ecog performance scale （ps）≤ 1, weight loss \<10% during last 6 months; 3. ct films of patients during last 4 weeks were accessible when patients were selected into the groups, the lesions were measurable; (according to the standard of recist1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral ct, pet-ct, with the largest diameter≥ 20mm by ordinary ct and mri.） 4. no major organ dysfunction, the function of heart, liver and kidney was normal, laboratory indicators should meet the following requirements: blood: wbc\> 4.0 × 109 / l, absolute neutrophil count \> 1.5 × 109 / l, platelet count\> 100 × 109 / l, hemoglobin\> 110g / l; liver function: serum bilirubin was less than 1.5 × maximum normal value ; alt and ast were less than 1.5 × maximum normal value; bun, cr within the normal range; fev1 \> 1l or\> 40% of predicted value; 5. patients could understand the circumstances of this study and those who have signed the informed consent form; exclusion criteria: 1. pregnant or lactating women; women of child-bearing age without contraception; 2. acute infection or other serious underlying diseases; 3. significant neurological, psychiatric history, including dementia which may influence the ability to understand and the informed consent; 4. receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs a the same time; have joined other drug clinical trials 30 days before this clinical trial; 5. diabetes without control (blood-glucose is unstable or ≥ 8mol / l after administration); 6. patients who are allergic to e. coli preparation; 7. patients who are unsuitable to participate in this trial determined by the researchers.

Keywords: radiotherapy rh-endostatin chemotherapy nsclc
the efficacy of human acellular dermal matrix in the treatment of anal fistula

Conditions: Anal Fistula; Treatment; Postoperative Complications; Acellular Dermal Matrix

Summary: the purpose of this study is to determine whether human acellular dermal matrix plug is effective in the treatment of anal fistula

recently, the use of biomaterial for the treatment of anal fistula has drawn great interest. the advantages of this technique include simple and repeatable application, preservation of sphincter integrity, minimal patient discomfort, and the ability for subsequent surgical options if needed. champagne et al reported using a biologic absorbable anal fistula plug which is made from lyophilized porcine small intestinal submucosa (surgisis®). in their series of 46 patients treated with the anal fistula plug, a success rate of 83 percent was achieved at a median follow-up of 12 months. in addition, evaluation of the functional outcome after fistula closure showed no impairment of continence with significant improvement in quality of life showed. however, the long term success rates of surgisis® are variable according to other studies. human acellular dermal matrix (adm) is a biologic material consists of dermis without its cellular components. early and rapid revascularization of the implanted adm, as was shown in our previous experimental study, is thought to enhance resistance to infection and contamination. these properties make adm an attractive alternative for the treatment of anal fistula. the ability of adm to become vascularized and remodeled by autologous cells may be advantageous for anal fistulas healing. the purpose of this study is to determine whether human acellular dermal matrix plug is effective in the treatment of anal fistula.

Eligibility criteria:
inclusion criteria: * complex anal fistula exclusion criteria: * pregnancy or lactation * with operation contraindication * allergic constitution to heterogeneous protein * complicated with tumor * complicated with acute infection

Keywords: anal fistula acellular dermal matrix treatment postoperative complications recurrence
can treatment with bismuth reduce toxicity to chemotherapy and radiotherapy?

Conditions: Hematological Diseases; Hematological Malignancies; Blood Diseases; Malignant Lymphoma; Leukemia; Multiple Myeloma

Summary: the purpose of this study is to determine whether treatment with bismuth can reduce the toxicity of chemotherapy and radiotherapy in patients with malignant diseases of the blood.


Eligibility criteria:
inclusion criteria: * patients of 18 years or over referred to the department of haematology l, herlev hospital, with a view to 'cytostatic'? treatment of or radiotherapy for haematological malignancy exclusion criteria: * pregnant women and nursing mothers * no informed consent from patient * known hyper sensitivity to bismuth or other tablet content * severe renal insufficiency with creatinin clearance below 25 ml/min. * patients receiving other treatment for protection of the mucous membrane except cryo treatment of the oral cavity (lumps of ice in the mouth) * other experimental treatment within past four weeks.

Keywords: haematology haematological hematology hematological malignancy lymphoma myeloma leukemia blood diseases malignant bismuth
study to evaluate the effects of ono-2952 on pain perception produced by rectal distention in female subjects with diarrhea-predominant irritable bowel syndrome (ibs-d)

Conditions: Irritable Bowel Syndrome (IBS)

Summary: the objective is to evaluate whether ono-2952 modulates visceral pain perception produced by rectal distention in female patients with ibs-d


Eligibility criteria:
inclusion criteria: 1. female 18-65 years of age (inclusive) 2. diagnosed with ibs based on the following criteria (rome iii criteria): * symptom onset at least 6 months prior to diagnosis, and * recurrent abdominal pain or discomfort at least 3 days per month for the past 3 months, and * abdominal discomfort or pain associated with two or more of the following at least 25% of the time: * improvement with defecation * onset associated with a change in frequency of stool/defecation * onset associated with a change in form (appearance) of stool 3. diagnosed with ibs-d, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations exclusion criteria: * any structural abnormality of the gastrointestinal (gi) tract (other than esophagitis or gastritis) * history of chron's disease, ulcerative colitis, diabetes mellitus, lactose malabsorption, malabsorption syndromes, celiac sprue, or any upper gi symptoms that may impact the assessment of ibs symptoms

Keywords: irritable bowel syndrome ibs ono-2952
study of the combined influence of sepsis and mechanical ventilation on the human diaphragm

Conditions: Respiration, Artificial

Summary: the aim of this study is to study the combined impact of mechanical ventilation and sepsis on the human diaphragm in order to establish the neutral, protective or destructive character of mechanical ventilation by studying the diameter of the fibers, activation of proteolytic systems, inhibition of protein synthesis, tissue inflammation as well as contractile function.


Eligibility criteria:
inclusion criteria: * patient at least 18 years of age, male or female requiring abdominal or thoracic surgery or multi-organ sampling; * affiliated to a social security or similar system; * not subject to legal protection; * having given consent to participate in the study (or consent from the trusted person) * control group (c): non-septic mesocolic programmed abdominal or thoracic surgery: gastrectomy, esophagectomy, pancreatectomy, hepatectomy * sepsis group (s): abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess) * group mechanical ventilation (mv): patient in brain death for which a multi organ sample is planned * mechanical ventilation + sepsis (s-mv) group: patient under controlled mechanical ventilation to undergo abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess) exclusion criteria: * pregnant woman (diagnosis of interrogation) * severe and / or unbalanced chronic respiratory disease; severe malnutrition * long-term corticosteroids\> 5mg / day for more than 1 month * myopathy * surgery by laparoscopic by group: * control group: sepsis, preoperative controlled mechanical ventilation and preoperative hemodynamic instability * mechanical ventilation group: sepsis, duration of controlled mechanical ventilation \ 7 days * sepsis group: preoperatively controlled mechanical ventilation * mechanical ventilation - sepsis group: duration of controlled mechanical ventilation \ 7 days
assessment of medrol dosepak to reduce opioid consumption in foot and ankle surgical patients

Conditions: Foot Injuries and Disorders; Ankle Injuries and Disorders; Achilles Tendon Injury

Summary: this clinical trial aims to determine the effects of a 6-day low-dose methylprednisolone course on pain, nausea, and total opioid consumption in patients undergoing foot and ankle surgeries. the secondary objective of the study is to determine and monitor the effects of the course on complications following surgery and patient-reported outcomes

the opioid epidemic continues to create a lasting impact on society, leading researchers to focus on ways to decrease opioid prescription rates and subsequently, opioid consumption. opioid-naïve patients undergoing minor to major surgeries have been shown statistically to be largely affected.1 this includes significant numbers resulting from forefoot surgery specifically with around 6.2% of the mentioned population being at risk for new persistent opioid use. this has provoked researchers to seek a new route that decreases exposure to opioid use through proposals for multimodal pain regimes. a recent addition to some of these proposed treatments has been a 6-day low-dose oral methylprednisolone taper beginning on the day of surgery. this has been tested with "terrible triad" elbow injuries, distal radius fractures, and total shoulder arthroplasties with promising results showing decreased consumption of the as-needed opioid prescription. furthermore, the results of these studies show a significant decrease in pain and increased range of motion following surgery. this is likely due to the anti-inflammatory functioning of glucocorticoids, without inhibiting the healing process. based upon the findings stated above, the proposed research will attempt to apply this new pain regime to foot and ankle surgeries, specifically forefoot, ankle, and achilles surgeries, to take another step towards bettering perioperative care with opioid-free treatment

Eligibility criteria:
inclusion criteria: -emory orthopedic patients undergoing foot and ankle surgery exclusion criteria: * concurrent or significant injuries to other bones or organs * local infections * history of alcohol or medical abuse, including prior opioid abuse * smoking * history of severe heart disease, renal failure, liver dysfunction, active peptic ulcer disease, diabetes, rheumatoid arthritis, neurological or psychiatric diseases that could influence pain perception * pre-existing immune suppression * those deemed possibly non-compliant by the study team and, * all vulnerable populations (those unable to give consent, juveniles, pregnant women, prisoners, cognitively impaired and non-english speaking).

Keywords: vas scale: visual analog scale medrol dosepak
the application of fibrin glue in ocular surface diseases

Conditions: Pterygium; Corneal Ulcer

Summary: this clinical trial tries to use tissue fibrin glues (tisseel) to treat various ocular surface diseases or surgeries, which includes pterygium surgery, corneal melting/perforation, gunderson's flap, conjunctival laceration, and muscle/clinical/filtering surgery.

this clinical trial tries to use tissue fibrin glues (tisseel) to treat various ocular surface diseases or surgeries. the inclusion criteria are: 1. ocular surface disease which may need amniotic membrane transplantation (corneal pro epithelization, pterygium surgery, etc) 2. infectious or noninfectious corneal ulcer with perforation less than 3 mm 3. conjunctival transplantation/suture 4. corneal surgeries which can be treated by conventional suture technique or application with cyanoacrylic acid tissue glues. informed consents will be obtained from the patients before applications. after surgeries, topical steroids and antibiotics will be used, and therapeutic contact lens will be used. the patients will be followed up for at least three months.

Eligibility criteria:
inclusion criteria: * ocular surface diseases, which are expected to be treated by tissue fibrin glues exclusion criteria: * pregnancy * children younger than 3 years old

Keywords: fibrin glue corneal perforation pterygium conjunctiva corneal ulcer
vinorelbine metronomic plus lapatinib for overexpressing her-2 metastatic breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of metronomic oral vinorelbine taken three times a week plus daily lapatinib without break, as salvage treatment in patients with metastatic breast cancer.

continuous administration of oral vinorelbine, given three times a week (metronomic) is feasible and exceptionally well tolerated at doses up to 50 mg. early results show activity against refractory tumors and provide evidence towards clinical proof of efficacy for metronomic chemotherapy. recently, lapatinib plus capecitabine was proven superior to capecitabine alone in women with her2-positive advanced breast cancer that has progressed after treatment with regimens that included an anthracycline, a taxane, and trastuzumab.

Eligibility criteria:
inclusion criteria: * histologically- or cytologically- confirmed metastatic breast adenocarcinoma * age 18-75 years * her2 status positive according to the local institution reported grade 3+ staining intensity (on a scale of 0 to 3) by means of immunohistochemical analysis or grade 2+ staining intensity by means of immunohistochemical analysis with gene amplification on fluorescence in situ hybridization * previous therapies had to include, regimens containing an anthracycline and a taxane * previous treatment with trastuzumab, alone or in combination with chemotherapy for locally advanced or metastatic disease, is required * measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions) * performance status (who) 0-2 * adequate liver (serum bilirubin \<1.5 times the upper normal limit; ast and alt \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases); adequate renal function (serum creatinine \<1.5 times the upper normal limit); and bone marrow (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l) function * no radiation of measurable disease (except brain metastases) * no progressive brain metastases according to clinical or radiological criteria * no brain metastases without prior radiation therapy * written informed consent exclusion criteria: * patient unable to take oral medication * active infection * history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * other invasive malignancy except nonmelanoma skin cancer * psychiatric illness or social situation that would preclude study compliance * pregnant or lactating women

Keywords: vinorelbine metronomic-lapatinib chemotherapy targeted therapy
prospective wcd post cabg registry (cabg registry)

Conditions: Cardiomyopathy Ischemic; Cardiomyopathies; Cardiovascular Diseases; Heart Disease, Ischemic

Summary: the primary objective is to observe the rate of recovery of ventricular function (ef\>35%) after first-time coronary artery bypass graft surgery in patients who were prescribed the wearable cardioverter defibrillator (wcd) post-surgery prior to being discharged after hospitalization as part of standard clinical care.

the primary objective of this study is to determine the rate of recovery of ventricular function (ef\>35%) in patients with ischemic heart failure with reduced ejection fraction (ef ≤35%) after undergoing first time, coronary artery bypass grafting (cabg) procedure while being treated with guideline-directed medical therapy (gdmt). it is anticipated that more patients will have ef recovery as compared to a retrospective register where 54% of isolated cabg patients had ef recovery by end of wcd use (kuehn et al., 2022), mostly driven by the modern improved usage of gdmt drugs. this study is designed as a multi-center prospective observational study of patients who underwent first time coronary artery bypass grafting procedure with hfref at hospital discharge to test the hypothesis that ef recovery will be improved by end of wcd wear due to increased usage of gdmt. the study will target 20% female enrollment and recruitment will be adjusted if the percentage of female subjects enrolled are far from 20%.

Eligibility criteria:
inclusion criteria * patient underwent first-time cabg surgery \<10 days before enrollment. * patient is prescribed wcd for a primary reason of hf with reduced ef \< 35% measured after surgery but before hospital discharge. * patient is ≥18 years old exclusion criteria: * patients having combination cabg surgery with heart valve repair. * patients with prior cabg. * patients who have an active unipolar pacemaker. * patients with a physical or mental condition that could impair their ability to properly interact with the wcd. patients currently participating in an interventional clinical study. patients with any skin condition that would prevent wearing the device. patients with an advanced directive prohibiting resuscitation.
a study to evaluate efficacy and safety of hcp1401 for stage 2 hypertension patients not controlled by hcp0605

Conditions: Hypertension

Summary: a phase 3 study to evaluate efficacy and safety of hcp1401

a randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of hcp1401 for stage 2 hypertension patients not controlled by hcp0605

Eligibility criteria:
inclusion criteria: * hypertension patient who satisfied below condition at visit 1. * patient who takes antihypertensive drug * 140mmhg \<= sitsbp \<= 200mmhg * patient who doesn't take antihypertensive drug * 160mmhg \<= sitsbp \<= 200mmhg * 140mmhg \<= sitsbp \<= 200mmhg at visit 2 exclusion criteria: * patient who have received 4 or more antihypertensive drug * patient with 20mmhg of difference in sitsbp or 10mmhg of difference in sitdbp between 3 times of bp measuring at visit 1 * patient with sitdbp \>= 120mmhg at visit 2 * patient with secondary hypertension
lung ultrasound score in covid 19 infectious disease in critical care (lus-covid19)

Conditions: COVID

Summary: it might be necessary with sars-cov2 pneumopathy patient to repeat thoracic images, the tomodensitometry ones in particular. this task is difficult and nearly impossible for several reasons: respiratory and hemodynamic unstable patient, prone position and due to the high contagious nature of the disease. the lung ultrasound is an easy tool, fast (between 5 and 10 minutes) and as a limited training. in the context of the sars-cov2 epidemic, buonsenso and al case report depict the first lung ultrasound for a covid 19 patient. peng and al in intensive care medicine accentuate the usefulness of this particular technic. in the american journal of respiratory and critical care medicine, a study has been published as a point-of-care, in which the doctors reported using the lung ultrasound with intensive and critical care patient. in critical care 2016, it has been showed that ultrasound allowed with neat precisions, to predict severe ards patient response to the prone position, all-cause. another researchers team found a good correlation between lung ultrasound, the sofa, apache ii, cpis score, and patient mortality. and a new applicability in the pulmonary recruitment by peep titration has been presented. the aim of this study is to evaluate the lung ultrasound in covid19 ards.


Eligibility criteria:
inclusion criteria: * diagnosed sars-cov2 patient, with pcr method qualitative or quantitative as usual. * intensive or critical care admission * ards with pao2/fio2 \<300 at the admission * ventilatory support or oxygen-therapy exclusion criteria: * age \< 18 years-old * pregnancy * patient with tutor- or curatorship or in prison
early changes in positron emissions tomography (pet/ct) scan as predictors of clinical outcome in nsclc treated with egfr tyrosin kinase inhibitors (tki)

Conditions: Non-small Cell Lung Cancer Patients

Summary: erlotinib, an anti-cancer agent targeting the epidermal growth factor receptor (egfr), is an active treatment of patients with non-small cell lung cancer (nsclc). effect of treatment is primary seen in patients harboring a mutation in the egfr. however, 10-15% of patients does not harbor a mutation but respond as well. identifying these patients is a problem and methods are lacking. studies have shown that an early 18f fdg-pet might can predict response and outcome in these patients, but further studies are needed to confirm these findings.


Eligibility criteria:
inclusion criteria: * lung cancer patients with non-small cell histology and stage iv disease * candidate for erlotinib treatment as first/ second/ third line of treatment exclusion criteria: * pregnancy * severe dyspnoea
safety and accuracy of the saranas ebbms for the detection of endovascular procedure related bleeding events

Conditions: Endovascular Procedures

Summary: to evaluate the safety and accuracy of the saranas ebbms for the detection of access site related internal bleeding events during large-bore endovascular procedures.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * willing and capable to sign an informed consent form * planned endovascular procedure such as trans-femoral transcatheter aortic valve replacement (tavr), balloon aortic valvuloplasty, percutaneous coronary intervention, complex or high-risk percutaneous coronary intervention requiring hemodynamic support device (impella 2.5, impella cp, and ecmo), endovascular aortic repair (evar), any other endovascular procedures requiring arterial or venous access or surgical insertion of hemodynamic support exclusion criteria: * subject is participating, or planning to participate in a clinical trial or study of an investigational product that may influence the data collected for this investigation * inability to access artery or vein for the endovascular procedure * current active bleeding * pre-procedural conditions precluding the realization of a post-procedural ct scan * pregnancy * mental disability or any other lack of fitness, in the investigator's opinion, to preclude subject's participation in or ability to complete the study as planned

Keywords: large bore femoral access internal bleeding retroperitoneal hematoma bleeding complications