Kornimate/medical-research-clean huggingface dataset:
erlotinib, gemcitabine and nab-paclitaxel in advanced pancreatic cancer

Conditions: Advanced Pancreatic Cancer

Summary: this is a phase 1b study to evaluate the combination of gemcitabine and tarceva (erlotinib) and nab-paclitaxel in patients with advanced pancreatic cancer.

this is a single-arm, phase 1b study to determine the maximum tolerated dose (mtd) of the combination of erlotinib (daily), gemcitabine (weekly), nab-paclitaxel (weekly) in patients with advanced pancreatic cancer.

Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status (ps) 0-1 * predicted life expectancy of \>= 12 weeks * previous surgery * histologically or cytologically confirmed, measurable, locally advanced, unresectable or metastatic pancreatic adenocarcinoma * no prior therapy for pancreatic cancer * adequate organ and marrow function * absolute neutrophil count \>= 1.5 x 10\^9/l * platelets \>= 100 x 10\^9/l * total bilirubin \<= institutional upper limits of normal * ast (sgot)/alt(sgpt) \<= 2 x institutional upper limits of normal * serum creatinine \<= 1.5 x upper limits of normal * negative pregnancy test * informed consent * patient must agree not to smoke while on study exclusion criteria: * significant history of cardiac disease unless the disease is well controlled * active or uncontrolled infections or serious illness or medical conditions that could interfere with the patient's ongoing participation in study * history of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent * history of smoking within the previous 14 days before enrollment or positive cotinine test at baseline * pregnant or breast-feeding females * symptomatic brain metastases that are not stable, that require steroids, that are potentially life-threatening, or that have required radiation within the last 14 days * history of allergic reactions attributed to compounds of similar chemical or biological composition to the study drugs

Keywords: erlotinib nab-paclitaxel gemcitabine adenocarcinoma advanced pancreatic cancer phase 1b
pm8002 in the treatment of patients with advanced solid tumors

Conditions: Malignant Neoplasm

Summary: this study is to characterize the safety, tolerability, pharmacokinetics (pk), immunogenicity, pharmacodynamics (pd) and anti-tumor activity of pm8002, a pd-l1/vegf bispecific antibody, as a single agent in adult subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures; 2. male or female aged 18 to 75 years; 3. patients with malignant tumor confirmed by histology or cytology; 4. the toxicity of previous anti-tumor therapy has not been alleviated； 5. adequate organ function； 6. ecog score was 0-1; 7. expected survival \>=12 weeks; 8. according to recist 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally. exclusion criteria: 1. history of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study; 2. evidence of major coagulopathy or other obvious risk of bleeding; 3. patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy; 4. patients with uncontrolled brain metastases should be excluded from this clinical trial; 5. patients ever experienced other active malignant tumors within 5 years prior to the study treatment; 6. prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. known history of alcohol abuse, psychotropic drug abuse or drug abuse; 8. syphilis antibody positive; 9. patients with active tuberculosis (tb) are excluded; 10. pregnant or lactating women; 11. other conditions lead to inappropriate to participate in this study as judged by the investigator.
comparison of tkas using force plate analysis

Conditions: Knee Osteoarthritis; Total Knee Arthroplasty; Knee Injuries; Knee Arthritis

Summary: the purpose of this study is to evaluate performance of two modern total knee arthroplasty designs using patient reported outcomes and force exhibited during various activities of daily living.

48 patients with primary osteoarthritis of the knee who have been appropriately designated for treatment with a total knee arthroplasty (tka) will be randomly assigned to one of two groups; one group (24 patients) will receive a depuy attune pcr knee implant, and one group (24 patients) will receive a microport orthopedics evolution medial pivot knee implant utilizing standard and modern techniques. these two implants are designed to recreate the kinematic motion of a native knee articulation using different biomechanical design philosophies. the patients will be monitored post-operatively using subjective and objective measures. subjective patient reported outcomes will be analyzed using the knee injury and osteoarthritis outcome score (koos), recorded preoperatively, as well as at 6 weeks, and 3 months postoperatively. objective outcomes will be measured by having the patients perform four activities over force plates that will measure the amount of force a patient generates. the four activities will be: walking, standing from a seated position in a chair, squatting to a seated position, and walking up stairs. these objective measures will also be recorded preoperatively, 6 weeks, and 3 months postoperatively. the patient reported outcomes and the objective measures will then be compared between the two groups.

Eligibility criteria:
inclusion criteria: * subjects who have been appropriately designated for treatment with a primary total knee arthroplasty * subjects who are willing to participate and are willing to sign the informed consent/hippa documents. exclusion criteria: * subjects who are unsuitable candidates for the two types of knee implants under investigation. * subjects with significant deformities or arthritis that might affect the procedural decision making, expected outcomes and functions are total knee arthroplasty. * subjects with significant comorbidities that might be at an increased risk of post-operative complications. * subjects who are unwilling to sign informed consent/hipaa documents. * subjects who cannot perform the required activities after the surgery.
emotional lived in patients suffering from psychogenic nonepileptic seizures : study by functional magnetic resonance imaging

Conditions: Psychogenic Non-epileptic Seizures

Summary: currently, hypothetical models of understanding psychogenic non-epileptic seizures (pnes) involve emotional dysregulation. the hypothesis of a disorder of emotional experience is mainly based on behavioral data and disturbance of autonomic responses in response to images in emotional content (mignot et al 2015, in submission; bakvis et al 2013). various imaging studies have identified brain structures belonging to the limbic system in particular that seem functionally impaired in this population. these functional connectivity abnormalities are correlated with dissociation scores in pnes patients (van der kruijs et al 2012 and 2014). investigators propose to specifically study the brain activity of pnes patients during tasks emotional content to identify the mechanisms involved in this emotional dysregulation. this work is essential to understanding the mechanisms and the development of new therapeutic strategies


Eligibility criteria:
common inclusion criteria: * female, * right-handed * affiliation to the french social security system, * informed signing of the study consent. specific inclusion criteria for pnes group : * pnes diagnosed by a neurologist specialized in epilepsy, based on clinical symptoms analysis and video-eeg recording, * absence of concomitant epilepsy. specific inclusion criteria for ptsd group : ptsd diagnosed by a psychiatrist, based on clinical symptoms as recorded in dsm5 (diagnostic and statistical manual of mental disorders). specific inclusion criteria for healthy controls : healthy controls will be paired up with patients on age and level of schooling criteria. exclusion criteria: common criteria for all groups: * neurological history or comorbidity (epilepsy included), * current neurological treatment, * posology change or introduction of psychoactive treatment dating back to less than a month, * psychotic comorbidity (schizophrenia), * addiction history apart for smoking, * history of head trauma, * mental retardation, * being the subject of articles l.1121-5 to l.1121-8 and l1122-1-2 of the french code of public health (i.e. being a not responsible adult), * lack of french language proficiency or inability to understand instructions, * uncorrected visual impairment, * any contraindication to mri (pacemaker, ferromagnetic foreign body, claustrophobia, etc.). specific exclusion criteria for pnes group : diagnosis of pnes challenged or denied by the patient. specific exclusion criteria for ptsd group : * diagnosis of ptsd challenged or denied by the patient, current or history of functional neurological symptom disorder, * history of pnes (conversion disorder). specific exclusion criteria for healthy controls : * history of ptsd, * history of pnes (conversion disorder).
transfer to another health care facility following critical illness

Conditions: Transfer to a Health Care Facility After Critical Illness

Summary: the purpose of this study is to identify acute and chronic medical conditions that are identifiable early in the course of critical illness that are associated with transfer to another health care facility (versus to home) upon hospital discharge.

many patients who survive critical illness are unable to return home upon hospital discharge and require prolonged or permanent care in other health care facilities. it would be useful to clinicians, researchers, patients, and patients' families to be able to identify early in the course of critical illness those patients who are at increased risk for this outcome. currently, few data exist regarding the risk factors for this outcome. this study examines a cohort of survivors of critical illness to identify factors associated with transfer to another health care facility upon hospital discharge.

Eligibility criteria:
inclusion criteria: * admission to the university of chicago medical intensive care unit during the following periods: july 1997 to february 1998, november/december 2001, and march/april 2002. exclusion criteria: * death during the index hospitalization. * residence in another health care facility 2 weeks prior to admission.

Keywords: chronic critical illness functional status outcomes post-icu
this is an extension study of the roche p-trials to investigate safety and effectiveness of ocrelizumab in participants with multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: this extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (ms) participants who were previously enrolled in a f. hoffmann-la roche (roche) sponsored ocrelizumab phase iiib/iv trial (i.e. the parent, p-trial).

this is a single arm, open label, multicenter extension study in participants who completed treatment period with ocrelizumab in the roche p-trials. participants will receive treatment with ocrelizumab as single 600 mg infusions every 24 weeks for two years.

Eligibility criteria:
inclusion criteria: * signed informed consent form * able to comply with the study protocol, in the investigator's judgment * completed the treatment period of roche sponsored ocrelizumab p-trials exclusion criteria: * hypersensitivity to ocrelizumab or to any of its excipients. * participantss in a severely immunocompromised state until the condition resolves. * evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation. * existence of a contra-indication as per smpc * prohibited concomitant medication as specified in protocol * participants intending to become pregnant during the study or within 6 months after the last dose of the study drug in the parent study
comparing the diagnostic accuracy of clinical dehydration scales among small children

Conditions: Dehydration

Summary: the assessment of clinical dehydration scales diagnostic accuracy (cds scale, who scale, gorelick scale) among small children.

the eligible patient admitted to the hospital with acute diarrhea, after given written consent for participation in the study by the child's parents, will be clinically assessed. dehydration syndromes noted by physician will be recorded in special form (in attachment). than, the child will be weighted on a standard scale. the next body mass evaluation will take place, when patient's clinical condition will by classified as good by the attending physician and the child will be at least 24 hours after finishing intravenous or probe rehydration therapy.

Eligibility criteria:
inclusion criteria: * age: 1 - 36 months for cds scale; 1 month - 5 years old for who scale and gorelick scale * hospitalisation caused by acute diarrhea (acute diarrhea -increase in the frequency of evacuations ≥ 3 in 24 hours; with or without fever or vomiting) * duration of symptoms under 5 days * parents' written consent for child's participation in the study exclusion criteria: * dehydration caused by other mechanisms than acute diarrhea, for example dehydration caused by: * acidosis * kidney failure * heart failure * chronic liver disease * respiratory failure * condition after surgery

Keywords: dehydration children gastroenteritis
efficacy of activated lymphocytes in renal cell carcinoma.

Conditions: Metastatic Renal Cell Carcinoma

Summary: renal cell carcinoma represents today 3% of the solid tumors of the adult. their bad prognosis is due to the frequency of metastasis and the resistance to chemotherapy. immunotherapy (interferon-α, interleukin-2) has shown some good results but an important toxicity. in our study, we evaluate the response to a new therapeutic strategy which combines an injection of patient's own activated lymphocytes to a classic immunotherapy with interferon-α and interleukin-2.

phase i and ii trials for the treatment of melanoma or renal cell carcinoma have already evaluated lymphokine-activated killer cells and tumor-infiltrating cells. in metastatic renal cell carcinoma, these therapies have shown some complete responses and a low toxicity. in our study, we evaluate the response to a new therapeutic strategy which combines an injection of patient's own activated lymphocytes to a classic immunotherapy with interferon-α and interleukin-2. a secondary objective is to improve cell preparation methods and to characterize functionally and phenotypically injected cells.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 70 years * metastatic renal adenocarcinoma histologically proven * karnofsky performance status ≥ 70% * life expectation \> 3 months * at least one target, in a non-irradiated area * objective response or steady-state after a treatment with cytokines * informed written consent exclusion criteria: * patients presenting more than one metastatic site with one hepatic metastasis diagnosed within the last 12 months * white blood cells count \< 2.5 g/l, platelet count \< 100 g/l * serum creatinine rate \> 150 µmol/l * positive serology for : hepatitis b, hepatitis c, retrovirus * patient not available for a long-term follow-up * bellini duct tumor * history of allograft or tumor within the five past years * severe cardiovascular, hepatic, renal or pulmonary troubles * auto-immune disease * severe infection * pregnancy or breast-feeding * corticotherapy

Keywords: immunotherapy renal cell carcinoma metastasis lymphokine activated killers cell therapy
chemoembolization with or without stereotactic body radiosurgery for liver cancer

Conditions: Carcinoma, Hepatocellular

Summary: this is a randomized, open-label, active comparator-controlled trial of subjects with advanced (barcelona stage b/c) hepatocellular carcinoma. subjects will be receive one treatment with trans-arterial chemo-embolization (tace) prior to randomization. subsequently, subjects will be randomized to observation or, if indicated, up to an additional tace treatments, or to stereotactic body radiotherapy (sbrt). tumor response following interventions will be evaluated at three months.


Eligibility criteria:
inclusion criteria: * hepatocellular carcinoma (barcelona stage b or c) * treatment with stereotactic body radiosurgery can occur within 6 weeks of enrollment * age ≥ 18 years and ≤ 70 years * eastern cooperative oncology group performance status ≤ 2 * patient has a) radiographic enhancing liver lesions with early wash out on triple phase ct or mri or b) histological confirmation of hcc as determined by the liver tumor board * hemoglobin \> 10.0 g/dl * total bilirubin \> 3.0 mg/dl * ast (sgot) ≤ 3x institutional upper limit of normal * alt (sgpt) ≤ 3x institutional upper limit of normal * absolute neutrophil count ≥ 1,500/μl * platelet count ≥ 50,000/μl (may be post-transfusion if clinically indicated) * aggregate maximal dimension of liver tumors ≤ 8 cm * cirrhosis classified as child pugh class a or b (score ≤ 7) * determined by the treating physician to be medically eligible for liver transplantation measured by imaging modality (mri/ct scan) three months post final treatment * life expectancy ≥ 12 weeks * ability to understand study and provide legally effective written informed consent * women of child-bearing potential must have a negative test within 4 weeks to the start of the sbrt treatment and must not be pregnant or nursing a child * sexually active women must agree to use accepted forms of birth control throughout the study, which include abstinence, oral contraceptives (birth control pills), iud, diaphragm with spermicide, norplant, hormone injections, condoms with spermicide, or documentation of medical sterilization exclusion criteria: * history of abdominal radiation * cirrhosis classified as child pugh class b with score ≥ 8 * prior invasive malignancy other than primary liver malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years * evidence of metastatic disease prior to registration * evidence of main portal vein thrombosis * history of cardiac ischemia or stroke within 6 months prior to enrollment * any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppressant that would constitute a contraindication to liver transplantation * history of sorafenib therapy within 21 days prior to enrollment

Keywords: radiotherapy chemoembolization
use of heliox in the management of neonates with meconium aspiration syndrome

Conditions: Meconium Aspiration Syndrome

Summary: the aim of the study: to assess the effect of short-term mechanical ventilation with heliox in newborns with meconium aspiration syndrome on vital signs, oxygenation, acid-base balance and respiratory function parameters.


Eligibility criteria:
inclusion criteria: * meconium aspiration syndrome diagnosed based on clinical and radiological findings, * respiratory failure requiring mechanical ventilation exclusion criteria: * congenital malformations or congenital genetic syndromes, * persistent pulmonary hypertension of the newborn (pphn) requiring inhaled nitric oxide treatment

Keywords: meconium aspiration syndrome heliox mechanical ventilation newborn
effect of steroids during pneumocystis infection among non hiv immunocompromised patients

Conditions: Pneumocystis; Steroids; Immunocompromised Patient; Hematologic Neoplasms; Immunosuppressive Agents; Neoplasms

Summary: pneumocystis jiroveci pneumonia (pcp) increased in non hiv immunocompromised patients. mortality remains high for those patients with comorbidities (50% for patients with the most severe pneumocystis pneumonia). physiopathology, characteristics and outcome of pcp in non-hiv patients remains different from those in hiv patients. steroids in hiv patients with pcp has been associated with decreased mortality but in non-hiv patients, adjunctive steroids remains controversy. some retrospective studies in that field did not find any beneficial effects of steroids ((1mg/kg/jour d'equivalent prednisone (ep)). however, all the studies were retrospective, non randomised studies including various underlying disease and severity of pcp was variable. moreover, dosage and delay of steroids were variable leading difficult to interpret all the results. the investigators want to demonstrate the beneficial effect of steroid during pcp in non-hiv immunocompromised patients with a double blinded randomised clinical trials comparing adjunctive steroids to placebo.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * severe pcp : 1 / interstitial acute pneumonia with possible or typical criteria for pcp and positive specimen for pneumocystis jirovecii (excluding pcr) ; or interstitial acute pneumonia with typical criteria for pcp and positive pcr in respiratory specimen. 2/ arterial pression of oxygen (pao2) \ 92% or tachypnea\>30min need of mechanical ventilation for acute respiratory failure. * treatment for pcp started for less than 7 days. * non-hiv immunosuppression : malignant hematological disease, solid tumor cured for less than 5 years, allogenic stem cell transplant, steroids (\>0.3mg/kg equivalent prednisone for more than 3 weeks or \> 20mg/days for more than one months) or other immunosuppressive treatment for more than one months or solid organ transplantation. * signed inform consent by patient or relatives * health insurance exclusion criteria: * hiv serology hiv 1 or 2 positive * need of steroid ≥1mg/kg/j equivalent prednisone for another pathology (acute graft versus host disease (gvh= for example) * contra-indication for steroids * pregnancy of breath-feeding * denied to participate * no health insurance * tutelage