Kornimate/medical-research-clean huggingface dataset:
a phase ii study of palbociclib for recurrent or refractory advanced thymic epithelial tumor

Conditions: Thymic Cancer

Summary: this is a phase ii single center, open-label, single arm study of palbociclib treatment in patients with recurrent or metastatic advanced tets after failure of one or more cytotoxic chemotherapy regimens. patients will receive oral palbociclib 125mg daily for 21days followed by a 7-day break. cycle will be repeated every 28 days.

patients will continue to receive palbociclib until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawn of consent, whichever occurs first. disease assessments will be performed every 8 weeks (±7 days) from the date of initiation of treatment. each assessment will be performed as scheduled according to the calendar regardless of any dosing delay to prevent the introduction of bias into the assessment of efficacy. tumor assessments will be performed until radiographically and/or clinically (ie, for photographed or palpable lesions) documented progressive disease (pd) as per recist v.1.1, initiation of new anticancer therapy, or discontinuation of patient from overall study participation (eg, death, patient's request, lost to follow-up), whichever occurs first.

Eligibility criteria:
inclusion criteria: 1. histologically proven thymic epithelial tumor (tet) patients 2. be ≥18 years of age on day of signing informed consent. 3. documented progressive disease according to recist v1.1 following receipt of at least one cytotoxic chemotherapy regimen administered for inoperable or metastatic disease. 4. measurable disease as defined per recist v 1.1. tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated sited after completion of therapy is clearly documented. 5. availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue \[block preferred, or 10 unstained slides\]), which will be used for retrospective biomarker analysis. if archived tumor tissue is not available, then a de novo biopsy will be required for patient participation. 6. ecog performance status of 0 to 2 exclusion criteria: 1. known active uncontrolled or symptomatic central nervous system (cns) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. patients with a history of cns metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization. 2. inability to swallow capsules. 3. prior treatment with any cdk4/6 inhibitor.
therapeutic study evaluating the efficacy of noradrenaline in the prevention of hypotension related to intubation for cardiac or thoracic surgery

Conditions: Cardiac Disorder; Hypotension

Summary: arterial hypotension during general anaesthesia (ga) is a serious event. while hypotension can occur during surgery, it usually occurs following induction of ga (i.e. following the injection of drugs to enable intubation). this is due to the injection of large doses of anaesthetic drugs with a vasodilatory effect over a short period of time to induce a deep sleep to allow intubation to take place for artificial ventilation. the prevention of hypotension during surgery has been extensively studied. in contrast, the prevention of hypotension following ga induction has been the subject of only two randomised studies in the icu and three non-randomised studies in the or with small numbers of patients. the level of evidence for the use of noradrenaline in the operating theatre remains low. the hypothesis of the study is that noradrenaline initiated during preoxygenation can reduce the incidence of hypotension during induction of general anaesthesia.


Eligibility criteria:
inclusion criteria: * requiring cardiac or thoracic surgery under general anaesthesia * requiring a blood pressure catheter prior to ga induction exclusion criteria: * hemodynamic instability on arrival in the operating room * hypotension on arrival in the operating theatre: systolic blood pressure \< 100 mmhg or mean arterial pressure \< 65 mmhg * hypertension on arrival at the operating theatre: systolic blood pressure \> 160 mmhg or mean arterial pressure \> 100 mmhg * adult under guardianship, curatorship or safeguard of justice * unable to give consent * pregnant or breastfeeding woman * emergency surgery (cannot be delayed by 24 hours) * current participation in an interventional protocol that interferes with the evaluation criteria of the study * not affiliated to or not benefiting from a social security scheme * lack of informed and written consent from the patient * patient with a dilated aorta with a risk of rupture (e.g. chronic dissection for example) * patient with severe aortic insufficiency * treated hypertensive history that may have hypersensitivity to noradrenaline and hypertensive flares hypertensive attacks

Keywords: general anesthesia intubation cardiac surgery hypotension noradrenaline
a study of tumor-treating fields (ttfields) in people with lung adenocarcinoma

Conditions: Adenocarcinoma of Lung

Summary: the researchers are doing this study to find out if treatment with ttfields using the novottf-200t system is safe and practical (feasible) before surgical removal (resection) of lung adenocarcinoma (adc). the researchers will also look at how the treatment may help the body's immune system to fight cancer.


Eligibility criteria:
inclusion criteria: * the participant (or legally acceptable representative \[lar\], if applicable) provides written informed consent for the study. * the participant is ≥22 years of age on the day of signing informed consent. * the participant has clinical stage 1a2, 1a3 or ib biopsy-proven lung adc and is eligible for anatomical resection. * the participant has a lung nodule \>1 cm and suspected lung adc with a plan to undergo biopsy. * the participant with multiple nodules has one nodule that meets the criteria. * the participant has no history of prior malignancy in the chest or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy. exclusion criteria: * patients receiving therapy for concurrent active malignancy * patients with a history of cardiac arrhythmias and/or pacemaker use * patients with lung nodules \<1cm * patients with lung nodules that are pure ground glass opacities (ggos) of any size * patients with lung nodules that are \<50% solid of any size

Keywords: novottf-200t system ttfields treatment 22-387
hemp seed awareness

Conditions: Allergy

Summary: hemp is a plant of the cannabaceae family. cannabis sativa, derived from female flowers, is the first illicit substance used by adolescents and is a major public health problem. its psycho-active effects come from tetrahydrocannabinol (thc). unlike recreational cannabis, industrial hemp derived from cannabis sativa has a high level of cannabidiol (cbd) but a negligible level of tetrahydrocannabinol. its seeds are now consumed in various forms and generate increasing interest. seeds have many nutritional benefits. it seems important to take an interest in hemp, given the recent expansion of medical cannabis and the increasing use of cannabis for recreational purposes. it is incriminated in various allergies (contact dermatitis, asthma, rhinoconjunctivitis) but also in the occurrence of anaphylaxis to certain foods by cross-allergy in atopic subjects, in association with an lipid-transfer proteins (ltp protein), present in the flower of cannabis sativa. unlike the allergy to recreational cannabis, the allergenicity of hemp seeds is little studied. hemp seed can cause severe anaphylactic reactions. in all reported cases, the prick-tests were positive for the seeds. often, patients had never been in contact with hemp seeds but had already been exposed to cannabis by respiratory or manual routes. the investigators hypothesize that sensitization by the skin or respiratory route (cannabis smokers, passive exposure to cannabis, workers exposed to hemp, etc.) could lead to the development of a food allergy to hemp seed.


Eligibility criteria:
inclusion criteria: * major patient * patient referred to the allergology unit of the hospital of angers, in consultation or in hospitalization - for conducting prick-tests * patient affiliated or beneficiary of a social security scheme * patient with informed consent exclusion criteria: * pregnant women, parturients * persons deprived of liberty by administrative or judicial decision * persons receiving psychiatric care under duress * adults under legal protection measure * people out of state to express consent * people not able to understand french language * patients whose skin reactivity prevents interpretation of tests (patients who cannot interrupt anti-histamines or have severe eczema)
effects of mandibular advancing device in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the goal of this clinical trial is to learn if mandibular advancing devices work to treat obstructive sleep apnea in adults. selected participants have a mild or moderate degree of obstructive sleep apnea.the main questions it aims to answer are: do mandibular advancing devices (mads) lower the number of times participants experience apneas or hypopneas during sleep? do mads lower apnea hypopnea index in adults when worn during sleep?

this clinical trial aims to evaluate comprehensively the effects of a custom made titrable bi-block mandibular advancing device on the respiratory variables in polysomnography. this includes the apnea hypopnea index and the oxygen desaturation index. also sleep variables such as sleep efficiency and snoring duration are evaluated. also cone beam computed tomography scans are taken before treatment and after 6 weeks of using te appliance. the second cbct scan is taken with the appliance intra-orally. the cahnge in airway volume and minimal axial area are measured.

Eligibility criteria:
inclusion criteria: * adults (18 years and older) * mild/moderate obstructive sleep apnea * sufficient number of teeth( having at least one terminal molar) * healthy teeth and periodontal ligament * good physical and mental capability helping the subjects to be able to deal with the appliance. exclusion criteria: * severe osa, * central sleep apnea, * pregnant females * somatic or psychological disease, or medications for psychological conditions.

Keywords: mandibular advancing device
plasma free fatty acids in risk assessment of sepsis in the emergency department: a prospective pilot study

Conditions: Sepsis

Summary: plasma free fatty acids (ffas) are thought to play a role in the generation of organ dysfunction. the investigators hypothesize that plasma ffa levels are a marker of poor prognosis in patients with sepsis. the present study will examine the relation between plasma ffa levels and severity of illness in patients with sepsis presenting to the emergency department. it will also examine the relation between plasma ffa levels and the risk of developing late morbidity, multiple organ dysfunction syndrome (mods) and/or mortality during initial hospitalization and over a 30-day follow-up period.

the long term objective of this study is to investigate the mechanism by which plasma free fatty acids (ffas) contribute to the progression of sepsis severity in infectious patients presenting to the emergency department. in the present study, pilot data will be generated to validate our hypothesis that elevated free fatty acids are related to outcome in sepsis. we will examine our hypotheses with the following specific aims: 1. to determine if plasma ffa levels are related to severity of illness in patients with sepsis presenting to the emergency department. 2. to study the prognostic value of plasma ffa levels at predicting future morbidity and mortality in patients with sepsis presenting to the emergency department.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * able to provide informed consent (or has surrogate present that can do so) * presenting to the emergency department (ed) for evaluation * clinical suspicion of infection, as indicated by the ed physician's ordering a blood culture or a current temperature of ≥38c. exclusion criteria: * liver disease * hepatitis * alcohol consumption \>2 drinks/day for longer than 6 months * pregnant women * prisoners or other institutionalized individuals * unable to speak the english language * unwilling or unlikely to be reachable by telephone for the 30-day follow-up status assessment call

Keywords: sepsis free fatty acids emergency department
multicenter study on dialysis modalities for end-stage chronic renal failure patients with heparin-induced thrombocytopenia

Conditions: Dialysis; Complications; Heparin-induced Thrombocytopenia; Chronic Renal Failure

Summary: this research is based on the hypothesis that the hydrolink®-nv dialysis membrane could allow the realization of quality dialysis with a significant reduction in the doses of orgaran®, or even a total cessation of the anticoagulant, in patients with chronic renal failure. with heparin-induced thrombocytopenia. thus, this study aims to show that the use of this dialysis membrane without prior anticoagulation does not increase the risk of coagulation of the circuit and allows the realization of quality dialysis sessions.


Eligibility criteria:
inclusion criteria: * patient, male or female, over 18 years of age. * patient on dialysis in a hemodialysis unit of the ramsay santé group. * patient with diagnosed heparin induced thrombocytopenia. * patient whose dialysis sessions benefit from extracorporeal circulation anticoagulation with orgaran® or its equivalent (arixtra® or arganova®). * patient informed and having signed his written consent to participate in the study. * affiliated patient or beneficiary of a social security scheme. * woman of childbearing age with effective contraception, after verification of the absence of active pregnancy (negative pregnancy test) exclusion criteria: * patient whose duration of dialysis is less than 1 month. * medically unstable or fragile patient. * patient participating in another clinical study. * protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision. * pregnant, breastfeeding or parturient women. * patient hospitalized without consent. * patient with severe hepatic failure
7.0t magnetic resonance imaging study for hepatic encephalopathy

Conditions: Hepatic Encephalopathy (HE); MRI; fMRI Research

Summary: this clinical trial study aims to detect the imaging characteristics of patients with hepatic encephalopathy (he) using 7-tesla (7t) magnetic resonance imaging (mri).

in this study, we analyzed the imaging characteristics of he. first, with the advantages of 7tmri, we analyzed the differences in imaging characteristics between he patients and the healthy, including brain functional imaging and structural imaging. second, we analyzed the differences in imaging characteristics between different subgroups of he patients. finally, we analyzed the correlation between the prognostic results of he patients after follow-up and the imaging characteristics.

Eligibility criteria:
inclusion criteria: * patients with clinical suspected or diagnosed hepatic encephalopathy according to relevant guidelines.the patient's education level is above primary school level. * regular follow-up. exclusion criteria: * contraindications to mri. * patients with cerebrovascular disease, brain tumors, epilepsy, other neurodegenerative disease.

Keywords: hepatic encephalopathy fmri
a study of capecitabine (xeloda) in participants with advanced or metastatic gastric cancer

Conditions: Gastric Cancer

Summary: this study will evaluate the efficacy and safety of oral capecitabine (xeloda) versus 5-fluorouracil (5-fu), in combination with intravenous (iv) cisplatin, in participants with advanced and/or metastatic gastric cancer. the anticipated time on study treatment is at least 6 weeks and continued up to disease progression, and the target sample size is 300 individuals.


Eligibility criteria:
inclusion criteria: * adults 18 to 75 years of age * advanced and/or metastatic gastric cancer with at least 1 measurable lesion exclusion criteria: * uncontrolled infection * evidence of central nervous system (cns) metastases * history of other malignancy within the last 5 years, except cured basal cell cancer of the skin or cured in-situ cancer of the uterine cervix * radiation therapy or major surgery within 4 weeks of study drug * previous chemotherapy
the safety, tolerability, and pharmacokinetics of inhaled tlc19 in healthy volunteers

Conditions: COVID-19

Summary: phase 1 randomized, vehicle-controlled, blinded study to assess the safety, tolerability, and pk of single ascending doses of inhaled tlc19 in healthy volunteer subjects.

a phase 1 randomized, vehicle-controlled, blinded study to assess the safety, tolerability, and pk of single ascending doses of inhaled tlc19 (hydroxychloroquine liposome inhalation suspension) in healthy volunteer subjects. three dose levels will be assessed in sequential cohorts, with 2 ml, 4 ml, and 6 ml. total of approximately 30 subjects will be randomized in the study in 3 cohorts. subjects will be enrolled and randomized to receiving either tlc19 or tlc 19 vehicle. drug administration: blinded study medication will be administered through inhalation via a portable vibration mesh nebulizer.

Eligibility criteria:
inclusion criteria: 1. male or female 18 to 65 years of age 2. body mass index (bmi) 18.0 to 30.0 kg/m2. 3. never-smoker exclusion criteria: 1. body weight \<50 kg 2. donation of blood (450 ml) or blood loss within 3 months prior to study 3. contraindication, allergy, or hypersensitivity to hydroxychloroquine or chloroquine or other 4 aminoquinolines 4. use of any prescription or otc medications or herbal supplements within 2 weeks (or 5half-lives if longer) prior to study 5. use of any investigational product/medical device within 30 days or 5 half-lives prior to study, or participation in ≥4 investigational drug studies within 1 year prior to study 6. history or presence of any of the following conditions: * autoimmune or rheumatoid inflammatory disease * cardiac disorders * lung disease, prior intubation, or requiring use of an inhaler * liver cirrhosis or child-pugh class c * retinopathy or maculopathy * neuromuscular diseases * glucose-6 phosphate dehydrogenase deficiency * hematologic malignancy * chronic kidney disease or renal failure * psoriasis or porphyria * diabetes mellitus * severe allergic or anaphylactic reactions * any other significant condition that would preclude participation 7. history of substance abuse or dependency in the last 12 months, or a history of recreational intravenous drug use over the last 5 years 8. fever or symptomatic viral or bacterial infection within 2 weeks prior to study 9. any clinically significant laboratory abnormality

Keywords: hydroxychloroquine inhalation
trial of disc biacuplasty to treat chronic discogenic low back pain

Conditions: Low Back Pain

Summary: the purpose of this randomized controlled trial is to evaluate the effectiveness of disc biacuplasty in relieving pain, reducing medication intake and improving function, satisfaction and quality of life of patients with chronic mechanical discogenic low back pain.


Eligibility criteria:
inclusion criteria: * age \>18 years * able to understand the informed consent and baseline/follow-up questionnaires * chronic low back pain \> leg pain for longer than 6 months, unresponsive to comprehensive non-operative treatment * no clinical evidence of si joint mediated pain * concordant pain reproduced on provocative discography at an intensity of \>6/10 at low pressure (\<50 psi) at not more than 2 discs and a negative response at an adjacent control disc * preservation of at least 50% height of the symptomatic disc(s) exclusion criteria: * active radicular pain * nucleus pulposus herniation \> 5 mm, extrusion or sequestration on mri * spondylolithesis at the symptomatic level * prior surgery at the symptomatic level * concomitant cervical or thoracic pain \>2/10 (vas) in severity * other chronic pain conditions (i.e. fibromyalgia syndrome) * immunosuppression (i.e. cancer, aids, rheumatoid arthritis) * third-party (wsib, litigation or insurance) involvement * psychological issues impeding recovery by history, examination and/or a beck depression inventory score of \>20 * systemic or localized infection (at the anticipated needle entry sites) * bmi \> 35 (obesity) * substance or opioid abuse * coagulopathy

Keywords: cooled radiofrequency disc biacuplasty transdiscal system discogenic pain
epidemiology of patients consulting for original lbp spinal adult emergency

Conditions: Lumbar Pain

Summary: lumbar pain is an extremely common complaint in general population. the direct and indirect costs incurred in are a real public health problem. cohort studies show that improving symptoms after consultation for lumbar pain is insufficient, but there are few data on emergency medical and surgical services in france. in order to reflect on areas for improvement the investigators to carry out an inventory of consultations for lumbar pain emergencies of hautepierre hospital.


Eligibility criteria:
inclusion criteria: * patients admitted to adult emergencies in hautepierre for lumbago pain, with or without sciatica, * age greater than or equal to 18 years * having signed non-opposition to participation in the study * having completed the initial questionnaire exclusion criteria: * spinal trauma in the month before the consultation * pain of non-spinal origin (pyelonephritis, colic nephritic, aortic dissection ...) * non-francophone patients * patient under tutorship or under curatorship * patient under safeguard of justice