Kornimate/medical-research-clean huggingface dataset:
selinexor, carfilzomib, and dexamethasone versus placebo, carfilzomib, and dexamethasone in multiple myeloma

Conditions: Multiple Myeloma

Summary: double-blind study will compare the efficacy and assess safety of selinexor plus carfilzomib (kyprolis®) plus low-dose dexamethasone versus placebo plus carfilzomib plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma.

this is a phase 2, two-arm, randomized, placebo-controlled, double-blind, multicenter study of relapsed/refractory multiple myeloma patients who have received at least two prior therapies, including a proteasome inhibitor and an imid. patients who meet all the eligibility criteria will be randomized to one of two blinded treatment arms: * selinexor + carfilzomib + dexamethasone * placebo + carfilzomib + dexamethasone

Eligibility criteria:
inclusion criteria: * symptomatic, histologically confirmed mm, based on imwg guidelines. patients must have measurable disease as defined by at least one of the following: * serum m-protein ≥ 1.0 g/dl by serum protein electrophoresis (spep) or for immunoglobulin (ig) a myeloma, by quantitative iga; or * urinary m-protein excretion at least 200 mg/24 hours; or * serum flc ≥ 100 mg/l, provided that the serum flc ratio is abnormal. * if serum protein electrophoresis is felt to be unreliable for routine m- protein measurement, then quantitative ig levels by nephelometry or turbidometry are acceptable. * must have received ≥ 2 prior anti-mm therapies including a proteasome inhibitor and an imid. the most recent proteasome inhibitor must not have been carfilzomib. * patients previously treated with carfilzomib are eligible as long as they meet the following criteria: * not received carfilzomib within 6 months (183 days) of cycle 1 day 1 (c1d1), and * carfilzomib was not part of their most recent therapy for the treatment of mm, and * did not discontinue carfilzomib treatment because of adverse effects. * mm that is refractory to the most recent treatment regimen. refractory is defined as ≤ 25% response to therapy, or progression during therapy, or progression on or within 60 days after completion of therapy. exclusion criteria: * smoldering mm. * active plasma cell leukemia. * mm that does not express m-protein or serum flc (i.e., non-secretory mm is excluded; plasmacytomas without m-protein or serum flc are excluded). * documented active systemic amyloid light chain amyloidosis. * active mm involving the central nervous system. * active polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (poems) syndrome. * prior autologous stem cell transplantation \< 1 month or allogenic stem cell transplantation \< 3 months prior to c1d1. * active graft versus host disease (after allogeneic stem cell transplantation) at c1d1.

Keywords: karyopharm selinexor kpt-330 multiple myeloma score
chidamide for patients with relapse or refractory diffuse large b-cell lymphoma and follicular lymphoma

Conditions: Experimental

Summary: study of chidamide as a single-agent treatment for patients with relapse or refractory diffuse large b-cell lymphoma (dlbcl) and follicular lymphoma (fl)

chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral t-cell lymphoma in china. the aim of this study was to observe the efficacy and safety of chidamide as a single-agent treatment in patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) and follicular lymphoma (fl). moreover, the aim was to study the correlation of clinical efficacy to mutation of certain genes as well.

Eligibility criteria:
inclusion criteria: 1. diagnosed as diffuse large b-cell lymphoma (dlbcl) and follicular lymphoma (fl) according to "2016 who classification of tumors of haematopoietic and lymphoid tissues"; 2. patients must have received systemic treatment (including chemotherapy or hematopoietic stem cell transplantation), but did not achieve remission or had relapse after remission; 3. at least one measurable lesion; 4. age 18-75 years, male or female; 5. ecog performance status 0-1; 6. without bone marrow involvement. blood routine test: absolute neutrophil count ≥1.5 × 109/l, platelet ≥80 × 109/l, hb ≥ 90g/l;. 7. life expectancy no less than 3 months; 8. not received chemotherapy, targeted medicine or stem cell transplantation 3 weeks before enrollment; 9. patients have signed the informed consent form. exclusion criteria: 1. women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures. 2. qtc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment; 3. pericardial effusion ≥10mm sum of echo-free spaces by echocardiography; 4. patients have undergone organ transplantation; 5. patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment. 6. patients with active hemorrhage. 7. patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction. 8. patients with active infection, or with continuous fever within 14 days prior to enrollment. 9. had major organ surgery within 6 weeks prior to enrollment. 10. impaired liver function ( total bilirubin ˃ 1.5 times of normal maximum, alt/ast˃ 2.5 times of normal maximum, for patients with infiltrative liver disease alt/ast ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum). 11. patients with mental disorders or those do not have the ability to consent. 12. patients with drug abuse, long term alcoholism that may impact the results of the trial. 13. patients who have central nervous system involvements; 14. non-appropriate patients for the trial according to the judgment of the investigators.
preoperative exercise test and postoperative intensive care unit need in bariatric surgery

Conditions: Morbid Obesity; Weaning Failure

Summary: the aim of our study is to evaluate the efficacy of "60 meters 60 seconds exercise test" (a test designed by the study group) done preoperatively as a predictor test for postoperative intensive care unit need and extubation success in patients undergoing bariatric surgery.


Eligibility criteria:
inclusion criteria: patients between 18-60 years old patients with bmi \> 40 patients undergoing laparoscopic sleeve gastrectomy exclusion criteria: patients with chronic obstructive pulmonary disease (copd) or asthma, patients with uncompensated heart failure patients who have orthopedic problems that effects the exercise test (such as gonarthrosis)

Keywords: bariatric surgery extubation
intratumoral gemcitabine, paclitaxel, carboplatine and intravenous nivolumab for locally recurrence of head and neck cancers

Conditions: Squamous Cell Carcinoma of the Head and Neck; Paclitaxel; Carboplatin; Nivolumab

Summary: patients with locally recurrent squamous-cell carcinoma of the head and neck (scchn) after chemotherapy and immunotherapy have a very poor prognosis and limited therapeutic options. intratumoral chemotherapy (itc) with cisplatin and epinephrine in order to increase the local cisplatin retention lead to a 50 % response rate in several studies but was given up due to the poor local tolerance with frequent necrosis of the peritumoral tissues. gemcitabine, carboplatin and paclitaxel (gcp) are used in advanced scchn. these chemotherapies seem to be interesting options for intratumoral infusion: their different effect could lead to avoid chemotherapy resistance with a good tolerance profile, without tissue necrosis profile. the other major option for recurrent scchn is immunotherapy by nivolumab, an anti pd-1 with a 13% mediane response rate. nevertheless, the failure of this treatment stay unclear, but immunosuppressive action of the tumour is suspected. the presence of tumoral antigen could lead to better response to immunotherapy; association of chemotherapy and immunotherapy seems a promosing association to avoid treatment resistance as cytotoxic release tumoral antigen; it could also be associated to an abscopal effect. the aim of the study is to evaluate the efficacy of itc using gcp in local recurrent scchn treated by nivolumab.


Eligibility criteria:
inclusion criteria: * who status : 0, 1 or 2. * age \> 18ans * locally recurrence of a histologically-proven scchn after failure of conventional treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab) * nivolumab treatment in second line encouring according to amm but with insufficient efficacy * possible location of the tumour by clinical examination, ct-scan * metastases are admitted if there is no vital prognoses threaten and if a clinical benefit is expected by treating local recurrence. * neutrophils \> 1000/mm3. * platelets \> 100 000/mm3. * blood créatinine \< 15 mg/l. blood bilirubine \< 30 mg/l * prothrombin rate \> 70 %. * social insurance * informed consent exclusion criteria: * who status : 0, 1 or 2. * age \> 18ans * locally recurrence of a histologically-proven scchn after failure of conventional treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab) * nivolumab treatment in second line encouring according to amm but with insufficient efficacy * possible location of the tumour by clinical examination, ct-scan * metastases are admitted if there is no vital prognoses threaten and if a clinical benefit is expected by treating local recurrence. * neutrophils \> 1000/mm3. * platelets \> 100 000/mm3. * blood créatinine \< 15 mg/l. blood bilirubine \< 30 mg/l * prothrombin rate \> 70 %. * social insurance * informed consent

Keywords: squamous cell carcinoma of the head and neck local reccurence of malignant tumor intrumoral chemotherapy gemcitabin paclitaxel carboplatin nivolumab
repercussion of the covid-19 pandemic on physical activity, psychological state and sleep

Conditions: Healthy

Summary: the covid-19 outbreak in our environment has caused significant changes in the population. the main objective of this research project is to evaluate the level of physical activity, psychological state and sleep during the covid-19 pandemic in different populations.


Eligibility criteria:
inclusion criteria: • healthy people exclusion criteria: * cognitive impairment. * diagnose of autism spectrum disorder or severe intellectual disability * physical or functional impairment that limits the performance of evaluation
a study to learn about the study medicine zavicefta after it is released into the markets in korea

Conditions: Complicated Intra-abdominal Infection; Complicated Urinary Tract Infection; Hospital-acquired Pneumonia

Summary: the purpose of this study is to learn about the safety and effectiveness of zavicefta once released into the markets in korea. this study is to learn about zavicefta in patients with difficult types of infections in the abdomen, urinary tract and pneumonia which could have come from hospitalizations. this study was required by the ministry of food and drug safety (mfds) of korea's regulations.

the objective of this study is to determine any problems or questions associated with zavicefta after marketing, with regard to the following clauses under conditions of general clinical practice, in compliance with the regulation "re-examination guideline of new drugs". 1. serious adverse event/adverse drug reaction 2. unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label. 3. known adverse drug reaction 4. non-serious adverse drug reaction 5. other safety and effectiveness information as required for any new medication approved by ministry of food and drug safety (mfds), information on safety and effectiveness of new medication should be researched on certain number of subjects taking the drug in the setting of routine practice during the initial 6 years after the approval of new drug. this reserach shall begin after approval of marketing in korea by mfds.

Eligibility criteria:
1. adults and paediatric patients aged 3 months and older, who have been administered at least one dose of zavicefta for the treatment of one of the indications as follows: * complicated intra-abdominal infection (ciai) * complicated urinary tract infection (cuti), including pyelonephritis * hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap) * other aerobic gram-negative organism infection with limited treatment options 2. adults 19 years of age or older, who have been administered at least one dose of zavicefta for the treatment of the indication as follows: •bacteremia associated with or suspected to be associated with ciai, cuti or hap including vap. 3. patients are treated with zavicefta for the first time 4. patients have signed the data privacy statement.

Keywords: ceftazidime avibactam safety efficacy
guided and unguided internet treatment for problematic alcohol use

Conditions: Alcohol Abuse; Alcohol Addiction

Summary: the purpose of this study was to determine whether a 10-week internet-based program based on cognitive behavioral therapy (cbt) is effective in the treatment of alcohol problems, and if having therapist guidance leads to greater effects.

objectives: an 10 week internet-based self-help program based on cognitive behavioral therapy (cbt) was tested among internet help seekers.the design was a three-armed randomized controlled design, and outcomes were measured in terms of changes in problematic alcohol use, as well as depression, anxiety and quality of life. 80 participants were recruited entirely online from an open access website and randomized into three different groups. all participants had access to the same self-help program. however, one group was given a choice between two forms of therapist guidance (messages or weekly chat sessions), one group received therapist guidance in the form of secure messages, and one group received no therapist guidance.

Eligibility criteria:
inclusion criteria: * ≥ 18 years * access to the internet * problematic alcohol use defined as ≥ 8 p or more for men and ≥ 6 p or more for women in the alcohol use identification scale exclusion criteria: • not adequately fluent in swedish

Keywords: randomized controlled trial alcohol internet internet based therapy cognitive behavior therapy
pulmonary diffusing capacity during postural postural changes and acute exercise

Conditions: Clinical Assessments of Pulmonary Diffusing Capacity

Summary: the combined measurement of the pulmonary diffusing capacity to carbon monoxide (co) and nitric oxide (no) (dlco/no) has recently been standardised and validated for clinical use. it involves a very short breath-hold time (≤5 seconds), and it may be repeated up to 12 times without affecting measurements, and it is thus ideal for assessing acute changes in pulmonary diffusing capacity and its components during various physiological manoeuvres. the aim of the present study is to compare the test-retest reliability of pulmonary diffusing capacity measurements during postural changes (sitting vs. supine) vs. rest-to-exercise. dlco/no will either be measured in the sitting position during rest vs. exercise or in the sitting and supine posture, and this will be repeated within 1-7 days in 20 healthy individuals that will be randomised to one of the two interventions. statistically,the test-retest relaibility of sitting-to-supine vs. rest-to-exercise changes in dlco/no will be compared by parametric methods.


Eligibility criteria:
inclusion criteria: • regular exercise (1-3 timer per week) exclusion criteria: * any known medical condition that requires regular medication or any known lung condition * smoking * symptoms of disease within 2 weeks prior to the study * abnormal lung function test * pregnancy
cancer genome analysis

Conditions: Malignant Tumor

Summary: next generation sequencing (including targeted gene seqeuncing, exome and transcriptome sequencing) will be performed from fresh frozen tumor samples to understand the genetic alteration of tumors and to aid in optimal selection of further therapeutic agents.


Eligibility criteria:
inclusion criteria: * patients with malignant tumor * receiving or planning to receive chemotherapy * with fresh frozen tumor tissue * with informed consent
the effect of general anesthesia on the middle ear pressure

Conditions: Ear Deformities, Acquired

Summary: the investigators aimed to examine the effect of sevoflurane and desflurane, agents used in patients who do not have any ear pathology and undergo surgery under general anesthesia, on the mep.

studies reported that inhalation agents are more likely to have impacts on the middle ear pressure compared to intravenous anesthetic agents. despite numerous studies comparing the effects of inhalation agents on the middle ear pressure, this is the first clinical trial in which end tidal carbon dioxide and effects of sevoflurane and desflurane, along with other anesthetic analgesic agents used, on the middle ear pressure were compared. our purpose in this study was to investigate the effect of sevoflurane and desflurane, inhalation agents used in patients who do not have any ear pathology and undergo non-ear surgery under general anesthesia, on the middle ear pressure.

Eligibility criteria:
inclusion criteria: * (asa) ii-iii physical status * elective inguinal hernia * lower extremity surgery * general anesthesia * supine position exclusion criteria: * nasal septum, * adenotonsillar hypertrophy, * perforated tympanic membrane, * middle ear pathology * receive medications for middle ear pressure .

Keywords: middle ear pressure sevoflurane desflurane
comparing cpap and bipap for sleep-disordered breathing in people with cervical spinal cord injuries

Conditions: Spinal Cord Injuries (SCI); Sleep Disordered Breathing (SDB); Sleep Apnea; Cervical Spinal Cord Injruy

Summary: sleep-disordered breathing (sdb) is common in individuals with cervical spinal cord injuries, with studies suggesting prevalence rates ranging from 27% to 62%. the condition often leads to daytime sleepiness, fatigue, and poor participation in rehabilitation. positive airway pressure therapy can be used to treat the condition; however, some individuals find continuous positive airway pressure (cpap), which applies the same pressure during inhalation and exhalation, difficult to use. bilevel positive airway pressure (bipap) offers different pressures for inhalation and exhalation, which may be more comfortable and potentially improve adherence in this patient population. however, limited evidence compares cpap and bipap in individuals with cervical spinal cord injuries. this pilot study will enroll 32 adult participants with cervical spinal cord injuries who have moderate to severe sdb (defined as an ahi of 15 events/hour or greater). participants will be randomly assigned to either cpap or bipap therapy for 4 weeks. device usage per night will be measured, and data on daytime sleepiness, fatigue, and sleep quality will be collected at baseline, 2 weeks, and 4 weeks. the investigators aim to determine whether bipap improves adherence and symptoms compared to cpap in this patient population.


Eligibility criteria:
inclusion criteria: * age \>= 19 years * cervical spinal cord injury (asia a, b, or c). this will include patients with upper (c1-c4) and lower (c5-c7) spinal cord injuries * presence of sleep disordered breathing, defined as ahi \> =15 events/hour by home sleep apnea test (hsat) exclusion criteria: * on cpap or bipap prior to spinal cord injury * hypoventilation syndrome (elevated venous carbon dioxide, pvco2\>50 mm hg)

Keywords: sleep disordered breathing cervical vertebrae obstructive sleep apnea spinal cord injuries positive pressure respiration continuous positive airway pressure sleep quality quadriplegia polysomnography tetraplegia sleep wake disorders diaphragmatic paralysis autonomic dysreflexia muscle weakness nocturnal hypoventilation phrenic nerve pulmonary atelectasis spinal cord compression ventilator weaning neurological rehabilitation sleep disorders activities of daily living
a clinical trial of a quadrivalent influenza vaccine

Conditions: Influenza

Summary: the aim of this study is to assess the immunogenicity and safety of a quadrivalent influenza vaccine compared with a trivalent influenza vaccine in participants aged above 3 years.


Eligibility criteria:
inclusion criteria: * over the age of three years,healthy population * subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required * to comply with the requirements of clinical trial program * temperature≤37.0℃ on day of enrollment exclusion criteria: * a history of influenza virus infection or suspected infection abnormal blood routine, blood biochemistry and urine routine examination indexes in last three months * any prior administration of influenza vaccine in last six months * allergy to any component in the vaccine, especially for egg allergy * allergy history of any previous vaccination or drug * acute episodes of chronic illness or acute illness on the day of vaccination * received a live vaccine within fourteen days prior to receiving the vaccine, or received a subunit or inactivated vaccine within seven days * congenital or acquired immune deficiencies, or treatment with immunosuppressive agents, such as long-term treatment with systemic corticosteroids * suffering from severe chronic diseases (such as down's syndrome, diabetes, sicklemia or neurological disorders, green's barre syndrome) * asthma, required urgent treatment in last two years * the blood products were received prior to the acceptance of the vaccine * known or suspected of respiratory disease, acute infection or chronic disease active period, hiv infection, cardiovascular disease, severe hypertension, malignant tumor during treatment, skin diseases * history of epilepsy, convulsions, or a family history of psychosis * abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities), or obvious bruising or coagulopathy * plan to move or leave the area for an extended period of time before the end of the study * under anti-tb treatment * any prior administration of other research medicine/vaccine in last one month * women are pregnant or in the near future planned pregnancy or pregnancy test positive