Kornimate/medical-research-clean huggingface dataset:
a study to learn how safe and how well linvoseltamab works compared to standard treatment in adult patients with multiple myeloma who are not eligible for transplant

Conditions: Multiple Myeloma

Summary: this study is researching an experimental drug called linvoseltamab. the study is focused on participants with newly diagnosed multiple myeloma (ndmm) who are ineligible for autologous stem cell transplantation (transplant-ineligible). the main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.


Eligibility criteria:
inclusion criteria: 1. participants must have confirmed diagnosis of symptomatic mm per imwg criteria. 2. participants must not be considered a candidate for high-dose chemotherapy (hdt) and asct, as described in the protocol. 3. participants must have measurable disease as defined in the protocol. 4. eastern cooperative oncology group (ecog) performance status of 0, 1, or 2. 5. participants must have clinical laboratory values within a prespecified range. exclusion criteria: 1. international myeloma working group frailty index of 2 with the exception of participants who have a score of 2 based on age alone. 2. participants who defer transplant due to personal preference. 3. participants with non-secretory mm, active plasma cell leukemia, known light-chain (al) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, waldenström macroglobulinemia, or known poems syndrome. 4. any prior therapy for monoclonal gammopathy of undetermined significance (mgus), smoldering multiple myeloma (smm), or mm, with the exception of: * focal radiation and/or * a short course of corticosteroids as defined in the protocol. 5. participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against mm 6. participants who have known central nervous system (cns) or meningeal involvement with mm or known or suspected progressive multifocal leukoencephalopathy (pml), a history of a neurocognitive condition or cns movement disorder, or a history of seizure, transient ischemic attack (tia), stroke or seizure within 12 months prior to study c1d1. 7. participants who have uncontrolled intercurrent illness. 8. known contraindications to the use of daratumumab or lenalidomide per local prescribing information. 9. history of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time. note other protocol defined inclusion/exclusion criteria apply.

Keywords: multiple myeloma (mm) transplant ineligible newly diagnosed linvoseltamab bcma x cd3 bispecific antibody cd38 antibody lenalidomide
clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection

Conditions: Suture, Complication

Summary: bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. there are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. so the investigator wants to conduct a prospective study, trying to figure out this problem.

lung cancer has been one of the most serious life-threatening diseases of human society. it has the highest morbidity and mortality worldwide among all the malignant tumors. although the treatment of lung cancer is increasingly diverse, surgical resection is still the mainstay. pneumonectomy, as a surgical approach for central primary lung cancer, is very harmful to patients. bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. both absorbable and non-absorbable suture are used for it. but there are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. so the investigator wants to conduct a prospective study, trying to figure out this problem. the investigator sets incidence rate of anastomotic complications as the primary endpoint. according to the calculation, a total of 40 patients will be enrolled (each group has 20 patients).

Eligibility criteria:
inclusion criteria: 1. age 18 to 75 years old. 2. the tumor is located in the opening of bronchus, or the edge of the tumor is less than 2 cm away from the opening of the bronchi, while the distance between the edge of the tumor and the carina is more than 1.5 cm. 3. patients with pathological diagnosis of non-small cell lung cancer. 4. no distant metastasis in preoperative clinical evaluation. 5. adequate cardiac function, pulmonary function, liver function and renal function for anesthesia and bronchial sleeve resection. 6. american society of anesthesiologists (asa) score: grade i-iii. 7. patients who can coordinate the treatment and research and sign the informed consent. exclusion criteria: 1. patients with a significant medical condition which is thought unlikely to tolerate the surgery or unsuitable for this study after the evaluation of the investigator. 2. patients with psychiatric disease who are expected lack of compliance with the protocol.

Keywords: suture bronchial sleeve resection central primary lung cancer non-small cell lung cancer (nsclc)
liraglutide or insulin in real life usage in patients with diabetes mellitus type 2

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the intention of this health service research study is to obtain data from daily routine to evaluate the quality of life and the costs of the disease for patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities. (study-related activities are any procedures related to recording of data according to the protocol) * patients willing and able to give signed consent on matching patient data with sick fund data * patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetic medication, who need treatment intensification with insulin or liraglutide (victoza®) due to inadequate blood glucose control * patient is a member of the involved sick fund (aok plus) exclusion criteria: * known or suspected contra-indication to the relevant study product according to current spc * previous participation in this study * history of type 1 diabetes mellitus * previous insulin treatment excluding emergency administration (treatment duration up to a maximum of 3 days) * previous treatment with liraglutide * history of diabetic gastroparesis, diabetic precoma or diabetic ketoacidosis * progressive fatal disease * any reason in judgement of the treating physician that precludes study participation e.g. lack of compliance, safety concerns, alcohol or drug abuse * patients without legal capacity
sedation with sevoflurane versus propofol in patients with acute respiratory distress syndrome caused by covid19 infection

Conditions: Acute Respiratory Distress Syndrome; COVID19 Infection

Summary: it is a multicenter, national, randomized 1:1 ratio, controlled, parallel, open study. patients with severe ards-covid19 will be included in the trial within the first 24 hours. patients will be randomized to one of the treatment groups: * sev group: 25 patients with sevoflurane sedation by inhalation, starting at 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved (bis 40-50) * pro group: 25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( bis 40-50)


Eligibility criteria:
inclusion criteria: * age 18 years or more. * diagnosis of acute respiratory distress syndrome caused by covid19 infection. * signature of patient's consent or verbal consent of legal representative exclusion criteria: * intracranial hypertension * hypersensitivity to the active ingredient (propofol or sevoflurane) or to any of the excipients * current volume \< 250ml * history of malignant hyperthermia * liver failure * neutropenia (\<0.5x109) * pregnant or lactating women * have received chemotherapy in the last month since their inclusion in the study
bronchoreversibility and radiologic morphology of emphysema

Conditions: Emphysema; COPD

Summary: to assess response to bronchodilation with tiotropium plus salbutamol in patients with severe emphysema and analyze relationships between bronchoreversibility response and semiquantitative computed-tomography based emphysema severity measures.


Eligibility criteria:
inclusion criteria: * radiologic evidence of severe heterogeneous emphysema * gold copd class iii-iv * no other significant pulmonary comorbidity * quit smoking since at least 4 months

Keywords: emphysema, copd, bronchoreversibility, ventilatory obstruction, lung volume reduction surgery, lvrs
piriformis syndrome; extracorporeal shock wave therapy and dry needling

Conditions: Piriformis Syndrome; Extracorporeal Shock Wave Therapy

Summary: this study is being conducted on patients with piriformis syndrome. patients are divided into two groups by list randomization method: extracorporeal shock wave therapy (eswt) group and dry neddling (dn) group. both groups of patients agreed to perform basic stretching exercises. the eswt group received 3 sessions of radial eswt, 1 session per week. the dn group received 3 sessions of ultrasound-guided needling, 1 session per week. clinical evaluations of the participants were performed at the beginning of treatment, 1 month, and 3 months after treatment.


Eligibility criteria:
inclusion criteria: * \>18 years * complaint for more than 3 months exclusion criteria: * disc pathologies according to radiological imaging * hip joint and soft tissue pathologies * recent history of trauma, history of surgery in the lumbar and hip region * history of rheumatologic disease * history of polyneuropathy * history of sciatic nerve injury * history of malignancy * opioid analgesia or corticosteroid intervention for pain in the last month * patients receive another treatment during the study * having a contraindication for dn treatment or eswt treatment

Keywords: eswt dry needling piriformis syndrome
dosing and outcomes study of erythropoietic stimulating therapies in patients with chemotherapy induced anemia

Conditions: Anemia; Cancer

Summary: the purpose of this study is to describe patient characteristics, treatment patterns, and clinical outcomes in adult patients with cancer who are receiving erythropoiesis-stimulating therapy (est).

the dosing and outcomes study of erythropoietic stimulating therapies (dose) is a prospective, observational multicenter registry of approximately 1200 adult cancer patients receiving treatment with est; eg, epoetin alfa or darbepoetin alfa. the planned duration of the dose registry is three years. based on initial results, the registry sponsor may elect to extend the duration of the registry.this study does not specify treatment protocols, require any particular assignment of patients to treatment protocols, or in any other way require participating physicians to alter their practice patterns. participating physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on baseline patient characteristics, treatment patterns, and clinical outcomes. baseline determinations will include patient demographics, tumor and treatment type, hematologic parameters, and patient reported outcomes. data will be collected over the 16-week study period with regard to est treatment, hematologic outcomes and patient reported outcomes.

Eligibility criteria:
inclusion criteria: * patients with cancer who are being treated with an erythropoiesis-stimulating therapy (est) for anemia of cancer or cancer-related treatment * must be est ''naive'' globally or must have been off treatment with an est for at least 90 days * must speak and read english and be able to answer the type of simple questions presented in the patient questionnaires * if the patient is identified for the study while an inpatient, they must be able to be followed for up to 16 weeks * the patient must give consent to participate in the registry by signing the informed consent form exclusion criteria: * patients currently participating in any other clinical study of est (however, the patient may be undergoing treatment under an investigational cancer treatment protocol) * have or had been on dialysis for end stage renal disease in the past * has myelodysplasia or any myelodysplastic syndrome * patients are known to need stem cell transplant * patient who will self-administer the epoetin alfa or darbepoetin alfa

Keywords: anemia cancer epoetin alfa darbepoetin alfa registry
lateral rectus muscle and anterior segment optical coherence tomography (as-oct) in two recession surgeries

Conditions: Intermittent Exotropia

Summary: * background and study aims : the investigators conducted this study to compare the movement of extraocular muscle after two types of recession surgery with non-invasive tool called as-oct. * who can participate? patients who will undergo two types (conventional method and hang-back method) of typical bilateral lateral rectus recession surgery for correcting intermittent exotropia * what does the study involve? volunteers will attend a clinic for four visits over three months. they will undergo as-oct at every visits during follow up period. as-oct is non-invasive test to evaluate operation site. the test only requires their cooperation when they undergo as-oct. * what are the possible benefits and risks of participating? this is non-invasive test for your postoperative follow up. therefore, there will be no risks about this test. * where is the study run from? samsung medical center * when is the study starting and how long is it expected to run for? from april 2015 to dec 2015

this study is a following study of our prior study about as-oct in strabismus. the aim of this study is to compare the longitudinal changes of lateral rectus (lr) muscle insertion between two types of bilateral recession surgery. an as-oct scan of the lr muscle was performed every visits. data on gender, age, degree of deviation (prism diopter), and spur-lr insertion distance using as-oct were collected at postoperative months 1,3 in each group.

Eligibility criteria:
inclusion criteria: * patients who will undergo bilateral lateral rectus recession surgery for correcting intermittent exotropia exclusion criteria: * previous ocular surgery * other ocular diseases except intermittent exotropia * amblyopia
prognostic value of exercise capacity measured as peak oxygen uptake (pvo2) in recipients of left ventricular assist devices

Conditions: Left Ventricular Assist Device; Prognosis; Advanced Heart Failure

Summary: pooling of earlier vo2-studies conducted at the dept. of cardiology, rigshospitalet, denmark, and all lvad centres of the world that wish to participate. the purpose is to investigate the prognostic value of vo2 in recipients of durable lvads using data from studies already conducted.

background and purpose: peak oxygen uptake (pvo2) is used extensively in hf to predict prognosis and time for heart transplantation. many centers are increasingly measuring pvo2 in lvad supported hf patients, though this has mostly been for research or rehabilitation purposes. it is unknown if pvo2 predicts outcome in lvad treated hf patients. the investigators will pool data from all willing centers of the world to investigate the prognostic value of pvo2 (e.g. outcome in lvad supported patients) and, secondly the investigators will investigate wether the predictive power of pvo2 in lvad recipients depends on the treatment indication (btt and dt). methods: data is collected in anonymized form from all centers willing to contribute data. hypothesis: the hypothesis is that lower pvo2 is associated with higher rates of death or urgent transplantation (primary endpoint).

Eligibility criteria:
inclusion criteria: * durable lvad implantation * vo2 in stable post implant phase exclusion criteria: * no vo2 data available * concomittant rvad (temp/durable device)
an open label, safety and tolerability continuation study of intracerebroventricular administration of snn0029 to patients with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: this is an open label safety and tolerability continuation study of intracerebroventricular administration of snn0029, containing the growth factor vegf165, in patients with amyotrophic lateral sclerosis that have previously participated in study snn0029-001. the intention of the study is to investigate safety and tolerability of intracerebroventricular administration of snn0029 and whether it can improve motor function and prolong survival in patients with als.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of als classified as definite, or probable with or without additional laboratory evidence, according to the revised wfn el escorial criteria (appendix b). 2. previous participation in study snn0029-001 with completion of 12 weeks study drug administration. 3. to have completed the investigations associated with safety in study snn0029-001 without development of clinically significant safety concerns. 4. patient has been given written and verbal information about the continuation study, has had the opportunity to ask questions about the study, and understands the time and procedural commitments. 5. patient has given oral and / or signed consent (written) to participate in the study. in the event that a patient who gives oral informed consent is not physically able to sign the informed consent form (icf) due to disease progression, a witness may sign the icf on the patient's behalf. exclusion criteria: 1. hypertension defined as blood pressure \>160 mmhg systolic or \>90 mmhg diastolic. 2. proliferative retinopathy. 3. non-proliferative retinopathy of moderate severity or higher. 4. concurrent clinically significant dementia as determined by the investigator. 5. concurrent clinically significant depression as determined by the investigator. 6. need for administration of any antiplatelet or anticoagulant medication (e.g. aspirin, plavix, non-steroidal anti-inflammatory drugs \[nsaids\]). low dose aspirin or occasional use of nsaids is allowed (see appendix e). 7. clinically significant abnormalities in haematology or clinical chemistry parameters as assessed by the investigator. 8. for female patients, ongoing pregnancy or planned pregnancy 9. breast feeding

Keywords: als vegf165 safety intracerebroventricular infusion implantable
evaluating a mobile self-management application for patients with copd chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the objective of the study is to evaluate the effects of a mobile self-management app in clinical practice for recently discharged copd patients on application use, self-management, anxiety and depression, expectations and experiences, patients' and health care professionals' satisfaction and hospital readmissions.

usability testing techniques were used to receive feedback on a prototype of the app, before starting the feasibility study. patients were recruited from a large teaching hospital. the copd app provided patients with an 8 week self-management program. the application had three views: timeline, information page, and contact page. the start date was each patients' date of discharge. the timeline was classified in 8 weeks, and each week included the lung exacerbation plan, daily and extra medication, information and education and questionnaires. the first week also included a video of a pulmonologist explaining the purpose of the app and additional information about the functionalities of the copd app. the timeline consisted of the lung exacerbation action plan, medication overview, weekly questionnaires and monitoring, and consultations (video consultation after 4 weeks and face-to-face consultation after 8 weeks).

Eligibility criteria:
inclusion criteria: * age \> 18 years * diagnosed with copd * admissions to the hospital for exacerbation * having (access to) a tablet or smartphone * working internet connection * proficiency in using a tablet or smartphone * ability to read and understand the dutch language * signed informed consent * at least one hospitalization for copd exacerbation in the year preceding the study (outcome was...) exclusion criteria: * no exacerbation of copd * comorbidities: cancer, severe cognitive or psychiatric comorbidities * no access to a tablet or smartpone

Keywords: mhealth self-management blended care
safety, pharmacokinetics, and antitumor activity of bgb-b167 alone and in combination with tislelizumab (bgb-a317) in participants with advanced solid tumors

Conditions: Solid Tumor

Summary: this study will evaluate the safety, tolerability, pharmacokinetics (pk), and preliminary antitumor activity of bgb-b167 monotherapy and in combination with tislelizumab (bgb-a317) in participants with select advanced solid tumors.


Eligibility criteria:
inclusion criteria: * age 18 or older * participants with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors previously treated with standard systemic therapy or for whom treatment is not available, not tolerated, or refused, or not expected to provide significant clinical benefit or be tolerated in the medical judgement of the investigator * eastern cooperative oncology group (ecog) performance status ≤ 1 * adequate organ function as indicated by laboratory values during screening or ≤ 7 days before the first dose of study drug(s) exclusion criteria: * active leptomeningeal disease or uncontrolled, untreated brain metastasis * active autoimmune diseases or history of autoimmune diseases that may relapse * any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent * history of severe hypersensitivity reactions to other monoclonal antibody products or their excipients * women who are pregnant or are breastfeeding note: other protocol defined inclusion/exclusion criteria may apply.