Kornimate/medical-research-clean huggingface dataset:
a safety and efficacy study of defibrotide in the prevention of chimeric antigen receptor-t-cell-associated neurotoxicity

Conditions: DLBCL; Neurotoxicity Syndromes

Summary: this is a prospective, open-label, single-arm study evaluating the safety and efficacy of defibrotide for the prevention of car-t-associated neurotoxicity in subjects with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) receiving yescarta.


Eligibility criteria:
inclusion criteria: 1. subject must be ≥ 18 years of age at signing of informed consent. 2. subject must be diagnosed with relapsed or refractory dlbcl (including dlbcl not otherwise specified, primary mediastinal large b-cell lymphoma, high grade b-cell lymphoma, and dlbcl arising from follicular lymphoma) and scheduled to receive treatment with yescarta. 3. female subjects of childbearing potential who are sexually active and male subjects who are sexually active and have female partners of childbearing potential must agree to use a highly effective method of contraception with their partners during exposure to defibrotide and for 30 days after the last dose of defibrotide. 4. subject must be able to understand and sign written informed consent. exclusion criteria: 1. subject is currently receiving dialysis or expected to receive dialysis. 2. subject has used any investigational anticancer agent within 3 weeks prior to the first dose of defibrotide, or is using or plans to use any investigational agent during the study. 3. subject has previously been treated with car-t therapy. 4. hemodynamic instability requiring vasopressors or uncontrolled hypertension with persistent systolic blood pressure \> 180. 5. subject has clinically significant active bleeding, history of intracranial bleeding, or is at risk for intracranial bleeding as determined by the investigator. 6. subject plans to use any medication that increases the risk of bleeding. 7. subject is pregnant or lactating and does not agree to stop breastfeeding. 8. subject has a known history of hypersensitivity to defibrotide or any of the excipients. 9. subject has primary cns lymphoma.

Keywords: car-t
effects of repetitive transcranial magnetic stimulation in patients with alzheimer's disease

Conditions: Alzheimer Disease

Summary: previous studies have shown that repetitive transcranial magnetic stimulation (rtms) can improve cognitive function in alzheimer's disease (ad), but studies on the improvement of sleep disorders in ad are limited. the aim of this study was to evaluate the effects of rtms on sleep and cognition in patients with mild-to-moderate alzheimer's disease (ad).

transcranial magnetic stimulation (tms) is a non-invasive brain stimulation technique. some studies have showed that its positive effects in patients with alzheimer's disease. the aim of this study was to evaluate the effect of rtms on sleep and cognitive function in patients with mild to moderate ad, and to evaluate the glymphatic system function's mediating role between sleep and cognitive function. the study involves participants receiving 10 sessions of high frequency rtms treatment applied to the dorsolateral prefrontal cortex over a 5 days period or sham rtms. neuropsychological testing and polysomnography will be used as the primary outcome measures. in addition, magnetic resonance imaging will be used to explore the effect of rtms on the glymphatic system function in patients with alzheimer's disease. follow-up assessments of the patients' status will be conducted at one and three-month intervals.

Eligibility criteria:
inclusion criteria: 1. participant meets 2014 iwg-2 criteria for hippocampal amnestic syndrome, typical of ad, with progressive episodic memory impairment confirmed by neuropsychology. cerebrospinal fluid markers (aβ40, aβ42, t-tau, p-tau) consistent with ad, or av-45 pet imaging showing significant cortical tracer retention, in line with ad pathophysiology. 2. age range: 55-80 years. 3. no visual or hearing impairment. 4. right-handed. 5. han nationality. 6. signed informed consent. 7. reliable caregivers as information providers. 8. mmse score: 10-27; cdr: 0.5-2 points. 9. if receiving approved ad treatment (e.g., acetylcholinesterase inhibitor or memantine), dose must be stable for ≥3 months prior to screening and unchanged unless medically necessary. exclusion criteria: 1. history of seizures or epilepsy diagnosis; 2. stroke history; 3. nervous system diseases causing brain dysfunction (schizophrenia, severe anxiety/depression, dementia, huntington's, brain tumors, parkinson's, metabolic encephalopathy, encephalitis, ms, epilepsy, brain trauma, hydrocephalus); 4. severe liver/kidney/lung dysfunction, anemia, gastrointestinal disease, arrhythmia, recent mi; 5. barbiturate/benzodiazepine use within 2 weeks; 6. mri/tms contraindications (metallic implants); 7. systemic diseases causing cognitive impairment (hypothyroidism, folate/b12 deficiency, infections, alcohol/drug abuse); 8. aphasia, consciousness disturbance, inability to cooperate; 9. tms/tdcs/dbs has been processed; 10. underlying pathology other than ad; 11. focal brain lesions on t1/t2 images; 12. refusal to sign informed consent.

Keywords: alzheimer disease sleep glymphatic system transcranial magnetic stimulation cognitive impairment
patient-ventilator interaction during niv with helmet: a comparison between psv and the new niv nps software

Conditions: Respiratory Failure; Mechanical Ventilation Complication

Summary: the goal of this clinical trial is to evaluate if neural pressure support ventilation is able to improve patient-ventilator synchrony, in icu patients undergoing non-invasive ventilation (niv). the main question it aims to answer is: • is neural pressure support ventilation better than the pressure support ventilation with respect to patient-ventilator synchrony during helmet niv? researchers will compare neural pressure support ventilation versus pressure support ventilation (gold standard assisted mode in europe) to see if the new mode improve patient-ventilator synchrony.

non-invasive ventilation (niv) has found many different uses in clinical settings, shortening intubation times and preventing orotracheal intubation. niv success is highly affected by patient comfort and patient-ventilator synchrony. the helmet is one of the most comfortable interfaces, even if synchrony is low due to dead space. the use of neurally adjusted ventilatory assist (nava), in which the electrical activity of the diaphragm (eadi) drives the ventilator, has shown improvement in comfort and synchrony but still some limitation with helmet, due to the long pressurization time. pressure-support ventilation (psv) is still the most used and diffused assisted mode in europe due to its simplicity and effectiveness in helmet-niv. the aim of this study is to test a new ventilation software called neural pressure support ventilation (npsv), which merges the rapid pressurization of psv along with the eadi trigger, onto a population of 24 critical care patients ventilated with a helmet niv.

Eligibility criteria:
inclusion criteria: * adult patients (\>18aa) * non invasive ventilation with helmet * ng tubing for clinical use in position * invasive arterial monitoring for clinical use in position exclusion criteria: * unable to express consent * expected niv \< 24hrs * gastric-esophageal surgery in the preceding 12 months * upper-gi bleeding in the last 30 days * history of esophageal varices * recent trauma or facial surgery * haemodynamic instability even a after liquid infusion (need of at least dopamine \>5 γ/kg/min or norepinephrine \>0.1 γ/kg min to obtain systolic pressure \>90 mmhg) * core temperature \>30 c° * coagulation disorders (inr \> 1.5 and/or aptt \>44 sec)

Keywords: mechanical ventilation non invasive ventilation weaning neurally adjusted ventilator assist
the hepatitis delta international network

Conditions: Hepatitis D

Summary: hepatitis delta is a major health problem, not only because of the severity of the disease, but also due to the lack of effective antiviral treatment. to improve the current therapeutic options, a better understanding of the pathophysiology is essential. reliable research in this direction is only possible with large patient study groups. however, given the geographic distribution of hepatitis delta, larger patient cohorts would only be possible through multicenter collaboration.

the hepatitis international network cohort is a multicenter, observational study that will build up a research registry of hdv patients all over the world. the aims of this project are: i. collect clinical information from hepatitis delta patients from multiple centers distributed worldwide in order to build up a large database that will enable and facilitate further research on chronic hepatitis delta. ii. to better inform patients about their viral infection, present status and evolution of liver disease throughout time. to give them the tools needed to inform other peers and medical professionals about the significance and consequences of a chronic hepatitis delta infection. iii. to allow the participating physicians to track course of the disease, therapies, signs and symptoms of the hepatitis delta patients included by their center.

Eligibility criteria:
inclusion criteria: • positive hbs antigen and antihdv for longer than 6 months. exclusion criteria: absence of any cause of relevant liver disease other than hdv (i.e. hemochromatosis, autoimmune hepatitis, alcoholic or toxic liver disease, etc.)

Keywords: hdv, hepatitis delta
a study evaluating the bioavailability and food effect of veliparib tablets followed by an extension in subjects with ovarian cancer

Conditions: Cancer - Ovarian

Summary: this study will evaluate the bioavailability between the veliparib tablet formulation to the capsule formulation; and will assess the effect of food on veliparib bioavailability in participants with ovarian cancer.


Eligibility criteria:
inclusion criteria: * diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. * laboratory values meeting protocol-specified criteria, including hematologic, kidney and liver function. * life expectancy of 12 weeks or greater. * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2. * able to swallow and retain oral medication. * discontinued anti-cancer therapy and biological agent for antineoplastic intent 21 days prior to the first dose of study drug, not have undergone major surgery 28 days prior to the first dose of study drug; and have recovered to grade 0 - 2 for any clinical significant adverse event effect(s)/toxicity(s) from previous therapy. * non-childbearing potential. exclusion criteria: * history or active medical condition(s) affecting absorption or motility or any surgical procedure that might interfere with gastrointestinal motility, ph or absorption. * evidence of refractory ascites. * has clinically relevant or significant electrocardiogram abnormalities.

Keywords: cancer - ovarian cancer bioavailability pharmacokinetics bioequivalence
an 8-week study to evaluate the dose response of ahu377 in combination with valsartan 320 mg in patients with mild-to-moderate systolic hypertension

Conditions: Systolic Hypertension

Summary: the purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of ahu377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg).


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any assessment is performed. patients with mild-to-moderate systolic hypertension, untreated or currently taking antihypertensive therapy. * ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the run-in period. exclusion criteria: * severe hypertension * history of angioedema, drug-related or otherwise, as reported by the patient. * pregnant or nursing (lactating) women. * women of child-bearing potential (wocbp), unless they are using adequate birth control methods. * history or evidence of a secondary form of hypertension. * other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension blood pressure lcz696 dual-acting neprilysin nep inhibitor vasopeptidase angiotensin receptor angiotensin receptor neprilysin inhibitor (arni)
prospective study of nanotite implants placed into fresh sinus-lift augmentation sites (vssl)

Conditions: Tooth Disease; Partial Edentulism

Summary: this prospective, randomized-controlled, clinical study evaluates the ability of the nanotite implant system to achieve integration and provide long-term support of a prosthesis when placed immediately in fresh sinus augmentation material. control cases will be those where the sinus augmentation material is allowed four months of healing prior to nanotite implant placement. in addition to implant performance, radiographic evidence of crestal bone regressive modeling will be used to evaluate differences between test and control cases. study (null) hypothesis: the implants placed into sinus augmentation sites at the time of grafting will have the same integration success and maintenance of integration as for the implants placed after four months of graft healing.

this will be a prospective, randomized-controlled, longitudinal study in which qualified patients with partial edentulism and thin maxillary ridges will have as part of their treatment at least one sinus ridge augmentation procedure and have their edentulism restored with an implant-supported short-span or long-span fixed bridge. each patient may have up to two cases included in the study should they need bilateral sinus augmentation using unilateral bridge restorations on either side. each patient (or side if a bilateral case) will be randomly assigned to one of two groups: treatment group 1 (test) cases will have implants placed into the sinus cavity during the graft augmentation procedure. treatment group 2 (control) will have a sinus lift augmentation and implant placement into this area will take place after four months of graft healing. for both groups the implants will be submerged and allowed four months of healing before second stage surgery.

Eligibility criteria:
inclusion criteria: * patients of either sex and any race greater than 18 years of age * patients for whom a decision has already been made to augment one or both maxillary sinuses for the purpose of placing dental implants in a maxillary ridge no less than 3 mm high and no greater than 5 mm in height * patients must be physically able to tolerate conventional surgical and restorative procedures. * patients must agree to be evaluated for each study visit, especially the yearly follow-up visit exclusion criteria: * patients with active infection or severe inflammation in the areas intended for implant placement. * patients with a \>10 cigarettes per day smoking habit. * patients with uncontrolled diabetes mellitus. * treatment with therapeutic radiation to the head within the past 12 months. * patients who are pregnant at the screening visit. * patients with evidence of severe para-functional habits such as bruxing or clenching.

Keywords: dental implants, maxilla, sinus lift, augmentation
tranexamic acid in hip fracture surgery (thif study)

Conditions: Hip Fracture

Summary: the purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.

studies in hip and knee arthroplasty (scheduled surgery) have shown that tranexamic acid decreases allogeneic red blood cell transfusion. in hip fracture surgery, an emergent procedure, transfusion is frequent. transfusion increases adverse events such as postoperative bacterial infection and venous thrombosis. the purpose of this study is to assess the efficacy of tranexamic acid, an anti-fibrinolytic agent, in hip fracture surgery on the reduction of allogeneic red blood cell transfusion. the trial will also evaluate if the reduction in transfusion will be associated with less postoperative infection and without an increase in the thrombotic risk. patients with an isolated hip fracture of less than 48 hours will be randomized to either tranexamic acid 15mg/kg iv at skin incision and three hours later or saline.patients will receive fondaparinux for prophylaxis of venous thrombosis.

Eligibility criteria:
inclusion criteria: * patient requiring surgery for an isolated hip fracture of less than 48 hours exclusion criteria: * contraindication to tranexamic acid * contraindication to fondaparinux * contraindication to general anesthesia associated with a femoral nerve block * pregnancy

Keywords: hip fracture transfusion tranexamic acid fondaparinux
hypopituitarism following traumatic brain injury or spontaneous subarachnoidal haemorrhages

Conditions: Brain Injuries; Intracranial Aneurysm

Summary: the purpose of this study is to assess the prevalence and predictors of pituitary dysfunction, as well as secondary out-come in patients with traumatic brain injury or spontaneous subarachnoidal haemorrhages.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of traumatic brain injury (tbi) or subarachnoidal haemorrhages (sah) exclusion criteria: * alcohol or drug abuse * prior tbi or sah * chronic use of glucocorticoids * pregnancy or breast feeding * diagnosis of psychiatric diseases or malignant neoplasms
the plasma for alzheimer symptom amelioration (plasma) study

Conditions: Mild-To-Moderate Alzheimer's Disease; Alzheimer's Disease

Summary: the plasma for alzheimer symptom amelioration (plasma) study: intravenously-administered plasma from young donors for treatment of mild-to-moderate alzheimer's disease


Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer's disease (nia-aa criteria) * mini-mental state examination (mmse) score 12-24 * availability of a study partner who knows the patient well and is willing to accompany the subject to all trial visits, to participate in questionnaires and to complete daily journal assessments exclusion criteria: * pregnancy or unwilling to use adequate birth control method for duration of and 6 months beyond study participation * positive for hepatitis b, hepatitis c or hiv at screening * any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study * related to medical history: * stroke * anaphylaxis * prior adverse reaction to any human blood product * any history of a blood coagulation disorder or hypercoagulability * congestive heart failure * uncontrolled hypertension * renal failure * prior intolerance to intravenous fluids * recent history of uncontrolled atrial fibrillation * iga deficiency (by history) * related to medications or other treatments: * any concurrent use of an anticoagulant therapy. antiplatelet drugs (e.g., aspirin or clopidogrel) are acceptable * initiation or change in the dosage of a cholinesterase inhibitor or memantine during the trial. a participant already on a cholinesterase inhibitor or memantine must be on a stable dose for at least one month prior to screening * concurrent participation in another treatment trial for alzheimer's disease. if there was prior participation, the last dose of the investigational agent must have been at least 6 months prior to screening * treatment with any human blood product, including intravenous immunoglobulin, during the 6 months prior to screening or during the trial * concurrent daily treatment with benzodiazepines, typical or atypical antipsychotics, long-acting opioids, or other medications that, in the investigator's opinion, interfere with cognition. intermittent treatment with short-acting benzodiazepines or atypical antipsychotics may be permitted, provided that no dose is administered within the 72 hours preceding any cognitive assessment * related to magnetic resonance imaging: * claustrophobia * any metallic surgical implant, like a pacemaker or clip that is incompatible with 3t mri. certain metallic implants like joint replacements may be permitted, provided that specific manufacturer specifications are available and that the device is known to be safe for 3t mri.
giant cell arteritis - optimization of diagnostics

Conditions: Giant Cell Arteritis

Summary: giant cell arteritis - optimization of diagnostics

a prospective study. investigating the use of ultrasound, temporal artery biopsy, biomarkers and 18f-fluorodeoxyglucose positron emission tomography-computed tomography for establishing a diagnosis of giant cell (temporal) arteritis.

Eligibility criteria:
inclusion criteria: clinical suspicion of giant cell arteritis meets the american college of rheumatology criteria: age at disease onset =\> 50 years new headache temporal artery abnormality elevated erythrocyte sedimentation rate \>=50 mm/hour abnomal artery biopsy exclusion criteria: active cancer use of steroid for more than a week (the prior 6 months)

Keywords: temporal artery biopsy, giant cell arteritis ultrasound 18f-fdg pet/ct
observational study of anti-reflux surgery

Conditions: GERD; Gastroesophageal Reflux; Gastro Esophageal Reflux

Summary: the anti-reflux surgical study has been established to: * collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation and fundoplication) in everyday clinical practice * track the clinical course of patients from pre-operative assessment to three years post-surgery

this study will track and monitor patients treated with either the magnetic sphincter augmentation or fundoplication, making it the first registry to collect data on both anti-reflux surgical options in the setting of everyday clinical experience.

Eligibility criteria:
inclusion criteria: * individuals treated with linx reflux management system or fundoplication * individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the anti-reflux surgical registry. * individuals willing to complete questionnaires and comply with the three years of follow-up. exclusion criteria: * known circumstances that would make it unlikely for an individual to complete the three year follow-up (e.g. life expectancy \<3 years)

Keywords: gastroesophageal reflux disease fundoplication magnetic sphincter augmentation proton pump inhibitors gerd ppi msa