Kornimate/medical-research-clean huggingface dataset:
a study of bcma-targeted car-t cells therapy for refractory/relapsed multiple myeloma

Conditions: Relapse Multiple Myeloma; Refractory Multiple Myeloma

Summary: clinical trial for the safety and efficacy of bcma-targeted car-t cells therapy for refractory/relapsed multiple myeloma

in this study, 100 patients with relapsed refractory multiple myeloma were proposed to undergo bcma car-t cell therapy. under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of bcma car-t cell therapy for relapsed refractory multiple myeloma; at the same time, on the basis of expanding the sample size, more safety data on bcma car-t cell treatment for relapsed refractory multiple myeloma were accumulated, including rare and delayed complications.

Eligibility criteria:
inclusion criteria: * 1. histologically confirmed diagnosis of multiple myeloma (mm): 1. patients with bcma positive relapsed/refractory mm; 2. relapsed after hematopoietic stem cell transplantation; 3. cases with recurrent positive minimal residual disease; 4. repeated mrd(+) refractory resistant cases 5. extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy. 2. anticipated survival time more than 12 weeks; 3. transplant patients, regardless of their previous treatment, are eligible after relapse; 4. those who voluntarily participated in this trial and provided informed consent. exclusion criteria: * subjects with any of the following exclusion criteria were not eligible for this trial: 1. history of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; 2. electrocardiogram shows prolonged qt interval, severe heart diseases such as severe arrhythmia in the past; 3. pregnant (or lactating) women; 4. with a graft-versus-host response, immunosuppressants are required; 5. patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 6. active infection of hepatitis b virus or hepatitis c virus; 7. concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids; 8. previously treated with any car-t cell product or other genetically-modified t cell therapies; 9. creatinine\>2.5mg/dl, or alt / ast \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; 10. other uncontrolled diseases that were not suitable for this trial; 11. patients with hiv infection; 12. any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Keywords: multiple myeloma car t-cell therapy bcma
a notch signalling pathway inhibitor for patients with advanced breast cancer (0752-014)

Conditions: Advanced Breast Cancer; Other Solid Tumors

Summary: an investigational study to determine the safety/tolerability, and efficacy of a notch signaling pathway inhibitor in patients with metastatic or locally advanced breast cancer and other advanced solid tumors.


Eligibility criteria:
inclusion criteria: * women or men greater than or equal to 18 years of age * ecog status less than or equal to 2 (a measurement to determine your ability to perform daily activities) * in parts i, iii, and iv, patient must have a histologically confirmed, metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. there is no limit on the number of prior treatment regimens * in part ii, only breast cancer patients are eligible * in part v, only patients with numb negative breast cancer (i.e., tumor shows numb immunoreactivity in less than 10% of the neoplastic cells assessed) are eligible * patient has recovered from and is at least 2 weeks from previous antineoplastic therapy, including chemotherapy, biological therapy (including herceptin), hormonal therapy, radiotherapy, or surgery exclusion criteria: * patient has had an investigational treatment in the preceding 21 days * uncontrolled congestive heart failure or myocardial infarction (heart attack) within 3 months of study start * history of hepatitis b or c or hiv * patient has the presence of clinically apparent central nervous system metastases or carcinomatous meningitis. patients with cns metastases who have completed a course of radiotherapy and are clinically stable in the judgment of the investigator are eligible * patients with "currently active" second malignancy, other than non-melanoma skin cancer, should not be enrolled. patients are not considered to have a "currently active" malignancy if they have completed therapy for prior malignancy and are considered by their physician to be at \<30% risk of relapse

Keywords: advanced breast cancer solid tumors advanced solid tumors
sucrosomial iron vs. oral iron sulfate for the treatment of iron deficiency anemia in patients with ulcerative colitis

Conditions: Anemia, Iron Deficiency; Ulcerative Colitis

Summary: the aim of the study is to compare the tolerability and efficacy of sucrosomial iron to oral iron therapy in a randomized controlled trial for the treatment of iron deficiency anemia in ulcerative colitis patients.

ulcerative colitis (uc) is an inflammatory bowel disease (ibd) characterized by chronic inflammation limited to the mucosal layer of the colon. anemia is a consistent clinical feature of ibd, and is encountered in one third of patients \[1\] and anemia in ulcerative colitis is most commonly the result of iron-deficiency due to chronic blood loss through ulcerations in the colon. oral iron supplementation has been used for the treatment of iron deficiency anemia but may cause disease exacerbation in patients with uc \[2\]. iron also can increase cancer risk \[3\], and is associated with many side effects such as constipation, diarrhea, nausea, vomiting, abdominal pain and hyperchromia of feces. furthermore, studies have shown that oral iron supplementation fails to resolve anemia in 2 of 3 ibd patients. \[4\] sucrosomial iron is a new preparation of iron pyrophosphate delivered within a phospholipid membrane and coated with sucrester (sucrose esters of fatty acids). it has been shown to have better absorption and higher bioavailability while minimizing side effects in multiple patient populations.

Eligibility criteria:
inclusion criteria: * age above 18 * confirmed diagnosis of ulcerative colitis * proven iron deficiency anemia (hb \< 12 for females and hb \< 13 for males and iron saturation \<20%) * hemoglobin level \> 8g/dl exclusion criteria: * age below 18 * hemoglobin level \< 8g/dl * recently hospitalized for disease flare (within 3 months) * hemoglobinopathies (including thalassemia) * isolated proctitis * indeterminate colitis * known liver or kidney disease * known celiac disease * extensive small bowel resection * use of anticoagulants or aspirin * known intolerance to oral iron therapy * uninvestigated anemia * pregnant or lactating women * known hypersensitivity to iron sulfate * transfusion in the past 4 weeks * erythropoetin within the last 8 weeks * rheumatoid arthritis * history of menometrorrhagia or frequent epistaxis

Keywords: sucrosomial iron sideral forte iron supplementation iron deficiency anemia ulcerative colitis inflammatory bowel disease
management of third-stage of labor after second trimester medical pregnancy termination

Conditions: Retained Placenta

Summary: prospective randomized trail which compare 2 regimens for third-stage management after second trimester medical pregnancy termination : 10ui intra venous oxytocin or no additional medication after fetal expulsion. primary outcome was the incidence of placental retention.

complication of third stage of labor in second trimester medical pregnancy termination is not well studied. accord to publications, the placental retention rate is 30 to 40% in these situations. placental retention may be associated with increased blood loss, increased requirement for blood transfusion anesthetic and operative complications, and infectious morbidity. the high incidence of retained placenta is an area of clinical concern. publications reveal a wide variation in practices but there are only few studies about third stage of labor in second trimester medical pregnancy termination. the study is a prospective randomized trial. two third stage management strategies are compared: 10 units of intra venous oxytocin (group 1) and no additional medication (group 2) after fetal expulsion. it concerns pregnancies between 14 and 28 weeks gestation.

Eligibility criteria:
inclusion criteria: * 18 years old and older * medical pregnancy termination between 14 and 28 weeks gestation * informed consent obtained exclusion criteria: * less than 18 years old * refusal to consent * in utero fetal death

Keywords: retained placenta second trimester medical termination third stage labor oxytocin
finding ideal blood culture volume in nicu

Conditions: Ideal Sample Volume for Blood Cultures

Summary: the investigators want to assess the effectivity of different sample volumes in blood cultures.

the investigators intend to compare yield of 0.5ml sample x2 vs 0.25 ml samples x2 (aerobic and anaerobic media for each volume) taken from the sample taken from the same site and time. time to positivity will also be compared, as well as possible contamination rates.

Eligibility criteria:
inclusion criteria: * suspected sepsis exclusion criteria: * need for extra puncture in order to withdraw enough blood for the second set of cultures. * urgent need for antibiotic without time for cultures.

Keywords: neonatal sepsis
force feedback joystick in upper limb rehabilitation following stroke

Conditions: Stroke

Summary: the purpose of this study is to assess the influence of force feedback joysticks and haptic feedback in improving upper limb rehabilitation outcomes following stroke.

upper limb paresis or plegia following stroke remains a significant cause of impairment and disability. regaining function requires learning through repetitive movements and activities of daily living(adls). the aim of the study in this application is to test the usability of the system in specialized rehabilitation hospital settings. in this first stage of development, after developing and testing the system together with expert physiotherapists, we will examine the system for usability (is it "user friendly"), comfort level, and therapeutic efficacy. the system consists of an ordinary pc computer, specially written software, and a commercially available force feedback joystick. (force feedback joysticks, are usually used for gaming; they contain miniature motors that allow the joystick to either help or resist the movements of the person using it). patients who are unable to grasp the joystick will use a specially built arm rest that is attached to an ordinary office chair without wheels. patients rest their forearm on the arm rest and thus can manipulate the joystick by means of movement of the shoulder and elbow joints instead of by movements of the wrist, since wrist movements are often difficult for brain damaged individuals.

Eligibility criteria:
inclusion criteria: * medically stable post first stroke patients * score of more than 17 on the mini mental scale test(mmst) exclusion criteria: * a history of psychiatric illness * inability to understand the informed consent form * inability to understand and follow 2-3 step instructions * receptive aphasia (sensory aphasia)

Keywords: force feedback joystick stroke haptics kinematics rehabilitation robotics force feedback joystick in stroke rehabilitation
novel complex radiodiagnostics of peripherial arthropathies

Conditions: Arthritis, Rheumatoid; Arthritis, Psoriatic; Crystal Arthropathies

Summary: chronic peripherial arthritides are common diseases with soaring public health consequences. our goal is to assess the role of photon-counting detector computed tomography in the diagnostics of peripherial arthropathies.

background: chronic peripherial arthritides include immune-mediated (rheumatoid arthritis, psoriatic arthritis) and crystal deposition diseases (gout, pseudogout, hydroxiapatite-deposition disease). conventional radiographs are utilized to screen arthritis-associated deformities, bone erosions and joint space narrowing. mri is able to detect bone marrow edema, synovitis and the swelling of soft tissues. sonography can also detect synovitis and soft tissue involvement but does not provide information about bone marrow edema and poorly assess erosions. photon-counting detector computed tomography (pcd-ct) is a novel type of ct device which provides many advantages like improved signal-to-noise ratio, intrinsic spectral information, lower radiation exposure, and better spatial resolution. pcd-ct is a type of x-ray computed tomography in which x-rays are detected using a photon-counting detector. these detectors are able to directly transform x-ray photons into electrical signals. compared to previous generation scintillation detectors, photon-counting detectors have several advantages: being able to count the charges created by individual x-ray photons and measuring their energy level also providing multi- energy spectral sensitivity. 0.2 mm slice thickness potentiates the detection of bone erosionss. collagen-rich structures like cartilage, ligaments, and tendons are easier to identify on pcd-ct images. bone marrow edema can be visualized with virtual non- calcium reconstruction. pcd-ct could both detect and differentiate cristal deposits. aims: to assess the possible role of pcd-ct technique in the diagnostics of peripherial arthropathies.to compare the role of pcd-ct in the detection of arthritis-related pathologies with other imaging modalities like mri and conventional radiography.

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis (eular/acr criteria) / psoriatic arthritis (caspar criteria)/ crystal arthropathies * signed informed consent exclusion criteria: * age: \ 100 years * pregnant * breastfeeding

Keywords: photon-counting detector computer tomography, magnetic resonance imaging, radiography, rheumatoid arthritis, psoriatic arthritis, crystal arthropathies
sleep quality and mechanisms of cardiovascular risks in adults with hypertension

Conditions: Hypertension; Insomnia

Summary: the objective of this study is to elucidate the potential mechanisms responsible for the increased risk of cardiovascular disease among patients with hypertension and comorbid insomnia.

the investigators propose to utilize a behavioral intervention to manipulate sleep quality in 150 adults with hypertension and comorbid insomnia, who will receive a 6-week cognitive behavioral therapy for insomnia (cbt-i) intervention, which has been shown to markedly improve sleep quality and promote consolidated sleep in approximately 60% of those treated. a lowering of nighttime blood pressure is one of several proposed mechanisms to be examined.

Eligibility criteria:
inclusion criteria: * systolic bp ≥ 130 mm hg based upon two standardized bp screening assessments * a current diagnosis of insomnia disorder as defined in the international classification of sleep disorders (icsd-3); or undiagnosed, but suspected, insomnia disorder that is confirmed at their screening lab visit exclusion criteria: * uncontrolled hypertension (screening office bp \> 160/100 mm hg) * antihypertensive medication use * cardiovascular medications * previously diagnosed moderate or severe obstructive sleep apnea * severe obesity defined by bmi\>40 kg/m2 * pacemakers * atrial fibrillation * acute coronary syndrome or coronary revascularization procedure within 6 months of enrollment * congestive heart failure * identifiable cause of hypertension (e.g., primary hyperaldosteronism, renal artery stenosis, untreated hyper- or hypothyroidism, chronic kidney disease, cushing's disease, pheochromocytoma, coarctation of the aorta) * severe uncorrected valvular heart disease * current pregnancy * active diagnosis of psychosis, bipolar disorder * diabetes * severely impaired hearing or speech * participation in another interventional study to address insomnia * rotating shift workers * prominent suicidal or homicidal ideation (as assessed through a clinical interview) * psychiatric hospitalization within the past 12 months * alcohol or drug abuse within 12 months * exposure-based ptsd treatment * dementia * unstable comorbid sleep disorder requiring assessment and/or treatment outside of the study protocol * medical or psychiatric conditions judged to be the primary cause of insomnia * inability to comply with the assessment procedures or inability to provide informed consent.
hpi for prevention of hypotension during cardiac surgery

Conditions: Cardiac Surgery Patients

Summary: hypotension prediction index (hpi) was applied in various types of non-cardiac surgery with convincing benefits of preventing hypotensive events and clinical sequelae. although hpi was validated in cardiac surgery, its clinical benefits are not proven yet. we aim to evaluate its effects on intraoperative hypotension and postoperative adverse events in cardiac surgery. in this randomized, single-blind trial, we will enroll adults scheduled for elective primary cardiac surgery under general anesthesia. participants will be randomly assigned to intraoperative hpi-guided or non-hpi-guided hemodynamic management. the primary endpoint is the time-weighted average intraoperative hypotension below a mean arterial pressure threshold of 65 mmhg. the secondary endpoints are postoperative complications.


Eligibility criteria:
inclusion criteria: * adult * elective, primary, isolated coronary arterial bypass surgery (cabg) or isolated valve surgery * provide inform consent. exclusion criteria: * arrhythmia (e.g., atrial fibrillation, atrial flutter) * intracardiac shunts * preoperative inotropic usage * preoperative supportive devices usage (e.g., intra-aortic balloon pump, extracorporeal membrane oxygenation, left ventricular assist device, or right ventricular assist device) * receiving urgent or emergent procedures.

Keywords: cardiac surgery hypotension prediction index hypotension randomized controlled trial
a phase ii, multicenter, double blind, placebo-controlled safety, tolerability study of bms-708163 in patients with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to determine the safety and tolerability of bms-708163 in patients with mild to moderate alzheimer's disease over a treatment period of 12-weeks and the course of any potential effects during a 12-week wash-out period


Eligibility criteria:
inclusion criteria: * clinical diagnosis of mild to moderate alzheimer's disease (mmse 16-26) * 6 month cognitive decline * stable marketed ad therapy x2 months or additional marketed ad therapy during study * score of \<=4 on the modified hachinski ischemia scale * ct results consistent with alzheimer's disease * medically stable * 6 years education * reliable study partner (caregiver) * must be able to swallow capsules exclusion criteria: * premenopausal women * dementia due to other causes than alzheimer's disease * history of stroke * immunocompromised * active peptic ulcer, gi bleed, chronic inflammatory bowel disease, chronic diarrhea or past gi surgery that would impact drug absorption * unstable vitamin b-12 deficiency * hematologic or solid malignancy within 5 years * geriatric depression scale \>= 6 * unstable medical condition * alcohol or drug abuse history with 12-months of study entry * significant drug allergy * alzheimer's disease modification experimental therapy with 12 months of study entry * prisoners, compulsory psychiatric patients, or residents of nursing home or skilled nursing facility at entry * any other experimental therapy with 30-days of study entry
effect of nanochitosan impregnated calcium hydroxide as an intracanal medication on postoperative pain intensity and bacterial load reduction

Conditions: Intervention

Summary: this research will study the effect of nanochitosan impregnated calcium hydroxide versus calcium hydroxide as an intracanal medication on postoperative pain intensity measured using numerical rating scale (nrs) and bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (cfu/ml) in necrotic teeth.

primary outcome: postoperative pain measured using numerical rating scale (nrs) 1. after placement of intracanal medicament at 6, 12, 24 and 48 hours. 2. after root canal obturation at 6, 12, 24 and 48 hours. secondary outcome: bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (cfu/ml) 1. sample 1 (s1): after access preparation and pre-instrumentation. 2. sample 2 (s2): post-instrumentation. 3. sample 3 (s3): post-intracanal medicament removal at 7 days.

Eligibility criteria:
inclusion criteria: 1. age between 25-45 years old. 2. males or females. 3. healthy patients who are categorized as i or ii according to the american society of anesthesiologists. (asa i or ii) 4. patients' accepting to participate in the trial. 5. patients who can understand the pain scale and can sign the informed consent. 6. mandibular single rooted premolars, having single root canal: diagnosed clinically with pulp necrosis. 7. positive pain on percussion denoting apical periodontitis.(20) 8. slight widening in the periodontal membrane space 9. normal occlusal contact with opposing teeth exclusion criteria: 1. medically compromised patients having significant systemic disorders (asa iii or iv). 2. if analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively. 3. pregnant women 4. patients reporting bruxism, clenching, tmj problems or traumatic occlusion 5. patients with two or more adjacent teeth requiring endodontic treatment. 6. teeth that require further procedural steps or multidisciplinary approach. 1. association with swelling or fistulous tract. 2. acute periapical abscess. 3. mobility grade ii or iii. 4. pocket depth more than 5mm. 5. previous root canal treatment. 6. non-restorable. 7. immature root. 8. radiographic evidence of external or internal root resorption, vertical root fracture, perforation, calcification. 7. inability to perceive the given instructions.