Kornimate/medical-research-clean huggingface dataset:
a clinical study evaluating the effects of memantine on brain atrophy in patients with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. previous studies have shown that memantine helps to treat the symptoms of alzheimer's disease (ad). in ad, the rate of brain tissue loss, or atrophy, is faster than in normal aging and this seems to go hand in hand with some of the symptoms of the disease. this suggests that memantine treatment in ad could provide both symptomatic improvement and neuro-protective effects. the purpose of this study was to show whether memantine, in addition to providing symptomatic benefits, can slow the rate of brain atrophy as assessed using magnetic resonance imaging (mri) technology.

the primary objective of this study was to evaluate the effects of memantine on the rate of brain atrophy compared to placebo in patients with ad (moderate severity) over a 1-year period. this was a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study (20 mg memantine). the study also included secondary imaging, cognitive and behavioural measures.

Eligibility criteria:
inclusion criteria: * outpatients at least 50 years of age with a current diagnosis of probable ad of moderate severity (mmse score between 12 and 20, inclusive) consistent with nincds-adrda criteria and mri scans * patients must have had a knowledgeable and reliable caregiver to accompany them to all clinic visits during the study * patients were either on or off existing acetylcholinesterase inhibitor (achei) treatment provided that the treatment had been initiated \>6 months prior to screening, had stabilised with respect to dose for \>3 months, and remained fixed during the entire study. achei treatment could not be initiated or modified during the study exclusion criteria: * the patient had evidence of clinically significant active disease (including recent myocardial infarction and uncompensated congestive heart failure \[nyha ii-iv\]) * the patient had evidence of any clinically significant neurodegenerative disease or neurological disorder other than ad * the patient was contraindicated for mri other protocol-defined inclusion and exclusion criteria applied.

Keywords: memantine neuroimaging mri brain atrophy
an exploratory study of 68ga-dota-sema in preoperative precise imaging of patients with glucagon-like peptide-1 receptor (glp1r) positive insulinomas

Conditions: Hypoglycaemia

Summary: traditional imaging techniques for insulinomas have a low detection rate. this study aims to evaluate the safety, internal radiation dosimetry, and targeted imaging capability of the novel glp1r imaging agent, 68ga-dota-sema, in patients with glp1r-positive insulinomas.


Eligibility criteria:
inclusion criteria: 1. patients who are capable of understanding and voluntarily signing an approved informed consent form (icf). 2. age ≥ 18 years. 3. normal renal function (serum creatinine ≤ 1.5×uln or creatinine clearance ≥ 50 ml/min, and estimated glomerular filtration rate (egfr) \> 80 ml/min/1.73 m²). 4. recurrent hypoglycemia with biochemically confirmed endogenous hyperinsulinemic hypoglycemia (at least 3 episodes of biochemically confirmed endogenous hyperinsulinemic hypoglycemia within the past 3 months, each with detailed blood glucose monitoring records and symptom descriptions confirming endogenous hyperinsulinemia as the cause). 5. negative for sulfonylurea drugs and insulin autoantibodies. 6. ecog performance status ≤ 2, able to tolerate the examination. 7. all other toxicities must be ≤ nci-ctcae v5.0 grade 0 or 1. exclusion criteria: 1. history of allergy or hypersensitivity to the components or excipients of the investigational drug. 2. claustrophobia or inability to tolerate imaging procedures for other reasons. 3. clinically significant active infection as determined by the investigator. 4. history or current presence of uncontrolled primary or metastatic brain tumors. 5. serious and/or uncontrolled and/or unstable conditions that may affect the study as judged by the investigator, including but not limited to: 1. poorly controlled diabetes. 2. congestive heart failure. 3. myocardial infarction within the past 12 months. 4. uncontrolled and unstable hypertension. 5. chronic kidney disease or liver disease. 6. severe pulmonary diseases. 6. poor compliance and inability to complete study procedures as expected. 7. any other conditions that the investigator considers unsuitable for participation in the clinical study.
chimeric antigen receptor modified t cells targeting bcma for the treatment of relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma; Relapsed/Refractory

Summary: to evaluate the safety and tolerability of chimeric antigen receptor gene-modified t cells targeting bcma for the treatment of relapsed/refractory multiple myeloma

subjects who meet the eligibility criteria, pbmc will be collected by blood cell separator and 50 ml of plasma will be collected for preparation of car-t and frozen storage of car-t preparations; patients will be treated with autologous bcma car-t transfusion and followed up for a period of 3 years, with specific efficacy judgments referring to the imwg clinical efficacy evaluation criteria.

Eligibility criteria:
inclusion criteria: 1. age 18-80 years, no gender restrictions; 2. diagnosed with refractory/relapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies; 3. flow cytometry or histology confirms positive bcma expression in myeloma cells; 4. as judged by the investigator, the expected survival time is \>3 months; 5. ecog performance status score ≤2, kps \>60%; 6. the patient has good liver, kidney, heart, and lung function: alt and ast ≤2.5×uln, those with liver involvement can be relaxed to ≤5×uln; serum total bilirubin \ 30 ml/min; heart ejection fraction (ef) ≥40%, no pericardial effusion and significant arrhythmia; indoor spo2 ≥92%; 7. peripheral blood lymphocyte absolute count alc ≥0.5 ×10\^9/l, plt \>30×10\^9/l, hb \>80 g/l and has a single collection venous access, and there are no other contraindications for hematopoietic cell separation; 8. those with fertility must agree to use highly effective contraceptive methods; 9. the subject or their legal guardian can understand and is willing to sign a written informed consent form voluntarily. exclusion criteria: 1. pregnant or nursing women, as well as women planning to become pregnant within the next six months; 2. positive virology tests for hepatitis b, hepatitis c, hiv, syphilis, or cytomegalovirus; 3. history of other tumors (except for those with skin or cervical in situ cancers that have been cured by radical treatment and show no evidence of disease activity); 4. previously received treatment targeting bcma; 5. underwent autologous hematopoietic stem cell transplantation within the last 6 weeks; 6. presence of uncontrolled active bacterial or fungal infection; 7. allergic to research-related drugs or cell components; 8. presence of active autoimmune diseases; 9. currently have unstable or active ulcers or gastrointestinal bleeding; 10. unable to cooperate with treatment and efficacy evaluation due to mental or psychological disorders; 11. received other experimental drug treatments within the last 3 months; 12. the researcher believes that for other reasons, the individual is not suitable for the clinical trial.
a study to evaluate the safety and efficacy of an investigational drug in the treatment of postoperative dental pain (mk-2295-005)

Conditions: Pain, Postoperative; Tooth Extraction

Summary: this study is being conducted to evaluate the safety and tolerability of the drug and to evaluate its efficacy compared to placebo and to ibuprofen in the treatment of postoperative dental pain in male patients.


Eligibility criteria:
inclusion criteria: * patients in generally good health who are scheduled to have two or more third molars removed, at least one of which is partially or completely embedded in bone and is a mandibular impaction exclusion criteria: * patient has a temperature of 37.5c or greater prior to dosing * patient has participated in another clinical study within the last 4 weeks

Keywords: dental pain, postoperative
endoscopic pilonidal sinus treatment with additional crystalized phenol

Conditions: Pilonidal Sinus

Summary: this study presents 23 sacrococcygeal pilonidal disease cases treated with endoscopic cleaning and fulguration of pilonidal sinus inner surfaca followed by application of crystallized phenol into the sinus.

endoscopic treatment and crytallized phenol application are two sovereign treatments described for pilonidal disease. the curative rate may be as low as 65 % and the recurrence rate is at least 10 % after crystallized phenol alone application for pilonidal disease. the experience with endoscopic treatment of pilonidal sinus is only limited but at least 4 % recurrence rate was reported. in this study a preliminary group of 23 patients were treated with combination of these two modalities between february to may 2014 and at the end of 6-9 months follow up, there was no recurrence after excellent cosmetic results. patients were all operated and mild sedation and local anesthesia. there was no serious complication but only some skin irritation was noticed secondary to phenol burn. some patients felt mild pain and the pain was self limited in most cases where only a few needed oral pain killers. some patients were observed to have mild drainage from the sinus but only two of them needed further application of phenol crystals.

Eligibility criteria:
inclusion criteria: * patients with pilonidal disease with no acute abscess exclusion criteria: * patients with aacute pilonidal disease abscess
effect of fluid challenge on intracranial pressure

Conditions: Fluid Challenge; Increased Intracranial Pressure

Summary: fluid challenge is frequently used in fluid management of critically ill patients. assessing whether there is a preload reserve that can be used to increase the stroke volume by delivering a small amount of fluid in a short period of time. optimization of fluid therapy is very important in intensive care patients. inappropriate fluid therapy can cause significant morbidity and even mortality. increased intracranial pressure is one of these important complications. in the present study, we planned to evaluate the effect of a fluid challenge on intracranial pressure by measuring the optic nerve sheath diameter (onsd).

the fluid challenge is a simple volume resuscitation evaluation method that provides an indication of the patient's likelihood of benefiting from an increase in the intravenous fluid volume. both the fluid challenge and fluid responsiveness are evaluated by interpreting the change in hemodynamic parameters after 500 ml of crystalloid (or 250 ml of colloid) solution is infused over 10-15 min. this is done in an attempt to regulate the fluid therapy of hemodynamically unstable patients in order to prevent fluid overload. in the present study, we aim to investigate the effect of the fluid challenge maneuver on intracranial pressure in icu patients with hemodynamic instability through measuring the optic nerve sheath diameter by ultrasonography. patients in the intensive care unit undergoing a fluid challenge were included in this prospective observational study. a fluid challenge is defined as a 500 ml crystalloid infusion administered over 10 min, and fluid responsiveness is defined as a subsequent increase in stroke volume of at least 15%. the onsd and hemodynamic variables will be measured by ultrasonography before (t0), at the end (t1), and 30 min after the fluid challenge (t2). the primary outcome of the study is the change in intracranial pressure associated with the fluid challenge, and the secondary outcome is the relationship between fluid responsiveness and the change in onsd.

Eligibility criteria:
inclusion criteria: 1. patients with no known intracranial pathology. 2. patients with systolic blood pressure \< 90 mmhg 3. patients with mean blood pressure \< 65 mmhg 4. patients with tachycardia (heart rate 100 beats/min) 5. patients with mottled skin, oliguria (diuresis of less than 20 ml/hr or 0.5 ml/kg/hr for two hours), and acute renal failure. 6. patients with arterial lactate concentration \> 2 mmol/l exclusion criteria: 1. patients with known intracranial hypertension 2. patients in the early postpartum period 3. patients with severe mitral or aortic regurgitation 4. patients with cardiac arrhythmia 5. patients unable to be evaluated due to poor echogenicity

Keywords: optic nerve sheath diameter, fluid challenge
pharmacokinetic and safety study of raltegravir and atazanavir in a once daily dose regimen in hiv-1 infected patients

Conditions: HIV Infection; HIV Infections

Summary: the licensed dose of raltegravir is 400 mg twice daily with or without food. raltegravir is metabolized predominantly through glucuronidation by ugt1a1. atazanavir increases the plasma concentrations of raltegravir 400 mg twice daily by 72% due to inhibition of ugt 1a1. this suggests that combined use of atazanavir and a lower dose frequency of raltegravir, once daily for example, is possible. another reason why raltegravir most likely can be applied is that its pharmacodynamic effect is not related to cmin but to auc which is expected to be similar for an 800mg qd dose when compared to 400mg bd. phase iii clinical trials evaluating qd dosing of raltegravir are currently ongoing and interim results are expected to be published in mid 2009. a regimen of atazanavir and raltegravir in combination with lamivudine or emtricitabine may be a well tolerated and effective nnrti-, and ritonavir-sparing regimen that could be an attractive option for both first and second line (after nrti/nnrti failure) treatment regimens.


Eligibility criteria:
inclusion criteria: * hiv-infected as documented by positive hiv antibody test and confirmed by western blot. * subject is at least 18 years of age at the day of screening. * subject is able and willing to sign the informed consent form prior to screening evaluations. * hiv-1 rna \< 40 copies/ml for at least 6 months on antiretroviral therapy. * subject has no history of previous virological failure or documented resistance mutations exclusion criteria: * history of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the trial. * relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. * inability to understand the nature and extent of the trial and the procedures required. * pregnant female (as confirmed by an hcg test performed less than 3 weeks before the first dose) or breast-feeding female. * abnormal serum transaminases determined as levels being \> 5 times upper limit of normal (see appendix a for normal ranges of clinical laboratory values). * concomitant use of medications that interfere with raltegravir or atazanavir pharmacokinetics: rifampicin, irinotecan, midazolam, triazolam, ergotamine, dihydroergotamine, cisapride, pimozide, lovastatin, simvastatin, indinavir, proton pump inhibitors, h2 receptor antagonists, st. john's wort, ginkgo biloba, didanosine, tenofovir, efavirenz, nevirapine, antacids, clarithromycin, phenytoin, phenobarbital, carbamazepine. * active hepatobiliary or hepatic disease (including chronic hepatitis b infection). * alcohol abuse.

Keywords: pharmacokinetics single dose raltegravir treatment experienced
bioequivalence study of nexvax2 in subjects with celiac disease

Conditions: Celiac Disease; Intestinal Disease; Malabsorption Syndromes; Gastrointestinal Disease; Digestive System Diseases; Metabolic Disease; Coeliac Disease; Gluten Sensitivity

Summary: a randomized, double-blind, placebo-controlled clinical study in non-homozygous human leukocyte antigen (hla)-dq.2.5+ adults with celiac disease (ced).

a phase 1, randomized,double-blind, placebo-controlled clinical study of nexvax2, in adult subjects with confirmed ced who, have been following a gluten free diet for at least 12 consecutive months prior to screening. the study will evaluate the safety and tolerability of nexvax2 administered subcutaneously and will compare the bioavailability of subcutaneous versus intradermal administration. the study plan consists of 3 periods: a screening period of 3 to 5 weeks, a 46-day treatment period, and a 30-day post-treatment observational follow-up visit.

Eligibility criteria:
inclusion criteria: * adults 18 to 70 years of age (inclusive) * history of medically diagnosed celiac disease (ced) that included duodenal biopsy. * maintenance of gluten free diet (gfd) for at least 12 consecutive months prior to screening. * willingness to consume a moderate amount of gluten on one occasion during screening. * able to read and understand english. exclusion criteria: * history of inflammatory bowel disease and/or microscopic colitis. * any medical condition or lab abnormality that in the opinion of the investigator may interfere with study conduct or would impact the immune response (other than ced), confound interpretation of study results, or pose an increased risk to the subject. * use of immunomodulatory or immune-suppressing medical treatment during the 6 months prior to screening * use of oral or parenteral immunomodulatory corticosteroids, within the 6 weeks prior to screening. topical or inhaled corticosteroids are acceptable. * receipt of any investigational drug or participation in another clinical study within 6 months prior to screening. * females who are lactating or pregnant * receipt of any vaccine within 1 week prior to planned first day of the treatment period.
car-t cell therapy targeting to cd19 for r/r all

Conditions: Acute Lymphoblastic Leukemia with Failed Remission

Summary: refractory and relapsed (r/r) acute lymphoblastic leukemia (all) patients with active disease always have a dismal outcome. chimeric antigen receptor (car) t-cell therapy targeting to cluster of differentiation antigen 19 (cd19) has been proved as a potent approach to attain remission in b-cell r/r patients. therefore, the investigators conduct atrial to evaluate the the efficacy and safety of locally producing car t cells targeting cd19, and to analyze the outcome of enrolled b-cell all patients with active disease or persistent residual disease.


Eligibility criteria:
inclusion criteria: * diagnosed as cd19+ b-cell acute lymphoblastic leukemia; * fail to achieve remission, or with persistent residual disease after at least 2 cycles of consolidation; * with an estimated survival of higher than 3 months (according to investigator's judgement); * sufficient organ function: left ventricular ejection fractions≥ 0.5 by echocardiography, creatinine \< 1.6 mg/dl, aspartate aminotransferase/aspartateaminotransferase \< 3 x upper limit of normal, bilirubin \<2.0 mg/dl; * karnofsky performance status ≥ 60 or ecog ≤ 2. exclusion criteria: * intolerant to immunosuppressive chemotherapies; * with active infection or other uncontrolled complications; * with history of seizure; * active hepatitis b or hepatitis c infection and hiv infection; * pregnant or lactating women, or patients refusing to take effective contraception measures; * other contraindications that considered inappropriate to participate in this trial (according to investigator's judgement).

Keywords: acute lymphoblastic leukemia refractory and relapsed chimeric antigen receptor t-cell therapy
evaluation of birdshot retine choroidopathy treatment by either steroid or interferon alpha2a

Conditions: Birdshot Chorioretinopathy; Cystoid Macular Edema; Transient Partial Visual Loss

Summary: birdshot retine choroidopathy (brc) is a sight threatening posterior uveitis. the long term visual outcome has recently be studied showing a legal blindness to 14% at 5 years. visual acuity is threatened by macular edema (80%), macular atrophy, and choroidal neovascularization.

birdshot retine choroidopathy (brc) is a sight threatening posterior uveitis. the long term visual outcome has recently be studied showing a legal blindness to 14% at 5 years. visual acuity is threatened by macular edema (80%), macular atrophy, and choroidal neovascularization. the conventional therapy includes in first line steroid therapy of which side effects are well known. if the daily steroid dose necessary to control the intra ocular inflammation is superior to 0.3 mg/kg/d a combined therapy to immunosuppressive drug is suggested in order to do a steroid sparing effect. immunosuppressive drugs include increased infectious risks, hematologic and sterility troubles, and secondary malignancies. moreover immunosuppressive drugs have a own toxic effect and the classical immunosuppressive drug used in brc the cyclosporinea has a high level of nephrotoxicity. that is the reason why immunomodulatory drugs as interferons have been suggested in brc. interferon alpha2 a has been shown efficient in uveitis in behcet's disease. we propose to analyse the potential therapeutic effect of interferon alpha2 a versus steroid therapy with a control group for a 4 months period. this short period could not make the disease worse because of the slow pathologic processus.

Eligibility criteria:
inclusion criteria: * patients with birdshot retine choroidopathy with macular edema * hla a29 positive * work up of infection or sarcoidosis disease negative exclusion criteria: * pregnancy * alcohol addiction * mood disturbance * medullar, hepatic, renal deficiency

Keywords: birdshot retine choroidopathy macular edema prednisone interferon alpha 2a associated with cystoid macular edema with visual acuity loss
transcutaneous spinal cord electrical stimulation combined with kunming locomotor training for the treatment of spinal cord injury

Conditions: Spinal Cord Injuries

Summary: spinal cord injury (sci) is a common and severe traumatic central nervous system injury in clinical practice. currently, the treatment of sci remains a worldwide challenge.international studies have confirmed that tscs is an effective non-invasive technique to activate the body's movement-related circuits. this method utilizes a unique stimulation waveform that is transmitted through electrodes placed on the skin of the spine and spreads through the dorsal roots (drs) to activate the spinal cord neural circuits.the main objective of this study is to have patients with chronic incomplete (ais b/c/d) spinal cord injuries wear "transcutaneous spinal cord electrical stimulator " and undergo "kunming locomotor training" for 6 months, observe the synergistic effects of the two, and evaluate whether this treatment method can improve patients' motor functions.


Eligibility criteria:
inclusion criteria: * 1. chronic (≧6 months) paraplegics (t1-t10) with incomplete(ais b/c/d) spinal cord injury incomplete aged 16-50 years; * 2.subjects must be able to read, understand, and complete the visual analogue scale; * 3.subjects voluntarily sign the informed consent form approved by the ethics committee. exclusion criteria: * 1. obvious renal, cardiovascular, hepatic, and mental diseases; * 2.pregnant or lactating women and women of childbearing age who are unwilling to use contraception; * 3. limb contracture deformity; * 4. modified ashworth \> grade 2; * 5. unhealed fractures; * 6. the subject is currently participating in other studies; * 7. the researcher's opinion is that the subject does not comply with the research protocol and/or is not suitable to participate in this study.