Kornimate/medical-research-clean huggingface dataset:
a phase 1b/2 study of intravenous brincidofovir in patients with relapsed or refractory lymphoma and relapsed or refractory extranodal natural killer/t-cell lymphoma

Conditions: Relapsed or Refractory Lymphoma Including ENKL

Summary: this study is a multi-center, global, open-label, phase 1b/2 clinical study, and it will be conducted at multiple study sites in several countries, including japan, korea, and singapore, to reveal the safety, tolerability, dose limiting toxicity (dlt), maximum tolerated dose (mtd)/recommended phase 2 dose (rp2d), pharmacokinetics (pk), and preliminary efficacy of bcv in patients with relapsed or refractory lymphoma and to assess the efficacy and safety of brincidofovir (syb v-1901, bcv) in patients with relapsed or refractory extranodal natural killer/t-cell lymphoma (enkl). this study consists of 2 parts and will enroll a total (maximum) of 43 male and female participants who meet the eligibility criteria (phase 1b part: up to 18 participants \[3 to 6 participants in each of the 3 cohorts\], phase 2 part: 25 participants).


Eligibility criteria:
inclusion criteria: * patients who are histopathologically diagnosed with enkl based on the world health organization (who) classification of malignant lymphoma 5th edition (who-haem5) (can be enrolled in the phase 1b part and the phase 2 part) or patients diagnosed with ebv-positive nodal t- and nk-cell lymphoma (ebv + ntnkcl), nodal t-follicular helper cell lymphoma (ntfhcl) (including angioimmunoblastic t-cell lymphoma (aitl) as defined in the who classification, 4th edition), peripheral t-cell lymphoma not otherwise specified (ptcl, nos), anaplastic large cell lymphoma (alcl), diffuse large b-cell lymphoma (dlbcl) (e.g., dlbcl, nos), or adult t-cell leukemia lymphoma (atll) (can only be enrolled in the phase 1b part) * patients with relapsed or refractory lymphoma and previously treated with systemic chemotherapy (history of multidrug chemotherapy including l-asparaginase such as smile therapy for enkl is mandatory) who are ineligible for other systemic therapies * patients with the following eastern cooperative oncology group (ecog) performance status (ps): * phase 1b part: 0-1 * phase 2 part: 0-2 exclusion criteria: * patients with another active malignant tumor requiring treatment * patients with nci-ctcae grade 2 or higher diarrhea (increase of 4 or more bowel movements per day compared to usual number of bowel movements) within 7 days prior to starting the first dose of bcv * graft-versus-host disease (gvhd) patients requiring immunosuppressive agents * patients with a history of cidofovir intolerance * patients with a history of being diagnosed with cirrhosis

Keywords: syb v-1901 bcv relapsed or refractory lymphoma extranodal natural killer/t-cell lymphoma enkl ebv-positive nodal t- and nk-cell lymphoma ebv + ntnkcl nodal t-follicular helper cell lymphoma ntfhcl angioimmunoblastic t-cell lymphoma aitl peripheral t-cell lymphoma not otherwise specified ptcl-nos anaplastic large cell lymphoma alcl diffuse large b-cell lymphoma dlbc dlbcl-nos adult t-cell leukemia lymphoma atll
reducing intracranial atherosclerosis with repatha

Conditions: Ischemic Stroke

Summary: the purpose of this study will be to understand the underlying mechanism by which pcsk9 inhibition reduces the rate of ischemic stroke seen in the pivotal studies that led to its fda approval for ascvd such as ischemic stroke. those trials (fourier and odyssey) enrolled almost 50,000 patients and showed that pcsk9 inhibition therapy is safe and effective. the investigators hypothesize that pcsk9 inhibition lowers the rate of stroke by reducing atherosclerotic plaque, which would be particularly beneficial for patients with intracranial atherosclerosis, who have the highest rate of recurrent stroke of any stroke mechanism.


Eligibility criteria:
inclusion criteria: * adult patients, ≥ 18 years of age * history of ischemic stroke, defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction (american heart association definition). * large vessel atherosclerosis of an intracranial artery in the circle of willis with 50-99% stenosis by wasid criteria (percent stenosis = (1-\[diameter stenosis/diameter normal\]) x 100%) on mra, cta or dsa ------ eligible arteries: vertebral (v4), basilar, pca (p1, p2), mca (m1, m2), tica, aca (a1) * current statin use or contraindication to statin * fasting ldl-c ≥ 70 mg/dl or ldl-c ≥ 60 mg/dl if lipoprotein (a) \> 30 mg/ dl exclusion criteria: gadolinium or pcsk9 inhibitor allergy * acute or chronic kidney disease with egfr\<30 ml/min/1.73m2 * pacemaker or other mri contraindications per american college of radiology guidelines * inability to return for 78 week follow-up clinic visit and vwmri

Keywords: intracranial atherosclerosis
performance of mammoalert™, point of care system, for the screening of breast cancer in women 18 years of age or older

Conditions: Breast Cancer

Summary: poc medical systems has developed a point of care system for the screening of breast cancer in the general population. via a proprietary algorithm, the mammoalert™ is expected to determine breast cancer's risk level for a subject by identifying the presence in plasma of known biomarkers. the present study aims to determine the sensitivity and specificity of the test in plasma samples of subjects of whom the status vis-à-vis breast cancer is known.

2400 subjects will be screened for breast cancer in seven enrolling sites across the country to ensure diverse ethnicity. "positive" subjects should be confirmed breast cancer positive by mammography and/or biopsy. breast cancer positive samples will be compared to the control group of samples obtained from women attending clinics for non-cancerous related pathology. both positive and negative predictive values will be evaluated to determine accuracy and sensitivity of the screening test. subjects whose known cancer positive or negative status do not match the test report will be followed up as appropriate, on case by case basis to identify false positive and false negative results.

Eligibility criteria:
inclusion criteria: 1. ability to give informed consent. written informed consent by the patient/patient's legally acceptable representative (lar) for donating blood sample 2. documented absence of cancer (other than breast cancer) 3. documented (mammography and/or biopsy) diagnosis of breast cancer (idc/ilc/dcis ), any stage 4. blood sample taken before any treatment for breast cancer was administered to the subject. exclusion criteria: 1. other malignancy besides breast cancer in the 5 years prior to obtaining the sample. 2. therapies for breast cancer that have been administered within 1 year of obtaining the sample 3. any condition (including psychiatric), which in the investigator's opinion, places the patient at undue risk by participating in the study.

Keywords: screening mammography
nonsurgical periodontal treatment in patients with social phobia

Conditions: Social Phobia; Periodontal Diseases

Summary: objective: to investigate the impact of nonsurgical periodontal treatment in patients with social anxiety disorder (sad) and controls without phobia.

study design: randomized controlled trial. setting: institute of psychiatry from fmusp (ipq-fmusp). subjects: patients seeking for social phobia treatment at ipq-fmusp ( before and under treatment). controls: hospital staff at the hc-fmusp or volunteers from a list of other studies conducted at the ipq-fmusp. methods: dental evaluation: probing depth, clinical attachment level and bleeding on probing will be recorded at 6 sites per tooth, as well as the plaque and/or calculus indexes. the number of decayed, missing and filled teeth (dmft index) will be also assessed. the visual analogue scale (vas) will be applied for the assessment of pain after probing after the probing recording. patients will receive a clinical evaluation for halitosis using a halimeter® to verify the concentration of the volatile sulfur compounds (before and after periodontal treatment). main psychiatric assessment: structured clinical interview (scid) for dsm-iv-tr adapted for dsm-5, the liebowitz social anxiety (lsas). duration and frequency: after the initial clinical assessment (dental and psychiatric) patients will be randomized into three groups. two groups (experimental- social phobia with no psychiatric treatment and control) will receive periodontal treatment after the initial psychiatric evaluation. one group will receive periodontal treatment after the improvement of psychiatric condition (3 months after the initial assessment). the non-surgical periodontal treatment will be performed preferably within 24 h. patients will be reevaluated 3 and 6 months after the end of nonsurgical periodontal treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of social phobia according to the dsm-iv tr adapted for the dsm-5 * patients with cut-off score of 4 (moderately ill) in the global clinical impression (gci) rating scale * informed consent signature exclusion criteria: * patients with severe major depressive disorder at risk for suicide; substance abuse or dependence, psychotic disorders or psychotherapy treatment * patients in psychotherapy treatment * systemic alteration that precludes periodontal clinical examination

Keywords: social phobia anxiety disorders dsm-iv tr periodontal disease non surgical periodontal treatment
remote evaluation of mind diet

Conditions: Multiple Sclerosis; Cognitive Change; Nutrition, Healthy

Summary: the goal of this clinical trial is to learn if increasing adherence to a mediterranean-dash intervention for neurodegenerative delay (mind) diet pattern improves thinking ability and memory compared to a healthy control diet in persons with multiple sclerosis (ms). the main question it aims to answer is: does the mind diet improve cognitive performance relative to a control diet in persons with ms? participants will: consume one meal that follows the mind diet or a control meal every day for 3 months, complete online surveys and cognitive testing before and after, and keep a record of the food they eat during the study.

the purpose of this study is to understand how a healthy diet is related to thinking ability and memory in people with multiple sclerosis (ms). this study is fully remote consisting of meals being delivered to participant homes using daily harvest meal delivery service. participants will be asked to consume a microwaveable study meal or prepackaged smoothie every day for 12 weeks. the study meals and smoothies will follow either a dietary pattern thought to improve brain health (mediterranean-dash intervention for neurodegenerative delay; mind), or a control diet, and will include foods commonly found in grocery stores. participants will not know which diet they are assigned to (active or control). participants will also be asked to follow simple dietary guidance on a healthy diet in addition to the meals provided. participants will complete a series of online forms or surveys. additionally, participants will complete an online cognitive battery from cambridge neuropsychological test automated battery (cantab) at the beginning and end of the study.

Eligibility criteria:
inclusion criteria: 1. individuals aged 18-64 years old 2. self-reported diagnosis of multiple sclerosis (ms) 3. 20/20 or corrected vision 4. no other neurodegenerative disease diagnosis 5. stable disease-modifying therapy (dmt) within 6 months 6. not pregnant or lactating 7. no food allergies or intolerances 8. able to consume study meals 9. not enrolled in another dietary, exercise, or medication study during the study 10. access to a computer/laptop with internet exclusion criteria: 1. individuals younger than 18 or older than 64 years old 2. no self-reported diagnosis of multiple sclerosis (ms) 3. not 20/20 or uncorrected vision 4. other neurodegenerative disease diagnosis 5. disease modifying therapy (dmt) less than 6 months 6. pregnant or lactating 7. food allergies or intolerances 8. not able to consume study meals 9. enrolled in another dietary, exercise, or medication study during the study 10. no access to a computer/laptop with internet

Keywords: executive function mind dietary pattern telehealth
efficacy of 0.12% chlorhexidine gluconate for peri-implant mucositis and gingivitis

Conditions: Mucositis; Gingivitis

Summary: the purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a chemical adjuvant for the treatment of peri-implant mucositis in single implants compared with homologous teeth with gingivitis, in a non-surgical treatment protocol with a six-month follow-up.

the following clinical parameters were evaluated in both test and control groups; visible plaque index (vpi) and gingival bleeding index (gbi) were obtained for full mouth (ipv and isg) and for each implant and teeth (vpi implant; vpi teeth; gbi implant; gbi teeth). for statistical purposes, percentages of faces with biofilm and marginal bleeding at teeth and implants were calculated. these parameters were evaluated at baseline and at one, three and six months post-therapy. probing depth (pd implant; pd teeth) and bleeding on probing (bop implant; bop teeth) were collected for all implants and teeth with a north carolina periodontal probe at six sites. after data collection, an arithmetic averages of the sites with bleeding on probing and probing depths were calculated at baseline, three and six months. the peri-implant and periodontal biotype for each implant and teeth was rated as thin or thick, according to probe transparency during probing depth.

Eligibility criteria:
inclusion criteria: * systemically-healthy partially edentulous patients rehabilitated with functional dental implants and prostheses for at least 1 year; * patients had been diagnosed with peri-implant mucositis, probing depth up to 5 mm, bleeding on probing and no radiographic evidence of bone loss beyond the first two threads of the implant; * patients had been diagnosed with gingivitis in homologous teeth to implants. exclusion criteria: * non-smokers and not in maintenance therapy; * periodontal treatment during the last six months; * have not used antimicrobial (systemic or topical), anti-inflammatory or immunosuppressive drugs during the six months preceding the study.

Keywords: dental implantation chlorhexidine gluconate
effects of saline on circulation in children

Conditions: Pulmonary Hypertensive Crisis

Summary: pulmonary hypertensive crisis is a life-threatening condition, in which the blood pressure in the pulmonary artery, vein, and capillaries. infusion of hypertonic saline solutions expand the circulating volume, thus allowing more blood to flow and reducing pressure in the artery, vein, and capillaries. furthermore, infusion of hypertonic saline has been shown to reduce both systemic and pulmonary vascular resistances in adults. if the pulmonary vascular resistance decreases more or to the same degree as the systemic resistance, infusion of hypertonic saline may prove beneficial in the treatment of pulmonary hypertensive crisis. the primary objective of this study is to investigate how a clinically relevant dose of hypertonic saline affects the systemic and pulmonary circulations in children undergoing cardiac catheterization during general anesthesia. this study hypothesizes that an infusion of hypertonic saline over 10 minutes will reduce the pulmonary vascular resistance more than the systemic vascular resistance.


Eligibility criteria:
inclusion criteria: * children who have had a heart transplant and are scheduled for elective endomyocardial biopsies during general anaesthesia * age \> 2 years exclusion criteria: * plasma na \ 150 mmol/l * refusal of consent * an estimated pulmonary arterial pressure which is greater than or equal to 66% of systemic blood pressure * children with heart failure (right and/or left), i.e clinical suspicion by either a cardiologist or an anesthesiologist of inability to tolerate a fluid bolus of 3 ml/kg 7.2% nacl corresponding to an expansion of the circulatory volume by approximately 9% (see the section on safety), which is the equivalent of infusion approximately 20 ml/kg 0.9% nacl over 10 minutes.

Keywords: pulmonary hypertensive crisis pediatrics hypertonic saline
the meaning of suicidality for older persons with suicidal tendencies and their families

Conditions: Suicide; Aged; Family

Summary: the purpose of the proposed study is to examine the phenomenon of suicidality in old age and its unique characteristics. this will be performed through observing the multigenerational aging family from the life-course perspective, which enables the researchers to address life transitions, including crises leading to suicidal tendencies.


Eligibility criteria:
inclusion criteria: * hebrew speaking * suicidal * families of elderly suicides * cognitive ability exclusion criteria: * all others
improving safety of antivenom in people bitten by snakes

Conditions: Snake Bites

Summary: a study to increase the safety of polyvalent antivenom involving 1000 patients in three centres: low dose adrenaline, promethazine, \& hydrocortisone (alone and in combination) to prevent acute adverse reactions to antivenom in people bitten by snakes: randomised, double blind, placebo-controlled trial.


Eligibility criteria:
inclusion criteria: * above 12 years of age * patients admitted to hospital after snake bite in whom antivenom is indicated * patients who give informed consent exclusion criteria: * patients who are pregnant or nursing * patients who are currently taking beta- or alpha-adrenoceptor antagonists, or tricyclic antidepressants * patients in whom adrenaline may be contraindicated (this may include patients with the following: history of ischaemic heart disease, stroke, uncontrolled hypertension, and tachyarrhythmias)

Keywords: controlled trial snake bite safety antivenom
the efficacy and tolerance of tacrolimus sustained-release capsules on refractory nephrotic syndrome (rns)

Conditions: Nephrotic Syndrome

Summary: it is a pilot study to explore the efficacy and safety of tacrolimus sustained-release capsules (advagraf) on 6-month induction therapy of refractory nephrotic syndrome (rns).


Eligibility criteria:
inclusion criteria: * subjects of either sex, 14-60 years of age * diagnosis of nephrotic syndrome with hypoalbuminemia (\ 3.5g/24hr) and exclude secondary nephrotic syndrome * refractory nephrotic syndrome 1. steroid resistant: failure to respond (either complete or partial remission) after a course of 8 weeks of 1.0 mg/kg/d prednisone or equal dose of steroid therapy 2. steroid dependent: recurrence of nephrotic proteinuria during tapering of prednisone at a dose \> 10 mg/day or within the first 2 weeks after withdrawal of prednisone 3. frequently recurrence: initial remission with steroid induction therapy, but relapsed 2 or more in 6 months or 3 or more within 12 months 4. failure to respond (either complete or partial remission) even after ctx, mmf or csa therapy combined with steroid * egfr ≥ 60 ml/min/1.73 m2 * provision of written informed consent by subject or guardian exclusion criteria: * systemic disease * egfr \< 60ml/min/1.73m2 * diagnosed dm * malignant tumors (except fully cured basal cell carcinoma) * familial nephritic syndrome * history of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study * any active systemic infection or history of serious infection within one month of entry or known infection with hiv, hepatitis b, or hepatitis c * known hypersensitivity or contraindication to tacrolimus, corticosteroids * participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening * pregnancy, nursing or use of a non-reliable method of contraception * inability or unwillingness to provide written informed consent * usage of immunosuppression therapy (mmf, ctx, cysa, mtx ect) for more than 1 week within 1 month prior to first randomization or intravenous mp pulse treatment

Keywords: refractory nephrotic syndrome tacrolimus
effect of oligopin® on blood pressure.

Conditions: Blood Pressure; Hypertension

Summary: the objective of the study is to evaluate the effect of consumption of a food supplement rich in procyanidins extracted from the bark of french pine, oligopin®, on blood pressure of people with mild / moderate degree of hypertension. furthermore, the effect oligopin® consumption on markers involved in the development of hypertension, and endothelial function in key enzymes that regulate blood pressure, inflammation and oxidation are considered. also, try to advance the understanding of the molecular mechanisms that regulate blood pressure.


Eligibility criteria:
inclusion criteria: * early stages of hypertension (systolic bp ≥ 140 and ≤ 159 mm hg) and/or diastolic bp: ≥ 90 and ≤ 99 mm hg * not receiving bp-lowering medication. * obtained written informed consent before the initial screening visit. exclusion criteria: * body mass index (bmi) \> 30 kg/m2 * taking antihypertensive medications * smoking * pregnant or who intends to become pregnant * wife in breastfeeding period * persons with a self-reported history of clinical cardiovascular disease, cancer, chronic kidney disease (or a serum creatinine ≥ 1.7 mg/dl for men and ≥ 1.5 mg/dl for women) hypercholesterolemia (ldl-c ≤ 189 mg/dl, diabetes mellitus (or serum glucose ≥126 mg/dl), or consumption of more than 14 drinks of alcoholic beverages per week.
pragmatic trial comparing symptom-oriented versus routine stress testing in high-risk patients undergoing percutaneous coronary intervention

Conditions: Coronary Artery Disease With Myocardial Infarction

Summary: the primary objective of the post-pci trial is to compare the clinical outcomes of a post-percutaneous coronary intervention(pci) aggressive management strategy of routine noninvasive functional testing to a usual-care strategy of symptom-oriented functional testing in patients with high risk clinical, anatomical, and procedural characteristics who received pci with contemporary drug-eluting stent and bioresorbable vascular scaffold.


Eligibility criteria:
inclusion criteria: 1. subject was \> 19 years of age. 2. subjects who underwent successful percutaneous coronary intervention with contemporary drug eluting stent, contemporary bioresorbable scaffold or drug eluting balloon at in-stent restenosis (isr) lesion. 3. patients must have at least one of the following high-risk clinical, lesion, or procedure-related risk factors. 3-1. clinical factors; diabetes, renal insufficiency/failure, enzyme positive acute coronary syndrome (acs) (stemi or nstemi). 3-2. lesion- or procedure-related factors ; left main lesion, bifurcation lesion, ostial lesion, chronic total occlusion lesion, multivessel disease (≥ 2 vessels stented), restenotic lesion, diffuse long lesion (lesion length ≥30 mm or stent length ≥32 mm), or vein bypass graft stented 4. the patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site. exclusion criteria: 1. cardiogenic shock at the index admission 2. subject treated with only bare metal stent or balloon angioplasty during the index procedure. 3. pregnant and/or lactating women. 4. concurrent medical condition with a life expectancy of less than 1 years 5. patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. 6 subject was unable to provide written informed consent or participate in long-term follow-up.

Keywords: noninvasive stress testing high risk unstable angina pci