Kornimate/medical-research-clean huggingface dataset:
assessment of an anemia model predictive controller for anemia management in hemodialysis patients

Conditions: End Stage Renal Disease; Renal Anemia; Chronic Kidney Diseases

Summary: the purpose of this randomized, controlled pilot study is to evaluate the performance of this novel anemia controller (vis-à-vis standard of care) for anemia management in hemodialysis patients. since the anemia controller is designed to bring patients to a pre-defined hgb target level and keep them there, the target population for this study are patients whose hgb levels are currently not well-controlled (rather than patients who are already relatively stable within the hgb target range under a standard anemia management algorithm). specifically, therefore, the target population for this clinical study are chronic hemodialysis patients who are exhibiting hgb cycling.


Eligibility criteria:
inclusion criteria: * age ≥18 years * ability to give written informed consent to the study * end-stage renal disease treated with thrice-weekly hemodialysis for at least 180 days preceding enrollment * receiving intradialytic crit-line® monitoring, with available crit-line® data going back at least 180 days from the date of enrollment * laboratory hgb data going back at least 180 days from the date of enrollment * on average, hgb values available from at least 2 treatments per week (from either source, crit-line® or laboratory) during the past 180 days preceding enrollment * renal anemia treated with intravenous mircera®, with at least 2 mircera® dose administrations during the 150 days preceding enrollment * on an active mircera® anemia management algorithm order during the 180 days preceding enrollment * exclusively on mircera® (no other esas) during the 180 days preceding enrollment * pattern of hgb cycling as defined above during the 180 days preceding enrollment exclusion criteria: * having received the maximum mircera® dose (225 µg every other week) consistently throughout the 90 days preceding enrollment * hospitalization for more than 10 days during the 30 days preceding enrollment * severe iron deficiency (tsat \<20%, ferritin \<100 ng/ml) in the most recent routine blood work prior to enrollment * any known cause of esa resistance other than iron deficiency and inflammatory states (e.g. hematologic malignancies, hypersplenism, antibody mediated pure red cell aplasia) * simultaneous participation in another clinical study that may impact anemia management or the outcomes of this trial * inability to communicate in english or spanish
a trial of shr-7367 in subjects with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a dose-escalation and dose-expansion phase 1 trial to evaluate the safety and tolerability of shr-7367 in subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. ability to understand and voluntarily agrees to participate by giving written informed consent for the study; 2. male or female aged ≥18 years and ≤75 years at the time of signing the icf; 3. histopathologically or cytologically documented advanced or metastatic malignancies; 4. at least 1 measurable lesion conforming to recist 1.1 criteria; 5. an eastern cooperative oncology group (ecog) performance status (ps) score of 0 or 1; 6. female and male patients of reproductive potential must agree to use highly effective contraception. exclusion criteria: 1. any immunostimulants administered within 4 weeks; 2. systemic anti-tumor therapy within 4 weeks; 3. any investigational cancer therapy administered within 4 weeks; 4. surgical procedures requiring general anesthesia within 4 weeks; 5. history of autoimmune diseases; 6. history of immunodeficiency; 7. severe infections within 2 weeks prior to the first study treatment; 8. clinically significant cardiovascular condition; 9. prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment; 10. known history of serious allergic reactions to the investigational product or its main ingredients.
efficacy of peg-400 and systane artificial tears (alcon) on quality of vision

Conditions: Myopia

Summary: to evaluate the effect of peg-400 and systane on quality of vision after lasik.


Eligibility criteria:
inclusion criteria: * males or females \> 21 years old * scheduled to undergo bilateral lasik * likely to complete all study visits and able to provide informed consent exclusion criteria: * prior or current use of topical cyclosporine within the last 1 year * known contraindications to any study medication or ingredients * ocular disorders * active ocular diseases or uncontrolled systemic disease * active ocular allergies * complications at the time of surgery

Keywords: quality of vision
effect of olive leaf extracts on endothelial dysfunction in patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome (ACS); Reactive Hyperemia; Endothelial Dysfunction

Summary: the study aims to examine the short-term (30 days) effects of olive leaf extract on endothelial function in patients with acute coronary syndrome (acs). this investigation will be conducted on patients admitted to the emergency department for acs. all participants will be screened and included within 24 hours post-acs event and prior to discharge from the emergency department.


Eligibility criteria:
inclusion criteria: age over 18 years. patients presenting with st-segment alterations at rest, including st elevation, with or without troponin elevation. patients who have not undergone surgery or have no additional primary percutaneous coronary intervention (p-pci) planned within 8 weeks from the initial p-pci. patients who provide informed consent. patients available for and willing to adhere to follow-up procedures. patients without significant cognitive impairment. patients with a life expectancy of at least 2 years. exclusion criteria: * severe lv hypertrophy (\>15 mm); * patients with any evidence of inflammatory or malignant disease. * patient having valvular heart disease, pacemaker; cardiogenic shock * patient having any serious non-cardiac disease associated with a life expectancy \<1 year * patients undergoing surgery within 30 days * patient having gastrointestinal disorder such as crohn's disease

Keywords: acute conary syndrome endothelial dysfunction olive leaf extract
interpersonal psychotherapy for depressed adolescents engaging in non-suicidal self-injury

Conditions: Depression; Self-injurious Behavior

Summary: the purpose of this study is to examine the feasibility of using interpersonal psychotherapy for depressed adolescents (ipt-a) to treat adolescents who are experiencing symptoms of depression and are engaging in non-suicidal self-injurious behaviors. the trial will include recruiting 10 particpants, administering 12-sessions of individual ipt-a, and determining how the ipt-a protocol needs to be amended to adequately address the self-injury in addition to depression.

engagement in non-suicidal self-injury (nssi), purposefully harming oneself without the conscious intent to die such as cutting or burning, is pervasive among adolescents. lifetime prevalence estimates among community samples of high school students range from 13.0% to 23.2%. despite the significance of this public health problem, there are no known interventions that successfully reduce the frequency of nssi or prevent nssi in adolescents. the goal of the current study is to develop an effective psychosocial intervention for nssi among adolescents who are engaging in self-injury and have a depressive disorder. specifically, we will amend interpersonal psychotherapy for depressed adolescents (ipt-a), a psychotherapy that has demonstrated efficacy in treating depressed adolescents (mufson et al., 1994, 1999, 2004), for use with adolescents with depression who are engaging in nssi, with the ultimate goal of curing the depression and nssi. ten participants will be administered ipt-a and assessed several times throughout the course of the trial. it is expected that ipt-a will be a useful treatment for co-morbid depression and self-injury, although adaptations to the protocol will likely be needed to address the behavioral aspect of the self-injury. data analyses will be descriptive in nature and involve examining the individual trajectories of depression and nssi over time. the data obtained from the current study will lay the groundwork for an ultimate randomized controlled trial in which we plan to compare ipt-a versus nondirective supportive therapy in the treatment of co-morbid depression and nssi.

Eligibility criteria:
inclusion criteria: 1. 12 to 18 years of age 2. diagnosis of mdd, dysthymic disorder, depressive disorder nos, adjustment disorder with depressed mood 3. non-suicidal self-injurious behavior 4. cdrs \>= 36 5. c-gas \<= 65 6. english speaking patient 7. one english speaking caregiver - exclusion criteria: 1. suicide attempt within past 6 months or actively suicidal 2. severe incident of non-suicidal self-injury in past 3 months 3. severe episode of mdd 4. treatment resistant non-suicidal self-injury 5. frequent non-suicidal self-injury 6. mentally retarded 7. current diagnosis of: ptsd, ocd, schizophrenia, bipolar disorder, psychosis, substance dependence, adhd 8. current substance use 9. currently in active treatment for same condition 10. currently taking antidepressant medication 11. medical illness likely to interfere with treatment -

Keywords: self-injurious behavior depression adolescents psychotherapy
d4t or abacavir plus vitamin enhancement in hiv-infected patients (dave)

Conditions: Acidosis, Lactic

Summary: the purpose of this study is to determine the best way to treat people on d4t (stavudine) with high levels of lactic acid. switching from d4t to abacavir will be assessed. adding riboflavin and thiamine will also be assessed. participants will be randomly assigned to one of four groups: * group 1 participants will continue to take d4t as part of their antiretroviral (arv) regimen, and will be given the vitamin supplements * group 2 will continue to take d4t without vitamin supplements * group 3 will switch from d4t to abacavir and receive the vitamins * group 4 will switch from d4t to abacavir without vitamin supplements. the study plans to involve eighty participants from canada and argentina for a treatment period of 16 weeks and a follow-up visit at week 24.


Eligibility criteria:
inclusion criteria: * be hiv-positive * be 18 years of age or older * have a viral load equal to or below 50 copies/ml * have been on a d4t-containing multiple drug regimen (at least three agents in total) for at least six months * have been on a stable arv regimen for the three months prior to enrollment * have a venous lactic acid measurement above 2.1 mmol/l within the three months prior to enrollment and two consecutive measurements above 2.1 but lower than 6.0 within a two-week period of screening * be willing to discontinue l-carnitine and/or coenzyme q10 * be willing and able to provide informed consent exclusion criteria: * pregnancy or breastfeeding * venous lactic acid equal to or above 6.0 mmol/l * previous exposure to abacavir * virologic rebound while on a previous regimen consisting of dual or triple nucleoside reverse transcriptase inhibitors (nrtis) * use of hydroxyurea within the three months prior to enrollment * use of metformin * any acute cardiopulmonary illness or infection * new aids-defining illness diagnosed within four weeks of enrollment * riboflavin or thiamine supplementation above 20 mg/day within 30 days prior to enrollment

Keywords: elevated lactic acid
study of ati-2138 in adult participants with moderate to severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a phase 2 open label study of ati-2138 in participants with moderate to severe atopic dermatitis.

this open-label, single-arm study of ati-2138 in moderate to severe ad participants between the ages of 18 and 60 years (inclusive) will investigate the safety, tolerability, pharmacokinetics, efficacy and pharmacodynamics of ati-2138 administered over 12 weeks.

Eligibility criteria:
inclusion criteria: * able to comprehend and willing to sign the irb approved icf/assent prior to administration of study-related procedures. * male patients or non-pregnant, non-nursing female patients 18 to 60 years old, inclusive, at the time of informed consent/assent. * have at least a 1-year history of moderate or severe ad prior to the screening visit, and no significant ad flares for the 4 weeks prior to the screening visit as determined by the investigator upon review of participant medical history. exclusion criteria: * any prior exposure to systemic (oral) jak inhibitors or tyk inhibitors at any time prior to screening. * unstable course of ad (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the screening period. * refractory ad (ie, ad that required frequent hospitalizations and/or frequent intravenous treatment for skin infections within the year before the screening visit). * concomitant skin disease or clinically infected ad or presence of other skin disease in the area to be dosed that may interfere with study assessments. * female patients who are pregnant, nursing, or planning to become pregnant during the study.

Keywords: eczema dermatitis dermatitis, atopic skin diseases, eczematous skin diseases
post study continuation of c7 for g1d

Conditions: Glut1 Deficiency Syndrome; Glucose Transporter Type 1 Deficiency Syndrome

Summary: this protocol provides ongoing access to triheptanoin for patients who did complete an initial pilot protocol, and provides the opportunity to collect long-term safety data from patients treated with triheptanoin.

only patients who completed the initial pilot study were eligible. the study is ongoing with these patients only.

Eligibility criteria:
inclusion criteria: * patients enrolled in the pilot trial (utsw 122010-186) exclusion criteria: * subjects who did not complete the pilot trial (utsw 122010-186)

Keywords: g1d glut1 deficiency glucose transporter type 1 deficiency glucose transporter type i deficiency
stereotactic radiosurgery or other local ablation then erlotinib in epidermal growth factor receptor (egfr)

Conditions: Non Small Cell Lung Cancer

Summary: - progression free survival after locally ablative therapy and erlotinib in egfr patients progressed after egfr-tki therapy

primary objectives - to estimate progression free survival (pfs) after locally ablative therapy and erlotinib in egfr-mutant nsclc patients who progressed on prior egfr-tki therapy secondary objectives * to evaluate local control of sites previously progressive on erlotinib following stereotactic radiosurgery (srs) followed by erlotinib * to estimate overall survival (os) after locally ablative therapy and erlotinib in egfr-mutant nsclc patients who progressed on prior egfr-tki therapy * to characterize the toxicity of srs * to characterize the toxicity of erlotinib when preceded by srs exploratory objectives * to explore if veristrat results at initial progression are associated with longer pfs or os after study treatment * to explore if veristrat results following completion of srs are associated with longer pfs or os after re-initiation of erlotinib * to explore whether "poor" veristrat signatures ever turn to "good" signatures with the study therapy, and to explore pfs and os of patients whose signature changes

Eligibility criteria:
inclusion criteria: * written informed consent * 18 years of age or older * histologically or cytologically confirmed stge iv egfr-mutant nsclc * history of previous response to egfr-tki defined by a recist 1.1 criteria * progressive disease following egfr-tki therapy * eastern cooperative oncology group (ecog) performance status 0 or 1 * adequate organ and marrow function * negative urine or serum pregnancy test for female patients * patients who can have children must agree to adequate contraception exclusion criteria: * unresolved chronic toxicities greater than 2, measured by ctcae v4 * treatment with any fda approved or experimental cancer treatment following progression on egfr-tki * any history of previous greater than grade 3 toxicity attributable to erlotinib * pregnant or lactating female * any previous radiation to sites of planned stereostatic radiosurgery * history of another malignancy * concomitant anticancer therapy, immunotherapy, or radiation therapy (within 4 weeks) * evidence of severe or uncontrolled systemic diseases * known hypersensitivity reaction or idiosyncrasy to erlotinib * psychological, familial, sociological, or geographical conditions * any other condition in investigator's opinion jeopardize compliance with protocol

Keywords: non small cell lung cancer egfr mutant phase ii erlotinib tarceva cyberknife lineberger
pcv13 impact on pneumococcal nasopharyngeal carriage study

Conditions: Community-acquired Pneumonia

Summary: prospective, observational, hospital based, nasopharyngeal carriage (npc), vaccine effectiveness study comparisons will be made in filipino children, aged 8 weeks to ≤60 months of age at enrollment, who have been hospitalized with a radiologically-confirmed, community-acquired pneumonia (cap).

this study will be the first of two phases (a and b). phase a will compare a pcv13-vaccinated setting (spmc) with an unvaccinated setting (pcmc)

Eligibility criteria:
inclusion criteria: 1. child 8 weeks to ≤60 months of age 2. resident of the national capital region (ncr) or region x-xiii 3. child admitted with a medical diagnosis of clinical cap based on history and physical exam 4. written informed consent obtained from a parent or legal guardian 5. at spmc site, child must have received at least 1 dose of pcv13 given at \<12 months based on history-taking 6. for phase b at pcmc site, child must have received at least 1 dose of pcv13 given at \<12 months based on history-taking exclusion criteria: 1. children with a known primary or secondary immunodeficiency 2. child with a contraindication to doing a nasopharyngeal swab which may include, but is not limited to: dyscrasias, coagulation disorders, or other diseases (e.g., hemophilia, purpura), presence of craniofacial abnormalities32 3. for phase a at pcmc site, child with any pcv in the past based on history-taking

Keywords: clinical cap
short vs long dental implants for the fixed rehabilitation of the fully edentulous mandible

Conditions: Edentulous Jaw

Summary: the aim of this study is to clinically and radiographically compare the performance of short (6 mm-long) versus long (≥11 mm-long) dental implants placed in the interforaminal region of fully edentulous mandibles, supporting a screw-retained full-arch cantilever bridge.

the use of short dental implants provides undeniable benefits in sites where the reduced available volume would otherwise need bone augmentation procedures and their use has greatly expanded in the recent years. however, well designed clinical trials which provide a sound evidence of their performance and reliability are still lacking to date. in this post-market, multi-center, open, parallel-group, randomized, controlled clinical trial the investigators aim to to clinically and radiographically compare the performance of short (6 mm-long) versus long (≥11 mm-long) dental implants supporting a mandibular screw-retained full-arch cantilever bridge. five 4mm-wide/6mm-long (test) or 4mm-wide/≥11mm-long (control) titanium dental implants (osseospeed™, astra tech implant system™, dentsply sirona) are placed in the interforaminal region of fully edentulous mandibles, in non-regenerated sites, with at least 1 mm of peri-implant bone circumferentially. all products are ce (european conformity) marked and used within their intended use. two-stage surgery is performed, implants are positioned in healed bone and exposed after 3 months to be connected with the prosthesis. this is a medium-term follow-up study including evaluations also at 1 and 3 years from the baseline. three italian centers participate: naples (university of campania "luigi vanvitelli"), naples (aorn "a. cardarelli"), catania (private office). the study protocol has been approved by the institutional review board of the university of campania "luigi vanvitelli".

Eligibility criteria:
inclusion criteria: * total edentulous patients in the lower region since at least 8 months, * sufficient amount of native bone (no augmentation procedures) in the recipient sites to allow ≥11 mm long and 4 mm wide implant installation (≥1 mm of peri-implant bone circumferentially) * systemic health * compliance with good oral hygiene * informed consent signed. exclusion criteria: * any disease, medication or drug that could jeopardize healing, osseointegration or treatment outcome, * untreated caries or periodontitis of the remaining teeth, * mucosal and bone tissue lesions, * severe bruxism or other parafunction habits, * unrealistic aesthetic demands, * patient taking part to another study

Keywords: short dental implants full-arch prosthesis
a clinical trial to assess the safety and the anti-caries efficacy of col 101 (arginine) non-fluoride dentifrices in comparison with 0.24% sodium fluoride (1100 ppm f) dentifrice control in 10 to 14-year-old children

Conditions: Dental Caries

Summary: the objective of this study is to assess the safety and to evaluate the anti-caries efficacy of col101 (arginine) non-fluoride dentifrices compared to a 0.24% sodium fluoride dentifrice in 10-14 year-old children over a one year period.


Eligibility criteria:
inclusion criteria: * subjects meeting all criteria below will be included in the study: 1. subject assent and parental/guardian informed consent for voluntary participation. 2. willingness and ability to use the assigned products according to instructions, availability for all appointments and likelihood of completing the clinical trial. 3. children ages 10-14 years at baseline. 4. presence of permanent second molars or evidence of at least one permanent second molar erupting as indicated by cuspal break through the mucosa. 5. good general health as evidenced by a review of the medical history. 6. subjects who, at study entry, have present two or more active caries lesions (icdas scores of 2 or greater) in permanent teeth and previous caries experience (dmft \>1), d= decayed is defined as icdas scores of 3 or greater exclusion criteria: * subjects presenting any of the criteria below will be excluded from the study: 1. presence of fixed or removable prosthetic appliance or orthodontic treatment involving more than four permanent teeth. 2. use of medication that could increase the risk of developing dental caries, i.e. medications that reduce saliva flow and those with high sugar content. 3. long-term antibiotic therapy. 4. children with a confirmed diagnosis of cognitive and/or motor impairment. 5. severe malocclusion. 6. subjects who, at study entry, have present severe caries (icdas 5 or 6) on five or more permanent teeth. 7. evidence of moderate to severe periodontal disease. 8. participation in any other clinical study within the 30 days preceding the start of the clinical study. 9. known history of allergies or other adverse reactions to arginine, or oral care products, or their ingredients. 10. self-reported history of being currently pregnant, intending to become pregnant during the trial period or breast-feeding.

Keywords: fluoride arginine prevention caries icdas dmfs