Kornimate/medical-research-clean huggingface dataset:
a phase i clinical study with investigational compound ltt462 in adult patients with specific advanced cancers.

Conditions: Ovarian Neoplasms; Non-Small-Cell Lung Carcinoma; Melanoma; Other Solid Tumors

Summary: a phase i study of ltt462 in patients with advanced solid tumors that harbor mapk pathway alterations.


Eligibility criteria:
inclusion criteria: * patient (male or female) ≥12 years of age * ecog (eastern cooperative oncology group) performance status ≤1 * must have progressed following standard therapy, or for whom, in the opinion of the investigator, no effective standard therapy exists, is tolerated or appropriate. * patients must be willing and able to undergo study required biopsies. * presence of at least one measurable lesion according to recist v1.1. * documented mapk pathway alteration exclusion criteria: * prior treatment with erk inhibitors. * history or current evidence of retinal vein occlusion (rvo) or current risk factors for rvo. * any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures. * patients receiving proton pump inhibitors (ppi) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study. * patients with malignant disease other than that being treated in the study. * clinically significant cardiac disease. other protocol-defined exclusion criteria may apply.

Keywords: ltt462 erk mapk solid tumor
impact of exercise training on endothelial function in cad

Conditions: Coronary Artery Disease

Summary: bradykinin has been identified to contribute to the release of nitric oxide (no), prostacyclin, and edhf through activation of specific bradykinin 2 (b2) receptors, which is finally promoting a vasodilatory respone. regular physical exercise training results in an improvement of endothelial function in patients with cad. these positive effects were partially attributed to an increased expression of endothelial no synthase (enos) and cyclooxygenase (cox) as a result of the training intervention. aim of this trial is therefore to determine, whether the training-induced correction of endothelial dysfunction is also bradykinin-dependent.

a total of 20 patients with stable coronary artery disease are prospectively randomized to 4 weeks of exercise training or sedentary lifestyle. endothelial function of the radial artery is determined by a high-resolution a-mode ultrasound.

Eligibility criteria:
inclusion criteria: * stable cad * male gender exclusion criteria: * insulin-dependent diabetes mellitus * significant valvular heart disease * smoking * exercise-induced myocardial ischemia * conditions prohibiting exercise training

Keywords: exercise training endothelial function
preventing pneumonia and other respiratory problems in persons with spinal cord injury

Conditions: Spinal Cord Injury

Summary: it is known that individuals with spinal cord injury are at increased risk for respiratory tract infections like pneumonia. part of this risk is due to weakened chest and abdominal muscles that are vital to deep breathing and the ability to cough. the purpose of this study is to look at the effectiveness of two different treatments in preventing pneumonia and other respiratory problems in persons with sci. this is a randomized controlled trial investigating the effectiveness of two different treatments. participants will be randomly assigned to one of the two treatment groups. they will not be told the details of the other intervention since this could influence or change their activities during the study.


Eligibility criteria:
inclusion criteria: * chronic spinal cord injury that occurred more than 6 months ago * an impaired ability to cough (cough peak flow less than 300 l/min) * oxygen saturation greater than or equal to 95% when awake and not receiving supplemental oxygen * end-tidal carbon dioxide level less than 43 mm hg * without a fever or other signs of an acute illness for the previous 2 weeks * able to learn the treatment protocol and have someone available at home to assist if needed to help set-up and use the equipment exclusion criteria: * under 18 years of age * currently have a tracheotomy tube * have a history of an acute illness in the last 2 weeks * have lung disease as seen on chest x-ray that results in a baseline oxygen saturation decreasing below 95% during daytime hours and cannot be normalized by usual way of coughing * already utilizing an oximetry protocol * have a significant medical complication and psychiatric condition that would interfere with the conduct of the study or interpretation of the study results.

Keywords: spinal cord injuries cough peak cough flow respiratory therapy rehabilitation
a study of baricitinib in participants with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (tnf) inhibitors with respect to venous thromboembolic events (vtes) when given to participants with rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * participants must have at least one of the following characteristics: * documented evidence of a vte prior to this study * at least 60 years of age * a body mass index (bmi) greater than or equal to 30 kilograms per meter squared (kg/m²), or * age 50 to less than 60 years and bmi 25 to less than 30 kg/m² * participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (dmard) (synthetic or biologic) exclusion criteria: * participant must not have prior use of a janus kinase (jak) inhibitor or have received more than 1 prior tnf inhibitor that was: * discontinued for ir (lack or loss of efficacy) for ra, or * discontinued for intolerance (ae) when used for any indication * participants must not be pregnant or breastfeeding * participants must not have had more than one vte * participants must not have cancer * participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness * participants must not have had a live vaccine within four weeks of study start * participants must not have participated in any other clinical trial within four weeks of study start * participants must not have a history of iv drug use, other illicit drug abuse, or chronic alcohol abuse in the past year
ima401 tcer® in recurrent and/or refractory solid tumors, alone or in combination with a checkpoint inhibitor

Conditions: Refractory Cancer; Recurrent Cancer; Solid Tumor, Adult; Cancer

Summary: primary objective: * to determine the maximum tolerated dose and/or recommended dose for extension for ima401 as monotherapy and in combination with pembrolizumab secondary objectives: * to characterize the safety and tolerability of ima401 as monotherapy and in combination with pembrolizumab * to evaluate initial anti-tumor activity of ima401 as monotherapy and in combination with pembrolizumab * to describe the pharmacokinetics of ima401 as monotherapy and in combination with pembrolizumab


Eligibility criteria:
inclusion criteria: * patients must have voluntarily signed a written icf, be able to understand and comply with clinical trial procedures * patients ≥ 18 years old * patients must have pathologically confirmed and documented advanced and/or metastatic nsclc or hnscc, other solid tumor may be considered * confirmed hla status and ima401 tumor target magea4/8 expression (imadetect®) * life expectancy \> 2 months * ecog performance status of 0 to 1 * measurable disease according to recist 1.1 * adequate baseline hematologic, renal and hepatic function; acceptable coagulation status * patients must have recurrent and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatments * the patient must have recovered from any side effects of prior therapy to grade 1 or lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo) prior to treatment start. as determined by the investigator, the patient may still be eligible if the patient has not fully recovered from grade ≥ 2 toxicities, in case if these toxicities are not anticipated to further improve (e.g., chronic peripheral neuropathy) and such toxicities are not anticipated to worsen with the ima401 therapy exclusion criteria: * other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed) * history of hypersensitivity to components of ima401, cpi treatment or rescue medications, contraindication for pembrolizumab * patients with prior allogeneic stem cell transplantation or organ transplantation * patients with autoimmune diseases needing disease-directed treatment * any serious or uncontrolled health condition, which, in the opinion of the investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results * positive for hiv or with active hepatitis b or c infection. * patients with active infection * systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) received 2 weeks prior to starting trial treatment * patients with active brain metastases and leptomeningeal metastases
registry of subjects with drug resistant epilepsy and treated with the vns therapy system.

Conditions: Epilepsy; Seizures; Drug Resistant Epilepsy

Summary: multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the vns therapy system.

the purpose of this registry is to evaluate clinical outcome and safety data in subjects with drug resistant epilepsy treated with the vns therapy system. the study will collect outcomes for subjects treated with vns therapy in a real-world setting.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of drug resistant epilepsy treated with vns therapy. eligible subjects include those not previously treated with vns therapy as well as subjects receiving replacement generators. * able and willing to comply with the frequency of study visits. * subject, or legal guardian, understands study procedures and voluntarily signs an informed consent in accordance with institutional policies. in the event that the subject is under the age of 18, the subject may also be required (per ec/irb) to sign an assent affirming their agreement to participate. exclusion criteria: • there are no exclusion criteria in this study. investigators should refer to the local instructions for use for vns therapy.

Keywords: vns vns therapy vagus nerve stimulation
post-instrumentation pain after use of the fanta and m3 pro gold systems

Conditions: Endodontic Treatment

Summary: comparing the intensity of post-operative pain following endodontic treatment of posterior teeth with fanta (pepsi gold) (fpg) and m3-pro+ gold (assorted) (mpg) rotary files.


Eligibility criteria:
inclusion criteria: * 20-50 years old * no systemic diseases * mandibular first molar * asymptomatic tooth * normal periapical film * restorable teeth * periodontal scoring index \<2 exclusion criteria: * age \ 50 * systemic disorders * articaine allergy * inability to take paracetamol. * pregnancy or nursing * symptomatic pulpitis. * pulp necrosis * pdl is widening. * periapical radiolucency * the sinus tract * periapical abscesses. * existence of resorption * tooth malposition. * fixed partial dentures. * analgesics intake in the last 12 hours.
effects of low and high intensity exercise in improving working memory among students with anxiety symptoms

Conditions: Aerobic Exercise

Summary: anxiety levels among the younger generation especially students have been increasing drastically in recent years. this severely affects a student's academics as previous studies have shown a strong correlation between high anxiety levels and poor working memory. working memory, also known as short term memory is an important component in studying as it aids in holding important information needed to understand following information for a short period of time. this concerning phenomenon has drawn the attention of researchers to find solutions to this issue where recent studies have found physical exercise to contribute in the improvement of cognition which also includes working memory. hence, the aim of this study is to compare the effects of low and high intensity exercises on working memory among students with high anxiety levels. thirty female undergraduate students from utar with relatively high levels of anxiety will be conveniently sampled using beck anxiety inventory. participants will then be randomly allocated into 2 groups to undergo low and high intensity exercise on a treadmill according to balke's protocol. 2 memory assessments involving verbal memory task will be conducted for each participant before and after the intervention.


Eligibility criteria:
inclusion criteria: * female students (age group: 18-25 years) * participants with mild to severe anxiety levels (score of \>8) exclusion criteria: * participants with cardiorespiratory problems (e.g. asthma, congestive heart disorders) or severe musculoskeletal problems that prevent them from carrying out any physical exercise or advised by personal physician not to. * participants that have had a recent head injury (recent 5 years)
post-authorization safety study of euforvac-hib vaccine for active primary immunization in infants from 6 weeks

Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenza Type B

Summary: a multicenter, observational study to evaluate the safety of euforvac-hib vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis b and haemophilus influenza type b in infants.

euforvac-hib vaccine manufactured by lg life science in korea, but it's not marketed in korea. it is distributed to un agencies in diverse countries. thus, who recommended lg life science to conduct the safety study for assessing the vaccine safety if euforvac-hib is prequalified. the objectives of this safety study are to identify any problems and questionable issues likely to emerge from the actual use of euforvac-hib vaccine after launching in the market.

Eligibility criteria:
inclusion criteria: 1. patients who had been signed informed consent by subjects legally acceptable representative 2. infant from 6 weeks of age.who is given this vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis b and haemophilus influenza type b exclusion criteria: 1. patients with hypersensitivity to any component for the vaccine 2. patients who had a severe reaction to a previous dose of the combination vaccine or any of its constituents is absolute contraindication to subsequent doses of the combination vaccine. 3. patients who had pertussis, encephalopathy or other serious neurological abnormality in the newborn period
study on osseospeed™ tx implants in the upper jaw in a chinese population

Conditions: Partially Edentulous Jaw

Summary: the purpose of this study is to investigate the clinical efficacy of osseospeed™ tx implants in a chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior maxilla up to 3 years after loading. hypothesis: early loading of the posterior maxilla is a safe and predictable procedure.


Eligibility criteria:
inclusion criteria: 1. provision of informed consent 2. aged 20-75 years at enrollment 3. history of edentulism in the posterior maxilla, kennedy classes i or ii, of at least four months. last natural tooth in function is canine or first bicuspid. 4. neighboring tooth to the planned bridge must have natural root. 5. presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge. 6. deemed by the investigator to have adequate bone height and a bone width of minimum 5.5 mm. 7. deemed by the investigator as likely to present an initially stable implant situation exclusion criteria: 1. unlikely to be able to comply with study procedures, as judged by the investigator 2. earlier graft procedures in the study area 3. current need for pre-surgical bone or soft tissue augmentation in the planned implant area. 4. uncontrolled pathologic processes in the oral cavity 5. known or suspected current malignancy 6. history of radiation therapy in the head and neck region 7. history of chemotherapy within 5 years prior to surgery 8. systemic or local disease or condition that could compromise post-operative healing and/or osseointegration 9. uncontrolled diabetes mellitus 10. corticosteroids or any other medication that could influence post-operative healing and/or osseointegration 11. smoking more than 10 cigarettes/day 12. present alcohol and/or drug abuse 13. involvement in the planning and conduct of the study (applies to both astra tech staff and staff at the study site) 14. previous enrollment in the present study. 15. simultaneous participation in another clinical study or participation in a clinical study during the last 6 months. 16. subjects that are unable to give informed consent
4-d visualization using magnetic resonance imaging (mri) in the congenital heart disease population

Conditions: Congenital Heart Disease

Summary: in this study, the investigators wish to use images obtained from standard of care cardiac mri's performed at children's healthcare of atlanta and transfer the images to a different computer in order to analyze them with a new computer. the investigators are hoping to better their understanding and management of complex congenital heart disease.

all patients enrolled in this study will be receiving standard of care cardiac mri as prescribed by their physician. these mri dicom images will be transferred to a sgi fuel workstation, where they will be manipulated using the newly developed 4-d visualization software. no additional scanner time or new imaging sequences are required as presently prescribed sequences and produced data can be analyzed. the workstation is designed to include acceleration hardware for volume rendering, and was developed for advanced cardiac mri viewing.

Eligibility criteria:
inclusion criteria: * scheduled for a cardiac mri at children's healthcare of atlanta * informed consent * meet mri eligibility inclusion criteria exclusion criteria: * not having a cardiac mri * no informed consent * not meeting mri eligibility exclusion criteria

Keywords: pediatric, cardiology, diagnostic imaging using mri
dextenza for the treatment of pain and inflammation following surgical trabeculectomy and ahmed valve procedures

Conditions: Glaucoma Following Surgery

Summary: this is a prospective, comparative, open-label, single-center, randomized, investigator-sponsored clinical study and seeks to investigate clinical outcomes with standard of care and high dose dextenza treatment compared to standard of care topical dexamethasone in patients undergoing trabeculectomy, trabeculectomy ex-press, xen gel stent, and ahmed valve surgery. patients will be followed through 6 months. after screening a given patient for inclusion and exclusion criteria, and gaining informed consent, eyes of n=30 patients will be randomized to one of the following two groups (n=15per group) and followed from baseline through month 6.


Eligibility criteria:
inclusion criteria: * able to provide signed written consent prior to participation in any study-related procedures * patient is diagnosed with glaucoma and undergoing trabeculectomy, trabeculectomy ex-press, xen gel stent, or ahmed valve surgery exclusion criteria: * have used topical corticosteroid treatment up to 48 hours prior to the baseline visit * have used oral corticosteroid within the past 14 days prior to baseline visit (patients using stable doses of inhaled corticosteroids for 30 days prior to baseline visit can be included in the study) * have received intravitreal or sub-tenon corticosteroid treatment prior to baseline visit or ozurdex ® in the study eye within the 6 months prior to the baseline visit * are currently using prescribed nonsteroidal anti-inflammatory agents or prescribed immunosuppressive agents, unless the dose has been stable for the last 6 weeks and no change in dosing is anticipated for the duration of the study * are pregnant or lactating female, or female of childbearing age using inadequate birth control method * have participated in another investigational device or drug study within 30 days of the baseline visit * anterior chamber cells present at time of enrollment * known allergy to dexamethasone or prednisolone
comparative effects of milk thistle extract with vitamin-e in hemodialysis patients

Conditions: Hemodialysis; End Stage Renal Disease

Summary: for end-stage renal disease (esrd) patients, cardiovascular disease remains the single most common cause of excess morbidity and mortality. among the examined nontraditional risk factors, an increase in oxidative stress as well as inflammation are postulated to contribute to excessive cardiovascular risk in this population. flavonoids are naturally occurring substances that possess various pharmacological actions and therapeutic applications. some due to their phenolic structures have antioxidant effect and inhibit free radical-mediated processes, as well as anti-inflammatory effects. silymarin,a mixture of three isomeric flavonolignans, is isolated from milk thistle (silybum marianum) seeds, and is proven to have anti-oxidant, anti-inflammatory, cell regenerating, and antifibrotic action. in this study, the effect of silymarin on oxidative stress and inflammation (2 major risk factors for cardiovascular morbidity and mortality in hemodialysis patients)is evaluated, and compared to vit e, a well known antioxidant.


Eligibility criteria:
inclusion criteria: * all hemodialysis patients age 18-60 * on hemodialysis for over 3 months, 3 times a week, and for 4 hours each time * signed informed consent exclusion criteria: * heart failure nyha class iii or iv * recent mi (within 1 year) * use of anti-oxidant supplements: n-acetyl-cystein, omega 3, vit c, vit e, green tea, soy extracts, pomegranate extract, grape extract.. * hepatitis b or c * active infection * psychiatric illness * active malignancy

Keywords: hemodialysis oxidative stress plasma malondialdehyde glutathion peroxidase