Kornimate/medical-research-clean huggingface dataset:
observational national vaccine study

Conditions: COVID-19 Infection

Summary: to assess the long-term safety of turkovac in individuals who have not previously received the covid-19 vaccine or who have received their primary vaccination with inactivated or mrna vaccine, or who have received their primary vaccination with similarly inactivated or mrna vaccine and who subsequently received the first dose or second dose of booster vaccine, who meet the inclusion/exclusion criteria of the study.

the primary objective of the study was to evaluate the long-term safety of turkovac in individuals who had never received a covid-19 vaccine before, or who received their primary vaccination with inactivated or mrna vaccine, or who received their primary vaccination with similarly inactivated or mrna vaccine, and who subsequently received a first dose or second dose of booster vaccine, in individuals who met the inclusion/exclusion criteria of the study. the secondary objective of the study was to evaluate the immunogenicity of turkovac in individuals who meet the inclusion/exclusion criteria of the study.

Eligibility criteria:
inclusion criteria: * subjects who meet all of the following criteria will be included in the study: 1. individuals aged 18 and over, 2. individuals who have never had a covid-19 vaccine before or who have received covid-19 mrna or inactivated vaccines in the primary vaccination and have selected turkovac as the booster dose (3rd dose and 4th dose), 3. individuals who have not had covid-19 during the last trimester, 4. only for subjects who will receive 4th dose of vaccine: those who have received the third dose of turkovac vaccine and those who have spent at least 90 days since the third dose, 5. individuals who agree to provide blood samples and verifiable identification information (in accordance with local regulations), who may be contacted by the investigator during the study and who may come into contact with the investigator, 6. individuals who will be able to voluntarily understand and sign informed consent, 7. individuals who accept phone calls to be made to them for the purpose of collecting safety-related data. exclusion criteria: * subjects who meet one of the following criteria will be excluded from the study. 1. for subjects who will receive primary vaccination: individuals who have received any vaccine and/or flu vaccine within 14 days prior to the covid-19 vaccine. 2. individuals who have chosen a vaccine other than turkovac as a booster dose.

Keywords: covid-19 effectiveness immunogenicity safety observational
efficacy of osteopathic visceral treatment in patients with chronic neck pain

Conditions: Cervical Pain

Summary: this study aims to analyze the effects of visceral osteopathic treatment of the diaphragm, stomach and liver in the treatment of chronic neck pain.

cervical pain is a very common condition, whom can originate from bad posture, cervical tension, anxiety, depression and occupational or sportive activities. the influence of mobility and function changes of the abdominal viscera in the cervical region is a mechanism that is still poorly described in literature. it is expected to find, through mechanical and neural pathways, that the visceral osteopathy treatment will have some effect on chronic neck pain. this study intends to check the effects of the diaphragm stretching, inferior mobilization of the stomach and liver pump techniques (restoring mobility and normalizing function of the viscera) on the neck region, by employing some questionnaires/instruments. during the present study, the effects of the visceral techniques will be analyzed in the following variables: neck disability index (ndi), numeric pain scale (nps or end) and global pain scale (gps or epgm).

Eligibility criteria:
inclusion criteria: * pain in the posterior cervical region for more than 3 months; * knowing how to read and write; exclusion criteria: * recent cervicothoracic or thoracoabdominal trauma (less than 6 months); * surgical procedure in the cervical region less than 6 months ago * surgical procedure in the abdominal region less than 6 months ago; * diagnosis of disc disease/radiculopathy; * rheumatic and/or neurological disease; * pregnancy status

Keywords: chronic neck pain diaphragm manual therapy osteopathy visceral techniques
conditioning regimens for patients with severe aplastic anemia transplanted with marrow from an unrelated donor

Conditions: Anemia, Aplastic

Summary: a single arm dose optimization study in which all patients are given a fixed dose of cytoxan (4 x 50 mg/kg) plus atg (3 x 30 mg/kg) and the tbi dose starting at 3 x 200 cgy is escalated or de-escalated dependent upon engraftment and toxicity.


Eligibility criteria:
inclusion criteria: * life-threatening marrow failure of nonmalignant etiology; * failure to respond to the best available immunosuppressive treatment; * lack of a hla-identical family member exclusion criteria: * severe disease other than aplastic anemia that would severly limit the probability of survival during the graft procedure; * hiv seropositive patients; * clonal abnormalities or myelodysplastic syndrome;
a study of mbg453 in combination with azacitidine and venetoclax in aml patients unfit for chemotherapy

Conditions: Acute Myeloid Leukemia

Summary: this trial will seek to extend the preliminary findings of efficacy of mbg453 in combination with hypomethylating agents (hma) by evaluating mbg453 in combination with the hma azacitidine and the bcl-2 inhibitor venetoclax.

the primary purpose of part 1 (safety run-in) is to rule out excessive toxicity of mbg453, when administered in combination with azacitidine and venetoclax. the primary purpose of the combined part 1 and part 2 (safety run-in and expansion part) is to evaluate efficacy of mbg453, when administered in combination with azacitidine and venetoclax in adult patients with newly diagnosed aml, who are not suitable for treatment with intensive chemotherapy. there will be an analyis of the cr rate, after all subjects have completed at least 12 cycles of treatment ( cycle =28days) or discontinued earlier.

Eligibility criteria:
inclusion criteria: 1. signed informed consent must be obtained prior to participation in the study. 2. age ≥ 18 years at the date of signing the informed consent form (icf) 3. newly diagnosed with aml based on 2016 who classification (arber et al 2016) and not suitable for intensive chemotherapy defined as: age ≥75, ecog performance status 2 or 3, or any of the following comomorbitities: severe cardiac comorbities (including congestive heart failure, lvef ≤ 50%, chronic stable angina) , pulmonary comorbidity (dlco ≤ 65% or fevi ≤ 65%). moderate hepatic impairment (with total bilirubin \>1.5 to 3x uln) , renal impairment (egfr≥ 30 ml/min/1.73m\^2 to 45 30 ml/min/1.73m\^2), or other comorbidity incompatible with intensive chemotherapy per investigator assessement and approved by the novartis medical monitor) 4. .not planned for hematopoietic stem-cell transplantation (hsct) 5. .eastern cooperative oncology group (ecog) performance status of 0, 1 , 2 or 3 exclusion criteria: 1. prior exposure to tim-3 directed therapy 2. history of severe hypersensitivity reactions to any ingredient of study drug(s) (azacitidine, venetoclax or mgb453) or monoclonal antibodies (mabs) and/or their excipients 3. current use or use within 14 days prior to randomization of systemic, steroid therapy (\> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy. topical, inhaled, nasal, ophthalmic steroids are allowed. replacement therapy, steroids given in the context of a transfusion are allowed and not considered a form of systemic treatment. 4. previous treatment at any time, with any of the following antineoplastic agents, approved or investigational; checkpoint inhibitors, venetoclax and hypomethylating agents (hmas) such as decitabine or azacitidine. 5. active autoimmune disease requiring systemic therapy (e.g.corticosteroids). 6. live vaccine administered within 30 days prior to randomization other protocol-defined inclusion/exclusion may apply.

Keywords: mbg453 venetoclax azacitidine phase 2 aml acute myeloid leukemia sabatolimab
zirconia versus lithium di-silicate overlays for restoring hypomineralized molars affected with mih

Conditions: Molar Incisor Hypomineralization

Summary: the study evaluate the clinical outcome of zirconia versus lithium disilicate overlays restorations for restoring vital young permanent first molar teeth affected with moderate form of molar incisor hypomineralization: randomized clinical trial.

to compare the one-year clinical outcome of zirconia versus lithium disilicate overlays restorations. materials and methods: twenty patients were distributed into two groups in relation to the material used for the fabrication of overlays restorations; group (z) (n=10): patients received zirconia restorations, group (ec): patients received ips e.max cad restorations. clinical and radiographic evaluations of these restorations were carried out at base line (1 week), 3, 6 and 12 months after cementation using fdi world dental federation criteria

Eligibility criteria:
inclusion criteria: * children's age ranging from 10 to 15 years old. * existence of large carious lesion in young permanent first molar teeth associated with weak cusps. * signs of vital pulp without symptoms of pulpitis. * presence of antagonists and adjacent teeth and occlusal contacts with good level of oral hygiene. * children should be able to physically and psychologically tolerate conventional restorative procedures. exclusion criteria: * children with poor oral hygiene and symptoms of pulpitis. * children suffer from parafunctional habits. * children with any debilitating systemic disorder.

Keywords: mih - zironia - lithium disilicate - overlays
treating multiple sclerosis with sirolimus, an immune system suppressor

Conditions: Multiple Sclerosis (MS) - Relapsing-remitting

Summary: the purpose of this study is to determine the safety and tolerability of the drug sirolimus in patients with multiple sclerosis (ms) who have failed other treatments.

ms is a chronic autoimmune disease of the central nervous system in which myelin, the protein sheath that protects nerve cells, is degraded by t cells and macrophages, leading to an eventual loss of neurologic function. ms can be classified as either relapsing-remitting, in which patients experience worsening in symptoms followed by partial or complete recovery of function; or progressive, in which patients have a gradual increase in symptoms, with or without relapses. standard treatments used to treat relapsing-remitting ms are only modestly effective and may be associated with significant toxicity. there is a need to develop therapies with lower toxicities that can be administered early during the course of disease and have the potential to stop disease progression altogether. sirolimus has been demonstrated to provide potent immunosuppression in recent clinical trials involving kidney transplantation, and may help people with autoimmune diseases like ms. this study will determine the benefit of sirolimus in ms patients. blood and urine collection will occur at screening. participants will take daily doses of sirolimus for 6 months. there will be nine study visits; they will occur at days 14, 28, 42, 56, 90, 120, 150, 180, and 225. medication adverse events, concomitant medications, and vital signs will be recorded at visits 1 through 8. at all visits, patient compliance to the sirolimus regimen will be measured, and blood and urine collection will occur. physical and neurological exams, magnetic resonance imaging (mri) brain scans, ms status tests, and a chest x-ray will be conducted at selected times throughout the study.

Eligibility criteria:
inclusion criteria: * relapsing-remitting ms * evidence of demyelination on magnetic resonance imaging (mri) scan * expanded disability status scale (edss) score between 0 and 6 * nonresponsive to beta-interferon or glatiramer acetate therapy * discontinuation of beta-interferon or glatiramer acetate therapy within 1 month prior to study entry * willing to use acceptable methods of contraception exclusion criteria: * primary progressive ms * prior treatment with immunosuppressants * steroid therapy within 1 month prior to study entry * evidence of active infection or cancer * heart or hematologic dysfunction * high levels of lipids in the blood * use of lipid-lowering agents * history of cirrhosis or liver disease requiring treatment * history of hepatitis b or c * active cytomegalovirus infection * kidney disease requiring treatment * active lung disease * diabetes * hyperthyroidism * hiv infection * tuberculosis * history of alcohol or drug abuse within 6 months prior to study entry * claustrophobia or inability to undergo mri * pregnancy or breast-feeding

Keywords: relapsing-remitting ms nonresponsive to standard of care ms sirolimus
optami (optimized therapy of acute myocardial infarction) - registry

Conditions: Myocardial Infarction; ST-Elevation Myocardial Infarction; Non-ST-Elevation Myocardial Infarction

Summary: optami documents the characteristics of consecutive patients with acute stemi and nstemi in hospital everyday-life in germany, their acute and adjuvant medication treatment, events until discharge (e.g. mortality, stroke, re-mi), and their medication for secondary prevention at discharge. in the follow up-period of one year, information is collected concerning events as mortality, stroke, re-mi, coronary interventions (pci, cabg) and re-hospitalisation. the implementation of guideline-adjusted therapy in hospital everyday-life is reviewed. the usefulness of the european standard for data acquisition in cardiology (cards = cardiology audit and registration standards) is evaluated.


Eligibility criteria:
inclusion criteria: * all patients admitted to hospital with an acute st-elevation myocardial infarction or with an acute non-st-elevation myocardial infarction, both not older than 24 h exclusion criteria: * missing informed consent

Keywords: myocardial infarction st-elevation myocardial infarction non-st-elevation myocardial infarction register cards
trial of pcit-ed in school for preschoolers in poverty

Conditions: Childhood Mental Disorder

Summary: a shorted form of the previously tested, parent child interaction therapy emotion development (pcit-ed) will be conducted with a sample of preschoolers who exhibit symptoms of behavioral problems as rated by teacher. children aged 3-7 will be randomized to a 12-week pcit-ed delivered by trained therapists in the school setting or an on-line parent training called "parenting wisely (pw)". children will have a 60% chance of being randomized to pcit-ed and 40% to pw. the treatment will be provided to eligible children in the jennings school district at the school site. in order to test the efficacy of pcit-ed, to estimate accurate effect sizes, and to investigate mediators and moderators of treatment response, participants will complete comprehensive pre- and post-assessments at washington university school of medicine early emotional development program. preschoolers over age 3 will be offered the option of enrolling in an add-on electroencephalography and magnetic resonance imagery study, to investigate neural changes associated with pcit-ed or pw. compared to those randomized to pw, we expect preschoolers who undergo pcit-ed will show significantly increased rates of remission of behavioral problems, greater reductions in symptoms, and decreases in impairment. we hypothesize that they will show significantly greater increases in emotional competence measured by the ability to accurately identify emotions in themselves and others and the ability to effectively regulate intense emotions. compared to those on the pw, parents who undergo pcit-ed will show significantly greater increases in emotion skill learning and reductions in mdd symptoms and parenting stress.


Eligibility criteria:
inclusion criteria: * over the clinical threshold on the teacher report form exclusion criteria: * autism * major neurological disorder * participating in active weekly individual or family therapy

Keywords: preschool parent-child relationship emotion development therapy
a study for participants with advanced cancer

Conditions: Advanced Cancer; Metastatic Cancer

Summary: this study is being conducted to determine the safety of ly2523355 for the treatment of advanced and/or metastatic cancer (including non-hodgkin's lymphoma).

this study is a multi-center, non-randomized, open label, dose-escalation, phase 1 study of intravenous ly2523355 in participants with advanced and/or metastatic cancer (including non-hodgkin's lymphoma) for whom no treatment of higher priority exists.

Eligibility criteria:
inclusion criteria: * have a diagnosis of advanced and/or metastatic cancer (solid tumors or non-hodgkin's lymphoma) that is refractory to standard therapy or for which no proven effective therapy exists. participants entering part b of the study must also have a tumor that is safely amenable to serial biopsies * have the presence of measurable or nonmeasurable disease as defined by the response evaluation criteria in solid tumors (recist, therasse et al. 2000) or revised international working group lymphoma response criteria (cheson et al. 2007) * have a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale * have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 28 days (6 weeks for mitomycin-c or nitrosoureas) prior to study enrollment * males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug * females with child bearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug * have an estimated life expectancy of greater than or equal to 12 weeks exclusion criteria: * have symptomatic, untreated or uncontrolled central nervous system (cns) metastases. participants with treated cns metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. screening of asymptomatic participants without history of cns metastases is not required * have current acute or chronic leukemia * have had an autologous or allogenic bone marrow transplant * have the following conduction abnormalities: pr \>250 milliseconds (msec), second degree or complete atrioventricular (av) block, intraventricular conduction delay (ivcd) with qrs ≥120 msec, left branch bundle block (lbbb), right branch bundle block (rbbb), wolf-parkinson- white syndrome (wpw), left anterior fascicular block (lafb), left posterior fascicular block (lpfb), or other conduction abnormality that in the opinion of the investigator would preclude safe participation in this study. * females who are pregnant or lactating * known hypersensitivity to pegfilgrastim or filgrastim

Keywords: advanced cancer metastatic cancer cancer
safety and efficacy study of amg 820 and pembrolizumab combination in select advanced solid tumor cancer

Conditions: Pancreatic Cancer; Colorectal Cancer; Non-Small Cell Lung Cancer

Summary: a multi-center phase 1b/2 study testing the combination of amg 820 and pembrolizumab in subjects with select advanced solid tumors.

phase 1b is amg 820 dose determining and aimed at assessing the safety and tolerability of the selected starting dose of amg 820 in combination with pembrolizumab. phase 2 of the study will further evaluate safety and tolerability and additionally test whether amg 820 can enhance the anti-tumor activity observed historically with pembrolizumab alone and/or overcome lack of response to pembrolizumab monotherapy in subjects with select solid tumors.

Eligibility criteria:
inclusion criteria: * pathologically documented, advanced colorectal, pancreatic or non-small cell lung cancer that is refractory to standard treatment, or the subjects have been intolerant to or refuse standard treatment. * measurable disease per recist 1.1 guidelines. * eastern cooperative oncology group (ecog) performance status of 0 - 1 * adequate hematologic, renal, and hepatic function determined by laboratory blood and urine tests. * availability of recent tumor tissue within 3 months prior to enrollment, when feasible. exclusion criteria: * has known active central nervous system metastases and/or carcinomatous meningitis. * history of other malignancy with the past 2 years with some exceptions * evidence of active non-infectious pneumonitis/interstitial lung disease * evidence of other active autoimmune disease that has required prolonged systemic treatment in past 2 years. * evidence of clinically significant immunosuppression such as organ or stem cell transplantation, any severe congenital or acquired cellular and/or humoral immune deficiency, concurrent opportunistic infection. * receiving systemic immunostimulatory agents within 6 weeks or 5 half-lives, whichever is shorter, prior to first dose of study treatment (except ant pd-1/pd-l1 treatment if recruited into group 4a or 4b). * evidence of active infection within 2 weeks prior to first dose of study treatment. * prior chemotherapy, radiotherapy, biological cancer therapy or major surgery within 28 days prior to enrollment * currently participating or has participated in a study (treatment period only) of an investigational agent or used an investigational device within 28 days of enrollment * received live vaccine within 28 days prior to enrollment * adverse event due to cancer therapy administered more than 28 days prior to enrollment that has not recovered to common terminology criteria for adverse events (ctcae) grade 1 or better. * positive for human immunodeficiency virus (hiv), hepatitis b or c * women planning to become pregnant or who are lactating/breastfeeding while on study through 4 months after receiving the last dose of study drug.

Keywords: solid tumor pancreatic cancer colorectal cancer non-small cell lung cancer
mechanisms of cbd for chronic pain

Conditions: Chronic Pain

Summary: this is a study designed to examine the neurochemical mechanisms associated with cannabidiol (cbd) versus placebo for chronic non-cancer pain.

the aim of this trial is to examine the neurochemical mechanisms associated with cannabidiol (cbd) versus placebo for chronic non-cancer pain. participants will include individuals with chronic pain, who will be randomized into one of two intervention conditions: low thc/high cbd or placebo. in addition to receiving cbd or placebo, participants also will complete symptom assessments of chronic pain data (intensity, quality, interference/disability) throughout the study. these measures will be gathered prior to and following the fifth doses (dosing will occur once per day for five days) of cbd or placebo. a secondary objective will be to examine the association between clinical and inflammatory markers.

Eligibility criteria:
inclusion criteria: * age between 18-50 yrs. * chronic musculoskeletal and joint pain for at least 3 months or longer. * participants must live within a 60 mile radius of salt lake city, utah to be eligible. exclusion criteria: * current or past neurological illness. * substance abuse or dependence within the prior 90 days. * contraindication to brain mri. * type i and type ii diabetes. * unstable medical conditions. * consumption of more than 2 drinks of alcohol per night. * current pregnancy or planning to become pregnant or breastfeeding. * history of seizures or head trauma at pi discretion. * active or history of major mental illness * use of opioid medications in the past 30 days. * lft results 3 times greater than the upper limit of normal at the screening. * participants may be excluded if the pi feels they do not meet safety criteria.