Kornimate/medical-research-clean huggingface dataset:
aptoll for the treatment of covid-19

Conditions: COVID-19

Summary: there is a clear and urgent medical need of developing new medicinal products for covid-19 since there are poor pharmacological tools to block the progression of patients to cytokine storm syndrome (css). to this aim, this phase ib clinical study (aptacovid) pretends to determine whether aptoll, in combination with the standard of care, is safe and shows any biological effect) in those patients infected with sars-cov-2 who are not developed css yet.


Eligibility criteria:
inclusion criteria: 1. men or women with age ≥18 and ≤85 years. 2. in case of women of childbearing potential (wocbp), they should confirm menstrual period and a negative highly sensitive urine or serum pregnancy test to be included. 3. laboratory-confirmed sars-cov-2 infection. 4. informed consent obtained . 5. hypoxia (spo2\<95%). 6. documented lung opacities/infiltrates. 7. confirmed hyperinflammation. exclusion criteria: 1. onset of symptoms of covid-19 \>14 days. 2. pregnant or nursing (lactating) women. 3. hospitalized \>10 days for covid-19. 4. need of high concentration non-rebreather mask, high-flow nasal cannula , non-invasive mechanical ventilation or invasive mechanical ventilation. 5. systolic blood pressure \< 90 mmhg. 6. serious concomitant illness. 7. recent treatment with cell-depleting therapies. 8. enrolled in another clinical trial. 9. severe renal dysfunction. 10. in the opinion of the investigator, unable to comply with the requirements to participate in the study.
zn-c3 in adult participants with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to evaluate the safety, tolerability, and potential clinical benefits of zn-c3 administered in combination with encorafenib and cetuximab in adult participants with metastatic braf v600e mutant colorectal cancer previously treated with one or two treatment regimens.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed metastatic stage iv colorectal adenocarcinoma. * documented evidence of a braf v600e mutation in tumor tissue or blood * presence of measurable disease per recist version 1.1 guidelines. * disease progression after 1 or 2 previous systemic regimens for metastatic disease * adequate bone marrow function * adequate hepatic and renal function exclusion criteria: * documented clinical disease progression or radiographic disease progression during the screening period * leptomeningeal disease. * symptomatic brain metastasis. * presence of acute or chronic pancreatitis. * unable to swallow, retain, and absorb oral medications. * clinically significant cardiovascular diseases * evidence of active noninfectious pneumonitis. * evidence of active and uncontrolled bacterial or viral infection, within 2 weeks prior to start of any of the study interventions * participants with known positivity for hiv * active hepatitis b or hepatitis c infection * concurrent or previous other malignancy within 2 years of study entry * has had an allogeneic tissue/solid organ transplant * pregnant or females of childbearing potential who have a positive β-hcg laboratory test result within 14 days prior to enrollment or is breastfeeding

Keywords: metastatic colorectal cancer crc braf v600e
diagnostic value of anti-mcv in pts with ra

Conditions: Anti-MCV in Rheamatoid Arthritis

Summary: the aim of this work is to evaluate the diagnostic value of anti-mcv antibodies in rheamatoid arthritis patients and to correlate its relationtion disease activity and manifestations.

rheumatoid arthritis (ra) is a chronic systemic autoimmune disease characterized by joint inflammation, subsequent joint destruction leading to loss of joint function, and disability. joint erosions develop quickly in 25 % of ra patients during the first 3 months of the disease and in about 75% of patients during the first 2years . early therapeutic intervention with synthetic disease-modifying antirheumatic drugs (sdmard) and biological agents that target specific molecules can prevent joint damage and improve the prognosis of the disease. since these therapies can have potential toxic effects ,it is very important that practitioners diagnose early and reliably the disease, especially the more aggressive forms, in order to select the appropriate treatment for patients. early diagnosis of ra can be challenging. during the last 15 years, there has been significant progress on the pathogenesis of ra with the discovery of antibodies against citrullinated protein antigens (acpas). acpa production is associated with the hla-drb1 shared epitope, cigarette smoking, and periodontitis . acpas have been shown to predict joint damage and are associated with more severe disease and extra-articular manifestations . in order to better identify ra patients at earlier stages, new 2010 classification criteria for ra by the american college of rheumatology (acr)/european league against rheumatism (eular) include rheumatoid factor (rf) and acpas . the most common commercial assay for the detection of acpas is anti-cyclic citrullinated peptide (anti-ccp) test, which uses synthetic cyclic citrullinated peptides that mimic ra epitopes. citrullination occurs also in other autoimmune diseases . . indeed, histone citrullination may lead to the release of neutrophil extracellular traps, and juxtaposition of citrullinated histones with infectious pathogens, complement and immune complexes may compromise tolerance of nuclear autoantigens and promote autoimmunity . antibodies to other citrullinated peptides or proteins have been suggested as good candidates for diagnosing ra. anti-mcv antibodies have been recommended to be better diagnostic marker for early arthritis . vimentin is an intermediate filament that is widely expressed by mesenchymal cells and macrophages and easy to detect in the synovium. modification of the protein occurs in macrophages undergoing apoptosis, and antibodies to citrullinatedvimentin may emerge if the apoptotic material is inadequately cleared .

Eligibility criteria:
inclusion criteria: * . all patients were previously diagnosedaccording to the 2010 acr/eular ra classification .. with both ( early and late ) rheamatoid arthritis exclusion criteria: * patients with other autoimmune disease . * patient with renal diseaes .
mirena or conventional medical treatment for menorrhagia

Conditions: Menorrhagia

Summary: the aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of mirena in treatment of prolonged or heavy menstrual bleeding (menorrhagia) under daily-life treatment conditions. it is planned to conduct the study in about 10 countries with a total of 1000 patients. in several countries, a comparator group will also be documented. for each patient, an initial visit and one to three follow-up visits after about 3, 6 and 12 months will be documented by the treating physician on the case report form. observations include the patient's demographic parameters (date of birth, height, weight, race and smoking habits), previous contraceptives and menorrhagia treatment, gynaecological history, baseline menstruation, result of insertion, concomitant medications and diseases as well as menorrhagia symptoms. overall treatment success will be evaluated at the end of treatment including number of weeks until improvement and reduction of menstrual bleeding with respect to duration and severity, and patient's satisfaction.

the "mico - mirena or conventional medical treatment for menorrhagia" study consist of two parts, mico asia-pacific and mico ma0901 (rest of world). data from both parts will be analysed in separate pools as well as in a global pool. the trial alias are impact nos. 14697, 14536 (nct01085487).

Eligibility criteria:
inclusion criteria: * women between the ages of 18-45 (inclusive) not intending to get pregnant during the next year * women complaining of heavy menstrual bleeding over several consecutive cycles * women without structural or histological abnormality of the uterus, or with fibroids less than 3 cm in diameter which are causing no distortion of the uterine cavity (eligible for pharmaceutical treatment according to the nice guideline 2007) * informed consent (where required by laws or regulations) exclusion criteria: * the contraindications and warnings of the respective summary of product characteristics (mirena, combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug, or anti-fibrinolytic agent) must be followed. * women taking hormone replacement therapy * women with symptoms such as intermenstrual or post-coital bleeding, unless an endometrial biopsy has been performed and pathology excluded * women with fibroids that are palpable abdominally or who have intra-cavity fibroids and/or whose uterine length as measured at ultrasound or hysteroscopy is greater than 12 cm (nice guideline 2007) * women on anticoagulative therapy or other treatment (including e.g. copper iud use) known to cause menorrhagia
targeted training for trunk control_case series cerebral palsy

Conditions: Cerebral Palsy; Traumatic Brain Injury

Summary: if a child with cerebral palsy does not develop independent sitting balance by 4 years of age, their prognosis for walking is very poor. surprisingly little is known about how to facilitate head control or upright sitting balance and functional mobility in the child who is not developing these skills. this is one of the first studies that will examine intermediate stages in the development of the postural control system in children with neurologic deficits. clinical researchers at the movement centre in oswestry, england have developed a method called targeted training in which trunk control is trained in children segment by segment using a specific training device. this study aims to examine kinematic and electromyographic changes in a case series of children who undergo a 6-month targeted training intervention.


Eligibility criteria:
inclusion criteria: * neurologic diagnosis that results in a deficit in trunk control (i.e. cerebral palsy, traumatic brain injury) * age 4-17 years * gross motor function classification system (gmfcs) level iii, iv or v for children with cerebral palsy exclusion criteria: * spinal fixation * fixed scoliosis * uncontrolled seizures

Keywords: postural control targeted training cerebral palsy trunk segments
mental health related to school dropout in luxembourg

Conditions: Anxiety Disorders; Mood Disorders; Eating Disorders; Substance-related Disorders; Impulse Control Disorders; Psychotic Disorders; Antisocial Personality Disorder

Summary: this study aims to investigate psychosocial risk- and protective factors such as psychiatric disorder, socio-economic background and family functioning among school dropouts and to compare the findings with those by a matched control group of regularly enrolled students.

in luxembourg, the national authorities had to face school dropout rates of more than 15%. as a result, they introduced accompanying and preventive measures to reduce linguistic and cultural risk factors that may impede educational engagement and vocational decisions. since 2006, the dropout rate has overall declined. however the proportion of early school leavers who remain without any specific occupation is still alarming. this study aims to identify psychosocial risk - and protective factors of secondary school dropout in order to deliver solid insight on how to tailor early detection and intervention programs. in the light of prior findings, the investigators hypothesize that school dropouts have significantly more mental health problems than their peers who go to school. they are also more likely to report a poor socio-economic background, negative school experiences and difficulties in family functioning. to test those hypotheses, the investigators will have an exploratory case control study.recruitment of cases will be prospective, from an exhaustive population of dropouts and recruitment of matched controls will be done by random sampling. data will be collected using self-report questionnaires on mental health, family life and problematic internet use as well as a structured clinical interview to consider psychiatric diagnosis according to the criteria of dsm iv.

Eligibility criteria:
inclusion criteria: * enrolled in a public secondary school in luxembourg * cases have to be reported as "school dropouts" in the electronic records of the ministry for education * informed consent obtained and signed by the adolescent and his/her legal guardian if the participant hasn't reached full age * understand german or french, which are the two languages of testing * resident in luxembourg exclusion criteria: * acute hospitalization or arrest
spinal cord stimulation and small fiber peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: this is a prospective randomized control trial. participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group. a time course of measurements before and after spinal cord stimulation (scs) treatment (where applicable) will assess pain, dpn severity, small fiber nerve activity, and metabolic health markers.

peripheral neuropathy (pn) is caused by diabetes, aging, chemotherapy, and over 30 other conditions, and impacts more than 30 million patients in the us alone. diabetes is the number one cause of peripheral neuropathy, and more than half of patients with diabetes will eventually develop diabetic peripheral neuropathy (dpn), a complex set of symptoms including pain, numbness, tingling, and burning. spinal cord stimulation (scs) is an approved intervention for the treatment of chronic pain, including dpn. spinal cord stimulation has had fda approval for the treatment of painful dpn since 2015. this study is being done to learn more about the diagnosis of dpn and treatment of dpn with scs.

Eligibility criteria:
inclusion criteria: * over 18 years old * diagnosis of diabetic peripheral neuropathy refractory to treatment with gabapentin or pregabalin and at least 1 other class of analgesic * diagnosis of medically refractory pain secondary to diabetic neuropathy * presence of pain for 12 months * lower limb pain intensity score ≥4 on a visual analog scale * dn4 ≥4 * pass pre-operative neuropsychological assessment (surgical group only) * capable of providing informed consent exclusion criteria: * severe medical comorbidities that, in the opinion of the surgeon, exclude the patient from surgical intervention * spinal disease with severe spinal stenosis or spinal cord compression in the region of the proposed spinal cord stimulator lead placement * coagulopathy that cannot be corrected * unable to discontinue blood thinning medications * hemoglobin a1c level greater than 10 * presence of systemic infection * pregnancy
relationship of pni and clinical outcome in patients undergoing brain tumor surgery

Conditions: Clinical Outcome

Summary: there are several predictors of clinical outcome in patients undergoing brain tumor surgery. among those, nutritional parameters and calculated nutritional index are known to have ability to predict mortality and clinical outcomes in some patients with brain tumor. however, there are lack of consistent results on predictability of nutritional index and clinical outcome in patients undergoing brain tumor surgery.

in this retrospective study, we evaluated the relationship between prognostic nutritional index, which was calculated from laboratory parameters, and clinical outcome including mortality in patients undergoing brain tumor surgery.

Eligibility criteria:
inclusion criteria: * adult patients undergoing brain tumor surgery at seoul national university hospital, south korea exclusion criteria: * lack of results of laboratory parameters, such as serum albumin, lymphocyte count, cholesterol * lack of data on clinical outcome, including mortality, acute kidney injury, renal replacement therapy, length of hospital stay, and other major adverse outcome

Keywords: nutritional index brain tumor surgery mortality
pharmacokinetics of simvastatin and its metabolite simvastatin acid with and without concomitant administration of telmisartan in healthy subjects

Conditions: Healthy

Summary: to assess the pharmacokinetics of simvastatin and simvastatin acid with/without concomitant administration of telmisartan


Eligibility criteria:
inclusion criteria: * healthy subjects as determined by results of screening * signed written informed consent in accordance with good clinical practice (gcp) and local legislation * age ≥ 18 and ≤ 55 years * broca ≥ -20 % and ≤ +20 % exclusion criteria: * any findings of the medical examination (including blood pressure, pulse rate and ecg) deviating from normal and of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * surgery of the gastro-intestinal tract (except appendectomy) * diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * supine blood pressure at screening of systolic ≤ 110 mmhg and diastolic ≤ 60 mmhg * history of orthostatic hypotension, fainting spells or blackouts * chronic or relevant acute infection * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * intake of drugs with a long half life (\> 24 hours) ≤ 1 month prior to administration or during the trial * use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial) * participation in another trial with an investigational drug (30 days prior to administration or during the trial) * smoker * alcohol abuse (\> 60 g/day) * drug abuse * blood donation (≤ 1 month prior to administration or during the trial) * excessive physical activities (≤ 5 days prior to administration or during the trial) * any laboratory value outside the reference range of clinical relevance * hypersensitivity to telmisartan and/or simvastatin and/or related classes of drugs for female subjects: * pregnancy * positive pregnancy test * no adequate contraception (e.g. sterilization, intrauterine device (iud), oral contraceptives) * inability to maintain this adequate contraception during the whole study period * lactation period
safety and efficacy study of the hydrus aqueous implant in subjects with poag

Conditions: Primary Open Angle Glaucoma

Summary: the purpose of this study is to evaluate the ocular hypotensive effect of the hydrus aqueous implant (standard and low-profile), as determined by the change in iop from baseline (preoperative) and change in the number of glaucoma medications from baseline.

this is a prospective, multi-center study that will examine subjects with documented mild to advanced primary open angle glaucoma (poag), who may or may not have a cataract requiring removal and placement of an intraocular lens. study subjects will be grouped by the severity of their disease (either mild/moderate or advanced). if all inclusion and exclusion criteria are met subjects in all four groups will be implanted with the hydrus aqueous implant. subjects in whom a cataract is present will undergo standard cataract removal and iol implantation concurrent with implantation of the hydrus. postoperatively, subjects will undergo a complete ophthalmic evaluation at regularly scheduled intervals.

Eligibility criteria:
inclusion criteria: * elevated intraocular pressure (iop) * diagnosis of mild to advanced open-angle glaucoma * shaffer grade iii * mental capacity to cooperate when undergoing operative and postoperative examination * 18 years of age or older * provide written informed consent * willing and able to return to scheduled follow-up examinations for 24-months exclusion criteria: * closed-angle and narrow-angle forms of glaucoma * secondary glaucomas * congenital or developmental glaucoma

Keywords: primary open angle glaucoma poag
phase i/ii, fih, dose escalation trial of tl-895 and expansion of tl-895 monotherapy and combination therapy with navtemadlin in tx-naïve and r/r cll/sll subjects

Conditions: Relapsed/Refractory B Cell Malignancies; Mantle Cell Lymphoma and Diffuse Large B Cell Lymphoma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Treatment-Naive B Cell Malignancies

Summary: the purpose of this research study is to determine the safety and tolerability of tl-895. there are 2 parts of this study. part 1 tested increasing doses of tl-895 to identify the recommended safe dose for participants with relapsed/refractory (r/r) b cell malignancies who failed at least 1 but no more than 3 prior therapies. part 1 of this study is no longer enrolling participants. arms 1 \& 2 of part 2 of this study will test different doses of tl-895 in participants with r/r cll or sll who have failed at least 1 prior therapy. arms 1 \& 2 of part 2 of this study is randomized (like the flip of a coin) to receive a specific treatment dose. if someone participates in arms 1 or 2 of part 2, the dose they receive will be either 100mg twice a day or 150mg twice a day. arms 3 and 4 of part 2 of this study will test the 150mg and 100mg bid dose of tl-895, respectively in treatment naïve participants with cll/sll. arms 5 and 6 of part 2 will test 150mg tl-895 bid in combination with 240 mg navtemadlin qd in participants with relapsed/refractory and treatment naïve without 17p(del). arm 7 will test 150mg tl-895 in combination with 240 mg navtemadlin qd in participants with relapsed/refractory cll/sll with 17p(del). every participant in this study will receive tl-895.


Eligibility criteria:
inclusion criteria * relapsed/refractory cll or relapsed/refractory sll (arms 1, 2, 5, and 7) * treatment naïve cll or sll (arm 3, 4, and 6) * ecog performance status of ≤ 2 * adequate hematologic, hepatic, and renal functions exclusion criteria * prior treatment with any btk or pi3k inhibitors * history of major organ transplant * women who are pregnant or breastfeeding

Keywords: tl-895 tyrosine kinase inhibitor lymphoma open phase i phase ii cll sll