Kornimate/medical-research-clean huggingface dataset:
a non-interventional trial of erlotinib (tarceva) metastatic non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this is a non-interventional, open label, single arm, multicenter study to assess the safety and efficacy of erlotinib in participants with non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * it is the physician's decision to prescribe erlotinib in participants and to document their treatment * participants must be candidates for receiving erlotinib for locally advanced or metastatic non-small cell lung cancer according to the product label exclusion criteria: * participants will be excluded if safety concerns occurred * if the participant was not compliant or if the participant would wish to stop erlotinib therapy

Keywords: non-small cell lung cancer
assessment of uti symptoms and quality of life according to antibiotics treatment in acute uncomplicated cystitis

Conditions: Acute Cystitis

Summary: although cystitis includes a clinical syndrome characterized by various combinations of dysuria (painful urination), frequency, urgency, gross haematuria, lower back and/or abdominal/suprapubic discomfort with pyuria and bacteriuria. an acute uncomplicated uti (referred to as cystitis) has been focused microorganisms and drug-resistance. there has been little research on clinical aspects on cystitis treatment such as bothersomeness, or the impact of symptoms on patients' quality of life (qol). the investigators want to study for assessment of uti symptoms and quality of life according to antibiotics treatment(ciprobay) in acute uncomplicated cystitis in korean women.


Eligibility criteria:
inclusion criteria: * female outpatients (20-65 years old) * acute cystitis symptoms (subject-reported) for \< 1 week prior to visit 1. exclusion criteria: * acute cystitis symptoms for ≥ 1 week prior to visit 1. * diabetes mellitus * congenital urinary tract abnormality * female subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant during the study or within 3 months after the completion of the study. * hypersensitivity to the active substance (ciprobay). * subjects who have vaginal discharge * fever ( ≥ 37.5 ºc) * sexually transmitted diseases. * documented significant renal disease (scr \> 1.5) * subjects who cannot consent to this study. * subjects who had received antimicrobial agents in the previous 4 weeks. * recurrent urinary tract infection defined as treatment for uti \> 3 times in the last year. * use of an indwelling catheter or an intermittent self-catheterization program. * neurogenic bladder.

Keywords: acute cystitis antibiotics quality of life
the out-patient, non antibiotic management of patients with acute uncomplicated colonic diverticulitis

Conditions: Colonic Diverticulitis

Summary: previous multicentre study nct 01008488 indicates that a patient with ct-proven uncomplicated diverticulitis has a very low risk (1.4%) of developing severe complications such as perforations or abscesses. the question is whether or not hospitalization is necessary, and if patients in that case could return home without antibiotics. the purpose of this study is to evaluate if out-patients managements in uncomplicated colonic diverticulitis is possible without readmission or complications.

at the emergency room all patients with computed tomography verified acute uncomplicated diverticulitis will be asked about participation in the study. if they accept the participation, they will be send home with pain relief medicine. every morning a nurse from our colorectal unit call the patient asking about the condition. the patients will have a visit at the surgery unit within 10 days.

Eligibility criteria:
inclusion criteria: * adults (age above 18 years, acute abdominal pain (duration\< 3 days), abdominal tenderness, elevated inflammatory parameters, ct- scan sign of uncomplicated diverticulitis(without sign of abscess or free air). exclusion criteria: * diffuse peritonitis sepsis or abscess, drying patients who are unable to intake of fluids orally, severe pain with need of repeated parenteral morphine treatment, immunological deficient patients incl. steroid treatment, pregnancy, dementia, patients who need hospitalization of other reasons

Keywords: diverticulitis out-patient management antibiotics
study of anlotinib hydrochloride capsule in subjects with small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as vegfr1/2/3, fgfr1/2/3, and other tumor-associated kinases involved in cell proliferation such as pdgfrα/β, c-kit, and ret have significant inhibitory activities.


Eligibility criteria:
inclusion criteria: 1. small cell lung cancer patients. 2. the clinical stage at baseline is extensive. 3. a measurable lesion. 4. disease progression. 5. ≥ 18 years old; eastern cooperative oncology group (ecog) performance status of 0 to 1; life expectancy ≥ 3 months. 6. adequate laboratory indicators. 7. no pregnant or breastfeeding women, and a negative pregnancy test. 8. understood and signed an informed consent form. exclusion criteria: 1. has used topotecan and anlotinib hydrochloride capsules. 2. has used other anti-angiogenic drugs and immunologically targeted drugs. 3. has other malignant tumors within 5 years. 4. symptomatic brain metastasis. 5. has a variety of factors affecting oral medications. 6. uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage. 7. spinal cord compression. 8. has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization. 9. adverse events caused by previous treatment did not recover to grade 1. 10. has received major surgical treatment within 4 weeks before randomization. 11. arteriovenous thrombosis occurred within 6 months. 12. has drug abuse history that unable to abstain from or mental disorders. 13. has severe or uncontrolled disease. 14. participated in other clinical trials within 4 weeks. 15. tumor invades the large blood vessels. 16. daily hemoptysis ≥2.5 ml within 1 month before the first dose. 17. according to the investigators' judgement.
tdcs and aphasia therapy in the acute phase after stroke

Conditions: Aphasia Following Cerebral Infarction

Summary: this study evaluates the neuromodulatory effect of combined tdcs and aphasia therapy in patients in the acute stage after stroke. half of the participants will receive aphasia therapy and tdcs, the other half will receive aphasia therapy and sham-tdcs.

aphasia is present in about one third of all stroke patients in the acute phase. the first few months after stroke, considerable spontaneous recovery is initiated, including neuronal plasticity and reorganization processes. language recovery in aphasic stroke patients involves reorganization of brain functions. longitudinal fmri studies reveal that the right hemisphere shows increased activity at different times in the recovery process, but in the long-term is correlated with poorer performance. left re-lateralization, if possible, seems to be the most effective in restoring language function. for a large subgroup of patients, aphasia therapy is not sufficient to resolve language deficits and not all patients are capable to endure intensive aphasia therapy. therefore, non-invasive techniques (nibs) such as transcranial direct current stimulation (tdcs) are currently explored as an add-on treatment to improve or accelerate therapy outcomes. tdcs is a painless and safe stimulation tool that modulates cortical excitability through weak polarizing currents (1 ma - 2 ma) between two electrodes. these weak currents are thought to induce a subthreshold shift of resting membrane potentials towards depolarization or hyperpolarization. the effects of stimulation depend on the polarity of the applied current relative to the axonal orientation. it has been found that tdcs not only triggers immediate aftereffects, but also long-lasting effects that persist beyond the stimulation time, even for up to 12 months. it was suggested that long-term potentiation (ltp) and long-term depression (ltd) might be responsible for these long-term effects, however the precise physiologic mechanisms of action are not yet fully understood.

Eligibility criteria:
inclusion criteria: * diagnosed with mild-moderate aphasia (token test score between 7 and 40) * inclusion in the first few days after stroke (acute phase) * age 18 - 85 years * being right-handed * mothertongue: dutch * able to undergo functional and specific linguistic testing and therapy in the acute phase following stroke * imaging (ct or mri) prior to inclusion (standard of care) * signed informed consent exclusion criteria: * history of other diseases of the central nervous system, psychological disorders and (developmental) speech and or language disorders * serious non-linguistic, cognitive disorders (as documented in the patients' medical history and inquired in anamneses) * prior brain surgery * excessive use of alcohol or drugs
the appropriate level of continuous adductor canal block in patients undergoing total knee arthroplasty (tka)

Conditions: Degenerative Arthritis

Summary: adductor canal catheters are being used to provide continuous postoperative analgesia after total knee arthroplasty surgery (tka). there is much debate about where is the best position of continuous adductor canal block in patients undergoing tka. therefore, the investigators aim to compare the postoperative pain at three different level of continuous adductor canal block. ninety six patients scheduled for total knee arthroplasty will be randomly divided into the three groups. in group 1, the adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal). in group 2, the adductor canal catheter is inserted femur length/15\*2 cm above the location where the nerve block performed in group 1. in group 3, the adductor canal catheter is inserted femur length/15cm below the location where the nerve block performed in group 1.


Eligibility criteria:
inclusion criteria: * 1. patients undergoing total knee arthroplasty exclusion criteria: * 1. patients who have infection or had surgery on the thigh * 2. the subject is a foreigner or illiterate * 3. patients who have cognitive dysfunction
swisstavi registry

Conditions: Aortic Valve Disease Mixed

Summary: the purpose of this prospective multi-center, observational national registry in switzerland is to obtain clinical baseline, procedural and follow-up data of all patients treated with tavi in switzerland and to assess short, mid- and long-term clinical outcome data of the ce approved devices. all centers in switzerland implanting the ce approved devices for tavi will be invited to include patients in the registry. each site will collect baseline and procedural data as well as clinical outcome data up to five years.

the present registry aims to assess the safety and efficacy of tavi with ce approved devices at swiss cardiovascular centers. the swiss working group of interventional cardiology and acute coronary syndrome decided to establish a nationwide registry in collaboration with the swiss society of cardiac surgery in order to assess the procedural and clinical outcome of tavi patients. this prospective registry will help to identify candidates for tavi, will report on peri-procedural outcome and on long-term efficacy of the devices. last but not least it is a tool to increase quality of treatment of this high-risk patient population. methods this is a prospective multi-center, observational registry performed in switzerland. all centers in switzerland implanting the ce approved devices for tavi will be invited to consecutively include patients in the registry. each center will sign an agreement that all patients will be included in the registry. each site will collect baseline and procedural data as well as clinical outcome data up to 15 years after tavi.

Eligibility criteria:
inclusion criteria: * native aortic valve stenosis * native aortic valve regurgitation * degenerated aortic bioprosthesis requiring treatment exclusion criteria * patients refuses informed consent to participate in the registry * contraindication for tavi * high probability of non-adherence to the follow up - requirements

Keywords: aortic valve heart valve varc transcatheter minimal-invasive tavi tavr
shade matching potential of universal shade resin composite materials compared to multi shade resin composite in restoration of carious cervical lesions in anterior teeth

Conditions: Class V Dental Caries

Summary: the aim of the study is to clinically evaluate the shade matching and clinical performance of the universal shade composites omnichroma and gc essentia versus the multi shade composite filtek z350xt in restoring cervical lesions of anterior teeth.


Eligibility criteria:
inclusion criteria: * class v carious lesions in anterior teeth * vital upper or lower anterior teeth with no signs of irreversible pulpitis and necrosis. * presence of favorable occlusion and teeth are in normal contact with the adjacent teeth exclusion criteria: * deep carious defects ( close to pulp, less than 1 mm distance) * periapical pathology or signs of pulpal pathology * endodontically treated teeth * tooth hypersensitivity * possible prosthodontic restoration of teeth * heavy occlusion and occlusal contacts or history of bruxism * severe periodontal affection * lesions in premolars and molars * posterior teeth
hemodynamic effects of chronic ketosis.

Conditions: Heart Failure

Summary: heart failure (hf) is a major public health issue because the disease affects 1-2% of the western population and the lifetime risk of hf is 20%. despite major improvements in the management and care of patients with hf, the 1-year mortality in patients with hf is 13% and \>50% of hf patients are admitted during a 2.5 year period. furthermore, patients with hf have markedly decreased physical capacity and quality of life. thus, there is a need for new treatment modalities in this group of patients. we have shown, using positron emission tomography, that ketone body infusion reduces myocardial glucose uptake and increases myocardial blood flow in healthy subjects. data from another study conducted by our group show a 40% increase in cardiac output during infusion of 3-ohb in patients with hf and reduced left ventricular ejection fraction (hfref). presently there are no data on the clinical cardiovascular effects of long-term oral ketone-supplementation in patients with chronic hf. in this study we aim to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with hfref.


Eligibility criteria:
inclusion criteria: * chronic heart failure with nyha ii-iii * left ventricular ejection fraction ≤40% * negative urine-hcg for women with childbearing potential exclusion criteria: * known diabetes or hba1c ≥48 mmol/mol * significant cardiac valve disease * severe stable angina pectoris * age \<18 years
mitigate immune-mediated loss of therapeutic response to asfotase alfa (strensiq®) for hypophosphatasia

Conditions: Hypophosphatasia

Summary: the primary objective of this study is to evaluate the effect of immunosuppressive therapy (ist) in participants treated with asfotase alfa who demonstrate immune-mediated loss of effectiveness (loe).

the administration of biological drugs to patients, especially for chronic conditions, carries a risk of eliciting anti-drug antibodies. neutralizing antibodies can neutralize the clinical benefit of the agent. in postmarketing safety surveillance, some patients treated with asfotase alfa demonstrated an initial response, but subsequently recurrence and progression of disease. consequently, the fda requested a study to assess a potential serious risk of immune-mediated loss of effectiveness.

Eligibility criteria:
inclusion criteria: * reoccurrence or worsening of rickets for at least the past 3 months in participants who showed an initial efficacy response to asfotase alfa after at least 6 months of continuous treatment and currently receiving asfotase alfa. rss will be used to determine severity at baseline. * presence of adas, with or without nabs, irrespective of their titers. * confirmation by the tmb that both the clinical evidence and immunogenicity-mediated association noted above are present. * female participants of childbearing potential and male participants with partners of childbearing potential must follow protocol-specified contraception guidance as described in section 10.5. * participant, or participant's legal guardian, is capable of signing informed consent or assent as described in section 10.1.3, which includes compliance with the requirements and restrictions listed in the informed consent or assent form and in this protocol. exclusion criteria: * known history of human immunodeficiency virus (hiv) infection (evidenced by hiv type 1 or type 2 \[hiv 1, hiv 2\] antibody) or hepatitis b or c viral infection. * known or suspected history of drug or alcohol abuse or dependence within 1 year prior to screening. * inability of the participant, or the participant's legal guardian, to provide informed consent. * pregnant, breastfeeding, or intending to conceive during the course of the study. * inability to travel to the clinic for specified visits during the treatment period caused by disease per se or logistics (does not apply to external travel restrictions). * the participant is at risk of reactivation or has an active significant viral infection such as hepatitis b, cytomegalovirus, herpes simplex, human polyomavirus (also known as john cunningham \[jc\] virus), parvovirus, or epstein barr virus. * the participant is at risk of reactivation of tuberculosis or has regular contact (eg, in the household) with individuals who are being actively treated for tuberculosis. * the participant has had or is required to have any live vaccination within 1 month prior to enrollment.

Keywords: hypophosphatasia hpp asfotase alfa strensiq
a retrospective analysis of the effects of red light therapy on body contouring

Conditions: Obesity

Summary: the purpose of this study is to determine whether red light therapy using led 635nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using laser 635nm red light.

red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. this study hypothesizes that red led light therapy using 635nm red light led (light emitting diode) technology produces similar results to the laser device (red laser 635nm) when performed using a specified treatment protocol. furthermore, it is hypothesized that the ultraslim cold light therapy program achieves the results after a single 32-minute treatment. the predicate 635nm laser device (zerona by erchonia) achieves its results after six treatments combined with a diet and exercise regimen. ultraslim cold light® is a patented process using the photonica professional device for fat removal using led red light therapy. this multi-site study reviews results from 58 randomly selected patients after a single treatment using the photonica professional device (i.e. ultraslim cold light®).

Eligibility criteria:
inclusion criteria: * 18 years or older. * male or female. * generally good health. exclusion criteria: * pregnancy. * active cancer within the past year. * diminished ability to void waste (liver or kidneys). * photosensitive condition or medication.
relationship between oxytocin level, trust, and attachment in individuals with borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: we aim to assess the baseline oxytocin levels in individuals with borderline personality disorder and correlate those levels with social behavior, and compare the results with controls. primary hypothesis (h1): there is a significant difference in trust-related behavior as measured by oxytocin (oxt) levels between borderline personality disorder (bpd) patients and healthy controls. secondary hypotheses: h2: the trust-related behavior in bpd patients is significantly influenced by their level of emotional sensitivity. specifically, higher emotional sensitivity in bpd patients is associated with lower trust-related behavior and vice-versa. h3: there is a significant correlation between trust-related behavior and childhood trauma in bpd patients. bpd patients with higher levels of reported childhood trauma will exhibit lower trust-related behavior compared to those with lower levels of trauma. h4: trust-related behavior in bpd patients varies depending on their attachment styles. specifically, bpd patients with insecure attachment styles will exhibit lower trust-related behavior compared to those with secure attachment styles. h5: there is a significant correlation between trust-related behavior and bpd severity. patients with more severe bpd symptoms will exhibit lower trust-related behavior compared to those with less severe symptoms. h6: the levels of oxt in bpd patients will significantly correlate with their reported levels of emotional sensitivity, childhood trauma, attachment styles, and bpd severity. these hypotheses aim to address the complexities surrounding the modulation of trust-related behavior by oxytocin in bpd patients, taking into account various factors like emotional sensitivity, childhood adversity, attachment styles, and bpd severity. by testing these hypotheses, the study aims to provide a comprehensive understanding of the interplay between these factors in influencing trust-related behavior in bpd patients.


Eligibility criteria:
inclusion criteria: * individuals with borderline personality disorder will qualify as cases * controls will be age, gender matched individuals without any psychiatric/mental health concerns exclusion criteria: * for all: pregnancy, hormonal or neurological disorders, and any kind of regular medication * additional exclusion criteria for cases: a lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or significant neurological disease, current alcohol/ drug dependence * for controls: maclean screening instrument for bpd will be used at the time of screening to exclude bpd diagnosis in controls

Keywords: oxytocin borderline personality disorder trust-related behavior attachment styles childhood trauma emotional sensitivity