Kornimate/medical-research-clean huggingface dataset:
neurobehavioral intervention as a novel treatment approach for emotion-regulatory deficits

Conditions: Anxiety; Depression

Summary: the present study will explore the effectiveness of a computer based neurobehavioral intervention in alleviating symptoms and improving emotion regulation in psychiatric populations. it will increase understanding of psychopathology at a neural-circuit level and aid development of new non-pharmacological treatment for emotion regulatory deficits.


Eligibility criteria:
inclusion criteria: * current anxiety or depression symptoms * internet access exclusion criteria: * lifetime psychotic disorder, past-year substance dependence

Keywords: computerized neurobehavioral intervention
effect of povidone-iodine 5% vs 1% on the ocular surface in intravitreal injections of anti-vegf

Conditions: Dry Eye

Summary: objective and subjective comparison between the use of povidone-iodine 1% vs 5% as antiseptic in patients that need anti-vegf intravitreal injection

randomized, prospective clinical trial. one group was intervened with povidone-iodine at 5% and the other at 1% as antiseptic for anti-vegf intravitreal injection. each patient was evaluated before and after the injection of anti-vegf for tear break up time, bulbar redness and ocular surface satining with fluorescein. pain perception was also evaluated 15 minutes after the injection and 48 hours after.

Eligibility criteria:
inclusion criteria * having anti-vgef intravitreal injection scheduled * informed consent signed exclusion criteria * under 45 years * opacity that prevents ophthalmological evaluation and fixation * patients with severe dry eye * patients with signs of infection on the ocular surface * allergy to iodine * pregnancy

Keywords: povidone-iodine pain
ascending dose tolerability/safety of slv308 for the treatment of parkinson's disease

Conditions: Parkinson's Disease

Summary: this study is a multicenter, randomized, double-blind, placebo controlled, parallel group study of a seven-week ascending dose period of slv308 adjunctive to l-dopa treatment in patients with advanced stage parkinson's disease (pd) and dose-dependent motor fluctuations. patients (outpatients) will be randomized to one of three different treatment arms.


Eligibility criteria:
inclusion criteria: * patients who have signed an informed consent; diagnosis of idiopathic pd. * presence of recognizable "on" and "off" stages * minimum hours of "off" time per day of 2.5 hours * able to keep diaries. exclusion criteria: * unclear diagnosis or a suspicion of other parkinsonian syndromes * have undergone surgical treatment for pd * history of non-response to l-dopa.

Keywords: parkinson's disease adjunctive to l-dopa therapy advanced stage parkinson's disease
a study of label compliance for attention deficit/hyperactivity disorder (adhd) medications in japan

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the purpose of this study is to document the extent of on-label and off-label use of methylphenidate (mph) (concerta), mph (ritalin), atomoxetine (ato), and guanfacine (gfc) in japan.


Eligibility criteria:
inclusion criteria: * participants have been in the database for greater than or equal to (\>=) 30 days * have received, between 1 january, 2013 and 30 september, 2018, a prescription for concerta, ritalin, atomoxetine (ato) or guanfacine (gfc) exclusion criteria: - participants who received an unspecified methylphenidate (mph) formulation
turner syndrome prenatal diagnosis study

Conditions: Turner Syndrome

Summary: the goal of this study is to compare the features of turner syndrome in girls who are diagnosed before birth because of fetal concerns versus those who are diagnosed when their mother has an amniocentesis for another reason.

this is an observational study which will look at girls who are diagnosed with turner syndrome before they are born. girls will be divided into two groups: 1) those diagnosed because of features seen on ultrasound which raised the question of turner syndrome and 2) those diagnosed incidentally when their mother had an amniocentesis for another reason such as advanced maternal age. no clinical procedures nor interventions will be done as part of this data collection study which will occur for the first 3 to 6 years of the girl's life. the investigators will be looking to see if girls who are diagnosed incidentally have less features of turner syndrome than those girls who are diagnosed because of fetal ultrasound.

Eligibility criteria:
inclusion criteria: * turner syndrome diagnosed prenatally * less than 4 months of age at time of enrollment exclusion criteria: * turner syndrome diagnosed postnatally * older than 4 months of age at time of enrollment

Keywords: turner syndrome diagnosis, prenatal
assessment of tumor vascular effects of axitinib with dynamic ultrasonography in patients with metastatic colorectal cancer

Conditions: Colorectal Carcinoma

Summary: the purpose of this study is to evaluate and quantify the dynamic modifications of tumor blood perfusion on axitinib therapy in patients with refractory mcrc for each dose of axitinib.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed diagnosis of crc * measurable metastatic disease to the liver in proven disease progression (according to recist criteria) at baseline (within 4 weeks prior to study entry), with at least one lesion \> 2cm considered appropriate for dce-us examination * previously exposed to at least, irinotecan, oxaliplatin and a fluoropyrimidine, all 3 administered at optimal doses, over one or two chemotherapy (ct) lines for metastatic disease with a clear resistance to these drugs. previous exposure to bevacizumab and/or anti-egfr monoclonal antibody is allowed. * age ≥18 years; performance status (ps) 0-2 and life expectancy \> 3 months. * adequate biological functions: neutrophils ≥ 1.5 x 109/l; platelets ≥ 100 x 109/l; hemoglobin \> 9 g/dl; creatinine clearance \> 30 ml/min (cockcroft \& gault formula). serum bilirubin \< 1,5 x the upper normal limit (unl) and ast/alt \< 5 x unl. * signed written informed consent * female patients with childbearing potential (\<2 years after last menstruation) and male must use effective means of contraception during the study treatment and at least 6 months after the last study drug administration.
humanized car-t therapy for treatment of b cell malignancy

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Summary: the present study evaluates the safety and efficacy of humanized chimeric antigen receptor t cells (car-t) in treating recurrent or refractory b cell malignancy targeting cd19 with a humanized scfv. all participants will receive autologous chimeric antigen receptor engineered t cells.

cd19 has been extensively evaluated as a therapeutic target for recurrent or refractory b cell malignancy by chimeric antigen receptor t cell therapy, the single chain antibody sequence (scfv) against cd19 derived from a mouse hybridoma was widely employed. however, the immunogenicity of the mouse scfv sequence might be one of the reasons that car-t cells cannot persist in vivo for long. in present study investigators replace the mouse-derived scfv with a a humanized one and evaluate its safety and efficacy.

Eligibility criteria:
inclusion criteria: * age≥3 at the time of consent * survival time\>12 weeks * b cell hematological malignancies by pathological examination * chemotherapy failure or recurrent b cell malignancy * creatinine\< 2.5mg/dl * glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level * karnofsky performance status\>50% at the time of screening * bilirubin\<2.0mg/dl * adequate pulmonary, renal, hepatic, and cardiac function * fail in autologous or allogenic haemopoietic stem cell transplantation * free of leukocytes removal contraindications exclusion criteria: * pregnant or nursing women * active hepatitis b, active hepatitis c, or any human immunodeficiency virus (hiv) infection at the time of screening * previous treatment with any gene therapy product * abnormal vital signs * highly allergic constitution or history of severe allergies, especially allergy to interleukin-2 * general infection or local severe infection, or other infection that is not controlled * dysfunction in lung, heart, kidney and brain. * severe autoimmune diseases * other symptoms that are not applicable for car-t
hysterectomy versus uterine preservation for pelvic organ prolapse surgery

Conditions: Pelvic Organ Prolapse

Summary: pelvic organ prolapse (pop) is the descent of pelvic organs into the vagina resulting in bulge symptoms and occurs in approximately 50% of women. almost 20% of women will elect surgical correction of this condition by age 85. removal of the uterus (hysterectomy) with concomitant vaginal vault suspension is a longstanding practice in pop surgery to address apical (uterine) prolapse. yet, contemporary evidence on the merits of this approach relative to preservation of the uterus through suspension is needed to better inform surgical decision-making by patients and their healthcare providers. the objective of this trial is to evaluate pop-specific health outcomes and service utilization of women electing uterine suspension compared to those electing hysterectomy and vaginal vault suspension for pop surgery up to 1-year post-surgery.


Eligibility criteria:
inclusion criteria: * have diagnosed pop of stage ≥2 using the globally recognized pelvic organ prolapse-quantification system (pop-q) * elect surgical management of pop * demonstrate presence of apical prolapse on clinical exam deemed to require either a hysterectomy and concomitant vaginal vault suspension or uterine suspension to properly address their pop during surgical correction * desire no further pregnancy * can communicate in english * are ≥18 years in age exclusion criteria: * prior hysterectomy

Keywords: pelvic organ prolapse gynecologic surgery female epidemiology
pemetrexed plus gemcitabine as front-line chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer: a clinical trial

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purposes of this study are to determine: 1. the safety of pemetrexed plus gemcitabine and any side effects that might be associated with the combination of these two drugs. 2. whether pemetrexed plus gemcitabine can help patients with non-small cell lung cancer live longer. 3. whether pemetrexed plus gemcitabine can make the tumor smaller or disappear, and for how long. 4. to see if patients feel better while taking pemetrexed plus gemcitabine.


Eligibility criteria:
inclusion criteria: * diagnosis of non-small cell lung cancer that can be treated with chemotherapy. * have received no prior chemotherapy for non-small cell lung cancer. * have at least one measurable lesion. * have an adequate performance status. * sign an informed consent. exclusion criteria: * a female who is pregnant or breastfeeding. * treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating pemetrexed. * treatment with radiation therapy within the last 4 weeks. * brain metastasis that is uncontrolled. * active infection or other serious condition.
trinetx study of hypereosinophilic syndrome (hes) without an identifiable non-haematological secondary cause

Conditions: Hypereosinophilic Syndrome (HES)

Summary: the purpose of this study is to build the knowledge base on clinical characteristics, clinical management, and treatment outcomes of hes.

retrospective database analysis using trinetx database to describe hes patient characteristics, journey, and disease burden.

Eligibility criteria:
inclusion criteria: * diagnosis record of hes (icd-10-cm d72.11) anytime during 01 october 2020 to 30 june 2023 * at least 12 months of patient insurance record prior to first hes record. exclusion criteria: * any mutation in pdgfra, pdgfrb or fgfr1 genes (to exclude clonal hes). * history of bcr-abl tyrosine kinase inhibitor use: imatinib, dasatinib, nolitinib, bosutinib, ponatinib, asciminib (to exclude clonal hes) * history of myeloid leukemia, myeloproliferative disorder, myelodysplastic disorder, myelomonocytic leukemia, acute erythroid leukemia, acute megakaryoblastic leukaemia, acute panmyelosis with myelofibrosis, and other specified leukaemias (to exclude reactive hes) * history of helminthiasis or use of anthelmintic medication (to exclude reactive hes) * history of autoimmune disease (to exclude reactive hes) * history of use of specific drugs: antiepileptics, sulfonamides, allopurinol, and immune checkpoint inhibitors (to exclude reactive hes)
chemotherapy with pemetrexed in combination with platinum for advanced non-small cell lung cancer (nsclc)

Conditions: Non-Small-Cell Lung Cancer

Summary: this is a two-arm, parallel, open-label, phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage iiib and iv non-small cell lung cancer patients. approximately 130 patients will be included in about 15 centers in germany and randomized to one of the above treatment regimens in a 1:1 ratio. chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. primary objective will be the progression free survival time of patients as assessed in both treatment arms.


Eligibility criteria:
inclusion criteria: * cytologically and/or histologically confirmed nsclc stage iiib or iv * no previous systemic chemotherapy for this cancer * at least one uni-dimensionally measurable lesion meeting response evaluation criteria in solid tumors (recist) criteria * eastern cooperative oncology group (ecog) performance status of 0 or 1 and adequate organ function * prior radiation therapy allowed but limited to \<25% of the patient's bone marrow exclusion criteria: * serious concomitant systemic disorder or active infection * mild to moderate renal insufficiency, but unable to interrupt salicylates or other nonsteroidal anti-inflammatory drugs * symptomatic central nervous system (cns) metastases requiring concurrent corticosteroid therapy * presence of clinically significant third-space fluid collections
evaluation of gingival crevicular fluid and serum asprosin levels in obese and normal-weight individuals with periodontitis

Conditions: Periodontitis; Obesity

Summary: obesity and periodontitis are chronic inflammatory diseases that share common pathological mechanisms. asprosin, a novel adipokine discovered in 2016, has not been extensively studied in relation to periodontal tissues. in our study, we investigate the levels of asprosin in both serum and gingival crevicular fluid of patients with obesity and those of normal weight who have periodontitis. additionally, our research aims to clarify the pathophysiological mechanisms linking periodontitis and obesity by examining local and systemic levels of tnf-α, il-6, and asprosin, alongside clinical periodontal parameters.


Eligibility criteria:
inclusion criteria: 1. willingness to participate in the study. 2. weight classification: * obese individuals: body mass index (bmi) of 30 kg/m² or higher. * normal-weight individuals: bmi between 18.5 and 24.9 kg/m². 3. periodontal health status: * bleeding on probing: less than 10%. * periodontal pocket depth: less than 3 mm. * no sites showing attachment loss or alveolar bone loss on radiographs. 4. for individuals with periodontitis: * at least two non-adjacent teeth must show signs of interdental attachment loss. * periodontal pocket depth greater than 3 mm. exclusion criteria: 1. individuals who have received periodontal therapy, any oral decontamination treatment, or antibiotics or steroids in the six months prior to the start of the study. 2. individuals who are pregnant or breastfeeding. 3. individuals diagnosed with rheumatoid arthritis or lupus erythematosus. 4. individuals with a medical history of radiation or cancer therapy. 5. patients with diabetes, defined by: * hemoglobin a1c (hba1c) level greater than 6.5%. * fasting blood glucose (fbg) greater than 126 mg/dl. * an abnormal oral glucose tolerance test (ogtt). 6. smokers.

Keywords: periodontitis obesity asprosin chronic inflammatory diseases
samba eu femoropopliteal trial

Conditions: Peripheral Vascular Disease

Summary: the primary objective of this study is to evaluate the safety and performance of the samba stent and delivery system in the treatment of femoropopliteal lesions.


Eligibility criteria:
inclusion criteria: screening 1. patient must be ≥ 21 years of age with life expectancy \> 1 year. 2. symptomatic leg ischemia requiring treatment of the superficial femoral and/or popliteal artery (rutherford category 2-4; claudication, rest pain). 3. patient must be a suitable candidate for pta and stenting. 4. patient is willing and able to return to the site of the investigation at the specified study intervals and undergo follow-up requirements. 5. the patient or legal representative has provided written informed consent using a form that is reviewed and approved by the ec for the clinical site. pre-intervention 1. target lesion has ≥ 50% stenosis as demonstrated angiographically. 2. lesion length ≤ 15 cm. 3. reference vessel diameter of 5 to 6 mm. 4. patient has at least 1 vessel run-off prior to treatment. exclusion criteria: screening 1. the subject is pregnant or will become pregnant during the study or has any other condition that would preclude having x-rays. (pre-menopausal women must have a negative pregnancy test within 7 days of the procedure.) 2. patients who have experienced a cardiovascular accident (cva) or a myocardial infarction (mi) within 3 months prior to the procedure. 3. subject has had or plans to have a surgical or interventional procedure within 30 days before or after the implantation procedure of the samba stent. 4. existing hemorrhagic disease or coagulation problems or inability to take dual anti-platelet therapy. 5. contrast allergy that cannot be corrected with medication (e.g. steroids, etc.). 6. subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment. 7. patient is currently participating in another investigational drug or device study. pre-intervention 1. uncorrectable severe aorto-iliac occlusive disease or severe common femoral artery stenosis preventing access or limiting inflow (e.g., stenosis greater than 50%). 2. uncorrectable occlusive disease limiting outflow (e.g., stenosis greater than 50%) 3. patients with previous surgery in the target vessel or stent that will be closer than 2 cm to either edge of samba stent(s). 4. lack of 1 cm of healthy vessel proximal to proximal target 5. lack of popliteal reconstitution (at least 2 cm of normal distal popliteal). 6. inability to cross the lesion with a guidewire. 7. more than 1 lesion in the same limb requiring treatment that will not be covered by continuous stenting. 8. unsuccessful balloon pre-dilation (i.e., the residual stenosis is greater than 30%).

Keywords: peripheral vascular disease - sfa and popliteal arteries.
responses to covid-19 vaccination in patients with cancer

Conditions: Cancer

Summary: this is an observational study that will prospectively record and monitor responses and clinical outcomes of patients with cancer after covid-19 vaccination, including measurements of antibody titers in serum and also record potential factors that affect immunity, such as type and stage of cancer, type and time of systemic therapy in relation to covid-19 vaccination.

it is well recognised that patients with cancer are at an increased risk of severe covid-19 disease and should be at high prioritisation for vaccination against sars-cov-2. in greece the vaccination of healthcare workers has been initiated in january 2021, elderly citizens as well and for cancer patients of all ages will be initiated early february 2021. there are very little available data on the efficacy of immunisation with vaccines overall in cancer patients, with most existing data involving the influenza vaccine. the covid-19 vaccine trials have not included cancer patients, therefore, the efficacy and duration of immunity in patients with cancer are still unknown. those patients are often immunocompromised due to their disease or the side-effects of their treatment. based on the above this study was designed to prospectively record and monitor patients with cancer after covid-19 vaccination. the study will record and measure clinical outcomes, such as possible infection from covid-19 despite vaccination, severity and mortality, but also possible side effects post vaccination. within the study serological responses (igg antibody titers) will also be monitored in three timepoints (prior to vaccination, one month and three months after completion of the two doses of vaccination). potential factors that affect immunity, will be recorded, such as type and stage of cancer, type and time of systemic therapy in relation to covid-19 vaccination.

Eligibility criteria:
inclusion criteria: * patients with solid tumours and potentially immunocompromised, ie. currently with active disease and/or undergoing active antineoplastic therapy of any type (chemotherapy, immunotherapy, biologic therapy, targeted therapy) that will be vaccinated for covid-19 within the national program of vaccination * patients must sign informed consent for their data monitoring and also for serum antibody titers to covid-19 vaccination measured in three timepoints, prior to 1st dose and 1 and 3 months post completion of two doses exclusion criteria: * patients with haematological malignancies are excluded * patients with prior diagnosis of cancer and now on follow-up without active disease are excluded * patients on adjuvant hormonal therapy are excluded

Keywords: covid-19 vaccination cancer patients immunity
insulin glulisine in healthy lean and obese subjects

Conditions: Diabetes Mellitus

Summary: primary objective * to investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration of two different doses (low dose, 0.2 iu/kg and high dose, 0.4 iu/kg) of insulin glulisine across healthy subjects in 4 different bmi-classes (lean, overweight, moderately obese, severely obese), using the euglycemic clamp technique with the biostator™. secondary objective * to investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous administration of insulin glulisine in comparison to insulin lispro and to investigate the safety and tolerability after subcutaneous administration of insulin glulisine in comparison to insulin lispro.


Eligibility criteria:
inclusion criteria : * normal hba1c * women have to either be postmenopausal, surgically sterilized, or not pregnant and using adequate contraception. exclusion criteria : * systemic concomitant medication