Kornimate/medical-research-clean huggingface dataset:
radiomic markers for breast cancer metastasis and treatment response using mri

Conditions: Invasive Breast Cancer

Summary: the primary aim of the study is to identify radiomic features as biomarkers of metastatic progression following primary therapy.

the study aims to evaluate radiomic markers in breast tumors to evaluate metastatic risk based on radiomic features following primary therapy. the investigators aim to analyze images at various time intervals before, during and after primary treatments using two advanced imaging techniques (dce-mri \& dwi-mri).

Eligibility criteria:
inclusion criteria: 1. subjects must give appropriate written informed consent prior to participation in the study; 2. subjects must be able and willing to comply with the safety procedures during the scanning period; 3. subjects must be men and women age 18+ 4. biopsy-confirmed diagnosis of invasive breast cancer; (er+/-, pr+/-, her2+/-). 5. stage i-iii disease according to the ajcc v7 criteria. 6. patients with sufficient renal function (creatinine clearance, i.e., \>=30 ml/min/1.73 m2). 7. primary treatments can include neoadjuvant chemotherapy or surgery exclusion criteria: * 1. subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. silicone/saline implants) involving either breast, exclusive of the lesion at issue. 2. subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast 3. subjects with a current or past medical history of connective tissue disease 4. subjects who are pregnant or lactating 5. subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator 6. subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety, history of musculoskeletal disease which may predispose them to discomfort during the imaging/scanning period. 7. allergies to any contrast agent administered to this study.
a new interdisciplinary collaboration structure to improve medication safety in the elderly

Conditions: Health Services for the Aged; Medication Therapy Management

Summary: suboptimal use of medications among geriatric patients is well-known problem and leads to medication errors, re-hospitalizations and death. by using a randomized controlled trial (rct) design the investigators aim to explore a new inter-professional working structure. the working structure is based on the scientifically and clinically acknowledged integrated medicines management (imm) model. the overall aim of the study is to explore the effect of the new working structure on the composite endpoint re-hospitalization + visit to an emergency department during 12 months after hospital discharge.


Eligibility criteria:
inclusion criteria: * aged ≥70 years * admitted to the geriatric internal medicine ward in the university hospital of north norway (unn) tromsø or the general internal medicine ward in unn harstad. * willing to provide written informed consent during hospital stay (patient or next of kin) exclusion criteria: * unable to communicate in norwegian (patient or next of kind) * terminally ill, e.g cancer in end-life stage * control group patients where the physician request an assessment from a pharmacist * time from admittance to the ward to inclusion is more than 72 hours * occupying a bed in the study wards but under the care of physicians from a non-study ward. * planned discharged on the inclusion day
italian ittp registry

Conditions: TTP - Thrombotic Thrombocytopenic Purpura

Summary: italittp is an observational, prospective, single-arm, national, multicenter, non-pharmacological cohort study aimed at better defining and understanding the natural history, disease severity, and clinical outcomes of patients with immune-mediated thrombotic thrombocytopenic purpura (ittp) in italy. a minimum of 132 consecutive patients with acute ittp (first event or relapse) will be enrolled for 3 years, with the possibility of extension, with a follow-up period of 3 years.

acquired immune-mediated thrombotic thrombocytopenic purpura (ittp) is a rare, life-threatening thrombotic microangiopathy characterized by episodes of thrombocytopenia, microangiopathic hemolytic anemia, and extensive microvascular thrombosis leading to multiorgan involvement. despite advances in understanding ittp etiology and management in the acute phase, significant gaps in knowledge about its progression, particularly during clinical remission and concerning long-term complications, persist. italittp, a national, multicenter, observational, prospective, non-pharmacological cohort study, aims to elucidate the natural history, severity, and outcomes of ittp in italy. the study will enroll hospitalized ittp patients (experiencing either initial or recurrent episodes) and follow them in outpatient settings across participating italian centers. the study plans to include at least 132 patients of any gender, aged 12 to 99, over a three-year period, with an option for extension, and a three-year follow-up. during hospitalization and subsequent outpatient visits, participants will undergo routine clinical assessments and laboratory tests. in addition to these data, peripheral blood samples will be collected for adamts13 analysis and potential future research.

Eligibility criteria:
inclusion criteria: * patients with an acute ittp episode (first event or relapse), defined by thrombocytopenia and microangiopathic hemolytic anemia, in the absence of alternative causes, and the presence of severe deficiency of adamts13 activity (\< 10 iu/dl or \<10% of normal value) and anti-adamts13 autoantibodies * both male and female patients, aged 12 years or older * patients who have signed the informed consent for the participation to the study exclusion criteria: * patients who have not signed the informed consent for the participation to the study

Keywords: adamts13 thrombotic microangiopathy
dose de-escalation to the elective nodal sites in head and neck cancer

Conditions: Head and Neck Cancer

Summary: a randomized clinical trial was initiated to investigate whether a reduction of the dose to the elective nodal sites and the swallowing apparatus delivered by imrt would result in a reduction of acute and late side effects without compromising tumor control.

1. study hypothesis dose de-escalation in the elective nodal sites and off-target regions of the swallowing apparatus delivered by imrt does reduce overall rate of late dysphagia and neck fibrosis comparing to the standard dose to the elective nodal sites. 2. primary endpoint to estimate the difference in overall rate of late dysphagia and neck fibrosis 1 year after the end of radiotherapy in patients receiving dose de-escalation to the elective nodal sites and off-target regions of the swallowing apparatus applying imrt. 3. secondary endpoints local, regional and distant control recurrence and site of recurrence overall, disease-free and disease-specific survival acute toxicity quality of life

Eligibility criteria:
inclusion criteria: oral cavity, oropharynx, hypopharynx and larynx scc histolocervical lymph node metastases of unknown primary cancer primary unresectable tumor and/or patients refused surgery stage t2-4; t3-4 n0 tany n1-3 for laryngeal cancer karnofsky performance status ≥70% age ≥ 18 years old exclusion criteria: treatment combined with brachytherapy prior irradiation to the head and neck region history of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease at least 5 years distant metastases pregnant or lactating women patient unlikely to comply with the protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
tf-antigen targeting molecular probe for pet imaging in solid tumors

Conditions: Solid Tumors

Summary: the objective of the study is to construct a noninvasive approach using 124i-labeled monoclonal antibody radiotracer to detect the thomsen-friedenreich antigen (tf-antigen, cd176) expression of tumor lesions in patients with solid tumors and to identify patients benefiting from tf-antigen targeting treatment.

analysis plan: 1. recruit 3-5 participants to analyze preliminary pharmacokinetic/first-in-human dose (fih), major organ distribution, and tumor uptake information via whole-body pet/ct imaging; 2. recruit 20 participants to analyze in vivo safety and tumor targeting information; 3. recruit all participants for a final summary.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤ 75 years, male or female; 2. ecog performance status score of 0 or 1; 3. expected survival time ≥ 6 months; 4. at least one measurable tumor lesion exists according to recist 1.1 criteria (e.g., lung cancer, gastric cancer, colorectal cancer, breast cancer, pancreatic cancer, hepatocellular carcinoma). the lesion must be eligible for biopsy within one month before or after a pet scan, and the patient must be able to provide 2-3 tissue slices of the lesion; 5. subjects must fully understand and voluntarily agree to participate in the study and sign an informed consent form. exclusion criteria: 1. pregnant or breastfeeding women, or women planning to become pregnant during the study period or within three months after drug administration, as well as individuals donating sperm or eggs; 2. individuals known or suspected to be allergic to the investigational drug or any of its components; 3. individuals with significantly impaired liver or kidney function; 4. individuals unable to comply with pet examinations or those with conditions such as claustrophobia that prevent them from undergoing pet scans.

Keywords: solid tumors tf-antigen cd176 pet imaging
first trimester of pregnancy: impact of a history of miscarriage on women's stress

Conditions: Pregnancy

Summary: miscarriage is the spontaneous termination of pregnancy before 22 weeks of amenorrhea. the most frequent complication of pregnancy, it represents 10 to 25% of pregnancies and affects one in four women. miscarriage is considered by medical personnel to be common and trivial. however, for women, it is very often a traumatic event, a source of worry for futures pregnancies.

the aim of the study is to evaluate association between history of spontaneous termination of pregnancy and women's stress during the first trimester of pregnancy.

Eligibility criteria:
inclusion criteria: * female * pregnant (positive plasma hcg) * in the first trimester of pregnancy * aged 18 years old and more * agreeing to participate in the study exclusion criteria: - less than 18 years old

Keywords: pregnancy women's stress history of spontaneous termination of pregnancy
feasibility clinical investigation using the inpress device for the treatment of postpartum hemorrhage

Conditions: Post Partum Hemorrhage

Summary: feasibility trial of the inpress device to treat postpartum hemorrhage (pph).

10 subjects in first in woman trial with ethics committee oversight. women who developed postpartum hemorrhage were treated with the inpress device. the intent of treatment was to quickly reduce or stop blood flow by addressing the driving cause of hemorrhage: uterine atony. the primary objective is to verify the safety of the inpress device in humans, including: 1. absence of saes related to the use of the inpress device intra- and post-procedure. 2. evaluate any observable damage of the uterus, cervix, or vagina due to the use of the inpress device. 3. evaluate occurrence of uterine inversion or folding during the use of the inpress device. the secondary objectives include evaluations of: 1. ability to easily place the inpress device transvaginally. 2. ability to connect the inpress device to vacuum and maintain desired negative pressure. 3. ability of inpress device to contract the uterus to a level that reduces or stops blood loss and avoids further surgical intervention. 4. evaluate time from insertion and start negative pressure to visible reduction of blood loss.

Eligibility criteria:
inclusion criteria: * subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation * female adult subjects (\>18 years of age) * subjects who present with an atonic uterus for at least 10 minutes after expulsion of placement with failure to obtain contraction and/or subjects who have lost blood post-partum \>= 500 ml and according to the investigator's judgment, require an intervention. exclusion criteria: * subjects who do not provide informed consent to participate in the clinical investigation. * subjects who deliver at a uterus size \< 34 weeks. * subjects who have lost greater than 1000 ml of blood. * subjects who have abnormal pt, ptt and inr * subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.

Keywords: post partum hemorrhage
study intestinal complaints during chemotherapy.

Conditions: Constipation

Summary: study intestinal complaints during chemotherapy. a prospective study into intestinal complaints in patients undergoing chemotherapy treatment. a pre and post implementation design is used to establish if eating two kiwi fruits per day can prevent constipation.

the medical research involving human subjects act (wmo) does not apply to this research. nonetheless it will be conducted according to the principals of good clinical practice (gcp), privacy legislation (avg) and medical treatment agreement act (wgbo). the consumption of eating two kiwi's a day can be seen as a slight variation on standard advice with regards to a healthy diet. maintaining a diary may take some time from the participant but at the same time is of use during follow up visits where side effects, including the occurrence of constipation are discussed. the the study is approved by the advisory committee on local feasibility (aclu) of the spaarne gasthuis.

Eligibility criteria:
inclusion criteria: 1. first chemotherapy/cytostatics treatment 2. neo-adjuvant or adjuvant treatment 3. performance status world health organization (who) 0-1 4. age 18+ 5. written informed consent 6. command of the dutch language exclusion criteria: 1. kiwi allergy 2. patients using standard laxatives prior to the first chemotherapy/cytostatic treatment. 3. patients with a history of bowel resection 4. patients with stoma

Keywords: kiwifruit chemotherapy
study to evaluate the safety and efficacy of sdp-4 in subjects with dry eye disease (ded)

Conditions: Dry Eye

Summary: sdp-4-cs201, is a phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the ocular and systemic safety and efficacy of sdp-4 ophthalmic solution in subjects with moderate to severe dry eye disease over a 12-week treatment period. three concentrations (0.1%, 1.0% and 3.0%) of sdp-4 ophthalmic solution will be given to parallel groups via topical ocular instillation bid.


Eligibility criteria:
inclusion criteria: * have ded in both eyes for ≥ 6 months prior to visit 1/screening. * total score ≥ 40 on the sande questionnaire. * tear break-up time (tbut) of ≤ 6 seconds in both eyes. * anesthetized schirmer's test tear volume ≥ 4 mm and \<10 mm in both eyes. exclusion criteria: * ocular surface corneal disease, other than ded. * lid margin disorder other than meibomian gland dysfunction (mgd). * any previous reconstructive or cosmetic eyelid surgery that may affect the normal function of the lids * any previous invasive glaucoma and/or corneal surgery * corneal refractive surgery in the 12 months prior to visit 1/screening. * cataract extraction within 90 days prior to visit 1/screening. * use of ophthlamic corticosteroids, nsaids, antibiotics, antihistamines, iop lowering medication, in the 30 days prior to visit 1/screening * serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments
prehospital risk stratification in acute coronary syndromes

Conditions: Acute Coronary Syndrome; Non-ST Elevation Myocardial Infarction (nSTEMI)

Summary: a feasibility study of prehospital echocardiographic examination and point-of-care troponin analysis, conducted by paramedics, in patients with suspected acute coronary syndrome. echocardiographic images are sent together with information of tnt values and ecg signs to there cardiologist on call, deciding for immediate cath lab (pci) evaluation or local hospital evaluation.

assessing the feasibility and sensitivity and specificity of prehospital risk stratification by echocardiography and troponin t in patients with suspected acute coronary syndrome, compared with conventional in-hospital evaluation. the trial will be conducted at sørlandet hospital, norway. one acute care ambulance in agder county will be equipped with a high-end cardiac ultrasound scanner with wireless communication to the cardiac centre/cardiologist, and a point-of-care troponin t quantitative analysis kit paramedics will be offered a comprehensive hands-on course in cardiac ultrasound image acquisition by an echo-technician and a cardiologist. similar, a short course will be given in point-of-care troponin analysis. imaging quality communication between paramedic and cardiologist established image transfer and interpretation by cardiologist functional technical problems addressed and solved in collaboration with manufacturer

Eligibility criteria:
inclusion criteria: * patients presenting to the medical dispatch center (amk) with chest pain; norwegian medical index criteria a10.2- a10.11 * men and women * age ≥ 18 * informed consent for participation * examined by paramedics in a prehospital setting due to newly onset (\ 20 min) and suspected ami exclusion criteria: * any condition which interfere with the ability to cooperate * hemodynamic instability * severe mental disorder * pregnancy or breast-feeding * stemi * obvious non-cardiac origin of the chest pain
effect of treatment with insulin sensitizer on arterial properties, metabolic parameters and liver function in patients with nonalcoholic fatty liver disease

Conditions: Nonalcoholic Fatty Liver Disease

Summary: abstract background: insulin resistance has an important role in the development of nonalcoholic fatty liver disease (nafld) and is involved in both pathological processes: hepatic steatosis and atherosclerosis. therefore, treatment of nafld with insulin sensitizers is likely to have a favorable effect towards hepatic steatosis and cardiovascular outcomes. objectives: the present study investigated the effect of metformin on arterial properties, metabolic parameters and liver function in patients with nafld. methods in randomized, placebo controlled study, 63 patients with nafld were assigned to one of two groups: group 1 received daily metformin; group 2 received placebo. pulse wave velocity (pwv) and augmentation index (ai) were performed using sphygmocor (version 7.1, atcor medical, sydney, australia) at baseline and at the end of 4-month treatment period.. metabolic measures and serum adiponectin levels were determined.


Eligibility criteria:
inclusion criteria: * in a single-center study, 63 patients (32 males and 31 females) diagnosed with nonalcoholic fatty liver disease were recruited from the outpatient clinic and evaluated for the study. exclusion criteria: * patients with history of unstable angina, mi, cva or major surgery within the six months preceding entrance to the study. * patients with unbalanced endocrine disease or any disease that might affect absorption of medications. * patients with plasma creatinine \> 1.5 mg/dl, and electrolyte abnormalities.

Keywords: nonalcoholic fatty liver disease pulse wave velocity augmentation index metformin
mucociliary clearance time in chronic rhinosinusitis (crs) patients after sinus surgery

Conditions: Chronic Rhinosinusitis

Summary: the investigators are looking at the effects of baby shampoo nasal irrigation on the movement of mucous in the nose in patients who have undergone sinus surgery for chronic sinus problems.


Eligibility criteria:
inclusion criteria: * crs * s/p sinus surgery exclusion criteria: * nasal polyps
denosumab in combination with chemotherapy as first-line treatment of metastatic non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this randomized phase 2 trial is studying the effect of adding denosumab to standard chemotherapy in the treatment of advanced lung cancer.

this is a global randomized double-blind placebo-controlled study in patients with stage iv untreated non-small cell lung cancer (nsclc) with or without bone metastasis. eligible participants are to receive 4 to 6 cycles of a standard of care platinum-doublet chemotherapy regimen. participants will be randomized in a 2:1 ratio to receive denosumab or matching placebo with the first investigational product dose coinciding with participant's first cycle of chemotherapy and continuing until the primary analysis, unacceptable toxicity, withdrawal of consent, death, or lost to follow-up. participants who discontinued the investigational product early (ie, before primary analysis) were followed for disease status and survival. the primary analysis took place when 149 events of death had been reported. all participants were followed for 2 years after the last dose of blinded investigational product.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iv non-small cell lung carcinoma (nsclc), according to 7th tumor/node/metastasis (tnm) classification (cytological specimens obtained by bronchial washing or brushing, or fine-needle aspiration are acceptable) * subject has available and has provided consent to release to the sponsor (or designee) a tumor block with confirmed tumor content (or approximately 20 unstained charged slides \[a minimum of 7 slides is mandatory\]) and the corresponding pathology report * planned to receive 4 to 6 cycles of pemetrexed or gemcitabine in combination with cisplatin or carboplatin • for subjects to receive pemetrexed, planned to receive vitamin b12 and folate per pemetrexed approved labeling * radiographically evaluable (measurable or non-measurable) disease (according to modified response evaluation criteria in solid tumors (recist) 1.1 criteria * other inclusion criteria may apply exclusion criteria: * known presence of documented sensitizing epidermal growth factor receptor (egfr) activating mutation or echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (eml4-alk) translocation (screening following local standards, but strongly encouraged in non-squamous histology) * known brain metastases (systematic screening of patients not mandatory) * any prior systemic therapy (before randomization) for the treatment of nsclc (including chemoradiation), except if for non-metastatic disease and was completed at least 6 months prior to randomization * planned to receive bevacizumab * significant dental/oral disease, including prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw, or with the following: * active dental or jaw condition which requires oral surgery * non-healed dental/oral surgery * planned invasive dental procedures for the course of the study.