Kornimate/medical-research-clean huggingface dataset:
prevention of arteriovenous thrombotic events in critically-ill covid-19 patients trial

Conditions: COVID-19; Venous Thromboembolism; Arterial Thrombosis

Summary: the researchers wanted to learn how to help sick patients who are in the hospital because of covid-19. they are trying to find out the best way that is safe to stop blood clots that could be dangerous from forming in patients with covid-19. this research study happened at 34 hospitals. all patients in the study took medicines that help prevent blood clots. these medicines are called blood thinners or anticoagulants. patients got different amounts of blood thinners to see what works better and is safer. researchers randomly chose some patients to get more and some to get less. the researchers also wanted to know if another medicine called clopidogrel can safely help stop blood clots from forming. this kind of medicine helps keep parts of the blood, called platelets, from sticking together. in some patients who did not have other reasons to take a platelet-blocker the researchers randomly chose the patient to take clopidogrel or not. this type of medicine is also called an antiplatelet.

this is a multicenter, open-label, randomized-controlled trial in critically-ill patients with novel coronavirus disease 2019 (covid-19) evaluating the efficacy and safety of full-dose vs. standard prophylactic dose anticoagulation and of antiplatelet vs. no antiplatelet therapy (in a nested second randomization) for prevention of venous and arterial thrombotic events. in a subcohort without an ongoing indication for antiplatelet therapy at screening, the second randomization is performed to either antiplatelet or no antiplatelet therapy

Eligibility criteria:
inclusion criteria: 1. age ≥18 years (male or female) 2. acute infection with severe acute respiratory syndrome coronavirus 2 (sars-cov2) 3. currently admitted to an intensive care unit (icu) key exclusion criteria: 1. ongoing (\>48 hours) or planned full-dose (therapeutic) anticoagulation for any indication 2. ongoing or planned treatment with dual antiplatelet therapy 3. contraindication to antithrombotic therapy or high risk of bleeding due to conditions including, but not limited to, any of the following: 1. history of intracranial hemorrhage, known central nervous system (cns) tumor or cns vascular abnormality 2. active or recent major bleeding within the past 30 days with untreated source 3. platelet count \<70,000 or known functional platelet disorder 4. fibrinogen \<200 mg/dl 5. international normalized ratio (inr) \>1.9 4. history of heparin-induced thrombocytopenia 5. ischemic stroke within the past 2 weeks patients who meet the following criterion are excluded from the second randomization (antiplatelet therapy vs. no antiplatelet therapy): 1. ongoing or planned antiplatelet therapy, including aspirin monotherapy
sequencing of endocrine therapy in post-menopausal women with early breast cancer (fast)

Conditions: Post Menopausal Women With Early Breast Cancer

Summary: quality of life under therapy with aromasin® (exemestane) according to ibcsg (international breast cancer study group) questionnaire. change of the endometrium after switching from tamoxifen to aromasin® (exemestane). deeper knowledge of adverse events during routine administration.


Eligibility criteria:
inclusion criteria: * early breast cancer, post-menopausal, 2-3 yrs adjuvant tamoxifen therapy. exclusion criteria: * not applicable.

Keywords: aromatase inhibitor switch after tamoxifen quality of life safety
ultrasound paravertebral block in breast surgery.

Conditions: Breast Cancer

Summary: the purpouse of the study is to determine wether ultrasound guided,ens-assisted paravertebral block with single shot is a safe and reliable anesthetic technique in breast surgery.

general anaesthesia is currently the conventional technique used for breast surgery. thoracic paravertebral block (pvb) has been used with multiple injection. we compared a single injection thoracic pvb with general anaesthesia (ga) in 20 consenting patients, scheduled for unilateral breast surgery.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists classification i-iii * written informed consent * age older than 18 years old exclusion criteria: * allergy to local anesthetics * local sepsis

Keywords: ultrasound-guided paravertebral block regional anesthesia breast surgery
home study of subjects who have completed a previous continuous negative external pressure (cnep) clinical trial

Conditions: Obstructive Sleep Apnea

Summary: this study is designed to determine whether subjects who were responders to cnep during an overnight sleep lab titration in a previous clinical trial, study som-012, will maintain a response throughout the night for up to two weeks in a home setting. it will also be determined whether two weeks of home use of cnep is associated with any adverse events.


Eligibility criteria:
inclusion criteria: * must have completed study som-012 and been categorized as a "responder" * the subject agrees to participation by signing an informed consent statement exclusion criteria: * medical or social circumstances have changed since participation in som-012 such that continued use of cnep may provide questionable benefit or associated with increased risk
intraoperative optic nerve sheath diameter changes after laparoscopic surgery

Conditions: Optic Nerve Sheath Diameter; Intracranial Pressure Increase

Summary: laparoscopic surgery is a widely used alternative to open surgery; advantages include reduced bleeding and pain intensity, shorter hospital stay, and improved cosmetic results. laparoscopic surgery involves the creation of a carbon dioxide (co2) pneumoperitoneum to facilitate a clear surgical view, which can result in increased intracranial pressure (icp). ultrasonographic measurement of optic nerve sheath diameter (onsd) is a simple, non-invasive, yet reliable technique for icp assessment.ultrasonographic assessment of optic nerve sheath diameter (onsd) has been proposed as a non-invasive measurement of intracranial pressure.

ultrasonographic measurement of optic nerve sheath diameter (onsd) is a simple, non-invasive, yet reliable technique for icp assessment. previous studies have demonstrated that ultrasonographic measurement of onsd correlates with the degree of icp and can detect intracranial hypertension in a variety of clinical settings. it was planned to measure the optic nerve sheath throughout the surgery with the help of a linear ultrasound probe. ultrasonographically, in each measurement, the optic nerve sheath diameter (onsd) was detected 3 mm behind the entry point of the optic nerve into the globe in both eyes. onsd will be measured bilaterally 3 mm behind the papilla. it will be evaluated by transverse measurement for each optic nerve.

Eligibility criteria:
inclusion criteria: * 18-75 aged patients * american society of anesthesiologists classification (asa) i-ii-iii patients * patients undergoing laparoscopic surgery exclusion criteria: * american society of anesthesiologists classification (asa) iv-v patients * those with known ophthalmic disease * those with a history of ophthalmic surgery * those with any known neurological disorder * history of intracranial hypertension * patients who will undergo open abdominal surgery

Keywords: ultrasonography optic nerve sheath diameter laparoscopic surgery
myopia control with simultaneous vision approach

Conditions: Myopia

Summary: to determine if the 'defocus incorporated soft contact' (disc) lens slows myopia progression in hong kong schoolchildren using simultaneous vision approach.

the investigators hypothesize that the natural process of emmetropization in human is regulated by the equilibrium between the opposite hyperopic and myopic defocus. a sharp focus of retinal image (foveal fixation) is fundamental for co-ordination of the equilibrium. the disc lens is a custom-made multi-zone bifocal soft contact lens which is based on simultaneously provides clear vision and defocus at all viewing distances. it comprises of correcting zones for correcting distant prescription(correction of refractive error, and defocusing zones to incorporate constant myopic defocus for slowing down myopia progression.

Eligibility criteria:
inclusion criteria: * age 8-13 years * myopia (se) between -1d to -5d * astigmatism less than or equal to -1d * anisometropia: less than or equal to 1.25d * aided va (monocular): 0.00 log mar or better * willingness to wear contact lens constantly * availability for follow-up for at least 2.5 years * parents' understanding and acceptance * willing to provide refractive status of grandparents exclusion criteria: * severe ocular or systemic allergies * taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial * ocular or systemic condition that might affect refractive development * strabismus at distance or near * prior use of bifocal or progressive lenses * prior use of rigid gas permeable lenses and ortho-k lenses

Keywords: myopia progression myopia control simultaneous vision myopic defocus
graz study on the risk of atrial fibrillation

Conditions: Atrial Fibrillation; Hypertension; Diabetes; Chronic Heart Failure; Vascular Disease

Summary: atrial fibrillation (af) is the most common clinical arrhythmia. af is associated with increased risk for stroke due to blood clots formed in the fibrillating atria. some patient characteristics increase the likelyhood of af and at the same time the risk of stroke when af has developed. to reduce the risk of stroke, anticoagulation therapy is recommended in patients with af and risk factors (such as high blood pressure, diabetes, vessel disease). however, occasional (paroxysmal) af may occur without symptoms and remain undetected, leaving patients at risk. aim of the prospective randomized study is to compare two management strategies for patients at increased risk for af but without a known history of af. patients are seen regularly (monthly, then quarterly) for follow-up (incl. ecg recording and blood sample). one group of patients additionally receives a subcutaneous implantation of a loop recorder for continuous rhythm monitoring, while the control group remains on standard follow-up. observation period is one year (optional extension for 3 years). the time to first diagnosis of af is compared between groups, blood samples are analyzed for potential biomarkers of af.


Eligibility criteria:
inclusion criteria: * cha2ds2-vasc risk score \>= 4\* * 18 years or older exclusion criteria: * known history of atrial fibrillation * implanted rhythm device * pre-existing indication for oral anticoagulation (\*)cha2ds2-vasc: c - chronic heart failure (1 point); h - hypertension (1 point); a - age \>= 75 years (2 points); d - diabetes (1 point); s - stroke (2 points); v - vascular disease (1 point); a - age \>=65 and \< 75 years (1 point); sc - sex category (female) (1 point) ;

Keywords: atrial fibrillation biomarkers stroke prevention implantable loop recorder
to compare the efficacy and safey of vildagliptin compared to voglibose in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study is designed to evaluate the efficacy, safety and tolerability of vildagliptin compared to voglibose in patients with type 2 diabetes. please note this study is not being conducted in the united states.


Eligibility criteria:
inclusion criteria: * diagnosis as type 2 diabetes * patients who have been placed on dietary therapy/exercise therapy, without achievement of glycemic control * outpatients exclusion criteria: * type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes * significant heart diseases * significant diabetic complications other protocol-defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin hba1c
psychosocial factors and central sensitization in chronic pelvic pain

Conditions: Pelvic Pain; Vulvodynia; Pudendal Neuropathy

Summary: the purpose of this study is to determine if the psychosocial factors in women with chronic pelvic pain are predisposing, precipitant or maintenance factors, and relate these factors with central sensitization and dysfunctional pain.

this study pretends clarify the psychosocial factors presents in women with chronic pelvic pain, and determine if this factors are predisposing, precipitant or of maintenance, through an interview and a series of validated questionnaires. in addition, these findings will be related to the presence of central sensitization, as measured by quantitative sensory testing.

Eligibility criteria:
inclusion criteria: * age between 18 and 55 years * chronic pelvic pain diagnosis, defined as persistent pain in pelvis related structures * pain duration ≥6 months * average pain intensity ≥3/10 in nrs during the previous week * to understand the objectives of the study exclusion criteria: * suspicion or knowledge of current organic pathology that requires medical or surgical treatment * pain as a consequence of surgery known * pending litigation or financial compensation * psychiatric disorders: major depression, bipolar syndrome, etc .. * cognitive difficulties * not sign the informed consent

Keywords: chronic pelvic pain vulvodynia pelvic pain psychosocial factors central sensitization
study evaluating intepirdine (rvt-101) in subjects with mild to moderate alzheimer's disease on donepezil: mindset study

Conditions: Alzheimer's Disease

Summary: this study seeks to confirm a demonstrated treatment effect of intepirdine (rvt-101) as an adjunctive therapy to donepezil for the treatment of subjects with alzheimer's disease.

this phase 3 study seeks to confirm a demonstrated treatment effect of intepirdine (rvt-101) on both cognition and activities of daily living when added to stable donepezil treatment in subjects with mild-to-moderate alzheimer's disease after 24 weeks of double-blind treatment. this study will also provide further information on the safety and tolerability of the 35-mg dose of intepirdine (rvt-101) when used in combination with donepezil compared to donepezil alone. this study is being conducted under the agreement of a special protocol assessment by fda. subjects completing this study will be eligible to enroll in a 12 month open-label study of rvt-101 (rvt-101-3002) in which concomitant medications for the treatment of alzheimer's disease including memantine will be allowed.

Eligibility criteria:
inclusion criteria: * male or female subject with ad * ongoing donepezil therapy for ad * an mmse score 12 to 24 inclusive at screening; mmse score 10-26 inclusive at baseline * hachinski ischaemia score less than or equal to 4 at screening. * if female, subject must be: a. of non-childbearing potential or surgically sterile; or, b. willing to use an adequate methods of birth control. male subjects who are sexually active will also be required to use an adequate form of birth control. * subject has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator. * subject has a reliable caregiver who is willing to report on subject's status throughout the study. exclusion criteria: other causes for dementia * diagnosis of vascular dementia * atypical clinical features or clinical course of dementia that would lead the investigator to conclude symptoms are more likely due to an alternate dementia diagnosis including, but not limited to, frontotemporal dementia, lewy body dementia, or others. confounding medical conditions * history of significant psychiatric illness such as schizophrenia or bipolar affective disorder or any other significant psychiatric illness that in the opinion of the investigator would interfere with participation in the study; * any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.

Keywords: alzheimer's disease rvt-101 donepezil intepirdine dementia
a clinical study to evaluate safety and immunologic response of combig-dc, in patients with metastatic kidney cancer

Conditions: Metastatic Renal Cell Carcinoma

Summary: the primary objective of this study is to answer the question "is it possible to inject the combig-dc vaccine in a renal tumour without getting unacceptable side effects"? patients newly diagnosed with metastatic renal cell carcinoma will get combig-dc vaccinations at two occasions in a two weeks period (day 1 and day 14). after another two weeks the kidney will be eliminated. adverse events will be registered, as well as changes in vital signs(heart rate, blood pressure and body temperature) and lab parameters. immunologic response will be evaluated by measuring immunologic markers in blood and tumour tissue, and measuring the size of the metastases three months after nephrectomy.


Eligibility criteria:
inclusion criteria: 1. be informed of the nature of the study and have provided written informed consent 2. at least 18 years of age. 3. diagnosis of renal cell carcinoma with at least one distant metastasis, and/or one distant lymph node metastasis. 4. tumor size (renal cell carcinoma; primary tumor) at least 4.0 cm in longest diameter as measured by ct. distant metastasis at least 1 cm diameter as measured by ct or a distant lymph node metastasis at least 2,5 cm diameter as measured by ct. clinical stage 't1b or more; nx; m1' 5. adequate hematological parameters, i.e: b-leukocyte count ≥ 4.5 x 109/l b-platelet count ≥ 150 x109/l b-haemoglobin ≥ 100 g/l 6. women of childbearing potential (wocbp) should use adequate contraception (oral or injectable contraceptives, hormone releasing intrauterine device) throughout the study period. exclusion criteria: 1. performance status \> ecog 2 after optimization of analgesics 2. adequate coagulation parameters, i.e: p-prothrombin complex (pk), p-apt time 3. ongoing treatment with systemic corticosteroids (inhaled, intranasal and local steroids accepted) within 28 days before first vaccination. 4. previously known or ongoing active autoimmune disease which requires treatment with systemic immunosuppressive agents. e.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid arthritis, sle, vasculitis, sjögren's syndrome, scleroderma, autoimmune hepatitis, and other rheumatological diseases. 5. patients with previous or ongoing skin malignancy (basal-cell carcinoma, squamous cell carcinoma, melanoma), other hematological or solid malignancy or blood dysfunctions. 6. ongoing infection that requires treatment with antibiotics. 7. known major reaction/adverse event in connection with previously made vaccination (e.g. asthma, anaphylaxis or other serious reaction) 8. known malignancy in cns. 9. active or latent virus disease (hiv, hbv and hcv). 10. ongoing pregnancy or lactation. females needs to have negative pregnancy test at screening visit. 11. life expectancy less than 3 months. 12. concomitant exposure to other investigational products. 13. any reason that, in the opinion of the investigator, contraindicates that the patient participates in the study.
telephone-based program to promote inhaled corticosteroid adherence among individuals with asthma

Conditions: Asthma

Summary: inhaled corticosteroids (ics) are often prescribed as a treatment for asthma. however, many individuals who take these medications do not adhere to their prescribed treatment regimen. the purpose of this study is to evaluate the effectiveness of a telephone-based program at improving medication adherence among individuals with asthma.

asthma is a serious, chronic disease that affects lung function and impairs an individual's ability to breathe normally. ics reduce airway inflammation and are often prescribed to treat these conditions. however, poor medication adherence is a common problem that can lead to treatment failure, hospitalization, or death. a telephone-based system that uses interactive voice recognition technology to remind individuals to follow their medication regimen may prove beneficial in promoting adherence. the purpose of this study is to evaluate the effectiveness of such a telephone-based intervention at improving adherence to inhaled corticosteroid regimens among individuals with asthma. if this study proves successful, telephone-based interventions may be developed to promote treatment adherence for other chronic medical conditions. this 19-month study will enroll approximately 14,000 members of the kaiser permanente northwest or hawaii health system. participants will be randomly assigned to either take part in the telephone intervention or receive usual medical care. over the 19-month period, participants in the intervention group will receive between one and eight phone calls that will remind them to refill their prescriptions and offer education about ics. if needed, the call may also offer a transfer to a pharmacy refill line or to speak with a pharmacist. approximately 2,000 participants will complete questionnaires at study entry and at the end of the 19-month intervention period. the questionnaires will assess quality of life, respiratory health, asthma control, depression, inhaler use beliefs, and satisfaction with the intervention. electronic medical record data and questionnaires will be used to determine adherence rates.

Eligibility criteria:
inclusion criteria: * received treatment for asthma in the year prior to study entry * received at least one respiratory medication at a kaiser permanente northwest (kpnw) or kaiser permanente hawaii (kph) outpatient pharmacy in the year prior to study entry * continuous kaiser permanente membership from the year prior to study entry through study entry * willing to participate in the study exclusion criteria: * excluded from primary analyses if fewer than three months of follow-up

Keywords: inhaled corticosteroids ics adherence