Kornimate/medical-research-clean huggingface dataset:
testosterone implants and the incidence of breast cancer

Conditions: Breast Cancer

Summary: this current chart review study was designed to investigate the incidence of breast cancer in women treated with subcutaneous testosterone therapy for symptoms of hormone deficiency.

a prior ten-year prospective, observational, study was initially approved in march of 2008 by the irb board through the atrium medical center, premier health partners in middletown, ohio 45005 and registered through the office for human research protections (ohrp). expedited approval continued annually through 2013 at which time the irb board was closed. all participants signed a study consent and hippa consent. recruitment closed in 2013. the original protocol was designed to investigate the incidence of breast cancer in women presenting with symptoms of hormone deficiency treated with subcutaneous testosterone implants or, testosterone combined with the aromatase inhibitor anastrozole implants. a computer program was specifically designed to track and follow patients prospectively and all patients continued to be followed through 2018.

Eligibility criteria:
inclusion criteria: * female patients treated between march 2008 - march 2013 * women who received at least two testosterone pellet insertion procedures * women previously accrued to the prospective cohort study exclusion criteria: * pre-existing breast cancer * women who received a single testosterone pellet insertion
predictive value of the "cytocapacity test" patients with lymphoproliferative diseases and high-dose therapy

Conditions: Hodgkin's Disease; Non-Hodgkin Lymphomas; Multiple Myelomas

Summary: this investigator initiated trial was a prospective, open, single-arm, diagnostic-prognostic study. patients who received high-dose therapy with autologous stem cell transplantation for the treatment of their lymphoproliferative disease were included into the study. after completion of the high-dose therapy (day -2 with respect to the stem cell transplantation) the first blood sample a for the cytocapacity test with determination of leukocytes and neutrophils was taken in the evening of day -1. directly thereafter the study medication was administered. the second blood sample b for the cytocapacity test with determination of leukocytes and neutrophils was taken in the morning of day 0, 12-14 hours after administration of the study medication. thereafter the stem cell re-infusion was performed. the primary objective of this study was to show that the cytocapacity test with lenograstim is a useful predictive tool with respect to the risk of post-transplant complications and prolonged myelosuppression, typically occurring after high-dose chemotherapy. the primary variables were: * the rate of patients with documented infections * the time to platelet engraftment


Eligibility criteria:
inclusion criteria: * presence of histologically proven lymphoproliferative disease specified as hodgkin's disease, non-hodgkin's lymphoma (nhl) or multiple myeloma * indication of high-dose therapy and autologous peripheral blood stem cell transplantation * availability of a sufficient amount of blood stem cells (cd34+ cells \>= 2.0 x 106/kg) * age between 18 and 70 years * high-dose therapy with one of the following high-dose regimes: melphalan 140 mg/m2 or 200 mg/m2, beam, beac, bucy or cbv (the last permitted according to amendment 2, see section 9.8.1) * patient's written consent to participation in this trial exclusion criteria: * previous high-dose therapy and blood stem cell transplantation except for melphalan 140 mg/m2 or 200 mg/m2 in patients with multiple myeloma who did not participate in the cytocapacity test previously (according to amendment 2, see section 9.8.1). * known intolerance to lenograstim * out-patient therapy following high-dose therapy and blood stem cell transplantation * myocardial infarction \< 6 months prior to inclusion into the study * cardiac arrhythmias lown iv b * clinically manifest cardiac insufficiency (\> nyha ii) * renal insufficiency with serum creatinine \> 2 mg% * hepatic diseases with elevated levels of transaminases and bilirubin greater than 3-fold above normal * severe infections (hiv, hepatitis b/c) * severe psychiatric diseases * non-curative treatment of other malignoma within the past 5 years * pregnant women or women breast-feeding

Keywords: lymphoproliferative diseases (hodgkin's disease, non-hodgkin's lymphomas, multiple myelomas) and high-dose therapy
postmarketing surveillance of atrovent® in chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to obtain further information on the tolerability and efficacy of atrovent® inhalets in long term treatment of chronic obstructive pulmonary disease under conditions of daily practice


Eligibility criteria:
inclusion criteria: * primarily patients of both gender, older than 40 years, who suffer from chronic obstructive pulmonary disease * only patients who had not been treated with atrovent® within the last year were to be considered for inclusion exclusion criteria: • contraindications listed in the instructions for use/summary of product characteristics for atrovent® inhalets
cardiac telerehabilitation versus in-person after acute coronary syndrome

Conditions: Acute Myocardial Infarction (AMI); Cardiac Rehabilitation

Summary: the purpose of this trial is to evaluate wether a cardiac telerehabilitation programme is as effective as an in-person rehabilitation program after acute coronary syndrome in the control of cardiovascular risk factors

the purpose of this trial is to evaluate wether a cardiac telerehabilitation programme is as effective as an in-person rehabilitation program after acute coronary syndrome in the control of cardiovascular risk factors via the following variables: % patients with a positive result in the composite variable integrating different targets for secondary prevention in cardiovascular disease and lifestyle habits; adherence to cardiac rehabilitation program; adherence to pharmacological treatment; quality of life improvement ; anxiety and depression; satisfaction rate; functional capacity; cardiac cause hospitalization; emergency visits; and angioplasty revascularization procedure.

Eligibility criteria:
inclusion criteria: * acute myocardial infarct prior to 2 months * killip i-ii classification * no previous myocardial infarction * no angina pectoris * no ischemia in complementary explorations * normal arterial pressure response during stress test. * no relevant arrythmias * left ventricular ejection fraction \>= 35% * functional capacity \>5 mets * signing of the inform consent exclusion criteria: * physical or intellectual disability that prevents patients from enrolling in a cardiac rehabilitation program * impossibility for digital media use
a study of shr-a1811 as neoadjuvant treatment for patients with hr-positive, low her2 expression breast cancer

Conditions: HER2 Low Breast Carcinoma

Summary: hr-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. neoadjuvant chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. however, the pathological complete response (pcr) rate obtained is low. her2 is an important prognostic indicator and therapeutic target for breast cancer. nearly 60% of hr-positive breast cancers have low expression of her2, and antibody-drug conjugates (adc) targeting her2 may achieve better efficacy in this subtype.

this prospective, single-arm study is being conducted to evaluate the efficacy and safety of shr-a1811 for early-stage or locally advanced breast cancer patients with hr-positive, low her2 expression. subjects will receive the neoadjuvant therapy of shr-a1811 for eight cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. the follow-up visit will last for at least 5 years.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 to 70 years old (inclusive); 2. treatment-naive patients with clinically confirmed t2-t3, any nodal status and m0; 3. hr-positive, her2 low expression, the expression of ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology; 4. ecog performance status of 0-1; 5. normal organ and bone marrow function; 6. patients of childbearing age must consent to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding; 7. patients voluntarily joined the study and signed informed consent; exclusion criteria: 1. patients have evidence of metastatic breast cancer, or inflammatory breast cancer; 2. patients previously received antineoplastic therapy or radiotherapy for any malignancy, excluding cured malignancies such as cervical carcinoma in situ, basal cell carcinoma, or squamous carcinoma; 3. patients received any other anti-tumor therapy at the same time, including endocrine therapy, bisphosphonates or immunotherapy; 4. patients have major surgical procedures unrelated to breast cancer within 4 weeks before the first medication, or not fully recovered from surgical procedures; 5. clinically significant pulmonary or cardiovascular disease; 6. failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption; 7. known to be allergic to any study drug or any of its excipients; 8. history of immunodeficiency, including hiv-positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 9. pregnant and lactating women; 10. patients with serious concomitant diseases or other comorbidities that will interfere with the planned treatment, or any other condition that is not suitable for participation assessed by investigator.
phase ii study of ribose, uridine, and thymidine for a complex syndrome involving excessive 5'-nucleotidase activity

Conditions: 5'-Nucleotidase Syndrome

Summary: objectives: i. evaluate the efficacy of oral ribose in patients with a complex 5'-nucleotidase syndrome who have not received uridine (ur) and thymidine (tdr). ii. evaluate the efficacy of ur/oral ribose and ur/tdr. iii. evaluate the efficacy of oral ribose given in combination with ur/tdr.

protocol outline: newly identified patients receive ribose daily for 8 weeks. patients who improve continue therapy. if improvement then reaches a plateau, uridine (ur) and thymidine (tdr) are added to the regimen. patients who receive no benefit after 8 weeks of ribose are treated with ur/tdr. patients who improve after 8 weeks of this combination continue therapy. ribose is added to the treatment regimen for patients on ur/tdr at entry. at maximal improvement, tdr and ur are sequentially tapered.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- complex syndrome with excessive skin fibroblast 5'-nucleotidase activity characterized by: recurrent infection seizure disorder speech impairment attention deficit and behavior problems --prior/concurrent therapy-- concurrent uridine and thymidine therapy allowed --patient characteristics-- other: no pregnant women

Keywords: 5'-nucleotidase syndrome inborn errors of metabolism rare disease
association between post-operative anemia and mortality after valvular heart surgery

Conditions: Patients Undergoing Valvular Heart Surgery

Summary: the investigators aimed to evaluate whether postoperative anemia can predict 1-year mortality after valvular heart surgery independent of preoperative anemia. patients who underwent valvular heart surgery were divided into four groups according to whether or not they had preoperative and postoperative anemia. postoperative one-year mortality, as well as overall mortality and a composite of death and heart failure requiring hospitalization, was investigated according to the groups, adjusted by confounders.


Eligibility criteria:
inclusion criteria: * patients who underwent valvular heart surgery between january 2016 and july 2023 at severance cardiovascular hospital of yonsei university health system. exclusion criteria: * patients who underwent only pulmonary valve surgery * those with missing hemoglobin values at 2months after the surgery, due to loss of follow up or death.
gene expression profiling to help define the need for neo-adjuvant chemotherapy in hr+, her- breast cancer patients

Conditions: Breast Cancer

Summary: the goal of the experiment is surgical de-escalation. patients with newly diagnosed ct1-3, cn1, cm0 and hr+, her2- breast cancer and low clinical risk usually first receive breast cancer surgery, after which chemotherapy can be added based on the final anatomopathological results or additional gene expression profiling (gep) testing. chemotherapy helps reduce the cancer recurrence or metastasis risk. adjuvant chemotherapy (ac) can be given for large tumours, aggressive tumours with high grade tumour cells, or if axillary lymph node invasion is discovered during surgery. if the investigators were able to identify patients requiring chemotherapy prior to surgery, they could treat them with neo-adjuvant chemotherapy (nac) instead. by using mammaprint® gep, the investigators would be able to stratify patients into either a low- or high-risk category. since the high-risk group is known to benefit from chemotherapy to improve overall survival, they would be treated with nac, which could also potentially lead to surgical de-escalation. breast conserving procedures, such as a lumpectomy instead of a mastectomy, could allow more aesthetically pleasing results and increase patient quality of life. using nac for patients with axillary lymph node invasion could lead to nodal complete pathological response (cn1 -\> ypn0), allowing patients that are willing to enter the tadanac trial a lymph node sparing procedure instead of a full axillary lymph node dissection.


Eligibility criteria:
inclusion criteria: * tumour characteristics: hr+, her- * histopathological tumour characteristics: ct1-3, cn1, cm0, all histological types included * age: 18-85 years exclusion criteria: * tumour characteristics: ct4, cn2-3, cm1 * age: \ 85 years old * received chemotherapy in the last 5 years * pregnancy

Keywords: neoadjuvant chemotherapy gep
evaluating tools for health promotion and disease prevention

Conditions: Coronary Heart Disease; Stroke; Diabetes; Breast Cancer; Ovarian Cancer; Colorectal Cancer

Summary: the study will evaluate the effect of familial risk assessment and prevention prompts tailored to familial risk on health behaviors and use of preventive services among adults who are members of primary care practices in the u.s.

the purpose of this study is to evaluate the clinical utility of a new family history tool, family healthware™ by determining whether family history risk assessment and personalized prevention messages have any impact on health behaviors and use of medical services. the hypothesis to be tested is that patients who are provided with personalized prevention messages based on an assessment of their family history of disease will be more motivated to make behavior changes and use preventive health services than patients who do not have their family history assessed and who receive only generalized (not personalized) prevention messages. an additional hypothesis, tested when participants see their primary care physician during the study, is that providing a copy of the graphical family history, risk and prevention messages to the patient's physician will increase delivery of recommended preventive services (screening, referral, and health habit advice). the study will consist of enrolling approximately 8360 patients aged 35-65 years who attend primary care practices that are part of research networks affiliated with the three research centers. the practices will be randomized into two groups. patients in practices randomized to group 1 will complete a pre-test and the family history tool, and will receive personalized prevention messages based on their level of familial risk and current risk behaviors. after six months, group 1 patients will complete a post-test. patients in group 2 will complete the pre-test and receive standard prevention messages (appropriate for sex) about maintaining good health and preventing disease. after 6 months group 2 patients will complete the post-test and the family history tool. the pre- and post-test will include assessment of risk factors, use of medical services (especially preventive services), interest in modifying health behaviors, risk perceptions, etc. the analysis will compare changes in health behaviors between patients in groups 1 and 2 and will also examine differences by familial risk strata (average, moderate, high).

Eligibility criteria:
inclusion criteria: * member of participating primary care practice network * able to provide informed consent * able to complete data assessment tools in english exclusion criteria: * diagnosis of chd, stroke, diabetes, breast cancer, ovarian cancer, or colorectal cancer * currently pregnant * evidence of cognitive impairment

Keywords: family history familial risk behavior change
difference in central fatigue during two ultra-endurance practices: running vs. cycling

Conditions: Ultra-marathon Runners

Summary: the mechanisms contributing to muscle fatigue in extreme long-duration exercise bouts are poorly understood. ultra-endurance exercise is an excellent model for the study of adaptive responses to extreme loads and stress and it is an especially useful model for documenting the origins of central fatigue. this protocol will compare fatigue during and after ultra-endurance exercise bouts that result in moderate lower-limb tissue damage (i.e. cycling) or significant damage (i.e. running). the results of this protocol will allow us to further understanding of the reasons for major central fatigue, i.e. within the central nervous system, in ultra-endurance.


Eligibility criteria:
inclusion criteria: * specialist in endurance and ultra-endurance. in the 2 disciplines: running and cycling (triathletes, duathletes or trailers achieving at least 30% of their training volume in cycling), and having at least finished one long distance event in the last 2 years, * affiliated or beneficiary of a social security scheme. * signature of the consent form exclusion criteria: * any subject who has been injured in the 3 months prior to the protocol * anyone with chronic joint pathologies (e.g.: repetitive sprains, patellar or ligament problems). * any subject with chronic or central neurological pathologies * any subject with a contraindication to magnetic stimulation * use of neuro-active substances likely to alter cortico-spinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) on the study. * contraindication to the application of a magnetic field: * heart or respiratory insufficiency. * subject with a cardiac pace maker. * cardiac valve wear and serious cardiovascular diseases. * presence of prosthetic material or ferromagnetic foreign bodies in the head. * presence of cochlear implants or ocular prosthetic material. * history of neurosurgical interventions. * neurological diseases that may affect brain structures and cognitive abilities (e.g., intracranial tumour, multiple sclerosis, history of stroke or traumatic brain injury). * history of comitiality, contralateral knee disease or musculoskeletal disease. * any subject participating at the same time in another interventional experiment requiring physical exercise. * any subject who has taken corticosteroids within 3 months (inhalation, infiltration or history of prolonged corticosteroid therapy). * any subject under guardianship or curatorship

Keywords: central fatigue peripheral fatigue ultra-endurance exercise corticospinal excitability
argatroban plus r-tpa for acute ischemic stroke

Conditions: Stroke

Summary: acute ischemic stroke (ais) is the most common type of stroke, which has high rate of morbidity, mortality and disability. a large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. therefore, all guidelines recommend intravenous thrombolysis as the first treatment of ischemic stroke patients within 4.5 hours of onset. however, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. how to improve the neurological prognosis of thrombolytic patients has been a hot topic in the world. recent studies have found that the combined application of argatroban and rt-pa in the treatment of ais might improve the clinical prognosis and not significantly increase bleeding. some studies have reported that the combined application of argatroban and rt-pa could improve the blood vessel opening rate, and prevent re-occlusion after opening. based on the discussion, the present study is designed to explore the efficacy and safety of argatroban plus rt-pa in the treatment of ais.


Eligibility criteria:
inclusion criteria: 1. 18-80 years old; 2. time from onset to treatment ≤4.5 hours; 3. nihss ≥ 6 4. diagnosis of ischemic stroke 5. signed informed consent by patient self or legally authorized representatives. exclusion criteria: 1. mrs≥2; 2. history of stroke within 3 months; 3. history of intracranial hemorrhage; 4. suspected subarachnoid hemorrhage; 5. intracranial tumour, vascular malformation or arterial aneurysm; 6. major surgery within 1 month; 7. systolic pressure ≥180 mmhg or diastolic pressure ≥110 mmhg; 8. platelet count \< 105/mm3; 9. heparin therapy or oral anticoagulation therapy within 48 hours; 10. abnormal aptt; 11. thrombin or xa factor inhibitor; 12. severe disease with a life expectancy of less than 3 months; 13. blood glucose \< 50 mg/dl (2.7mmol/l); 14. patients who have received any other investigational drug or device within 3 months; 15. pregnancy; 16. researchers consider patients inappropriate to participate in the registry.