Kornimate/medical-research-clean huggingface dataset:
association between individual clotting factor level monitoring and the risk of bleeding whilst physical active conditions

Conditions: Hemophilia A

Summary: the aim of this prospective multicentre study is to evaluate the influence of individual clotting factor level while being physically active

in patients with haemophilia (pwh) repetitive joint bleedings result in a so called haemophilic arthropathy, which is often associated with chronic pain as well as functional restrictions. due to the opportunity of sufficient factor treatment regimes, physical activity is no longer considered as a risk factor for pwh. in contrast, the large amount of current scientific evidence demonstrated high benefits of regular exercising for pwh. meanwhile, physical activity is integrated as recommendation in the ´guidelines for the management of hemophilia´. nevertheless, the detailed influence of the exact course of the individual clotting factor level corresponding to the intensity of physical activities in consideration of possible bleeding events in adult pwh have not been examined to date. the aim of this prospective multicentre study is to evaluate the influence of individual clotting factor level while being physically activie. hereby the focus is on haemophilic specific parameters such as bleeding events, factor treatment and pain. on the basis of this study, an individualized clotting factor level should be determined which ensures a minimized risk of a bleeding event, considering type and intensity of the exercises. in line with these new findings, further interventional studies could be initiated in order to safely enhance the degraded physical performance as well as quality of life in pwh. the generated knowledge could be further used in the development of haemophilic specific recommendations regarding physical activity in consideration of the individual clotting factor level.

Eligibility criteria:
inclusion criteria: * patients suffering from moderate or severe hemophilia a (fviii \<5%, ≥ 12 years old) * factor treatment with advate© or adynovi© * use of mypkfit exclusion criteria: * patients suffering from other coagulopathies * participants without written consent * participants \< 12 years old * joint surgery like arthroscopy, synovectomy up to six months before study * suffering from different rheumatologic diseases like m. bechterew, psoriasi or other local or generalized joint infections (borreliosis, septic arthritis)

Keywords: hemophilia a clotting factor level exercise pharmacokinetics physical activity
savvy system project

Conditions: Caregiver Burnout; Dementia

Summary: the study goal is to develop a web-based system that uses distance education methods and provides manuals and protocols to train, certify, and monitor the performance of interventionists to deliver the savvy caregiver program (savvy), an evidence-based dementia family caregiver psychoeducation program. the system has a potential to increase the scalability of savvy.

the number of people living with disability (plwd) in the u.s. will rise from 5.7 million to 14 million by 2050, and the number of family caregivers who maintain these persons in the community will rise proportionately from 15 million at present. several psychoeducation programs, including savvy, have successfully ameliorated the adverse effects of caregiving, but these programs are only minimally available and accessible. the study goal is to develop a web-based system that uses distance education methods and provides manuals and protocols to train, certify, and monitor the performance of interventionists to deliver the savvy caregiver program (savvy), an evidence-based dementia family caregiver psychoeducation program. the system has a potential to increase the scalability of savvy.

Eligibility criteria:
inclusion criteria: organizational leaders 1. able to understand and speak english 2. affiliated with an organization serving caregivers for family members living with alzheimer's disease or related dementias 3. 18 years or older interventionists 1. able to understand and speak english 2. affiliated with a participating organization 3. 18 years or older caregivers 1. able to understand and speak english 2. caregiver for a person living with alzheimer's disease or related dementias (plwd) who is providing informal care for at least 3 hours a day. plwd should not be bound for institutional care within the next 6 months. 3. 18 years or older

Keywords: people living with disability plwd caregiver interventionist distance education savvy
the recurrence gene profiles of adjuvant osimertinib therapy in resected non-small-cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this is a phase ii, prospective, multicenter, study to evaluate the recurrence gene profiles of adjuvant osimertinib therapy in resected egfr-mutated nsclc.

this is aprospective, multicenter, phase ii study to evaluate the recurrence gene profiles of adjuvant osimertinib therapy in resected egfr-mutated nsclc. approximately 60 nsclc patients with egfr-sensitive mutations (19del, l858r) who received adjuvant osimertinib after complete resection were enrolled. the primary endpoint was to assess the recurrence gene profiles of adjuvant osimertinib therapy. the secondary endpoint was to explore of subgroups recurrence gene profiles of different recurrence types (local /distant) after adjuvant osimertinib therapy and to describe the diverse treatment patterns in real clinical practice after the disease progressed.

Eligibility criteria:
inclusion criteria: 1. informed consent signed; 2. age ≥ 18 years; 3. histologically confirmed diagnosis of non-squamous non-small cell lung cancer; 4. patients with stage ib-iiia (tnm 8#) nsclc undergo confirmed radical r0 resection; 5. confirmed egfr sensitive-mutations (exon 19 deletions, 21 l858r point mutations) prior to adjuvant osimertinib therapy; 6. recurrence after/on osimertinib treatment according to recist 1.1; 7. ngs gene test report (tumor or blood sample) at the time of recurrence; 8. receiving or not receiving neoadjuvant treatment before surgery. exclusion criteria: 1. patients with stage i-iii nsclc whose surgical resection cannot be confirmed; 2. received adjuvant therapy other than that specified in the adaura study; 3. no ngs test report at recurrence; 4. history of other malignant tumors within 2 years; 5. patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has treatment-related complications high risk etc.

Keywords: egfr osimertinib
strategies to continue gynae-oncology services in the era of covid-19 outbreak: concerns and challenges in a referral centre in malaysia

Conditions: Covid19; Vaccination Refusal; Survivorship

Summary: a short survey involving 100 participants was conducted online to explore the understanding of covid 19 pandemic impact and importance of vaccination among cancer survivors.


Eligibility criteria:
inclusion criteria: female cancer survivors or care-taker undergoing national covid 19 vaccine - exclusion criteria: male, not cancer survivors -

Keywords: covid19 vaccination gynaeoncology cancer cancer survivor
balloon catheters in cases of abnormal placentation

Conditions: Post Partum Bleeding

Summary: placenta accreta is a relatively rare event, in which the placenta is abnormally implanted into the uterine myometrium. the most significant complication is intense bleeding, mainly during labor. the most important risk factors are previous cesarean delivery, placenta previa, and advanced maternal age. cesarean hysterectomy is the recommended management. during the recent years, inserting intravascular balloon catheter for occlusion and/or arterial embolization, was introduced as an adjuvant therapy in order to minimize blood loss during cesarean hysterectomy or in conduct with conservative management with the intent of avoiding hysterectomy in selective cases. contradicting reports exist regarding the effectiveness and safety of the catheters in cases of placenta accreta. the objective of this study is to estimate the efficacy of the balloon catheters among women diagnosed with a placenta accreta.


Eligibility criteria:
inclusion criteria: * pregnant women age 18-45 * antepartum diagnosis of placenta accreta exclusion criteria: - women who refuse to participate

Keywords: placenta accreta internal iliac artery catheterization post partum bleeding
consolidative metastasis and primary directed therapy (mpdt) for renal cell carcinoma (rcc)

Conditions: Renal Cell Carcinoma

Summary: this is a non-randomized, open-label phase ii study designed to estimate 12-month treatment-free survival rate following total consolidative metastasis-and-primary directed therapy (mpdt) among patients with partial response/stable disease after at least 6 months of immune checkpoint blockade-based therapy for metastatic clear cell rcc. the investigators hypothesize that patients who undergo total consolidative mpdt followed by systemic therapy discontinuation will have a 12-month treatment-free survival rate of 32% compared to a null hypothesis of 13%


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma (mixed histology acceptable but must have clear cell component) * metastatic clear cell rcc with 5 or fewer metastases at enrollment (excluding pulmonary nodules \<1.0cm) * stable disease or partial response as assessed by investigators following at least 6 months of immune checkpoint blockade-based therapy. * has disease amenable for total consolidative focal therapy (this will be determined by a multidisciplinary team which may include a combination of medical oncologists, urologists, interventional radiologists, and radiation oncologists). * ecog performance status \< 2 * must have archival tissue (slide or formalin-fixed paraffin-embedded tissue) preceding prior systemic treatment for comparison to tissue from consolidation * consolidation surgery and biopsies are strongly encouraged to be within 42 days +/- 7 days of holding systemic therapy. exclusion criteria: * subjects who have progressed during the first 6 months of immune checkpoint-blockade based therapy as determined by study investigator. * subjects who have a need for urgent focally directed therapy (i.e. symptomatic brain or spinal metastases). stable spinal metastases resected and/or treated with sbrt in advance of or concurrently with immune checkpoint-blockade based therapy are allowed to participate. * any female of child-bearing potential who has a positive urine pregnancy test within 72 hours before screening. if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. participants must be excluded/discontinued from the trial in the event of a positive or borderline positive serum pregnancy test result.
the incidence and risk factors of central nervous system adverse events of lorlatinib in patients with alk-positive advanced non-small cell lung cancer: a real-world study

Conditions: ALK; NSCLC

Summary: the goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of lorlatinib in patients with alk-positive advanced non-small cell lung cancer.

the goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of lorlatinib in patients with alk-positive advanced non-small cell lung cancer.

Eligibility criteria:
inclusion criteria: * patients with locally advanced (stage iiib/iiic), metastatic, or recurrent (stage iv) nsclc confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the tnm staging classification by the international association for the study of lung cancer and the american joint committee on cancer; * alk-positive and the test results were based on rt-pcr /fish /ihc /ngs methods in the laboratory department or testing institution of the hospital * receiving targeted therapy with lorlatinib * age ≥18 years old * follow-up after receipt of lorlatinib * voluntarily participate in the study and sign informed consent exclusion criteria: * evidence of any severe or uncontrolled systemic illness, including uncontrolled hypertension and active bleeding, active infections including hepatitis b, hepatitis c and human immunodeficiency virus (hiv). * combined with other malignant tumors and received other anti-tumor therapy during the treatment of lorlatinib

Keywords: alk nsclc
immune responses in oncology patients to novel coronavirus vaccines (iroc)

Conditions: Cancer

Summary: the goals of this study are to assess initial or booster vaccine performance (safety and efficacy) and to collect serum and peripheral blood mononuclear cells (pbmcs) pre and post-vaccination to assess immune and other response parameters following immunization in cancer patients receiving either the pfizer (btn162b2), moderna (mrna-1273), or the janssen (ad26.cov2.s) vaccines.


Eligibility criteria:
inclusion criteria: 1. ability to provide written informed consent and hipaa authorization 2. patients deemed eligible and willing to receive a covid-19 vaccine by treating physician per standard of care. 3. subjects must be ≥ 18 years old at the time of consent. 4. diagnosis of cancer and fall into one of the groups below: 1. group 1: patients with solid tumors receiving courses of cytotoxic therapy. 2. group 2: patients with hematological cancers receiving courses of cytotoxic chemotherapy. 3. group 3: patients with solid tumors receiving tyrosine kinase inhibitors (tkis) or other targeted therapies, but not cytotoxic regimens within 3 months. 4. group 4: patients with hematologic cancers receiving tkis or other targeted therapies, but not cytotoxic regimens within 3 months. 5. group 5: patients receiving immune checkpoint inhibitors. 6. group 6: patients who underwent allogeneic stem cell transplant within 12 months. 7. group 7: patients who underwent cellular therapy, including chimeric antigen receptor t-cells (car-t) cells or t-cells with engineered t-cell receptors (tcrs) within 12 months. 8. group 8: patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches. 9. group 9: patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted). 10. group 10: patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants 11. group 11: patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants 12. group 12: patients who have a cancer diagnosis but do not fall into group 1-11 3. estimated survival of 8 weeks or more following enrollment on the study. exclusion criteria: 1. uncontrolled intercurrent illness including, but not limited to, ongoing or active covid-19 infection or influenza-like-illness. if subjects have previously tested positive for covid-19 infection, they are eligible to participate in this study after 90 days 2. unwilling or unable to follow protocol requirements.

Keywords: covid-19 vaccine pfizer moderna janssen covid
long-term treatment and follow up of subjects completing 24 months of treatment with tesevatinib on study kd019-101

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Summary: subjects who received tesevatinib in study kd019-101 and completed 24 months of treatment will continue on the dose of tesevatinib they were receiving at 24 months on the kd019-101 study.


Eligibility criteria:
inclusion criteria: * the subject must have received 24 months of treatment with tesevatinib on study kd019-101. (twenty-four months of study drug treatment includes days without treatment that were allowed by the kd019-101 protocol.) * sexually active subject (male and female) has agreed to use two forms of accepted methods of contraception during the course of the study and for 3 months after the last dose of study drug. effective birth control includes (a) iud plus one barrier method; (b) on stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method; or (c) 2 barrier methods. effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). * female subjects of childbearing potential have a negative pregnancy test at screening. females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. however, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.
evaluation of coagulation in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: recent research in multiple sclerosis (ms) have suggested that altered coagulation and vascular inflammation may play a role in pathophysiology of ms. sonoclot is viscoelastic method of analyzing clot formation. this instrument will be used to compare coagulation in individuals with ms to healthy controls. a 24-hour dietary recall and food frequency questionnaire will help determine whether coagulation is modified by fish consumption.

this case-control study will recruit individuals with a diagnosis of ms and healthy controls. individuals will be asked to come to bastyr clinical research center for a single study visit, at which time dietary intake, current medications and supplements, other medical diagnoses, and coagulation will be evaluated.

Eligibility criteria:
inclusion criteria: * diagnosis of clinically probable of clinically definite multiple sclerosis made by board certified neurologist. subject must be willing to release medical information regarding diagnosis * controls must consider themselves healthy and be free of any neurological, autoimmune, endocrine or other chronic disease. must also be free of any recent acute illness/injury that can influence inflammatory activity. * individuals must be 18 or older exclusion criteria: * diagnosis of coagulation defect * use of anticoagulants (eg. warfarin, coumadin) or aspirin within 30 days of entry. * nsaid within 7 days of entry (dietary intake of fish oil or tumeric is acceptable) * pregnancy

Keywords: multiple sclerosis coagulation alternative medicine clotting complementary medicine inflammation
value of transthoracic ultrasonography (ttu) for etiological diagnosis of acute dyspnea: cross sectional study

Conditions: Dyspnea

Summary: evaluating the capability and efficiency of transthoracic ultrasound in attempting to identify the etiology of acute dyspnea.

acute dyspnea is a frequent challenge for physicians due to having multiple etiologies, leading to difficulty in establishing an accurate diagnosis. the presence of this symptom is already a predictor of increased mortality and a lot of investigations are required to differentiate between etiologies. hence, prompt diagnosis is needed to streamline these patients' appropriate management and disposition from the ed. transthoracic ultrasound has traditionally been used for the detection of pleural effusion and evaluation of the chest wall, but the indications have been expanded. the gold standard imaging technique for the majority of pulmonary disorders is high-resolution computed tomography (hrct), but it has negatives which are: * hazard of ionizing radiation * high cost * being nonportable

Eligibility criteria:
inclusion criteria: * clinical history of acute dyspnea exclusion criteria: * subcutaneous emphysema. * patients with more than 24 h interval between hrct and ttu. * patients with poor-quality of ttu image.
study of the mass balance of oral ftd and tpi as components of tas-102 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of this study is to evaluate, in patients with advanced solid tumors, the mass balance of ftd and tpi after a single dose of tas-102 with a light tracer dose of \[14c\]ftd or \[14c\]tpi.

this is a phase 1, open-label study evaluating the mass balance of ftd and tpi after a single dose of tas-102 with a light tracer dose of \[14c\]ftd or \[14c\]tpi. the study will be conducted in 2 parts: mass balance part and tas-102 extension part. after completion of the mass balance part, patients will receive continued treatment with tas-102 during the study extension part.

Eligibility criteria:
inclusion criteria: 1. has advanced solid tumors (excluding previously treated breast cancer) for which no standard therapy exists 2. ecog performance status of 0 or 1 3. is able to take medications orally 4. has adequate organ function (bone marrow, kidney and liver) 5. women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. males must agree to adequate birth control. exclusion criteria: 1. has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration 2. certain serious illnesses or medical condition(s) 3. has had either partial or total gastrectomy 4. has a medical condition that jeopardizes or impairs ability to collect representative excreta 5. has unresolved toxicity of greater than or equal to ctcae grade 2 attributed to any prior therapies 6. known sensitivity to tas-102 or its components 7. is a pregnant or lactating female 8. refuses to use an adequate means of contraception (including male patients) 9. is an occupationally exposed worker as defined by relevant ionizing radiation regulations 10. has been exposed to 14c in the last 12 months

Keywords: advanced solid tumors
sex-related differences in outcome after hybrid coronary revascularization

Conditions: Coronary Artery Disease

Summary: hybrid coronary revascularization (hcr) has emerged as a favorable technique over traditional coronary artery bypass grafting (cabg) in a select group of patients with multivessel coronary artery disease (cad). till date, multiple individual studies comparing hcr with cabg have been carried out, but no data on the potential impact of sex on the outcome of hcr exist. to fill this knowledge gap, the investigators aim to perform an international collaborative multi-center study in order to examine gender differences in short-term and long-term outcomes among patients who underwent hcr or cabg.

hybrid coronary revascularization (hcr) has emerged as a favorable technique over traditional coronary artery bypass grafting (cabg) in a select group of patients with multivessel coronary artery disease (cad). till date, multiple individual studies comparing hcr with cabg have been carried out, but no data on the potential impact of sex on the outcome of hcr exist. limited by their sample size, these individual studies may have been under-powered to detect a difference. to fill this knowledge gap, the investigators aim to perform an international collaborative multi-center study in order to examine gender differences in short-term and long-term outcomes among patients who underwent hcr or cabg.

Eligibility criteria:
inclusion criteria: patients with coronary artery disease and indication to cardiac surgery exclusion criteria: contraindications to cardiac surgery