Kornimate/medical-research-clean huggingface dataset:
catheter guided chemo-infusion in breast cancer

Conditions: Breast Cancer

Summary: in the present prospective study, we will analyze the outcome of image-guided delivery of intra-arterially infused chemotherapeutic drugs for patients with breast cancer in iii, iv stages.

breast cancer is one of the most common malignancies affecting women worldwide, and its incidence has seen a steady increase over the years with the involvement of women at a much younger age, which poses a serious health threat to women and has a staggering global impact. lymph node and hematogenous metastasis occurs at the early stage of breast cancer and is the principal cause of mortality of breast cancer patients. surgical resection is the most effective method for the treatment of breast cancer, and neoadjuvant chemotherapy reduces the risk of disease recurrence and death in women who have operable breast cancer. for patients with inoperable breast cancer, neoadjuvant chemotherapy reduces tumor bulk and tumor stage, thereby increasing the chance of surgical resection and reducing postoperative tumor recurrence and metastasis. local or regional chemotherapy is an alternative for reducing metastatic lesions and increasing patient survival .intra-arterial infusion chemotherapy (chemoinfusion), a form of regional chemotherapy, has been used in the treatment of gastrointestinal tumors, liver cancer, and pancreatic cancer. in the present prospective study, we will analyze the outcome of image-guided delivery of intra-arterially infused chemotherapeutic drugs for patients with breast cancer in iii, iv stages.

Eligibility criteria:
inclusion criteria: * adult female had stage iii,iv breast cancer. * female had received no prior chemotherapy, radiotherapy, or definitive surgical therapy for breast cancer. * patient had adequate organ function. exclusion criteria: * patients known to have absolute contraindications for contrast. * patient known to have systemic organ failure.

Keywords: breast cancer chemotherapy
efficacy, safety, and tolerability of ancrod in patients with sudden hearing loss

Conditions: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases

Summary: the purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (sshl).


Eligibility criteria:
inclusion criteria: * unilateral idiopathic sudden sensorineural hearing loss ≥30 db * symmetric hearing prior to onset of sshl * enrollment has to be accomplished within 7 days after sshl onset exclusion criteria: * bilateral sshl * incomplete recovery after previous sshl * previously existing, known retrocochlear hearing loss * any history of any ear operation or local inflammatory disease in the past one year * history of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding sshl * history of meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops. * treatment with steroids for any reason within the preceding 30 days. * body weight \> 140 kg
the cost-efficacy of psychological intervention for strengthening parental authority among parents of diabetic adolescents with poor glycemic control

Conditions: Diabetes

Summary: a three arms, open, randomized interventional study including 100 participants in order to evaluate the cost-efficacy of psychological intervention for strengthening parental authority among parents of diabetic adolescents with poor glycemic control. all participants will be randomized into three groups:1.the first group will get a psychological treatment in order to strengthen the parent's authority. 2.the second group will get an education of a nurse and a dietician. 3.the third group will serve as a control group and will not go through an intervention. the following data will be analyzed during the study: 1.changes in hba1c. 2.changes in parents authority. 3.changes in the diabetes treatment by the adolescents. 4.consumption of health services. 5.the costs of all psychological treatments.

a three arms, open, randomized interventional study including 100 participants in order to evaluate the cost-efficacy of psychological intervention for strengthening parental authority among parents of diabetic adolescents with poor glycemic control. objectives: 1. the primary purpose of the study is to evaluate the immediate effectiveness and the long run effectiveness of psychological intervention for strengthening parental authority among parents of diabetic adolescents with poor glycemic control. 2. to evaluate the cost as appose to the benefit of the psychological intervention. 3. to characterize the different variables in parent's attitude that improve their children's glycemic control. 4. to develop a therapy model for strengthening parent's authority which will be suitable for parents of diabetic adolescents. study design: all participants in the study will be randomized to three different groups: 1. a treatment group that will go through psychological treatment to strengthen the parents authority. 2. a control group that will get an education of a nurse and a dietician 3. a control group that will not get any intervention. all groups will include parents of diabetic adolescents with poor glycemic control. the following data will be analyzed during the study: 1. changes in glycemic control will be measured by levels of hba1c. 2. changes in the diabetes treatment by the adolescents will be measured by adherence to insulin injections, the number of times a day in which the patient checked his blood glucose values, number of visits in the clinic and psychological questionnaires. 3. consumption of health services 4. changes in parents attitude and changes in the wellbeing of the diabetic adolescents and their parents will be based on questionnaires.

Eligibility criteria:
inclusion criteria: 1. parents of adolescents between the ages of 10-18 2. more than one year diabetes 3. adolescent's hba1c\>8 exclusion criteria: 1. adolescents or parents of adolescents that are mentally retarded. 2. another chronic disease besides diabetes. 3. adolescents that are taking medications that might disturb their glycemic control.

Keywords: diabetes adolescents psychological therapy
professional and personal toxic exposure in systemic sclerosis : type, intensity and probability of exposition

Conditions: Systemic Sclerosis

Summary: systemic sclerosis (ssc) is an inflammatory chronic disease that can lead to structural damage and handicap. the ssc physiopathology is multifactorial, including genetic and environmental risk factors. the identification of environmental factors implication is crucial to understand the ssc mechanism, and improves the diagnosis and the treatment of the disease.

studies show that the risk associated with high cumulative exposure to silica and organic solvents appears to be strongly increased in ssc. moreover, exposure to silica is associated with a specific type of ssc phenotype with a worse prognosis. however, the type, intensity and probability of these expositions are unknown. the aim of the study is to precisely determine type, intensity and probability of toxic substances exposition in systemic sclerosis patients through an auto-questionnaire and integration of these data in a computer matrix.

Eligibility criteria:
inclusion criteria: * patients aged over 18 years old * speaking and understanding french language * being informed about the study and having given his consent * affected by ssc according to eular 2013 criteria exclusion criteria: * patient under tutorship * patient who refuse to participate

Keywords: silica organic solvents toxic substances exposure
umbilical cord mesenchymal stem cell transplantation for lupus nephritis

Conditions: Lupus Nephritis

Summary: to investigate the safety and efficacy of umbilical cord mesenchymal stem cell transplantation in patients with systemic lupus erythematosus (sle) and lupus nephritis (ln).

systemic lupus erythematosus (sle) is a multisystem autoimmune disease. lupus nephritis (ln) is one of the most serious complications of sle. the current clinical treatments of ln mainly include steroids and immunosuppressive drugs, but drug side effects are obvious.

Eligibility criteria:
inclusion criteria: * meeting the 1997 american college of rheumatology (acr) classification criteria of sle. * age 18-60 years. * of either sex and of any ethnicity. * lupus nephritis (ln) group: (1) receiving more than 6 months of regular treatment, 24-hour urine protein ≥ 1.0 g, serum creatinine ≥1.5 mg/dl; (2) renal biopsy: class iii, iv or v ln included, and class vi excluded. * after conventional treatment (glucocorticoid therapy and immunosuppressive drugs) prior to grouping, sledai scores ≥ 10. * receiving 12 months of treatment while using birth control. * provision of informed consent. exclusion criteria: * poor blood pressure control by drug treatment (≥ 160/100 mmhg) * abnormal hepatic function (a 3-fold increase in alanine aminotransferase level relative to normal liver). * renal failure (glomerular filtration rate \< 15 ml/min/1.73 m2). * severe heart and lung failure, or injury to other important organs * uncontrollable infection. * having not taken biological agents for 6 months. * pregnant or lactating women, or those women who are trying to get pregnant or those men who are trying to make their partners pregnant.
evaluation of geriatric questionnaires to predict toxicities of cdk 4/6 inhibitors in older breast cancer patients?

Conditions: Can the Geriatric Questionnaires Predict Adverse Effects in Geriatric Breast Cancer Patients Treated With Cyclin-dependent Kinase 4 and 6 Inhibitors

Summary: cdk 4/6 inhibitors (palbociclib, ribociclib) have taken their place in our practice recently with their clinical benefits in the treatment of hormone-positive and her2 negative metastatic breast cancer. abemaciclib, another cdk 4/6 inhibitor, is not frequently preferred because of reimbursement problems in turkey. the most obvious advantages of cdk 4/6 inhibitors are that they are used orally and have relatively fewer side effects against chemotherapy. neutropenia, diarrhea, elevation in liver function tests are the main dose-limiting side effects. in the geriatric age group, it can be thought that the expected benefit from the treatment will not be achieved in cases where these side effects cannot be predicted or managed well. the geriatric age group (65 years and older) deserves special attention in oncology practice, considering both the treatments and the disease itself. although a number of very useful clinical scales have been developed regarding this subject, it is important that the scale used should be comprehensive as well as being easily applicable for integrating it into daily practice. geriatric 8 (g8) was found to be a highly sensitive test based on a comprehensive geriatric examination, while the groningen frailty scale with high specificity. the common feature of these two tests is that they are suitable for daily practice as they are easy to fill. in the light of this information, we aimed to examine whether the g8 and groningen frailty scale could shed light on clinicians in predicting side effects during the use of cdk 4/6 inhibitors (palbociclib and ribociclib) in geriatric breast cancer patients. we also aimed to reveal the adverse events of these cdk 4/6 inhibitors as real-life experience.


Eligibility criteria:
inclusion criteria: * breast cancer 65 years and older treated with cdk 4/6 inhibitors (palbociclib or ribociclib) exclusion criteria: * below 65 years old
soft tissue mobilization versus therapeutic ultrasound for subjects with neck and arm pain

Conditions: Cervical Radiculopathy

Summary: the purpose of this study is to investigate effects of soft tissue mobilization versus therapeutic ultrasound in subjects with neck and arm pain who demonstrate neural mechanical sensitivity.

to investigate the immediate effects of soft tissue mobilization (stm) versus therapeutic ultrasound (us) in patients with neck and arm pain who demonstrate neural mechanical sensitivity. twenty-three patients with neck and arm pain and a positive upper limb neurodynamic test (ulnt) were randomly assigned to receive stm or therapeutic us during a single session. outcome measures were collected immediately before and after treatment, and at 2-4 day follow-up. primary outcomes were the global rating of change (groc), range of motion (rom) during the ulnt, and pain rating during the ulnt. secondary measures included the neck disability index (ndi), patient-specific functional scale (psfs), numeric pain rating scale (nprs), and active range of shoulder abduction motion combined with the wrist neutral or wrist extension.

Eligibility criteria:
inclusion criteria: 1. active movement dysfunction that could be related to mechanical sensitivity of the neural structures of the upper limb. (i.e. painful shoulder abduction with elbow extension that is limited more when the wrist is extended than when the wrist is in neutral.) 2. positive response to upper limb neural provocation testing (ulnt 1) (see description below for details) 3. tenderness to palpation over the cervical nerve trunks, brachial plexus, or along the median nerve. 4. tender points or taut bands in the muscles of the upper quadrant including the scalenes, cervical paraspinals, trapezius, deltoid, pectoralis major or minor, rotator cuff, biceps, triceps, coracobrachialis, brachialis, radiobrachialis, pronator teres, supinator, forearm extensor, forearm flexor, pronator quadratus, and hand intrinsic muscles. exclusion criteria: 1. red flags noted in the medical screening questionnaire such as tumor, fracture, history of metabolic disease, prolonged history of corticosteroid use. 2. signs of central nervous system involvement such as hyper-reflexia (exaggerated response to deep tendon reflex testing), unsteadiness during gait, ataxia, disturbed vision, nystagmus, altered taste, positive babinski's or hoffman's reflexes. 3. cervical spine surgery within the last 3 months. 4. litigation associated with their neck and/or upper limb pain. 5. insufficient english language skills to complete the questionnaires and follow-up instructions. 6. inability to complete the treatment and follow-up schedule. 7. current pregnancy.
cd123-cd33 ccar in patients with relapsed and/or refractory, high risk hematologic malignancies

Conditions: Hematologic Malignancy; Acute Myeloid Leukemia; Myelodysplastic Syndromes; Myeloproliferative Neoplasm; Chronic Myeloid Leukemia

Summary: phase i, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of cd123-cd33 ccar in patients with relapsed and/or refractory, high risk hematologic malignancies.

aml bears heterogeneous cells that can consequently offset killing by single-car-based therapy, which results in disease relapse. leukemic stem cells (lscs) associated with cd123 expression comprise a rare population that also plays an important role in disease progression and relapse for myeloid malignancies. cd33 is widely expressed in aml, high risk myelodysplastic syndromes (mds) and myeloproliferative neoplasms. targeting both cd33 and cd123 surface antigens together may offer two distinct benefits. first, targeting both bulk disease and leukemic stem cells together allows for a more comprehensive ablation of the disease. second, dual targeting of myeloid malignancies by both cd33 and cll1 directed therapy overcomes the pitfalls of single-antigen therapy by preventing relapse due to antigen loss. while loss of a single antigen under antigen-specific selection pressure is possible, loss of two antigens simultaneously is much less likely. cd123-cd33 ccar is a compound chimeric antigen receptor (ccar) immunotherapy with two distinct functional car molecules expressed on a t-cell, directed against the surface proteins cll1 and cd33. ccar intends to target the mechanisms of single-car relapse, specifically antigen escape and leukemic stem cells.

Eligibility criteria:
inclusion criteria: 1. prior hsct relapse beyond 6 months without active gvhd; systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks 2. de novo aml 3. transformed aml 4. mds with excess blasts (raeb-2) 5. mds that is not a candidate for induction chemotherapy. 6. myeloproliferative neoplasms with blastic transformation 7. patients have exhausted standard therapeutic options exclusion criteria: 1. prior solid organ transplantation 2. potentially curative therapy including hematopoietic cell transplant 3. prior treatment with cd123xcd3 or cll1x3 bispecific agents, t cells expressing cd123 car or cll1 car, or toxin-conjugated to cd123 or cll1 antibodies.

Keywords: cd123 cd33 cd123-cd33 ccar leukemia hematologic malignancies
drug use surveillance for brentuximab vedotin intravenous infusion "untreated cd30-positive hodgkin's lymphoma"

Conditions: Untreated CD30-Positive Hodgkin's Lymphoma

Summary: the purpose of this survey is to monitor and identify the occurrence of neutropenia and febrile neutropenia in untreated cd30-positive hodgkin's lymphoma participants on concomitant brentuximab vedotin and doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (avd) in routine clinical practice.

the drug being tested in this survey is called brentuximab vedotin intravenous infusion 50 mg. this intravenous infusion is being tested to treat people with untreated cd30-positive hodgkin's lymphoma. this survey is an observational (non-interventional) study and will look at the occurrence of neutropenia and febrile neutropenia in untreated cd30-positive hodgkin's lymphoma patients on concomitant brentuximab vedotin and avd in the routine clinical setting. the planned number of observed patients will be approximately 100. this multi-center observational trial will be conducted in japan.

Eligibility criteria:
inclusion criteria: 1. untreated participants 2. cd30-positive participants 3. participants on concomitant brentuximab vedotin and avd exclusion criteria: 1. participants contraindicated for brentuximab vedotin
metabolism and the activity of the autonomic nervous system in patients with paroxystic sympathetic hyperactivity, psh

Conditions: Autonomic Nervous System Imbalance

Summary: adult patients suffering from acquired brain damage run the risk of developing psh. this group of patients is admitted to our unit, the neurointensive stepdown unit, at silkeborg regional hospital for intensive care and early neurorehabilitation. after weaning from intensive carethey are transferred to hammel neurocentre. aim is to assess whether hrv-derived variables in the frequency domain mirror therapeutic and/or nursing and/or pharmacologic interventions. to the extent clinically available brs and metabolism are included in the assessment.

see report: honore h, eggertsen k, sondergaard s: a study into the feasibility of using hrv variables to guide treatment in patients with paroxystic sympathetic hyperactivity in a neurointensive step-down unit. neurorehabilitation 2019, 44(1):141-155.

Eligibility criteria:
inclusion criteria: symptoms of psh according to baguley scoring table exclusion criteria: no symptoms of psh

Keywords: psh, rehabilitation, medication, ans
effect of angiotensin converting enzyme and sacubitril valsartan in patients after bone marrow transplantation

Conditions: Hematopoietic Stem Cell Transplantation; Cardiotoxicity

Summary: the purpose of the present study is to investigate the effect of ace inhibitors and the sacubitril-valsartan complex in bone marrow transplant patients by assessing cardiovascular and endothelial parameters in order to search for a potent protective role.

the purpose of the present study is to investigate the effect of ace inhibitors and the sacubitril-valsartan complex in bone marrow transplant patients in preventing cardiotoxicity when administered immediately after transplantation. the effect of medication will be studied in detail: i) in global longitudinal strain of left ventricle (gls), ii) in the volume change of the right and the left ventricle, through the cardiac cycle using 3d echocardiography, iii) in the myocardial work index (mwi) of the left ventricle, with a strain -pressure curve study iv) in the 4d strain of the left atrium, v) in elastic properties of aorta (pulse wave velocity (pwv), central systolic pressure (csbp-mmhg) and augmentation index (aix%), vii) in permeability of glycocalyx and viii) in serum biomarker values, namely troponin i high sensitivity and atrial natriuretic peptide (nt-probnp).

Eligibility criteria:
inclusion criteria: * adolescents male and female * that have just been treated with bone marrow transplantation due to haematological malignancies. exclusion criteria: * coronary artery disease * permanent atrial fibrilation * signs of left ventricular hypertrophy on electrocardiography or echocardiography * left ventricle ejection fraction\<50% or segmental wall motion abnormalities of left ventricle * more than moderate valvular disease * primary myocardiopathy * blood pressure\<90 mmhg * gfr\<30 ml/min/1,73m2 * unwilling to recruit * uncontrolled arterial hypertension

Keywords: cardio-oncology
a study of avastin (bevacizumab) combined with chemotherapy in patients with metastatic cancer of the colon or rectum

Conditions: Colorectal Cancer

Summary: this study will assess the efficacy and safety of intravenous avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. the anticipated time of study treatment is until disease progression.


Eligibility criteria:
inclusion criteria: * patients with metastatic colon or rectal cancer, progressing or relapsing after first-line treatment; * women of childbearing potential must use adequate contraception up to at least 6 months after the last dose of bevacizumab. exclusion criteria: * patients with metastatic colon or rectal cancer scheduled for a first-line systemic treatment; * untreated brain metastases, spinal cord compression or primary brain tumours; * pregnant or lactating women; * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start; * treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment.
efficacy and safety of bimagrumab/bym338 at 52 weeks on physical function, muscle strength, mobility in sibm patients

Conditions: Sporadic Inclusion Body Myositis

Summary: this study evaluated the efficacy, safety and tolerability of multiple doses of bimagrumab/bym338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic inclusion body myositis (sibm).


Eligibility criteria:
key inclusion criteria: * diagnosed with sporadic inclusion body myositis; * must be able to walk (assistive aids allowed, including intermittent use of wheelchair); key exclusion criteria: * must not have other conditions that significantly limit ability to move around; * must not be using corticosteroids. must not have used systemic corticosteroid (at daily dose \>=10mg prednisone) for the past 3 months; * must meet cardiovascular requirements; * must not be pregnant or nursing; * must not have a chronic active infection (e.g., hiv, hepatitis b or c, tuberculosis, etc.);

Keywords: sporadic inclusion body myositis, myositis, muscle wasting, controlled clinical trial, randomized, body mass, muscle function, strength, performance, physical function