Kornimate/medical-research-clean huggingface dataset:
label-free raman spectroscopy for discrimination between breast cancer tumor and adjacent tissues after neoadjuvant treatment

Conditions: Diagnosis

Summary: after neoadjuvant therapy, the primary lesion in breast cancer patients may experience tumor regression, which increases the difficulty of distinguishing between breast cancer and adjacent tissues. raman spectroscopy is a form of scattering spectroscopy, which offers rapid and sensitive analysis, delivering detailed biochemical information and molecular signatures of internal molecular components within the sample. this study aims to discern between cancer and adjacent tissues after neoadjuvant therapy in breast cancer patients using label-free raman spectroscopy.


Eligibility criteria:
inclusion criteria: * (1) aged ≥ 18 years; (2) histologically confirmed invasive breast cancer (clinical tumor stage t1 to t4, nodal stage n1-3, and metastasis stage m0); (3) previous treatment with neoadjuvant chemotherapy with or without target therapy (such as trastuzumab, pertuzumab), or endocrine therapy; (4) enough frozen samples of breast cancer tumor and adjacent tissue. exclusion criteria: * (1) undergoing sentinel lymph node biopsy with indocyanine green dye or methylene blue injection after neoadjuvant therapy; (2) breast cancer during pregnancy and lactation, inflammatory breast cancer.
shock wave versus iontophoresis in treatment of subjects with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: both extra corporeal shock wave and dexamethasone iontophoresisare effective in treatment of knee osteoarthritis but which one is more effective is not clear yet . so the purpose of this study was to investigate and compare between the effect of shock wave and iontophoresis in treatment of knee osteoarthritis . it was hypothesized that there will be no difference between the effect of shock wave and iontophoresis on treatment of knee osteoarthritis.

60 subjects with grade ii knee osteoarthritis will be recruited from outpatient clinic of faculty of physical therapy and then they will be assigned randomly by sealed envelope into three groups ;group a (shock wave group) will received radial extracorporeal shock wave ,group b (iontophoresis group ) will receive deaxamthasone iontophoresis and group c (control group) will receive traditional tratment ( stregnthening exerciseces) all treatment will be once session per week for four weeks .pain intensity ,knee rom and knee injury and osteoarthritis outcome score physical function short (koos-ps).

Eligibility criteria:
inclusion criteria: 1. symptomatic knee oa for at least 3 months according to clinical criteria of american college of rheumatology 2. radiologic findings had to be compatible with knee oa, with kelgren and lawrence (k-l) grade 2 in a simple x ray . 3. tenderness on medial tibial plateau 4. intensity of pain: visual analogue scale equal to 5 or greater 5. failure of two or more types of previous conservative treatment (medication, anti-inflammatory drugs, physical therapy, stretching, acupuncture, orthotics and others) exclusion criteria: 1. neuorological and vestibular system disorder, systematic inflammatory disease, steroid injections in the last six months 2. any contraindication to magnetic resonance imaging or radiography, or trauma history on knee 3. history of previous knee surgery -
bacteriophage therapy in patients with prosthetic joint infections

Conditions: Prosthetic Joint Infection

Summary: this is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.

this is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections of the hip or knee caused by 1 or 2 of the following organisms: staphylococcus aureus, staphylococcus epidermidis, staphylococcus lugdunensis, streptococcus sp., enterococcus faecium, enterococcus faecalis, escherichia coli, pseudomonas aeruginosa, and/or klebsiella pneumoniae. this study will also compare the safety and efficacy of phage therapy in conjunction with antibiotics versus standard of care (soc) two-stage exchange arthroplasty plus antibiotics.

Eligibility criteria:
general inclusion criteria: * males or females ≥18 years of age. * female patients of childbearing potential who agree to use contraception. * candidate for a two-stage exchange arthroplasty. * chronic prosthetic joint infection general exclusion criteria: * prior history of prosthetic joint infections (pji) of same joint treated surgically other than one prior debridement antibiotics and implant retention procedure * soft tissue defect requiring reconstruction * hardware misalignment or loosening * active osteomyelitis * septic shock or hemodynamic instability * stage 4 or greater chronic kidney disease * liver disease * decompensated cirrhosis * alcohol abuse or alcohol induced liver disease or non-alcoholic steatohepatitis * decompensated heart failure * any other clinically significant disease, per judgement of the investigator * neutropenia (neutrophil count \ 3 time the upper limit of normal * hiv, hepatitis c, hepatitis b infection * positive drug screen * receipt of chemotherapy, immunosuppressants or immune modulators * anti-viral medication * any known phage allergy * breast feeding or pregnancy

Keywords: prosthetic joint knee hip phage bacteriophage prosthetic joint
study of botox injections to assess change in disease symptoms in adult participants with upper limb essential tremor

Conditions: Upper Limb Essential Tremor (UL ET)

Summary: upper limb essential tremor (ul et) is a movement disorder characterized by postural and/or kinetic tremor. it can cause difficulty with everyday tasks such as writing, pouring, and eating, and patients also experience associated social embarrassment. this study will assess how safe and effective botox is in treating ul et. adverse events and change in disease activity will be evaluated. botox is an investigational drug being developed for the treatment of ul et. participants are randomly assigned to 1 of the 4 groups, called treatment arms. each group receives different treatment. there is 1 in 2 chance that participants will be assigned to placebo. around 174 participants, aged 18 to 80 years with ul et will be enrolled in approximately 40 sites in north america. participants will receive botox or placebo injections in cycle 1 and cycle 2. in cycle 3, participants will receive unilateral or bilateral botox injections. each cycle is 12 weeks. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * diagnosis of essential tremor in accordance with modified tremor investigation group (trig) criteria as described in the protocol. * treds-revised scale (1-4 scale, whole numbers) unilateral score of \>= 3 for the tremor disability scale (treds) on any of the 7 unilateral items; no more than a single item score of 1 among the 7 unilateral items in the dominant limb. * tetras activities of daily living (adl) (recorded on a 0-4 scale, whole numbers) minimum score of \>= 3 on any of the 5 unilateral items; no more than a single item score of \<=1 among the 5 unilateral items in the dominant limb. * at least one of the following criteria must also be met: * tetras ul score (0-4 scale, with 0.5 increments) of \> 2 in the dominant limb on at least one of the 3 maneuvers or * tetras archimedes spiral task score (0-4 scale, with 0.5 increments) of \> 2 in the dominant limb exclusion criteria: * any uncontrolled clinically significant medical condition other than the one under study. * any medical condition that may put the participant at increased risk with exposure to botox purified neurotoxin complex.

Keywords: upper limb essential tremor ul et botox botulinum toxin type a
rufus - group rumination-focused cbt for negative symptoms

Conditions: Psychotic Disorders

Summary: abstract - -- introduction: psychosis spectrum disorders are characterized by both positive and negative symptoms, but whereas there is good effect of treatment on positive symptoms, there is still a scarcity of effective interventions aimed at reducing negative symptoms. rumination has been proposed as an important and fundamental factor in the development and maintenance of symptoms across psychiatric diagnoses, and there is a need to develop effective interventions targeting rumination behaviors and negative symptoms in patients with psychotic disorders. the aim of the current study is to investigate the feasibility and acceptability of group rumination-focused cognitive behavioral therapy (rfcbt) in the treatment of young people with psychosis spectrum disorders as well as investigating potential indications of treatment efficacy. methods and analysis: the study is a mixed-method clinical randomized controlled pilot trial with a target sample of 60 patients, who are randomized to either receive 13 weeks of group cfcbt or 13 weeks of treatment as usual (tau). all patients are examined at the start of the project and at the 13-week follow-up. the researcher will compare changes in outcomes from baseline to posttreatment between group cfcbt and tau. in addition, qualitative analyzes are carried out to explore feasibility and acceptability and to uncover the patients' experience of receiving the intervention.


Eligibility criteria:
inclusion criteria: 1. diagnosed with a psychosis spectrum disorder (icd-10 f2x) 2. at least 8 months left of their opus treatment 3. the presence of rumination behavior as assessed by a score of minimum 30 on the perseverative thinking questionnaire (ptq) 4. danish-speaking exclusion criteria: 1. substance abuse or positive symptoms that make participation in therapy difficult 2. severe suicidal thoughts/behavior 3. lacks capacity to consent 4. mild, moderate, or severe intellectual disability (iq ˂ 70) 5. planned adjustment of antidepressant and/or antipsychotic treatment (noted in the patient's medical record)
direct measurement of leukemic cell turnover (synthesis and removal) in patients with chronic lymphocytic leukemia (cll) using deuterated water

Conditions: Chronic Lymphocytic Leukemia

Summary: chronic lymphocytic leukemia. b-cell chronic lymphocytic leukemia (b-cll) is the most prevalent leukemia in the western hemisphere, accounting for \~25% of all leukemia's. it represents a monoclonal expansion of small, long-lived, apparently slowly dividing cd5+ b cells. because of the low proliferative index and a presumed uniform proliferative rate of b-cll cells in vivo (a fact not yet tested or documented), b-cll appears to be primarily a disease of accumulation rather than proliferation.

chronic lymphocytic leukemia. b-cell chronic lymphocytic leukemia (b-cll) is the most prevalent leukemia in the western hemisphere, accounting for \~25% of all leukemia's. it represents a monoclonal expansion of small, long-lived, apparently slowly dividing cd5+ b cells. because of the low proliferative index and a presumed uniform proliferative rate of b-cll cells in vivo (a fact not yet tested or documented), b-cll appears to be primarily a disease of accumulation rather than proliferation. b-cll remains an incurable illness and there is no survival benefit to early intervention. therefore, patients with early stage disease are usually followed closely without initiating treatment. patients with more extensive disease or progressive cytopenias are eventually treated with cytotoxic agents, with or without prednisone, or with nucleoside analogues that promote apoptosis in the leukemic cells. the clinical outcome of the disease is determined both by the profound dysregulation of the immune system that results in infection and autoimmunity and by leukemic infiltration and destruction of organs. autoimmune phenomena are common and frequently directed against hematopoietic cells, resulting in autoimmune hemolytic anemia (10-25%) or immune thrombocytopenia.

Eligibility criteria:
inclusion criteria: * must be 18 years of age. * must meet the clinical and laboratory criteria for b-cll (i.e., compatible clinical history and physical exam, presence of lymphocytosis, i.e., \>10,000 lymphocytes / mm3, evidence for a monoclonal population of cd5+/cd19+/cd23+ cells in the periphery that have dim surface membrane lg with l chain isotype restriction). * all patients will be staged according to the system of rai. only new onset patients who are not receiving therapy will be entered into the heavy water leukemic cell turnover studies. exclusion criteria: * patients hospitalized for an acute medical problem, related or not to their leukemia, within 4 weeks of enrollment. * a history of a second malignancy involving the hematopoietic system, or the need for extensive chemotherapy for any second malignancy; patients with active immunologic disorders (e.g., hiv and aids), especially autoimmune problems (e.g., autoimmune hemolytic anemia of any cause other than b-cll). * patients with impaired decision-making capabilities, e.g. dementia, psychosis, alcoholism, and illicit drug use will also be excluded.

Keywords: chronic lymphocytic leukemia
novel medical device for pharmacological therapy

Conditions: Vascular Access; Vascular Access Complication; Vascular Access Complications; Catheter Malfunction; Catheter Infection; Therapeutic Drug Management; Nurse; Nurse Based Care Management; Innovative Procedures

Summary: background: different co-creation methods were used to design and prototype a new fixative device for multiple intravenous therapies with the ability to control and identify the pharmacological therapy administered to a patient. objectives: to validate a newly created device for the reduction of complications related to the use of intravenous therapy methods: a multidisciplinary team composed of eight professionals specializing in the field of critical care and an engineering professional in industrial design was responsible for collecting, evaluating, and materializing the ideas and needs arising from clinical practice in a device that met the standards of the same.


Eligibility criteria:
inclusion criteria: * patients admitted to the intensive care unit * patients with authorization to take part in the study exclusion criteria: * patients with pre-existing medical conditions: patients with diseases affecting coagulation, such as hemophilia or thrombocytopathies, could be excluded. * active infection patients: any patient with vascular access site infections or systemic infections may be excluded to avoid complications. * inability to give informed consent: patients who are unable to understand or consent to participate in the study.

Keywords: vascular access catheter therapy complication device central vascular access
clinical specimen collection from pompe disease patients

Conditions: Pompe Disease

Summary: clinical specimens are required from individuals with pompe disease to support process and analytical development for a genetically modified autologous bone marrow cell product currently in preclinical research, ftx-pd01. the intent is for this product to be investigated in a subsequent clinical trial under a future fda ind to treat pompe disease. enrolled participants provide a venous blood specimen (approximately 20ml) to be used in preclinical studies and research and development of ftx-pd01. subjects may eventually be asked to undergo mobilized leukapheresis for bone marrow stem cell collection and their specimens will be used to further develop the ftx-pd01 cell product, including a cgmp compliant process to be applied under the future fda ind.

this protocol is to collect blood and hspc specimens from individuals with pompe disease. the first blood draw will be done at the first study visit and if eligible, the second collection will be done via mobilized leukapheresis at the second visit. the mobilized leukapheresis procedures will follow the facility's standard operating procedures and protocol requirements for mobilized leukapheresis. donors will be males or females between and including the ages of 3 years and 30 years. volunteers will provide written informed consent and meet all inclusion and exclusion criteria. each participant can be in the study for up to 120 days (3 months). the study will be conducted in accordance with human research for the purposes of obtaining clinical specimens for research. there is no endpoint for this study, however, data collected from this study will include, but not be limited to, gender, demographics, medical history, clinical laboratory values, and volume of the blood collected. the data will be summarized in future studies reporting results from a future clinical trial under fda ind.

Eligibility criteria:
inclusion criteria: * male of female aged 3-30 * documented diagnosis of pompe disease * participants who has not participated in a cell or gene therapy trial for pompe disease exclusion criteria: * active acute infection at screening * uncontrolled diabetes * uncontrolled hypertension * active dic, bleeding or coagulopathy which cannot be corrected with minimal intervention * symptomatic, uncontrolled or severe intercurrent illness that would compromise the ability to tolerate blood collection or mobilized leukapheresis procedure * systemic chemotherapy less than or equal to 2 weeks (6 weeks for clofarabine or nitrosoureas) or radiation therapy less than or equal to 3 weeks prior to leukapheresis * pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test at screening * any patient that in the opinion of the investigator is not medically stable to undergo the leukapheresis procedure or will not comply with the visit schedules or procedures

Keywords: pompe pompe disease hspc modified bone marrow stem cell
bibw 2992 (afatinib) versus chemotherapy as first line treatment in nsclc with egfr mutation

Conditions: Carcinoma, Non-Small-Cell Lung; Adenocarcinoma

Summary: this randomised, open label phase iii trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an epidermal growth factor receptor activating mutation. the objectives of the trial are to compare the efficacy of single agent bibw 2992, arm a, with pemetrexed/cisplatin chemotherapy, arm b, as first line treatment for this group of patients.


Eligibility criteria:
inclusion criteria: * pathologically confirmed diagnosis of stage iiib (with cytologically proven pleural effusion or pericardial effusion) or stage iv adenocarcinoma of the lung. patients with mixed histology are eligible if adenocarcinoma is the predominant histology. * epidermal growth factor receptor mutation detected by central laboratory analysis of tumour biopsy material. * measurable disease according to recist 1.1. * eastern cooperative oncology group score of 0 or 1. * age \>/= 18 years. * life expectancy of at least three months. * written informed consent that is consistent with international conference on harmonisation-good clinical practice guidelines. exclusion criteria: * prior chemotherapy for relapsed and/or metastatic nsclc. neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation. * prior treatment with epidermal growth factor receptor targeting small molecules or antibodies. * radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation. * active brain metastases * any other current malignancy or malignancy diagnosed within the past five years * known pre-existing interstitial lung disease. * significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom. * history or presence of clinically relevant cardiovascular abnormalities. * any other concomitant serious illness or organ system dysfunction. * adequate absolute neutrophil count and platelet count * adequate liver and kidney function * active hepatitis b infection, active hepatitis c infection or known hiv carrier.
body composition analysis in cirrhotic undergoing paracentesis

Conditions: Liver Cirrhosis; Ascites

Summary: ascites is a frequent complication of liver cirrhosis, initial treatment consists on diuretics intake, however, as the disease progresses this complication becomes more severe, consequently other therapeutic options are used. paracentesis is indicated when severe ascites is present and it should be accompanied by albumin infusion. nutritional status is generally affected in patients with liver cirrhosis, even more patients with severe ascites show decreased energy intake due to gastric compression.


Eligibility criteria:
inclusion criteria: * any genre. * age 18-70 years old. * diagnosis of liver cirrhosis of any etiology (documented by clinical, biochemical, radiological and / or biopsy. * presence of high volume ascites * the signing of informed consent will be required for the inclusion of any patient. exclusion criteria: * hepatic encephalopathy grade iii or iv. 2) liver transplantation. * congestive heart failure. * hemodialysis. * acute or chronic renal failure. * nephrotic syndrome with protein loss. * alcoholism active in the last 6 months. * pregnancy. * upper gastrointestinal bleeding.

Keywords: paracentesis liver cirrhosis ascites body composition
prospective observational long-term safety registry of multiple sclerosis participants who have participated in cladribine clinical trials

Conditions: Multiple Sclerosis

Summary: prospective observational long-term safety registry of multiple sclerosis participants who have participated in cladribine clinical trials


Eligibility criteria:
inclusion criteria: * prior enrollment into selected oral cladribine clinical trials as of randomization to either study drug or placebo, once participation in the clinical trial has ended * written informed consent was given exclusion criteria: * participants who cannot be reached by telephone * participants unable to answer the registry questionnaires and who do not have a next of kin or caregiver able to answer the registry questionnaires * participants who - either during the lag interval or subsequently enter an interventional study

Keywords: multiple sclerosis cladribine premiere observational study