Kornimate/medical-research-clean huggingface dataset:
vaccine therapy plus qs21 in treating patients with progressive prostate cancer

Conditions: Prostate Cancer

Summary: rationale: vaccines may make the body build an immune response to kill tumor cells. purpose: phase i trial to study the effectiveness of vaccine therapy given with qs21 in treating patients who have progressive prostate cancer.

objectives: i. determine the optimal dose of thompson-friedenreich \[tf(c)\]-keyhole limpet hemocyanin (klh) conjugate plus adjuvant qs21 that induces an antibody response in patients with prostate cancer. ii. determine the safety of the tf(c)-klh conjugate prepared using an mbs heterobifunctional linker plus qs21. iii. assess postimmunization changes in prostate specific antigen levels and other objective parameters of disease in these patients. outline: this is a dose escalation study. patients receive tf(c)-klh conjugate with adjuvant qs21 subcutaneously weekly for 3 weeks, then once during weeks 7 and 19. cohorts of 5 patients each receive escalating doses of tf(c)-klh vaccine until the optimal dose, based on antibody response, is reached. patients are followed monthly for 6 months, then every 3 months for 1 year.

Eligibility criteria:
disease characteristics: histologically proven progressive prostate cancer after primary therapy radiographic changes or psa at least 1.0 ng/ml and rising after prostatectomy or psa at least 2.0 ng/ml and rising after radiotherapy or psa rising 50% during intermittent hormonal therapy no metastatic disease by radiography no active cns or epidural tumor registered on mskcc-9040 patient characteristics: age: 18 and over performance status: karnofsky 70-100% life expectancy: at least 6 months hematopoietic: wbc at least 3500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin less than 2.0 mg/dl or sgot less than 3.0 times upper limit of normal renal: creatinine no greater than 2.0 mg/dl or creatinine clearance at least 40 ml/min cardiovascular: no new york heart association class iii/iv cardiac disease pulmonary: no severe debilitating pulmonary disease other: no other active malignancy within 5 years except nonmelanomatous skin cancer no infection requiring antibiotics no narcotic dependent pain no positive stool guaiac excluding hemorrhoids no radiation induced proctitis no allergy to seafood prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 4 weeks since prior chemotherapy and recovered no concurrent chemotherapy endocrine therapy: see disease characteristics at least 2 weeks since change in hormonal therapy (except to maintain castrate levels of testosterone), including prednisone or dexamethasone at least 8 weeks since prior suramin and/or serum concentration of suramin must be less than 50 micrograms/ml (replacement hydrocortisone allowed) radiotherapy: see disease characteristics at least 4 weeks since prior radiotherapy and recovered no concurrent therapy to only measurable lesion surgery: see disease characteristics no concurrent surgery

Keywords: stage i prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer recurrent prostate cancer
rosa knee intraoperative planning flexibility study

Conditions: Osteo Arthritis Knee; Rheumatoid Arthritis

Summary: the purpose of this study is to verify that an orthopedic surgical assist robot (rosa knee system) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (tka) based on feedbacks obtained from intraoperative soft tissue conditions. a total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2 years.

the objectives of the study are to document that rosa knee system can provide intraoperative planning adjustment based on feedbacks obtained by laxity as well as gaps to locally preferred surgeon's operative philosophy. this will also provide accuracy, intraoperative soft tissue release as well as patient outcome on locally preferred surgical technique. the primary endpoint is defined as the mean absolute difference between x-atlas image-based pre-op plan \& intra-op final plan. the secondary endpoints include kinematic analysis, euroqol 5 dimensions (eq-5d), rehabilitation record, knee society score (kss) 2011, image assessment and safety up to 2 years postoperatively.

Eligibility criteria:
inclusion criteria: * 20 years and over * skeletally matured * decision to have total knee arthroplasty with rosa knee system being made independently and prior to recruitment into study * willing and able to complete scheduled follow-up evaluations as described in the study protocol * has participated in the informed consent process and is willing and able to sign an institutional review board (irb)/ethics committee (ec) approved informed consent form exclusion criteria: * has serious bone defect(s), which require(s) metallic augment, synthetic bone or allograft * is septic, has an active infection or has osteomyelitis at the affected joint * has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery * has any concomitant disease which is likely to jeopardize the functioning or success of the implant * is known to be pregnant * is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails * has a known sensitivity or allergy to one or more of the implanted materials
the effect of reiki application on depression, anxiety and physical activity in patient with multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: during reiki application, individuals may report feeling a slight warm sensation under and near the therapist's hand. the only rule in reiki practice is that the individual must give permission to the practitioner to facilitate the flow of energy. the person receiving reiki during the application does not have to believe in reiki. because reiki is universal life energy and is available to everyone. reiki is generally safe and no serious side effects have been reported. reiki practice in the last 10 years; it is increasing among physicians, nurses and other healthcare professionals. this study was planned to investigate the effect of reiki application on depression, anxiety and physical activity in individuals diagnosed with relapsing-remitting multiple sclerosis. geri bildirim gönder yan paneller


Eligibility criteria:
inclusion criteria: * being over 18 years of age * having the ability to use technological devices * not using reiki and similar integrative treatment methods * no verbal communication disability (hearing and speaking) * not having a diagnosed psychiatric disorder * patients who have been receiving relapsing-remitting ms treatment for more than three months exclusion criteria: * patients using any complementary alternative treatment methods * patients who cannot communicate by phone to participate in remote reiki application * patients with autoimmune diseases other than multiple sclerosis * patients with communication disabilities * patients with another known neurological system disease (dementia, alzheimer's, etc.).

Keywords: reiki anxiety physical activity
a study of t-dxd for the treatment of solid tumors harboring her2 activating mutations

Conditions: Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast

Summary: this is an open-label, multi-center, single arm, phase ii study to evaluate the efficacy and safety of t-dxd for the treatment of unresectable and/or metastatic solid tumors harboring specific her2 activating mutations regardless of tumor histology. the target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. pre-specified her2 mutations will be locally assessed using ngs tests or alternative methods. prior her2 targeting therapy is permitted.


Eligibility criteria:
inclusion criteria: * adults ≥18 years old. other age restrictions may apply as per local regulations. * unresectable and/or metastatic solid tumors with pre-specified her2 mutations (s310f, s310y, g660d, r678q, d769y, d769h, v777l, y772_a775dup / a775_g776insyvma, l755s, g778_p780dup / p780_y781insgsp, t862a, and v842i locally determined by ngs or a validated nucleic acid-based methodology (eg, qpcr, digital pcr) on tumor tissue, who have progressed following prior treatment or who have no satisfactory alternative treatment options. * prior her2 targeted therapy is permitted. * all patients must provide an ffpe tumor sample for retrospective central her2 testing. * lvef ≥50% * ecog 0-1 * all patients have measurable target disease assessed by the investigator based on recist v1.1 exclusion criteria: * her2 overexpressing (ihc3+ or ihc2+/ish+) breast, gastric or gastroesophageal junction adenocarcinoma. * her2 mutant nsclc. * medical history of myocardial infarction within 6 months before randomization/enrolment, symptomatic chf, unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (\< 6 months) cardiovascular event including stroke. * history of non-infectious pneumonitis/ild, current ild, or where suspected ild cannot be ruled out by imaging at screening * corrected qt interval by fridericia's formula (qtcf) prolongation to \> 470 msec (females) or \> 450 msec (males) based on average of the screening triplicate 12-lead ecg. * lung-specific intercurrent clinically significant severe illnesses. * history of active primary immunodeficiency, known hiv, active hbv or hcv infection * uncontrolled infection requiring intravenous (iv) antibiotics, antivirals, or antifungals * pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (cart). * has spinal cord compression or clinically active central nervous system metastases.

Keywords: her2 t-dxd ds-8201a trastuzumab deruxtecan metastatic solid tumors histology agnostic
performance and safety of i-020805 in prevention of cerebrospinal fluid (csf) leakage following elective craniotomy

Conditions: Cerebrospinal Fluid Leakage

Summary: this is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (csf) leakage after an elective cranial surgery.

patients who consented to participate in the trial and fulfilled the preoperative inclusion and exclusion criteria underwent screening prior to surgical treatment. after dural suturing, if patients met the intra operative inclusion and exclusion criteria, they received i-020805. if necessary, autologous grafts were to be used to augment dural closure. i-020805 was delivered from a double syringe applicator that creates a fine layer over the dura. this layer quickly sets within seconds to form a watertight seal.

Eligibility criteria:
inclusion criteria: pre-operative * male or female of 18 years old or over * elective cranial procedure entailing a dural incision of at least 2 cm in length * requires a procedure involving surgical wound classification class i/clean * signed informed consent form * negative pregnancy test at screening for women of childbearing potential and agreeing to use an acceptable birth control method or abstinence until 90 days post-surgery intra-operative * surgical wound classification class i/clean * dural margin from bony edges of at least 3 mm throughout * spontaneous expression of csf assessed visually or a csf leakage upon valsalva maneuver exclusion criteria: pre-operative * cranial procedure requiring translabyrinthine, transoral and/or any procedure penetrating the air sinus or mastoid air cells * presence of symptomatic hydrocephalus * pre-existing external ventricular drainage or lumbar csf drain * radiotherapy in the planned surgical region which ended within 3 months prior to planned surgery * presence of systemic infection * known history of hemophilia or other clinically significant coagulopathy * known oral anticoagulant use * pregnancy or breast feeding * known allergy to any components of i-020805 * previous participation in this trial or any investigational drug or device study within 30 day of screening * known clinically significant organ or systemic diseases * known or suspected non-compliance with trial procedures intra-operative * patient not meeting the pre-operative eligibility criteria * not able to tolerate a valsalva maneuver * gap of more than 2 mm remaining after primary closure of dura * use of synthetic or non-autologous duraplasty material

Keywords: dura sealant cranial craniotomy csf leakage csf leakage following cranial surgery
genetic risk factors of the sneddon syndrome

Conditions: Sneddon Syndrome

Summary: sneddon syndrome (ss) is a rare disorder with an incidence of about 4/million/year that affects mainly young and predominantly female adults. it is characterized by recurrent strokes and livedo reticularis, a purple reticular patterning of the skin. a genetic predisposition to this disease, for which there is still no single therapy, is being discussed. our group recently identified a homozygous nonsense mutation within epidermal growth factor repeat (egfr) 19 of notch3 in two siblings of a consanguineous family with sneddon syndrome and pediatric stroke. in an attempt to find other possible contributing genes in sneddon syndrome patients with adult-onset stroke, we also searched for loss-of-function variants in genes downstream of notch3. in doing so, we found 2 patients carrying heterozygous loss-of-function variants in the palld and angptl4 genes. our results suggest that a bi-allelic loss-of-function mutation in notch3 is a cause of familial sneddon syndrome with pediatric stroke and that impaired notch3 signaling is an underlying disease mechanism in general. in addition, we have identified several other promising variants that are either located in genes associated with notch3 signaling or play a role in vascular function and stroke. based on these results, we now want to investigate whether these aforementioned variants are detectable in a larger number of patients and additionally analyze whether other genetic variants also play a role in disease pathogenesis. the goal of our project is to identify risk variants for sneddon syndrome by whole exome sequencing and subsequent conventional sequencing.... the detection of a risk gene would be a helpful tool for the diagnosis of sneddon syndrome and a possible basis for new therapeutic approaches.


Eligibility criteria:
inclusion criteria: * subjects must be at least 18years old. * affected subjects must have been clinically diagnosed with sneddon syndrome. when analyzing families with sneddon syndrome, healthy family members and participants with only symptoms of the skin will be included if consent is obtained.frau elli greisenegger * unaffected subjects or subjects with symptoms restricted to the skin must have at least one family member with the clinical diagnosis sneddon syndrome participating in the study. * subjects must be able to communicate well with the investigator, to understand the requirements of the study, as well as to understand and sign thewritten informed consent(= informed consent approved by thelocalethics committee). exclusion criteria: - subjects who are unable to communicate well with the investigator, to understand the requirements of the study, as well as to understand and sign the written informed consent, are not eligible for inclusion in this study.
respiratory disease cohort studies of chinese medicine for pneumonia (research-pneumonia)

Conditions: Pneumonia

Summary: the purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with pneumonia after discharge in a prospective cohort study: one is the traditional chinese medicine (tcm) cohort, which has been evaluated and has certain effects; the other is a non traditional chinese medicine queue.

the incidence, hospitalization rate, and mortality associated with pneumonia are significant, contributing to a substantial disease burden. post-discharge follow-up and intervention strategies for pneumonia patients are often insufficient, leaving patients vulnerable to readmission or mortality due to recurrent pneumonia and related complications. in clinical practice, there is a predominant focus on the amelioration of clinical symptoms during hospitalization, with limited attention to ongoing outpatient interventions aimed at reducing readmission rates. consequently, there is a pressing need for cohort studies on pneumonia. this study is a multicenter, prospective cohort study involving adult patients discharged after pneumonia treatment. approximately 5,000 patients will be enrolled, with follow-up assessments conducted every three months over the course of one year. after one year, patients will be stratified into two cohorts based on the duration of traditional chinese medicine (tcm) treatment received (e.g., continuous treatment for two months or intermittent treatment for three months per year). one cohort will consist of patients receiving tcm, while the other will include those who did not receive tcm. the primary endpoint is the rate of hospital readmission, while secondary outcomes include treatment satisfaction, physician-reported outcomes, patient-reported outcomes, quality of life, nutritional status, incidence of acute upper respiratory tract infections, and survival. this study aims to evaluate the clinical efficacy and safety of tcm in the management of adult pneumonia patients following discharge.

Eligibility criteria:
selection criteria: * hospitalized patients with a confirmed diagnosis of pneumonia (hap, cap). * age ≥18 years. * signed informed consent form. exclusion criteria: * patients with confusion, consciousness disorders, dementia, and various mental illnesses; * patients with altered mental status, dementia, consciousness disorders, or various psychiatric conditions; * those who are completely unable to care for themselves or are bedridden long-term; and those currently participating in other clinical drug trials. * known to be allergic to treatment drugs.

Keywords: pneumonia chinese medicine cohort
the effect of exercise and oral supplement intervention in sarcopenia markers in hemodialysis patients

Conditions: Sarcopenia

Summary: objective: to assess the effect of different post-exercise oral nutritional supplement intake timing on sarcopenia indicators in hemodialysis patients. study design: 24-weeks randomized control trial (rct), includes 12-wk intervention period and 12-week follow up period. setting \& participants: maintenance hemodialysis patients who were older than 20 years old meet sarcopenia diagnosis criteria. intervention: group a: during intervention period, participants have 3 times exercise program per week. each program is 30 minutes of resistance exercise and aerobic exercise. participants take oral supplement in 1 to 2 hours after exercise program. group b: participants have the same exercise program and oral supplement as group a. however, they take oral supplement in 2.5-4 hours after exercise program. group c: participants only take oral supplement. control group: participants maintain usual diet and physical activity without any intervention.


Eligibility criteria:
inclusion criteria: * hemodialysis treatment longer than 3 months * hemodialysis treatment 3 times treatment per weeks * kt/v≥1.2 or urr≥65% * taking foods by oral * meeting the criteria of sarcopenia. exclusion criteria: * soy allergy * amputation * significantly edema * receiving palliative care * severe angina * unstable arrhythmias * severe infection * heart failure (class 4 of new york heart association scale) * central venous catheter or femoral arteriovenous fistula * pacemaker * pregnancy * severe paleness * severe difficulty breathing * chest pain * hospitalization 3 months before recruited in this study * oral supplement intolerance diagnosed by the doctor or dietitian * bone injury/nerve damage/cognition impairment affecting physical activity intervention
comparison of yttrium-90 absorbed doses using pet/ct versus pet/mr imaging for hepatic malignancies

Conditions: Hepatic Malignancies

Summary: the purpose of this study is to compare the results of positron emission tomography/computer tomography (pet/ct) to positron emission tomography/magnetic resonance imaging (pet/mri) to help determine any added advantage of one over the other in relation to a tumor which might assist in further management plans.

participants in this study will undergo pet/ct (standard imaging) and pet/mr (additional imaging), within 6 hours after sirt with y-90 for palliative treatment of the liver malignancy. patients will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart. upon acquirement and construction of pet/ct and pet/mr images, a software (mim sureplan livery90) would be utilized for semi-automatic determination of the liver/tumor contours and calculation of the y-90 absorbed doses (gy) in the regions of interest (including within tumor and background liver outlines) using the local deposition method. the primary objective of this study is to assess the agreement between post-y-90 re absorbed doses (gy) in the liver tumor tissues based on pet/ct versus pet/mr imaging. this would permit the comparison of y-90 tumor absorbed doses, acquired from pet/mr, with the current standard of care pet/ct imaging to verify the data consistency and to validate its application for the prediction of tumor response to treatment. the secondary objective of this study is to assess the agreement between post-y-90 re absorbed doses (gy) in the background liver tissues (surrounding tumors), based on pet/ct versus pet/mr imaging. this would permit the comparison of y-90 background liver absorbed doses, acquired from pet/mr, with the current standard of care pet/ct imaging to verify the data consistency and to validate its application for the prediction of dose toxicity.

Eligibility criteria:
inclusion criteria: * the patient has a liver malignancy and is scheduled for sirt with y-90; and * the patient is an adult, self-competent, and able to provide informed consent to participate in the study exclusion criteria: * the patient loses competence, has a condition that questions their ability to provide informed consent independently (e.g. cannot communicate in english), or withdraws consent to participate within any time in the study period; or * the patient is not eligible to undergo mri due to the presence of metal devices or implants in their body; or * both imaging modalities cannot take place within 6 hours after y-90 re; or * both imaging modalities cannot take place within 1 hour apart from each other