Kornimate/medical-research-clean huggingface dataset:
end-of-life intervention for african american dementia caregivers

Conditions: Encephalopathy, Ischemic

Summary: in a community-based approach, the investigators long-term goal is to empower african american family caregivers who are designated healthcare proxies to make informed end-of-life treatment decisions for participants with moderate to severe dementia before a life-threatening medical crisis occurs.

the investigators conducted a randomized controlled trial for efficacy of the advance care treatment program in an african american church-based community model. the investigators compared the effect of the experimental and control groups on knowledge, self-efficacy, intentions and behaviors from 4 urban african american churches randomly assigned to experimental (n=2) or control (n=2) conditions,304 (experimental n=152; control (n=152) health care proxies of participants that have advanced stage dementia: (a) were concurrently recruited in small classes each with 8-9 healthcare proxies.

Eligibility criteria:
"inclusion criteria" * caregiver spouse or adult child of care recipient * caregiver knowledgeable about care recipient's medical history * care recipient must be african american * care recipient must have moderate to severe stage dementia * care recipient must lack decisional capacity "exclusion criteria" * not a caregiver * care recipient not african american, * care recipient without moderate to severe dementia
clinical comparison of a postbiotic-gel with placebo gel for gingival inflammation in patients with down syndrome

Conditions: Down Syndrome; Gingival Bleeding

Summary: the aim of the study is to evaluate the efficacy of home treatment with a postbiotic-based gel for the management of periodontal inflammation in patients with down syndrome. patients will be enrolled at the s.c. odontostomatologia dell'azienda ospedaliera "ordine mauriziano di torino", turin, italy. after the collection of the periodontal clinical indexes (bop%, pcr%, dental mobility, mmgi, compliance and satisfaction questionnaire), patients will undergo a professional mechanical debridement with ultrasonic instruments and glycine powders. then, they will be randomly divided into two groups according to the home treatment: * in the trial group biorepair plus parodontgel intensive (containing microrepair®, hyaluronic acid, lactobacillus ferment and aloe barbadensis leaf juice powder) will be used once a day for all the duration of the study * in the control group, a placebo gel without (active ingredients) will be used once a day for all the duration of the study. indexes will be re-evaluated after 1 (t1), 3 (t2) and 6 months. the professional mechanical debridement will be performed again at t3 timepoint.


Eligibility criteria:
inclusion criteria: * not bedridden patients with down syndrome * gingival inflammation and bleeding exclusion criteria: * lack of compliance signalled by caregivers * other systemic diseases
knowledge, attitudes, and practice of surgeons toward nutrition support in hipec patients

Conditions: Pseudomyxoma Peritonei; Appendiceal Neoplasms; Pancreatic Neoplasms; Neoplasm Metastasis; Adenocarcinoma; Sarcoma; Uterine Neoplasms

Summary: the goal of this survey of international hipec (hyperthermic intraperitoneal chemotherapy) surgeons is to determine their knowledge of and attitudes towards the nutritional support needs of hipec patients and what their practice patterns are with this patient population.


Eligibility criteria:
inclusion criteria: * surgeon trained in and performing the hipec procedure exclusion criteria: * not performing the hipec procedure
treatment of elderly chinese acute myeloid leukemia patients aged 65 to 75 years old

Conditions: Acute Myeloid Leukemia

Summary: this study focus on the comparison of cag regimen to the low dose cytarabine therapy in elderly aml patients who are unfit or unwilling to receive intensive chemotherapy.

low dose cytarabine remains to be the choice of standard for elderly aml patients who are unfit or unwilling to receive intensive treatment. cag regimen, which is a combination of aclacinomycin，low dose cytarabine±g-csf is used often in elderly aml patients in china. it is proved effective and safety in some pilot studies，while there is no prospective，randomized study yet.

Eligibility criteria:
inclusion criteria: * acute myeloid leukemia except apl * ecog ps：0-3 * unfit or unwilling to receive intensive therapy exclusion criteria: * the one who has already received induction therapy no matter what the outcome is. * active cancer patients who are needed to receive treatment; * serious uncontrolled infectious diseases(eg.tuberculosis or invasive pulmonary aspergillosis）； * active heart disease
the effect of meditation on quality of life in women with breast cancer and other gynecological cancers

Conditions: Breast Cancers; Gynecologic Cancer

Summary: women with breast cancer and other gynecologic cancers often suffer significant distress and disability from their disease. a practice of meditation-based stress reduction and cognitive-affective-behavioral learning may help women with these conditions decrease their suffering and improve their quality of life.

the objective of this project in women recently treated for breast or other gynecologic cancer is to determine whether an intervention program consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning has the potential for reducing disabling distress and improving quality of life in a population vulnerable to the progression or recurrence of disease. quality of life will be assessed at 12 months.

Eligibility criteria:
inclusion criteria: * all women with stage i-iii breast or other gynecologic cancer who have received treatment within the preceding year will be eligible for inclusion in the study. exclusion criteria: * patients who refuse to participate will be excluded * patients with metastatic cancer are excluded.

Keywords: breast cancer gynecologic cancers meditation stress-reduction cognitive-affective behavioral learning
xolair in patients with chronic sinusitis

Conditions: Sinusitis

Summary: the purpose of this study is to determine if treatment with the anti-ige antibody, xolair (omalizumab), will improve objective and subjective evidence of chronic sinusitis.

at its most basic level, sinusitis is defined as an inflammation of the lining membrane of the paranasal sinuses. sinusitis affects all age groups, including 17% of people above the age of 65 years. on the basis of national population surveys and insurance-reimbursement claims, sinusitis is one of the most common health problems in the u.s. thus, each year, billions of dollars are spent on direct medical costs for the treatment of this enigmatic illness. despite the enormous cost of the problem, there are no definite studies of treatment and management. there are some data indicating that intranasal steroids are effective, and recently nasonex was approved for the treatment of nasal polyps. all other treatments are empirically based. there is evidence that ige antibodies play a role in chronic sinusitis. the investigators have shown that total ige levels correlate with the severity of sinusitis, as assessed by ct scan. staphylococcus enterotoxins cause local increases in total ige in over 50% of nasal polyp patients. allergies occur more frequently in patients with chronic sinusitis than in the general population. elevations in total ige have been shown to occur in patients with allergic fungal sinusitis and the levels of total ige decrease with successful treatment. thus, the investigators speculate that ige contributes significantly to the pathogenesis of chronic sinusitis. the purpose of this study is to determine if treatment with the anti-ige antibody, xolair, will improve objective and subjective evidence of chronic sinusitis.

Eligibility criteria:
inclusion criteria: * chronic sinusitis, as defined by symptoms for greater than 12 weeks, despite treatment * paranasal sinus ct scan showing evidence of chronic sinusitis * positive skin or rast test to an inhalant allergen * serum total ige between 30 and 700 international units/ml * body weight less than 150 kg * impaired quality of life, as measured by the rhinosinusitis disability index (rsdi) exclusion criteria: * women of childbearing potential not using a contraception method(s) (birth control pills, depo provera, double barrier) as well as women who are breastfeeding * known sensitivity to xolair * patients with severe medical condition(s) that, in the opinion of the investigator, prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease) * use of any other investigational agent in the last 30 days * no measurable disability on the rsdi * immunocompromised patients or patients with ciliary disorders

Keywords: chronic sinusitis
mri characterization of mammographically detected dcis

Conditions: Breast Cancer, Stage 0

Summary: this is a single institution, prospective observational clinical trial for women with mammographically identified calcifications that may represent ductal carcinoma in situ (dcis). the purpose of this study is to determine whether quantitative, multiparametric breast mri performed prior to surgical resection can biologically characterize this common pre-invasive malignancy, ductal carcinoma in situ (dcis), which typically presents in asymptomatic women as suspicious calcifications on mammography.

the investigators will assess whether mri signatures can determine which calcifications identified prior to surgical resection actually harbor dcis, and whether these imaging features correlate with pathologic markers of proliferation (ki-67) and inflammation (cox-2) within dcis lesions. the investigators will also explore whether quantitative mri features in the peri-tumoral region correlate with prognostic microenvironment markers of inflammation (tnfα) and angiogenesis (vegf). finally, investigators will assess whether a multivariate model using these markers can accurately predict risk of recurrence based on a multi-gene assay (oncotype dx dcis score).

Eligibility criteria:
inclusion criteria: * \[cohort a\] women aged 18 or older with suspicious calcifications identified on mammography without an associated mass * \[cohort b\] women aged 18 or older with recent biopsy-proven dcis with residual calcifications present on mammogram after biopsy exclusion criteria for both cohorts: * patients with prior history of breast cancer in the ipsilateral breast * patients with a newly diagnosed breast cancer in the contralateral breast * contra-indication to contrast-enhanced breast mri (e.g. renal insufficiency with gfr\<60, contrast allergy, incompatible metal) * patients who currently are undergoing chemoprevention therapy (e.g. aromatase inhibitors or selective estrogen receptor modulators) * women who are pregnant

Keywords: ductal carcinoma in situ mri oncotype dx
effects of breathing training on psychosocial functioning and heart rate variability in postmenopausal women with depressive symptoms-3

Conditions: Postmenopause

Summary: the specific aims of this study are: 1. to develop a breathing training protocol specifically designed to improve hrv and psychosocial functioning for postmenopausal women with depressive symptoms, 2. to examine the immediate effects of an 8-week breathing training program on hrv and psychosocial end points in postmenopausal women with depressive symptoms, 3. to examine the intermediate-term effects of an 8-week breathing training program on hrv and psychosocial end points in postmenopausal women with depressive symptoms, and 4. to determine whether the change in depressive symptoms with breathing training in postmenopausal women is associated with the change in hrv.

postmenopausal women without hormone replacement therapy are associated with higher risk of cardiac morbidity and mortality. they are likely to experience depressive symptoms after menopause, and the comorbidity of depression are related to altered autonomic function. we expect that postmenopausal women with depressive symptoms who receive breathing training will demonstrate decreased depressive symptoms and increased heart rate variability immediately upon and later after completion of training, and optimally contributing to improve autonomic nervous regulation in their later life to prevent undesired cardiac outcomes.

Eligibility criteria:
inclusion criteria: * permanent termination of menstruation of natural cause. * cessation of menstrual cycles for more than 12 consecutive months. * a score of the chinese version of beck depression inventory-ii of greater than 10. * able to speak mandarin or taiwanese. * age from 45 to 64 years. exclusion criteria: * subjects who are clinically diagnosed with history of cardiac arrhythmia, coronary heart disease, heart failure, kidney disease, hypertension, chronic low blood pressure, diabetic neuropathy, psychosis, mental deficiency. * subjects who received hormone replacement therapy prescribed by gynecological physicians. * subjects who took cardiac and/or psychotropic medications which may affect the autonomic functions

Keywords: depression depressive symptoms postmenopause rsa biofeedback
safety and clinical performance of a biological matrix used in abdominal wall reconstruction

Conditions: Abdominal Wall Defect; Abdominal Wall Injury; Abdominal Hernia

Summary: the general objective of the study is to confirm the medium/long-term safety and clinical performance of the cellis membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, and to identify emerging risks in comparison to the clinical data related to other types of fixation material. the present study will be a prospective multicentric non-randomized and noncontrolled trial involving 112 patients followed for 24 months. the study will be conducted in france in 3 investigational centres.

the study will be prospective, multicentric, single-arm, observational (non-interventional) to evaluate the safety and performance of the cellis membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure. all evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure. the study will be conducted in france in 3 investigational centres including 112 patients scheduled for an abdominal wall reconstruction. each patient will participate in one assessment period including a preoperative visit, followed by the day of surgical procedure and a hospitalization period. patients will return for ambulatory visits on day 30 (+/- 7 days), on month 3 (+/- 2 weeks), on month 12 (+/- 2 weeks) and on month 24 (+/-2 weeks) post-surgery. cellis will be implanted by open technique following standard techniques. the membrane can be used in bridged or reinforced repairs. mesh placement can include inlay (bridging), underlay intraperitoneal, sublay (retrorectus/retromuscular) positions.

Eligibility criteria:
inclusion criteria: * patient aged ≥18 years, * patient with an indication of abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, * patient being informed of its participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access, * patient being informed of the porcine origin of the device in advance of the procedure. exclusion criteria: * patient with known hypersensitivity to porcine materials, * patient who is pregnant, * patient having refused to participate to the study, * patient refusing to return for the follow-up visits.

Keywords: abdominal wall reconstruction biological mesh
paraspinal muscle remodeling

Conditions: Lumbar Disc Herniation

Summary: lumbar disc herniation is the most common diagnosed degenerative pathology in the lumbar spine with a prevalence of 2 to 3% in the adult population. unilateral lumbar disc herniation is characterized by compression or irritation of the lumbar nerve roots or dural sac by either protrusion, extrusion or sequestration of the nucleus pulposus, mostly in the posterolateral region. compression or irritation of the lumbar nerve roots and dural sac can induce unilateral sensory and motor symptoms. therefore, it is the principal cause of lumbar spinal surgery. different imaging studies have investigated asymmetry of the paraspinal muscles in patient with unilateral low back pain due to lumbar discus herniation. both animal and human studies indicate a reduction in total muscle cross-sectional area, increased fat infiltration and fibrosis within the lumbar multifidus at the affected side. increased fat infiltration is clinically important because there is a correlation between the amount of intramuscular fat and lumbar muscle dysfunction. not only fat infiltration correlates with lumbar dysfunction, also a lower multifidus cross-sectional area is associated with and predictive for low back pain. this indicates that there is an association between paraspinal muscle changes/ remodeling and muscle dysfunction that could lead to low back pain. the aim of this research is to quantify the decrease in muscle and muscle fibre size, the amount of fat infiltration, and the amount of fibrosis present within the multifidus muscle at the herniated side in relation to the unaffected side. the second aim is to investigate the possible role of different cell types in the process of muscle remodeling. the last aim of this study is to correlate these muscular changes with long-term functional outcomes such as pain, fear and disability. this information can possibly contribute to the etiology of paraspinal muscle changes, and provide a handgrip to future research.


Eligibility criteria:
inclusion criteria: * unilateral lumbar disc hernia (diagnosed using mri) * age between 18-55 * understanding the dutch language exclusion criteria: * spinal surgery within the last year * degenerative or other spinal pathology (except disc hernia) * contraindications to undergo a mri * other known pathologies that might affect muscle biology/ morphology

Keywords: lumbar disc herniation hernia
effect of peek and co-cr framework reinforcement on marginal bone loss around implants supporting a fixed all-on-four prosthesis in completely edentulous mandibles. a randomized controlled clinial trial

Conditions: All on Four, Marginal Bone Loss, PEEK

Summary: a fixed all-on-four prosthesis will be fabricated for the mandibular arch for each patient and the marginal bone loss will be evaluated at baseline, 3,6,9 and 12 months


Eligibility criteria:
inclusion criteria: * completely edentulous patient with old satisfactory maxillary and mandibular dentures requiring an implant supported restoration * implant sites must allow for implant placement * patients with no systemic conditions that may interfere with implant placement exclusion criteria: * general contraindications for implant surgery( poor oral hygiene- diabetes- pregnancy or nursing- drug abusers)
fluoxetine for the modification of colorectal tumor immune cells before surgery in patients with colorectal cancer

Conditions: Colorectal Adenocarcinoma

Summary: this phase i trial tests whether fluoxetine (prozac) works to modify the tumor immune cells before surgery in patients with colorectal cancer. fluoxetine is a commonly used selective serotonin reuptake inhibitor (ssri) prescribed for major depressive disorder and generalized anxiety. giving fluoxetine may modify the immune cell composition in the tumor and its microenvironment and may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread in patients with colorectal cancer.

primary objective: i. to evaluate alterations in tumor immune cell composition and activity under ssri treatment. outline: patients receive fluoxetine orally (po) once daily (qd) for 10 days prior to surgery.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age at visit 1 * previously untreated cytologically or histologically confirmed colorectal adenocarcinoma that will not need neoadjuvant therapy * written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study * world health organization (who) eastern cooperative oncology group (ecog) performance status 0-2 * absolute neutrophil count (anc) ≥ 1.5x10\^9/l * platelets ≥ 100x10\^9/l * hemoglobin ≥ 9 g/dl * serum creatinine (scr) ≤ 1.5 x upper limit of normal (uln) * creatinine clearance (ccr) ≥ 40 ml/min (as calculated by modified cockcroft-gault formula) * serum total bilirubin ≤ 1.5 x uln * aspartate aminotransferase (ast)(serum glutamic-oxaloacetic transaminase \[sgot\]) / alanine aminotransferase (alt)(serum glutamate pyruvate transaminase \[sgpt\]) ≤ 2.5 x uln * baseline corrected qt (qtc) within normal limits per the bazett formula. any electrocardiogram (ekg) done prior to consent is acceptable for baseline qtc monitoring. * normal qtc ranges from 350-450 ms for adult men and from 360-460 ms for adult women exclusion criteria: * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the participant or the quality of the data * a diagnosis of metastatic colorectal adenocarcinoma * individuals who have received neoadjuvant chemotherapy prior to the planned colon cancer resection * individuals with absolute or relative contraindications to fluoxetine * baseline prolonged qtc * concurrently taking tamoxifen, pimozide, or thioridazine * individuals using other ssris, serotonin and norepinephrine reuptake inhibitors (snris), monoamine oxidase inhibitors (maois), lithium or other antidepressants at time of initial biopsy * currently active second primary malignancy or history of malignancy less than 5 years prior to the time of study eligibility (patients with history of skin cancers excluding melanoma will be eligible for participation)
rituximab maintenance therapy in aggressive cd20 (cluster of differentiation antigen 20) positive lymphoma and mantle cell lymphoma

Conditions: CD20+ Aggressive Lymphoma, Mantle Cell Lymphoma

Summary: clinical and pharmacokinetic data suggest that the effect of rituximab could be improved by prolonged exposure to the drug. to test for this hypothesis we performed a prospective randomized trial of rituximab maintenance therapy versus observation in patients (pts) with aggressive cd20+ b-cell lymphoma and mantle cell lymphoma.

after completion of standard treatment, pts with aggressive cd20+ b-cell lymphoma and mantle cell lymphoma were randomized to either observation or maintenance therapy with rituximab (375 mg/m2) administered every 3 months for 2 years. both pts after first line therapy and pts after relapse treatment were included in the study. pts with aggressive lymphoma were enrolled if they had achieved a complete response (cr) after initial treatment. pts with aggressive lymphoma with residual tumor mass underwent positron emission tomography (pet) and qualified for randomization if this examination showed no signs of tumor activity. pts with mantle cell lymphoma were eligible for the study if at least a partial response (pr) was achieved. primary endpoint of the study was progression free survival (pfs), secondary endpoints were time to progression (ttp), overall survival (os) and response to treatment. differences between pfs and os were analysed using the logrank test and the proportional hazard model of cox. ttp was analyzed using a competing risk model with death as competing event.

Eligibility criteria:
inclusion criteria: * aggressive b-cell lymphoma or mantle cell lymphoma * cr (complete remission) oder cru (complete remission unconfirmed) after previous therapy * pr (partial remission) only when pet is negative * minimal age 18 years * cd20+ expression on tumor cells * effective contraception * karnofsky status \> 60 * written informed consent

Keywords: cd20+ aggressive lymphoma mantle cell lymphoma rituximab maintenance