Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of rhumab vegf to treat metastatic renal cell carcinoma

Conditions: Renal Cell Cancer

Summary: the purpose of this study is to determine whether rhumab vegf (bevacizumab) is safe and effective for the treatment of renal cell cancer when other treatments have failed.


Eligibility criteria:
inclusion criteria: * written informed consent * histologically confirmed, metastatic renal cell cancer (rcc) of clear cell histology * clinical or radiographic evidence of disease progression (as assessed by the investigator and reviewed by the sponsor) during or after completion of one, and only one, cytokine-based regimen for metastatic disease * at least 21 days since any prior therapy for rcc * prior nephrectomy * use of an acceptable means of contraception (potentially fertile men and women) * ecog performance status of 0 or 1 * life expectancy \>= 3 months * age 18 years or older exclusion criteria: * rcc of papillary or collecting-duct type * more than one nonsurgical therapy for metastatic rcc (note that medroxyprogesterone acetate not used for physiologic replacement or birth control is considered a therapy for rcc for the purposes of this study) * prior treatment with thalidomide * radiotherapy within 14 days of day 0 * current, recent (within 21 days of day 0), or planned participation in an experimental drug study * pregnant or breast-feeding subjects * any of the following screening clinical laboratory values: 24-hour urine collection with \>= 1 g of protein; serum creatinine \> 2.0 mg/dl; absolute neutrophil count (anc) \ = 1.5; total bilirubin \> 2.0 mg/dl; ast or alt \> 5 x the upper limit of normal (uln) for subjects with documented liver metastases or \> 2.5 x the uln for subjects without evidence of liver metastases; hemoglobin \< 9 gm/dl (may be transfused or receive epoetin alfa \[e.g., epogen\] to maintain or exceed this level) * other invasive malignancies within 5 years of randomization (other than squamous or basal cell carcinoma of the skin) * history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications * inability to comply with study and/or follow-up procedures
the effect of mindfulness-based mandala activity on anxiety and spiritual well-being levels of senior nursing students

Conditions: Anxiety; Nursing Caries; ART

Summary: this research was conducted to determine the effect of mindfulness-based mandala activity on the spiritual well-being and anxiety levels of senior nursing students in a parallel-group pretest-posttest randomized controlled study design. the required institutional permission and ethics committee approval was received. the study group of the study consisted of 170 senior nursing students (intervention group \[n=84\], control group \[n=86\]). mindfulness-based mandala activity was applied to the intervention group via the zoom online program. data were collected using the descriptive features form, the spielberg trait, and state anxiety inventory, the spiritual well-being scale, and the scale of the positive-negative experience. the data were stored in the spss 24 program.

this research was conducted to determine the effect of mindfulness-based mandala activity on the spiritual well-being and anxiety levels of senior nursing students in a parallel-group pretest-posttest randomized controlled study design. the required institutional permission and ethics committee approval was received. the study group of the study consisted of 170 senior nursing students (intervention group \[n=84\], control group \[n=86\]). mindfulness-based mandala activity was applied to the intervention group via the zoom online program. data were collected using the descriptive features form, the spielberg trait, and state anxiety inventory, the spiritual well-being scale, and the positive-negative experiences scale. students will be divided into groups of 6-10 and mandala activities will be carried out. 3 weeks of mandala activity, breathing exercises, affirmations, etc. a therapeutic application program was created and implemented. for the students in the control group, the standard support program given by the school administration and course instructors will be applied for clinical problems. at the end of the study, it is planned to apply mandala activities among the students in the control group. the research is based on watson's "human caring" theory.

Eligibility criteria:
inclusion criteria: * registering the theoretical and practical courses within the scope of nursing vocational courses application ii, * with internet access, * students who agree to participate in the study exclusion criteria: * receiving psychiatric treatment (pharmacological and/or psychotherapy), * with substance addiction, * must have participated in any meditation-based therapy program before.

Keywords: art therapy; nursing student; anxiety spirituality;
the effect of anesthesia on pain in percutaneous nephrolithotomy

Conditions: Percutaneous Nephrolithotomy

Summary: it is aimed to determine the ideal application by determining the effect of different anesthesia methods applied in percutaneous nephrolithotomy surgeries on analgesic consumption and pain level.

different anesthesia methods are used in percutaneous nephrolithotomy.in addition to traditional analgesia methods such as intravenous paracetamol, nsaids, opioids, various methods such as epidiural analgesia or blocks added to general anesthesia are used.in this study, it was aimed to investigate whether central or peripheral block applications are preferred in percutaneous nephrolithotomy, and the need for intraoperative and postoperative analgesics in patients.in addition, it was aimed to investigate whether there was a change in analgesic consumption, recovery and pain level, and hospital stay in patients who were given general anesthesia or regional anesthesia, in a multicentric observational manner.

Eligibility criteria:
inclusion criteria: * patient giving consent * accessing patient information exclusion criteria: * missing information in the patient file

Keywords: general anesthesia postoperative pain
gem/cisplatin/s-1 vs gem/cisplatin for biliary tract cancer

Conditions: Biliary Tract Cancer

Summary: to validate the superiority of gemcitabine/cisplatin/s-1 over gemcitabine/cisplatin for unresectable biliary tract cancer.

gemcitabine/cisplatin combination therapy (gc) has been the standard palliative chemotherapy for patients with advanced biliary tract cancer (btc). investigators have evaluated the efficacy and safety of gemcitabine/cisplatin/s-1 combination therapy (gcs) for patients with advanced btc and observed the promising efficacy. in this randomized phase ⅲ study, investigators aimed to compare gcs with gc in patients with advanced btc.

Eligibility criteria:
inclusion criteria: 1. patients with cytologically or histologically proved biliary tract cancer 2. age \>=20 years 3. performance status (ps) 0-2 4. no prior history of chemotherapy or radiotherapy. 5. adequate bone marrow function (neutrophil count \>=1,500/mm3, and platelet count \>=100,000/mm3), liver function (total bilirubin \>=3 mg/dl and ast/alt \>=150 iu/l), and renal function (creatinine clearance \>=45 ml/min) 6. adequate oral intake 7. provided written informed consent - exclusion criteria: 1. patients with interstitial pneumonia or pulmonary fibrosis 2. patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months 3. patients with severe active infection 4. patients with moderate or marked pleural effusion or ascites necessitating drainage 5. patients with a history of severe drug allergy 6. patients with other serious comorbid disease 7. patients who are pregnant or lactating, or have an intention to get pregnant 8. patients with mental disease 9. patients who are judged inappropriate for the entry into the study by the principle doctor -
efficacy and safety of retrograde intraarticular injection, topical soaking of tranexamic acid (txa), or placebo in femoral neck fractured patients undergoing cementless bipolar hemiarthroplasty

Conditions: Femoral Neck Fracture

Summary: the goal of this randomized controlled trial is to evaluate in household ambulatory, elderly patients sustaining femoral neck fracture who are subjected to be treat with cementless bipolar hemiarthroplasty. the main questions it aims to answer are: * the efficacy in reducing blood transfusion for topical tranexamic acid administration * the safety of tranexemic acid, topically used as having undergone bipolar hemiarthroplasty surgery, participants will either receive retrograde intraarticular tranexamic acid injection via drain tube, or topical soaking administration. researchers will compare, with standard procedure (procedure), whether topically administered tranexamic acid would reduce rate of blood transfusion.


Eligibility criteria:
inclusion criteria: * elderly patients (age \&gt; 60 years) * femoral neck fractures from low energy mechanism * household ambulator * undergoing cementless bipolar hemiarthroplasty at kcmh * informed consent exclusion criteria: * allergy to txa * history of vte * history of hip surgery, pathological fracture, hip infection * congenital or acquired coagulopathy * hb \&lt; 10 g/dl or platelet \&lt; 140,000

Keywords: tranexamic acid femoral neck fracture bipolar hemiarthroplasty topical blood transfusion
cognitive stimulation therapy for dementia

Conditions: Dementia

Summary: aim: the aim of this study is to reveal the effectiveness of cognitive stimulation therapy on activities of daily living, depression and life satisfaction in individuals with mild dementia living in nursing homes.

this randomized controlled experimental study was conducted between 30 march-27 may 2022, with a total of 60 individuals (30 in control and 30 in intervention group) living in adana and seyhan nursing home elderly care and rehabilitation centers. the data of the study were collected with the personal information form based on the literature, the standardized mini mental test (smmt), the barthel activities of daily living index, the lawton and brody instrumental activities of daily living (iadl) scale, the cornell dementia in dementia scale (cds) and the satisfaction with life scale. in order to conduct the study, the approval of the clinical research ethics committee, written institutional permission and written permission from the participants were obtained. the individuals in the intervention group started with the introduction and pre-test application in the first week and applied cst for 45 minutes twice a week for the next 7 weeks, while the individuals in the control group started with the introduction and pre-test application in the first week and performed two sessions for one week and two days and continued their daily lives in the following weeks. the study was terminated in 9 weeks by applying the post-test to both groups in the last week. due to the 3-month follow-up study, measurements will be made for the last time in september with the smmt, badl, iadl, cds and ldl measurement tools.after being informed about the study, all individuals with dementia were given written informed consent form.

Eligibility criteria:
inclusion criteria: * having been diagnosed with dementia according to the diagnostic and statistical manual of mental disorders, 5th edition (dsm v) by a physician * agree to participate in the study * being literate and speaking turkish fluently * have communication and understanding skills * standardized mini mental test result being between 18-23 points * having adequate vision and hearing functions for group participation exclusion criteria: * presence of any sensory impairment * having a physical health problem that may impair group cohesion and integrity

Keywords: cognitive stimulation therapy dementia activities of daily living depression life satisfaction
derm health economics study

Conditions: Melanoma; Non-melanoma Skin Cancer

Summary: this study aims to provide an initial assessment of the potential impact derm could have on the number of onward referrals for a face to face dermatologist review and/or biopsy from a teledermatology-based service, and to improve the understanding of the patient pathways that exist.

derm, an artificial intelligence (ai)-based diagnosis support tool, has been shown to be able to accurately identify melanoma, non-melanoma skin cancers (nmsc) and other conditions from historical images of suspicious skin lesions (moles). this study aims to establish whether the use of derm in the patient pathway could reduce the number of unnecessary referrals to dermatologist review and/or biopsy. suspicious skin lesions that are due to be photographed for a dermatologist to review, will have two additional photographs taken using a commonly available smart phone camera with and without a specific lens attachment. the images will be analysed by derm, and the results compared to the clinician's diagnosis (all lesions) and histologically-confirmed diagnosis (any lesion that is biopsied).

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study, * male or female, aged 18 years or above, * has at least one suspicious skin lesion which is being photographed as part of standard of care (soc), * in the investigators opinion, able and willing to comply with all study requirements. exclusion criteria: * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
effectiveness of cognitive stimulation treatment in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: the goal of this observational study is to evaluate the relationship between gba mutation and cognitive stimulation treatment response in patients with parkinson's disease. the main questions it aim to answer are: • assess whether the gba mutation is associated with greater or lesser response to cognitive training treatment compared to a control group of pd patients without genetic mutations. • investigate the effect of cognitive stimulation program on behavioural aspects as secondary consequence induced by the possible improvement of cognitive abilities following treatment. participants will be undergo to: - a neuropsychological evaluation describing their cognitive profile; - a genetic investigation and finally included in a cognitive stimulation programs according to regular clinical practice. researchers will compare pd patients with gba mutation and patients without genetic mutation to evaluate the effectiveness of cognitive stimulation treatment.


Eligibility criteria:
inclusion criteria: * patients with parkinson's disease according to the gelb et al. criteria; * patients who have carried out genetic screening for mp; * patients who have a raw score in the range 15.50 to 22.23 at montreal cognitive assessment (moca); * patients who have signed the informed consent and the privacy policy; * patients who are included in cognitive stimulation programs according to regular clinical practice. exclusion criteria: * patients with the initial suspicion of mp that during the diagnostic work-up they were suffering from a different pathology; * patients who have refused consent to participate in the study; * patients with a diagnosis of mp and cognitive profile of dementia; * patients undergoing deep brain neurostimulation (dbs-stn) treatment. patients treated with dbs-stn were excluded because such treatment involves a surgical procedure whose effects on cognitive functioning could represent an interfering variable.

Keywords: parkinson's disease gba gene mutation cognitive training psychological and behavioral aspects
a study of rucaparib in patients with pancreatic cancer and a known deleterious brca mutation

Conditions: Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma

Summary: the purpose of this study is to determine whether oral rucaparib is effective in the treatment of patients with locally advanced or metastatic pancreatic cancer and a known deleterious brca mutation.

rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[adp\] ribose polymerase (parp) that inhibits a specific dna repair pathway known as base excision repair (ber). parp inhibitors (parpi) have been shown to effectively kill tumors with a defect in brca1 or brca2. clinical benefit has been observed in patients with a gbrca mutation as well as in those with a somatic brca (sbrca) mutation. clinical data have also shown that pancreatic cancer patients with a gbrca mutation benefit from parpi treatment. clinical activity of parp inhibitors in brca-mutated pancreatic cancer combined with the paucity of 2nd line therapies support evaluation of rucaparib in pancreatic cancer patients known to harbor a deleterious brca mutation.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pancreatic cancer (ductal adenocarcinoma and related subtypes eligible; endocrine and neuroendocrine tumors excluded) * received at least 1, but no more than 2, chemotherapy-based regimens for locally advanced or metastatic disease and has relapsed or progressive disease. patients no longer able to continue treatment with chemotherapy due to intolerable toxicity may be considered for study participation provided that radiology assessment confirms either stable disease or disease progression (i.e. no response to treatment) * documented deleterious or suspected deleterious (or equivalent interpretation) brca mutation (germline or somatic) as assessed by a local laboratory * measurable disease exclusion criteria: * presence of another active cancer * prior treatment with any parp inhibitor, including rucaparib. patients treated with prior iniparib are eligible. * symptomatic and/or untreated central nervous system metastases. * clinical evidence of malabsorption and/or any other gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with the absorption of rucaparib.

Keywords: brca brca mutation germline brca somatic brca parp inhibitor rucaparib co-338 pf 01367338 ag 14699 clovis clovis oncology rucapanc
phase iii randomized, controlled study of ganciclovir for symptomatic congenital cytomegalovirus infection

Conditions: Cytomegalovirus Infections

Summary: objectives: i. evaluate the efficacy of ganciclovir (12 mg/kg per day) versus no treatment in neonates with symptomatic congenital cytomegalovirus infection with central nervous system disease.

protocol outline: this is a randomized study. patients are stratified by participating institution. patients are randomly assigned to no antiviral therapy or intravenous ganciclovir every 12 hours for 6 weeks. patients are followed at weeks 1-4 and 12, months 6, 12, 24, 36, 48, and 60, and yearly thereafter until puberty (when possible).

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * symptomatic cytomegalovirus (cmv) infection: central nervous system disease, with or without other organ system involvement, e.g.: microcephaly, i.e., less than 5% for age radiologic changes indicating brain disease cerebrospinal fluid exam abnormal for age chorioretinitis hearing defects * cmv confirmed by urine, throat, buffy coat, and/or conjunctiva culture * no hydroencephalopathy or other devastating brain involvement --prior/concurrent therapy-- * no concurrent antiviral agent no concurrent immune globulin --patient characteristics-- * age: under 1 month (preferably under 2 weeks) * life expectancy: no imminent demise * renal: creatinine no greater than 1.5 mg/dl * other: birth weight at least 1200 g gestational age at least 32 weeks no hiv infection no concurrent bacterial infection eligible if resolved following 2-week treatment and cmv symptoms persist

Keywords: congenital cytomegalovirus infection cytomegalovirus infection herpesvirus infection immunologic disorders and infectious disorders neonatal disorders rare disease viral infection
quality of life of transgender people - implementation and monitoring of an online cohort (e-qol-trans)

Conditions: Transgenderism; Gender Identity

Summary: transgender people have an identity or an expression gender that differs from the sex assigned to them at the birth. transgender people and their needs remain misunderstood, and more generally by society. the transgender populations express poor quality of life compared to the general population. however, very few of studies are interested in these people, in their diversity of paths, trajectories and characteristics of life. more of research is needed to study the quality of life, understand the experiences, in their diversity and in the health, social and life trajectories. researches must be carried out, in particular on how to interrogate by the seeks out transgender people, in order to prevent stigmatization within population studies. the main objective of this study is to assess the quality of life of people transgender people during their life trajectory and their transition path, based on validated questionnaires scientifically in french, for major themes of the population concerned (quality of life, social support perceived).


Eligibility criteria:
inclusion criteria: * transgender people (having a gender identity or expression that differs from the sex assigned to them at birth); * people with any of the following characteristics regarding their trans identity: * consultant in one of the transgender reference centers and services for questions/information on the transition; * integrated or having completed a course of care with or without gender reassignment surgery; * not integrated into a health or care pathway. * french-speaking people; * adults; * people able to use the tools digital; * people with internet or 4g access (total or limited) exclusion criteria: * people who do not identify as transgender; * non-french speaking people; * minors * people who do not know how to handle the tools digital data collection; * people without internet access. * non-french speaking people, unable to speak understand the research questions * protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by court order or administrative
caustic esophageal burns in children and high doses of methylprednisolone

Conditions: Esophageal Diseases

Summary: corrosive substance ingestion in childhood is a public health issue in developing countries and several management protocols were proposed to prevent esophageal strictures. the role of corticosteroids in preventing corrosive-induced strictures is controversial. the investigators' aim is to study the influence of high doses of corticosteroids to prevent esophageal strictures.


Eligibility criteria:
inclusion criteria: -corrosive substance ingested children with grade iib esophageal burn exclusion criteria: * caustic substance ingested chldren grade i, iia and grade iii esophageal burns * caustic subtance ingested children with signs of perforation, mediastinitis, peritonitis, sespis * caustic substance ingested children with any chronic disease

Keywords: caustic corticosteroid therapy stricture children