Kornimate/medical-research-clean huggingface dataset:
spine unit modelling coupled with high throughput analysis (suit)

Conditions: Degenerative Disc Disease

Summary: ageing and inflammation represent two main drivers of ddd, a progressive, chronic condition involving vertebral bone, cartilaginous endplate and intervertebral disc. in vitro investigation of the ddd-associated processes on single compartments of the spine unit or ex vivo animal models fail in recapitulating the complex spine pathophysiology or suffer from inter-species differences. given these premises, a human organotypic model of the spine unit would represent a suitable tool to investigate the ddd-related pathways and to screen promising treatments such as msc-based therapies.

the primary aim of this study is to investigate the response of an inflamed organotypic spine unit model, intended as a 3d in vitro representation of an in vivo environment, to the treatment with mesenchymal stem cells (msc)-derived secretome. in particular to investigate the ability of msc-derived secretome to modulate genes found to be upregulated or downregulated by the inflammatory stimulation in the spine unit model and bring their expression back to a basal state. secondary aims of the study are: * to identify specific degenerative features related to ageing and inflammation in patients affected by degenerative disc disease (ddd) correlating circulating features and tissue degeneration * to develop an organotypic spine unit model using patient-derived cells to investigate the response of cells derived from nucleus pulposus (np), annulus fibrosus (af) and cartilaginous endplate (cep) to inflammation

Eligibility criteria:
ddd patients: * signature of the informed consent for the study * age 30-60 years (included) * pfirrmann grade iii-v * need to undergo spinal surgery subjects for the isolation of adipose-derived mscs: * signature of the informed consent for the study * age 18-50 (included) * need to undergo surgery that involves the removal of adipose tissue subjects for the isolation of placenta-derived mscs: * signature of the informed consent for the study * age 18-50 (included) * women who are pregnant or who have not given birth from more than 6 hours all enrolled subjects: - presence of hiv, hbv, hcv or tp infection

Keywords: inflammation degeneration spine unit intervertebral disc mesenchymal stem cell
perioperative pain management of pediatric appendectomy patients

Conditions: Appendicitis

Summary: acute appendicitis is the most common illness that brings pediatric patients to the hospital for surgical treatment. abdominal pain is the symptom because of which the patients go to the hospital. some patients have severe pain and need analgesics before the final diagnosis and before surgery. after surgery most patient experience pain and at least 80 % of the patients need postoperative pain medication. for two decades there has been a clinical guideline for pain management in kuopio university hospital (kuh). the investigators aim was to evaluate how well the pain management for pediatric patient works in clinical practice.


Eligibility criteria:
inclusion criteria: * in prospective patients informed consent obtained * appendectomy performed exclusion criteria: * no informed consent

Keywords: acute appendicitis pain management analgesics pediatric patients laparoscopy open surgery
tailored treatment in metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: to compare the response rate of single agent chemotherapy in advanced colorectal cancer given as standard treatment versus tailored treatment in a randomised phase iii trial.

the ts and mthfr polymorphism has been investigated in a new study based on analysis of normal tissue. the results indicated that protein with a 3/3 ts polymorphism or a mthfr t polymorphism had a significantly higher response rate and a longer time to progression than the other groups when treated with bolus 5-fu. capecitabine is metabolised to 5-fu through a number of enzymatic steps. it is the first rationally designed drug that is based upon the high concentration of thymidine phosphorylase (tp) in many human tumors compared to normal tissue. tp is the last step in the conversion of capecitabine to 5-fu and seems to be the limiting factor for the activation. capecitabine may to some extent mimic continues 5-fu infusion as opposed to bolus 5-fu. a number of small investigations have indicated that patients with 2r/2r ts polymorphism have a higher response rate than heterozygous patients. the ts and mthfr polymorphism analysis can easily be performed on sputum, which means an easy collection and sending of the samples. at present single agent chemotherapy is based on three drugs (5-fu, capecitabine, and irinotecan) with almost the same overall activity. it seems rational to investigate if improvement can be obtained by tailoring the treatment according to gene polymorphism.

Eligibility criteria:
inclusion criteria: * metastatic colorectal cancer * histopathological verification of the primary tumor * measurable disease according to resist criteria * single agent chemotherapy indicated * performance status \>=2 * age \>= 60 years * life expectancy \> 3 months * adequate liver and kidney function as evaluated by bilirubin \<= 3 times of normal upper limit, alat \<= 3 times upper normal limit (\<= 5 times upper normal limit in case of liver metastases), serum creatinine \<= 1.5 times normal upper limit. * anc \>=1.5 x 109/l and platelets \>= 100 x 109/l * informed consent exclusion criteria: * patients with cns metastases * other malignant disease within the last 5 years except for non-melanoma skin cancer and carcinoma in situ of cervix uteri * previous chemotherapy for metastatic disease * adjuvant chemotherapy \< 6 months before inclusion * patients with previous major toxic or allergic reaction to the protocol drugs

Keywords: metastatic colorectal cancer tailored treatment genetic markers gene polymorphism chemotherapy
probiotic modulates vaginal microflora

Conditions: Microbial Colonization

Summary: the purpose of this study is to evaluate the effects of oral administration of probiotic at 9 log colony forming unit (cfu)/day on vaginal microbiota profiles compared to placebo via the use of vaginal self-swab microbiota profiling.

1. to evaluate differences in general women's health of women on probiotic and placebo via the use of questionnaire. 2. to evaluate differences in immunity of women on probiotic and placebo via blood immunity profiling. 3. to evaluate differences in gut microbiota profiles of women on probiotic and placebo via blood fecal microbiota profiling.

Eligibility criteria:
inclusion criteria: * generally, healthy women aged 18-80. - currently free from urogenital infections such as urinary tract infection (uti), bacterial vaginosis (bv), or yeast vaginitis. * willing to commit throughout the experiment. exclusion criteria: * pregnant. * on vaginal suppository treatments within 4-weeks prior to entering the study. * on oral medication for vaginal illnesses or any vaginal therapy such as hormones and estrogen within 4-weeks prior to entering the study. * on long term medication (\> 6 months) for any illnesses. * have used vaginal estrogen cream, ring or tablet within 4-weeks prior to entering the study. * have used vaginal moisturizers, lubricants or homeopathic preparations within 4-weeks prior to entering the study. * have used spermicide agent within 4-weeks prior to entering the study. * pelvic or any gynecologic surgery 6-months prior to entering the study.

Keywords: probiotics
fibroid ablation study - large fibroids

Conditions: Leiomyoma; Uterine Fibroids; Menorrhagia

Summary: the purpose of this study is to establish the effectiveness and confirm the safety of the vizablate system in the ablation of large (\> 5 cm) symptomatic uterine fibroids.


Eligibility criteria:
inclusion criteria: * 28 years of age or older * consistent menstrual cycles * history of excessive bleeding for at least 3 months * baseline ufs-qol symptom severity score ≥ 20 * at least one target fibroid having a maximum diameter \> 5cm and ≤ 10 cm * not at material risk for pregnancy * willingness to participate, adhere to follow-up requirements, and sign the informed consent form * willing to have uniform maintenance of antifibrinolytic or non steroidal anti-inflammatory agents * menstrual pictogram score ≥ 120 during a one-month screening period. exclusion criteria: * presence of type 0 intracavitary fibroids * target fibroid \> 10cm in maximum diameter * abnormality of the endometrial cavity that obstructs access of the treatment device * postmenopausal * desire for current or future fertility * hemoglobin \< 6 g/dl * evidence of disorders of hemostasis * use of gnrh agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen, serm or sprm within the last 6 months prior to screening * evidence for current cervical dysplasia (cin ii or greater) * endometrial hyperplasia * confirmed abdominal / pelvic malignancy within previous five years * active pelvic infection or positive screen for pelvic gonorrhea or chlamydia * clinically significant adenomyosis * previous uterine artery embolization * previous surgical or ablative treatment for fibroids or menorrhagia within 12 months prior to screening * current use of anticoagulant therapy * major medical or psychiatric illness affecting general health or ability to adhere to follow-up * contraindication to mri * renal insufficiency * uncontrolled hypertension lasting 2 years or more * calcified fibroids * presence of extrauterine pelvic mass * presence of tubal implant for sterilization * previous pelvic irradiation * endometrial cavity length \< 4.5 cm

Keywords: uterine fibroid rf ablation intrauterine ultrasound vizablate
desmopressin as a therapy for bedwetting in children with sickle cell disease

Conditions: Nocturnal Enuresis; Anemia, Sickle Cell

Summary: this study assesses if using the medication desmopressin will decrease nightime bedwetting in children with sickle cell disease.

night time bedwetting is a common complication of sickle cell disease, and affects up to 30 % of children . desmopressin is an oral medication that increases water reabsorption in the kidneys. studies have shown that it is effective in decreasing bedwetting episodes in children without sickle cell disease. chronic sickling episodes causing damage to the kidneys could cause permanent damage and may make this treatment ineffective in sickle cell disease. this trial will inform pediatric sickle cell doctors if desmopressin is an appropriate treatment for bed wetting in the investigators patients. this work is being continued on study id: 2020-11268.

Eligibility criteria:
inclusion criteria: 1. patients with hemoglobin ss, sc, sb0thal or sb+thal 2. patients with at least two episodes of primary nocturnal enuresis per week or four episodes over the two weeks prior to enrollment. 3. patients with secondary enuresis who have been evaluated and cleared by a pediatric urologist as not having other etiologies of enuresis (e.g. overactive detrusor activity, a genitourinary anatomic abnormality) exclusion criteria: 1. patients with developmental delay or neurologic dysfunction secondary to stroke. 2. patients with hypertension or underlying renal disease. 3. patients with genitourinary anatomic abnormalities. any prior renal ultrasound showing normal genitourinary anatomy is sufficient to clear a patient for the study. 4. patients with daytime urinary incontinence 5. patients with glucosuria on urinalysis. 6. patients with secondary nocturnal enuresis who have not been evaluated by a pediatric urologist to rule out other etiologies of enuresis. 7. patients who are pregnant. 8. patients receiving another medicine for nocturnal enuresis (e.g. imipramine).
trial ready (clinical trial readiness)

Conditions: Amyotrophic Lateral Sclerosis; Frontotemporal Dementia; ALS-Frontotemporal Dementia; Primary Lateral Sclerosis; Progressive Muscular Atrophy

Summary: this study, being conducted under the auspice of the create consortium, will enroll patients with als and related disorders as well as healthy controls, with the goal of facilitating clinical validation of leading biological-fluid based biomarker candidates that may aid therapy development for patients with als and related disorders.

this multi-center study aims to clinically validate leading biological-fluid-based biomarker candidates as potential prognostic and pharmacodynamic biomarkers that have the potential to facilitate therapy development for patients with als and related disorders. biomarker candidates that will be considered include: urinary p75 neurotrophin receptor extracellular domain (p75ecd), blood and cerebrospinal fluid (csf) phosphorylated neurofilament heavy (pnfh), blood and csf neurofilament light (nfl) and, in the population with a c9orf72 hexanucleotide repeat expansion, peripheral blood mononuclear cell (pbmc) and csf levels of the dipeptide repeat protein poly(gp). in pursuit of these goals, the create consortium is already collecting longitudinal biological samples from patients with als and related disorders through the ongoing phenotype-genotype-biomarker (pgb) study. trial ready aims to identify additional patients with the c9orf72 hexanucleotide repeat expansion mutation (hrem), the most common genetic cause of als, who may be further followed through the pgb study. this study will also enroll and longitudinally evaluate a cohort of age- and gender-match healthy controls.

Eligibility criteria:
inclusion criteria: * member of at least one of the following categories: 1. individuals with a clinical diagnosis of als or a related disorder, including ftd, als-ftd, pls, and pma. 2. individuals never diagnosed with and not at particular risk of developing als or a related disorder. * able and willing to comply with relevant procedures. exclusion criteria: * a condition or situation which, in the pi's opinion, could confound the study finding or may interfere significantly with the individual's participation and compliance with the study protocol. this includes (but is not limited to) neurological, psychological and/or medical conditions.
tap block with two different doses of levobupivacaine

Conditions: Pain, Postoperative

Summary: the aim of the current study is to investigate the effects of two different doses of levobupivacaine in tap (transversus abdominus plane) block for postoperative management. for this purpose we planned to include 50 children aged between 2 and 12 that will undergo unilateral inguinal surgery. the doses that will be used in the study were within usual dose limits which is stated in prospectus of the study drug.

fifty children undergoing tap block were randomly divided into two groups as levobupivacaine 0.25% 0.5 ml/kg and levobupivacaine 0.25% 0.25 ml/kg. postoperative pain was evaluated with observational pain scale and modified pediatric objective pain scale.

Eligibility criteria:
inclusion criteria: * volunteers planned to undergo unilateral inguinal surgery under tap (ilioinguinal and iliohypogastric block) and general anesthesia * aged between 2 and 12 exclusion criteria: * patients with coagulation dysfunction * patients with chronic pain * patients having infection at the site of intervention * patients with a history of allergy * patients having chronic diseases (hepatic dysfunction, renal failure)
personalized detection of ctdna for patients with her2-positive metastatic breast cancer who achieved durable response by anti-her2 treatment (her2 cr)

Conditions: Breast Cancer, Metastatic; HER2 + Breast Cancer

Summary: anti-her2 therapy, such as trastuzumab and pertuzumab, has significantly improved long-term survival in her2-positive breast cancer. the updated data of the cleopatra trial showed significant kaplan-meier curves, suggesting the potential for a cure. however, the efficacy of maintenance therapy in long-term responders remains unexplored. this study will assess mrd in unresectable her2-positive breast cancer cases with long-term response using the signatera™ ctdna assay, which could contribute to future treatment strategy development.

more than 20 years have passed since the introduction of trastuzumab as a treatment for human epidermal growth factor receptor 2 (her2)-positive breast cancer. the additive effect of trastuzumab, an anti-her2 antibody, was evaluated in combination with chemotherapy (paclitaxel or anthracycline plus cyclophosphamide) in previously untreated, unresectable her2-positive breast cancer. the number of cases achieving long-term survival with anti-her2 therapy has been increasing, and this trend is also observed in our institution. the treatment for unresectable breast cancer is systemic therapy, which is typically continued as long as it remains effective and side effects are tolerable. however, in cases of long-term response in her2-positive breast cancer, the impact of continuing anti-her2 therapy alone as maintenance therapy on prognosis and the safety of treatment discontinuation remains unclear. in recent years, the clinical application of circulating tumor dna (ctdna) has attracted attention for early diagnosis and detection of minimal residual disease. signatera™, an assay developed by natera inc., detects minimal residual disease. it is a personalized ctdna test for individual patients, and a study targeting breast cancer patients post-surgery reported a detection sensitivity exceeding 90% for variant allele frequencies (vaf) as low as 0.01%. this high sensitivity has been reported not only in breast cancer but also in other cancer types. however, there have been no reports of signatera analysis in unresectable breast cancer. in this study, investigators will use signatera™ to evaluate and analyze ctdna status (ctdna positive or negative) in cases of unresectable her2-positive breast cancer that have achieved long-term response. by assessing ctdna in such cases, this study may lead to new therapeutic strategies, such as de-escalating anti-her2 therapy in ctdna-negative cases.

Eligibility criteria:
inclusion criteria: * her2 + metastatic breast cancer * pre / post menopausal * previously treated with anti-her2 therapy * continuing cr or pr for more than 2 year exclusion criteria: * patients who were deemed inappropriate as research subjects based on the physician's judgment, such as those possibly receiving inappropriate treatment.

Keywords: ctdna monitoring mrd minimal residual disease her2+ breast cancer dual response
prognostic role of free psa ratio at biochemical recurrence after radical treatments for prostate cancer

Conditions: Metastasis; Castration-resistant Prostate Cancer; Death

Summary: measurement of free psa ratio in patients after definitive radical treatment for prostate cancer, and assessment of whether post-treatment free psa ratio can function as a biomarker for advanced disease in prostate cancer patients.

prostatic specific antigen (psa) circulates mostly in complex with protease inhibitors, but 10-30% circulates as inactive free-psa (fpsa). in patients with prostate cancer (pca), pretreatment fpsa is lower and used to risk-stratify patients for biopsy. however, posttreatment fpsa ratio (fpsar) is rarely quantified, with an unexplored clinical value. methods the institutional database was queried to identify patients following radical prostatectomy (rp cohort) or radiotherapy (rt cohort) between 2000 and 2017. for validation, the investigators identified an independent prospective cohort with biochemical recurrence (bcr) after rp, using biobank samples (biobank cohort). all patients had at least one posttreatment fpsar test. kaplan-meier (km) method was used to compare the metastasis-free (mfs), castration-resistant pca (crpc)-free, and cancer-specific-survival (css) rates. multivariable cox models determined the association between posttreatment fpsar, metastases, and crpc.

Eligibility criteria:
inclusion criteria: for the two retrospective cohorts: 1. all patients that older than 18 treated for localized adenocarcinoma of the prostate between 2000 and 2017 with either radical prostatectomy or radiotherapy 2. all treated patients had a rising post-treatment psa, with at least one post-treatment free psa blood test. for the biobank validation cohort: 1. all patients treated with radical prostatectomy for localized prostate cancer between 2000 and 2017 who had biobank samples taken when developing biochemical recurrence. exclusion criteria: 1. patients that were younger than 18, 2. patients with prostate cancer other than adenocarcinoma, such as small cell and neuroendocrine cancer 3. patients with prostate adenocarcinoma that did not develop biochemical recurrence. 4. in the retrospective cohorts - patients that did not have at least one post-treatment free psa blood test.
impact of auditory stimulation in eating pleasure (edere 2021)

Conditions: Frailty; Malnutrition; Anorexia; Presbycusis; Edentulism Nos

Summary: background. decreased taste and smell contribute to loss of appetite (anorexia), and the resulting protein-energy malnutrition increases the frailty of the elderly. the risk of falls, disability, infections and depression often requires them to be institutionalized. elderly, undernourished and toothless patients often complain about the monotony of a soft, mixed-texture diet. in a previous study, some participants highlighted the pleasure of crunching cookies that have a solid texture that can be eaten in any dental condition. however, the age-related decrease in hearing (presbyacusis) is frequent and progressive from the age of 60. the hypothesis of this work is that older patients may perceive a crunchy food crunching in their mouth, despite presbycusis. if the hypothesis is verified, this would make geriatric caregivers aware of the possibility of diversifying the texture of food, in order to stimulate the pleasure of eating and increase the dietary intake in this population of patients who are often undernourished, dysphagic, edentulous and hearing impaired. the originality of this study is to share the expertise of geriatricians and specialists in mastication/swallowing (dental surgeon, speech-language pathologist), hearing (ent doctor, hearing care professional) and nutrition (dietician). type of study. type of study mr-004 "research not involving the human person". protocol. compare the noise and pleasure of crunching between two hyperprotein nutritional supplements: a soft filled cookie (nutra cake™, délical, france) and a crunchy cookie of the breton type (protibis™, solidages, france). blind study impossible: each subject will eat a cookie then the other in a random order and will be his own control. the tests will be performed without the possible hearing aids, but with or without the dentures according to the patient's preference. indeed, some patients have dental prostheses that are no longer suitable for chewing, and that they wear only for aesthetics. objective. validate the evaluation criteria "do you hear the biscuit crunch?" and "is it a pleasure?" if so, encourage diversification with crunchy foods with a suitable texture, as well as dental and prosthetic rehabilitation of dependent elderly people.


Eligibility criteria:
inclusion criteria: subjects 65 years of age or older, hospitalized in geriatrics or ehpad residents. exclusion criteria: risk of false route when eating cookies, allergy to an ingredient in cookies