Kornimate/medical-research-clean huggingface dataset:
the role of fitostimoline proctogel in symptoms relief and healing in patients affected by anal fissure

Conditions: Fissure in Ano

Summary: evaluate the effectiveness of fitostimoline proctogel in the anal fissure healing and in the need for invasive interventions (primary endpoints) and in the healing of the fissure (secondary endpoint) using fitostimoline in addition to or without other topical devices available on the market. three groups will be established: one for the exclusive use of fitostimoline, the second for the use of fitostimoline in addition to one of the other topical devices already on the market and the third group only for the use of other topical therapies.


Eligibility criteria:
inclusion criteria: * none previous therapies for anal fissure * symptomatic anal fistula * signing of informed consent * age \>18 years old exclusion criteria: * patients unable to complete the questionnaire and with a legal guardian. * patients with concomitant abscess/fistula * pregnant women
comparison of efficacy and safety of treatment with a calcineurin inhibitor (cni)versus a cni-free treatment in renal transplantation (cime)

Conditions: Kidney Failure

Summary: the main objective of this protocol is to compare the impact on renal function of two different immunosuppressive regimens in patients with de novo renal transplant. renal function will be accurately evaluated by measuring the clearance of iohexol. the protocol will also evaluate the efficacy and safety in a short term of these two different immunosuppressive regimens.


Eligibility criteria:
inclusion criteria: * males and females aged between 18 and 70. * patient receiving a first or second kidney transplant from a deceased donor, living related or unrelated. * patient with a maximum pra \<20%. * patient wishing and being able to participate fully to the study, and having given a written consent. * patient covered by a social insurance or beneficiary of such a regime. * women of childbearing age must use a recognized method of contraception throughout the study period and continue for 8 weeks after discontinuation of study treatment. exclusion criteria: * patient receiving a kidney from a heart attack donor , or an abo incompatible donor or a donor with a positive t-cross match. * patient with a maximum pra\> 20% twice. * cold ischemic time \> 36 hours. * patients with thrombocytopenia (\<75000/mm3), neutropenia (\<1 500 / mm3), leukopenia (\<2 500 / mm3) or a hemoglobin concentration \<8 g / dl, at inclusion visit. * patient with severe hyperlipidemia: total cholesterol ≥ 9 mmol / l (≥ 3.50 g / l) and / or triglycerides ≥ 8.5 mmol/l (≥ 7.5 g / l) despite appropriate lipid-lowering therapy. * patient with known hiv positive status, know active hepatitis b or c. recipients of an organ from a donor with positive hiv status, hepatitis b or hepatitis c are excluded. * patient with severe systemic infections requiring continued therapy. * treatment with an experimental drug within 4 weeks before the first dose of study treatment. * patient for whom the initial disease or other pathology requires a long-term corticosteroid treatment. * patient with a history of hypersensitivity or known contra-indications for macrolide or inhibitors of mtors drugs; drugs similar to myfortic ® (erl080) or other components of the formulation such as lactose, or cyclosporine, or prednisone (cortancyl ®), or thymoglobuline ® or iohexol. * patient with a malignant disease or a history of malignancy over the past 5 years except squamous-cell or basal cell carcinoma wich was excised. * medical condition or surgical procedure, except transplantation, which could exclude the patient in the opinion of the investigator. * patient with symptoms of mental or significant somatic illness. disability to cooperate or communicate with the investigator. * pregnant, sucking or of childbearing age and refusing or being unable to use a recognized contraceptive method. * patient under guardianship, or any patient protected by law.

Keywords: kidney transplantation graft creatinin
feasibility study of presurgical hormone therapy (anastrozole) in breast cancer patients

Conditions: Breast Cancer

Summary: 1. women with operable breast cancer with a 2-8 week preoperative waiting period will accept preoperative therapy trials and specifically taking a standard drug for breast cancer such as anastrozole in this study 2. short term anastrozole treatment will induce measurable changes in biomarker levels (er, pr, her2, ki67) within the tumor. 3. degree of response to short term anastrozole varies with a) duration of treatment and b) breast cancer subtype (based on initial pre-treatment biomarker status)


Eligibility criteria:
inclusion criteria: 1. newly diagnosed postmenopausal women (women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum fsh levels \> 40 miu/ml and estradiol \< 20 pg/ml or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago.) 2. confirmation of estrogen receptor positive invasive carcinoma on core biopsy 3. patients whose cancers are palpable and have been deemed to be "operable" by the surgeon 4. surgery is planned for the next 2-8 weeks. exclusion criteria: 1. history of hormone replacement therapy in the last 6 months 2. previous treatment by tamoxifen or aromatase inhibitor treatment in six months 3. known hypersensitivity or contraindications to aromatase inhibitors 4. known metastatic disease on presentation 5. recurrent breast cancer 6. inability to give informed consent

Keywords: estrogen receptor positive
long-term follow-up of tandem high-dose therapy with peripheral blood stem cell for adults with high-risk age-adjusted ipi aggressive non-hodgkin's lymphomas

Conditions: Lymphoma

Summary: phase ii multicenter pilot trial (073) evaluating tandem hdt with pbsc support in aa-ipi=3 untreated aggressive nhl.

high-dose chemotherapy; untreated aggressive non-hodgkin's lymphoma; high-risk; peripheral blood stem cell support patients were aged from 15 to 60 years

Eligibility criteria:
inclusion criteria: * patients aged from 15 to 60 years * previously untreated * histologically proven aggressive nhl * high aa-ipi (equal to 3) * proper underlying organ function exclusion criteria: * transformed low-grade, lymphoblastic, mantle-cell, or burkitt's lymphoma

Keywords: high-dose chemotherapy aggressive nhl high-risk pbsc
swiss autoimmune hepatitis cohort study

Conditions: Hepatitis, Autoimmune

Summary: research project in which biological material is sampled and health-related personal data is further used and collected. coded data are used.

to collect high quality prospective data on a rare disease in order to elucidate epidemiology, natural history, response to treatment and outcome. in addition, a biobank allows addressing specific scientific issues on a variety of open questions. the cohort will provide a platform for carrying out scientific research projects on aih. in addition, the cohort will allow collaborations with reference networks on aih abroad. measurements and procedures: enrolment visit and one follow-up visit at least once a year are planned. an additional follow-up visit at 6 months postdiagnosis is planned for newly diagnosed patients. whole blood is collected for biobanking once a year optionally, if available and collected during normal clinical procedures, liver fragments are obtained. number of subjects projected for the entire study (all sites combined): 500 (corresponding to 1/3 of the estimated global aih population residing in switzerland, assuming a disease prevalence of 20:100,000)

Eligibility criteria:
inclusion criteria: * diagnosis of aih, either type i or type ii * only patients living in switzerland exclusion criteria: * n/a
efficacy of linaclotide in patients with overlapping functional gastrointestinal disorders

Conditions: Functional Dyspepsia; Constipation-predominant Irritable Bowel Syndrome

Summary: this study aims to assess the efficacy and safety of linaclotide in patients with overlapping symptoms of both functional dyspepsia (fd) and constipation-predominant irritable bowel syndrome (ibs-c).

after being informed about the content and risks of the research, all eligible patients giving written informed consent will be randomly allocated in a 2:1 ratio to linaclotide (290μg, once daily) or lactulose (20ml, once daily). treatment will last consecutively for 4 weeks, and patients' symptoms will be assessed before and after four-week treatment.

Eligibility criteria:
inclusion criteria: 1. outpatients 2. diagnosis of fd (including postprandial distress syndrome \[pds\] with or without epigastric pain syndrome \[eps\]) (rome ⅲ criteria) 3. diagnosis of ibs-c (rome ⅲ criteria) exclusion criteria: 1. helicobacter pylori infection 2. gi symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents 3. pregnancy

Keywords: functional dyspepsia irritable bowel syndrome constipation linaclotide lactulose
evaluation of pharmacokinetic and pharmacodynamic parameters of somatropin produced by laboratory blausiegel indústria e comércio ltda., compared to saizen® from laboratory merck serono s.a.

Conditions: GH Deficiency (GHD); Growth Retardation

Summary: the primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect between two preparations of somatropin (t and c) after a single administration of 5 mg in healthy subjects by altering serum somatropin pharmacokinetic parameters (auc0-24h, auc0-inf, cmax, tmax and t1 / 2) and pharmacodynamic (measurement of serum levels of igf-1 presented by the concentration-time profile, auc 0-24h and auc0-inf.).

secondly, the investigators will observe the clinical safety and tolerability after single dose administration in subjects, by comparing clinical parameters and the incidence of adverse events between groups.

Eligibility criteria:
inclusion criteria: 1. research subjects who agree with all study procedures, sign and date, of their own free will, the ic; 2. research subjects were male, aged between 18 and 32 years; 3. research subjects with body mass index greater than or equal to 20 and less than or equal to 25; 4. considered healthy subjects, both clinical and laboratory. exclusion criteria: 1. have donated or lost 450 ml or more blood in the 6 months preceding the study; 2. having participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study; 3. having made use of regular medication less than two weeks to interfere with the pharmacokinetics / pharmacodynamics of the drug under study, such as glucocorticoids, anabolic steroids, androgens, estrogens and thyroid hormones; 4. present history of alcohol abuse, drug or drugs; 5. have a history of liver disease, renal, pulmonary, gastrointestinal, hematologic, or psychiatric; 6. have made previous use of somatropin; 7. make use of energy supplements and / or be frequent consumers of soy products (eg replacement of animal milk for soy milk).

Keywords: children
patient-reported outcomes in long-term survivors of colon and rectal cancers

Conditions: Colorectal Cancer; Fatigue; Long-term Effects Secondary to Cancer Therapy in Adults; Pain; Psychosocial Effects of Cancer and Its Treatment

Summary: rationale: learning about quality of life, symptoms, and health behaviors in colorectal cancer survivors may help to determine the long-term effects of colon and rectal cancer treatments and may help to improve the quality of life for future cancer survivors. purpose: this clinical trial is looking at patient-reported outcomes in long-term survivors of colon and rectal cancers.

objectives: * characterize 3 separate types of patient-reported outcomes (quality of life \[e.g., generic and disease-specific\], functional outcomes \[e.g., bowel and sexual function and activities of daily living\], and clinical symptoms \[e.g., pain, fatigue\]) in long-term (5+ years) survivors of colon and rectal cancers in a large national sample recruited from five national surgical adjuvant breast and bowel project (nsabp) treatment trials. * explore the degree to which patient-reported outcomes are impacted by individual characteristics (e.g., specific predisposing factors, enabling resources, and need), by health behaviors (e.g., use of services for cancer-related and non-cancer-related issues), and, when appropriate, by the specific treatments that were received. * examine patient-reported outcomes prior to randomization and treatment, 1 year after treatment, and in long-term follow up \> 5 years after diagnosis in patients with colon cancer treated with adjuvant chemotherapy on protocols nsabp c-06 or nsabp c-07. outline: this is a cohort, single-group, multicenter study. patients complete a one-time, computer-assisted telephone interview assessing their overall quality of life (qol), disease-specific qol, function and symptoms (including pain and fatigue), use of healthcare services, prevalence and severity of comorbidity, and demographics. projected accrual: a total of 1,167 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * prior diagnosis of colon or rectal cancer * at least 5 years since participated in 1 of the following clinical trials: * nsabp-r-02 * nsabp-r-03 * nsabp-c-05 * nsabp-c-06 * nsabp-c-07 patient characteristics: * able to speak english prior concurrent therapy: * as per participation requirements of previous nsabp treatment trials

Keywords: pain fatigue long-term effects secondary to cancer therapy in adults psychosocial effects of cancer and its treatment stage ii rectal cancer stage iii rectal cancer stage ii colon cancer stage iii colon cancer adenocarcinoma of the colon
adjuvant vs surgery only in early-stage recurrent npc

Conditions: Recurrent Nasopharyngeal Carcinoma

Summary: adjuvant therapy versus endoscopic surgery alone in early-stage recurrent nasopharyngeal carcinoma: a multicenter randomized controlled trial

this study is an open-label, multicentered, evaluator-blinded , randomized clinical trial. patients with early-stage recurrent nasopharyngeal carcinoma were randomized into the control group and the experimental group. patients in the control group would go through observation and follow-up after recurrent endoscopic surgery, while patients in the experimental group would be treated with adjuvant therapy such as chemotherapy and immunotherapy. a total of 176 subjects are required, with 88 patients in the control group and 88 patients in the experimental group.

Eligibility criteria:
inclusion criteria: 1. pathologically diagnosed with recurrent nasopharyngeal carcinoma; 2. stage rt1 or rt2(superficial parapharyngeal space, distance to internal carotid artery ≤5mm)or rt3 (confined to the bottom wall of the sphenoid sinus),according to ajcc 8th edition; 3. cervical lymph node metastasis can be controlled locally 4. age 18 to 75 years; 5. without distant metastasis; 6. informed consent forms signed; 7. ≥6months from the accomplishment of radiation to recurrence 8. previously radiotherapy for only 1 course; 9. ecog score 0-2 and can tolerate chemotherapy and immunotherapy 10. sufficient organ function; 11. undergone endoscopic surgery with negative pathological margin; exclusion criteria: 1. participation in other interventional clinical trials; 2. uncontrolled illnesses which will interfere with the ability to undergo therapy; 3. suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ); 4. any contradiction to immune and chemotherapy; 5. with serious autoimmune disease; 6. currently usage of immunosuppressive agents or systemic glucocorticoid therapy (dosage\>10mg/day prednisone or other glucocorticoids), and continuing to use them within 2 weeks before the first administration of trial drugs; 7. severe allergic reactions to other monoclonal antibodies; 8. history of radioactive particle planting; 9. vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period; 10. female patients who are at pregnancy or lactation; 11. other situations that the researchers believe are not suitable for enrollment
magna mitral - 23mm

Conditions: Mitral Heart Valve Disease

Summary: the purpose of this clinical study is to obtain human clinical data that demonstrates that the size 23mm carpentier-edwards perimount magna mitral pericardial valve, model 7000tfx, is a safe and effective replacement heart valve.

this is a prospective, non-randomized, multi-site, descriptive study. a minimum of 15 and up to 20 subjects will be implanted at a minimum of 2 and up to 8 participating investigational sites within the us and internationally.

Eligibility criteria:
inclusion criteria: 1. patient has mitral valve disease requiring surgical replacement 2. patient has provided written informed consent prior to mitral valve surgery 3. patient is expected to survive surgery and be discharged 4. patient is willing to comply with specified follow-up evaluations 5. patient is 13 years of age or older exclusion criteria: 1. patient has life expectancy \< 12 months due to non-cardiac co-morbid conditions; 2. patient has/had active endocarditis within the last 3 months 3. patient requires replacement of a native or previously implanted prosthetic, tricuspid, pulmonic or aortic valve; 4. patient was previously enrolled and implanted in the study 5. patient has/had prior aortic, tricuspid and/ or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ 6. patient has a body surface area (bsa) \> 1.9m2 7. female patients who are pregnant, planning to become pregnant, or lactating 8. patient has a documented history of substance ( drug or alcohol) abuse 9. patient is currently a prison inmate 10. patient is currently participating in an investigational drug or another device study 11. patient is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism 12. patient has active myocarditis 13. patient has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event and has not returned to baseline or stabilized \> 30 days prior to the planned v alve implant surgery 14. patient has an abnormality such as an aortic aneurysm (e.g. due to cystic medial necrosis or marfan's syndrome), aortic dissection, or ventricular aneurysm that might place

Keywords: mitral valve replacement 23mm cep magna
effect of "breath of fresh air" flash activity on dementia agitation : pilot study

Conditions: Dementia

Summary: non-drug therapies (ndt) constitute a strong axis of the person with dementia behaviour management. among these ndt, the flash activities constitute a mode of intervention to prevent and control the expression of the most disruptive behavior. these are short-term activities with the objective of decreasing the behavioural disorders intensity in less than 15 minutes. the aim of this pilot study is to test the effect of a flash activity "breath of fresh air" compared to the usual relational care on the short-term decrease (15 min.) of the agitation in hospitalized dementia patients.

the "breath of fresh air" flash strategy is to offer the patient the possibility to go out of the medical unity and walking outdoor. when the caregiver identify a level of agitation greater or equal to two on the gravity score and greater or equal to two on the impact score with the npi test (the neuropsychiatric inventory test), the caregiver let the patient wandering in the outside lanes of the hospital and encourage him to us his senses. for example, the sight could be stimulated by looking at a bird. this variation of sensory stimulations enable a temporo-sensory break on the crisis, allowing the patient to turn his attention from the crisis context to another stimulation.

Eligibility criteria:
inclusion criteria: * new patients admitted in the unit to the management of the psychological and behavioural symptoms of dementia * dementia regardless of etiology and severity * score greater than 2 than npi established on entry into service * free, informed and written consent signed by the person trust and/or family member and/or legal representative * health insurance membership exclusion criteria: * absence of agitation * juveniles * pregnant women * patient who has previously participated in the study * persons under protection of justice

Keywords: agitation flash activity breath of fresh air
musculoskeletal system ultrasound examination data collection study for the development of an artificial intelligence software

Conditions: Ultrasound Imaging of Anatomical Structures; Musculoskeletal Diseases

Summary: the primary objective of this observational study is to acquire ultrasound images (raw data) encompassing various planes within the musculoskeletal system. this data will be instrumental in the development of artificial intelligence-guided software. the study aims to enlist 300 volunteers, comprising individuals with both healthy musculoskeletal systems and those presenting pathologies. these participants will undergo ultrasound scans administered by two experienced professionals, employing fda-cleared ultrasound devices. the main question it aims to answer is: -are the collected ultrasound images of diagnostic quality?

ultrasound's cost-effective and user-friendly attributes have positioned it as a cornerstone in diagnosing musculoskeletal system disorders. in this single-centered and prospective study, the study aims to enlist 300 volunteers, comprising both individuals with healthy musculoskeletal systems and those with pathologies. the collected ultrasound raw data will be used to train models for the identification and highlighting of key anatomical landmarks on ultrasound images. participants' gender, age, bmi, and medical history will be considered and reported. all scans will be performed on fda-cleared general-purpose ultrasound devices. obtained images will be used to develop artificial intelligence-based medical software by smart alfa teknoloji san. ve tic. a.ş., ankara, turkey. smart alfa has similarly conducted a study in the field of anesthesia using the same method in nerveblox artificial intelligence software. the study methodology encompasses the following components: * specific body views, guided by established protocols, will be scanned from different body planes. the focus areas encompass musculoskeletal structures. * a cohort of 300 volunteers, evenly distributed by gender (150 male, 150 female), will have their demographic data (bmi, gender, age) documented. * to counteract potential biases, the sequence of volunteer participation will be randomized. * each scan is expected to take 45 minutes.

Eligibility criteria:
inclusion criteria: * volunteers over the age of 18 * able to accept and sign the informed consent form before participating in the study exclusion criteria: * volunteers below the age of 18 * unwilling to accept or having psychiatric or neurological diseases to sign an informed consent form before participating in the study * inability to lie flat * anatomical deformity in the area to be scanned

Keywords: artificial intelligence ultrasound imaging musculoskeletal system data collection