Kornimate/medical-research-clean huggingface dataset:
preoperative magnetic resonance (mr) imaging of prostate cancer

Conditions: Prostate Cancer

Summary: the investigators want to evaluate if preoperative mri improves the surgical results, especially in respect to surgical margins. the impact on the surgical procedure will be evaluated. in addition the investigators will examine the accuracy of tumor detection, localization and staging.

background: during the last two decades, magnetic resonance imaging (mri) of the prostate has evolved to become a promising tool in preoperative evaluation of prostate cancer. several studies have evaluated the radiological and histopathological correlation. however, the sensitivity and specificity in regard to staging have shown wide ranges and poor reproducibility. these discrepancies can be explained by difference in patient selection, mri methods, and criteria used for diagnosis. more studies are therefore needed to evaluate the clinical impact of preoperative mri in patients with prostate cancer. aims of the study: to evaluate 1) detection rate of tumor 1-3 (tumor 1 = index tumor), size of tumor 1-3, possible extraprostatic extension and predict presence of gleason grade 4 and 5 tumor, 2) the influence of preoperative mri on the surgical decision process with respect to the operative procedure for removal of the gland and pelvic lymph node dissection, and 3) the impact of preoperative mri on the rate of positive surgical margins and functional results. material and method: a prospective study including 400 consecutive patients referred to robot assisted laparoscopic prostatectomy randomised to preoperative mri (intervention group) and no mri (control group). the prostatectomy specimens will be histopathologically examined, and tnm classification will be performed according to 2002 ajcc standard.

Eligibility criteria:
inclusion criteria * all patients suitable for surgery. * positive biopsy (gleason grade \>3). * informed consent. exclusion criteria: * patients who do not sign the consent paper for any reason or do not accept the study premises. * patents who want to withdraw for any reason during the study. * patients with contraindications to mri (pacemaker, claustrophobia etc) and/or surgery. * patients who have undergone a high quality mri examination of the prostate at another radiological center. in this situation the mr examination is evaluated together with the surgeon but the patient is not included in the study. (in case of a low quality examinations, we will disregard the findings, and include the patient). * if the surgeon finds it unacceptable to perform ralp without mri, because of various reasons (eg. patient demand, too high risk etc) the patient will not be included in the study. * if preoperative mri reveals extensive tumor invasion into adjacent organ (t4) or skeletal metastases (m1), as these cancer stadiums do not benefit from ralp.

Keywords: prostate cancer preoperative staging mri free surgical margins
a study to assess how the body processes a strong painkiller when it is given alongside a drug that counteracts the side effects of strong painkillers in a fasted and fed state.

Conditions: Pain

Summary: to assess whether an opioid antagonist has any impact on the release of a strong painkiller in the blood when it is given to healthy volunteers when they have eaten and also when they have fasted.

this is an exploratory study to assess the influence of an opioid antagonist on the pharmacokinetics of a strong painkiller when co-administered in a fasted and fed state. determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 32 hours post-dose, following an administration of a single oral dose. pharmacokinetics parameters of auc and cmax are the primary endpoints.

Eligibility criteria:
healthy male or female subjects aged 18 to 55 inclusive healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ecg.

Keywords: healthy volunteer pharmacokinetics
comparison of a new formulation of insulin glargine with lantus in patients with type 2 diabetes on non-insulin antidiabetic therapy

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to compare the efficacy of a new formulation of insulin glargine and lantus in terms of change of hba1c from baseline to endpoint (scheduled at month 6, week 26) in participants with type 2 diabetes mellitus secondary objectives: to compare a new formulation of insulin glargine and lantus in terms of: - occurrence of nocturnal hypoglycemia

the maximum study duration was up to approximately 54 weeks per participant, consisting of: * up to 2 week screening period; it can be exceptionally extended of up to one additional week * 6-month comparative efficacy and safety treatment period * 6-month comparative safety extension period * 2-day post-treatment safety follow-up period

Eligibility criteria:
inclusion criteria : * adult participants with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s); * signed written informed consent. exclusion criteria: * hba1c less than (\ ) 11% (\> 97 mmol/mol) * history of type 2 diabetes mellitus for less than 1 year before screening * less than 6 months before screening with non-insulin antihyperglycemic treatment * change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening * initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of glucagon-like peptide-1 (glp-1) receptor agonist in the last 6 months before screening visit * participants receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinide (note: non-insulin antihyperglycemic drugs not approved for combination with insulin, sulfonylurea and glinide are to be discontinued at baseline) * current or previous insulin use except for a maximum of 8 consecutive days (for example, acute illness, surgery) during the last year prior to screening * unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (for example, laser, surgical treatment or injectable drugs) during the study period the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
prevention of coronary aneurysms in kawasaki syndrome

Conditions: Cardiovascular Diseases; Coronary Aneurysm; Heart Diseases; Mucocutaneous Lymph Node Syndrome

Summary: to test the efficacy of intravenous gamma globulin (ivgg) in preventing coronary artery aneurysms in children with kawasaki syndrome.

background: kawasaki syndrome is an acute febrile illness that occurs predominantly in previously healthy young children. it is of unknown etiology and was first described in japan in 1967. the illness carries an acute mortality rate of approximately 3 percent. the centers for disease control defines kawasaki syndrome as a fever lasting five or more days for which no explanation can be found. patients also must have at least four of the following symptoms: bilateral conjunctival infection; infected or fissured lips, pharynx, or a 'strawberry tongue'; erythema of the palms or soles, or edema of the hands or feet, or generalized or periungual desquamation; rash; and cervical lymphadenopathy. coronary artery aneurysms occur in 15-20 percent of children with the illness. in the past, no treatment had been shown to be effective in preventing this complication. investigators in japan began to use ivgg to reduce the aneurysm formation. preliminary results showing the usefulness of this therapy led to a multicenter trial in japan in which 400 mg/kg/day of ivgg were given for five days to children also receiving aspirin for the condition. results of the japanese trial showed that within 29 days of the onset of the disease, coronary artery dilatation had developed in 42 percent of the aspirin-treated children and in 15 percent of the ivgg and aspirin-treated children. design narrative: phase i was randomized, unblinded and stratified by age, sex, and center. subjects were randomized to receive either 80 to 120 mg/kg/day of aspirin through day 14 of illness, subsequently reduced to 3 to 5 mg/kg/day as a single daily dose or to 400 mg/kg/day of intravenous gamma globulin for four consecutive days plus aspirin as above. primary endpoint was formation of aneurysms as demonstrated by echocardiograms. follow-up was for 7 weeks. phase ii of the trial began enrollment of 549 patients in may 1986 and ended enrollment in november 1989. two hundred and seventy six children were randomized to receive 400 mg/kg of intravenous gamma globulin over four consecutive days. two hundred and seventy-three received a single infusion of 2 g/kg of body weight over 10 hours. both treatment groups received 100 mg/kg of aspirin per day through day 14 and then 3 to 5 mg/kg per day. the primary outcome variables were the presence or absence of coronary artery abnormalities evident at the two week and seven week follow-up examinations. echocardiograms were obtained for 523 children at the two week visit and for 520 children at the seven week visit.

Eligibility criteria:
boys and girls who met the cdc criteria for kawasaki syndrome. subjects were excluded if they presented themselves to the participating centers after the tenth day of illness.
improving female sexual wellness

Conditions: Sexuality; Sexual Dysfunction; Sexual Desire Disorder; Hypoactive Sexual Desire Disorder; Orgasmic Disorder; Pelvic Organ Prolapse; Urinary Incontinence; Interstitial Cystitis; Pelvic Floor Disorders; Female Sexual Dysfunction

Summary: the purpose of this study is to assess the effect of commercially available genital vibrator use on sexual health, female pelvic floor disorders, and overall quality of life among a diverse population of women.


Eligibility criteria:
inclusion criteria: * english speaking * diagnosis of female sexual dysfunction, pelvic floor dysfunction, genito-urologic issues (stress urinary incontinence, urge urinary incontinence, pelvic organ prolapse, interstitial cystitis, pelvic pain, dyspareunia, lichen sclerosis) * manual dexterity to use vibrator exclusion criteria: * non english speaking * pregnancy or \<12 months postpartum * poor manual dexterity

Keywords: sexuality sexual dysfunction sexual desire disorder hypoactive sexual desire disorder orgasmic disorder pelvic organ prolapse urinary incontinence interstitial cystitis pelvic floor disorders wellness female sexual dysfunction
a safety study on posterior pedicle screw system

Conditions: Degenerative Disc Disease; Trauma Injury; Tumor

Summary: the goal of this study is to assess the must mini system safety in patient who will undergo a posterior cervical spine fusion intervention. patients will be invited to partecipate during preoperative visit and follow the postoperative visits according to the standard practice.

patient who will undergo a posterior cervical spine fusion intervention, will be invited during preoperative visit to take part to the study. the study is an observational multicentric study with an enrolment period of 12 months with the aim to assess the safety of must mini system. all adverse events will be collected for all study duration, classified as device and not device related. screw failure rate is calculated considering screw loosening, breakage, lost-reduction events. standard radiological investigations are previewed at preoperative visit, before discharge and at 6 weeks and 12 months follow-up after surgery visits; the risk of any further exposure to radiation other than it's routine use in a diagnostic manner within the follow-up period can be excluded. a final visit at 12 months level index fusion will be evaluated clinically as well as radiographically, with a confirmation ct scan as per standard of care. screw placement accuracy will be evaluated during this visit. a functional cervical x-ray is considered also during last follow-up (12 months after surgery) in order to assess cervical spine functionality.

Eligibility criteria:
inclusion criteria: * those affected by degenerative disc disease needing a posterior surgical instrumented treatment aimed at segmental fusion, * those who will undergo posterior fixation due to traumatic lesion or tumor, * patients with bmi ≤ 35 kg/m2, * those who signed the consent form to participate to the study. exclusion criteria: * patients \<18 years, * patients who are pregnant or intend to become pregnant during the study.
comparative study of pdvf and polypropylene transobturator suburethral tapes

Conditions: Urinary Stress Incontinence

Summary: this study evaluates the effectiveness and complications of polyvinylidene fluoride (pvdf) and polypropylene (pp) transobturator suburethral tapes (tots) in the treatment of female stress urinary incontinence. half of participants will be operated with pvdf-tots, while the other half will be operated with pp ones.


Eligibility criteria:
inclusion criteria: * women with stress urinary incontinence. * women with stress-predominant mixed urinary incontinence. exclusion criteria: * incapacity to understand the information or give their consent. * previous anti-incontinence surgery with slings. * low pressure urethra (mucp \< 20cmh2o). * neurogenic bladder.

Keywords: urinary incontinence materials surgery transobturator tape polyvinylidene fluoride polypropylene
a phase i study of ocv-501 in acute myeloid leukemia patients

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to assess the safety, tolerability of ocv-501 in patients with acute myeloid leukemia (aml) who achieved complete remission after induction regimen and who completed a standard consolidation therapy.


Eligibility criteria:
key inclusion criteria: * patients with acute myeloid leukemia including patients with secondary leukemia. however, the patients with mds apparently evolved itno aml and patients with aml accompanied by t(15;17)(q22;q12),(pml/raralpha) , should be excluded. * patients who achieved the first complete remission after the induction regimen and finished a standard consolidation therapy. * age: ≥ 60years of age(at the time of signature of the informed consent form) * sex: male and female * patients who are capable of giving informed consent * patient's blasts cells show expression of wt1mrna, detected by quantitative rt-pcr. * patients must be one of the following hla drb1 types: hla-drb1\*01:01, \*04:05, \*15:01, \*15:02, \*08:03 and \*09:01. key exclusion criteria: * patients who are scheduled for a bone marrow transplantation * patients who were administered exceeded acceptable therapeutic dose of immunosuppressants and adrenal cortical steroids. * patients with uncontrollable active infectious diseases * patients with autoimmune diseases (including hashimoto's disease, idiopathic thrombocytopenic purpura, and autoimmune hepatitis) or with a medical history of active autoimmune diseases * immunocompetent patients * patients with a complication of interstitial pneumonia or with a medical history of interstitial pneumonia

Keywords: acute myeloid leukemia wt1
retrospective analysis of de-identified deceased hcc patients

Conditions: Survival

Summary: de-identified deceased hcc patients who were not surgical candidates were evaluated for their clinical baseline characteristics associated with their survival. baselines included tumor markers, blood counts and liver function tests and cat-scan based tumor size and numbers and presence of portal vein thrombosis.


Eligibility criteria:
inclusion criteria: * biopsy-proven hcc exclusion criteria: * none

Keywords: hcc, afp, mtd, survival, nlr, plr, tumor aggressiveness
complementary effect of reflexology on chemotherapy-induced nausea and vomiting

Conditions: Reflexology

Summary: reflexology treatment may influence the severity of chemotherapy-induced nausea and vomiting. this study aims to investigate the clinical effect of reflexology on chemotherapy-induced nausea and vomiting.


Eligibility criteria:
inclusion criteria: * chemotherapy patients exclusion criteria: * myocardial infarction in previous 6 months * mechanical colonic obstruction
topical lidocaine for needle insertion and injection pain

Conditions: Needle Insertion and Injection Pain

Summary: skin infiltration with local anesthetic is commonly used to decrease patient discomfort during peripheral nerve blocks. topically applied local anesthetic gel might provide analgesia while eliminating the need for additional injections. the primary objective of this study was a noninferiority comparison between the analgesia achieved with topical gel with that of skin infiltration for pain upon needle insertion and injection during administration of the interscalene brachial (isbp) and axillary (ax) plexus blocks.


Eligibility criteria:
inclusion criteria: * ability to understand dutch, french or english language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (phi) in accordance with national and local subject privacy regulations * age \>18 at the time of informed consent * asa i-iii physical class * scheduled for elective shoulder or upper arm surgery requiring a preoperative interscalene brachial (isbp) or axillary (ax) plexus block exclusion criteria: * history of an allergy or contra-indication to a local anesthetic * baseline neurological deficit * medical condition that will make it difficult to assess sensory distribution or communicate with a staff member * presence of preexisting coagulation disorders * infection at injection site * concomitant opioid therapy * recent history (\<3 months) of drug or alcohol abuse * female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at first visit
study evaluating ins018_055 administered orally to subjects with idiopathic pulmonary fibrosis (ipf)

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Summary: the goal of this clinical trial is to learn about ins018_055 in adults with idiopathic pulmonary fibrosis (ipf). the primary objective is to evaluate the safety and tolerability of ins018_055 orally administered for up to 12 weeks in adult subjects with ipf compared to placebo.


Eligibility criteria:
inclusion criteria: 1. male or female patients aged ≥40 years based on the date of the written informed consent form 2. diagnosis of ipf as defined by american thoracic society/european respiratory society/japanese respiratory society/latin american thoracic association guidelines 3. in a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ecg, and laboratory evaluation 4. subjects with background pirfenidone or nintedanib may be enrolled if their regimen of antifibrotic therapy has been stable for \> 8 weeks prior to visit 1 5. meeting all of the following criteria during the screening period: 1. fvc ≥40% predicted of normal 2. dlco corrected for hgb ≥25% and ≤80% predicted of normal. 3. forced expiratory volume in the first second/fvc (fev1/fvc) ratio \>0.7 based on pre-bronchodilator value exclusion criteria: 1. acute ipf exacerbation within 4 months prior to visit 1 and/or during the screening period, as determined by the investigator 2. patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study 3. female patients who are pregnant or nursing 4. abnormal ecg findings other protocol inclusion and exclusion criteria may apply.

Keywords: pulmonary fibrosis idiopathic pulmonary fibrosis fibrosis pathologic processes lung diseases, interstitial lung diseases respiratory tract diseases
real-world effectiveness of regorafenib in the treatment of patients with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: real-world effectiveness of regorafenib in the treatment of patients with metastatic colorectal cancer- a retrospective, observational study

to analyze the real-world usage pattern, effectiveness and factors associated with the effectiveness of regorafenib in the treatment of patients with metastatic colorectal cancer (mcrc). this retrospective, observational study included clinicopathological and follow-up data of patients with mcrc who were treated with regorafenib from june 2017 to september 2020. patients with incomplete data were excluded. overall survival (os) stratified by combination therapy with programmed cell death ligand-1 (pd-l1) inhibitors, chemotherapy and regorafenib dose was calculated by kaplan meier method and log rank test. r software version 4.0 was used for the analysis.

Eligibility criteria:
1. inclusion criteria: 1. must be a pathologically proven colorectal adenocarcinoma 2. must have been treated with regorafenib 3. regorafenib must be used after two lines of standard antitumor therapy 2. exclusion criteria: 1. application is less than one course of treatment with regorafenib 2. first - or second-line treatment with regorafenib 3. patients with multiple primary cancers

Keywords: metastatic colorectal cancer regorafenib
study of akcea-angptl3-lrx (isis 703802) in participants with familial partial lipodystrophy (fpl)

Conditions: Familial Partial Lipodystrophy

Summary: this is a single-center, open-label study to evaluate the efficacy of akcea-angptl3-lrx for reduction of fasting triglycerides in participants with familial partial lipodystrophy.


Eligibility criteria:
key inclusion criteria: * must give written informed consent to participate in the study. * clinical diagnosis of familial partial lipodystrophy plus diagnosis of type 2 diabetes mellitus and hypertriglyceridemia. * diagnosis of diabetes mellitus, made at least 6 months prior to the screening with hemoglobin a1c (hba1c) ≥ 7% to ≤ 12% at screening and on anti-diabetic therapy as defined in study protocol. * hypertriglyceridemia as defined by fasting triglycerides (tg) levels ≥ 500 milligrams per deciliter (mg/dl) at both screening and qualification visits. participants with the clinical diagnosis of fpl and with fasting tg levels ≥ 200 (≥ 2.26 millimoles per liter \[mmol/l\]) to \< 500 mg/dl (≥ 5.7 mmol/l) who meet the genetic or family history criteria for study inclusion may be further screened and enrolled in the study. * presence of hepatosteatosis (fatty liver), as evidenced by a screening magnetic resonance imaging (mri) indicating a hepatic fat fraction (hff) ≥ 6.4%. key exclusion criteria: * diagnosis of generalized lipodystrophy. * diagnosis of acquired partial lipodystrophy (apl). * acute pancreatitis within 4 weeks of screening. * acute coronary syndrome within 6 months of screening. * major surgery within 3 months of screening. * have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study.

Keywords: lipodystrophy lipodystrophy, familial partial lipid metabolism disorders dyslipidemias kobberling-dunnigan syndrome (type 1 and 2) lipoatrophic diabetes