Kornimate/medical-research-clean huggingface dataset:
identification of prostate cancer specific markers in patients compared to healthy participants

Conditions: Prostatic Neoplasms

Summary: this is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of prostate cancer. blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors.

in this research study different commercial ruo (research use only) antibodies will be purchased and then tested on blood samples obtained by patients affected by prostate cancer and by healthy participants as control. sixty participants will be enrolled belonging to different risk categories:20 participants affected by prostate cancer at low risk, 20 participants affected by prostate cancer at high risk, and 20 participants without a cancer disease (healthy volunteers) as control. risk categorization is based on the definition of the european association of urology. after signing the informed consent form, participants will be screened to evaluate if they meet the eligibility criteria. if all the criteria are met, participants will be enrolled into the study and will be asked to provide some demographic and other data. a 13 ml blood sample will be collected by the participants and shipped to sponsor's laboratories, in order to be processed and analysed.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give and sign a written informed consent for participation in the study * male, aged 18 years or above * diagnosed with prostate cancer at low or high risk * candidate to active surveillance (in case of low-risk disease) or treatment with curative intent such as radical prostatectomy or radiation therapy (in case of low risk patients not willing to undergo active surveillance or patients with high risk disease) * healthy participants undergoing a visit at the site for reason other than cancer diagnosis (including prostate cancer) exclusion criteria: * history of other malignancies other than prostate cancer (for healthy participants includes also prostate cancer) * undergone surgery or treatment for prostate cancer before enrolment * presence of known severe coagulation or haematological disorder * absence of written signed informed consent for participation in the study

Keywords: prostate cancer biomarker circulating tumoral cell immunofluorescence assay prostate cancer
an open-label, single-arm study to evaluate pharmacokinetics and safety of subcutaneous sonelokimab in adolescents with moderate to severe hidradenitis suppurativa (vela-teen)

Conditions: Hidradenitis Suppurativa

Summary: this is a study to evaluate the pharmacokinetic (pk) and safety of sonelokimab in adolescent patients with hs.


Eligibility criteria:
inclusion criteria: 1. participants must be between ≥12 and ≤17 years of age at the time of signing the informed consent. 2. participants who are diagnosed with hs as determined by the investigator and have a history of signs and symptoms of hs for ≥6 months before signing the informed consent. 3. participants who have moderate to severe hs as determined by the refined hurley staging (stages ib and ic, iib and iic, and iii). 4. participants who have had an inadequate response to appropriate systemic antibiotics for treatment of hs . 5. participants must be up to date with age-appropriate vaccine requirements 8 weeks prior to entry in the study. 6. participants with a body weight of ≥ 40 kg. exclusion criteria: 1. participants with a known hypersensitivity to sonelokimab or any of its excipients. 2. participants with a draining fistula count of ≥20 at the screening visit. 3. participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of hs. 4. participants with underlying conditions that, in the opinion of the investigator, potentially compromise the participant and/or places the participant at unacceptable risk. 5. participants who have history or concurrent clinically significant medical conditions or any other reason, including any physical, psychological, or psychiatric condition, that in the opinion of the investigator would compromise the safety or interfere with participation in the study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk. 6. participants with any other skin disease or other medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of hs. 7. participants with a confirmed or suspected diagnosis of inflammatory bowel disease.

Keywords: hidradenitis suppurativa hidradenitis sweat gland diseases skin diseases skin diseases, bacterial suppuration anti-inflammatory agents sonelokimab nanobody apocrine gland disease
anovo surgical system in ventral hernia

Conditions: Ventral Hernia

Summary: the study is aimed to clinically assess the anovotm surgical system in ventral hernia procedures. extensive preclinical testing of the system's integrity and safety has been performed to assure adequate safety for this trial.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years old. * subjects able to provide written informed consent. * subject deemed eligible candidate by surgeon and will comply with the study procedures. * subjects with ventral hernia. * subjects with asa grade i to iii. * subject must sign and date informed consent prior to treatment. * subject can undergo general anesthesia per anesthesiologist assessment. exclusion criteria: * women who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical investigation. * subject has medical condition, which in the judgement of the investigator makes the subject a poor candidate for the investigational procedure. * participation in another clinical trial that is in the active phase. * subject unwilling or inability to follow procedures outlined in the protocol. * subjects who are not suitable for robotic surgery, the subject will be excluded from the study and the will be considered a screen failure and the surgeon will proceed with a standard multiport laparoscopic hernia repair. * subjects who present any adverse event before use the anovo surgical system ("anovo") that can affect evaluation of safety and performance of investigational device.
heal study: healing results, efficacy and acceptability of a new contact layer

Conditions: Wound

Summary: assessment of efficacy, tolerance and acceptability for the wound dressing urgo awc_019 in the treatment of acute wounds, chronic wounds and epidermolysis bullosa skin lesions

non-comparative clinical study, conducted in france, to evaluate efficacy, tolerance and acceptability for the wound dressing urgo awc_019 in the treatment of acute wounds, chronic wounds and epidermolysis bullosa skin lesions

Eligibility criteria:
inclusion criteria: a. related to every wounds types: * patient over 18 years old who has provided his/her written informed consent * patient affiliated to the french social insurance * patient who can be monitored by the same investigation team throughout the whole duration of the study, * acute wound (postoperative non-cavitary and non-sutured wound, superficial, middle or deep second degree burn, dermabrasion) or chronic wound (venous or mixed leg ulcer, pressure ulcer) or epidermolysis bullosa skin lesion * use of a contact layer as a primary dressing justified by the wound b. related to leg ulcer: * venous leg ulcer or mixed leg ulcer, i.e. with an ankle brachial pressure index (abpi) not less than 0.7 and not more than 1.3, (0.7≤abpi≤ 1.3) * patient who agrees to wear an effective venous compression system every day, associated with the trial dressing c. related to pressure ulcer: * stage 2, 3 according to the epuap (european pressure ulcer advisory panel) classification system * wound on the pelvis (trochanter, ischio or sacrum) or on the heel exclusion criteria: * patient under authorship or guardianship * woman of child-bearing potential who has no effective contraception method * pregnant or breastfeeding woman * patient taking part in another clinical trial * patient with a known allergy to carboxymethylcellulose (hydrocolloid), * patient with a severe illness that might lead to the premature discontinuation of the trial before the 4 weeks of treatment * wound requiring surgical treatment or for which surgery is scheduled during the 4 weeks after inclusion * patient with an evolving neoplasia condition, treated by radiotherapy, chemotherapy or hormone therapy * malignant wound * patient with a systemic infection not controlled by suitable antibiotic treatment, * wound which is clinically infected
optimized volumetry in radiology: interest in pediatric brain mri in the exploration of focal epilepsy

Conditions: Focal Epilepsy

Summary: multicentre cross-sectional study with prospective recruitment comparing the detection rate of lesions on brain mri without and with quantitative volumetry and t1 relaxometry information during the management of children with suspected focal epilepsy.

focal epilepsies are a very heterogeneous group comprising epilepsies of structural, genetic, metabolic, immune and infectious etiologies. in daily practice, epilepsy is considered as structural if lesions are visible on brain mri in a location consistent with electro-clinical data. in the absence of visible lesion and clinico-biological arguments for a genetic, metabolic, immune or infectious cause, these epilepsies can be divided into two groups: self-limited focal epilepsies (formerly called idiopathic or functional), such as benign epilepsy with centrotemporal spikes (slects) and secondly epilepsies of unknown causes. this classification underlines the idea that a lesion might be responsible for the epileptic disease but could be invisible due to the lack of sensitivity of our current diagnostic methods, especially in imaging. the prevalence of patients with non lesional epilepsy defined by mri is significantly higher in children (31%) than in adults (21%). epileptic patients with normal conventional mri have a lower chance of having surgery than those with lesions demonstrated by presurgical mri and, if so, less chance of becoming seizure-free. it can be challenging to depict brain volume abnormalities in the pediatric population on mri. the major challenge is therefore to raise sensitivity of brain imaging analysis. voxel-based morphometric mri post-processing in mri-negative epilepsies can be a practical and valuable tool to aid subtle mri abnormalities detection and confirm visually identified questionable abnormalities in patients with focal epilepsy. in this study, we prospectively included children with suspected focal epilepsy having a brain mri using a mp2rage sequence and a post-processing morphometric analysis program (map) allowing us to obtain automatically both brain volumetry and t1 relaxometry. the map has been validated with reference ranges in healthy children. our hypothesis was that the quantitative information will improve the sensitivity of brain mri in children with suspected focal epilepsy. the objectives were to compare the rate of detection of a focal cerebral lesion on the brain mri carried out during the exploration of suspected focal epilepsy without then with the quantitative volumetry and t1 relaxometry obtained in the inclusion center and then by double anonymized review.

Eligibility criteria:
inclusion criteria: * patient aged 1-18 years * referred or followed by a pediatrician for epilepsy with focal onset * requiring brain mri as part of the work-up exclusion criteria: * opposition of the child and/or parent to data processing * mri not interpretable * clinical and epileptic data not available or not specifying focus

Keywords: brain mri radiology pediatry
a double-blind, placebo-controlled study with open-label follow-up to determine the safety and efficacy of r-huepo in aids patients with anemia induced by their disease and azt therapy

Conditions: HIV Infections; Cytopenias

Summary: to determine the safety and efficacy of erythropoietin administered to aids patients with anemia secondary to their disease and/or concomitant zidovudine (azt) therapy.


Eligibility criteria:
exclusion criteria co-existing condition: patients with the following are excluded: * history of any primary hematologic disease. * clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying aids. * aids-related dementia. * uncontrolled hypertension (diastolic blood pressure 100 mmhg). * presence of concomitant iron deficiency. * anemia attributable to factors other than aids or zidovudine (azt) therapy. * acute opportunistic infection. * history of seizures. patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying aids are excluded. prior medication: excluded within 30 days of study entry: * experimental drug or experimental device. * cytotoxic chemotherapy. * excluded within 2 months of study entry: * androgen therapy. clinical diagnosis of aids related anemia. * clinical diagnosis of aids. * clinically stable for 1 month preceding study entry. substance abuse.

Keywords: recombinant proteins erythropoietin acquired immunodeficiency syndrome anemia zidovudine
intra-arterial stem cell therapy for patients with chronic limb ischemia (cli)

Conditions: Peripheral Vascular Diseases; Arterial Occlusive Diseases; Leg Ulcer; Gangrene; Ischemia

Summary: the purposes of this study are to determine whether intra-arterial injection of autologous stem cells is effective in the treatment of chronic limb ischemia (cli), to characterize stem cell dysfunction in patients with cli, and to relate the stem cell function with clinical outcome.

despite advances in surgical and radiological vascular techniques, a significant number of patients with chronic critical limb ischaemia (cli) are not eligible for revascularization procedures, often leaving amputation as the only option. consequently, exploring new strategies for revascularization of ischemic limbs is of major importance. preclinical studies and pioneering clinical trials suggest that administration of bone marrow (bm) mononuclear cells (mnc) into ischemic limbs enhances neovascularization, improves tissue perfusion and prevents amputation. however, no definite proof is available as the clinical studies thus far have been small and lacked double-blinded controls. juventas is a randomized, double-blinded placebo-controlled trial in 109 - 160 patients with cli to investigate the potential clinical effects of repeated intra-arterial infusion of bm-mnc in these patients (the exact number of patients to be included cannot be specified in advance because of the planned group sequential interim analyses). in addition, it will study the functional characteristics of the bm-mnc obtained from cli patients and relate bm-mnc dysfunction to clinical outcome.

Eligibility criteria:
inclusion criteria: * age \> 18 years * severe infra-popliteal peripheral arterial occlusive disease \[paod\] (fontaine class iib, iii or iv) * invalidating intermittent claudication, persistent, recurring rest pain requiring analgesia and/or non-healing ulcers present for \> 4 weeks without evidence of improvement in response to conventional therapies * ankle brachial index \< 0.6 or "unreliable" * not eligible for surgical or radiological revascularization * written informed consent exclusion criteria: * history of neoplasm or malignancy in the past 10 years * serious known concomitant disease with life expectancy of less than one year * anticipated inability to obtain 100 ml of bone marrow aspirate * known infection with human immunodeficiency virus (hiv), hepatitis b or hepatitis c virus * follow-up impossible

Keywords: clinical trial chronic critical limb ischemia leg pain cell therapy bone marrow mononuclear progenitor cell stem cell critical limb ischemia nonhealing leg ulcer
psychosocial needs of ymsm

Conditions: HIV+ YMSM

Summary: the proposed study will use both qualitative and quantitative research methods (mixed methods) to gather data that will support the eventual development of interventions for young men who have sex with men (ymsm) living with behaviorally acquired hiv infection. the overall goal of the study is to gain an understanding of the psychosocial/developmental needs of ymsm by focusing on two critical developmental issues-identity development and future life goals.


Eligibility criteria:
inclusion criteria: potential participants must meet all of the following inclusion criteria in order to participate in the study: * biologically male at birth and identifies as male at time of study participation; * hiv-infected as documented by medical record review or verbal verification with referring professional; * between the age of 16 years, 0 days to 24 years, 364 days at the time of informed consent/assent; * hiv infection occurred through sexual or substance use behavior of the participant; * ability to understand both written and spoken english; and * history of at least one sexual encounter involving either anal or oral penetration (either receptive or insertive) with a male partner during the 12 months prior to enrollment. exclusion criteria: * acquired hiv through perinatal infection; * transfusion acquired hiv infection; * presence of serious psychiatric symptoms (active hallucinations, thought disorder) that would impair participants' ability to complete the study measures; * visibly distraught (suicidal, homicidal, exhibiting violent behavior); or * intoxicated

Keywords: hiv positive ymsm risk factors coping identity development psychosocial needs
a study to evaluate the effects of gw679769 on sleep and cognitive function in subjects with primary insomnia

Conditions: Sleep Initiation and Maintenance Disorders

Summary: a study to investigate the effects of gw679769 on sleep and cognition. potential subjects participate in a clinical screening visit and a two-night psg recording session in the sleep laboratory. eligible subjects then participate in three separate two-night psg sessions in which they are randomized to receive placebo or one of two doses of gw679769 60 minutes prior to bedtime, one treatment for each session in a balanced order. each treatment session is separated by a two-week drug-free period and occur on the same day of the week. a safety follow-up visit occurs 2 weeks after the last treatment session.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects with primary insomnia with normal eg may be eligible for inclusion. exclusion criteria: * clinically significant physical or psychiatric illness or abnormal sleep patterns.

Keywords: sleep, polysomnography. gw679769, primary insomnia, cognitive function,
influenza vaccine effectiveness of a quadrivalent vaccine in pregnant women and young infants, 2019-2020

Conditions: Influenza in Human

Summary: influenza is associated with an increased risk for serious illness, hospitalization and death in pregnant women and young infants. the investigators estimated the effectiveness of a quadrivalent inactivated influenza vaccine (qiv) in pregnant women and their infants in 2019-2020 influenza season. women were activelly followed during the influenza season on a weekly basis through telephone call in order to collect data about the onset of fever and/or respiratory symptoms by them or their young infants. polymerase chain reaction testing in pharyngeal samples was offered to pregnant women and infants with influenza-like illness (ili). a total of 636 pregnant women and 474 infants were studied. a bayesian beta-binomial model was used.

study period: influenza 2019-2020 season the investigators followed actively the pregnant women and their infants in order to collect prospectively data on a weekly basis through phone calls during the entire influenza season. definitions: * ili was defined as the sudden onset of symptoms and fever, malaise, myalgia or headache, and cough, sore throat or shortness of breath. * ari was defined as the presence of at least one respiratory symptom, regardless of fever. * febrile episode was defined as the presence of fever only. * fever was defined as a temperature of 38.0 c in at least two measurements within 24h. * the diagnoses of pneumonia and aom were accepted as reported by the physicians who provided care to the women or their infants. the 2019-2020 qiv vaxigrip-tetra was used to vaccinate pregnant women.

Eligibility criteria:
inclusion criteria: pregnant women \>18 years old and \<45 years old, cared at alexandra general hospital (athens, greece) between october 16 and january 27, 2020 exclusion criteria: * \ 45 years old * not in stable health * already vaccinated against influenza * history of guillain-barré syndrome * history of hypersensitivity to influenza vaccines * immunosuppression * history of investigational drug \<30 days * history of immunoglobulins or blood products \<3 months * fever at day of interview (enrollment day)

Keywords: influenza quadrivalent influenza vaccine influenza vaccine effectiveness pregnancy pregnant women infants