Kornimate/medical-research-clean huggingface dataset:
affixing polypropylene mesh using barbed suture (quill™ srs) during robotic assisted laparoscopic sacrocolpopexy

Conditions: Prolapse

Summary: 1.0 study objective 1.1 primary objective - to compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (ralsc): running technique using self-anchoring 1 barbed delayed absorbable suture (quill™ srs, angiotech pharmaceuticals, inc. vancouver, canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (pds ii™, ethicon, somerville, nj, usa). 1.2 secondary objective - to compare robotic assisted laparoscopic sacrocolpopexy anatomic failure rates at 6 months post-operative follow-up using self-anchoring 1 barbed delayed absorbable suture (quill™ srs, angiotech pharmaceuticals, inc. vancouver, canada) versus 0 non-barbed delayed absorbable suture (pds ii™, ethicon, somerville, nj, usa). the investigators will also assess mesh erosion rates, costs, and surgeon satisfaction rates. 2.0 hypothesis 2.1 primary: 2.1.a. attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (quill™ srs, angiotech pharmaceuticals, inc. vancouver, canada) will be faster than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (pds ii™, ethicon, somerville, nj, usa). 2.2 secondary: 2.2.a. attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (quill™ srs, angiotech pharmaceuticals, inc. vancouver, canada) will be less costly than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (pds ii™, ethicon, somerville, nj, usa). 2.2.b. failure rates and mesh erosion rates for each technique will be equally low. 2.2.c. surgeons will prefer the barbed running technique over the interrupted technique based on subjective surgeon satisfaction questionnaires.


Eligibility criteria:
inclusion criteria * \>18 years old * undergoing ralsc with or without other procedures for pelvic organ prolapse or incontinence * willing to return for follow-up visits * written informed consent obtained from each subject * must be having a robotic assisted laparoscopic sacrocolpopexy exclusion criteria: * decline to participate * pregnant or contemplating future pregnancy * unable to participate in the informed consent process

Keywords: sutures pelvic organ prolapse sacrocolpopexy robotic assisted laparoscopy
assesment of the effectiveness of high frequency oral oscillation and mask of pep in children with pneumonia

Conditions: Pneumonia

Summary: the hypothesis of this study is that the physiologic effects of these (pep/ hfoo) resources may have positive effects in this population of children with acute respiratory illness. thinking about this physical and physiological issue and due to the absence of a study that has evaluated the effectiveness of these instruments in patients with pneumonia, the objective of this study is to evaluate the short-term effects ooaf and mask of epap in children hospitalized for community-acquired pneumonia.

the pneumonia is characterized by an acute infectious and inflammatory process, usually compromises the alveoli, bronchioles and interstitial space difficulting hematosis and may be in some or all of the cells filled with liquid and blood cells. the accumulation of secretion occurs as a consequence of this infectious and inflammatory process and contributes to clinical worsening by increasing airway resistance. respiratory physiotherapy has been questioned in patients with pneumonia and recent clinical studies have shown that there is no benefit to these patients. respiratory physical therapy in addition to manual techniques has in his repertoire instrumental resources such as therapeutic high-frequency oral oscillator (hfoo) and the mask of expiratory positive pressure (pep). the hypothesis of this study is that physical and physiological effects of these resources may have positive effects in this population of children with acute respiratory illness. the aim of this study is to evaluate the short-term effects hfoo and mask of pep in children hospitalized for community-acquired pneumonia.

Eligibility criteria:
inclusion criteria: * age between 03 and 11 years old; * have pneumonia diagnosis done by a physician pediatrician (1) presence of cough and/or fever; (2) tachypnea according to age group (1-5 years-40 bpm; 5 years -30 bpm); (3) radiological change with consolidation or infiltrators associated or not with other findings compatible with pneumonia. all films will be evaluated by a radiologist and a pediatrician exclusion criteria: * chronic neurological disease, or respiratory arrest * failure to collaborate with therapy or assessment * need of invasive or non-invasive ventilatory assistance * hemodynamic instability * vomiting or nausea * not drained pneumothorax * not drained extensive pleural effusion * dyspnea * do not agree with research
decrease in circulating tumour cell count reflects the effectiveness of postoperative adjuvant transarterial chemoembolization (tace) in preventing hepatocellular carcinoma recurrence

Conditions: Circulating Tumor Cell;; Hepatocellular Carcinoma

Summary: circulating tumour cell (ctc) count could reflect the effect of postoperative transarterial chemoembolization (tace) on hepatocellular carcinoma (hcc) recurrence.

early metastases of hepatocellular carcinoma (hcc) may be detected by the isolation of circulating tumor cells (ctcs) in the bloodstream. during the course of therapeutic attempts, monitoring ctc changes in patients with hcc is helpful for the efficacy assessment. nevertheless, the markers used for the detection, such as a-feto protein, asialoglycoprotein receptor or epithelial cell adhesion molecule, cd133 or cd90, are not specific for hcc ctcs. in spite of these limitations, a timely determination of the existence of ctcs will be beneficial for the monitoring of distant metastases, the evaluation of therapeutic attempts, and the prediction of prognosis.

Eligibility criteria:
inclusion criteria: * definitive pathological diagnosis of hcc based on world health organization (who) criteria; * underwent curative resection one month ago, ct or mri detecting no new lesions when recruited; * ctc counts≥2 after resection; * age between 18 and 75 years; * adequate hematologic function (platelet count: \>60 × 109 platelets/l; hemoglobin: \>90g/l; and prothrombin time: \<3 seconds above control); * adequate renal function (serum creatinine: ≤1.5 × upper limit of normal); * child-pugh classification a or b grade exclusion criteria: * a hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the nontumorous liver parenchyma on arterial phase computed tomography scans); * diffuse-type hcc; * evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy; * severe underlying cardiac or renal diseases; * color doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; * obstructive jaundice

Keywords: circulating tumour cell; transarterial chemoembolization; hepatocellular carcinoma; recurrence
sexual health integration in treatment of gynecological oncology

Conditions: Ovarian Cancer; Endometrial Cancer; Cervical Cancers; Vaginal Cancers; Sexual Health Quality of Life; Sexual Counselling

Summary: the goal of this cross-section observational and questionary based study is to learn how geological cancer survivors perceive sexual health support given by health care professionals during diagnosis and treatment process. the main question to be answered is: who, when and to what extend should discuss the sexual health issues the participants will answer online survey questions about sexual health issues and sexual counselling during diagnosis, treatment and follow-up.

the main aim of the study is to verify who, from medical specialist, should discuss the sexual health issues in gynecological cancer survivors, when that discussion should take places and to what exited all sexual issues should be discusses. the secondary end points are: * to establish factors affecting returning to sexual activities defined as any type of physical contact with a partner engaging sexual organs as well as mutual and solo masturbation. * to verified if gender of counselling specialist is important to patients. the study is a cross-section observation one. it is based on a survey containing questions regarding basic socioeconomical factors, treatment history, reproductive history, and those concerning the opinion who, when, to what extend and how should ask about sexual issues during therapy modalities planning, treatment and follow-up. women after completing a treatment irrespectively of its type (surgery, radiation, chemotherapy, immune check point inhibitors) will be eligible for the study. those who are no more sexually active and currently have no sexual partner will also be included. after collecting the date three main analysis will be conducted to answer the study questions. the results will be used as a basic for further work on recommendation on sexual health counselling in gynecological malignancies.

Eligibility criteria:
inclusion criteria: * diagnosed with gynecological malignancies except breast cancer * completion of treatment irrespectively of its type (surgery, cth, rth, immunotherapy) * ecog≤2 exclusion criteria: * diagnosed with breast cancer * currently being treated for gynecological or other malignancies * ecog \>2 * not being able to have any type of sexual activity due to physical limitations or comorbidities

Keywords: gynecological cancer sexual health sexual counselling paradigma sexual activity
efficacy of extracorporeal magnetic stimulation, pelvic floor muscle exercise, and combination of both in management of post radical prostatectomy urinary incontinence

Conditions: Post Radical Prostatectomy Urinary Incontinence

Summary: urinary incontinence is one of the most common complications of radical prostatectomy. multiple prevention and treatment modalities have been proposed in the management of post prostatectomy urinary incontinence. this is a randomized controlled comparative study to evaluate the efficacy of extracorporeal magnetic stimulation alone and combined with pelvic floor muscle exercise versus pelvic floor muscle exercise alone in the management of post radical prostatectomy urinary incontinence. this study is expected to be performed over 7 years. the study population will be all male patients who are prepared for radical prostatectomy under urology department in hmc and were referred to voiding dysfunction for preoperative counselling and postoperative rehabilitation. patients will be randomized into one of three treatment groups. the first group will receive sessions of extracorporeal magnetic field stimulation only. the second group will receive extracorporeal magnetic stimulation in addition to pelvic floor muscle exercise. the third group will receive pelvic floor muscle exercise only. the recruitment phase will take 3 years. patients will be followed for 18 months for the course of urinary incontinence symptoms, severity of urinary incontinence on 1-hour pad test, urodynamic leak point pressure and the international consultation on incontinence questionnaire - short form (iciq-sf) and the iciq quality of life (qol) score. this study is proposed to reveal strong evidence on the efficacy of extracorporeal magnetic stimulation on the management of post radical prostatectomy urinary incontinence.


Eligibility criteria:
inclusion criteria: * the study population will include all adult male patients 18 years of age and above, with localized prostate cancer of low or intermediate risk disease who chose definitive treatment with radical prostatectomy either through open radical retropubic prostatectomy (rrp) or through robotic assissted laparoscopic radical prostatectomy (ralp) as first line for treatment and had the surgery under hamad general hospital urology department care. exclusion criteria: * patients with high risk , locally advanced or metastatic prostate cancer at time of diagnosis * patients with low to intermediate risk prostate cancer who received chemo or radiotherapy then had salvage surgery * patients with urinary incontinence or diagnosed overactive bladder before radical prostatectomy. * patients with complicated surgery resulting in anastomotic leak, prolonged catheterisation more than 3 weeks, reinsertion of catheter due to retention of urine. * patients who refuse to participate in the clinical trial.

Keywords: radical prostatectomy magnetic stimulation pelvic floor exercises
safety and efficacy of the gts400 stent in conjunction with cataract

Conditions: Open-angle Glaucoma

Summary: to evaluate the safety and efficacy of the glaukos trabecular micro-bypass stent model gts400 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate open angle glaucoma.

the objective of this trial is to evaluate the safety and efficacy of the glaukos trabecular micro-bypass stent model gts400 (hereinafter referred to as gts400) in combination with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma. this is a prospective, randomized, concurrently controlled, parallel groups, multicenter clinical investigation of the gts400. treatment will consist of either implantation of gts400 stents in the study eye in conjunction with cataract surgery (group 1, investigational group), or cataract surgery only (group 2, control group). clinical data through 12 months postoperative will form the basis of a pre-market approval (pma) submission. subjects will be followed for two years postoperatively.

Eligibility criteria:
inclusion criteria: * mild to moderate open-angle glaucoma with specific criteria, in need of cataract surgery * subject willing to attend scheduled follow-up exams for two years postoperatively, subject willing to provide written informed consent on the institutional review board approved informed consent form exclusion criteria: not meeting inclusion criteria

Keywords: open angle glaucoma cataract surgery
a study for the treatment of painful diabetic neuropathy

Conditions: Diabetic Neuropathy, Painful

Summary: the purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.

the protocol will assess the efficacy and safety of duloxetine. it will also look at how duloxetine affects quality of life.

Eligibility criteria:
inclusion criteria: * male or female outpatients at least 18 years of age. * patients with pain due to diabetic neuropathy in both legs. * females must not be pregnant or plan to become pregnant during the study. * stable glycemic control. * average mean pain severity score of at least 4.0 as assessed by completion of a daily diary. exclusion criteria: * you are related to or work for the physician conducting the study or are employed by eli lilly and company. * you have a severe or serious medical condition that causes you to be hospitalized often; or you have had a kidney transplant or are on current dialysis. * you have participated in a study for an investigational drug within the last 30 days. * you have a history of major depressive disorder, generalized anxiety disorder, or alcohol or eating disorders. * you have a past medical history or diagnosis of mania, bipolar disorder, or psychosis.

Keywords: neuropathy pain diabetes chronic pain persistent pain leg pain peripheral neuropathy foot pain painful neuropathy diabetic neuropathy
efficacy and safety of aeye-ds software device for automated detection of diabetic retinopathy from digital fundus images

Conditions: Diabetes Mellitus; Diabetic Retinopathy

Summary: aeye-ds is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital fundus images using artificial intelligence (ai)-based software. this study has been designed to validate the safety and efficacy of the device at primary care and other point of care sites.


Eligibility criteria:
inclusion criteria: * age ≥22 * male or female * documented diagnosis of diabetes mellitus, meeting the criteria established by the american diabetes association (ada) and world health organization (who). * understand the study and volunteer to sign the informed consent exclusion criteria: * uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters. * diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion. * history of laser treatment of the retina or injections into either eye, or any history of retinal surgery. * currently participating in another investigational eye study and actively receiving investigational product for diabetic retinopathy (dr) or diabetic macular edema (dme). * participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation). * participant is contraindicated for imaging by fundus imaging systems used in the study: 1. participant is hypersensitive to light 2. participant recently underwent photodynamic therapy (pdt) 3. participant is taking medication that causes photosensitivity 4. participant has a history of angle-closure glaucoma or narrow anterior chamber angles
dna damage and oxidative stress in hospitalized covid-19 patients

Conditions: Covid19

Summary: the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) is responsible for the coronavirus disease 2019 (covid-19) pandemic challenging health systems worldwide. while there is a clear correlation between oxidative stress markers and the severity of many viral diseases such as hepatitis c, for sars-cov clinical data is limited. the investigators aim at 1.) investigating dna damage, oxidative stress, inflammation, and aging markers in covid-19 patients and compare them with age and gender matched healthy controls and patients with influenza; and 2.) investigating all aforementioned parameters during "cytokine storm" via repeated blood sampling.


Eligibility criteria:
covid 19 group: inclusion criteria: * gender: female/male * age: ≥40 years * patients admitted at the emergency department * covid-19 suspected patients * able to give written informed consent exclusion criteria: * children (≤ 18 years) and adults 19-39 years * not hospitalized, but confirmed covid-19 patients (outpatients) * patients without definitive covid-19 confirmation control group: inclusion criteria: * gender: female/male * age: ≥40 years * absence of severe illnesses/serious diseases * able to give written informed consent exclusion criteria: * children (≤ 18 years) and adults 19-39years * any current or past clinically significant pathology/disease (comorbidity) such as: * malignancies * cardiovascular diseases * diabetes mellitus (i and ii) * obesity class iii (bmi \>40) * other severe diseases (e.g. renal, hepatic, thyroid disease, bone metabolic diseases, rheumatoid osteoarthritis, human immunodeficiency syndrome, ...) influenza group: inclusion criteria: * gender: female/male * age: ≥40 years * patients admitted at the emergency department * influenza suspected patients * able to give written informed consent exclusion criteria: * children (≤ 18 years) and adults 19-39 years * patients without definitive influenza confirmation

Keywords: dna damage oxidative stress inflammation
adipose tissue transfer for moderate breast cancer conservative treatment sequella

Conditions: Breast Cancer

Summary: this is a phase iii randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision. it is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision. follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\\or from a distance relapse. during these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos.


Eligibility criteria:
inclusion criteria: * history of breast cancer treated by conservative surgery . * normal inclusion radiological assessment normal (acr1 or acr2) * moderate deformations (type i and ii of the classification of clough). * delay with regard to the end of the radiotherapy superior or equal to one-year-old. * moderated radio-dystrophies (\< grade 2 of the score lent/soma). * signature of the informed consent * patient benefiting from social security * patient of more than 18 years old exclusion criteria: * abnormal radiological assessment (acr3, acr4 or acr5) * absence of fatty excess . * radio surgical relapses with vast fibroses of the breast (\> grade 2 of the score lent/soma). * patient under 18 years old. * administrative difficulties: impossibility to provide enlightened information to the patient, the refusal to sign the consent . * pregnant women or breast feeding women * patient under legal guardianship * bilateral breast cancer regardless histologic type.

Keywords: breast cancer treated by conservative surgery
dysphagia handicap index: a structured translation from english to german

Conditions: Dysphagia

Summary: establishment of a questionnaire in german to determine in a structured and quantifiable manner the quality of life of patients with dysphagia.


Eligibility criteria:
inclusion criteria: all patients with dysphagia exclusion criteria: inability to fill in the questionnaire
prophylactic fenestration of the peritoneum in kidney transplantation

Conditions: Incidence of Symptomatic Lymphocele After Kidney Transplantation; Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks

Summary: a single centre open randomised parallel-group study to evaluate whether prophylactic fenestration of the peritoneum at the time of renal transplantation prevents lymphocele formation. adult (\>18 years old) recipients of renal transplants from deceased donors were eligible for inclusion. from march 2007 to may 2009 130 patients were included. the patients were randomized either to peroperative peritoneal fenestration, or to serve as controls. block-randomization was conducted in groups of 10, drawn from envelopes containing five notes from each group. patients who previously had undergone extensive abdominal surgery, or were included in other studies were excluded.


Eligibility criteria:
inclusion criteria: * adult recipients of kidney transplants from deceased donors exclusion criteria: * former extensive abdominal surgery * participation in other studies

Keywords: kidney, transplantation, surgery, complications, lymphocele, fluid collections.