Kornimate/medical-research-clean huggingface dataset:
evaluating the relationship between blood clotting disorders, inflammation, and obesity in individuals with venous disorders and post-thrombotic syndrome

Conditions: Venous Thrombosis; Venous Insufficiency

Summary: venous thrombosis is the development of a blood clot in a vein. post-thrombotic syndrome (pts) is a painful condition that can develop following a venous thrombosis in one of the deep veins of the leg. while pts is mainly thought to occur because of damage to the vein, other factors may be responsible for the development of this condition. this study will analyze genetic and biologic samples from participants of a previous study to examine other possible causes of venous diseases and pts.

the long-term effects of venous thrombosis, known collectively as pts, include persistent swelling, pain, cramps, and numbness in the leg. these symptoms result from impaired return of blood through the veins of the lower leg to the heart. pts is believed to occur as a result of direct damage to the valves and walls of the vein. there may be specific factors that make certain individuals more prone to pts. individuals who are obese, have a genetic predisposition to blood clotting disorders, or have high levels of inflammation biomarkers may have an increased risk of developing venous diseases. the purpose of this study is to investigate the possible link between these factors and the occurrence of chronic venous disease and pts. the study's findings will be useful in developing new prevention and treatment strategies. this study will examine previously collected data from participants in the san diego population study, a study that gathered information on the prevalence of chronic venous disease in a multi-ethnic group of individuals. there will be no study visits specifically for this study. researchers will examine stored genetic and biologic samples of 370 control participants and 370 participants with chronic venous disease. specifically, levels of inflammation biomarkers, levels of obesity-related biomarkers, and genetic predispositions for blood clotting disorders will be studied.

Eligibility criteria:
inclusion criteria: * participated in the san diego population study

Keywords: deep vein thrombosis chronic venous insufficiency post thrombotic syndrome blood coagulation inflammation
study of alwextin® cream in treating epidermolysis bullosa

Conditions: Epidermolysis Bullosa

Summary: the purpose of this study is to determine how safe and effective allantoin 3% cream (alwextin) is in improving the healing of recurrent skin lesions and reducing overall blistering in people with epidermolysis bullosa (eb). allantoin 3% cream is applied topically to the entire body once daily.

potential subjects came to the for a screening visit. eligible subjects had baseline assessments performed and were provided study medication, allantoin 3% cream. subjects were instructed to apply the study medication to the entire body once daily and to keep daily record of study medication use. subjects returned every 4 weeks for a total of 12 weeks for repeat assessments.

Eligibility criteria:
inclusion criteria: * history of epidermolysis bullosa exclusion criteria: * use of any skin product containing allantoin for 30 days prior to enrollment

Keywords: epidermolysis bullosa
clinical trial to evaluate the efficacy and the safety of antihypertensive tablets

Conditions: Essential Hypertension

Summary: the purpose of this study is to determine the optimal dosage of the clinical trial which is evaluating the antihypertensive efficacy and the safety of ojp-2028 tablets in patients with the uncomplicated essential hypertension.

evaluating the antihypertensive efficacy and the safety of ojp-2028 tablets in patients with the uncomplicated essential hypertension.

Eligibility criteria:
inclusion criteria: 1. adult men and women (age 18-75 years) 2. uncomplicated essential hypertension: clinic sitting sidbp between 90 and 109 mmhg after 2 week placebo run-in period exclusion criteria: 1. secondary hypertension 2. history and/or signs of cardiovascular complications (eg; myocardial infarction, unstable angina) 3. pregnancy or lactation 4. contraindications to the antihypertensive drugs to be used during the treatment period
clinical survey study to assess physical function and the incidence of hypoglycemia in participants with glycogen storage disease type iii

Conditions: Glycogen Storage Disease Type III

Summary: the primary objective of this study is to evaluate the incidence of hypoglycemia in adult and pediatric participants with glycogen storage disease type iii (gsd iii).


Eligibility criteria:
key inclusion criteria: * diagnosis of gsd iii, confirmed by amylo-alpha-1,6-glucosidase 4-alpha-glucanotransferase (agl) sequencing or glycogen debranching enzyme (gde) enzymatic testing key exclusion criteria: * participant is unwilling to remain blinded to continuous glucose monitor (cgm) data for the first 13 weeks of the study, or the investigator determines that blinding would compromise subject safety * presence or history of any condition that, in the view of the investigator, would interfere with participation or pose undue risk * use of any ip or investigational medical device within 30 days or 5.5 half-lives, whichever is longer, prior to screening, or during the study note: other criteria may apply per protocol
prospective clinical study of retinal microvascular alteration after icl implantation

Conditions: Adolescent; Adult; Human; Male; Female; Follow-up Studies; Prospective Studies; Lens Implantation, Intraocular; Myopia; Phakic Intraocular Lenses; Retinal Vessels; Postoperative Period; Preoperative Period; Tomography, Optical Coherence

Summary: to observe the retinal microvascular alteration during 3 months follow-up after implantable collamer lens (icl) operation in moderate and high myopia patients using quantitative optical coherence tomography angiography (octa) analysis.

the study object is moderate and high myopia patients, underwent icl implantation. octa was used to image the superficial and deep retinal vascular plexuses before icl implantation surgery and at 3 months follow-up. octa images were corrected for magnification, skeletonized, separated the large vessels and partitioned. retinal microvascular density was measured by using fractal dimension analysis. the aim of this study was to uncover potential retinal vascular network alterations induced by icl implantation surgery.

Eligibility criteria:
inclusion criteria: * 18 to 45 years old; * binocular myopia, with a refraction of greater than -3 diopters (d); * anterior chamber depth (acd, measured from the endothelium to the crystalline lens) \> 2.8 mm; * corneal endothelial cell count (cecc) ≥ 2000 cells/mm2; * stable refraction at least 1 year before surgery; * unsatisfactory vision with contact lenses or spectacles. exclusion criteria: * history of intraocular surgery * other ocular pathology (uveitis, glaucoma, cataract, keratoconus, severe dry eye, etc.) * other serious systemic disease (diabetes, uncontrolled hypertension, severe hyperthyroidism, etc.).
a study to evaluate the effects of veliparib on heart rhythms in patients with solid tumors

Conditions: Breast Cancer; Ovarian Cancer; Colon Cancer; Lung Cancer; Gastric Cancer; Solid Tumors

Summary: this is a randomized phase 1 study to evaluate the effects of veliparib on cardiac repolarization in patients with solid tumors who's cancer has recurred or is no longer responding to current treatment.


Eligibility criteria:
inclusion criteria: * confirmed solid malignancy that is metastatic or unresectable for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective. * subjects with brain metastases must have clinically controlled neurologic symptoms. * subject is able to swallow and retain oral medications and does not have uncontrolled emesis. * subject has adequate bone marrow, renal and hepatic function per local laboratory reference ranges. exclusion criteria: * uncorrected serum potassium, serum magnesium, serum calcium or free thyroxin (ft4) and thyroid stimulating hormone (tsh) outside of normal reference ranges, or grade 2 hyponatremia or hypernatremia. * subject has severe ecg morphologic abnormalities that make qtc evaluation difficult. * subject has a history of cardiac conduction abnormalities. * subject has a significant history of cardiovascular disease. * subject has received any anti-cancer therapies 21 days prior to the first dose of study drug, or has recovered to no better than a grade 2 or higher clinically significant adverse effect(s)/toxicity(s) of the previous therapy. * use of drugs with a known risk for qt prolongation and torsades de pointes within 7 days prior to the first study dose. * use of tobacco or nicotine-containing products within 12 hours prior to the first study dose.

Keywords: solid tumors ovarian cancer colon cancer lung cancer breast cancer gastric cancer
pilot pharmacokinetic clenil study with aerochamber plus™ or volumatic™ spacer devices

Conditions: Asthma

Summary: the purpose of this study is to evaluate, at steady-state, the systemic exposure and the lung deposition of b17mp (active metabolite of bdp) as auc0-12h,ss and cmax,ss, after inhalation of bdp (clenil® modulite®) with the aerochamber plus™ spacer device or with the volumatic™ spacer device without or with charcoal block.


Eligibility criteria:
inclusion criteria: * male or non-pregnant female patients aged 18-65 years included. * diagnosis of asthma according to gina guidelines 2009 made at least 6 months prior to screening. * patients already treated with a dose of bdp or equivalent up to 2000 µg/day. * fev1 ≥ 60% of predicted for the patient's normal value at screening and randomisation exclusion criteria: * patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit. * exacerbation of asthma symptoms or hospitalization due to asthma exacerbation within the previous one month before screening until randomisation. * lower respiratory tract infection within one month prior to screening. * diagnosis of copd as defined by the current gold 2009 (global initiative for chronic obstructive lung disease) guidelines. * significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the investigator's opinion. * treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening. * any enzyme inducing or inhibiting drug (from 8 weeks before screening visit) * patients who received any investigational new drug within the last 8 weeks before the screening. the patients cannot participate in another clinical study at the same time as the present study. * blood donation (450 ml or more)or significant blood loss less than 12 weeks before the first intake of study drug.

Keywords: asthma pk adults
is hyacinth exercise better than kegel's exercise in women with urinary incontinence?

Conditions: Urinary Incontinence

Summary: to determine whether hyacinth exercises are more effective than kegel's exercise at improving pelvic floor weakness among women aged 55 and above with urinary incontinence.

individuals who admit to have urinary leakage will be examined to determine the nature of their problem and individuals for whom kegel exercises are likely to be for benefit will be recruited into this study. one hundred and eighty women who participants who agree to be randomized to kegel's or hyacinth exercises will be randomized. the treatment allocation will be sealed opaque enveloped and stored in a secure location. participants will be blinded from the treatment arm, and as much as possible, participants in different arms of the study would be given different appointment dates to avoid contamination. exercises will be prescribed by a trained personnel, and flexibility is added to the routine to enable tailoring to individual lifestyles and choices.

Eligibility criteria:
inclusion criteria: * woman aged above 55 with urinary incontinence. exclusion criteria: * individuals who are unable or unwilling to provide written informed consent. * stage 3 and 4 pelvic organ prolapse. * individuals who have physical weakness and are unable to do kegel plus exercises. * neuropathic injury of pelvic floor muscles.
isolated roux loop versus conventional pancreaticojejunostomy following pancreaticoduodenectomy

Conditions: Pancreatic Fistula

Summary: pancreaticoduodenectomy is a commonly applied operation for the treatment of benign and malignant diseases of periampullary region. although recent progress in surgical techniques and medical care reduced the mortality rate of this operation below 5% in some institutes, the morbidity rate still remains high as 40-50% (1,2). pancreatic anastomotic leaks and fistulas continue to be the main source of morbidity and mortality after pancreaticoduodenectomy. although there are several recommended techniques to reduce the rate of pancreatic fistulas, optimal pancreatic reconstruction technique is still controversial (3-5). one of the recommended techniques for pancreatic reconstruction is isolated roux loop pancreaticojejunostomy (6). with this method, as pancreatic anastomosis is kept away from biliary and gastric anastomoses, activation of the pancreatic enzyme precursors is blocked and in this way a reduction in the rate and severity of pancreatic fistula and also in the overall morbidity and mortality can be achieved (6-8). in this study, it is aimed to examine if isolated roux loop pancreaticojejunostomy is superior to conventional pancreaticojejunostomy on postoperative outcomes.


Eligibility criteria:
inclusion criteria: * patients who underwent pancreaticoduodenectomy. exclusion criteria: * patients with missing data * patients who underwent total pancreatectomy * patients who had pancreaticogastrostomy as the reconstruction method * patients who had emergency pancreaticoduodenectomy

Keywords: pancreatic fistula pancreatic leak whipple operation roux-en-y
predictors of proton pump inhibitor (ppi) response in eosinophilic esophagitis

Conditions: Gastroesophageal Reflux Disease; Eosinophilic Esophagitis; Dysphagia

Summary: the investigators will determine the prevalence of gastroesophageal reflux disease (gerd) in eosinophilic esophagitis (eoe) and importantly determine the predictors of response to proton pump inhibitor (ppi) therapy in eoe. moreover, the investigators will determine the effect of gerd on the location of esophageal eosinophilia.


Eligibility criteria:
inclusion criteria: * 18 years of age \< 80 years of age * 14 eosinophils / hpf on biopsies from esophagus * abnormal validated mayo dysphagia questionnaire (mdq-30) (question 2"yes", question 4 \> "moderate" and question 7 \> "once a week") * clinically performed egd with \> 14 eosinophils/hpf completed within last 3 months exclusion criteria: * other cause of dysphagia identified at endoscopy (e.g. stricture, web, infection, ring, achalasia, esophageal neoplasm) * dilatation of esophagus at time of index endoscopy * treatment with topical steroid within 3 months of index endoscopy * treatment with ppi in last 30 days prior to index egd patient population - adults with eoe recruited from mayo clinic rochester, mn patient population

Keywords: gerd eosinophilic esophagitis proton pump inhibitor dysphagia
evaluation of autonomic nervous system changes in response to stimulation by sacral neuromodulation

Conditions: Bladder Hyperactivity; Sacral Neuromodulation

Summary: overactive bladder syndrome (oab) is defined by urgent and frequent urges to urinate associated with frequent night-time urination and sometimes urinary incontinence. sacral neuromodulation (snm) is now one of the second-line treatments for oab. the mode of action of snm is still poorly understood but a number of data from recent scientific literature suggest that snm may act, among other things, by altering the balance of the autonomic nervous system (ans) - located at the interface between the urinary tract and the brain structures regulating the functioning of the urinary tract. the aim of this study would therefore be to develop a predictive tool for the effectiveness of snm.


Eligibility criteria:
inclusion criteria: * male of female ≥ 18 years * oab syndrome * indication for a two-staged snm * under general anaesthesia with remifentanil and propofol * patient who has given written consent to participate in the trial * patient willing to comply with all study procedures and duration exclusion criteria: * tibial neuro-stimulation (last 3 months) * sacral neuromodulation (last 3 months) * botulinum toxin a intra-detrusor injection (last 9 months) * pregnancy in progress * administrative reasons * guardianship/curatorship

Keywords: bladder hyperactivity autonomic nervous system sacral neuromodulation urodynamic assessment heart rate variability
antithrombotics' therapeutic optimization in hospitalized patients using physiologically- and population-based pharmacokinetic modeling

Conditions: Cardiovascular Diseases

Summary: the main goal of the optimat study main goal is to validate a pbpk model for 3 direct oral anticoagulants (rivaroxaban, apixaban, dabigatran) and 3 p2y12 inhibitors (clopidogrel, ticagrelor, prasugrel) in hospitalized patients.

patients treated with antithrombotics are at risk of both severe ischemic and bleeding events. however, current clinical scores are insufficiently discriminant to predict the most favorable drug and dosing for an improved net clinical benefit. physiologically and population-based pharmacokinetic models (pbpk and poppk respectively) incorporate substrate specific properties obtained from experimental in-vitro experiments as well as patients' demographic, genetic and physiological in vivo data in order to characterize the dose-concentration relationships. as such, they can be used to simulate and predict pk profiles accounting for specific patients' characteristics and are the basis of dosing optimization. these models could be a valuable tool to predict antithrombotic blood concentration in a given patient. our main goal is to elaborate predictive models characterizing the dose-concentration relationship with influencing variables of three direct oral anticoagulants (doac) (rivaroxaban, apixaban, dabigatran) and three p2y12 inhibitors (clopidogrel, prasugrel, ticagrelor) in hospitalized patients, which will serve as basis for drug selection and dosage optimization.

Eligibility criteria:
inclusion criteria: * hospitalized patients at any of the geneva university hospitals 18 yo and older * treated with doac (dabigatran, rivaroxaban, apixaban) or/and p2y12 (clopidogrel, ticragrelor et prasugel) at the time of study blood sampling * understanding of french language and able to give an inform consent. exclusion criteria: * patients with a reduced life span (\<6 mois) * exclusion criteria during follow up * change in dosage or cessation of the doac or p2y12 taken by the participant follow up data will be censored at the time of change.

Keywords: direct oral anticoagulant p2y12 inhibitors physiologically-based pharmacokinetic model (pbpk) population-based pharmacokinetic model (poppk)
radial and focused eswt in the treatment of coccydynia according to age and body mass index

Conditions: Coccyx Disorder

Summary: to date, focused and radial types of eswt have been effectively used in the treatment of coccydynia. however, studies directly addressing a comparison between radial and focused types of eswt in coccydynia have not been done. therefore, this study aims to evaluate comparative effects of radial and focused eswt options on coccydynia.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of coccydynia by clinical examination and x-ray imaging. * be aged ≥18 at the time of diagnosis * be give informed consent exclusion criteria: * malignancy * those who have received eswt treatment before * pediatric patients * patients with infection.
navigated oct imaging with the p200txe

Conditions: Retinal Disease

Summary: the p200txe will be used to obtain peripheral oct (optical coherence tomography) images.


Eligibility criteria:
inclusion criteria: 1. male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed; 2. subjects who can follow the instructions by the clinical staff at the clinical site, 3. subjects who agree to participate in the study; 4. subjects presenting with some form of peripheral retina pathology or retina pathology with peripheral manifestations. exclusion criteria: 1. subjects unable to tolerate ophthalmic imaging; 2. subjects with ocular media not sufficiently clear to obtain acceptable oct images;
market research - acceptability trial for a new pku amino acid based protein substitute

Conditions: PKU; Phenylketonurias; Inborn Errors of Metabolism; Metabolic Disease

Summary: the aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with pku.


Eligibility criteria:
inclusion criteria: * diagnosis of pku or pku variant requiring a phenylalanine-free protein substitute * subjects who are already taking a phenylalanine-free protein substitute and are willing to try the study product for 7 days * patients aged 3 years of age to adulthood * written informed consent obtained from parental caregiver exclusion criteria: * presence of serious concurrent illness * investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements * participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study. * any patients having taken antibiotics over the previous 2 weeks leading up to the study. * patients less than 3 years of age.