Kornimate/medical-research-clean huggingface dataset:
ophthalmologic outcomes in patients with carotid artery stenosis

Conditions: Choroid Disease; Carotid Stenosis; Carotid Atherosclerosis; Retinal Disease

Summary: the retinal vessels have been shown to reflect vascular changes inherent to systemic pathologies, even when no ocular disease is identified. as such, the eye's vasculature is ableto serve as a window to the vascular health of the human body and a means of assessing systemic endothelial function. optical coherence tomography angiography (octa) employs optical means to image all the retinal vascular layers and the choroid, providing an extremely detailed image of the microvascular network in a fast, reproducible and totally non-invasive way. as such, it is currently the best non-invasive way of having an image of human capillaries. recently, octa has been used to study the retinal vessels' structure and function in several cardiovascular diseases. as an example of its predictive potential, reduced retinal microvascular density has been associated with the cardiovascular risk profile in patients admitted to the hospital for an acute coronary syndrome. recent studies have also shown the retinal microvasculature density to be reduced in patients with carotid artery disease (cad), namely carotid stenosis, and that endarterectomy increases retinal flow and vessel density.

the authors hypothesize that fgf-23, gdf-15, vegf-a, mmp-9 and retinal/choroidal microvascular density could predict cerebral ischemia, postoperative complications, long term major cardiovascular events and short term ophthalmologic alterations particularly in patients developing symptomatic neurologic ischemia after circulation shutdown. the purpose of this study is to compare different cardiac risk scores in carotid endarterectomy. the main aim of this study is to test the risk factors individually and determine its discriminatory ability. combinations of traditional preoperative risk factors and scores will be evaluated to enhance the assessment of major adverse cardiac events in vascular surgery patients. establish and validate biomarkers that improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.

Eligibility criteria:
inclusion criteria: * consecutive carotid stenosis exclusion criteria: * blind patients * radic stenosis

Keywords: carotid endarterectomy optimal coherence tomography,
gingival recession (rt1) treatment with different gingival augmentation surgeries

Conditions: Gingival Recession

Summary: thin gingival phenotype is one of the major causative factors of gingival recession type 1 which can result in hypersensitivity, discomfort, and compromised esthetics. this study assess the efficacy of increasing the gingival thickness from thin gingival phenotype to thick gingival phenotype in the treatment of patients suffering from gingival recession (rt1) and maintenance of results using either connective tissue graft or de-epithelized free gingival graft after non-surgical periodontal debridement compared to non-surgical periodontal debridement alone.

this parallel arm randomized controlled clinical trial study will include systematically free patients with thin gingival phenotype. they will be randomly allocated to three equal groups. group a (test group, n=10) will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique, group b (test group, n=10) will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft, while group c (control group, n=10) will receive non-surgical periodontal treatment only. after 3, 6 and 12 months gingival biotype will be clinically assessed (1ry outcome). this parameter will be recorded at baseline, 3, 6 and 12 months. the 2ry outcomes will include recording of recession depth, plaque index, bleeding on probing, keratinized tissue width . postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post-surgically. postoperative instructions and medication will be given to the patient. all readings will be carried out by a calibrated outcome assessor who will be masked. follow-up will be performed to assess the outcomes and to ensure performing proper oral hygiene. data collected will be tabulated and statistically analyzed.

Eligibility criteria:
inclusion criteria: * medically free patients (american society of anesthesiologists i; asa i) * patients diagnosed with recession (rt1) * fair oral hygiene * patient accepting to provides an informed consent and the follow-up exclusion criteria: * carious teeth and teeth with periapical infection. * patients diagnosed with periodontitis * smokers * pregnant and lactating females
cutaneous sensory block area of the subcostal ultrasound-guided transversus abdominis plane block

Conditions: Postoperative Pain

Summary: patients planned for elective laparoscopic cholecystectomy received a peroperative ultrasound-guided subcostal transversus abdominis plane block (ustap) at the beginning of the procedure. at t90 minutes after the end of anaesthesia the cutaneous sensory block area (csba) was measured using cold sensation and mapped with a sterile marker. the csba was photodocumented and the area calculated.


Eligibility criteria:
inclusion criteria: * planned for elective laparoscopic cholecystectomy, age 18 or older, written and verbal consent exclusion criteria: * non-compliant due to language or psychiatric disease, previous surgery to the upper abdomen, incisional hernia, pregnancy, sensory deficit of the abdomen or thorax.

Keywords: transversus abdominis plane block
health experiences & early life disadvantages

Conditions: Early Life Adversity; Chronic Stress

Summary: growing up in a low-income household has been shown to increase risk for, and susceptibility to many illnesses.the purpose of the study is to test an affective intervention for reversing biological risk factors, as related to childhood adversity, in midlife. participants will be asked to make two lab visits; attend six weekly, 1-hour meditation classes; as well as complete brief online daily surveys for 11 weeks, five biweekly surveys, and two 30-minute surveys prior to each lab visit. during the lab visits, participants will have their psychophysiology monitored for heart rate, blood pressure, respiration, and pulse. participants will also have their blood drawn. all surveys and questionnaires inquire about participants' current demographics, family history, perceptions about life and well-being, physical health, and monetary choices.


Eligibility criteria:
inclusion criteria: * fluent in written and spoken english * have daily access to internet and a computer exclusion criteria: * engaged in regular meditation practice, either recently or in the past * previously participated in a meditation study * have allergies to adhesive materials (includes latex)
the effectiveness of silver alginate (algidex) patch in the prevention of central line infections in very low birth weight infants

Conditions: Central Line Bloodstream Infections

Summary: the purpose of this study is to determine whether silver alginate (algidex) patch is effective in the prevention of central line infections in very low birth weight infants.

with rapid technological advancement, the increased use of vascular catheters has not only improved patient care strategies, but also contributed to the risk of infection. unfortunately, catheter related blood stream infections still remain one of the major causes of morbidity in vlbw infants. in the united states, approximately 850,000 infections are attributed to catheters annually, occurring primarily in intensive care unit patients. the national institute of child health and human development stated that 20% of infants less than 1500 grams will have at least one positive blood culture delaying their stay in the neonatal intensive care unit (nicu). one approach to reducing the incidence of infection could be utilizing the antimicrobial properties of silver. silver alginate has been proven safe and beneficial in the adult population in preventing catheter related infections. studies done in mice and rats suggest acute toxicity occurring when the animals were given 23 mg of silver acetate/kg of body weight and chronic toxicity noticed when animals were given 1.5 mg/kg/day (5) chronic toxicity in humans was shown with ingestion of 13 mg/kg/day (3) in our recently concluded pilot randomized controlled trial done in vlbw infants, safety of silver alginate was demonstrated by lack of skin reactions to the patches and mild increase in serum silver level ( khattak et al; pediatrics research march 2008, clinicaltrials.gov id: nct00593684 ). however, there is no clinical evidence of efficacy in vlbw neonatal population. based on the data from our pilot safety study, we hypothesize that using silver alginate dressing in this population will be efficacious in the prevention of blood stream infections. although initial studies suggest that absorbed silver is not in a range toxic to human infants, we will continue to monitor silver levels in certain infants.

Eligibility criteria:
inclusion criteria: 1. infants with birth weights between 500 and 1500 grams admitted to the nicu with any of the following lines will be eligible for inclusion in this study 1. umbilical arterial line (ual) 2. umbilical venous line (uvl) 3. peripheral arterial line (pal) 4. peripheral long line (pll) 5. central venous line (cvl) 2. each eligible subject will be randomized to receive either standard of care or silver alginate dressing. dressings will be changed every 7 days in accordance to current facility protocols. exclusion criteria: 1. any infant born with a lethal abnormality or who has received topical silver therapy will be excluded from the study.

Keywords: premature infection central line very low birth weight silver alginate algidex neonatal nicu
follow-up of spts in patients with raynaud's phenomenon

Conditions: Raynaud Phenomenon

Summary: background: raynaud's phenomenon is a vasospasm of the extremities, leading to extensive discomfort in daily life and potentially severe ischemia. some patients are resistant to conventional vasodilatory drug treatment. in the university medical center groningen, single-port thoracoscopic sympathicotomy (spts) was developed. this is a new minimally invasive endoscopic technique, extensively limiting surgical burden. in many hospitals in the netherlands, this operation is sometimes performed on patients with raynaud's phenomenon. however, the techniques used are more invasive than the spts technique. furthermore, studies on sympathectomy and sympathicotomy in raynaud's are limited and encompass obsolete more invasive techniques. also, it is unclear which patients would benefit the most and for how long and in which percentage of patients treatment effects persist over time. in a recent study on the new spts technique, it was found that one month after the procedure, the raynaud's attacks were substantially reduced and the hand perfusion increased on the operated side. based on these short term effects and previously reported broad experience with this technique for other indications, it is possible to offer this option to a broader range of patients with raynaud's as a reasonable and safe treatment option. however, whether the effects persist on the long-term needs to be established. main research question: the aim of the study is to assess the 5 year efficacy and outcome in patients with primary and secondary raynaud's phenomenon in whom spts has been performed. design (including population, confounders/outcomes): patients with raynaud's, who will undergo spts in patient care setting, will be included. data from the patient file will be collected, including vascular measurements to assess hand perfusion, a raynaud diary (raynaud condition score, duration and frequency of the attacks), quality of life questionnaires, and adverse events.


Eligibility criteria:
inclusion criteria: * raynaud's phenomenon of the hands * scheduled spts as treatment for rp * age ≥ 16 years exclusion criteria: • spts for other indications than rp
a bioequivalence study of two oral formulations of topotecan in patients with advanced solid tumors

Conditions: Lung Cancer, Small Cell; Solid Tumor Cancer

Summary: the purpose of this study is to compare two capsules of topotecan made by slightly different methods. this will be done by giving the drug made by the two different methods to patients orally and testing blood levels.


Eligibility criteria:
inclusion criteria: * written informed consent * patients with confirmed advanced solid tumors. * no prior chemotherapy within 5 years of the diagnosis of sclc (small cell lung cancer). * at least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery. * laboratory criteria: patients must have adequate bone marrow reserve and adequate kidney and liver function. exclusion criteria: * women who are pregnant or lactating. * patients of child bearing potential refusing to practice adequate contraception. * patients with uncontrolled vomiting. * active infection. * patients with clinical evidence of any gastrointestinal (gi) conditions which would alter gi absorption or gi motility. * patients requiring treatment with cyclosporin a. * severe medical problems other than the cancer, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk. * ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for cancer treatment. * use of investigational drug within 30 days prior to the first dose of study medication.

Keywords: oral bioequivalence hycamtin topotecan
routine care study evaluating ocular torsion

Conditions: Superior Oblique Muscle Palsy

Summary: the paralysis of the fourth cranial nerve (paralysis iv), commonly known as the superior oblique muscle (so) paralysis, represents half of vertical strabismus. the diagnosis of so paralysis and of its congenital or acquired etiology, are based on a range of clinical findings. the three main clinical diagnostic elements are the hypertropia in paralyzed side which increases in adducted position, the positivity of bielschowsky head tilt test and the twisting of the eye fundus. these criteria are always considered together and are interdependent. the diagnostic value and the sensitivity of each of these signs is not defined. brain and orbital magnetic resonance imaging (mri) allowed a better understanding of the physiopathology of a number of oculomotor disorders. for this reason, mri constitute a reference for the so palsy. the atrophy of the so muscle is qualitatively determined by the asymmetry of muscle volume on two contiguous coronal mri. the diagnostic value of various clinical signs observed in so paralysis (sensitivity, specificity) remains unknown.


Eligibility criteria:
inclusion criteria: for the subjects without oculomotor disorder * no diplopia in different positions of gaze; * no oculomotor disorder during the orthoptic examination (horizontal phoria \<8 prism diopter, vertical phoria \<4 prism diopter); * corrected visual acuity \> 8/10 on both eyes; * binocular vision present in lang i test (defined by 3 elements seen or appointed); * orbital mri: normal oculomotor muscles (including absence of atrophy of the superior oblique muscle) and lack of intra orbital expansive process; * brain mri: no abnormalities in the ways of oculomotor (especially no abnormalities in posterior fossa). for the patients with so muscle unilateral paralysis * clinical features compatible with unilateral paralysis of the so muscle * muscular body atrophy of the so on the orbital mri without other orbital or cerebral abnormality * binocular vision in lang i test exclusion criteria: * high refractive error (\ 6 diopter); * history or current oculomotor disorder or restrictive neurological disorder (dysthyroid orbitopathy, orbital trauma, retinal detachment surgery, paralysis oculomotor palsy other than iv); * optic nerve head abnormalities in the fundus (edema for example) * lack of binocular vision lang i test; * pregnant or breastfeeding patient * patient under legal protection * patient opposition to participate in the study

Keywords: mri excyclotorsion
effect of geriatric intervention in frail elderly patients receiving chemotherapy for colorectal cancer

Conditions: Colorectal Neoplasms

Summary: gerico is a randomized, controlled prospective trial. the aim is to investigate if frail, elderly patients with stage ii-iv colorectal cancer, will profit from full comprehensive geriatric assessment and intervention before and during treatment with chemotherapy. the hypotheses are: optimizing the health conditions and functional status of frail elderly patients who suffers from stage ii-iv colorectal cancer, with geriatric intervention will lead to a higher grade of completing the planned chemotherapy and at higher dose intensity. this will also result in a higher overall survival and improve quality of life.


Eligibility criteria:
inclusion criteria: * frail according to the screening tool g8 ( ≤14 / 17points) * performance status 0-2 and life expectancy ≥ 3 months * patients who have undergone surgery for stage iii / high-risk stage ii colorectal cancer or patients with unresectable or metastatic disease * are assessed to receive adjuvant chemotherapy or first -line chemotherapy * meets the criteria to receive preventive chemotherapy with 5-fu or capecitabine +/- oxaliplatin or first -line chemotherapy with 5-fu / irinotecan and / or oxaliplatin , capecitabine +/- possibly with the addition of immunotherapy in the form of cetuximab , panitumumab or bevacizumab. * informed written and oral consent exclusion criteria: * other malignancy except basal cell carcinoma and squamous cell carcinoma in situ cervicis uteri in 5 years * patients in simultaneously drug trials * the patient must not have previously received adjuvant chemotherapy in the gerico protocol

Keywords: elderly intervention study geriatrics chemotherapy
the "vision" trial: ventavis inhalation with sildenafil to improve and optimize pulmonary arterial hypertension

Conditions: Pulmonary Hypertension

Summary: the purpose of this multi-center international trial is to evaluate the safety and effectiveness of adding iloprost or placebo (an inactive substance that contains no active study drug) to sildenafil therapy for pulmonary arterial hypertension (pah). the study will also examine whether patients on sildenafil can reduce the number of iloprost inhalations from the approved 6 doses per day to 4 doses per day.


Eligibility criteria:
inclusion criteria: * aged 12-85 years; of either gender. * confirmed pah due to idiopathic pulmonary arterial hypertension (ipah) or familial pulmonary arterial hypertension (fpah). * 6-minute walk distance (6-mwd) between 100-450 meters at screening. * on a stable dose of sildenafil, with or without bosentan. exclusion criteria: * any treatment for pah with prostacyclins, prostacyclin analogues, endothelin-1 antagonists, or phosphodiesterase-5 (pde-5) inhibitors other than sildenafil within the past 12 weeks. * pulmonary hypertension due to conditions other than those stated in inclusion criteria. * additional pah medications added within the past 12 weeks.

Keywords: pah pulmonary arterial hypertension
pulmonary embolism after liver resection

Conditions: Liver Disease; Pulmonary Embolism; Thrombophilia; Death

Summary: major surgery is associated with a postoperative hypercoagulable state related to the surgical trauma that may lead to thromboembolic complications. to the investigators knowledge, only two series have reported the risk of pe after liver surgery with an incidence of up to 6.3% the purpose of this study is to identify the independent risk factors associated with the development of pe after elective liver surgery.


Eligibility criteria:
inclusion criteria: * age \>18 years * malignant liver diseases * benign liver diseases exclusion criteria: * age \<18 years * previous history of thromboembolic events * living donor hepatectomies

Keywords: liver disease pulmonary embolism thrombophilia death
efficacy of transference-focused psychotherapy for borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: the purpose of this study is to find out whether transference-focused psychotherapy (tfp) is effective in the treatment of borderline personality disorder.

borderline personality disorder represents a sever clinical condition that affects 1-2% of the community and is characterized by a pervasive instability of interpersonal relationships, self-image, and affects, as well as a marked impulsivity; up to 10% of the patients commit suicide. transference-focused psychotherapy (tfp) is one psychotherapeutic approach among five that have been manualized and evaluated in rcts. so far, tfp has not been compared to a control condition which is a crucial step in the evaluation of the efficacy of a psychosocial intervention. this study is an rct that compares one year of outpatient tfp to treatment by experienced community psychotherapists for borderline personality disorder.

Eligibility criteria:
inclusion criteria: * written informed consent to the participation in the study * diagnosis of bpd according to dsm-iv as assessed using the scid-ii * age between 18 and 45 years * sufficient knowledge of the german language exclusion criteria: * diagnosis of schizophrenia, bipolar disorder, severe substance abuse, organic pathology, or mental retardation according to dsm-iv as assessed using the scid-i * diagnosis of antisocial personality disorder according to dsm-iv as assessed using the scid-ii

Keywords: borderline personality disorder randomized controlled trial transference-focused psychotherapy treatment by experienced community psychotherapists
an observational study to compare the safety and effectiveness of novomix® 30 and levemir™ for the treatment of diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this observational study is to compare the clinical safety profile and effectiveness of novomix® 30 and levemir™ for the treatment of diabetes in the philippines.


Eligibility criteria:
inclusion criteria: * patients diagnosed with type 1 or type 2 diabetes mellitus * patients uncontrolled on oral antidiabetic drugs * insulin naïve patients or patients currently on human insulin exclusion criteria: * subjects who are unlikely to comply with protocol requirements * subjects who are previously enrolled in novomix® 30 and levemir™ study * subjects on novomix® 30 and levemir™ therapy * subjects with hypersensitivity to novomix® 30 or to any of the excipients * subjects with hypersensitivity to levemir™ or to any of the excipients * females of child bearing potential who are pregnant, breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures are required by local law or practice * contraindications and warnings specified in the current prescribing information