Kornimate/medical-research-clean huggingface dataset:
post-market evaluation of clinical outcomes in china for the tecnis model zmt

Conditions: Cataract

Summary: this is a prospective, multicenter, single-arm, open-label clinical study of the commercially available tecnis multifocal toric 1-piece iol. the study will enroll up to 120 subjects from up to 8 sites in china. the subjects will be followed for 12-months postoperatively.


Eligibility criteria:
inclusion criteria: 1. male or female at least 22 years of age 2. have a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation 3. regular corneal astigmatism that is planned for correction with an intraocular lens in the study eye(s) 4. availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with postoperative visits that are required by the study protocol 5. voluntary participation indicated by the study informed consent form (icf) signed by the patient or legal guardian. exclusion criteria: 1. concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit 2. ocular disease (other than cataract) that may significantly affect postoperative vision, such as visually significant keratopathy, macular lesions, diabetic retinopathy, chronic or severe uveitis, etc. 3. planned monovision correction (one eye designated for near correction) 4. severe or unstable systemic disease that may affect the heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, or psychoneurological dysfunction 5. any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study. -
drotaverine hydrochloride versus hyoscine-n-butylbromide for duodenal antimotility during endoscopic retrograde cholangiopancreatography (ercp)

Conditions: ERCP; Pancreatic Diseases; Bile Duct Diseases

Summary: the aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-n-butylbromide in reducing duodenal motility during diagnostic and therapeutic ercp.

ercp is an important endoscopic technique in the diagnosis and treatment of pancreatic and biliary diseases. duodenal peristalsis can make cannulation of the papilla and the necessary therapeutic procedures difficult. intravenous hyoscine-n-butylbromide is often used during ercp to inhibit duodenal motility and enhance cannulation in china. however, the pharmaceutical agent is occasionally associated with serious complications such as cardiovascular events or anaphylactic shock. hyoscine-n-butylbromide may also affect the ocular, urinary, and salivary systems. drotaverine hydrochloride is an analogue of papaverine with smooth muscle relaxant properties. it is a non-anticholinergic antispasmodic, which selectively inhibits phosphodiesterase iv and is accompanied by a mild calcium channel-blocking effect. adverse effects with drotaverine hydrochloride, such as hypotension, vertigo, nausea, and palpitation, are mostly mild. it can be supposed that intravenous drotaverine hydrochloride might be a feasible antimotility alternative to intravenous hyoscine-n-butylbromide in ercp. but there is no clear evidence to recommend the use of drotaverine hydrochloride as an antispasmodic during ercp. the aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-n-butylbromide in reducing duodenal motility during diagnostic and therapeutic ercp. the effects of drotaverine hydrochloride on facilitative cannulation and its adverse effects were also compared to hyoscine-n-butylbromide.

Eligibility criteria:
inclusion criteria: * all patients undergoing ercp above the age of 18 years exclusion criteria: * patient with billroth ii gastrectomy * known previous sphincterotomy * active acute pancreatitis before ercp * ongoing acute cholangitis before ercp * hypotension (systolic blood pressure \< 100 mmhg) * second-degree and third-degree atrioventricular block * heart failure * glaucoma * obstructive uropathy * impaired renal function (serum creatinine \> 133μmol/l) * pregnant or breastfeeding women

Keywords: ercp drotaverine hydrochloride hyoscine-n-butylbromide
safety and effectiveness of a new anti-hiv drug (ag1549) in combination with other anti-hiv drugs in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to see if two different doses of ag1549 plus other anti-hiv drugs are safe and effective in hiv-infected patients who are not taking anti-hiv drugs.

\[note: as of 2/28/2001, due to toxicity studies and concerns for safety, sites were notified that they need to discontinue patients from the capravirine/placebo arms and continue patients with their background therapies or switch patients to new therapies, as deemed appropriate by the investigators.\] patients are randomized to receive one of two doses of ag1549 plus viracept (nelfinavir) plus combivir (zidovudine/lamivudine). patients remain on their assigned therapy for 48 weeks, with a follow-up visit at 28 to 35 days after the last dose of study medication. blood samples are taken regularly to quantify hiv-1 rna, cd4 and cd8 counts, peripheral blood mononuclear cells (pbmc), ag1549, viracept, and m8 plasma concentrations. physical exams, safety assessments, and other tests are also done throughout the study. on day 8 and at the end of week 48, pharmacokinetic samples are collected at 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, and 12.0 hours postdose. at the end of weeks 4, 8, 16, 24, and 36, pharmacokinetic samples are taken prior to dosing and between 2 to 4 hours post-dose.

Eligibility criteria:
inclusion criteria patients may be eligible if they: * are hiv-positive. * are at least 18 years old. * have a cd4 cell count of more than 50 cells/mm3. * have an hiv level of more than 5000 copies/ml. exclusion criteria patients will not be eligible if they: * have ever taken any of the following anti-hiv drugs: nonnucleoside reverse transcriptase inhibitors (nnrtis), ag1549, viracept, zidovudine, lamivudine, or combivir. other anti-hiv drugs are allowed only if taken for no more than 30 days with the last dose taken more than 6 months prior to study entry. * have taken an experimental drug within 28 days of study entry.

Keywords: drug therapy, combination zidovudine hiv protease inhibitors lamivudine reverse transcriptase inhibitors anti-hiv agents nelfinavir combivir
study comparing moxidectin and ivermectin in subjects with onchocerca volvulus infection

Conditions: Onchocerciasis

Summary: this is a phase 3 study comparing the efficacy, safety and tolerability of moxidectin and ivermectin in subjects infected with onchocerca volvulus, which is the parasite that causes river blindness. subjects participating in the study will be randomly assigned (by a 2 to1 ratio) to receive one orally-administered dose of either moxidectin or ivermectin.


Eligibility criteria:
inclusion criteria: * male and female subjects with onchocerca volvulus infection exclusion criteria: * pregnant or breast feeding women; coincidental loiasis

Keywords: onchocerciasis river blindness onchocerca volvulus moxidectin ivermectin
preoperative subclinical dvt screening in locally advanced bladder cancer patients candidate for radical cystectomy.

Conditions: Bladder Cancer Patients Candidate for Radical Cystectomy

Summary: preoperative subclinical dvt screening in locally advanced bladder cancer patients candidate for radical cystectomy.

60 patient with local advanced bladder cancer are subjected to preoperative lower limb duplex within 1 week preoperative to radical cystectomy

Eligibility criteria:
inclusion criteria: * any age * any sex * muscle invasive bladder cancer local advanced patients candidate for radical cystectomy exclusion criteria: * unfit patients * any contraindication for surgery * obese * coagulopathy * bedridden
nitrate-based nutritional formula for oxygen saturation and patient-reported outcomes in covid-19

Conditions: COVID-19

Summary: a preliminary open-label case report demonstrated the beneficial effects of an innovative nitrate-based nutritional formula on oxygen saturation in patients with covid-19. whether these initial findings are relevant in a more robust research design currently remains unknown. therefore, the main objective of this randomized controlled trial was to analyze the acute effects of nitrate-based nutritional formula on peripheral spo2, patient-reported outcomes, and safety indices in patients with acute covid-19 infection.


Eligibility criteria:
inclusion criteria: * age 3 18 years * confirmed sars-cov-2 infection * spo2 \< 95% * covid-19 patients in stable condition (i.e., not requiring hospital admission) exclusion criteria: * regnant or lactating women * concomitant pulmonary and cardiovascular conditions * history of dietary supplement use during the past four weeks * participation in another covid-19-related study * unwillingness to give informed consent
epigenetics and periodontal treatment

Conditions: Periodontitis

Summary: objective: the aim of this pilot study is to evaluate the alterations of epigenetic patterns in periodontally diseased individuals, before and after periodontal treatment, also in comparison to periodontally healthy patients. materials \& methods: twenty patients were voluntarily enrolled in two groups: 10 participants with healthy periodontium, and 10 participants with chronic periodontitis. clinical parameters were recorded and gingival biopsies were collected within the following timelines: at baseline (for both groups), after 15 days (for the diseased group only) and after two months (for the diseased group only).

study design baseline: before harvesting gingival biopsies, bleeding on probing (bop), periodontal pocket depth (ppd) and clinical attachment level (cal) were registered at the biopsy site, for all study participants. following the registration of the clinical parameters, gingival biopsies were obtained from the periodontally-healthy individuals during crown lengthening surgery or surgical removal of wisdom teeth. in the periodontally-diseased group, biopsies were harvested from two sites: healthy site and periodontally-involved site. after harvesting of biopsies, patients with periodontal disease underwent scaling and root planing. two weeks after periodontal treatment: clinical parameters were registered and gingival biopsies were harvested (from two sites) for the periodontally-diseased group only, to evaluate if the epigenetic patterns (dna methylation) were altered by conventional periodontal therapy, in comparison to the patterns observed at baseline for both diseased and healthy groups. two months after initial periodontal treatment: clinical parameters were registered and gingival biopsies were harvested (from two sites) for the periodontally-diseased group only, to evaluate if the epigenetic patterns were still altered by conventional periodontal therapy, in comparison to the patterns observed at baseline for both diseased and healthy groups, and at 15 days for the diseased group.

Eligibility criteria:
inclusion criteria: * all participants should be systemically healthy * all patients should be non-smokers * study participants should not be on antibiotics or non-steroidal anti-inflammatory drugs (nsaids) within one month before enrolment in the study * all participants should be of a caucasian ethnicity exclusion criteria: * patients with systemic diseases * smoking patients * patients taking antibiotics or nsaids
effect of gait training with a walking assist robot on gait function and balance in elderly adults

Conditions: Gait, Unsteady; Healthy

Summary: the purpose of this study was to investigate the effects of gait training with the new wearable hip assist robot developed by samsung advance institute of technology (samsung electronics co, ltd, korea) in elderly adults.

eight elderly adults will participate in this study. all subjects will receive training 3 times per week for 8 weeks for 24 training sessions. each session is directed by a licensed physical therapist and lasted 60 min (including rest period of 10 min). brain activity and gait assessment will be performed at visits 0 (baseline), 24 (post-test), and at 3 months (follow-up) after training. primary objective is to demonstrate the effects of hip assist robot on spatio-temporal parameters measured by motion capture system (motion analysis corporation, santa rosa, ca, usa), muscle activation patterns measured by surface electromyography (semg) (noraxon inc., scottsdale, az, usa), metabolic energy cost parameters measured by portable cardiopulmonary metabolic system (cosmed k4b2, rome, italy) and cortical activation measured by functional near-infrared-spectroscopy (fnirs) (nirscout, nirx, germany). secondary objective is to demonstrate the effects of hip assist robot on motor function improvement evaluated by short physical performance battery protocol and score sheet (sppb), berg balance scale (bbs), dynamic gait index (dgi), timed up and go (tug) test, push and release (p\&r) test, functional reach test (frt), korean version fall efficacy scale (k-fes), manual muscle test (mmt) and range of motion (rom).

Eligibility criteria:
inclusion criteria: 1. age: between 65 and 84 years elderly adults who had no neurological or musculoskeletal abnormalities affecting gait 2. ability to walk at least 10m regardless of assist devices 3. high levels of physical performance (sppb \> 7) 4. subject is willing to be randomized to the control group or the treatment group exclusion criteria: 1. history of any diseases (eg. lower extremity orthopedic diseases, neurologic disorders, cardiovascular disease, heart failure, uncontrolled hypertension that affect walking capacity, efficiency, and endurance) 2. severe visual impairment or dizziness that increases the risk of falls

Keywords: exoskeleton device elderly gait rehabilitation
development for the peritoneal carcinomatosis index (pci) in ovarian cancer

Conditions: Ovarian Cancer

Summary: * primary objectives: to develop peritoneal carcinomatosis index (pci) for ovarian cancer, tubal cancer and primary peritoneal cancer that can represent perioperative intraperitoneal tumor burden objectively * secondary objectives: to establish the relationship and find out clinical significance between pci, tumor location and tumor characteristics

patients with primary ovarian cancer * informed consent * digital photography \& checking pci (tumor size, number, and characteristics) * postoperative surveillance(tumor marker, image and physical examination) 1. developing the best fitting pci model to reflect recurrence-free survival and overall survival * selection of items * weighting by items and tumor characteristics 2. analysis of prognostic impact of pci compared to conventional staging system (figo stage) for ovarian cancer

Eligibility criteria:
inclusion criteria: 1. preoperative clinical diagnosis of ovarian cancer, tubal cancer, and primary peritoneal carcinoma (all stage) 2. available preoperative image study (ct and/or mri and/or pet) 3. patients who gave a written informed consent 4. patients must be surgical candidate considering medical and psychological condition exclusion criteria: * patients who refuse to participate or want to withdraw at anytime.

Keywords: pci ovarian cancer
comparison between intralesional injection of plasma rich platelets and candida antigen in plane warts

Conditions: Plane Wart

Summary: to compare the efficacy of intralesional injection of autologous plasma rich platelets and candida antigen in treatment of patients with plane warts .

cutaneous warts are benign tumors caused by infection of keratinocytes by different serotypes of human papillomavirus(hpv). its incidence increases during the school years to reach a peak in adolescence and early adulthood, then declines rapidly through the twenties and more gradually thereafter. plane warts are mainly caused by hpv serotypes 3, 10, 28, and 41, presenting mainly in children and young adults. they present as skin colored or may be hyperpigmented smooth-surfaced, slightly elevated or flat-topped papules. they are polygonal or round in shape and range in sizes from 1 to 5 mm. the main sites of predilection for the plane warts are the face, dorsal aspects of the hands and forearms, often in a linear array. platelet rich plasma (prp) is an autologous blood-derived product enriched in platelets. platelets, also called thrombocytes, are blood cells that cause blood clots and other necessary growth healing functions. prp represents a new bio technology that is part of the growing interest in tissue engineering and cellular therapy today. while it is of autologous origin, it reduces the possibility of adverse effects and transfusion-transmitted infections, so it is well-tolerated therapy for the patients. prp has been used in the treatment of many cutaneous diseases such as alopecia and acne vulgaris. its utility has been extended to other cutaneous diseases as melasma, hyperpigmentation, and burns, wherever it elicits tissue repair and regeneration. intralesional immunotherapy depends on the ability of the immune system to recognize certain viral, bacterial, and fungal antigens, such as candida or trichophyton antigens that induce a delayed-type hypersensitivity reaction, not only to the antigen but also against the wart virus, which in turn increases the ability of the immune system to recognize and eradicate hpv. this stimulated immune response could then subsequently destroy all the injected and noninjected lesions on the body, rather than the locally treated lesion. intralesional antigen immunotherapy has recently received increased attention and is considered by many authors a promising modality for the treatment of different types of warts, including the recurrent and recalcitrant variants.

Eligibility criteria:
inclusion criteria: * patients proved as having clinically evident plane warts. * patients with both sexes with no age limits. exclusion criteria: * patient receiving immune suppressive drugs. * patients with major comorbidities or concomitant malignancies. * patients with any evidence of immunosuppression including hiv infection. * patients with any eczematous skin disorder * those with any history of hypersensitivity to candida albicans antigen. * patients with chronic systemic medical diseases and bleeding disorders .
predictors of failure of non-invasive ventilation and high flow nasal cannula

Conditions: Acute Respiratory Failure Patients on NIV and HFNC

Summary: comparison between some predictors of failure of non-invasive ventilation and high flow nasal cannula.

delayed intubation after niv / hfnc failure is associated with high mortality rate in acute respiratory failure patients. there are many factors to predict early failure but world still searching for new factors and comparing between each ;in order to eatablish best one that achieve the least mortality rate. little studies about effiecacy of hacor score as a predictor of failure in hfnc patients. little studies about effiecacy of rox index as a predictor of failure in niv ventilating patients.

Eligibility criteria:
inclusion criteria: acute respiratory failure patients who need ventilatory support either niv or hfnc due to : 1. rr \> 25 cycle / min 2. using accessory muscles and paradoxical breath. 3. pao2 / fio2 ratio \< 300 exclusion criteria: 1. absolute indication for intubation like coma, haemodynamically unstable... etc 2. contr-indication of niv like untreated pneumothorax.
value of cardiac magnetic resonance (cmr) derived parameters for diagnosing left ventricular non-compaction cardiomyopathy

Conditions: Left Ventricular Non-compaction Cardiomyopathy; Left Ventricular Failure; Left Ventricular Hypertrophy

Summary: left ventricular non-compaction (lvnc) is a rare cardiomyopathy characterized by numerous excessively prominent left ventricular (lv) trabeculation and deep intertrabecular recesses communicating with the ventricular cavity and severely altering myocardial structure. although most authors assume a developmental arrest in embryogenesis as the underlying pathology, the mechanisms of lvnc are not fully understood yet. several gene mutations have been identified to be linked with lvnc and an autosomal dominant inheritance pattern is frequent to date the most commonly used imaging tool for diagnosing lvnc is echocardiography applying the criteria established by jenni and coauthors however, qualitative parameters to differentiate normal compaction of the myocardium in healthy subjects from lvnc or from other cardiomyopathies like dilative cardiomyopathy (dcm) or hypertrophic cardiomyopathy (hcm) may fail due to highly variable lv trabeculation. therefore, absolute quantification should be performed. cardiac magnetic resonance (cmr) has been reported as a promising imaging modality to characterize patients with lvnc as it provides both a high spatial resolution and a good contrast between trabeculation and blood pool jacquier et al. recently described a value of trabeculated lv myocardial mass above 20% of the global mass of the lv to be highly sensitive and specific for lvnc however, in their approach, a substantial degree of the lv cavity was included into calculated trabecular lv mass and led to systemic overestimation of the latter. furthermore, the role and prognostic value of myocardial scarring as assessed by delayed enhancement (de) cmr was not evaluated. the aim of the retrospective study was to establish revised and extended cmr criteria to distinguish lvnc from dcm, hcm and a group of healthy controls and to improve the assessment of trabeculated mass by excluding intertrabecular blood pool.


Eligibility criteria:
inclusion criteria: * left ventricular non-compaction cardiomyopathy * dilatative cardiomyopathy * hypertrophic cardiomyopathy or healty controls exclusion criteria: * contraindications for magnetic resonance imaging like pacemakers or other metallic implants
protocol for the evaluation of dario™ bgms performance at elevated altitude

Conditions: Diabetes

Summary: the purpose of this study is to assess the performance of the dario blood glucose monitor (bgms), at elevated altitudes, by obtaining whole blood fingerstick samples from individuals and analyzing the blood on the dario blood glucose monitor (bgms) and comparing the readings to readings obtained from the ysi 2300 stat plus glucose analyzer.

the study will be performed with 50 fresh capillary blood samples, collected by fingerstick using dario single use lancet. additional fingerstick with dedicated disposable lancets will be used to collect sufficient capillary fresh blood to be analyzed by the ysi 2300 stat plus analyzer. additional fingersticks may be necessary if volume of blood from first fingerstick is insufficient.

Eligibility criteria:
inclusion criteria: * age of subject is 18 years or older * able to speak and read english exclusion criteria: * pregnant * has any condition that the principal investigator believes may interfere in the subject's participation in the trial.