Kornimate/medical-research-clean huggingface dataset:
comparison of two different intraocular lenses implanted with yamane technique

Conditions: Secondary Cataract Surgery; Aphakia; Complicated Cataract Surgery

Summary: in case of instability or rupture of capsular bag occurs during cataract surgery, yamane technique is one of the options to fix intracocularlens' haptics. yamane technique uses a double-needle technique that seamlessly fixes the haptics intrascleral by creating a scleral tunnel. aberrations, iol tilting or even dislocations might occur and influence the final outcome of iol implantation. the aim of this study is the evaluation of the postoperative tilt of kowa pu6as using yamane technique. furthermore of the corrected and uncorrected visual acuity and the anterior chamber depth are being developed.

during uncomplicated cataract surgery, an intraocular lens (iol) is implanted into the patient's capsular bag. if increased instability or rupture of this capsular bag occurs due to aggravated intraoperative conditions or iol dislocation, several options are available to the surgeon to correct the aphakia, all characterized by their respective advantages and disadvantages, but with no clear superiority of any one method. the popular yamane technique, or "flanged iol fixation", uses a double-needle technique that seamlessly fixes the haptics intrascleral by creating a scleral tunnel using two 30-gauge needles. examples of lenses used for this purpose are the tecnis za9003 (johnson\&johnson, usa) and the kowa pu6as (kowa, japan). another approach is the carlevale fil-ssf iol (soleko, italy), which was developed specifically for use in aphakia with lack of capsular stability. all types of implantation are not immune to aberrations, tilting or even dislocation. many factors influence the final outcome of iol implantation, be it the optimal choice of intraocular lens power, the surgeon's experience regarding fixation in more challenging eyes, or individual anatomical conditions. as part of quality assurance, an evaluation of monthly and six-monthly data will now be performed. the aim of this study is the evaluation of the postoperative tilt of the kowa pu6as in yamane technique, as well as the evaluation of the corrected and uncorrected visual acuity and the anterior chamber depth within the clinical quality management.

Eligibility criteria:
inclusion criteria: * minimum age: 21 years * planned or performed lens implantation using the kowa pu6as or the johnson \& johnson za9003 using the yamane technique * signed patient consent form exclusion criteria: * best corrected visual acuity \>0.1 (snellen) * pregnancy
study of ocular penetration of topically administered fluoroquinolones

Conditions: Cataract Extraction

Summary: this study is being conducted to evaluate the intraocular penetration of moxifloxacin 0.5% ophthalmic solution (vigamox) and besifloxacin 0.6% ophthalmic suspension (besivance) after pre-operative topical administration in subjects undergoing cataract surgery.


Eligibility criteria:
inclusion criteria: * subjects who have a visually significant cataract and are planning to have cataract surgery. * subjects who are willing/able and have signed informed consent approved by the institutional review board. exclusion criteria: * subjects who have a known hypersensitivity, allergy, or contraindication to any fluoroquinolone medication, in any form. * subjects who signs of ocular infection or active inflammation in the study eye. * subjects who have corneal pathology, including epithelial defect, corneal scarring, or severe dry eye syndrome. * subjects who have used any disallowed medication (including antibiotics) during the time period designated as described in the protocol. * subjects who have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and is likely to increase the risk of infection to the patient or confound the results of the study. * subjects who are pregnant (or suspect to be pregnant) or nursing/lactating. * subjects who have participated in any study of an investigational drug or device within 30 days prior to enrollment.
correlation study between heart rate variability and anxiety in anorexia nervosa

Conditions: Anorexia Nervosa

Summary: the heart rate variability (hrv) is a measure of the autonomic nervous system (ans). in the model of anorexia nervosa, ans is disturbed with mostly a predominance of activation of the parasympathetic nervous system and a decrease of the sympathetic system. various explanations of this these dysfunctions are proposed in literature, mainly malnutrition, physical hyperactivity, anxiety, that are known characteristics of anorexia nervosa. the primary aim of this study is to evaluate correlation between ans dysfunction and anxiety in anorexia nervosa. other objectives of this study are firstly to evaluate correlation between ans dysfunction and others parameters (weight, body mass index, depression, physical activity, purgative ou restrictive type, duration of disease, smoking) in anorexia nervosa and secondly to see if hrv is a predictive parameter of the evolution of anorexia nervosa.


Eligibility criteria:
inclusion criteria: * women * aged from 18 to 65 years * criteria of anorexia nervosa (dsm v) * body mass index (bmi) \< 18 kg/m2 * written consent to participate in the study * patient affiliated to a social security system exclusion criteria: * pacemaker or other implantable electronic device * current comorbidity psychiatric disorder according to axis i of dsm iv : severe depression (bdi \> 8/13), substance use disorder . * psychotropic drugs or ongoing steroid therapy ; * pregnancy or breast-feeding ; * history or known cardiovascular disorder, including hypertension ( \> 140/90 mmhg ) , heart failure, arrhythmia and conduction disorder . * major protected by a legal protection * minors * patient involved in another research with an exclusion period ongoing at the run-in

Keywords: heart rate variability anxiety autonomic dysfunction
impact of environmental factors and metabolomics on colorectal cancer.

Conditions: Colorectal Cancer; Metabolic Disease

Summary: colorectal cancer is one of the malignant tumours with high morbidity and mortality worldwide, posing a serious threat to human health. in recent years, the incidence of colorectal cancer has been on the rise with changes in lifestyle and dietary habits. although some progress has been made in treatments such as surgery, chemotherapy and radiotherapy, however, the early diagnosis, prognosis assessment and personalised treatment of colorectal cancer still face great challenges. therefore, it is of great academic value and practical significance to deeply explore the influencing factors of colorectal cancer occurrence, development and its prognosis, especially the research on environmental factors and metabolomics.

in this study, investigators collected clinical information, blood, urine and stool for ambient air pollution analysis, blood metabolomics analysis and stool macro-genetic sequencing by including patients from healthy control and colorectal cancer groups, respectively. environmental factors, metabolomics and intestinal microbiota data were integrated and analysed to screen for indicators that play a key role in colorectal cancer development and construct a colorectal cancer prediction model.

Eligibility criteria:
inclusion criteria: 1. healthy control group: * age ≥18 years old; * no history of malignant tumour; * willing to participate in this study and sign the informed consent form; * complete basic data. 2. gastric cancer group: * age ≥18 years old; * patients diagnosed with gastric cancer by pathological biopsy before operation; * no chemotherapy, radiotherapy, targeted and immunotherapy before enrolment; * willing to participate in this study and sign the informed consent; complete clinical data. exclusion criteria: * patients with primary malignant tumours other than gastric cancer; * patients with serious cardiopulmonary insufficiency and other systemic diseases that affect the choice of treatment plan; * patients who are not suitable for enrolment as assessed by the investigator.

Keywords: colorectal cancer air pollution metabolomics intestinal flora
establishment of precise histological evaluation criteria for nash fibrosis reversal

Conditions: Non-alcoholic Fatty Liver Disease

Summary: collect confirmed cases of nafld patients and enroll them in the study. select patients with nash and fibrosis stage f2-4 confirmed by liver biopsy, and collect clinical and pathological data for relevant evaluation and definition. establish a nash "fibrosis reversal" pathological evaluation system, based on a new reversal standard, establish non-invasive alternative indicators, and observe indicators.

confirmed nafld patients were enrolled, and those with nash and fibrosis f2-4 stages confirmed by liver biopsy were selected, and clinical and pathological data were collected for relevant evaluation and definition. a nash "fibrosis reversal" pathological evaluation system was established based on the new standard, and an alternative non-invasive indicator and observation index were established based on the reversal standard.

Eligibility criteria:
inclusion criteria: * aged between 18 and 70 years at the time of liver biopsy; * gender is not limited; * hepatic perforation suggested that nash complicated with fibrosis stage f2-4; * signed written informed consent. exclusion criteria: * combined hcv infection, hiv infection, alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease disease, drug-induced liver injury and other chronic liver diseases; * women during pregnancy; * there are the following conditions before liver perforation: hcc or possible hcc (imaging suggests malignant liver occupation); decompensation of cirrhosis (ascites, hepatic encephalopathy, gastrointestinal bleeding, hepatorenal syndrome, etc.); patients with other malignant tumors; recipients of liver transplantation; * patients considered by the investigator to be unsuitable for this study.

Keywords: non-alcoholic fatty liver disease nonalcoholic steatohepatitis liver biopsy fibrosis reversal histopathology
rehabilitation after total knee arthroplasty (tka) - pfc rotating versus fixed bearing

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine whether patient rehabilitation is equal for patients operated with two different knee implant designs. the patients are randomized to treatment with either a simple hinge design implant (fixed bearing) or an implant with a mobile bearing polyethylene. this design difference might in principle enable the patients in the latter group to rehabilitate towards a more normal gait pattern.


Eligibility criteria:
inclusion criteria: * patients at silkeborg regional hospital, orthopedic dept. referred to total knee arthroplasty. exclusion criteria: * neurologic disease with impact on gait. * orthopaedic disease ipsilateral hip joint. * patients outside the age limits. * no informed consent signed. * patients suffering from dementia. * patients primarily included, but who perioperatively has their posterior cruciate ligament injured or sacrificed. * patients who later develop deep venous thrombosis or infection in the operated knee.

Keywords: knee arthroplasty rsa dxa gait analysis motion analysis
antifungal potential of moringa olifera against otomycosis

Conditions: Otomycosis

Summary: patients with otomycosis were recognized by an ent specialist. 20 patients were distributed randomly into two groups. the first group will be treated with nystatin ear drops twice daily. the second group will be treated with moringa ear drops. patients will be examined endoscopically by the ent specialist. patient's swabs will be isolated and analyzed by elisa.

inclusion criteria: (1) otomycosis . exclusion criteria: 1. tympanic membrane perforation; 2. concurrent immune suppression, 3. and concurrent bacterial infection.

Eligibility criteria:
inclusion criteria: 1. otomycosis 2. ear inflammation exclusion criteria: 1. tympanic membrane perforation 2. concurrent immune suppression, 3. concurrent bacterial infection.
relationship between endoscopic ultrasound staging and degree of stricture in esophageal cancer

Conditions: Esophageal Cancer

Summary: the primary objective of this study is to document all cases of eus in patients with esophageal cancer and determine if the inability to advance the gastroscope beyond the tumor correlates with locally advanced disease stage at endoscopic ultrasound.

this will be an observational prospective study. the investigators will aim to enroll 100 male and female adult patients (aged 19 years and over) of all ethnicities/races, who have been referred to florida hospital for endoscopic ultrasound staging of esophageal cancer. all vulnerable populations will be excluded. the investigators will be using a standardized data collection form to record presenting symptoms, endoscopy findings, endoscopic ultrasound features and final esophageal cancer staging. this is an observational study in which standard of care is being practiced and also as the patients are not placed at additional risk from participating in this study. however, as the investigators are collecting data prospectively, all participants will sign consent. an attempt will be made to see if there is a correlation between stricture tightness encountered at endoscopy (egd) with advanced disease stage diagnosed at endoscopic ultrasound.

Eligibility criteria:
inclusion criteria: 1.all patients aged \> 18 yrs, who can provide informed consent and referred to florida hospitals endoscopy unit for eus staging of esophageal cancer. exclusion criteria: 1. age \< 18 yrs 2. inability to provide informed consent. 3. unable to safely undergo endoscopy for any reason 4. coagulopathy (prolongation of prothrombin time \> 18 secs, thrombocytopenia \< 80,000 platelets/ml) 5. limited mental capacity or language skills to the extent simple instructions cannot be followed or information regarding adverse events and follow-up phone visits cannot be provided 6. non-english speaking without a translator.
open-label extension study of pridopidine (acr16) in the symptomatic treatment of huntington disease

Conditions: Huntington Disease

Summary: huntington disease (hd) is a hereditary neurodegenerative disorder causing impairment in movement, behavioral dysfunction and dementia. the movement disorder is mainly characterized by chorea (involuntary movements) and a progressive loss of voluntary movement causing a substantial functional impairment over time. the study will assess the long-term safety of pridopidine and the treatment effects during long-term, open-label treatment.


Eligibility criteria:
inclusion criteria: * subject is able to, and has provided written informed consent prior to any study related procedure. * patient has completed the hart (acr16c009) or the pride-hd (tv7820- cns-20002) studies and had remained on imp during the full on-treatment part of the study (including de-escalated patients) or has transitioned from the open-hart pre-virtualization study period. * willing and able to take oral medication and able to comply with the study specific procedures. * patient has a wireless internet connection at home (and/or applicable locations) at the first remote visit. * patient has the ability to transition from in-person study visits to virtual study visits. the first remote visit (rv1) will take place within approximately 30 days after the last in-person visit. * additional criteria apply, please contact the investigator for more information exclusion criteria: * ongoing treatment with tetrabenazine or deutetrabenazine, seizure threshold lowering medications, or certain antipsychotics and antidepressants. * newly instigated or changed treatment with neuroleptics/antipsychotics * use of tricyclic antidepressants or class i \& iii antiarrhythmics at any time during the study period. * severe intercurrent illness that, in the opinion of the investigator (or qualified designee), may put the subject at risk when continuing participation in the study. * alcohol and/or drug abuse as defined by the diagnostic and statistical manual - fourth edition - text revision criteria for substance abuse - this includes the illicit use of cannabis. * subjects with a known history of epilepsy or a history of febrile seizure(s) or seizure(s) of unknown cause. * females who are pregnant or lactating. * females who are of child bearing potential and not taking adequate contraceptive precautions (either oral, barrier or chemical contraceptives) are excluded from the trial. females of child bearing potential taking acceptable contraceptive precautions can be included. * known allergy to any ingredients of the trial medication. * additional criteria apply, please contact the investigator for more information

Keywords: huntington disease.
pharmaco-epidemiological study describing a population of hypertensive patients treated with a fixed-dose combination of telmisartan and hydrochlorothiazide

Conditions: Hypertension

Summary: study to compare the level of blood pressure control in hypertensive, hypertensive diabetics and hypertensive with renal insufficiency (observed data) in the study population, with the objectives of the high authority for health recommendations (benchmark)


Eligibility criteria:
inclusion criteria: * hypertensive patients already treated for at least 1 month with telmisartan plus hydrochlorothiazide, consulting the physician consecutively for whatever reason exclusion criteria: * na
registrational study with omecamtiv mecarbil (amg 423) to treat chronic heart failure with reduced ejection fraction

Conditions: Heart Failure

Summary: the purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (hfref).

this study was conducted by amgen as the ind holder, with cytokinetics as a collaborator. due to the termination of the collaboration agreement between amgen and cytokinetics in may 2021 and subsequent transfer of the omecamtiv mecarbil ind from amgen to cytokinetics, cytokinetics is now listed as the sponsor.

Eligibility criteria:
key inclusion criteria: * subject has provided informed consent * male or female, ≥ 18 to ≤ 85 years * history of chronic heart failure (hf), defined as requiring treatment for hf for a minimum of 30 days before randomization * left ventricle ejection fraction (lvef) ≤ 35%, per subjects most recent medical record, within 12 months prior to screening. * new york heart association (nyha) class ii to iv at most recent screening assessment. * managed with hf standard of care (soc) therapies consistent with regional clinical practice guidelines according to investigator judgment of subject's clinical status * current hospitalization with primary reason of hf or one of the following events within 1 year of screening: hospitalization with primary reason of hf; urgent visit to emergency department (ed) with primary reason of hf. * elevated b-type natriuretic peptide (bnp) or n-terminal-prohormone brain natriuretic peptide (nt-probnp) other inclusion criteria may apply key exclusion criteria: * currently receiving treatment in another investigational device or drug study, or \< 30 days since ending treatment on another investigational device or drug study(ies). other investigational procedures while participating in this study are excluded. * malignancy within 5 years prior to randomization with the following exceptions: localized basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ. * subject has known sensitivity to any of the products or components to be administered during testing other exclusion criteria may apply
effect of nicotinic acid on adipose tissue inflammation in obese subjects

Conditions: Obesity

Summary: our working hypothesis postulates that lipolysis is a determinant of inflammation in adipose tissue (at). inhibition of lipolysis, e.g. using the oldest normolipidemic drug, nicotinic acid, has proved valuable to combat the metabolic syndrome. our proposal will determine whether part of the beneficial effects of this antilipolytic compound is due to a diminution of at inflammation. to this aim, the effect of nicotinic acid or placebo will be studied in male obese subjects with or without a training program which goal is to enhance lipolysis.

24 male obese insulin resistant subjects will receive nicotinic acid or placebo for 16 weeks. the last 8 weeks, the subjects will follow a training program calculated to optimize use of lipid. insulin sensitivity and glucose tolerance will be assessed using, respectively, fasting-based estimates of insulin sensitivity (plasma and muscle) and oral glucose tolerance test. plasma parameters of adipokines and, inflammatory and metabolic parameters will be determined. as an index of at inflammation, the percentage and the phenotype of macrophages will be determined using flow cytometry of cells of the stromavascular fraction of subcutaneous at. macrophage infiltration will be investigated by light microscopy. the characterization of the inflammatory profile of at will be completed by measurements of the expression of genes that are either specific markers of human at macrophages or inflammatory and anti-inflammatory adipokines. this combination of approaches has never been carried out during a pharmacological intervention in humans. the following points will be addressed: * determine the influence of lipolysis on at inflammation, specifically on macrophage activation and adipokine production. * examine the causal relationship between adipocyte fa metabolism, at inflammation and insulin sensitivity. * establish whether the beneficial effect of antilipolytic drugs may be attributable at least in part to a decrease in at inflammation.

Eligibility criteria:
inclusion criteria: * signature of informed consent form * age 25 to 45 year-old * male, insulin resistant obese subjects (30\<bmi\<40 kg/m2), * blood arterial pressure\<140/90 mmhg exclusion criteria: * history of cardiovascular disease * treatment with drugs which can interfere with cardiovascular system and autonomic nervous system (i.e. beta blockers). * treatment with nicotinic acid * treatment with fibrates, statins, cholestyramine and ezetimibe * treatment with thiazidics * fasted hyperglycaemia \> 1,26 g/l (diabetes) * triglycerides \>5 g/l * blood arterial pressure \> 140/90 mm hg

Keywords: nicotinic acid lipolysis training program adipose tissue inflammation obese