Kornimate/medical-research-clean huggingface dataset:
estrogen therapy as prevention in the progression of aneurysm (eppa) trial

Conditions: Cerebral Aneurysm; Menopause; Treatment

Summary: this study aims to determine if hormone replacement therapy, given during perimenopause may prevent the progression of saccular cerebral aneurysms.

this is a prospective, randomized, placebo-control trial to test the effect of estradiol in the prevention of progression of cerebral aneurysms. to evaluate the effect, each subject will be treated with either oral estradiol or placebo for 6 months. subjects will be randomly assigned to 1 of 2 groups as follows: double blind treatment group open-label regimen a1 1 mg estradiol daily for 180 days b1 placebo for 180 days each group will be given oral progesterone (3300 mg) for 10 days at the end of 90 days regardless of menstrual pattern. subjects will be asked to keep a menstrual calendar throughout the trial. serum markers will be drawn at baseline and every 90 days with the results blinded until the end of the trial. magnetic resonance angiography (mra) studies of the brain will be performed at month 6.

Eligibility criteria:
inclusion criteria: * generally healthy women, 40-52 years of age. * at least one documented saccular intracranial cerebral aneurysm detected via catheter angiography, magnetic resonance angiography or computed tomography angiography. * clinical diagnosis of perimenopause, defined as regular or irregular menses with or without vasomotor symptoms. exclusion criteria: * known or suspected estrogen-dependent neoplasia. * endometrial proliferation, hyperplasia, or malignancy at screening. * known hypersensitivity to estrogens, progestins. * history of myocardial infarction, ischemic heart disease, lipid disorder, or congestive heart failure. * known or suspected pregnancy, or recent breast feeding (within 6 months).

Keywords: intracranial aneurysm estradiol
tenecteplase thrombolytic therapy for acute ischemic stroke in china

Conditions: Ischemic Stroke

Summary: the objective of the study is to investigate the effectiveness and safety of rhtnk-tpa in acute ischemic stroke patients within 4.5 hours of symptom onset in a real-world clinical setting.

recombinant human tenecteplase tissue-type plasminogen activator (rhtnk-tpa) has the logistic advantage of a single bolus infusion over recombinant tissue plasminogen activator (rt-pa) which needs a 1-hour infusion. the non-inferiority of rhtnk-tpa compared to rt-pa was proved by two recent randomized controlled clinical trials but the evidence is lacking regarding the real-world effectiveness and safety of rhtnk-tpa. this is a multi-center, observational, retrospective study that enrolled acute ischemic stroke patients treated with rhtnk-tpa thrombolysis in china.

Eligibility criteria:
inclusion criteria: * all acute ischaemic stroke patients who met eligibility for thrombolysis with intravenous alteplase or tnk and presenting within 4·5 hours of symptom onset. exclusion criteria: * variables with a missing rate \> 40%

Keywords: intravenous thrombolysis tenecteplase
sacrocolpopexy with posterior repair obstructed defecation symptoms

Conditions: Vaginal Prolapse

Summary: participants who undergo laparoscopic sacrocolpopexy (lscp) plus posterior repair (pr) will demonstrate greater improvement bowel symptom scores compared to participants who undergo lscp alone at 3 months postoperatively.

those who provide informed consent will be randomized into either laparoscopic sacrocolpopexy (lscp) alone or laparoscopic sacrocolpopexy (lscp) plus posterior repair (pr). participants will be randomized with equal probability to the lscp only arm or lscp plus pr arm. the surgical technique for lscp will be similar to that described by paraiso et al. for lscp \[14\] and by elliott et al. for robot-assisted lscp \[15\], with minor variations. a y-shaped polypropylene mesh graft, 10 cm in standard length and tailored to each patient's anatomic specifications during surgery, will be used with all scp procedures. pr is performed by midline fascial plication. plication of superficial perineal muscles (perineorrhaphy) is performed in conjunction with pr. all repairs are performed using polydioxanone 2/0 for fascial repair and 4/0 polyglactin suture for skin closure. participants will also complete questionnaires and undergo an endovaginal ultrasound (using a 9-16 mhz, 360° rotational transducer, type 8838, bk medical, peabody, ma) prior to surgery and three months following surgery.

Eligibility criteria:
inclusion criteria: * female gender * able to complete english language questionnaires * able to complete study visits for 6 months * bowel symptom score (pfdi-o) score ≥ 3 * posterior vaginal bulge ≤2cm beyond the hymen exclusion criteria: * age \< 21 * pregnancy * history of colorectal surgery * history of pelvic radiation * inflammatory bowel disease * history of prior scp

Keywords: vaginal, prolapse, laparoscopic, sacrocolpopexy
comparison between percutaneous femoral nerve neuromodulation associated with femoral nerve block and standard clinical practice in patients undergoing knee arthroplasty.

Conditions: Acute Pain

Summary: the goal of this clinical trial is to compare the maximum isometric contraction force differential of the quadriceps in the postoperative period after the use of a peripheral nerve neuromodulation program in patients undergoing knee arthroplasty. the main questions it aims to answer are if the combination of a peripheral neuromodulation program in the perioperative period improves analgesic quality and short-term functional recovery in patients undergoing knee arthroplasty, participants will be asked to reach a maximum knee extension prior to neurostimulation patients will have the electrodes inserted under direct ultrasound vision and placed near the femoral nerve. researchers will compare whether there is a difference in both quadriceps contraction force and analgesia between the stimulated group and the control group.


Eligibility criteria:
inclusion criteria: * over 18 years * those who sign the informed consent * not pregnant * cognitive capacity that allows subjective postoperative evaluations. exclusion criteria: * under 18 years old * ic rejection or withdrawal * pregnancy * cognitive impairment * contraindication for regional anesthesia

Keywords: pens neuromodulation percutaneous peripheral nere stimulation postoperative pain acute pain after surgery total knee arthtolasty
programmes de marche active et qualité de vie dans la maladie de parkinson

Conditions: Parkinson Disease

Summary: the aim of this randomized controlled pilot trial is to assess the impact of different gait rehabilitation programs on the level of physical activity and gait in daily life in patients with parkinson's disease (pd). two groups of 25 patients with pd will benefit from one of two gait training programs (treadmill vs. nordic walking), 3 times a week for 12 weeks. activity level and number of steps will be remotely recorded over 7 days before, at the end, 3 and 6 months after the end of the program. quality of life will be recorded at each time point. the impact of the gait programs on the patients' level of daily activity will be examined, comparing the changes brought about by the two programs, taking into account the modulating influence of age and cognitive function. gait under conditions of daily life will be compared to gait parameters collected in the laboratory.


Eligibility criteria:
inclusion criteria: * parkinson's disease, diagnosed for at least 2 years, * medical treatment (if any) unchanged in the past 4 weeks at least * hoehn \& yahr score \< 3 * montreal cognitive assessment (moca) score between 20 and 30 * able to understand the aim and methods of the study and provide signed informed consent- exclusion criteria: * atypical parkinsonian syndrome * cardiovascular pathology preventing moderate physical exercise * orthostatic hypotension * any condition (other than pd) interfering with gait * pregnant or nursing

Keywords: adapted physical activity gait quality of life actimetry parkinson's disease
prospective study to evaluate outcomes from transoral bot resection for osahs

Conditions: Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)

Summary: this is a prospective observational study that will collect outcome data for patients who choose to undergo transoral tongue base operations for obstructive sleep apnea hypopnea syndrome (osahs)as part of their standard of care treatment. this is a data collection study only and does not provide for evaluations or treatment of osahs.

obstructive sleep apnea hypopnea syndrome (osahs) is a major public health problem, and studies suggest that the incidence of osahs may be even higher than estimated. transoral base of tongue resections are commonly preformed to improve symptoms in osahs, but among surgeons there is not yet consensus as to the best tongue base operation. the difficulty in treating the tongue base is illustrated by the abundance of available procedures - including genioglossus advancement, hyoid advancement, tongue base suspension, radiofrequency treatment, transoral midline glossesctomy, submucosal coblation-assisted tongue base resection and recently; transoral robotic-assisted surgery (tors) for base of tongue (bot) resection. we will evaluate tors bot resection for use in osahs by assessing pre- and post-operative osahs scores and comparing them to historical data for alternative bot operations. though routine, bot resection may result in significant post-operative pain leading to dysphagia. in certain patients, major complications such as aspiration pneumonia, malnutrition and dehydration can occur as a result. thus, reducing post-operative dysphagia is critical to improving patient outcomes and limiting complication-associated hospital admissions. several studies have addressed the management of post-operative dysphagia, but none have evaluated tors bot resections in osahs. additionally, tors bot resections for malignant neoplasms have been previously shownto be safe and feasible. an outcome analysis of tors bot resections for osahs may therefore yield recommendations for reducing patient morbidity and mortality.

Eligibility criteria:
inclusion criteria: 1. any patient with documented osahs who is scheduled for tongue base resection at uab 2. age \> 18 3. patients must sign informed consent exclusion criteria: 1. psychological condition that renders the patient unable to understand the informed consent 2. any situation or condition that will interfere with adherence to study activities
class ii restorations with high-filled flowable composites

Conditions: Dental Caries; Class II Dental Caries

Summary: in the study, class ii restorations will be performed with g-aenial universal injectable (gc/ tokyo, japan), grandio flow (voco/ germany), and clearfil majesty flow (kuraray/ japan) composites will evaluated. restorations will be assessed according to modified usphs criteria in 1st week, 6th months, and 12th months from the placement date. the chi-square test will used for statistical analysis of the difference between the groups, and the cochran q test will used for the significance of the difference between time-dependent changes within each group (p\<0.05).


Eligibility criteria:
inclusion criteria: a patient presenting with; 1. over 18 years of age 2. a normal periodontal status and good general health 3. proximal caries that are similar in size to premolar and molar teeth 4. vital teeth 5. teeth in contact with the opposing tooth and subjected to normal occlusal forces 6. attend follow-up appointments exclusion criteria: 1. poor oral hygiene status 2. those with severe or chronic periodontitis 3. absence of adjacent and antagonist teeth 4. potential behavioral problems (e.g. bruxism) 5. allergy to any product used in the study 6. exposure of the pulp during cavity preparation 7. systemically unhealthy 8. pregnant and lactating women
clinical and pathophysiological description of ocular ischemic syndrome

Conditions: Retinal Degeneration; Diabetic Retinopathy

Summary: the purpose of this study is to characterize the disease ocular ischemic syndrome.

the disease ocular ischemic syndrome (ois) is not a well described entity. it occurs after a long-standing period of extremely low blood supply to the retina caused by atherosclerosis of the carotid arteries. in this study we will analyze why ois is developed in some patients and not developed in others. the patients with ois will be thorough examined and will be compared with 1) a control group of healthy people and 2) with control group of patients with diabetic retinopathy. furthermore the impact of vascular surgery on ois will be analyzed.

Eligibility criteria:
inclusion criteria: * ocular ischemic syndrome exclusion criteria: * any other active ocular disease

Keywords: ocular ischemic syndrome
clinical outcomes in elderly patients with preoperative cognitive dysfunction

Conditions: Cognitive Decline; Age Problem; Outcome

Summary: preexisting cognitive impairment, such as mild cognitive impairment, is common in many elderly patients who undergoing major surgeries. accumulating evidence has demonstrated that preexisting cognitive impairment is associated with increased mortality, increased incidence of postoperative complications, decreased quality of life, and worse outcomes. however, few studies have evaluated the relationship between preexisting cognitive impairment and cognitive trajectories and clinical outcomes.

preexisting cognitive impairment is common in many elderly patients who undergoing major surgeries. the number of surgical procedures in the elderly will increase dramatically as a result of the increased elderly population in the future. it has been suggested that preexisting cognitive impairment is associated with increased incidence of postoperative complications, decreased quality of life, and increased mortality. preoperative risk assessment is becoming increasingly important because preoperative risk stratification allows the clinical team to forecast postoperative outcomes. currently, the most common strategy to identify high-risk patients before surgery is assessment of single end-organ function. this tactic is most widely recognized by the american heart association's guideline for cardiac evaluation, but is also well described for pulmonary, hepatic, and renal organ systems. little is known about the effects of pre-existing cognitive (or brain) function (perhaps the most vital human organ) on postoperative outcomes. therefore, the present study evaluated whether patients with pre-operative cognitive impairment would have a more precipitous drop in cognitive function and worse outcome in geriatric surgical patients.

Eligibility criteria:
inclusion criteria: - inclusion criteria were persons 65 years and older undergoing an elective operation on the general, noncardiac thoracic, urologic, and vascular surgical services. exclusion criteria: - patients with vision or hearing impairment who could not visualize pictures or hear instructions associated with the delirium assessments and patients who could not provide informed consent.

Keywords: preexisting cognitive impairment elderly outcomes
dose and duration of metronidazole and amoxicillin for treatment of chronic periodontitis

Conditions: Chronic Periodontitis

Summary: the aim of this study was to compare the clinical and microbiological outcomes of different dosages of metronidazole (mtz) and of the duration of the systemic administration of mtz and amoxicillin as adjunct to scaling and root planing (srp) in the treatment of generalized chronic periodontitis (gchp).

randomized clinical trials and systematic reviews have shown that the use of the combination of metronidazole (mtz) and amoxicillin (amx) significantly improves the benefits of the srp in the treatment of subjects with periodontitis. however, the optimal dosage and interval of administration of these antibiotics are still unclear. therefore, the aim of this study was to compare the clinical and microbiological outcomes of different dosages and duration of the systemic administration of the combination of mtz and amx as adjunct to scaling and root planing (srp) in the treatment of generalized chronic periodontitis (gchp). one hundred ten subjects will be randomly assigned to receive srp plus placebo, or srp combined with 250 mg or 400 mg of mtz, plus amx (500 mg) tid, for either 7 or 14 days. subjects will be clinically and microbiologically monitored up to 1 year post-therapy.

Eligibility criteria:
inclusion criteria: * ≥30 years of age; * at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction) * a minimum of 6 teeth with at least one site each with probing depth (pd) and clinical \* attachment level (cal) ≥5 mm; * at least 30% of the sites with pd and cal ≥4 mm and bleeding on probing (bop). exclusion criteria: * pregnancy * breastfeeding * current smoking and former smoking within the past 5 years; * systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis); * scaling and root planing an in the previous 12 months; * antibiotic therapy in the previous 6 months; * long-term intake of anti-inflammatory medications; * need for antibiotic pre-medication for routine dental therapy; * allergy to metronidazole and/or amoxicillin.

Keywords: periodontal diseases metronidazole amoxicillin chronic periodontitis root planing
a clinical study to evaluate the pharmacokinetics (pk) of corplex™ donepezil transdermal delivery system (tds) applied to different body locations

Conditions: Alzheimer's Disease

Summary: a phase 1, crossover study to evaluate the pharmacokinetics of corplex™ donepezil 10 mg transdermal delivery system applied to different body locations

randomized, open-label, 3-way crossover study up to 66 healthy, adult male and female subjects will be enrolled. all subjects will receive corplex donepezil tds patches applied to 3 different locations on each subject (back, buttock, and leg) during 3 different, consecutive treatment periods. for each subject, the location of product administration during each treatment period will be randomized. during each treatment period, all subjects will receive a once-weekly 10 mg tds, target dose 10 mg donepezil/day, applied for 7 days (1 week) on either the back, buttock, or leg in accordance with the randomized treatment location for that treatment period. blood samples for donepezil pk will be collected pre-dose until the end of each treatment period. the pk sample collection time points are as follows: week 1: pre-tds application prior to 0 hour and post-tds application at 2, 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 hours. week 2: pre-week 1 tds removal at 168 hours, and post-tds removal at up to 528 hours adhesion and skin irritation will be monitored throughout tds treatments. safety will be monitored throughout the study by adverse event reporting, repeated clinical and laboratory evaluations.

Eligibility criteria:
inclusion criteria: * healthy, adult, male or female * body mass index ≥ 18.0 and ≤ 32.0 kg/m2 at screening * medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ecgs), as deemed by the investigator * have a fitzpatrick skin type of i, ii or iii or have skin colorimeter scores equivalent to the allowed fitzpatrick skin type key exclusion criteria: * history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (including piperidine derivatives and other cholinesterase inhibitors) * has intolerance to venipuncture and/or inability to comply with the extensive blood sampling required for this study or does not have suitable veins in both arms * potential for occupational exposure to anticholinesterase agents * estimated creatinine clearance in non-elderly subjects \<80 ml/min at screening and in elderly subjects (i.e., ≥55 years of age) \<60 ml/min at screening * hemoglobin value of less than 11.5 g/dl for females, 13.0 g/dl for males at screening and first check-in * muscle relaxants, anti-parkinsonian or neuroleptic medications prior to the first dose of study drug * history or presence of significant skin damage or other skin disturbances as deemed by the investigator to potentially interfere with patch procedures * use of donepezil hydrochloride or related drugs within 60 days prior to the first study drug administration * clinically significant depression symptoms or suicidal ideation or behavior as determined by the investigator
study of orphenadrine' in the treatment of muscle cramps in patients with cirrhosis

Conditions: Liver Cirrhosis; Muscle Cramps

Summary: muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. patients with cirrhosis often experience muscle cramps with varied frequency and severity. the exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes (1) orphenadrine is an anticholinergic drug with prominent central nervous system (cns) and peripheral actions used to treat painful muscle spasms and other similar conditions. the combination of anticholinergic effects and cns penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. \[3,4\]

muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. patients with cirrhosis often experience muscle cramps with varied frequency and severity. the exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes \[1\]. although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. several agents as vitamin e, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking \[2\]. orphenadrine is an anticholinergic drug with prominent central nervous system (cns) and peripheral actions used to treat painful muscle spasms and other similar conditions. the combination of anticholinergic effects and cns penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. \[3,4\] orphenadrine is structurally related to diphenhydramine and carries relatively stronger anticholinergic and weaker sedative properties, it is mostly excreted through the kidneys.\[5\]

Eligibility criteria:
inclusion criteria: * cirrhosis * muscle cramps( ≥3 cramps per week ) exclusion criteria: * • allergy to orphenadrine * renal impairment * pregnant and lactating women * peripheral vascular disease * peripheral neuropathy * medications as calcium channel blockers, conjugated estrogens and naproxen. glaucoma prostatic enlargement