Kornimate/medical-research-clean huggingface dataset:
ezetimibe/simvastatin (mk-0653a) versus rosuvastatin versus doubling statin dose in participants with cardiovascular disease and diabetes mellitus (mk-0653a-133)(completed)

Conditions: Cardiovascular Disorder; Diabetes Mellitus

Summary: the purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg.


Eligibility criteria:
inclusion criteria: * patient has not taken common statins or ezetimibe within 6 weeks of study screening or patient is currently taking a daily dose of the following statins for 6 weeks prior to study screening: simvastatin, atorvastatin, pravastatin, fluvastatin, ezetimibe, lovastatin, or ezetimibe + fluvastatin * patient is willing to go on a cholesterol and glucose lowering diet for the duration of the study * patient is willing to remain abstinent or use birth control for the duration of the study * patient has diabetes mellitus with cardiovascular disease exclusion criteria: * patient has sensitivity to certain common statin drugs * patient is asian and would not be able to start taking the higher doses of rosuvastatin necessary for the study design * patient consumes more than 2 alcoholic drinks per day * patient is pregnant or breast-feeding * patient has been treated with other investigational drugs within 30 days of first visit * patient is currently on prohibited doses of the following statin drugs: rosuvastatin, simvastatin, atorvastatin, and pravastatin * patient has congestive heart failure * patient has uncontrolled high blood pressure * patient has kidney disease * patient has uncontrolled endocrine or metabolic disease which are known to possibly increase blood lipoproteins * patient has diabetes mellitus that is not well controlled * patient is human immunodeficiency virus (hiv) positive * patient is currently taking medications that inhibit cytochrome p450 3a4 (cyp3a4) * patient is currently taking therapies that would increase the risk of muscle weakness * patient has been taking certain over- the-counter lipid-lowering agents within 6 weeks prior to visit 1 * patient is currently taking psyllium or other fiber-based laxatives

Keywords: cardiovascular disorder
potential vertebroplasty use in the treatment of vertebral metastasis from breast and prostate cancer

Conditions: Breast Cancer; Prostate Cancer; Vertebral Metastasis; Pain

Summary: the study aims to evaluate if adding vertebroplasty to radiotherapy, in the treatment of spine metastasis from breast and prostate cancer, is preferable to radiotherapy alone. the investigators hypothesize that, by combining vertebral augmentation with cement and radiotherapy, they could achieve an enhancement in pain relief and level of activities, as well as a decrease in the side effects of multiple medications used for pain control.

included patients presenting with spinal metastasis secondary to breast or prostate cancer are randomized to two groups, intervention and control. both groups receive standard radiotherapy, which is currently the gold standard of care for such patients. the intervention group will also receive a vertebroplasty \[single or multiple level(s)\], while the control group will receive a simulated vertebroplasty, where local anesthesia and gentle hand manipulation will be used but the vertebra will not be accessed. the primary outcome is pain relief, though other factors such as quality of life and pain medications will also be evaluated. there will be an interim analysis after half of the patients have been treated with a follow-up of 3 months. in the analysis, comparisons will be made between the two groups and each patient's individual progress will also be analyzed.

Eligibility criteria:
inclusion criteria: * between 35 and 75 years old * biopsy-proven breast cancer (bc) or prostate cancer (pc) * radiographic evidence of spine metastases from the bc or pc in the lumbar and/or mid-low thoracic spine * microfractures or compression fractures up to 40% of the original height of the vertebral body in an mri \[magnetic resonance imaging\] (reported by an independent radiologist) * incidental back pain (verbal analog scale \> 5/10) felt to be related to those metastases exclusion criteria: * spinal cord compression * massive rupture of the posterior wall of the vertebral body (according to blinded radiological report) * coagulopathy (international normalized ratio \[inr\] \> 1.5, platelets \< 80,000) * inability to communicate in english, french or spanish * previous radiotherapy to the spine in the area presently affected * mental cognitive impairment * vertebral metastasis without fracture in the mri

Keywords: breast cancer prostate cancer vertebral metastasis vertebroplasty vertebral metastasis from breast cancer vertebral metastasis from prostate cancer
povidone-iodine versus normal saline solution in vaginal cleansing in laparoscopy

Conditions: Postoperative Infection

Summary: laparoscopy is a minimally invasive method used for diagnostic and therapeutic purposes. it allows surgeons to take a look on the abdominal and pelvic organs. diagnostic laparoscopy is usually done in an operating room under general anesthesia. the procedure takes about 25 minutes and the patients usually discharged in the same day. the laparoscopy can diagnose pelvic pathological conditions in approximately 50% of the cases. however, the laparoscopy has some complications, such as infections, hemorrhage and injuries of visceral organs. a preoperative vaginal preparation is important to prevent the bacteria colonization in a trial to avoid postoperative infection after laparoscopic surgery. the povidone-iodine (pi) is normally used as a skin and vaginal disinfectant to prevent postoperative infections, however; it can be the cause of significant postoperative irritation. there are many reports in the literature proved that the mechanical cleansing of the vagina, not the use of an antiseptic solution, is responsible for the efficacy of vaginal preparations. in the field of assisted reproductive technology; a study in 1992 concluded that the infection rates with normal saline solution are comparable to pi. another proved that, a normal saline solution can be effective in prevention of preventing postoperative infections after vaginal surgery. the most recent study by lewis et al has been shown that the baby shampoo is preferable than pi in vaginal cleansing before gynecologic procedures because it has minimal vaginal irritation and cheaper than pi. so the optimal vaginal antiseptic solution is unknown, the investigators want to conduct a randomized trial comparing 2 commonly used vaginal antiseptic solutions: pi and the saline solution before the laparoscopic surgery. the normal saline is used in medicine as an intravenous isotonic infusion and for cleaning wounds. it is a mild but effective cleaning agent and will not harm normal tissue, unlike many stronger antiseptics. it is available and inexpensive in comparison to povidone iodine.


Eligibility criteria:
inclusion criteria: 1 - all women who will subject to laparoscopy (diagnostic or operative) for gynecological problems exclusion criteria: 1 - all women who will subjected to operative laparoscopy for myomectomy or hysterectomy. 2- all patients have current vaginitis or urinary tract infection before the laparoscopy. 3- diabetic women. 4- women with bmi \> 25 kg/m2.
the cranial-caudal mixed medial approach for laparoscopic right hemicolectomy

Conditions: Intraoperative Blood Loss; Postoperative Complications; Pathology

Summary: to explore the feasibility and effectiveness of the cranial-caudal mixed medial approach in laparoscopic right hemicolectomy with complete mesocolic excision. laparoscopic right hemicolectomy using the cranial-caudal mixed medial approach is safe and feasible, can shorten the operation time, reduce the risk of intraoperative bleeding, and has good clinical results.

the data of patients undergoing laparoscopic right hemicolectomy performed in the same surgical group of gastrointestinal surgery at northern jiangsu people's hospital from february 2017 to june 2022 were retrospectively analyzed. according to different surgical approaches, patients were divided into the cranial-caudal mixed medial approach group and the medial approach group. intraoperative and postoperative data were collected. intraoperative data is obtained through surgical records and pathological reports, including total operation time, laparoscopic procedure time, intraoperative blood loss, sample length, number of lymph nodes collected, and number of positive lymph nodes. postoperative data includes exhaust time, liquid intake time, postoperative hospitalization and complications. among them, complications are short-term postoperative complications (surgical related complications, non-surgical related complications) within the first 30 days after surgery (or throughout the hospitalization period, if more than 30 days, and are classified according to the clavien-dindo classification method. to explore the feasibility and effectiveness of the cranial-caudal mixed medial approach in laparoscopic right hemicolectomy with complete mesocolic excision.

Eligibility criteria:
inclusion criteria: * age range: 18-70 years old * right colon cancer confirmed by colonoscopy and pathological diagnosis * single primary tumor without distal metastasis * laparoscopic operation exclusion criteria: * age below 18 and above 70 years old * patients who need urgent surgery * persons with a history of malignant tumors * multiple primary tumors or distant metastases
shanghai non-pharmacological intervention of mild cognitive impairment

Conditions: Cognitive Dysfunction

Summary: this study evaluates the effects of "computerized cognitive training" and "cognitive training plus exercise training" on different cognitive domains in mild cognitive impairment (mci) patients. patients will be randomized into the computerized training group, cognitive training plus exercise training group and the control group.

mild cognitive impairment (mci) is an early stage of alzheimer disease (ad). increasing evidence has indicated that cognitive trainings improve cognition functions of mci patients in multiple cognitive domains, making it a promising therapy for mci. however, the effect of long-time training has not been widely explored. it is also necessary to evaluate the extent of its function in reducing the conversion rate from mci to ad.

Eligibility criteria:
inclusion criteria: * male or female, aged 50-85; * mci diagnosed according to the national institute on aging-alzheimer's association (nia-aa) workgroups\[1\]; * 24≤mini-mental state examination (mmse) ≤28； * the hamilton depression scale/17-item (hamd) score ≤10; * not on medication for dementia; * mri t2 weighted image (t2wi) scan: aged ≤70 , fazeca scale for white matter lesions rating level≤1; \>70 years, white matter damage rating scale ≤2. the number of lacunar infarcts larger than 2 cm in diameter ≤2. no infarcts in hypothalamus, entorhinal cortex, para-hypothalamus, cortical and subcortical cavity infarction near gray matter nuclei. the medial temporal lobe atrophy (mta) score: grade ii or above. * accompanied by reliable caregivers (at least intensive contact of 4 days every week and 2 hours every day) who are expected to participate in the follow-up visits and provide useful information for scores of scales like adcs-adl; * education level: primary school (grade 6) or above. * expected good compliance with the therapy and follow-up. each patient gives a written informed consent, and the study has been approved by ruijin hospital's ethical committees. exclusion criteria: * cognitive decline caused by other diseases (cerebrovascular disease, central nervous system infections, parkinson's disease, metabolic encephalopathy, intracranial space-occupying lesions, deficiency of folic acid/vitamin b12 and hypothyroidism); * medical history of other neurological disorders (including stroke, neuromyelitis optica, parkinson's disease, epilepsy, etc.); * psychiatric disorders defined by (diagnostic and statistical manual of mental disorders) dsm-iv criteria; * unstable or severe disease of heart, lung, liver, kidney or hematopoietic system; * history of alcohol or drug abuse; * participation in other clinical trial less than 30 days before the screening of this study; * inability to complete the study.

Keywords: mild cognitive impairment
evaluation of the accuracy of percutaneous biopsy by vacuum-assisted biopsy (vab) to assess pathological complete response in patients with clinical and radiological complete response after neoadjuvant chemotherapy (neovab)

Conditions: Vacuum-assisted Biopsy

Summary: breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in females in the world. neoadjuvant chemotherapy (nac) is increasingly used in patients with operable breast cancer to enhance the likelihood of breast conservation. new generation of treatments or combinations lead to a high rate of pathological complete responses (pcr) in patients with human epidermal growth factor receptor 2 positive (her2) and triple negative tumours. safe omission of surgery in patients who receive nac and achieve radiologic complete response depends on the ability to accurately estimate pcr preoperatively. if pathological complete response after nac could be accurately assessed by vab, surgery could be avoided. in the context of new treatments or combinations with an increased pcr rate, this new strategy could induce major changes in clinical practice, leading to breast surgery de-escalation.

a total of 66 patients will be submitted to percutaneous vacuum-assisted biopsy (vab), followed by breast surgery. the primary endpoint of the study is the false negative rate of vab procedure. this rate will be calculated by comparing the detection of invasive or in situ carcinoma on surgical specimen versus vab samples. the secondary endpoints of the study are feasibility, vab procedure technical complications and safety.

Eligibility criteria:
inclusion criteria: 1. patient aged 18 years or older. 2. written informed consent provided. 3. triple negative or her2-positive / er-negative or her2-positive / er-positive breast tumours. 4. patients eligible for breast conservation after nac. 5. patients with t2-t3 n0 invasive breast cancer initially treated by nac to allow breast conservation, who have received a minimum of 6 cycles of adequate nac +/- anti-her2. 6. clinical complete response after nac. 7. radiological (mammography, breast us, breast mri) complete response after nac. 8. patients predicted to be node-negative at treatment initiation. exclusion criteria: 1. patient younger than 18 years old. 2. pregnant or breastfeeding women. 3. proven metastatic axillary or internal mammary chain lymph node involvement before nac proven by biopsy or cytology. 4. bilateral breast cancer. 5. contraindication to mri. 6. contraindication to breast conservation 7. patients with a brca mutation or other autosomal dominant high-penetrance genetic predisposition to breast cancer. 8. patients with limitation of freedom or under guardianship 9. inability for psychological reasons 10. hypersensitivity to local anaesthesia 11. initial imaging showing acr6 micro calcifications and/or acr6 non-mass enhancement associated to the index lesion

Keywords: breast cancer neoadjuvant chemotherapy vacuum-assisted biopsy pathological complete response
a randomized, double-blind, placebo-controlled trial of curcumin in leber's hereditary optic neuropathy (lhon)

Conditions: Optic Atrophy, Hereditary, Leber

Summary: background leber's hereditary optic neuropathy (lhon) is a maternally inherited ocular disorder associated with a mutation in mtdna . the common manifestation is visual loss which caused by the respiratory chain enzymes complex dysfunction resulting in increased oxidative stress enzymes production. purpose to determine whether curcumin which is an antioxidant agent is beneficial to the patients with 11778 lhon mutation. material and method seventy patients with 11778 lhon mutation were randomly treated with oral curcumin (500 mg/day) and placebo for 1 year. the visual acuity, computerized visual field, electrophysiologic parameters and oxidative stress enzymes in plasma were compared before and after treatment at 3, 6, and 12 months interval.

leber's hereditary optic neuropathy (lhon) is a maternally inherited disease that is characterized by a simultaneous or more common sequential bilateral loss of central vision, which typically occurs during the teenager years or early adulthood. the disease may be progressive and the patients eventually become blind. in contrast to blindness in patients caused by congenital diseases, the patients who develop blindness caused by lhon will have more trouble in their life because they previously had better vision. although lhon is associated with mitochondrial dna mutation at a variable nucleotide position but no certain mechanism of optic nerve injury has been found. it has been postulated that a defect in a complex of respiratory chain enzyme which is caused by mitochondrial dna dysfunction, results in an increase of free radical substances that interfere with optic nerve function in lhon. some antioxidant substances have been used to decrease the progression of visual impairment. however, there have been few therapeutic trials for lhon. curcumin, a component of tumeric, which comes from the root curcumin longa has antioxidant, anti-inflammatory and anti-carcinogenic activities. there is some evidence which suggests that curcumin contributes to the in vitro removal of free radical gradients in thalassemic serum and to a clinical improvement of thalassemic patients. we propose a randomized controlled trial study of curcumin, which is an antioxidant substance, for lhon. this study will provide not only an insight into the therapeutic efficacy of curcumin, a kind of thai herb, for lhon but also the development of future therapeutic strategies to prevent blindness.

Eligibility criteria:
inclusion criteria: * lhon patient with 11778 point mutation exclusion criteria: * lhon patient with other point mutation

Keywords: curcumin, lhon, antioxidant, visual outcome
neuromuscular electrical stimulation following total hip arthroplasty

Conditions: Deep Vein Thrombosis; Total Hip Arthroplasty

Summary: patients post total hip arthroplasty (tha) remain at high risk of developing deep vein thrombosis (dvt) during the recovery period following surgery despite the availability of effective pharmacological and mechanical prophylactic methods. the use of calf muscle neuromuscular electrical stimulation (nmes) during the hospitalised recovery period on this patient group may be effective at preventing dvt. however, the haemodynamic effectiveness and comfort characteristics of nmes in post-tha patients immediately following surgery have yet to be established. the main objectives are: 1. to establish if patients in the early post-operative period have tolerance for nmes. 2. to determine if applying nmes to patients immediately post-tha increases venous outflow from the lower limb over resting conditions.


Eligibility criteria:
inclusion criteria: * patients who underwent total hip arthroplasty the previous day exclusion criteria: * patients with diabetes mellitus * patients with peripheral vascular disease * patients currently involved in another trial * previous diagnosis of dvt

Keywords: neuromuscular electrical stimulation nmes deep vein thrombosis dvt total hip arthroplasty lower limb hemodynamics
oncological outcome of contralateral submental artery island flap versus primary closure in tongue squamous cell carcinoma

Conditions: Tongue Squamous Cell Carcinoma

Summary: the purpose of this study is to compare the oncological and functional results of the contralateral submental flap with primary closure for reconstruction of tongue squamous cell carcinoma.

resection of tongue malignancies remains one of most surgical challenges because of its adverse effects on speech articulation, swallowing, and eventual quality of life. a variety of local flaps such as infrahyoid flap and the platysma flap, and free flaps like the radial forearm and anterolateral thigh (alt) flap have been available for reconstruction of tongue. however, all these options have their shortcomings. when reconstructing particular oral cavity defect the tissue used should be reliable; functional and cosmetically acceptable with minimum donor site morbidity and match the recipient site in terms of color, texture and thickness. the submental island flap (smi-flap) which has been first introduced by martin et al in 1990, meets all these requirements and due to its optimal location, ease of harvest, and favorable arc of rotation, the smi-flap has gained acceptance as a simple, reliable and convenient to repair defects of tongue and oral cavity cancer. the oncological safety of submental flap in oral cancer patient still debate, this is due to its proximity to the main nodal basins of levels 1a and 1b and the possibility of transfer of occult metastatic lymph node to the recipient site during reconstruction. in addition some authors has not been recommended submental flap for cases with clinically or radiologically established nodal disease as it might compromise the oncological resection and continuity of neck dissection and so alternative options should be considered. the contralateral submental island flap (csmi-flap) is believed to offer such alternate option for patient with contralateral negative node. our a priori-hypothesis is that utilization of the csmi-flap is not related to an altered prognosis in tongue squamous cell carcinoma patients. in order to test this hypothesis, we will compare the oncological outcome of group of patients receive csmi-flap with the results of another group of patients not receive csmi-flap and close tongue defect by primary closure, which is another well-established concept of management tongue cancer defect.

Eligibility criteria:
inclusion criteria: * patient with t1\&t2 tongue squamous cell carcinoma. exclusion criteria: * patients with contralateral n positive. * patients with previous neck surgery that interrupt contralateral facial artery or vein. * patients with prior radiotherapy to the neck. * patients with lesions crossing the midline, or those reaching the base of tongue requiring total glossectomy. * patients second primary tumors at the time of diagnosis. * patient with recurrent tongue squamous cell carcinoma.

Keywords: tongue squamous cell carcinoma, contralateral submental flap submental flap oncological safety