Kornimate/medical-research-clean huggingface dataset:
comparison of viusal outcomes after implantation of the pod 26% finevision toric (physiol) and pod 26% toric (physiol)

Conditions: Cataract

Summary: the study is an observational non-randomised controlled study comparing the visual acuity after implantation of the pod 26% finevision toric with respect to the pod 26% toric

the study is an observational non-randomised controlled study comparing the visual acuity after implantation of the pod 26% finevision toric with respect to the pod 26% toric this study includes both eyes of 24 patients implanted with the pod 26%finevision toric (group 1: 12 patients) and the pod 26% toric (group 2: 12 patients) . the study primary goal is to compare the near visual acuity in both groups. distance and intermediate visual acuities, defocus curve, refraction and straylight will be compared.

Eligibility criteria:
inclusion criteria: * patient older than 50 years old * regular corneal astigmatism \>1.0 dioptres by iol master (regularity determined by the topography of the keratometry). * regular corneal astigmatism \<2.5 dioptres by iol master (regularity determined by the topography of the keratometry). * group 1: patients after cataract surgery with fine vision toric implanted in both eyes * group 2: patients after cataract surgery with ankoris implanted in both eyes * availability, willingness and sufficient cognitive awareness to comply with examination procedures exclusion criteria: • - irregular astigmatism * difficulty for cooperation (distance from their home, general health condition) * acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...) * any ocular comorbidity * history of ocular trauma or prior ocular surgery including refractive procedures * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic uveitis, marfan's syndrome) * pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions) * iol spherical equivalent power lower than 10 d or greater than 30d * complicated surgery
a comparison of changes in bone density with the same bone-health plan, but with different bone-health supplements

Conditions: Osteopenia

Summary: a comparison of changes in bone density following the same bone-health plan, but with a different bone-health supplement.

the us surgeon general's report on bone health suggests america's bone-health is in jeopardy and issued a "call to action" to develop bone-health plans that: 1. improve nutrition, 2. increase health literacy and, 3. increase physical activity. the purpose of this study was to use a comparative effective research model to compare 6-month changes in bone mineral density (bmd)in two study groups. both followed the same bone health plan that contained the three components listed above with the same plant-source calcium supplement, but enhanced with different levels of calcium, vitamin d3, vitamin k and magnesium.

Eligibility criteria:
inclusion criteria: * all subjects were required to contact the physicians to ensure they had no medical issues that would preclude their participation. exclusion criteria: * younger the 18 years of age, and * recommendations not to participate from their physicians.
study comparing concomitant docetaxel + gemcitabine to sequential therapy of docetaxel followed by gemcitabine

Conditions: Breast Cancer

Summary: the purpose of this study is to compare the time to disease progression (ttdp) between those patients with unresectable, locally recurrent or metastatic breast cancer who are treated with concomitant docetaxel plus gemcitabine to those patients treated with sequential therapy of docetaxel followed by gemcitabine.

this is an open, multicenter, two-armed phase iii study patients will be randomized to either of the following two arms: arm a (concomitant arm), gemcitabine 1000 mglm2 will be administered intravenously on days 1 and 8, repeated on day 22. docetaxel 75 mg/m2 will be given on day 8 (before gemcitabine), repeated on day 22. this 3-week schedule defines a cycle of treatment for this arm. overall 8 cycles will be administered. arm b (sequential arm) four cycles of docetaxel 100 mg/m2 an day 1, repeated an day 22, followed by four cycles of gemcitabine 1250 mg/m2 an a day 1 and 8, repeated an day 22, will be given. both drugs will be administered in a 3-week schedule. bimonthly follow-up for patients without confirmed disease progression until progression of disease. long-term follow-up for patients with confirmed disease progression will be done in 4 intervals. for therapy control frequent blood chemistry and hematology, physical examination, weight control, potential adverse events and imaging procedures (ct, x-ray, mri, bone scan) am foreseen.

Eligibility criteria:
inclusion criteria: * patients with histologic or cytologic diagnosis of breast cancer with evidence of unresectable, locally recurrent, or metastatic disease. * females, 18 to 75 years of age * pre-treated with one anthracyclines containing chemotherapy either in neoadjuvant/adjuvant or 1st line metastatic setting will be enrolled into the study * patients with clinically measurable lesions will be enrolled in this study. measurability is determined according to recist criteria * performance status of 70 or higher on the karnofsky performance scale * adequate bone marrow reserve * adequate liver function * adequate renal function * informed consent form patient or guardian * childbearing potential either terminated by surgery, radiation, or menopause, use of an approved contraceptive method exclusion criteria: * active infection (at the discretion of the investigator). * known or suspected brain metastases requiring steroid or radiation treatment. * pregnancy (recent negative urine pregnancy test for pre-menopausal patients mandatory) * breast-feeding * serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator). * second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin). * bone metastases, pleural effusion, or ascites as the only site of disease. * bone marrow transplantation or autologous stern cell infusion following high-dose chemotherapy for adjuvant or metastatic disease.

Keywords: breast cancer docetaxel
blood proteome profiling identifies biomarkers in ischemic stroke

Conditions: Stroke

Summary: endovascular thrombectomy and intravenous thrombolysis have become key therapeutic approaches for acute ischemic stroke. however, due to time window limitations, many patients are unable to receive reperfusion therapy, and the majority only receive supportive treatment. ischemic stroke-related complications, including edema and infection, gradually subside after 7 days post-stroke, with the patient's condition generally stabilizing. endogenous repair mechanisms will play a critical role in the coming months. this study aims to predict prognostic biomarkers for ischemic stroke patients who have not undergone reperfusion therapy, using blood proteomics data. all samples in our study are derived from this experiment. our goal is to elucidate the molecular mechanisms underlying post-reperfusion prognosis and to provide insights for optimizing stroke treatment strategies.


Eligibility criteria:
inclusion criteria: * age ≥18. * clinical signs consistent with acute ischemic stroke (toast classification: large artery atherosclerosis) * 7 to 30 days from symptom onset. exclusion criteria: * severe infection or multiple organ failure. * untreated moderate or severe coronary artery stenosis, or a history of coronary artery bypass surgery. * ongoing hemodialysis or peritoneal dialysis, or severe renal insufficiency characterized by a glomerular filtration rate (gfr) of less than 30 ml/min or serum creatinine levels exceeding 220 mmol/l (2.5 mg/dl). * known intracranial aneurysm or cerebral arteriovenous malformation. * malignant brain tumor or central nervous system (cns) infection. * pre-existing neurological or psychiatric conditions that could confound the neurological or functional assessments. * baseline platelet count \<50 × 109/l. * pregnancy or lactation at the time of admission.
efficacy of polyglucosamine for weight loss

Conditions: Overweight and Obesity

Summary: the polyglucosamine, specification l112 is a medical device and in this clinical trial used for weight reduction of overweight and obese participants. the rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals with the highest fat content.

to have a comparable diet condition, all participants in both groups had to follow the recommendations of the german clinical practice guidelines on the management and prevention of obesity. one group had to take the polyglucosamine tablets and the other group placebo tablets for at least 24 weeks. it is known, that polyglucosamine is a fat binder acting in a physical-chemical manner, the positive charged fiber is bound to the negative charged dietary fat and this complex in unable to pass the gut wall into the body but is naturally excreted, hence this energy is not available. therefore, this medical device should show a measurable reduction in body weight.

Eligibility criteria:
inclusion criteria: * bmi \> 26 and \< 45 * waist circumference of more than 88 cm for women and greater than 102 for men. exclusion criteria: * pregnancy or breast-feeding, alcohol abuse, drug abuse or drug addiction, inability to fulfill the criteria of the trial protocol, cancer diseases, malignant tumors, pre-existence of chronic intestinal disease and known hypersensitivity reactions to crustaceans

Keywords: obesity, body weight, overweight, weight loss, polyglucosamine, l112 caloric restriction physical activity
banded sleeve gastrectomy improves weight loss compared to non-banded sleeve: mid-term results

Conditions: Obesity, Morbid

Summary: weight regain after laparoscopic sleeve gastrectomy (lsg) is nowadays a growing concern. sleeve dilatation and loss of food restriction is considered the main mechanism. the placement of a silicon ring around the gastric tube seems to give benefits in the short-term. the investigators evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the mid-term. fifty patients were randomized between lsg and laparoscopic banded sleeve gastrectomy (lbsg), and they underwent a mean follow-up of 4 years. patients' management was exactly the same, apart from the band placement. after surgery differences in weight loss, operative time, complication rate and mortality were analyzed.


Eligibility criteria:
inclusion criteria: * morbid obesity * failure of medical treatment * \>18yrs; \<60 yrs exclusion criteria: * previous bariatric or gi surgery * psychiatric disease * pregnancy * contraindication to laparoscopy

Keywords: sleeve gastrectomy banded sleeve obesity surgery
safety and efficacy of neoadjuvant radiochemotherapy in adenocarcinoma of the gastric-oesophageal junction

Conditions: Esophageal Neoplasms; Stomach Neoplasms

Summary: the purpose of this study is to determine the dose limiting toxicity and the maximum tolerable dose of the radiochemotherapy with docetaxel and oxaliplatin in patients with adenocarcinoma of the gastric-oesophageal junction.

radiotherapy starts on day 1 of chemotherapy after the application of docetaxel and oxaliplatin and will be administered in single doses of 1.8 gy once daily and five times a week for 5 weeks. in the sixth treatment week a boost of 3 further radiations with 1.8 gy will be applied. simultaneous chemotherapy: initially, in part a of the study the maximum tolerable dose (mtd) for the simultaneous chemotherapy will be identified with a 3-step dose escalation scheme: level 1: docetaxel: 20 mg/m2 oxaliplatin 40 mg/m2 i.v., level 2: docetaxel: 20 mg/m2 oxaliplatin 50 mg/m2 i.v., level 3: docetaxel: 25 mg/m2 oxaliplatin 50 mg/m2 i.v., the treatment starts with 3 patients in level 1. if no dose limiting toxicities appear, it will be switched to dose level 2. the same applies for the switch from level 2 to level 3. if a dlt appears on one level, a further 3 patients will be treated within this dose level. if in one level at least 2 of 6 patients show dlt, the subjacent level will be defined as the maximum tolerable dose (mtd).

Eligibility criteria:
inclusion criteria: * adenocarcinoma of gastric-esophagal junction * stage ii to iii * unidimensional measurable disease exclusion criteria: * surgery of primary tumor * metastasis * prior chemo- or radiotherapy

Keywords: chemoradiation docetaxel oxaliplatin gastric neoadjuvant radiochemotherapy
cognitive behavioral therapy (cbt) pain prevention intervention for women undergoing surgery

Conditions: Back Pain; Cognitive Behavioral Therapy; Surgery

Summary: this study investigates a cognitive behavioral therapy (cbt) intervention for women who are undergoing elective surgery. the objective is to provide a toolkit of stress management techniques to decrease pain and opioid use following surgery.

the investigators are doing this research to understand whether a pre-surgery virtual cognitive behavioral therapy (cbt) group intervention combined with an activity tracker can reduce pain and opioid use in women with chronic stress undergoing elective spine surgery. participants will be randomly divided in two groups and one of the groups will be invited to attend four weekly virtual cbt group sessions designed to improve reactions to stress, increase motivation for physical activity, develop tools for managing pain, and utilize mindfulness techniques. two optional sessions will be available following surgery. individuals randomized to usual care will not attend the online sessions but will continue to wear the activity tracker to provide information about their physical activity as well as the use of an app to track their pain and medication use. the ultimate goal of this research is to enhance stress management and coping skills to help patients better manage pain after surgery and reduce their need for opioid medications.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. female gender 3. patients own a compatible smartphone (iphone or android) or tablet and can download the fitbit app on their device 4. planned elective spine surgery exclusion criteria: 1. cognitive impairment (judged to interfere with study participation) 2. male gender 3. non-english speaking 4. pain conditions requiring urgent surgery 5. a diagnosis of cancer 6. a present psychiatric condition (e.g. dsm diagnosis of schizophrenia, delusional disorder, psychotic disorder or dissociative disorder) that would be judged to interfere with the study 7. visual impairment or motor impairment that would interfere with study participation

Keywords: chronic stress elective spine surgery cognitive behavioral therapy digital phenotyping fitbit tracker back pain
fast muscle activation and stepping training (fast) post-stroke

Conditions: Stroke; Hemiparesis

Summary: the purpose of this study is to determine whether fast (fast muscle activation and stepping training) exercises will improve walking balance in individuals after stroke to a greater extent than usual care. hypothesis: the primary hypothesis is that improvements in walking balance will be larger following 12 sessions of fast exercise retraining compared to usual care in persons in the sub-acute phase after stroke.

it is estimated that 75-80% of individuals who have had a stroke will survive the acute event and be left with residual disability. regaining independence in standing and walking is of utmost importance for patients recovering from stroke. walking balance requires muscles in the legs and trunk to contract quickly if people lose their balance. physical therapy plays a key role in the rehabilitation of walking balance in individuals after stroke. given that maintaining one's balance requires fast muscle activity, rehabilitation post-stroke should focus on speed of movement. thus we are proposing to compare a program that emphasizes speed of movement, fast muscle activation and stepping training versus an active control (usual care).

Eligibility criteria:
study population: subjects with a diagnosis of stroke inclusion criteria: * first stroke (\<6 months ago) * presence of hemiparesis in the lower extremity * minimum berg balance score (bbs) of 30/56 * cognitive ability to give informed consent exclusion criteria: * bilateral stroke, or a previous stroke in the other hemisphere * severe co-morbidity that is likely to dominate the pattern of care * co-existing peripheral neuropathies or disorders of the vestibular apparatus * musculoskeletal problems * global aphasia or receptive aphasia

Keywords: physical therapy exercise therapy
intracoronary administration of levosimendan in cardiac surgery patients

Conditions: Myocardial Stunning

Summary: incomplete recovery from ischemia causes stunned myocardium. ischemia may be due to coronary artery disease or aortic cross-clamping during surgery. stunning leads to myocardial dysfunction. it has been suggested that the mechanism responsible for the contractile depression in stunned myocardium is a decreased sensitivity of the myofibrils to calcium. levosimendan is a calcium sensitizer, which has been shown to improve the function of stunned myocardium without obvious impairment of diastolic function. systemic vasodilation and need of vasoconstrictive medication is usually apparent after administration of levosimendan. colucci et al have demonstrated that with intracoronary administration of milrinone, another inodilator, systemic vasodilation could be excluded. if this is true with levosimendan, it may be possible to improve left ventricular hypo/dyskinesia without afterload reduction by adding levosimendan into cardioplegia solution. the investigators hypotize that levosimendan, delivered together with cardioplegia, can improve lv dysfunction after opening of aortic cross-clamp in patients undergoing aortic valve and coronary artery bypass operation. our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline. secondary endpoints are a change in lv ejection fraction from baseline to 5 min after sternal closure and ctnt/ck-mb on the first postoperative morning.


Eligibility criteria:
inclusion criteria: * preoperative lvef 40% or less * septal wall thickness more than 11mm * less than moderate aortic insufficiency * sinus rhythm before cpb exclusion criteria: * oesophageal disease * known allergy to levosimendan or its metabolites or adjuvants.
myocardial performance at rest and during exercise in heart failure with preserved ejection fraction

Conditions: Heart Failure

Summary: this study is being done to study how well the heart contracts and relaxes during exercise. in addition to traditional measures of heart function, we will use a new computer program that may improve understanding of why people feel shortness of breath or fatigue.

heart failure with preserved ejection fraction is not well understood, although account for nearly half of all heart failure cases. this study aims to collect data about systolic (contracting portion of a heart beat) and diastolic (relaxing portion of a heart beat) dysfunction at rest and during exercise. participants with normal cardiac function will serve as a control group and compared to participants who are at risk of heart failure.

Eligibility criteria:
inclusion criteria: * 18 years of age or older, * able to exercise on a bicycle exclusion criteria: * heart arrhythmias, * severe chronic obstructive pulmonary disease, * congenital heart abnormalities, * infiltrative or hypertrophic cardiomyopathy.

Keywords: heart failure hfpef dyspnea fatigue shortness of breath exercise strain myocardial deformation cardiac rehabilitation cardiac hemodynamics
intermittent compression maneuver of upper arm to reduce axillary brachial plexus block onset time

Conditions: Forearm Injuries; Hand Injuries

Summary: this study evaluates the addition of intermittent pneumatic compression maneuver to axillary brachial plexus block in forearm and hand surgery. half of participants will receive axillary brachial plexus block and intermittent pneumatic compression maneuver, while the other half will receive only axillary brachial plexus block.


Eligibility criteria:
inclusion criteria: 1. adults between ages of 20 and 50 2. patients who are scheduled forearm and hand surgery with axillary brachial plexus block 3. american society of anesthesiologists physical status classification 1 or 2 4. patients who voluntarily agree to participate in the trial exclusion criteria: 1. patients who are pregnant or lactating 2. patient who does not agree to participate in the study 3. patient with side effects on local anesthetics 4. patient with neurologic deficit of upper arm 5. patients with comorbidities of cardiac, pulmonary, renal, cerebral, and hepatic systems 6. patients with peripheral vascular disease

Keywords: brachial plexus block intermittent pneumatic compression maneuver
a trial of episil® oral liquid in cancer patients suffering from chemotherapy- and/or radiation-induced oral mucositis

Conditions: Chemotherapy- and/or Radiation-induced Oral Mucositis

Summary: this is a randomized, multi-center, single-use, active-controlled, two-stage open study of episil®. the purpose of this study is to assess the local analgesic effect of episil® in cancer patients suffering from chemotherapy- and/or radiation-induced oral mucositis, which will provide scientific and reliable clinical data in the product registration in china.


Eligibility criteria:
inclusion criteria: * male/female patient 18 years of age; * pathological histologic and/or cytological diagnosis of malignant tumor; * patients who are suffering from symptomatic oral mucositis (who grade 2 or above) during chemotherapy and/or radiotherapy during screening period; * patients who are suffering from pain inside the oral cavity caused by oral mucositis, and pain assessment by likert scale (0-10) results in a score of at least 6 out of 10 during screening period and at enrollment on day 1; * patients undergoing chemotherapy and/or radiotherapy: patients must have received at least one cycle of multiple-cycle chemotherapy regimen and/or have received multiple doses of radiation, prior to the enrollment on day 1; * patients at eastern cooperative oncology group (ecog) performance status of 0, 1, 2 and 3; and * patients are able to provide written informed consent to participate in the study freely after the nature of the study and disclosure of data has been explained to the patients.
genetic risk of osteonecrosis of the jaw (onj) in patients with metastatic cancer: concordance study

Conditions: Breast Cancer

Summary: this study will examine genes in three different tissues and look for similarities and differences between normal cells and cancer cells. the tissues to be studies come from blood, lymph node and cancer.

subjects will be given an informed consent to read and sign the medical chart will be reviewed for diagnosis and treatment history blood (about 4 tablespoons) will be drawn at a clinically available time. the lymph node and breast tumor tissue in the university of michigan pathology repository will be used for research purposes

Eligibility criteria:
inclusion criteria: * age at least 18 years of age * able to read and sign the informed consent * able to provide specimens: one blood draw for white blood cells, provide permission to use tissue already collected.

Keywords: bone metastasis, snp concordance