Kornimate/medical-research-clean huggingface dataset:
pilot study of acrysof® iq restor® +3.0 d multifocal toric intraocular lens (iol)

Conditions: Cataract

Summary: the purpose of this study is to describe visual outcomes, in particular spherical equivalent by manifest refraction and visual acuity across a range of distances, 6 months post implantation of the acrysof® iq restor® +3.0 d multifocal toric iol in adult patients with corneal astigmatism. additionally, patient reported outcomes will be assessed.

each subject completed a preoperative examination of both eyes, implantation of iol at the operative visit for each eye, and up to 5 postoperative visits (each eye examined at day 1-2, with binocular visits at month 1, month 3, and month 6 after the second implantation). the second implantation generally occurred within 30 days of the first.

Eligibility criteria:
inclusion criteria: * sign informed consent; * require cataract extraction followed by posterior iol implantation or eligible for refractive lens exchange (rle) in both eyes; * able to undergo second eye surgery within one month (30 days) of first eye surgery; * able to attend postoperative examinations per protocol schedule; * qualify for a acrysof iq toric iol in both eyes; * preoperative astigmatism of ≥0.75 to ≤2.5 diopters (d) in both eyes; * residual refractive cylinder of ≤0.5 d in both eyes; * good ocular health; * other protocol-defined inclusion criteria may apply. exclusion criteria: * planned multiple procedures, including lri, during cataract/iol implantation surgery; * amblyopia; * previous corneal surgery; * clinically significant corneal endothelial dystrophy; * history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.); * history of retinal detachment; * pregnant or planning to become pregnant during course of study; * other protocol-defined exclusion criteria may apply.

Keywords: intraocular lens multifocal toric
autologous chondrocyte intra-articular implantation in patients with severe hip osteoarthritis

Conditions: Hip Osteoarthritis

Summary: hip osteoarthritis is degeneration of hip cartilage and inflammation of subchondral bone and soft tissue linings. patients have pain, stiffness, swelling, and difficulty walking. there are treatments available to help manage these symptoms like weight loss, and analgesics. surgery is the appropriate treatment in patients who have failed these conservative treatments. the aim of this clinical study is to assess safety of autologous cultured chondrocyte intra-articular injection and obtain its clinical results in patients with severe hip osteoarthritis.

in this phase i clinical study 6 patients with severe hip osteoarthritis will be recruited. all patients will have a cartilage biopsy taken from the knee cartilage non-weight bearing zone. chodrocytes will be extracted and cultured for 4 weeks. patients then will receive chondrocyte injection under the guide of fluoroscopy. patients will be evaluated post injection for 6 months at time intervals. parameters considered being evaluated are, adverse effects, pain intensity and joint physical function and cartilage repair. these effects are measured by visual analogue scale, womac, harris hip score questionnaire and mri.

Eligibility criteria:
inclusion criteria: * osteoarthritis diagnosed by mri exclusion criteria: * pregnancy or lactating * positive tests for hiv, hcv, hbv * active neurologic disorder * end organ damage * uncontrolled endocrine disorder.

Keywords: chondrocyte hip osteoarthritis intra articular injection
the effect of probiotics on depression syndrome and risk factors of cardiovascular disease in hemodialysis patients

Conditions: Depression Mild; Cardiovascular Diseases

Summary: as the investigators know, only few researches focus on the effect of probiotics on depression in hemodialysis patients. besides, probiotics also have benefit effect on dyslipidemia and hypertension in general population. both of them are the risk factors of cardiovascular disease which is the major cause of death in hemodialysis patients. therefore, this study looks for the effect of probiotics on depression syndrome and risk factors of cardiovascular disease in hemodialysis patients. this is a randomized controlled trial. all patients will be assigned at random to intervention group or control group. this study plans to recruit 70 hemodialysis patients and expects at least 30 patients in each group at the end of study period. the investigators provide probiotics (c. butyricum miyairi 588) to intervention group and provide nothing to the control group. all patients need to maintain the lifestyle during study period. genomic analysis of gut microbiota on patients' fecal samples will be used to evaluation their compliance.


Eligibility criteria:
inclusion criteria: * adults aged 20 years or older undergoing hemodialysis (at least 3 months), 3 times per week, and urr ≥65% exclusion criteria: 1. allergic to the components of the intervention drug, low tolerance of milk or dairy products 2. has the diagnosis of dementia, delirium, bipolar disorder, schizophrenia, or liver failure 3. beck depression inventory chinese version 2.0 score higher than 14, or has significant suicide risk during study 4. following significantly clinical syndrome: obsessive compulsive disorder, schizoid personality disorder, schizotypal personality, paranoid、antisocial personality disorder, histrionic personality disorder 5. with addiction to alcohol or drugs, terminal cancer, severe infection, heart failure, central venous catheter in the past 6 months 6. taking antibiotics, anti-oxidant vitamin supplement, probiotics, prebiotics, antidepressants, anti-anxiety medicine, yogurt and the products in the past 3 months 7. pregnant or lactating
ultrasound diagnosis of cleft lip and palate

Conditions: Cleft Lip and Palate

Summary: cleft lips and palate are one of the most frequent congenital malformation. from 2005 to 2009, a french study, conducted by dr bäumler et al. evaluated the accuracy of prenatal ultrasound in the diagnosis of cleft palate when cleft lip is present. the aim of this study is to continue this study from 2009 till 2016. the hypothesis is that the diagnosis rate is constant since 2005.


Eligibility criteria:
inclusion criteria: * age over 18 * prenatal ultrasound diagnosis of cleft palate/lip. * viable pregnancy or intrauterine fetal demise or medical termination of pregnancy exclusion criteria: - diagnosis not confirmed at birth and ultrasound picture not interpretable

Keywords: ultrasound pregnancy diagnosis
role of vacuum in open fracture tibia grade iii type b

Conditions: Open Fracture of Tibia

Summary: - evaluate the role of vac in decreasing the time needed for soft tissue coverage and definitive fixation in open iiib tibial fractures

* open fractures are injuries in which the skin and soft-tissue integument are disrupted and the underlying bone is exposed to the external environment. this communication results in contamination by microorganisms that can cause deep or superficial infection. impaired vascularity, devitalized tissue, and loss of skeletal stability are all factors leading to increased susceptibility to infection after open fracture \[1, 2\]. * current protocols for treating open fractures include early administration of antibiotics, timely surgical debridement, skeletal stabilization, sterile dressing, systemic support, and establishment of soft-tissue coverage in a wound environment that is clean \[3, 4-8\]. * vac is being used to obviate the need for, or enhance the success of, free-flap coverage in open fractures that are significant enough to preclude primary closure, delayed primary closure, or healing by secondary intention. vac device and its components, which in a closed system expose the open wound bed to negative pressure. this pressure removes edema or hemorrhage, mechanically pulls on the wound edges, decreases in wound surface area, improves circulation, and enhances proliferation of granulation tissue that filled the soft tissue defect, enhance debridement of wound debris, reducing the need for costly free-flap transfers. vac devices have been used in many surgical disciplines but only recently have become popular in orthopedics \[7, 9,\].

Eligibility criteria:
inclusion criteria: * - gustilo type iii b open fractures of the tibia \[10\]. * skeletal mature patients. exclusion criteria: * - bone defect more than 5 cm gustilo type iii b open fractures of the tibia. * medical commodities that make the patient unfit for surgery. (e.g. liver cell failure, liver cirrhosis, renal failure )
study of ngr-htnf as single agent in patients affected by advanced or metastatic hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma

Summary: the main objective of the trial is to document the progression free survival (pfs) in advanced or metastatic hepatocellular carcinoma patients treated with ngr-htnf as single agent. safety will be established by clinical and laboratory assessment according to nci-ctc criteria

this is a phase ii, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic hepatocellular carcinoma (hcc) previously treated with no more than one systemic therapeutic regimen, that will be conducted using simon's two-stage design method.

Eligibility criteria:
inclusion criteria: * patients \>18 years affected by advanced or metastatic hcc previously treated with no more than one systemic therapeutic regimen * histologically confirmed hcc not amenable to curative surgery * child-pugh scale class a * ecog performance status 0 - 1 * patients in progression disease at study entry ct documented * adequate baseline bone marrow, hepatic and renal function, defined as follows: * neutrophils \> 1.5 x 10\^9/l and platelets \> 100 x 10\^9/l * bilirubin \< 2 x uln * transaminases \< 3 x uln * absence of any conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (reference appendix "technical data sheet human albumin") * normal cardiac function and absence of uncontrolled hypertension * patients must give written informed consent exclusion criteria: * decompensated cirrhosis (child-pugh score \>7) * concurrent anticancer therapy * patients may not receive any other investigational agents while on study * clinical signs of cns involvement * patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol * known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol * pregnancy or lactation. patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration

Keywords: ngr-htnf, hepatocellular carcinoma (hcc)
the foods & oil to repair, correct and enhance strength (forces) study

Conditions: Sarcopenia

Summary: the proposed research is a parallel arm, randomized placebo-controlled clinical trial designed to assess changes in muscle strength, volume, fatigue resistance, and mobility in older adults after daily consumption of 12g of linoleic acid-rich oil.

study objectives 1. to assess the effect of linoleic acid supplementation on muscle strength, muscle volume, fatigue- resistance, and physical mobility. 2. to quantify the impact of linoleic acid supplementation on cardiolipin species and mitochondrial function in skeletal muscle of older adults

Eligibility criteria:
inclusion criteria: * linoleic acid intake \<75% of the adequate intake * probable sarcopenia exclusion criteria: * gastrointestinal diseases or disorders (including pancreatic and gastric bypass surgery) where consumption of the study foods would be contraindication or where the disease or disorder could negatively affect nutrient absorption and/or would prevent participants from tolerating the study foods * hyperthyroidism diagnosis * food allergy or intolerances * any dietary restriction where consumption of the study foods or any ingredient would be contraindicated * unstable management of heart failure, heart disease events (including stroke or heart attack) within last 3 months prior to enrollment, a plan for heart surgeries or cardiac procedures * current or previous diagnosis of severe kidney failure, liver cirrhosis, other liver diseases/infections that cause liver damage and some pulmonary diseases or severe/uncontrolled pulmonary diseases * severe or uncontrolled rheumatologic or orthopedic diseases * current diagnosis of or current treatment of cancer other than non-melanoma skin cancer * neuromuscular or neurological conditions or diseases or use of mobility assistance (wheelchair, walker etc..) that would impact movement needed to perform the muscle function tests or prevent completion of the muscle function tests * use of mobility assistance (wheelchair, walker etc..) that would prevent completion of the muscle function tests * current use of supplements or medications for weight loss or following a weight loss program * use of supplements high in linoleic acid in the past 4 weeks prior to enrolling * pregnancy and lactation * alcohol or drug abuse * allergy/intolerance to lidocaine or similar medication * use of anticoagulant, antiplatelet, or other blood thinner medications * terminal illness * any condition leading to muscle loss or weakness, impaired mobility or range of motion in legs (excluding normal aging)
whole egg intake and choline concentration in the aging brain

Conditions: Alzheimer Disease

Summary: by doing this study, researchers hope to learn to see if there is relationship between whole egg consumption and brain choline status. additionally, researchers also plan to see if there is a relationship between brain choline status and cognition.

participants will come to the research center for 2 different visits. visit 1 will include anthropometric measurements, surveys, and a cognitive test. approximately 7-10 days after visit 1, participants will come back to the research center for visit 2. at visit 2, participants will return surveys and a mri scan will be performed to measure brain choline status. potential participants need to be located within the kansas city metro area.

Eligibility criteria:
inclusion criteria: * aged between 60 - 85 years of age * good general health with no concomitant diseases * cognitively normal as defined as mini-mental state examination (mmse) score ≥ 25 * bmi range: 20 - 40 kg/m2 exclusion criteria: * presence of central neurological disease (e.g., brain tumor, stroke, epilepsy, motor neuron disease, multiple sclerosis, alzheimer's, parkinson's) * prior major head trauma with loss of consciousness * presence of active unstable and life-threatening illness (e.g., cancer) * presence of major psychiatric disorder within the past 3 years including depression, anxiety, and alcohol (over 3 drinks per day or total of 18 per week) or drug abuse (dsm-iv criteria; geriatric depression score \> 6) * presence of diabetes mellitus or use of anti-diabetic agents * use of psychoactive and investigational medications * use of hormone replacement therapy * tobacco smokers * subjects with mri contraindications

Keywords: choline egg consumption alzheimer disease cognitive impairment dementia
duloxetine versus placebo in chronic low back pain

Conditions: Back Pain Without Radiation

Summary: the primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition. whether duloxetine once daily can help patients with chronic low back pain. patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. after the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.


Eligibility criteria:
inclusion criteria: * male/female outpatients 18 years of age with chronic low back pain * females of child bearing potential must test negative on a pregnancy test at visit 1. exclusion criteria: * have a serious or unstable diseases of the heart or blood vessels, liver, kidney, lungs, or blood-related illness * problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions * psychiatric conditions that, in the opinion of the investigator, would affect your participation or be likely to lead to hospitalization during the course of the study * have acute liver injury (such as hepatitis) or severe cirrhosis * have had previous exposure to duloxetine * have a body mass index (bmi) over 40 * have a major depressive disorder * require daily narcotics * have suicidal risk * have a presence of any factors/conditions, medical or other, that in the judgment of the investigator may interfere with performance of study outcome measures
pain perception during chorionic villus sampling

Conditions: Chorionic Villi Sampling

Summary: chorionic villous sampling is a frequent procedure used for antenatal genetic testing. this procedure is associated with anxiety and fear of pain that can be expected during the procedure, often prejudicing patients against this definitive antenatal testing. it is important to determine if different approaches to pain and anxiety reduction are effective. currently there is no randomized study to evaluate the efficacy of analgesia for pain reduction during chorionic villous sampling. multiple studies have been published suggesting that analgesia during the similar procedure of amniocentesis does not significantly reduce pain scores.

chorionic villous sampling (cvs) is a frequent procedure used for antenatal genetic testing. this procedure is associated with anxiety and fear of pain that can be expected during the procedure, often prejudicing patients against this definitive antenatal testing. it is important to determine if different approaches to pain and anxiety reduction are effective. previous studies have not shown that local anesthesia affects pain experience during amniocentesis (1-5). there are no randomized studies evaluating interventions for pain reduction during chorionic villous sampling which constitutes an important evidence gap. the study will be offered to women at \<13 weeks gestation, with a singleton fetus who are seen at mount sinai medical center for chorionic villous sampling. the eligible women will be randomized to one of two groups: use of analgesia using injectable lidocaine or ethyl chloride topical anesthetic spray. this study intends to show that local anesthesia during chorionic villous sampling will not decrease the perception of pain in patients undergoing this procedure. this trial is trying to determine perception of pain based on use of injectable lidocaine or ethyl chloride anesthetic spray; it is noted that the form of anesthesia may be a factor in perception of pain. the investigators do not know if there is a difference in perception for topical or injectable. if the perceived pain is comparable in topical and injectable, this trial could conclude that both are viable options, and while both present minimal risk to patients, topical is less invasive.

Eligibility criteria:
inclusion criteria: * \<13 week gestation * singleton gestations undergoing cvs exclusion criteria: * multiple gestations * more than one attempt of needle insertion * allergy or hypersensitivity to local anesthesia

Keywords: chorionic villus sampling pain anxiety
trajectory of body composition identifies lagc with cachexia following nact

Conditions: Locally Advanced Gastric Cancer; Trajectory

Summary: this longitudinal, multicentre cohort study included lagc patients treated with nact between 01/2010-12/2021. bc measurements including skeletal muscle mass (smm) and total adipose tissue area (tata) were evaluated by computed tomography at the third lumbar vertebra at baseline and follow-up imaging. unsupervised latent class growth mixed models were applied to distinguish potential longitudinal smm and tata trajectories for identifying cachexia. the primary study endpoint was overall survival (os), with secondary endpoints including recurrence-free survival (rfs), objective response rate (orr) and safety. multiple cox proportional hazards models were used to calculate adjusted hazard ratios (hrs) for survival.

this is a retrospective, longitudinal, multicenter, real-world cohort study

Eligibility criteria:
inclusion criteria:(1) locally advanced gastric cancer (ct2-4nxm0) with clinical staging before neoadjuvant chemotherapy, (2) no history of other malignant tumors, (3) no evidence of distant metastasis or invasion of adjacent organs, and (4) patients who underwent radical gastrectomy following neoadjuvant chemotherapy. - exclusion criteria: (1) history of gastric surgery; (2) acute cardiovascular disease (such as cerebrovascular or coronary artery injury) within the past three months; (3) emergency surgery; (4) active infection or severe systemic immunodeficiency; and (5) incomplete serological, computed tomography, or anthropometric data. -

Keywords: locally advanced gastric cancer neoadjuvant chemotherapy cachexia ct adjuvant chemotherapy
oral vancomycin for preventing clostridium difficile recurrence

Conditions: Clostridium Difficile Infection

Summary: this study evaluates the role of oral vancomycin in the prevention of recurrent clostridium difficile for hospitalized patients receiving systemic antibiotic therapy. half of participants will receive oral vancomycin daily, while the other half will receive a placebo.

clostridium difficile colitis is a significant cause of morbidity and mortality among hospitalized patients. following the first episode, up to 15% of people experience recurrent disease. a major risk factor for recurrent disease is exposure to systemic antibiotics. oral vancomycin given four times daily is one of the treatments for clostridium difficile infection; it is not known if giving oral vancomycin at a lower dose such as once daily may help prevent recurrences. oral vancomycin may be most helpful in preventing recurrences when given to patients at greatest risk of recurrent disease, such as when they are receiving systemic antibiotics. to evaluate this, the investigators propose comparing the rates of recurrent clostridium difficile infection in patients who receive oral vancomycin with systemic antibiotics to when patients take systemic antibiotics alone.

Eligibility criteria:
inclusion criteria: * age 18 years and older * any history of clostridium difficile infection based on a positive clostridium difficile stool test performed at a lab affiliated with rochester regional health system or patient report * a new in-patient admission, with an antibiotic treatment plan for greater than 48 hours exclusion criteria: * documented allergy and/or adverse drug reaction to vancomycin * pregnant * patients who are admitted with a current episode of clostridium difficile infection * patients with total colectomy

Keywords: clostridium difficile c diff oral vancomycin prophylaxis