Kornimate/medical-research-clean huggingface dataset:
natural course and prognosis of hospitalized patients with cirrhosis

Conditions: Liver Cirrhosis

Summary: the aim of this prospective study is to evaluate the natural course and prognosis of hospitalized patients with liver cirrhosis.

the aim of this prospective study is to collect data on hospitalized patients with liver cirrhosis at four institutions in korea (kangbuk samsung hospital, hallym university dongtan sacred heart hospital, chosun university hospital, and national medical center). if patients agree to participate in this clinical trial, the patients' data (such as age, sex, height, weight, nutrition status \[rfh-npt\], history of medication, laboratory findings, endoscopic findings, and radiologic findings) will be collected in a research database. the research database will be updated, every 6 months, to include data on patients' disease outcomes and follow-up care.

Eligibility criteria:
inclusion criteria: * hospitalized patients with liver cirrhosis * admission to the hospital because of cirrhotic complications such as uncontrolled ascites, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, hepatocellular carcinoma, acute kidney injury, bacterial infection, acute liver failure, and etc. exclusion criteria: * admission to the hospital without cirrhotic complications * patients who refuse the follow-up of outpatient department
the use of flowmet-r technology to predict wound healing in cli patients in a wound care center setting

Conditions: Critical Limb Ischemia

Summary: single-institution, prospective nonrandomized pilot study of critical limb ischemia patients with planned lower extremity revascularization will undergo flowmet-d measurements in a wound care center setting to determine threshold values associated with wound healing and amputation. a subset of patients will undergo hyperbaric oxygen therapy and will have flowmet-d measurements to determine those who respond best to therapy.

a single-institution, prospective nonrandomized pilot study will be conducted at stanford hospital and the stanford advanced wound care center (awcc). patients with clti by wifi criteria (abi or toe pressures) and a concomitant non-healing lower extremity wound will be recruited. inclusion criteria will include clti, at least one active lower extremity wound and planned lower extremity revascularization. abi/tbis will be recorded preintervention, post intervention and at one and three month intervals. intraprocedural characteristics including the number and location of vessels revascularized, patent runoff vessels pre and post procedure, pedal arch anatomy and presence of angiographic "blush" to wound will be documented. post-operatively, patients will be followed at the awcc where they will receive standard of care wound management including offloading, regular debridement, infection and edema management. flowmet-r perfusion values will be obtained prerevascularization, immediately post revascularization as well as weekly at each follow up awcc visit for a total of up to 6 months or until wound healing.wound size will be recorded. patients who undergo hyperbaric oxygen therapy (at the discretion of awcc surgeon) will have perfusion values performed before and after hyperbaric oxygen therapy sessions 1, 2, 10, 20, 30 and 40. hyperbaric oxygen therapy will be conducted 5 days a week for duration of 90 minutes. patients who undergo other advanced wound care treatments such as stem cell therapies or skin substitutes will also received flowmet-r prior to and after treatment. primary outcomes will be wound healing defined as complete skin epithelialization, wound improvement rate, major and minor amputations as well as need for repeat revascularization.

Eligibility criteria:
inclusion criteria: cli cohort: * cli by wifi criteria (abi or toe pressures) * non-healing lower extremity wound * planned lower extremity revascularization * able to provide informed consent * able to comply with study procedures hbo cohort: * all of the above * enrolled in hbo therapy post revascularization (at the discretion of the provider) exclusion criteria: * under 30 * wound not suitable for flowmet-d probe attachment
hysteroscopic guided endometrial sampling: prospective comparison between 5fr and 7fr biopsy forceps (hysterobio)

Conditions: Biopsy

Summary: indication for hysteroscopic guided biopsy compared to blind biopsy have been little evaluated. however, this kind of biopsy is usually performed in many centre. they allow exploration of uterine cavity but also to perform guided biopsies on the most suspicious area. however, with 5fr forceps, biopsy are often too small to conclude.

blind biopsies using novak or cormier cannula had limits. demirkiran et al conclude on 673 women that histology was similar between biopsies and hysterectomy in only 67% of cases. others studies conclude thatit is difficult to conclude about focal disease with blind biopsies. a study compared blind biopsies to biopsy performed under hysteroscopic guidance in women using tamoxifene and conclude that guided biopsies were more specific (80% versus 68.9%) and a better positive predictive value (68.9% versus 43.7%) for all kind of endometrial pathologies

Eligibility criteria:
inclusion criteria: * • woman over 18 year-old with abnormal uterine bleeding (or endometrium thickness over 10mm) and risk factors of endometrial carcinoma, or endometrium thickness over 5mm in a menopausal woman or abnormal uterine bleeding after 45 years old. * woman who speak and understand french * woman who give her written informed consent * woman covered by french medical insurance exclusion criteria: * • pregnant or breastfeeding patient * patient under guardianship, curators or safeguard of justice. * patient participating in another ongoing study.

Keywords: endometrial sampling hysteroscopy postmenopausal bleeding endometrial carcinoma
aminoglycosides and duct

Conditions: Patent Ductus Arteriosus

Summary: the aim of the study is to assess the effect of aminoglycoside treatment on ductal closure in preterms


Eligibility criteria:
inclusion criteria: infants born at or above 32 weeks of gestation - exclusion criteria: * infants who are unlikely to survive or have congenital heart defects
emotional disorders and outcomes in adults with type 2 diabetes mellitus at primary care

Conditions: Type 2 Diabetes Mellitus

Summary: this study aims to determine which factors are related to change in diabetes-related distress and change in depressive symptoms after three years of follow-up in asian adults with type 2 diabetes mellitus in primary care. the investigators will explore the impact of patient demographics, cardiometabolic control, medications adherence, health-related quality of life, self-efficacy and self-management behaviors on diabetes-related distress and depressive symptoms.

patients with type 2 diabetes mellitus (t2dm) have been shown to experience psychological burden and distorted illness perception. these psychological burden include feeling of burned-out, fatigue, distress and depression, and in addition of distorted illness perception often lead to difficulty in coping with the demands of life-style changes and adherence to medication. diabetes-related distress (drd) and depressive symptoms (ds) were associated with glycaemic control and medication adherence, and life-styles behaviors, respectively. however, evidence on the relationships between drd, ds and clinically significant outcomes are scarce in asian adults with t2dm. primary care patients who participated before will be re-invited. this is a repeated cross-sectional study of a cohorts of 700 patients who were first studied in 2013 (emotional distress in adults with type 2 diabetes mellitus \& quality of life \[eddmqol\] study with the national medical research register (nmrr) identification number: nmrr-12-1167-14158). demographic data (age, gender, ethnicity, religion, educational level, occupation and monthly income), smoking status, self-perceive social support and health literacy will be collected by questionnaires.

Eligibility criteria:
inclusion criteria: 1. those who participated in the eddmqol study 2. adults aged at least 30 year-old 3. diagnosed of t2dm more than three years ago 4. on regular follow-up with at least three visits in the previous year exclusion criteria: 1. patients who are pregnant or lactating 2. having psychiatric/psychological disorders that could impair judgments and memory 3. patients who cannot read or understand english, malay or mandarin

Keywords: mood disorders illness perception primary care medication adherence
pharmacokinetic study of ondansetron administered as ir (zofran) and mr (eur1025)

Conditions: Nausea

Summary: the objective of the study is to assess blood levels of ondansetron (eur1025 24 mg) dose and zofran 8 mg dose after single and multiple doses are given when taken with a meal and taken on an empty stomach.

the objective of this study is to evaluate the pharmacokinetics (pk) of ondansetron administered as a novel modified-release formulation (eur1025 24 mg) as well as the immediate-release formulation (zofran 8 mg) after single and multiple oral dose administration under fasting and fed conditions based on the requirements of the respective indications. the safety profile of each treatment will also be assessed by recording the nature, severity, frequency, duration and relation to the treatment of any adverse events.

Eligibility criteria:
inclusion criteria: * male and female volunteers * non- or ex-smokers * at least 21 years of age but not older than 55 years * body mass index targeted to be at least 18.5 and less than 30 kg/m2. * acceptable lab tests * normal 12 lead ecg * negative human chorionic gonadotropin (hcg) for females. exclusion criteria: * no known hypersensitivity to ondansetron or any related products * no presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption * no presence of significant heart disease or disorder discovered on screening ecg * not pregnant * no alcohol or drug abuse history * no use of any enzyme-modifying drugs, including strong inhibitors of cytochrome p450 (cyp) * no previous investigational product (in another clinical trial) or donated 50 ml or more of blood in the previous 28 days before day 1 of this study

Keywords: ondansetron, eur-1025
dendritic cells in lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: vaccination with autologous dendritic cells pulsed with allogeneic melanoma cell lysate (melcancervac) in combination with the cox-2 inhibitor of celecoxib for the treatment of patients with advanced or metastatic non-small cell lung cancer (nsclc). adjuvant aldara cream will be used as adjuvant for induction of inflammation at the injection site, and the lymphocyte growth factor of interleukin-2 (il-2) will be given as s.c. injection. the treatment aims at boosting the patient's specific immune system against the cancer cells.

vaccination with autologous dendritic cells pulsed with allogeneic melanoma cell lysate (melcancervac) in combination with the cox-2 inhibitor of celecoxib for the treatment of patients with advanced or metastatic non-small cell lung cancer (nsclc). adjuvant aldara cream will be used as adjuvant for induction of inflammation at the injection site, and the lymphocyte growth factor of interleukin-2 (il-2) will be given as s.c. injection. the treatment aims at boosting the patient's specific immune system against the cancer cells. patients with disseminated, inoperable nsclc after chemotherapy and patients not wanting chemotherapy for which no other systemic treatments can be offered. primary objective: to measure the antigen specific immunological reaction between vaccine antigens and the patients' immune system in vivo and in vitro. secondary objectives: to estimate the patients' survival time, to estimate response according to recist criteria, and to estimate the patients' quality of life during the study period. the study is designed as an open, phase ii, clinical study and will be carried out in accordance with the present protocol, ich/gcp guidelines and national, regulatory requirements. the first patient is expected to be included towards the end of 2006. inclusion period will continue for 2 years. follow-up will continue for approx. 6 months prior to reporting. fifty patients are planned for inclusion. in case none of the first fourteen (14) evaluable patients will respond, the inclusion and the study will be discontinued.

Eligibility criteria:

Keywords: dendritic cell tumor vaccine nsclc
treatment for nicotine addiction in women

Conditions: Nicotine Dependence

Summary: the purpose of this study is to use a medication tolcapone and or placebo to test if the symptoms of nicotine withdrawal lessens , and or changes in smoking urges, and mental reasoning in female smokers over a 72 hour period.

the proposed trail will be use a double-blind, placebo-controlled design to conduct the first randomized controlled trial of the comt inhibitor, tolcapone, in nicotine dependent women. this study will determine if tolcapone is superior to placebo by attenuation the severity of nicotine withdrawal and smoking urges during short-term abstinence. withdrawal severity will be assessed by a self-report scale and cognitive assessment, including a sustained-attention task. smoking urges will be assessed by a self-report scale.

Eligibility criteria:
inclusion criteria: * must be 18yrs to 45yr old woman, read and write in english. * must smoke at least 5 or more cigarettes a day * ftnd score at least 4 or higher * a co reading of 10 or higher during screening * must be in good health as verified by medical history, screening exam, screen laboratory tests. exclusion criteria: * excluded if using psychotropic medications, have contraindications to tolcapone use (e.g.. liver problems, allergy to tolcapone, history of no traumatic rhabdomyolysis or hyperpyrexia, confusion possibly related to medication), have other substance use disorder, are pregnant or breast feeding, have a current psychotic disorder, bipolar disorder, homicidal or suicidal ideation, have current (past month) substance use disorder, other than nicotine dependence, or are unable to fulfill the scheduled visits and procedures.
pilot study to evaluate a pharmacologically active nasal sponge following endoscopic sinus surgery

Conditions: Sinusitis; Chronic Sinusitis

Summary: this study will compare the incidence of post-op infection after sinus surgery using conventional post-op oral antibiotics to the incidence of infection after sinus surgery when a bio-resorbable antibiotic soaked nasal sponge is used in the nasal cavity in lieu of post-op oral antibiotics. the nasal sponge is a routine nasal dressing used after sinus surgery and will therefore be placed in all patients.

sinusitis affects 37 million people each year making it one of the most common health problems in the united states. it has a large impact in direct healthcare expenditures, significant loss of workplace productivity and a greater impact on quality of life than diabetes or congestive heart failure. the most frequently used treatments are medications and/or functional endoscopic sinus surgery(fess). 100 subjects undergoing ess will participate, randomized into two groups, treatment and control. all subjects will have a nasopore sponge placed into the middle meatus of the nose at the end of the procedure(the sponge is fda approved and commonly used. subjects in the treatment group will receive a nasopore sponge soaked in bacitracin solution. these subjects will not receive oral antibiotics post-operatively. the control group subjects will have a saline soaked nasopore sponge laced during surgery and will receive routine oral antibiotics post-operatively. the hypothesis is that subjects who receive the antibiotic soaked nasal sponge in lieu of saline soaked nasal sponge will have infection rates comparable to those who receive systemic antibiotics, but because they will not receive systemic antibiotics, the treated group will have fewer side effects and the cost to treat them will be less.

Eligibility criteria:
inclusion criteria: * subjects requiring endoscopic sinus surgery exclusion criteria: * pediatric subjects \<18 years

Keywords: sinusitis chronic sinusitis nasal surgery functional endoscopic sinus surgery (fess) enoscopic sinus surgery (ess)
intra-operative nasal compression after lateral osteotomy to minimize post-operative peri-orbital ecchymosis and edema

Conditions: Rhinoplasty; Ecchymosis

Summary: periorbital edema and ecchymosis are common morbidities in the post-operative period after rhinoplasty. lateral osteotomy techniques used to reshape the bony nasal pyramid are large contributing factors to the degree of bruising and edema. this is due to injury to the angular vessels that are crossing the osteotomy sites. depending on the degree of swelling and bruising, it can cause difficulty with visual acuity in the early post-operative period. most importantly, this can be quite distressing to the patient and impact the time required to return to normal social activities. numerous studies have examined various interventions to reduce periorbital swelling and ecchymosis. these include peri-operative steroids, lidocaine with epinephrine injections, fibrin sealant, permissive intra-operative hypotension and subperiosteal osteotomy techniques. peri-operative steroids have been most extensively studied. recent meta-analysis by hatef et al, found that pre-operative steroids were effective for decreasing post-operative edema and ecchymosis. steroids however, carry with it the risks of psychosis, immunosuppression, weight gain, uncontrolled blood glucose and avascular necrosis of the hip. as such, broadly applicable and cost-effective techniques to minimize post-operative edema and ecchymosis without the risk profile of steroids would be ideal. taskin et al. recently examined the efficacy of the combination of intraoperative cold saline-soaked gauze compression and corticosteroids on rhinoplasty morbidity. the study group received compression with a cold saline soaked gauze to the nasal dorsum during the surgery and the control group received compression with a dry gauze. both groups received a pre-operative dose of intravenous steroids. the study group had significantly less periorbital edema and ecchymosis on post-operative days 1, 3, 5 and 7. this study unfortunately did not examine the role of compression alone and the study was performed in the presence of steroids, which is not routinely utilized by all surgeons. as such, the proposed study will provide evidence for the use of direct compression intra-operatively after lateral osteotomy in order to reduce post-operative edema and ecchymosis. the findings of this study may provide a simple, effective and non-costly technique to minimize the morbidity of rhinoplasty.


Eligibility criteria:
inclusion criteria: * all adult patients (18 years old and greater) undergoing rhinoplasty requiring lateral osteotomy exclusion criteria: * patients taking anti-coagulation medication, history of bleeding disorder and those who do not complete the follow-up schedule will be excluded from the study.
stem cell therapy for limbal stem cell deficiency

Conditions: Limbal Stem-cell Deficiency

Summary: this phase i study will collect preliminary information on the activity and safety of clsc. we will investigate the ability to manufacture and transplant clsc onto the cornea successfully at the time of surgery (feasibility), and have clsc begin to populate the ocular surface (efficacy) without serious adverse events (safety).

20 patients with severe to total limbal stem cell deficiency (lscd) in one eye attributable to injury or ocular surgery. the first 5 eyes will receive the clscs to determine the feasibility and safety. then the subsequent 15 eyes will be randomized into clsc group and a scleral lens treatment (scl) control group in a 2:1 ratio in blocks of 3 or 6 using a random number generator.

Eligibility criteria:
main inclusion criteria: 1. male or female ≥18 years of age. 2. best corrected visual acuity in the affected eye of 20/200 or less. 3. documentation of a lscd diagnosis and the central cornea is affected. 4. absence of lagophthalmos and eyelid abnormality 5. adequate forniceal depth is ≥ 5 mm. 6. lscd fails to resolve by surgical treatments of the ocular surface during the previous 6 months of screening visit. 7. if the etiology of lscd is due to chemical injury, a minimal interval of 1 year since the initial chemical injury is required. 8. a schirmer test result at 5 minute of ≥5 mm of wetting. 9. absence of active infectious keratitis in either eye at the enrollment visit. 10. have a life expectancy ≥ 2 years after enrollment. main exclusion criteria: 1. pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. 2. presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. 3. exposure keratopathy or lagophthalmos of the study eye. 4. persistent severe ocular surface inflammation and/or meibomian gland dysfunction 5. chemical injury occurred less than 12 months ago. 6. presence of ocular surface tumor. 7. uncontrolled diabetes with last hemoglobin a1c (hga1c) \>8.5. 8. presence of known allergies to any of the clsc components. 9. current participation in another simultaneous medical investigation or trial. 10. unable to be compliant with or complete the requirements of the study.
effect of life style modification and metformin on hypothyroidism with insulin resistance

Conditions: Hypothyroidism; Insulin Resistance

Summary: the aim of the study is the effect of lifestyle modification and metformin on hypothyroidism with insulin resistance

hypothyroidism happens when the thyroid does not create and release enough thyroid hormone in the body this make the metabolism slow down . thyroid hormones t3 and t4 maintain a fine balance of glucose homeostasis by acting as insulin agonistic and antagonistic. hypothyroidism can break this equilibrium and alter glucose metabolism, which can lead to insulin resistance. insulin resistance is defined clinically as the inability of a known quantity of exogenous or endogenous insulin to increase glucose uptake and utilization in an individual as much as it does in a normal population. in this work we assess the lifestyle modification (i.e. diet and exercise)and metformin on insulin resistance

Eligibility criteria:
inclusion criteria: * 1_ above 18 years with insulin resistance criteria according (the american association of clinical endocrinologists (aace) * 1)bmi of 25 kg/m2 or higher * 2)waist circumference of more than 102 cm in men or more than 88 cm in women * 3)triglyceride level of 150 mg/dl . or higher. * 4) hdl-c level of less than 40 mg/dl in men or less than 50 mg/dl in women * 5)blood pressure of 130 /85 mmhg or higher * 6)fasting glucose level of 110 ـ126 mg /dl * 7)glucose level of more than 140 mg/dl2 hour after administration of 75 g of glucose 2_ patients known to have hypothyroidism and achieving diagnostic criteria of insulin resistance exclusion criteria: * patients don't have other secondary causes of insulin resistance i.e. acromegaly, cushing syndrome 3- patient have renal or hepatic impairment (contraindication to metformin )