Kornimate/medical-research-clean huggingface dataset:
evaluating the efficacy and safety of oral ranirestat (40 and 80 mg) in mild to moderate diabetic sensorimotor polyneuropathy

Conditions: Mild to Moderate Diabetic Sensorimotor Polyneuropathy

Summary: the purpose of this study is to determine the effect of 40 mg and 80 mg ranirestat on peroneal motor nerve conduction velocity relative to placebo in subjects with mild to moderate diabetic sensorimotor polyneuropathy.


Eligibility criteria:
inclusion criteria: * subjects with type 1 or type 2, insulin-dependent or non insulin-dependent diabetes mellitus. * subjects with a history of distal symmetric polyneuropathy, secondary to diabetes, diagnosed in accordance with the american academy of neurology criteria. * female subjects, who are of non-reproductive potential (\>=12 months post-menopausal or surgically sterile) or who are using adequate contraception which includes abstinence or double barrier methods (diaphragm and condom with spermicidal cream, intrauterine device and condom with spermicidal cream). male subjects with partners of child-bearing potential must also use adequate contraception. * subjects must be able to read, understand, and provide written informed consent before enrolling in the study at screening. exclusion criteria: * history of diabetic foot ulcers or lower extremity amputation. * diabetic amyotrophy or non-diabetic cause of lower limb neuropathy/neuropathic symptoms. * clinically significant illness which, in the opinion of the investigator, would compromise a subject's suitability to participate in the study for reasons of safety or would confound the efficacy assessments.
diet versus control pregnant barbadian women gestational weight gain trial

Conditions: Obesity; Gestational Weight Gain; Obesity, Maternal

Summary: the researcher will study a group of pregnant barbadians with bmi at booking of greater than or equal to 35. all of the women will be given leaflets telling them about healthy diets in pregnancy and how to limit weight gain. half of the women will be sent to the dietitian for small group classes on diet and how to limit weight gain. the two groups of women will be compared to see which group gains more weight and which group has more complications during the pregnancy.

more than 2100 pregnant women per annum deliver their babies at the queen elizabeth hospital, the lone publicly-funded hospital providing secondary and tertiary-level obstetric care in barbados. routinely recorded data do not capture whether patients are overweight or obese. thus, the prevalence of obesity is not known amongst this population. additionally, these women are not routinely referred for dietician services, and thus the impact of dietician intervention is not known. the aim of this research is to determine whether a dietitian-led intervention could lead to decreased gestational weight gain and less incidence of foetal macrosomia in a sample of barbadian women, with class ii obesity, attending a public antenatal clinic. prior studies examining gestational weight gain, found no statistically significance between groups when a bmi of 30 was used. it is hoped that by using a group with higher obesity a larger difference will be seen with the intervention. participants with body mass index greater than 35kg/m\^2 who meet the eligibility criteria will be selected from one of five antenatal clinics at the queen elizabeth hospital on the island of barbados. they will be randomised to either receive didactic dietary sessions or a standard education tool. mean weight change will be compared amongst the two groups after delivery to determine if there was a decrease in gestational weight gain amongst the intervention group.

Eligibility criteria:
inclusion criteria: * woman over 18 years old * live singleton pregnancy * bmi of greater than or equal to 35kg/m\^2 * registered patient of the queen elizabeth hospital antenatal clinic exclusion criteria: * presence of gestational diabetes or chronic diabetes mellitus, * have had bariatric surgery * do not speak english * pregnancy with a multiple gestation.

Keywords: obesity gestational weight gain pregnancy afro-caribbean barbadian barbados
expression of s100a2 and trefoil factor family members in epstein-barr virus related gastric cancer

Conditions: Gastric Cancer

Summary: the investigators hypothesize that aberrant hypermethylation of tumour suppressor genes is an important mechanism for epstein-barr virus (ebv) - related gastric carcinogenesis, the promoter hypermethylation status and the expression of s100a2 and tff1 might be different between ebv-associated gastric cancer (gc) and non ebv-associated gc.


Eligibility criteria:
inclusion criteria: * nil exclusion criteria: * nil
study of mocetinostat in patients with urothelial carcinoma having inactivating alterations of specific genes

Conditions: Urothelial Carcinoma

Summary: mocetinostat is an orally administered histone deacetylase (hdac) inhibitor. this study is a phase 2 trial evaluating the efficacy of mocetinostat in patients that have advanced urothelial carcinoma that has specific changes in tumor genes. patients must have previously received treatment with chemotherapy that included a "platinum-containing agent" such as cisplatin. the study will enroll in stages, with 15 patients in the first stage. more patients will be added to the study if enough patients having beneficial responses are observed. mocetinostat will be administered using oral capsules three times each week (eg, monday, wednesday and friday). the study is designed to evaluate whether the number of patients responding to treatment is substantially higher than would be expected with other available treatments.

to be eligible for this study, patient tumor testing must demonstrate a genetic alteration resulting in the loss of function of the histone acetyltransferase (hat) family genes, crebbp and/or ep300, including gene deletions or selected inactivating mutations. if testing has not already been performed, the study will provide for the testing.

Eligibility criteria:
inclusion criteria: * diagnosis of urothelial carcinoma * metastatic or locally advanced disease * prior chemotherapy that included a platinum agent * test results showing genetic change in tumor gene for crebbp and/or ep300 * at least one tumor that can be measured exclusion criteria: * uncontrolled tumor in the brain * impaired heart function

Keywords: urothelial bladder hdac mgcd0103 mocetinostat crebbp ep300 mirati methylgene
risk-adapted screening in first-degree relatives of patients with colorectal cancer

Conditions: Colorectal Neoplasms

Summary: background: first-degree relatives of patients with colorectal cancer are at increased risk for colorectal cancer as well. nevertheless, participation in the german national screening program stagnates at 2-3 percent per year even in this high-risk population. aim: the study is aimed to increase the portion of the first-degree relatives on 50% which take up a preventive colonoscopy. methods: cluster-randomized controlled multi-center trial. study sites (clusters) are mainly certified cancer centers and office-based gastroenterologists from all over germany. index-patients with colorectal cancer of different stages are asked to hand over the study material to their relatives, consisting of an invitation to a nurse-led counseling on preventive colonoscopy and an one-to-one appointment with a clinical expert of one of the study sites next.


Eligibility criteria:
inclusion criteria: * aged 18 and over * being first-degree relatives of patients with diagnosed colorectal cancer * able to understand german exclusion criteria: * familial adenomatous polyposis * utilization of diagnostic colonoscopy within the past 5 years * being ever treated for colorectal cancer * actual inflammatory bowl disease * comorbidities associated with reduced further life expectancy (ecog performance status \>3

Keywords: colorectal neoplasms/*drug therapy/*secondary health services accessibility humans supportive care needs psychooncology primary health care/*methods treatment outcome socioeconomic factors quality assurance, health care adult aged aged, 80 and over
study of sdmb (2,2 dimethylbutyrate, sodium salt) in beta thalassemia intermedia in thailand

Conditions: Beta Thalassemia Intermedia

Summary: beta thalassemia intermedia is an inherited blood disease caused by molecular mutations which reduce the beta globin protein chain of adult hemoglobin a, the protein in red blood cells which carries oxygen throughout the body. beta thalassemias cause progressively severe anemia, widespread organ damage, and often require blood transfusions. there is no fda approved therapeutic to treat the underlying cause of beta thalassemia. fetal hemoglobin is another type of endogenous hemoglobin which can replace the reduced beta globin protein, reduce the anemia, and even abolish transfusion requirements. this type of hemoglobin is normally suppressed in infancy. sodium 2,2 dimethylbutyrate (st20, or hqk-1001) is a small molecule which stimulates production of fetal hemoglobin in nonhuman primates and in human patients in phase i/ii trials. this is a phase 2 open-label trial to evaluate the ability of this oral therapeutic to reduce anemia in patients with beta thalassemia intermedia, when administered once daily for 26 weeks. all participants will receive the study drug.

this trial will: 1. determine the proportion of patients in which treatment with the study drug results in an increase in total hemoglobin by 1.5 g/dl above baseline levels when administered for 26 weeks in thai patients with beta thalassemia intermedia, including hemoglobin e beta thalassemia. 2. determine the number and proportion of participants in whom treatment with the study drug results in an increase in fetal hemoglobin. 3. determine the number of participants who have adverse events.

Eligibility criteria:
inclusion criteria: * diagnosis of beta thalassemia intermedia * splenectomized * average of two hgb levels between 6.0 and 9.0 g/dl exclusion criteria: * red blood cell transfusion within 3 months of study drug initiation * enlarged spleen * use of hydroxyurea within 6 months * qt segment corrected (qtc)\> 450 msec (men) or 470 msec (women) on screening ecg * use of iron chelating agents within 7 days of first dose * alanine transaminase(alt)\> 4 times the upper limit of normal * use of erythropoiesis stimulating agents (esas) within 90 days of first dose * serum creatinine \> 1.5 mg/dl

Keywords: thalassemia anemia fetal hemoglobin
the evaluation of postoperative pain after caesarean section

Conditions: Pain

Summary: the aim of this study is to determine the effect of surgical priority either emergency or elective on postoperative pain in caesarean section operations. patients whose undergo caesarean section operation are included into this study. patients will invite to complete the pain catastrophizing scale questionnaire in preoperative period. the patients will be divided into two groups in terms of applied surgical priority whether emergency or elective. after caesarean section, patient controlled analgesia is used for pain relief. and the intensity of pain will be measured by using numerical rating scale.

pain is the main problem of postoperative period. postoperative analgesic consumption can be associated with physical and psychological condition of the individual. this study is aimed to investigate the effect of surgical priority either emergency or elective on postoperative pain in caesarean section operations. patients are invited to complete the pain catastrophizing scale questionnaire in preoperative period. a total of 100 patients will be included into the study. patients are divided into two groups in terms of surgical priority whether emergency or elective. spinal or general anesthesia will be performed to the patients. in postoperative period, patient controlled analgesia will be applied for pain relief and numerical rating scale is used to determine the pain intensity in 1st, 2nd, 6th, 12th, 24th hours. the analgesic consumption in 24 hours will be recorded.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists score of 1 or 3 and 1-emergency or 3-emergency exclusion criteria: * patients whose not to participate * patients whose have communication problems * patients whose have been using antipsychotic or antidepressant drugs

Keywords: pain pain catastrophizing cesarean section
long covid-19 and mab study

Conditions: COVID-19

Summary: this study will be observational only. it will provide real-world evidence generated from a representative and large-scale covid patient base. the adoption, pilot testing and use of nih pros among viral tested patients with research purpose on long covid will be unique and innovative. with the existing and proven scientific rigor, nih pro system will be adopted, then modified and tailored to form the long hauler specific, comprehensive instrument, helping generalize future knowledge regarding covid-infected patients.


Eligibility criteria:
inclusion criteria: * have been tested for covid at one of the multicare facilities, * and 18 years old or older at the viral test, * and have no problem understanding english or spanish. exclusion criteria: * pediatric patients younger than 18 years old at the time of testing, * or patients who are pregnant, * or patients who plan to get pregnant in 3 months, * or patients who are hospitalized at the time of recruitment, * or patients who have cognitive impairment(s) at the recruitment.
renal perfusion, filtration and oxygenation during cardiopulmonary bypass (cpb)

Conditions: Complication of Extracorporeal Circulation; Renal Impairment

Summary: acute kidney injury is a common complication after cardiac surgery with cardiopulmonary bypass (cpb). this study aims to investigate the effects of cpb on renal perfusion, filtration and oxygenation.

after approval of the regional ethics committee, patients (n=16) undergoing combined cardiac surgery procedures during normothermic cpb will be included after informed consent. systemic and renal variables will be measured by pulmonary artery and renal vein catheters. glomerular filtration rate (gfr) will be measured by renal extraction of 51cr-edta and renal blood flow (rbf) by the infusion clearance technique for para-aminohippuric acid (pah) corrected for by renal extraction of pah. repeated measures anova followed by fisher's plsd post-hoc test were used for statistical analyses

Eligibility criteria:
inclusion criteria: * preserved left ventricular function (lvef \> 50%) * normal preoperative s-creatinine exclusion criteria: * contraindications to radiocontrast * cardiac transplantation och dissection
spinal cord stimulation for chronic and intractable back pain

Conditions: Back Pain

Summary: the purpose of this study is to evaluate the efficacy of spinal cord stimulation (scs) using the precision implantable neurostimulation device for chronic and intractable back pain in subjects who are not candidates for surgery or who have chosen to seek alternative therapy.

management of symptoms of chronic back pain and/or lumbar radiculopathy is often difficult and inadequate. current treatment options include pharmacological treatments, physical therapy, nerve blocks, surgical interruption of the pain pathway, or back surgery. many patients either do not have adequate pain management with conventional treatments or are not able to tolerate the treatments due to significant side effects. similarly, many patients are either not candidates for surgical interventions, or are unwilling to undergo such procedures. spinal cord stimulation has proven to be an effective treatment for patients with pain following a failed back surgery, and this study will investigate spinal cord stimulation as a treatment option for the treatment of chronic back pain in patients who have never had back surgery. a successful study outcome will establish spinal cord stimulation as a less-invasive treatment option to be considered prior to surgery.

Eligibility criteria:
inclusion criteria: * have chronic and intractable neuropathic back pain and/or lumbar radiculopathy of moderate to severe intensity and have elected spinal cord stimulation (scs) as next line of treatment. * be 18 years of age or older. * be an appropriate candidate for the surgical procedures required for scs implant. * be willing and able to comply with all study related procedures and visits. * be capable of reading and understanding patient information materials and giving written informed consent. exclusion criteria: * have had any back or spine surgery. * have any evidence of neurologic instability or any anatomic problem of the spine that requires surgery. * have any other chronic pain conditions likely to confound evaluation of study endpoints. * are a current substance abuser (including alcohol and illicit drugs). * have a significant psychiatric disorder. * have a condition currently requiring or likely to require the use of mri or diathermy. * have an active implantable device. * are pregnant or lactating or planning to become pregnant in the next year. * have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study during the year.

Keywords: chronic back pain intractable neuropathic back pain lumbar radiculopathy spinal cord stimulation
efficacy and safety assessment of ire of localized prostate cancer.

Conditions: Prostate Cancer; Prostate Adenocarcinoma

Summary: the purpose of this study is to evaluate safety and short-term oncological efficacy of the nanoknife irreversible electroporation system for localised prostate cancer. irreversible electroporation (ire) is the method of focal treatment for prostate cancer, which is already proven by fda as method of the surgical ablation of soft tissue. it has not received clearance for the therapy or treatment of any specific disease or condition.

irreversible electroporation is a newly developed non-thermal tissue ablation technique in which short duration electrical fields are used to form permanent nanoscale defects in the cell membrane which leads to cell apoptosis. thus, ire is a non-thermal technique, which means that changes associated with tissue freezing or heating are not relevant. moreover, animal studies of ire in the canine prostate have demonstrated that structures such as ejaculatory ducts, neurovascular bundles, blood vessels, and the urethra heal normally after ablation. the reason is that collagen matrix during treatment with ire is not destroyed thus allowing for a large structures (blood vessels, nerves, etc.) to heal normally. this study is a prospective and non-randomized with one group of 10 patients eligible for focal therapy of prostate cancer with ire (eligibility defined by this protocol). before the surgery all patients will underwent transperineal mri-fusion biopsy to localize the prostate cancer foci. objectives of the study: to asses safety of ire in patients with localized pca, to asses short-term oncologic efficacy of ire in patients with localized pca, to asses functional outcomes after ire. all patients will be followed up for 1 year (each 3 months).

Eligibility criteria:
inclusion criteria: * verified with mr-fusion biopsy localized pca * psa \< 15 ng/ml * gleason score 3+3=6; 3+4=7 or grade group 1 and 2 * life expectancy \> 10 years * no post-void residual urine or infravesical obstruction exclusion criteria: * patients with artificial cardiac pacemaker * patients without rectum * patients not eligible for general anesthesia * pirads\<3 * patients after primary pca treatment * hormonal therapy six months before the study * radiotherapy of pelvic organs * urinary infection * extracapsular pca * patients with metastatic lesions

Keywords: prostate irreversible electroporation prostate cancer
effectiveness of a web-assisted quitline for smokeless tobacco users

Conditions: Tobacco Use Disorder

Summary: the purpose of this record is to test whether (a) participants who receive a web-based smokeless tobacco cessation intervention will be more likely to be abstinent than participants who do not receive this intervention, and (b) whether participants who receive a telephone quitline intervention will be more likely to be abstinent than participants who are not in a quitline intervention.

many americans engage in the habitual use of smokeless tobacco (st), and many wish to quit but lack resources. there is a need for innovative, validated, and easily delivered low-cost interventions to facilitate st cessation in this under-served population of tobacco users. in our current chewfree study, we have developed a user-friendly, interactive web-based intervention, and in a randomized trial we have shown this website to be more efficacious than a rigorous control condition that offered web-based basic textual information on st cessation. we now seek to extend this proven approach by marrying it with a quitline telephone counseling service that has been used with noteworthy success for smoking abstinence but has not yet been evaluated with st users. our 2 x 2 design and large sample size allow us to test both main effects - web program, phone counseling - as well as explore planned comparisons to examine the value-added contribution of the web-based intervention to phone counseling, and vice-versa. this project takes advantage of the opportunity to conduct a study of two tobacco cessation interventions that are growing in use. the use of tobacco help lines is now almost ubiquitous, with more than 30 state and national services now being offered. the use of the internet for health information and behavior change (including tobacco cessation) has been growing in popularity as well. the proposed project would be an extension of both lines of research, evaluating the relative efficacy of our internet-based program, telephone counseling, and the combination of both. we will use a multifaceted promotional plan to recruit more than 2,000 st users. the recruitment plan builds on the collaborative marketing efforts of a state tobacco control organization and organized promotion through media mailings, on-line advertising, and direct mailing. follow-up assessment data will be collected electronically via the internet supplemented by telephone follow-up. additional data will be derived from phone counselor notes and measures of website usage.

Eligibility criteria:
inclusion criteria: * current users of smokeless tobacco products (snuff or chewing tobacco) * use of smokeless tobacco products for at least 1 year * use of at least one tin or pouch per week * interest in quitting all tobacco * u.s. resident 18 years of age or older * ability to read english * willingness to share a phone number, e-mail, and mailing address * use of personal internet e-mail account at least once per week * informed consent exclusion criteria: * none

Keywords: smokeless tobacco chewing tobacco internet adolescent