Kornimate/medical-research-clean huggingface dataset:
evaluating blood glucose levels during infusion with hepagam b (hbig) in post-liver transplant patients

Conditions: Hepatitis B

Summary: hepagam b hepatitis b immune globulin (hbig) solution contains 10% maltose, which could possibly interfere with the measurement of glucose levels when using glucose non-specific tests. the purpose of this study is to determine whether use of hepagam b hbig shows an increase in glucose levels in the body using non-specific glucose monitoring, as well as specific glucose monitoring. the sponsor believes that this medication will not cause a significant increase in glucose levels in the body when measured by glucose non-specific tests.

background: hepatitis b immune globulin (hbig) is used post liver transplantation (olt) in hepatitis b surface antigen-positive recipients to prevent recurrence of hepatitis b. one formulation of hbig, hepagam b, contains the disaccharide maltose, which can potentially falsely elevate glucose readings when glucose nonspecific point of care (gnspoc) testing is used, such as a glucose dehydrogenase pyrroloquinolinequinone (gdh-pqq)-based method. this can result in inappropriate administration of antidiabetic agents and resultant episodes of clinically significant hypoglycemia. glucose specific point of care (gspoc) testing, such as a glucose oxidase-based method, however, is not affected by the presence of maltose. the purpose of this study was to determine if there was a significant difference in glucose readings using gspoc and gnspoc monitoring devices after hbig administration. methods: this is a nonrandomized, prospective study evaluating patients receiving maintenance hbig therapy over 3 months post liver transplantation. blood glucose levels in each subject were analyzed by gspoc and gnspoc devices at specific times around hbig administration.

Eligibility criteria:
inclusion criteria: * written informed consent * hbsag positive candidates for hbv related liver transplant to be placed on hepagam b therapy for the prevention of hbv recurrence in both the acute phase (immediately post operative) and the long term maintenance phase * at least 18 years of age exclusion criteria: * unable or unwilling to provide written informed consent * concomitant administration of other maltose containing products such as dietary supplements, dietary aids, ivig, external peritoneal dialysis solution in both arms * concomitant administration of corticosteroids in the long term maintenance phase * pregnancy, as determined by a pregnancy test administered after consent has been signed

Keywords: hepatitis b immune globulin hbig hepagam b orthotopic liver transplant
autologous platelet-rich plasma for clomiphene citrate-induced thin endometrium

Conditions: Infertility, Female, Associated With Anovulation

Summary: this is a prospective self-controlled clinical study. women with clomiphene citrate failure with thin endometrium less than 7 millimeters for at least 3 cycles will be selected (n = 30). patients will receive 2 ovarian stimulation cycles with clomiphene citrate (cc) 100 mg/ day for 5 days from cycle day 3. a control cycle (cc only cycle) woman will continue on cc alone plus cervical irrigation of cervix with 1 ml of 0.9% normal saline at cycle day 8 and 10 to assure patient-blinded method. the study group, the same will be done plus the intrauterine infusion of autologous platelet-rich plasma (prp) in 8th and 10th days of the cycle. in both groups, the endometrial thickness and power doppler evaluation of their endometrial and sub-endometrial blood flow will be measured on the day of human chorionic gonadotropin (hcg) administration.

this is a pilot prospective self-controlled clinical trial. women with clomiphene citrate failure with documented thin endometrium less than 7 millimeters for at least 3 stimulation cycles will be chosen (n = 30). patients will experience 2 ovarian stimulation cycles with clomiphene citrate (cc) in a dose of 100 mg/ day for 5 days starting from cycle day 3. a control cycle (cc only cycle) woman will continue on clomiphene citrate alone plus cervical irrigation of cervix with 1 ml of 0.9% normal saline at cycle day 8 and 10 to confirm patient-blinded process. the study group, the same will be done in addition to the intrauterine infusion of with autologous platelet-rich plasma (prp) in 8th and 10th days of the cycle. in both groups, the endometrial thickness and power doppler evaluation of their endometrial and sub-endometrial blood flow will be measured on the day of hcg administration.

Eligibility criteria:
inclusion criteria: * women with clomiphene citrate failure (defined as at least previous 3 ovulatory cycles with clomiphene citrate, with no pregnancy), * persistently thin endometrium (less than 7 millimeters in at least 3 cycles). * normal baseline follicle stimulating hormone, luteinizing hormone, and free testosterone levels, patent tubes by hysterosalpingography, and satisfactory male semen analysis exclusion criteria: * previous ovarian surgery; * endocrine disorders ; * pelvic pathologies; * chronic hepatic, cardiovascular, or renal disease; * other factors of infertility and * use of gonadotropins or hormonal contraception through the latest 6 months.
a study of edp-297 in healthy subjects

Conditions: NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis

Summary: this study is a randomized, double-blind, placebo-controlled study. it will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of edp-297 in healthy adult subjects.

the first phase assesses single ascending doses of edp-297 or placebo in healthy subjects. a "fasted" and "fed" two-part cohort will also assess food effect. the second phase assesses multiple ascending doses of edp-297 or placebo for 14-days in healthy subjects. each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive edp-297 or placebo. the cohort assessing food effect will enroll 10 subjects randomized to receive edp-297 or placebo

Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject. * healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive. exclusion criteria: * clinically relevant evidence or history of illness or disease. * pregnant or nursing females. * history of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. * a positive urine drug screen at screening or day -2. * current tobacco smokers or use of tobacco within 1 months prior to screening. * any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). * history of regular alcohol consumption exceeding 14 drinks/week for females and 21 drinks/week for males within 6 months of screening. * participation in a clinical trial within 30 days prior to the first dose of study drug.

Keywords: "first-in-human" single ascending dose multiple ascending dose healthy volunteer
financial support in an underserved and low-income population with heart failure

Conditions: Heart Failure, Systolic; Financial Stress; Medication Adherence; Quality of Life

Summary: the goal of this clinical trial is to test whether financial support in the form of a one-time $500 stipend would improve medication adherence and quality of life in low-income, socially-needy patients with heart failure with reduced ejection fraction in the post-discharge setting. the main questions it aims to answer are: * will financial support improve heart failure quality of life? * will financial support improve medication adherence? participants will complete surveys on quality of life, social stress, and spending habits at their baseline visit. participants will be randomly assigned to receive $500 at their baseline visit or $0 at their baseline visit. at their one month visit, quality of life and medication adherence will be assessed. these results will be compared between groups. the group that received $0 at their baseline visit will be provided $500 at their one-month visit and return for a two-month visit. at that visit, quality of life and medication adherence will be assessed. these results will be compared to their one-month results. researchers will compare the 1-month quality of life scores and medication adherence scores between the immediate financial support vs delayed financial support. researchers will also compare 1-month vs 2-month quality of life and adherence data for participants who were randomized to the delayed financial support group.


Eligibility criteria:
inclusion criteria: * age \> 18 * english speaking participants who completed social-hf study surveys * ejection fraction \<=40% and eligible for at least one component of gdmt * has at least some difficulty paying monthly bills (somewhat difficult and very difficult) * annual household income \<130% federal poverty limit * have at least two additional social needs based on the following domains: * cost-related nonadherence * food insecurity * housing instability * transportation difficulty * unemployment * household crowding: person/room ratio \>1 * rent burden: rent/income ratio \>30% * low social support * interpersonal violence * history of discrimination exclusion criteria: * unwilling to return for 1 and 2-month follow-up visits. * currently in jail or prison * primary residence outside dallas county * legal blindness * systolic blood pressure \<90 mmhg on screening * contraindications or intolerance all medications available for therapeutic drug monitoring (metoprolol, losartan, lisinopril, valsartan, and spironolactone) * unable to answer orientation questions.

Keywords: social determinants of health
effect of melatonin in pediatric hemodialysis patients

Conditions: Hemodialysis Complication; Oxidative Stress; Inflammation

Summary: a prospective, randomized, double-blinded, placebo-controlled trial will be conducted at the pediatric dialysis unit, children's hospital, ain shams university in order to investigate the benefits of melatonin supplementation on oxidative stress, inflammation and to assess sleep quality by using psqi questionnaire in pediatric hemodialysis patients.

1. patients will be recruited and evaluated for eligibility. 2. patients who meet the eligibility criteria will be randomly assigned to either placebo or intervention group. 3. patient demographics, clinical characteristics and full medical and medication history: will be obtained at baseline and every 4 weeks after the beginning of the study. 4. blood samples will be withdrawn from each patient before the dialysis session for assay of each of the following: 1.oxidative stress marker malondialdehyde (mda) by elisa assay. 2. inflammatory marker level nuclear factor kappa b (nf-kb) by elisa assay 3. complete blood picture (cbc). 4. lipid profile (total cholesterol(tc), triglycerides(tg), high-density lipoprotein (hdl) and low-density lipoprotein (ldl) 5)safety will be assessed weekly after the beginning of the study by monitoring the side effects or any adverse drug reactions. * a total of (40) patients on regular hd will be enrolled in the study. these patients will be randomly assigned in a 1:1 ratio into two groups: * the first group (n=20):the patients in the first group will receive a total daily dose of 5mg of melatonin tablets 1-hour before bedtime for 12 weeks. * the second group (n=20): the patients will receive one tablet of placebo for the same duration. * all subjects will sign an informed consent statement prior to inclusion in the study. * all subjects will be followed up weekly for 12 weeks and blood samples will be withdrawn at baseline and the end of the study.

Eligibility criteria:
all patients will be assessed for eligibility according to the following inclusion and exclusion criteria: inclusion criteria: 1. male or female patients age from 6-18 years old. 2. undergoing regular hd for at least 6 months prior to enrollment 3. not enrolled in any other clinical trial. 4. judged by the physician to be physically stable exclusion criteria: 1. patients receiving anti-epileptics. 2. patients with some autoimmune conditions as sle, ra or post-organ transplant 3. patients taking immunosuppressants. 4. patients taking warfarin. 5. patients receiving vitamin e, green tea or zinc during the past 3 months 6. patients with malignancy and/or active inflammatory disease 7. patients with mal absorption, mental retardation or psychiatric illness. 8. patients who had hemorrhagic episodes or received blood transfusion in the past 3 months prior to the enrollment.

Keywords: pediatric hemodialysis
effect of different materials used in orogastric tube removal on skin condition in premature babies

Conditions: Neonatal Skin Conditions

Summary: while medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. the study aims to compare the effectiveness of sunflower oil and silicone-based remover spray used during the removal of medical adhesives used in oragastric catheter fixation in preterm babies in the neonatal intensive care unit in preventing skin damage.

use of materials such as an endotracheal tube, orogastric catheter, nasal cannula, and peripheral vein catheter, which are frequently used in neonatal intensive care. medical adhesives are needed for fixing. while medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. many materials are being tested and developed in clinics to reduce this risk.skin barrier products minimize trauma in the removal of medical adhesives by creating a protective layer between the epidermis and the adhesive. silicone-based spray removers, one of the skin barrier products, are used in the entire patient population, including newborns.silicone-based spray removers leave residue on the skin as they evaporate easily. doesn't let go. since it does not contain alcohol, it does not cause pain. sunflower oil is a traditional method for premature when used in baby massage applied to babies, it increases the weight gain and height growth of babies and reduces the morbidity rate.the study aims to compare the effectiveness of sunflower oil and silicone-based remover spray used during the removal of medical adhesives used in oragastric catheter fixation in preterm babies in the neonatal intensive care unit in preventing skin damage.

Eligibility criteria:
inclusion criteria: * babies born between 32-36 gestational ages * babies admitted to neonatal intensive care * babies who have not had medical adhesive tape applied to their lips before * babies who do not have any skin diseases * noninvasive mechanical ventilation or free ventilation in the intensive care unit * babies who need oxygen * babies who do not have any obstacle to inserting an oragastric catheter exclusion criteria: * babies followed intubated in care * babies with any skin disease * babies with a disease that is not suitable for oragastric catheter insertion * babies for whom medical adhesive should not be applied on the lips

Keywords: neonatal skin care sunflower preterm slicone based spray
customized oral and maxillofacial reconstruction

Conditions: Prosthesis Failure, Dental; Dental Implant Failed

Summary: regional oral and maxillofacial defects secondary to ablative tissue resection can contribute to severe aesthetic and functional loss, which influences patients' regular life and may cause psychological problems. microvascular free flaps are considered the gold standard for reconstructing large oral and maxillofacial defects. in the past decade, with the help of computer-aided design (cad)/ computer-aided manufacturing (cam) customized implants and prosthesis (cip) have led to a significant improvement of the operative accuracy, improve the flap survival rate and enhance the patients' quality of life. concerning the increased overall survival rate of the patients, people pay more attention to the quality of life and aesthetic appearance which are influenced by the fitness and compatibility of the cip. however, from literature reviews, the evaluation was various to be concluded in some certain conditions from pooled studies.

the trial will be conducted in compliance with the principles of the declaration of helsinki (specifying which amendment), the principles of gcp, and all of the applicable regulatory requirements. this protocol and related documents will the for review to the ethics committee. the investigator and the participating site shall treat all information and data relating to the study disclosed to participating site and/or investigator in this study as confidential and shall not disclose such information to any third parties or use such information for any purpose other than the performance of the study. the collection, processing, and disclosure of personal data, such as patient health and medical information is subject to compliance with applicable personal data protection and the processing of personal data (directive 95/46/ec and belgian law of december 8, 1992, on the protection of the privacy in relation to the processing of personal data). the extracted data will be encoded, the subject's ead-number will be stored separately(site file) from the research data and replaced with a unique study id-code to create a new identity for the subject. the file containing the patient-specific ead-numbers will be kept on a secured uz leuven servers.

Eligibility criteria:
inclusion criteria: * 1. patients with grafted bone (fibula, iliac, scapula) and receive postoperative implant surgery. 2.clinical and radiogram data were available for all treatment periods and follow-up visits (pre-/post-cbct and panoramic radiographs). 3.over twelve months follow-up period after implant placement. 4.age \> 18 years. 5.fabrication and delivery of prosthesis following implant installation. 6.treatment with a one-stage/two-stage surgical protocol. exclusion criteria: 1. patients diagnosed with osteoporosis. 2. lost or missing medical history during follow-up period. 3. follow-up period of dental implants was less than 12 months.

Keywords: dental implants mandibular reconstruction mouth rehabilitation
goal attainment scaling (gas) sub-study

Conditions: Alzheimer's Disease in Down Syndrome

Summary: this is an optional sub-study that will enroll participants from life-dsr parent protocol. the aim is to assess change over 16 months in individuals with down syndrome through individualized goals set by their caregivers. this sub-study also aims to assess the feasibility of goal attainment scaling in the ds-ad population.

people with down syndrome are living longer. a longer life increases the chances of age-related risks of developing alzheimer's disease and other forms of dementia. there is also growing evidence that people with down syndrome respond differently to treatment than people without down syndrome. this creates an important need to create a way to identify and follow changes in thinking and behavior as people with down syndrome age and start to experience symptoms of dementia. here, the investigators are testing a new method to monitor changes (in thinking and behavior) called goal attainment scaling. during this study, the participant will be asked to take part in a goal attainment scaling interview, which means working with a clinical rater (the participant's health care provider or other study team) to identify personally meaningful goals to follow for the study. "goals" are based on symptoms or challenges experienced by the person for whom cares for the participant with down syndrome. the identified goals may be related to potential early signs and symptoms of alzheimer's disease. these goals will then be reviewed at 2 time-points over the next 16 months. the investigators want to learn whether this type of interview can help the investigators understand what symptoms or challenges are important to the participant and whether this type of interview can help the investigators understand how these might change over time. the investigators also want to hear the participant's feedback about the participant's experience with goal attainment scaling at the end of the sub-study. the investigators will be asking about 45 participants to take part in this study. this study is observational and does not test a study drug.

Eligibility criteria:
inclusion criteria: the participant with ds and caregiver must be currently enrolled in the life-dsr parent protocol. the participant with ds must be age 35 years or older. both the participant with ds, or lar, and their caregiver must be able to understand and be willing to sign written informed consent. in the opinion of the investigator, a participant's caregiver must have frequent interaction with the participant on a regular basis, agree to participate in clinic and remote visits, be able to provide accurate responses to questions about the participant with ds, and be capable of facilitating participation in the study visits. participant with ds and caregiver must be capable of reliably completing all study assessments at each time-point. the caregiver must be able to converse in english. exclusion criteria: unable to complete trial procedures or adhere to the schedule of study assessments, in the opinion of the site pi.

Keywords: down syndrome alzheimer's disease