Kornimate/medical-research-clean huggingface dataset:
tacrolimus and risk factors for glucose metabolism disorders in kidney transplant patients

Conditions: Kidney Transplant

Summary: many people who receive a kidney transplant develop problems with how their body processes sugar (glucose). this includes conditions like prediabetes and diabetes, which can lead to more health issues, such as heart problems and infections. one of the main medications used after a kidney transplant, called tacrolimus, can contribute to these sugar problems. tacrolimus helps protect the new kidney, but it can also harm the cells in the pancreas that produce insulin, a hormone that controls blood sugar. other factors, such as stress on the body and insulin resistance, can make things worse. the effect of tacrolimus on blood sugar may depend on how the body processes the drug. some people break down tacrolimus quickly (fast metabolizers), so they need higher doses to reach the right level in their blood. others break it down more slowly (slow metabolizers) and require lower doses. doctors can measure how fast someone metabolizes tacrolimus using aparameter called the concentration-to-dose (c/d) ratio. this study aims to find out what increases the risk of developing blood sugar problems after a kidney transplant. it will focus on how quickly patients process tacrolimus and whether this affects their risk of developing diabetes. the study will also look at how common these issues are in kidney transplant patients in poland.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * recipients of a kidney transplant from a living or deceased donor * standard immunosuppressive regimen post-kidney transplantation (ktx) including envarsus® * lcp tacrolimus therapy initiated from the day of ktx or conversion from another tacrolimus formulation to lcp tacrolimus by day 8 at the latest, according to the institution's routine practice * informed patient consent to participate in the study exclusion criteria: * diagnosis of diabetes (type 1 or type 2) treated with diet or glucose-lowering drugs * random glycemia/hba1c levels justifying a diagnosis of diabetes at the time of study enrollment * kidney retransplantation * recipients of a multi-organ transplant * use of glucagon-like peptide-1 (glp-1) receptor agonists for weight loss * use of flozins for renal or cardiac indications * chronic use of drugs affecting carbohydrate metabolism, such as glucocorticosteroids
study of en-374 gene therapy in participants with x-linked chronic granulomatous disease

Conditions: X-Linked Chronic Granulomatous Disease

Summary: the goal of this clinical trial is to evaluate the safety and potential efficacy of the en-374 treatment regimen and identify a dose level for further evaluation in participants with x-linked chronic granulomatous disease. the main questions it aims to answer are: * safety of the en-374 treatment regimen * effect of the en-374 treatment regimen on the production of functional neutrophils with nadph oxidase activity

chronic granulomatous disease (cgd) is a rare primary immune deficiency disorder characterized by recurrent bacterial or fungal infections starting in infancy. the x-linked form of cgd (x-cgd) is caused by mutations in the cybb gene. en-374 is a helper-dependent adenoviral (hdad)-based gene therapy in development for the treatment of x-cgd using an in vivo approach, which is administered by iv infusion, to genetically modify hematopoietic stem cells (hscs) to express a wild-type cybb gene. the en-374 treatment regimen includes hsc mobilization, immune prophylaxis, en-374 administration, and enrichment of genetically modified hscs. adult participants with x-cgd will be enrolled into the dose-escalation part of the study. following completion of the adult cohorts, then pediatric participants will be enrolled into the dose-expansion part of the study in decreasing age cohorts from ≥ 12 and \< 18 years of age, to ≥ 2 and \< 12 years of age, and finally to ≥ 3 months and \< 2 years of age.

Eligibility criteria:
inclusion criteria: * male * ≥ 18 years of age during dose escalation, then ≥ 3 months of age during dose expansion * diagnosis of x-cgd with dhr+ cells ≤ 5% and a pathogenic mutation in the cybb gene * history of at least 1 severe infection requiring medical intervention or chronic inflammatory disorder * does not have a suitable, available, and willing human leukocyte antigens (hla)-matched (10/10) related donor * non-sterile male participants who are or may become sexually active with female partners of childbearing potential are required to use highly effective contraception * informed consent, with informed assent from capable participants * adequate organ function exclusion criteria: * active bacteremia or fungemia * history of human immunodeficiency virus (hiv), hepatitis b, or hepatitis c * history or clinical evidence of any medical or social issues likely to put the participant at additional risk or to interfere with study conduct * history of hsct or granulocyte transfusions * known hypersensitivity to elements in the treatment regimen * undergone investigational gene therapy * treated with another investigational drug product within 30 days before screening * unable to comply with the visits and requirements of the protocol as determined by the investigator

Keywords: cgd x-cgd chronic granulomatous disease x-linked chronic granulomatous disease granulomatous disease, chronic genetic therapy gene therapy in vivo gene therapy gene addition therapy in vivo gene addition therapy hematopoietic stem cell gene therapy in vivo hematopoietic stem cell gene therapy
a study of poziotinib in previously treated participants with locally advanced or metastatic nsclc harboring her2 exon 20 mutations

Conditions: NSCLC

Summary: the primary purpose of this study is to compare the progression-free survival (pfs) in participants with locally advanced or metastatic non-small cell lung cancer (nsclc) harboring human epidermal growth factor receptor 2 (her2) exon 20 mutations when treated with poziotinib versus docetaxel.

this is a phase 3, active-controlled, multicenter study to compare the efficacy and safety/tolerability of poziotinib versus docetaxel in previously treated participants with locally advanced or metastatic nsclc harboring her2 exon 20 mutations. participants will be randomized in a 2:1 ratio to: * arm a: poziotinib 8 milligrams (mg), twice daily (bid) or * arm b: docetaxel 75 milligrams per meter square (mg/m\^2) the screening period lasts up to 21 days prior to cycle 1, day 1 (c1d1). participants will be treated in 21-day cycles or until disease progression, death, intolerable adverse events (aes), initiation of non-protocol anti-cancer treatment, or other protocol-specified reasons.

Eligibility criteria:
inclusion criteria: participant must: 1. be willing and capable of providing signed and dated informed consent, adhering to dosing and visit schedules, and meeting the study requirements 2. have histologically or cytologically confirmed nsclc 3. have at least one measurable nsclc target lesion per recist v.1.1 by local assessment 4. participant has had at least one prior systemic treatment for locally advanced or metastatic nsclc, including platinum and a checkpoint inhibitor (cpi) therapy, unless the investigator affirms that a cpi was not medically indicated. 5. have documentation of her2 exon 20 mutation 6. have an eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 7. have adequate hematologic, hepatic, and renal function at baseline as per protocol exclusion criteria: participant: 1. has had previous treatment with poziotinib for treatment of nsclc 2. has egfr or anaplastic lymphoma kinase (alk) genome tumor alterations 3. has had previous treatment with docetaxel for locally advanced or metastatic nsclc. if docetaxel was received in the neo-adjuvant or adjuvant setting, progressive disease must have occurred ≥6 months after the last dose to be eligible 4. has spinal cord compression or leptomeningeal disease 5. has a high risk of cardiac disease, as determined by the investigator 6. has a history of, or signs of grade ≥2 pneumonitis on current imaging studies 7. is unable to take drugs orally 8. is pregnant or breast-feeding

Keywords: epidermal growth factor receptor (egfr) her2 exon 20 mutation
regional ventilation during high flow nasal cannula and conventional nasal cannula in patients with hypoxia

Conditions: Hypoxia; Oxygen Therapy; High Flow Nasal Cannula; Ventilation

Summary: high-flow nasal cannula (hfnc) that uses heated and humidified oxygen was recently introduced for bedside care. it has been shown to be associated with reduced risks of tracheal intubation rates and mortality in adult hypoxic patients. the mechanisms of the effects of hfnc are thought to be related to the favorable effects of the heated and humidified gas, the high-flow rate used to minimize the entrainment of room air, and an increase in the ventilation efficiency, including the elimination of nasopharyngeal dead space, positive end-expiratory pressure (peep) effects, and improvements in paradoxical abdominal movement. regarding the effects on lung volume, global ventilation in the lungs increases during hfnc, which is thought to attribute to peep effects. however, how regional ventilation is affected during hfnc in comparison with conventional nc remains unknown. because peep in mechanically ventilated patients improves the regional homogeneity of ventilation, investigators postulated that hfnc via peep effects would result in more homogeneous regional distributions in the ventilation changes. investigators therefore assessed global and regional ventilation in patients with hypoxia receiving care via hfnc using electric impedance tomography and compared these results with conventional nasal cannula.


Eligibility criteria:
inclusion criteria: * age \>20 years * subjective dyspnea in room air * sao2\< 90% in room air * oxygen requirement for nasal cannula \< 6 l/m exclusion criteria: * unstable vital signs * sbp \<90 mmhg * dbp \< 60 mmhg * heart rate \> 120 bpm * respiratory rate \> 30 bpm * persistent dyspnea under oxygen therapy using nc * severe hypoxia * pao2/fio2\< 200 mmhg * unable to cooperate * delirium * reduced cognitive function
effects of community-center based dietary intervention on frailty prevention and regression in the elderly.

Conditions: Frailty

Summary: recent interventional studies have shown that frailty can be improved by modifying dietary quality. in this study, a set of nutrition-centric health promotion activities was developed in accordance with the taiwanese daily food guide for elderly participants of the community centers to improve their nutrition in everyday practice and examined the efficacy of these activities on slowing down the development or regression of frailty. the study was a cluster-randomized controlled trial. recruited community centers were randomly assigned into either the control or the intervention group. the intervention period lasted for 3 months. both the control and intervention groups received weekly one-hour group exercise training. the intervention group had an additional weekly one-hour group nutrition session. the intervention programs included: (a) training on-site staffs to use motivational interview techniques to communicate, to estimate participant's energy requirements, and to learn how to provide proper amounts of foods to individual elderlies, (b) nutrition grouped activities on ①know my plate, ②wholegrains, ③drinking teas with dairy, and nuts, ④novel ways to eat fruit and vegetables, ⑤healthy breakfast ideas. in the first month, participants were intervened with the activities laid out above; in the second month, participants were intervened with qualitative discussions on dietary changes; in the third month, participants were intervened with designed activities that helped break down barriers in order to establish a long-term change in dietary habits. improvement in nutritional status was the primary outcome. secondary outcomes included frailty scores, physical performance, and mental health. the measurements were performed at baseline, 3 months, and 6 months.


Eligibility criteria:
inclusion criteria: * aged 65 years or older * able to walk independently for 14 meters within 1 minute * willing to sign the informed consent exclusion criteria: * under dietary control by doctors' instructions * with mental illness, mental disorders, or unable to communicate * with severe diseases such as under treatments for cancer
a survey of maribavir tablets in participants with cytomegalovirus infection

Conditions: Cytomegalovirus (CMV)

Summary: this study is a survey in japan of maribavir tablets used to treat participants with cytomegalovirus (cmv) infection refractory to existing anti-cmv therapy in organ transplantation (including hematopoietic stem cell transplantation). the main aim of the study is to check if treatment with maribavir can protect japanese people against cmv infection, and to check side effect from the study treatment. the study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. during the study, participants with cmv infection will take maribavir tablets according to their clinic's standard practice. the study doctors will check for side effects from maribavir tablets for 27 weeks.


Eligibility criteria:
inclusion criteria: - all participants with cytomegalovirus (cmv) infection refractory to existing anti-cmv therapy in organ transplantation (including hematopoietic stem cell transplantation). exclusion criteria: - none

Keywords: drug therapy
vonoprazan in helicobacter pylori treatment an rct

Conditions: Helicobacter Pylori Infection

Summary: rct for comparison of standard triple therapy (omeprazole+amoxil+clarithromycin) for h pylori erradication with vonoprazan+amoxil dual therapy.

objective to compare the efficacy of vonoprazan based dual treatment versus ppi based treatment for the eradication of helicobacter pylori infection. operational definition helicobacter pylori infection: hp infection will be labelled by any one of following investigation: * helicobacter pylori stool antigen * histopathology on giemsa stain material and methods: study design: randomized control trial. setting: this study will be conducted in the medical opd and medical unit 1 of dr. ruth k.m. pfau, civil hospital karachi affiliated with dow university of health sciences data collection procedure: all patients presenting to the opd or medical unit 1 of dr. ruth km pfau, civil hospital karachi and fulfilling the inclusion criteria will be included after taking informed consent. the participants will be randomly allocated to 2 groups with help of random number table and will be treated for 2 weeks. group a: will be given: capsule amoxicillin 1 gm twice daily tablet clarithromycin 500 mg twice a day capsule omeprazole 20 mg twice a day group b will be given: capsule amoxicillin 1 gm twice daily tablet vonoprazan 20 mg twice a day confirmation of hp eradication will be done by stool hp antigen test 4 weeks after completion of treatment. data analysis data will be stratified according to age \& gender. frequency of gender \& mean (sd) of age will be compared between groups using pearson's chi-square test and student's t-test respectively. frequency of hp eradication between two groups will be compared using pearson's chi-square test. a p value \< .05 will be taken as significant.

Eligibility criteria:
inclusion criteria: * helicobacter pylori positive by any one of following: histopathology by giemsa stain stool antigen exclusion criteria: * • previous surgery of the stomach such as partial gastrectomy. * allergy to any of the antibiotics used in the study. * intake of antibiotics, ppis, corticosteroids, or nonsteroidal anti-inflammatory drugs within the last 2 weeks. * pregnant or lactating females. * alcohol abuse or drug addiction. * severe neurological or psychiatric disorder.

Keywords: helicobacter pylori vonoprazan potassium-competitive acid inhibitor
tanezumab in osteoarthritis of the knee (2)

Conditions: Arthritis; Osteoarthritis

Summary: the purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis.


Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee according to kellgren-lawrence x-ray grade of 2 exclusion criteria: * pregnancy or intent to become pregnant * bmi greater than 39 * other severe pain, significant cardiac, neurologic or cardiac disease

Keywords: monoclonal antibody rn624 pf-04383119 nerve growth factor anti-nerve growth factor oa pain
laser assisted liposuction and facial autologous fat grafting with the lipolife system

Conditions: Laser Assisted Liposuction

Summary: multi-center, prospective, open-label, single arm study. the study aims to evaluate the safety and efficacy of laser assisted liposuction procedure performed with the lipolife system. the study will include twenty (20) eligible subjects, that are willing to undergo abdominal or outer thighs laser-assisted liposuction. five to twenty (5-20) subjects out of this study group should also be eligible for facial fat grafting. follow up visits to evaluate study endpoints will take place at 1, 3 and 6 months after the surgery.


Eligibility criteria:
inclusion criteria: * subjects with excessive fat in the lower abdomen or subjects with excessive fat in the outer thighs that are willing to undergo laser-assisted liposuction * estimated fat harvesting of 1-3 liters * subjects (5-20) eligible for facial fat grafting of at least 5 cc for each cheek * between 18 and 70 years of age * provided written informed consent exclusion criteria: * body mass index (bmi) \>35 * sever skin laxity * positive pregnancy test * current smoker * presence of known malignancy * active infection in the treatment area * history of autoimmune disorder (e.g., systemic lupus erythematosus \[sle\]) * history of connective, metabolic or atrophic skin disease * history of keloid scarring * chronic use (\>7 consecutive days) of anticoagulants (such as aspirin) or nsaids within 15 days prior to enrollment * subjects with immune system diseases * subject unable to follow post-treatment instructions * any other reason that in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
vitamin d supplementation in postmenopausal women with osteoporosis: proposal of a therapeutic regimen in practice

Conditions: Osteoporosis

Summary: the vitamin d deficiency (25ohd) is very common and affects about 80% of the population of french osteoporotic women over 50 years \[5\]. it contributes significantly to bone fragility and consequently the risk of fracture. to remedy this deficit, it is necessary to provide a suitable and sustainable supplementation. changes in vitamin d deficiency ranging from undetectable to a 25ohd value very close to 30ng / ml lead to differences in therapeutic regimens, specific to each clinician in the absence of precise data in the literature. no consensus on supplementation dosages and methods have been proposed so far. also, given the frequency of vitamin d deficiency including osteoporosis observed in the population, it became necessary to establish a single, uniform regimen for all patients with osteoporosis


Eligibility criteria:
inclusion criteria: * postmenopausal women ≥ 50 years * osteoporosis with bmd t-score ≤ -2.7ds -2.5ds to at least one of the two main sites analyzed, with or without fracture * having signed an informed consent exclusion criteria: * taking a "loading dose" of vitamin d in the last six months (a daily intake in combination with calcium will not be a cause of exclusion but should be discontinued during the study). * taking an osteoporosis treatment combined with vitamin d in the same tablet (or adrovance fosavance \* \*) * treatment with thiazide diuretic * known malabsorption (celiac disease) * scalable endocrine disorders: hyperthyroidism, hyperparathyroidism, hypoparathyroidism. * persistent or nephrolithiasis occurred in the previous 5 years * known sarcoidosis * persons under guardianship or trusteeship * hypercalcemia and hypercalciuria * 25oh vitamin d levels\> 50ng / ml
impact of the choice of gastric tube placement sites on the incidence of ventilator associated pneumonia

Conditions: Intubated Patient Requiring a Gastric Tube

Summary: in intensive care, many gastric tubes are inserted on a regular basis. there are different practices in terms of the location of the gastric tube. in some cases, the tube is inserted through the nose and in others, it is inserted through the mouth. in the literature and in practice, these gastric tubes create discomfort and complications that have an impact not only on the patient, but also on the treatments and the length of the patient's stay in hospital. nosocomial ventilator associated pneumonia is the most serious common complication for patients intubated with a gastric tube. it is possible that placement site may have an impact on the risk of developing ventilator associated pneumonia, particularly by increasing the risk of bacterial pullulation opposite the sinuses when the tube is placed via the nasal route. investigator hypothesises that placing the gastric tube orally will reduce the rate of ventilator-associated pneumonia compared with the nasal route in mechanically ventilated intensive care patients.


Eligibility criteria:
inclusion criteria: * patient in intensive care, intubated, ventilated * adult * requiring a gastric tube * with an expected duration of mechanical ventilation of more than 48 hours * affiliated to social security * patient or relative consent or, failing that, emergency inclusion of the patient exclusion criteria: * pregnant, breast-feeding or parturient women * patients under legal protection: curatorship and guardianship * contraindication to placing a gastric tube through the nose or mouth * patients who already have a gastric tube when they enter the service * patient intubated for more than 24 hours * patient intubated via the nasotracheal route

Keywords: orogastric tube nasogastric tube ventilator associated pneumonia
evaluation of methods of teaching self-management strategies to patients with symptomatic knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: symptomatic knee osteoarthritis greatly impacts the quality of life, mobility, independence, and even safety of the individuals who suffer from it. one of the most powerful tools for these patients can be education on self-care and self-management strategies that can be taught to a patient by a physician, physical or occupational therapist, or a nurse. these self-management strategies can help patients treat daily stiffness through exercise or manage flares of osteoarthritis. there is a lack of consensus on the best teaching methods to accomplish the goal of educating our patients. feedback from both patients and providers regarding teaching methods is needed. this study will evaluate teaching methods on self-management strategies for patients who are undergoing hyaluronic acid injections for knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * patients of co-investigator physicians * age 18+ years * diagnosis of symptomatic knee osteoarthritis * scheduled for a hyaluronic acid injection into the knee * provider is available to administer teaching method exclusion criteria: * patients who are already enrolled in the study * non-english speaking
treating sleep apnea induced hypoxemia with oxygen in acute stroke patients

Conditions: Stroke, Acute

Summary: we want to determine if treating acute ischemic stroke patients who have evidence of hypoxemia due to sleep apnea with low flow o2 during sleep might help improve clinical and functional outcomes.

acute stroke patients will be tested for nocturnal hypoxemia using overnight oximetry. those with evidence of hypoxemia will be randomized into two groups. one group will receive standard medical care. the other group will receive standard medical care as well as receiving low flow oxygen during sleep.

Eligibility criteria:
patients presenting to mayo clinic hospital with acute ischemic stroke