Kornimate/medical-research-clean huggingface dataset:
switch to doravirine/islatravir (dor/isl) in human immunodeficiency virus 1 (hiv-1) participants treated with bictegravir/emtricitabine/tenofovir alafenamide (bic/ftc/taf) (mk-8591a-018)

Conditions: HIV Infection

Summary: this study will evaluate the safety and efficacy of a switch to mk-8591a (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (hiv-1)-infected participants virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (bic/ftc/taf). the primary hypothesis is that a switch to mk-8591a will be non-inferior to continued treatment with bic/ftc/taf as assessed by the proportion of participants with hiv-1 ribonucleic acid (rna) ≥50 copies/ml at week 48. participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.


Eligibility criteria:
inclusion criteria: * is hiv-1 positive with plasma human immunodeficiency virus 1 (hiv-1) rna \<50 copies/ml at screening. * has been receiving bic/ftc/taf therapy with documented viral suppression (hiv-1 rna \<50 copies/ml) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen. * female is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (wocbp); is a wocbp and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; a wocbp must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. in such cases, the participant must be excluded from participation if the serum pregnancy result is positive. exclusion criteria: * has hiv-2 infection. * has an active diagnosis of hepatitis due to any cause, including active hepatitis b virus (hbv) co-infection. * has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous kaposi's sarcoma. * is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies. * is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to day 1 through the study treatment period. * has a documented or known virologic resistance to dor. * female expects to conceive or donate eggs at any time during the study.
biomarkers in blood and tumor tissue samples from patients with wilms tumor

Conditions: Kidney Cancer; Renal Failure

Summary: rationale: studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research study is studying biomarkers in blood and tumor tissue samples from patients with wilms tumor.

objectives: * to determine whether wilms tumor (wt) patients without wt1-associated congenital anomalies or syndromes, but with end-stage renal disease (esrd) unrelated to progressive bilateral tumors, carry germline wt1 mutations. * to determine whether non-syndromic wt1 germline mutation carriers have a substantially higher incidence of esrd than do wt patients who do not harbor wt1 mutations. outline: archived blood and tumor tissue specimens (or dna isolated from these samples) are analyzed for wt1 mutations by gene sequencing and pcr.

Eligibility criteria:
disease characteristics: * diagnosis of wilms tumor (wt) * patients who participated in the nwts-5 protocol * non-syndromic patients who developed end-stage renal disease (esrd) during 5-10 years for reasons other than progressive bilateral wt * matched control patients who had not developed esrd by the time (since wt onset) of esrd diagnosis * blood and tumor tissue samples available patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: stage i wilms tumor stage ii wilms tumor stage iii wilms tumor stage iv wilms tumor stage v wilms tumor renal failure
fmt for alcohol use disorder in cirrhotics.

Conditions: Liver Cirrhosis

Summary: * title "fmt for alcohol use disorder in cirrhotics: a randomized controlled trial" * the aim of the study is to study the efficacy of fecal microbiota transplantation in patients with alcohol liver disease over a 6 month duration without liver related side effects. the project will be conducted at ilbs over the period of 1 year. * the concept is to test the efficacy of fmt in alcohol related cirrhotics by its effect on achieving and maintaining abstinence and in reducing lapses and relapses. thereby reducing the progression of alcoholic liver disease as continued ethanol consumption is an important predictor in increasing overall morbidity and mortality.

hypothesis :- - fmt is useful in reducing craving and return to heavy drinking in patients with alcohol related cirrhosis with active drinking, through modulation of gut microbiota and correction of dysbiosis aim and objective - - to assess the efficacy of fmt in decreasing lapse, relapses and maintaining alcohol abstinence in aud in patients with cirrhosis study population: - patients with cirrhosis with recent alcohol use attending outpatient clinic at ilbs, new delhi study design: - open label, parallel group, randomized, controlled study. study period: - 1 year sample size with justification: - assuming that abstinence in placebo group is 50% and we assume that there will be 40% absolute increase in fmt group (90%; bajaj js, hepatology 2021) with alpha 5 and power of 80%, investigator need to enroll 48 cases, further assuming 10 % dropout rate it was decided to enroll 54 cases that is 27 in each group.

Eligibility criteria:
inclusion criteria: 1. all consecutive patients with alcohol related cirrhosis with serum bilirubin \<5mg/dl with an active alcohol consumption atleast within last 4 weeks aged between 18 -70yrs. 2. fulfilling dsm - 5 criteria for alcohol use disorder (association, 2013). exclusion criteria: 1. pregnancy 2. acute illness or fever on the day of planned fmt 3. ongoing/past 2 weeks antibiotic use 4. unclear diagnosis of cld 5. non-elective hospitalization within last month 6. serum bilirubin \>5mg/dl 7. grade 2 or more ascites 8. any episode of he grade 2 or more or requiring hospital admission within 3 months 9. episode of avb within last 3 months 10. treatment with corticosteroids/immunosupression within the past 60 days 11. unwilling to participate 12. dependence on any other substance (except nicotine) 13. psychiatric disorder requiring pharmacotherapy/suicidal tendency 14. known untreated, in-situ luminal gi cancers \& chronic intrinsic gi diseases.
study of karenitecin (bnp1350) to treat malignant melanoma

Conditions: Melanoma; Neoplasm

Summary: the purpose of this study is to evaluate the safety and efficacy of karenitecin (bnp1350) as a treatment for malignant melanoma.


Eligibility criteria:
* confirmed diagnosis of malignant melanoma * measurable disease * granulocytes ≥1,500/µl, platelets ≥100,000/µl, creatinine ≤uln, bilirubin ≤1.5 mg/dl, ast ≤2.5 x uln * no prior treatment with other camptothecin drug. * ≥ 21 days since completion of prior chemotherapy, ≥6 weeks since prior mitomycin-c * ecog performance status 0-1 * negative pregnancy test for female patients
right and left ventricle remodeling predictors after pulmonary valve replacement in patients with repaired tetralogy of fallot

Conditions: Tetralogy of Fallot With Pulmonary Stenosis

Summary: long term survival of patients with repaired tetralogy of fallot is excellent (about 85% at 35 year-old). however these patients are exposed to residual pulmonary stenosis (ps) and/or pulmonary regurgitation (pr). it is well established that these lesions can lead to irreversible sequelae such as right ventricle dilatation and dysfunction. pulmonary valve replacement technique was developed to avoid long term right ventricular dysfunction. pulmonary valve replacement indications are based upon the presence of symptoms at exercise and/or morphological or functional parameters such as severe pulmonary regurgitation with right ventricle dilatation/dysfunction. the best timing of such intervention is still underdebate with the main aim of having the right balance between avoiding long term sequelae of pr or ps and being the latter possible to push ahead the need for new intervention. recent publication showed that myocardial diffuse fibrosis can contribute to irreversible alteration of myocardial contractility. quantification of diffuse fibrosis by magnetic resonance imaging is feasible and could help the physician to best determine the right timing for pvr in this population of patients. cardiac function assessment at rest and during exercise is possible using mr and our centre has developed a program for cardiac exercise during mri. this could help to detect infra clinic abnormality and to analyse myocardial adaptation during exercise.


Eligibility criteria:
inclusion criteria: - older than 14 year-old, with repaired tetralogy of fallot requiring pulmonary valve exclusion criteria: * liver failure, kidney failure, * contra indication to mri study, * non-affiliated to the national health care program

Keywords: pulmonary valve replacement tetralogy of fallot
a pilot study of altens in improving dysphagia induced by imrt for head and neck cancers

Conditions: Head and Neck Cancer; Dysphagia

Summary: study hypothesis: altens techniques, administered within the first 3 months after radiation completion, can improve radiation-induced dysphagia and associated symptoms in head and neck cancer patients. this beneficial effect is mediated by the reduction of chronic inflammatory response of swallowing musculature to radiation, consequently a reduction in muscle fibrosis. primary study objective: to evaluate the effectiveness of altens in relieving radiation-induced dysphagia. eating assessment tool (eat-10) scores will be used for this primary study endpoint.

difficulty in swallowing is a concerning symptom after radiation treatment for some types of head and neck cancers. swallowing becomes difficult when radiation damage induces inflammation (with swelling and pain) in the inner covering tissues of the throat and muscles that involve in the swallowing process. currently, supportive measures are used to manage this symptom while waiting for the tissue damages to heal. in some patients, the inflamed muscles develop scar tissues causing long-term swallowing difficulty and narrowing of the swallowing passage. needle acupuncture may help to reduce tissue inflammation and may lessen the severity of swallowing difficulty. however, needle puncture is often not desired by patients. acupuncture-like transcutaneous electrical nerve stimulation (altens) is like acupuncture treatment, but the acupuncture points are stimulated with mild electrical stimulation without needles, simplifying treatment delivery. this study is to examine if a pre-selected set of acupuncture points treated using altens can reduce swallowing difficulty. there will be a total of 12 treatments given over 6 to 8 weeks. changes in severity of swallowing difficult after treatment will be assessed using 2 subjective assessment tools.

Eligibility criteria:
inclusion criteria:this study will recruit patients with head and neck cancers treated with radiation+/- chemotherapy and who meet the following criteria (eat-10 assessment will be used for screening): inclusion criteria 1. present with dysphagia symptoms 2. with no evidence of residue cancer 3. are within 3 months (but past 1 month) after treatment completion 4. show positive dysphagia (eat-10 score of \> 3) and/ or aspiration on barium swallow study 5. are over 18 years old 6. are able to read and write fluent english 7. can give informed consent exclusion criteria: 1. have unstable heart disease 2. have infectious disease transmissible by blood or body fluid, including hepatitis and hiv 3. have skin disease at site of study acupuncture points that prevents the application of electrodes

Keywords: radiation treatment head and neck cancer dysphagia
confocal endomicroscopy for non-erosive reflux disease detection

Conditions: Non-erosive Reflux Disease; Gastroesophageal Reflux

Summary: primary objective: evaluate response to nerd treatment between patients with normal endomicroscopy findings compared with patients with abnormal endomicroscopy findings. secondary objectives: to evaluate the role of probe based endomicroscopy in the diagnosis of nerd by evaluating dilated intercellular spaces, evaluation of ipcl, and quantification of fluorescein leak. quality of life at study entry and end of study. compare two medications under study within each group as a subgroup analysis.

the purpose of this study is to evaluate response to non-erosive reflux disease (nerd) treatment between patients with normal endomicroscopy findings compared with patients with abnormal endomicroscopy findings. the researchers will compare two different drug regimens for the nerd subjects to evaluate their effectiveness in reducing nerd-related symptoms. in addition, the researchers will be testing the function and effectiveness of the confocal endomicroscopy procedure to be used during the study. researchers will be continuing to assess the status, symptoms, and any changes associated with the symptoms subjects are experiencing. the confocal endomicroscopy procedure utilizes a powerful microscope that is used during an endoscopy. an endoscopy is a procedure that allows us to scope/view the inside of the esophagus and stomach using a camera in precise detail. an endoscopy procedure and measurements of acid in the esophagus have been used to determine if the investigators think acid is causing the symptoms. traditionally, acid blocking medications called proton pump inhibitors (ppis such as esomeprazole, lansoprazole, omeprazole, and pantoprazole), or medications such as sucralfate have been used to treat the symptoms of nerd. the medical community believes that these symptoms are due to increased spaces between the cells that make up the esophagus. they can directly see those spaces using the confocal endomicroscopy. patients are asked to participate in this study if they are 18 years of age or older and have typical symptoms for patients diagnosed with nerd that have not responded to the first attempted medication.

Eligibility criteria:
inclusion criteria: 1. individuals older than 18 years who score a 12 or greater on the reflux disease questionnaire and have failed a four week trial of daily proton pump inhibitor. 2. subjects without gastroesophageal reflux disease (gerd) undergoing upper endomicroscopy for other indications will be recruited into study as controls. exclusion criteria: 1. barrett's esophagus 2. use of twice daily proton pump inhibitor within 4 weeks of study entry 3. esophageal varices 4. coagulopathy (aspirin, nsaids and plavix are allowed. coumadin, xarelto, heparin are not allowed.) 5. gastrointestinal cancer or mass 6. previous surgery involving the esophagus, stomach or duodenum 7. pregnancy 8. allergy to either sucralfate or proton pump inhibitors
preconditioning with hyperbaric oxygen in cardiovascular surgery

Conditions: Brain Injury; Myocardial Injury

Summary: animal studies have shown that preconditioning with hyperbaric oxygen can induce central nervous system and heart ischemic tolerance. this study was designed to determine the protective effect of hyperbaric oxygen preconditioning on brain and myocardium ischemia-reperfusion injury during coronary artery bypass graft surgery.

60 patients scheduled to undergo coronary revascularization were recruited for this trial. exclusion criteria included emergency operation, age older than 80 years, learning difficulty, previous cerebrovascular disease, visual or hearing impairment, history of pneumothorax, claustrophobia, middle ear disease, ef \< 35%. patients were randomized either to the control group or hyperbaric oxygen group. the laboratory analysis of markers included s100b, nse and troponin i. the assessment of cognitive dysfunction was performed 5 days before surgery and 7 days after surgery and haemodynamic measurements, length of stay in icu, length of stay in hospital post-operation were recorded.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo coronary revascularization surgery. exclusion criteria: * emergency operation * age older than 80 years * learning difficulty * previous cerebrovascular disease * visual or hearing impairment * history of pneumothorax, claustrophobia, middle ear disease, ef \< 35%

Keywords: cabg hyperbaric oxygen preconditioning s100b nse troponin i cabg surgery neuroprotection
study to evaluate efficacy of shunt operation for idiopathic normal pressure hydrocephalus

Conditions: Idiopathic Normal Pressure Hydrocephalus

Summary: this study evaluates the efficacy of shunt operation for idiopathic normal pressure hydrocephalus, and determines the diagnostic value of noninvasive procedures commonly practiced in the clinic.

idiopathic normal pressure hydrocephalus (inph) is a syndrome characterized by ventricular dilatation due to disturbed cerebrospinal fluid (csf) circulation, accompanied by gait disturbance, dementia and/or urinary incontinence without causative disorders. with the aging of japanese society, the number of patients is increasing, requiring diagnostic and therapeutic guidelines for the improvement of the patients' quality of life and social care. under such conditions, this project was made as the prospective study of inph on neurological improvement (sinphoni ). this study aims 1) to establish methods for non-invasive diagnosis of inph, and 2) to demonstrate therapeutic outcome of shunting operation by codman hakim programmable valve (chpv). in this protocol, the evaluation of validity on mri, tap test, ct cisternography, and cbf (3d-ssp) will be done in the diagnosis, and manual of initial setting pressure in chpv for prevention of overdrainage problems will be estimated by modified rankin scale (as primary endpoint) and some another scales during 1 year.

Eligibility criteria:
inclusion criteria: patients who had at least one more points of the triad (gait disturbance, cognitive impairment, and urinary incontinence) in japan nph grading scale revised, and had disproportionate ventriculomegaly (evans index \>0.3) with closing of the csf space at high convexity on mri. these patients must be diagnosed clinically other causative disorders, and ventricular dilatation due to disturbance of the cerebrospinal fluid (csf) circulation. be able to give informed consent. exclusion criteria: 1) cannot have an mri scan 2) has a problem with bleeding tendency and other serological examination. (liver enzyme and renal dysfunction, blood coagulopathy, and etc.) 3) is unable to understand the risks of the testing and surgical therapy. 4) is tolerable for one year follow up after shunting operation.

Keywords: idiopathic normal pressure hydrocephalus shunt
pneumonia due to stenotrophomonas maltophilia in icus

Conditions: Pneumonia, Ventilator-Associated; Stenotrophomonas Infection; Critical Illness; Pneumonia, Bacterial

Summary: pneumonia is a major cause of icu admission, or may complicate icu course. among the causative pathogens, stenotrophomonas maltophilia is a rare pathogen, but affects usually patients with chronic pulmonary co-morbidities, or with long duration of mechanical ventilation and multiples treatment with broad spectrum antimicrobial therapy. however, there are only a paucity of data regarding epidemiology, impact and outcome of pneumonia due to stenotrophomonas maltophilia in critically ill patients. primary objective was to study factors associated with mortality in case of pneumonia due to stenotrophomonas maltophilia. secondary objectives were to describe factors associated with morbidity of pneumonia due to stenotrophomonas maltophilia (duration of mechanical ventilation, icu length of stay), and to report the characteristics of critically ill patients presenting pneumonia due to stenotrophomonas maltophilia.


Eligibility criteria:
inclusion criteria: patients older than 18 years documented stenotrophomonas maltophilia pneumonia: * clinical suspicion (≥ two criteria including: fever\> 38.5°c, leukocytosis \> 10\^9/l or leukopenia \< 4.10\^8/l, purulent tracheobronchial secretions and a new or persistent infiltrate on chest radiography). * documented stenotrophomonas maltophilia positive quantitative culture of a respiratory sample: bronchoalveolar lavage fluid (significant threshold, \>10\^4cfu/ml) or plugged telescopic catheter (significant threshold, \>10\^3cfu/ml) or quantitative endotracheal aspirate (significant threshold, \>10\^6cfu/ml). exclusion criteria: * none

Keywords: stenotrophomonas maltophilia pneumonia intensive care unit
emmy trial: uterine artery embolization (uae) versus hysterectomy for uterine fibroids

Conditions: Menorrhagia; Leiomyoma; Uterine Neoplasms

Summary: the emmy trial is set up to evaluate the safety and efficacy of uterine artery embolization (uae) in comparison to hysterectomy for the treatment of symptomatic uterine fibroids. uae was considered equivalent to hysterectomy when at least 75% of patients had normalization of heavy menstrual blood loss after treatment.

uterine artery embolization (uae) is a new treatment for heavy menstrual bleeding caused by uterine fibroids. uae is already being performed on a regular basis, without profound evidence: no good quality randomized controlled trials have been conducted. the emmy trial evaluates the safety and efficacy of uae in a randomized comparison to hysterectomy. patients were included when they had uterine fibroids and menorrhagia, and were eligible for hysterectomy. the primary endpoint is the elimination of menorrhagia after a two-year follow-up period. secondary endpoints comprise: effect on complaints of pain and pressure, quality of life issues, uterine volume reduction, effect on ovarian function and cost-effectiveness. patients were randomly assigned to either uae or hysterectomy (1:1). all patients were followed for two years after treatment. whether uae can be an alternative to hysterectomy as treatment of first choice depends on the balance of efficacy, costs, and quality of life.

Eligibility criteria:
inclusion criteria: * uterine fibroids * menorrhagia * scheduled for hysterectomy * pre-menopausal exclusion criteria: * childwish (planning to conceive) * pregnancy * suspected malignancy * untreated pelvic inflammatory disease (pid) * clotting disorders * contrast fluid allergy * presence of intrauterine device (iud) * renal failure (creatinine \> 150 mmol/l)

Keywords: hysterectomy fibroids uterine artery embolization therapeutic embolization uterus menorrhagia