Kornimate/medical-research-clean huggingface dataset:
dose-escalation study of e7727, an oral cytidine deaminase inhibitor with oral decitabine in subjects with solid tumors

Conditions: Solid Tumor

Summary: this is a phase 1 study of the combination of cedazuridine with decitabine in patients with solid tumors. at least 6 patients will be enrolled per treatment level to assess optimal hypomethylation and toxicity (up to 35 patients total).


Eligibility criteria:
inclusion criteria: * participants must have advanced, unresectable, and/or metastatic solid tumor malignancy that is histologically or cytologically confirmed. * patients must have received at least 2 lines of therapy in the advanced/metastatic setting (if 2 lines exist) and have no other possible therapies or refuse therapies that have shown clinical benefit for their condition. * ecog performance status \<1 * ability to understand and the willingness to sign a written informed consent document. * patients must have measurable disease * ability to swallow oral medications exclusion criteria: * participants who have had chemotherapy or radiotherapy within 3 weeks * participants may not be receiving any other investigational agents. * active hepatitis b or hepatitis c infection. * active or untreated gastric or duodenal ulcer * symptomatic bowel obstruction within 3 months prior to screening visit. * symptomatic ascites in the last 4 weeks other protocol defined inclusion/exclusion criteria may apply.
digivis: self-testing vision app for telephone consultations

Conditions: Visual Impairment; Amblyopia Suspect

Summary: this trial aims to assess the accuracy and test-retest variability of a new digital app which enables community visual acuity testing without requirement of an trained examiner.

eye problems like macular degeneration and amblyopia (lazy eye) require regular monitoring to prevent permanent visual impairment. over 2000 patients a month are seen in cambridge university hospitals national health service trust (cuh) eye clinics; concern about covid-19 infection has led to over 80% of consultations being conducted by telephone with few clinical clues to inform decision making. patients will face long delays even when routine clinics restart: there is no doubt that some will suffer preventable visual loss. digivis is a web-based vision testing app enabling self-testing of vision at home. early testing and patient feedback is positive: 80% of children prefer digivis to regular testing. the investigators wish to test how accurately the app works for home use, by asking older children and adults to self-test their vision prior to their planned face to face clinic appointment. once tested, digivis will be available free of charge to patients, not only during the covid-19 crisis, but also to support telephonic consultations in the future. visual acuity (va) is a fundamental measure of vision required for all ophthalmic assessments. it is measured by health professionals using vision charts. digivis is a new app which enables self-testing of va using two wirelessly connected digital devices. by matching letters on a handheld device to those displayed on the second device a distance away, threshold va can be measured using a staircase algorithm. the distance and scaling of the test is vital to its accuracy and a concept (patent filed by cambridge enterprise) in digivis enables this without the need for manual distance measurement or an observer. early validation using two tablet computers in 150 clinic patients has given positive results, both in testing accuracy and patient feedback. with the current covid-19 crisis limiting face to face appointments, there is an urgent need for accurate home va assessment. the digivis app has been re-coded for free website delivery for this purpose. the investigators wish to formally validate digivis home testing following conformitè europëenne (ce class i) marking so that it can be recommended for clinical use. 250 patients will be invited to self-test their va twice using digivis prior to a planned face to face clinic appointment. the test-retest variability and comparison of digivis va to chart based assessment will be compared.

Eligibility criteria:
inclusion criteria: * age between 5 and 85 years * previous recorded visual acuity of at least +0.8 logmar in or both eyes exclusion criteria: * individuals with poor conversant english * individuals with cognitive impairment * subjects unable to access the internet on two digital devices
clinical value of adding dapagliflozin in patients with nephrotic syndrome

Conditions: Nephrotic Syndrome; Sodium-Glucose Transporter 2 Inhibitors

Summary: conducted as a randomized controlled clinical trial, this study aims to assess the potential benefits of incorporating dapagliflozin, an sglt-2 inhibitor, into the treatment regimen of patients diagnosed with primary nephrotic syndrome. the primary focus is on examining the impact of dapagliflozin on two key parameters: proteinuria and estimated glomerular filtration rate (egfr). the trial involves adult participants who have been definitively diagnosed with primary nephrotic syndrome through renal biopsy. in conjunction with their standard care, these participants will receive a daily dose of dapagliflozin at 10 mg. over a span of six months, they will undergo comprehensive monthly assessments. these assessments will involve the collection and analysis of urine samples to quantify proteinuria and perform urinalysis. additionally, blood samples will be taken to determine the estimated egfr, lipid profile, glycated hemoglobin. participants will also be encouraged to report any potential side effects resulting from their medication intake.


Eligibility criteria:
inclusion criteria: * egfr \> 25 ml/min/1.73m2 * evidence of primary nephrotic syndrome by renal biopsy * non-diabetic kidney disease exclusion criteria: * nephrotic syndrome secondary to lupus nephritis, aav, amyloidosis, or secondary membranous nephropathy * hepatic impairment \[ast or alt \>3 times uln or total bilirubin \>2 times the uln\] at the time of enrolment * pregnant or breast-feeding females
multihormonal deficiencies and mirna profile in chronic heart failure: effects of combined hormonal replacement therapy

Conditions: Patients With Ischemic or Idiopathic Dilated Cardiomyopathy

Summary: the results from this study will be useful to gain detailed information on the correlation related to pathophysiological aspects between endocrine system and clinical status of patients with heart failure, and to identify factors correlated with the progression and prognosis of icc


Eligibility criteria:
inclusion criteria: * ischemic or idiopathic dilated cardiomyopathy, stable medications for at least three months including ß-blocker that must be started at least 6 months before entering the study, fraction of left ventricular ejection less than or equal to 49% exclusion criteria: * age \< 18 years, inability to perform a bicycle ergometer exercise test. diabetes mellitus in poor glycometabolic control and/or proliferative retinopathy or nonproliferative retinopathy severe grade. severe renal failure; hepatic cirrhosis advanced. active neoplastic disease or history of malignancy. patients with severe acute illness caused by complications from open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure. active infection or sepsis. any allergies to growth hormone, testosterone, vitamin d, or other excipients such as benzyl alcohol, sucrose, phosphoric acid, sodium hydroxide, or methacresol. acute coronary syndrome within the previous 6 months
efficacies of two bismuth quadruple therapies in the second-line treatment of h pylori infection

Conditions: Helicobacter Pylori Infection

Summary: from the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

the h pylori-infected adult patients with failure of standard triple therapy and h pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either tl quadruple therapy (esomeprazole-bismuth-tetracycline-levofloxacin regimen) or al quadruple therapy (esomeprazole-bismuth-amoxicillin-levofloxacin regimen) for 10 days. repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-h pylori therapy.

Eligibility criteria:
inclusion criteria: * consecutive h pylori-infected outpatients, at least 20 years of age with failure of first-line eradication treatments (standard triple, non-bismuth quadruple and bismuth quadruple therapies) exclusion criteria: * previous allergic reactions to the study medications, * history of gastrectomy, * use of antibiotics within the previous 4 weeks, * pregnant or lactating women, * coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia, and malignancy).

Keywords: helicobacter pylori eradication rate rescue treatment
act-de for diabetes distress in adults with type 2 diabetes: a pilot rct

Conditions: Acceptance and Commitment Therapy; Type 2 Diabetes; Diabetes Distress

Summary: this study is a pilot rct to examine the feasibility, acceptability and preliminary effectiveness of a 6-week acceptance-based diabetes education programme (act-de) on diabetes distress, self-care efficacy and behaviours of adults with type 2 diabetes in hong kong. it is hypothesise that the act-de programme will: * be acceptable, feasible and beneficial for adults with type 2 diabetes to improve their psychological distress and self-care. * significantly reduce participants' diabetes distress (primary outcomes), when compared with the usual care (control) group immediately post-intervention; * significantly improve self-care efficacy, self-care behaviour and psychological flexibility (secondary outcomes) than the control group immediately post-intervention.

diabetes distress is an aversive feeling and emotional disturbance specific to diabetes, including the burden of daily self-care, worry and guilty feelings, and low satisfaction level with health care professionals. around 36% of people with type 2 diabetes worldwide suffered from diabetes distress, which is associated with poor self-care performance, low self-efficacy in diabetes management and higher blood glucose levels. acceptance and commitment therapy, one of the mindfulness and acceptance-based interventions, integrated with diabetes education are found to be potentially effective interventions for reducing diabetes distress. participants who agreed to participate in the study were randomly allocated into the intervention (n=24) and the control group (n=24). participants in the intervention group received a 6-week group-based acceptance and commitment therapy integrated with diabetes education (act-de). there were five sessions in 6 weeks with 120 minutes per session. the group size were 6. while participants in the control group received one session of diabetes education without any information on acceptance and commitment therapy.

Eligibility criteria:
inclusion criteria: * community-dwelling adults hong kong chinese residents, * aged 18-64, * diagnosed with type 2 diabetes for over one year; * at least moderate level of diabetes distress as measured with the chinese diabetes distress scale (cdds-15; mean score \>2 per item); * having suboptimal blood glucose control as shown by hba1c level of ≥ 7% in the laboratory results within the past six months; * able to communicate in cantonese and give written content. exclusion criteria: * history of a clinically diagnosed mental illness such as depression and anxiety disorder, and/or an acute/severe medical disease; * noticeable cognitive impairment(s) as indicated by the total score (\<6 of 10) of the abbreviated mental test; * recently received/receiving any psychological therapy such as mindfulness or acceptance-based therapy.
a study to evaluate the effect of jnj-28431754 (canagliflozin) on post-meal glucose in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate the effect of canagliflozin on post-meal glucose blood levels in patients with type 2 diabetes mellitus.

this is a double-blind (neither study staff or the patient will know the identity of the treatment assigned) study of canagliflozin in patients with type 2 diabetes mellitus (t2dm) who are currently taking metformin at a stable dose of \>=1500 mg/day. patients will participate in the study for up to approximately 16 weeks. during the study, patients will receive 4 treatments (a, b, c, and d); each treatment will be administered during a 3-day treatment period. patients will receive 1 dose of study medication in the morning of day 1 and day 2 of each treatment period and treatment periods will be separated by approximately 2 weeks. treatments will consist of placebo (a), canagliflozin 300 mg and placebo (b), canagliflozin 300mg (c), and canagliflozin 300mg and canagliflozin 150mg (d).

Eligibility criteria:
inclusion criteria: * patients with t2dm with inadequate glycemic control (based upon fasting glucose measurements \>=130 mg/dl and \<=250 mg/dl) on metformin monotherapy or on metformin in dual combination with other glucose lowering agents (sulphonylurea \[su\] or a meglitinide or a dipeptidyl peptidase-4 \[dpp-4\] inhibitor) are eligible for enrollment in the study. exclusion criteria: * history of diabetic ketoacidosis, type 1 diabetes mellitus (t1dm), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy * history of a severe hypoglycemic episode within 6 months before screening * has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (fpg) and/or fasting self-monitored blood glucose (smbg) measurements \>=250 mg/dl (13.88 mmol/l) during the pre-treatment phase, despite reinforcement of diet and exercise counseling * history of or current illness considered to be clinically significant by the investigator

Keywords: canagliflozin placebo type 2 diabetes mellitus
extended access program with lorcaserin for the treatment of dravet syndrome and other refractory epilepsies

Conditions: Epilepsies, Myoclonic; Drug Resistant Epilepsy

Summary: the primary purpose of this study is to provide continued access of lorcaserin to participants with dravet syndrome and other refractory epilepsies.


Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of dravet syndrome (according to recommendation from a north american consensus panel, 2017) or other refractory epilepsy (per the judgment of the treating physician) 2. male or female, age at least 2 years at the time of informed consent 3. currently treated with lorcaserin, that the treatment is for dravet syndrome or other refractory epilepsies, and the treatment was initiated before 13 feb 2020; or has completed study e2023-a001-304 4. has a clinical benefit from lorcaserin in the opinion of the treating physician exclusion criteria: none

Keywords: extended access program expanded access program dravet syndrome refractory epilepsies lorcaserin
using m-health tools to reduce the misuse of opioid pain relievers

Conditions: Prescription Drug Abuse

Summary: the aim of this study is to pilot test a web-based, patient-centered educational program that encourages the patient to have an informed discussion about pain medication options with their emergency department (ed) provider.

this multi-site, randomized trial will evaluate an m-health program designed to aid the patient in making an informed decision about their pain treatment. patients reporting to the ed with an injury-related chief complaint who agree to participate are randomized to receive the intervention program, my healthy choices, or an attention-matched control. my healthy choices pairs tailored education with a patient decision aid to describe what opioid and non-opioid pain medications are, assess the patient's risk factors for opioid-related adverse effects, and produce a tailored report that patients are encouraged to share with their doctor. data are collected through surveys at three time points during the ed encounter (baseline, immediately after the intervention, and just before discharge), and at a 6-week follow-up survey. the primary outcomes are whether the patient prefers an opioid pain reliever (opr) and whether the patient takes an opr. the investigators hope this program will facilitate patient-provider communication, as well as reduce the number of prescriptions written for oprs and thus the number of patients exposed to prescription opioids and the associated risks of addiction and overdose.

Eligibility criteria:
inclusion criteria: 1. ed visit for an injury- or pain-related chief complaint 2. 18 years of age or older 3. speak english 4. has a smart phone or email address that is used on a regular basis 5. no previous medical care for the current complaint 6. triage pain score between 7-10 exclusion criteria: * allergy to pain medications * have used a prescription pain medication for more than two days in the past month * report renal problems or a history of dialysis
the efficacy of salvage surgery in patients with residual tumor after concurrent chemoradiation for locally advanced cervical cancer.

Conditions: Cervical Cancer

Summary: this is a single-center single-arm study. the main purpose of this study is to study the efficacy of surgical treatment for patients with locally advanced cervical cancer (figo ib3, iia2-iva) who still have residual tumor after concurrent radiotherapy and chemotherapy.


Eligibility criteria:
inclusion criteria: 1. stage ib3 and iia2-iva (figo2018) cervical cancer with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma. 2. complete standard ccrt(pelvic ebrt+ concurrent platinum-containing chemotherapy+ brachytherapy). 3. after 4-12 weeks of treatment, the cervical biopsy pathology confirmed residual cancer, or the cervical biopsy was negative, but pet /ct showed that suvmax of the residual lesions in the cervical and/or pelvic lymph nodes were ≥ 2.5, two or more gynaecological oncologists with grade iv operation qualification and the title of deputy director or above have gynecological examination, and the multidisciplinary team(mdt) evaluation recommended surgical treatment. 4. ecog score:0 \~ 1. 5. the expected survival time\>6 months; 6. there is no absolute contraindication of surgery and the patients with good compliance. exclusion criteria: 1. the radiotherapy and chemotherapy are not completed or the radiotherapy dose is not reached. 2. pet /ct and/or pathological indicates that there is a distant metastasis including para-aortic lymph nodes. 3. other malignancies were diagnosed within five years or needed treatments. 4. history of important organ transplantation. 5. history of immune disease who need to take immunosuppressive drugs. 6. history of serious mental illness and brain functional disorder. 7. drug abuse or drug use history. 8. participants in other clinical trials at the same time. 9. those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements. 10. without surgical conditions: 1) chronic renal insufficiency or renal failure; 2) liver insufficiency; 3)chronic lung disease with restrictive respiratory dysfunction; 4) cardiac dysfunction (patients with relative and absolute contraindications to surgery after consultation by cardiac physicians. 11. patients who cannot understand the research regimen and refuse to sign the informed consent form. 12. other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.

Keywords: locally advanced cervical cancer chemoradiotherapy redsidual tumor salvage sugery os
evaluation of anti-mullerian hormone levels as predictive of ivf outcomes in women over 38 years old

Conditions: AMH Levels; Inhibin B Levels; IVF Patients Over 38 Years Old

Summary: the present study is designed to evaluate the basal serum levels of anti-mullerian hormone (amh) and inhibin b as early predictors of ovarian response, implantation rate, and pregnancy rate in women 38 years old or older that are undergoing an ivf cycle.

specifics aims are: a) to describe amh and inhibin levels on day 3 previous to art cycle; b) to analyze the association between these hormone levels and the retrieved metaphase ii oocytes quantity; c) to analyze the association between these hormone levels and quality embryo score d) to analyze the association between these hormone levels and the number of gestational sacs per transferred-embryo (implantation rate); e) to analyze the association between these hormone levels and the pregnancy rate; f) to make a prediction model for pregnancy rate by using a multivariable regression analysis. patient participation includes signing the consent and having additional tubes of blood drawn at a regularly scheduled blood draw. this blood is used to run the study tests (amh and inhibin levels).

Eligibility criteria:
inclusion criteria: 1. women 38 years old or older at the time of initiating treatment exclusion criteria: 1. uterine disease: malformation, septum, submucosal myomas, endometrial polyps advanced endometriosis with endometrioma (s) 2. no uterus 3. single ovary

Keywords: amh inhibin b infertility
data-driven personalization of a digital health solution to support family caregivers of children with chronic conditions

Conditions: Obesity, Childhood

Summary: the goal of this feasibility study is to explore the needs of families with children with obesity and evaluate the impact of a combined intervention (children with obesity receiving pharmacological therapy in combination with the adhera caring digital program®) on treatment satisfaction, adherence, and mood. the main objectives are: * to evaluate the impact of the treatment combination (acdp® and pharmacological treatment) in terms of satisfaction, engagement, adherence and mood, in families with children with obesity. * to better understand the educational and support needs of the families of children with obesity while under treatment and lifestyle changes. participants will: * use the adhera caring digital program® (acdp®) for obesity, which includes digital therapeutic software, personalized messages, and educational materials. * take pharmacological treatment as prescribed for one year. * wear activity wristbands/watches to collect biometric data. * attend monthly clinic visits for assessments and monitoring. * complete psychometric questionnaires to measure satisfaction, adherence, and emotional outcomes. * engage in chat-based communication and video conferencing with health coaches for support and monitoring.


Eligibility criteria:
inclusion criteria: * caregivers of children between 13 and 18 years who are diagnosed with obesity and undergoing treatment according to the approved label by aemps1 (adolescents with obesity aged 12 years and older with an initial bmi at the 95th percentile or greater for age and sex). * families of children with obesity who have been under pharmacological treatment before screening. this includes treatment with any of the following medications orlistat, metformin, liraglutide, semaglutide. * participants who are willing to join acdp® for 10 months and can interact with a smartphone during that time. * the family is willing to complement the pharmacological obesity treatment with a digital intervention. * participants (patients and their caregivers) must be willing to use wearables for the entire length of the study. * parents previously using a wearable will agree not to use it during the length of the study, as their wearable account must be synched to the patient's device. further, they may need to agree on changing the account data for height, weight, and gender in their google account. exclusion criteria: * families not fluent in spanish. * families of children with obesity and comorbidities. * families of children with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes).

Keywords: obesity digital health treatment satisfaction pharmacological treatment for obesity