Kornimate/medical-research-clean huggingface dataset:
persistence of protection by shingrix

Conditions: Herpes Zoster

Summary: the study plans to learn more about how the shingles vaccine, shingrix (srx), successfully prevents shingles in older people. two vaccines are currently approved by the food and drug administration (fda) to prevent shingles. zostavax is a live virus vaccine which has been available since 2006 and prevents shingles about 50% of the time, though it is less effective the older a person is when they receive it. shingrix, which was approved by the fda in 2017, is not a live virus, but has an additive in the vaccine to boost immune response. it is about 97% effective at preventing shingles regardless of a person's age and so far has been effective for at least 4 years after vaccination. because zostavax has live virus in it, giving a "challenge" dose of zostavax - voka varicella zoster virus - to people who have received both vaccines (zostavax or shingrix) in the past, will allow researchers to learn more about how the body works to prevent shingles and how any shingles vaccination helps protect against shingles.

the primary endpoint of this study was the area under the concentration/time curve of quantitative vzv dna in plasma. however, all the vzv dna measurements were below the lower limit of quantitation of the assay. due to this unexpected outcome, we performed a qualitative analysis of presence or absence of vzv dna in plasma at day ≥3 after the voka challenge.

Eligibility criteria:
inclusion criteria: * age 50-85 * general good health * women of non-childbearing potential must be postmenopausal or have undergone hysterectomy or bilateral oophorectomy * arm 1 only: documented evidence of immunization with zvl or srx at least 5 years previously * arm 2 only; documented evidence of immunization with zvl 6-12 months prior to enrollment * arm 3 only: have never received any shingles vaccination exclusion criteria: * prior history of herpes zoster (hz) * blood products received in the 3 months prior to study enrollment or planned for the subsequent week for arm 1; arm 2 requires same exclusion; arm 3 extends the exclusion to the week after the voka challenge, which is 6 months after completing srx administration. * significant immune suppressive illness or therapy * concomitant vaccine received within 2 (inactive) or 4 (live) weeks prior to the study or during the first week of the study. * women of childbearing potential. * pregnancy or breastfeeding. * participation in a concurrent clinical study in which the subject will be exposed to and investigational product during the period starting 7 days before the first dose of study vaccine through the completion of the study.

Keywords: immunology
observational registry study of chinese patients treated with revlimid (lenalidomide)

Conditions: Multiple Myeloma

Summary: the primary objective of this study is to document efficacy and safety data in a real-world setting of chinese multiple myeloma patients who have received at least one prior therapy treated with revlimid (lenalidomide).

this registry is prospective, multi-center, observational study and will collect efficacy and safety data on multiple myeloma adult patients who have received at least one prior therapy and take revlimid as part of standard care associated with patients' treatment in order to characterize the use, efficacy and outcomes of revlimid treatment. the registry will capture data from 600 patients being prescribed revlimid in specified hospitals and all patients will be followed in the registry for two years after enrollment of the last patient.

Eligibility criteria:
inclusion criteria: * must understand and voluntarily sign written informed consent at least 18 years old at the time of signing informed consent diagnosed with multiple myeloma must have received at least one prior multiple myeloma treatment at the time of signing informed consent exclusion criteria: * none

Keywords: revlimid, lenalidomide, multiple myeloma, pfs, response rates
a phase iii study of tmc435 in genotype 1, hepatitis c-infected participants who failed to respond to previous ifn-based therapy

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to evaluate the efficacy and safety of tmc435 in combination with peginterferon alfa-2a (pegifnα-2a) and ribavirin in genotype 1 hepatitis c virus (hcv)-infected participants who failed to respond to previous interferon (ifn)-based therapy in japan.

this is a randomized (study drug assigned by chance), 2-arm, open-label study to evaluate the efficacy and safety of tmc435 (also referred to as jnj-38733214-aaa) in combination with the standard of care (soc) therapy consisting of peginterferon alfa-2a (pegifnα-2a ) and ribavirin (rbv) administered according to the manufacturer's prescribing information in adult, genotype 1 hepatitis c virus (hcv)-infected participants who failed to respond to previous interferon (ifn)-based therapy in japan. the study objective is to evaluate the efficacy of tmc435 by the proportion of participants with undetectable hcv ribonucleic acid (rna). participants will receive 12 weeks of treatment with tmc435 (100 mg) once daily plus pegifnα-2a (p) and rbv p) followed by 12 or 36 weeks of treatment with pr or participants will receive 24 weeks of treatment with tmc435 (100 mg) once daily plus pr followed by 24 weeks of treatment with pr. tmc435 is a 100-mg capsule and will be taken orally (via the mouth). treatment with pr will last 24 or 48 weeks: pegylated interferon is supplied as a vial containing 1.0 ml solution with 180 mcg pegifnα-2a and will be injected by a syringe under the skin once weekly. ribavirin is given as 200-mg tablets (daily dose: 600-1000 mg based on body weight), and taken orally by mouth two times a day after meals. participants will receive oral capsules of tmc435 (100 mg) once daily up to week 12 or 24.

Eligibility criteria:
inclusion criteria: * participant must have chronic genotype 1 hcv infection with hcv rna level \>= 5.0 log10 iu/ml * participant failed to respond to previous ifn-based therapy * participant must be willing to use contraceptive measures from the time of informed consent to 6 months after last dose of study medication. exclusion criteria: * co-infection with any other hcv genotype or co-infection with the human immunodeficiency virus (hiv) * diagnosed with hepatic cirrhosis or hepatic failure * a medical condition which is a contraindication to pegifnα-2a or ribavirin therapy * history of, or any current medical condition which could impact the safety of the patient in the study

Keywords: hepatitis c, chronic hepatitis c hepatitis c virus interferon alfa-2a ribavirin viral rna
are sporadic colorectal cancers in young distinct from elderly?

Conditions: Colorectal Neoplasms

Summary: in this study, the investigators compared and evaluated the clinicopathological and oncological characteristics of sporadic colorectal cancer (crc) in young adults without genetic mutations associated with hereditary crc syndrome and sporadic crc in elderly individuals.

the ambiguity in the findings among several previous studies might be because of the difference in the age of the study population, ycrc and ecrc. the family history of crc and cancer due to crohn's disease or ulcerative colitis were also not excluded in such previous studies. most importantly, those studies did not rule out the risk of hereditary cancer through the genetic testing in ycrc. since hereditary crc accounts for approximately 34% of those under the age of 35 years, it is necessary to exclude it to accurately compare the clinicopathological characteristics of sporadic cancer developed in ycrc and ecrc.

Eligibility criteria:
inclusion criteria: * histologically confirmed cases of adenocarcinoma in the colon and rectum * the age at the time of diagnosis should be ≤ 40 years (for ycrc) or ≥ 70 years (for ecrc) * genetic testing confirmation of non-hereditary cancer. exclusion criteria: * inflammatory bowel disease * a family history of crc * a history of other cancers * underwent any emergency operation or palliative surgery * the amsterdam criteria with mutations in genes associated with apc, mlh1, msh2, msh6

Keywords: young colorectal cancer patients elderly colorectal cancer patients sporadic colorectal cancer
prenatal video-based education and postpartum effects

Conditions: Breastfeeding

Summary: the purpose of this randomized controlled trial is to examine the impact of a remotely-delivered antenatal milk expression (ame) intervention versus an attention control condition on breastfeeding outcomes among a sample of 280 nulliparous, non-diabetic women with pre-pregnancy body mass indices ≥ 25. ame involves milk expression and collection in the third pregnancy trimester and is theorized to address multiple barriers to breastfeeding among women with higher bmi, including impaired breastfeeding self-efficacy, insufficient milk supply (critical period endocrine modulation of milk volume), and early formula supplementation in the context of a medically complex birth (availability of banked antenatal milk). participants will be enrolled in their third trimester of pregnancy and allocated into one of two study arms: 1) ame instruction delivered by remote, live international board certified lactation consultants via an innovative app-based telelactation platform; or 2) an attention control condition (video-based infant care education unrelated to infant feeding). video-based education for both groups will occur in weekly study visits from 37 to 40 weeks gestation, with women in the intervention group continuing ame 1-2 times per day at home. measured outcomes of interest will include short and long-term breastfeeding practices (e.g., breastfeeding duration, exclusivity) and participants' experiences with and perceptions of ame.

the purpose of the prepare trial is to examine the impact of an antenatal milk expression (ame) intervention among women with pre-pregnancy bmi 25 or more on breastfeeding outcomes, including breastfeeding self-efficacy, breastfeeding duration and exclusivity, and perception of insufficient milk supply. specifically, the investigators will: 1. determine the effect of the ame intervention on short-term breastfeeding outcomes, including breastfeeding self-efficacy and exclusivity, to two weeks postpartum. 2. explore the sustained effect of the ame intervention on longer-term breastfeeding duration and exclusivity over the first year postpartum. 3. examine participants' experiences with and perceptions of ame.

Eligibility criteria:
inclusion criteria: * pregnant women who: 1. have a pre-pregnancy bmi ≥ 25 2. are ≥ 18 years 3. are english-speaking 4. are 34 0/7-36 6/7 gestational weeks 5. are nulliparous 6. intend to/have interest in breastfeeding after birth 7. are having a singleton pregnancy 8. plan to receive prenatal care and deliver at select hospital/birth facility systems (access to emr data) exclusion criteria: 1. contraindications to breastfeeding as specified by the american academy of pediatrics 2. history of breast reduction surgery or radiation 3. indication for delivery by 37 weeks gestation 4. gestational or pre-existing diabetes

Keywords: antenatal milk expression antenatal colostrum
evaluation and management of metabolic bone disease in kidney transplant recipients

Conditions: Skeletal Anomalies; Kidney Transplant; Complications

Summary: there is a well-documented increased risk for disordered mineral bone homeostasis in kidney transplant recipients (ktrs) when compared to the general population, leading to a markedly increased risk for fragility fractures and their associated morbidity and mortality. a more uniform and rigorous evaluation of bone and mineral homeostasis,than is afforded to patients under "normal care", will result in better clinical outcomes in ktrs.

the aim is to comprehensively characterize the mineral metabolism and skeletal phenotype in kidney transplant recipients (ktrs) to being to identify risk factors for post-kidney transplant mineral bone disease (pkt-mbd); and to evaluate whether treatment of abnormalities in these parameters will improve skeletal health as quantified by bone mineral density (bmd), bone turnover markers (rate of skeletal remodeling) and osteoprobe (a direct index of bone quality using reference point indentation technology. participants in the rigorous evaluation arm will be followed with a) mineral metabolism: blood calcium, phosphorus, parathyroid hormone (pth), 25(oh) vitamin d; b) bone turnover markers: bone-specific alkaline phosphatase, cross-linked c-telopeptide of type i collagen (ctx), and n-terminal propeptide of type i collagen (pinp); c)bone mineral density using a dual energy x-ray absorptiometry which is the standard method by which bone mass is measured clinically. note: the use of the osteoprobe was discontinued on 9/5/19 due to safety concerns from the fda about the device in other trials/other sites. the control cohort is essentially an historical control group who will have received standard of care for the 18 months ending just prior to the enrollment of our intervention cohort. a coincident control cohort will not be used because knowledge of the additional data to be collected in the control cohort will undoubtedly influence their care by their attending nephrologists and surgeons.

Eligibility criteria:
inclusion criteria: * kidney transplant subjects within the first 3 months after surgery (intervention cohort) and 18 months after surgery (control cohort) * age between 30 to 65 years old * estimated glomerular filtration rate (gfr) \> 35 ml/min/1.73 m2 exclusion criteria: * major acute post-operatory complications (infection, urine leak, delayed graft function) * living related-donor ktrs * estimated gfr ≤ 35 ml/min/1.73 m2 * significant skin disorder, bruising, local edema, skin infection or are being treated with anticoagulants (such as warfarin, heparin, low molecular weight heparin or direct thrombin inhibitors) or have known or acquired clotting disorders since the osteoprobe® procedure would be unsafe * patients who do not plan to be followed at yale new haven for at least 18 months * morbidly obese (bmi \>40) * history of gastroparesis
exploring the psychophysics of keratoconus using the moorfields acuity chart

Conditions: Keratoconic Subjects

Summary: the measurement of visual acuity is made using black letters of varying size superimposed on a uniform white background. the objective is to determine the smallest letter, or optotype, that can be correctly identified. one limitation of current tests is the variability of measurements, this making it difficult for clinicians to determine if changes in visual acuity are related to ocular disease. this variability has been attributed to the design of current optotypes, in particular their differing legibilities. our group has recently demonstrated that a new type of letter chart (moorfields acuity chart), containing letters with a black core and a white border presented on a grey background, reduces the variability of visual acuity measurements. in this study the investigators wish to determine if changes in vision owing to keratoconus, a disease that causes the cornea to adopt an irregular shape, may be detected more easily using the moorfields acuity chart compared with conventional letter charts.


Eligibility criteria:
keratoconic subjects (50): * age 18-40 years. * the presence of keratoconus in at least one eye. * the absence of significant media opacities (e.g. cataract, corneal scarring). * the absence of any other ocular pathology (e.g. glaucoma, diabetic retinopathy, uveitis). * the absence of amblyopia in the test eye. * no previous ocular surgery (e.g. corneal crosslinking, cataract surgery, etc.) * best corrected visual acuity better than or equal to 6/60 (1.0 logmar). * pupil diameter ≥3 mm and ≤7 mm in normal room illumination. healthy subjects (30): * age 18-35 years. * the absence of clinically significant keratoconus. * the absence of significant media opacities. (e.g. cataract, corneal scarring). * the absence of any other ocular pathology (e.g. glaucoma, diabetic retinopathy, uveitis). * the absence of amblyopia in the test eye. * no previous ocular surgery (e.g. corneal crosslinking, cataract surgery, etc.) * best corrected visual acuity better than or equal to 6/9 (0.1 logmar). * pupil diameter ≥3 mm and ≤7 mm in normal room illumination.
a study to investigate the effect of baxdrostat on ambulatory blood pressure in participants with resistant hypertension

Conditions: Resistant Hypertension

Summary: this is a phase iii, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg baxdrostat vs. placebo, administered qd orally, on the reduction of sbp, measured by average 24-hour abpm in 212 participants with rhtn (defined as seated sbp ≥ 140 mmhg at screening and mean ambulatory sbp ≥ 130 mmhg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).

this is a phase iii, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg baxdrostat versus placebo, administered once a day (qd) orally, on the reduction of ambulatory sbp in participants with rhtn, defined as bp targets not being achieved in an individual despite the use of at least 3 antihypertensive agents of different classes (at maximum tolerated dose in the judgement of the investigator), one of which is a diuretic.

Eligibility criteria:
inclusion criteria: * participant must be ≥ 18 years old, at the time of signing the informed consent. * mean seated sbp on aobpm of ≥ 140 mmhg and \< 170 mmhg at screening. * have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the investigator, for at least 4 weeks prior to screening (participants who do not meet this criterion may be rescreened at the investigator's discretion). beta blockers used to treat other conditions (ie, migraine, hf, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study. * have egfr ≥ 45 ml/min/1.73 m2 at screening. * serum potassium (k+) level ≥ 3.5 and \< 5.0 mmol/l at screening, determined as per central laboratory * randomization criteria: mean ambulatory sbp of ≥ 130 mmhg at randomisation. exclusion criteria: * mean seated sbp on aobpm ≥ 170 mmhg at screening. * mean seated dbp on aobpm ≥ 110 mmhg at screening. * serum sodium level \< 135 mmol/l at screening, as per central laboratory. * participant has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, cushing's syndrome, aortic coarctation. * new york heart association functional hf class iv at screening. * persistent atrial fibrillation.

Keywords: hypertension resistant hypertension blood pressure baxdrostat cin-107 aldosterone aldosterone synthase aldosterone synthase inhibitor
gastric electrical stimulation (ges) and pyloroplasty for the treatment of gastroparesis

Conditions: Gastroparesis

Summary: gastroparesis (gp) is describing a condition when stomach does not empty as fast as it should. this fact creates the situation, when food stays in the stomach for a long time and it causes symptoms of nausea, vomiting, loss of appetite, bloating, inability to finish normal size meal and abdominal pain. there are not many drugs available to treat this condition and majority of gastroparetic patients are not responding well to them after they are on it for some time. many investigators are able to implant gastric stimulator system (ges) under fda approved status of humanitarian device exemption (hde) definition. in the last few years it became possible to add another surgical procedure, which is called pyloroplasty (making bigger opening on the end of stomach), may help even more as it is also increasing the rate of the emptying of the stomach. therefore this study is proposing to evaluate if ges in combination with pyloroplasty is much better than pyloroplasty alone. for this reason, two of these procedures will be introduced surgically at the same time, but ges devices will not be turn on in half of these participants for 3 months. after that time all subjects will have their devices turned on. all subjects will be asked to evaluate their symptoms of gastroparesis and their quality of life during clinical visits, and investigators will conduct pathological analyses of tissue obtained during surgery.

ges system (enterra therapy) involves surgical implantation of a pulse generator in the abdominal wall and 2 electrodes into the muscularis propria of the stomach. well established procedure, called pyloroplasty, will be performed during the implantation of ges system, therefore all participants will have both surgeries done at the same time. half of them will be randomized to keep ges on after surgery, and other half will have ges turned off for 3 months. both groups will be followed for additional 3 more months. study related questionnaires and diagnostic/ clinical tests will be obtained at all points of interest of this study.

Eligibility criteria:
inclusion criteria: * documented diagnosis of gp for \> 1 year and refractoriness to anti-emetics and prokinetics; more than 7 emetic episodes per week; * delayed ge (gastric retention greater than 60% at 2 h and/or greater than 10% at 4 h) based on a 4-h standardized radionuclide solid meal test exclusion criteria: * organic or pseudo-obstruction, primary eating or swallowing disorders, positive pregnancy test result, psychogenic vomiting, peritoneal dialysis, drug dependent, morbid obesity, active malignancy

Keywords: diabetes mellitus gastroparesis gastric electrical stimulation pyloroplasty idiopathic -unknown etiology
an investigational study of bms-986165 in participants with normal liver function and participants with mild to severe liver damage

Conditions: Liver Dysfunction; Healthy Volunteers

Summary: the purpose of this study is to investigate bms-986165 in participants with different levels of liver function.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening * normal renal function at screening as evidenced by an estimated glomerular filtration rate (gfr) \> 80 ml/min/1.73 m2 for participants exclusion criteria: * clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ecg, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant * history or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening * have a history of cancer (malignancy) with the following exceptions: (1) participants with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) participants with other malignancies who have been successfully treated ≥10 years prior to the screening visit where, in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the screening visit other protocol defined inclusion/exclusion criteria could apply