Kornimate/medical-research-clean huggingface dataset:
sleep coach: a mobile app to address insomnia symptoms among cancer survivors

Conditions: Insomnia; Breast Cancer; Prostate Cancer; Colon Cancer

Summary: this clinical trial will evaluate the adherence, usefulness, satisfaction and effect size for the sleep coach app as an intervention for insomnia in 30 adult post-treatment cancer survivors.

difficulty sleeping, falling and/or staying asleep, is common in people after they have been diagnosed and treated for cancer. cognitive behavioral therapy for insomnia (cbt-i) is considered to be the preferred treatment but until now, there has been limited access for most people to cbt-i because it has required an in-person visit with a trained therapist. this research study is to test a mobile cbt-i app called mi sleep coach to deliver cbt-i. the goal of this study is to understand if people are willing to use the app, if they find it useful in helping with sleep difficulty and if they are satisfied with using it. the investigators hope to use information from this small feasibility study to study the effectiveness of the app in a larger group of cancer survivors and ultimately to help cancer survivors with sleep difficulties to sleep better.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * has completed curative-intent treatment (chemo, surgery, rt) for prostate, colon or breast cancer at least three months and not more than 5 years prior to study entry. note: ongoing hormonal therapy (i.e., tamoxifen, aromatase inhibitors, casodex), herceptin and maintenance therapies are allowed. * ability to read and write english * ability to complete questionnaire(s) by themselves or with assistance. * reports trouble falling asleep or staying asleep on at least 3 nights per week (most weeks) for the last 3 months. * own an android phone version 8 or higher (the latest version of android is 11.0) or an iphone running ios 11 or higher (the latest version of ios is 14.3.) * ability to provide informed written consent. exclusion criteria: * inability to read and write english * diagnosis of a sleep disorder other than insomnia (e.g. sleep apnea, restless legs syndrome, narcolepsy) * diagnosis of insomnia prior to cancer diagnosis * reports physical symptoms that interfere with sleep, such as shortness of breath, pain, hot flashes, frequent urination * major psychiatric or medical condition other than cancer suspected to contribute to their sleep disturbance * evidence of active cancer (i.e. not considered ned) * currently or previously received cbt-i * patients who are night shift workers or subject to other external restrictions on their opportunity to sleep at night.

Keywords: cancer survivor
usability of myfood24 in clinical populations

Conditions: Gastroenterology Surgery; Colorectal Surgery; Weight Loss; Weight Change, Body

Summary: many patients would benefit from dietary/nutritional support to better manage their conditions but evaluating current intake in relation to personal targets is labour-intensive and often does not feature as part of clinical consultations. primary objective: test usability and acceptability of 'myfood24 health' for monitoring dietary intake in a group of patients. recruit 60 gastroenterology surgery patient (leeds) and 60 tier 3 weight management patients (30 leeds/ 30 york). randomise to 3 groups 1. usual care 2. myfood24health 3. myfood24health plus personalised feedback 'diet optimisation engine' which suggests changes to amounts or types of foods during a 2-month follow-up, patients in group 2 or 3 will be asked to record daily diet in myfood24, including weekend and weekdays and use it a minimum of 4 times. hcps will be able to review diet/nutrients for group 2 and 3 patients and can support dietary change or nutritional goals, as part of patients' ongoing clinical management, during existing scheduled clinic visits (n.b. not all participants will have a scheduled clinic appointment during the study). 2 months after recruitment, all participants will receive a link to an online feedback questionnaire. at end of study, hpcs will be invited to provide feedback during a 30 minute interview.

see published results at https://www.mdpi.com/2072-6643/14/9/1768

Eligibility criteria:
inclusion criteria: * able to use a smartphone or tablet * have regular access to the internet * aged 18 years or over * not receiving palliative treatment for their condition * no pre-existing condition, eg. diabetes which requires a specific diet or eating disorder * no food allergies * be receiving ongoing gastrointestinal surgery or weight management treatment * be able to read and understand english exclusion criteria: -

Keywords: diet monitoring diet optimisation nutrition
real-world performance and safety of cerviron® in the treatment of vaginitis

Conditions: Vaginitis; Bacterial Vaginosis

Summary: vaginitis is a broad term that includes a range of gynecological disorders characterized by infection of vaginal mucosa, inflammation of vulva and alteration of the normal vaginal microflora. the most prevalent is bacterial vaginosis, followed by other clinical entities such as candidiasis, trichomoniasis and non-specific vaginitis. a collection of clinical data was conducted to assess the tolerability of cerviron® ovules in the treatment and management of various types of vaginitis in clinical practice. a total of 111 women aged between 20 and 70 years were recruited, 71 of whom were treated with cerviron® ovules as monotherapy and 40 who used cerviron® ovules as supportive treatment in conjunction with antibiotic therapy. the aim of our study was to assess the relief in vaginal symptoms and changes in the normal vaginal ph level after 3 months of treatment with cerviron® medical device in real-life clinical practice settings.

this study was designed as real-world evidence study with the primary purpose to assess the performance and tolerance of cerviron® ovules in the treatment and management of various types of vulvovaginitis. the study collected clinical data from 28 different specialized gynecology clinical facilities. the study was conducted between may 20, 2021 and august 31, 2021. the primary objective of this study was to assess the tolerability of cerviron® ovules in the treatment and management of various types of vulvovaginitis, but also to confirm its performance both on symptoms relief and as a user-friendly device. the secondary objective of this study was to assess the performance of the medical device by clinical exam and patients' degree of satisfaction. the study design consisted of 3 or 4 visits over 90 ± 3 days. cerviron® ovules were applied intravaginally, once per day, on the first day after menstruation and for 15 days during 3 consecutive months. data of 111 women aged between 20 and 70 years were analyzed, 71 of whom were treated with cerviron® ovules as monotherapy and 40 who used cerviron® ovules as supportive treatment in conjunction with anti-infectious therapy. the symptoms recorded in the medical charts were followed to determine the performance of the medical device during the treatment.

Eligibility criteria:
inclusion criteria: * adult females with a diagnosis of infectious or non-infectious vaginitis and treated with cerviron® with or without anti-infectious treatment for at least three months: * negative result for gardnerella vaginalis, candida albicans, trichomonas vaginalis. exclusion criteria: * subjects with diagnosed abnormal genital bleeding; * subject with vulvar, vaginal or cervical cancer; * subjects with other inflammatory gynecological conditions.

Keywords: vulvovaginitis vaginal discharge vaginal ph
pharmacokinetics and optimal dose of ertapenem in hemodialysis patients

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to determine the amount of ertapenem in the blood over time between hemodialysis session.

after a hemodialysis session, subject will be administered ertapenem and the amount of ertapenem in the blood will be measured at seven time periods before the initiation of the next hemodialysis session.

Eligibility criteria:
inclusion criteria: * men or women age between 18 and 88 at the time of admission to oakwood hospital and medical center during january 1, 2014 or date of institutional review board (irb) approval to december 1, 2015 * diagnosed with end stage renal disease and requires hemodialysis three times a week * no allergy to β lactam medications * existing iv access for parenteral ertapenem infusion * willing for blood draws, at predose, 0.5, 1, 2, 6, 12 hours post-hemodialysis and pre-hemodialysis for the following hemodialysis and immediately post hemodialysis session and 1 hour post. * no evidence of hepatic disease * no history of alcoholism or drug abuse within pervious 2 years * not pregnant exclusion criteria: * history of any form of epilepsy, seizure or convulsion * currently taking any forms of valproic acid or divalproex sodium for treatment of any disease states * currently taking probenecid * current clostridium difficile (c. diff.) infection, defined as 30 days prior to day-1 of receiving ertapenem for this study * currently receiving any antimicrobial agents for prophylaxis or treatment

Keywords: ertapenem pharmacokinetic pharmacodynamics hemodialysis requires hemodialysis three times a week
a study of infliximab in the treatment of chinese children with crohn's disease

Conditions: Crohn Disease

Summary: the main purpose of this study is to record the use of infliximab (ifx) in the treatment of chinese children with crohn's disease (cd) in routine clinical practice and to summarize the clinical efficacy and safety of ifx in the treatment of pediatric cd.


Eligibility criteria:
inclusion criteria: * must have a confirmed diagnosis of crohn's disease * must sign, and their legal guardians/legally-acceptable representative where applicable must sign, a participation agreement/icf allowing data collection and source data verification in accordance with local requirements * first-time received ifx treatment exclusion criteria: * history of medical contraindications for infliximab (ifx), example. serious infections, active tuberculosis (tb), lymphoma and other malignancies, moderate to severe heart failure, hypersensitivity to inactive components of the product or to any murine proteins * previous exposure to infliximab or any other biologics * received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the start of the study or the first data collection time point * currently enrolled in an investigational study * have other crohn's-like disease that are associated with mono-genetic immune disorders
impact of mindfulness-based stress reduction meditation practice on patients after cardiac rehabilitation.

Conditions: Cardiac Disease

Summary: cardiac rehabilitation is a major component of treatment for patients suffering from coronary pathology revealed by myocardial infarction or acute coronary syndrome warranting transluminal coronary angioplasty, as well as in the aftermath of cardiac surgery. a significant proportion of patients in this situation (40%) suffer from varying degrees of anxiety and depression, which are difficult to treat. these impair their quality of life and can make it more difficult for them to take part in the rehabilitation program, compromising the results that can be expected. finally, they are often associated with lax compliance with medical treatment, less control of risk factors and less regular exercise. cardiac rehabilitation teams are well aware of this anxiety-depressive picture, and various therapies such as sophrology, relaxation and yoga have been proposed as alternatives to conventional medical treatments to help patients through this period. among these alternatives is the concept of "mindfulness-based meditation", based on the mindfulness-based stress reduction (mbsr) protocol described by dr. jkabat zinn. it has been the subject of several prospective randomized studies, which have demonstrated that it is suitable for the management of patients in this situation, and that it has measurable beneficial effects on their sense of well-being. to our knowledge, the mbsr program used in cardiac rehabilitation has never been the subject of a randomized comparative study in france to assess its effectiveness on medium- and long-term anxiety-depressive disorders. this is the objective of this study.


Eligibility criteria:
inclusion criteria: 1. cardiac patients eligible for cardiac rehabilitation, 2. patient with a hospital anxiety and depression scale (hads) score for the anxiety dimension (hads-a) \>7 or a score for the depression dimension (hads-d) \> 7 3. age ≥ 18 years 4. affiliated with a social security scheme or beneficiary of such a scheme 5. patient signed free and informed consent form exclusion criteria: 1. patients already treated for severe psychiatric disorders (major depression, psychosis, schizophrenia) 2. inability to follow the 8-week mbsr program 3. protected patient: minor, adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision 4. medical conditions which may interfere with the conduct of the study and the investigator's judgment, and which may render the patient unfit to participate in the study. 5. pregnant or breast-feeding patient 6. refusal to participate in the study or inability to comply with the study protocol for any reason whatsoever

Keywords: cardiac rehabilitation mbsr
tace(transcatheter arterial chemoembolization ) associated with systemic chemotherapy versus systemic chemotherapy alone in patients with unresectable crlm(colorectal liver metastases)

Conditions: Colorectal Adenocarcinoma Metastatic to the Liver

Summary: to date no randomized controlled trials have been completed that demonstrated whether tace(transarterial chemoembolization) is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversion resection rates and survival compared with chemotherapy (target therapy) alone for patients who failed with first-line chemotherapy.the primary objective of this trial is to determine conversion resection rates and survival for patients with colorectal cancer liver metastasis are treated with tace plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy in the 2nd, and 3rd line.


Eligibility criteria:
inclusion criteria: * patients must have histologically confirmed crlm * disease limited to the liver unresectable disease by surgery or other local therapies * age \> 18 years * eastern cooperative oncology group (ecog) performance status 0-2,child pugh a or b * expected survival ≥ 3 months * adequate hematological, hepatic and renal function * pd(progressive disease) after first line chemotherapy exclusion criteria: * pregnant or lactating women * patients with severe organ dysfunction or failure * with severe cardiovascular or mental disease

Keywords: colorectal cancer liver metastasis transarterial chemoembolization conversion resection rates chemotherapy
effects of lactose on fecal microflora

Conditions: Lactose Intolerance

Summary: the genetics of lactase divides the population into 2 phenotypes: those who can(lp) and those who cannot(lnp)digest lactose. this division may help modify disease risks according to geographic population distribution. at least some of the putative mechanism of risk modification may relate to an effect of undigested lactose on lower intestinal bacteria. the effect may provide for support of beneficial microbes. the amount of lactose reaching the colon is made easier in lnp than lp subjects who have to consume larger amounts to have meaningful spillover into the lower bowel.the current study examines whether there are quantifiable qualitative fecal bacterial differences to a standard intake of lactose(milk sugar)between these 2 different phenotypic populations. finding of differences would lend support to the notion that for some diseases lp and lnp subjects face different risks even in an area of uniform disease risk if they consume lactose (found in dairy foods). the primary end point is comparison of 4 groups of specific bacteria between lp and lnp participants before and after 2 weeks of lactose(in powder form mixed in water) consumption. classification is based on genetic analysis and secondarily on breath hydrogen results. results are compared within groups. the secondary outcome is comparison of 4 groups of bacteria between lp and lnp subjects against each group of stool samples obtained on the first visit. results are obtained between groups. additional information and other secondary outcomes are to evaluate any relationship between diet intake and the 4 groups of bacteria on the first visit another outcome will be to compare within groups any effect of lactose consumption on insulin and glucose levels within the 2 groups.

healthy volunteers between the ages of 18 and 49 are recruited. 1. each participant fills a lactose targetting diet questionnaire(3 day recall). 2. a 50g lactose challenge tets is administered,breath hydrogen and symptoms are recorded for 4.5hrs. 3. blood is drawn for analysis of lactase genetic status. 4. a stool sample is collected(10-15g)and analysed fo total anaerobes, enterococci, bifidobacteria and lactobacilli. 5. all subjects are withdrawn from dairy foods(calcium replacement suggested in diet) for 2 weeks and are aked to return to repeat parts 2 and 4. 6. a voluntary segment has glucose and insulin measured for 4 hrs via an indwelling venous catheter. 7. subjects are asked to consume 50g lactose in divided doses for 2 further weeks 8. at the end they return and repeat sections 2 and 4 for the third time. 9. participants who volunteered to have glucose and insulin measured repeat this segment of the study as well.

Eligibility criteria:
inclusion criteria: * 18-49 yr old male or female. * healthy except may take chronic thyroid or hypertension medication. exclusion criteria: * pregnancy * antibiotics in last 6 weeks * any active illness.

Keywords: lactase lactose microflora
trial of holep vs. pvp in treating bph in patients with bleeding tendency

Conditions: Benign Prostatic Hyperplasia

Summary: patients presented for bph surgery at our out patient clinic will be assessed for abnormal bleeding profile. patients with bleeding tendency will be offered either holep or greenlight laser pvp based on prostate size cut off point of 80ml larger prostates will be treated with holep smaller prostates will be treated with greenlight pvp

elderly patients with bleeding tendency either secondary; 1. strict antiplatelet intake 2. strict anticoagulant intake 3. uncorrected natural bleeding tendency e.g; patients with liver cell failure are at higher risk of perioperative bleeding when subjected to prostate surgery. laser prostate surery was introduced to overcome this difficulty. however, till now there is no head to head comparision of different types of laser procedures in treating this subset of patients in the current study patients presented for bph surgery in a tertiarry referral prostate unit will be assessed for bleeding tendency and will be treated either by holmium laser enucleatiuon of the prostate or greenlight laser vaporization of the prostate single surgeon will perform all cases

Eligibility criteria:
inclusion criteria: * bph patients candidate for transurethral prostate surgery after failure of medical treatment * perioperative uncorrected blleding tendency 1. patients with naturally induced uncorrectable bleeding tendency; 1. platelet count less than 100000/mm3 2. inr more than 1.5 2. patients on oral antiplatlet that deemed unsafe to stop prior to surgery as per intenist 3. patients on oral anticoagulant that deemed unsafe to stop prior to surgery as per intenist exclusion criteria: * correctable bleeding tendency

Keywords: bph- laser- prostate- bleeding tendency
calibration of a non-invasive glucose measurement device and assessment of its performance in the hypoglycemic range in patients with type 1 diabetes

Conditions: Diabetes Mellitus

Summary: this clinical study has been launched to collect spectral raman data and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. the study is a combined home-based and in-clinic study where subjects will attend the clinic two times.


Eligibility criteria:
inclusion criteria: * male and female subjects between 18 and 40 years of age. * diagnosed with type 1 diabetes mellitus. * uses an insulin pen or pump. * hb1ac \> 55 mmol/mol at baseline visit. * skin phototype 1-4 according to fitzpatrick skin tone scale. * willing to perform a minimum of 8 finger sticks per day during the study for the home-based study and approximately 16 finger sticks for the in-clinic study days. * willing to have a peripheral venous catheter inserted. * willing to provide written signed and dated informed consent. exclusion criteria: * breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control according to approved contraceptives from nca during the study execution (applicable to female subjects only). * subjects not able to understand and read danish. * inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator. * subject is not able to hold hand/arm steadily (including tremors and parkinson's disease). * reduced circulation in hand. "allen's test" is used for assessing hand circulation to evaluate occurrence of reduced blood. * extensive skin changes, tattoos or diseases on probe application site (thenar) that could interfere with the accuracy of the interstitial glucose measurements. * known allergy to medical grade alcohol. * having active cancer treatment and/or use tetracyclines and other medication / topical agents known to increase photosensitivity in skin. * medical history or any condition that may, in the opinion of the investigator, compromise the subject's ability to participate * concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff. * diagnosed with cardiovascular diseases. * subjects currently enrolled in another study. * radiotherapy for the past six months.

Keywords: non-invasive glucose monitoring raman spectroscopy
cohort study for patients using fuzeon (enfuvirtide)

Conditions: HIV Infections; Antiretroviral Treatment

Summary: the radata-fuzeon cohort is an observational cohort study to gain a better understanding of fuzeon (enfuvirtide) in daily clinical practice. patients planned to take this drug in a new antiretroviral combination therapy (art) are eligible to participate in this observation. physicians may register patients online via the internet. they are offered to get an expert advice suggesting therapeutics for a new art. observation interval is every three month. however physicians are allowed to initiate new diagnostics, expert advice and therapeutic changes independently from these intervals if necessary. total observation time for each patients is planned for two years.


Eligibility criteria:
inclusion criteria: * diagnosis of hiv-infection * planned to switch to a fuzeon-containing antiretroviral therapy exclusion criteria: * inability to understand or sign inform consent

Keywords: treatment experienced