Kornimate/medical-research-clean huggingface dataset:
rct of automated telephone outreach to improve colorectal cancer screening

Conditions: Colorectal Cancer

Summary: this large randomized controlled trial is testing the effectiveness of automated telephone outreach with speech recognition to improve rates of screening for colorectal cancer. the hypothesis is that the intervention improves rates of screening overall and specifically rates of colonoscopy.

colorectal cancer (crc) is the second leading cause of cancer-related mortality in the united states. despite widespread dissemination of evidence-based guidelines recommending crc screening, a large proportion of eligible individuals do not undergo screening. a variety of interventions have been tested to increase screening in primary care, but there remains an urgent imperative to develop and evaluate cost-effective and widely applicable approaches to promoting screening. in march 2005, harvard pilgrim health care, a large non-profit hmo in new england, carried out an internally funded program to increase crc screening. the hmo randomized 80,000 members aged 50 to 64 years to receive automated telephone outreach with speech recognition or usual care. the intervention entailed the telephone engagement of members in a dialogue with a computer-programmed, responsive human voice about the importance of crc screening, the options for undergoing screening, and encouragement to follow-up with their primary care physicians. the present study involves a 12-month follow-up of all eligible members randomized to intervention or usual care in march 2005, with assessment of the effect of the intervention on rates of crc screening. this study has important implications for increasing crc screening. with health plans expanding efforts to screen large populations for crc and other malignancies, automated telephone outreach with speech recognition can reach large numbers of individuals with educational and reminder messages. it is important to know whether these efforts to promote screening are effective in overcoming known disparities in screening for crc. if proven effective and cost-effective, this technology has the potential for widespread adoption and population-wide improvements in crc screening and other prevention-related behaviors, with the ultimate public health goal of reducing the burden of suffering attributable to cancer and its complications.

Eligibility criteria:
inclusion criteria: * age 50-64 at baseline * continuous enrollment in health plan exclusion criteria: * prior request for exclusion from research or quality improvement * no telephone number on file * enrolled in other telephone-based outreach program of the health plan * share household with another eligible member * evidence of colorectal cancer or polyps at baseline * evidence of prior screening at baseline such that screening is not due at time of intervention

Keywords: colon cancer prevention screening telephone
a study on the use of educational programs prior to lumbar spinal surgery

Conditions: Decompression, Surgical

Summary: this study evaluated the hypothesis that the implementation of an educational program that informs spine patients about their condition, treatment options, prioritization on the wait list, and post-operative care would improve functional outcome and quality of life scores following surgery

previous literature has shown that longer waits to lumbar spine surgery can have negative effects on the patients perceived function and quality of life both pre- and post-operatively. patients report deterioration during this long wait, commonly over 6 months in ontario. the proposed study intends to evaluate the impact of two different educational methods for patients undergoing lumbar spine surgery. this prospective randomized clinical trial will assign patients to two different educational groups: one of solely standard care, and the other of standard care with the addition of presentation of a 10 minute educational video informing spine patients about their condition, treatment options, prioritization on the wait list and post-operative care. outcome measures will be assessed through four different questionnaires concerning specific conditions, pain, quality of life, etc., both pre-operatively and post-operatively. providing patients with this accurate information may coincide with positive outcome measures. the more successful educational program, as found by this study, may then be provided to all spine patients. this educational program may bring about an increase in overall well-being of spine patients by having a positive impact on the quality of life both pre- and post-operatively.

Eligibility criteria:
inclusion criteria: * degenerative condition of the lumbar spine requiring decompressive surgery exclusion criteria: * emergent spinal condition * acute bowel/bladder dysfunction * cervical spine condition * inability to participate in follow up and/or functional tests or questionnaires during study timeline (due to substance abuse, etc...) * revision surgery

Keywords: lumbar decompression
effects of pgs2.0 in patients with unexplained rpl

Conditions: Recurrent Pregnancy Loss; Infertility, Female

Summary: 50%-60% of the known causes of recurrent pregnancy loss(rpl) are associated with embryonic aneuploidy, such that preimplantation genetic screening (pgs) on embryos acquired by assisted reproductive treatment should improve the rate of pregnancy and live birth in those patients. in dispute though the clinical application of pgs has been, a series of studies show that the new generation of pgs(pgs 2.0), based on blastocyst biopsy followed by whole genome analysis, has significantly improved the clinical outcome of ivf treatment. at present, there is still a need for the evidence of the use of pgs 2.0 in rpl patients, who may benefit from this emerging technology considering the prevalence of genetic abnormalities and the number of transferable embryos in this population. an earlier single center rct conducted by our ivf center displayed higher implantation rate, clinical pregnancy rate and ongoing pregnancy rate calculated by per embryo transfer(et) cycle in ivf/icsi+pgs group compared with ivf/icsi group. this multi-center prospective randomized clinical trial is to provide more data to determine whether the clinical outcomes are significantly improved per treatment cycle such that provide evidence for the application of pgs in rpl patients. besides, risk factors of pgs outcome are to be analyzed from multi-center data to build a model for prediction of the possible outcomes of pgs and direction of the clinical choice.


Eligibility criteria:
inclusion criteria: 1. the couple has experienced two or more failed pregnancies (according to asrm definition). 2. the karyotypes of both husband and wife are normal (polymorphic chromosomes are considered normal either). 3. women ages ≥20 and \<38 years old. exclusion criteria: 1. the wife has history of the following diseases: a, the history of thyroid disease; b, the history of adrenal diseases; c, the history of sexually transmitted diseases; d, the history of hereditary diseases; e, the history of mental and psychological disorders. 2. the wife has the following uterine abnormalities: a, uterine malformations (uterus unicorns and duplex uterus), untreated septate uterus, adenomyoma, submucous uterine fibroids, endometrial polyps, or intrauterine adhesions (including the history of intrauterine adhesions). 3. the wife has a medical condition that contraindicate art or pregnancy, including poorly controlled type i or type ii diabetes; undiagnosed liver and renal disease or liver and renal insufficiency (based on blood test); deep vein thrombosis; pulmonary embolism; history of cerebrovascular accident; uncontrolled hypertension; cardiac disease; carcinoma; severe anemia; suspicious or undiagnosed vaginal bleeding.

Keywords: unexplained recurrent pregnancy loss infertility, female preimplantation genetic screening in vitro fertilization intracytoplasmic sperm injection
myocardial contrast echocardiography in congenital heart disease

Conditions: D-Transposition of Great Arteries; Tetralogy of Fallot

Summary: patients with congenital heart disease in whom the right ventricle is exposed to pressure or volume overload show progressive systolic dysfunction of the right ventricle, the fact of which conveys substantial morbidity and mortality. the aim of this study is to investigate the myocardial perfusion in these patients by myocardial contrast echocardiography (mce) in order to determine whether disturbed blood flow plays a role in the development of right ventricular systolic dysfunction.


Eligibility criteria:
inclusion criteria: * d-tga or fallot-tetralogy or healthy person * written informed consent * age \>= 18 years exclusion criteria: * anaemia * pregnancy and breast feeding * diabetes mellitus * contraindications to stress testing (ergometry or adenosine) * known adverse reaction or hypersensitivity against v08da (sonovue) or its components or against adenosine
sexual health after endometriosis surgery

Conditions: Endometriosis

Summary: endometriosis is a disease affecting between 5 and 15% of women and more than 40% of infertile women. the main stakes of this disease are that it is benign but difficult to diagnose, often very painful, difficult to predict, potentially recurrent, while being resolvable at menopause. it affects women of childbearing age and can cause infertility and pain during intercourse. also, by its characteristics, it can significantly deteriorate the quality of life. the management of endometriosis, from diagnosis to treatment, is not consensual. there are medical or surgical treatments depending on the severity of the lesions, their location and the severity of the symptoms. deep endometriosis, that is to say when there is digestive, urinary, utero sacral or peritoneal ligament more than 5mm deep, poses, in particular, a therapeutic problem because surgery is often the only option but it can be decadent. due to genital involvement, this disease has a real impact on the sexuality of patients. surgery allows in a number of cases to reduce pain, including those occurring during intercourse. but the impact on sexuality in a more global way remains to be studied. the latter can be improved by the reduction of pain, but impacted by the surgery which is not insignificant on the representation of the woman of her own body.


Eligibility criteria:
inclusion criteria: * major women operated for deep endometriosis at the lyon sud hospital center (chls) of the hospices civils de lyon (hcl). exclusion criteria: * minor patient * no indication for operation or indication of hysterectomy * isolated uterine adenomyosis * patient opposing her participation in the study
phase i/ii ct 2106 and 5-fu/fa in colorectal cancer

Conditions: Colorectal Cancer

Summary: ct-2106, a camptothecin (cpt) conjugate, is a new generation of topoisomerase i inhibitors designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to normal tissues. the objective of this study is to determine the dose limiting toxicities, safety profile and antitumor activity of ct-2016 in combination with 5-fu and folic acid for the treatment of colorectal cancer.


Eligibility criteria:
inclusion criteria: * histologically proven metastatic colorectal adenocarcinoma, failing one prior treatment containing oxaliplatin plus 5-fu/fa * at least one measurable lesion according to recist criteria for both phase i and ii * ecog performance status 0 or 1 * adequate hematologic, renal and hepatic function * wash out period of at least 4 weeks from surgery, 4 weeks from radiotherapy exclusion criteria: * past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix. * pregnant or lactating patients * prior treatment with camptothecins * presence or history of cns metastasis or carcinomatous leptomeningitis * current active infection per investigator assessment * unresolved bowel obstruction or partial obstruction, uncontrolled crohn's disease or ulcerative colitis * current history of chronic diarrhea greater than or equal to grade 1 (ctcae version 3)

Keywords: colorectal cancer camptothecin
acupoint stimulation improves fatigue and sleep quality in patients with postdialysis

Conditions: Hemodialysis

Summary: hemodialysis is a necessary treatment to prolong the lives of patients with end-stage kidney disease. however, long-term dialysis can lead to fatigue and decreased sleep quality. acupoint stimulation can regulate meridians and improve physical function. nevertheless, the effectiveness of low-level laser stimulation on fatigue and sleep quality in hemodialysis patients remains unclear. this study is designed to use low-level laser stimulation as an intervention measure to evaluate its effectiveness in improving fatigue and sleep quality in hemodialysis patients.

hemodialysis is a necessary treatment to prolong the lives of patients with end-stage kidney disease. however, long-term dialysis can lead to fatigue and decreased sleep quality. acupoint stimulation can regulate meridians and improve physical function. nevertheless, the effectiveness of low-level laser stimulation on fatigue and sleep quality in hemodialysis patients remains unclear. this study is designed to use low-level laser stimulation as an intervention measure to evaluate its effectiveness in improving fatigue and sleep quality in hemodialysis patients. the experimental group will receive low-level laser stimulation on seven acupoints, including shenmen (ht7), neiguan (pc6), hegu (li4), zusanli (st36), yanglingquan (gb34), sanyinjiao (sp6), and taixi (ki3). the stimulation will be administered three times per week for a duration of six weeks. the control group will receive sham low-level laser stimulation on the acupoints, without emitting laser beams. before and after each intervention, fatigue will be measured using a visual analog scale for a total of 18 measurements. additionally, at baseline and at the 2nd, 4th, and 6th weeks, the hemodialysis patients will be assessed using the fatigue scale for hemodialysis patients, dialysis recovery time scale, pittsburgh sleep quality index, dialysis symptom index, and beck depression inventory.

Eligibility criteria:
inclusion criteria: 1. adults aged 20 years and above. 2. diagnosed with end-stage kidney disease and receiving regular outpatient hemodialysis three times a week for at least three months. 3. conscious and capable of communication in mandarin or taiwanese (hokkien). 4. willing to participate in this study and have signed the informed consent form. exclusion criteria: 1. presence of skin lesions or infectious wounds at the acupoint locations. 2. taking immunosuppressive medication. 3. photosensitivity or sensitivity to light. 4. individuals with implanted cardiac pacemakers. 5. patients using sleep medication.

Keywords: fatigue sleep
i-cbt functional gastrointestinal disorders in youth: the impact of negative illness understanding and parental illness worries

Conditions: Functional Abdominal Pain Syndrome; Functional Gastrointestinal Disorders; Irritable Bowel Syndrome

Summary: the aim of the current study, embedded in the danish fgid treatment study, is to test danish versions of swedish i-cbt programs for children and adolescents with fgid in a danish clinical context and to further evaluate the presence and impact of important psychological and parental factors.

functional gastrointestinal disorders (fgid) are common among children and adolescents. they affect quality of life, cause functional disability, school absence and high health care use. parental behavior can significantly influence the young person's perception of bodily symptoms, which are thought to be part of development and maintenance of symptoms fgid. so are cognitive biases which are distortions in attention, memory and interpretation. the programs involve both the youth and their parents, which provides a unique possibility, to examine illness-related cognitive biases and the effectiveness of graded exposure in youths with fgid with an additional focus on parental distress and illness worries for treatment adherence and outcome.

Eligibility criteria:
inclusion criteria: * child age: 8-12 years, adolescents: 13 - 17 years * a primary diagnosis according to the rome-iv criteria of one of the fgid sub-types: irritable bowel syndrome (ibs) or functional abdominal pain not-otherwise-specified (fap-nos) * the diagnosis should be documented by their regular physician in the somatic setting, and recommended routine medical investigations should be evaluated as normal or without clinical significance (include growth; blood samples including tsh, total iga, iga tissue transglutaminase, complete blood count, c-reactive protein analysis, liver enzymes; and fecal calprotectin) * stable dosage of fgid-related medication such as laxatives, anti-diarrheal medication or pain-modulating psychopharmacological medication during the past month. exclusion criteria: * another disease that explains the symptoms; * severe psychiatric or social problems (e.g., high level of suicidal ideation or ongoing abuse); * ongoing psychological treatment; * insufficient language or computer skills (patients and parents); * severe family problems (e.g. child abuse, parental substance abuse or severe psychiatric illness, ongoing custody fight) * school absence of more than 40% over the past month.
citalopram titration in early non-responder patients with major depressive disorders

Conditions: Major Depressive Disorder

Summary: major depressive disorder is a common mental disorder and the leading cause of disability worldwide. according to the canadian network for mood and anxiety treatment, early improvement following an antidepressant treatment is correlated with response and remission. escalation of an antidepressant dose after 2 weeks, as opposed to 4 to 8 weeks, is proposed to favor early improvement. however, this has never been tested systematically in a controlled study involving major depressive disorder patients that are non-responders to their antidepressant treatment.

the investigators sought to assess whether it is feasible to perform a prospective randomized controlled double-blind feasibility study with a 2 week run-in period and 3 parallel groups randomized controlled study using citalopram. citalopram has physicochemical properties compatible with over-encapsulation and a has a simple titration that allows the study of early dose increase.. it is among the most prescribed antidepressant in the province of quebec and at the hospital maisonneuve-rosemont - university family medicine group (u-fmg). since establishment of a randomized controlled trial is complex and expensive, a feasibility design is appropriate to identify all the obstacles and to minimize sources of possible bias (recruitment, follow up, resources).

Eligibility criteria:
inclusion criteria: * understand french or english * primary diagnostic of major depressive disorder based on the diagnostic and statistical manual of mental disorders criteria (5th edition) * prescription of citalopram * citalopram started less than 4 days ago * able to receive informed consent * not participating to another study exclusion criteria: * pregnancy or breastfeeding * unable to participate to follow-up * hypersensitivity to citalopram or any component of the formulation * known qt interval prolongation or congenital long qt syndrome * hepatic impairment (child pugh a, b or c) * renal impairment (clcr \< 30 ml/min) * known cytochrome p450 2c19 poor metabolizers * history of non-response to citalopram * head trauma or severe cognitive impairment * substance-related and addictive disorders controlled less than 3 months or uncontrolled * schizophrenia or psychotic disorder * mixed depression * history of manic/hypomanic episodes * use of prohibited drugs : monoamine oxidase inhibitors, cytochrome p450 2c19 inhibitors, drugs at risk of causing prolongation of the qt interval, cimetidine, pimozide and antidepressors taken for another psychiatric condition.

Keywords: citalopram major depressive disorder non responder madrs
study of dehydrex in patients with corneal erosion

Conditions: Corneal Diseases; Recurrence

Summary: this is a compassionate-use treatment study to provide dehydrex to patients with corneal erosion syndrome who have previously used dehydrex.

this study continues to provide dehydrex to patients who have received it previously under other studies. patients continue to be treated with their current dose of dehydrex. upward dose adjustments may be made as clinically indicated. patients undergo eye exams every 3 to 4 months or more often. downward dose titration will be attempted in patients who are stable, free of symptoms, and willing to attempt downward adjustments. in patients who are able to discontinue the medication, duration of healing will be determined. in those patients who experience a recurrence after discontinuing the medication, dehydrex will be restarted at a dose higher than the minimum effective dose. after at least 8 weeks of treatment and resolution of symptoms, the dose may again be reduced. further attempts to discontinue the medication will not be made. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
inclusion criteria: * clinical diagnosis of symptomatic recurrent corneal syndrome due to anterior membrane dystrophy or posttraumatic abrasion * not responsive to standard medical therapy with artificial tears, hypertonic saline, or bandage soft contact lenses * at least 3 episodes of erosion within the past 4 months documented by slit lamp examination exclusion criteria: * allergy to any component of the medications to be used * active ocular surface infection due to bacteria, virus, or fungus * chronic atopic disease affecting the ocular surface or adnexa * dry eye, exposure, trichiasis, entropion, ectropion, or neurotrophic keratopathy * concurrent use of contact lenses * diagnosis of persistent epithelial defect in eye to be treated * concurrent use of topical medication to eye to be treated * any ocular eyelid surgery within the past 6 months * pre-existing corneal stromal edema * diabetes mellitus * postsurgical infection * dry eye condition of 16 or greater on patient's dry eye questionnaire * other investigational medications within the past 6 months * other corneal dystrophy

Keywords: corneal erosion dextrans administration, topical ophthalmic solutions thimerosal