Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of tegaserod in opioid-induced constipation in patients with non-cancer pain.

Conditions: Opioid-induced Constipation

Summary: this study will evaluate the safety and efficacy of tegaserod in opioid-induced constipation in patients with non-cancer pain. patients who enter this study prior to the core study (chtf919n2201) interim analysis receive the treatment as follows: patients will be randomly assigned to receive open label tegaserod 6 mg b.i.d. or tegaserod 12 mg o.d. using an allocation ratio of 1:1. patients who enter this study after the core study interim analysis receive the treatment as follows: patients will be assigned to receive the selected tegaserod dose regimen (as determined by the core study interim analysis) in an open label fashion.


Eligibility criteria:
inclusion criteria: * male and female outpatients 18 years of age or older. * patients with chronic non-cancer pain that necessitates the use of non- injectable opioid analgesics. * chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief. * constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain. opioid-induced constipation (oic) is defined as follows: less than 3 spontaneous bowel movements per week and at least one of the following on at least 25% of occasions: 1. hard or very hard stools 2. sensation of incomplete evacuation 3. straining while having a bowel movement exclusion criteria: * 1. who are receiving opioids for abdominal pain or connective tissue disorders. * planned discontinuation of opioids during the study * who underwent major surgery within 3 months prior to screening. * with a history of prior chronic constipation (cc) that was present for more than three months and that was not related to opioid use. * with a current diagnosis of irritable bowel syndrome (ibs) constipation predominant or alternators. * with a previous use of tegaserod within 3 months prior to baseline. other protocol-defined inclusion/exclusion criteria may apply

Keywords: opioid, constipation, tegaserod
comparison of amniofix laser and standard of care treatment

Conditions: Rhytides

Summary: this is a comparison trial with novel application of amniofix and a control arm. patients electively being treated with facial lasers will be assigned to receive amniofix in addition to the normal standard of care placed on half of their face after laser procedure, and normal post laser standard of care alone on the other half of their face. the investigators will investigate the end points of healing, recovery time, re-epitheliaziation, and other cosmetic factors. the study is designed to compare amniofix to the current standard of laser care.

amniofix is a dehydrated human amnion/ chorion membrane (dhacm) allograft and is composed of multiple layers including a single layer of epithelial cells, a basement membrane and an avascular connective tissue matrix. amniotic membrane is a unique material and its composition contains collagen types i, iii, iv, v, and vii. amniotic membrane is composed of structural extracellular matrix (ecm), that also contains specialized proteins fibronectin, laminins, proteoglycans and glycosaminoglycans. in addition, amniotic membrane contains essential, active, healing growth factors such as epidermal growth factor (egf), transforming growth factor beta (tgf-b), fibroblast growth factor (fgf), and platelet derived growth factor (pdgf). the study is designed to compare amniofix to the current standard of laser care. * patients coming in for fraction or total ablative resurfacing with any methods will be studied * patients will be assessed prior to any treatment by clinician * additionally patients will participate in a clinician constructed survey * patients will be assessed on a rating scale of 1-4 based on erythema, edema/induration, oozing/drainage, and epithelialization * preoperative photos will be taken of patients * laser resurfacing will proceed under clinician guidance, and under clinician selected settings * repeat photographs * patients will be randomized as to which side of the face receives amniofix treatment, and which side receives standard of care * epifix will be applied appropriatly * repeat photographs and repeat assessment on 1-4 scale * patients will follow up at day 1, 4, 7, 14, and 28 +/-3 days to repeat scoring and photography

Eligibility criteria:
inclusion criteria: * adult patients ages 18-100 seeking laser facial treatment exclusion criteria: * patients with treatment areas with active or latent infection * patient with a disorder that would create an unacceptable risk of post-operative complications

Keywords: facial laser fraction ablative resurfacing total ablative resurfacing epifix rhytides wrinkles amniofix
exergaming intervention in all patients

Conditions: Acute Lymphoblastic Leukemia

Summary: this is a pilot feasibility study to collect preliminary data for a large-scale exergaming intervention in children undergoing maintenance therapy for acute lymphoblastic leukemia (all). patients, ages 5-17 years will be randomized to the intervention or non-intervention control group. the intervention will consist of 30 minute sessions of exergaming 3-5 times a week for 6 months, with weekly assessment of exercise level and phone calls by kinesiology graduate students for safety and compliance. physical activity at baseline and at the end of study will be assessed using accelerometers. outcome measures will include: anthropometrics, blood pressure, body composition, visceral fat, vascular function, fasting insulin, fasting glucose, ldl-cholesterol, hdl- cholesterol, triglycerides, functional mobility and endurance, and strength.


Eligibility criteria:
inclusion criteria: * eligibility will not be restricted by race or sex * pediatric patients with all diagnosis, treated at the university of minnesota amplatz children's hospital or children's hospitals and clinics of minnesota * at least 3 months into the maintenance phase, with at least 6 months left of maintenance therapy * age 5-17 years at time of study enrollment * not smoking * currently not involved in a regular (3 times per week) exercise program exclusion criteria: * individuals with a physical or mental impairment which would preclude their ability to perform the intervention. * bone marrow transplant recipients. * any woman currently pregnant will not be eligible, but may participate 3 or more months after the end of her pregnancy if the study is still ongoing * due to the intervention being in english, non-english speakers will be excluded

Keywords: acute lymphoblastic leukemia all fitness intervention
sano v first in human study to treat ed

Conditions: Erectile Dysfunction (ED)

Summary: a prospective, first in human study to evaluate the safety and performance of a flow modification system


Eligibility criteria:
inclusion criteria: 1. patient understands and has signed the study informed consent form. 2. documented history of erectile dysfunction 3. sexually active exclusion criteria: - 1. current participation in any clinical study with any investigational drug or device. 2. patient is known or suspected not to tolerate the procedure, including exposure to contrast 3. active infection or fever that may be due to infection 4. life expectancy \< 2 years due to other illnesses
congenital cataract with persistent fetal vasculature

Conditions: Persistent Fetal Vasculature; Congenital Cataract

Summary: to observe the clinical characteristics and surgical treatment of 24 cases of congenital cataract complicated with persistent fetal vasculature (pfv) in 28 cases of congenital cataract in our hospital.

methods the clinical data of 28 eyes of 24 children with congenital cataract complicated with pfv who underwent surgical treatment in our hospital were analyzed retrospectively.

Eligibility criteria:
inclusion criteria: * congenital cataract with persistent fetal vasculature exclusion criteria: * congenital cataract with no persistent fetal vasculature

Keywords: persistent fetal vasculature congenital cataract
improving uptake of surveillance in colorectal cancer survivors through navigation and web education

Conditions: Stage I Colorectal Cancer AJCC v8; Stage II Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8

Summary: this pilot clinical trial looks at whether patient navigation services, an interactive web education intervention, called current together after cancer (ctac), or both navigation and ctac works to improve the uptake of surveillance in patients with stage i-iii colorectal cancer (crc). post-treatment surveillance is critical to detect recurrence early, yet many crc survivors do not receive recommended surveillance care. surveillance is a complex process that includes laboratory tests, cross-sectional imaging, and endoscopic procedures. patient navigation services, interactive web education, or a combination of both may improve surveillance care for patients with stage i-iii colorectal cancer.

outline: patients are assigned to 1 of 3 arms based on the clinic location they receive cancer care at. arm a: patients receive access to navigation services, including education on surveillance care, reminders to complete care and assistance in scheduling surveillance, within 3 months of standard of care surgical resection for stage i-iii crc. arm b: patients receive access to the ctac intervention, which includes self-directed, interactive web-based education about surveillance and a checklist of care, within 3 months of standard of care surgical resection for stage i-iii crc. arm c: patients receive access to navigation services, including education on surveillance care, reminders to complete care and assistance in scheduling surveillance, and access to the ctac intervention, which includes self-directed, interactive web-based education about surveillance and a checklist of care, within 3 months of standard of care surgical resection for stage i-iii crc. patients are followed up at 3 and 9 months post study-enrollment and 12-18 months after surgical resection.

Eligibility criteria:
inclusion criteria: * age ≥ 18 due to disease and clinic population * stage i-iii crc survivor within 3 months post-surgical resection * being seen at a participating clinic * ability to understand and complete surveys in english
supported employment in a swedish context

Conditions: Psychosis

Summary: this project aims at generating evidence of a work-rehabilitation strategy that benefits the people with severe mental illness (smi) who want to work, increase their sense of well-being and integration in society, decrease their financial dependence and experiences of stigma and discrimination. the project is likely to help form the basis of how to implement the evidence based supported employment (se)-model, individual placement and support model (ips), in a swedish work-rehabilitation context. in the long run, evidence of se in a swedish context could help to decrease the period of sick-leave and increase fulfilling and productive lifestyles among people with severe mental illness. in all, the effectiveness of se can improve the quality of life for the target group, the quality in mental health care rehabilitation and decrease the costs of treatment and care.

evidence-based mental health treatment and scientific support has gained increased attention in sweden. the swedish national board of health and welfare emphasizes the importance of supported employment. especially since there are no study in sweden that has an rct-design, and that fully take on the responsibility of implementing a se- intervention in concordance with the evidence based version of se in mental health care, the individual placement and support model, ips. internationally, se according to ips is an evidence-based approach to help people with smi find and keep employment. rct and quasi-experimental studies showed that ips (place-then-train), is more effective than the traditional stepwise vocational rehabilitation model(train-then-place. however, there is no research evidence if the se/ips will function in relation to a swedish benefit and health system and work-rehabilitation context. this intervention project will therefore not only study the effects of vocational and health-related outcomes and experiences, but also study the implementation of se/ips, its feasibility and level of fidelity in a swedish context.

Eligibility criteria:
inclusion criteria: * people with severe mental illness, which mostly means having a diagnosis of psychosis * communicate in swedish * express interest in working in the near future * have professional care or support from psychiatric clinic * attend to a se-introductory meeting exclusion criteria: * additional organic or physical disability to having psychosis

Keywords: vocational rehabilitation severe mental illness psychosis mental health
assisted-vats sleeve lobectomy for non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to examine the feasibility of assisted-vats (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. success is defined as assisted-vats sleeve lobectomy without conversion. if success rate over 90%, assisted-vats sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.

sleeve lobectomy is removal of a portion of a main stem bronchus in continuity with the adjacent lobe or bilobe followed by end-to-end bronchial anastomosis. the first reported bronchial sleeve resection was performed in 1947 at the brompton hospital in london, england, by sir clement price thomas. whether sleeve resection is radical enough and indicated for patients who could tolerate pneumonectomy continues to be debated, although many recent reports have suggested that sleeve resection can achieve adequate curability rates. however, sleeve lobectomy has a definite role in the surgical management of lung cancer for patients whose pulmonary reserve is considered inadequate to permit pneumonectomy, and should be used anytime it is possible to achieve a margin-negative (r0) resection. although video-assisted thoracic surgery (vats) is regarded as a minimally invasive procedure with good long-term survival results, many surgeons think that vats is too complex and has too many technical limitations to be applied to bronchoplasty. therefore, there are few reports in the literature of vats bronchoplasty for lung cancer. the purpose of this study is to examine the feasibility of assisted-vats (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. success is defined as assisted-vats sleeve lobectomy without conversion. if success rate over 90%, assisted-vats sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.

Eligibility criteria:
inclusion criteria: * histologically confirmed non-small cell lung cancer (squamous, adenosquamous, large cell, or poorly differentiated) * patients with central tumors located at the origin of a lobar bronchus. * ecog performance status 0-1 * hematopoietic: wbc at least 4,000/mm\^3; platelet count at least 100,000/mm\^3 * hepatic: bilirubin normal; ast/alt no greater than 1.5 times upper limit of normal (uln); alkaline phosphatase no greater than 2.5 times uln * renal: creatinine clearance greater than 60 ml/min * cardiovascular: cardiac function normal exclusion criteria: * severe complications or infections * pregnant or breast-feeding women * clinically significant heart disease * uncontrolled hepatitis, chronic liver disease, or diabetes mellitus * another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma

Keywords: assisted-vats (video-assisted thoracoscopic surgery) sleeve lobectomy bronchoplasty
a study of chronic hepatitis c patients treated with sof/vel/vox

Conditions: Hepatitis C

Summary: this is a retrospective, non-interventional study. investigators from infectious diseases and gastroenterology departments will participate this study. patients data will be collected from hospital medical records.

pangenotypic sofosbuvir/velpatasvir/voxilaprevir for 8-12 weeks has been shown highly effective, safe, and well-tolerated in treating patients with chronic hcv infection in clinical trial settings, however, there are no real-world setting data are available.this is the first opportunity from all over the world to demonstrate sof/vel/voxs efficacy and safety in real world setting especially for the naive patients. sof/vel/vox is often positioned in retreatment by international guidelines. previously the reimbursement guideline in turkey did not allow patients to be re-treated after the failure of daa treatments. with current guideline vosevi is approved as the only option for failures of daa treatments. in the past years in turkey, sof+rbv in gt2, sof+pef+rbv in gt3, ldv/sof in gt1.4-6 patients and viekirax/exviera in gt1,4 patients have been used and unfortunately, some patients did not benefit from these suboptimal treatments. the efficacy and safety of sof/vel/vox in patients who have experienced treatment failure in real life will be another objective of the research. this research will support 1. efficacy and safety of 8-week pangenotypic sof/vel/vox for treatment naive non-cirrhotics 2. efficacy and safety of 12-week pangenotypic sof/vel/vox for treatment naive compensate cirrhotics 3. efficacy and safety of 12-week pangenotypic sof/vel/vox for retreatment of ns5a or ns3a4 and non-ns5a treatment-experienced patients (incl. noncirrhotics and cirrhotics)

Eligibility criteria:
inclusion criteria: * patients diagnosed as chronic hepatitis c and aged 18 and older * patients received sof/vel/vox treatment exclusion criteria: * decompensated cirrhotic hcv patients * having hcc * egfr\<30 ml/min

Keywords: hepatitis c vosevi
the effect of sitagliptin in type 2 diabetes mellitus with inadequate glycemic control (mk0431-118)

Conditions: Diabetes Mellitus Non-insulin-dependent

Summary: to assess the effect of treatment with sitagliptin (mk0431) on hba1c (hemoglobin a1c) and the safety and tolerability of sitagliptin.


Eligibility criteria:
inclusion criteria: * patients who are 18 years of age with type 2 diabetes mellitus who are either: * not on antihyperglycemic (aha) medication (off for at least 2 months) * or on a single aha
asp8825 - pharmacokinetics study in patients with impaired renal function and haemodialysis

Conditions: Patients With Impaired Renal Function and Haemodialysis

Summary: the objective of this study is to evaluate the pharmacokinetics and safety of asp8825 in patients with impaired renal function and haemodialysis.


Eligibility criteria:
inclusion criteria: * body weight: ≥40.0 kg and \<80.0 kg * body mass index bmi: ≥16.0 and \<30.0 \[bmi= body weight (kg)/(height (m))2\] * for renal impairment patients: patients with egfr by gfr predictive equation for japanese within \< 50 ml.min/1.73m2 at screening and who is not undergoing dialysis * for haemodialysis patients: patients who receive dialysis at screening * patients whose treatment regimen (including diet) for renal impairment or complications remain unchanged within 14 days prior to dosing, or patients who receive treatments (including diet) that need not to be changed during the period from 14 days before dosing to follow-up examination in the opinion of the investigator or sub-investigator. * female subjects who agree use effective contraception starting at informed consent and throughout the study period exclusion criteria: * patients with a complication or history of the inappropriate for this study (except for a complication of primary disease for renal dysfunction, like diabetes etc., or complication of hypertension or anemia etc.) * patients with a complication or history of recurring alimentary disease * patients with a history of gastrointestinal surgical operation * patients with a complication of severe heart disease * patients with a complication or history of malignant tumor (however, a patient without recurrence of the malignant tumor for more than 5 years after the treatment may be eligible for the study.) * patients judged ineligible by the investigator or sub-investigator based on the results of medical examination, vital sign, 12-ecg and laboratory test * patients who have an hb value \<9g/dl at screening * patients who received or are scheduled to receive any study drugs in other clinical trials or post-marketing studies within 120 days before screening * patients who received or are scheduled to receive medications within seven days before the dosing of the investigational drug * patients who previously received administration of gabapentin or asp8825

Keywords: impaired renal function haemodialysis asp8825 xp13512
effects of soy compounds on breast cancer, prostate cancer, and bone health

Conditions: Breast Cancer; Prostate Cancer

Summary: this study will determine the effects of soy products on in vitro surrogate cancer markers as well as bone density markers and quality of life parameters in men and women. this study will also determine concentrations of isoflavones (naturally occurring plant compounds that act like estrogen in the body) in prostate tissue that has been removed during prostatectomy, as well as in the blood.

in the united states, consumption of soy products has dramatically increased in the past several years. foods made from soy are high in isoflavones and evidence suggests that these isoflavones, genistein in particular, have many beneficial properties such as alleviating menopausal side effects and reducing the risk of osteoporosis, breast cancer, and prostate cancer. however, this data has been derived largely from studies with animal or cell models; human trials are limited. this study will determine the effects of soy isoflavones on quality of life and cancer and bone density markers. while isoflavones have been purported to inhibit the proliferation of cancer cells, the concentrations required for this anti-cancer effect were determined to be much higher than the concentrations that can be achieved in plasma after intake of isoflavones. recent animal studies have suggested that isoflavones may be concentrated 10-fold in tissue compared to blood concentrations. if this is true, then the higher concentration would be in the range found in the cancer cell line research to be protective of cancer. this study will determine whether tissue concentrations are similar to, higher than, or different than blood concentrations. this study will last 5 years and will comprise three populations: men with prostate cancer on androgen ablation therapy, postmenopausal women on hormone replacement therapy (hrt), and postmenopausal women not on hrt. participants will be randomly assigned to receive either isoflavone or placebo for two to four weeks. participants' serum and serum extracts will be incubated with cultured human cell lines (prostate cancer, breast cancer and osteoblasts) and estrogenic and non-estrogenic mechanisms of action investigated. the human sera data will be complemented by parallel studies of direct addition of crystalline isoflavones (genistein, daidzein and equol) to the same cultured human cell lines. participant's serum and urine also will be tested for markers of bone resorption and formation. quality of life issues will be assessed with questionnaires.

Eligibility criteria:
inclusion criteria * scheduled for prostatectomy * willing and able to consume study tablets for at least 2 weeks prior to surgery * willing to accept random assignment * signed informed consent exclusion criteria * unwilling to avoid soy intake during the study period * currently taking antibiotics

Keywords: isoflavones soy postmenopausal men prostate breast bone