Kornimate/medical-research-clean huggingface dataset:
study of tas-102 in patients with metastatic colorectal cancer refractory to standard chemotherapies

Conditions: Colorectal Cancer

Summary: the purpose of this study is to compare the efficacy and safety of tas-102 versus placebo in patients with refractory metastatic colorectal cancer.

this is a multinational, double-blind, two-arm, parallel, randomized phase 3 comparison study evaluating the efficacy and safety of tas-102 versus placebo in patients with refractory metastatic colorectal cancer. patients will be randomly assigned (2:1) to tas-102 (experimental arm) or placebo (control arm).

Eligibility criteria:
inclusion criteria: 1. has provided written informed consent 2. has adenocarcinoma of the colon or rectum 3. has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer 4. ecog performance status of 0 or 1 5. is able to take medications orally 6. has adequate organ function (bone marrow, kidney and liver) 7. women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. males must agree to adequate birth control. exclusion criteria: 1. certain serious illnesses or medical condition(s) 2. has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration 3. has received tas-102 4. has unresolved toxicity of greater than or equal to ctcae grade 2 attributed to any prior therapies 5. is a pregnant or lactating female

Keywords: refractory, metastatic colorectal cancer
brain visual perception training for prevention and control of premyopia

Conditions: Visual Function; Myopia Progressing

Summary: the goal of this clinical trial is to investigate whether brain visual perception training can effectively prevent myopia in children with pre myopia. it will also learn about the safety of brain visual perception training. the main questions it aims to answer are: does brain visual perception training slow down the growth of axial length? what medical issues may participants encounter when using the brain visual perception training system? researchers will compare participants who receive brain visual perception training with a control group to see if the training group can delay the onset of pre myopia in children participants will: the training group will receive 20 minutes of brain visual perception training once a day for a period of one year. follow up check ups at the hospital every 3 months. keep a diary of the values of axial length and refractive diopter.


Eligibility criteria:
inclusion criteria: children aged 6-10 years with premyopia, defined as a cycloplegic spherical equivalent refraction (ser) of the more myopic eye in the range of -0.50 to 0.75 (inclusive) diopters (d) and having at least 1parent with an ser in either eye of -3.00d or less. exclusion criteria: children have astigmatism of 1.50d or more, anisometropia of 1.50 d or more, strabismus and other ocular abnormalities, any systemic diseases, or a history of any myopia interventions.

Keywords: brain visual perception training premyopia
prediction of liver-related outcomes after hcv cure

Conditions: Hepatitis C, Chronic; Sustained Virological Response; Direct-acting Antivirals; Hepatocellular Carcinoma; Hepatic Decompensation

Summary: objectives: to develop and validate a predictive model, applicable to daily practice, of liver complications emergence in hepatitis c virus (hcv)-infected patients and advanced fibrosis, who have achieved sustained viral response (svr) with direct-acting antivirals (daa)-based therapy. methods: design: mulsite prospective multicenter cohort study. study subjects: hcv-monoinfected and hiv/hcv-coinfected individuals recruited from two parallel cohorts (gehep-mono cohort clinicaltrials.gov id: nct02333292(hepavir-daa cohort clinicaltrials.gov id: nct02057003). these cohorts enrolled patients with hcv infection, treated with daa-based regimens after october 2011, at the units of infectious diseases of 18 hospitals throughout spain. patients who fullfilled the following inclusion criteria are included in this study: 1) have received a regimen with one or more daa; 2) have achieved svr 12 weeks after treatment; 3) have an evaluable liver stiffness (ls) of more than 9.5 kpa in the three months prior to the start of treatment. follow-up: the baseline time point is the date of svr. all participants are evaluated by a common protocol every six months. at every visit, clinical and laboratory examination focusing on the early detection of liver complications are carried out. ls is assessed by vibration-controlled transient elastography, according to a standardized procedure, every 12 months. in patients with cirrhosis, liver ultrasound and plasma alpha-fetoprotein determination are conducted for hepatocellular carcinoma screening, every six months. variables and data analysis: the primary outcome variable of the study will be the emergence of liver complication (hepatic decompensation or hepatocellular carcinoma) or liver transplant. predictive models will be develop with clinical, analytical, and genetic variables independently associated with the primary variable in a cox regression for competitive risks applied to a developmental subpopulation. the performance of the model will be evaluated using cor curves. sensitivity, specificity, and positive and negative predictive values will be calculated, both in the developmental population and in a validation population.


Eligibility criteria:
inclusion criteria: * had achieved svr 12 weeks after daa-based regimen, either with or without peg-interferon * showed liver stiffness (ls) value ≥9.5 kpa prior to treatment * had ls measurement available at svr time-point exclusion criteria: * individuals seropositive for hbsag * individuals who refuse to participate * individuals under 18 years old
stereotactic radiation therapy in treating patients with kidney tumors

Conditions: Kidney Cancer

Summary: rationale: stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. giving stereotactic radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. purpose: this phase i trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with kidney tumors.

objectives: primary * determine the maximum tolerated dose of radiation in patients undergoing stereotactic radiotherapy for renal tumors. * determine radiotherapy-associated toxicity in these patients. secondary * determine preoperative pathologic response to this regimen in these patients. outline: this is a dose-escalation study of radiotherapy. * radiotherapy: patients undergo stereotactic radiotherapy to 1 tumor. cohorts of 4-8 patients receive escalating doses of radiotherapy twice daily for 2 days until the maximum tolerated dose (mtd) or upper limit is reached. the mtd is defined as the dose preceding that at which at least 2 of 4 or 3 of 8 patients experience dose-limiting toxicity (dlt). dlt is assessed at 4 and 8 weeks after radiotherapy. * surgery: two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy. after completion of study therapy, patients are followed periodically for at least 2 years. projected accrual: a total of 20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * radiologically confirmed renal tumor * at least 4 cm in greatest dimension * no clinically, radiologically, or pathologically involved lymph nodes * no distant metastases patient characteristics: * karnofsky performance status 70-100% * negative pregnancy test * fertile patients must use effective contraception * medically eligible for tumor resection * no major medical condition or psychiatric illness that would preclude study compliance * no active connective tissue disease, such as lupus or dermatomyositis * no active crohn's disease or active ulcerative colitis prior concurrent therapy: * no prior chemotherapy * no prior abdominal or pelvic radiotherapy * no prior cryosurgery * no prior radiofrequency ablation

Keywords: stage i renal cell cancer stage ii renal cell cancer
minimal access versus conventional latissimus dorsi flap harvest for breast reconstruction

Conditions: Breast Neoplasms

Summary: for patients refusing implants for breast reconstruction after cancer surgery, autologous tissue flap reconstruction using the latissimus dorsi muscle is an alternative. conventional surgery leaves a long incision on the back, affecting aesthetics and quality of life. minimal access techniques result in a smaller, more concealable scar. while previous studies suggest its safety and effectiveness, most are retrospective. to further validate patient satisfaction and short-term outcomes, a prospective, randomized controlled trial comparing minimal access with conventional surgery is planned. the primary endpoint is breast q-satisfaction with back score at 6 months. secondary outcomes include other breast q subscales, surgical metrics, and complications. the study aims to enroll 94 patients in total, providing evidence for surgical decision-making in breast cancer reconstruction.


Eligibility criteria:
inclusion criteria: 1. female patients with early-stage breast cancer between the ages of 18 and 70. 2. breast cancer was confirmed by histology or biopsy. 3. breast-conserving surgery or multifocal breast cancer or large unifocal breast cancer (\<5cm) can be accepted. 4. after neoadjuvant therapy, large monofocal carcinoma (\>5 cm) confined to the breast shrunk to \<5 cm. 5. no chest wall, cutaneous or nac invasion (including paget's disease). 6. mild to moderate breast sagging, and the patient has the willingness to undergo autologous reconstruction of the latissimus dorsi. 7. there is no need to obtain additional back skins. 8. willing to participate and able to complete follow-up and evaluation during the study. exclusion criteria: 1. patients with advanced breast cancer (stage iii and above) or metastatic breast cancer or inflammatory breast cancer. 2. the risk of recurrence is expected to be high. 3. history of thoracic and dorsal vascular injury. 4. patients with severe heart, lung, or liver disease who cannot withstand surgery and anesthesia. 5. patients with active infection or severe immune system disease. 6. patients with severe allergic reactions to materials related to latissimus dorsi muscle flap transplantation. 7. patients with other major surgeries or reconstructive surgeries planned for the near future. 8. patients with cognitive dysfunction or psychiatric disorders who cannot understand and cooperate with the requirements of the study. 9. patients who refuse to participate in the study or are unable to complete follow-up and evaluation during the study.
evaluating the risk of serious ventricular arrhythmia and sudden cardiac death among users of domperidone

Conditions: Arrhythmias, Cardiac

Summary: the purpose of this retrospective observational study is to obtain information to confirm or contradict the results of prior studies on domperidone and sudden cardiac death. the population studied are the saskatchewan residents who used domperidone or another type of medication known as a proton pump inhibitor (ppi) between 1990 and 2005. information will be collected from various sources including the saskatchewan health (sh) database and cancer registry.

the purpose of this population-based, observational study is to evaluate the combined risk of serious ventricular arrhythmia (irregular heart rhythm) and sudden cardiac death in users of domperidone (a medication used to treat certain gastrointestinal disorders) compared with users of proton pump inhibitors (another group of medications used to reduce gastric or stomach acid production. the study will be conducted using patient information from saskatchewan health (sh) who had recorded dispensings of domperidone or a ppi from 1990 through 2005. the first objective of the study is to estimate the combined relative risk of the occurrence of a particular type of irregular heart rhythm known as serious ventricular arrhythmia (sva) and sudden cardiac death scd (defined as a natural death from an unexpected circulatory arrest) during current use of domperidone or current use of proton pump inhibitors (ppis) as compared with nonuse in a diabetic population. the second objective is to estimate the combined relative risk of sva and scd during current use of domperidone or current use of ppis as compared with nonuse in a non-diabetic population. study drug dosing information not required for observational study

Eligibility criteria:
inclusion criteria: * saskachewan residents who received domperidone or a proton pump inhibitor (ppi) between january 1, 1990, and december 31, 2005 exclusion criteria: * cancer free \>=1 year of history in the database before receiving the first dose of domperidone or a ppi

Keywords: serious ventricular arrhythmia sudden cardiac death domperidone case-control study saskatchewan residents observational study
accuracy and reliability of fetal heart rate and uterine contraction monitoring method

Conditions: Pregnancy; Habitual Aborter; Weeks of Gestation 37 or More

Summary: clinical investigation protocol for a study designed to determine the equivalence of the monica an24 monitor to philips 50xm for fetal heart rate (fhr) and uterine contraction (uc) monitoring during labor. the study will be carried out on subjects in the first and second stages of labor.

the study is a prospective, randomized, single-center observational study designed to compare the fetal heart rate (fhr) and uterine activity (ua) output data obtained by the monica an24 monitor during the first and second stages of labor to those generated by existing fda-approved devices.patients were enrolled at the facility but the patient details were removed from the results in order that the data could be randomized for the statistical analysis.

Eligibility criteria:
inclusion criteria: * pregnant, age 15-40 * term gestation (\>36 completed weeks) * singleton fetus * active labor * vertex presentation * requiring internal monitoring exclusion criteria: * clinical contraindication for intra uterine pressure catheter * major fetal malformation

Keywords: fetal heart rate (fhr) uterine activity (ua) labor & delivery
intraoperative ultrasound in crohn's disease

Conditions: Crohn Disease

Summary: to study the role of intraoperative ultrasound of small bowel as a possible tool that can reduce the rate of histologically involved resection margins from crohn's disease.

patients with indication for resective surgery for crohn's disease will be enrolled and undergo to the planned surgery. during surgery the site where to conduct the bowel resection will be decided according to the current indications in the literature and according to good clinical practice (absence of macroscopical signs of disease). before conducting the surgical resection, will be performed intraoperative ultrasonography of the small bowel at the intestinal segment chosen as the site of the resection. ultrasound features will be evaluated to determine whether or not there are any ultrasonographic signs ascribable to crohn's disease. once the above ultrasound has been completed (estimated time approximately 5-10 minutes), the predetermined resection will be conduct and the surgical piece will be sent for final histological examination as usual. the outcome of intraoperative ultrasound will be schematized as positive or negative based on the presence or absence of specific ultrasound signs of intestinal inflammation attributable to crohn's disease. the data will be collected and subsequently analyzed in order to compare the ultrasound findings acquired on the resection margins with the outcome of the histological examination conducted on the same site. patients will then enter a regular gastroenterological/surgical follow-up and undergo colonoscopy at 12 months after surgery as usual. data on clinical, surgical or endoscopic recurrence in the follow-up period will be collected and analyzed to compare the recurrence rate in the group of patients with intraoperative ultrasonographic features with the group without intraoperative ultrasonographic features on the resection margin.

Eligibility criteria:
inclusion criteria: * patients aged 12 years or older. * confirmed diagnosis of crohn's disease * indication for intestinal resection surgery for crohn's disease (first surgery or surgery for postoperative recurrence). exclusion criteria: * patients who did not express their consent to participate in the study by signing the appropriate informed consent * patients younger than 12 years of age * patients with an indication for non-resective surgery for crohn's disease (e.g., ileostomy closure).
effect of nike fuelband on exercise and function in claudicants; a randomised controlled trial

Conditions: Peripheral Vascular Disease; Intermittent Claudication

Summary: this is a randomised controlled study of patients suffering from intermittent claudication (ic), to assess the impact of wearing a nike fuelband (nfb) on walking distances, exercise levels and quality of life.

ic manifests as pain in the calf, thigh or buttock muscles when walking. it is caused by narrowing or blockage of the blood vessels in the legs. the nfb is a discrete wristband with a built-in accelerometer to measure motion. it provides estimates of the number of steps taken and the amount of distance covered each day. this study will be conducted over a period of 18 months at imperial college trust's vascular outpatients service. patients that meet the inclusion/exclusion criteria will be asked to consider participating. participants will receive routine diagnostic work up with the addition of having their walking distances measured on a lab treadmill. they will also have their functional status and mood assessed using a questionnaire. these assessments will be carried out a total of five times over the course of the study. patients will not need to make any additional visits to hospital. patients will be randomly allocated to either the nfb group or the control group. patients in the nfb group will be given a fuelband with instructions on how to use it. all patients will be given routine instructions on maintaining activity and target daily walking distances. target walking distances will be programmed into the nfb. patients in the nfb group will be asked to record estimates of how far they have walked each day directly from their band. all patients will be contacted by telephone at a pre-arranged time to collect recordings. patients will be followed up at their routine 3-month follow up appointment and additionally at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * age 40-80 * referred to vascular rehabilitation service at st marys hospital (uk) * ic involving the calf muscles * clinical and duplex investigations indicate superficial femoral artery stenosis or occlusion exclusion criteria: * clinical and duplex investigations indicate iliac disease * major joint disease in lower limb or lumbar spine/entrapment syndrome * significant cardiopulmonary limitations (nyha\>1) * maximum walking distance \>500m * hospital inpatient/ living in a care home * \*unfamiliarity with required technology * history of dementia * unable to mobilize independently (does not include walking aids) * ic not limiting factor of mobilization, limited by other medical problems * unable to attend supervised exercise programme * patient owns or uses any type of activity monitor * uses a walking frame \*patients should be able to use the nfb technology with minimal assistance

Keywords: peripheral vascular disease
barriers associated with timely adjuvant chemotherapy administration in patients with invasive breast cancer

Conditions: Invasive Breast Carcinoma

Summary: this trial studies the barriers associated with timely chemotherapy given after surgery (adjuvant) in patients with invasive breast cancer. meeting with patients and asking questions may help doctors to learn about factors that can cause delays in the start of chemotherapy after surgery in patients with breast cancer.

primary objectives: i. to comprehensively and qualitatively assess and identify the determinants of time to chemotherapy (ttc) delays in a vulnerable population using qualitative methods. ia. to describe the health literacy/numeracy, social support and level of trust in physicians of the study participants. (exploratory) outline: patients complete questionnaires and participate in an interview to answer questions about the information patients received before starting the chemotherapy, any medical problems after the surgery that could have been related to the start of the chemotherapy, how the chemotherapy affected patients' life, and anything else patients may remember between the time when the breast surgery ended and the first dose of chemotherapy started. patients' medical records are also reviewed.

Eligibility criteria:
inclusion criteria: * diagnosed with primary invasive breast cancer * for patients receiving adjuvant chemotherapy: first dose of chemotherapy administered \>= 60 days after definitive breast cancer surgery. for patient treated with neoadjuvant chemotherapy: first dose of chemotherapy administered \>= 60 days after pathological diagnosis * diagnosis of breast cancer within three years of study enrollment * can speak, read, and understand english and/or spanish * patient of lyndon b. johnson general hospital-harris health system (lbj-hhs) or md anderson cancer center exclusion criteria: * women hospitalized for a critical condition or who are considered medically unstable by their medical team * patients that started chemotherapy \>= 3 years after definitive breast cancer surgery