Kornimate/medical-research-clean huggingface dataset:
evaluation of the prandial treatment adjustment effect via continuous glucose monitoring on type 2 diabetes mellitus (dm) patients uncontrolled with a basal insulin or premix once a day

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: to evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen

the study duration for each patient is 24 weeks +/- 1 week broken down as follows: * run-in phase: 8 weeks * follow - up period: 16 weeks the maximal possible time window during the study is +/- one week throughout the study.

Eligibility criteria:
inclusion criteria: run-in period: 1. type 2 diabetes 2. hba1c≥ 8.5% (in a test of the last month) 3. age above 21 years 4. patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months 5. signed informed consent form 6. patients who according to their physician are eligible to the study randomization: 1. hba1c \> 7.5% 2. fpg \< 130 mg/dl exclusion criteria: 1. type 1 diabetes 2. patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months. 3. pregnant or breastfeeding women. 4. patients with allergy to insulin. 5. patients with severe diseases characterized by recurrent hospitalizations, including: severe renal insufficiency, severe cardiac insufficiency, active oncological disease or oncological disease requiring chemotherapy. 6. patients with mobility difficulties and/or difficulties communicating with the investigator the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
the purpose of this study is to look at pelvic support problems, also commonly known as pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: femmejock is a pelvic floor support system developed by pelvic floor physiotherapists for patients with pelvic organ prolapse in order to ameliorate symptoms of pelvic floor pressure and discomfort. the device is a girdle to be worn on the outside of underwear. the device is machine washable and there are no documented risks with wearing it. this product is currently being used by pelvic floor physiotherapists and has been subjectively reported by individual accounts as being successful in improving pelvic floor symptoms. the efficacy of this product has not been previously studied in women with pelvic organ prolapse. the investigators are proposing a pilot study with the following specific aims: 1. to assess patient satisfaction and continuation of use of the femmejock support system after 3 months of treatment. 2. to describe, if any, the reasons for discontinuation associated with the use of this product, and 3. to assess whether women experience improvement of pelvic floor symptoms after using this product.

this will be a prospective pilot study in order to determine the efficacy and tolerability of femmejock in patients with pelvic organ prolapse. we plan to enroll 30 patients who will be recruited from the ou health science center. we will offer study participation to patients who meet the inclusion criteria listed below, and who are: (1) awaiting surgical management and desire a temporary nonsurgical option, (2) seeking permanent nonsurgical treatment, or (3) who have a contraindication to surgical management.

Eligibility criteria:
inclusion criteria: * pelvic organ prolapse, \> stage ii * 1 or more prolapse associated symptoms: * herniation symptoms * pelvic pressure * bulging tissue * sexual dysfunction * patient willingness to enroll * available for 3 months of follow-up exclusion criteria: * pregnancy or planning pregnancy within the next 3 months * perineal ulcers or trauma * anticipating relocation in next 3 months * current pessary use * dementia or inability to complete questionnaires * chronic inflammatory or infectious vulvar condition (i.e., dermatologic conditions: lichen sclerosis or lichen planus, or vulvar candidiasis)

Keywords: femmejock pelvic organ prolapse
the effect of rf turbinoplasty in polypoid change of middle turbinates

Conditions: Nasal Polyposis; Sinusitis

Summary: the aim of this study is to evaluate the effect of middle turbinate radio frequency (rf) turbinoplasty with middle turbinate resection and medialization

the management of middle turbinate in treatment of nasal polyposis is still an interesting debatable topic. the surgical access and its possible role in pathophysiology of sinusitis are two important points about its treatment. on the one hand, middle turbinate resection can improve surgical access and possibly reduce the nasal polyposis recurrence. on the other hand, there are some reports of anosmia, empty nose syndrome, synechia, and difficulties in revision surgery. also, synechia, lateralization, and possibly recurrence can be the possible outcome after middle turbinate preservation. among different modalities, radiofrequency (rf) gradually increase its popularity as surgical tools, which can treat mucosal hypertrophy without any tissue removal. inferior turbinate is a famous place for its usage, especially for decreasing of the nasal obstruction. also, some authors have showed its effect on refractory allergic rhinitis, which is not only related to reducing of nasal obstruction, but also it is related to changing of the allergic mediators. \[5, 6\] comparing to other treatments for turbinates is sparing its overlaid mucosa, which can reduce the possible future morbidities. probably considering of the above mention points, rf has a possible impact on the polypoid changes of middle turbinates and possibly does not have the same deleterious effect of the resection on cilia of mucosal layer. therefore, we performed a randomized clinical trial to compare its outcome with two famous methods of the middle turbinate management: partial resection and medialization.

Eligibility criteria:
inclusion criteria: the patients with sinusitis who suffered from nasal polyposis which was resistant to maximal medical treatment (i.e. one puff of fluticasone nasal spray twice daily plus amoxicillin clavulanic acid 625 mg tablet three times daily, for at least one month ). exclusion criteria: * floppy' change of the middle turbinate in the end of surgery. * systemic disease (e.g. hypertension, wegener's granulomatosis, cystic fibrosis or sarcoidosis), * immune suppression, * revision surgery, * counter-indications for any of the postoperative drug usage (e.g. diabetes or pregnancy), or * any type of septoplasty indications are excluded from this study.
epidemiology of coronary heart disease in men aged 40 and over

Conditions: Atherosclerosis; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Cardiovascular Diseases

Summary: to examine whether the prevalence of subclinical coronary and aortic atherosclerotic disease is different among japanese in japan, japanese in hawaii, and black and white americans.

background: substantial change toward a more westernized lifestyle has taken place among younger individuals who were born after world war ii (wwii) in non-western countries including japan. data from national sample surveys in japan clearly demonstrate that risk factor profiles for coronary heart disease (chd) are very similar to those in the united states (us) in this post wwii cohort. men in japan do have a considerably higher prevalence of cigarette smoking and men in the us have a higher prevalence of obesity. chd mortality among men in japan is, however, still less than a half of that in the us. careful review of mortality statistics confirms this. this difference remains unique among industrialized countries. design narrative: the study is a collaboration between dr. akira sekikawa at the university of pittsburgh and dr. j. david curb of the pacific health research institute in honolulu, hawaii. the study tests the null hypothesis that there are no differences in the extent of atherosclerosis among japanese men in japan, japanese american men in hawaii, and us white and black men in this post wwii birth cohort. the project is based on recent and ongoing successful japan/us collaborations in the intermap, interlipid and honolulu heart program studies including development of the first standardized us/japan diet tables. the investigators will examine 300 white men and 100 black men aged 40-49, randomly selected from allegheny county, pa, 300 japanese american men aged 40-49 from the population-based sample recruited from the offspring of the members of the honolulu heart program cohort, and 300 japanese men aged 40-49, randomly selected from kusatsu city, japan. the japanese recruitment and examination has already been supported in japan. the extent of atherosclerosis and risk factor profiles for chd will be evaluated and compared, as well as the relationship of specific risk factors to the measures of atherosclerosis. the measures of subclinical disease proposed include calcium scores of coronary artery and aorta measured by electron beam computed tomography (ebct) and carotid intima thickness measured by ultrasound. other proposed measures include dietary intake by food frequency questionnaire, total cholesterol, ldlc, hdlc, lipids by nmr spectroscopy, blood pressure, cigarette smoking, thiocyanate, omega-3 fatty acid, alcohol consumption, body mass index (bmi), intra-abdominal fat, and others.

Eligibility criteria:
inclusion: - men aged 40-49 at the time of enrollment exclusion: -individuals with clinical cardiovascular disease (coronary heart disease, stroke), and other severe disease
safety, tolerability, and antiviral activity of ana598 administered in combination with pegylated interferon and ribavirin for the treatment of genotype-1 chronic hcv infection

Conditions: HCV Infection

Summary: the purpose of this study is to assess the safety, tolerability and effectiveness of ana598 when administered with pegylated interferon and ribavirin (standard of care \[soc\]) compared to placebo + soc.

the safety, tolerability and antiviral activity of ana598, administered orally at 200 mg bid or 400 mg bid for 12 weeks in combination with pegylated interferon and ribavirin (soc) will be compared to placebo + soc. treatment-naïve patients with genotype 1 infection will be eligible for enrollment. patients randomized to ana598 will receive a loading dose of 800 mg q 12 hours administered on the first day of dosing. patients with undetectable hcv rna at week 4 and week 12 will be randomized to receive either an additional 12 or 36 weeks of soc alone. ninety patients will be randomized into 2 cohorts. the forty-five patients in each cohort will be randomized as 30 active: 15 placebo.

Eligibility criteria:
inclusion criteria: * male or female, ages 18 to 65 years * documented chronic hcv infection, genotype 1a or 1b * treatment-naïve exclusion criteria: * female patients who are pregnant or breast-feeding * infection with non-genotype 1 hcv * previous treatment for hcv infection * hiv or hbv positive * any medical contraindication to peg-ifn or rbv therapy * history of any other known cause of liver disease
dose escalation of neoadjuvant proton beam radiotherapy with concurrent chemotherapy in locally advanced esophageal cancer

Conditions: Esophageal Cancer

Summary: patients with esophageal cancer to be treated with concurrent preoperative proton therapy along with carboplatin and paclitaxel.

1. to identify the maximally tolerated radiation dose (mtd) of dose-escalated proton radiotherapy in combination with carboplatin/paclitaxel in the preoperative setting for esophageal cancer. 2. to estimate pathologic response rates by esophagectomy surgical specimens after escalated doses of chemoradiotherapy. 3. to assess the utility of circulating tumor cells and tumor vesicles as biomarkers to predict treatment response to chemoradiotherapy

Eligibility criteria:
inclusion criteria: * patients with a histologic diagnosis of adenocarcinoma of the esophagus located distal to the carina * patients with ajcc 7th edition clinical stage iib-iiic * patient must be \>18 years of age. * patients must have an ecog performance status of 0-1 * patients must be able to provide informed consent. * patients must be surgical candidates with adequate hematologic, renal, hepatic and pulmonary function * serum ast and alt \< 2 times the upper limit of normal * patients must have bilirubin \< 1.5 × normal. * wbc \> 3000/mm3, platelets \> 100,000 mm3. * hemoglobin \> 10 g/dl serum creatinine \< 1.5 times the upper limit of normal * women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, iud, condoms or other barrier methods etc.). hysterectomy or menopause must be clinically documented. exclusion criteria: * patients with primary tumors exceeding 8 cm in length or 5 cm in width ( length should be measured by endoscopic findings, width should be measured by diagnostic ct or ct portion of pet/ct) * patients with primary tumors located at or above the carina * prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) * pregnant women, women planning to become pregnant and women that are nursing

Keywords: esophageal cancer neoadjuvant proton beam radiotherapy
integrative medicine of iga nephropathy

Conditions: Primary IgA Nephropathy

Summary: the present study was designed to identify the efficacy and safety of integrative medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe iga nephropathy. furthermore, search for potential diagnostic predictor in iga nephropathy by proteomics and metabolomics.

the present study was designed to identify the efficacy and safety of integrative medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe iga nephropathy. furthermore, search for potential diagnostic predictor in iga nephropathy by proteomics and metabolomics. combined with tcm syndrome research, the investigators will clarify targets or mechanisms of herbal treatment. eventually, to form a more clinically appropriate standardized combination treatment of severe iga nephropathy.

Eligibility criteria:
inclusion criteria: 1. the primary igan was confirmed by renal biopsy and clinical examination, and the pathological manifestations were lee's grade and above; 2. tcm is liver kidney yin deficiency syndrome; 3. age 18-70 years old, sex, nationality is not limited; 4. ckd phase 2-4 （89 ml/min\>egfr（epi formula）\>15ml/min/1.73m2）; 5. 24 hour urinary protein≥1g. exclusion criteria: 1. it had received immunosuppressive drugs and cytotoxic therapy within the past 3 months more than 4 weeks; 2. it had received corticosteroids (prednisone or prednisolone) within the past 3 months more than 20mg/d for more than up to 4 weeks; 3. acute or progressive glomerulonephritis patients; 4. severe complications threat to life, such as severe infection; 5. active hepatitis b and liver function test sustained abnormal; 6. patients with malignant tumor or have a history of cancer, hiv infection, history of mental illness, acute central nervous system diseases, severe gastrointestinal diseases, prohibition of the use of hormone; 7. abnormal glucose metabolism, fasting blood glucose over 6.2mmol/l; 8. gravid or lactation woman; 9. other clinical trials are being studied; 10. merger with other serious disease and dysfunction of the organ.

Keywords: liver-kidney yin deficiency syndrome primary severe iga nephropathy lee's grade ⅲ
quality of life in parents of adolescents with spinal deformities: development of a new questionnaire.

Conditions: Quality of Life; Spinal Deformity; Scoliosis; Adolescence

Summary: this study aims to develop a new instrument capable of providing an efficient measure of the quality of life of parents of conservatively treated patients with spinal deformity. the development of a questionnaire in a rasch environment and specifically developed for parents of conservatively treated patients will ensure greater sensitivity and specificity of the questionnaire.


Eligibility criteria:
inclusion criteria: * have at least one child between the ages of 10 and 18 with adolescent idiopathic scoliosis of 10 degrees or more, or with scheuermann's kyphosis or idiopathic hyperkyphosis * prescription of a brace or specific exercises for the child's vertebral deformity. exclusion criteria: * child with a history of spinal surgery * child with a history of significant diseases with possible impact on the quality of life of the parents * child with a history of spinal trauma * child with positive neurological evaluation

Keywords: scoliosis quality of life spinal deformity
brazilian network for lymphoma registry

Conditions: Lymphoma

Summary: currently there are no official data concerning incidence, progression and prognosis of patients with lymphoma in brazil.this project aims the establishment of a network of 12 brazilian institutions to implement a lymphoma registry (relinfo) with the brazilian national cancer institute (inca) as the coordinating center.we intend to develop and implement a computerized system for data entry and information management of patients with lymphomas. this will enable create a virtual registry of demographic, clinical, epidemiological, histopathological, molecular, and therapeutic data. this clinical record must be linked to histopathological and molecular diagnosis, allowing institutions that work in the context of the public health system have access to new technologies for early cancer diagnosis.we expect is that this record reliably portrays the scene of lymphomas in our state and will become a management model that can be replicated at the national level. thus, the implementation of relinfo will strengthen the multidisciplinary diagnosis, promote the standardization of clinical record of patients with lymphomas and provide subsidies to cooperative research projects between participating institutions.

data collection and management: for data collection will use a common system for all institutions participating.we developed a computerized tool that utilizes models of case report forms (crf) and allows the inclusion and management of clinical, epidemiological, histopathological and molecular data. the clinical and laboratory data of patients included in relinfo will be obtained from the hospital records. the integration of local databases allows constitute the relinfo, conceived as a virtual database of patients with lymphoma. the inca as coordinating center is committed to the security of this database.standardization of diagnosisthis phase includes structuring a technological platform for the standardization of histopathologic diagnosis (establishing common routines in hematopathology) and the incorporation of molecular methods in the diagnosis of lymphoma.

Eligibility criteria:
inclusion criteria: * all patients (adult or child) with diagnosis of hodgkin's or non-hodgkin lymphoma with available with available clinical, histopathology and treatment data * patient enrolled on study sites included on this project exclusion criteria: * patients (adult or child) with other diagnoses of cancer
reducing underuse of early-stage breast cancer treatment in minority communities

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if a physician-centered intervention will help women with early stage breast cancer receive appropriate treatment.

efficacious adjuvant treatments such as radiotherapy following breast conserving surgery, and chemo- or hormonal therapy for stage 1b or 2 breast cancer improve disease-free and overall survival. lower rates of radiotherapy following breast-conserving surgery have been reported among black women. few data exist about racial disparities in receipt of chemo- or hormonal therapies; however, poorer stage-specific survival rates among blacks and among women with poor or no insurance suggest underuse of these treatments. despite elimination of racial disparities in rates of mammography screening, the full benefit of screening will not be realized unless underuse of effective treatments for early-stage breast cancer is eliminated. little is known about reasons for underuse of these treatments or ways to increase treatment rates. our preliminary work suggests omitted referrals and lack of follow-up tracking account for a majority of underuse particularly among minority patients. the proposed breast cancer project will measure the extent of underuse of efficacious breast cancer treatments among patients of the hospitals serving east and central harlem and other minority communities in lower manhattan. we will first interview physicians and patients about their reasons for omission of efficacious adjuvant treatments. at the 6 participating hospitals, we will then implement an intervention consisting of: a) computerized reminders to prompt surgeons to refer patients for adjuvant treatment, and b) an individual to track referrals for and receipt of adjuvant treatments. we will assess racial/ethnic differences in rates of underuse and explore racial differences in reasons for underuse. we will assess the impact of the intervention on reducing underuse of efficacious therapies among 2 years of 695 pre-intervention and 2 years of 695 post-intervention patients. this study will provide new knowledge about racial disparities in treatment for early-stage breast cancer; patient and physician reasons for underuse; and the effectiveness of a simple, sustainable intervention to improve rates of efficacious adjuvant treatments.

Eligibility criteria:
inclusion criteria: * all patients, who are english or spanish speaking, with a new primary stage 1 or 2 breast cancer who have undergone either breast conserving surgery or mastectomy and those with tumors \> 1 cm or \< 1 cm and poorly differentiated * all surgeons performing breast surgery at the participating hospitals exclusion criteria: * patients with dementia or those with a poor prognosis due to end-stage organ failure or other concomitant conditions such as those undergoing treatment for other cancers

Keywords: breast cancer adjuvant treatment racial disparities early-stage breast cancer