Kornimate/medical-research-clean huggingface dataset:
a single-center trial of high frequency pegaptanib for rapid restoration of vegf levels in diabetic retinal edema

Conditions: Diabetic Macular Edema

Summary: establish the efficacy of initial high frequency loading of intravitreal pegaptanib bi-weekly during the initial treatment period when the vegf levels are the greatest and then gradually extending the administration frequency to monthly as homeostasis ensues for the treatment of dme, as measured by best-corrected visual acuity.

determine if high frequency loading intravitreal pegaptanib will reduce the area and/or volume of dme, as assessed by spectral domain optical coherence tomography (sd-oct) and to determine if this loading with gradual taper schedule of intravitreal pegaptanib will reduce the need for macular laser treatment.

Eligibility criteria:
inclusion criteria: * type i or type ii diabetics, with an age of 18 years of older * vision of 20/40-20/400 in the study eye * diabetic macular edema as documented by sd-oct and fluorescein angiogram. exclusion criteria: * cannot attened all trail required visits * eyes in which retinal surgery is needed now are is likely to be needed within 6 months, which the surgeon believes will not respond to non-surgical intervention. * presence of any abnormality that is likely to confound assessment of visual acuity improvement in eyes in which macular edema resolves, or improves, such as non-perfusion greater than 1 disc area involving the foveal avascular zone, epiretinal membrane associated with signs of contraction and/or significant opacification, or presence of chorioretinal atrophy involving the center of the macula. * vitreomacular traction determined clinically and/or by oct, which, in the investigator's opinion, contributes to the macular edema, or causes associated foveal detachment, and would preclude improvement with pegaptanib sodium. * previous treatment with intravitreal corticosteroids in the study eye within 3 months of day 0 visit. * previous treatment with intravitreal anti-angiogenic drugs in the study eye within 2 months of day 0 visit. * previous intraocular surgery within 30 days of day 0 visit. * any ocular or periocular infection within 30 days of day 0 visit. * any of the following underlying diseases including: history or evidence of severe cardiac disease (e.g., nyha functional class iii or iv - see appendix 16.6), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrythmias requiring ongoing treatment. history or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation. history or evidence of clinically significant impaired renal or hepatic function stroke (within 12 months of trial entry). any major surgical procedure within one month of trial entry. * any treatment with an investigational agent in the past 30 days for any condition. * known serious allergies to the fluorescein dye used in angiography or to the components of pegaptanib sodium formulation.

Keywords: dme
a study of tmc435 in combination with peginterferon alfa-2a and ribavirin for hepatitis c virus genotype-1 infected patients who participated in a control group of a tmc435 study

Conditions: Hepatitis C

Summary: the purpose of this study is to investigate the efficacy of a treatment with tmc435 in combination with peginterferon alfa-2a and ribavirin in patients who did not clear their hepatitis c infection with peginterferon alfa-2a and ribavirin alone within a previous trial conducted by tibotec, or who participated in tibotec trials in which antivirals directed against hepatitis c virus (hcv) were evaluated for short periods of time.

this is a roll over trial of tmc435 for patients with genotype-1 hcv infection who participated in the control (placebo; substance containing no active medication) group of a tmc435 trial or who received a treatment for up to 14 days with antivirals directed against hcv in a previous tibotec trial. patients in this study will receive tmc435 in combination with peginterferon alfa-2a (pegasys) and ribavirin (copegus) followed by peginterferon alfa-2a and ribavirin alone. the total treatment duration will be 24 or 48 weeks, depending on how the patients respond to treatment and which was their previous response to peginterferon alfa-2a and ribavirin alone. the study doctor will inform each patient about how to take their study medication and when they should stop taking it. after a patient stops taking study medication, they will contiue to come to the doctor's office for study visits until 24 weeks (in some cases up to 48 weeks) after end of treatment. the total duration of the study is 78 weeks (including screening). patients will be monitored for safety throughout the study. study assessments at each visit may include but are not limited to: blood and urine collection for testing, electrocardiogram (ecg) assessments (a measurement of the electrical activity of the heart) and physical examinations. tmc435 will be taken as an oral capsule of 150 mg once per day. peginterferon (pegasys) will be given as an injection of 180 µg once each week. ribavirin will be taken as tablets (copegus) twice each day and the dose will depend on patient's body weight.

Eligibility criteria:
inclusion criteria: * patients who participated in the placebo arm of a tmc435 study who did not achieve undetectable hcv rna levels at end of treatment or who relapsed within 1 year after end of treatment or patients who received short-term direct-acting antiviral therapy in a tibotec-sponsored study. * liver disease stage documented by liver biopsy is required within 3 years prior to screening unless contraindicated. exclusion criteria: * infection with human immunodeficiency virus. * liver disease not related to hepatitic c infection. * significant laboratory abnormalities or other active diseases. * pregnant or planning to become pregnant. * prematurely stopped medication in previous tmc435 study for non-compliance or for safety reasons.

Keywords: tmc435-tidp16-c213 tmc435-c213 tmc435 hcv hepatitis c
impact of type 2 diabetes peer counseling on behavioral, metabolic, and health outcomes among latinos

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: the objectives of this study are: * to develop a comprehensive culturally tailored model of diabetes management that integrates the work of community-based peer counselors and clinical specialists into a multi-disciplinary health care team serving the latino community. * to implement an intervention that provides education and support to latino adults diagnosed with type 2 diabetes in both clinical and home settings. * to evaluate this intervention for its impact on program adherence, and improved outcomes sustained over time as reflected by metabolic, clinical, cognitive and behavioral measures.

a randomized two group longitudinal design with clinical measurements and behavioral assessments collected at baseline, 3,6,12 and 18 months will be used. it is hypothesized that participants in the home-based peer-counseling intervention will have greater reductions and will better maintain their reductions in their hba1c levels compared to participants in the standard of care hospital based program currently in place. additional secondary hypotheses state the participants in the home-based peer-counseling intervention will have improved lipid profile values, cholesterol levels, and bmi compared to participants in the standard of care hospital based program. participants in the home-based peer-counseling intervention will monitor their glucose more regularly (defined by the mean and variance in number of monitored days per month) than participants in the standard of care hospital based program. lastly, participants in the home-based peer-counseling intervention will have a higher rate of program participation (defined by adherence to appointments and referrals) and completion than participants in the standard of care hospital based program.

Eligibility criteria:
inclusion criteria: * latinos older than 21 * diagnosed with type 2 diabetes * referred to the "amigos en salud" program at hartford hospital * residents of hartford exclusion criteria: * advanced renal failure * advanced heart disease * diagnosis of major psychological disorder or mental condition * limb amputation(s) that prevent following study's exercise recommendations * any other health condition that prevents individual from consuming all their meals orally

Keywords: type 2 diabetes
standardization of chortoglyphus arcuatus allergenic extract. determination of biological activity in hep units

Conditions: Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic

Summary: the main purpose of the trial is to prove the therapeutic value of the product and enable an effective and safe dosage schedule to be recommended

the skin testing procedure, based on the nordic guidelines is the reference method for the biological calibration of in-house reference preparations (ihrp). the method is not intended for routine testing of allergen extracts. the use of this procedure is the basis for the definition of biological activity units: "the activity of an allergen extract is 10,000 biological units (bu) per ml (10 hep per ml), when the extract provokes an specific skin reaction in the median sensitive patient with a wheal of the same size as a wheal provoked by a positive reference solution consisting of histamine 54.3 mmol/l (for example histamine dihydrochloride 10 mg/ml), when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are clinically allergic and cutaneously reactive to the allergen concerned".

Eligibility criteria:
inclusion criteria: * voluntarily signed informed consent form by the patient * patients should live in a geographic zone where allergy caused by chortoglyphus arcuatus is a relevant problem. * patients should not be excluded due to low or high sensitivity to the allergen, when they otherwise fulfil the inclusion criteria. * a positive case history with inhalant allergy related to exposure to the allergen to be tested. * a positive prick test (mean wheal diameter \> 3 mm) when tested with a standardized extract prepared from the allergen source in question and/or a positive test for specific ige. * a mean wheal diameter \> 7 mm2 obtained in a prick test with histamine dihydrochloride 10 mg/ml. * age: 18-50 years. * both genders exclusion criteria: * immunotherapy in the past 2 years with an allergen preparation known to interfere with the allergens to be tested. * use of drugs that may interfere with the skin reactions. * pregnancy * dermographism * atopic dermatitis (locally at the test site) * urticaria.

Keywords: allergen-extract standardization
effect of low frequency ultrasound on kidney function

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to find out what effect, if any, low frequency therapeutic ultrasound (lotus) has on kidney function in patients with chronic kidney disease.


Eligibility criteria:
inclusion criteria: * must be \>/= 18 years of age * must have documented stage 3 to stage 4 (egfr 15 - 59) chronic kidney disease * females with childbearing potential must not be pregnant at the time of study * subject must provide written informed consent exclusion criteria: * unable or unwilling to cooperate with study procedures * currently enrolled in another clinical study for which the follow-up period is not complete

Keywords: low frequency ultrasound glomerular filtration rate
vacuum-formed retainer versus bonded retainer to prevent relapse after orthodontic treatment

Conditions: Orthodontics; Retention

Summary: the purpose of this trial is to evaluate and compare stability after orthodontic treatment with an essix retainer and a bonded cuspid-to-cuspid retainer (ctc), respectively in the mandibular arch and longitudinally follow these patients over time up to 5 years. the patients' perceptions of the two methods are also evaluated with questionnaires during the follow-up period. a further aim of this study is to analyze the relationship between diagnosis, treatment outcome, treatment time, age at start of treatment and stability with an essix retainer in the maxilla. the null hypotheses are: * that there is no difference in retention capacity between essix retainer and cuspid-to-cuspid retainer * that there is no difference in patients' perception between essix retainer and cuspid-to-cuspid retainer * that there is no difference in retention capacity for essix retainer in the maxilla concerning diagnosis before treatment, treatment outcomes, treatment time and age at start of treatment

the study is conducted at the orthodontic clinic, gävle, sweden and consists of 104 patients. all patients are treated with fixed appliances in the upper and lower jaw (standard .022 straight wire), both with and without extractions. the patients are randomized into two groups with 52 patients in each group (group a: cuspid-to-cuspid retainer, group b: essix retainer). dental cast are obtained at the debond appointment (t1) and at the follow-up controls after six months (t2), 18 months (t3) and 60 months (t4) for both groups. at the visit two weeks in retention and at the follow-up visits after 6, 18 and 60 months the patients assess questionnaires in order to evaluate their experience of retention with the retention device.

Eligibility criteria:
inclusion criteria: * patients treated with fixed appliances in both the maxilla and the mandible exclusion criteria: * rapid maxillary expansion (rme) for patients with severe transversal malocclusion * treatment with segmented appliances * patients with craniofacial anomalies and patients requiring orthognatic surgery * patients with missing mandibular incisor

Keywords: essix retainer vacuum-formed retainer cuspid-to-cuspid retainer
bacterial contamination in transrectal hybrid notes sigmoidectomy

Conditions: Diverticular Disease

Summary: transrectal hybrid natural orifice translumenal endoscopic surgery sigmoidectomy has gained popularity. it is an appealing technique as a minilaparotomy in order to retrieve the specimen is avoided. therefore less postoperative pain and a better cosmetic result are expected. the feasibility of the technique has been demonstrated. still an open question is the risk of intraperitoneal contamination as in this procedure the colon has to be opened. this is the case for (a) retrieval of the specimen thru the opened rectal stump and (b) for intracorporeal insertion of the anvil of the circular stapler in order to fashion an anastomosis. in this study the bacterial contamination in the rectal stump as well as in the peritoneal cavity is assessed. the results are compared to bacteriological samples taken in a comparison group consisting of conventional laparoscopic assisted sigmoidectomies.


Eligibility criteria:
inclusion criteria: * status post several episodes of diverticulitis * status post contained diverticulitis exclusion criteria: * not able to give informed consent * \<18 years of age * pregnancy * emergency operation * acute diverticulitis
mychart in patients with inflammatory bowel disease.

Conditions: Inflammatory Bowel Diseases

Summary: this study will be the first to assess the use of an electronic health records patient portal for patients with inflammatory bowel disease. patients with inflammatory bowel disease (ibd), have reduced quality of life, high rates of depression and anxiety, do not receive routine preventative health maintenance (such as vaccines) at the same rate as the general public, and have low adherence to medications. the investigators are seeking to understand whether an electronic health record patient portal (epic's mychart), can be utilized to improve quality of life in this patient population.

this study will be a single site randomized control trial. patients will be randomized into a control arm and intervention arm. at baseline the investigators will obtain demographic data, quality of life measures, and satisfaction with mychart for those patients who are alrealy active portal users. the control arm will receive periodic messages through mychart that are not specific to ibd. the intervention arm will receive more specific disease related information such as ibd educational information, reminders to take their medications, and reminders to get vaccinated. the intervention arm will also receive questionnaires that assess their mood (depression and anxiety). the investigators will then inform the primary gastroenterologist for those patients in whom mild, moderate or severe depression and anxiety is identified. at the end the study, in both groups investigators will measure quality of life as measured by the short inflammatory bowel disease questionnaire (sibdq), a validated questionnaire for measuring health-related quality of life in patients with crohn's and ulcerative colitis. secondary outcomes will include: satisfaction with mychart as measured by a mychart satisfaction survey, time to referral to mental health provider for patients identified with mild, moderate, or severe depression, or anxiety (promis depression and anxiety questionnaires), and vaccine uptake (using a simple yes/no questionnaire asking patients if they received flu, pcv13 or ppsv23. the findings of this study will allow future clinicians to better understand how a patient portal can be utilized as a tool for the management of patients with ibd. this findings may lead to increased physician and patient engagement with the mychart patient portal.

Eligibility criteria:
inclusion criteria: * men and women 18 years and older with a diagnosis of inflammatory bowel disease (crohn's or ulcerative colitis, or indeterminate colitis by standard criteria) who are scheduled for an upcoming appointment at the outpatient gastroenterology clinic or infusion unit. exclusion criteria: * non-english speaking patients * patients identified by their physicians as being too cognitively impaired to participate * patients without access to computer with internet * patients not expected to be in the study area for the duration of the study such as patients only seen for a one time second opinion

Keywords: inflammatory bowel disease ibd electronic health record patient portal quality of life
stocrin re-examination study (0831-028)

Conditions: HIV Infection

Summary: this survey is conducted for preparing application materials for re-examination under the pharmaceutical affairs laws and its enforcement regulation, its aim is to reconfirm the clinical usefulness of stocrin through collecting the safety and efficacy information according to the re-examination regulation for new drugs. post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. the results will be submitted to public health officials as required by applicable national and international laws.


Eligibility criteria:
inclusion criteria: * hiv-1 infected patient * patient who is treated with stocrin 600 mg tablet within local label during the enrollment period (a patient who changes the therapy from stocrin 200 mg capsule to stocrin 600 mg tablet can be eligible.) exclusion criteria: * patient who has a contraindication to stocrin according to the local label

Keywords: hiv infection
loop ileostomy closure:stapled or hand-sewn anastomoses? suture or mesh closure of the stoma site?

Conditions: Rectal Neoplasm

Summary: there are severel problems associated with the closing of a temporary loop-ileostomy after surgery for rectal cancer. the purpose of this study is to answer two questions: 1. the choice of anastomotic method - does it influence the postoperative course? 2. the use of a prophylactic mesh when closing the stoma site - will there be less hernias?

postoperative complications after closure of a temporary loop ileostomy after rectal cancer surgery are common. in this study the investigators propose the hypothesis that a stapled anastomotic technique will decrease postoperative small bowel obstruction and a mesh closure of the stoma site in the abdominal wall will decrease hernia formation. all patients will be randomized to stapled or hand-sewn anastomosis. the randomization to mesh or suture closure of the abdominal wall is optional. the stapled anastomotic technique is performed by the use of a linear staple device and the hand-sewn technique with a running seromuscular monofilament suture. the stoma site has two options and will be closed either by the use of mesh (lightweight), positioned under the muscle (retromuscular), or just by long-lasting suture. the anterior fascia of the rectus as well as the skin are closed by the use of running monofilament longlasting sutures, the latter in a pursestring procedure.

Eligibility criteria:
inclusion criteria: * loop ileostomy after rectal cancer surgery * loop ileostomy closure is permitted and possible according to clinical practice exclusion criteria: * patient unable to understand written or oral information

Keywords: ileostomy
assessment of the psychosocial impact of the covid-19 pandemic on the md anderson cancer center workforce

Conditions: COVID-19 Infection

Summary: this study investigates the impact of the covid-19 pandemic on the psychosocial health of employees of md anderson cancer center. epidemics have been shown to promote psychological stress among medical staff in high risk areas, which may lead to mental health problems. assessing how the pandemic is affecting employees may allow for more comprehensive actions to be taken to protect the mental health of employees.

primary objective: i. to assess psychosocial and stress-related outcomes in employees at md anderson cancer center during and post the covid-19 pandemic. secondary objective: i. to identify demographic and occupational factors associated with covid-19 related psychosocial and stress outcomes. outline: participants complete 2 online questionnaires over 10 minutes each at baseline and at 3 months after the pandemic ends.

Eligibility criteria:
inclusion criteria: * md anderson employees