Kornimate/medical-research-clean huggingface dataset:
irinotecan plus s1 versus s1 in patients with previously treated advanced esophageal cancer: eswn 01 trial

Conditions: Esophageal Neoplasms

Summary: esophageal cancer is a highly aggressive malignancy with a poor overall outcome. the purpose of this study is to evaluate the progression free survival and safety of irinotecan plus s1 versus s1 alone in the patients with previously treated advanced esophageal cancer

two arms, phase 3 study of irinotecan plus s1 versus s1 alone in previously treated patients with recurrent or metastatic esophageal cancer. 240 patients will be enrolled in this trial. the primary objective of this study is to determine the pfs of the two arms. one arm is as follows: irinotecan 160 mg/m2 will be administered as an intravenous infusion over 60 minutes on days 1, followed by s1 80mg to 120 mg per day on days 1-10, every 14 days per cycle. the other arm is s1 80mg to 120 mg per day on days 1-14, every 21 days per cycle.this study will also include the investigation of ugt1a1polymorphisms in the study population.

Eligibility criteria:
inclusion criteria: * histologically proven esophageal squamous cell carcinoma; * 18 ≤ age ≤ 70; * ecog 0-2; * previously treated with platinum or paclitaxel based regimen; * uni-dimensionally measurable disease (ct or mri as per recist); * patients should have a projected life expectancy of at least 3 months; * completion of baseline quality of life questionnaire * adequate bone marrow functions (anc ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl); * adequate renal functions(serum creatinine ≤ 1.5mg/dl) * liver functions (serum bilirubin ≤ 1.5unl, ast/alt ≤ 3 times(normal value) * written informed consent exclusion criteria: * previous chemotherapy with 5-fu or irinotecan after recurrence or metastasis; * adjuvant chemotherapy with 5-fu-based chemotherapy within 6 months prior to the start of study treatment; * active infection requiring antibiotics * pregnant, lactating women * psychiatric illness, epileptic disorders * concurrent systemic illness not appropriate for chemotherapy * history of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma

Keywords: esophageal neoplasms
assessment of fractional co2 laser in treatment of post-surgical scarring of cleft lip

Conditions: Cleft Lip Post-surgical Scar

Summary: this is a prospective comparative study on 120 patients divided to three groups. group a: 40 patients laser will be applied 3 weeks post-surgical. group b: 40 patients laser will be applied 3 months post surgical. group c: 40 patients as a control not treated with laser from 2017 to 2020 which will be conducted on patients with post-surgical cleft lip repair scaring. all patients will have 5-7 sessions with 4 weeks interval. photographic documentation and evaluation of the scar will occur every 4 weeks.

the carbon dioxide laser (co2 laser) was one of the earliest gas lasers to be developed. it was invented by kumar patel of bell labs in 1964. co2 laser is the highest power continuous wave lasers that are currently available which produces a beam of infrared light with the principal wavelength bands centering on 9.4 and 10.6 micrometers. patel, c. k. n. (1964). when co2 beam of light is selectively applied to the skin, it heats and vaporizes various layers of skin, instantly treating damaged skin and wrinkles while smoothing out the surface of the skin. the skin remodeling occurs with new skin and collagen growth. the healing typically involves an open surface which takes weeks to heal and typically results in loss of the baseline pigmentation leading to variable lightening of skin. dover, j. s. (2012) fractional co2 laser resurfacing is a revolutionary delivery system that provides dramatic skin improvement without surgery. matrix combines the benefits of co2 laser by using micro laser columns "points of light" to treat the epidermis and dermal layers of your skin. bernstein et al, (1997) cleft lip is a form of lip malformation that occurs very early in pregnancy, the incidence of cleft lip in the population is approximately 0.5-2 in 1000 live births. male children are affected more often than female children. michalski am et al, (2015). because each cleft is unique, definitive repair of the cleft lip should be individualized as mirault, le mesurier, tennison, and millard. stal s et al, (2009)

Eligibility criteria:
inclusion criteria: * any age with acceptable scar which would not need further revision. * group a: three weeks after repair \& group b: three months after repair with no hypertrophy, erythema or any other scar complication. exclusion criteria: * any case with deformity needing further surgical interference.
management of peri-implant mucositis with ozone water jet: a randomized clinical trial.

Conditions: Peri-implant Mucositis

Summary: the aim of this study is to assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants. patients willl undergo professional dental hygiene also with the use of glycine powders, then they will be randomly divided into two groups: * trial group: irrigation of peri-implant periodontium with mucositis with ozonized water. * placebo group: irrigation of peri-implant periodontium with mucositis with water. periodontal indices will be recorded at the baseline, after 1 and 2 months. after 1 and 2 months, only glycine powders will be performed, together with ozonized water or water irrigation and the collection of periodontal indices.

the aim of this study is to assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants. patients who respond to eligibility criteria and that will sign the informed consent will undergo a professional oral hygiene procedure. patients willl undergo professional dental hygiene also with the use of glycine powders. then, glycine powders air-flow will be administered. then they will be randomly divided into two groups: * trial group: irrigation of peri-implant periodontium with mucositis with ozonized water. * placebo group: irrigation of peri-implant periodontium with mucositis with water. periodontal indices will be recorded at the baseline, after 1 and 2 months. after 1 and 2 months, only glycine powder will be performed, together with ozonized water/water irrigation and the collection of periodontal indices.

Eligibility criteria:
inclusion criteria: * presence of one or more dental implants * presence of peri-implant mucositis at least at one implant * bleeding score \> 0 exclusion criteria: * patents without dental implants * presence of systemic diseases * patients with cardiac pacemaker

Keywords: ozonized water
characterization of signs and symptoms of participants with and without meibomian gland dysfunction

Conditions: Meibomian Glands

Summary: this is an exploratory study to evaluate endpoints used to characterize participants with and without meibomian gland dysfunction (mgd) and will evaluate the correlation between signs and symptoms of mgd. no investigational drug will be administered in this study.


Eligibility criteria:
inclusion criteria: -participants characterized as with or without meibomian gland dysfunction. exclusion criteria: * lid heating therapy, therapeutic gland expression, or meibomian gland probing within 12 months of enrollment * contact lens use in the 30 days prior to enrollment * lid hygiene within 48 hours prior to enrollment * use of eye makeup within 8 hours of enrollment * eyelash growth-stimulating products within 30 days prior to enrollment * use of systemic vitamins and/or systemic supplements containing omega 3 fatty acids within 60 days of enrollment * use of systemic anti-histamines within 30 days prior to enrollment.
a motivational enhancement approach to skin cancer prevention

Conditions: Ultraviolet Rays; Motivation

Summary: the specific aims of this research are: aim 1 - to describe the uv protection behaviors and beliefs of young adult patients in a dermatology clinic. aim 2 - to examine whether or not the uv protection behaviors and beliefs of young adult dermatology patients are associated with age, gender, level of education, marital status, contact with skin cancer, time outdoors, skin type, the reason for their visit, and the date of data collection. aim 3 - to test the efficacy of a motivational enhancement approach to uv protection counseling for young adult dermatology patients, as manifested by favorable changes in uv protection stages of change, uv protection self-efficacy, and uv protection attitudes.

although skin cancer is the most common form of cancer in the united states, it is highly preventable by reducing exposure to ultraviolet (uv) radiation. however, recent primary prevention efforts have been inadequate in evoking behavior change, as manifested by increasing rates of ultraviolet radiation exposure, particularly among young adults. these findings indicate the need to research novel approaches to skin cancer prevention. motivational enhancement techniques facilitate patient-centered, directive discussions wherein practitioners provide clear structure and encourage patients to play an active role in the consultation. the use of motivational enhancement techniques for health behavior change in medical settings has thus far yielded encouraging results for other health behavior change topics, but research has not yet investigated the application of these techniques to skin cancer prevention discussions.

Eligibility criteria:
inclusion criteria: * dermatology patient presenting for scheduled appointment * 18-30 years old exclusion criteria: * seeking treatment for sunburn * unable to read and understand english * having previously received medical treatment from the interventionist

Keywords: ultraviolet rays motivation health education randomized controlled trial health knowledge, attitudes, practice
retrospective data collection of routine use with spectra optia® for platelet depletions

Conditions: Thrombocythemia; Myeloproliferative Disease; Thrombocytosis

Summary: multicenter, retrospective data collection of routine clinical use with the spectra optia® apheresis system for platelet depletion procedures.

this is a multicenter, retrospective data collection to evaluate the in routine use performance and safety of platelet depletions performed via the spectra optia system. data collection will include procedures in 2- 3 different centers in europe done between november 2011 and april 2014.

Eligibility criteria:
inclusion criteria: * patients having received a minimum of one platelet depletion procedure via the spectra optia system. * availability of complete blood count results prior to starting and after completing the platelet depletion procedure via the spectra optia system. exclusion criteria: * none

Keywords: platelet depletion apheresis
evaluation of adherence to solifenacin treatment in overactive bladder patients

Conditions: Urinary Bladder, Overactive; Overactive Bladder

Summary: the purpose of the study is to assess patient's persistency in maintaining solifenacin treatment for overactive bladder.


Eligibility criteria:
inclusion criteria: * overactive bladder symptoms lasting for more than 3 months * the question 3 score of the overactive bladder symptom score(oabss)≥ 2 and the sum score of oabss ≥ 3 * symptoms of urinary urgency defined as a level of 1 to 2 in a 3-point urgency perception scale (ups) exclusion criteria: * any condition that would contraindicate their usage of anticholinergic treatment, including: urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis * symptomatic acute urinary tract infection (uti) * diagnosed or suspected of interstitial cystitis * treatment with anticholinergic drugs for over 3 months within 12 months prior to the study * pregnant or nursing women * treatment within the 14 days before the study or expected to initiate treatment during the study with any anticholinergic drugs other than solifenacin or treatment for overactive bladder with other drugs * any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Keywords: solifenacin overactive bladder persistency of the treatment vesicare
study of the safety and efficacy of amt-101 in subjects with pouchitis

Conditions: Pouchitis

Summary: phase 2 study investigating the efficacy of amt-101 in subjects with chronic antibiotic-resistant pouchitis

a phase 2 12-week, randomized, double-blind, placebo-controlled study investigating the efficacy of amt-101 in subjects with chronic antibiotic-resistant pouchitis

Eligibility criteria:
inclusion criteria: • chronic or recurrent pouchitis exclusion criteria: * known gastrologic, or systemic condition that may compromise severity or diagnosis of disease. * history or current evidence of colonic or abdominal abnormalities. * previous exposure to amt-101 or similar and known hypersensitivity to amt-101 or its excipients.

Keywords: inflammatory bowel disease
a study of arry-142886 in patients with advanced cancer

Conditions: Advanced Cancer

Summary: this is a phase 1 study during which patients with advanced solid tumors will receive investigational study drug arry-142886. this study has 2 parts. in the first part, patients will receive increasing doses of study drug in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. approximately 25 patients from the us will be enrolled in part 1 (completed). in the second part of the study, patients will receive the best dose of study drug, determined from the first part of the study, and will be followed to see what side effects the study drug causes and what effectiveness the study drug has, if any, in treating the cancer. approximately 35 patients from the us will be enrolled in part 2 (completed).


Eligibility criteria:
key inclusion criteria (part 2): * histopathologically or cytologically confirmed solid tumor that is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study. * eastern cooperative oncology group (ecog) performance status (ps) of 0, 1 or 2. * estimated life expectancy of greater than or equal to 3 months. * patient must have a tumor that is accessible for biopsy and must consent to paired tumor biopsies and normal skin biopsies being taken pre- and post-dose of study drug. * additional criteria exist. key exclusion criteria (part 2): * uncontrolled or symptomatic brain metastases. * use of investigational drug or device within 30 days prior to first dose of study drug. * major surgery within 30 days prior to study start. * radiotherapy or chemotherapy within 21 days prior to study start (not including palliative radiotherapy at focal sites). * pregnancy or lactation. * known positive serology for the human immunodeficiency virus (hiv), hepatitis b and/or hepatitis c. * additional criteria exist.
study to evaluate the effectiveness of a high-dose quadrivalent influenza vaccine (qiv-hd) compared to a standard-dose quadrivalent influenza vaccine (qiv-sd) in adults 65 years of age and older

Conditions: Influenza (Healthy Volunteers)

Summary: primary objective: to demonstrate the superior relative effectiveness of qiv-hd as compared to qiv-sd among persons 65 years of age and older for the prevention of cardiovascular and/or respiratory hospitalizations. secondary objective: * to assess the clinical relative effectiveness of qiv-hd as compared to qiv-sd in prevention of: * inpatient hospitalization for selected circulatory and respiratory causes * death, either all-cause or cardiovascular or respiratory causes * inpatient hospitalization (using primary and secondary discharge diagnoses) * inpatient hospitalization (using admission diagnoses) * hospital emergency room visits * primary care visits to physician or * major acute cardiovascular events (mace) * to assess the characteristics of inpatient hospitalization or hospital emergency room visits or primary care visits to physician by qiv-hd and qiv-sd groups. * to describe the clinical relative effectiveness of qiv-hd as compared to qiv-sd: * by age group and by group with specific comorbidities * for different periods of observation * to describe all serious adverse events (saes) (including adverse event of special interest \[aesis\]) for all subjects in both qiv-hd and qiv-sd groups.

study duration per participant was 1 day of screening and vaccination. the study was planned to be conducted over a period of 3 influenza seasons beginning in 2019-2020. the vaccination period was from october to december.

Eligibility criteria:
inclusion criteria: - aged 65 years or older on the day of inclusion ("65 years" means from the day of the 65th birthday). exclusion criteria: * participation at the time of study enrollment (or in the 4 weeks \[28 days\] preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. * previous vaccination against influenza (in the preceding 6 months) with either the study vaccines or another vaccine. * known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
evaluation of a facility-based test, treat, and prevent hiv program among men who have sex with men and transgender women in thailand

Conditions: PrEP Test and Treat

Summary: this is a prospective observational cohort study that aims to enroll a total of 2000 thai msm and tg at five health facilities in four provinces of thailand. each participant will be followed for 18 months. baseline and historical rates of hiv testing/re-testing, initial cd4 counts, retention in care, and art adherence at the study clinics, at the study clinics combined, and national data (if available) will be compared with rates after implementation of the test and treat strategy. analysis will also include an assessment of hiv prevalence and incidence. this study will use similar objectives, indicators, and procedures as those used in an ongoing test and treat study by the thai red cross aids research centre in three tertiary care hospitals, and a study to be conducted with pepfar key populations implementation science (kpis) funding through united states agency for international development (usaid), in community-based centers, allowing comparison of uptake and follow-up of msm and tg using the test and treat strategy in a variety of settings.


Eligibility criteria:
inclusion criteria: * thai national * age \>18 year * male or transgender women who reports anal intercourse with a man without using a condom at least one time in the past 6 months * not known to be hiv-infected * able to read and write thai additional inclusion criteria for prep: * a negative hiv test result * no signs or symptoms of acute hiv infection (fever, sore throat, fatigue, rash, swollen glands, nausea, diarrhea, white spots in the mouth) during the previous month * creatinine clearance \>60 ml/min * no contraindication to prep medication exclusion criteria: • participating in community-based test and treat study

Keywords: msm/tg who agree to start prep
sitagliptin in non-diabetic patients undergoing general surgery

Conditions: Hyperglycemia

Summary: the purpose of this study is to compare sitagliptin with a placebo for the prevention of high glucose after general surgery.

approximately 30-40% of hospitalized patients will develop stress hyperglycemia (high glucose in response to surgery or illness). high glucose is linked to an increased risk of hospital complications including wound infection, kidney failure and death. patients with high glucose are treated with insulin given through an arm vein or by frequent insulin injections under the skin. recent studies have found that inpatient therapy with oral dipeptidyl peptidase-4 inhibitor (dpp4-i) is an effective alternative to insulin in improving glycemic control with low risk of hypoglycemia in general medicine and surgical patients. sitagliptin is an oral medication approved by the food and drug administration (fda) to treat patients with diabetes. the aim of this study is to determine whether treatment with sitagliptin once daily can prevent the development of stress hyperglycemia during the postoperative period in non-diabetic patients undergoing general surgery.

Eligibility criteria:
inclusion criteria: * undergoing non-cardiac surgery * no previous history of diabetes or hyperglycemia * fasting blood glucose level of \<126 mg/dl * blood glucose \<126mg/dl at the time of randomization (could occur at any time of the day) exclusion criteria: * history of hyperglycemia (blood glucose equal to or above 126 mg/dl or hba1c greater than 6.5%) or previous treatment with oral antidiabetic agents or insulin * patients undergoing cardiac surgery * patients anticipated to require icu care following surgery * severely impaired renal function (gfr \< 30 ml/min) or clinically significant hepatic failure * moribund patients and those at imminent risk of death (brain death or cardiac standstill) * patients with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction * patients with clinically relevant pancreatic or gallbladder disease * treatment with oral (\> 5 mg/day) or injectable corticosteroid * mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study * pregnancy or breast-feeding at time of enrollment

Keywords: stress hyperglycemia blood glucose