Kornimate/medical-research-clean huggingface dataset:
imaging trial of the distribution of topical gel in the human vagina: enhanced mri techniques to increase resolution

Conditions: HIV

Summary: this study will assess the distribution of topical gel in the human vagina, using enhanced mri techniques. the number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using mri.

this study will assess the distribution of topical gel in the human vagina, using enhanced mri techniques. the number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using mri. mris will be performed with both a standard pelvic coil and an enhanced resolution endo-rectal coil in order to obtain maximal resolution. mri images will be acquired before and after simulated coitus.

Eligibility criteria:
inclusion criteria: * 18 to 45 year old women * not pregnant * willingness to use effective method of contraception * regular menstrual cycle * normal pap test result exclusion criteria: * abnormal pelvic exam * pregnant or breastfeeding * claustrophobia or other mri contraindications * hypertension, hemolytic anemia,latex allergy * history of hemorrhoids or irritable bowel syndrome
abx combined with cisplatin compared with gemcitabine combined with cisplatin in nsclc

Conditions: Non Small Cell Lung Cancer

Summary: assess the pfs/orr/os of abx combined with cisplatin compared with gemcitabine combined with cisplatin in first treatment of nsclc


Eligibility criteria:
1.18\~75 years 2.patients who were diagnosed by the histologic, cytologic diagnosis of iiib-iv non-small cell lung cancer 3.presence of at least one index lesion measurable by ct scan or mri 4.ecog0-1 5.expected life time longer than 12 weeks 6.normal laboratory values: * leucocyte ≥ 4×109/l * neutrophil ≥ 1.5×109/l * platelet ≥ 100×109/l * hemoglobin ≥ 10g/l * alt and * ast ≤ 2.5×uln (≤ 5×uln if liver metastasis) 7.signed written informed consent exclusion criteria: * patients have used drugs according to protocol * patients were allergic to pemetrexed or cisplatin * patients received radiotherapy or other biological treatment 4 weeks before the trial * uncontrolled hydrothorax or hydropericardium * neuropathy toxicity ≥ ctc 3 * severe symptomatic heart disease * active upper gastrointestinal ulcer or digestive disfunction * severe infection or metabolic disfunction * patients with other malignant tumor * uncontrolled brain metastases * patients have accepted other clinical trials * female patients during their pregnant and lactation period, or patients without contraception

Keywords: pfs
comparison of three combination therapies in lowering blood pressure in black africans

Conditions: Hypertension

Summary: the creole study is a a multi-centre, multinational, randomised single-blind, parallel group, three-armed superiority trial which is aimed at comparing the efficacy of three "free" combinations of two anti-hypertensive agents on 24 hour ambulatory systolic blood pressure (asbp) in black african hypertensive patients.

the creole trial will be performed at ten investigational sites in six countries in sub-saharan africa which include cameroun, kenya, mozambique, nigeria, south africa and uganda. subjects will be randomised to one of three treatments which are perindopril plus amlodipine or perindopril plus hydrochlorothiazide or amlodipine plus hydrochlorothiazide.patients will commence treatment at a starting dose of amlodipine plus hydrochlorothiazide 5/12.5 mg or amlodipine plus perindopril 5/4 mg or perindopril/hydrochlorothiazide 4/12.5 mg. these doses will increase at the two months visit, to amlodipine/hydrochlorothiazide 10/25 mg or amlodipinepperindopril 10/8mg or perindopril/hydrochlorothiazide 8/25 mg. the patients will have ambulatory blood pressure monitoring at randomization and at six months and office blood pressure measurements at randomization and at two-month, 4-month and six-month visits.the overall aim is to discover the best combination of front-line anti-hypertensive medications for black patients residing in sub-saharan africa.

Eligibility criteria:
inclusion criteria: * patients with sitting sbp ≥140 mm hg and \< 160 mmhg on one antihypertensive agen or * sitting sbp ≥ 150 mm hg and \< 180 mm hg on no antihypertensive treatment. exclusion criteria: * congestive heart failure (clinically defined). * serum creatinine levels greater than 170 µmol/l or estimated glomerular filtration rate (egfr) \< 30 ml/min. * history of coronary heart disease (i.e., chronic stable angina, myocardial infarction or acute coronary syndrome). * history of a stroke or other cerebrovascular accident (i.e. transient ischaemic attack or reversible ischaemic neurological deficit). * known or suspected secondary hypertension. * any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study. * pregnancy or those of child-bearing age who are not taking reliable contraception. * patients with a history of intolerance to any of the study medications for example angioedema or dry cough with angiotensin converting enzyme inhibitors. * patients on maximum dose of any of the study medications as monotherapy (i.e. amlodipine 10 mg/day or hydrochlorothiazide 25 mg/day or perindopril 8 mg/day) * gout. * serum potassium \< 3.5mmol/l at screening.
ribomustin in the second line therapy of relapsed or refractory indolent b-cell non-hodgkin's lymphoma

Conditions: Lymphoma, Non-Hodgkin

Summary: prospective multicenter observational non-interventional study to assess routine clinical practice of bendamustine use in the second line therapy of relapsed or refractory indolent b-cell non-hodgkin's lymphoma


Eligibility criteria:
inclusion criteria: * doctor's decision to prescribe ribomustin and rituximab combined therapy for the treatment of relapsed or refractory indolent b-cell non-hodgkin's lymphoma (inhl) * informed consent form for personal data handling signed by the program participant, authorized by the independent ethics committee * eastern cooperative oncology group (ecog) status \< 2. * confirmed relapse or disease progression of b-cell cd20+ non-hodgkin's lymphoma (lymphocytic, lymphocytoplasmocytic, follicular, marginal zone) after minimum one line of inhl treatment * patients with relapsed or refractory indolent b-cell non-hodgkin's lymphoma with current or planned ribomustin and rituximab combined therapy with following rituximab maintenance therapy exclusion criteria: * indolent non-hodgkin's lymphoma transformation * lymphoma with central nervous system (cns) involvement * presence of second malignant tumor. * currently participating in any clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment. * contraindications for ribomustin usage in accordance with product label * contradictions for rituximab usage in accordance with product label

Keywords: relapsed refractory non-hodgkin lymphoma bendamustine
effectiveness and safety of topical hyaluronic acid of different molecular weights in xerotic skin treatment

Conditions: Xerosis Cutis

Summary: the goal of this clinical trial is to compare 0,1% topical low molecular weight (7 kda) hyaluronic acid with 0,1% high molecular weight (1.800 kda) hyaluronic acid as therapy of xerotic skin in elderly

this clinical trial is conducted to compare the effectiveness and safety between moisturizers containing 0,1% low molecular weight hyaluronic acid, 0,1% high molecular weight hyaluronic acid, and its vehicle on skin hydration of elderly with xerotic skin. it is designed to answer following questions: 1. is the skin capacitance in the elderly after using moisturizers containing low molecular weight hyaluronic acid higher than high molecular weight hyaluronate acid and vehicle? 2. is the transepidermal water loss in the elderly after using moisturizers containing high molecular weight hyaluronic acid lower than low molecular weight hyaluronate acid and vehicle? 3. is the dry skin score (srrc) in the elderly after using moisturizers containing low molecular weight hyaluronic acid lower than high molecular weight hyaluronate acid and vehicle? 4. is there any difference in occurence of side effect in elderly between the use of moisturizers containing low molecular weight hyaluronic acid, high molecular weight hyaluronic acid, and vehicle?

Eligibility criteria:
inclusion criteria: * female or male diagnosed with xerotic skin * 60-80 years old * willing to participate in clinical trial and sign informed consent exclusion criteria: * history of hypersensitivity to moisturizer * dermatitis or any dermatosis on intervention area in the leg * score of erythema and crack more than 2, based on srrc scoring
health coaching: a pilot trial among reintegrating veterans

Conditions: Veteran Reintegration

Summary: health coaches help people focus on goals, identify strengths and values, and work towards building the life they wish to live. health coaching may be especially helpful for people navigating a life transition, such as veterans who recently separated from military service (i.e., reintegrating veterans). in this pilot trial the investigators will 1) examine the feasibility of study procedures and acceptability of health coaching among reintegrating veterans, 2) evaluate measures for suitability in a future trial that will examine efficacy of the intervention, 3) determine barriers and facilitators to implementing the intervention among reintegrating veterans.

this pilot study is designed to provide data to inform the design and procedures of a future efficacy trial of health coaching among reintegrating veterans. an enrollment rate 30% and an assessment completion rate 65% at 9 months will be considered feasible enrollment and assessment completion rates for a future efficacy trial. an intervention completion rate 70% and mean score 27 on the client satisfaction questionnaire-8 will indicate acceptability. evaluation of measures will entail quantifying the mean levels in this population, characterizing typical variation in the outcomes, descriptive analyses of within-person change across time, and adjusted estimates of treatment effect sizes with 95% confidence intervals to calibrate the sample size needs of a fully powered trial. qualitative interviews with participants will provide information on barriers and facilitators to implementation as well as perceived benefits and potential harms.

Eligibility criteria:
inclusion criteria: * united states military veterans recently separated from service exclusion criteria: * currently living in an institution (e.g., nursing home, prison) * cognitive impairment as indicated by a score equal to or greater than 10 on the short blessed test * currently experiencing psychosis as indicated by endorsing thought interference or hallucinations on the psychosis screening questionnaire * at acute risk for suicide as indicated by the p4 screener * unable to read or understand english

Keywords: veterans vocational rehabilitation
preoperative anxiety during covid-19

Conditions: Anxiety; Pandemic, COVID-19

Summary: the modified preoperative anxiety scale (mpas) questionnaire as given in the article by viola et al, will be used after permission from the authors, to investigate the preoperative anxiety of patients undergoing surgery during the 4th wave of the pandemic

studies have been conducted on the stress and anxiety induced by the covid-19 pandemic in both the general population as well as specific groups, such as health care workers, pregnant women and adolescents. given that anxiety has a strong bearing on the physical, mental and emotional well-being of the patients and their subsequent recovery from surgery and other procedures, we were interested in assessing anxiety among the patients presenting for elective procedures in the post-lockdown phase of the pandemic. the primary objective of the present study was to assess the anxiety levels among the preoperative patients scheduled for surgeries in the 4th wave of the covid-19 pandemic, and the secondary objective was to assess the factors accentuating the same. the modified preoperative anxiety scale (mpas) questionnaire as given in the article by viola et al will be used after permission from the authors.

Eligibility criteria:
inclusion criteria: * adult consecutive patients, \>18 years old * undergoing surgery in the uhl exclusion criteria: * patients aged\<18 years * patients that will refuse to participate * patients unable/not fit to consent

Keywords: anxiety sars cov-2 pandemic perioperative
trial of a novel brief intervention on health behaviors for youth with chronic medical conditions

Conditions: Substance Use

Summary: the primary goal of this project is to develop a tailored screening, brief intervention and referral to treatment (sbirt) model for youth with chronic medical conditions (ycmc) for delivery at point of care during a routine healthcare visit, through conducting a rigorous randomized control trial among adolescent patients with type 1 diabetes (tid) or rheumatologic conditions. the secondary goal is to assess the attitudes and knowledge of parents of these same adolescents, to explore links between parent beliefs and adolescent behavior around substance use.

the proposed project is a randomized control trial to assess the efficacy of an sbirt model tailored to youth with chronic medical conditions. this trial is being built into a larger, longitudinal cohort study to assess whether a set of brief, substance specific questions can accurately predict adolescent substance use outcomes when compared to more lengthy, criterion standard assessment questions, in cross-sectional and prospective analysis. the first component of the project will consist of pre-testing an assessment battery and brief electronic intervention with a small sample of 14-17 year old youth. in the second component the investigators will randomize consented eligible participants into intervention or control arms of the study and administer the 1) baseline assessment battery and the 2) brief intervention or treatment as usual (tau). in the third component the investigators will follow up with all participants at 6 and then 12 months after study entry to reassess rates of substance use through follow up assessment batteries. at baseline, the investigators will also attempt to enroll parents of all participants who are present at the time of enrollment. the investigators will separately consent and administer a brief assessment battery to parents to assess their knowledge and attitudes around substance use, as well as opinions and attitudes regarding other health and risk behaviors.

Eligibility criteria:
inclusion criteria: * 14-17 year-old youth presenting for routine medical care in the rheumatology clinic or endocrinology clinic at boston children's hospital (bch) * a diagnosis of type 1 diabetes for at least a year or a diagnosis of a rheumatologic condition for at least a year. * able to read and understand english at a middle school level or greater * consent to participation in the study and consent to the 6 month and 12 month follow up assessments. exclusion criteria: * patients who are medically or emotionally unstable or otherwise unable to provide assent at the time of their appointment as determined by their clinician or the research team * unable to speak/read english at a middle school reading level * unable to use a computer keyboard and/or complete an interviewer-assisted questionnaire * do not consent to 6 month and 12 month re-assessment. * patients who are pregnant at baseline
study of t3 on the incidence of atrial fibrillation in patients undergoing cardiac surgery

Conditions: Atrial Fibrillation

Summary: the purpose of this project is to see whether treatment with a thyroid hormone, called triiodothyronine or t3, following open heart surgery reduces the risk of developing atrial fibrillation.


Eligibility criteria:
inclusion criteria: 1. patients requiring cabg or valve repair/replacement surgery. 2. patient must be able to provide informed consent. exclusion criteria: 1. patients less than 18 or over 85 years of age. 2. patients less than 50kg or greater than 120kg. 3. patients currently with endocrine disorders, excluding diabetes. 4. patients currently with thyroid dysfunction (e.g., hyper- hyperthyroidism, goiter, grave's disease), myxedema, or myxedema coma, even if treated. 5. patients currently receiving thyroid replacement therapy. 6. patients currently receiving ketamine, levarterenol or dietary (non-food) iodine supplementation. 7. patients who have received any investigational drugs within the previous one month or five half-lives of the drug. 8. patients who are pregnant. pregnancy testing will be done for women of child-bearing potential. 9. patients currently in atrial fibrillation.
single ascending dose study of amg 570 in healthy subjects

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single dose of amg 570.


Eligibility criteria:
inclusion criteria: * healthy as determined by the investigator * normal or clinically acceptable electrocardiogram (ecg) * female subjects must be of documented non-reproductive potential * subjects must be current for all vaccinations * other inclusion criteria may apply exclusion criteria: * current or chronic history of liver disease * history of active infections * history of significant respiratory disorder * evidence of renal disease * other exclusion criteria may apply

Keywords: lupus healthy volunteer safety study placebo control phase 1
the silicone study

Conditions: Proliferative Vitreoretinopathy; Retinal Detachment

Summary: to compare, through a randomized, multicenter surgical trial, the postoperative tamponade effectiveness of intraocular silicone oil with that of an intraocular long-acting gas (initially sulfur hexafluoride \[sf 6 \], later perfluoropropane \[c 3 f 8 \]) for the management of retinal detachment complicated by proliferative vitreoretinopathy (pvr), using vitrectomy and associated techniques. to evaluate the ocular complications that result from the use of silicone oil and gas.

the treatment of retinal detachment complicated by pvr remains controversial. although some cases are managed successfully by pars plana vitrectomy and with temporary tamponade provided by intraocular gas, others eventually redetach with this technique. preliminary reports indicate that prolonged tamponade with liquid silicone results in improved anatomical success, but the eventual visual outcome may be prejudiced by silicone-related complications, particularly glaucoma and keratopathy. the addition of hydraulic reattachment by simultaneous fluid/gas exchange to vitrectomy surgery has proved to be an important development. although complications are few with these procedures, subsequent redetachment is frequent. the silicone study was a randomized trial to investigate the relative merits of silicone oil or gas as tamponade modalities. all study patients underwent vitrectomy and were randomized intraoperatively either to silicone oil or to gas. two groups of eyes were entered into the study: eyes that had not had a prior vitrectomy (group 1) and those that had undergone previous vitrectomy outside the study (group 2). a critical element in the study was a standardized surgical procedure for pvr. this surgical procedure, intended to relieve retinal traction with vitrectomy techniques, was followed by assessment of the relief provided by an intraocular air tamponade. the eye was randomized to silicone oil or gas only after completion of the entire surgical procedure to eliminate investigator bias that might develop through knowledge of the treatment modality. patients were examined 5 to 14 days following the randomization and again at 1, 3, 6, 12, 18, 24, and 36 months after that date. repeated surgery was permitted for either treatment modality. the fundus photograph reading center staff processed and analyzed photographs taken at all the clinics, graded the preoperative severity of pvr on the basis of baseline visit photographs, and confirmed the macular status at followup visits. end points of the study were visual acuity of 5/200 or greater and macular reattachment for 6 months following the final surgical procedure. the successful outcomes and complication rates of the two modalities were compared.

Eligibility criteria:
eligibility criteria included but were not limited to pvr of grade c-3 or greater according to the retina society classification and visual acuity of light perception or better.
clinical research on retinal neovascularization of diabetic retinopathy

Conditions: The Mechanism of Retinal Neovascularization of Diabetic; Retinopathy.

Summary: retinal neovascularization of diabetic retinopathy might be associated with genetic risk factors and environmental risk factors.


Eligibility criteria:
inclusion criteria: * t2dm was diagnosed according to the world health organization expert consultation report 1999 and consisted of one of the following: fasting blood glucose (fbg) ≥7.0 mmol/l (≥126 mg/dl), blood glucose ≥11.1 mmol/l (≥200 mg/dl) 2 hours after an oral glucose tolerance test (ogtt); or a random blood glucose ≥11.1 mmol/l (≥200 mg/dl). * dr was clinically graded in accordance with the international clinical diabetic retinopathy guidelines based on fundus fluorescence angiography. * all participants with pdr underwent a comprehensive dilated fundus examination to detect dr by indirect ophthalmoscopy and were diagnosed by fundus fluorescence angiography. exclusion criteria: * patients were excluded if they had acute complications of diabetes mellitus, type 1 diabetes mellitus, other types of diabetes, serious cardiovascular, hepatic, nephritic or other complications, other serious primary diseases or mental illness.