Kornimate/medical-research-clean huggingface dataset:
a study to compare two anti-hiv drug combinations that include amprenavir in hiv-infected patients who have failed anti-hiv drug combinations that did not include amprenavir

Conditions: HIV Infections

Summary: this study will compare the safety and effectiveness of two anti-hiv drug combinations in fighting hiv infection in patients whose viral loads (levels of hiv in the blood) rose with other anti-hiv drug treatments.

patients experiencing virologic failure while receiving an idv-containing antiretroviral regimen will receive the 3tc/abc/apv/nfv combination. patients experiencing virologic failure while receiving an nfv-containing antiretroviral regimen will receive the 3tc/abc/apv/idv combination.

Eligibility criteria:
inclusion criteria you may be eligible for this trial if you: * are hiv-positive. * are 13 years of age or older. * are currently taking anti-hiv drugs, 1 of which must be nfv or idv, and have taken these same drugs for at least 12 weeks. * in the last 16 weeks your viral load (level of hiv in the blood) dropped below 400 copies/ml and has since increased to at least 1,000 copies/ml, even though you continue to take your anti-hiv drugs. * have the written consent of a parent or legal guardian if you are under age 18. * agree to practice abstinence or use effective barrier methods of birth control (unless you are physically incapable of becoming pregnant). * are willing to complete the 48-week study. exclusion criteria you will not be eligible for this trial if you: * have ever taken the following anti-hiv drugs: abc, apv, efavirenz (efv), delavirdine (dlv), nevirapine (nvp), or loviride. * have certain aids-related infections or diseases, have other serious medical conditions such as diabetes and certain types of heart trouble, or have a history of lymphoma. * have had certain types of hepatitis in the past 6 months. * have received an hiv vaccine in the past 3 months or a flu vaccine in the past 30 days. * have certain digestion problems that make it difficult to take anti-hiv drugs by mouth. * have received certain other drugs or treatments in the past 30 days, or will need certain drugs or treatments during the study.

Keywords: drug therapy, combination hiv protease inhibitors lamivudine indinavir nelfinavir vx 478 reverse transcriptase inhibitors anti-hiv agents viral load abacavir
alternate-day buprenorphine administration. phase iv - 5

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to determine if three times a subject's daily maintenance dose will hold for 72 hours without changes in agonist and antagonist effects.


Eligibility criteria:
please contact site for information.
multi-family therapy and school refusal: an exploratory study with adolescents and their families

Conditions: School Phobia

Summary: the purpose of this study is to determine whether multi-family therapy is effective in the treatment of school refusal with anxiety in adolescence.

anxious school refusal in adolescence is a major public health problem. the involvement of families is essential and multi-family therapy has shown its effectiveness for many mental disorders. this study aims to explore the benefit of multi-family therapy in the care of anxious school refusal in adolescence. the method will be qualitative with phenomenological analysis of semi-structured interviews with adolescents and their parents and quantitative with a sced design to assess the evolution of the level of anxiety of adolescents and parents, as well as personalized objectives. the objective is therefore to improve the care of adolescents with anxious school refusal.

Eligibility criteria:
inclusion criteria: * families with an adolescent * aged 12 to 18 * totally out of school for more than 2 consecutive weeks and less than 18 months * follow-up at the maison de solenn-maison des adolescents (cochin hospital ap-hp) for a school refusal * having agreed to participate in a multi-family therapy * domiciliation in ile de france * agreement of the parents and the adolescent to participate in the study: collection of the non-opposition of non-emancipated minors and their legal representatives exclusion criteria: * any family situation that makes it impossible to bring parents and children together in family therapy * patient under curatorship or tutorship * patient with ame (french state medical aid)

Keywords: adolescence school phobia multi-family therapy anxiety disorder
effect of maxillary nerve block for septoplasty

Conditions: Post Operative Pain

Summary: the aim of this study was to determine the effect of maxillary nerve blockage on both postoperative pain scores and recovery quality index in septoplasty operations. thus, it was aimed to determine an alternative method that can be used in postoperative analgesia that will suppress postoperative pain complaints and increase the comfort level of patients after septoplasty operations.

patients who were planned to be operated for septoplasty at adıyaman university training and research hospital, who were informed about the study and agreed to participate in the study with their written consent were included in the study. the patients who agreed to participate in the study were divided into two groups by closed envelope method and bilateral maxillary nerve blockade was planned to be performed using 10 cc 0.25% bupivacaine via suprazigomatic approach after providing airway safety in the block group with general anaesthesia applications in both groups. the haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (qor-15) values at the 24th hour were recorded and these values were compared in both groups. thus, it was aimed to evaluate the effects of maxillary nerve blockade in septoplasty operations.

Eligibility criteria:
inclusion criteria: * asa i-ii , septoplasty patints exclusion criteria: * asa iii-iv * deny to participte in study

Keywords: postoperative pain maxillary nerve block septoplasty
evaluating hearing aid service delivery models

Conditions: Presbycusis; Aging; Hearing Loss

Summary: the purpose of this study is to compare the outcomes for two different hearing-aid delivery models. in one model, the audiologist selects and fits the hearing aid and, in the other model, the consumer does this directly.

the objectives of this study were to determine efficacy of hearing aids in older adults using audiology best practices, to evaluate the efficacy of an alternative over-the-counter (otc) intervention, and to examine the influence of purchase price on outcomes for both service-delivery models. the design of this study was a single-site, prospective, double-blind placebo-controlled randomized trial with three parallel branches: (a) audiology best practices (ab), (b) consumer decides otc model (cd), and (c) placebo devices (p). outcome measures were obtained after a typical 6-week trial period with follow-up 4-week ab-based trial for those initially assigned to cd and p groups. older adults from the general community were recruited via newspaper and community flyers to participate at a university research clinic. participants were adults, ages 55-79 years,with mild-to-moderate hearing loss. intervention(s): all participants received the same highenddigital mini-behind-the-ear hearing aids fitted bilaterally.ab and p groups received best-practice services from audiologists; differing mainly in use of appropriate (ab) or placebo (p) hearing aid settings. cd participants self-selected their own pre-programmed hearing aids via an otc model. primary outcome measure was a 66-item self-report, profile of hearing aid performance/benefit. secondary outcome measure was the connected speech test benefit.

Eligibility criteria:
inclusion criteria: (for groups 1-4) * 55-79 yrs of age * native english speaker * no prior hearing aid use * ability to read 18 point font exclusion criteria: (for groups 1-3) * hearing loss too severe or too mild for hearing aid * middle-ear conductive pathology present * asymmetrical hearing loss * presence of dementia, parkinson's disease, or other neurological disorder exclusion criteria : (for groups 1-4) - subject not interested in purchasing hearing aids

Keywords: presbycusis hearing aids
effect of hydroxychloroquine on atrial fibrillation recurrence

Conditions: Atrial Fibrillation

Summary: atrial fibrillation is the most common arrhythmia in clinic. it can lead to heart failure or stroke, and has a high disability rate and mortality rate. at present, although radiofrequency ablation can cure atrial fibrillation, the success rate is only 50\~70%, and has a high recurrence rate. in recent decades, no effective new antiarrhythmic drugs have been introduced, but there are side effects in long-term application of the existing antiarrhythmic drugs. therefore, it is urgent to provide new and effective antiarrhythmic drugs. autophagy level of atrial myocytes in atrial fibrillation patients was significantly higher than that in sinus rhythm. hydrochloroquine (hcq) is a hydroxychloroquine sulfate composed of 4- amino quinoline compounds. as an effective inhibitor for autophagy, hcq could effectively prevent the increased autophagy level of atrial myocytes in atrial fibrillation rabbits, prevent atrial effective refractory period (aerp) shortening, and decrease the rate and duration of atrial fibrillation. at present, hydroxychloroquine is mainly used in the treatment of rheumatic immune system diseases and anti malaria. because of its good safety and small side effects, hcq has become an indispensable member of drugs in the combined treatment of rheumatoid arthritis and systemic lupus erythematosus patients. in recent years, studies have reported that hydroxychloroquine plays an important role in the prevention and treatment of cardiovascular diseases. chloroquine could effectively shorten the action potential of atrial myocytes by blocking the inward rectifier potassium ion channel (kir2.1) and reducing the inward potassium ion current ik1. hcq could also reduce 72% (p=0.002), and 70% for the risk of coronary heart disease, stroke, and transient ischemic disease. so the investigators speculate that hcq may be a potential drug to block the occurrence of acute atrial fibrillation.


Eligibility criteria:
inclusion criteria: * successful radiofrequency ablation of atrial fibrillation within 24 hours exclusion criteria: * history of cerebrovascular disease: ischemic stroke, cerebral haemorrhage and transient ischemic attack. * history of cardiovascular disease:unstable angina, myocardial infarction, coronary revascularization and congestive heart failure. * history of renal impairment. * history of type i diabetes mellitus or type ii diabetes uncontrolled. * history of liver impairment. * history of alcoholism or drug abuse. * known severe skin rash or damage. * known retinal pigmentation and visual field defect. * allergy to any component of hydroxychloroquine.
the effect of exercise training on muscle mass in patients with total knee arthroplasty

Conditions: Knee Osteoarthritis; Arthropathy of Knee Joint

Summary: background: total knee arthroplasty (tka) is one of the most common operations in orthopedics. after surgery, the decline of bone mineral density and muscle mass was proved, oral bisphosphonate is commonly used to prevent bmd loss in clinic treatment, however, the loss of muscle mass can only be maintained with exercise intervention. the goals of tka rehabilitation should be based on control pain, improve ambulation, maximize the range of motion, develop muscle strength, and provide emotional support. we planned to find out a potential adjuvant effective option in muscle mass for the management of post-tka. literature suggested that exercise training has been found to have the considerable effect on tka. however, no suitable exercise prescription was established on the scientific basis. the current study aimed to find out a potential treatment mode. study rationale: this project will be performed for consecutive three years, the patients with post-tka patients are managed with the treadmill exercise training in the first year. in the second year, resistance exercise is prescribed. in the third year, eccentric exercise plus resistance training will be arranged in the exercise group. we will analyze the data of the three years and cross-comparative analysis. a prescription of exercise training, a period of 24 weeks each year, 3 times a week, for each 10 minutes warm-up, 40 minutes exercise training, and 10-minute cool down for exercise prescription study objectives: to investigate the effect of long-term exercise training, eccentric and resistance exercise on muscle mass in patients with total knee arthroplasty. to monitor the performance index included: physiological indices, muscle mass, ambulation and the quality of life index. study design duration of treatment: total of 6-month exercise intervention in each year. the number of planned patients: 35 subjects in each control and exercise group in one year, the total of 210 subjects in three years. investigational product: automated biochemistry analyzer, biospace inbody 7.20 analysis of body composition instrumentation; dual energy x-ray absorptiometer (dexa), isokinetic muscle strength measurement, vicon to analysis ambulation, functional fitness, the questionnaire including sf-36, koos and vas pain score. endpoints: data collection in pre-surgery, 3 months, 6 months, 9 months and 12 months after surgery.


Eligibility criteria:
inclusion criteria: * the inclusion criteria of this study were the patients diagnosed with serious osteoarthritis (oa) and recommended to receive tka surgery. exclusion criteria: * the exclusion criteria were the patients with diabetes, neuromusculoskeletal disorder, severe chronic disease, history of fracture of a lower limb, artificial limb, and unsuitable for exercise training
observational study to evaluate the safety and efficacy of novomix® 70 in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this observational study is to evaluate the incidence of adverse events while using novomix® 70 under normal clinical practice conditions in austria.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c over 7% * no contraindication with novomix® 70 exclusion criteria: * type 1 diabetes * subjects participating in a clinical trial or another observational study * subjects under previous basis-bolus insulin therapy * women who are pregnant, breast feeding and women of child bearing capacity who are not using any reliable contraceptive method
180 degree vs. 360 degree selective laser trabeculoplasty as initial therapy for glaucoma

Conditions: Open Angle Glaucoma; Ocular Hypertension; Glaucoma, Open Angle, Pseudo-exfoliative; Pigment Dispersion Syndrome; Glaucoma

Summary: selective laser trabeculoplasty (slt) is a well-recognized way to lower eye pressure in treatment of glaucoma. this treatment is performed for 180 degrees or 360 degrees, and studies at academic centers have shown mixed results when comparing the success rates of 180 degrees or 360 degrees. both protocols are now typically done by comprehensive ophthalmologists. however, there is no data that compares success rates of 180 degrees and 360 degrees in the community setting.

this study is designed as a prospective evaluation of the two treatment algorithms for slt by measuring intraocular pressure (iop) after treatment. the hypothesis is that 360 degrees of slt will produce a greater reduction in iop than 180 degrees of slt at 3 months follow up.

Eligibility criteria:
inclusion criteria: * patients who have been diagnosed with open-angle glaucoma including ocular hypertension, pseudoexfoliation and pigment dispersion syndrome * greater than 18 years of age * initial intraocular pressure (iop) of ≥ 21 mmhg exclusion criteria: * prior medical or laser therapy to lower iop * previous incisional glaucoma surgery before the study period

Keywords: glaucoma elevated iop selective laser trabeculoplasty slt open angle glaucoma ocular hypertension glaucoma, open angle, pseudo-exfoliative pigment dispersion syndrome pseudoexfoliation iop ≥ 21 mmhg
study combining bortezomib with high dose melphalan to treat multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to determine the tolerance and potential efficacy of combining dose intense melphalan with escalating doses of bortezomib in patients with multiple myeloma undergoing autologous stem cell transplantation.

multiple myeloma is the second most common hematological malignancy that has affected approximately 40,000 americans.conventional chemotherapy has achieved limited control of this disease but studies have reported improved response rates for patients who are treated with dose-intense therapy and autologous hematopoietic stem cell transplantation. this phase i/ii study will investigate the potential of combination therapy of dose-intense melphalan with escalating doses of bortezomib.

Eligibility criteria:
inclusion criteria: 1. a confirmed diagnosis of multiple myeloma 2. show progression of disease after a previous cycle of dose-intense melphalan, or less than 25% decrease in paraprotein measured at 8 weeks after a prior cycle of dose-intense melphalan * may have received intervening therapies for disease progression after dose-intense melphalan and enrollment in this protocol 3. age:18yrs-76yrs at time of melphalan administration 4. gender: there is no gender restriction 5. availability of \>2x10\^6 autologous peripheral blood cd34+ cells/kg or a syngeneic donor meeting eligibility criteria for syngeneic donation * syngeneic transplantation is preferred * for patients enrolled in the phase i part of this study, \>1x10\^6 autologous or syngeneic peripheral blood cd34+ cells/kg remaining in storage as "backup" in case of engraftment failure 6. recovery from complications of salvage therapy, if administered - exclusion criteria: 1. diagnosis other than multiple myeloma 2. chemotherapy or radiotherapy within 28 days of initiating treatment in this study 3. prior dose-intense therapy within 56 days of initiating treatment in this study 4. uncontrolled bacterial,viral,fungal or parasitic infections 5. uncontrolled cns metastases 6. known amyloid deposition in heart 7. organ dysfunction * lvef\<40% or cardiac failure not responsive to therapy * fvc,fev1,or dlco\<50% of predicted and/or receiving supplementary continuous oxygen * evidence of hepatic synthetic dysfunction, or total bilirubin\>2x or ast\>3x uln * measured creatinine clearance \<20ml/min * sensory peripheral neuropathy grade 4 8. karnofsky score\<70% unless a result of bone disease directly caused by myeloma 9. life expectancy limited by another co-morbid illness 10. history of another malignancy in remission \<2yrs (other than basal cell carcinoma) 11. pregnant (women)or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment 12. documented hypersensitivity to melphalan or bortezomib or any components of the formulation 13. patients unable or unwilling to provide consent
trabeculectomy versus 2-istent and prostaglandin study

Conditions: Glaucoma, Open-Angle

Summary: investigators hypothesize that the synergistic action of istent in increasing aqueous outflow through the trabecular meshwork and use of prostaglandin analog such as travoprost or latanoprost to increase uveoscleral outflow will achieve good intra-ocular pressure (iop) control with minimal complications in primary open angle glaucoma (poag) patients with suboptimal iop on 2 or more medications compared to mitomycin c (mmc) augmented trabeculectomy.

this will be a prospective randomized controlled study. 20 phakic or pseudophakic open angle glaucoma patients with an iop in the range of 18-30 mmhg on 2 or more topical glaucoma medications will be randomly selected to undergo either (1) mitomycin-augmented trabeculectomy or (2) placement of 2 istent devices and initiation of a daily prostaglandin analog. this study is looking at the combined effects of the 2 istents and a prostaglandin analog as a method to achieve low iop. at 3 months (+/- 2 weeks) postoperatively, the istent patients will be left only on the prostaglandin analog with a washout performed for any other hypotensive medication used. patients who had a trabeculectomy will be have a terminal washout of all iop-lowering medications at 3 months (+/- 2 weeks) post-surgery. the iop will then be measured for both groups at 4 months (+/- 3 weeks) postoperatively.

Eligibility criteria:
inclusion criteria: * patients who have mental capacity to give consent * age \>= 21 years * pseudophakic or phakic without visually significant cataract * open angle glaucoma * iop in the range of 18-30 mmhg with 2 or more topical medications * cup-disc ratio =\< 0.9 * best corrected visual acuity of 20/100 or better exclusion criteria: * inability to give consent * inability to tolerate or presence of allergy to prostaglandin analogs * patient preference for non-surgical treatment or preference for either of the recommended surgical modalities in the study * age \< 21 years * visually significant cataract that would benefit from cataract surgery, as determined by the treating surgeon in consultation with the patient * secondary glaucoma or angle closure glaucoma * aphakia * prior glaucoma incisional surgery (trabeculectomy, tube surgery, other microinvasive glaucoma surgery (migs) surgeries, deep sclerectomy) * prior laser trabeculoplasty \< 90 days prior to screening or absolute failure of prior laser trabeculoplasty.
diagnostic power of basal lh compared to peak lh after stimulus test in the diagnosis of central precocious puberty

Conditions: Central Precocious Puberty (CPP)

Summary: this is an observational, retrospective, single-center study focused on the diagnosis of central precocious puberty in female patients.

the study enrolls female patients undergoing gnrh testing for suspected diagnosis of central early puberty between january 2017 and december 2020 at the pediatrics unit of irccs azienda ospedaliero-universitaria di bologna policlinico di sant'orsola. the study design provides 2 cohorts of female patients on the basis of the lh peak value in gnrh test: patients with lh peak value \ 5u/l. the primary aim is to assess the diagnostic power of basal lh comparing with the lh peak value after stimulus test with gnrh in female patients with suspected precocious puberty. the secondary aim is to assess the association of the following variables between the two cohorts: uterine volume, longitudinal uterine diameter, presence of endometrial rhyme, ratio of peak lh/fsh values and dose per kg of gnrh administered during stimulus test.

Eligibility criteria:
inclusion criteria: * female patients with onset of signs of early pubertal development (onset of telarche) before the age of 8 years, who referred to the pediatrics unit of irccs azienda ospedaliero-universitaria di bologna policlinico di sant'orsola between january 2017 and december 2020; * female patients undergoing gnrh testing for suspected diagnosis of central early puberty between january 2017 and december 2020; * obtaining informed consent from parents/legal guardian of pediatric patients. exclusion criteria: • patients with peripheral precocious puberty.

Keywords: central precocious puberty