Kornimate/medical-research-clean huggingface dataset:
atazanavir/ritonavir, once daily + raltegravir, twice daily, switch study in hiv-1-infected patients

Conditions: HIV, Combination Therapy

Summary: the purpose of this study is to determine whether hiv-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.

allocation: randomized nonstratified intervention model: parallel versus comparator

Eligibility criteria:
key inclusion criteria * current treatment regimen of 2 nucleoside reverse transcriptase inhibitors (nrtis) plus any third agent for at least 3 months immediately prior to screening * virologic suppression (hiv-1 rna \<50 c/ml) for at least 3 months immediately prior to screening * virologic suppression (hiv-1 rna \<40 c/ml) using the abbott m2000rt® polymerase chain reaction assay during screening period * treatment-related safety and/or tolerability issues to a regimen consisting of 2 nrtis plus any third agent key exclusion criteria * history of switch in highly active antiretroviral therapy due to virologic failure * history of genotypic resistance to any component of the study regimen (atazanavir, raltegravir, tenofovir/emtricitabine) * history of exposure to atazanavir/ritonavir or raltegravir prior to entering the study * experiencing safety and/or tolerability issues to tenofovir/emtricitabine or raltegravir * switch of any component of hiv antiretroviral medication regimen in the last 3 months immediately prior to or during the screening period
efficacy of pulsed electromagnetic field therapy on neurogenic bladder in children with myelomeningocele

Conditions: Neurogenic Bladder

Summary: this study was conducted to assess the efficacy of pulsed electromagnetic field therapy on neurogenic bladder in children with myelomeningocele .intervention: a pretest-post test controlled study was conducted in out-patient clinic in faculty of physical therapy cairo university.

myelomeningocele is the most common cause of neurogenic bladder in children. bladder function in these children is affected by disordered innervation of detrusor muscle and external urethral sphincter that may lead to hydronephrosis. thirty myelomeningocele children with neurogenic bladder were enrolled in this study and were assessed for eligibility. their aged between 4 and 12 years. they were divided randomly into two groups. group (a) which is the control group received medical care and standard urotherapy only. and group (b) which is the study group received medical care and standard urotherapy in addition to pulsed electromagnetic field therapy for three successful months. all children were assisted using urodynamic studies before and after three months of intervention.

Eligibility criteria:
inclusion criteria: * their age was ranging from four to twelve years. * children participated in this study were from both sexes. * all children with stable medical and psychological status and had the same socioeconomic status. * they were able to follow the verbal commands or instructions. exclusion criteria: * children with visual or auditory problems. * children with any neurological manifestation rather than spina bifida. * medically unstable children especially with cardiovascular disorders, or mentally retarded children. * children with any sign of urinary tract infection, or any implanted metal. * uncooperative children.

Keywords: myelomeningocele pulsed electromagnetic field therapy
a multicenter, randomized, double-blind, parallel group study to determine the optimal dose of hl301 after 7 days oral administration in acute bronchitis or acute exacerbations of chronic bronchitis patients (hl301: mixed extract of rehmannia glutinosa, schisandra and so on)

Conditions: Acute Bronchitis; Acute Exacerbations of Chronic Bronchitis

Summary: the purpose of this study is to determine the optimal dose of hl301 in patients with acute bronchitis or acute exacerbations of chronic bronchitis. - bss(bronchitis severity score), bcss(breathlessness, cough, and sputum scale), evaluation of symptoms of cough and sputum


Eligibility criteria:
inclusion criteria: 1. both gender, 19 years ≤ age ≤ 80 years 2. acute bronchitis or acute exacerbations of chronic bronchitis patients with bss(bronchitis severity score)\* ≥ 5point at visit1 and visit2 3. written consent voluntarily to participate in this clinical trial exclusion criteria: 1. patients who were increased the bleeding tendency 2. patients with any of alanine aminotransferase, aspartate aminotransferase or serum blood urea nitrogen, creatinine\> 2 times of the normal upper range 3. patients who investigators determines to severe respiratory disease that would interfere with study assessment 4. patients with copd(chronic obstructive pulmonary disease) history of stage 3 or more 5. patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to study participation 6. patients who were treated with oral β2-agonist, anticholinergic, methylxanthine, antibiotics, antihistamines, sympathomimetic agent or oriental medicine/health functional food for antitussive and mucolytic effect within 1 weeks prior to study participation 7. patients who were treated with oral antitussive, mucolytic agents,systemic antimicrobial agent within 3 days prior to study medication dosing 8. patients with drug or alcohol abuse 9. patients with clinically significant active liver, renal, cardiovascular, respiratory, endocrine, central nervous system disease or history of malignant tumor or mental illness(except no relapse for 5 years after surgery) 10. the aged person with severe medical history which is mental disorder(dementia), cancer, chronic renal failure, chronic liver failure 11. pregnant or breast-feeding 12. patients currently participating in or has participated in other clinical study within 30 days prior to study participation 13. patients who investigators determines not appropriate to take part in this clinical study

Keywords: acute bronchitis acute exacerbations of chronic bronchitis
sutimlimab (bivv009) for the adult participants with cold agglutinin disease (cad) who have completed phase 3 studies (cardinal or cadenza) in japan

Conditions: Cold Agglutinin Disease

Summary: this was a multi-center, single treatment-group, open-label study to provide sutimlimab to the adult participants with cold agglutinin disease (cad) who had completed the cardinal (nct number: nct03347396) or cadenza (nct number: nct03347422) studies and benefitted from sutimlimab treatment in japan. • study and treatment duration: the period between the participant's completion of the cardinal and cadenza studies and sutimlimab or other appropriate cad therapy becoming commercially available to participants in japan.

the period between screening/baseline visit (upon the participant's completion\* of the cardinal and cadenza studies) and end of treatment with sutimlimab in this study was determined by sutimlimab or other appropriate cad therapy becoming commercially available to participants in japan.

Eligibility criteria:
inclusion criteria: --participant must be adults. * participants who had been enrolled in and had completed part b of cardinal or cadenza study. * participants who had ongoing diagnosis of cad. * participants who continued to require treatment for cad upon completion of participation in the previous study evidenced by return of cad-related symptoms of anemia and/or deterioration on markers of hemolysis after the end of study visit following the 9-week safety follow up period. (9-week follow up period). * participants who had acceptable benefit/risk profile. * participant who had acceptable infection risk. * participants who had no available appropriate alternative therapy for cad. * body weight \>= 39 kg. * gave signed informed consent. exclusion criteria: --clinical diagnosis of systemic lupus erythematosus or immune complex-mediated autoimmune disorders. * participants who met recent rituximab and/or immunosuppressive therapy. * any of the following medical conditions: 1. active, serious intercurrent illness which precluded enrolment until recovery was complete. 2. pregnancy or breast-feeding. * end of study visit in cardinal or cadenza took place more than 3 months before baseline visit in this study. * hypersensitivity reactions to sutimlimab or components thereof, or other allergy that, in the opinion of the investigator, contraindicated participation in the study.
ak112 or placebo plus nab-paclitaxel as first-line treatment in inoperable locally advanced/ metastatic triple-negative breast cancer

Conditions: Triple-Negative Breast Cancer (TNBC)

Summary: this multicenter, randomized, double-blind study aims to assess the safety and efficacy of ak112 in combination with nab-paclitaxel, compared to a placebo plus nab-paclitaxel, as a first-line treatment for inoperable locally advanced or metastatic triple-negative breast cancer (tnbc).


Eligibility criteria:
inclusion criteria: 1. voluntarily sign a written informed consent form. 2. age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible. 3. eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. life expectancy of ≥ 3 months. 5. histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for er, pr, and her-2. 6. subjects who have not received prior systemic treatment for advanced breast cancer are eligible for the study. 7. suitable for monotherapy with taxane-based agents. 8. at least one measurable lesion per response evaluation criteria in solid tumors (recist) v1.1. 9. adequate organ function. exclusion criteria: 1. patients with locally recurrent disease who are eligible for surgery or radiotherapy. 2. history of other malignancies within the past 5 years. 3. active autoimmune disease requiring systemic treatment within the past 2 years. 4. pregnant or breastfeeding women. 5. concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study. 6. participants with clinically symptomatic pleural effusion, pericardial effusion, or ascites that require repeated drainage. 7. participants with a history of immune deficiency; those who test positive for hiv antibodies; those currently using systemic corticosteroids or other immunosuppressive agents on a long-term basis. 8. individuals with known active tuberculosis (tb), or those suspected of having active tb (who must undergo clinical evaluation for exclusion), and those with known active syphilis infection.
a study of belinostat in combination with warfarin in patients with solid tumors or hematological malignancies

Conditions: Solid Tumor; Hematological Malignancy

Summary: the purpose of this study is to evaluate the plasma concentration and pharmacodynamics effects of warfarin 5 mg, in the presence or absence of belinostat 1,000 mg/m². pharmacokinetic evaluation of belinostat 1,000 mg/m² and metabolites in the presence of warfarin 5 mg.

this is an open-label, single center, pharmacokinetic and pharmacodynamic study in patients with solid tumor or hematological malignancies. upon providing informed consent and satisfying screening procedures, eligible subjects will report to the clinic for part i of the study 14 days before the first dose of belinostat (day -14) for clinical laboratory tests, warfarin (5mg) single dose and a series pk collections. on days 1-5 of each 21-day cycle patients will receive belinostat 1000mg/m\*2 and will have a series of subsequent pk samples collected. on day 3 of cycle 1 only, the patient will also receive warfarin 5mg single dose prior to belinostat infusion. pk samples, urine samples, electrocardiogram (ecg) and safety measurements will be collected from day 1 through day 10 of cycle one. if it is in the interest of the patient, belinostat can be continued during part ii- extension phase for 5 additional cycles of belinostat treatment on days 1-5 of each subsequent cycle, or until disease progression, patient withdraws consent or if unacceptable toxicity occurs. during the extension phase routine physical exams, laboratory tests and safety and efficacy assessments will be performed. disease evaluations will be conducted per standard of care. patients who discontinue for reasons other than disease progression will be followed until new anti-cancer treatment is initiated or death.

Eligibility criteria:
inclusion criteria: * informed consent * histological or cytological confirmed diagnosis of malignant disease * age ≥18 years old * adequate organ function * ecog 0-2 * estimated life expectancy \>3months * negative pregnancy test for women of child bearing potential exclusion criteria: * low dose anticoagulation therapy within 2 week prior to study treatment * anticancer therapy within 2 weeks prior to study treatment * investigational therapy within 4 weeks of study treatment * major surgery within 2 weeks of study treatment * coexisting active infection or other medical condition likely to interfere with trial procedures * significant cardiovascular disease (nyha class iii or iv) * baseline prolongation of qt/qtc * clinically significant cns disorder, altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completing trial procedures * symptomatic or untreated cns metastases * pregnant or breast feeding women * patients not willing to use effective contraception * known infection with hiv, hep b or hep c

Keywords: belionstat warfarin hematological malignancy solid tumors pk/pd study
characterization of metabolic and brain effects of rising glucagon during an oral glucose challenge

Conditions: Metabolic Syndrome; Diabetes

Summary: the investigators previously characterized a phenotype with non-suppressed glucagon at 120 minutes after standardized oral glucose load. this phenotype is associated with healthy metabolic traits such as lower bmi, higher insulin sensitivity and lower liver fat content. glucagon is a pleiotropic hormone that, besides its main action on increasing endogenous glucose production, also reduces appetite and increases basal energy expenditure. the aims of this study are to i. detect functional differences in the appetite-related central nervous system (cns) areas between the suppressed and non-suppressed glucagon phenotype ii. mimick the non-suppressed glucagon phenotype in those participants who suppress glucagon by administering a very-low-dose glucagon infusion and retest them.


Eligibility criteria:
inclusion criteria: * bmi 18.5- 29.9 kg/m2 * written informed consent exclusion criteria: * current 1. febrile infection with temperatures\> 38.5 ° c in the last 14 days 2. blood donation within the last 12 weeks pre-study inclusion * chronic diseases: 1. diabetes mellitus 2. known liver diseases (hepatitisb/c, hemochromatosis, nash) 3. chronic inflammatory diseases (rheumatoid arthritis, crohn's disease, ulcerative colitis) chronic renal insufficiency 4. cancer (known malignant disease) 5. psychiatric diagnoses (bipolar disorder, schizophrenia, psychoses, depression, agoraphobia) 6. persons with non-removable metal parts, e.g: * pacemaker * artificial heart valves * metal prostheses * implanted magnetic metal parts (screws, plates of operations) * spiral * metal slivers / garnet splinters * fixed braces * acupuncture needle * insulin pump * totally implantable venous access device (port) * tattoos, metallic eye shadows 7. persons with impaired sensitivity and / or increased sensitivity to heating of the body 8. medical history of venous thromboembolism 9. alcohol consumption of more than 50g / day 10. in physical examination: blood pressure \> 160/100 mmhg pathologic cardiac murmurs (diastolic or systolic louder than 2/6) 11. in the blood test: fasting glucose ≥ 125 mg/dl or hba1c ≥ 6.5% ast or alt\> 2.5x upper limit of the reference range (\> 125 u/l) hb \ 5 mg / dl or leukocytes\> 15000/μl
physiotherapist approach to shoulder's diseases, differences between fascial manipulation and standard exercises

Conditions: Shoulder Pain; Manual Therapy

Summary: the study purpose is to compare the effects of fascial manipulation added to standard exercises protocol versus the simple exercises protocol.

the shoulder degenerative diseases are recurring in hospital employees. the early approach, as we see in literature, has high probability to reduce the pain and the disfunction in the long term. in particular stretching and strengthening exercises are the standard protocol applied. the fascial manipulation is a manual therapy that works on the connective tissue, by increasing mobility and reducing pain. we have added the fascial manipulation to prove if it make a faster recovery and a pain reduction in the short and the middle term.

Eligibility criteria:
inclusion criteria: * shoulder pain and acute and relapse in six months * positive results in two orthopedic testes exclusion criteria: * degenerative diseases and neurological diseases * rheumatological diseases and cancer * fracture of the humerus, scapula and collarbone * documented injury of rotator cuff. * cortisones therapy in action
nc enhanced wisewoman project

Conditions: Cardiovascular Disease

Summary: the overall aim of the study was to test the feasibility and effectiveness of a cardiovascular disease risk reduction intervention program for midlife, low-income women. we enhanced an existing nutrition and physical activity intervention tool, a new leaf...choices for healthy living, which was designed specifically for this demographic group as part of the cdc's wisewoman program. the enhanced intervention was tested in a randomized controlled trial in a community health center setting.

we conducted a 2 year study to test the feasibility and effectiveness of a cvd risk reduction intervention program for older, under or uninsured women. we used an existing nutrition and physical activity (pa) intervention tool (new leaf...choices for healthy living) designed specifically for this demographic group as part of the wisewoman program (a cdc-funded cvd risk factor screening and intervention program for older, low-income women). we enhanced this already tested intervention to include: 1) the latest recommendations regarding dietary fat and carbohydrate intake, 2) group education sessions and follow-up telephone contacts from lay health advisors (lhas); and 3) a community resource linkage component delivered primarily by lhas. we tested the enhanced intervention in a randomized controlled trial in a community health center setting. a total of 240 women aged 40-64 were randomized to the enhanced new leaf intervention or minimum intervention groups. women in the enhanced new leaf group received a 6 month intensive intervention consisting of 2 individual counseling sessions at the chc, postcard mailings, 3 group sessions, and lay health advisor (lha) guided linkages to community resources for diet and pa. this was followed by a 6 month maintenance period led by the lha and including 6 phone contacts, and 3 tailored mailings along with continued community resource linkages. primary outcome measures at 6 and 12 months included 1) pa measured by csa accelerometer and 2) fruit, vegetable, and fat intake. secondary outcomes included biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids), cvd risk factors (total and hdl cholesterol, blood pressure), and psychosocial variables.

Eligibility criteria:
inclusion criteria: * women 40-64 years old * patient at participating site who is considered an appropriate candidate by the primary care clinician * ability and willingness to provide informed consent * availability for follow-up--plan to reside within 50 miles of study site for 1 year * home phone or easy access to phone exclusion criteria: * medical condition for which intervention may not be appropriate * pregnancy/lactation * severe chronic medical conditions such that interventions to improve diet and physical activity are not appropriate

Keywords: diet physical activity smoking cessation
comparison of two phacoemulsification-methods: easytip 2.2mm vs. infusion assisted easytip 2.2mm

Conditions: Cataracts

Summary: the aim of this study was to compare the intraoperative efficiency, safety and postoperative outcomes of cataract surgery with two different "high-fluidic" settings.


Eligibility criteria:
inclusion criteria: * bilateral age-related cataract * good overall physical constitution * locs 2-5 exclusion criteria: * previous intraocular surgery or ocular trauma * previous corneal pathology * previous endothelial cell count \<1200 * glaucoma * uveitis * pex * diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely * intraocular complication like posterior capsular * postoperative comlpications (e.g. postoperative uveitis)

Keywords: efficiency and safety
dilute versus concentrated epidural bupivacaine in labor

Conditions: Pain; Labor Complications

Summary: this study studies labor epidural analgesia and compares dilute (0.0625%) with concentrated (0.25%) bupivacaine. we hypothesize that patients randomize to receive the concentrated drug will require more drug, will have a more profound motor block, will be more likely to require instrumental delivery and will be less satisfied than those receiving dilute epidural drugs.

this study examines the effect of two different local anesthetic concentrations used for epidural analgesia in labor. patients are randomized to receive epidural bupivacaine, either as a concentrated (0.25%), or a dilute (0.0625%) solution, both administered by patient-controlled epidural analgesia (pcea).

Eligibility criteria:
inclusion criteria: * nulliparity, active spontaneous labor, cervical dilatation greater than 2cm and less than 5 cm, request for epidural analgesia, age between 18 to 40, american society of anesthesiologists (asa) physical status i or ii, body weight less than 110kg, gestational age greater than 36 completed weeks, singelton pregnancy and vertex presentation exclusion criteria: * narcotic administration in the previous 3 hours, non-reassuring fetal heart rate tracing at any stage in labor prior to enrollment, previous uterine surgery, pre-eclampsia and the inability to adequately understand the consent process.

Keywords: labor pain analgesia, obstetrical pharmacology treatment outcome
efficacy and safety of superior trunk block versus interscalene block for post-operative analgesia in shoulder surgeries

Conditions: Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries

Summary: efficacy and safety of superior trunk block versus interscalene block for post-operative analgesia in shoulder surgeries

the interscalene brachial plexus block is the gold standard analgesic technique for surgery involving the shoulder and upper arm. however, due to its complications as hemidiaphragmatic paralysis, the superior trunk block was developed in an attempt to reduce major complications.the utility of the superior trunk block has yet to be studied in shoulder surgeries.

Eligibility criteria:
inclusion criteria: * patients american society of anaesthesiologists physical status (asa) is i to ii. * both genders. * aged group from 21 to 50 years old. * patients electively scheduled for shoulder surgery under general anesthesia with normal coagulation profile. exclusion criteria: * refusal of the procedure or participation in the study. * any history or evidence of coagulopathy. * evidence of infection at injection site. * allergy to study drugs. * patients with pulmonary severe respiratory disease. * herniated cervical disc or cervical myelopathy. * pre-existing neuropathy of the operative limb

Keywords: superior trunk block interscalene block