Kornimate/medical-research-clean huggingface dataset:
safety and effectiveness of three anti-hiv drugs combined in one pill (trizivir)

Conditions: HIV Infections

Summary: the purpose of this study is to look at the safety and effectiveness of a pill called trizivir that is a combination of three anti-hiv drugs (zidovudine, lamivudine, and abacavir). zidovudine and lamivudine are often given combined in one pill (combivir). in this study, trizivir will be compared to combivir plus abacavir.

patients are randomized to receive either the triple combination tablet (trizivir) or to receive combivir plus abacavir as a separate tablet. patients take their study medications for 24 weeks.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are at least 18 years old. * are hiv-positive. * are currently receiving one of the following anti-hiv drug combinations: combivir plus abacavir, combivir plus abacavir plus a protease inhibitor, or combivir plus abacavir plus a non-nucleoside reverse transcriptase inhibitor (nnrti). patients must have been taking this drug combination for at least the past 16 weeks. this also must be the first anti-hiv drug combination the patient has received. * have a viral load (level of hiv in the blood) less than or equal to 400 copies/ml. * have cd4+ cell count greater than 200 cells/mm3. * agree to use effective methods of birth control. exclusion criteria patients will not be eligible for this study if they: * have been diagnosed with aids. * have a gastrointestinal disorder that makes it difficult for patients to absorb food or to take medications by mouth. * have hepatitis. * have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease. * are allergic to any of the study drugs. * abuse alcohol or drugs. * will not be available for the entire 24-week study period. * are pregnant or breast-feeding. * have taken or will need to take certain medications, including radiation therapy, chemotherapy, drugs that affect the immune system (such as interleukin), an hiv vaccine, foscarnet, and hydroxyurea. * are enrolled in another experimental drug study.

Keywords: drug therapy, combination zidovudine drug administration schedule lamivudine rna, viral reverse transcriptase inhibitors anti-hiv agents viral load combivir abacavir
peripartum cesarean hysterectomy for placenta percreta

Conditions: Placenta Accreta

Summary: the aim of this study is to address the possible preoperative determinants of extrauterine diseases in cases of placenta previa percreta and to compare the operative and postoperative characteristics of cases with and without extrauterine disease.

this will be a retrospective study of the data of women who underwent cesarean hysterectomy on placenta previa percreta who were classified as federation of gynecology and obstetrics (figo) grade 3. women without extrauterine disease (figo grade 3a) will be compared to women with extrauterine disease (figo grades 3b and 3c)

Eligibility criteria:
inclusion criteria: * women who underwent cesarean hysterectomy on placenta previa percreta (figo grade 3). exclusion criteria: * medical conditions complicating pregnancy. * blood diseases or bleeding tendencies

Keywords: pas placenta previa placenta accreta cesarean hysterectomy
advancing niacin by inhibiting flushing (anti-flush)

Conditions: Flushing

Summary: niacin, or vitamin b3, is known to improve cholesterol disorders and is the most effective drug to raise hdl, or the "good cholesterol". the use of niacin has been limited because of a peculiar adverse effect referred to as "flushing', which consists of redness, warmth, tingling and burning. a recent animal study suggests that flavonoids may prevent flushing due to niacin better than drugs like aspirin. the anti-flush study is being done to assess whether a presently available dietary supplement known as quercetin, which is a flavonoid, can reduce the flushing that occurs with niacin. we will also assess whether using quercetin to prevent flushing from niacin, can improve how niacin lowers cholesterol.

this study involves people between 21 and 75 years. it will be conducted over a period of 8 weeks, with 4 visits, each separated by 2 weeks. the duration of each visit is 9-10 hours. we will test a different dose of quercetin in each visit.

Eligibility criteria:
inclusion criteria: 1. men and women from the age of 21 to 75, inclusive - 16 subjects, 8 men, 8 women. 2. ability to understand and agree to informed consent. 3. are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures. exclusion criteria: 1. contra-indications or known intolerance to the study medications. 2. history of congestive heart failure, carcinoid, rosacea, renal failure (gfr\<60 ml/min/m2). 3. active liver disease. 4. active diabetes (defined as any history of type 1 diabetes, or history of type 2 diabetes plus one or more of the following: fasting glucose\>= 126mg/dl at screening or use of anti-diabetic medications within 12 months, or glucose\>200mg/dl 2 hours after a 75 g oral glucose challenge within 12 months. 5. history of major surgery within the past 6 weeks, or anticipated major surgery during the course of the study, or any history of organ transplant. 6. history of drug abuse within the past 3 years, or regular alcohol use of greater than 14 drinks per week. 7. women who are pregnant, plan to conceive or lactate. 8. peri-menopausal women or women currently experiencing flushing. 9. currently taking vasoactive medications, anti-hypertensives, anti-histamines, selective serotonin re-uptake inhibitors (ssris), nsaids, oral steroids, leukotriene inhibitors, supplemental quercetin and \> 50mg niacin.

Keywords: skin pharmacology metabolism lipid
application of the web-based acceptance and commitment therapy for depression

Conditions: Major Depressive Disorder

Summary: prospective intervention study; efficacy of web-based acceptance and commitment therapy

acceptance commitment therapy (act) is known to help people recover from depression by improving psychological flexibility through acceptance, defusion, self-as-context, present moment, committed action, and helping them live a values-based life. this study is a randomized controlled trial to determine if web-based act leads to changes in the psychological flexibility and cognitive fusion. also, through the functional mri study, possible treatment mechanisms by which the web-based act exerts will be identified.

Eligibility criteria:
inclusion criteria: * patients who diagnosed major depressive disorder exclusion criteria: * patients who have serious medical problems, metal implants in their bodies, severe brain injury or brain disease * women who were pregnant or nursing * patients at high risk for suicide
brady mx a quality improvement study

Conditions: Sinus Node Disfunction

Summary: medtronic is sponsoring a quality improvement study called brady mx. it is hypothesized that lack of awareness of treatment and diagnostics pathways result in lower number of referrals to implanters of ipg.


Eligibility criteria:
inclusion criteria: * patient at least 18 years of age * patient´s heart rate meets at least one of the following: patient has a sinus rate ≤ 50 or a junctional escape rhythm no faster than 50 patient has a history of exercise intolerance * patient complains of general fatigue, shortness of breath, shortness of breath with exertion, syncope, light headed dizziness, palpitations, lethargy, dyspnea or malaise within the last 30 days that are not related to other discovered causes (such as untreated hypothyroidism or anemia) * patient (or patient´s legally authorized representative) is willing and able to sign and date written patient consent form/data release form exclusion criteria: * patient has recent history of blood loss * patient has a medical history leading to suspicion of neurological disorder * patient has a history of chronic atrial fibrilation * patient is enrolled or planing to participate in a concurrent drug and/or device study at any time during the course of this clinical study without documented pre-approval from medtronic study manager * patient is not expected to survive 12 months * patient is anticipated to be unwilling or unable to comply with the clinical investigation plan
cesarean scar characteristics after scheduled and emergency cesarean deliveries

Conditions: Cesarean Scar Niche; Cesarean Wound; Dehiscence; Cesarean Section; Dehiscence

Summary: this study was designed to evaluate the scar characteristics following scheduled and emergency cesarean deliveries.

design and settings: this study is a descriptive, cross-sectional and multicenter study conducted at tanta and benha universities, egypt in the period from august, 1, 2018 to december, 31, 2018. patients: eligibility: nine hundred patients were selected carefully according to inclusion and exclusion criteria. the inclusion criteria were: (i) primipara having prior cesarean delivery whether scheduled or emergency (ii) term delivery ≥ 37 weeks of gestation (iii) multipara having the last delivery by cesarean either scheduled or emergency (iv) the interval following cesarean delivery to be 6 months at least and (v) double-layer repair of uterus and (vi) cesarean by pfannensteil incisions. the exclusion criteria were: (i) repeat cesarean sections (ii) preterm delivery (iii) associated placental abnormalities (iv) single-layer repair of uterus and (v) refusal to participate. allocations: this study is not a clinical trial so allocation is made based on characteristics of patients and eligibility to be allocated in either scheduled cesarean group or emergency cesarean group. the allocation was not equal based on the percentage of patients in either group. the scheduled cesarean group included 580 cases while the emergency cesarean group included 320 cases from both universities. intervention: cesarean scar assessment included both uterine scar and cutaneous scar. the uterine scar was assessed by transvaginal 3d ultrasound. the used device in both universities was dc-30 device of mindray company. all ultrasound examinations were conducted by third author in this study. cutaneous scar was assessed by surgery department represented by the fourth author in this study. the uterine scar in both groups was examined for distance from internal os, length, thickness, volume, vasculature and presence of any defects. cutaneous scar was examined for distance from symphysis pubis, length, shape, any depressed areas, any defects (hernia orifice), sinus and presence of keloid or hypertrophic scar.

Eligibility criteria:
inclusion criteria: * primipara delivered by cs * multipara with last delivery by cs * full term delivery \>37 weeks * double layer cesarean repair * pfannenstiel incison exclusion criteria: * repeat cs * any placental abnormalities * preterm delivery * single layer cesarean repair * refusal to participate
a study of mk0663 and an approved drug in the treatment of osteoarthritis (0663-077)(completed)

Conditions: Osteoarthritis

Summary: the purpose of this study is to compare the safety and effectiveness of an investigational drug and an approved drug in the treatment of osteoarthritis of the knee and hip.

the duration of treatment is 26 weeks.

Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee or hip which requires treatment with medication for pain relief exclusion criteria: * any known allergies to the study drugs

Keywords: arcoxia
percutaneous nephrolithotomy in patients with stage 2-4 chronic kidney disease

Conditions: Percutaneous Nephrolithotomy

Summary: the study aims to evaluate the effect of percutaneous nephrolithotomy (pcnl) on estimated glomerular filtration rate (egfr) in patients with stage 2-4 chronic kidney disease

nephrolithiasis affects an estimated 5-10% of the general population, and this percentage continues to rise. it has a prevalence of 1.7% to 18% in patients with chronic kidney disease (ckd), and nephrolithiasis-related ckd contributed to 3.2% of the total patients who started maintenance dialysis therapy. the etiology of renal insufficiency in patients with nephrolithiasis is multifactorial and includes renal obstruction, recurrent urinary tract infections, frequent surgical interventions and coexisting medical disease. according to national kidney foundation, chronic kidney disease is classified into 5 stages as follows: stage 1: kidney damage with normal or elevated gfr \ 15 ml/min/1.7 m2 management of nephrolithiasis in patients with ckd is often difficult. options for preserving kidney function include watchful waiting, shockwave lithotripsy (swl), an endourologic approach (percutaneous nephrolithotomy or retrograde intra-renal surgery), laparoscopic surgery or conventional open surgery. percutaneous nephrolithotomy (pcnl) is considered as the gold standard intervention for large burden and complex renal stone disease and is associated with the highest stone free rates (sfrs). however, potentially significant complications include bleeding, sepsis, pleural and visceral injury. therefore, the optimal management plan needs to be tailored to individual patient. serum creatinine level has been used as a crude index of renal function in studies of patients with ckd, but it is not reliable. the glomerular filtration rate (gfr) should be used instead. gfr is the most accurate way to give health providers an estimate of functioning renal mass. estimating gfr with the use of prediction equations is cost effective. in this study, we will prospectively evaluate the effect of percutaneous nephrolithotomy on the estimated glomerular filtration rate in patients with stage 2-4 chronic kidney disease.

Eligibility criteria:
inclusion criteria: * adult patients with age group ≥ 18 years old with renal stones candidate for pcnl with pre-operative estimated gfr less than 90 ml/min/1.7 m2 and ≥ 15 ml/min/1.7 m2 exclusion criteria: * patients with chronic renal failure on regular dialysis. * patients with bleeding diathesis. * patients who are unfit for surgery. * pregnancy * patients who are refusing the participation in our study.
investigation of the hdac4 copy number variation and its effect on gene and protein expression in patients with asd

Conditions: Autism Spectrum Disorder

Summary: specific aims of this study: 1. to understand the distribution of hdac4 cnv in the families of the asd patients with hdac4 cnv; 2. to perform the analysis of gene expression; 3. to investigate the hdac4 protein level expression; 4. to investigate the correlation of clinical/cognitive features with hdac4 cnv, rna and protein expression in asd patients, and compare with their unaffected family members.

autism spectrum disorder (asd) is a common neurodevelopmental disorder affecting up to 1/50 in the world and 1% in taiwan. asd is a clinically and genetically heterogeneous complex disorder with high heritability. due to its high prevalence, lifetime impairment and no effective prevention and treatment, asd has been prioritized for molecular genetic study. among the genetic findings based on our copy number variation (cnv) analysis of 335 patients with asd, hdac4 gene is selected to help us understand the pathogenesis of asd by investigating parent-of-origin and the gene and protein expression of this gene, alongside neurocognitive and behavioral phenotypes. based on our findings on hdac4 cnv analysis, the patients with hdac4 cnvs (\~30 patients) and their families will be invited to participate the investigation of the cnv, rna and protein expression analysis. five healthy controls without any diagnosis of psychiatric disorders will be recruited to perform the comparison with asd patients with hdsc4. the autistic symptoms and behavioral phenotypes assessed by the chinese scq and srs, and the cognitive function assessed by intelligence test and wcst will be used to reveal the associations among the cnvs, rna expression, protein level and clinical/cognitive phenotypes. according to our previous cnv findings at the hdac4 locus, we expect to find cnv in hdac4 variation in another independent sample of our asd cohort and to explore how hdac4 cnvs affect the rna and protein expression of hdac4. we anticipate our endeavors will provide the comprehensive profiles of the cnv, rna and protein expressions and the clinical features of asd patients with hdac4 cnvs and contribute to our understanding of the pathogenesis of asd.

Eligibility criteria:
inclusion criteria: * asd group: subjects who met the diagnostic criteria of either autistic disorder or asperger's disorder defined by the dsm-iv criteria. exclusion criteria: * td group: subjects with any current or lifetime dsm-iv psychiatric disorders.
controlled hypotension during functional endoscopic sinus surgery

Conditions: Hemorrhage

Summary: it is very important to decrease the bleeding during functional endoscopic sinus surgery (fess) in order to increase the visibility of the surgical site. our primary goal was to investigate the effects of magnesium sulfate and dexmedetomidine used for controlled hypotension on visibility of surgical site.

background: it is very important to decrease the bleeding during functional endoscopic sinus surgery (fess) in order to increase the visibility of the surgical site. our primary goal was to investigate the effects of magnesium sulfate and dexmedetomidine used for controlled hypotension on visibility of surgical site. methods: sixty patients aged between 18-65 years were enrolled. patients were divided into two groups. in the magnesium sulfate group (group m) patients were administered 40 kg-1 magnesium sulfate in 100 ml saline solution in 10 minutes as iv loading dose 10 minutes before the induction and 10-15 mgkg-1hour-1 infusion during the surgery. in the dexmedetomidine group (group d) patients were administered 1 µgkg-1 dexmedetomidine in 100 ml saline solution as loading dose 10 minutes before the surgery and 0.5-1 µgkg-1hour-1 dexmedetomidine during the surgery. deliberate hypotension was defined as a mean arterial pressure (map) being 60-70 mmhg.

Eligibility criteria:
inclusion criteria: 18 and 65 years scheduled for functional endoscopic sinus surgery exclusion criteria: * patients with kidney, liver, hematological and neuromuscular diseases, diabetic neuropathy, any known allergy history to studied agents. * weight exceeding the ideal body weight more than 30%, * being treated with calcium channel blockers, non-steroidal anti-inflammatory drugs, agents affecting neuromuscular blockage,and agents contraindicated for controlled hypotension

Keywords: controlled hypotension, dexmedetomidine, magnesium sulfate.
boron neutron capture therapy in treating patients with stage iii melanoma

Conditions: Melanoma (Skin)

Summary: rationale: boron neutron capture therapy may selectively kill tumor cells without harming normal tissue. purpose: phase i trial to study the effectiveness of boron neuron capture therapy in treating patients with stage iii melanoma.

objectives: i. estimate the maximum tolerated dose of neutron irradiation that can be given in combination with borophenylalanine-fructose complex (bpa-f) in patients with stage iii melanoma. ii. evaluate the safety of this regimen. iii. evaluate tumor response to this regimen. outline: this is a dose-finding study. patients receive a test dose of borophenylalanine-fructose complex (bpa-f) for biodistribution studies and undergo punch biopses of tumor and normal tissue to measure b-10 concentration. later, a treatment dose of bpa-f over 1 hour is followed by neutron irradiation. groups of 3 patients receive escalated doses of neutron irradiation until the maximum tolerated dose is determined. patients who complete protocol treatment and continue to meet the eligibility criteria may re-enter the study, provided at least 6 months has elapsed since the completion of prior therapy and the field boundary for the new irradiation site is seperated from the boundary of the previously irradiated site. patients are followed monthly for 12 months, then every 3-6 months as needed. projected accrual: approximately 15 patients will be entered.

Eligibility criteria:
disease characteristics: biopsy-proven melanoma that is clinical stage iii estimated clinical tumor depth 1.0-6.0 cm from the epidermis tumor surface diameter no greater than 10 cm grossly evident cutaneous or subcutaneous tumor nodules are eligible for irradiation patient characteristics: age: 18 and over performance status: karnofsky 70%-100% life expectancy: more than 3 months hematopoietic: not specified hepatic: not specified renal: not specified other: no history of phenylketonuria negative serum pregnancy test required of fertile women adequate contraception required of fertile women during and for 6 months after the study prior concurrent therapy: no prior radiotherapy to the target area

Keywords: stage iii melanoma recurrent melanoma
oral oxycodone after major cardiac surgery

Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery

Summary: postoperative pain and analgesic treatment still remains a challenge in daily perioperative medicine. skin incisions, intraoperative tissue retraction and -dissection, intravasal cannulations and drainages, sternotomy and pericardiotomy are the most important reasons for postoperative pain. poorly controlled pain can contribute directly or indirectly to postoperative complications, such as myocardial ischemia, pulmonary dysfunction like hypoventilation, pneumonia and atelectasis, a delayed return of gastrointestinal function and decreased mobility. in addition, prolonged acute pain also results in chronic pain. opioids are internationally recognized as the golden standard in the treatment of acute postoperative pain. on one side, the high potency of opioids in pain relief is clearly undisputed, but on the other hand, the administration of opioids is associated with nausea, vomiting, sedation and with the development of bowel dysfunction, which encompasses symptoms including bloating, abdominal spasm, cramps and constipation. opioid-induced constipation is a frequently reported adverse effect and sometimes requires discontinuation of therapy, which results in analgesic under-treatment, severely impairing quality of life. however, there are many different regimes for the treatment of postoperative pain using opioids. patient-controlled analgesia (pca) using morphine is widely used, but requires trained staff and expensive equipment. once patients are able to tolerate oral medications, the oral route is preferred postoperatively because it is more convenient, noninvasive and less expensive.


Eligibility criteria:
inclusion criteria: * age from 18 to 90 years * asa physical status 1-3 * elective major cardiac surgery requiring sternotomy * oral and written consent * postoperative extubation within four hours after arrival at the icu * cognitive ability in the use of the pca pump and the vas exclusion criteria: * chronic use of opioids in the last three months * chronic use of tranquilizer or pain medications * hypersensitivity against opioids * use of monoamine oxidase inhibitors in the last two weeks before surgery * alcohol or drug abuse * renal dysfunction (gfr \< 30 or necessity of dialysis) * liver dysfunction defined as child-pugh-score 7-15 * ejection fraction (ef\< 40%) * malabsorption syndrome * neurologic or cognitive dysfunction * pregnancy * participation in another clinical trial * severe respiratory depression with hypoxia and/or hypercapnia * severe chronic obstructive pulmonary disease * severe bronchial asthma * non-opioid induced paralytic ileus * risk of seizures