Kornimate/medical-research-clean huggingface dataset:
radiographic and histological evaluation of regenerated bone after grafting using allograft shell and autogenous chips

Conditions: Alveolar Bone Resorption

Summary: the clinical cases in the present study described the khoury shell technique using an allograft plate and autogenous chips, for horizontal reconstruction of the anterior alveolar ridge in the esthetic zone. without need to use autogenous bone graft techniques that are characterized by more aggressive surgery.


Eligibility criteria:
inclusion criteria: * patients with class iv of cawood and howell classification in the anterior maxilla. * males and females 18-50 years of age. * patients with adequate oral hygiene. * patients with healed sites for at least 6 months after tooth extraction. * patients with an inter-arch distance of at least 6 mm. * compliance with all requirements in the study and signing the informed consent. exclusion criteria: * patients with diseases of the immune system or systemic disease affecting bone healing * patients who are chronic users of medications known to affect the periodontal status. * patients with history of intravenous and/or oral bisphosphonate use. * pathologic lesions or acute infection in the area of defect. * patients who are pregnant or lactating mothers. * heavy smokers who smoke more than 10 cigarettes a day. * patients with poor oral hygiene that are not amenable to motivation and improvement. * patients with history of irradiation of the head and neck region. * vulnerable patients.

Keywords: allograft autogenous chips horizontal augmentation khoury shell technique
to study the effect of sc-fos prebiotics in women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to determine if there is a difference in the clinical characteristics of patients with polycystic ovary syndrome after the administration of sc-fos in the enteral diet compared to patients with a standard diet.

the protocol will be discussed with the patients and/or relatives of the patients, who will understand the consequences and advantages of the study and will thus sign the consent. once informed consent has been obtained, the group to which each patient belongs will be randomly assigned. patients will be selected according to the inclusion and exclusion criteria of the population diagnosed with pcos with useful enteral route for random assignment into two groups, one will be administered short-chain fructooligosaccharides at a dose of 12 g every 24 hours, another group will be given saline as a placebo to the enteral diet every 24 hours for 10 days. patients should take the solution on an empty stomach. once the type of intervention has been determined, the patient will be given the suspensions corresponding to group 1 or placebo, with vials in which the content cannot be visualized, numbered according to the sheet obtained by the corresponding randomization. the initial evaluation will be completed with all the clinical characteristics to be evaluated. the patient will be told that every 24 hours he must take 1 suspension on an empty stomach, which will be prepared at a rate of 12 grams of sc-fos in 15 cc of saline solution for the prebiotic preparation vs 15 cc of saline solution for the placebo group. the solution will be administered enterally for 10 consecutive days at a single dose per day, and a reassessment will be made on the seventh day of the clinical characteristics of the patients, to compare and evaluate the results.

Eligibility criteria:
inclusion criteria: * female sex * age 18 to 65 years * polycystic ovary syndrome diagnosed by specialist * useful enteral feeding exclusion criteria: * pregnancy * diabetes mellitus * risk of intestinal perforation

Keywords: polycystic ovary syndrome prebiotics enteral diet clinical manifestations sc-fos
determining disease activity biomarkers in individuals with giant cell arteritis

Conditions: Temporal Arteritis

Summary: giant cell arteritis (gca), also known as temporal arteritis, is a disease that usually only occurs in older adults. gca causes inflammation of blood vessels, or vasculitis. in order to properly treat this disease, it is critical that the level of disease activity can be determined over the course of the disease. the purpose of this study is to determine new biological markers, or biomarkers, that may be used to assess the severity of disease in people with gca.

gca is a rare autoimmune disorder and is the most common type of inflammation of medium- to large-sized blood vessels in the body. it usually only occurs in older adults. the most common symptoms of gca include headache, pain in the shoulders and hips (polymyalgia rheumatica), pain in the jaw (jaw claudication), fever, and blurred vision. organ-specific markers of injury or damage as well as direct markers of vascular damage and inflammation are currently used by clinicians to assess gca disease progression; however, these markers are not very useful in guiding treatment. there are also blood tests that clinicians use to monitor gca activity, such as erythrocyte sedimentation rate (esr) and c-reactive protein (crp), but these tests lack specificity and sensitivity. most treatments available now for gca are toxic, therefore if other markers indicating disease activity can be found, it may lead to the development of less toxic treatments. this study will use new scientific methods to identify new biomarkers that can be used to monitor disease activity in gca patients. these biomarkers may be used to help direct clinical care for gca patients and assist in future drug development. study visits will occur monthly for the first year, then every 3 months thereafter for the remainder of the study. blood and urine collection will occur at every visit. a physical exam and medical and medication history will occur every 3 months; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use. participants may have additional study visits if a disease flare or disease-related complications occur during the study.

Eligibility criteria:
inclusion criteria: * diagnosis of gca, meeting at least 3 of the following 5 american college of rheumatology (acr) criteria for the diagnosis of gca: 1. at least 50 years of age at disease onset 2. new onset or new type of localized pain in the head 3. temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation unrelated to arteriosclerosis of cervical arteries) 4. esr of greater than 40 mm in the first hour by the westergren method 5. temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells exclusion criteria: * unable to give informed consent and sign the consent form

Keywords: giant cell arteritis
study to assess safety, pharmacokinetics, and efficacy of oral cc-223 for patients with advanced solid tumors, non-hodgkin lymphoma or multiple myeloma

Conditions: Multiple Myeloma; Diffuse Large B-Cell Lymphoma; Glioblastoma Multiforme; Hepatocellular Carcinoma; Non-Small Cell Lung Cancer; Neuroendocrine Tumors of Non-Pancreatic Origin; Hormone Receptor-Positive Breast Cancer

Summary: the main purpose of this first human study with cc-223 is to assess the safety and action of a new class of experimental drug (dual mtor inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor type for later-stage clinical trials.

initially, patients will be treated with oral cc-223 for one month. during this time, various tests (involving blood and urine collections, ecgs, etc) will be performed. those whose tumors stabilize or regress may continue receiving treatment for as long as they benefit from cc-223. different dose levels of cc-223 will be tested in a dose-rising study design.

Eligibility criteria:
inclusion criteria: * histologically-confirmed advanced solid tumor, non-hodgkin lymphoma or multiple myeloma * patients have not tolerated or progressed on standard therapy, and no further standard therapy is available * archival and screening tumor biopsy * eastern cooperative oncology group (ecog) performance status 0-1 (solid tumors), 0-2 (hematologic malignancy) * adequate organ function exclusion criteria: * prior systemic cancer-directed treatments or investigational drugs within 4 weeks or 5 half lives, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy. subjects must have recovered from any effects of recent radiotherapy that might confound the safety evaluation of study drug * symptomatic brain metastases (prior rx and stable metastases are ok) * acute or chronic liver or renal disease or pancreatitis * diarrhea ≥ grade 2, impaired gi absorption * impaired cardiac function * diabetes requiring rx, glucose \>126 mg/dl, hba1c ≥6.5% * peripheral neuropathy ≥ grade 2 * pulmonary fibrosis * known hiv infection * known chronic hepatitis b or c virus (hbv/hcv) infection, unless comorbidity in subjects with hcc * pregnant, inadequate contraception * most concurrent second malignancies

Keywords: advanced solid malignant neoplasms,non-hodgkin lymphoma, multiple myeloma
phase iii randomized study of diazepam vs lorazepam vs placebo for prehospital treatment of status epilepticus

Conditions: Status Epilepticus

Summary: objectives: i. compare the efficacy, onset of clinical anticonvulsant activity, and complications of diazepam and lorazepam given intravenously as prehospital therapy to patients in status epilepticus. ii. determine the effect of prehospital therapy on the incidence of status epilepticus at the subsequent emergency department admission. iii. establish whether prehospital therapy alters hospital management of these patients and ultimately affects patient outcome.

protocol outline: this is a randomized, double blind, multicenter study. patients are stratified by center. patients en route to the hospital in a san francisco department of health paramedic division ambulance are randomly assigned to 1 of 3 treatment groups. informed consent is waived due to impaired consciousness. patients receive intravenous diazepam, lorazepam, or placebo during transport. the patient is re-treated if the seizure is sustained after the first dose or recurs after the first dose without the patient regaining consciousness. upon arrival at the hospital, all patients receive the standard status epilepticus treatment in use at that site.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- status epilepticus with at least 5 minutes of sustained seizure activity with a depressed level of consciousness, or 2 or more discrete seizures without recovery or consciousness between seizures verified by bystander or observed by paramedic from san francisco department of health --prior/concurrent therapy-- no chronic benzodiazepines for seizure disorder --patient characteristics-- cardiovascular: systolic blood pressure at least 100 mm hg no second- or third- degree atrioventricular block no sustained ectopic tachyrhythmia pulse rate between 60 and 150 no severe myocardial insufficiency no hypovolemic, cardiogenic, or obstructive shock pulmonary: no history of asthma no history of chronic obstructive airway disease no history of limited pulmonary reserve other: no allergy or prior sensitivity to benzodiazepines no distributive shock (e.g., septic, neurogenic, or anaphylactic)

Keywords: epilepsy neurologic and psychiatric disorders rare disease seizures status epilepticus
a phase ii, single-arm trial of poziotinib as salvage treatment in patients with metastatic breast cancer who has her2 or egfr mutation or activated ar or egfr pathway

Conditions: Metastatic Breast Cancer

Summary: metastatic breast cancer (mbc) is an incurable disease and is needed to improve effective therapeutic strategies including targeted agents. poziotinib is a panher tyrosin kinase inhibitor (tki) that showed stable activity with feasible toxicity for mbc patients as a salvage treatment strategy after failure of anthracycline and taxane in phase i trial. poziotinib has rational benefit compared with other salvage agents, especially for patients with her2 overexpression breast cancers. additionally, a recent report showed that possible rational background for patients with her2 mutation-positive breast cancers. based on this rationale, the investigators are to conduct phase ii single-arm study of poziotinib for patients with mbc who showed refractoriness to conventional treatments as salvage treatment.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed metastatic breast cancer with measurable or evaluable disease 2. age ≥ 20 years 3. her2 mutation or egfr mutation/gene amplification confirmed by cancerscan or activated ar pathway confirmed by rna seq \& ncounter assay, ar expression was confirmed by immunohistochemistry(ihc) or egfr high expression (≥ ihc 2+ \& lower er / ≥ ihc score + and her2 2+ or sish negative) 4. ecog performance status 0 - 2 5. two or more regimens for locally recurrent or metastatic breast cancer, including an anthracycline and a taxane 6. life expectancy ≥ 3 months 7. progression within 6 months or less of latest chemotherapy 8. the patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. prior radiotherapy must be completed 2 weeks before study entry. 9. adequate bone marrow function (≥ anc 1,500/ul, ≥ platelet 100,000/ul, ≥ hemoglobin 9.0 g/dl) 10. adequate renal function (serum creatinine ≤ 1.5 x upper normal limit or ccr ≥ 50 ml/min) 11. adequate liver function (serum bilirubin ≤ 1.5 x upper normal limit, ast/alt ≤ 3 x upper normal limit) 12. no prior history of pan-her tki including poziotinib for metastatic breast cancer 13. written informed consent exclusion criteria: 1. her2-overexpressing breast cancer 2. serious uncontrolled intercurrent infections 3. serious intercurrent medical or psychiatric illness, including active cardiac disease 4. pregnancy or breast feeding 5. second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or resected thyroid papillary carcinoma or other malignancy treated at least 5 years previously with no evidence of recurrence) 6. documented leptomeningeal brain metastasis 7. known brain metastases unless treated and stable 8. peripheral neuropathy ≥ grade 3 9. prior treatment with pan-her tki including poziotinib will not be allowed. 10. use of any investigational drug within 4 weeks of the study 11. treatment with chemotherapy or hormone therapy within 3 weeks of the study
the pharmacokinetics and effectiveness of local levobupivacaine injection on primary total joint replacement model.

Conditions: Arthropathy

Summary: total joint replacement is an ideal procedure to treat end stage joint disease. good post-op pain relief could accelerate patient recovery and rehabilitation, and decrease admission days and medical cost. local injection of levobupivacaine is an effective method in post-operative pain control. the effectiveness of local analgesia was noticed clinically. however, thorough studies about the pharmacokinetics of levobupivacaine, maintenance of effect, influence of post-operative rehabilitation are not well studied in different way of injection. the purpose of this study is to evaluate and analyze the pharmacokinetics and effect of local levobupivacaine injection in different ways, the amount of post-operative fentanyl requirement after local injection, time to first fentanyl request, pain score, immediate post-operative function, side effect of analgesic agents, and medical cost, and to improve the quality of total joint replacement post-operative care.

single large dose of levobupivacaine had been proved good analgesic effect in total joint replacement surgery. however, the safety was not well studied. for better understanding the effect and safety of local analgesic agent, we choose levobupivacaine with different injection way to find out. we divide patient to three groups, for comparing the effectiveness of levobupivacaine, and safety of levobupivacaine by checking intra-blood concentration. the pre-emptive analgesics and post-operative analgesics were the same as routine protocol in other total joint replacement.

Eligibility criteria:
inclusion criteria: 1. primary total joint replacement, no previous open surgery on the same joint 2. age 50\~80 y/o, pre-operative diagnosis: degenerative osteoarthritis 3. pre-operative deformity: varus \<15°, valgus \<15°, flexion contracture \<15°. 4. patients with normal heart function 5. willing to receive post-operative questionnaire and outpatient clinic follow-up exclusion criteria: 1. allergy to patient-controlled analgesia or levobupivacaine 2. mental or cognitive illness that couldn't well response to questionnaire 3. american society anesthesiologist more than iii degree 4. liver cirrhosis, chronic renal insufficiency, heart disease or arrhythmia, insulin-dependent diabetes mellitus, and previous narcotic abuse history. 5. not suitable for using patient-controlled analgesia pump by evaluation of anesthesiologist

Keywords: local analgesia, pharmacokinetics, total joint replacement
safety, tolerability, pharmacokinetics, and pharmacodynamics study of pf-04427429 in healthy women volunteers

Conditions: Pain; Migraine Disorders

Summary: the purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of pf-04427429 in healthy women.


Eligibility criteria:
inclusion criteria: * generally healthy women, of non-child bearing potential, between the ages of 18 and 65 years, inclusive. healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg or clinical laboratory tests. * body mass index (bmi) of 17.5 to 35.0 kg/m2; and a total body weight between 50 kg (110 lbs) and 120 kg (265 lbs) inclusive. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, or neurologic, disease. subjects with asymptomatic, seasonal allergies at the time of dosing will not be excluded. * women of childbearing potential. * history or diagnosis of ocular disease or conditions that would confound the assessment of ocular safety, such as diabetic retinopathy, uveitis, severe wet or dry amd.

Keywords: phase 1 pf-04427429
improving glycemic control with electrical stimulation

Conditions: Obesity; Overweight; Insulin Resistance

Summary: once written consent is obtained, the participant will be provided with an accelerometer to be worn for 7 days to assess current physical activity levels. subjects will be provided with a standardized diet (55/15/30% cho/pro/fat) prior to collection of pre-intervention data of insulin sensitivity. individuals will then participate in an 8-week electrical stimulation intervention (30min/day, 3x/week) and randomized into placebo/control, nmes, resistance training combined with nmes (rt +nmes), or resistance training (rt) group (n=15 per group), followed by collection of post-intervention data. the control group will receive electrical stimulation up to sensory level, the nmes group will receive stimulation up to tolerable intensity to induce visible muscle contraction, the rt+ nmes will receive stimulation up to tolerable intensity during resistance training, and the rt group will only receive exercise training. pre-and post-intervention data includes measurements for body composition, resting metabolic rate, vo2max, insulin sensitivity, and comprehensive blood work.


Eligibility criteria:
inclusion criteria: * overweight/obese (bmi ≥25) * sedentary lifestyle: physical activity level\<1.4 * less than 150min/week of structured exercise exclusion criteria: * use of anti-hypertensive, lipid-lowering or insulin sensitizing medications * excessive alcohol, drug abuse, smoking * pregnant women * unwilling to adhere to the study intervention

Keywords: obesity
pilot study of health information technology for chronic kidney disease management

Conditions: Chronic Kidney Disease

Summary: researchers now know that treating chronic kidney disease (ckd) in its early stages can prevent dialysis and reduce heart problems that go along with kidney disease. computerized tools may help primary care doctors to diagnose the disease earlier and computer reminders may help doctors to prescribe the best treatments. in this project the investigators will test computer reminders in primary care clinics to see if they improve treatment of early chronic kidney disease and to see if it can promote referral to nephrology.

the investigators are conducting a randomized trial to determine the effect of a health information technology (hit) application to calculate risk progression of end stage renal disease (esrd). the primary outcome is the completion of the necessary tests for the risk prediction model (urine albumin to creatinine ratio, serum calcium, serum phosphate, serum albumin, and serum bicarbonate) for ckd patients in primary care. secondary outcomes will include nephrology referrals, doubling of serum creatinine, initiation of hemodialysis, and primary care provider (pcp) satisfaction. in the analysis, all patients over the age of 18 who have a visit with one of physicians involved in the trial during the intervention period will be eligible and patients with stage 3-5 ckd will be included. physicians are the subjects in this study, as the intervention is a behavioral intervention for physicians. the physicians' patients will not actively be recruited and will only indirectly be affected by the study. the application creates blocks of patient appointments for each physician and randomly assigns patients to intervention and control arms within these blocks.

Eligibility criteria:
inclusion criteria: * patients who are 18 years or older * patients of primary care providers who are included in the study * patients with ckd (defined as two estimated glomerular filtration rate (gfr) values under 60 ml/min per 1.73 m\^2 90 days apart) exclusion criteria: * patients without ckd (defined as two gfr values under 60 ml/min per 1.73 m\^2 90 days apart) * patients under the age of 18

Keywords: medical informatics quality of care referral