Kornimate/medical-research-clean huggingface dataset:
evaluation of the efficacy and safety of fentanyl delivered by adhesive skin patch in out-patients with chronic cancer pain

Conditions: Pain

Summary: the purpose of this study is to determine the safety and efficacy of pain control by fentanyl, administered via adhesive skin patches, at doses of 25 to 100 micrograms per hour in 80 out-patients with intense chronic cancer pain. higher doses are allowed by permission of the investigator and rescue oral morphine medication is allowed.

patients with cancer pain are frequently under-medicated with morphine. this is a 56-day open-label study of the efficacy and safety of self-administered fentanyl skin patches for cancer pain control in patients in the home-care setting not previously using morphine. the first 15 days of the study are for dose stabilization and the rest of the study assesses pain control and quality of life at stable doses of medication. the dose is determined by the patient with oversight by the investigator, and rescue oral morphine medication can be used when necessary. the patient records all medication use in a diary and fills out questionnaires concerning pain control, intestinal function (constipation) and overall quality of life. the hypothesis is that patients will be able to control their cancer pain by self-administering transdermal fentanyl at home and that they will well tolerate the medication. individualized doses, with a target dose of 25 to 100 micrograms per hour of fentanyl for 56 days via skin patches applied every 3 days to deliver 25 to 100 micrograms of fentanyl per hour per patch; oral morphine as rescue medication for pain.

Eligibility criteria:
inclusion criteria: * less than a month of opioid treatment over the past 3 months * proven cancer and chronic stable, cancer-related pain * pain control medication (aside from opioids) at the maximum authorized dose in the 24-hours preceding the first study visit * a pain score of at least 4 on the vas scale and pain that justifies intervention by opium-derived drugs in the opinion of the investigator exclusion criteria: * liver or kidney problems * previous heart, lung or nervous disorders * allergy to fentanyl * skin condition that might interfere with absorption of the fentanyl through the skin * surgery or chemotherapy in the month preceding the study or scheduled during the 56 days of the study * history of substance abuse

Keywords: fentanyl analgesia pain cancer pain opioid analgesia transdermal fentanyl patient-controlled analgesia
hypar trial - hydrocortisone vs. pasireotide in reducing pancreatic surgery complications

Conditions: Pancreatic Fistula; Pancreatic Neoplasms

Summary: pancreatic resections carry a high risk for complications, especially pancreatic fistula. both hydrocortisone and pasireotide have been shown to be effective in reducing complications in earlier rcts. the aim of this study is to compare the effectiveness and safety of these two drugs in preventing complications of pancreatic surgery.


Eligibility criteria:
inclusion criteria: * patients scheduled for pancreatic surgery (pancreaticoduodenectomy, distal pancreatectomy, enucleation, or other type of pancreatic resection) exclusion criteria: * preoperative exclusion criteria: * atrophic pancreas and/or dilated pancreatic duct at the site of planned pancreatic transsection (applies only to patients undergoing pancreaticoduodenectomy) * total pancreatectomy planned * allergy or other contraindication for hydrocortisone or pasireotide * age \< 18 years * no informed consent * intraoperative exclusion criteria: * pancreatic resection cancelled (e.g. disseminated cancer) * hard pancreas and/or dilated pancreatic duct discovered during operation (applies only to patients undergoing pancreaticoduodenectomy) * total pancreatectomy is performed
reducing target volumes in npc treated with induction chemotherapy followed by concurrent chemoradiotherapy

Conditions: Nasopharyngeal Carcinoma; Induction Chemotherapy; Radiotherapy

Summary: to evaluate the long-term locoregional control, survival rate, late toxicity and quality of life after reducing the target volume in patients with locoregionally advanced nasopharyngeal carcinoma patients treated with induction chemotherapy plus concurrent chemoradiotherapy.

this phase 3, multicenter, non-inferiority, randomized controlled clinical trial recruits patients with newly-diagnosed locoregionally advanced nasopharyngeal carcinoma patients treated with induction chemotherapy plus concurrent chemoradiotherapy. the intervention is delineating the gross tumor volume according to pretreatment tumor extension (the pre-ic gtv group) or post-induction chemotherapy tumor extension (the post-ic gtv group). the objective is to compare the long-term locoregional control, survival rate, late toxicity and quality of life between the two groups.

Eligibility criteria:
inclusion criteria: * histologic confirmation of nonkeratinizing nasopharyngeal carcinoma; no previous treatment for cancer; nondistant metastatic, newly diagnosed stage iii to iva disease that was staged according to the american joint committee on cancer-union for international cancer control 8th edition stage-classification system; a karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability); planned to receive 3 cycles of induction chemotherapy (regimens included docetaxel and cisplatin; docetaxel, cisplatin, and fluorouracil; and gemcitabine and cisplatin); and adequate hematologic, renal, and hepatic function. exclusion criteria: * younger than 18 years or elder than 70 years; receipt of treatment with palliative intent; a history of cancer; receipt of previous treatment (radiotherapy, chemotherapy, or surgery \[except diagnostic procedures\]) to the nasopharynx or neck; lactation or pregnancy; or severe coexisting illness; had disease progress after ic
pulmonary vasculature and right heart dysfunction in chronic obstructive pulmonay disease

Conditions: COPD; Pulmonary Vascular Disorder; Right Ventricular Dysfunction

Summary: the pulmonary vasculopathy and right heart dysfunction in copd are drawing increasing attention these days. recent researches show that pulmonary vasculopathy and right heart dysfunction relate to greater severity in copd. applying appropriate modalities for early detection of pulmonary vasculopathy and right heart dysfunction is of great importance. what's more, the interaction mechanism between pulmonary vasculature, right heart and copd still needs to be further studied. the aim of our study is to develop an assessment system of pulmonary vasculopathy and right heart dysfunction in copd patients and elucidate their impact on copd course and outcome.


Eligibility criteria:
inclusion criteria: * stable copd patients exclusion criteria: * patents with other respiratory diseases and pulmonary hypertension other than group 3 ph; * psychopath, addict or patients not able to coordinate; * patients in pregnancy or breastfeeding; * patients with limited life expectancy; * patients with contraindiction for mri or pet; * patients having cerebrovascular events in 3 months; * unstable copd patients
a study for patients with complicated skin and skin structure infections

Conditions: Staphylococcal Skin Infections; Wounds and Injuries; Abscess; Cellulitis; Streptococcal Infections

Summary: two phase iii trials to demonstrate the efficacy and safety of oritavancin in the treatment of complicated skin and skin structure infections (csssi) have been completed. the pharmacokinetic profile of oritavancin in humans suggests that oritavancin has the potential to be used safely and effectively when given either as a single dose or as an infrequent dose for csssi. data from animals support this theory. simplifi has been designed to evaluate the efficacy and safety of either a single dose of oritavancin or an infrequent dose of oritavancin (first dose on day one with an option for a second dose on day five) compared to the previously studied dosing regimen of 200mg oritavancin given once daily for 3 to 7 days.


Eligibility criteria:
inclusion criteria * complicated skin and skin structure infection, presumed or proven to be caused by gram-positive pathogen(s). * patients, ages 18 years and older, must not be below normal body weight or morbidly obese. * female patients must not be pregnant at time of enrollment and must agree to a reliable method of birth control during the study and for 6 months following the last dose of study drug. exclusion criteria: patients: * with a condition which would prevent performing protocol safety and efficacy assessments. * who have received antibiotics for more than 24 hours within the last 3 days. * with an infection involving deep tissues or unlikely to be caused by gram positive bacteria * who are nursing and will not stop nursing for at least 6 months * with a prior allergic reaction to glycopeptides (e.g. vancomycin) * with any of the following: 1. toxic shock syndrome or toxic-like syndrome 2. presumed or proven infection caused by clostridium species 3. bone infections 4. ischemic or gangrenous ulcers or wounds 5. infections caused only by gram-negative bacteria 6. infection of an artificial joint that cannot be removed 7. infection of the scrotum, perineum or perianal region 8. infection of a severe burn wound 9. severe ear infection involving bone and/or cartilage 10. infection following injury in water possibly containing vibrio species or following a history of eating raw oysters within 1 week prior to disease onset
sanctura muscarinic receptor antagonist resists transport (smart-ii) trial

Conditions: Overactive Bladder

Summary: this study will evaluate the cerebrospinal fluid levels of trospium chloride (sanctura xr®) and oxybutynin immediate release (oxybutynin ir) on memory performance in patients with overactive bladder and age associated memory impairment.


Eligibility criteria:
inclusion criteria: * patient presents symptoms of overactive bladder * patient has age associated memory impairment * no acute or unstable medical conditions exclusion criteria: * history of alcohol or substance abuse within 1 year prior to study * has donated in excess of 500ml of blood or plasma in the 30 days prior to study * has known bleeding disorder (hemophilia) * previous abdominal bypass surgery for obesity
a study to assess the safety, pharmacokinetics, and antiviral activity of abi-5366 in healthy participants and participants seropositive for hsv-2 with recurrent genital herpes

Conditions: Recurrent Genital Herpes Simplex Type 2

Summary: this study is designed to assess safety, tolerability, and pharmacokinetics (pk) of single ascending dose (sad) of abi-5366 in part a in healthy participants and multiple-ascending doses (mad) of abi-5366 in part b in participants seropositive for herpes simplex virus type 2 (hsv-2) with recurrent genital herpes. effect of food will also be evaluated in part a.


Eligibility criteria:
part a: inclusion criteria: * subject has a body mass index (bmi) between ≥ 18.0 and \< 32.0 kg/m2 * in good health (as determined by the investigator) based on medical history, physical examination, ecg, and clinical laboratory results. * female subjects must be non-pregnant and have a negative serum pregnancy test at screening and a negative urine pregnancy test at day -1 or day 1 (predose) * agreement to comply with protocol-specified contraceptive requirements part b: inclusion criteria: * subject has a body mass index (bmi) between ≥ 18.0 and \< 32.0 kg/m2 * other than hsv infection, is in good health (as determined by the investigator) based on medical history, physical examination, ecg, and clinical laboratory results. * female subjects must be non-pregnant and have a negative serum pregnancy test at screening and a negative urine pregnancy test at day 1 (predose) * agreement to comply with protocol-specified contraceptive requirements part a and b: exclusion criteria: * current infection of human immunodeficiency virus (hiv), hepatitis b virus (hbv), hepatitis c virus (hcv), acute hepatitis a virus (hav), or acute hepatitis e virus (hev). * history of any illness that, in the opinion of the investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or a condition known to interfere with the absorption/distribution/elimination of drugs. * history of any significant drug-related allergic reactions such as anaphylaxis, stevens-johnson syndrome, urticaria, or multiple drug allergies * history of persistent alcohol abuse or illicit drug abuse within 3 years prior to screening * has participated in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 half-lives before screening, whichever is longer.

Keywords: abi-5366 pk healthy participants hsv-2 recurrent genital herpes
use of wharton jelly derived mesenchymal stem cells for knee osteoarthrosis

Conditions: Knee Osteoarthrosis

Summary: wharton jelly derived mesenchymal stem cells (wjmsc) will be injected in patients diagnosed with knee osteoarthrosis

ten patients from both genders diagnosed with knee osteoarthrosis, will be enrolled according to strict inclusion and exclusion criteria. these patients will be injected with wharton jelly derived mesenchymal stem cells. then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (mri) of the injected knee.

Eligibility criteria:
inclusion criteria: * severe koa stage iii or iv by laurance \& kellgren staging as judged by posterioranterior (pa) xray of the knee joint. * willing to participate by signing the informed consent exclusion criteria: 1. sublaxation beyond 20 degrees of the bones of the knee joint 2. oral anticoagulants or heparin therapy 3. heart failure or arrhythmia 4. body mass index \> 35 5. uncontrolled diabetes mellitus. 6. evidence of infectious diseases. 7. active infection 8. malignancy 9. pregnancy 10. anemia less than 11g/dl or thrombocytopenia less than 100,000 or leucopenia less than 3000. 11. unreliable patients 12. non-resident in jordan

Keywords: osteoarthrosis knee wharton jelly
targeting the hippo transducer taz in breast cancer with statins

Conditions: Breast Neoplasms

Summary: this pre-surgical, window-of-opportunity study is designed to investigate whether atorvastatin reduces the proliferation marker ki-67 via modulation of the hippo transducer taz.


Eligibility criteria:
inclusion: * signed written informed consent * female aged \>18 years and \<75 years at the time of the enrolment * histologically confirmed breast cancer (bc) independently on the intrinsic subtype * stage i-iia bc patients candidate for elective surgery * bc expressing ki-67 ≥ 15% and taz \> 10% in diagnostic core biopsies * adequate baseline organ function * negative pregnancy test exclusion: * previous systemic therapy including chemotherapy, hormone therapy and targeted agents * administration of an investigational drug prior to enrolment * history of another malignancy, except for a history of completely resected non-melanoma skin cancer or successfully treated cervical in situ carcinoma * eastern cooperative oncology group (ecog) performance status ≥2 * subjects who have current active hepatic or biliary disease (with exception of patients with gilbert's syndrome and asymptomatic gallstones) * serious cardiac illness or medical conditions including but not confined to: history of documented congestive heart failure (chf) or systolic dysfunction (lvef \ 180mm hg or diastolic \>100mm hg) * have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent) * current or recent therapy with statins for hypercholesterolemia or other lipid-lowering drugs * current or recent therapy with glucose-lowering drugs for diabetes * current or recent therapy with strong cyp3a4 inhibitors (e.g., clarithromycin, hiv protease inhibitors, itraconazole) given potential interactions with atorvastatin * current or recent therapy with gemfibrozil or other fibrates given potential interactions with atorvastatin. * patients who are pregnant or breastfeeding

Keywords: atorvastatin taz hippo pathway ki67
study of irofulven plus capecitabine in patients with advanced thyroid cancer

Conditions: Thyroid Cancer

Summary: irofulven is an investigational chemotherapeutic agent being studied in a variety of solid tumors. the purpose of this study is to assess the efficacy and safety of irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * cancer of the thyroid confirmed by a biopsy sample. specific types of thyroid cancer included in this study are anaplastic, differentiated (papillary, follicular, or hürthle cell), and medullary thyroid cancers. * for patients with differentiated (papillary, follicular, or hürthle cell) thyroid cancer, no more than 1 prior chemotherapy treatment is allowed. * measurable disease is required (at least one lesion at least 2 cm in length by conventional computed tomography (ct) techniques or at least 1 cm by spiral ct scan). * any prior chemotherapy or radiation therapy must be stopped at least 4 weeks before the first dose of study treatment. prior radioiodine (i131) therapy must be stopped at least 3 (or 6) months before first dose of study treatment (depending on responsiveness to this therapy). * recovery from any toxic effects of prior chemotherapy, radiation therapy and surgery. * patients with reproductive potential must use a medically acceptable contraceptive method. women of childbearing potential must have a negative pregnancy test at screening. exclusion criteria: * history of retinopathy. * serious ongoing medical or psychiatric disorder (as determined by the clinical investigator). * external beam radiation therapy to \>30% of the bone marrow at any time prior to study entry. * prior treatment with irofulven or capecitabine, or protracted infusion of 5-fluorouracil (5-fu) (infusion duration greater than or equal to 5 days) or other fluoropyrimidines. * therapeutic doses of coumarin derivatives (warfarin) 14 days prior to receiving the first dose of study treatment or during the study period. please note: there are additional criteria that must be met in order to be eligible for this study.

Keywords: irofulven, thyroid cancer
a study comparing skin fluorescence to coronary artery calcification

Conditions: Diabetes; Coronary Artery Calcification

Summary: this study examines the relationship between the scout dm device and coronary artery calcification as determined by rapid computed tomography in patients at risk for coronary heart disease.

this is a cross-sectional, single site, cohort screening trial. the correlation between the measured skin fluorescence and the cacs will be determined using a design that includes stratification by gender, subject age and subject cac score. this design requires a single patient visit to the clinical site and a single measurement on the scout device.

Eligibility criteria:
inclusion criteria: * males ≥ 45 years or females ≥ 50 years old that have had a coronary artery calcification score determined by rapid computed tomography at the clinical site within the last six months. exclusion criteria: * receiving investigational treatments * psychosocial issues that interfere with an ability to follow study procedures * known to be pregnant * receiving dialysis or having known renal compromise * scars, tattoos, rashes or other disruption/discoloration on the left volar forearm. * recent or current oral steroid therapy or topical steroids applied to the left forearm * current chemotherapy, or chemotherapy within the past 12 months * receiving medications that fluoresce\* * known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)

Keywords: coronary artery calcification
evaluation of the effects of different ventilation modes used during anesthesia awakening on the frequency of postoperative atelectasis

Conditions: Atelectasis, Postoperative Pulmonary

Summary: in our study, we aimed to detect atelectasis developing in patients undergoing surgery under general anesthesia using transthoracic lung ultrasonography and to investigate the effect of ventilation methods used during recovery from anesthesia on the formation of postoperative atelectasis.

postoperative atelectasis is one of the most common pulmonary complications seen in surgical patients. postoperative pulmonary complications and possible respiratory side effects have long been associated with anesthesia. pulmonary complications are an important cause of morbidity and mortality in the postoperative period. the incidence of postoperative pulmonary complications due to long-term anesthesia varies between 5% and 80%, depending on the patient population, the surgery performed, and the criteria used to define the complication. it is known that the recovery period makes a significant contribution to the total amount of postoperative atelectasis. spontaneously breathing patients are under the influence of anesthetic agents and neuromuscular blockers and cannot regain their functional residual capacity. for this reason, it is emphasized that atelectasis may develop in the postoperative period in cases whose anesthesia application is terminated by applying a spontaneous breathing period. pressure support ventilation (psv) is widely used for ventilator weaning in the intensive care unit (icu) and has recently been available on anesthesia machines. it is expected that the use of lung ultrasonography in operating rooms can reduce the complications that may develop in the postoperative period with evidence-based detection and early postoperative detection of atelectasis in the early postoperative period. in this study, it was aimed to compare the effect of pre-extubation ventilation mode applied by anesthesia practitioners with ultrasound in the postoperative period on the frequency of atelectasis in adult patients who underwent surgery and whose lungs were evaluated as normal by ultrasound in the preoperative observation room. modified lus scores were used as lung ultrasonography evaluation criteria in the study.

Eligibility criteria:
inclusion criteria: * patients undergoing general anesthesia with supine position * endotracheal intubations and mechanical ventilation during general anesthesia * operation time is more than 2 hours exclusion criteria: * patients who will undergo surgical intervention under emergency conditions * pregnancy * upper respiratory tract disease in the last 3 weeks * previous lung surgery * advanced cardiac and/or pleural lung disease and chest wall deformity, and primary or metastatic lung cancer

Keywords: lung ultrasonography atelectasis postoperative pulmonary complications pressure support ventilation