Kornimate/medical-research-clean huggingface dataset:
clinical translation of 18f-labeled hydroxyphenethylguanidines

Conditions: Autonomic Peripheral Nervous System Diseases

Summary: the purpose of this study is to perform first-in-human pet imaging studies of two new cardiac sympathetic nerve imaging agents, 4-\[18f\]fluoro-meta-hydroxyphenethylguanidine (\[18f\]4f-mhpg) and 3-\[18f\]fluoro-para-hydroxyphenethylguanidine (\[18f\]3f-phpg).

in this study, pet imaging studies of two structurally related 18f-hydroxyphenethylguanidines, 4-\[18f\]fluoro-meta-hydroxyphenethylguanidine (\[18f\]4f-mhpg) and 3-\[18f\]fluoro-para-hydroxyphenethylguanidine (\[18f\]3f-phpg) will be performed. all studies will be performed in normal healthy volunteers. pet stands for positron emission tomography which is a type of imaging that uses a radioactive tracer. this is also called a radiotracer which is a compound linked to a radioactive element. most compounds are short-lived, meaning that the radioactivity breaks down quickly or is excreted from the body. in the first stage of the study, dynamic pet imaging for 90 min will be done with \[18f\]4f-mhpg (n = 4) and \[18f\]3f-phpg (n = 4). data from these studies will assess each radiotracer's imaging properties, pharmacokinetics and metabolic breakdown in plasma. application of tracer kinetic analysis methods to the kinetics of each tracer in heart and plasma will be studied to see if these methods can provide accurate measurements of regional nerve sympathetic nerve density in the hearts of human subjects. results from these initial studies will be used to select the lead compound for further studies in patient populations. in the second stage of the study, whole-body pet imaging studies (n = 4) with the selected lead radiotracer will be performed to acquire data necessary for generating more accurate human radiation absorbed dose estimates.

Eligibility criteria:
inclusion criteria: * non-obese (bmi \< 30) * normal blood pressure * normal blood lipid profile * no history of prior cardiovascular disease * not susceptible to claustrophobia * ability to lay flat for 90 min exclusion criteria: * obesity (bmi \> 30) * risk factors for heart disease (age \> 55y, hypertension, smoking, high blood pressure, high cholesterol levels, diabetes, etc.) * history of heart disease (heart attack, atrial fibrillation, ventricular tachycardia, exertional angina) * currently using certain medications that may interact with cardiac nerves (antidepressants, cold medications, nasal decongestants, monoamine oxidase inhibitors, etc.) * claustrophobia * inability to lie flat for 90 min * pregnant or breast feeding
ultrasound guided thoracic espb for post mastectomy pain control, comparing 2 dosing regimens of lidocaine with different drug volumes

Conditions: Analgesia

Summary: the investigators compare 2 different drug regimens using 2 different volumes of lidocaine with the same drug content (i.e. different concentrations) as regards efficacy of post operative analgesia following mastectomy surgery


Eligibility criteria:
inclusion criteria: * asa 2 \& 3 for elective breast cancer surgery exclusion criteria: * asa \> 3 * bmi \> 35 kg/m2 * contraindications to la (coagulopathy and local infection) * allergy to the drug * cardiac, hepatic and renal patients
neoadjuvant fdc with melatonin or metformin for locally advanced breast cancer.

Conditions: Breast Cancer

Summary: this study evaluates the addition melatonin and metformin to conventional chemotherapy fdc (fluoruracil, doxorubicin, cyclophosphamide) in the treatment of locally advanced breast cancer. third of patients will receive fdcх6 cycles, other third will receive combination of melatonin and fdcх6 cycles and other patients will receive combination of metformin and fdcх6 cycles.

the treatment of locally advanced breast cancer is a complicated issue. for neoadjuvant treatment is often needed to downstage locally advanced bc tumors prior to surgery, however many patients do not achieved objective response during treatment. the ability of melatonin and metformin to decrease side effects of chemotherapy had been investigated, moreover several studies confirm, that this drugs in combination with conventional treatment may increase objective response. but, this data is still controversial. we hypothesized that combinations of melatonin and conventional chemotherapy regimen such as fdc could be more effective than fdc alone in terms of response rate.

Eligibility criteria:
inclusion criteria: * age \>18. obtained inform consent morphologically confirmed breast cancer stage iib, iiia,iiib,iiic. ( triple negative, luminal b) eastern collaborative oncology group performance status scale 0 - 2. expected survival \>6 month adequate liver and bone marrow function exclusion criteria: * systemic treatment for breast cancer iv stage disease evidence of liver and bone marrow clinically meaningful disfunction severe uncontrolled concomitant conditions and diseases pregnancy or lactation second malignancy diabetes mellitus requiring drug therapy any condition preventing study participation by investigator opinion

Keywords: melatonin, metformin, chemotherapy
a pilot study of creative arts interventions for neurology inpatients

Conditions: Epilepsy; Migraine

Summary: the purpose of the study is to assess the feasibility of a creative artists program intervention with epilepsy and headache patients admitted to dartmouth-hitchcock medical center for care by the department of neurology.

qualifying patients admitted to epilepsy monitoring or headache treatment will be approached for participation in the study. patients who consent to the study will be given a chance to work with one of three creative artists (visual artist, creative writer, therapeutic musician). the artist will be selected according to a pre-determined schedule, and the arts intervention may last up to 90 minutes. subjects will be asked to complete study questionnaires before and after the arts intervention.

Eligibility criteria:
inclusion criteria: 1. age \> or = 18 years 2. diagnosis of refractory chronic epilepsy, status migrainosus, or chronic daily headache 3. elective admission to the dartmouth-hitchcock medical center epilepsy monitoring unit or headache service 4. capable of giving informed consent exclusion criteria: 1. active psychiatric illness that prohibits safe visitation by artists 2. impairment of vision or hearing that would prohibit able to participate with participation in instructions necessary for the interventions. 3. active general medical condition that would impair consciousness.
the relationship between intraoperative etco2 levels and postoperative pain and nausea-vomiting

Conditions: Pain, Postoperative; Nausea, Postoperative; Vomiting, Postoperative

Summary: the aim of our study is to investigate the relationship between intraoperative etco2 levels and postoperative nausea-vomiting and pain scores in patients undergoing robotic laparoscopic radical prostatectomy. the investigators will monitor patients' 24-hour postoperative pain, nausea-vomiting and the consumption of additional analgesic and antiemetic medications.

robotic surgery provides several advantages in the field of surgery, including a three-dimensional view of the surgical site, the elimination of surgeon hand tremors, and enhanced precision in movements. additionally, it offers benefits such as reduced intraoperative bleeding, faster return to daily functions for patients, and decreased hospitalization duration. consequently, the use of robots in various surgical procedures has become widespread in contemporary medical practice. robot-assisted laparoscopic radical prostatectomy is a surgical technique performed in a head-down trendelenburg position with intraperitoneal insufflation of carbon dioxide (co2). this positioning and pneumoperitoneum lead to an increase in intraabdominal pressure, as well as elevated intracranial and intraocular pressures. end-tidal carbon dioxide (etco2) levels can vary during laparoscopic surgery. an increase in etco2 levels has been reported to cause an elevation in intracranial pressure, leading to an increased incidence of postoperative nausea and vomiting. some studies in the literature have investigated the relationship between etco2 values and the incidence of postoperative nausea and vomiting in patients. furthermore, it is believed that hypercarbia (elevated carbon dioxide levels) may have an impact on postoperative pain. the aim of our study is to investigate the relationship between intraoperative etco2 levels and postoperative nausea, vomiting, and pain scores in patients undergoing robotic laparoscopic radical prostatectomy. the investigators will monitor patients' 24-hour postoperative pain, nausea, vomiting, and the consumption of additional analgesic and antiemetic medications.

Eligibility criteria:
inclusion criteria: 1. individuals between the ages of 18 and 80. 2. patients with american society of anesthesiologists (asa) scores i, ii, or iii. 3. patients who have undergone robotic laparoscopic prostatectomy in the operating room. exclusion criteria: 1. patients under 18 years old or over 80 years old. 2. patients with american society of anesthesiologists (asa) scores iv and above. 3. patients who refuse to participate in the study. 4. patients undergoing emergency surgery.

Keywords: end-tidal carbon dioxide laparoscopic robotic prostatectomy
opioid sparing effect of an isp nerve block on post-op pain control in posterior cervical spine surgery

Conditions: Pain, Postoperative

Summary: participants who have a surgical procedure called posterior cervical (neck) spine surgery will normally need pain medication to relieve post operative pain. this usually includes opioid medications. in this study, the consented participant may receive a nerve block procedure, in addition to the pain relieving medication. there is a fifty-fifty chance to receive the nerve block. the goal is to see if the nerve block group needs less opioid medication, has lower pain scores and is discharged from the hospital sooner.

the purpose of this research study is to evaluate the opioid-sparing effect of the use of an inter-semispinalis plane (isp) block after posterior cervical spine surgery. posterior cervical fusion (pcf) is a painful procedure that often requires the use of high doses of opioids to minimize postoperative pain. uncontrolled pain can result in a delay in recovery and discharge. additionally, high doses of opioids carry the risk of opioid dependence, and other side effects, include nausea, vomiting, sedation, and, in rare cases, respiratory depression. for all of the above reasons, reducing the use of opioids is of utmost importance. nerve blocks are one alternative to opioid use. the isp block is a procedure described in 2017; it is a relatively simple procedure that entails injecting local anesthetic between two muscles in the back of the neck, bilaterally, to block the nerves that run in this plane. it is done under ultrasound guidance and, although a limited number of studies have shown promise, more data on its safety and efficacy are needed. the addition of dexamethasone to local anesthetics, in nerve blocks, resulted in significant prolongation of the analgesia.

Eligibility criteria:
inclusion criteria: * having posterior cervical spine surgery from c2 - c7, which may extend to the upper thoracic vertebrae, inclusive to t3. * capacity to provide informed consent exclusion criteria: * fusion and decompression due to trauma * emergent procedures * patient is on a medication-assisted treatment, e.g., buprenorphine, naltrexone or methadone. * there is an infection near or in the area of neck where the block will be placed. * the patient is having a complicated surgery or a revision surgery * female patient with a positive pregnancy test on the day of surgery (hospital standard-of-care). * patient has diabetes * patients who have had a prior adverse reaction to bupivacaine or dexamethasone * patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia

Keywords: cervical fusion opioids
hsv-2 suppression to reduce maternal hiv-1 rna levels during pregnancy and breastfeeding

Conditions: HIV Infections; Herpes Simplex

Summary: in this study, we will determine whether treating pregnant and breastfeeding women co-infected with human immunodeficiency virus type 1 (hiv-1) and herpes simplex virus type 2 (hsv-2) with daily valacyclovir will reduce hiv-1 levels in plasma, genital, and breast milk and will decrease the risk of mother-to-child hiv-1 transmission (mtct).

each year over 500,000 children become hiv-1-infected in sub-saharan africa after exposure to maternal virus in blood, genital secretions, and breast milk. identifying feasible, safe, and affordable interventions that prevent mother-to-child transmission remains a priority for hiv-1 prevention research. interventions to reduce breast milk hiv-1 transmission are lacking and most urgently needed. we propose a randomized clinical trial to determine whether incorporating hsv-2 suppression with valacyclovir into standard prevention of mother-to-child hiv-1 transmission regimens will reduce plasma, cervical, and breast milk hiv-1 rna levels and risk of transmission among hiv-1-infected and hsv-2-seropositive women. we plan to enroll a total of 148 hiv-1 and hsv-2 co-infected pregnant women with cd4\>200 cells/μl who seek antenatal care prior to 32 weeks gestation at a clinic in nairobi, kenya. women will be randomized to receive either valacyclovir suppressive therapy or placebo at 34 weeks gestation and mother-infant pairs will be followed for 12 months postpartum. follow-up visits will be scheduled at 38 weeks gestation; birth; 2, 6, 10 and 14 weeks; and 6, 9, and 12 months postpartum. maternal blood, genital, and breast milk specimens obtained at follow-up visits will be used to determine the effect of valacyclovir suppressive therapy on plasma and breast milk hiv-1 rna levels. infant filter paper specimens for hiv-1 dna assays will be collected at birth; 2, 6, 10 and 14 weeks; and 6, 9, and 12 months in order to compare the proportion of infants acquiring hiv-1 by 12 months in the two study arms and determine the timing of hiv-1 infection. in addition, we will monitor maternal and infant renal function in preparation for a larger randomized clinical trial in africa. the results of this study will help guide the design of a multi-site clinical trial with adequate power to determine the effect of hsv-2 suppression on vertical (mtct) transmission of hiv-1 infection.

Eligibility criteria:
inclusion criteria: * hiv-1 seropositive * hsv-2 seropositive * plans to deliver in nairobi * resides and plans to remain in nairobi for 12 months postpartum * 18 years of age or older * cd4 count\>250 cells/μl exclusion criteria: * indication for highly active antiretroviral therapy (e.g., who stage iii or iv) * hypersensitivity to valacyclovir or acyclovir

Keywords: disease transmission, vertical valacyclovir randomized controlled trials hiv herpes herpesvirus 2, human hiv seronegativity
the sourt out iv trial

Conditions: Ischemic Heart Disease; Coronary Atherosclerosis; Percutaneous Coronary Intervention

Summary: in a randomized study the xience v coroary artery stent may be non inferior to the cypher select+ coronary stents in the treatment of unselected patients with coronary artery disease.

2 purpose in a randomized study to compare the cypher select+ and the xience v coronary stents in the treatment of unselected patients with coronary artery disease. 2.1 primary objective in a randomized study to compare the xience v and the cypher select+ coronary stents by assessing safety (cardiac death, myocardial infarction and/or stent thrombosis) and efficacy (target vessel revascularization) after 9 months. 2.2 secondary objective to compare device success rate, procedure success rate and complication rate during hospitalization, after 1 month and after 9 months and the incidence of late stent thrombosis after 12, 24 and 36 months.

Eligibility criteria:
inclusion criteria: * all patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centres in denmark (gentofte, rigshospitalet, odense, skejby, aalborg) can be included in the study. exclusion criteria: * the patient will not participate * the patient participates in other randomised stent studies * expected survival \< 1 year * allergy to aspirin, clopidogrel or ticlopidine * allergy to sirolimus or abt-578

Keywords: pci drug-eluting stent
endoscopic treatment of difficult bile duct stones: spyglass + ehl x balloon dilation of the papilla

Conditions: Common Bile Duct Gallstones; Choledocholithiasis

Summary: this study compare 2 techniques to treat difficult bile duct stones endoscopically

before enrollment of the patients into the study, the two investigators, eghm and tapf, will perform 10 complete cases each of ercp (endoscopic retrograde cholangiopancreatography) + spyglass + ehl, to get more experience with the methods. this will be a comparative study of methods, prospective, randomized study assessing the successful removal of bile duct stones considered to be difficult between the two proposed methods. a total of 100 patients will be recruited, according to the criteria for inclusion / exclusion of appendix i. randomization will be performed using a computer generated system. fifty patients will be distributed in group 1 (spyglass + electrohydraulic lithotripsy) and fifty in group 2 (with hydrostatic balloon dilation of the papilla with a extractor balloon sweep). endoscopic retrograde cholangiopancreatography (ercp) will be performed, and after the diagnosis of difficult stone, will be followed by randomization between the two proposed methods. in group 1, the examination with the direct visualization system of bile ducts ("spyglass direct visualization system") will be held soon after the diagnosis of difficult stone and partial endoscopic papillotomy. after access to the biliary duct with the system described, and the visualization of the stone, it will be introduced gently through the working channel of a spyglass the probe to perform the electrohydraulic lithotripsy. when the fragmentation is complete the system spyglass will be removed and the pieces of stone are removed by conventional endoscopic methods. in group 2, after the diagnosis of difficult calculi and performing the partial endoscopic papillotomy, the papilla (as with papillotomy) will be dilated with a hydrostatic balloon until the maximum size allowed by the diameter of common bile duct, followed by scanning with extractor balloon. in both groups, the stone clearance will be confirmed using spyglass cholangioscopic exploration of the bile duct. in case of failure in stone removal by some of the methods studied, it will be performed biliary drainage with plastic stent.

Eligibility criteria:
inclusion criteria: * over 18 years * able to give consent * submitted to the examination of endoscopic retrograde cholangiopancreatography (ercp), with identification of stones in the bile duct considered difficult. * agreed and signed the term of consent. exclusion criteria: * age below 18 years * incapable of giving consent * pregnant * gastrointestinal bypass surgery with previous reconstructions as a billroth ii or roux-en-y * patients with signs of severe acute cholangitis requiring biliary drainage with fast plastic stent and minimal or no contrast infusion * patients with previous liver transplantation
clinical trial, open-label, randomised, in order to compare the quality of life for those vih+ patients that start with monotherapy on lpv/r tablets vs. triple therapy with a boosted protease inhibitor

Conditions: HIV Infection

Summary: the study will help to compare the quality of life for those hiv patients that are on monotherapy with lpv/r vs. triple therapy with a boosted protease inhibitor

the study will help to compare the quality of life for those hiv patients that are on monotherapy with lpv/r vs. triple therapy with a boosted protease inhibitor.

Eligibility criteria:
inclusion criteria: * patients infected with hiv-1, documented with a positive hiv-1 antibodies test and/or positive pcr confirmed for hiv-1 rna. * patients on triple antiretroviral therapy with any boosted protease inhibitor. * patients with an undetectable viral load, which will be defined as \<50 viral rna copies/ml within the last six months. * men or women aged≥18. * for women with childbearing potential, negative urine pregnancy test during the screening visit. * patients who would have granted a written informed consent prior to any study-specific screening procedure. exclusion criteria: * patients with a written proof of resistance in the accumulated genotype, which would lead to a sensibility loss to lopinavir/ritonavir, or, in case of genotype absence, a documented failure to a protease inhibitor therapy. * patients with a cd4 cells nadir cd4 \<100 cell/microl. * patients who, for any reason, could not be treated with lopinavir/ritonavir. * prior medical history of psychiatric disorders, such as depressive syndrome, schizophrenia or psychotic disease. * known previous medical history of drug abuse/addiction or alcohol chronic consumption, which in the investigator's opinion, would be incompatible with his/her study participation. * pregnant or breastfeeding women, or women of childbearing potential who do not use an appropriate contraceptive method, according to the investigator's opinion. * documented past(within four weeks prior to screening) or active current opportunistic infection. * patients who, due to severe toxicities related to any of their current haart compounds, there is a planned discontinuation or modification concerning any of the drugs from their triple therapy. * patients for which, according to the investigator, will have to change their haart, regardless of the reason, within the next six months. * renal disease with creatinine clearance \<60 ml/min. * concomitant use of lopinavir/ritonavir contraindicated drugs, such as rifampicin, dihydroergotamine, ergotamine, methylergonovine, cisapride, hypericum perforatum, lovastatin, simvastatin, pimozide, midazolam and triazolam. * concomitant use of nephrotoxic or immunosuppressor drugs. * patients currently treated with systemic corticosteroids, interleukine-2 or chemotherapy. * patients treated with other investigative medical product. * patients with acute hepatitis. * any disease or condition that, according to the investigator, would be incompatible with the patient's participation in the study.