Kornimate/medical-research-clean huggingface dataset:
pancreas-sparing duodenectomy versus pancreatoduodenectomy for early-stage periampullary carcinoma

Conditions: Periampullary Carcinoma Nos

Summary: the purpose of this study is to investigate the feasibility, safety, and long-term prognosis of pancreas-sparing duodenectomy with regional lymphadenectomy in the treatment of early-stage (ptis/pt1/pt2) periampullary carcinoma with or without lymph node metastasis

pancreaticoduodenectomy (pd) is commonly used for periampullary carcinoma (pc). in recent years, morbidity and mortality rates following pd have decreased, but the operative stress induced by pancreatectomy is considerable. less-invasive surgery should thus be elected for pc without pancreatic and diffuse lymph node involvement. from the perspective of organ-preserving resection, pancreas-sparing duodenectomy (psd) represents an attractive option for selected periampullary tumors, and offers an alternative to pd. previous reports have described psd for benign, premalignant and some selected malignant conditions of duodenum, and have emphasized this procedure as a safe and effective treatment associated with good quality of life. however, use of psd for pc is still controversial.available data about psd for pc and published data from the follow-up evaluation in the literature are still limited. given the fact that 20%-60% pt1/pt2 patients have regional lymph node metastasis, regional lymph node dissection should be essential for pc. however, lymphadenectomy has never been promoted as a regular procedure of psd.the aim of the present study was to investigate the feasibility, safety, and long-term results of psd with regional lymphadenectomy for early-stage (ptis/pt1/pt2) periampullary cancers.

Eligibility criteria:
inclusion criteria: * pathologically proven periampullary carcinoma (including cancers of distal common bile duct, ampulla or papilla of vater) * pre- and intra-operative stage(ct, eu stage):ptis or pt1 or pt2, n0 or n1, m0 * asa score: \< 3 * liver function:child-pugh a * no history of other cancers * no history of preoperative chemotherapy or radiotherapy * written informed consent exclusion criteria: * there are concurrent cancers or the patients have been treated due to other type of cancers before diagnosed as periampullary carcinoma * pre- and intra-operative stage: more advanced than t2,or with remote metastasis * the patients received other non-surgical therapy, such as chemotherapy, immunotherapy, radiotherapy or endoscopic therapy * the patients received upper abdominal surgery * asa score: ≥ 3 * liver function:child-pugh b or c * pregnancy patients

Keywords: periampullary carcinoma pancreas-sparing duodenectomy pancreaticoduodenectomy lymphadenectomy
motor parameters in patients with limb girdle muscular dystrophy

Conditions: Limb Girdle Muscular Dystrophies

Summary: the primary objective of the study is to perform 2-year follow up with motor parameters evolution using instrumental assessments in patients with limb girdle muscular dystrophie, and to identify which motor parameters are sensitive to change. the secondary objectives of the study are: * to describe the changes of the parameters obtained from instrumental evaluations in comparison with the changes obtained from clinical assessments. * to characterize the muscular impairments, the biomechanical gait disorders, the standing postural control disorders, the biomechanical upper limb disorders in spatial exploration, the limitation of upper limb capacities, the fatigue, the endurance, the patients' participation to their activities and their quality of life, in comparison with a healthy paired population. * to highlight the relationships between muscular assessment parameters, biomechanical gait parameters, standing posture control and upper limb spatial exploration. * to highlight the relationships between data from instrumental assessments and data from clinical assessments. * to highlight the relationships between instrumental assessments data and clinical assessments data on one side, and features of patients (age, sex, duration since diagnosis, type of lgmd, rehabilitation in follow-up, sportive practices...) on the other side.

this is a monocentric study in which 2 sub-groups of people will be enrolled: lgmd patients and healthy volunteers. each enrolled lgmd patient will have 5 visits during 2 years, one baseline visit and four half-yearly visits. each enrolled healthy volunteer will have one planned visit only. the duration of enrollments will last 20 months.

Eligibility criteria:
inclusion criteria: * for limb girdle muscular dystrophie group: * patients diagnosed limb girdle muscular dystrophie; * aged between 18 and 70 years; * covered by the french social security scheme; * patient able to maintain upright position alone; * able to walk at least 10 meters and 6 minutes consecutively without help. * for volunteer group: * adult (18 to 70 years) without neuromuscular or squeletic disorder. exclusion criteria: § for all: * without associated neuromuscular disorders such as respiratory or muscular-squeletic diseases, apart from the consequences of dystrophy; * contraindication to the tests; * noncontrol cardiac rhythm disorders; * lying down position intolerance due to severe respiratory troubles; * pregnant or breastfeeding woman.

Keywords: limb girdle muscular dystrophies (lgmd) motricity instrumental assessment
observational study on predictors of response to invirase (saquinavir) treatment in treatment-naïve patients with hiv infection

Conditions: HIV Infections

Summary: this prospective observational study will evaluate predictors of response to invirase (saquinavir) treatment in treatment-naïve patients with hiv infection. data will be collected during 48 weeks of treatment.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * hiv infection * treatment-naïve * initiation of treatment with invirase exclusion criteria: * contraindications according to invirase summary of product characteristics
control of epistaxis with surgiflo

Conditions: Epistaxis

Summary: this is a blind trial to test if surgiflo is effective in posterior epistaxis. after the investigators see than anterior tamponade is not effective stopping epistaxis, the investigators try using surgiflo and if it does not work the investigators continue with a nasal catheter. this is the usual way to stop nasal bleeding, but is painful and has serious after-effects in the nose. surgiflo is a hemostatic matrix that can be put into the nose, painlessly and easily. so the investigators think it can be useful controlling nasal bleeding, so the investigators could avoid to put nasal catheters in these patients.

epistaxis is one of the most frequent diseases in otolaryngology emergencies. most of them are anterior and stop with an anterior packing. some of them does not stop with this, therefore the investigators have to put into the nose a catheter balloon. this is very painful and has many after-effects in the nose. surgiflo is a haemostatic matrix used for bleeding. the investigators have design a trial to know if some people can benefit from surgiflo instead to put a nasal catheter. this a randomized trial with two arms. in one arm the investigators will put surgiflo and not in the other.the patient will be admitted to the hospital. the investigators will see the difference in the hospital staying and in the effects in the nose, including discomfort or pain. the investigators will report age, gender, other diseases or treatments of the patients,type and length of bleeding, transfusions needed, arterial tension, coagulation. to do that the investigators will make hematological tests for haemoglobin and coagulation. to know the discomfort of the device the investigators will give the patient an analog visual scale in the moment the investigators will put the device, the day after and in any of the next visits. the patient can go home again after 16h without bleeding and the investigators will see the patient again in the office after 15 days, 1, 3 and 6 months. all the patients will receive the same analgesic protocol so the investigators can compare the discomfort. the investigators have make statistic analysis, and they will need 24 patients for this trial. the investigators will need 2 years, approximately, to recruit them.

Eligibility criteria:
inclusion criteria: * patients with epistaxis in emergency room. * epistaxis does not stop with anterior nasal packing. exclusion criteria: * pregnancy * allergy or intolerance to any component of surgiflo. * septal perforation. * nasal surgery within 3 months previous to epistaxis. * patients admitted to hospital for other reasons.

Keywords: nasal packing haemostatic matrix epistaxis control
dignity therapy+: a brief psychological and existential intervention for dying patients and their families.

Conditions: Palliative Care

Summary: background: there has been significant progress in symptom management, pain relief and improvement of quality of life in patients nearing death by implementing palliative care programs. existential and dignity related issues, such as loss of autonomy and sense of meaning or feeling a burden to others are frequent reasons for psychological distress and desire for hastened death. dignity therapy (dt), developed by chochinov et al., is a brief, individualized psychotherapy for the purpose of relieving distress by directly addressing dignity conserving factors. aims: to test whether the inclusion of a patient's partner or designated family member into dignity therapy (dt+) could mitigate psychological distress (anxiety and depression) in both, the patient nearing the end of his life experiencing increased psychological distress and the patient's partner/family member compared to the control groups receiving dignity therapy in the single setting (dt) or standard palliative care (spc). methods and design: in this randomized controlled trial a total of 159 patients with a diagnosis of an advanced disease and poor prognosis (life expectancy \< 6 months) who receive palliative care either in the palliative care centre of the university hospital zurich (usz) or the clinic susenberg, zurich, or in the "lighthouse" hospice zurich, will be randomly assigned to either dt+, dt, or spc in a 1:1:1 ratio. patients will be pre-screened and included if they report increased psychological distress (anxiety, depression using the hospital anxiety and depression scale=hads). the therapy is guided by trained therapists and consists of 3 audiotaped sessions. the main focus of the intervention is to invite patients to reflect on their most important achievements, roles or other things in their lives or things that they would most want remembered. on completion, the audiorecording is transcribed and edited to provide a clear and readable narrative, the generativity document, which can be passed to a person of the patient's choice. dt+, in contrast to the original intervention developed by chochinov et al., is a systemic approach in which patient's partners or designated family members are included.


Eligibility criteria:
inclusion criteria: * informed consent * diagnosis of advanced cancer and life expectancy \< 6 months * receiving palliative care at the palliative care centre or oncological wards at the university hospital zurich, the susenberg clinic, or zurich 'lighthouse' hospice * ≥ 18 years of age * hads score ≥ 8 exclusion criteria: * delirious (icd-10: f05.9) * cognitively impaired * too ill to complete the requirements of the protocol * unable to speak and read german

Keywords: dignity, end of life, existential, treatment
caffeine versus placebo for spinal headaches

Conditions: Post Dural Puncture Headache

Summary: caffeine will be studied against placebo in patients with positional headache after a lumbar puncture (aka "spinal headache").

pain will be assessed at set intervals using a visual analog scale. blood patch therapy will be offered to all those still in pain at the end of one hour after drug administration.

Eligibility criteria:
inclusion criteria: * diagnosed with post dural puncture headache exclusion criteria: * age \< 18 * pregnant * allergic to caffeine * cardiac or peripheral vascular disease * uncontrolled hypertension

Keywords: headache caffeine pain
pet imaging and bariatric surgery

Conditions: Obesity, Morbid

Summary: the purpose of this study is to look at certain areas of the brain that are related to addictive behaviors, such as overeating. these areas are called 'dopamine type 2 receptors' (drd2/3) and other studies have shown that obese people have less of these. we propose that low drd2/3 availability seen in morbidly obese subjects will change with weight loss associated with bariatric surgery.

the purpose of this study is to look at certain areas of the brain that are related to addictive behaviors, such as overeating. these areas are called 'dopamine type 2 receptors' (drd2/3) and other studies have shown that obese people have less of these. we propose that low drd2/3 availability seen in morbidly obese subjects will change with weight loss associated with bariatric surgery.

Eligibility criteria:
inclusion criteria: * ages 18-60 years * bmi equal to or greater than 40, or equal to or greater than 35 if there are 2 or more co-morbidities * weight less than 350 pounds exclusion criteria: * history of substance abuse,including but not limited to alcohol, cocaine, marijuana, heroin, nicotine * history of psychiatric disorders * use of any antidepressants or psychotropics in the past 12 months * diabetes mellitis * positive pregnancy test * any condition felt by the pi or co-investigators to interfere with the individual's ability to complete the study * subjects on medications for the last 3 months, such as sibutramine, which could affect the quality of the study, as determined by the pi * inability to travel to nashville, tn four times

Keywords: obesity addiction pet imaging
eus-guided celiac plexus neurolysis for the treatment of abdominal pain in pancreatic cancer

Conditions: Pancreatic Cancer

Summary: studies have shown that injecting local anesthetics in areas rich in blood vessels increases the risk of drug injection into blood vessels by mistake and increases the systemic absorption of drugs, which may increase the incidence of central nervous system and cardiovascular system toxic events caused by local anesthetics.eus-cpn-related complications have not been clearly associated with local anesthetic adverse events.however, eus-cpn local anesthetic injection area is located around the beginning of the abdominal trunk with abundant large and small blood vessels. the choice of local anesthetics with higher safety than bupivacaine, such as ropivacaine, is of great significance to ensure the safety of eus-cpn, especially for eus-cpn beginners.at present, there are no reports on the application of ropivacaine in eus-cpn.


Eligibility criteria:
inclusion criteria: 1. aged between 18-75; 2. athologically confirmed as pancreatic cancer and clinically evaluated as advanced and unresectable; 3. the visual analogue scale (vas) for pain ≥ 4； 4. never received treatment for peritoneal plexus lesion or block； 5. voluntary signing of written informed consent exclusion criteria: 1. women during pregnancy； 2. cannot or refuses to sign the informed consent； 3. blood clotting disorder（plt \ 1.5）； 4. celiac infection； 5. severe esophageal or gastric varices and ulcers which may affect operation; 6. the anatomical variation of the abdominal trunk abdominal aorta and could not be accurately located; 7. alcohol allergy 8. severe cardiopulmonary dysfunction and inability to tolerate the risk of intravenous anesthesia; 9. history of mental illness; 10. patients with other chronic and acute diseases with unstable conditions that are expected to affect the efficacy evaluation and completion of the study.

Keywords: eus-guided cpn
a study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in patients with chronic plaque psoriasis

Conditions: Chronic Plaque Psoriasis

Summary: this is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis


Eligibility criteria:
inclusion criteria: * subject has provided informed consent * subject completes all dosing requirements in feeder study and completes ps0010 study without meeting any withdrawal criteria * female subjects of childbearing potential and male subjects with a partner of childbearing potential must continue to use an acceptable method of contraception (as detailed in ps0010) for up to 20 weeks after the last dose of study treatment in ps0011 exclusion criteria: * subject has previously participated in this study. * female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication. male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose * subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study. * subject must have a negative interferon gamma release assay (igra) as measured at week 8 of ps0010

Keywords: chronic plaque psoriasis psoriasis bimekizumab
ketamine for the rapid treatment of major depressive disorder and alcohol use disorder

Conditions: Major Depressive Disorder; Alcohol Use Disorder

Summary: the investigators will compare 3 treatment groups (ketamine plus naltrexone vs. ketamine alone vs. placebo) for treating major depressive disorder (mdd) and alcohol use disorder (aud) in an 8-week randomized, double-blind, placebo-controlled, between-subjects trial. first, prior to the double-blind trial, the investigators will conduct an open-label trial that will include 5 patients with comorbid mdd and aud to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a total of 4 ketamine infusions) with a follow-up of 4 weeks. second, after reviewing the safety and efficacy of repeated ketamine treatment from the open-label trial, the investigators will conduct an 8-week, randomized, double-blind, placebo-controlled trial that will include 60 patients with comorbid mdd and aud to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a total of 4 ketamine infusions) plus naltrexone with a follow-up of 4 weeks. the 4-month follow-up session will also occur.


Eligibility criteria:
inclusion criteria: * male or female veterans and civilians, 21-65 years old * current major depressive disorder without psychotic features by dsm-5 (antidepressant regimens can be allowed and changed during the trial) * montgomery-asberg depression rating scale (madrs) 20 or higher * a minimum of 4 of 11 current alcohol use disorder symptoms by dsm-5 * heavy drinking at least 4 times in the past month ('heavy drinking' defined as 5 standard drinks per day for men and 4 standard drinks per day for women * able to provide written informed consent exclusion criteria: * current substance use disorder by dsm-5 in the past 3 months (except alcohol, tobacco, or cannabis) * current or past history of psychotic features or psychotic disorder * current dementia * current uncontrolled hypertension (systolic bp \> 170 mm hg or diastolic bp \> 100 mm hg) * unstable medical condition or allergy to ketamine, midazolam, naltrexone, or lorazepam---clinically determined by a physician * imminent suicidal or homicidal risk * pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential * positive opioid or illicit drug screen test (except marijuana) * opioid use within 10 days prior to study medication (injectable naltrexone) or risks for opioid use during the study * liver enzymes that are three times higher than the upper limit of normal * current use of benzodiazepine * acute narrow-angle glaucoma * severe sleep apnea---clinically determined by a physician
evaluation of the safety and efficacy of insulin glargine 300 u/ml (gla-300) in insulin-naïve patients with type 2 diabetes mellitus uncontrolled on oral antihyperglycemic drugs

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to evaluate the safety of gla-300 in insulin naïve t2d participants uncontrolled on oral antihyperglycemic drugs secondary objective: to assess the efficacy of gla-300 on glycemic control in insulin naïve t2d participants uncontrolled on oral anti-hyperglycemic drugs to assess change in participant's treatment satisfaction using dtsqs (diabetes treatment satisfaction questionnaire)

the maximum study duration per participant is 27 weeks including a screening period of up to 2 weeks, a 24-week treatment period and a post-treatment follow-up phone call visit after 3 days after the end of treatment.

Eligibility criteria:
inclusion criteria : * participants with type 2 diabetes mellitus * participants who are insulin naïve on at least one oral antihyperglycemic drug (metformin,sulfonylurea, thiazolidinedione, dpp-4 inhibitor, sglt-2 inhibitor, glinide, α-glucosidase inhibitor) with or without glucagon-like peptide 1 receptor agonists (glp-1 ras) for a minimum period of 6 months prior to screening. * hba1c between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening. exclusion criteria: * history of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit. * proliferative retinopathy or maculopathy requiring treatment according to the investigator * treatment with any insulin including basal insulin, mixed insulin (premixes), rapid insulin, and fast-acting insulin analogues in the last 6 months before screening visit (use ≤10 days in relation to hospitalization or an acute illness is accepted). * use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
use of a dual-agent local analgesic (bupivacaine-meloxicam) for abdominal incisions in patients undergoing retropubic mid-urethral sling surgery

Conditions: Stress Urinary Incontinence; Surgical Incision; Pain Vulva

Summary: this study will compare the use of a dual-agent local analgesic (bupivacaine-meloxicam) for abdominal incisions in patients undergoing retropubic mid-urethral sling surgery to see if narcotic usage and pain are impacted.


Eligibility criteria:
inclusion criteria: * undergoing retropubic mid-urethral sling surgery (with concomitant anterior repair or urethrocele repair) * english as first language exclusion criteria: * patients undergoing concomitant posterior repair, vaginal vault suspension, or any other intra-peritoneal surgeries including hysterectomy * nsaid use within 7 days of surgery * steroid use within 10 days * daily opioid use in the last 3 months * long acting opioids within 3 days * any opioids within 24h * patients unable to consent for themselves * patients allergic to meloxicam or bupivacaine * pregnant or lactating patients