Kornimate/medical-research-clean huggingface dataset:
improving situational awareness before acute care

Conditions: Critical Illness; Trauma

Summary: this study aims to assess the impact on the trauma team's situational awareness of using a dashboard to synthesize and disseminate available information on a critical patient incoming to the trauma center.

this trial will be carried out at the grenoble alpes university hospital's simulation center. volunteer professionals will run scenarios simulating the information transmission chain "pre-hospital team - trauma leader - trauma team" just prior to the admission of a critical patient to the trauma center. in each scenario, the trauma leader will be alerted by phone that a patient is being managed by a pre-hospital medical team and is about to be transferred to the trauma center. the trauma leader will have to synthesize and disseminate the available information to the trauma team (composed of a junior physician, a resident and a nurse). depending on the allocation group, the transmission chain will be supported or not by a specific trauma dashboard. the scenario will be discontinued at the end of this handover and before the patient's arrival.

Eligibility criteria:
inclusion criteria: * physicians, residents and nurses from the grenoble alpes university hospital volunteering to participate. exclusion criteria: * prior knowledge of the study scenarios * study investigator

Keywords: simulation training non-technical skills data processing trauma team briefing situational awareness cognitive support
short term outcome of pediatric fracture of neck femur fixation by plate and screws

Conditions: Fracture of Pediatric Neck Femur

Summary: the incidence of femoral neck fracture in children ranges between 0.3 and 0.5 of all childhood fractures per year. the incidence is maximum at the ranges of 11 and 12 years with a male preponderance ranging from 1.3 to 1.7:1. in contrast to osteoprotic proximal femur fractures in the eldery. although rarely seen in children fracture neck of femur has aconsiderable risk of complications such as avascular necrosisos femoral head, coxa vara, non union, delayed union, premature physeal arrest and infection. in infants and toddlrs below age of 2 years, closed reduction and fixation with smooth 1.8 or 2 mm k wires may be carried out, in children there are many methods of fixation, cannulated 4,4.5 screws, plates,dynamic hip screw.

the incidence of femoral neck fracture in children ranges between 0.3 and 0.5 of all childhood fractures per year. the incidence is maximum at the ranges of 11 and 12 years with a male preponderance ranging from 1.3 to 1.7:1. in contrast to osteoprotic proximal femur fractures in the eldery. although rarely seen in children fracture neck of femur has aconsiderable risk of complications such as avascular necrosisos femoral head, coxa vara, non union, delayed union, premature physeal arrest and infection. in infants and toddlrs below age of 2 years, closed reduction and fixation with smooth 1.8 or 2 mm k wires may be carried out, in children there are many methods of fixation, cannulated 4,4.5 screws, plates,dynamic hip screw.

Eligibility criteria:
inclusion criteria: * children between 2 and 16 years having fracture of neck femur exclusion criteria: * patients more than 16 years, cases with open fractures, preexisting deformity, other pelvic or ipsilateral femoral injuries
gabapentin in functional dyspepsia refractory to proton pump inhibition

Conditions: Functional Dyspepsia

Summary: the purpose of this study is to evaluate the effectiveness of gabapentin on symptom control in patients with defined functional dyspepsia refractory to conventional proton pump inhibitor therapy and to compare these effects to that of placebo.

in this pilot study we hypothesize that the patients on gabapentin will have an increase in the adequacy of dyspepsia symptom control at two months as well as improvement in dyspepsia symptom index scores which are a surrogate of quality of life measures, when compared to placebo. while functional dyspepsia is divided into four subtypes most studies have grouped all four as 'functional dyspepsia' and treated them as one. proton pump inhibition may benefit those with epigastric pain or burning but typically not those with post-prandial fullness or early satiety. (tack et al). those patients with symptoms refractory to proton pump inhibition might benefit from a medication that modifies visceral hypersensitivity such as gabapentin. it is possible that by modifying their pain syndrome we can decrease the need for follow-up appointments and improve patient quality of life.

Eligibility criteria:
inclusion criteria: * patients to be included in this study are adults (age \>18 years) with defined functional dyspepsia per the rome iii criteria with a negative egd who are on proton pump inhibitor therapy yet still have a sense of inadequate symptom control. exclusion criteria: * patients excluded will be women of childbearing age who refuse to have a baseline pregnancy test and/or who refuse to prevent pregnancy during the trial period. exclusion criteria will also include anyone with a history of adverse effect or allergy to gabapentin. finally, any patient undergoing hemodialysis or with a history of creatinine chronically greater than 1.5 will be excluded.

Keywords: dyspepsia functional
single dose escalation study of pf-05190457 in healthy volunteers

Conditions: Diabetes Mellitus, Type II

Summary: pf-05190457 is a novel compound proposed for the treatment of type 2 diabetes mellitus. the purpose of the study is to evaluate the safety and tolerability of pf-05190457 after administration of a single dose to healthy volunteers and to evaluate the plasma drug concentrations after single dose in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy males and females (non-childbearing) between the ages of 18 and 55 with bmi of 17.5 to 30.5 kg/m2; and a total body weight between 50 kg (110 lbs) and 100 kg (220 lb) inclusive exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
lenalidomide based immunotherapy in the treatment of dlbcl

Conditions: Diffuse Large B Cell Lymphoma

Summary: this study is to evaluate the efficacy related molecular biomarker of lenalidomide plus rchop or rice in the treatment of de novo or refractory and relapsed dlbcl patients


Eligibility criteria:
inclusion criteria: histologically diagnosed as diffuse large b-cell lymphoma and may provide a desirable lymph node tissue sample (10 paraffin sections or rolls) or lymph node biopsy sample (15 paraffin sections or rolls) previously treated with lenalidomide plus rchop regimen in de novo dlbcl or lenalidomide plus rice regimen in relapse refractory dlbcl. no history of stem cell transplantation. written informed consent. exclusion criteria: chemotherapy or large field radiotherapy within 3 weeks prior to entering the study. clinically significant active infection. impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule. any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures. subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment. patients who are pregnant or breast-feeding. hiv infection.
paracetamol and glutathion

Conditions: Chronic Pain; Elderly

Summary: paracetamol is one of the most widely used analgesics in the world especially for chronic pain in the elderly. the metabolism of paracetamol occurs in the liver and involves the use of glutamyl-cysteinyl-glycine (glutathione (gsh)). medications such as paracetamol, may reduce the reserves of gsh because it is used for detoxification and elimination. it is well known that the concentration of gsh decrease after administration of paracetamol in humans and animals. aging is associated with decreased concentration of gsh in cells and tissues. in the elderly, a decrease of gsh concentration in plasma or red blood cells is associated with decreased physical and mental health. we wish here to determine, in subjects aged over 70 years, the blood concentration of glutathione (gsh) and urinary loss of cysteine in the detoxification of paracetamol, when taking paracetamol treatment repeated.

paracetamol is one of the most widely used analgesics in the world especially for chronic pain in the elderly. the metabolism of paracetamol occurs in the liver and involves the use of glutamyl-cysteinyl-glycine (glutathione (gsh)). medications such as paracetamol, may reduce the reserves of gsh because it is used for detoxification and elimination. it is well known that the concentration of gsh decrease after administration of paracetamol in humans and animals. aging is associated with decreased concentration of gsh in cells and tissues. in the elderly, a decrease of gsh concentration in plasma or red blood cells is associated with decreased physical and mental health. we wish here to determine, in subjects aged over 70 years, the blood concentration of glutathione (gsh) and urinary loss of cysteine in the detoxification of paracetamol, when taking paracetamol treatment repeated.

Eligibility criteria:
inclusion criteria: * elderly patients over 70 years and treated for over two weeks by oral paracetamol, 3 grams per day (doliprane ® 1000 mg) as part of their usual care. * male and female. exclusion criteria: * subject to compliance with the prescribed drug therapy is questionable. * subject taking the n-acetyl-cysteine. * renal or hepatic disease.

Keywords: glutathione paracetamol elderly people
a trial of tisotumab vedotin in cervical cancer

Conditions: Cervical Cancer

Summary: a single arm, multicenter, international trial of tisotumab vedotin (humax®-tf-adc) in previously treated, recurrent or metastatic cervical cancer.

the purpose of the trial is to evaluate the efficacy and safety/tolerability of tisotumab vedotin in patients with previously treated, recurrent or metastatic cervical cancer. tisotumab vedotin is an antibody-drug conjugate (adc) targeting tissue factor (tf), a protein aberrantly expressed in a wide number of tumors including cervical cancer. preliminary safety and efficacy data observed in a cohort of previously treated cervical cancer patients suggest a positive benefit risk profile for this population of high unmet need.

Eligibility criteria:
inclusion criteria * patients with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology who have experienced disease progressed on standard of care chemotherapy in combination with bevacizumab, if eligible. * measurable disease according to recist v1.1 as assessed by irc. * age ≥ 18 years. * acceptable renal function * acceptable liver function * acceptable hematological status * eastern cooperative oncology group (ecog) performance status of 0 or 1 * a negative serum pregnancy test for patients of reproductive potential. * all patients must provide a fresh or archival biopsy during screening. * following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out. exclusion criteria * have received no more than 2 prior systemic treatment regimens for recurrent or metastatic cervical cancer. * known past or current coagulation defects leading to an increased risk of bleeding; * ongoing major bleeding * active ocular surface disease * known past or current malignancy other than the inclusion diagnosis. * peripheral neuropathy grade ≥ 2
the effects of exercises on gait in hemophilic individuals

Conditions: Hemophilic Arthropathy

Summary: arthropathy characterized by synovitis, cartilage degeneration, subchondral and interosseous cysts occur due to hemorrhage in hemophilia. this situation causes to chronic pain, decreasing in range of motion, muscle strength, proprioception. disorders in these parameters are the main causes of gait dysfunction. the aim of this study is to investigate the effects of therapeutic exercises on target joint functions and gait kinematics, and to determine possible complications related to exercise in hemophilic patients.


Eligibility criteria:
inclusion criteria: * to be diagnosed as hemophilia a or hemophilia b * to be over 18 years old * to have hemophilic arthropathy in at least one joint * undergoing prophylaxis or factor viii-ix replacement therapy exclusion criteria: * having another congenital coagulopathy, such as von willebrand syndrome * to be unable to walk due to hemophilic arthropathy * having another musculoskeletal problem * individuals with inhibitors against factor viii-ix

Keywords: hemophilia exercise gait kinematic
a behavioral intervention to reduce sexual risk among african-american men who have sex with men

Conditions: HIV Infections

Summary: the purpose of this project is to test the efficacy of an hiv prevention behavioral intervention to reduce sexual risk among african-american men who have sex with men (msm).


Eligibility criteria:
inclusion criteria: identify as african-american, black, caribbean black or multiethnic black, report sex with men exclusion criteria: * participated in pilot * identify as transgender * plan to move before end of study * refuse hiv testing at baseline or identified as a newly diagnosed hiv through testing at the baseline * under 18 years of age

Keywords: hiv prevention african-american gay bisexual intervention trial hiv seronegativity
community paramedicine program to improve diabetes care quality, equity, and outcomes

Conditions: Diabetes; Diabetes Mellitus

Summary: the purpose of this study is evaluate the effectiveness of diabetes-rem (rescue, engagement, and management), a comprehensive community paramedic (cp) program to support adults in southeast minnesota (mower, freeborn, and olmsted counties) and northwest wisconsin (barron, rusk, and dunn) who have uncontrolled diabetes (hba1c ≥ 9%) and have experienced an emergency department (ed) visit or hospitalization for any cause in the prior 6 months.


Eligibility criteria:
inclusion criteria (patients): * most recent hemoglobin a1c ≥ 9% within the last 2 years. * age ≥ 18 years old. * type 1 or type 2 diabetes. * paneled to a mayo clinic or mayo clinic health system practice. * able to provide informed consent. * proficient in english. * community-dwelling. * live in southeast minnesota (mower, freeborn, or olmsted counties) or northwest wisconsin (barron, rusk, or dunn counties). inclusion criteria (paramedics): •community paramedics who delivered the diabetes-rem intervention. exclusion criteria: * cognitive impairment precluding informed consent. * lack of conversational english skills. * resident of a long-term care facility. * enrolled in hospice. * enrolled in a care coordination or disease management program. * advanced or terminal illness.

Keywords: community paramedicine diabetes mellitus diabetes distress
ph 2a study of hu6 on energy metabolism, muscle and liver substrate metabolism, and mitochondrial function in subjects who are overweight or obese with type 2 diabetes

Conditions: Diabete Type 2; Obesity

Summary: this is a randomized, double-blind, placebo-controlled parallel group study of hu6 and placebo in subjects who are overweight or obese with t2d. the study will be conducted in 4 stages.

this is a randomized, double-blind, placebo-controlled parallel group study of hu6 and placebo in subjects who are overweight or obese with t2d. the study will be conducted in 4 stages (figure 1). * stage 1: (screening) is conducted over a 29-day window (day -48 to day -20). subjects who meet all of the eligibility criteria may proceed stages 2 to 4 of the study. * stage 2 (baseline \[pre-randomization\]) is conducted over a 19-day period prior to randomization and includes a 13-day run-in and the first 6-day inpatient assessment period. at the end of stage 2, subjects will be randomized 1:1 to hu6 or placebo. * stage 3 (double-blind dosing) is conducted after randomization. day 1 is the first dose of double-blind study drug, and dosing continues over an approximate 26-week period. during this time, there will be study visits for safety, pk, and pd. stage 3 of the study concludes with a 3-day run-in followed by the second 6-day inpatient assessment period. * stage 4 (washout) is conducted after dosing has ended and includes an approximate 4-week washout duration including a 3-day run-in followed by the third inpatient assessment period (3-day duration). the last day of the 3-day inpatient stay is the end-of-study. (note that there will be a separate early termination visit for any subject who prematurely discontinues from the study

Eligibility criteria:
inclusion criteria: 1. able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure. 2. willing and able to comply with the requirements of the study protocol. 3. male or female 18 to 70 years of age, inclusive, at time of informed consent. 4. body mass index (bmi) \>28.0 kg/m2 and able to fit into the mri machine. 5. subject has t2d meeting all of the following criteria: exclusion criteria: 1. body weight \>450 pounds. 2. subject-reported history of weight gain or loss \>5% in 3 months prior to screening. 3. the subject participates in programmed exercise \>3 hours per week.
biofiber scaffold post-market observational study

Conditions: Full Thickness Rotator Cuff Tear

Summary: the aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for ce mark approval in the european union.

rhe biofibertm scaffold post-market surveillance study is a prospective, single arm, multi-center observational study with sites in the us and france.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * patients with full thickness rotator cuff tears (confirmed at time of surgery) that are eligible for rotator cuff repair. * patients willing and able to comply with the requirements of the study protocol and provide informed consent. exclusion criteria: * patients with active or latent infection * patients with decreased vascularity * patients with pathological soft tissue conditions * patients with a known allergy or sensitivity to tetracycline hydrochloride or kanamycin sulfate * patients with a known allergy or sensitivity to bovine collagen (biofiber-cm only) * participating in a concurrent study that has not been approved for concurrent enrollment by the clinical study manager
pilot study: combined molecular breast imaging/ultrasound system for diagnostic evaluation of mbi-detected lesions

Conditions: Breast Cancer

Summary: a combined molecular breast imaging / ultrasound system will enable coregistration of a functional abnormality seen on molecular breast imaging (mbi) with the corresponding anatomical abnormality seen on ultrasound.


Eligibility criteria:
inclusion criteria: * the pilot study will comprise 12 women age 40 and older who have at least one of the following inclusion criteria: 1. have a finding of a mass lesion on mammography or breast mri (birads 0, 4 or 5) that is \>0.5 cm and \< 2 cm in size and has had or will have additional workup with focused ultrasound. 2. have a finding of a mass lesion on ultrasound (birads 0, 4 or 5) that is \> 0.5 cm and \< 2 cm in size. 3. have a positive finding on mbi that is \< 2 cm in size and requires additional diagnostic workup with focused ultrasound. exclusion criteria: 1. are unable to understand and sign the consent form 2. are pregnant or lactating 3. are physically unable to sit upright and still for 40 minutes 4. have undergone bilateral mastectomy 5. are not scheduled to undergo conventional ultrasound

Keywords: breast cancer molecular breast imaging breast breast lesion
magnesium and dexmedetomidine in pheochromocytoma

Conditions: Phaeochromocytoma Crisis; Hemodynamic Instability

Summary: anesthesia management of pheochromocytoma excision surgery is associated with severe hemodynamic fluctuations.the objective of this study was to compare the hypertensive episodes requiring sodium nitroprusside administration between the group treated with magnesium-dexmedetomidine and conventional group in pheochromocytoma.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists classification (asa) 1-3 * high urinary catecholamine or metabolites * tumor sizes \< 5 cm * body mass index (bmi) \<35 kg/m2 exclusion criteria: * open surgery * bilateral masses * tumor larger than 5 cm * incomplete data

Keywords: magnesium dexmedetomidine nitroprusside pheochromocytoma
evaluation of serum prostatic specific antigen (psa) after cyproterone compound treatment compared with oral contraceptives pill in hirsute polycystic ovary syndrome patients

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to evaluate the effect of oral contraceptive on the serum free prostatic specific antigen (psa)in women with polycystic ovary syndrome(pcod)compared with cyproterone compound.

the purpose of this study is to evaluate the effect of oral contraceptive on the serum free prostatic specific antigen (psa)in women with polycystic ovary syndrome(pcod)compared with cyproterone compound. this randomized clinical trial included 60 polycystic ovary syndrome patients with hirsutism who were referred to infertility and reproductive health research center and governmental public educational hospital from feb2007 till dec 2007. polycystic ovary syndrome was defined as the diagnostic criteria of 2003 census rotterdam. hirsutism was defined as the presence of excessive hair in body and ferriman -gallway scores more than 7. women who received hormone therapy during the last 3 months, on a diet or herbal treatment were excluded from the study. the other exclusion criterion's consisted of hyperprolactinemia, thyroid disorders, ovarian tumors and cushing disease. hirsutism was determined by the ferriman-gallway score and recorded for every patient. blood samples for serum psa, and the hormonal profile including free testosterone, dehydroepiandrostenedione sulfate(dheas) and 17-hydroxyprogesterone(17-ohp) were taken at baseline and at the end of the treatment at the early follicular phase between 3th to 5th days of menstrual cycle at 8 am. patients were divided randomly in two treatment groups according to the computer based table. one group received oral contraceptive pills and the other one received cyproterone acetate combined ethinyl-estradiol(diane) for 3 months. hirsutism score was evaluated after treatment again. the blood samples were taken during the early follicular phase after 3 months of treatment to avoid pharmacological effect of treatment and serum psa, free testosterone, dheas,17-ohp were measured again. the university ethics committee approved the study and the informed consent was obtained from patients.

Eligibility criteria:
inclusion criteria: * pcos patients exclusion criteria: * women who received hormone therapy during the last 3 months, * on a diet * herbal treatment * hyperprolactinemia * thyroid disorders * ovarian tumors * cushing disease.

Keywords: psa pco pcos